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Fluoride: The Ultimate Cluster Flux Folder 3B

Fluoride: The Ultimate Cluster Flux Folder 3B

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Published by violakitty4124
Information on fluoride and those associated with it. This folder contains mostly information on phosphates, toxic waste.
This collection is dedicated to those who wrote the original works and
made them available on the internet. I have spent countless hours
searching for information on fluoride and it is my wish, by assembling
these works, to enable others to save time looking and make available
more time for them to ‘do’.
Folder 3B
Information on fluoride and those associated with it. This folder contains mostly information on phosphates, toxic waste.
This collection is dedicated to those who wrote the original works and
made them available on the internet. I have spent countless hours
searching for information on fluoride and it is my wish, by assembling
these works, to enable others to save time looking and make available
more time for them to ‘do’.
Folder 3B

More info:

Categories:Types, Research
Published by: violakitty4124 on Mar 15, 2009
Copyright:Attribution Non-commercial

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01/30/2013

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Fluoride: The Ultimate Cluster-Flux

And the Players Involved

A Compilation of Documents and Articles
Relating to Fluoride




This collection is dedicated to those who wrote the original works and
made them available on the internet. I have spent countless hours
searching for information on fluoride and it is my wish, by assembling
these works, to enable others to save time looking and make available
more time for them to ‘do’.

If you are sickened and appalled by the approved use of fluoride in
food, beverage and other consumer products then I ask that you spread
this knowledge on to others and contact your local representatives in the
hopes that one day fluoride will be more strictly regulated or, banned
altogether.

These documents are listed in roughly the order I found them. It would
be nearly impossible to group them in some kind of order since they are
all linked together – a cluster-flux of monumental proportions.

I would like to thank (or curse) Christopher Bryson whose excellent
book, The Fluoride Deception, opened my eyes to fluoride and started
me on this journey of uncovering the truth.

For more information on fluoride, I would recommend the Fluoride Action
Network (FAN) http://www.fluoridealert.org/ as a good place to start.


NOTICE
In accordance with Title 17 U.S.C., section 107, some material on this web site is provided without
permission from the copyright owner, only for purposes of criticism, comment, news reporting,
teaching, scholarship and research under the "fair use" provisions of federal copyright laws. These
materials may not be distributed further, except for "fair use" non-profit educational purposes,
without permission of the copyright owner.










































Inert (other) Ingredients in Pesticide Products
Pesticide products contain both "active" and "inert" ingredients. The terms "active ingredient"
and "inert ingredient" have been defined by Federal law, the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), since 1947.
An active ingredient is one that prevents, destroys, repels or mitigates a pest, or is a
plant regulator, defoliant, desiccant or nitrogen stabilizer. By law, the active
ingredient must be identified by name on the label together with its percentage by
weight.
An inert ingredient means any substance (or group of structurally similar substances if
designated by the Agency), other than an active ingredient, which is intentionally
included in a pesticide product. Inert ingredients play a key role in the effectiveness
of a pesticidal product. For example, inert ingredients may serve as a solvent,
allowing the pesticide's active ingredient to penetrate a plant's outer surface. In
some instances, inert ingredients are added to extend the pesticide product's shelf-
life or to protect the pesticide from degradation due to exposure to sunlight.
Pesticide products can contain more than one inert ingredient, but federal law does
not require that these ingredients be identified by name or percentage on the label.
Only the total percentage of inert ingredients is required to be on the pesticide
product label.
Name Change: From Inert to Other Ingredients
In September 1997, the Environmental Protection Agency (EPA) issued Pesticide Regulation
Notice 97-6 which encourages manufacturers, formulators, producers, and registrants of
pesticide products to voluntarily substitute the term "other ingredients" as a heading for the
"inert" ingredients in the ingredient statement on the label of the pesticide product. EPA made
this change after learning the results of a consumer survey on the use of household pesticides.
Many comments from the public and the consumer interviews prompted EPA to discontinue
the use of the term "inert." Many consumers are mislead by the term "inert ingredient",
believing it to mean "harmless." Since neither federal law nor the regulations define the term
"inert" on the basis of toxicity, hazard or risk to humans, non-target species, or the
environment, it should not be assumed that all inert ingredients are non-toxic.
Last updated on Thursday, August 28th, 2008.
http://www.epa.gov/opprd001/inerts/

International Chemical Safety Cards
SODIUM HEXAFLUOROSILICATE
ICSC: 1243

Sodium fluorosilicate
Sodium silicofluoride
Disodium hexafluorosilicate
Na
2
SiF
6

Molecular mass: 188.0

ICSC # 1243
CAS # 16893-85-9
RTECS # VV8410000
UN # 2674
EC # 009-012-00-0
October 27, 1994 Validated

TYPES OF
HAZARD/
EXPOSURE
ACUTE HAZARDS/
SYMPTOMS
PREVENTION
FIRST AID/
FIRE FIGHTING
FIRE
Not combustible. Gives off
irritating or toxic fumes (or
gases) in a fire.

In case of fire in the
surroundings: use
appropriate extinguishing
media.
EXPLOSION

EXPOSURE

PREVENT DISPERSION
OF DUST!

•INHALATION
Burning sensation. Cough.
Sore throat. See Ingestion.
Avoid inhalation of fine
dust and mist. Local
exhaust or breathing
protection.
Fresh air, rest. Refer for
medical attention.
•SKIN
Redness. Pain. Protective gloves.
Protective clothing.
Remove contaminated
clothes. Rinse skin with
plenty of water or shower.
•EYES
Redness. Pain. Safety goggles or eye
protection in combination
with breathing protection if
powder.
First rinse with plenty of
water for several minutes
(remove contact lenses if
easily possible), then take
to a doctor.
•INGESTION
Abdominal cramps.
Burning sensation. Nausea.
Vomiting.
Do not eat, drink, or smoke
during work. Wash hands
before eating.
Rinse mouth. Refer for
medical attention.
SPILLAGE DISPOSAL STORAGE
PACKAGING &
LABELLING
Do NOT wash away into sewer.
Sweep spilled substance into
sealable containers; if
appropriate, moisten first to
prevent dusting. Carefully collect
remainder, then remove to safe
place. Personal protection: P3
filter respirator for toxic particles.
Separated from acids, food and
feedstuffs
Do not transport with food and
feedstuffs.
Marine pollutant.
Note: A
T symbol
R: 23/24/25
S: 1/2-26-45
UN Hazard Class: 6.1
UN Packing Group: III
SEE IMPORTANT INFORMATION ON BACK
ICSC: 1243
Prepared in the context of cooperation between the International Programme on Chemical Safety
& the Commission of the European Communities (C) IPCS CEC 1994. No modifications to the
International version have been made except to add the OSHA PELs, NIOSH RELs and NIOSH
IDLH values.


International Chemical Safety Cards
SODIUM HEXAFLUOROSILICATE
ICSC: 1243
I

M

P

O

R

T

A

N

T


D

A

T

A
PHYSICAL STATE;
APPEARANCE:
WHITE GRANULAR POWDER.

PHYSICAL DANGERS:


CHEMICAL DANGERS:
The substance decomposes on
heating producing toxic and
corrosive fumes including fluorine.
Reacts with concentrated acids to
produce corrosive hydrogen fluoride
(see ICSC0283).

OCCUPATIONAL EXPOSURE
LIMITS:
TLV: (as F) 2.5 mg/m³ as TWA A4
(not classifiable as a human
carcinogen); BEI issued (ACGIH
2004).
MAK: (as F) (Inhalable fraction) 1
mg/m³
Peak limitation category: I(4);
skin absorption (H);
Pregnancy risk group: C;
ROUTES OF EXPOSURE:
The substance can be absorbed into
the body by inhalation of its aerosol
and by ingestion.

INHALATION RISK:
Evaporation at 20°C is negligible; a
harmful concentration of airborne
particles can, however, be reached
quickly.

EFFECTS OF SHORT-TERM
EXPOSURE:
The substance is irritating to the
eyes the skin and the respiratory
tract The substance may cause
effects on the calcium metabolism ,
resulting in cardiac disorders and
impaired functions Medical
observation is indicated.

EFFECTS OF LONG-TERM OR
REPEATED EXPOSURE:
The substance may have effects on
the bone , resulting in fluorosis.
(DFG 2005).


PHYSICAL
PROPERTIES
Melting point (decomposes): see Notes
Relative density (water = 1): 2.7
Solubility in water: none

ENVIRONMENTAL
DATA

N O T E S
Melts at red heat with decomposition.
Transport Emergency Card: TEC (R)-61GT5-III

ADDITIONAL INFORMATION

ICSC: 1243 SODIUM HEXAFLUOROSILICATE
(C) IPCS, CEC, 1994


IMPORTANT
LEGAL
NOTICE:
Neither NIOSH, the CEC or the IPCS nor any person acting on behalf of NIOSH,
the CEC or the IPCS is responsible for the use which might be made of this
information. This card contains the collective views of the IPCS Peer Review
Committee and may not reflect in all cases all the detailed requirements included in
national legislation on the subject. The user should verify compliance of the cards
with the relevant legislation in the country of use. The only modifications made to
produce the U.S. version is inclusion of the OSHA PELs, NIOSH RELs and NIOSH
IDLH values.


1
For The Record, Inc.
Waldorf, Maryland
(301)870-8025
FEDERAL TRADE COMMISSION 1
2
3
JOINT FTC/DEPARTMENT OF JUSTICE HEARING 4
ON HEALTH CARE AND COMPETITION LAW AND POLICY 5
6
7
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9
10
Thursday, June 12, 2003 11
9:15 a.m. 12
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601 New Jersey Avenue, N.W. 18
Washington, D.C. 19
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FEDERAL TRADE COMMISSION 1
I N D E X 2
PANELISTS: PAGE: 3
4
Newt Gingrich, The Gingrich Group 5 5
Warren Greenberg, George Washington University 26 6
Helen Darling, Washington Business Group on Health 31 7
Greg Kelly, Coalition Against Guaranteed Issue 36 8
Michael Young, Aon Consulting 40 9
David Lansky, Foundation for Accountability 49 10
Marcia L. Comstock, J.D., Wye River Group on Health care 55 11
Helen Darling, Washington Business Group on Health 99 12
Bernie Dana, American Health Care Association 149 13
Laura Carabello, CPRi Communications 161 14
Thomas Henry Lee, Jr., M.D., Partners Health care 179 15
Douglas D. Koch, M.D., Baylor College of Medicine 190 16
Richard Kelly, Federal Trade Commission 200 17
Peter M. Sfikas, American Dental Association 210 18
John E. Gebhart, III, DoctorQuality.com 219 19
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For The Record, Inc.
Waldorf, Maryland
(301)870-8025
P R O C E E D I N G S 1
DR. HYMAN: I'm David Hyman, special counsel here 2
at the Federal Trade Commission. Let me welcome you all to 3
the reconvening of the Hearings on Health Care and 4
Competition Law and Policy jointly sponsored by the Federal 5
Trade Commission and the Department of Justice. 6
This is the latest in a series of hearings that 7
started in February and are going to last through September, 8
perhaps October, unless I can make it September, and 9
represent an ongoing investigation of the performance of 10
differing parts of the health care market with regard to the 11
cost of the services that are provided, the quality of those 12
services, and the extent to which ordinary Americans can 13
access information about those services and obtain those 14
services at a time and in a fashion that is desirable to 15
them. 16
This morning we have a very distinguished panel and 17
extensive bios for each of the speakers, not all of whom, 18
unfortunately, are here just yet, and are published in this 19
beautiful book that's available outside. Our rule is, 20
accordingly, short introductions because you can read about 21
the people in the book. 22
The format we're going to follow this morning is 23
our first speaker, Newt Gingrich, is going to make somewhat 24
extended remarks. And then there will be a panel discussion 25
4
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(301)870-8025
of those remarks, and we'll include, as time allows, members 1
of the audience in that discussion if they have questions or 2
comments that they'd like to make. 3
And then following the time that we've allotted for 4
that portion of the program, we will then move into 5
presentations by individual speakers. At the end of that 6
time, we will then have a moderated panel discussion among 7
the speakers about the issues that we'll be discussing today. 8
The focus of our discussion today is financing 9
options and consumer information. It's essentially a 10
constellation of subjects relating to how Americans get their 11
health insurance coverage, the availability of information 12
regarding that coverage, the extent to which current 13
institutional arrangements insure a range of options 14
available to them, and the impact of those financing 15
arrangements on the delivery system for health care. 16
Our first speaker of the morning is former Speaker 17
of the House Newt Gingrich, the author of seven books, 18
including one he's going to speak about today, "Saving Lives 19
and Saving Money." And there's a very nice handout outside 20
that outlines some of the book, which presents Newt's vision 21
of a 21st century system of health and health care. 22
Newt is currently the CEO of The Gingrich Group, a 23
communications and consulting firm specializing in 24
transformational change. He recently launched the Center for 25
5
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Health Transformation, which advocates for market-oriented 1
health care. 2
And just two other preliminary announcements. If 3
everyone can turn off their cell phones. The Speaker likes 4
nothing better than being interrupted by the sound of your 5
cell phone. And second, time will be kept by Cecile Kohrs 6
over at the table there. So if the speakers can just keep an 7
eye out for that, it will ensure that we'll have adequate 8
time for discussion. 9
Newt, you can either sit or stand at your option. 10
MR. GINGRICH: If it's okay, I'll just sit, if 11
that's all right. And I'll try to go through this pretty 12
rapidly as an outline. 13
But first of all, Dave, let me thank you and the 14
Federal Trade Commission and the Department of Justice 15
Antitrust Division for hosting us today. I think trying to 16
think about impediments to competition in health is a very, 17
very important topic, first because of the rising cost of 18
health care, second because the scientific and technological 19
breakthroughs are likely to increase the cost of health care, 20
and third, because the aging of the baby boomers guarantees 21
that the sheer volume of health care over the next decade of 22
15 years is going to continue to go up. 23
If you look at the current crisis in Europe and 24
Japan, one of my mentors, Steve Hanser, just spent a month in 25
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Europe. I called him when he got back. I said, "What did 1
you learn?" He said, "Well, I was in four countries and 2
there were four issues: pensions, pensions, pensions, and 3
pensions," he said, "with the cost of health care and 4
unemployment being a distant second and third." 5
And I think if we don't in the next few years bring 6
to bear a much different approach to how we have a 7
competitive health system, that in fact we will rapidly move 8
towards some kind of bureaucratic redistributionist and, I 9
think, mediocre system. 10
So what you're focusing on is exactly at the cusp 11
of either finding really dramatic solutions or getting in 12
trouble. As you mentioned, we just finished a book called 13
"Saving Lives and Saving Money," and we just opened up a 14
website called the Center for Health Transformation, which is 15
at HealthTransformation.net, or you can go to just my first 16
name, Newt.org. But in "Saving Lives and Saving Money," we 17
outline a model for transforming the health system. 18
Let me start by making an argument that I think 19
gives the Federal Trade Commission a particularly important 20
role in the next ten or fifteen years. It should be the 21
natural product of a scientific, technological, 22
entrepreneurial, free market system to produce more choices 23
of better quality at lower cost. 24
And I'm going to repeat this because I think in 25
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both health and education you see a tremendous impediment of 1
government blocking what should be a natural pattern. The 2
natural pattern should be more choices of better quality at 3
lower cost. 4
And in a sense, Wal-Mart is, for the 21st century, 5
what Alfred Sloan and General Motors were for the 20th 6
century, in the sense that Sloan's investigation of consumer- 7
led mass production defined management for most of the 20th 8
century. 9
Wal-Mart's model, that lower everyday price is a 10
function of lower everyday cost, and that they see themselves 11
as the largest and most efficient market makers in the world, 12
is something really worthy of study. 13
And any institution that gets 100 million Americans 14
to voluntarily show up every week is worth looking at and 15
saying, what is it they're doing right? I mean, without 16
arguing about other aspects of Wal-Mart, it seems to me that 17
they are an institution worthy of study. 18
What we're suggesting is that lowest everyday price 19
being a function of lowest everyday cost should apply to 20
health and health care, and that producing more choices of 21
higher quality at lower cost should apply to health and 22
health care, and that to the degree it doesn't, it is largely 23
a function of the mis-design of the current system. 24
Now, there are three areas where you see real proof 25
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that traditional market behaviors work. They're all in 1
health. None of them are in the third party payment system. 2
The first, which we have here copies of, is looking 3
at a paper that was done by the National Center for Policy 4
Analysis, which looked at the cost patterns for cosmetic 5
surgery. And it turns out -- and the chart is very, very 6
revealing -- it turns out that all goods goes up at a certain 7
rate. Health care goes up at a much more rapid rate. 8
Cosmetic surgery went up at less than the rate of CPI. That 9
is, cosmetic surgery actually increased in cost from 1992 to 10
2001 at a lower rate than the consumer price index, while the 11
rest of health care went up dramatically faster. 12
The second example is laser surgery. The average 13
cost of surgery per eye dropped from $2,079 in 1999 to $1,631 14
in 2002. Now, again, this is a health procedure. It's a 15
fairly sophisticated health procedure. This is not a 16
question of cheap medicine or inappropriate medicine. This 17
is, in fact, an area where the breakthroughs technologically 18
have continued to accelerate, and the ability to perform 19
laser surgery has gotten better with better outcomes at 20
declining cost. 21
The third area is over-the-counter medications, 22
which have actually declined by about 2 to 3 percent in cost 23
as compared to the consumer price index and are dramatically 24
under prescription drugs. 25
9
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Now, our argument, both in "Saving Lives and Saving 1
Money" and at the Center for Health Transformation, is that 2
you can't succeed in reforming the current system, that the 3
current system is inherently, by design, mal-designed so that 4
a third party payment model is inherently conflict-ridden 5
because you have the person receiving goods not responsible, 6
the person paying goods confused about who they're 7
responsible to, and the person who's paying the money 8
irritated with both the provider and the patient. 9
In addition, we suggest that you want an 10
individually-centered system, not a patient-centered system, 11
because you want to use early diagnosis. You want to use 12
nutrition, attitude, and activity to extend individual 13
healthy behaviors. So we always talk about health and health 14
care. We don't start by talking about health care. 15
Interestingly, Dr. Zerhouni, the head of NIH, 16
believes that if you had a system that was refocused on 17
maximizing health and delaying the need for health care and 18
designing health care to be return to health rather than 19
long-term maintenance by the system, he thinks you actually 20
could take 40 percent out of the system. 21
That is, instead of having an increase of 22
20 percent a year or 15 percent a year or 10 percent a year, 23
it would be 40 percent less expensive. Interestingly, Dr. 24
Bill Stead, who's the head of informatics at Vanderbilt, 25
10
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independently from his perception of building expert systems 1
at Vanderbilt University believes you could also get about 40 2
percent out of the system. 3
So what we're describing is a transformation that 4
could literally be worth, if you're an optimist, 5 percent of 5
the entire economy. If you think that's too high, it could 6
be worth 3 or 4 percent, which is still fairly big money. 7
We think there are four drivers of this change that 8
the FTC ought to look at. The first is patient safety and 9
patient outcome. And the reason I start with that is health 10
is inherently moral. We called our book "Saving Lives and 11
Saving Money" in that order because saving lives is the moral 12
cause and saving money is the practical cause. 13
If you start with patient safety and patient 14
outcome -- and I used to serve as the ranking Republican on 15
the Aviation Subcommittee; this was in a distant past when we 16
were in the minority -- and I represent the Atlanta Airport. 17
We value life in commercial aviation by several orders of 18
magnitude more than we value life in the health system. 19
So when the Institute of Medicine reports that we 20
lose at least one New York to Washington shuttle a day to 21
medical error in hospitals, the country says, yes, hospitals 22
are dangerous, and we go on to the next topic. If we lose a 23
shuttle, the National Transportation Safety Board, the 24
Federal Aviation Administration, the airlines, the 25
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manufacturer, all collaborate in a stunningly intense effort 1
to change the system, and when they learn what needs to be 2
changed, they retrain the pilot, the manufacturer, or the 3
maintenance people within 48 hours. 4
By contrast, the Institute of Medicine reports it 5
can take up to 17 years for a doctor to learn a new best 6
practice, and over 80 percent of doctors do not practice best 7
outcome medicine. Now, that's unacceptable in civil 8
aviation, and I simply tell every audience we should value 9
you as much in the health system as we value you in aviation 10
and you'll get to a dramatically better system. 11
The second driver should be information technology, 12
computing, and communications. The amount of information we 13
could get is stunning. I just talked with Dr. Korpman at 14
Health Trio, who runs an information system. One of their 15
major clients is Brigham & Women's. 16
As soon as they went to electronic information, 17
they reduced the number of call-backs each month by 30,000 18
phone calls a month to verify prescriptions. At $6 a call, 19
that's $180,000 difference for one hospital. 20
But more importantly, Dr. Corpman advised the Blair 21
government in Britain, who have now put out a request for 22
bids on a national electronic health record. His estimate is 23
that they will sustain that record once it's established for 24
ten cents per month per patient. That means you could have a 25
12
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medical record in the U.S. that was sustained for around 1
$29 million a month. 2
Now, that is an absurdity not to have that. And 3
you go down the list of things IT, information technology, 4
should bring you, almost all of which are inhibited by the 5
current structure of the health system, legal structure, 6
cultural structure, and incentive structure. 7
The third thing we focus on is quality, a system 8
and culture of quality in the sense of Deming and Juran. And 9
again, if you look at manufacturing in the last 80 years, 10
essentially all of it is coming out of the Western 11
Electric/Hawthorne experiment and the rise of systems 12
analysis at AT&T's manufacturing system in the 20s, which 13
Deming actually was part of. And then you look at Deming 14
teaching 75 percent of Japanese industrial capital in 1951 in 15
a four-day course which led to the Japanese creating the 16
Deming prize for the best-run company in Japan. 17
We have had stunning explosions of productivity and 18
quality in manufacturing because we recognize it is a system 19
and we recognize you need a culture of quality. None of that 20
has happened in health. And it is -- despite the best 21
efforts of a number of people, it has simply not penetrated 22
again because the distribution of power in the health system 23
has allowed people to simply say no and walk off. 24
The fourth thing we focus on is the notion that you 25
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have to re-center the health system on the individual. The 1
individual has to have the knowledge. They have to have 2
access to clear information. They have to have real power in 3
order to make real choices. 4
And they have to be held accountable. You need an 5
incentive system which says, you know, if you're diabetic and 6
you don't manage your diabetes, you have a responsibility. 7
This is not just a magic system where you can do nothing, 8
live badly, and then demand that the doctor fix you. 9
And I say this having helped author the welfare 10
reform legislation. And the direct parallel I would argue is 11
if we as a country are prepared to say to the poorest people 12
in the country, you have to go out and get a job or get an 13
education, we should have the nerve to say to every American, 14
you have a responsibility for monitoring your own health, for 15
having a health indicator system. 16
And again, one of the things that we should be 17
looking at is what is it that inhibits us from creating 18
marketing and having a system in which people could literally 19
monitor their own health on a regular basis. 20
Our goal is to consistently look for better 21
outcomes at lower cost, and we think if you aggregate those, 22
it is startling how many places there are where you can get 23
very dramatic improvements by applying better outcomes at 24
lower cost. 25
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Now, there are essentially four kinds of 1
inhibitions. The first is the guilds. And here, Adam Smith 2
is very clear in the wealth of nations, for everybody who 3
believes in free markets, let me just suggest to you if you 4
think of being a doctor as a guild, you understand a great 5
deal of what I'm about to talk about. If you think about 6
being a lawyer as a guild, you understand a lot of what I'm 7
going to talk about. 8
The second thing to look at is obsolete laws which 9
are based on a different era and which is based on an era of 10
a different kind of economy, a different kind of information 11
flow, and a different kind of capability. 12
The third is the impact of bureaucracies, both 13
public and private. I mean, large corporations and large 14
insurance companies are truly as bureaucratic as large 15
governments, and bureaucracies have inherent patterns of 16
avoiding competition and avoiding change that are valid 17
whether they're public or private. 18
And the fourth is we create the wrong incentives. 19
We create incentives which are acute care-focused. We create 20
incentives which are doctor-centered rather than 21
individually-centered. And we created incentives which do an 22
immense amount once you're sick, but almost nothing to incent 23
you not to get sick. 24
Let me suggest six quick areas where I think the 25
15
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FTC could profitably explore. I'm not suggesting here you 1
necessarily have rulemaking authority, but because of your 2
underlying instruction from the law that you should be 3
looking at how markets could operate better and what are the 4
impediments to market, I think if you explore these six, you 5
would have recommendations to the Congress that would be 6
very, very helpful in directing congressional exploration of 7
these issues. 8
The first is the degree to which we artificially 9
constrain and raise the cost of insurance for the self- 10
employed, the unemployed, small businesses, and family farms. 11
There is no inherent reason we can't have a nationwide market 12
based on something like eBay, where people can go online with 13
very little intermediation cost and buy into a national risk 14
pool. That is, no one should ever buy individual insurance. 15
You should individually be able to buy group insurance. But 16
you need pooling. 17
Every effort I have seen to block a nationwide rise 18
of large-scale insurance for small businesses, the self- 19
employed, family farms, and the unemployed, every effort has 20
been essentially an effort to restrain trade on behalf of 21
people who have large market share within the 50 states. 22
It has nothing to do with the capacity to do it 23
technologically or the desirability of doing it for citizens. 24
We've seen studies that indicate you could lower the cost of 25
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insurance by 40 percent for the self-insured -- I mean, for 1
individuals, small businesses, and notice that under ERISA 2
we're quite cheerful about doing this for the biggest 3
companies in America. 4
So the biggest companies in America are exempted 5
from the 50 state mandates. They're exempted from the 50 6
state insurance commissioners. And if you get to be big 7
enough, you get to play in one league, but if you're not that 8
big, you're actually in an artificially -- and I want to 9
emphasize artificially -- dramatically more expensive league. 10
The second thing I want to suggest to you is to 11
look at medical rules that break America up into 50 states. 12
There's no doubt in my mind that many of the restrictions on 13
doctors are explicitly guild behavior designed to minimize 14
competition. 15
But beyond the question -- and I would argue that 16
there ought to be some kind of national registry, and if 17
you're a board-certified doctor you ought to be able to 18
practice in all 50 states. We live in a modern age. We live 19
in an age where information flows worldwide. The rules that 20
grew out of a 19th century industrial model strike me as 21
obsolete. 22
But in addition, you want to be able to move 23
medical information across state lines. The Mayo Clinic 24
exists in three states, Arizona, Minnesota, and Florida. 25
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They should be able to have a control digital database, have 1
you have an MRI in one state, and if the best person in the 2
world to read that MRI is in a different state, it is 3
irrational and destructive of life and money to say that you 4
can't have access to that. 5
So second, you ought to look at the degree to which 6
state lines today artificially inhibit these things. And let 7
me point out that in terms of interstate commerce, there is 8
no constitutional reason that the health system shouldn't be 9
seen as a national system. 10
And, by the way, the minute you have a SARS threat 11
or an anthrax threat or a new model of flu, we behave like a 12
national system. So I think this is when you look at what's 13
the additional cost in inhibition, both for lives and money, 14
by the current model of state-by-state guild behavior? 15
The third is to look at what inhibits the rise of 16
the right kind of investigation systems. There's a firm 17
called Health Share which has taken the Medicare data and has 18
developed an expert system which enables you to pull up 19
hospitals based on the Medicare data. 20
And it is very interesting that consistently the 21
best hospitals tend to be the least expensive. It is the 22
inverse of the automobile business. In the health business, 23
you very often can get a Ferrari for the cost of a Subaru, 24
and if you go to a Subaru quality, you very often pay the 25
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price of a Ferrari. 1
And this is a system which indicates -- and, now, 2
it's only Medicare data today; it's not all data -- but it 3
really begins to give you an ability to access what are 4
outcomes, how many medical errors are reported, how many 5
hospital-induced illnesses are there, what do they charge, 6
how many days do you spend in the hospital, et cetera. 7
There are all sorts of inhibitions against these 8
kinds of systems growing up, including -- and I'm going to 9
come to it at length -- the liability system, which inhibits 10
the development of this kind of information, but also, the 11
unwillingness of doctors and hospitals to share data. 12
And one should look at the question -- there was a 13
huge fight a number of years back about whether or not you 14
could put prices on cars. And as with all good guilds, the 15
manufacturers and the auto dealers did not want to put prices 16
on cars. And this was a big fight over the public's right to 17
know what does a car cost. 18
Well, let me suggest to you that you're in the same 19
cycle right now. Interestingly, in 1999 12 percent of the 20
country went online to find the price of a car before they 21
bought a car. In 2002, in three short years, that number 22
exploded to 58 percent of the country. And on average, they 23
save 2 percent on the cost of the car they purchase. So I 24
just want to suggest there's no inherent reason that you 25
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couldn't have an accurate information system about 1
capabilities and cost. 2
The fourth change, though, is one which you only 3
have an indirect interest in but a big interest in the 4
market, and that is HIPAA will almost certainly have to be 5
modified both for research data and for price and outcome 6
data. And there's no reason you can't design it so that you 7
can have a patient confidentiality-compliant system. 8
But the way HIPAA technically is written right now, 9
for example, it's very difficult to do longitudinal research 10
under HIPAA rules. And NIH will probably be making 11
recommendations on this topic. But again we have to say, to 12
what degree does the government become self-destructive? 13
Because in the name of protecting your privacy we have 14
designed a rule which actually makes it more likely you'll 15
die. 16
And so I think we have to look at, in the age of 17
electronics, how do we both protect your privacy and enable 18
the gathering of quantitative data that we need very badly. 19
The fifth proposal I want to suggest to you is a 20
radically different way to think about purchasing drugs. The 21
current drug system -- and this is particularly timely 22
because of Medicare, but again, it goes back to the issue of 23
how do you get markets to work right. 24
The current drug system is wrong on a couple of 25
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accounts. First of all, there is no pricing for drugs. 1
Drugs are almost -- particularly if you're in any kind of 2
group purchasing plan, drugs are purchased as a function of 3
rebates or kickbacks. 4
It is as though the Ford Motor Company announced 5
that they had a $600,000 truck, but for you there was a 6
$560,000 rebate so it's only a $40,000 truck for you; whereas 7
the Chrysler Company said, we have a $45,000 truck, and for 8
you we're willing to take off $5,000. Somehow, 9
psychologically, taking off 560,000 sounds better. 10
So the current system actually incents the 11
pharmaceutical manufacturers to optimize the price of the 12
drug in order to have the widest possible margin to rebate to 13
the pharmacy benefit manufacturers. 14
The second thing wrong with the current system is 15
that requiring copays up front perversely maximizes the price 16
of the drug for the person who has the choice. If I'm going 17
to put up $10 as a copay and my choice is a $40 drug or a $70 18
drug, I actually psychologically want the $70 drug because I 19
get the seven-to-one return on my money. The ideal model 20
would be to reverse that, that is, to put the subsidy up 21
front, so that every additional dollar cost came out of my 22
pocket. 23
Two other points. Historically, we couldn't handle 24
data as it related to the sheer flow of drugs. And in 1965, 25
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when Medicare was developed, drugs were a relatively small 1
part of medical care. Anyone who's gone to Travelocity, 2
Expedia, or Gallileo knows you can handle huge volumes of 3
data 24/7 for free. You can allow people to know every 4
airline flight in the world and go on and pick the seat they 5
want to be in and know every price permutation and pick based 6
on a combination of time and price. 7
NDC Health is a firm which handles four billion 8
drug transactions a year, 70 percent of the market. They 9
handle half of all of the doctors' practices of one, two, and 10
three doctors. They believe unequivocally you can design a 11
Travelocity model in which you'd get two kinds of 12
prescriptions. 13
You went to the doctor, the doctor said, you have a 14
unique genetic requirement. The only drug you can take is X, 15
and they issue a unique prescription. You get that 16
prescription, and say in the case of Medicare, it ought to be 17
subsidized if people want to subsidize it. 18
But in a very large number of cases, there are 19
multiple drugs available. Imagine the doctor then gave you a 20
class prescription and said, you need an allergy drug. There 21
are nine allergy drugs available, and I would explicitly 22
include medically appropriate over-the-counter drugs. 23
The idea that Claritin drops off when it becomes 24
cheap tells you everything you need to know about how 25
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perverse the current system is. This is a system that 1
because the doctor gets no psychological reward out of 2
prescribing a nonprescription drug -- you went to the doctor, 3
you want a prescription. 4
If the doctor said to you, you know, last year or 5
two years ago this was the second most prescribed drug in the 6
world -- I mean, for the FTC to just say, what's wrong with 7
this picture and how come the market isn't working, strikes 8
me as a very important investigation. 9
So here's how it would work. You'd have a 10
Travelocity-type page. It would list all the drugs available 11
and medically appropriate indicators. Your government, which 12
loves you, will pay 100 percent of the least expensive and 13
will give you the same dollar value for any other drug. 14
So it's an open formulary. You don't get into 15
politics. You don't get into bureaucrats picking. You don't 16
get into the kind of things we're going to see with all the 17
various closed formularies. And the drug company has to tell 18
you an honest price. It can't give you a rebated price 19
that's totally artificial because it's out in the open. 20
NDC Health believes they could provide for the 21
government every night the subsidy price for the next day 22
because they handle over ten million transactions a day. 23
Now, I just offer that as a model, but if you had a model 24
like that, the patient would have more information -- it's, 25
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by the way, a pharmacy benefit administrator system where the 1
patient with the pharmacist or the doctor is the manager. 2
So you return to a genuine marketplace. You 3
empower the patient. You have a downward-pricing mechanism, 4
which I think all the airlines will tell you is stunningly 5
powerful. And you would have a system in which you would 6
come back and have to raise the question at the level of the 7
FTC talking with the FDA and NIH, which is, building the page 8
that lists the medically appropriate drugs becomes really 9
important. 10
And you have to ask yourself why these things 11
haven't happened more rapidly, although there is a firm 12
called RXaminer. It's R-X-a-m-i-n-e-r dot com, I believe, 13
which actually does a variation of this for people who are 14
paying for their own drugs, and on average saves them between 15
60 and 70 percent of the cost of drugs. 16
The last thing I want to talk about is the impact 17
of the legal system. It is very important in a free society 18
to have an orderly, predictable system of law. A few lawyers 19
is central to the health of a free society. An epidemic of 20
lawyers is a disaster. And we clearly have a malfunctioning 21
system in which the signals are being sent to drop out of 22
medical school and go to law school so you can sue your 23
friends who were too dumb to follow you. 24
This is very dangerous for the country. And I want 25
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to suggest three areas for you to look at that I think are 1
central to having a healthy system. 2
The first is the degree to which there is 3
conspiracy behavior almost in a RICO sense when you have -- 4
recently, for example, the New York Times reports a hundred 5
law firms creating, in effect, an investment pool for suing. 6
It strikes me that this is behavior that has no relationship 7
to justice and no relationship to appropriate solving of 8
problems, but every relationship to an increasingly self- 9
directed profession of greed that designs strategies to 10
maximize -- to judge shop, jury shop, and maximize return on 11
investment. And that if one were actually to have access to 12
the internal documents of these law firms, you would be 13
startled by the degree to which this is economic behavior, 14
not legal behavior, and economic behavior essentially of a 15
predatory nature. 16
The second thing I think you need to look at is the 17
cost to the system on inhibiting the flow of information 18
about mistakes. In the aviation administration, one of the 19
things we did when I was a very junior member is work with 20
the FAA to change how pilots reported near-misses because 21
pilots wouldn't report them because they're afraid they'd get 22
penalized. 23
So they were simply suppressing the information, 24
and it was dangerous. And the ground rule came up that you 25
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could report it anonymously and that no disciplinary action 1
would be taken unless there was some extraordinary 2
circumstance -- you'd been drinking or you were doing 3
something really stupid in the cockpit. 4
The result was a dramatic increase of reporting 5
near-misses and significant systems modifications that 6
ultimately saved people from running into each other and 7
killing people. 8
There ought to be some tie between quality 9
reporting, error reporting, being open about things like 10
hospital-induced illnesses and protection with a reasonable 11
framework for having participated to improve the outcome of 12
the system to save lives. 13
And again, I draw a distinction. If the doctor is 14
drunk, if the doctor is egregiously misbehaving, if there's a 15
boundary condition that clearly is what would historically 16
before 1963 have been a guilty behavior, then you ought to be 17
able to sue in a different fashion. But there ought to be 18
protections and structures. 19
The last thing I think you have to look at is the 20
degree to which -- and you see this now in Pennsylvania, West 21
Virginia, and Mississippi and Nevada -- the degree to which 22
predatory legal behavior is actually beginning to endanger 23
lives because the principles that are being established drive 24
people out of practice. 25
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I was told recently that in Las Vegas, there are no 1
obstetricians willing to take any new patients. Now, there 2
has to be a public health cost here. An epidemic of lawyers 3
can be as dangerous as an epidemic of SARS, and literally 4
dangerous in the sense that by driving doctors away from 5
behavior they would otherwise engage in. We are killing 6
people. And there should be some way for this to be 7
investigated in a straightforward manner to find out to what 8
degree it is not, in fact, legal behavior but is economically 9
predatory behavior, and to recommend to the Congress ways of 10
thinking about these problems. 11
Because our interest is to have an orderly system 12
in which we optimize the activities that are productive and 13
in which we optimize the desirability to become a doctor or 14
to run a hospital or to provide good health, and in which the 15
individual citizen is guaranteed justice if they are 16
aggrieved, but we don't create classes of behavior as a 17
result of which we are economically self-destructive. 18
Thank you for letting me outline all this. 19
DR. HYMAN: Okay. Well, let me just start by 20
throwing it open to the panel generally and asking any of 21
them whether they have questions, comments. I have a whole 22
series of them, but let me defer to the panel first. 23
Warren? 24
DR. GREENBERG: I must say it was a very 25
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stimulating, very thoughtful group of remarks, and I 1
appreciate hearing them myself, and I'm sure everyone else 2
did. I'd like to have a world out there, which is perhaps 3
close to yours, and just describe it just for a second. It's 4
part of my talk, but what the heck, you're here and I'll do 5
it now. 6
You talked about Wal-Mart first, Wal-Mart the 7
department store. And you talked a lot about information, 8
the lack of information that we have. How about a world, Mr. 9
Gingrich, where we would have Wal-Mart in health care, 10
competing against K-Mart, competing against Bloomingdale's, 11
competing against Nordstrom's, competing against Lord & 12
Taylor. 13
Look at the information we would have in that 14
marketplace. Look how we know, when we go into K-Mart, we're 15
going to get a particular type of good, a particular quality 16
of jewelry, perhaps, at a lower price than we would going 17
into Bloomingdale's or Nordstrom's, knowing almost nothing 18
about jewelry, perhaps knowing very little about men's 19
clothes, yet that symbol of the department store that George 20
Stigler spoke about 40 years ago, the Nobel Prize-winning 21
economist, perhaps can be applied to health care. 22
Look at all the information we would get if firms 23
of health plans -- if we could name a health plan today that 24
we know is the Nordstrom's of health care, that we know is 25
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the Wal-Mart. Instead, it's ABB, blah, blah, blah, Fidelity 1
Mutual. We don't even know how good they are. But why don't 2
we have that development of brand names? 3
And this is what I'd like to address in my talk, 4
and I would ask you if you can believe that maybe this is the 5
way we ought to tie in information, and ask you and perhaps 6
other panelists, what are the imperfections that we have that 7
we don't have health plans. And it's not only the department 8
store approach. I'm talking about automobiles. I don't know 9
anything about what goes into a Lexus or who the mechanics 10
were in making that Chevrolet. But somehow, I know a Lexus 11
works better than a Chevrolet. 12
Why don't we have these brand names, from good to 13
bad, with prices, as a way to provide information to every 14
consumer in America? 15
MR. GINGRICH: Well, let me say first of all, Dr. 16
Greenberg, I agree with your core vision that -- with this 17
caveat, which I think you also agree with, because I want to 18
make this clear so we don't get some kind of attack on the 19
idea of markets. 20
Part of the genius of the modern system has been 21
the invention of regulated free markets in which, if I go 22
into McDonald's, I know that the water will be drinkable and 23
that the beef will actually be beef. And this is not a small 24
thing. 25
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If you go back to the rise of the Food & Drug 1
Administration under Theodore Roosevelt, this was in fact an 2
appropriate response to the need to have a refereed or 3
regulated framework within which the market operates and the 4
delivery is by the market, but it's a delivery guaranteed by 5
the government in terms of quality. 6
And I say that because otherwise we're going to get 7
somebody attacks us: How can you compare health to -- within 8
that framework, you're exactly right. Now, interestingly, 9
when we first went out to begin working on "Saving Lives and 10
Saving Money" back in 1999, we started by looking for 11
branding. 12
What are the startups? What are the better 13
outcomes at lower cost, et cetera. You have some limited 14
branding. The Mayo Clinic is a world-class name. The 15
Cleveland Clinic is a very good name. 16
But what you discover early on is that the 17
inhibitions against their growing, it almost resembles 18
Lancashire cottage industries prior to the rise of the mills 19
and the degree to which you can't aggregate behavior. It's 20
very hard. So that we look at firms -- Visicu is a Johns 21
Hopkins spinoff that deals with electronic intensive care 22
units. 23
Every hospital in the country ought to have either 24
their own intensivist or they ought to be attached to an 25
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electronic intensive care unit, period. I mean, this just 1
should be a minimum standard. 2
But when you go to the local intensive care doc, he 3
says, wait a second. What are you saying to me? Or you go 4
to the local group of doctors and you say, well, I don't know 5
that I want my hospital to do this, even though statistically 6
there is no question: If you go to a -- if you have 7
abdominal surgery in a hospital without an intensivist, the 8
odds are three times as high you'll die. 9
And so what I discovered, to go back to your point, 10
is it is very hard to get the rise of these branded 11
structures. Probably the Hospital Corporation of America is 12
as close as we've come to that kind of a model. But it's 13
also really hard to get to the aggregation of behavior. And 14
part of it is because of doctors and the way they're trained 15
by medical schools, which has to be redone. Part of it is by 16
legal inhibitions. 17
The other point I'd make is that historically, the 18
mistake that was made in the '80s was creating a so-called 19
health management approach, managed care approach, which 20
actually was about managed cost. There was no data for 21
managed care, and so you ended up in the wrong kind of fight 22
and you actually -- I think society was pushed back a step 23
because the design was backwards. 24
DR. HYMAN: Helen? 25
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MS. DARLING: Yes. I'd like to get back to one of 1
the excellent points you made about your vision, and 2
particularly combine your history as a politician and your 3
current activities as transforming the health system, for 4
which I'm sure everybody in the room will be very grateful, 5
especially if you can do it. 6
Over-the-counter drugs and generics offer the 7
consumer much of what you're talking about. First of all, 8
the minute they become generic and over-the-counter, a lot of 9
other things happen, usually. And just generally, you know, 10
you can debate about some of the data and what it shows, 11
especially absent the competitive system -- that is, more 12
than one generic. 13
But generally, consumers and employers will save a 14
lot of money to the extent that drugs are moved to over-the- 15
counter generics. But the industry, as you know, has, shall 16
we say, kindly made it as difficult as possible for that to 17
happen even to the extent that trying to use the authority 18
that the Congress has given, both the FDA and themselves, to 19
limit either movement to generics or anything that could 20
possibly work. 21
Could you please talk a little bit about your 22
thoughts about how, number one, we move that along faster, 23
and two, if there are other barriers that we should be paying 24
attention to that keeps those kinds of changes from happening 25
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in a timely way. 1
MR. GINGRICH: Thank you. I think that's a very 2
insightful question that goes to the heart of one of the 3
biggest changes that we need. 4
Let me start by saying that I think that American 5
history is filled with moments when economically very 6
powerful entities that forgot that profit is supposed to be a 7
by-product of service and began to try to rig the game for 8
themselves found that, in fact, this is a stunningly populous 9
society. I think of Robert LaFollette and the railroads as a 10
perfect example, leading to the rise of the progressive 11
movement. 12
I very much favor the branded pharmaceutical system 13
which has created two generations of therapeutic 14
breakthroughs that are extraordinary. But I think that they 15
are now trapped in exactly the same crisis that doctors are 16
trapped in. 17
Several years ago I went and spoke to the AMA when 18
I was Speaker, and I got a very nice round of applause 19
because I had followed somebody they didn't like. But when I 20
got up, I said to them, you're either going to go to Wal-Mart 21
or you're going to go to Canada. You're either going to end 22
up in a regulated, unionized, government-run bureaucracy, or 23
you're going to be in a genuine market where people have real 24
information. 25
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And that's my message, basically, to the 1
pharmaceutical companies. I am for people paying the 2
appropriate price with knowledge in a competitive setting for 3
the drugs they get. I think a system which is dominated by 4
detail people, a system which is dominated by rebates, a 5
system in which doctors prescribe in ignorance, is a system 6
that is doomed to failure. And let me talk briefly about how 7
that will happen, I think. 8
First of all, I have talked to no audience in the 9
last six months where you describe automatic teller machines, 10
self-service gas stations with credit cards, and Travelocity, 11
and then you mention the phrase "paper prescription." 12
They don't just get it. I mean, all of their 13
common experiences every day now are that you can have 14
electronic interfaces that are stunningly accurate, and then 15
you get a paper prescription. And paper prescriptions 16
require a massive volume of call-backs. Forty percent of all 17
prescriptions require a call-back. And the doctor very often 18
doesn't even know what else you're taking. So start with 19
that. 20
At a large scale, what you want to do is simple. 21
You want to take something like Scholar, which is a Stanford 22
spinoff that has been certified by the AMA for continuing 23
medical education, and you want to have a Scholar-quality 24
page, much like Travelocity, so the doctor is an informed 25
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prescriber. You can put it on a Palm. You can do -- but 1
doctors ought to know, here are the nine drugs and here's 2
what they cost. 3
By the way, in the studies that have been done, 4
when doctors do know the cost, they consistently prescribe 5
less expensive drugs. I mean, some outliers don't, but as a 6
general rule, it does have an impact. 7
Second, you want electronic prescribing. My hope 8
is that the Medicare drug bill is going to mandate electronic 9
prescribing. You want computer order entry in hospitals of 10
medications, and you want every drug that you get to have an 11
electronic indicator on it so that you automatically can 12
match up the drug and the patient. 13
And again, Pfizer has taken the lead in developing 14
that, but I think you're going to see it happen -- this has 15
been going on in grocery stores now for about 40 years. And 16
I think it's finally migrating into health. All of these 17
things have a big impact on accuracy, safety, and cost. 18
But what the country has to say, and I think the 19
Medicare drug debate may be precisely the place to start 20
saying it, is -- and this is historically how -- we 21
historically get change out of two things. We either have a 22
grievance, you know, again, Nader versus the big auto 23
companies, which whatever you may think of Ralph in terms of 24
being, from my standpoint, much too liberal, his crusade in 25
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the '60s and '70s clearly changed the standard of safety in 1
America, despite the fact that the biggest companies in the 2
United States were opposed to it. But in the end, they 3
couldn't stand up to the public debate. 4
Similarly, the most successful companies in America 5
right now may well be the pharmaceutical companies, but when 6
the country decides, A, this is what I'm missing -- you know, 7
why am I paying 65 percent more than I should be paying, or 8
why is it that a detail person's ability to get the 9
receptionist to schedule ten minutes becomes an integral part 10
of which drug I get. 11
And so I think you will see a different model 12
emerge fairly rapidly, and I think it will almost certainly 13
be an internet-based model. It will almost certainly be an 14
information-rich model. And it will happen either because 15
the government shifts in the direction I'm describing or 16
because ten or fifteen large payors shift and decide that 17
they'll subsidize 100 percent of the least expensive. 18
And again, what I'm arguing for is an open 19
formulary. So none of the pharmacy benefit management 20
companies are going to like this because it takes away the 21
rebate model and the information control model which is at 22
the heart of their being an intermediary. 23
But the modern information systems take out 24
middlemen, empower you to make choices, and drive prices 25
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downward by letting you choose what you want. 1
DR. HYMAN: Greg? 2
MR. KELLY: Yes. Going back to what you guys were 3
both touching in, Mr. Speaker and Dr. Greenberg, a little 4
earlier on quality and how you were mentioning it. One of 5
the questions I wanted to ask you to maybe elaborate on a 6
little further is how some of the best hospitals out there 7
are the least expensive. 8
And I think, from my standpoint, what is going to 9
be important going forward is for the consumer to have value, 10
which is the equation of both price and quality. And looking 11
at the car example, it's kind of an intuitive sense that we 12
have. We're spending our own money, and when you spend your 13
own money, you do it wisely and you don't add in all of the 14
data. 15
When I go and take a look at a car or buy something 16
at the store, I don't look at all the data. But intuitively 17
I know, since it's money out of my own pocket, what is the 18
best mixture of both price and quality. I'm not going to buy 19
the most expensive thing out there, but at the same time I'm 20
going to get the best deal for my money. 21
So you were elaborating a little bit on the 22
direction of where that was going right now, and I was also 23
inquisitive on why the best hospitals out there are also the 24
most -- the least expensive. Is it because the consumers are 25
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gravitating towards those hospitals, and just because of the 1
volume, the prices are lower, or what is the reason that is 2
currently taking place right now? 3
MR. GINGRICH: Well, it's interesting. I was a 4
student of Edwards Deming, and I ended up being a student of 5
Edwards Deming in part because I went down to Milliken, to 6
their annual management retreat, because I wanted to learn 7
more about management in the '80s. 8
And they spent a half-day out of their three-day 9
retreat redoing Deming's red bead experiment. And I asked 10
Roger Milliken how they'd gotten so deeply involved in Deming 11
and in quality, and he said he'd read a book by Phil Cosby 12
called, "Quality is Free." 13
And Cosby is the popularizer of Deming, and Cosby's 14
point was if you do the right thing right the first time, it 15
is cheaper -- quality in a manufacturing sense is never more 16
expensive than sloppiness. It's an exact mis-design. 17
And in fact, it was Phil Cosby's argument that as a 18
general rule for most manufacturing in America in 1980, about 19
a third of what they were doing was waste. And as Milliken 20
said, since he was the owner of Milliken, it suddenly hit him 21
that was his money. 22
And so they dramatically changed the entire company 23
from the ground up, made a remarkable -- made it far and away 24
the most effective textile company in the world in terms of 25
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output per dollar. So I studied under Deming as a result of 1
that experience. 2
You start with a premise: If you're really, really 3
good, you're probably less expensive. Toyota is less 4
expensive than Mercedes. In fact, there's a terrific book by 5
Womack called, "The Machine that Changed the World," which is 6
the MIT project on automobiles. They make the point that 7
Mercedes and Toyota produce about the same quality car, the 8
difference being Mercedes rebuilds one-third of their cars; 9
Toyota rebuilds 2 percent of their cars. 10
Then they make the point that if Mercedes can't 11
learn the Toyota production system, that you cannot compete 12
very long at the same price, if I have to rebuild a third of 13
my cars for quality and you're rebuilding 2 percent of yours. 14
And that's why Paul O'Neill, who had brought the 15
Toyota production system into Alcoa and had dramatically 16
reduced days lost to occupational accidents, had dramatically 17
reduced cost of production, he then migrated it into the 18
Pittsburgh health system in what I think is maybe the most 19
interesting experiment in trying to get doctors, for example, 20
to do statistical analysis of outcomes. So let me start with 21
that. 22
A place like Mayo that first of all selects out in 23
its recruiting for people who want to be part of teams, that 24
selects out for people who want to learn best practices, that 25
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selects out for people who want to engage in research -- so 1
you have to start with the idea that, I mean, best of class 2
very often recruit to best of class. 3
Second, they have the professional commitment to 4
force themselves to learn things they don't want to know, 5
which is very, very difficult. And it's part of the key to a 6
quality culture. 7
Third, if you in form, do it right, you don't have 8
medical errors and you don't have medication errors and you 9
don't have hospital-induced illnesses, all of which cost 10
money. There are two million hospital-induced illnesses a 11
year in the United States. If you stay in a hospital longer 12
than four days, the odds are even money the hospital will 13
give you a disease which it will then charge you to cure. 14
This goes back to perverse incentives. 15
The U.S. government ought to pay a bonus to every 16
hospital which has significantly less medical error and has 17
significantly less medication error, has significantly less 18
hospital-induced illness. One specific example: When 19
Wishard Hospital went to -- Wishard Memorial went to complete 20
order entry of drugs, they reduced the average stay by nine- 21
tenths of a day per patient. Now, seen from the standpoint 22
of the CFO, they just reduced their income. But they saved 23
nine-tenths of a day per patient by going to computer order 24
entry. 25
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Visicu, according to Centera Hospital, has -- 1
Visicu is the electronic intensive care system -- Centera, 2
which has it in five hospitals connected to one office for 3
electronic screening, says that they now save 20 percent of 4
the time per intensive care patient, on average, in moving 5
them through the intensive care unit because there are fewer 6
errors, fewer hospital-induced illnesses, better treatment. 7
So you actually -- true quality should actually 8
improve hospitals, not cost them more. And true quality 9
should actually improve doctors' incomes, not make them 10
poorer. But the incentive system does, in a perverse way, 11
almost incent you to have the errors and have the illnesses 12
because you get to charge for them. 13
DR. HYMAN: You get to double hit. You're having 14
them in first and then again. 15
Mike? 16
MR. YOUNG: I guess before I ask a question, I will 17
say -- you mentioned HIPAA. And HIPAA was a consulting gold 18
mine for us in the first -- for consultants for the first 19
quarter of this year. 20
But I absolutely agree with you that it has clearly 21
gone way too far, and we have a number of situations where 22
the access to data is very hard to get and seemingly, you 23
know, each holder of data makes their own determination of 24
how they use HIPAA, either as an excuse or a realistic way to 25
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protect peoples' rights. So I absolutely agree that it's 1
gone too far and I think we need to come back. 2
But what I'd like to touch on is this whole issue 3
of a lot of the consulting that I do is in rural communities. 4
And I've been doing it for many years. And two of the things 5
we see are situations -- and I'll use Hot Springs, Arkansas 6
as an example. They have 30,000 people there. They have 7
three hospitals. They have eight MRIs. And so there's just 8
an incredible glut of providers, if you will, more than they 9
need. 10
And then we see other communities where there are a 11
lack of physicians, especially. And I've found with rural 12
communities especially, there are two types of physicians. 13
One are the people that tended to either grow up in those 14
communities and want to give back and go back and work in 15
those communities. And, quite frankly, another group that 16
goes there to hide from the system. 17
And so there's kind of this double-edged sword. In 18
some of these communities, there seems to be such a glut that 19
everybody in Hot Springs who has any possible illness gets an 20
MRI, and in other areas there's just -- the only doctor in 21
town may not be a good doctor, but he's the only doctor in 22
town. 23
And how do we kind of allocate, I guess, resources 24
among those types of communities? 25
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MR. GINGRICH: Well, you raised a couple of things. 1
Let me go through quickly. 2
First of all, rather than complaining about HIPAA, 3
people ought to start drafting the modifications. Congress 4
writes laws so Congress can meet to hold hearings so Congress 5
can write laws. I mean, instead of saying, gee, this is now 6
locked in concrete, we ought to say, okay. This was a good 7
try in the right direction. It's largely better than having 8
no law. Now, what do we have to fix? 9
And just -- I think people should say certainly by 10
early next year that Congress should be holding hearings on 11
the better patient safety, better information model of HIPAA 12
based on what we're now learning. And this will be an 13
ongoing iterative process as we get used to living in an 14
information age. 15
Second, you reminded me, there really should be a 16
nationwide database, for example, of doctors who've been 17
disbarred or of doctors who have been heavily sanctioned. 18
And it ought to be an accessible database. That is, I should 19
be able to find out whether or not I'm dealing with a doctor 20
who has lost 14 malpractice suits in 14 different states. 21
Today there are state databases, but they're not 22
accessible. They're not together. And there's no reason you 23
couldn't have a nationwide database. This is pretty easy. 24
And at a minimum, it will flush out the worst 25
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doctors, which ought to be flushed out. I mean, there's no 1
reason the worst doctors should be allowed to practice. We 2
would not allow the worst airline pilots and the worst 3
airline mechanics to practice. We say there is a standard 4
above which you have to be or you kill people. 5
Third, when you have eight MRIs in a town that 6
size, as long as you know what the price is and as long as 7
that price is public, the least efficient ones are presently 8
going to go out of business unless they're self-directed, 9
which gets me to a fourth point. 10
But I think this is part of why pricing has to be 11
out in the open. Three hospitals won't survive unless they 12
can survive. I mean, I don't care how many retail stores -- 13
back to your point about department stores. I don't ask you 14
how many stores there are in a town. You know, if they can 15
make a living and they're willing to do it, that's fine. You 16
could have 30 MRIs if they can do it. But what I object to 17
is that they pass the cost on and it becomes part of an 18
embedded base of what we mean by health care costs. I think 19
that's inappropriate. 20
The other thing that's wrong, where I think the FTC 21
could usefully look at, is when you have a doctor-owned 22
facility which is also self-referred. And I want to draw a 23
real distinction because I think we made a mistake in 24
designing this. 25
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I have no problem with doctors investing in 1
hospitals unless they refer to the hospital they invest in. 2
But if you end up in a situation, as was described to me the 3
other day in another part of the country, where the 4
doctors -- the cardiologists are really pretty clever. 5
If it's going to be an easy cardiology problem, it 6
goes to their clinic. If it's going to be a really 7
expensive, hard cardiology problem, it ends up in the local 8
general hospital. Now, that kind of behavior strikes me as 9
absolutely wrong and unprofessional and inappropriate, and we 10
need to figure out how we monitor that. 11
The other example is places where hospitals tend 12
not to run emergency rooms so that they don't get the heart 13
attack patient until the second day when they've stabilized, 14
which again means that they have a very high likelihood of 15
success rate without having run the big risk. 16
The last point I want to make about rural America: 17
Rural America will profit more from the rise of internet 18
diagnostics and internet-based capabilities than will urban 19
America. And properly designed, you could have a Visicu for 20
an entire rural state that would literally allow you to have 21
an intensivist for all the hospitals in the state 22
simultaneously. 23
Visicu, for example, is now going to be monitoring 24
the intensive care unit in Guam for the Air Force from 25
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Hawaii. And there's technically no reason not to do that. 1
So you could imagine two years from now every rural state in 2
the country could have a connectivity to an intensivist even 3
for very small rural hospitals, and the coaching improvement 4
would be dramatic. 5
I'd also say for small rural areas -- and again, 6
this is the cultural crisis -- you know, you're now talking 7
to the local doctor who's been totally in charge for all 8
their life. No one has ever questioned them. They're the 9
only doctor within 25 miles. And somebody is now going to 10
look over their shoulder? 11
I mean, this is a -- you know, and what I'm arguing 12
is, yes. For patient safety reasons, for public outcome 13
reasons, you're right. And the other example I would cite is 14
Active Health, which is a very good firm, which works for 15
large corporations. And they basically get world class 16
doctors to coach your doctor if you have an expensive 17
illness. 18
And it turns out that by getting the world class 19
doctor to work with your doctor, your doctor's quality of 20
care goes up dramatically. And again, for rural America, 21
these things are potentially doable, but they're only doable 22
from the state level down. They're not doable by small 23
hospital by small hospital because they never aggregate the 24
resources to do it. 25
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DR. HYMAN: Let me ask a question about 1
information. I mean, information is an important part of a 2
functioning market. You've emphasized it in your remarks. 3
And the absence of good information is a quite traditional 4
and well-recognized justification for regulation. 5
But -- and you knew that was coming -- in health 6
care, the presence of information can result in adverse 7
selection problems on the coverage side, and moral hazard 8
problems on the delivery side; that is, knowing more about 9
what you've got will influence what kind of health care you 10
sign up for and what kind of benefits you end up receiving. 11
So I guess I'm wondering how you sort of see a 12
patient- or consumer- or individual-centered health care 13
system dealing with the problems that we've had that have 14
resulted in some of the institutions that you've criticized 15
here. 16
MR. GINGRICH: Well, I think -- first of all, the 17
absolute bias has to be in favor of information. I mean, 18
there is no evidence in the last 300 years of rising 19
prosperity and rising positive outcomes and longer lifespan 20
that keeping people from knowing things is a good idea. 21
So then you have to deal with the consequences of 22
the information. In some cases, we'll do that, I suspect, by 23
law. That is, we'll say, you can't use a certain kind of 24
information in employment decisions, or you can't use certain 25
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kind of information in insurance decisions. 1
I would argue in part that you want to have -- and 2
this may sound contradictory coming from a conservative, but 3
I think we want a country that is very close to 100 percent 4
insured. And the reason you want that is we made the 5
decision we're not going to let people die without caring for 6
them, and so to not have them insured just maximizes the 7
complexity of the delivery system. 8
I think between vouchers, tax credits, and tax 9
deductions, you can create a system in which people have 10
virtually 100 percent insurance. And then you want to make a 11
ground rule for offering insurance that you can't cherry- 12
pick. 13
And there are a variety of ways to do that by 14
having open access. You can have an open access system that 15
also incents good behavior. That is, you could have -- you 16
could say to people, if you keep your cardiovascular within 17
certain parallels, you know, we'll give you $100 back at 18
Christmastime. And you can do that without having cherry- 19
picked. 20
But I do think you want to say basically that in 21
the case of health insurance -- which is really an anomaly 22
because it's mostly not true insurance. Health insurance is 23
mostly prepaid medical care with some insurance components. 24
Now, we go a step further in "Saving Lives and 25
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Saving Money." We propose that Congress should pass a law 1
creating a personal health account, which would in essence 2
mean that when you first went to work, you'd get, say, a 3
$1500 deductible and we'd put the $1500 in your account so 4
you're now spending your dollars. 5
It would be -- it could carry and have tax-free 6
interest buildup. So when you're young, you probably 7
wouldn't spend it, and within a very few years, you'd be at 8
the 20-, $30,000 deductible level with it being your own 9
money. 10
When you got above the value at which you got any 11
kind of break on the -- now you would be on a true insurance 12
system because now you would have set aside your maintenance 13
health money, which you'd be spending, and the insurance 14
company would actually be offering genuine insurance. 15
The other piece of that is probably we need, 16
whether it's designing a government-sponsored enterprise that 17
would be competitive or some other model, we probably need 18
only to go to a reinsurance system, that is, to create a 19
national pool where, whether it's a $200,000 -- there's some 20
dollar value where the price becomes so large that you can 21
never really create smaller risk pools that make any sense. 22
Because what you want to do is take the cherry- 23
picking out of the system by saying, there'll be some kind of 24
universal reinsurance cost for -- whether it's 200,000 or a 25
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million or something -- probably done by a government- 1
sponsored enterprise. 2
But I think the inability today to have that kind 3
of insurance pool means you get grotesquely expensive small 4
business insurance plans because they are buying a risk 5
premium against one bad event in a way which really optimizes 6
cherry-picking. 7
So I'll just close by saying part of what you want 8
to do is think through a design which minimizes the incentive 9
for cherry-picking. 10
DR. HYMAN: Dr. Comstock, did you want to have a 11
question? Or Mr. Lansky, do you have a question or an 12
observation you want to make? 13
MR. LANSKY: I'll ask a question, yes. 14
The managed care/managed competition model 15
foundered for a variety of reasons. Its original premise was 16
system integration, integration of care delivery and 17
accountability for performance. And then in that model there 18
may have been a market to choose integrated systems. 19
The consumer-directed models, as commonly 20
discussed, radically fragment the system into individual 21
commodity services that are bought and sold. And you could 22
have an information flow and you could have pricing of those 23
individual elements. A mammography is one price. A doctor 24
visit is another. An insurance coverage policy is another. 25
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The information burden and the lack of integration 1
and coordination in the highly fragmented model are two big 2
problems. So one question is, how do you see the relative 3
balance between essentially bundling, creating continuity, 4
integration of services which manage, for example, chronic 5
conditions or end-of-life care, complex care, rather than a 6
highly fragmented marketplace? 7
And secondly, what do you see as the balance 8
between the regulatory function on the information 9
requirements in such a market and the self-issued information 10
opportunities? 11
And I'm probably interested in -- to the extent 12
that I've become more and more of a believer that there has 13
to be government standardization of information requirements 14
and disclosure requirements and so on and of infrastructure, 15
as you've supported for a long time, electronic 16
infrastructure to support that information capability. 17
But that becomes massively complex in a highly 18
fragmented system in which you've got very diverse products 19
competing, and the kind of lack of information that Dr. 20
Greenberg talked about. 21
MR. GINGRICH: Well, I mean, the fact is we've had 22
a very long track record, starting with railroad track size 23
and the development of the Morse code and the rise of 24
standard time, which are late 19th century developments, all 25
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of which are proof that you can have systematized national 1
standards. 2
There's a -- and I can't remember the name of it 3
right now; some of you will know -- there is a national 4
association founded, I believe, in 1916 for electric 5
standards during a period when the government wanted to 6
ensure things happened but didn't want to do it itself. And 7
so all electrical appliances in the United States go through 8
the same standard-setting, which is actually a private 9
association, legally empowered to do that. 10
You could -- you know, and whether you have HHS set 11
an information standard or you have the government establish 12
a freestanding commission for medical information, which may 13
be the right parallel -- but your point's exactly right. 14
I mean, jumping out five years, or no more than 15
eight but within five years, automatic electronic health 16
record -- I want to distinguish a health record from a 17
medical record. A health record is all the information that 18
you should carry with you for the next doctor. The medical 19
record is everything the doctor and the hospital need to keep 20
for the lawsuit. A very big difference in detail, in level 21
of detail. 22
Everybody ought to have an electronic health 23
record. It ought to be compatible across all the systems. 24
All the major providers of these kind of systems should be 25
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part of an open systems architecture as opposed to I'm going 1
to design some cute device so once I have you, you're a 2
captive and you can't use anybody else's equipment. 3
And again, all of us who use the internet and who 4
use laptops are -- you know, everybody who uses a cell phone 5
has experienced this. And I want to draw a distinction 6
between two different points you made, and then talk briefly 7
about managed care. 8
The model that Dr. Greenberg described is a model 9
of stunning consumer choice. You know, I decide today I want 10
to go buy X. I have lots of places to go buy X. It's the 11
job of the aggregator to provide me a reputation and a price 12
and a convenience I want to go to. 13
And then you're exactly right in your analogy. You 14
know, there are all sorts of places I can go for what I want, 15
and I get signals from the system about reputation, et 16
cetera. 17
So you could have a consumer-driven system in which 18
you had a very high level of common information, more, I 19
would say, than you get today. That is, if I had an 20
electronic health record so that the next doctor knew what 21
the last doctor had prescribed, you'd already be at a quantum 22
jump above current behavior. 23
The second part, though, I think, is a misnomer 24
about what happened with managed care. It goes back again to 25
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the moral cause. Health is different than buying clothing or 1
buying jewelry. There is a moral component because it's 2
about my life or my daughter's life or my granddaughter's 3
life or my mother's life. 4
And so the minute I think that a decision about 5
their life will be profit-driven as distinct from profit 6
being derived from the right decision, if it is a profit- 7
driven decision, I am very suspicious that I am now going to 8
have my granddaughter get bad care so somebody has a better 9
quarterly report. 10
I mean, the analogy -- and by the way, I'm told 11
this all the time. Insurance companies will tell you with 12
great openness, we don't do preventive care because people 13
don't stay with us long enough to justify it economically. 14
Well, that's like an airline saying, you know, we're going to 15
be as safe as our quarterly report permits. Now, we wouldn't 16
tolerate that for one minute. 17
So what the insurance company is tell you is they 18
are putting your health needs below their profit margin. And 19
it is a perfectly rational behavior in the current market. 20
And that's why people have this deep suspicion of the 21
financing of health care, that a decision will be made, I 22
won't get what I want. 23
Now, I'll give you a couple of examples. And here, 24
AARP and others are actually showing some real leadership. 25
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Comorbidities are the largest single problem in Medicare. 1
Five percent of the people on Medicare use up 50 percent of 2
the money. That 5 percent has, on average, somewhere between 3
five and seven comorbidities. It's very clear they ought to 4
get managed as a complete person and not have five to seven 5
separate verticals. 6
That can be done in a system where you basically 7
say, we're going to incent the doctor to have full 8
information through an electronic health record. And we're 9
going to incent the doctor to deal with all the comorbidities 10
at one time. 11
And you can design a system that does that while 12
still allowing the patient to pick which doctor they want to 13
go to. So it's not an either/or. It's not either that we've 14
got to trap people into a system where it's controlled for 15
them, or they've got to be out here in a chaotic jungle 16
without any kind of information. 17
If you use the incentives right and you use the 18
structure of information right, you can migrate to a system 19
in which I still have choice, but it's choice among a series 20
of very high value products with much more complete knowledge 21
than we have today. 22
I would argue if you've got the right electronic 23
health records and the right kind of requirements for 24
electronic prescriptions, et cetera, you will have 25
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dramatically better health almost overnight in terms of the 1
way in which we minimize medication errors and other kind of 2
mistakes. 3
DR. COMSTOCK: I do have a comment, actually. I 4
think everybody in this room, and certainly around the table, 5
agrees with a lot of what Newt has said. And whether you 6
believe that there's 30 percent waste in the system or 40 7
percent waste in the system and all of these dollars were 8
there that could be easily used to do things like create 9
access for everybody in this country or create the 10
infrastructure, improve the transparency of information, we 11
have been involved in a community project across the country. 12
And when you talk to health care leaders there, 13
fundamentally they say, well, it's all well and good to say 14
that money exists, but you can't wait to take all of that 15
efficiency and put more efficiency into the system. There 16
needs to be an investment now. 17
And what we're doing is we're talking about -- 18
we're not really talking about what we really want to 19
achieve. We're talking about where the dollar is coming 20
from. 21
And I guess I'm wondering whether you have any 22
ideas of how you manage that transition from an economic 23
perspective. I mean, do we suddenly decide we're going to 24
spend X billions more money in order to squeeze the 25
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efficiencies into the system and take that waste out so that 1
we can create access and infrastructure, or do we wait until 2
we've gotten some dollars up? It's all about money. 3
MR. GINGRICH: Well, okay. Let me give you three 4
parallel answers because I think there are actually three 5
different components. 6
First of all, we recommend strongly in "Saving 7
Lives and Saving Money" that the federal government pick up 8
the equivalent of Eisenhower's interstate highway system 9
because if you look -- we have a long chapter at the back of 10
the book on biological warfare. I personally am convinced 11
that biological threats -- if you're listing all the weapons 12
of mass murder, that biological threats are 80 percent of the 13
danger, nuclear is about 19-1/2, and chemical is about 1/2 14
percent. 15
And I talked to one Nobel prize-winning biologist 16
and said, if we had an engineered virus, what would a 17
reasonable casualty rate by? And by engineered, I mean 18
something which was not susceptible to a current vaccine. He 19
said, 50 percent. And I said, that would be 145 million. He 20
said, that's a reasonable number. And he said, I won't say 21
that publicly because I haven't got any solution. 22
But if you go back as a historian and you look at 23
really good epidemics, it is breathtaking. Florence as late 24
as the 1440s was losing 20 percent of its population in one 25
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year. This was some 80 years after the bubonic plague first 1
began sweeping through Europe. 2
So let's just start with the idea none of us -- and 3
we get scared by SARS, which has killed a couple hundred 4
people. I mean, none of us has seen what a real epidemic 5
would be like, and it would be horrifying. 6
So I would argue that under homeland security 7
requirements, we need about a $40 billion investment in the 8
equivalent of the interstate highway system. And in our 9
book, we quote Eisenhower, who specifically had the 10
interstate highway system as a national defense act, although 11
it's obvious from the middle class that it has been 12
enormously successful in other ways. 13
That system should also include a virtual public 14
health service which connects all 55,000 private pharmacies, 15
all retired nurses and doctors as well as currently active 16
nurses and doctors, and includes veterinarians. Because if 17
you lose a central city, one of the largest sources of health 18
resources in the surrounding countryside will turn out to be 19
veterinary hospitals. 20
Second, I want to suggest to you that here's a 21
place where there are opportunities for huge improvements. 22
We work with the people at IBM who do logistics supply system 23
modernization, where they take huge amounts of cost out of 24
logistics systems. 25
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And I was talking the other night with doctors at 1
the major medical groups, who said that the paper-handling 2
transaction cost of getting paid is three or four times 3
greater in health care than it would be if you were dealing 4
again with the big department stores you were describing. 5
Imagine a -- and it's particularly stupid for the 6
self-insured. I mean, for a self-insured company to engage 7
in a long-time value of money for doctors means the doctor 8
will countervail by charging more to make up for the lost 9
value of money and will then have to add clerical staff, et 10
cetera. 11
So imagine a system where doctors filed 12
electronically with your health record and your bill 13
simultaneously, by one click, and were paid every night by 14
electronic funds transfer on a post-payment reconciliation 15
system. 16
Now, you'd have dramatically fewer clerks. There 17
was a study done, I was told, for Blue Cross -- I have not 18
seen this, but a study, I was told, was done for Blue Cross 19
of Massachusetts that they figured out if you could have 20
realtime verification of eligibility, you would eliminate 21
one-half of their clerical staff. 22
Now, this is not heavy lifting. I mean, if you 23
think about what happens worldwide when you use your Visa, 24
MasterCard, American Express, you name it, I mean, we somehow 25
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are able to stand at a restaurant or at a store buying a 1
tourist trinket and in virtually real time, 20 seconds, two 2
minutes if it's a bad location, you know, they know who you 3
are no matter what country you're in and they validate the 4
payment. 5
And American Express doesn't have 600 people doing 6
physical labor reading your paperwork. I mean, that's not 7
how it works any more. So imagine you could take 2 to 4 8
percent out of the total cost just by going to the electronic 9
fund transfer with reconciliation. 10
But I want to make one last point, which is, 11
hospitals and doctors who explain to you that they can't 12
afford a Palm pilot -- I want to stick with electronic 13
prescriptions, which can be done on a Palm. This technology 14
has been around for at least six or seven years. 15
There have been three or four firms that have 16
designed systems on Palm -- I think Hippocrates is one of 17
them -- where -- and over a quarter million doctors have 18
downloaded Hippocrates because it's free, and it gives you 19
the formulary and all this stuff. 20
The notion that it's a price problem is just plain 21
baloney. And part of the reason you don't get change in 22
health care is people who are doctors and people who are 23
hospital administrators assert the right in a totemic manner 24
to explain to you that you don't know anything, and therefore 25
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you just don't understand because it's so complicated. 1
And the correct answer with some of this is, that's 2
silly. I mean, to tell me that a doctor can't afford to go 3
online and pull up Dell or Gateway or Compaq and get a 4
computer, when they have one? To tell me they can't use a 5
Palm? 6
It would be like somebody saying to you, I'd like 7
to use a cell phone but, you know, cell phones are so 8
expensive and we just can't invest in cell phones. I mean, 9
you'd break up laughing because you know all of their 10
teenagers have one. 11
So I would just assert that some of this stuff 12
isn't done because they don't want to do it. The excuse they 13
use is malarkey. And I say that in the context of saying, I 14
think we ought to have a nationwide IT investment of about 15
$40 billion in health care, and I think that we actually 16
ought to have the federal government much more concerned 17
about realtime connectivity. But I don't accept the idea 18
that you couldn't go to electronic prescriptions tomorrow 19
morning because doctors couldn't figure out how to use Palm 20
Pilots. 21
DR. HYMAN: Well, the panel has been such a 22
vigorous participant in the discussion, I'm afraid we've run 23
out of the time that we had allotted for having Newt speak. 24
So although he's going to be with us for a little bit longer, 25
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I'd like, since he's going to have to leave in the middle of 1
the presentations, a round of applause for the presentation. 2
(Applause.) 3
DR. HYMAN: I'm just going to introduce everyone on 4
the panel at once, and we can sort of go across. People can 5
either speak from where they're sitting or up at the podium. 6
The first speaker, since he's over on the far left, 7
is going to be Warren Greenberg, who's a professor of health 8
economics and health care sciences at George Washington. 9
Next will be -- he's going to speak for about ten minutes. 10
Next, David Lansky, who is sitting to Newt's left, 11
who is the president of the Foundation for Accountability, 12
has been the president since the organization was founded in 13
1995. 14
Following him will be Michael Young, who is senior 15
vice president at Aon Consulting, focusing on health and 16
welfare issues. 17
To my immediate left is Helen Darling, who wins the 18
frequent flyer award for the panel because she has spoken 19
more than anyone else on the panel, and I think probably more 20
than anyone else we've had, she's such a wonderful speaker. 21
She's the president of the Washington Business Group on 22
Health. 23
Seated to Helen's left is Dr. Marcia Comstock, 24
who's the chief operating officer and a member of the board 25
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of the Wye River Group on Health care, who has done a lot of 1
work on emerging trends in health care finance and delivery 2
and is going to talk about some reports that the Wye River 3
Group has released. 4
And then finally, batting cleanup, Greg Kelly, the 5
executive director of the Coalition Against Guaranteed Issue, 6
and I believe also the Coalition for Affordable Health 7
Insurance -- Council for that. 8
And so without further ado, why don't we start with 9
Warren. 10
DR. GREENBERG: Thank you very much, David. It's a 11
pleasure to be here and it's a pleasure to be with this 12
distinguished panel and the audience here as well. 13
I understand I only have ten minutes, but I'm glad 14
that the Speaker's talk was so comprehensive because I'll be 15
able to just fill in the blanks, I think, from what he had to 16
say. 17
I was at one time staff economist with the Federal 18
Trade Commission. I believed that every imperfection at that 19
time in the marketplace was due to an antitrust violation. I 20
soon found out that in addition to antitrust violations, 21
which are remedied by the FTC and DOJ here, that there are 22
many imperfections due to ill-conceived government 23
interference in the economy or simply market failures. 24
In this testimony, I suggest three examples of 25
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these latter imperfections. My goal, as I believe is the 1
goal Chairman of the Federal Trade Commission as well as the 2
entire FTC, is to achieve both price and quality competition 3
in the health care sector, and I mean the entire health care 4
sector, not just the Medicare program. 5
The three imperfections I'd like to focus on are: 6
the failure to tax employer-paid health insurance premiums; 7
adverse risk selection for health plans; and U.S. and state 8
"any willing provider" laws. This is filling in the blanks, 9
perhaps, for the Speaker's talk you heard previously. Now, I 10
shall go over each one of these in turn. 11
The failure to tax employer-paid health insurance 12
premiums has led to the retention of employer-paid health 13
insurance. Absent this tax, there would be no advantage to 14
the employer paying health insurance premiums instead of 15
providing increased wages in order to retain employees. 16
Employer-paid health insurance, which would be subject to 17
state and federal income taxes as well as Social Security and 18
Medicare taxes, would become less attractive for the employer 19
to offer and the employees to receive. It would soon 20
disappear if it were taxed. 21
An individual-based health insurance system without 22
the involvement of the employer would be much more conducive 23
to the introduction of quality and price into the 24
marketplace. What am I talking about here? 25
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There is a substantial amount of turnover in the 1
U.S. labor force. Although this differs by geographic areas, 2
location, type of job, age and gender of workers, it has been 3
estimated that job turnover is between 12 and 16 percent 4
throughout the economy. In higher turnover industries, such 5
as agriculture or construction, the turnover rate is even 6
much higher. 7
And we talk about incentives here. When job 8
turnover is high, there is little incentive by the employer 9
to invest in health plans, to invest in expensive but perhaps 10
better quality treatment and procedures, as well as superior 11
physicians and hospitals, which can improve quality of care 12
and perhaps lower cost in subsequent periods. Why? Because 13
within one or two years, those employees are going off to 14
other jobs with other health care plans. 15
In contrast, if there were an individual-based 16
health insurance system rather than an employer-based system, 17
individuals would retain their health plan whether employed 18
with the firm, self-employed, retired, or disabled. 19
Individuals would choose a health plan from a variety of 20
health plans during yearly open enrollment periods. 21
Individuals will buy health insurance in the same 22
way they purchase automobile insurance without regard to 23
employment status. Income-adjusted premiums may be needed to 24
help those with lesser incomes if universal coverage is 25
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desired. 1
Individual-based health insurance is found in many 2
European countries and Israel. In an individual-based 3
system, individuals might belong to a health care plan for 4
many years or decades, providing incentives for these health 5
care plans to do disease management and to try to insure 6
quality early on. 7
There would be greater incentives for the health 8
plan to invest in a person's health and to improve quality of 9
care rather than the current system that we have in force 10
with our individual -- with our employer-based health care 11
system. 12
However, under an individual-based system, and this 13
was touched on by the Speaker, precautions will be needed, 14
however, to insure that health plans are not avoiding high 15
risk enrollees. And therefore I would suggest we also need, 16
in addition to employer-based health insurance, the idea of a 17
case mix risk adjustment system. 18
Why? Because if health plans competed on a quality 19
of care basis, and we touched on this before, the plans which 20
provided the highest quality of care, in the language that we 21
talked about before the Nordstrom's, the Lord & Taylor, 22
perhaps, would attract the highest risk employees in the 23
following opening enrollment period, increasing its cost 24
considerably. 25
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This leaves little incentives for health plans to 1
compete on a quality of care basis or to disseminate 2
information on quality. This is why I say we don't have 3
Nordstrom's and Bloomingdale's. One health care plan that 4
comes out and says, we are the Lexus of all health care 5
plans, next year will see its costs go through the roof. 6
Changing these incentives will be therefore a 7
factor in achieving quality in health care. And how might we 8
focus on that? 9
A risk adjustment payment should be applied to each 10
competing health care plan. There's a market failure here. 11
We have to somehow solve it somehow. Risk adjustment may 12
improve quality of care, creating a marketplace based on 13
quality and price for the first time among competing health 14
care plans. An accurate risk adjustment payment will create 15
incentives for health plans to deliver a higher quality of 16
care to attract higher risk individuals since they will be 17
paid for enrolling these higher risk individuals. 18
However, achieving an accurate risk adjustment 19
payment has been difficult. But even Medicare has been 20
trying it under their risk adjustment PIP DCG approach, and 21
other countries have tried it with some success. The 22
Netherlands examines age, gender, employment status, and 23
region of the country. Germany uses age, gender, and 24
disability. Israel uses only age. 25
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Health plans would be reimbursed by a neutral party 1
according to the number and severity of the individual 2
enrolled. Those health plans with a great number of high 3
risk individuals would be reimbursed at a higher amount. 4
This would create incentives for health plans to compete on 5
quality in order to attract the higher risk individuals. 6
Those health plans which do not necessarily compete 7
on quality, and perhaps stress lower premiums, would receive 8
little or no risk-based reimbursement. Price and quality 9
competition here. Each of the health plans would be required 10
to help finance the payments to the health plans which have 11
enrolled the high risk individuals. 12
Again, I won't repeat what I said before. But 13
under these circumstances, I do believe we will see the 14
department store approach where health plans are competing 15
both on price and quality, the same way we might see a Saks 16
Fifth Avenue and Bloomingdale's approach. 17
Under this kind of competition, the difficulty in 18
determining quality of care would also be less daunting for 19
the patient. It is also possible that individuals with the 20
same price/quality tradeoffs may differ on their view of 21
particular department stores, yet with its faults, many 22
individuals are satisfied to make this one of our most 23
important buying tools. 24
Finally, in the third step, each health plan should 25
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be encouraged to utilize every avenue to improve both quality 1
of care and lower price. This would include selective 2
contracting with a limited number of physicians and hospitals 3
in the geographic area to attempt to achieve the lower cost 4
or higher quality. 5
Lower cost may be achieved by playing providers off 6
one against another to achieve increased volume and lower 7
cost. Improved quality can be maintained by contracting 8
only, perhaps, with the Cleveland Clinic or Mayo or a limited 9
number of hospitals. And physicians who increase volume may 10
translate into higher quality. 11
Unfortunately, recently the Supreme Court ruled 12
that "any willing provider" laws may be enacted by state 13
governments in which a health plan must contract with all 14
providers which would like to sign a contract with the health 15
plan. "Any willing provider" laws, if enacted by state 16
governments, would eliminate the potential for contracting 17
with only a limited number of providers. 18
In order for health plans to compete based on price 19
and quality, states should no longer to attempt to enact 20
these "any willing provider" laws, and those laws which have 21
been enacted should be repealed. Thus far, in 17 states, 22
"any willing provider" laws have been enacted to prevent 23
selective contracting with physicians. Thirteen states have 24
enacted laws which prevent selective contracting in regards 25
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to hospitals. 1
Health care expenditures, including studies here by 2
economists at the FTC, have been shown to be much higher in 3
those states where they have "any willing provider" laws. 4
I would sum up by saying these three steps -- an 5
individual-based health insurance, which could be achieved by 6
taxing employer-based health insurance; a risk adjustment 7
payment; and selective contracting -- are necessary to 8
achieve both price and competition in health. 9
Each of these steps is interrelated and is 10
essential to competition. Without the possibility of both 11
price and quality competition, the health care marketplace 12
will remain inefficient. There will be over-investment of 13
price competition at the expense of improved quality, 14
resulting in economic loss for those who desire improved 15
quality. Even those who put a greater emphasis on price 16
competition will be confronted with a downward spiral of 17
quality if there are no incentives to provide quality of 18
care. 19
With $1.4 trillion spent on health care in the 20
United States, it is imperative to create incentives for 21
improved quality as well as reduced costs and to eliminate 22
these three market imperfections to compliment the antitrust 23
efforts of the FTC and the Department of Justice. 24
DR. HYMAN: Dr. Lansky, your PowerPoint is up on 25
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the screen. So you can run it from up there if you like. 1
DR. LANSKY: Thank you, David and the Commission, 2
for letting me join you. I appreciate it. 3
My particular area of interest is in the 4
information requirements of consumers to be successful in 5
this health care system and market. And you had a marvelous 6
set of witnesses in the last few months covering much of what 7
I would normally have wanted to say. 8
So given that, I thought I would take a particular 9
slant on a theme, I think, that has not been adequately 10
addressed, which is the genuine experience of patients 11
seeking and getting health care, and what information is 12
needed in the course of our real lives, leaving a little bit 13
aside the legal and technical requirements that I think are 14
vital but I do think have been fairly well addressed. 15
So I'll introduce the term person-centered. And 16
the Speaker has certainly emphasized that throughout his 17
work. And I'll give you -- I wanted to start with a couple 18
of examples, but I'll have to figure out how to -- okay. 19
Just briefly, our organization, the Foundation for 20
Accountability, was founded in '95. It was primarily founded 21
by large purchasers, including HCFA, General Motors, American 22
Express, large consumer groups like AFL-CIO and AARP. And 23
our charge at that time was to make managed care work by 24
developing a set of quality measures that could be used to 25
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support competitive purchasing. 1
We developed about fifteen different sets of 2
measures addressing a number of chronic illnesses, end-of- 3
life care. We've done a great deal of work the last five 4
years on child and adolescent health, particularly to support 5
the CHIP and Medicaid purchasing requirements. 6
In the course of doing that, we quickly learned 7
that measures and data per se were not sufficient to support 8
a successful market, and we had to think about a framework 9
for presenting and communicating information. We developed 10
such a framework that's summarized very briefly here, and 11
NCQA, the National Quality Report, the IOM, Newsweek 12
Magazine, a number of organizations, have used that approach 13
we recommended. 14
More recently, the last three or four years, our 15
shift has been very much toward understanding what do 16
consumers do with information, how do they make decisions, 17
and how do they access information. We've done a lot of work 18
on how do you present comparative information to consumers 19
for their use, a set of interactive web tools to allow people 20
to make their own decisions using available comparison 21
information. 22
We've been doing quite a bit of work on the 23
personal health record the Speaker just spoke about, the idea 24
that you own your health information, that it's 25
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interoperable, it's transportable, and it is lifelong. And 1
we are just now working on a project with the maternal and 2
child health bureau here to develop what we call a data 3
resource center, which allows the consumer or a policy-maker 4
to access all the knowledge there is that may help them 5
understand and advocate for health improvements. 6
We've done about a hundred focus groups in the last 7
few years. We've done very large surveys. We do a lot of 8
interviewing. And we spend a lot of time working with 9
patients, veterans, labor organizations, to understand what 10
their constituency may be concerned about. 11
So that is context. I think the main theme I want 12
to mention today in terms of the quality, information, and 13
field that we work in is that the history of the last ten 14
years or so in this field -- and the Speaker spoke about the 15
idea of guilds influencing the behavior of the delivery of 16
care. 17
It's equally true in the information field, that 18
the information constructs that are often used to communicate 19
to the public are actually driven from above, not from the 20
experience of the person who needs to make a decision. 21
So the categories we use to fund health care and 22
the categories of specialty training tend to be the 23
categories we use to collect and disseminate information. I 24
don't think those always serve the needs of a real family 25
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making a difficult health care decision. 1
And therefore, I think as we think about the future 2
marketplace in health care and the use of information in 3
health care, we need to think harder and work harder at 4
embracing the patient and family experience, and having them 5
tell us what information they need to make decisions. 6
So let me tell you a couple quick stories. The 7
first one, of course, is a personal story. On the left of 8
this picture is my mother-in-law. Grandma Lou, we call her. 9
She at the time of this story was 72 years old. She was a 10
coal miner's daughter from up in the Canadian border area of 11
Washington state. She started smoking when she was 13, 12
stopped when she was 55. 13
When she was 72, she went in for a routine primary 14
care visit. They did an x-ray. They spotted an apparent 15
tumor on the x-ray, referred her for a CT scan. The primary 16
care doctor was concerned, referred her to a community 17
surgeon. 18
I asked around in my network to see if this surgeon 19
was any good, a common question we all ask. I was very much 20
reassured that not only was he good, he was a very aggressive 21
surgeon, which for cancer is taken to be a good thing. 22
We went to see this surgeon. He said he could not 23
biopsy the tumor in this location that was revealed on the 24
film, and therefore he immediately recommended a lobectomy, 25
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removal of the section of the lung to remove this tumor. 1
Obviously, my mother-in-law and my wife were 2
paralyzed with fear and anxiety, and immediately wanted to 3
pursue the doctor's recommendations. But my wife, on the far 4
right of this picture, being at least interested in the web, 5
got online. And this is her weekend's work, between the time 6
of the recommended scheduled surgery and the end of the 7
weekend. 8
She found a lot of resources to try to assess what 9
was going on in this case. You'll see the one on the left 10
there says "Probability of malignancy in solitary pulmonary 11
nodules," which is actually an online calculator that allows 12
you to enter the information that you may have from the film 13
and get a prediction of whether or not this is in fact a 14
malignancy or benign. 15
And my mother-in-law's data said it was 24 percent 16
chance of being malignant. So whether it was appropriate 17
with a 24 percent probability of malignancy to do this 18
radical surgery was certainly something needing a little more 19
discussion than we'd had the first time around. You also see 20
information from the cancer support groups, and a quick 21
education on imaging. 22
It turns out that one of the articles my wife found 23
has an NCBI study that she found in 1999 when this occurred 24
of a three-year-old study which talks about the evaluation of 25
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solitary pulmonary nodules by PET scanning, which was a 1
relatively new but not brand-new technology. And at the 2
bottom of this and circled, it says, "This technology is 3
highly accurate in differentiating malignant from benign 4
solitary tumors." 5
Now, the surgeon, in his guild and in his own 6
personal experience and community, had brought none of this 7
information to our attention. It turns out four miles down 8
the road from the surgeon's office was a PET scanner at the 9
University of Washington. 10
To make a long story short, my wife got involved in 11
this process, redirected the care to the PET scan. The PET 12
scan showed a benign tumor. That was four years ago and no 13
surgery took place. The taxpayers and Medicare were saved 14
40- to $60,000 of cost. My mother-in-law was saved a lung. 15
And the story has a happy ending. 16
One footnote to that story, just on the question of 17
choosing quality. Among the decisions to be made was where 18
do you go for this operation, if it had in fact been needed? 19
This data is available for some states. I happened to pick 20
this New York because I gave this presentation, or parts of 21
it, in New York. 22
You'll see that the Speaker again referred to the 23
differential mortality rates in different locations. In this 24
case, for this lobe resection surgery, there's about a 25
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fourfold difference in mortality if you go to a place that 1
does a lot of them versus a place that does only a few of 2
them. 3
And if you look at this New York City data, one of 4
our concentrations of medical excellence in America, only one 5
hospital in the entire central area of New York City performs 6
above the threshold number of lobe resection surgeries in a 7
year. A huge number of hospitals perform one, two, seven 8
operations a year in this very complex and very invasive 9
procedure. 10
My mother-in-law again had no information 11
whatsoever provided to her to guide her decision. And as I 12
suggested earlier, even in this one story, there are maybe 13
ten, fifteen important consumer decisions to be made: the 14
primary care doctor, the first imaging center, the second 15
opinion, the second imaging center, the facility to have the 16
operation done in, the surgeon to have conducted the 17
operation, in a moment of enormous anxiety, pressure, and 18
fear. It's a very complex set of consumer decisions to 19
unravel in the real world. 20
A second example I want to give is our development 21
of a set of quality measures for HIV and AIDS care. And this 22
would -- we had a wonderful commission or advisors, the 23
chairman of the President's Commission on AIDS, and a great 24
group of experts. 25
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And they listed, as you see here, about eighteen 1
things which they think are important to measure to describe 2
the quality of HIV and AIDS care. And if you're a patient or 3
if you're in an oversight position and you want to evaluate 4
the quality of care in this arena, here are the things you 5
might want to look at. 6
We asked the experts to rank order which of these 7
eighteen things are the most important to use to assess the 8
quality of care for HIV and AIDS. And you see the rank 9
ordering they have here. The first was that the patients 10
receive anti-retroviral therapy, the second that they be 11
regularly assessed for viral load, the third that we have 12
treatment to prevent opportunistic infections, and so on. 13
We then asked a series of focus groups of patients 14
how they regarded the priorities in making a decision on 15
where to seek care. And here's the ranking the patients 16
provided. We tapped quite a variety of different kinds of 17
patients -- gay white men, IV drug users, people who were not 18
primarily English-speaking -- to find out what their 19
perceived needs were in quality. And these are people who on 20
average had been diagnosed eight years earlier, so they were 21
very experienced patients. 22
Their number one concern was the prevention of 23
opportunistic infections. Their second most important 24
criterion was that they be involved in making decisions about 25
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their care. The third most important was that they can 1
function, down at the bottom of that slide, that they can 2
live. 3
The doctors had actually recommended we not include 4
that as a quality measure at all because they thought it was 5
beyond their ability to control and not a fair measure of 6
their performance. It was a pure outcome measure, and 7
therefore not within their responsibility of scope. 8
Now, the patients -- I'll just give you one quote 9
from one of the focus groups. "I'm not taking any drugs or 10
anything like that," basically because, he says, "I'm a young 11
black male and in my age group there's very little research 12
being done, and as a black male most of it doesn't affect me. 13
It's for white people 35 to 45. So until there's more 14
research, I'm not taking those drugs." 15
And a number of these patients said, if I don't 16
trust my doctor and if my doctor does not respect and 17
understand my life, I'm not following their advice. So the 18
concept of constructing information for consumer decision- 19
making has to capture the real behavior and real criteria of 20
patients themselves. 21
The third example I'll just mention just for one 22
observation from it, we've been doing a series of projects in 23
Vermont with family practice and pediatrics to understand 24
what do people want to know to evaluate their care. And this 25
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was actually given to the doctors, not to the patients. 1
But the thing I found most interesting in talking 2
to many patients -- these are parents of sick children -- was 3
that what they said was, I don't want to choose a new doctor. 4
I don't want to be told my doctor is poor. I want to make my 5
doctor better. I've been using this doctor for four years, 6
ten years, whatever. It's a place I'm comfortable getting 7
care. I want to know what they're doing poorly so that I can 8
basically beat them over the head with it and I can work with 9
them to improve the quality of care they receive. 10
So I think the ah-hah for us who had done an awful 11
lot of worn on exit, on choice, was that a lot of patients 12
really want voice and they want tools to improve their 13
interaction with their providers. So it's a much more 14
complex use of information than we had previously discussed. 15
Just to tie this all together and again reveal the 16
complexity of it, this is a map we did with the General 17
Electric workforce to identify all the information patients 18
want to know in real life -- these are people who've been 19
diagnosed with breast cancer. We asked them, what do you 20
want to know to get the best possible health care? 21
And as you look at a spectrum from the far left, 22
where people are at risk of breast cancer but not diagnosed, 23
to the far right, where they have had successful intervention 24
and are now living with the disease as a survivor, there's a 25
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lot of information. 1
And it's very contextual, not surprisingly. The 2
information a young woman who may feel at risk for cancer 3
because of her relatives' experience wants to know is 4
dramatically different than someone who's about to have an 5
operation to remove a vital part of their body or deciding on 6
a form of therapy postoperatively. 7
So the sensitivity, the specificity, the 8
personalization of information is in some ways self-evident, 9
but most of our discussions about making the market work have 10
not been very finely attuned to where patients are in their 11
experience of seeking care. 12
And one other footnote on this particular example. 13
This is a study done in comparing care in Massachusetts and 14
Minnesota for breast cancer. And I think there are two 15
astonishing numerical figures on this slide. 16
One is that twice as many people in Massachusetts 17
as Minnesota are even seeing an oncologist as part of their 18
decision-making, let along deciding which oncologist to see 19
or evaluating those oncologists. And ultimately, then, twice 20
as many women, almost, are not told that they have an option 21
of breast-conserving surgery, having been given a diagnosis 22
of early-stage breast cancer. And these are in two, 23
nominally speaking, excellent states for medical care and for 24
the dispersion of medical knowledge. 25
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So my conclusion, much like the Speaker's, is that 1
we need a modern information strategy which is sensitive to 2
these complexities of real life, and one which understands 3
that in a democratic consumer culture, people can and must be 4
capable of using information. 5
Let me just tick off some of the dimensions I think 6
we have to address in building such a modern information 7
system. First, medical care is very complex. My wife, 8
knowing nothing about medicine, is suddenly an expert on PET 9
scanning and solitary pulmonary nodules. And she had to be. 10
There was nobody else in the entire enterprise of medical 11
care in the Seattle area who stepped up and made the 12
investigations and decisions to support her decision-making. 13
Secondly, we have many, many sub-specialities and 14
many, many layered organizations. We have doctors, nursing 15
homes, home health agencies, and so on, all of which play a 16
part in achieving successful care. 17
Thirdly, care is multi-dimensional. There is 18
technical care, guidelines-based care, humanistic care, 19
patient education care, care in dealing successfully with 20
daily living, and simply the service aspects of care, all of 21
which have to be addressed by consumer information strategy. 22
Fourth, I am increasingly aware, as I mentioned in 23
my Vermont pediatric story, that what people are seeking in 24
health care are relationships, not transactions. So to treat 25
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medical care as a bundle of transactions underestimates the 1
complexity of the human exchange of information and decision- 2
making, let alone therapy, that goes on. 3
Fifth, the population is not uniform. Not only do 4
we vary where we are in the course of an illness, but each of 5
us in this room has a different way of processing information 6
and using it. And in a vital area like health care decision- 7
making, this is a very subtle and complex problem. 8
We did a segmentation model that identifies four 9
types of American health care consumers. And we 10
differentiate them partly by their level of independent 11
action and partly by how much they listen to their doctors. 12
And depending on which type of these four groups you see at 13
the top of the slide a person may be, that will affect the 14
kind of information they want and how they will use it. 15
Next is the issue of transparency or, actually, 16
lack of transparency. But there simply isn't the information 17
available, period. Not only does the patient not know the 18
information they would use to make good marketplace 19
decisions, neither do the providers. Neither does the 20
government. The information does not exist. It's not known. 21
Next, the issue of third party payment all of us 22
have talked about for quite a while creates a barrier between 23
the purchaser, the financial transaction source, and the 24
person who actually needs to receive the superior care. 25
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We have mediating decision-makers. In my mother- 1
in-law's case, there was a primary care doctor referring to a 2
surgeon, and a surgeon referring to a hospital. The actual 3
locus of control had been taken away from the patient. We 4
differ in where we are on the trajectory of illness, as my 5
breast cancer slide suggested, and we have to target 6
information to where a person really is in their decision- 7
making. 8
Therefore, just as we in getting medical care 9
expect personalization -- we want someone to hear our 10
history, understand our allergies, understand our values, and 11
help us make a good decision -- so in the information arena 12
we have to personalize the support of marketplace information 13
to the specific needs of each person. 14
Now, fortunately, as the speaker suggested, the web 15
and related technologies enable us to do that. But we 16
haven't really put our effort behind that so far. We've 17
tended to have very blanket strategies for public 18
information. 19
Finally, as I mentioned in my family's case, there 20
is nobody else out there who will do this for you. We may 21
not be confident that every American can step up, master all 22
this information, and make successful decisions. But there 23
really isn't an alternative. 24
There are some mediating organizations who will 25
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certainly help. There are information advisors. There are 1
ombudsmen. There are a variety of other sources. But for 2
the vast majority of us, there's no one else you can rely on 3
to take your illness as seriously as you do. 4
So what can be done about it, and what can the FTC 5
and other agencies do? A couple of focal points I want to 6
suggest. First is we need to do more work on outcomes, not 7
process. As I suggested in my question earlier, the more 8
that we try to have a process measure for every fragment of 9
the American health care system, the more crazy we will 10
become. We have an enormously rich and technically complex 11
system, and we can't possibly cover the landscape with 12
everything. 13
And unfortunately, most of our research and others' 14
shows that there are not good correlations between being good 15
at A and being good at B. A clinic may be great at heart 16
disease care, and the same group of doctors, nurses, 17
technicians, could be terrible as asthma care. And they're 18
sitting in the same offices. You can't say because they're 19
good at heart disease, I'll go there for my asthma. There's 20
no correlation in any evidence we've seen so far. 21
So what do you do? Do you expect to have a set of 22
quality measures for every conceivable health problem? 23
That's not very practical. So the benefit of focusing on 24
outcome measures is it drives innovation because people 25
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compete to achieve better results. It drives integration 1
because you cannot achieve a good result by only doing the 2
operation and then not doing the rehabilitation. And it 3
drives person-centeredness because ultimately the person 4
wants to get back to school, back to work, and achieve the 5
best functioning they can. 6
Second general point that I think many of us agree 7
on is we want more disclosure of information. The public 8
should be able to access information about the care and the 9
cost of the care that's provided. I put disclosure in 10
quotes, however, because again I'll say I don't think anyone 11
knows the information we'd like to disclose. 12
It's not sitting stuffed in a file cabinet in the 13
basement of the HMO or the medical group practice or the 14
nursing home. They don't know, either, how they're doing. 15
So we have an enormous problem of building infrastructure 16
which would provide that information. 17
I would encourage FTC and others to involve more 18
patients in their deliberations. Patients experience the 19
care. They are the taxpayers. They are the underwriters of 20
the benefit plan through their wages. And they have 21
ultimately to be convinced that they are receiving good care 22
if we're going to make a more successful system. 23
As I mentioned earlier, we should deal with the 24
voice as well as exit, that is, use information about quality 25
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not only to help individuals make personal choices, but to 1
help all of us see where quality is good and bad and 2
influence public policy and professional practices. 3
And last thing, the national health information 4
infrastructure at the bottom of this slide. I think we need 5
to use disclosure as a driver to force, as in the case of e- 6
prescribing that the Speaker mentioned -- we need to force 7
institutionalization of health information so that if we 8
require disclosure, that may in turn require PBMs or 9
providers to make more information available, and therefore 10
build the infrastructure to do so. 11
Lastly, we have learned, to our sadness, that 12
distribution of information is absolutely as important as 13
simply getting data. So you can mandate measures. You can 14
mandate data collection, what CMS is doing now. You can 15
publish report cards on nursing homes and dialysis centers 16
and hospitals. 17
Frankly, it doesn't matter. It doesn't influence 18
much behavior. It influences a little behavior at the 19
margin, but if you don't distribute that information in ways 20
that it is actionable in the context of real experience, 21
you're not really contributing to solving the problem. 22
Therefore, several -- four ways one might think 23
about distribution that are a little different than the norm. 24
Think about infusing that information into the relationship 25
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between a patient and doctor. We've been working on 1
something we call the ASK, the Agreement to Share Knowledge, 2
which is actually an agreement between a patient and their 3
doctor about the way they will each play their parts in the 4
care relationship and the way they will share information 5
with each other. 6
Using information intermediaries, whether it's AARP 7
or senior centers, to distribute information and make it 8
usable to people. 9
Providing interactive coaching of information on 10
the web. And I don't mean just simply portraying a table of 11
numbers on the web, but providing interactive decision 12
support tools. 13
And then finally, personalized choice aids using 14
the patient's own values and preferences as a way to help 15
them make decisions with this information. 16
I just wanted to illustrate a couple of ways on the 17
web that we've been approaching that, but let me just 18
conclude. Where I think there's a regulatory role per se: 19
In particular, I think it's the information infrastructure. 20
That does include what to measure and what must be disclosed, 21
but I think it goes further than that, and it goes back to 22
the Speaker's example of the interstate highway system. 23
There has to be a massive commitment and a public 24
awareness that we will not be able to improve this health 25
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system short of centrally managing it in a way that the 1
National Health Service or perhaps the VA or Kaiser might do, 2
short of a central management system working off a centrally 3
allocated budget. Otherwise, there's no way to improve this 4
health system short of building an information 5
infrastructure. 6
So that requires information standards. It 7
requires requiring every player in the health system to 8
collect and disclose the relevant information. It requires 9
that the content be patient-driven and patient-centered. It 10
requires that we integrate that information infrastructure. 11
It's not enough to say to every doctor, you must 12
buy a personal electronic medical record. Those medical 13
records, if they can't talk to each other and talk to the 14
pharmacy system and talk to the nursing home system and talk 15
to the patient in their living room, that's not going to add 16
value to the system. So there has to be an integrated 17
electronic information infrastructure. 18
And I would encourage the regulatory approach to be 19
wary of commoditization. That is, if you try to treat every 20
health care interaction as a commodity, as a discrete, 21
individually-priced transaction, which by itself has a flow 22
of information and set of requirements around information, 23
that will actually undermine the ability of us to improve the 24
health system through what I'll broadly call relationship- 25
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based care. 1
And finally, as public agencies, I hope that these 2
groups will realize that there is no one else out there 3
representing the patient and family. Everyone else has a 4
legitimate but primarily self-directed interest in the health 5
care system. 6
The public sector, part of why we use public funds 7
and why we have election is that someone has to say, we 8
represent the interests and the will, and we have means of 9
listening to the voice of, the American public in its breadth 10
and diversity. That's a very daunting challenge, and I'm 11
very concerned that some major initiatives going on at 12
present in the government don't fully make the effort to 13
listen to the public will. 14
Thank you. 15
DR. HYMAN: Okay. I think we'll take about a five- 16
minute break and then we'll continue with the rest of the 17
speakers. 18
(A brief recess was taken.) 19
DR. HYMAN: I'd like to get started again. Our 20
next speaker will be Michael Young. Your PowerPoint should 21
be up right now. 22
MR. YOUNG: Thank you for having me. When I first 23
saw these hearings, I talked to Ed and then to David. This 24
was exciting for me to come down from Philadelphia because 25
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for 25 years I've been working with employer groups of all 1
sizes, from 50 employees all the way up to 50,000. And 2
invariably, each year it gets tougher and tougher to get 3
through this process that we go through this time of year, 4
which is helping companies strategize about how to deliver 5
health care benefits to their employees for the next year. 6
So I was really excited to be able to come down and 7
share some of the thoughts. And what I did was I actually 8
took the questions from the hearing and threw them at some of 9
my clients of all sizes to get their perspective. Because 10
what I'd like to do today is be one of the panelists that 11
kind of shares with you, you know, what the specific employer 12
problems are and what their issues are when it comes to some 13
of the things we've been discussing today. 14
And the Speaker was right. Being from 15
Pennsylvania, I will say that not a week goes by that my wife 16
or another family member or a neighbor or somebody tells me 17
about somebody whose doctor has left the state. It is a very 18
serious problem in all of Pennsylvania, more so in Pittsburgh 19
and Philadelphia but just in the state in general. So 20
clearly, a significant issue. 21
What I did is actually -- because I work with 22
actuaries, although I'm not one. I'm somewhat anal about 23
this, so I actually put the questions into the overhead so I 24
knew what they were. 25
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But I thought, you know, I'd spend more time -- 1
since we don't have a lot of time and I'd like to leave space 2
for the other panelists and some questions -- but basically 3
wanted to talk about, you know, how do employers go through 4
that process of determining what kinds of health care 5
benefits they're going to offer the employees. And again, 6
I'll talk a little bit more in a minute about the various 7
size of employers and how that affects things. 8
But the bottom line is -- and I don't think this is 9
a surprise to anyone in this room -- employees want good 10
coverage at a reasonable price. That's fairly simple. And 11
what employees usually get when they deal with -- you know, 12
with their company is they tend to get choices. 13
They tend to get choices of health care plans. 14
Depending on the area, the geographic area they're in, the 15
size of the employer, the number of choices may vary. But 16
they get some choices. We find that invariably employees 17
like choice. They like to have a feeling that they can take 18
health care plans that they can pick because they meet their 19
particular families' needs. 20
A second thing they get is catastrophic coverage. 21
And what that means is that, you know, most company plans 22
provide a benefit for large catastrophic situations. Most 23
company plans have one million or sometimes two million or 24
sometimes even unlimited lifetime maximum benefits. So from 25
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the standpoint of being covered for a traumatic, large-cost 1
situation, employees tend to get that coverage. 2
They also get typically some sort of preventive 3
benefit covered -- we'll talk a little bit in a minute about 4
the move from HMOs to PPOs -- but the Speaker was right. 5
It's kind of a mixed bag. What we find is what one company, 6
what one client of ours or what their insurance company might 7
define as good preventive care benefits versus another could 8
vary drastically. 9
We have some with very -- schedules of benefits 10
based on peoples' ages and the types of tests they have, and 11
then we have other clients who basically say, well, we'll 12
give you $300 each year towards preventive benefits. You 13
decide how you want to spend them. So although preventive 14
benefits seem to make sense to a lot of employers, they don't 15
know how to deliver the right kind of preventive benefits. 16
What employees would like beyond those is lower 17
cost. And I would say clearly the vast majority of our 18
clients each year, and certainly this year, are going to be 19
passing along larger cost increases for health care coverage 20
than they're going to be passing along salary increases. 21
So at the end of the day, a lot of our clients will 22
have employees whose payroll deduction for health care will 23
be greater than their increase in their salary. And what 24
happens is their take-home pay becomes less. 25
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They also would like coverage for alternative 1
treatments. As you all know, there are more and more types 2
of treatments out there -- you know, acupuncture, 3
biofeedback, and all kinds of things that are on the horizon. 4
And employees are becoming more savvy. They are reading 5
the -- you know, they are going to the internet. They are 6
finding some of these kinds of treatments. They are making 7
suggestions that they would like to get those treatments 8
done. 9
Typically, though, the clients we have, the 10
companies we have, tend to rely on the insurance company, the 11
Blue Crosses, to set the standard as to what's covered and 12
what's not covered, what's considered valuable and reasonable 13
treatment and what's not. And that tends to lag from where 14
the marketplace is. So we have kind of a lag period, and as 15
employees find these kinds of information, they tend to get 16
pushed back from the plan still not covering them. 17
Administrative ease: Yes, we are getting close to 18
a world of having all this data pass electronically, but we 19
are not there yet. And it still does vary by each of the 20
claim intermediaries that exist. Some are better than 21
others. Some have spent more on technology and IT than 22
others. So it's still -- there are certainly still a lot of 23
employees out there who find, you know, working through the 24
health care system to still be an administrative nightmare. 25
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And then finally, coverage after retirement. I 1
think the latest study showed that there's only 23 percent of 2
large employer who provide a retiree medical benefit for 3
retirees after the age of 65, which is a continuing and fast- 4
dwindling percentage of employers. 5
Employees recognize, I think, at this point that 6
that trend is not going to change or reverse. What we see 7
now from employers, though, is at least the understanding 8
that they've got to educate their employees that even though 9
they're not going to provide a benefit, that you're going to 10
need to save significant amounts of money during your active 11
life to have that money to supplement Medicare, even with the 12
possibility of prescription drug coverage, when you do 13
retire. 14
There's a great article in Fortune, I think it's 15
this week or last week, suggesting huge amounts of money that 16
need to be put away prior to age 65 that you would need to 17
have to cover those expenses as you go forward. 18
I also had some other statistics. This is from the 19
Robert Wood Johnson Foundation. Again, 43 -- I thought this 20
was interesting -- 43 percent of people that were polled said 21
they feared that their employer or their spouse's employer 22
might eliminate some health benefits within one year, some of 23
their benefits. 24
Twenty-one percent said they feared that out-of- 25
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pocket expenses will increase to an unaffordable level, and 1
8 percent said that they fear that the company plan may just 2
go away in one year. So there's continued fear, there's 3
continued uncertainty, as to the role of whether the employer 4
is even going to provide a benefit in the near future. 5
I don't want to -- we can talk a little bit about 6
distortions. Again, I was very intrigued by what the Speaker 7
said. I think that there is a role for employers in this 8
process, although it does -- today, the way it's set up, 9
small employers clearly do not have the same size, the same 10
leverage in the marketplace as large employers to get the 11
kind of coverage they need. 12
And benefit levels, types of plans, those things, 13
are going to vary by the ability of a company to pay -- 14
what's their bottom line, whether they are a public or 15
private company, those kinds of things -- and whether they 16
need to be competitive. 17
And again, though, saying all that and despite all 18
that, I do believe that the employer does have a role here. 19
And I say that, and I think employers in general believe 20
that, although as the costs continue to skyrocket, there are 21
employers saying, you know what? Maybe we were the right 22
people to do that, but we're just not doing it well. The 23
infrastructure is not in place, and therefore maybe in the 24
next five years somebody else ought to come in and do that. 25
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We're hearing more and more of that from employers every day. 1
And again, I just wanted to put up this statistic 2
because I think it shows that the key problems that smaller 3
employers had -- and the Speaker made mention of this -- 4
because of the risk pools and the abilities for these small 5
employers, employers that have 24 employees or less, you 6
know, what kind of health coverage can they get? 7
And you can see that if you take employers with 8
less than 25 lives, 40 percent of those employers do not 9
provide health coverage today. And what that means is that 10
the spouse's plan has to pay or these people may be going 11
uninsured, you know. But in any way, it exacerbates the 12
problem in the system. 13
What changes have there been? Clearly, there's 14
been a move away from the more tightly managed HMOs -- and 15
again, the Speaker was absolutely right, it wasn't managed 16
care, it was managed cost -- to more loosely managed PPOs, 17
which the employees embraced, getting away from the referral 18
mechanism and all the paperwork with that, was just something 19
that they were very much in favor of. 20
But what that led to is, it's led to more cost as 21
it's become a more unmanaged system. So what employers have 22
done, what our clients have done, is basically used -- you 23
know, the good message is, we're getting rid of your HMO and 24
we're putting in a PPO, which is less managed. The bad news 25
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is, your costs are going to go up just as ours are at a 1
faster rate. 2
Clearly, most cost-sharing with employees, whether 3
it's in payroll deductions or higher deductibles, copays, 4
again, as companies feel that's the only way they can affect 5
their bottom lines. 6
I say more choices of plans. It's actually more of 7
a consolidation of vendors. There are far fewer vendors in 8
the marketplace today. There really is only a small handful 9
of national vendors -- Blue Cross, the association Blue 10
Cross, Cigna, Aetna, United Health care, and some would argue 11
they're not even national any more. So the number of vendors 12
has really dropped. 13
And consideration of consumer-driven plans, we 14
could probably have a whole segment on that. It's certainly 15
something that's out there. The whole concept of the 16
consumer-driven plan has been touched on, as we've discussed 17
this morning. The idea of financial incentives and providing 18
consumer education so that patients will more effectively buy 19
health care services is at the root of consumer-driven plans. 20
Unfortunately, we don't have enough data yet to 21
support whether that will happen or how well it will affect 22
utilization. But I will say to you is that many employers 23
will embrace consumer-driven plans, as they did the HMOs in 24
the '80s. Most of them will embrace it not because they 25
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philosophically believe it's the right thing, but quite 1
frankly because they have no other option and they're 2
desperate. Okay? 3
They probably wouldn't know the underpinnings of 4
why consumer-driven plans actually work, but their CFO has 5
said, we have to cut cost. It is a new thing to try and they 6
don't have many other strategies. So I think you'll see a 7
great proliferation of consumer-driven plans. 8
Is it going? No, it's not. Okay. Here we go. 9
Actually, this is from the Washington Business Group on 10
Health and I just wanted to touch on some of the access to 11
health care information. Again, because we're running low on 12
time, I'm going to skip that. Helen can certainly talk about 13
that. I think they do a wonderful job. 14
The Speaker did talk a little bit about group 15
underwriting, about the fact that when you're in an 16
employment-based situation you're able to take all risk -- 17
good risk, bad risk, whatever. Certainly, in the individual 18
market we've seen all kinds of issues with employees trying 19
to get coverage, questionnaires, you know, being selected 20
against, paying higher rates if they have certain medical 21
conditions, and then seeing the rates go up maybe on a 22
quarterly basis versus an annual basis. So clearly, the 23
individual market, unlike life insurance, is not anywhere 24
near as competitive as the group market. 25
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And I think what I would do to summarize this, 1
because I don't want to -- I'd like to save time for some 2
questions and things -- is just to leave you with the fact 3
that employers out there are questioning their roles today. 4
They're not ready to give up the ship yet, but they recognize 5
that they can't continue to maintain the structure the way it 6
is. 7
And I think the structure today has a lot of 8
inherent problems with it. And if we don't do something 9
soon, I think you're going to see employers start to take 10
more drastic actions. Thank you. 11
DR. HYMAN: Next is Helen Darling from the 12
Washington Business Group on Health. 13
MS. DARLING: Thank you. Thank you for the 14
opportunity for the FTC and the Department of Justice taking 15
on these complex issues that have burdened the system since 16
the turn of the century. But we're very grateful that 17
they're paying so much attention to these matters. 18
I'll skip some things that I would have said both 19
because they've been said by others and because they are 20
probably less central to what we need to -- I know that 21
actually Marcia will talk about some of these. 22
I'd like to talk about the trends in an employer- 23
based system and try to hit some of the things that haven't 24
been said, although I would say that what has been said in 25
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fact is very true, and especially what Michael was talking 1
about. Not just our data but his experience as well sounds 2
very familiar. 3
Also, you have researchers. Our very own David 4
Hyman and others like Judith Lave have done research. And 5
for those of us who are real benefits managers at heart or 6
have been at some other time, I think we are pleasantly 7
surprised to see repeated data of how much employees value 8
their benefits. 9
Because if you actually manage them, all you hear 10
about are the problems. Nobody says, yes, we really think 11
this is great. But interestingly, in the last five years, 12
thanks to the work of some really great health economists and 13
some survey researchers, we have seen evidence that employees 14
really do greatly value their health benefit. And we see 15
evidence, which again we didn't see till this past five 16
years, that employees actually are making decisions about 17
where they work, you know, relative to the benefits. 18
So if the economy turns around, health benefits 19
again could become a competitive advantage, which is one of 20
the things that had kind of gotten lost in the shuffle in the 21
last two years. I mean, things are just generally so bad out 22
there that, in fact, it's hard to sort out what's happening. 23
But if what we saw up until about two years ago is 24
true and the economy begins to pick up, then the companies 25
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that offer these better -- as the Speaker said, better 1
quality and more choice at a lower cost, those initiatives 2
will become far more important. 3
What I would like to say is that employers are 4
doing the best that they can right now to try to balance the 5
competing pressures that they have of trying to control cost. 6
And several people commented on the relationship between 7
wages and health benefits. 8
For the first time in my career, which is as long 9
or longer than anybody in the room, I'm sure, we also saw 10
direct tradeoffs. As the economists say, all benefits are 11
foregone wages or other benefits paid for by the worker. And 12
unfortunately, the worker doesn't get that message very 13
often, although we keep trying. 14
But for the first time, we actually began seeing 15
with this recession -- which, as you know, it's lasted longer 16
for particular sectors like the tech sector and others over 17
the last couple of years -- we saw companies like Charles 18
Schwab and Goodyear and others absolutely suspend their 19
contributions to 401(k) for their workers. They made some 20
changes in the health benefits, but they didn't suspend 21
those. But they did the 401(k). And, of course, you've seen 22
some of the strikes that have happened, and you see labor 23
unions going in and sitting down and saying, okay, this is 24
another nickel on the wage package. 25
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Now, the amazing thing to some of us is that they 1
will take the health benefits. And actually they'll take the 2
thing that's the worst thing for them, which is overly- 3
comprehensive packages with very low copayments and, you 4
know, further sheltering themselves, we would say foolishly, 5
from even getting the information on cost. 6
And when again, all of us try to explain, do you 7
realize not only are you giving up cash wages and other 8
benefits which you need, especially given how slowly wages 9
have grown, but you're also fueling the inflation in the 10
health system by doing it this way -- and, you know, my 11
experience and the people I talk to is they look at you like 12
you're crazy and they still go on strike. 13
You may recall that Hershey was on strike for 42 14
days over going from a 3 percent contribution to a 5 percent 15
contribution, which was -- you know, it's wild stuff. 16
So most employers right now are trying very hard to 17
ease into a new model, and ease is the right word. Because 18
while those of us sitting here talking about this know what's 19
happening because we can see across the country, and in some 20
ways because we talk in percentages, you know, it sounds like 21
a lot. 22
But in some instances we're going from a $5 copay 23
to a $7 copay in terms of, you know, what makes people move 24
and how that relates to the total cost of care is not so 25
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obvious. And so people will say, well, I'd rather have the 1
$5 copay. 2
So we've got a lot of confusion out there. But 3
employers are trying to move us to more cost-sharing, and not 4
just in symbolic terms but real cost-sharing. 5
We did a survey of our own members recently about 6
what they had been doing in the last few years, and this 7
won't surprise anybody here. They are doing more cost- 8
sharing and generally feel that enough cost-sharing for the 9
consumer to have a financial stake is really essential, and 10
that coinsurance, not copayments -- many people that I talk 11
to and work with and our own members feel that going to 12
copayments to encourage people to join managed care 13
organizations, where the delivery system did the management, 14
was one thing. But copayments have really become the kiss of 15
death for much of what we're trying to do in this system now. 16
Once you have a wide-open system, which we 17
essentially have now -- I mean, even the PPOs are -- 18
everything is wide open and the data show that -- then 19
copayments become truly absurd. So we're moving to 20
coinsurance across the board. 21
The second thing is that all of our members, our 22
large employers, believe and are working hard that consumer 23
involvement is essential. And if you've heard some -- and I 24
thought David's presentation was just superb on that point. 25
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And he's described, if you will, the world we all want to 1
have, especially with the actual data to do it. 2
I actually went through for a friend a similar 3
experience recently. Fortunately, he was being hospitalized 4
in New York City, and New York is one of the few states where 5
you can get information. He was going to have a radical 6
nephrectomy. Now, you'd think that that is a rare enough 7
event that it would be pretty easy to find out who's good and 8
not good. 9
Well, this is a very sophisticated consumer, 10
very -- had lots of time and money, really, because he was 11
under so much medical care simultaneously. And the way we 12
found out where he should go was by going online to the New 13
York data set and to just put in "radical nephrectomy" by 14
hospital throughout the state of New York. 15
And it was shocking, absolutely shocking, even to 16
us cynics, that there were only about two hospitals in the 17
entire state that did more than about 90 a year, and there 18
were -- almost every hospital in the state did a few. 19
Well, you know, this is a very complicated 20
procedure in just the postoperative care. And, I mean, you 21
can just think -- so, you know, we know that we want consumer 22
involvement and it's essential. But we have -- and many 23
around the table, of course, are working to make this 24
happen -- we've got to not only get the information out there 25
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that's there, but we also have to make sure that people can 1
access it and know it's there, and you don't have to know the 2
system. 3
Again, David's point and others about transparency, 4
we believe that's essential. And we have a report out on the 5
table -- I hope you all have picked it up -- about 6
transparency and accountability. It's essential. 7
We also believe that in the short term, that it 8
would be very easy to require that all currently publicly 9
reported information, which is already -- all the battles 10
have been fought about whether these are the right measures 11
and all those, and they're imperfect, to be sure. 12
But they're already in the public domain because 13
they have to be reported to somebody, whether it's Medicare 14
or the state health department or, like in Texas, the 15
commission. If that information just has to be required to 16
be available on the website of every hospital, and in 17
libraries and things like that, so that people can get to it. 18
One of the things that we've found is it's very 19
difficult to measure or to get information on cost and 20
benefits because the data are limited. We also found that 21
disease and health management programs are growing and 22
there's a lot of reliance on those, but that's also another 23
area where we don't have a lot of information about what 24
works and what doesn't and what's effective. And are these 25
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areas where some people would just be pouring a lot more 1
money into the system and may not in fact make much 2
difference. 3
And several people talked about patient safety and 4
adverse drug events. I sit on a hospital board where just a 5
year ago there started to be a requirement from the Joint 6
Commission that you report near-misses, not just adverse 7
events. And we've never had that. 8
The board now receives a report to the board that, 9
in fact, gives you exactly the number of, you know, adverse 10
events and near-misses. We never did that before. And each 11
of those is being used to investigate the root cause of that. 12
And just that small requirement has transformed the behavior 13
at the board level. 14
I just want to take a second to mention some of the 15
other things that are going on that are really important. We 16
need to move the system towards more health accounts. 17
And I won't go into the detail because of time, but 18
we are doing a lot of work trying to make certain that the 19
Congress authorizes and the federal government continues its 20
movement towards allowing employers to have health accounts, 21
employees to have health accounts, and for us ideally to have 22
this dream of the employee human personal health account, 23
financial account, in which individuals are allowed to pool 24
all of the money they may want to pool and employers can put 25
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the money in, and that can go into retirement, if you want. 1
Essentially, it becomes the 401(k) of health accounts, with 2
portability and lot more flexibility. 3
These are times of great challenge. We are 4
struggling with health care cost increases five years in a 5
row, 50 percent, this year 14 percent. They say next year 6
it's probably another 14 percent on top of that. 7
Some people have raised a question about whether or 8
not employers will stay in this business. And we would say 9
that the likelihood is that they will stay in the business, 10
but the account and the allowance and the amount of money 11
they pay will grow more slowly than the cost of health care 12
will, and therefore the employees and their retirees will be 13
spending a lot more money. 14
There was a story in today's New York Times, if you 15
haven't seen it, an excellent story. It starts on the front 16
page, Milt Freudenheim, about how the coinsurance is, in 17
fact, beginning to have an effect. So maybe we'll see some 18
changes soon. Thank you. 19
DR. HYMAN: Dr. Comstock? 20
DR. COMSTOCK: Yes. Good morning. When you come 21
at this point in the panel, you have to throw out everything 22
you were already going to say because it's already been said. 23
But I'm not ever at a loss for words, so I'm going to pick up 24
a little bit on some of the things that David said. But 25
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before I do that, I'm going to make a couple comments from 1
what I originally had prepared. 2
I'm a strong proponent of this whole, you know, 3
patient-directed health care movement. But there's a number 4
of caveats there and I think there's a number of cautions. 5
So let me just cite a couple of them. 6
One of them you've already alluded to, Helen, and 7
that is the whole regulatory framework for these kinds of 8
accounts. And as you all know, this movement was given a 9
significant boost last June when the IRS clarified the tax 10
status, that these health reimbursement arrangements could be 11
rolled over. They were tax-free. 12
But that is employer dollars, not employee dollars. 13
And we need to -- one of the things that needs to happen is, 14
as you've already alluded to, to make it even richer is to 15
allow those monies to be blended. 16
Another area that's been touched on is that whole 17
issue of selection of costs. And there are definitely 18
concerns about these things because while about three- 19
quarters of people spend less than $500 a year on health care 20
and they're going to be able to accumulate funds, well, those 21
who are going to -- who are hit with high medical bills are 22
likely to pay more. And that's a reality. And depending on 23
your perspective, you can say, when costs go up we can tax 24
everybody or we can tax the high users. And that depends, 25
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obviously, on your philosophy. 1
Another issue that's been talked about a great deal 2
this morning is information needs. There just is not enough 3
information out there for consumers. And I want to also 4
point out that we have to remember that at least 25 percent 5
of people in this country are medically illiterate, and they 6
are going to need a great deal of help, and that information 7
that is relevant and useful to a 45-year-old college 8
graduate, woman college graduate, may not be at all useful to 9
a 20-year-old Hispanic mother of three who doesn't speak 10
English. And so we have to remember that there's got to be 11
ways of getting information to people that is useful and 12
meaningful. 13
I really want to -- what I would like to talk about 14
a little bit is a project that is related to this in the 15
sense that we have had strong validation that this is a real 16
movement that is not the final form of health care, but it is 17
a major move in the right direction. 18
Wye River has been involved in the past year in a 19
project where we have gone around the country to ten 20
different carefully selected communities and conducted 21
listening sessions with leaders, health care leaders, 22
consumer advocates, hospital CEOs, employers, health plan 23
execs, the entire spectrum, 25 in a room, with the White 24
House and with Democratic support, Progressive Policy 25
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Institute, Senator Lieberman's office, and so on. So it's a, 1
you know, bipartisan, multi-stakeholder initiative to talk 2
about the values and principles that should drive health 3
policy. David Lansky participated in our Portland meeting. 4
The first thing I want to -- the first comment I 5
want to make about that is that there's much more agreement 6
than difference when you get out of Washington and you get 7
into communities. These leaders really want to roll their 8
sleeves up and work together to move this health care system 9
in the right direction. 10
There is broad support from liberals and 11
conservatives toward a patient-directed health care system. 12
But there are some caveats. From the perspective of the 13
liberal, they'll say, that's all well and good to talk about 14
personal responsibility. But remember that 25 percent who 15
need extra help. And also, it only is going to work if it 16
comes with system accountability, telling the patient you've 17
got to take care of yourself and you've got to be responsible 18
for your health behaviors. So that's very, very important. 19
The other thing that's very, very heartening to me 20
is that the most conservative elements in the meetings are 21
saying that the world's richest country cannot afford to have 22
40 million people in this country who do not have access to 23
health care. And, of course, we all know insurance doesn't 24
equal access, and getting care in the emergency room doesn't 25
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equal coverage. So this has to be balanced. 1
We also have heard in our meetings at every single 2
community across the country that if there's one thing that 3
we need to do, we need to start a dialogue that we've never 4
had in this country. And that is, what is it we want from 5
our health and health care system? We haven't even defined 6
health and health care. And how do we talk about whether 7
we're spending too much or too little or what kind of system 8
we should have when we don't know what we want out of the 9
system? So that's something that they feel very strongly. 10
And as we move forward into phase two of this 11
project, we have been told by both the White House, 12
Lieberman's office, the Food & Drug Administration, HRSA, are 13
all interested in getting engaged more in these dialogues. 14
We have listened to consumers about how do we 15
create a system that's focused on patients, that serves 16
patients? And as David put it so beautifully, it's about 17
relationships and not transactions. So I think that that's a 18
very, very critical issue. 19
Some of the barriers. Well, you've all alluded to 20
the financial incentives. Every one of these leaders, even 21
when you're talking about values and principles, will say, we 22
have the most pathetically malaligned incentives across the 23
board and we've got to start from square one and figure out 24
how do we create the incentives for people to be healthy and 25
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take responsibility, for providers to educate patients, and 1
to provide preventive care services? Because all of the 2
dollars being spent on end-of-life care or unnecessary 3
technology could do an awful lot. And that's why I 4
challenged Newt this morning about, okay, we can't wait for 5
all that money to be freed up. We need to make an investment 6
now. And I think he gave a good answer. 7
The biggest barrier, though, I think, is culture, 8
whether it's the culture of individuals or the culture of 9
organizations. The physician culture has been slammed 10
several times today, and I'm probably more guilty as a 11
physician of slamming the physician culture than many non- 12
physicians. 13
But the reality is, this is not a cottage industry 14
any more. It has to move away from being a cottage industry. 15
And in order to do that, physicians have got to take 16
responsibility for thinking totally differently about what 17
their role is. They have got to work as part of a team. And 18
doctors don't do that very well. So that's another barrier. 19
And I've already alluded to the issue on 20
information. We have to have multiple ways of providing 21
information. And in part, it's not just technology. There's 22
going to be millions in this country who'll never had access 23
to technology. So we need to find other ways of creating 24
outreach into these communities, these diverse communities in 25
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these rural areas, whether it's through community health 1
workers or lay educators. And this is kind of like, it's 2
very low tech but it's high touch, and people love it. And 3
we need to build that into what we're thinking about. 4
So I'm not sure -- you know, when I was invited to 5
come and talk to the Department of Justice, I went, oh, God. 6
I spent six years as a corporate medical director. I like to 7
steer clear of lawyers. But the reality is, I'm sure there 8
is a role, and certainly around creating the framework for a 9
system where communities can then build their own local 10
solutions. Because that is another theme that we hear loudly 11
from communities, is we need to be able to work together to 12
find the answers. But we need the support of the federal 13
government, whether it's with regard to that structure or 14
with regard to resources. But they want to find their own 15
solutions. 16
And I'm just going to stop there and let that go. 17
But I thought that would be something that would be a little 18
different twist on what's being talked about, but clearly the 19
things that you are saying about patient-directed health care 20
and the movement is definitely borne out in the communities. 21
DR. HYMAN: Thank you. 22
Finally, batting cleanup, Greg Kelly. 23
MR. KELLY: Thank you, David. First of all, I want 24
to commend David Hyman and the FTC for holding such an 25
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ambitious set of hearings this year talking about a wide 1
range of topics, 30 hearings on the competition in the health 2
care marketplace. I think it's very, very important. 3
Today I'm going to touch on -- a little bit on what 4
the Speaker, Dr. Greenberg, and David Hyman brought up 5
regarding adverse selection and some of the problems in 6
pooling of insurance and how we can move forward there. And 7
given the questions posed today, I'll focus on how a specific 8
regulation, that of guaranteed issue, affects costs and 9
availability of health care coverage in the marketplace. 10
Obviously, in our complex health care system, there 11
are many factors that drive up the cost of health care 12
coverage. But even so, there's ample empirical evidence that 13
isolates and displays the dramatic effects of one particular 14
regulation, guaranteed issue. 15
Perhaps the easiest way to take a look at that is 16
to look at the three different market segments. We have a 17
private insurance market system that is segmented into three 18
very distinct categories, the large group market, the small 19
group market, and the individual market. 20
I'm not going to spend a lot of time talking about 21
the large group market because it's the least regulated of 22
the three. There are no federal guaranteed issue 23
requirements on insurers to issue plans to large groups. 24
Insurance is widely available. There tends to be a choice of 25
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coverage. And so the focus of where I'm going to be looking 1
at is the federal and state regulations in the small group 2
and individual market. 3
The individual market, which accounts for about 10 4
percent of private coverage, is primarily regulated by the 5
states, while the small group market, which accounts for 6
about 25 percent of private coverage, is regulated by both 7
the state and the federal government. 8
Given these different regulatory environments, we 9
have guaranteed issue imposed by the states in certain 10
individual markets while guaranteed issue is opposed across 11
the board by the federal government on the entire small group 12
market? 13
First of all, what is guaranteed issue? Guaranteed 14
issue is a law that requires insurers to accept everyone who 15
applies for health insurance, regardless of their health 16
condition. Under guaranteed issue, an individual who has no 17
health insurance and becomes ill may apply for private 18
insurance coverage and must be accepted. This is comparable 19
to allowing a person to purchase auto insurance for their 20
accident after being involved in a car wreck. 21
When people know they can get insurance when 22
they're sick, they'll forego it when they're healthy. 23
Younger and healthier people cancel their policies. The 24
health insurance pool gets smaller and sicker. Escalating 25
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premiums occur, and eventually the pool is left with just the 1
sickest and most -- and people with the most expensive health 2
care needs. 3
We eventually reach a point where many insurers are 4
no longer able to offer a product under such chaotic 5
conditions. The end results are: inordinately high prices 6
for insurance; considerably reduced choices for coverage; a 7
greater number of uninsured; and ultimately, a health 8
insurance market where few, if any, insurers are offering 9
coverage. 10
I want to look at both the states' individual 11
market and what's happening on the state level as well as 12
what's happening across the board in the small group market. 13
Let's look at the state examples first. 14
States such as New Jersey, Maine, and New York have 15
passed guaranteed issue laws in the 1990s, with disastrous 16
consequences on competition and affordability. Rates have 17
increased and insurers have left these states. 18
For example, a family living in Portland, Maine 19
pays a minimum of $1,176 a month for a $500 deductible PPO 20
policy. A similar family living in Trenton, New Jersey would 21
pay $3,576 a month for a similar plan. In New York, you 22
cannot even purchase a PPO or indemnity plan, and if you live 23
in Ithaca, you have a choice of one plan and it costs $1,113 24
a month. 25
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Conversely, in states without a guaranteed issue 1
law, health insurance is much more affordable. Average 2
families in Arlington, Virginia, Pittsburgh, Pennsylvania, 3
and Madison, Wisconsin can purchase a $500 deductible PPO 4
policy for $410, $461, and $335 a month respectively. And 5
there tend to be a wider range of coverage choices and 6
options. 7
The bottom line is that no state has implemented 8
blanket guaranteed issue without a loss of consumer choices 9
and a dramatic increase in price. So it's pretty easy to 10
compare the wide range of affordable products available in 11
non-guaranteed issue states with the limited choice and 12
expensive coverage options, or non-options, should I say, in 13
guaranteed issue states. 14
Now I'd like to look at the small group market. 15
Remember that the small group market is a hybrid where we 16
have a mixture of both federal and state regulations. In 17
1996, HIPAA imposed guaranteed issue across the board in the 18
small group market, and almost all states have followed with 19
restrictions on the price that insurers can charge small 20
groups. 21
This means that insurers must make all plans 22
available to any small employer that applies for coverage. 23
And insurers are often limited in the variance on what they 24
can charge employers with different characteristics. 25
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Like in the individual market, guaranteed issue 1
destroys the basic risk classifications of insurance. Very 2
small employers, especially baby groups of ten and under, 3
will wait to obtain coverage until one of their employees 4
need it, or under guaranteed issue other employers will 5
switch to a plan with more generous benefits when one of 6
their employees need it. These adverse selection problems 7
cause healthier groups to leave the market, prices to 8
skyrocket, and insurers to stop offering coverage. 9
Small group guaranteed issue has impacted the cost 10
and availability of coverage nationwide. Mark Littow, an 11
actuary with Milliman USA, who has priced small group 12
products and premiums for over 27 years, recently provided 13
congressional testimony on the abysmal shape of the small 14
group market. 15
Mr. Littow has estimated that the small group is 16
poor to questionable in 35 out of the 50 states. He 17
determines this ranking based upon an environment where 18
losses exist for almost all group insurance companies, even 19
with prudent management. 20
He attributes much of the deteriorating market to 21
the federal guaranteed issue laws and the state rating 22
restriction laws. He submits that the small group market is 23
only viable today in about ten states. 24
With these losses, evidence clearly shows that the 25
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carriers are exiting the market in droves. The General 1
Accounting Office recently completed a study that showed a 2
disturbing market concentration in the small group market, 3
with the top five carriers controlling more than 75 percent 4
of the market share in the majority of the states that the 5
GAO studied. 6
Healthier groups are dropping coverage because of 7
escalating prices. For example, in Colorado, the state 8
division of insurance has reported a loss of 14,663 small 9
groups, covering more than 125,000 individuals, in just the 10
last two years. The state attributes much of this problem 11
due to the guaranteed issue requirements in the small group 12
market. Healthier groups are just leaving. 13
While the increases in health insurance costs and 14
the loss observe coverage options do not occur in a vacuum, 15
guaranteed issue is the one regulation where you can see the 16
distinct impact on the cost and availability of coverage. 17
Given that guaranteed issue is nationwide in the 18
small group market and limited only to certain states in the 19
individual market, guaranteed issue is one of the 20
contributing reasons why the small group market is more 21
expensive than the individual market. 22
Contrary to popular conception, the small group 23
market is, on average, much more expensive than the 24
individual market. For example, even though coverage is not 25
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quite as comprehensive always in the individual market as it 1
is in the employer-based market, policies sold through e- 2
health insurance are on average 25 percent higher for small 3
business members than they are for individual members, and 4
this is done in a state-by-state comparison. 5
So we get into a tricky situation. Results show 6
that if you make insurance available to everyone, it's simply 7
not going to be affordable. And if you make it widely 8
affordable, it's not going to be available to absolutely 9
everyone. 10
So if we want affordable and accessible policies, 11
instead of regulating 100 percent of the market, regulations 12
or programs should be designed to address the 1 to 2 percent 13
that cannot obtain coverage. For example, high risk pools 14
are such programs that allow the market to work for the 98 15
percent of the population who can obtain coverage while 16
providing a strong and viable safety net to cover the sick. 17
States with the least regulatory burden 18
successfully rely on high risk pools to cover their 19
uninsurables, and have affordable health insurance for the 20
rest of the population. 21
Since the effects of guaranteed issue, regulations 22
on the cost and availability of coverage can be pronounced 23
and identified. These regulations can often be repealed. 24
For example, on the state level, Kentucky, Washington, and 25
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New Hampshire repealed their guaranteed issue laws recently 1
after these laws caused a complete dearth of health insurance 2
options in their states. 3
With the deteriorating state of the small group 4
market, Congressman Mike Pence is planning on introducing 5
legislation to repeal guaranteed issue in the small group 6
market. 7
The clearcut effects of guaranteed issue on 8
competition, price, and availability of coverage should be 9
helpful to policy-makers as they revise these laws, and I 10
hope that this examination is helpful to the participants in 11
this room as we look at the effects of regulation and 12
competition in our health care marketplace. Thank you. 13
DR. HYMAN: Thank you. Well, everybody has done a 14
great job of staying on time. You're all very public 15
spirited. And so we've got about 20 to 25 minutes left to 16
have a panel discussion about these various presentations. 17
Let me just start, and people can feel free to ask 18
questions themselves of other panelists if they want. But 19
I'll exercise the speaker's privilege of filling the 20
uncomfortable silence that might otherwise result if I just 21
threw it out at the start and just ask the following 22
question. 23
There's been a lot of discussion today and in past 24
hearings about the extraordinary saliency when it's time to 25
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actually receive health care of the need for information, of 1
picking the right provider, of deciding whether the 2
recommendations that you're getting are sensible ones, and 3
the difficulties of obtaining information about that. 4
But the options that you have and who you get to 5
see are tremendously influenced by the nature of your 6
coverage. And the saliency of the coverage tradeoffs, it 7
seems to me, is a different matter entirely. 8
So I guess the question I would ask is how do you 9
make the coverage tradeoffs more salient to people? Is 10
consumer-directed health care a way of finessing that by 11
putting the burden on the patient to make those decisions at 12
the time they receive care? And is it really realistic to 13
expect people to pay close attention to their health 14
insurance when they only get to choose once a year and it's 15
aggregated for them, for many people, by employers? So 16
that's, I think, a range of questions we can start with. 17
Helen? 18
MS. DARLING: Well, I'd like to take that one on. 19
Actually, I'd like to take on your assumption. 20
DR. HYMAN: Go right ahead. Then it's a really 21
good question. 22
MS. DARLING: Yes. Because actually, most people 23
have choice. I mean, if you look at the numbers of -- you 24
know, you look at visits by coverage, between the fact that 25
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more than half of the employees are in PPOs. And usually 1
there's not a lot of constraint. There's some, but not a 2
lot. And you have -- a lot of the health care is under 3
Medicare and Medicaid, where with a few state exceptions, 4
it's still pretty wide open. 5
So actually, I almost wish it were the coverage 6
because that's easier to manipulate and do something about 7
than it is to deal with the lack of information when you're 8
ready to make a decision. 9
There may be some challenges on particularly kind 10
of obscure problems where research and experimental treatment 11
is the only thing that's available. But the vast majority of 12
care in this country is not that, and it is covered and you 13
do have lots of choices, but you don't have the information 14
that -- some of the things that David talked about. 15
So the pressure ought to be on that point, it seems 16
to me. 17
DR. HYMAN: Marcia? 18
DR. COMSTOCK: Some people only define consumer- 19
directed or patient-directed health care when there is 20
actually a decision made at the point of service as opposed 21
to just once a year. Because the reality is, under a 22
cafeteria plan that exists today, you can say, well, that's 23
consumer-directed health care. 24
But you're not incentivizing, thinking through 25
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decisions actually at the very time. Same thing in the 1
pharmaceutical business. I mean, if at the point of 2
purchasing something you have coinsurance and you make that 3
decision, as opposed to later on getting a bill for whatever 4
it is, you're not really going to drive good decision-making. 5
A couple thoughts. One, when people are really 6
sick, that is the great equalizer of everything. They 7
want -- they're not in a position, really, to make major 8
decisions. But assuming that you have some kind of a 9
consumer-directed plan where you have a high deductible 10
policy that's pretty broad and that you can basically go to 11
whomever you really want, the decision-making, as you say, 12
it's really around -- you're trying to drive the decision- 13
making toward that discretionary kind of care, not toward 14
those critical kinds of things. 15
And the other thing that I find quite interesting 16
is that almost by definition, quality is incompatible with 17
complete choice in the sense that every doctor is not 18
equivalent. I mean, you know from the Dartmouth Atlas and 19
from all the other work that's done. 20
So until you really have got the kind of 21
information for people to make decisions around serious 22
illness or whatever in terms of where they want to go, it's 23
kind of almost funny that people want complete choice, but 24
then that's opening you up to virtually any level of quality 25
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of care. 1
MR. YOUNG: No, I agree. I mean, I think we have 2
to be careful, though, and make sure we understand that there 3
are kind of exceptions to every situation. 4
And just as we have exceptions to the fact that not 5
everybody is going to be able to use the same level of health 6
care information, the other exception is that under the 7
current system, there is a need for, in the employer 8
marketplace, a claim intermediary, whether it's a Blue Cross 9
or an insurance company, but some sort of claim intermediary, 10
whether it's an insured plan or a self-insured plan. 11
And most employees -- most employers are relying on 12
that claim intermediary to not just process claims, but to 13
contract with providers and to provide information to the 14
employees and do all those things. And what happens is then 15
the employee is kind of held to whatever that claim 16
intermediary can provide. 17
And we have -- and I know you talked about this in 18
prior sessions -- but we have areas of this country, fairly 19
large areas of this country, where one claim intermediary has 20
a stranglehold on that geographic market because the network 21
discounts they have with their providers are so great 22
compared to everyone else that it precludes any type of -- 23
any other claim intermediary or any managed care 24
organization, whatever you want to call them, coming into the 25
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marketplace. 1
And if that claim intermediary says, I don't 2
believe in consumer-driven plans; I don't believe, you know, 3
in providing quality health care information to employees, 4
then you're stuck unless the employer circumvents the whole 5
system and overlays something on top of it, which large 6
employers may be inclined to do but small employers won't. 7
So, you know, there are a number of claim 8
intermediaries, without taking shots, that really have a lot 9
vested in keeping the status quo, you know. And so you can 10
talk all -- you know, consumer-driven will work for 60, 70 11
percent of the market, but 30 or 40 percent of the market 12
will not have access to it for a number of years, not from 13
their own choosing. 14
DR. HYMAN: Well, you'll be pleased to know that 15
the claim intermediaries were in here complaining about the 16
providers insisting that the status quo is preferable. So 17
there's a high degree of finger-pointing, certainly, in this 18
industry. 19
MS. DARLING: Everybody is a vested interest, 20
almost, I think. 21
DR. HYMAN: David? 22
DR. LANSKY: Another angle on the same issue. I 23
think this transition, the bridge between the coverage and 24
the care, that creates this tension. 25
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I think an interesting thing is going on where 1
those who are -- whether it's the intermediary or the payor 2
is creating transparency around the criteria of network 3
participation. So Leapfrog, I think, was an example where 4
they were trying to say you -- in theory, Leapfrog said, we, 5
the purchaser, will continue to do business with you, the 6
plan, if you in turn prefer -- do preferential business with 7
high safety institutions that adopt certain practices. 8
And they supported that, with an employee education 9
program to help the employee recognize, here's where care is 10
superior. And I'm part of a chain of relationships with my 11
employer, with the plan, and in a sense with Leapfrog as a 12
policy organization, that is trying to help me seek out and 13
get the safer quality care. 14
I think there's a series of initiatives in which 15
the payor or the intermediary can either give visibility to 16
or money to entities which adopt elements of superior care. 17
And so whether it's transparency or pay for performance, 18
either way it's a way to try to make the system work better 19
without directly managing care with a heavy hand. 20
DR. COMSTOCK: Actually, that just reminded me of 21
something I wanted to say earlier that the Speaker talked 22
about, and that is, whose job is it and on whom should we 23
rely to make certain that data are standardized and things 24
like that? 25
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And I would be very concerned if that became a 1
governmental role, except as a purchaser. And to the extent 2
that CMS and other powerful buyers in the system as a 3
purchaser, as a condition of participation, insist on 4
information being collected and analyzed and everything done 5
in a standardized way, that's terrific. 6
But the organization or organizations that decide 7
what those measures are going to be, I believe, has to be 8
outside of government, and for a couple of reasons. First, 9
there's no evidence that the government -- the government has 10
actually essentially owned the health system about 40 to 50 11
percent since 1965. They have enormous power. They have 12
never used it for those purposes. So counting on them at 13
this point to be our guide in that regard is not a good idea. 14
It's certainly not going to get us anything before I'm dead 15
in my grave, I'm sure. 16
The second thing is that a lot of these things, as 17
David knows because his foundation has done a lot of work and 18
I've been involved with NCQA's committee on performance 19
measurement, that you need a lot of people sitting around a 20
table working as fast as possible with a nimble approach to 21
it to get these things right and to keep making them better 22
and better. 23
And when you have new information, you do a pilot. 24
You can -- you know, FACCT and other organizations can 25
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decide, okay, it's not going to be this. We just found this 1
doesn't work out in Colorado, and so we're not going to do 2
it. 3
So having the organizations, whatever -- you know, 4
the private sector arm and how they're put together is less 5
important than there are people who have that as their 6
responsibility, organizations. They know what they're doing. 7
They're able and willing to test. They're able and willing 8
to bring from the best and the brightest whatever the issue 9
might be, come up with the best measures, pilot them, test 10
them, fine-tune them, and then they can be picked up by the 11
larger purchasers, including the government and be driven 12
that way. But if we try to put it in the government, it just 13
won't happen with the kind of speed. The other thing is that 14
once it gets in the government, it is so vulnerable to 15
pressures from narrow special interests who have no interest 16
in seeing progress in these areas. 17
DR. HYMAN: David? 18
DR. GREENBERG: All right. Let's take the 19
government out of that for a little bit and put it in the 20
third party payor. And I remember when we used to have HMOs, 21
and I remember when women on normal deliveries used to be in 22
the hospital for four and five days, and people having 23
surgery used to come one or two nights before, and stayed for 24
much longer than they are now. 25
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That wasn't my doing as a consumer or patient, or 1
the person next door's doing as a consumer or patient. I 2
don't really know how long a person has to be in the hospital 3
after a normal delivery, after a certain kind of surgery. 4
How many days, really, does that person have to be there 5
before the actual surgery? 6
That was done by a third party payor who has 7
thousands and thousands of patients, perhaps experts on the 8
team, who could make such decisions, provide information to 9
that patient. Gee, a normal delivery, two days may be 10
enough. 11
Okay. We can always debate that the managed care 12
firms overstep their bounds, that they have other incentives 13
to contain cost and only those incentives. But I would 14
maintain that I just can't do it. I can't do it as a patient 15
right there before the surgery in the hospital, even a couple 16
days before the surgery. 17
And we have these experts as managed care firms. I 18
still come back to perhaps my earlier point: Without the 19
government interference, Helen, let's have those third 20
parties -- when we pick them on a yearly basis, we decide 21
ourselves, based on a variety of information, brand name, 22
signaling, however you want to deal with it, the same way we 23
pick automobiles and other difficult -- we have so many 24
difficult products that we buy today, cell phones, whatever. 25
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Somehow, the market works, a little bit imperfectly, but the 1
market works. 2
In the comfort of our living room, picking a health 3
care plan based on price, quality, brand name, signaling -- 4
and I think that's the best we could do. I mean, you could 5
find things on the Web that says, this cures cancer, and go 6
another website and it says, this does not cure cancer. 7
DR. HYMAN: And we do enforcement on some of the 8
first category for fraud. 9
DR. GREENBERG: But anyway, I go back to the 10
comfort of the living room, deciding on the third party plan, 11
and creating incentives for those third parties to provide 12
health care cost containment as well as quality of care. 13
DR. HYMAN: Let me follow up on a point that got 14
made earlier and see if we can push this in a slightly 15
different direction because we could use all of our time just 16
to talk on this one. 17
On the issue of quality, David asked the Speaker a 18
question that I thought was quite insightful, which was, you 19
know, there's -- basically, do you fragment or do you 20
aggregate? And there are virtues and costs with both of 21
those strategies. 22
Aggregation allows you to sort of leverage your 23
purchasing power for both price and quality, if you choose. 24
And I guess the challenge is how do we think about these new 25
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arrangements for benefit design in the context of trying to 1
deal with the problems of integration and quality? And given 2
the information that we have, how confident can we be that 3
this is going to head off in the right direction? 4
MS. DARLING: I'm not sure I understand the 5
question. 6
DR. HYMAN: All right. I didn't ask it very well, 7
then. Do we -- when we disaggregate purchasing pools by 8
essentially open-ended choice and by allowing people to make 9
their own decisions as to who they go to and how much to pay, 10
it makes it much harder for employers to do things like 11
Leapfrog because they can't selectively contract, okay, 12
unless you're going to do it with everyone, and to impose 13
minimum quality standards. 14
So I guess I'm really just trying to put a sharper 15
point on David's question. 16
MS. DARLING: Well, but they could -- you can do it 17
two ways. You can give people lots of choice at the point of 18
care but still have a plan who administers. 19
The other thing is that you could provide 20
information that's especially penetrating and useful about 21
the providers. And you are allowing the employee or their 22
dependents or their retirees to choose, but with information, 23
just as they do now -- again, David's example. They suddenly 24
have information about different hospitals. 25
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Your pressure comes from -- and by the way, I've 1
actually seen this happen. The pressure comes from the fact 2
that the hospital goes on whatever it is, the website or 3
whatever's published, and says, oh, my heavens. We are like 4
number seven in this market. This is really bad news. 5
And we know -- in fact, the research on even the 6
use of quality metrics and plans was less used by consumers, 7
but it sure was used by providers. And I, again having been 8
on a hospital board, actually, all my adult life, it seems, I 9
can tell you that we pay a lot of attention to reports, even 10
those in these kind of fluffy magazines, using what many of 11
us would consider kind of questionable data, although it's 12
not terribly wrong. But it's just -- you know, you're not 13
totally comfortable with it. 14
But you will have hospital boards saying, what is 15
this? You know, we're number six in this market? I mean, 16
heads roll inside organizations when there's public 17
information about how something stands out. 18
So the data will drive at least the hospitals and 19
providers to change their behavior independent of whether or 20
not even the employees change their behavior because of it. 21
MR. YOUNG: I think one of the things -- one of the 22
criteria that employees sometimes use to determine quality is 23
if they are in a PPO or any kind of managed care plan is 24
their assumption is that the providers in the network are 25
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better providers, which in most cases probably has very 1
little to do with quality and has a lot more to do with the 2
contracting, you know, possibility of contracting between 3
that provider and that claim intermediary. 4
So you have to be very careful. I mean, there are 5
many times -- and this is where I think we have to have 6
pressure on -- and I keep coming back to these claim 7
intermediaries -- to if they're going to contract, if we're 8
going to have a structure where somebody is buying services 9
at a unit price discount, that some of -- that the criteria 10
for making the decisions of who those networks are has to 11
much more involve quality. 12
DR. COMSTOCK: I mean, that's all true. Just a 13
couple issues. One is we all know that the vast majority of 14
health care has not definitive best practice. I mean, so 15
much of what is done in health care does not have an 16
absolute, this is the right thing and the wrong thing. 17
Yes, if you have colon cancer, you need surgery, 18
whether to cure it or to keep you from being obstructed. But 19
for many other things, there is no definitive answer. The 20
real issue is: is the physician engaging with the patient in 21
a shared decision-making process around their values and 22
what's important for them? 23
But I wanted to make the comment -- you know, you 24
said the hospitals will respond to information. I know one 25
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of our supporting organizations is Jack Wennburg's group up 1
at Dartmouth. And they've done some wonderful work that 2
showed that, you know, physicians don't like to be measured a 3
whole lot. But they have a way of doing it that's 4
collaborative and collegial. 5
And what they do, for example, in the northern New 6
England cardiovascular disease project is physicians looked 7
at each others' processes of care and they began talking 8
about what did they do and what results did they get. And 9
they immediately responded. Nobody had to hit them over the 10
head with it. 11
So I think that getting back to the importance of 12
culture when it comes to any of these things related, you 13
know, to delivery changes. You've got to recognize the 14
culture. The hammer over the head doesn't work well with 15
physicians but other kinds of methodologies do work well with 16
physicians. So it's just a little bit of a flip side. 17
And then I just think we just have to remember that 18
quality metrics are great, but there's only so many things 19
that you can measure definitively. 20
I thought your question to Newt was different. I 21
thought -- was it different? Was your question -- 22
MR. LANSKY: It was a very subtle question. Go 23
ahead. I'd like to her your interpretation. 24
DR. COMSTOCK: I thought you were asking a very, 25
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very different question about is it more appropriate when 1
you're looking at quality: to look at quality of the entire 2
process of care, like around the chronic disease and the 3
outcome of that, versus a particular transactional kind of 4
metric. So I guess I misunderstood your question. 5
MR. LANSKY: No. I don't think you misunderstood 6
it. 7
DR. HYMAN: I did. 8
MR. LANSKY: No. I was actively asking two 9
questions at once. 10
DR. COMSTOCK: Well, you're very clever. I got one 11
of them, at least. 12
MR. LANSKY: Because I think they are -- I 13
personally think they are related problems to solve, that the 14
good managed care model which the original theorists 15
advocated for included both integration of care, particularly 16
in support of both preventative health maintenance, and 17
chronic care. 18
And that still seems to me to be a hallmark of 19
those kind of care models and tying incentives to the 20
successful performance across that spectrum. And that, in 21
turn, built the kind of teams you both just spoke about in 22
terms of internal recognition of quality rewards and 23
opportunities. 24
And I'm concerned that the current trends we're all 25
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talking about today may go in a different direction and also 1
create a technical problem that measurement becomes very 2
difficult if we fragment. And then access to information 3
becomes very difficult if we have a high fragmented system. 4
So I was concerned about both impulses. 5
I wanted to answer your question as well, David, or 6
start a piece of it. I think most of us in this field have 7
been fairly naive about thinking about the solutions, and we 8
need a new way of thinking that is more subtle. 9
We've got a system we're talking about here in a 10
room among ourselves that accounts for a sixth of the 11
national economy, millions and millions of peoples' 12
livelihoods, enormously complex. It's not a -- we use words 13
like system and managed care and chronic diseases if we're 14
talking about a thing that we can implement to address. And 15
we just can't. 16
So we have to -- we need some other way of 17
recognizing that it's a very layered problem. I think it is 18
more achievable for federal agencies, the regulatory process, 19
the legislative process, to deal with what we would call 20
infrastructure, making sure that the highways are there and 21
the railroad tracks are the right gauge and that the 22
underlying structure is in place that would permit us to do 23
all the things we've talked about today, without yet saying 24
what those things are. 25
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And we've gotten all of us a little bit ahead of 1
ourselves in some of the work we've done the last ten years, 2
fifteen years, in thinking we knew what some of the solutions 3
were rather than building pipes and paving roads that would 4
let us at least drive around a little bit without saying 5
where we drive or what kind of cars we drive in. 6
So I would encourage you -- and I think the 7
SEC/FASB model that was talked about a lot ten years ago and 8
underlay the President's advisory commission report but was 9
never implemented remains a very important model to think 10
about carefully. 11
In Helen's point, you know, what does the FASB part 12
of that need to look like, in which you have an open dialogue 13
with private sector interests, very involved? And what does 14
the heavy hand of government need to look like, which asserts 15
specific requirements upon the entire regulated industry, 16
having had that input and standard-setting done by the 17
private sector? 18
I am more concerned than Helen about allowing the 19
private self-regulating model to continue because I think 20
we've had some experience where, in both the case of the 21
Joint Commission and NCQA, a relatively voluntary 22
participation leads to under-participation and whole sectors 23
of the system not being involved at all if they don't choose 24
to. And that is a disservice to many patients interest the 25
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system. 1
FEHB, for example, still has 70 percent of the 2
employees in fee-for-service models. Therefore, in a sense, 3
those who choose the managed care models or the managed care 4
plans are punished for participating in NCQA and in doing the 5
right things. 6
So I think there has to be some government 7
standard-setting to ensure full participation and that the 8
public really has meaningful information to make decisions. 9
But where to draw that line is just a very difficult problem. 10
DR. HYMAN: Let me follow up on that point because 11
so far we've talked about information at great length. We've 12
talked about government purchasing a little bit. But we 13
haven't talked about what David nicely called the heavy hand 14
of government, the regulation, direct regulation. And to the 15
extent we have, it's been concerns expressed about guaranteed 16
issue, concerns expressed about the tax treatment. 17
And let me use as a springboard David's slide that 18
you showed about the number of institutions in New York state 19
that performed more than a minimum number of a particular 20
procedure. And it really doesn't matter which procedure; you 21
see the same patterns in every state and for every procedure. 22
So the question is, is there a role for government 23
directly in dealing with that? Is that a health planning 24
sort of thing? Is that, you can't do this procedure unless 25
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you have a minimum amount? Or do we want to instead 1
designate centers of excellence? And how do we guard against 2
the kinds of risks that Greg has talked about in the context 3
of guaranteed issue? 4
MS. DARLING: Well, I'll be happy to jump in on 5
that. A couple of things. The first study I did at the 6
Institute of Medicine was of the health planning certificate 7
of need program some years ago, and I can tell you that when 8
we were done, that even the most liberal people on the 9
committee that love that stuff and believe in it in their 10
souls concluded that it will never work in this country for a 11
whole bunch of reasons, which I could do a whole session on. 12
DR. HYMAN: We'll have you back. 13
MS. DARLING: Yes. Okay. But that was actually 14
when it was a lot easier. I mean, we were smaller by quite a 15
bit. We had a lot fewer hospitals. We had relatively few 16
surgery centers. And even at that, it just was -- and 17
actually, there was more of a belief in those days that the 18
government had a role. 19
We had PRSO programs developed. You know, there 20
was a lot going on. A lot of people even thought we had 21
national health insurance around the corner. So it was a 22
very different era. But even then, with everything much more 23
compatible with the concept, it was generally an utter 24
failure, and actually left a lot of people really turned off 25
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at the idea for the next 20 years. 1
Somehow, the government can play a role that is 2
both a combination of a carrot and standard-setting at a 3
minimum, but the concern is that it will always be the least 4
common denominator. If you look at every other program like 5
it and everything that's been done -- and I was a senate 6
staffer for a while, and among other things, I dealt with all 7
these issues from a senator's office. 8
And there's just nothing like getting 500 letters 9
from all the old ladies in a small town about a doctor who 10
has been demonstrated to have been absolutely fraudulent, 11
doing terrible things like, you know, charging Medicare for 12
30 colonoscopies a day or something like that -- I mean, 13
blatant, blatant, blatant fraud and errors, and yet the town 14
loved him. 15
So that's when you've got all the evidence. 16
Ninety-nine percent of the time, you don't have that much 17
evidence, and there are all these grey areas. And the second 18
you have grey areas, then as long as the government is doing 19
it, there will be somebody who says, you can't have the heavy 20
hand of government doing this, so a lot of really bad things 21
happen. 22
DR. GREENBERG: At the same time, David, I think 23
there may be a role, a continued role, for the FTC, is when 24
the private sector tries to regulate itself. The AMA in the 25
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early '70s and prior to that refused to allow physicians to 1
advertise or disseminate information, and in fact the FTC did 2
bring a case against the AMA, went to the Supreme Court, and 3
the FTC won that case, which submitted that the physicians 4
should be able to advertise. 5
We have something called the Joint Commission on 6
Accreditation of Health care Organizations. I submit this 7
would be another avenue for the FTC to go into. This Joint 8
Commission has acted like a cartel against hospital 9
dissemination of real information on hospitals for as long as 10
its existence, and should go after these people. 11
There have been other sorts of professional groups 12
that perhaps the FTC ought to do something as far as its 13
Section 5, Federal Trade Commission Act. So this might be a 14
role for government because those -- maybe some of these 15
accrediting medical schools or whatever might be examined by 16
the FTC. 17
DR. HYMAN: Greg, you haven't spoken yet. 18
MR. KELLY: Yes. Just that separately on what you 19
were mentioning a little bit earlier, as the Speaker brought 20
up, regulation sometimes is needed. When he goes into 21
McDonald's, he wants to make sure that he is ordering beef. 22
And it's up to the private market to decide how best to 23
deliver that. So some regulation is, of course, needed. 24
And going back to guaranteed issue, if you actually 25
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ensure that 100 percent of the people were participating in 1
the pool, theoretically it could work. But we have a 2
voluntary system in this country. And if you take auto 3
insurance, for example, we have mandates in the auto 4
insurance market and we suspend peoples' licenses. 5
We impound cars. We have financial penalties, and 6
we still have a 14 percent auto insurance uninsurance rate in 7
this country as well, with massive databases to also enforce 8
the law in 47 out of the 50 states. 9
So when you try to go against the very principle of 10
insurance, you have a lot of problems. So my standpoint on 11
the heavy hand of regulation, as you brought up, is that we 12
should be focusing regulations on areas that could work, and 13
looking at situations where government does have a role, like 14
insuring that what we are actually ordering is beef, but not 15
going into areas where we're looking at a situation where, in 16
a voluntary system, people will -- even with a mandate, will 17
not comply with that. 18
MS. DARLING: Let me just make one quick additional 19
point on this. 20
DR. HYMAN: Very quickly. 21
MS. DARLING: You know, it seems to me there's a 22
difference between the government saying we have to have 23
standards in this area and then asking a group to do that. 24
We know, in fact, with a lot of the requirements and 25
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standards, they are far too low, and frequently the voluntary 1
are higher -- you need both. I'm not saying you shouldn't 2
have government doing a certain thing. You need the 3
government to make sure it happens no matter what. 4
But frankly, some of these standards, when you 5
start reading about the latest -- you know, the monkeypox and 6
things like that, I mean, who even thought about letting 7
these creatures into the United States? You need somebody 8
who has got really high standards. The government is 9
always -- as a sort of general body is always going to be 10
more the least common denominator. 11
So if you could combine the authority and possible 12
legislation of government with the actual details being 13
worked out by multi-stakeholder groups, presumably, good ones 14
who -- and if they don't do what they're supposed to do, you 15
could always get it done yourselves. 16
But at least you're more likely to get much better 17
standards, in my judgment, not the chicken guarding the -- I 18
mean, the fox guarding the henhouse, but if you've got a 19
combination of the authority and you have a group of 20
stakeholders that include consumers and others who will drive 21
to a higher standard, that would be the best combination. 22
DR. HYMAN: Well, I think we unfortunately need to 23
stop here. I'd like to thank all of the speakers for their 24
excellent presentations and enthusiastic participation that's 25
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taken us past our authorized time. 1
We're going to reconvene at 2:00, when we'll be 2
discussing information and advertising. 3
(Whereupon, at 12:30 p.m., the hearing was 4
concluded.) 5
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A F T E R N O O N S E S S I O N 1
MS. KOHRS: Good afternoon. My name is Cecile 2
Kohrs. I'm with the General Counsel's Office in the Federal 3
Trade Commission. And on behalf of the Federal Trade 4
Commission and the Department of Justice, I'd like to welcome 5
you all here today. 6
We're continuing our hearings on the health care 7
and competition law, and policy. I'd like to particularly 8
thank our distinguished panelists who have taken the time and 9
made the effort to be present today to give us their 10
testimony. 11
To put today's testimony in context, I'd like to 12
let you know this is one of about 30 days of hearings that 13
we've been holding on myriad health care issues. Both the 14
Department of Justice and the Federal Trade Commission share 15
responsibility for enforcing the nation's antitrust laws. 16
But the FTC has the additional mandate of enforcing consumer 17
protection laws. 18
This panel today will allow both agencies to look 19
at an area of key interest to both agencies. The information 20
and advertising issues have played an important role in both 21
aspects of the FTC's enforcement areas. 22
We like to see how players -- that is, providers, 23
hospitals, insurance companies -- should be able to 24
coordinate in order to provide advertising and information to 25
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consumers. And we'd like to see how that information is used 1
by consumers and how it's interpreted. 2
We've already had some hearings on how consumers 3
receive and evaluate the information, and I would commend 4
that testimony to you. It's available on the FTC's website, 5
which is www.ftc.gov. 6
So after that incredibly long setup, I'd like to 7
introduce the panel very briefly and encourage you to pick up 8
the more complete booklet that has the bios of all of the 9
panelists. I'm going to keep this very, very short in the 10
interest of moving things along so that we'll have sufficient 11
time to have a really ample discussion of these issues. 12
I'd like to also ask you all if you would please 13
turn off your cell phones because I'm sure someone is going 14
to be saying something incredibly brilliant and I don't want 15
them to be distracted by anybody's cell phone ringing. 16
I'll introduce the speakers in the order of their 17
presentations. After the presentations go on, we'll take a 18
short break and then at the conclusion of the testimony will 19
have a panel discussion. Everyone will come to the front and 20
we'll be able to have a little bit of a dialogue. 21
First of all, we're going to have Bernie Dana, who 22
has come all the way in from Ohio. I think he's one of the 23
farthest fliers in today. He's an assistant professor of 24
business at Evangel University in Springfield -- I'm sorry, 25
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Springfield, Missouri. Sorry about that. 1
Second of all, we'll have Laura Carabello, who is 2
with CPRi Communications. 3
Following that will be Dr. Thomas Henry Lee of 4
Partners Health care. 5
Following that will be Dr. Douglas Koch, who's come 6
up from Baylor College of Medicine. 7
After that, the shortest trip was made by Richard 8
Kelly, who's representing the Federal Trade Commission. He's 9
an attorney in the Division of Advertising Practices. What 10
is that, sixth floor? 11
MR. KELLY: Third floor. 12
MS. KOHRS: Third floor. Sorry. Even shorter. 13
Following that, we'll have Peter Sfikas, who's 14
representing -- he's with the American Dental Association, 15
will be discussing some of the California Dental Association 16
issues. 17
And then John Gebhart of DoctorQuality.com. He's 18
chairman and CEO. He'll be speaking next. 19
And last will be Helen Darling, who's president of 20
the Washington Business Group on Health. And she'll be here 21
talking about some of the issues that some of the employers 22
in the region are looking at with regard to information and 23
advertising. 24
So I will stop. Mr. Dana? 25
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MR. DANA: Well, as was mentioned, my name is 1
Bernie Dana. I chair the American Health Care Association's 2
quality improvement subcommittee. And I'm representing AHCA 3
today. 4
I'm also, as was stated, an assistant professor of 5
business at Evangel University in Springfield, Missouri. And 6
prior to joining the faculty there two years ago, I spent 28 7
years as a corporate leader and consultant in all segments of 8
the long-term care industry, both nonprofit and for-profit 9
organizations. 10
Equally important to me, and I hope to others, is 11
the fact that I am also a consumer of long-term care 12
services. And I'll be explaining that a little bit later. 13
When we talk about long-term care, we're talking 14
about a dynamic, diverse, and evolving sector of our nation's 15
health care system that refers to many settings, not just 16
institutional settings like nursing homes and assisted living 17
facilities. Yesterday you heard from our sister 18
organization, the National Center for Assisted Living. Today 19
I will focus our nation's system on skilled nursing services. 20
The American Health Care Association represents 21
approximately 11,000 long-term care facilities of both 22
nonprofit and for-profit ownership. Many of these facilities 23
are providing multiple types of services, from post-acute 24
services to special care units for those suffering from 25
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Alzheimer's disease and related dementia. 1
Also, our membership includes a very specialized 2
area of long-term care that provides services to persons with 3
mental retardation and developmental disabilities, called 4
immediate care facilities and group residences. 5
Let's talk a little bit about our customers. 6
Nursing home care is something that most of us are likely to 7
deal with at some point in our lives, but is not a service 8
that very many of us are actively seeking either for 9
ourselves or for any of our loved ones. As a result, many 10
consumers end up not being very educated about the complex 11
issues of long-term care until they actually or suddenly need 12
that service. 13
Now, this was the case for my siblings and me when 14
we were advised that our mother, at age 89, was going to be 15
needing to transfer to a nursing home after a short stay in 16
the hospital. I was miles away in Nebraska at that time, and 17
my sister and my father in Ohio went through two days of 18
unbelievable pressure trying to navigate all of the admission 19
process and choose an appropriate nursing facility. 20
Our consumers do expect long-term care services to 21
continue to evolve and diversify. And we can look forward to 22
even more segmentation of the long-term care marketplace than 23
has already happened simply because our primary customers, 24
the residents and their families, want and demand more 25
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options. Clearly, adaptation to the consumers' needs and 1
wants is a positive trend and challenge for us. 2
Let's talk about the marketplace and how consumers 3
make choices. Any discussion on this subject, particularly 4
consumer choice, competition, advertising -- and remember to 5
flip the thing, excuse me -- and quality in nursing homes 6
must include an understanding of the relationship of 7
government policy to these issues. 8
Health planning policies in the '80s and '90s was 9
based on the concept that limiting the supply and usage of 10
health care services would help control the costs of those 11
services. The federal government provided incentives to 12
states to develop certificate of need laws and regulations 13
designed to limit or reduce the supply of nursing home beds. 14
As a result, consumer choices were limited and 15
nursing home providers were somewhat assured of high 16
occupancy rates. Under these policies, nursing home 17
providers had little incentive to compete for customers based 18
on quality or price. 19
As the cost of nursing homes increased, consumers 20
and public policy-makers began to seek lower-cost 21
alternatives to the highly regulated nursing homes. In 22
response, many states began to shift Medicaid funds to cover 23
payment of assisted living and home health care services for 24
consumers whose care needs were on the lower end of the 25
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spectrum. 1
Even though many states have continued policies 2
that limit the growth of nursing home services, the growth in 3
alternatives over the past ten years has reduced the demand 4
for nursing home services. And that lower demand for nursing 5
home services has reduced occupancy rates, and in many cases, 6
prompting nursing home providers to actively compete for 7
residents. 8
Even within the prevailing paradigm of regulatory 9
compliance, the increased competition has brought a renewed 10
interest in the expectations of the customers and in 11
providing value-added services to them. The lower occupancy 12
rates are once again giving consumers a choice in selecting 13
where they will receive nursing home services when they need 14
it. 15
Another important factor in consumer choice for 16
nursing homes relates to their ability to pay. Medicare and 17
Medicaid programs have become important resources to assist 18
nursing home residents with payment for their care. Medicaid 19
is a state-administered and federally-supplemented program 20
for the poor who can't pay for their own care and have very 21
limited resources. Medicare is a federal health insurance 22
program for people age 65 and over. 23
It's important to note that in both of these 24
programs, they determine the rate that they will pay the 25
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nursing home for the services being provided. The Medicaid 1
rate is usually significantly less than the rates charged to 2
people who pay from their own resources, and in some cases 3
even less than the cost of providing the care. 4
At any one time, approximately 65 percent of the 5
nursing home residents in the United States qualify for 6
Medicaid assistance, and approximately 10 percent of nursing 7
home residents are receiving Medicare assistance. The 8
remaining residents pay from their own financial resources, 9
and a small percentage of residents -- and it's growing -- 10
are covered by long-term care insurance. 11
Now, even though the Medicaid and Medicare programs 12
provide payment assistance to many residents, and they also 13
set extensive standards for providers' participation, it is 14
the customers -- again, the families and the resident, both 15
prospective and current, who choose where to receive those 16
services. 17
How are consumers informed about these services? 18
In addition to having a choice of where to go, consumers need 19
appropriate information to make the best choice related to 20
their wants and needs. Nursing home consumers rely on a 21
variety of sources of information. 22
Most nursing facilities do not spend large amounts 23
of resources to mass promote their services. Many rely on a 24
simple brochure, a Yellow Page advertisement, limited media 25
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advertising, a website, and a direct mail newsletter to 1
supplement their efforts to reach potential customers through 2
staff visits with referral agents such as physicians, 3
hospital discharge planners, and social workers for 4
congregate living facilities. They also rely on positive 5
interaction with staff, residents, and families to promote 6
word-of-mouth advertising. 7
Most potential customers will visit a facility or 8
personally observe and learn about the environment of 9
services from a facility staff. Many states severely limit 10
the amount of advertising costs that can be included in a 11
Medicaid cost report from which Medicaid rates are 12
determined. Because of that, many will only allow 13
informational advertisements. 14
Print or media ads usually include the facility's 15
licensure level and may list some of the services or special 16
features of the facility. Few if any facilities make quality 17
claims other than to announce the winning of a quality award 18
or perhaps provide a testimonial from a resident or family 19
member. 20
The American Health Care Association provides free 21
pamphlets for consumers through a toll-free call-in line and 22
the web. And many nursing facilities provide these or 23
similar tools to help educate and clear up common 24
misconceptions. 25
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Generally, the only quantitative information 1
available to consumers about nursing home quality relates to 2
the results of the federal inspections that are conducted 3
annually and whenever there is a complaint. In theory, these 4
unannounced surveys conducted by a team of state regulators 5
are okay, but in practice they are often plagued by surveyor 6
inconsistencies among regions and even within states. It is 7
a subjective process that encourages caregivers to focus on 8
paperwork and compliance with government regulations. 9
By regulatory requirement, consumers can easily 10
access these reports at every nursing home, or they can 11
obtain the reports from the state health department. 12
However, it is important to remember that these reports are 13
not designed for consumer information and they can easily be 14
confusing or misinterpreted. 15
In the 1990s, the Health Care Financing 16
Administration, HCFA, now known as Centers for Medicare and 17
Medicaid Services, CMS, launched the Nursing Home Compare 18
website so that consumers could more easily access 19
comparative information about the federal inspections of 20
nursing homes. The information is arranged to enable the 21
consumer to obtain this information about a single or 22
multiple nursing homes in a market area. 23
CMS continues to support this Nursing Home Compare 24
website as an answer to consumer education and informed 25
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decision-making. As a component of the Nursing Home Quality 1
initiative, which was launched this last year, the site now 2
includes the quarterly reporting of eight standardized 3
quality measures that are intended to provide meaningful 4
insight into nursing care outcomes. 5
Unfortunately, many of the quality measures are 6
flawed in their construction or they simply report 7
demographic characteristics of a nursing home's residents. 8
The measures do little to reflect the respect, 9
responsiveness, living environment, and quality of life that 10
really make a difference in the satisfaction level of nursing 11
home residents and their families. As a result, the 12
information has dubious value in enabling consumers to 13
actually compare and choose a nursing home. 14
I know this to be true from personal experience. 15
There are three nursing homes in the community where my 16
mother needed care six years ago before she passed away. We 17
picked the nursing home that had the fewest deficiencies at 18
their last inspection. In fact, they had zero deficiencies. 19
After Mom was in the nursing home for a week, my 20
sister called me in Nebraska and asked me to come to Ohio 21
because she was upset with the way Mom was being treated. I 22
flew to Ohio immediately, and after all, I, being the 23
executive vice president of a company that owned and operated 24
32 nursing homes in a five-state region, was the expert in 25
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nursing home care for our family. 1
I was appalled and frustrated at the lack of 2
consideration of my mother's needs and preferences simply 3
because of the operating policies. This facility was 4
compliant with the regulations but they didn't listen to the 5
customer very well. 6
What are the solutions? Most consumers don't want 7
confusing clinical statistics or deficiency information. 8
They simply want to know which facilities have the most 9
satisfied residents and families. Until recently, this kind 10
of information has only been available anecdotally. 11
In the last six years, several long-term care 12
provider associations have taken the initiative to 13
quantitatively measure, compile, and publish satisfaction- 14
based information. For example, the three trade associations 15
that represent nursing homes in Michigan have collaborated to 16
both publish and present on the internet a consumer guide to 17
nursing homes. 18
This consumer guide is published every two years 19
and reports the number of inspection citations for each 20
facility, but most importantly, it presents the percentage of 21
families that are satisfied with the facility's services and 22
the percentage that are willing to recommend the facility to 23
others. 24
The American Health Care Association affiliate in 25
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West Virginia publishes a similar consumer guide annually, 1
with the same kind of issues addressed. But they have also 2
added to the report, to the consumer guide, the percentage of 3
staff members who are satisfied with the facility as a good 4
place to work. 5
The various trade associations in Ohio have 6
collaborated with the state health department there to 7
require nursing homes to participate in collecting and 8
reporting on a state-funded website the results of family and 9
resident satisfaction surveys that measure all aspects of the 10
services in addition to overall satisfaction. 11
My dad's nursing home is in Ohio. Of the three 12
facilities in his community, his nursing home has the worst 13
record on the Nursing Home Compare website, but by far the 14
highest family satisfaction rating in Ohio's new consumer 15
guide web report. Interestingly, the nursing home that my 16
mom was in had the lowest family satisfaction rating, despite 17
having the fewest inspection issues. 18
When given a choice, consumers clearly prefer the 19
satisfaction results because they understand them. Nursing 20
home residents are not merely users of services. The nursing 21
home is their home, even their entire world sometimes, a 22
place where relationships and quality of life assume 23
paramount importance. 24
As a result, the focus of long-term care must not 25
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only be on the nursing care outcomes, it must also include 1
quality of life issues such as respect, dignity, and resident 2
choice. 3
Research conducted by Dr. Vivian Tellis-Nayak in 4
1999 analyzed satisfaction survey results of 11,715 families 5
of residents in 504 nursing homes across 26 states. The 6
research shows that family and staff satisfaction are 7
compelling measures of a nursing home's overall quality and 8
performance. 9
Family satisfaction is a window to that quality of 10
care that residents receive, to the stability and devotion of 11
the staff, to the way state surveys turn out, and to the 12
nursing home's overall operation. 13
For this reason, AHCA has developed a model to 14
encourage its state affiliates to begin developing a 15
satisfaction-based consumer guide. The model focuses on 16
reporting a nursing home's three-year trend of family 17
satisfaction, family willingness to recommend, and staff 18
willingness to recommend, as well as the inspection data, but 19
presented as a percentage of the 495 standards that each 20
nursing home must meet. 21
Our profession is committed to quality and is 22
further -- our commitment to quality is further demonstrated 23
by the launching of the Quality First initiative in July 24
2002. This is a proactive, profession-wide partnership of 25
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AHCA, the American Association of Homes and Services for the 1
Aging, and the Alliance for Quality Nursing Home Care. 2
The Quality First initiative declares that we are 3
collectively and individually committed to healthy, 4
affordable and ethical long-term care services that are 5
rooted in continuous quality improvement, openness and 6
leadership. An independent national commission is being 7
formed to assess the report to the public -- and report to 8
the public our collective improvement on six important 9
outcomes. 10
So where does all of this take us? Nursing homes 11
are facing tremendous challenges. We have 52,000 vacancies 12
for certified nursing assistants, the true backbone of the 13
long-term care system and the key to customer satisfaction. 14
The GAO predicts that the overall demand for nurse aide 15
positions in all areas of health care will grow by 38 percent 16
between 1998 and 2008. 17
Current challenges are compounded by knowing that 18
the number of individuals 85 and older are double from the 19
current -- will double from 3.5 million to 7 million in 2020, 20
and the number will again double to 14 million by 2040. 21
We are also facing a crisis in funding for Medicare 22
and Medicaid assistance. An analysis by the national 23
accounting firm of BDO Seidman found that Medicaid has 24
underfunded nursing care nationally by nearly $3.5 billion 25
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annually. Many nursing homes are experiencing extensive and 1
significant financial strength. 2
Long-term care providers are proactively working 3
with the federal and state governments to find solutions to 4
these critical problems. At the same time, we are also 5
actively pursuing ways to provide consumers with the 6
reliable, valid and timely information they need to make 7
informed choices about the type and quality of care of 8
services they need when they need it. 9
We are intent on hearing the voice of our customers 10
as we continuously improve and design long-term care services 11
for the future. Thank you. 12
MS. KOHRS: Thank you, Mr. Dana. 13
Next will be Laura Carabello. 14
MS. CARABELLO: Good afternoon. I am Laura 15
Carabello, founder and principal owner of CPRi 16
Communications. And I'm located in New Jersey. And when I 17
gave this presentation about a year ago in Texas, the doctors 18
in the audience wanted to know if I was related to the 19
Sopranos. And I am not. 20
CPRi Communications specializes in the positioning 21
of health care-related business and services, products and a 22
whole host of health care opportunities in the marketplace. 23
We offer a full range of market and communications services, 24
including public relations and media relations, advertising, 25
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online marketing, interactive communications including web 1
and multimedia development, direct mail programs and market 2
research. 3
We are headquartered in Teterborough, New Jersey. 4
We have a large airport there that serves the DEA 5
extensively. And we have an office in Scottsdale, Arizona. 6
We have clients in 35 states and strategic partners located 7
in London, and we have a global presence and a continuous 8
focus on generating results for our customer base. 9
I want to commend the Federal Trade Commission on 10
these hearings to address the quality of information provided 11
to consumers through physician advertising and marketing and 12
its impact on the decision-making processes for selecting a 13
provider of health care or financing arrangement. And I can 14
say that I've been involved in this for about 20 years -- 15
actually, 22, 23 years. 16
And at the time when I started this company, when I 17
founded this company, it was the time frame that coincided 18
with the U.S. Supreme Court decision to grant physicians the 19
right to advertise. And they went at it. And they flexed 20
their marketing muscles to really take on a lot of 21
advertising initiatives that were available to that time. 22
And over the past two decades I have witnessed a dramatic -- 23
I and my colleagues have witnessed a dramatic change in the 24
way that physicians look at the marketplace and the way they 25
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advertise their services. 1
And several key factors have influenced these 2
changes: obviously, regulatory oversight; guidance and 3
censure from professional trade associations and 4
organizations; increased competition, which is now fierce, 5
particularly for non-covered services classified as out-of- 6
pocket expenditures; the advent of the internet and website 7
communications; the commercialization of medicine; and 8
consumer empowerment. 9
And I think that all of these areas have had an 10
impact on the way physicians approach the marketplace and the 11
way that their advisors help them to structure their 12
advertising and marketing campaigns. 13
If you take a look at Yellow Page advertising, for 14
example, and you look back, how many of you in the audience 15
can look back to prior to the 1980s when Yellow Pages, for 16
example, in the Manhattan Yellow Page book revealed doctor 17
listings, including addresses and telephone numbers. 18
And if you jump ahead from 1980 to 1990, that same 19
section provides small space advertising and full-page 20
promotions in black and white promoting specific services. 21
And by the way, Yellow Page advertising is not inexpensive. 22
The listings became aggrandized with boxed 23
information as an upcharge, as well as detailed information 24
on practice offerings. And I can tell you that Yellow Page 25
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advertising gets more expensive because the Yellow Pages 1
tells you that you have to be in every single Yellow Page for 2
a particular community, and then they narrow those areas down 3
so that they have to spend more money. 4
And if you fast forward to the present, not only 5
did the Yellow Pages triple in size with the sheer number of 6
doctors listed, but also the number of color display ads has 7
grown exponentially. And if you look in any Yellow Pages in 8
any city or states, you will see that doctors advertise 9
extensively. And, by the way, the return on investment for 10
Yellow Page advertising is high. 11
I guesstimate, and I say guesstimate because 12
there's nobody really tracking the number of physicians, but 13
I would say that 95 percent of all physicians engage in some 14
form of paid advertising or marketing. And I will go into 15
that in a few moments because I think that the scope of the 16
opportunity is far greater than we realize. 17
And about 25 percent -- actually, that's an 18
approximation; it might even be less -- of all physicians opt 19
for public relations activities. When you look at public 20
relations versus advertising, public relations is considered 21
earned media. Advertising is paid media. 22
And consultants are usually offering a range of 23
both. They're paying for it. They are consulting with them. 24
They are helping them to work with their practices to 25
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generate coverage in local, regional, national print and 1
electronic media, whether it's press releases complimented by 2
outreach to editors, reporters, and producers. 3
And the results are mentioned in newspaper and 4
magazine articles, appearances on TV and radio, speaking 5
engagements and other venues where the physician is 6
positioned as an authority or thought leader in his or her 7
given field. Many physicians opt for this coverage since it 8
offers an opportunity to share quality information and may be 9
perceived as a third party endorsement. The credibility of 10
public relations versus paid advertising cannot be disputed. 11
Many physicians seek both. 12
The advent and growth of web-based communications 13
has clearly changed the marketplace. And this is taken from 14
the AMA. Approximately three out of ten, or 29 percent of 15
physicians using the web, currently have a website. And this 16
has been increasing every year and has remained constant over 17
the past few years. 18
Websites are greatest among physicians in solo or 19
two-physician practices, and lowest among physicians in a 20
hospital-based practice, as you would imagine. And the 21
primary reasons that physicians offer why they have a site on 22
the web is: 43 percent to promote and advertise their 23
practice; 35 percent to provide patient education and 24
information; and 11 percent increase in physicians using the 25
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web to advertise and promote their practice since the year 1
2000. I think that's pretty impressive in terms of their 2
confidence in web-based communications. 3
The Federal Trade Commission, which oversees 4
regulation and enforcement of physician advertising, has 5
raised some reg flags of concern regarding substantiation for 6
both the express and implied claims of some of the promotions 7
now being offered. These concerns may be well-founded. 8
We are seeing a rise in consumer-driven health care 9
which is really taking on a whole new aspect to how consumers 10
access information and obtain health care. They're taking on 11
a greater role in the selection of providers and services. 12
And there is increased physician participation in advertising 13
and marketing venues. And this is likely to continue. 14
Patients employee comparison shopping techniques, 15
scrutinizing media outlets for information and following up 16
with calls to providers to ascertain coverage options and 17
costs. 18
And I can tell you, in the thousands of physicians 19
that I have consulted with over the years, and that includes 20
physicians in solo practice, multi-physician practices, 21
IPAs -- they always complain to me that the physicians [sic] 22
call and they want to know, how much am I willing to do it 23
for? How much can they get? So they really do shop around. 24
In paid advertising, the quality of information is 25
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largely at the discretion of the physician advertiser. 1
Health care advertising in general, even for the 2
pharmaceutical companies, which are spending a ton of money, 3
is steep. And for physicians engaging in an advertising 4
opportunity, even for public relations, the costs are very, 5
very high. Most advertisers cannot afford to offer detailed, 6
quality information and prefer to tout benefits, if they're 7
real or otherwise. 8
Some advertising has led to misunderstandings and 9
has resulted in lawsuits involving false, deceptive, or 10
misleading claims. The FTC and others will make even greater 11
demands for competent and reliable scientific evidence as 12
substantiation, a burden that lies with the advertiser and 13
his consultants or her consultants. 14
Physician advertising, in my estimation, has 15
changed, the regulations now are so complex from state to 16
state. But they are receiving ample guidance for developing 17
and advertising and promotional materials with the FTC, AMA, 18
state legislatures, local and state medical societies, and 19
specialty medical organizations offering regulations, 20
policies, and guidelines. 21
There is certainly not a shortage of this 22
information. Regulations grant the relevant medical board 23
certain powers to take disciplinary action, which may result 24
in reprimands or lead to licensed suspension or revocation 25
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against a physician whose advertisements violate the 1
applicable regulations. 2
And I would say for the most part that physicians 3
are concerned. They are nervous. When they call our office 4
and they want to set up an advertising campaign, they say, 5
you know, I know certain of the regulations. So I think 6
there is definitely cognizance of these rules. 7
And the state attorneys general usually have the 8
authority to seek injunctive relief and civil penalties 9
against individuals or entities that violate general consumer 10
protection laws that prevent deceptive trade practices. 11
Physicians are urged and directed to avoid 12
deceptive advertising which may mislead consumers. 13
Physicians need not wonder what is allowed or appropriate. 14
State boards of medicine, state laws, and federal law govern 15
advertising by health care providers, with professional 16
organizations providing appropriate verbiage. 17
Ethical advertising is achievable but not always 18
practiced. And I can tell you that very often, physicians 19
will try to pressure into getting something into an ad that I 20
know in my heart is not right. And I will tell them so. 21
And I'm just going to go through a little bit of 22
the advertising rules, the FTC. According to the FTC, an 23
advertisement is deceptive under the Federal Trade Commission 24
Act if it contains a material misrepresentation or omission 25
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of fact that is likely to mislead consumers acting reasonably 1
under the circumstances. 2
I put this ad up because -- and this is not a real 3
ad; obviously, the numbers are made up -- but I happened to 4
see this in the paper a couple of days before I came to this 5
hearing. And is it good taste? Does it give you good 6
information? One of the things that sort of turned me off 7
was the $499 for the first 1,000 eyes. You know, how do you 8
ascertain that you're one of the first 1,000 eyes? That sort 9
of set up a red flag. But the question comes to mind: Is it 10
bad taste? A lot of ophthalmologists I know would say yes, 11
it is in very bad taste and we wouldn't have any part of it. 12
Obviously, there were people that liked it and wanted to use 13
it as their ad. 14
The AMA also offers policies governing advertising 15
and publicity, offering no restrictions on advertising by 16
physicians except those that can be specifically justified to 17
protect the public from deceptive practices. And it goes on 18
to say a physician may publicize him- or herself as a 19
physician through any commercial publicity or other form of 20
public communication -- newspapers, magazines, telephone 21
directories, radio, television, direct mail. I could go on 22
and on how physicians market their practices. 23
They do direct mail. They announce when their 24
office is changing. They announce when somebody is joining 25
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the practice. There are lots of ways that they go about it, 1
lots of opportunities to advertise. 2
When I called the AMA to see how they were tracking 3
physician advertising, the quote from their spokesperson 4
said, "The AMA is a membership organization, not a regulatory 5
body. The FTC put us out of that business in 1980," and had 6
very, very little information to offer, in fact, cut me 7
short. 8
It is evident, however, from their policies that 9
the organization is concerned about the quality of physician 10
advertising, and throughout the profession, most responsible 11
physicians endeavor to adhere to the guidelines cited. 12
If you go on the web and you look at all the 13
different states, every state has their own little quirks and 14
their own little tweaks on what is allowed and what is not 15
allowed. So I'll just give you an example here. 16
North Carolina, Maryland, Virginia, District of 17
Columbia, Illinois. Illinois doesn't allow testimonials or 18
claims of superior quality. A lot of states do not allow 19
testimonials. New York and Texas also preclude the use of 20
testimonials by physicians, but you can see that the trend is 21
that they all agree that you cannot use deceptive practices. 22
However, advertising is advertising, and they're 23
allowed to do so. And what is the purpose of advertising? 24
It's designed to spark the interest of the health care 25
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consumer and prompt the buyer, the patient, to access or 1
purchase services. In some instances, consumer expectations 2
are elevated, leading to liability for physicians who cannot 3
deliver what they promise. 4
How do consumers get this access to this 5
information? For those consumers who are employed, 6
information regarding health care financing and doctors is 7
usually provided by their employers. This is a hit-or-miss 8
opportunity at best, depending on the individual employer and 9
its concern to deliver good information. 10
For employers that are bearing the majority 11
of costs, particularly in the current economic environment, 12
plan selection may largely be a function of price. Large 13
employers usually distribute brochures, which are provided by 14
the plans, and often sponsor health fairs, offering plans the 15
opportunity to provide more information not only about the 16
plan but about the doctors. 17
Employees have come to count on the fact that their 18
employers have reviewed quality aspects of the plan. I'm an 19
employer, and employees just guess or have enough faith in 20
our power to review these plans, especially since we're in 21
the health care business. 22
In fact, it's interesting: Because we're in the 23
health care business, I think all of our employers think that 24
we know everything about health care. I can tell you that 25
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people call us all the time for doctor referrals, and I keep 1
saying, we are not a doctor referral agency. We can't give 2
you information. But we must get probably, I would think, 20 3
to 25 calls a week from consumers. 4
For small employers, which we are a small employer, 5
this information can be scant, leaving the consumer more 6
dependent upon the recommendation of the employer's insurance 7
broker or suggestions from friends and relatives. In both 8
settings, employees can log onto the plan website for 9
information, benefits, and provider rosters. 10
And I must say that most plans to have extensive 11
websites offering information about the plan and the doctors. 12
Since this information, however, is largely self-reported, 13
the quality of the information may be driven by marketing 14
objectives to drive enrollment. 15
Provider selection criteria are more vague. 16
Consumers turn to their health plans for provider bios and 17
don't always get them. And they usually rely upon word of 18
mouth from family and friends regarding quality of care. And 19
the bottom line is people still ask their friends and family 20
about doctors. 21
Quality indicators, including board certification, 22
may offer some comfort level, but people still don't 23
understand what a board-certified physician is. The bottom 24
line from consumers is often the personal recommendation from 25
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friends or colleagues. 1
When they select a health plan, when the price is 2
the determining factor, the provision of quality information 3
means little to the consumer. And consumers often select 4
plans based upon the participation of doctors that they know, 5
that their friends know, and not necessarily quality 6
benchmarks. 7
For those who are unemployed and do not have 8
coverage, the options to access information are even 9
narrower. These consumers must turn to advertising or web 10
messaging, and their reliance on personal recommendations is 11
heightened. 12
We can also look at web messaging, though. If you 13
think about the number of doctors that have websites now and 14
the number of people that are actually web connected, 15
internet connected, there is a disparity. Not everybody has 16
access to the web, although we all are electronically 17
connected today, here. 18
The growth of consumerism, including consumer- 19
driven health care plans, medical savings accounts, flex 20
spending accounts and other offerings may drive the need for 21
more quality information. 22
As consumers spend their own money -- and as my 23
kids always said to me, "This is my money I'm spending" -- to 24
pay for their own health care services, they may be seeking 25
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better information regarding quality. This will put more 1
emphasis on the advertising and marketing and further burden 2
on the providers themselves to establish credibility and 3
substitute claims. 4
Consumers can access select information regarding 5
provider quality. As noted earlier -- and that should be 6
NCQA; I'm going to have to smack somebody -- URAC, JCAHO 7
accreditations for plans and networks offer benchmarks. 8
Many, not all, employers utilize accreditation as 9
criteria for offering the plans to their workforce and tout 10
these achievements in a variety of advertising venues. 11
However, employees and consumers do not really have a clue. 12
They really don't understand accreditation, and may not 13
regard this as important to the selection process. 14
I always am tickled when I ride along the highway 15
and see those kinds of JCAHO accreditations and say, do 16
people really understand what they're talking about? 17
Furthermore, the economics of achieving accreditation or 18
issuing report cards often forces plans to forego the 19
process. 20
Condition-specific advertising dominates physician 21
advertising and often includes information about the nature 22
of the underlying condition, whether it's chronic or acute. 23
Many advertisers play upon the emotional aspects of the 24
condition, particularly those that represent life-threatening 25
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conditions such as cancer or heart disease. 1
There is usually a strong call to action with a 2
toll-free number or opportunity to respond. Many physicians 3
who advertise track the overall response and attempt to gauge 4
the return on investment of a particular venue. 5
Ads may target the impact on a spouse or loved one, 6
or the impact on patient quality of life or appearance. The 7
more responsible physicians do not claim to offer a cure, but 8
may offer diagnostic, treatment, or management options which 9
may be surgical or medical. 10
How do you communicate quality? The quality and 11
quantity may depend upon the advertising venue. For example, 12
billboards offer up to a two-second opportunity to deliver 13
the message, two to three seconds at the most, leaving little 14
room for information or quality communication. Radio spots 15
usually run 30 to 60 seconds, hardly enough time to cover 16
details. Here we go. That's the end of the billboard. 17
That's as much time as you probably had to get that message. 18
And what are the effects on the behavior of health 19
care providers? Physicians who advertise often adopt their 20
own marketing persona. For every patient generated -- this 21
is a rule of thumb -- through advertising, four additional 22
patients will be referred by that patient. So they look at 23
it as an opportunity to really drive their practices. 24
Physicians that make the investment in advertising 25
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must also follow through during the patient encounter to 1
ensure a pleasant experience regardless of the diagnosis. 2
And marketing-oriented physicians often undergo training, not 3
only to prepare them for media interviews but also to deal 4
with patients. 5
Practice management and public relations counselors 6
advise on a variety of issues impacting multiple aspects of 7
interpersonal relations, from developing appropriate body 8
language to eliminating bad breath. 9
Physician marketers may encounter some push-back 10
from their colleagues or a drop off in referrals. There's 11
professional jealousy. Their colleagues who do not engage in 12
advertising express disdain by minimizing referrals. For 13
successful marketers, however, these issues are no loner of 14
grave concern. 15
Physicians who run advertising for elective, out- 16
of-pocket procedures not covered by insurance usually tout 17
benefits, substantiated or otherwise, along with cost- 18
competitive positioning and opportunities to charge your 19
services to a credit card. Plastic surgery, corrective 20
vision procedures, laser hair removal, fertility, and diet 21
plans are among those conditions which fall into this 22
category. 23
The quality or credentials of the physicians are 24
not a key selling feature. In some of these instances, the 25
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volume of procedures performed or the number of pounds lost 1
are cited. Before and after photos are often featured as the 2
incentive. This hard-sell approach extolls the volume of 3
procedures, not the quality of the outcomes. 4
Is advertising driving up the cost of care or 5
simply fueling the competitive spirit? Physician 6
reimbursement is established by the government, Medicare and 7
Medicaid, or set by individual health plans. The fees do not 8
change for physicians who advertise. In the area of non- 9
covered benefits, however, physicians can use pricing as a 10
sales tool. 11
The competition for patients remain fierce and 12
competitive market forces come into play. What forms of 13
advertising are good? Quality pays off in the long term. 14
As the competitive climate escalates, there is 15
likely to be surge in comparative advertising. And one of 16
the things I want to point out is that a lot of physicians 17
are dying to be featured as the leading doctor, the best 18
doctor, New Jersey Monthly or New York Magazine, U.S. News. 19
But they realize this is a popularity contest unrelated to 20
performance, not a real litmus of quality. Hospitals and 21
health plans also use these ratings. 22
Marketing quality services and actually delivering 23
quality services are two distinct issues. There are no 24
restrictions, which limit the quality of -- limit the 25
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advertising of health care goods and services based on 1
quality, but there are regulations articulating standards for 2
avoiding advertising claims that are misleading. These 3
standards are widely respected and adhered to by most 4
physician marketers, and coupled with guidelines, they know 5
what to say. 6
The ability to advertise and market health care 7
services supports a competitive climate and should ultimately 8
drive improved quality. Competition is healthy, even in this 9
delicate market niche. And for those that stray from 10
restrictions and guidelines, however, there should be 11
enforcement that protects consumers. And obviously, selling 12
health care services is different than selling vacuum 13
cleaners. 14
My final thoughts: When developing and 15
implementing a marketing campaign, it is incumbent upon 16
physicians and their advisors to know and play by the rules? 17
Advertising that is in bad taste is simply distasteful. 18
Advertising that is false or misleading is illegal. 19
Guarantees are simply not allowed. The objective 20
is to elevate quality of care goals to the same level as 21
financial goals. And advertising that adheres to standards 22
set forth by government and others is mandatory. Advertising 23
that communicates quality and provides information should be 24
the end result. Thank you. 25
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MS. KOHRS: Thanks very much. We'll have Dr. Lee 1
speak. 2
DR. LEE: I'm Tom Lee. I'm an internist and a 3
cardiologist and the chief medical officer for the network of 4
Partners Health care System in Boston. And I'm speaking 5
today about direct-to-consumer marketing of high-cost 6
radiology tests, at least I will if we can get in slide show 7
mode. 8
The issue that I'm speaking about are high-cost 9
radiology tests that are being directly marketing to 10
consumers. And I'm really going to focus on two of them, the 11
two most common ones, which are general screening for 12
malignancies, the most common being lung cancer screening 13
with chest CT versus whole body CT, and then a coronary 14
artery disease screening with electron beam CT, EBCT, as it's 15
called. It's technology that I'll talk a little about more 16
on the next slide. 17
To summarize, you know, these technologies are 18
marvelous. Technologically, they are really incredible if 19
you understand what they're doing, particularly with the 20
EBCT. But just because they're marvelous doesn't mean they 21
actually help anyone, or at least given our current state of 22
medicine. So their value is unproven. They have not been 23
shown to make people live longer or live healthier lives. 24
In fact, there's concern. There's concern about 25
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the impact of false positive rates, the economic consequences 1
of false positive rates as well as the anxiety, and even the 2
medical consequences of false positive rates. 3
And there's also concern about whether the 4
advertising is misleading regarding the false negative rates. 5
That is to say, if you have a negative CT of your body 6
looking for cancer, do you really have -- should you really 7
have peace of mind? And as you can probably guess, my answer 8
is no. And as I said, there's no evidence that they improve 9
patient outcome. 10
The insurance companies are completely correct in 11
not paying for these tests. The evidence doesn't support it, 12
and where there are many things that are supported by 13
evidence that need to be paid for. 14
As a result, consumers are being asked to pay for 15
these tests out of their pocket. A lot of people would say, 16
well, if they want to pay for it out of their pocket, that's 17
fine. One of my arguments is that we are all paying, 18
however, for the sequelae of these tests being performed. 19
The sequelae are real, and as evidence I would cite 20
the fact that the tests are sometimes offered at very lost 21
cost or even free by health care organizations, physician 22
groups and other kinds of organizations, with the 23
expectations that the follow-up tests are going to be covered 24
by insurance, and that is where the health care providers 25
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will make their money. 1
I want to talk first about electron beam CT. I'm 2
not going to give you a lecture. I'm just going to try to 3
give you the bare minimum. It is an incredible technology 4
that was very promising when it was first developed. It can 5
detect calcium deposits in coronary arteries. 6
And what's remarkable about it is that it takes 7
such a quick image that the heart is essentially holding 8
still. And the heart is always moving, of course, but the 9
image is done so quickly that you can get a picture that 10
allows you to figure out whether or not there are calcium 11
deposits in the walls of the coronary artery. 12
It's not so sophisticated they can look inside the 13
coronary arteries and tell you whether the artery is 14
narrowed. But it can tell you whether there's calcification. 15
And such calcifications are present in virtually all patients 16
with coronary disease. And there are very good studies 17
showing that the higher your calcium score, the higher your 18
risk for having atherosclerosis and the higher your risk for 19
having a heart attack in the long run. 20
But tempering these facts which would support the 21
promise of this technology is the fact that the overall risk 22
for asymptomatic people -- that is to say, people who 23
currently feel fine, don't have chest pain or other symptoms 24
of heart disease -- the overall risk for a heart attack in 25
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the next year is very, very low, like in the 1, 2, 3 percent, 1
even if they have coronary artery disease. 2
And no study has shown that the treatment of high 3
calcium scores improves outcome. There have been studies 4
where they take people who feel fine but have high calcium 5
scores and randomize them to statin therapy versus placebo, 6
and there is no difference in outcome because all of them 7
tend to do very, very well. 8
There is, however, a very high false alarm rate. 9
Let me give you -- this is what the scans look like. This 10
is, you know, cut through horizontally the top of your heart, 11
and that is like the main artery going down the front of the 12
heart, a little segment of it, the left anterior descending 13
artery. And you see those bright white shadows are 14
calcifications in the wall of the left anterior descending 15
artery. And you would rather not have calcification than 16
have calcification. 17
This is the kind of image that gets people -- there 18
are some very good people who are very interested in the 19
technology, and this is why they're so interested. You can 20
get an image like that, and you would like to think that 21
would help you take better care of those patients. 22
However, it hasn't worked out that way, but 23
nevertheless, these are being advertised. You know, Father's 24
Day is Sunday, and you can get both the heart and lung scan 25
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rolled together for early disease detection. And this is a 1
New York Times ad, so it didn't reproduce too well on my 2
slide. And there are ads like this all over the country, for 3
$499. My children haven't gotten me one. I don't know what 4
that means. 5
So what do these results mean? Well, first, if you 6
have a low score, there's a 99 percent chance of no cardiac 7
events over the next year. If you have a high score, there's 8
a 1 to 5 percent risk over the next year. As I said, the 9
problem is that no one has shown that you can change that 10
risk, because it really is pretty low to begin with, by 11
giving people medications. 12
But here's what really bothers me most about these 13
tests. If you don't have obstruction in your coronary 14
arteries and you're over the age of 65 and you're an American 15
who's been eating an American diet, what are the chances that 16
you have a worrisome calcium score? It's 50 to 70 percent. 17
There's a very, very high false positive rate. It really is 18
calcium in the walls, but it isn't atherosclerosis that's 19
going to cause a heart attack. 20
So what are the implications? Most people do not 21
get the reassurance they seek. That's what they're hoping 22
for. They're hoping for this clean bill of health, and most 23
people don't get it. They get this intermediate calcium 24
score. Very few of them get the low calcium score that 25
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they're hoping for. 1
The result is that many patients can't sleep at 2
night until they get further testing and further treatment. 3
And every cardiologist I know who's active at all has 4
patients at this point who are perfectly fine, got these 5
tests, and it set in motion a series of other 6
interventions -- exercise tests, cardiac catheterizations. 7
They find some narrowings. They don't know what to 8
do with it. They do an angioplasty or even bypass graft 9
surgery. And some of the celebrities and very wealthy people 10
in our community, in Boston, have had the angioplasties and 11
bypass surgery and they think their lives were saved, but 12
they weren't. 13
The bottom line is that the American Heart 14
Association and American College of Cardiology do not 15
recommend this test. Nevertheless, a lot of the members of 16
the American College of Cardiology and American Heart 17
Association sell these tests. 18
Okay. A whole body CT scanning? It's basically 19
the same story. This is from the FDA website, I believe. 20
And you can see the bold print, you know: "At this time, the 21
FDA knows of no data demonstrating that whole body CT 22
screening is effective in detecting any particular disease 23
early enough for the disease to be managed, treated, or 24
cured." And I can tell you that that is the state of the 25
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science. There is no evidence indicating that it is helpful. 1
That doesn't stop other websites from telling you a different 2
story. And, you know, you don't need to read all this, but 3
this is from an organization that's trying to hook people up 4
with getting low-dose spiral CTs looking for lung cancer. 5
I'll just -- the next slide is the bottom part of 6
this. And I just want to highlight for you the third line 7
from the bottom: "Schedule a spiral CT today. It could save 8
your life." Well, maybe it could, but there's no evidence to 9
support that particular claim. That phrase, "It could save 10
your life," appears over and over and over in the advertising 11
for these technologies. 12
Well, do they save lives? Well, it's not proven in 13
any study. It's very difficult to prove something doesn't 14
save lives. You need huge, huge, huge studies, and no one's 15
got a particular interest in funding them. The government 16
is, in fact, though, funding some good research. 17
Research in the past has shown that chest x-rays do 18
not prevent death from lung cancer. They just lead to 19
earlier detection. And here's the reason why: Because 20
intuitively, you would expect if you find tumors earlier, you 21
would help save lives. 22
The problem is this, and it's discouraging -- I 23
wish it wasn't true, but this is the basic science: Tumors 24
have millions of cells by the time that they are one to two 25
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millimeters in diameter. That's the tip of a pencil point. 1
The tip of a pencil point is millions of lung cancer cells. 2
And there's plenty of good research -- not some, 3
plenty of research -- that indicates that genetic factors 4
have programmed those cells so that the ones who are 5
programmed to metastasize have already metastasized by the 6
time that there's a one- or two-millimeter mass, and the ones 7
that are not going to spread very easily are not going to 8
spread. And they may reach golf ball size, and you can take 9
them out then, and the patient will still have a good 10
prognosis. 11
So that by the time you can find them on a CT scan, 12
it's -- probably the game is going to be over one way or 13
another anyway. But it's an unanswered question, and at this 14
point I would say somewhere by saying proponents, the 15
optimists, say it would be unethical to ask people to wait 16
while the big studies are done. The opponents say it's 17
unethical to ask people to pay for an unproven technology. 18
Again, my problem here is the false reassurance 19
issue. A negative CT can easily miss small tumors, and some 20
tumors are just not visible by routine CT unless contrast 21
agents are given. So anyone who's a clinician here knows 22
that you can't find adrenal tumors and renal tumors and many 23
other tumors unless you infuse intravenous contrast, but 24
those contrast agents carry a small, about 1 percent, risk of 25
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reactions and they're also very expensive. 1
Fortunately, no one out there is doing screening 2
CTs with contrast. They're not that irresponsible. That 3
said, people walk out thinking that they've got a clean bill 4
of health. They may continue smoking because they believe 5
that they are getting away with it. 6
So, I mean, this -- I put this slide in here just 7
to say that I don't -- I hope I won't sound like a 8
paternalistic physician, but I'm very concerned that patients 9
just can't understand the risk information, at least as it's 10
being portrayed in the kind of marketing materials that I 11
see. 12
You've got physicians and celebrities advocating 13
testing. And my second bold point in that graph is just to 14
make the point that everyone -- patients, physicians, all 15
human beings -- have difficulty putting risks in perspective. 16
There is this whole interesting line of work about 17
prospect theory. And some of you may know that prospect 18
theory won the Nobel prize for economics in 2002. It's about 19
why you will drive five miles to save $5 on a $20 purchase, 20
but you won't drive five miles to save $5 on a $1,000 21
purchase. It's about why people can't be rational about 22
money. 23
Well, the same is true about health care risk. 24
Something that seems to increase your risk a tiny bit that 25
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you didn't know about before has disproportionate value in 1
your mind, so that you have people smoking cigarettes while 2
worrying about SARS or worrying about, you know, other things 3
that are just not, you know, important. 4
And, you know, for me the epitome was a car that 5
someone pointed out to me in Boston the other day, a sports 6
car with a bumper sticker saying, "Ban nuclear power," and 7
there was a radar detector in the front. So the chance this 8
person will die from a car accident, of course, is much, much 9
greater than from a nuclear accident. But the prospect of a 10
nuclear accident was much more worrisome. There is this 11
whole line of thinking. The bottom line of it is that we're 12
not rational animals and it's very difficult for us to put 13
risks in perspective. 14
Well, what do physicians do? These are my last two 15
slides. I did, after being invited to come down here, do an 16
e-mail poll of the internists and the cardiologists of Mass 17
General Hospital and Brigham & Women's Hospital. And I 18
actually got responses from 141 internists, and I asked them, 19
have you undergone a CT to screen yourself for cancer? And 20
then the follow-up question -- and I asked the cardiologists, 21
have you had an EBCT to screen yourself for coronary disease? 22
And then the follow-up question was, if so, did you pay with 23
your own money? And third question was going to be, did you 24
pay with post-tax dollars? 25
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But I never got to the third question because not 1
one internist at the Brigham or Mass General has had a CT 2
scan to screen themselves for lung cancer or other cancers. 3
Two out of the 26 cardiologists have had electron beam CT, 4
but neither paid. One of them indicated that he would have 5
paid, but as my wife said, she'd believe it when she saw it. 6
So these were some of the comments I got back in 7
the e-mail from the cardiologists on electron beam CT. You 8
know, "I would not have done it even if it was covered by 9
insurance. It's hype. I discourage my patients from having 10
it done if they ask." 11
"No. I was asked by my wife's rich uncle in 12
Argentina whether he should invest, and I told him if it was 13
a good plan to get in and then make sure there as a good exit 14
strategy once people figured out the limitations." 15
"No. I can't see use for it save to generate 16
anxiety and more business for the ETT lab" -- exercise test 17
lab -- "which would be good from a purely commercial 18
standpoint." 19
And the last one is, "Absolutely not. This test is 20
not ready for prime time." 21
The last comment I'd make is that I wish the 22
medical profession was effective enough in trying to regulate 23
it. When the leaders of cardiology and general medicine 24
don't believe these tests have value, I wish our profession 25
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was effective in keeping physicians from marketing things. 1
But it's not, and I don't have realistic 2
expectations it will be in the near future. So I'm hoping 3
that these hearings will lead to some other kinds of 4
interventions. Thanks very much. 5
MS. KOHRS: Thank you, Dr. Lee. 6
We're going to have Dr. Koch speak next, if I don't 7
have the computer shut down one more time. 8
DR. KOCH: Thank you very much. It's a pleasure to 9
be here. I was asked to speak because of the notoriety of 10
good and probably a lot bad that ophthalmology has with 11
regard to LASIK advertising and how it tends to dominate the 12
marketplace in terms of the amount of -- proportion of 13
medical ads. And I think that was shown or reflected in Ms. 14
Carabello's talk as well. 15
I'm from Baylor College of Medicine. I also would 16
like to acknowledge that I've been discussing this with my 17
colleagues at the American Society of Cataract and Refractive 18
Surgery, and as a society, we have a lot of interest in this 19
area and in appropriate mechanisms for informing patients 20
about LASIK surgery. 21
And I'll start with my recommendations or my 22
thoughts, which are, we'd like to see more stringent and 23
consistent enforcement of FTC regulations for advertising in 24
LASIK. And we would like the FTC to help us to -- you know, 25
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to reach out to our societies and other societies to 1
encourage them to give them a kind of maybe perhaps moral 2
support, and perhaps certainly to be a little bit more public 3
in their encouragement of medical societies to report member 4
violations, and maybe even consider some kind of complaint 5
hotline. 6
Let me tell you just a brief thing or two about 7
LASIK surgery. It's approved to treat a certain range of 8
nearsightedness, farsightedness, and astigmatism. It is not 9
for everyone. And very careful screening of patients is 10
required in order to maximize the likelihood of good outcomes 11
and to minimize the risk of complications. 12
It involves making a corneal flap with a device 13
called a microkeratome. Just recently there's a laser device 14
that can also make the flap. This flap is elevated -- the 15
microkeratome, by the way, uses a steel blade, and then the 16
flat is elevated and the XMER beam is then used to reshape 17
the corneal surface in the desired fashion in order to modify 18
the patient's refractive error. 19
And typical outcomes might include 80 percent of 20
patients seeing 20/20 or better without glasses, with 1 21
percent losing a certain amount of vision and a very small 22
number of patients losing large amounts of vision. But the 23
results do vary to a great extent by the magnitude of the 24
preoperative refractive error. So low corrections get better 25
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results, as you might logically feel. 1
It's a big business. In 2002, there were over one 2
million LASIK procedures, with a total cost of $1.9 billion. 3
And a marketing cost at about $140 an eye is about $160 4
million, so there's a lot involved here. 5
Now, where do our patients learn about LASIK? The 6
American Society of Cataract and Refractive Surgery just 7
worked with the Harris Interactive to do a poll, and you can 8
see that they learn about it from their eye physicians, 9
opthalmologists/optometrists; family and friends; internet; 10
other media; and then advertising. And of course, 11
advertising -- really, these things probably also are part of 12
the advertising, and then less so from the medical 13
associations. 14
As physicians, obviously, our first role is to do 15
no harm, to be the caretaker. And we have a pact with our 16
patients as ophthalmologists who are entrusting their vision 17
to us. And so cannot advertising be consistent with this 18
goal? 19
Absolutely. If it honestly informs the patients of 20
availabilities of practices and procedures, describes them, 21
and even fair comparisons are doing -- probably are 22
beneficial to our patients. They drive costs down. They 23
inform patients. We're not opposed to any of that. 24
Obviously, there must be no deception, stated or implied. 25
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The fundamental problem is this whole thing about 1
health care and commodities and is LASIK truly a commodity in 2
a free market? Clearly not in the traditional sense, and 3
again, this was alluded to earlier. 4
You can't test-drive your surgical result. You 5
can't try to remove one spot and see if this cleaner works 6
better than the other cleaner. You have one crack at having 7
surgery on your eyes. And it's difficult to get data 8
regarding quality of surgeons and outcomes. 9
The ads kind of run the spectrum. There are those 10
that are legal and ethical, those that are legal but we would 11
consider unethical, and then clearly illegal ads. So an ad 12
can be legal but not in the best interests of patients. And 13
we're also worried about the profession and about not only 14
the image of the profession to the public, but about what we 15
try to instill in our colleagues as physicians. 16
So the advertising can deceive patients in a 17
variety of ways. These are at least four ways that 18
advertising in LASIK surgery can deceive patients, the first 19
one being price. 20
The classic one was already really shown, the 21
asterisk, which is a bait and switch: 499 for your eye, and 22
all of a sudden you end up using -- the patient realizes 23
that's not the laser they want to have used. There's a 24
limited refractive range, up to myopia, up to minus 2, for 25
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example, a low correction. And no follow-up or retreatments 1
are included. So by the time everything is added in, in 2
fact, the fee is much higher. 3
I think money-back guarantees are particularly 4
pernicious because there's the implication of reversibility 5
so that 20/20 or your money back. Well, that doesn't help 6
you if you go blind from the operation. Your money back 7
doesn't quite cut it. So that's, I think, a problematic 8
area. 9
And look what we got here, 299 for the first 1,000 10
eyes. You're in the wrong market, you know. Your market's 11
overpriced, clearly. Why we have performed more laser -- and 12
this is the top part of the ad. This is in our Sunday paper 13
every Sunday, in the comic page, the head of the comic page, 14
by the way. 15
And not only do you get, this is all the stuff, oh, 16
you can get Botox, again with the asterisks. And the 17
asterisks start to -- you know, only for the -- they had the 18
VISX laser in the ad, but the low price is actually only for 19
the Nidek laser, et cetera, et cetera. And it goes on from 20
there. 21
Here's one: "Don't wait because this offer is too 22
good" -- two eyes for the price of one -- "to last." Let's 23
see here. The computer is having a hard time crunching my 24
large files. 25
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Here's one: "LASIK eye surgery for free. I can 1
see clearly now." Their website is seeclearly.com. And 2
again, the implication that everything is clear. "Win a free 3
laser vision correction." These kinds of inducements that 4
are misleading about price. Two-for-one pricing. 5
This is one of my favorites: "Guess what I won, 6
hon?" And, you know, which media? And you can see, there's 7
your fine print. You'd need LASIK surgery just to read the 8
fine print. 9
And my favorite of all time, and I want to 10
acknowledge Dr. Terry O'Brien, who sent me some of these: 11
"Kiss a pig and you can win free LASIK vision correction." 12
You know, it's a trivialization. It's a kind of -- the humor 13
in these kinds of approaches kind of minimize the seriousness 14
of the decision that patients make in contemplating this type 15
of surgery. 16
Well, what about the eligibility criteria? There's 17
the implication that the procedure is for everybody. And 18
I'll give you one example of that. Here's one -- let's 19
see -- "Get rid of your glasses. Cataracts. Nearsigned. 20
Farsightedness." So it doesn't matter what you've got, we 21
can fix you. 22
And again, it draws patients in. It makes them 23
think that, gee, I must be eligible for this, and makes them 24
less critical in thinking about the applicability of this 25
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procedure for themselves. 1
Outcome: There's implications of the perfect 2
result, of the permanent results, of no complications. 3
"20/20 for 2995." You can get rid of your contacts for life. 4
"The only laser vision correction facility offering a 20/20 5
promise." Refund the final fee. "To the best." How do they 6
define "best"? There are the glasses. No more glasses. No 7
more contacts. Things that are clearly not accurate or 8
correct. 9
"Participate in our free LASIK" -- dah dah dah dah 10
dah -- "seminar." The "get-rid-of-your-reading-glasses" 11
seminar. And learn how it uses -- for the best results. And 12
again, no data to substantiate these claims. 13
Other claims from recent ads: "Quick and pain-free 14
way to eliminate your way for corrective lenses." "The 15
world's most advanced ophthalmic lasers." "The only 3-D eye 16
tracker." "To treat a lifetime of nearsightedness, 17
farsightedness, and astigmatism." The eye tracker doesn't 18
even do the treatment. There's one who -- this physician is 19
referred to as an "opinion leader" here in the Washington 20
area. Nobody really knows who she is. 21
Fear: Fear of complications, and building on fear. 22
I actually object to this probably least because at least it 23
makes patients think about the seriousness of it. But it's 24
still obviously an issue. 25
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This surgeon no longer does LASIK. He does laser 1
on the surface, so he shows a razor blade and, "No blade 2
used. Safer than LASIK. Better quality and quantity of 3
vision." No proof for that. "Greater long-term comfort." 4
No proof of that. In fact, there's proof to the contrary of 5
that. "Don't subject your eyes to the risks," et cetera. 6
But he does himself one better. A box-cutter. So again, you 7
know, that's the kind of material that's out there being 8
viewed by our patients. 9
Other claims: "Can virtually eliminate potential 10
complications." "Ask about our no-glare, no-halo 11
technology." Nobody has no-glare, no-halo technology. 12
There's proven. CK, which is another operation, "is a non- 13
invasive procedure." CK involves putting a needle about two- 14
thirds of the way through the cornea and applying a current 15
to it and causing a little burn in the cornea. To me, if 16
you're sticking a needle in somebody's eye, that has a kind 17
of invasive feel to me. 18
"No hassles, just crisp, clear vision." So again, 19
the issue with testimonials is that again it implies that 20
patients are eligible; that the outcomes, you know, 21
incorporate safety components, and obviously ignores whatever 22
this person giving the testimonial often is paid. We see 23
baseball players, movie stars, et cetera. 24
So false advertising deceives patients. It fosters 25
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poor patient decisions regarding undergoing a procedure. It 1
demeans the profession, and is a violation of the implied 2
pact between physician and patient. 3
As part of this survey, we found that dissatisfied 4
patients after LASIK surgery were less likely to know what 5
procedure they had -- they didn't even know if they had LASIK 6
or another procedure -- or to be knowledgeable about the 7
benefits, risks, and expected amount of visual improvement 8
that could occur with the surgery. And they were more likely 9
to note advertising as a source of information about LASIK 10
surgery. 11
So how can we better protect our patients? We have 12
to provide better information. That falls upon the medical 13
profession to do that. And I think tighter scrutiny in 14
advertising is important. 15
Now, at the American Society of Cataract and 16
Refractive Surgery, we've developed the Eye Surgery Education 17
Council, and that has a website that has a range of 18
materials, including very detailed LASIK patient-screening 19
guidelines that are designed really to stimulate patients to 20
think about all aspects of what LASIK surgery involves and 21
whether they might be a candidate, and provide them with a 22
list of questions they can ask physicians. 23
We have guidelines for refractive surgery 24
advertising, and FTC was very helpful in this, actually. And 25
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combined with the American Academy of Ophthalmology and the 1
American Society of Cataract and Refractive Surgery, they 2
were approved by the FTC. They provide a legal framework for 3
those issues as you see. And they talk about the kinds of 4
claims, and they give good examples about efficacy, 5
comparative efficacy, safety, permanence and predictability, 6
and success rates. 7
So what we'd like to have is stronger enforcement 8
of the guidelines. And are there other things that -- maybe 9
some ideas about how we as professional organizations can 10
oversee our members without subjecting ourselves to these 11
threats of litigation. 12
We believe that if we work together, we can improve 13
our patients' welfare, and that FTC enforcement of current 14
regulations will bolster professional societies' self- 15
policing and make it easier for societies to enforce the 16
guidelines that FTC has worked with to create. 17
So we'd like to see this more stringent 18
enforcement, further working with our societies, dialogue 19
about this, public announcements of this, and consider maybe 20
even a hotline of some sort as a way of promoting or making 21
it easier to report these sorts of things. 22
And again, I appreciate the opportunity of being 23
with you this afternoon. 24
MS. KOHRS: Actually, our next speaker is going to 25
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be -- sorry. It's going to be Richard Kelly from the Federal 1
Trade Commission. 2
MR. KELLY: Good afternoon. I think the 3
presentations so far have really been excellent. Given me a 4
lot to think about even before I walked up here. 5
It reminds me of the story of why lab technicians 6
prefer lawyers to white rats for their laboratory 7
experiments. And maybe you've heard this story before, but I 8
think it's an interesting one. 9
One of them, of course, is there are just much more 10
lawyers than white rats. And the second reason is that the 11
lab technicians don't get attached to those lawyers. And the 12
third one, of course, is that there are just some things you 13
can't get a white rat to do. 14
So, you know, here I am today, listening to these 15
presentations and desires for the agency to do more. And 16
certainly we're listening and we want to respond. 17
And what I wanted to do today was to talk a little 18
bit about the FTC's experience with LASIK, but also to give 19
you a little background in case you don't know a little bit 20
about what this agency is about and the kinds of things we 21
do. 22
It's probably useful for this slide to be up there 23
in terms of the value, the positive value, of advertising. 24
Because inherently, we're going to hear about some negative 25
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things. These ads are deceptive. These ads have 1
misrepresented this or that. These ads lead people down the 2
wrong path. 3
And I think Laura had mentioned the Supreme Court's 4
intervention in the area to open up the doors to advertising 5
by health care professionals several decades ago. And that 6
was certainly over First Amendment concerns, but it's also a 7
recognition that advertising, if done well and right, can 8
help the marketplace. 9
Obviously, it can do all of those things that are 10
on that slide. You yourselves can think of experiences where 11
advertising has helped you make a choice or a selection or 12
become aware of something new that you just didn't know was 13
out in the marketplace. But that last point, that last point 14
on that slide, is of course essential. But of course it must 15
be truthful and non-misleading. 16
You know, it's interesting: When I hear the 17
discussions about the FTC, I mean, and all the things that we 18
might do or could do, today, right now, we're in court today, 19
not on a case involving physician advertising, but we're in a 20
court today, right now, seeking a temporary restraining order 21
against a marketer of a product called coral calcium. 22
And coral calcium was being marketed as to treat or 23
cure cancer and other diseases such as multiple sclerosis and 24
heart disease. Very widely promoted on television. So we're 25
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in court today challenging that. 1
Just last week we went into court, got a temporary 2
restraining order against a marketer of the Q-ray. Q-ray, 3
which is being marketed as something to relieve muscular and 4
joint pain, even though a very recent Mayo Clinic study 5
showed that it was no better than a placebo. 6
So there is much to do, and many areas for us at 7
the FTC on the consumer protection side to be focused on. 8
And that basic mission, as is set out in that slide, is to 9
prohibit unfair or deceptive acts or practices, and to go 10
against false advertisements for food, drugs, devices, and 11
services. 12
A practice is deceptive if it's likely to mislead 13
consumers acting reasonably under the circumstances, and is 14
material to a consumer's decision to buy or use a product. 15
And a practice is unfair if it is likely to cause injury to 16
consumers, injury as such that cannot be avoided by consumers 17
themselves and is not outweighed by some benefit. 18
One of my handouts was some pictures of some ads. 19
And the first one was for this, this amazing Gutbuster. The 20
ad says, "Turns ordinary sit-ups into tummy-tightening power 21
stretches." It's an old case from the FTC, old, I guess by 22
most standards, 1990. But what was interesting about that 23
case, it's a combination of both that unfairness and 24
deception concept. 25
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It turned out that Gutbuster really didn't do 1
anything to tighten your stomach. So those claims were 2
deceptive. But the other concern -- and this is a 3
Gutbuster -- the other concern about the Gutbuster was that 4
it could break upon use and maybe actually bust that gut by 5
piercing it or hurting some other part of the body. That 6
part of the advertising was unfair because it would cause 7
injury that consumers could not reasonably expect or avoid, 8
simply by using the product. 9
Core advertising principles: I don't think anybody 10
could disagree with any of these. Obviously, tell the truth. 11
But that's an important point, too: Tell all the truth. 12
Don't omit information that's needed to keep what's being 13
said in an ad from being deceptive. And, of course, to make 14
sure it's the truth, which is a core, very significant 15
approach that the Commission takes, and is certainly very 16
vital for any health care advertising. 17
The concept is, is before an advertiser makes a 18
claim in their ads, they'd better have a basis, a reason, to 19
believe that in fact that product or service will do what's 20
being said. And this standard, which we call the 21
substantiation standard as it says here, is flexible. It 22
depends on the claim. 23
So if you say in an ad, four clinical studies show 24
that this does this, well, then, you'd better have four 25
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clinical studies that show that. If you say in an ad that 98 1
percent of our customers or our patients or the consumers 2
taking this product achieve this result, that certainly is an 3
implication that you've done some kind of study or follow-up 4
with your patients to demonstrate that that's true. 5
But the point is that the standard is also flexible 6
so that if something new has been developed, some new 7
technology is being developed that information can get out in 8
an advertising about this technology so that there isn't some 9
absolute bar that you must have at this point this amount of 10
evidence before you can say anything, but still if you do 11
choose to do that you've got to present it in a fair and 12
reasonable way that consumers would understand what that 13
evidence means and what it doesn't mean. And of course, it 14
requires competent and reliable, and in the health care area 15
scientific, evidence, evidence that an expert would say is 16
needed. 17
A little concept here about ad meaning. When you 18
look at those ads that were being put up on the board before, 19
advertisers are certainly responsible for any express 20
statement they make in the ad, but also for ones that are 21
reasonably implied by the express statements they make. 22
The net impression of the ad -- we always look at 23
everything. Take a look at a couple of the other slides I 24
gave you, which are sort of interesting. Because they get 25
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into some of the issues that we might address in FTC cases. 1
This ad here, the one that has this big, blown up, 2
"A 1994 contemporary pediatrics recommendation study found 3
that 88 percent of pediatricians who recommend baby food 4
recommended this particular product." 5
Now, that's not what the -- that was a small fine 6
print disclaimer or disclosure at the bottom of the ad. The 7
ad actually looked more like this. I know you can't all see 8
it, but it was in bold print. "Four out of five 9
pediatricians recommend Gerber." Okay? Then they had put 10
this disclaimer that you see blown up. 11
Now, the facts are, and the Commission brought this 12
case in part because of these facts, there was in fact a 13
survey done of physicians. And they surveyed 562 docs. And 14
these were pediatricians. And 408 responded to the survey 15
that, yes, we recommend baby food. But almost all of them, 16
82 percent, said, but we don't recommend any specific brand. 17
So there were in fact 76 out of that original 562 18
that did recommend a specific brand. Now, there the company 19
was absolutely right. Of that 76 who recommended a specific 20
brand, 67, about 88 percent, recommended that product. 21
But it's still a sign that, you know, again, the 22
banner headline was, "Four out of five." Then there's a 23
disclaimer or an asterisk or an explanation in sort of fine 24
print. Then you hear the rest of the story and you go, is 25
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this exactly -- you know, this doesn't make sense. 1
The other ad is also interesting as well. This is 2
for a product that was being promoted as being 93 percent 3
fat-free. Now, I could take a survey in the audience here 4
and ask you, all right, how many grams of fat do you think 5
would have been in a serving of that product that was 93 6
percent fat-free? The answer is ten grams of fat. And about 7
14 percent of the product was actually fat. 8
Apparently where most of the fat was coming from 9
was not the light version of the ice cream. It was the 10
chocolate covering that was on the ice cream bar. And the 11
other fact that the commission noted in its complaint was 12
that the amount of calories in that product was very little 13
or hardly at all different from the calories that were in the 14
non-light version of this product. Most of the calorie 15
saving was because the product was smaller in size. So you 16
got less ice cream; therefore, you got less fat. 17
We've got this four-piece placement/proximity/ 18
prominence/presentation. I think we saw some of those 19
examples by some of the ads that have already been put up. 20
But we look at issues like, is the disclaimer big enough for 21
people to notice? Is it easy to understand? Is it where 22
consumers might look? And is it near the claim that it 23
qualifies? 24
We had a little discussion about consumers 25
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testimonials. It's worth pointing out that you can't say -- 1
basic rule: An advertiser cannot say in a testimonial what 2
they couldn't otherwise say in an ad. So just because 3
someone who has gone through a particular procedure or bought 4
the product had this particular result, if the advertiser 5
felt, I couldn't say that because I don't have substantiation 6
for that, I don't think that's true, just because some 7
consumer says it is, you couldn't use it in the ad. 8
And testimonials can often contain claims that are 9
basically statements of efficacy. We can see it in the area 10
of LASIK. We see it in many, many other areas, where that 11
testimonial is making some kind of statement that, you know, 12
basically says, this product will do this. It did it for me 13
and it will do it for you. And, of course, such claims need 14
to be supported. 15
Let's talk a little bit about LASIK. We've been 16
interested, involved, working with others in this area for a 17
number of years. And it seems like some of the issues 18
continue to be the issues that have been from day one: Throw 19
away, eliminate the need for glasses or contacts, has 20
certainly been a major question, a major issue. 21
Misrepresentations being made about the safety of the 22
procedure are certainly of issue. And concerns raised about 23
making comparisons. 24
And what our approach has been to date has sort of 25
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been this multi-faceted approach combining not just one area 1
exclusively, but looking at others. So we're going to do 2
education, we're going to encourage self-regulation, and 3
where needed, going to do law enforcement. 4
So we have over the years been working with a 5
number of groups, and again trying to come together. 6
Absolutely right, we did help and assist in the development 7
of guidelines. We have been in discussions and had meetings 8
with the various professional groups. We've talked with the 9
state medical boards. Again, where we have found examples of 10
advertising that have been questionable, we have tried to get 11
someone interested in going after it. 12
That last point: Bring cases where necessary. 13
And -- did I jump ahead? Well, let's go right there. Recent 14
Commission cases: We just announced two cases in March 15
against national advertisers, and they focus again on some of 16
these claims that people have been concerned about for a 17
number of years. 18
Eliminate glasses and contacts for life. Eliminate 19
the need for reading glasses. Risk of glare and halo. 20
Significantly less risk than contacts or glasses. It really 21
seemed to be an inappropriate thing to be comparing the risks 22
of going through a LASIK procedure with what might happen if 23
you put a contact on your eye or a pair of glasses on your 24
nose. They were really speaking to very different issues, 25
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and so we challenged that. 1
This false claim of free consultation: The problem 2
wasn't that the consultation wasn't free. The problem was, 3
the consultation didn't have anything to do with your 4
suitability for the procedure. Even though the ad expressly 5
said, come in for a free consultation to see if you qualify 6
for this procedure, when you showed up what you saw was 7
someone who basically told you what the price would be. 8
And then you had to pay over $300 if you wanted to 9
go to the next stage. At the next stage you would find out, 10
in fact, whether you were suitable, and you'd find out about 11
the risks. Those cases, again, were put out for comment in 12
March, and we're awaiting final action by the Commission. 13
Let me finish up here with some key points, and 14
look forward to the discussion that will occur later today. 15
Truthful and non-misleading advertising: Of course this can 16
be of great assistance too consumers. But deceptive 17
advertising, misleading advertising, will certainly distort 18
consumer choice. 19
So what we need, what we think we need here at the 20
FTC, is reasonable industry self-policing, informative 21
education efforts, and targeted government action, working 22
together to protect consumers and encourage fair competition. 23
Thank you very much. 24
MS. KOHRS: Thanks, Dick. 25
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And I'm very grateful to Mr. Sfikas, who's next, 1
because I don't have to worry about his PowerPoint 2
presentation because he doesn't have one. Mr. Sfikas argued 3
an advertising case a while ago before the Supreme Court, 4
California Dental, which was brought by the Federal Trade 5
Commission. Mr. Sfikas? Thanks for joining us today. 6
MR. SFIKAS: I would like to thank the Justice 7
Department and the Federal Trade Commission for inviting me 8
as a representative of the American Dental Association to 9
speak to you today. 10
As it was indicated, I did represent the California 11
Dental Association in a case that went to the United States 12
Supreme Court and thereafter was remanded to the Ninth 13
Circuit Court of Appeals. 14
In that case, the California Dental Association, 15
with reference to quality advertising, took the position that 16
in order for a dentist in California who was a member of the 17
association -- in order for that member to advertise quality 18
claims, the claims had to be verifiable. 19
The FTC took the position that that was a restraint 20
of trade, interfering with both the consumer's right to hear 21
that information and the dentist's right to utilize that sort 22
of information. The case ended up that the California Dental 23
Association prevailed and the case was dismissed against the 24
California Dental Association. 25
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Now, I'd like to give you a little bit of 1
background, and then I will try to answer some of the 2
questions that appeared on the FTC website relating to 3
quality advertising. 4
Quality advertising is considered by many 5
inherently deceptive because it cannot be verified and it 6
cannot be precisely measured. The rationale for this 7
statement is the striking disparity between the knowledge on 8
the other hand of the professional and the knowledge of the 9
consumer. 10
Professionals, obviously, supplying information 11
have far greater knowledge regarding the quality than the 12
individual consumer who is buying that service. Thus, it is 13
extremely difficult for a patient to discern whether he or 14
she has had, let's say in this case, good dentistry. 15
If there is an individual who goes into a dentist 16
and has a tooth filled, it is very difficult for the patient 17
to determine whether or not that restoration was a good 18
restoration. The same is obviously true for medicine and the 19
other health care professionals that we saw with their 20
presentations today. 21
The quality of professional services tend to resist 22
evaluation by patients in part, as noted above, because of 23
the specialized knowledge, but also with reference to whether 24
or not that service was the type of outcome that was expected 25
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as a result of what the health care professional did to the 1
patient. 2
Many economists in this area and other experts have 3
come to the conclusion that the lay public is totally 4
incapable of evaluating the quality of medical services. A 5
patient's loyalty to his or her dentist also complicates the 6
effectiveness of quality advertising. 7
In other words, there are bonds between patients 8
and dentists and patients and various physicians so that 9
irrespective of how you might rate that physician or dentist, 10
they will continue to go to that dentist because they have a 11
relationship with the dentist or the other health care 12
professional. 13
Now, as a result, the Supreme Court determined that 14
these various significant challenges to informed decision- 15
making by the customers for professional services suggest 16
that advertising restrictions arguably protecting the 17
patient -- this is the requirement for verification of the 18
quality advertising -- could not be looked upon in the rather 19
cursory manner that the Federal Trade Commission had in 20
determining that there was an antitrust violation. 21
The Bates case has been mentioned by a couple of 22
speakers now, and that was the case that first introduced 23
advertising to the professions. But even in the Bates case, 24
although it said advertising for routine services was fine -- 25
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and that was not an antitrust case; it was basically a First 1
Amendment case -- nevertheless, the Chief Justice at the 2
time, who wrote the opinion, also noted that: "Claims 3
relating to the quality of legal services probably are not 4
susceptible of precise measurement or verification, and under 5
some circumstances might well be deceptive or misleading to 6
the public or even false." 7
Now, with this background, I'd like to try to 8
answer some of the questions that were posed on the website 9
in introducing this hearing this afternoon. 10
What information regarding quality is available to 11
consumers? Well, of course, there is quality advertising. 12
However, we have all the cautions that not only I've raised 13
here in the background but that the other speakers in showing 14
various forms of advertising that were troubling. 15
But let me give you an illustration with reference 16
to dentistry. Let us suppose that Jane Jones, DDS, who 17
practices in the State of California, advertises herself as 18
the best dentist in the West. Is this misleading? Is it 19
verifiable? 20
Well, in California and as a result of this Supreme 21
Court decision, Jane Jones would have to try to show that she 22
is the best dentist in the West or she would not be 23
permitted, if she were a member of the association, to run 24
this ad. 25
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Now, how are the ways that Jane Jones can show that 1
she is the best dentist in the West? I suppose if something 2
like a magazine like Consumers Union did a study and 3
determined that she was the best dentist or among the very 4
best dentists, that would probably satisfy the fact that this 5
advertisement had been verifiable. 6
What are the problems that might arise if this type 7
of advertising is permitted? Well, a patient may go to Jane 8
Jones, believing that she is the best dentist in the State of 9
California, and Jane Jones may not be the best dentist in the 10
state and may, as a result, leave the patient with lips that 11
are sore and a mouth that is sore as a result of this. Well, 12
certainly this patient will not return to Jane Jones. She 13
will go on and look at other dentists, and it may be trial 14
and error before she finds a dentist who she considers is 15
best for her. 16
Well, that trial and error constitutes search 17
costs, which would therefore interfere with the delivery of 18
services. And one of the arguments in the California Dental 19
Association case was that the elimination of those search 20
costs meant that this type of advertising would be pro- 21
competitive and, in fact, the Ninth Circuit Court of Appeals 22
found that to be the case. 23
What is the difference -- here's another 24
question -- what is the difference between dentists who 25
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advertise and those who do not advertise quality services? 1
Well, there may be no difference between them in terms of 2
training and skill. It's simply one is advertising that she 3
is the best, and the other is not advertising. So it would 4
appear as if the advertisement might give the dentist who was 5
advertising sort of the ability to say that they are superior 6
to the other dentists in the community. 7
What role does comparative advertising play in 8
dental advertising? There is almost no comparative 9
advertising; at least, I've never come across comparative 10
advertising in dentistry. 11
Are there governmental and association limitations 12
on advertising? And yes, as you saw with Mr. Kelly speaking, 13
the advertisement does have to be truthful. And in the case 14
of the California Dental Association, it also has to be 15
verifiable. 16
And the question then is, is that -- what effect is 17
that on the marketplace? In my judgment, that's a salutary 18
effect on the marketplace because consumers in California, 19
for example, can rely on the fact that the professional 20
association of dentists in that state verify the 21
advertisements that are being run in the Yellow Pages or in 22
newspaper columns or newspapers in general. 23
There's another question: What empirical evidence 24
supports this justification? Well, I'm really not aware of 25
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any empirical evidence that supports this. However, I 1
suppose one way that you could determine that is to run a 2
study and see whether or not -- let's take California again 3
as the illustration -- whether dentists in California who are 4
not members of the California Dental Association run more 5
quality advertisements than members of the California Dental 6
Association, who cannot run quality advertising unless 7
they're ready to verify those. 8
As a matter of fact, just as others have said here 9
with various physician-type advertising, advertising among 10
dentists is flourishing. The last time the ADA survey center 11
took a survey on advertising was in 1996 and I'm sure the 12
numbers would be much higher today. But in 1996, 65 percent 13
of all dentists were advertising. Now, that's not to say 14
they were advertising quality, but they were advertising in 15
general. 16
And the survey further asked those dentists, did 17
they believe that their advertising was worthwhile? And 70 18
percent of the dentists of that 65 percent stated that the 19
advertising was in fact worthwhile. 20
Now, the aftermath of the CDA litigation indicates 21
that probably the California victory was a pyrrhic victory 22
because what has happened because of the expense of that 23
litigation, none of the state associations are enforcing 24
advertising principles of ethics. 25
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But it's even more significant: They are so 1
concerned about anything, any enforcement, any disciplinary 2
actions, under the ADA principles of ethics that they are not 3
moving forward to try to obtain discipline for any violation 4
of the principles of ethics. 5
Now, I'd like to make one other statement for the 6
record. There was a dentist here yesterday, I guess during 7
the Noerr Pennington discussions, whose name -- I'll leave 8
his name out. But he made a statement which I would like to 9
challenge. 10
His statement was that a dentist may not advertise 11
that he is a mercury-free dentist. And although the ADA 12
Judicial Council has never been called upon to resolve that 13
issue, nor am I aware of any state association ever being 14
called upon to make a determination with reference to this 15
ad, the likelihood is that that ad, without more -- mercury- 16
free dentist, John Smith is a mercury-free dentist -- that 17
would not violate the principles of ethics. 18
On the other hand, if that dentist went further and 19
stated that he or she were mercury-free dentists because of 20
the toxicity of a certain type of restorative material, that 21
very likely would violate the principles of ethics because 22
that claim is untruthful and it's not verifiable. 23
In fact, the Food & Drug Administration, Health and 24
Human Services, has an extraordinarily large body of 25
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literature, that supports the notion that that form of 1
restorative is not harmful to patients and, in fact, except 2
for a very small element of the population who may be 3
allergic to that restorative. 4
But with reference to history, that restorative has 5
been used for 150 years. All the governmental agencies, the 6
scientific bodies, all conclude that it does not harm 7
patients. And therefore, if this dentist were to go further 8
and say he is a mercury-free dentist because of the toxicity 9
of a certain restorative, that probably would violate the 10
principles of ethics. 11
Let me conclude by telling you a joke that I used 12
to tell all of the dentists when I litigated with the Federal 13
Trade Commission. And that litigation lasted for a number of 14
years. And that was, how many lawyers does it take to screw 15
in a light bulb? And the answer is, as many as you can 16
afford. 17
And I would tell the dentist that the United States 18
government has many, many lawyers that it affords who work 19
for them in litigation with the FTC. Thank you very much 20
for permitting me to speak to you today about this subject 21
matter. 22
MS. KOHRS: Thanks, Mr. Sfikas. I think we're just 23
going to take about a ten-minute break to give everybody just 24
a chance to get up and stretch your legs and think a little 25
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bit before we come back for the final speakers. So we'll 1
reconvene, actually, at about 4:00 by this clock here on our 2
wall. 3
(A brief recess was taken.) 4
MS. KOHRS: It's 4:00 here. So I'm going to go 5
ahead and start with our next presenter, who is John Gebhart. 6
MR. GEBHART: Thank you. Good afternoon, and I'd 7
like to express my appreciation to the FTC and the Department 8
of Justice for inviting me here today. DoctorQuality is a 9
company that perhaps many of you do not know. We serve 10
anonymously or invisibly, in many cases. But I'm interested 11
in giving you some background about what we do. No, I don't 12
see where it fits with the agenda of today's discussions. 13
First, a word about myself. I'm actually trained 14
as a financial executive, financial and general management, 15
although I've spent about the last 15 years in health 16
services in a variety of different activities. 17
I've worked in areas that pertain to health care 18
marketing, hospital marketing, demand and disease management, 19
where we've delivered advice directly to consumers; also, in 20
physician referral, physician practice management. I had 21
some brief involvement in providing information services to 22
mental health professionals, and most recently have been 23
focusing on patient safety and physician quality with 24
DoctorQuality. 25
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Earlier this year as well, I had the opportunity to 1
serve on a panel at the NCQA that dealt with the issues of 2
provider referral and what kind of directory information 3
should be available to consumers. So hopefully I have some 4
insights onto some of the issues we're dealing with today. 5
I'm also going to talk a little bit about the 6
company. We provide a couple services, one of which I think 7
is directly germane to today's discussions. And I would 8
submit the other one is as well, but perhaps not as obvious. 9
And we're going to focus primarily on my Quality Coach, which 10
is a provider service -- or a service that we provide to 11
health plans and large self-insured employers. 12
DoctorQuality was founded in 1999 during what I'd 13
like to refer to as the apex of the dotcom toga party. I 14
actually represent the second generation of management. The 15
academic physicians who founded the company are back in 16
academic medicine, and doing so, they were able to double 17
their salaries and they now have 401(k) matching, to which I 18
say God bless America. 19
Even though we have a very -- we're very young and 20
very new on the scene, we do have a very strong customer base 21
made up of some reputable clients who have really helped us 22
shape the platforms that we provide today. 23
We're also very fortunate to have the guidance of 24
some very prominent individuals on our board of directors. 25
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One is a gentleman named Chuck Buck, who actually is a member 1
of the Institute of Medicine, who published the frame- 2
breaking report in 1999, "To Err Is Human," which really kind 3
of blew the covers off of medical errors. And the other is 4
Dr. David Nash. Dr. Nash heads up the Center for Health 5
Policy and Outcomes Research at Thomas Jefferson University, 6
nationally known as one of the experts in quality and patient 7
safety. 8
We are a company that uses health care technology 9
to improve quality and safety. We believe in the transparent 10
marketplace. We believe that there's an opportunity to get 11
more information into the right hands as people try to either 12
monitor performance or make critical decisions. 13
To that end, we have a hospital and physician 14
selection tool that helps consumers choose resources based on 15
performance and quality. We also have a hospital incident 16
and adverse event reporting tool which is used for quality 17
assurance purposes, and from that activity we today house the 18
largest database that we know of -- we've looked everywhere 19
to find anything comparable, and we haven't been able to -- 20
we've got the largest database in existence for medical 21
errors and near-misses. And I'll talk a little bit about 22
that. 23
The two products that we offer are Risk Prevention 24
and Management, or RPM -- this is the hospital error 25
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collection tool. It's used for quality assurance purposes. 1
And we also have My Quality Coach, and that's the physician 2
and hospital selection tool. 3
I'd like to emphasize, it's very important as we're 4
trying to provide information to consumers to make informed 5
decisions. You must know that there is an impermeable wall 6
between these two platforms. The information that we collect 7
in the conduct of the RPM program is private, confidential 8
information for quality assurance purposes only. 9
Frequently I get the question, so you collect 10
hospital error information and tell consumers who makes the 11
most mistakes? That's not the objective of the program, nor 12
will it ever be. 13
I want to start by talking about the hospital error 14
reduction program. I think it's important -- maybe not 15
directly in the context of today's discussions, but I think 16
it's important in the context of: at some or another every 17
one of us here is going to be a patient or has been a 18
patient. 19
Between 44,000 and 98,000 people are killed 20
annually in the United States as a result of an unnecessary 21
medical error. Let's put that into context because 98,000 a 22
year is a big number. It's hard to really figure out what 23
that means. I've been given 15 minutes today. Three people 24
will die while I'm up here. And that's a pretty sobering 25
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fact. So it's a very significant problem. 1
The other thing that's very interesting is of the 2
numerous medical errors that are made, it's been estimated 3
that only about 5 percent are actually reported, reported in 4
the context of trying to analyze why the mistakes happened so 5
preventive measures can be taken. 6
Not only is it a tragedy, but it costs a lot of 7
money, too. Medical errors cost this country about $140 8
billion a year, both in terms of repeated procedures and the 9
costs for those procedures, and there's also a growing 10
concern, a crisis in many states, with respect to malpractice 11
insurance. And this is a piece of it. 12
Now, it's very encouraging to see that many of the 13
states in this country are now requiring some form of 14
mandatory medical error reporting. About 20 states today 15
actually have some legislation on the books requiring error 16
reporting. 17
I think two in particular are, I think, very near 18
and dear to DoctorQuality's heart. In New York, there's a 19
program called NYPORTS, and it might not be generally known, 20
but every single hospital in New York has a dedicated NYPORTS 21
terminal at which the hospital employees are required to 22
report certain errors to New York State. 23
Also, in Pennsylvania, I'm very proud to say that 24
yesterday our company submitted the bid to provide error 25
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reporting across the state to a new regulatory agency in 1
Pennsylvania known as the Patient Safety Authority. And 2
Pennsylvania is really going to be the first state of its 3
kind that is going to encourage not only what's known as 4
serious events -- in other words, the things that harm 5
patients -- but Pennsylvania wants to know about the near- 6
misses as well. And I think it's a big step forward in terms 7
of really being able to find ways to be proactive about some 8
of these problems. 9
The problems that we see here are not necessarily 10
individual acts of negligence or incompetence. The problems 11
that we see, we believe, most often are the result of a 12
system of care. 13
Here's a very startling statistic: From the time 14
that an individual is admitted to a hospital for what's 15
become a fairly routine procedure, coronary artery bypass -- 16
from the time that person is admitted to the time they're 17
discharged, about 400 people are going to be involved in 18
delivering care to that individual, 400. 19
Not all of these are going to be hands-on. Some of 20
these people are going to work in the lab, some in the 21
pharmacy, some in the kitchen. Some are going to work in 22
maintenance, and they're going to clean up the operating room 23
after the fact. 24
But 400 employees of the hospital are involved in 25
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delivering service to one person. If each of them do three 1
things, that's more than a thousand opportunities for an 2
error someplace in the process. 3
So we believe that it's important to be able to 4
collect data and understand where in the system things break 5
down. And we think this is a function of both variation from 6
accepted medical practices, and it's also an important 7
element in trying to house the right kind of culture in 8
medical institutions. 9
And this might be the point where the service that 10
we provide internally and the service we provide externally 11
overlap. And this might be the point that has the greatest 12
relevance for today's discussion. 13
We start with trying to help our hospital clients 14
get an understanding of their culture, and someone in public 15
relations told me a long time ago, public relations starts at 16
home. You have to understand your own organization's culture 17
if you're going to understand how you want to portray a 18
message or an image publicly. 19
One of the big problems in health care is that we 20
have not practiced an open and blame-free culture of 21
gathering information about mistakes. Whether if it's for 22
fear of reprimand or whether it's arrogance or something in 23
between, a lot of these mistakes don't happen -- pardon me, 24
they happen; they don't get reported. We'd like to be able 25
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to change that, help our clients change that, and start to 1
gather the information to help them figure out where the 2
problems are. 3
So we start with culture. We move to data capture. 4
Once we know -- once we have the data, we can start to 5
analyze the data to figure out what the solutions are, 6
implement the solutions. And we find among a lot of our 7
clients, once we've nailed down one solution, another one 8
pops up. Health care technology changes constantly. Or once 9
you've solved a problem on the surface, it might expose 10
several other problems underneath. 11
So we believe that it's important at every level, 12
and I think in particular with respect to health care policy, 13
legislative policy, something has to be done to really evolve 14
the culture of health care. 15
I mentioned a little bit earlier the database that 16
we have. Earlier this week we crossed the line. We now have 17
a little more than 80,000 medical errors. Next week, it will 18
be more than 81,000, collected from more than 150 health care 19
facilities across the country. 20
You'll see that about two-thirds fall into either 21
the adverse clinical or medication areas. And I think the 22
statistics on the right-hand side are pretty telling as well. 23
The one I like the most is that of all the items that are 24
reported to us, 43 percent involve a near-miss. 25
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You know, this might be a situation where in the 1
middle of the night you see the nurse come into your hospital 2
room and say, "It's time for your pill," and she hands you a 3
yellow pill. And maybe you're going to be awake enough to 4
say, "Wait a second. Mine is blue." That's a near-miss. It 5
was caught in time. And there could be about 15 people 6
someplace in the chain that somehow put a yellow pill on that 7
tray for you instead of your blue one. 8
We've seen numerous cases where our clients being 9
able to quantify the recurrence of near-misses has led to 10
some very significant improvements in their procedures. And 11
we were able to prevent similar recurrences in the future. 12
I'm just going to say one more thing about the 13
medical error situation before we roll into the physician and 14
provider selection tool that we provide. But I get a lot of 15
questions very frequently about why should anyone really want 16
to report a medical error? 17
The first one, you know, why should you want to do 18
it? Well, I believe that doctors went to medical school to 19
learn how to do a good job. And there's a little bit of a 20
Pollyanna in me about that. I don't believe doctors go to 21
medical school so they can golf on Wednesday. There are 22
cheaper ways to golf on Wednesday. 23
I think that health care professionals try very 24
hard to do a good job, and I think it's harder and harder to 25
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do a good job. And what we provide is an improvement tool 1
that helps people understand where their weaknesses are and 2
be able to react to them. 3
Next question: Won't error reporting lead to 4
lawsuits? A very, very common misperception. And the answer 5
is, in 49 states, no. In 49 states, any information that's 6
collected as part of a quality improvement is protected by 7
the peer review statutes, which means you cannot subpoena it. 8
I'm sure that will be challenged, and it's probably a 9
question that we're going to have to wrestle for a long time. 10
But I'm very pleased to say that at a policy level, in 49 11
states the answer is no. This does not lead to lawsuits. 12
This leads to better health care. 13
Who would want to report on a coworker? Well, let 14
me tell you about one of the programs that one of our clients 15
has in place, which I think is just the perfect embrace of 16
the kind of culture that we hope our clients are promoting. 17
We have a client who has a program called the Plant a Flag 18
program, and what happens is the hospital gives lapel pins 19
and collar pins to the doctors and nurses that report an 20
error. 21
They take the attitude that the errors are like 22
potholes in the road. If you stepped in the pothole, please 23
plant a flag so that your coworkers don't step into the same 24
pothole. And we see hospitals give out gift certificates for 25
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cookies in the cafeteria, movie tickets, anything to promote 1
a culture of blame-free reporting. 2
And does this offend doctors? Well, it doesn't 3
offend doctors if they've embraced this culture of blame-free 4
reporting. It's very important that we look at error 5
collection data in a non-punitive fashion. And I go back to 6
my first point: 98,000 people die because of medical errors. 7
It seems pretty apparent to me that blame has not worked. We 8
need to try something else. 9
Let me turn to our second product, My Quality 10
Coach, which is an online consumer decision support system 11
whereby consumers can choose physicians and hospitals based 12
on quality and satisfaction data. With this program, we 13
encourage consumers to log on and prepare ratings on their 14
doctors. And we also invite doctors and hospitals to present 15
certain information about themselves. 16
Now, this information, we think, is pretty 17
important in the context of how resources are chosen, VHA 18
did -- the Voluntary Hospital Association, that is, did a 19
study last year and it seems pretty clear that health care is 20
becoming more consumer-centric. I won't go ahead and read 21
all those, but you can probably them. 22
But in other words, this slide makes the point that 23
consumers are interested in finding out quality information. 24
They would be very pleased to make decisions based on the 25
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standards of performance and the quality of care that's 1
delivered. 2
It's also becoming an increasing trend that 3
employers are very interested in this as well. It doesn't 4
cost more -- in fact, it actually costs less -- for the 5
employees to go to better quality doctors and better quality 6
hospitals. And to the extent that this both is a way to 7
reduce health care cost and to bolster employee satisfaction, 8
this is something that large employers in particular are 9
increasingly becoming very interested in. 10
This last point on the slide: Network size is 11
taking a back seat to network quality. Actually, that's 12
backwards, and the person who drafted that is going to be in 13
big trouble tomorrow morning when I get back to the office. 14
Network quality -- no. I'm sorry. I'm backwards. 15
Start again. Network size is taking a back seat to network 16
quality. It used to be that when you'd get into a health 17
plan, you'd look at the book and say, is my doctor in here? 18
Well, now people are increasingly trying to figure out, is 19
the good doctor in here? 20
Just a snippet from the Philadelphia Business 21
Journal, where last year the Blue Cross organization in town 22
has actually developed an incentive program based on quality. 23
If institutions are delivering certain quality metrics, 24
they're paying bonuses, cash from a health plan, for doing a 25
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good job. 1
We have a number of prominent clients -- I see the 2
two-minute sign is up, so -- we have big clients and we're 3
proud of them. I do want to point out that Patient Choice, 4
Luminos, and Destiny Health are all in the defined 5
contribution, defined consumer choice plans. 6
My Quality Coach has information on about 750,000 7
physicians and all of the hospitals in the country. And it's 8
available via a secure password-protected site. 9
We offer our members an opportunity to rate 10
physicians. This is my -- one of my customs is to put up on 11
slide that's just not legible. This is it. But you can see 12
that there is a questionnaire that you can fill out, and 13
immediately upon completing the questionnaire, you can see 14
satisfaction rankings for your physician compared to other 15
physicians in the plan and other physicians in that same 16
specialty. 17
We, in addition to providing access to information 18
about how to find the best qualified physician and hospital, 19
provide some personal health information tools, health risk 20
assessments and health guides, that can help you better 21
understand your circumstances and prepare for your 22
interactions with the system. 23
Time is very short, so I'm going to go ahead and 24
skip over a couple of these. And I want to jump to, at the 25
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very end here, a couple of things on -- the impact of this 1
kind of information on the providers and the hospitals 2
themselves. 3
We work very closely with the Pennsylvania Health 4
Care Cost Containment Council, or PHC
4
. And they have 5
published a number of studies over the years. They got a lot 6
of attention in 1998 around a study regarding coronary artery 7
bypasses in Pennsylvania and the associated report cards that 8
emanated from that study. 9
David Nash, prior to the formation of our company, 10
was quoted in the Wall Street Journal pointing out that the 11
great thing about the report cards is it tells institutions 12
where to start looking. It's a place to start looking at 13
performance and what to do about it. One of the surgeons at 14
Lehigh Valley Hospital admits that they're under a 15
microscope, and says it's a good thing. It's causing them to 16
move forward. 17
In the interest of time, we'll jump over these 18
statistics. But I do want to point out that the public 19
dissemination of performance data has had a very positive 20
impact in Pennsylvania. You can see that in the ten years 21
concluding in the year 2000, there's been a pretty dramatic 22
decrease in mortality surrounding coronary artery bypasses. 23
This has also been demonstrated in other disease 24
states and other procedures, where the impact of revealing 25
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this performance data has had a very positive impact on the 1
actual performance of the physicians themselves. 2
And I'll end with the last one from a fellow you 3
might know of, Dan Rather. "When it comes to choosing a 4
heart surgeon, Pennsylvania is on the cutting edge in helping 5
consumers pick the right one." 6
So we like the idea of making information 7
available. We think it has a good impact on the institutions 8
themselves. And we think it's a trend that consumers are 9
continuing to demand. Thank you very much. 10
MS. KOHRS: Thank you, John. 11
I'll ask all of the panelists to come up. Helen, 12
you're going to speak. You don't have a PowerPoint, but 13
everyone else can come up and have a seat. You can choose to 14
speak from your seat or from the podium, whichever you would 15
prefer. Helen has been here all day. 16
MS. DARLING: I just -- obviously, the satisfaction 17
of what I have to say will be inversely related to how long 18
it takes me to say it. So I will try to make it as fast as I 19
can. 20
I'd like to mention that two of our Washington 21
Business Group on Health public policy goals, two of our 22
highest, are to increase transparency in the system -- and 23
there is a report out there; if you haven't gotten it, I hope 24
you will read it. It talks a lot about what's now available. 25
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I think for anybody who hasn't worked in this field 1
recently doesn't really appreciate how much incredible 2
information, DoctorQuality.com being one of the best 3
examples, is available to especially companies. I know one 4
of the companies that uses them is G.E. And they are a very 5
demanding purchaser and very sophisticated purchasers. 6
So they have a product. Others have products. The 7
interesting thing is how many are emerging, how all of them 8
are getting better, how -- I mean, they have data and tools 9
that would just make us salivate even as recently as five 10
years ago. 11
And the ability -- it's probably one of ours, 12
too -- but the ability to put in something like your personal 13
zip code, and say you want a hospital within ten or fifteen 14
miles, and these are the things you care about, like 15
complication rates and things like that, it will create its 16
own report for you, ranking all the hospitals in your 17
immediate area. 18
And again, if you're not familiar with that, what's 19
amazing is what's available and how critical it is that we 20
keep moving. They're now using data that I hear now, but 21
we're not going to have more data unless we have more 22
pressure to have more data. 23
We certainly think as an organization that 24
advertising can be fine, and we certainly wouldn't want to 25
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squelch that, whether it's First Amendment or not. But we do 1
think that the role of FTC -- and the FDA, by the way, and we 2
met with the Commissioner the other day about the role they 3
can play from where they have authority to try to drive the 4
system to more fact-based information, and also, obviously, 5
certainly no deceptive advertising. 6
If anybody has -- you should see Tom Lee's letter 7
in the -- article in the New England Journal of Medicine on 8
the topic, the best I've ever seen about how you don't get 9
peace of mind. For us, it's hard to believe that anyone can 10
even today run an ad and say that if you get this scan, you 11
can be assured and have peace of mind. I mean, if that's not 12
deceptive advertising, I don't know what is. 13
In the past, critics have said -- a lot of people 14
who are scornful of some of these things have said, neither 15
consumers nor purchasers use quality information. Well, that 16
is not true any more. And usually that was said based on 17
surveys at a time when we didn't have information, so you did 18
a survey with a two-year look-back and say, do you use 19
quality information? They'd say, no, they don't. Well, they 20
didn't have it. It wasn't available to anybody. 21
And in many instances now, it's available. Also, 22
in other instances, a lot of useful information is tucked 23
away in places like state health departments and quality 24
improvement organizations and that sort of thing. 25
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So one of the things we'd like to see in every 1
piece of legislation that goes through any time in the next 2
two years are requirements around reporting. At a minimum, 3
of all currently publicly reported information, that such 4
reporting would be easily accessible to consumers. But we'd 5
like to go further and eventually have even better 6
information. 7
There is evidence, as we just heard from John a 8
minute ago, that public disclosure of provider performance is 9
resulting in clinical quality improvement, in Pennsylvania 10
but also in New York. In fact, in every state that has such 11
information available, we are seeing improvements and people 12
do pay attention. The interesting thing is that providers 13
pay attention because they don't like looking bad, and for 14
obvious reasons. 15
We also know that consumer information needs to 16
move beyond hospital quality report cards, not because 17
they're not wonderful, but because the information has to get 18
much more complicated because we're going to have tiered 19
networks and they're going to be often by specialty and that 20
sort of thing. So the kind of drill-down detail will be more 21
important. 22
I would just say, just to end, really, we hope the 23
FTC and the FDA will be very aggressive in stopping all 24
deceptive and misleading advertising; that they will see 25
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protecting the consumer, especially in these complex areas, 1
at a time when consumers, employees will have much more of a 2
role to play, whether they want it or not; they will be 3
playing a much bigger role, and they're going to have to have 4
information. And the only way they're going to have it is if 5
we keep the pressure on. Thank you. 6
MS. KOHRS: Thank you very much, Helen. 7
It's sort of the policy here to give the first half 8
of the panel an opportunity to respond to some of the things 9
that were said after they spoke. To make things a little bit 10
easier for me and to move these things a little bit easier, 11
if you're interested in speaking, just tilt your name tent on 12
its side so that I can see. If it's tilted like that, I'll 13
know that you want to participate and ask a question. 14
So we'll go ahead and just start down the line, if 15
you want to just make a comment briefly. Bernie Dana had to 16
leave, so we have a fill-in. Ms. Condeelis? 17
CHRIS CONDEELIS: Thank you. I guess one of the 18
things that I'd just like to share, a couple points, is that 19
I think with the panelists today, we do in long-term care 20
share some things in common, in that our residents, our 21
consumers, come to us with a very critical need. We are not 22
an elective care service. 23
The fact that 75 percent of our customers are 24
coming to our homes and their payments are capped does have a 25
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very specific influence on the way we provide our services 1
that is -- you know, it kind of caps competitiveness. And I 2
think that's different from the other panelists. 3
We do for our consumers have quality measures. 4
There is difference in the marketplace about how good those 5
measures are, but I think that as a profession, we have 6
pioneered the consumer satisfaction data that is then 7
allowing us to give yet another indicator of quality to those 8
that are seeking our services. 9
MS. KOHRS: Great. Laura? 10
MS. CARABELLO: If we are to insist upon getting 11
quality information out to the consumer, what is going to be 12
the best way to get it out there? Whose responsibility is it 13
to do so? Is it incumbent upon the physician himself? Is it 14
the organization? Who's going to take on that job? Is it 15
going to be the FTC to help out? 16
Getting out information is not inexpensive. 17
There's a big price tag to it. And the fact that the quality 18
website is up there for getting quality information, if 19
you're not a member of G.E., does that mean you can't get the 20
information? Who is going to take that responsibility to get 21
that information, for example, that a body CT scan is not 22
advisable? Whose responsibility is it and who's going to pay 23
for it? 24
MS. KOHRS: Well, I think she's thrown that out 25
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generally. Helen, you look like you're -- 1
MS. DARLING: Well, I can always answer a question. 2
I think on that one, it's a good example of where the complex 3
system that we have will govern. That is, all purchasers 4
should make certain that it's available to the people they 5
purchase for -- Medicare to its beneficiaries, the states for 6
their Medicaid beneficiaries, and private purchaser employers 7
for their employees. 8
And many of the companies, as you saw, some of the 9
insurance companies that provide coverage for lots of middle- 10
sized and small employers, provide these tools as well. So 11
that is who's paying should pay for it. 12
Now, in a way, it isn't expensive. That is, we 13
already spend billions of dollars reporting information, and 14
you could go on and on on that. We have a lot of 15
information, but much of which isn't nearly as useful as it 16
could be. 17
It's already -- we have built into the system the 18
expenses of collecting that information. In fact, they 19
estimate, I guess -- some people estimate about 20 percent of 20
health care costs are the transactions that we have in our 21
system in contrast to other countries. So we've got a lot of 22
money already in the system. We simply need to use it 23
differently. 24
MS. KOHRS: Okay. Dr. Lee? 25
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DR. LEE: You know, I would actually add that I 1
think the professional societies, they should be challenged 2
more by the business community and by others to pick up the 3
role and really show some leadership in this area about 4
making even stronger statements about what is and isn't 5
supported by evidence. 6
And I actually think they're ready for it. I mean, 7
I do a lot of stuff with the American College of Cardiology, 8
and I think they're primed. They're actively discussing 9
having -- you know, taking stands on -- you know, to try to 10
reduce waste. Because frankly, they know they need to. You 11
know, providers need to show that they are also trying to 12
make the system work because they haven't been doing that 13
much thus far. 14
I'd also that, you know, people don't usually think 15
of physicians being in synch with the business community. 16
But I would say that in general, our physician -- at least 17
our leadership is very much in synch with what Helen said on 18
both counts, in that first, we would be very supportive of 19
strong action to try to reduce, you know, misleading 20
advertising that generates demand where there isn't really 21
need, and we'd do everything we could to try to support that 22
with our, you know, experts and so on. 23
And then the second half, which is that how do 24
physicians feel about public disclosure of data related to 25
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quality, and there's certainly a bit more neurosis and 1
ambivalence about that. But I would say that times have 2
changed, and that many of our physician leaders accept it and 3
are for it. They think that it's -- you know, it's like 4
having your teeth cleaned. It's, you know, uncomfortable, it 5
draws some blood, but it's good for you. 6
And then there are others who just understand that 7
it's going to be this way, and they're not going to resist it 8
any more. So I actually think that there's enough people who 9
understand that it's a tremendous driver for improvement, and 10
that wherever something isn't -- wherever we are against data 11
being made public, we'd better have a good internal sense of 12
accountability. And that's sort of where we've arrived in 13
our system. 14
So I actually think the providers are in synch on 15
both counts: better quality data being released to the -- 16
made available to the public, while a reduction in the poor, 17
misleading information that makes up a lot of advertising. 18
MS. KOHRS: Dr. Koch? 19
DR. KOCH: I think consistent with that, in terms 20
of elective procedures, if we get after something like LASIK 21
surgery, the manufacturers, industry and medicine, both want 22
procedures like this to be successful, to work, to give good 23
outcomes, because that's what drives it forward. 24
And so false advertising, patients who have the 25
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surgery who shouldn't have it, spoil it for everybody. In 1
addition, of course, to the primary problem, which is those 2
patients, you know, end up with an outcome that they weren't 3
expecting. 4
So I think that in general, really consistent with 5
what you're saying, there's a feeling about wanting to move 6
ahead. As far as the societies becoming involved, I think 7
Mr. Sfikas has given us a good feeling for what the down side 8
of societies becoming involved is in terms of the costs. And 9
that's always a problem. 10
I mean, what does a society do? Do you just -- do 11
you do the bully pulpit and just talk, talk, talk, because if 12
you proceed and try and get to any level of enforcement, then 13
the restraint of trade issues come up and it becomes 14
extremely expensive, time-consuming, and everybody washes 15
their hands of the next case. 16
MS. KOHRS: After the encouragement of Drs. Lee and 17
Koch about the FTC's involvement, I think it sort of leads me 18
to ask a question of Mr. Sfikas. I'm going to quote from the 19
Cal Dental decision. The concern -- the decision says that 20
there were many instances in which the dental association 21
suppressed such advertising claims as, "We guarantee all 22
dental work for one year," "Latest in cosmetic dentistry," 23
and, "Gentle dentistry in a caring environment." And I'm 24
wondering if the California Dental Association has changed 25
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its perspective, whether those types of claims would be 1
allowed now. 2
And you said that there was a reticence on the part 3
of the California Dental Association, or indeed any dental 4
association, to pursue any types of claims. How do we 5
encourage them to get involved in the process, as Drs. Lee 6
and Koch would want an association to be involved, without 7
causing anticompetitive problems? 8
MR. SFIKAS: Well, it's a real irony because, of 9
course, we prevailed in the California Dental Association 10
case. We won. The Court said that it was not an antitrust 11
violation. 12
I think you've heard that in the case of 13
guarantees, that they're really not a solution. If someone 14
is injured, the mere fact that they get the cost of the 15
dental services back is not really anything that's extremely 16
helpful. 17
How do you encourage the associations to get 18
involved? I think if the FTC -- I think from the standpoint 19
of the dental profession, it would be very helpful -- and 20
there's really no way to do this, I mean, because the 21
principles of ethics are already out there. But it would be 22
very helpful if we could present the principles of ethics to 23
the FTC where they would say, excluding the advertising -- we 24
wouldn't give those to you because we've already won that, in 25
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our opinion -- but if we gave everything else to you and you 1
said, you know, none of these would raise antitrust 2
concerns -- and many of these certainly would not raise 3
antitrust concerns. 4
For example, some of the things that are not being 5
done today, in the case of peer review, peer review was 6
always used as an alternative dispute resolution mechanism. 7
A patient comes forward, says they're unhappy with what the 8
dentist did. They don't like the procedure that was done. 9
The association hears it, often agrees with the patient, 10
would make the dentist reimburse the patient. 11
Now, because it's no longer obligatory since it's 12
not being enforced, the patient is left to file a lawsuit, 13
which is not a good way out of that. Consultation and 14
referral, when it is in the best interests of the patient, 15
certainly that doesn't raise any antitrust issues. This is 16
the dentist determining that the dentist ought to refer, more 17
likely than not, to a specialist. That's not being enforced. 18
And even a very recent one, the dentist should 19
avoid interpersonal relations that could impair personal 20
judgment, sort of something on the order of sexual 21
harassment. None of those are being enforced, and I'm sure 22
that we could agree that none of those would raise antitrust 23
issues. 24
So it's a real irony. It's the expense of the 25
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California Dental Association having to litigate that case, 1
first before the administrative law judge, then before the 2
Federal Trade Commission, then in the Ninth Circuit Court of 3
Appeals; then, because the first time, as you know, the Ninth 4
Circuit Court of Appeals ruled for the Commission, a two-to- 5
one decision, then the Supreme Court takes the case. The 6
Supreme Court reverses, and then sends it back down to the 7
Ninth Circuit Court of Appeals before that litigation came to 8
an end. 9
Well, the other state associations, not as large as 10
the California Dental Association, are saying, we just don't 11
want to get into that. So there is a great reluctance to 12
enforcing not only the advertising restrictions in the 13
principles of ethics, but other provisions as well. 14
MS. KOHRS: Go ahead. Dick? 15
MR. KELLY: Yes. I'm not an antitrust lawyer. I'm 16
not in the Bureau of Competition. So to directly respond to 17
some of those issues would be foolhardy on my part. 18
Clearly, in the California Dental case, there was a 19
debate as well as to what kind of record needed to be in 20
evidence to justify or not justify those restrictions. And 21
ultimately, that case, at least, turned in significant part 22
on what approach was being used. There's something called a 23
per se approach to evaluating restrictions, and then there's 24
a truncated rule of reason. And the Court was saying the 25
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Commission picked the wrong one, and sent it back. 1
The Commission at the time it dismissed that case 2
did say that it was concerned, and continued to be concerned, 3
about restrictions that would be in place that would 4
needlessly, in essence, restrict truthful or nondeceptive 5
advertising. And that discussion, I think, continues today. 6
On the consumer protection side, I mean, we worked 7
with AAO in adopting -- in their adoption of some guidelines 8
for advertising in 1997, I believe. We have been reached out 9
to by those groups as well as state medical boards to look at 10
and evaluate specific complaints. 11
And there is clearly agreement, at least in part, 12
on a number of things. I think everyone agrees, everyone 13
agrees, that false and deceptive advertising should not be 14
allowed. And what I think sometimes the debate turns on as 15
well: What methods can you use to prevent false and 16
deceptive advertising? How far can you go in adopting 17
restrictions? 18
The Commission, on the consumer protection side, 19
generally proceeds on a case-by-case basis. We look at the 20
record in a particular case. We look at the evidence in 21
support for a particular claim, and make a judgment whether 22
that advertiser at that time was engaged in deception. 23
And that is a contrast to adopting board rules that 24
seek to prevent -- prohibit broad categories of speech. I 25
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think one of the ones that went up there was prohibition on 1
using testimonials in advertising, for example. And that's 2
where I think the debate has been, at least in major part, 3
over these decades about this issue. 4
It seems to me that it is important to deal with 5
all of these issues that have been raised today and, of 6
course, are raised in other forums on other days on similar 7
kinds of problems. It requires a joint tri-part, multi-part 8
approach from the role of a consumer of having easy ways to 9
complain if they feel they've been taken and deceived, and 10
encouraged to come forward and complain so that people can 11
get access to that information. 12
It requires, on the part of responsive professional 13
groups that oversee that, to, in fact, be forthcoming if they 14
see problems or abuses within their industry; to try to find 15
a way to present them to the Commission in some sense in 16
which way some things were being presented today. 17
It requires a response on the part of government to 18
look at that and to evaluate that information, and if there 19
is a strong case being made, to proceed. I mean, we at the 20
FTC, like everyone else, have to have priorities. 21
I mean, we've been involved for a number of years 22
in looking at claims on the internet, health care claims, not 23
necessarily by doctors but health care claims. And there's a 24
huge number -- as you know, just filled with claims. So 25
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where do you draw the line? What do you focus on? And we 1
try to focus on claims that are making representations about 2
curing dread diseases, for example. And that's where our 3
focus is. 4
So it requires consumers, it requires the groups, 5
it requires government, in some sense working together to try 6
to address some of these problems as best as possible. And, 7
you know, I remain hopeful. 8
In the coral calcium case I mentioned today, one of 9
the things we're doing at the same time we were going into 10
court seeking this temporary restraining order, the FTC and 11
the FDA were together sending out letters to marketers on the 12
web, trying to get them to stop making similar claims for 13
coral calcium products. 14
So, you know, there is hope. There is approaches 15
that can be taken. And, you know, hopefully we're all 16
willing to try to work together to achieve that. 17
MS. KOHRS: And speaking of things going on on the 18
web, John, you have dealt with the gamut of physicians and 19
consumers and various entities. Can you talk a little bit 20
about what that experience has been like? Do you have a 21
minimum pool of doctors? If I wanted to look up my doctor, 22
John Smith, and I see that 100 percent of the comments have 23
been negative and I click on it, does it tell me that there's 24
only been one comment made, something like that? How do you 25
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assess -- how does a consumer assess the data? 1
MR. GEBHART: We try to make everything as 2
transparent as possible. So if one person has submitted the 3
rating, it will say one. You know, whatever the number of 4
ratings have been, that's obvious to the consumer when 5
they're using our site. 6
Some of our clients have actually asked us to 7
suppress any rating information until 30 ratings are 8
submitted, so at least there can be some semblance of an 9
average. Now, of course, you get into a little bit of a 10
Catch-22 game when that happens because if you submit a 11
rating but you can't see the results right away, then it's 12
not a very satisfying experience for the consumer. 13
So we've really encouraged keeping the information 14
as open as possible, not really trying to take sides, but 15
really just in trying to encourage more ratings. 16
MS. KOHRS: And what's the response been from the 17
physicians? 18
MR. GEBHART: Initially, physicians have been 19
pretty much against it, pretty much against it. And I can 20
certainly appreciate that. There's a lot of fear of the 21
unknown. There's a fear that they might have one bad case 22
and that person will continue to rate and tell all their 23
friends to rate. 24
And we actually have some safeguards for that as 25
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well. But this is a new territory, and obviously it's going 1
to be a little awkward and a little intimidating until 2
there's more trial in what we do. 3
I guess -- I'm not letting the social issues slow 4
us down here. I take the attitude that, you know, myself and 5
the rest of the baby boomers are really hitting our health 6
care consumption prime right now. And we're the ones that 7
fired a president 30 years ago, and getting health care 8
information is just another one of the things we're going to 9
solve. 10
MS. KOHRS: One of the issues that I wanted to ask 11
about with regard to LASIK is one of the concerns is that 12
there are a lot of consumers who are getting a great deal of 13
information about LASIK from the media, but they're not 14
really talking to a physician about it until they come in and 15
say, I want to have this procedure done. 16
How does that affect informed consent? Do you have 17
consumers who come in and say, I want this, and they will 18
not -- they just want to have the surgery, they want you to 19
go forward with it? 20
DR. KOCH: Well, I think that's true of all these 21
elective procedures. You've got people who are just 22
convinced they're going to have it done, whether it's a 23
facelift or LASIK or whatever. And they come in and they're 24
totally focused upon having that procedure done. 25
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And we just have to try to pull them back, you 1
know, show them the informational video. We give them the 2
informed consent. We tell them explicitly that there are 3
these risks of complications, and you do the very best job 4
possible. 5
And at the extreme, if you're cautious as a 6
physician, you will actually reject patients who clearly do 7
not appreciate that there is the risk of complications 8
because of the concern about what would happen both to the 9
patient and to yourself were there a bad outcome. 10
I don't know that the majority of -- probably the 11
majority of physicians do that, but there's certainly a 12
minority that do not. 13
MS. KOHRS: And as you said, they can't -- getting 14
your money back after a bad outcome is not going to do the 15
patient any good. But is there some kind of mechanism we 16
could use that would brand the doctor as being a more capable 17
provider, that there's some kind of way he can identify 18
himself as being somehow better, a safer risk, if you will? 19
DR. KOCH: Well, it gets into the whole issue of 20
self-reporting of results. And I have a colleague in my 21
community who reports that 98 percent of his patients see 22
20/20 after LASIK surgery, or some such statistic, and yet I 23
continue to see complications from his office drift into my 24
office and they are not in that 20/20 category. 25
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So you're at risk. We keep our own data, for 1
example, and for a while we used to put it up on the website. 2
But no matter whatever number we put up, the next person down 3
the street somehow had a number that was a little bit better. 4
And so unless you have some kind of an external, objective 5
measure of quality, either in terms of results or risks or 6
incidence of complications, it's a difficult problem. And 7
it's particularly difficult when you're not in a hospital or 8
other type of setting where you have other people overseeing 9
and monitoring your outcomes. 10
DR. LEE: You know, it's a very tough area and I 11
think you have to have realistic expectations about what you 12
can do. I mean, another area where a lot of numbers get 13
thrown around is prostate surgery for prostate cancer, and 14
what's the risk that someone is going to have incontinence? 15
What's the risk that they're going -- what's the chance that 16
they're going to have sexual function afterwards? 17
And you don't see this advertised on billboards or 18
in the newspaper, but believe me, when the patient gets in 19
the door, a lot of numbers are thrown around. And the 20
patients either are not sophisticated enough or they don't 21
even want to find out what's really behind the numbers. They 22
hear 99 percent, and they want to believe that the surgeon 23
they're talking to is great. 24
So I just don't know how -- I think that this is 25
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not an area where investment in energy and time is going to 1
have a great return. I mean, I'm not against going in there, 2
but I would be realistic. 3
One thing that ran through my mind that I -- you 4
know, this is going to sound like a, you know, like a 5
physician-like, Taliban-like perspective on things. But I 6
think that in the interests of promoting fair competition in 7
the health care marketplace, I think a number of my 8
colleagues would be -- they would support a ban of 9
advertising of anything which required a physician decision, 10
that is to say, a prescription being written, a test being 11
ordered, with the logic being that if the decision-making is 12
supposed to be restricted to a physician, then the lay public 13
doesn't have the expertise to judge their need for it. And 14
this obviously would limit all direct-to-consumer advertising 15
in pharmacy. 16
And I think that that kind of thing does provide -- 17
have some small benefit. I think it creates much more demand 18
where there isn't much need. You know, the ratio, you know, 19
of that to good is not a good ratio. 20
And I think that people should compete, but they 21
should compete fairly with people who can judge things 22
appropriately. I think physicians have the training. So 23
this is kind of a paternalistic point of view. I don't think 24
it's politically feasible. But I think that physicians would 25
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support a movement in that direction, which I know would be 1
not easy for you. But physicians would be right behind you. 2
MS. KOHRS: Well, our advertising specialist, who 3
assures us she's not related to the Sopranos, is behind you 4
chuckling. So Laura, do you want to weigh in on this one? 5
MS. CARABELLO: Well, I think it's unrealistic to 6
assume that we're going to turn back the clock at this point 7
on the pharmaceutical industry or on the physician industry, 8
or on the hospital industry, for that matter. 9
Hospitals are the ones who are driving the 10
marketing engine more than anybody else with issuing all 11
kinds of not only quality reports, but investing fortunes -- 12
and I have to say that over the years, I have handled many, 13
many marketing projects for hospitals where they want to get 14
out to the community. 15
My concern is this, and it comes down to: How does 16
the consumer -- and I've marketed products; I've marketed 17
physician services, disease management companies, and you 18
name it across the board in the health care spectrum -- how 19
does the consumer, who doesn't have access to the internet -- 20
we talk about all these websites -- who doesn't have access 21
to newsletters, who is the run-of-the-mill -- or who might 22
get his or her information at the beauty parlor or at the 23
barber shop, going to be able to judge quality? And is that 24
quality information simply going to come to them on a 25
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billboard that they may be able to read or not because it 1
wasn't in their language? 2
Are they going to get it from, you know, the health 3
club? Are they going to get it from some other source? Or 4
have they lost total confidence in the quality components of 5
advertising? 6
MS. KOHRS: Dr. Lee? 7
DR. LEE: My response is that I'm not really 8
worrying that much, actually, whether the consumer really 9
understands it. I think that if solid quality measures get 10
put out there, it produces the desired effect, which is it 11
makes consumers like, you know, me in my day job, you know, 12
sweat bullets and try to create systems to make it better. 13
So that it will be great if the consumers 14
understand it, but to me it doesn't really matter if your 15
goal is to actually improve care. 16
MS. KOHRS: Well, going back again to that Cal 17
Dental decision, when "gentle dentistry in a caring 18
environment" was seen as a quality assessment that Cal Dental 19
was not willing to allow dentists to advertise, how would you 20
assess what quality advertisement really is? Do you have 21
a -- can you give us a sense of what that might be? 22
MS. CARABELLO: Well, in my mind, anything that 23
flies in the face of the regulations is not quality. So that 24
has to be the first benchmark, whether it's the state 25
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regulation or it's the FTC or it's your association or some 1
guideline that you're following, as long as you're in the 2
guidelines. 3
It's a question of good taste versus bad taste. I 4
mean, there are doctors who are advertising regularly who are 5
advertising in good taste and promoting quality. And I think 6
quality wins no matter what. That's the bottom line. 7
And I somewhat take issue with the fact that, do we 8
care whether the consumer gets it? I think we have to care 9
whether the consumer gets it because ultimately, when they 10
get the right information, they take better care of 11
themselves, the outcomes are better, and it costs the system 12
less money. 13
So I think it is incumbent upon those who are on 14
leadership decisions, and certainly I take my 15
responsibilities very seriously when I work with clients, to 16
make sure that they are promoting quality. Because 17
ultimately, if we don't -- and the employer. And one thing 18
that Helen said about those who pay for the health care are 19
responsible for providing the information. And I think 20
that's true. 21
I think if an employer is going to recommend a 22
particular panel or endorse -- and by offering it, they're 23
really endorsing a particular PPO or HMO or whatever it is 24
they're offering as a health care option -- they should get 25
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behind giving that information. 1
How expensive that is becomes a different story, 2
and I think as far as the employers go, they sort of, from 3
what I hear, have had it up to here as far as assuming more 4
cost. So I think there's got to be a buy-in from other 5
sources as well as far as getting the information across. 6
MR. SFIKAS: I think quality is very important in 7
the hospital, in the physician's office, in the dentist's 8
laboratory. But quality advertising, it's pretty clear that 9
the difference between what a physician or dentist or other 10
health care professional knows and what the consumer knows, 11
there is a striking dissimilarity in their ability to 12
understand that. 13
So I think it's very, very difficult to use quality 14
advertising as you would some of the other types of 15
advertising, like price and other things, because of the 16
difficulty in consumers understanding it. 17
MS. KOHRS: Helen? 18
MS. DARLING: Well, I think we have a lot more 19
positive experience than the tone of this conversation is 20
headed. A number of people have been working on HEDIS 21
measures of health plans for, now, about ten years. In fact, 22
Tom and I co-chair the committee that oversees that 23
evolution. 24
And one of the things that's been very 25
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interesting -- because we've got about seven years' 1
experience now -- is that the health plans that allowed their 2
information to be reported publicly initially got better and 3
better; that the ones who were doing -- basically, people who 4
did a good job and made it available did better in lots of 5
ways. They got better. 6
The plans themselves in many instances, we know 7
from reports that if they didn't do well one year on 8
something inside the plan, then a lot of things happened. A 9
lot of steps were taken to improve it. 10
We do know that there are companies that pay a 11
differential and provide information. When I managed health 12
care at Xerox, we actually provided data from the HEDIS 13
report, and we had an allowance, and our employees had 14
numerous options. And they migrated to the better plans. 15
And this goes back several years, before we even 16
had the kinds of tools that DoctorQuality has. So now we've 17
got much richer tools. We already have evidence going back 18
as far as about eight years, as the data began to become 19
available for health plans in particular and then later 20
hospitals, that when people see it, they do pay attention. 21
And you can -- I don't know whether I'd want to see 22
ads doing this; I don't know that I really care -- but you do 23
have hospitals now advertising that they were, you know, 24
number one in a certain geographic area, with a little 25
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footnote and everything. 1
We have -- we know that health plans do that, that 2
they advertise in their markets around open enrollment 3
season. You know, they have 99 percent of all people who had 4
a heart attack got a beta blocker in our health plan, and all 5
women got mammograms, and things like that. 6
So there is a pretty rich area of information and 7
experience already that data move people. Measures, 8
especially those that are seen as quality, and which have a 9
certain either face validity or intuitive appeal, that people 10
know it's a good thing. They do pay attention. And they 11
will do even more so if we give them that information in an 12
easily understandable form. 13
MS. KOHRS: One of the other issues that we've seen 14
come up in the information and advertising area is a question 15
about providing adequate information to various cultural 16
groups. Have you seen anything like that, John, on 17
DoctorQuality? Any requests for other languages or are you 18
just seeing the traditional health care user? 19
MR. GEBHART: I have not seen it at DoctorQuality, 20
but at other companies, multilingual capability in 21
particular. And for that matter, not just different 22
nationalities, but any demographic sort -- you know, age- 23
specific services as well, I think, are very important. 24
I mean, when you take a look at health care 25
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decisions and interactions with the system, they're very 1
personal, very intimate interactions. And I think to the 2
extent that different age groups and different cultures have 3
different needs, we think one expression of quality is that 4
the services are appropriate for the individual 5
circumstances, not just their diagnosis. 6
So I think it's a very important component of it. 7
It hasn't been demanded of us yet at DoctorQuality, but, you 8
know, sure enough, it will be coming. 9
MS. KOHRS: Helen? 10
MS. DARLING: Actually, it's become the hot topic. 11
And cultural competence is the current language on this. 12
It's actually a big issue and very important, and large 13
employers who especially -- like the hotel industry, the 14
hospitality industry, companies that have a lot of people in 15
places like California and New York where you have large 16
immigrant populations with many languages. 17
I know, for example, not too long ago I was at a 18
meeting with some people from Oxford Health Plans and, you 19
know, they actually have to cover 14 languages. And that's 20
just one where they have a lot of people. That's not 21
counting all the other dialects. 22
So this is because our workforce has become so much 23
more diverse and we have a lot of large employers -- again, 24
Marriott is the best example, probably -- where basically all 25
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the HR material is done in Spanish or -- you know, they are 1
particularly good on, if you will, the easier languages for 2
us now as a country, where we have a lot of people speaking 3
that language in a lot of different places. It's easy to get 4
the resources. 5
But they're recognizing that there are many, many 6
categories of people from different cultures. It's going to 7
be very expensive, though, to deal with it. But employers 8
really think this is extremely important. 9
MS. KOHRS: Dr. Koch? 10
DR. KOCH: I want to just touch base again on this 11
issue of doctor quality and quality health care provision. 12
And I’m very intrigued by your website and what's occurring, 13
and also a little concerned about the possibility that, you 14
know, unhappy patients can try to get in multiple ways. And 15
certainly in the LASIK world, there are whole websites 16
devoted to complications, and then certain physicians will be 17
spoken of, you know, based on one case. 18
And when we try to think about who is best capable 19
of evaluating quality of care, it's really our peers, our 20
peers in our specialty and, to a certain extent, peers not in 21
our specialty. 22
And I guess maybe my request for your next project 23
is, why not have doctors evaluate doctors? Don't do it 24
through the best doctors of America, which is one way to do 25
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it, but why not have doctors evaluate doctors and have those 1
ratings become available? I know that's all the competitive 2
and all that sort of issues, but who else better than those 3
in their own peer group? 4
MR. GEBHART: I think that's a very valid 5
observation. And let me respond to that a couple of ways. 6
And I failed to mention this earlier. 7
It's interesting: We do not have enough ratings to 8
really see what the true pattern is going to be yet. But the 9
overwhelming majority of ratings that we have are quite 10
favorable. So we find there's probably a greater propensity 11
for people to get online and help their doctor out with, you 12
know, thank you for a good experience. 13
Having any kind of a peer review function, it would 14
be great to be able to present it. My immediate reaction was 15
to try to figure out how to organize it, and that would take 16
a little bit of work. But what we do provide is a survey 17
that both the doctor and the patient can use that for any 18
given condition displays what the evidence-based standard of 19
care is. And an evidence-based standard of care is prepared 20
by peers. 21
The doctor is able to get online and indicate 22
whether or not they follow that standard, and then that 23
standard is displayed to the member, to the user, so they can 24
determine if what's happening in the process is indeed in 25
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accordance with that standard. 1
So, you know, whether or not your doctor has a nice 2
office staff and free parking and things like that, that's 3
good to know. Whether or not you're actually going to get 4
the treatment you need and they're going to follow a pattern 5
that's been proven to be effective in the past, that's really 6
where the rubber meets the road. And we try to help people 7
with that as well. 8
MS. KOHRS: Well, I'm afraid that that's going to 9
have to be our last word on the topic today. I'd like to 10
thank everyone who was able to come and be a part of this 11
panel, and I'd like to ask everybody to join in a round of 12
applause at this point. Thanks very much. 13
(Whereupon, at 5:02 p.m., the hearing was 14
concluded.) 15
* * * * * 16
17
18
19
20
21
22
23
24
25
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C E R T I F I C A T I O N O F R E P O R T E R 1
2
DOCKET/FILE NUMBER: P022106 3
CASE TITLE: HEALTH CARE AND COMPETITION LAW AND POLICY 4
DATE: JUNE 12, 2003 5
6
I HEREBY CERTIFY that the transcript contained herein is 7
a full and accurate transcript of the tapes transcribed by me 8
on the above cause before the FEDERAL TRADE COMMISSION to the 9
best of my knowledge and belief. 10
11
DATED: JUNE 11, 2003 12
13
14
LISA SIRARD 15
16
C E R T I F I C A T I O N O F P R O O F R E A D E R 17
18
I HEREBY CERTIFY that I proofread the transcript for 19
accuracy in spelling, hyphenation, punctuation and format. 20
21
22
SARA J. VANCE 23
24
25
K-25
From Wikipedia, the free encyclopedia
Jump to: navigation, search


Oak Ridge K-25 Plant
The K-25 plant, located on the southwestern end of the Oak Ridge reservation, used the
gaseous diffusion method to enrich uranium by separating uranium-235 from uranium-
238. Based on the well-known principle that molecules of a lighter isotope would pass
through a porous barrier more readily than molecules of a heavier one, gaseous diffusion
produced through myriads of repetitions a gas increasingly rich in uranium-235 as the
heavier uranium-238 was separated out in a system of cascades. Although producing
minute amounts of final product measured in grams, gaseous diffusion required a massive
facility to house the thousands of cascades and consumed enormous amounts of electric
power.
Begun in June 1943 and completed in early 1945 at a cost of $512 million, the K-25 plant
employed 12,000 workers. The U-shaped K-25 building measures half a mile by 1,000
feet (over 2,000,000 sq. ft. (609,600 m²) and is larger than The Pentagon, and at the time
was the biggest building in the world. Construction began before completion of the
design for the process. Due to construction needs at K-25 and elsewhere on the
reservation, the town of Oak Ridge, originally designed for 13,000 people, grew to
50,000 by summer 1944. The people needed for the construction of K-25 lived near by, in
a community that came to be known as Happy Valley. Built by the Army in 1943, Happy
Valley was a temporary community that housed 15,000 people in trailer homes.
[1]

Gaseous diffusion was one of three isotope separation processes that provided uranium-
235 for the Hiroshima weapon (Little Boy) - the other two being electromagnetic
separation and liquid thermal diffusion. All of the plants were located on the Oak Ridge
reservation. The Y-12 electromagnetic separation plant was located about eight miles
northeast of the K-25 plant. The S-50 liquid thermal diffusion plant, using convection to
separate the isotopes in thousands of tall columns, was built next to the K-25 power plant,
which provided the necessary steam. Much less efficient than K-25, the S-50 plant was
torn down after the war. Gaseous diffusion was the only uranium enrichment process
used during the Cold War. K-25 was the prototype for later Oak Ridge plants and those at
Paducah, Kentucky and Portsmouth, Ohio. Uranium enrichment operations at K-25
ceased in 1987.
[2]

The code name "K-25" was a combination of the "K" from the Kellex Corporation, the
initial contractors of the plant, and uranium-235.
[3]

See also
• Oak Ridge National Laboratory
• Y-12 National Security Complex
Notes and references
1. ^ "Manhattan Project Signature Facilities". atomicarchive.com. Retrieved on 2 March
2008.
2. ^ "K-25 tour attracts international visitors". oakridger.com. Retrieved on 2 March 2008.
3. ^ "Response to letter from Mr. Gus Robinson to General Nichols, providing information
relating to Site designations and Site codes for Manhattan District facilities.,
10/17/1949", digitized and online as ARC Identifier 281585 at National Archives
Archival Research Catalog.
External links
• The Manhattan Project: Making the Atomic Bomb
• Site X A map of Manhattan Project Era Oak Ridge, Tennessee.
• Atomic Heritage Foundation Preservation Efforts at K-25
• Google Maps K-25 on Google Maps

US: Energy Dept. Audit Finds Overcharges On Contracts Alleged
'Padding' By KBR Affiliate

by Dana Hedgpeth, Washington Post
October 30th, 2007


The Los Alamos National Laboratory paid millions of dollars in questionable charges to a
contractor affiliated with KBR, according to a recent audit by the Energy Department's inspector
general.

In three-quarters of the "work order tasks" analyzed from the last two years, the inspector general
found cost overruns of 20 percent or more. The inspector general examined 94,561 cases.

KBR was formerly known as Kellogg, Brown and Root.

In several cases, the contractor -- KSL Services Joint Venture, which was formed by KBR, Shaw
Infrastructure and Los Alamos Technical Associates -- put estimates of 1 cent into a computerized
payment system as a "place holder," according to a report by Gregory H. Friedman, the Energy
Department's inspector general. For example, one work order actually totaled $101,978.08.

Eight of 10 managers at the Los Alamos lab whom auditors talked to said "estimates are overrun a
fair amount of the time" or "estimates are overrun consistently," the report said.

KBR spokeswoman Heather Browne disagreed with the findings. She said that before the report
came out, "KSL Services worked with LANL to implement new processes and procedures
designed to address many of the issues raised in the report."

KSL was awarded a contract in February 2003 valued at nearly $800 million over five years, under
which it provides mechanical and site-support services such as repairing doors, fixing plumbing
and maintaining landscaping.

The University of California and Bechtel have a $2 billion contract with the Energy Department to
run the laboratory. The facility recently has experienced several security lapses, lost computer
drives and contracting problems. KSL operates under a subcontract to the lab.

The inspector general's report also found substantial problems with KSL overcharging for labor
and materials.

In one case, $10,191 was paid for more than twice the amount of electrical wire that a job needed.
In another instance, a nuclear safety engineer charged $4,900 on a job, triple the expected cost. In
working on patching cracks on a loading dock, a foreman charged three hours to the work order --
more than four months before the job being done. And one KSL employee charged eight hours for
re-gluing carpet tiles, a job that only took him 15 minutes to finish, according to the report.

Another $9,780 was paid for work to upgrade fire alarms that was never done. Lab officials told
auditors that charges for labor and material were "questionable, inappropriate, excessive, or
unsupported based on their knowledge of the work performed," the inspector general said.

Auditors were told of inappropriate timekeeping charges, work orders being submitted by people
who did not work on them, unapproved overtime charges and other unexplained charges.

An official at the lab said that "when KSL workers have no work to do, they are being subsidized,
and work order 'padding' is common," the report said.

The lab's computerized billing system, called PassPort, had a category called "Other Costs" that
allowed KSL to recover up to $20,000 a year in unanticipated costs. But the costs reached $41
million last year and were already over $14 million by the end of May 2007, according to the
inspector general's report, and it was unclear what the lab had paid for.

The lab is also conducting an internal audit of the KSL contract.




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The Oak Ridge Gaseous Diffusion Plant
was part of the nation’s nuclear defense
complex built in the city of Oak Ridge,
TN. The facility processed large
quantities of uranium by gaseous
diffusion to produce enriched uranium in
the form of uranium hexafluoride (UF
6
).
UF
6

can conveniently be used in the gas
form for processing, in the liquid form for
filling or emptying containers, and in the
solid form for storage. “Depleted” UF
6

(DUF
6
) is a product of the enrichment
process and is stored at three uranium
enrichment sites, located at Paducah,
Kentucky; Portsmouth, Ohio; and the
East Tennessee Technology Park
(ETTP, formerly known as the K-25 site)
in Oak Ridge, Tennessee. DOE has
management responsibility for
approximately 700,000 metric tons of
DUF
6

contained in about 57,700 steel
cylinders at the three sites. DOE has
stored such material at these sites since
the 1950s.
The eventual disposition of DUF
6
is of
considerable interest to members of the
U.S. Congress, concerned citizens, and
other stakeholders. Public Law 105-204,
signed by the President on July, 1998
requires DOE to build two conversion
facilities, one each at Portsmouth, Ohio,
and Paducah, Kentucky.

































DEFINING URANIUM HEXAFLUORIDE

Uranium hexafluoride is a chemical
compound consisting of one atom of
uranium combined with six atoms of
fluorine. It is the chemical form of
uranium that is used during the uranium
enrichment process. Within a
reasonable range of temperature and
pressure, it can be a solid, liquid, or gas.
Solid UF
6
is a white, dense, crystalline
material that resembles rock salt.
UF
6
does not react with oxygen,
nitrogen, carbon dioxide, or dry air, but it
does react with water or water vapor.








































UF
6
is always handled in leak tight
containers and processing equipment.
When UF
6
comes into contact with
water, such as water vapor in the air,
the UF
6
and water react, forming
corrosive hydrogen fluoride (HF) and
uranyl fluoride (UO
2
F
2
).

TRANSPORTATION PACKAGING

DUF
6

has been transported safely for
more than 40 years. Specific
requirements exist for the shipment of
DUF
6
cylinders. Among other
considerations, DUF
6
cylinders must be
designed, fabricated, inspected, tested,
and marked in accordance with the
version of American National Standard
N 14.1, “Uranium hexafluoride -
Packaging for Transport” that was in
effect at the time the cylinder was
manufactured. Three requirements are
particularly important relative to DUF
6
cylinder shipments: (1) cylinders must
be filled to less than 62% of the certified
volumetric capacity; (2) the pressure
within cylinders must be less than 14.8
pounds per square inch; and (3)
cylinders must be free of cracks,
excessive distortion, bent or broken
valves or plugs, and broken or torn
stiffening rings or skirts, and must not
have shell thicknesses that have
U.S. Department of Energy
Oak Ridge Operations
Oak Ridge, Tennessee


Transporting DOE UF
6

Cylinders from
Oak Ridge, TN to Portsmouth, OH
U.S. Department of Energy
Oak Ridge Operations Office
Oak Ridge, Tennessee
Shipment Prepared for Highway
decreased below a specified minimum
value. Cylinders meeting these
requirements are often referred to as
compliant cylinders.
Compliant cylinders will be transported
via highway, using flatbed or low-boy
trailers, with the cylinders affixed to the
trailer via a specially designed
adherence cradle. Initially, only one
cylinder, with a maximum weight of 14
metric tons will be loaded per transport
vehicle.
However, at a later date and depending
on the cylinder size and weight, multiple
cylinders will be transported.

IDENTIFYING SHIPMENT CONTENTS

“Radioactive, Class 7" and “Corrosive”
placards will be placed on the front,
back, and both sides of the tractor trailer
in accordance with DOT placarding
requirements. In addition, all DOT
required emergency response
information will be contained in the
shipping papers and readily available for
all law enforcement and emergency
response personnel. These are located
in a pocket located on the driver’s door
or within arm’s length or the driver.
DOE maintains a 24-hour emergency
response phone number through its
plant shift superintendent’s (PSS)
offices. All PSS personnel are trained in
the communication and notification
system network in the unlikely event of a
transportation incident.

SHIPMENT ROUTING

The shipment route was accomplished
through a series of negotiations with
State emergency management,
radiological health, and state police
representatives from Tennessee,
Kentucky, and Ohio.























The preferred and alternate routes were
selected primarily upon quickest transit
time, lower population centers, road
conditions, and traffic flow patterns.
Cylinders will not be in transport for
more than 10 consecutive hours.

INSPECTIONS

ETTP contractors and the State of
Tennessee, through random
inspections, will perform radiological
surveys and inspections prior to cylinder
departure. Transport vehicles and
cylinders will be available to State
highway and radiological health
inspectors during loading and prior to
leaving ETTP, as well as upon arrival
and during unloading at Portsmouth.

SHIPMENT TRACKING

The ETTP UF
6

cylinder shipments will
be monitored 24 hours a day using the
shipment monitoring capabilities of the
DOE Transportation and Tracking
Communications system (TRANSCOM),
a satellite tracking/communication
system.

NOTIFICATION OF STATE OFFICIALS

The DOE Oak Ridge Operations Office,
within the Office of Site Closure, will
inform affected States two weeks prior
to initiation of the shipments. Included
with the notification will be a description
of cylinder(s) and contents; highway
route; and appropriate shipping
schedules. Real-time notification of daily
shipments will be available through
TRANSCOM.



























EMERGENCY RESPONSE

In the unlikely event of an incident
involving one of these shipments,
State and local government agencies
and the carrier would have the primary
responsibility for response.
DOE has provided radiological and
emergency response training regarding
these shipments to affected State and
local emergency response units through
its Transportation Emergency
Preparedness Program (TEPP).

DOE has also coordinated key
emergency response notification and
response issues with the affected State
emergency management agencies.
DOE Radiological Assistance Program
(RAP) teams are available at the Oak
Ridge Operations Office in the event of
an incident. RAP teams are deployed
within an hour.

Highway carriers have established
Emergency Response Plans and have
contingency plans for cleanup and
recovery, if needed. DOE-ORO and its
contractor, Bechtel-Jacobs Company,
LLC, have developed a Transportation
Plan and will maintain a 24-hour
emergency response telephone number
to provide responders on-scene with
comprehensive emergency response
and incident mitigation information
regarding the material in the shipment.

ADDITIONAL INFORMATION

Requests for additional information on
the ETTP shipments should be referred
to Steve Wyatt, DOE Public Affairs
Officer at (865) 576-0888.
E-mail: wyattsl@oro.doe.gov





Information on DUF
6
and Emergency Response Training:

• Transportation Emergency Preparedness Program
Website: www.em.doe.gov/otem

• Depleted UF
6
Program Information Site
Website: http://web.ead.anl.gov/uranium

• DOE Headquarters, Freedom of Information Reading Room, 1000 Independence Avenue, SW, Room 1 E-190, Washington, DC
20585. Telephone: (202) 586-3142.

• Oak Ridge/DOE Information Center, DOE Public Reading Room, 475 Oak Ridge Turnpike, Oak Ridge, Tennessee 37830.
Telephone: (865) 241-4780; 800-382-6938, option 6.

• Portsmouth/DOE, Environmental Information Center, 3930 U.S. Route 23, Perimeter Road, Piketon, Ohio 45661. Telephone:
(740) 289-3317

U.S. GEOLOGICAL SURVEY—MINERALS INFORMATION 1
PHOSPHATE ROCK
By Joyce A. Ober
Phosphorus is an essential element for plant and animal potential impacts for the fertilizer industry can be summarized
nutrition. Most phosphorus is consumed as a principal briefly. The most pertinent portions of the law are Title I—
component of nitrogen-phosphorus-potassium (NPK) fertilizers Agricultural Market Transition Act and Title III—Conservation.
used on food crops throughout the world. Phosphate rock
minerals are the only significant global resources of phosphorus.
The United States is the world's leading producer and
consumer of phosphate rock, which is used to manufacture
phosphate fertilizers and industrial products for domestic use
and export. In 1996, 10 companies operated 18 phosphate rock
mines. More than 90% of the phosphate rock mined was used
to produce chemical fertilizers, and in 1996, production
increased for the third consecutive year. Companies in Florida
and North Carolina produced about 86% of the marketable
phosphate rock mined in the United States and processed most
of the refined mineral in fertilizer upgrading facilities. The
average value of marketable phosphate rock increased by 8%
from that of 1995.
Phosphate rock also is produced in the Western States of
Idaho and Utah where the mineral was upgraded into high-
analysis phosphate fertilizers and elemental phosphorus (P ),
4
which is used to produce downstream industrial products. Idaho
and Montana produced most of the P consumed domestically
4
and exported from the United States.
In the United States, marketable phosphate rock production
and consumption each increased by about 4%. U.S. phosphate
rock sold or used by producers was 43.5 million metric tons,
which is equivalent to 85% of effective industry capacity. (See acres that contract participants could plant with a specified crop,
tables 1 and 2.) The U.S. Department of Commerce reports
that wet-process phosphoric acid (WPPA) production was 11.9
million tons as available phosphorus pentoxide (P O ), which
2 5
represented an industry operating rate of nearly 100% (U.S.
Department of Commerce, 1997). The United States accounted
for more than 55% of global interregional converted phosphate
P O trade in order of importance—ammonium phosphates Title III.—Changes to the conservation provisions of 1990
2 5
[diammonium phosphate (DAP) and monoammonium Farm Bill are also expected to affect the phosphate industry.
phosphate (MAP)], granular triple superphosphate (TSP), and Previous farm legislation had allowed annual rental payments to
WPPA. farmers who entered a contract to withhold voluntarily
Legislation and Government Programs
The Federal Agriculture and Improvement Reform (FAIR) million. FAIR reduced the cap to 14.7 million hectares and
Act, Public Law 104-127, also known as the Freedom to Farm allowed for CRP land that meets USDA requirements to be
Act, was passed into law and signed by the President of the withdrawn from CRP and to be enrolled in production flexibility
United States on April 4, 1996. Because the phosphate rock contracts. New acreage could be enrolled in CRP, but the
industry is so heavily dependent on the production and sales of criteria were more stringent. At a minimum, Title III will return
phosphate fertilizers, any changes in U.S. farm legislation are 650,000 hectares to production; increased acreage, however,
watched closely by phosphate producers. The law contains nine may be much more, perhaps as much as one-half of CRP
sections, but the major provisions that have the greatest hectares (Green Markets, 1996e). This would have a positive
Title I.—This portion of the new law changes the way
income-support payments to farmers are determined. In the
past, these deficiency payments were based on the difference
between actual market prices and target prices during a specific
time period or the price-support loan rates, whichever were
higher. FAIR eliminates the link between market prices and
income-support payments, and payments are based on the
number of acres covered by income support contracts and a
predetermined per-unit payment rate now determined annually
by the U.S. Department of Agriculture (USDA). Total contract
payments are set for each year specified in the plan and will
decrease annually for the following 7 years, which is the period
covered under FAIR; payment caps for individual farmers were
reduced from $50,000 per person to $40,000 per person.
Coupled with the changes to the way deficiency payments are
determined is the new flexibility that allows farmers to plant
contract acreage with any crop of their choosing, except fruits
and vegetables; in the past, farmers could only plant the crop
specified in the contract to receive payment. This provision
could affect the fertilizer industry because different crops have
different nutrient requirements, which would possibly alter the
patterns of fertilizer applications throughout the country.
Acreage Reduction Programs, which limited the number of
were eliminated. Opinions on how or if these changes will
affect the consumption of phosphate fertilizers are mixed; much
depends on what crops are actually planted. For the most part,
phosphate producers expect positive growth, but it may take
several years under the program to define new consumption
patterns.
environmentally sensitive land from agricultural production
under the Conservation Reserve Program (CRP). The number
of hectares that could be enrolled in CRP was limited to 15.4
2 U.S. GEOLOGICAL SURVEY—MINERALS INFORMATION
impact on the fertilizer industry. Any acreage returned to September 27 because of a drop in domestic phosphate demand
production would require additional fertilizer inputs, increasing (Green Markets, 1996k). The company also ran its New Wales,
fertilizer consumption and benefiting the phosphate industry. FL, facility at 80% of its 2.7-million-ton-per-year capacity from
Production
Consolidation of the fertilizer industry that began in 1995 plant remained idle (Green Markets, 1996h).
continued in 1996. In March, IMC Global Co. merged with IMC-Agrico announced that it will end phosphate rock
Vigoro Corp. IMC Global, which manufactures potash and supply contracts with overseas customers when the current
phosphate, acquired Vigoro’s potash and nitrogen businesses, contracts expire in July 1997. The company, which has been
as well as a retail business. In September, Potash Corp. of using its own production to supply rock needs at its chemical
Saskatchewan (PCS) announced plans to acquire Arcadian operations, is sensitive to finite reserves and wants to limit sales
Corp., a nitrogen producer. This acquisition would make PCS to the merchant market to ensure adequate internal supplies
a producer of all three major fertilizer elements—potassium, (Green Markets, 1996m).
phosphorus, and nitrogen. The shareholders’ final vote on the U.S. Agri-Chemicals, a subsidiary of China’s Sinochem,
merger was scheduled for January 1997. In December, completed a 450,000-ton-per-year MAP powder plant in Ft.
Canadian producer Agrium Inc. acquired Viridian Inc. for an Meade, which will enable it to use all the phosphoric acid it
estimated $887 million. Although Agrium already produced all produces. The powdered MAP will be sent to Sinochem
three fertilizer nutrients, it increased its nitrogen production by Fertilizer Co. Ltd.’s Nanjang, China, facility where it will be
acquiring Viridian (Kirschner, 1997). converted to NPK fertilizers. U.S. Agri-Chemicals had been
Southern States.—In Florida, phosphate rock was mined
and processed by six producers—Cargill Fertilizer, Inc.; CF
Industries, Inc.; IMC-Agrico Co.; Mobil Mining and Minerals
Corp.; PCS; and U.S. Agri-Chemicals Corp. Their mines and
plants were located in Hamilton, Hardee, Hillsborough, and
Polk Counties. Nu-Gulf Industries’ Wingate Creek Mine and
the associated Mulberry Phosphates Inc., Piney Point
ammonium phosphate conversion plant in Manatee County were
idle. Farmland Industries, Inc.-Norsk Hydro, L.P., and
Mulberry Phosphates operated WPPA and ammonium
phosphate plants at Green Bay and Bartow, respectively, using
phosphate rock purchased domestically as feed.
In January, Mobil Mining and Minerals sold its South Fort
Meade, FL, mining operations to Cargill Fertilizer Inc. for $283
million. The beneficiation plant at the operation was designed
to process 3.6 million tons per year of rock; rock reserves were
estimated to be 104 million tons. Mobil also announced plans Western States.—In Utah, Simplot-Farmland Phosphates
to sell its Nichols Mine to Nichols Phosphate Acquisitions Ltd. Co., a joint venture between J. R. Simplot and Farmland
Corp. (NPAC); NPAC’s name was changed later to Agrifos Industries, Inc., operated a major mining and phosphate rock
L.L.C. The acquisition also included about 4,000 hectares of benefication facility at Vernal, which supplied its phosphate
phosphate reserves in Polk County and a phosphate rock fertilizer production plant at Rock Springs, WY.
processing and drying plant and related equipment. Rock In Idaho, five firms mined or processed phosphate rock,
production capacity at the mine was estimated to be 1.36 million either for the production of P in electric furnaces for industrial
tons per year. NPAC agreed to a long-term tolling arrangement applications or for conversion to WPPA and finished phosphate
with Mobil to upgrade Nichols rock to DAP and MAP (Green fertilizers. Three producers conducted open pit mining from the
Markets, 1996n). As a result of Mobil’s exit from the Phosphoria Formation in Caribou County, producing phosphate
phosphate rock market, PhosRock, the association established rock as feedstock for P furnaces. FMC Corp. operated the Dry
in 1970 to market phosphate rock overseas for U.S. producers, Valley Mine, Caribou County, on Federal and private leases to
officially was dissolved on January 1, 1996. provide feedstock for P production at Pocatello. The Monsanto
Increased DAP inventories and seasonal downturns led IMC- Co. produced phosphate rock from the Enoch Valley Mine in
Agrico to reduce production or close temporarily some of its the Caribou National Forest for P production at Soda Springs.
DAP plants. Its 900,000-ton-per-year DAP plant in Taft, LA, Rhône-Poulenc Basic Chemicals Co. produced phosphate rock
was temporarily shut down between March 11 and July 22, from the Rasmussen Ridge Mine in the Caribou National Forest
when IMC-Agrico entered into a sales arrangement to ship for P manufacture at Silver Bow, MT, and domestic sales.
150,000 tons of DAP to China during the second half of 1996
(Green Markets, 1996l). The Taft plant was reidled on
April 18 to July 1, when it resumed full production capacity.
The Nichols DAP plant, with an annual capacity of 545,000
tons, was shut down temporarily on May 14; at yearend, the
selling its excess phosphoric acid to Cargill Fertilizer’s plant in
Bartow, where it was converted to DAP (Green Markets,
1996u).
IMC-Agrico purchased 9,700 hectares of land from
Consolidated Minerals Inc. for approximately $31 million. This
land in southeastern Manatee County and northwestern DeSoto
County is estimated to contain about 91 million tons of
phosphate rock reserves, averaging 67% bone phosphate of
lime. The purchase brings IMC-Agrico’s Florida phosphate
rock reserves to about 450 million tons (Green Markets,
1996g).
Rhône-Poulenc S.A. invested about $2 million to upgrade its
high-purity phosphoric acid plant near Nashville, TN. With the
investment, the company plans to produce an ultrapure
phosphoric acid to meet semiconductor standards (North
American Mineral News, 1996).
4
4
4
4
4
U.S. GEOLOGICAL SURVEY—MINERALS INFORMATION 3
Environment
Mulberry Phosphates received consent orders proposed by inland by rail and truck.
the Florida Department of Environmental Protection covering In North Carolina, PCS barged phosphate rock and finished
the firm’s phosphogypsum stacks at Mulberry and Piney Point. products to the port at Morehead City for export and domestic
At yearend, the company also was finalizing plans to restart shipment. Rail facilities also were utilized extensively for
production at its DAP plant in Piney Point by late 1997; the transport.
plant has been closed since 1992. Production of 500,000 tons Western producers moved phosphate rock from mines to
per year of DAP is expected when the plant reopens. Rock for plants by rail, truck, and slurry pipeline. Finished product was
the plant will be supplied by Mulberry’s Wingate Creek Mine, moved predominately by rail and truck.
which will be reopened about 1 month before the DAP plant.
Mulberry signed a letter of intent with Monsanto Envirochem to
refurbish the sulfuric acid plant that will be needed to feed the
DAP operation. Estimated cost for the restart is $35 million The weighted average value for marketable phosphate rock
(Fertilizer Week, 1996d). in 1996 was $23.40 per ton, f.o.b. mine. This was an increase
In response to a petition from The Fertilizer Institute, the
U.S. Environmental Protection Agency (EPA) reconsidered a
June 3, 1992, final rule revising the National Emission Standard
for Radon Emissions from Phosphogypsum Stacks. The EPA
proposed a rule to amend research and development regulations
that would make it easier for researchers to use phosphogypsum
in laboratory and field test settings and to change the
methodology used to establish average radium-226
concentrations for a phosphogypsum stack. After a hearing on
August 1, the comment period on the proposed regulations was
extended to August 31 (U.S. Environmental Protection Agency,
1996).
Consumption conversion plants at Geismar, LA, on the Mississippi River, and
In 1996, U.S. apparent domestic consumption of phosphate
rock increased by about 3% compared with that of 1995. About
94% of the total was consumed in the manufacture of 11.9
million tons P O WPPA for downstream fertilizer, animal feed
2 5
derivatives, and purified WPPA for industrial applications. The
balance was used to produce P for industrial applications,
4
including detergent and food additives, water- and metal-
treatment chemicals, plasticizers, pesticides, vitamins, soft
drinks, toothpaste, photographic film, light bulbs, bone china,
flame-resistant fabrics, optical glass, and other consumer goods.
(See tables 3 and 4.)
Stocks
Although producers’ yearend stocks increased about 12%
from the 1995 level, they remained equivalent to almost 2
months of production, the same production level as that of 1995.
Transportation
In Florida, beneficiated phosphate rock was moved by rail
and truck to phosphate upgrading facilities. Phosphate rock and
finished phosphate materials were railed to ports at Tampa and
Jacksonville, and then were shipped elsewhere for domestic use
or exported. Finished phosphate fertilizers and phosphate rock
were barged north on the Mississippi River and other major
tributaries for domestic consumption and were also transported
Prices
of almost 8% from the 1995 value. (See table 5.)
Foreign Trade
Exports of phosphate rock decreased by 47% from the 1995
level primarily because of IMC-Agrico’s decision to stop
exporting the material. About 77% of rock exports was shipped
to Asia (India, Japan, and the Republic of Korea), and 13% was
shipped to Oceania (Australia and New Zealand).
The United States was the third largest importer of phosphate
rock from Morocco, with nearly 1.7 million tons in 1996, a
decrease from that in 1995. Arcadian and Mississippi
Phosphates Corp. used Moroccan phosphate rock in phosphate
at Pascagoula, MS, on the U.S. Gulf Coast. Arcadian also used
imported ore as feedstock for a purified industrial-grade WPPA
plant at Geismar that it operates on behalf of Rhône-Poulenc.
U.S. converted phosphate trade in 1996 appeared to show a
significant decrease because of a drop in exports of DAP,
particularly to China and India. These DAP exports are
believed to be understated and are being investigated by the
Bureau of the Census. According to data from the International
Fertilizer Industry Association, 1996 U.S. DAP export
shipments were 76% of the global total; MAP, 90%; TSP, 48%;
and merchant-grade WPPA, 11%. (See tables 6, 7, 8, 9, 10, 11,
and 12.)
World Review
World phosphate rock production was about 133 million tons
in 1996, a slight increase compared with that of 1995.
Phosphate rock was produced in about 40 countries; the United
States was the largest, with about 34% of total production,
followed by China, Morocco, and Russia.
Production in the Middle East was at 98% of total capacity,
the highest utilization rate of any geographic region. Capacity
utilization in the United States was 89%; Latin America, 85%;
Asia, 81%; Africa, 78%; and Europe and Oceania, less than
50% each. (See tables 13 and 14.)
Australia.—WMC Fertilizers Ltd., a subsidiary of Western
Mining Corp., plans to mine a phosphate deposit in Queensland
4 U.S. GEOLOGICAL SURVEY—MINERALS INFORMATION
and to upgrade the mined rock into 1 million tons per year of market in western Canada, and Viridian is estimated to have a
DAP and MAP. Reserves at the Phosphate Hill deposit were less-than 5% share of the U.S. market. Both firms have
reported to contain 2 billion tons of phosphate rock, with mining ammonia and urea production facilities in Canada, Agrium has
reserves of 103 million tons; average grade of the rock is 23% a 499,000-ton-per-year DAP facility, and Viridian operates a
P O . The company also plans to construct a new sulfuric acid 300,000-ton-per-year phosphoric acid plant (Fertilizer Week,
2 5
plant, an ammonia plant, a phosphoric acid plant, and a 1996a ).
granulation plant. Plant construction is expected to begin by the Earth Sciences Inc. expects to begin producing purified
third quarter of 1997, with fertilizer production to begin in phosphates at a new 16,300-ton-per-year plant in Calgary,
1999. Most of the output will be used locally; some will be Alberta, by early 1997. The permits to build and operate the
exported to Southeast Asia (Green Markets, 1996v). An initial facility have been received, and the company is negotiating to
production level of 750,000 tons per year of DAP/MAP is purchase 11,800 tons per year P O of super phosphoric acid to
expected. upgrade. The purified product will be made into 75% white
Brazil.—Since the Government privatized the fertilizer
products industry in the early 1990's, production of almost all China.—IMC-Agrico announced that it signed an exclusive
fertilizer products has been controlled by a small number of letter of intent with the Yunnan Phosphorus Chemical Industry
companies. Several acquisitions in 1996 reinforced this control. (Group) Corp. and the Yunnan Provincial Petroleum &
Serrana S.A. reportedly purchased 51% of Fertisul, a fertilizer Chemical Industry Bureau to study phosphate ore resources in
producer, for an estimated $22 million. Serrana and Fertisul the Yunnan Province. If commercially feasible, IMC-Agrico
already operate two companies—Arafertil and Ipiranga- and the Chinese concerns plan to develop the deposits jointly
Serrana—through 50-50 joint ownership; Serrana will assume (Green Markets, 1996i).
full control of these operations. Arafertil has an annual capacity The Yunnan Phosphate Fertilizer Industrial Co. began
of 800,000 tons of phosphate rock and 750,000 tons of single operations at a new 140,000-ton-per-year P O phosphoric acid
superphosphate (SSP). Ipiranga-Serrana has a 1.2-million-ton- plant and a 400,000-ton-per-year TSP plant in Kunming,
per-year capacity to produce blended fertilizers. After the Yunnan Province, in the third quarter of 1996. The phosphoric
acquisition, Serrana will have control of 30% of Brazil’s acid plant uses a two-stage thermal acid process with elemental
phosphate rock production, 20% of its phosphoric acid phosphorus produced in the first stage and phosphoric acid
production, 20% of its MAP production, 15% of its SSP/TSP independently produced in the second stage. The TSP plant
production, and 10% of its blended fertilizer production uses the slurry process to produce a 46% P O product
(Fertilizer Markets, 1996f). Two companies in the Fertifos (Phosphorus & Potassium, 1996d).
Group—Fertiza and Fertibras—purchased Adubos Trevo AS’s The Canadian firm Spur Ventures Inc. reportedly signed a
SSP/TSP plant in Cubatao, Sao Paulo, for $8 million. The preliminary agreement with Yuanyi Phosphorus Chemical
plant, which has an annual capacity of 130,000 tons of Industries Group Co. to develop a phosphate rock deposit in
SSP/TSP, also can granulate 650 tons per day of product. This Hubei Province. The Yichang deposit reported proven and
purchase will enable Fertiza and Fertibras to expand production. probable reserves of 396 million tons, with an average P O
The Cubatao plant had been closed since 1995 because of content of 23%. Preliminary plans are to mine 2.5 million tons
Adubos Trevo’s financial difficulties (Fertilizer Markets, per year of rock and to construct a 500,000-ton-per-year DAP
1996a). plant near Yichang City. Capital costs for the mining operation
The Fertifos Group announced plans to invest $80 million to were estimated to be $138 million, and capital costs for the
expand capacity at its Fosfertil and Ultrafertil subsidiaries. A DAP plant were estimated to be $260 million. Spur estimated
200,000-ton per-year P O phosphoric acid plant and a operating costs to be $12 per ton for mining and $130 per ton
2 5
500,000-ton-per-year sulfuric acid plant will be constructed at for DAP production. All the production was targeted for the
Fosfertil’s Uberaba, Minas Gerais, complex by the second half Chinese market (Green Markets, 1996a).
of 1997. Estimated cost for these plants is $55 million. The In December, IMC-Agrico reported that it reached a new 2-
phosphoric acid plant is scheduled to be run initially at 40% of year DAP supply contract with Sinochem that covers the 1997
capacity; capacity would be increased depending on market and 1998 calendar years. Shipment volumes for the 2 years will
conditions. Phosphoric acid will feed Fosfertil’s MAP/TSP be approximately the same as those in 1996, and monthly
granulation complex, which has been operating at 80% of its 1- shipments will reflect market prices at the time of shipment.
million-ton-per-year capacity because of short phosphoric acid This is the first contract of this time length for U.S. exports
supply. The additional MAP/TSP produced is targeted for (Green Markets, 1996j).
competition with imported material in the domestic market
(Fertilizer Markets, 1996b).
Canada.—In October, Agrium and Viridian agreed to merge would switch from production of DAP to complex fertilizers
in a stock exchange deal, creating a company worth about $2 principally because high prices of DAP in India have led to
billion. The merger will require regulatory approval by the large inventories. The company had been in the process of
United States and Canada before it is finalized. Each of the two increasing DAP capacity from 300,000 tons per year to 450,000
companies is estimated to have a 25% share of the fertilizer tons per year; this increase will be used for complex fertilizer
2 5
acid for industrial uses (Green Markets, 1996b).
2 5
2 5
2 5
India.—One of the largest DAP producers in India,
Godavari Fertilisers and Chemicals Ltd., announced that it
U.S. GEOLOGICAL SURVEY—MINERALS INFORMATION 5
production instead (Green Markets, 1996f). joint venture between OCP and Belgium’s Société Chimique
The Spanish firm Incro S.A. was awarded a contract to Prayon-Rupel S.A.; construction is estimated to cost $50
upgrade Fertilisers & Chemicals Travancore Ltd.’s DAP/NPK million. Production is scheduled to begin in July 1997 (Green
plant in Cochin. The upgrading was expected to increase annual Markets, 1996c).
capacity to 400,000 to 450,000 tons. Startup was scheduled for In November, OCP announced that it had obtained $12.8
1997 (Green Markets, 1996d). million financing to construct a purified phosphoric acid plant
Indonesia.—PT Istana Kanematsu opened a new phosphate
fertilizer plant in Ciamis, West Java, in October. The new plant,
which will supply fertilizers for peat farming lands, has an
annual capacity of between 600,000 and 720,000 tons of ground
phosphate rock and SSP. Cost of the plant was estimated to be
$55 million. PT Istana Kanematsu is a joint-venture company
owned by PT Elang Istanamas of Indonesia (60%) and
Kanematsu Corp. of Japan (40%) (Fertilizer Week, 1996c).
Kazakstan.—In July, the U.S. trading company IBE Trade
Corp. acquired management control over the Kara Tau
phosphate complex with a 51% control of the shares of the
complex. IBE has an option to purchase the shares after 10
years. The complex includes five phosphate rock mines, the
Dzambul Superphosphate Works, and Nadphos, which is the
phosphate producer in Novodzambul. IBE reportedly offered
$92 million in investments over several years to improve the
complex. The first phase would include replacing equipment,
roads, and mills at the five phosphate rock mines. The second Peru.—As part of its privatization, Peru’s state mining
phase would include the construction of a new WPPA plant at company, Minero Peru, planned to sell its Bayovar phosphate
the MAP/DAP facility. deposits on February 11, 1997. The Bayovar deposits have
Although the Kara Tau mines were shut down through most estimated phosphate reserves of 262 million tons. At least 12
of 1995 because of lack of financing, they had been expected to companies have expressed interest in the property. The
produce up to 2.4 million tons of rock in the second half of eventual buyer will have 3.5 years to develop the deposits
1996. Most of this rock is exported to Uzbekistan, and the (Green Markets, 1996o).
MAP produced at the complex is shipped to China (Fertilizer
Markets, 1996c). By the end of October, IBE had invested
$23.6 million in the complex, and the complex produced more
than 2 million tons of phosphate rock. Work to upgrade the
Dzanbul superphosphate plant from an annual capacity of
180,000 tons of 42% P O MAP to 300,000 tons of 46% P O
2 5 2 5
MAP was planned to begin in December (Fertilizer Week,
1996b).
Morocco.—Office Cherifien des Phosphates (OCP) reported of peso depreciation, yen appreciation, and construction costs
exports of phosphate rock to be 10.1 million tons in 1996. from the early 1980's. Although Philphos supplies 70% of the
Spain (18%), Mexico (17%), and the United States (17%) were Philippines growing fertilizer needs, no decision on its fate had
the principal destinations. been reached by yearend (Phosphorus & Potassium, 1996a).
OCP plans to invest $1.06 billion within 5 years to expand
its operations. Expansions include phosphate rock and
phosphate fertilizer production. Phosphate rock production will
increase by 5 million tons per year to 25 million tons per year,
of which 14 million tons per year is earmarked for domestic
consumption. Annual phosphoric acid production is expected
to increase from 2.6 to 3.2 million tons at the Safi and the Jorf
Lasfar complexes. The construction of two new phosphoric acid
plants at Jorf Lasfar by 2000 was planned in joint ventures with
foreign partners; each plant has been designed to produce 1,000
tons per day (Green Markets, 1996p).
Construction of a new 120,000-ton-per-year phosphoric acid
plant in Jorf Lasfar was agreed to at the end of February. The
new plant, called Euro Maroc Phosphore (Emaphos) is a 50-50
about 200 kilometers south of Rabat. The project is a joint
venture with the Belgian firm Recticel, and acid production for
the industrial market is expected to begin in July 1997
(Fertilizer Markets, 1996d).
OCP entered into a 6-year agreement to supply France’s
Grande Paroisse with 600,000 tons per year of phosphate rock
beginning on January 1, 1997. The rock will go toward
production of phosphoric acid, and much of the acid produced
will be returned to OCP (Green Markets, 1996r).
Pakistan.—Morocco’s OCP entered into an agreement with
Al Noor Fertilizer Industries Ltd. to build a $220 million
fertilizer plant in the Sindh Province. Annual production
capacity at the new plant will be 1,300 tons per day of DAP,
1,200 tons per day of urea, and 955 tons per day of ammonia.
OCP will supply all the plant’s phosphoric acid needs from
Morocco. Scheduled startup for the operation is in early 1998
(Green Markets, 1996q).
Philippines.—The Philippine Government, which owns
50.01% of the Philippine Phosphate Fertilizer Corp. (Philphos),
proposed a plan to foreclose on Philphos’ assets and to form a
new company that would be fully owned by the Government.
This plan is opposed by the Government of Nauru, which owns
the remaining 49.99% of Philphos. Although Philphos has
some operating profits from 1995, the profits have been used to
pay interest charges, and the company remains in debt as a result
Russia.—Because of low demand from Former Soviet Union
(FSU) phosphate producers, Apatit, Russia’s largest phosphate
rock producer, announced that it would close one of its two
beneficiation plants on the Kola Peninsula on July 1, 1996, for
an indefinite period. The two beneficiation plants were
operating well below the combined 12-million-ton annual
capacity before the closure, and energy costs in the region made
operating the second plant at 50% of capacity prohibitive.
Apatit also ended rock deliveries to some FSU MAP and DAP
producers because of nonpayment for first half 1996 deliveries.
Because Apatit intended to increase exports of phosphate rock
to Norway, Finland, and Germany in 1997, it was dredging the
Murmansk port to allow panamax vessels to operate (Fertilizer
Markets, 1996e).
6 U.S. GEOLOGICAL SURVEY—MINERALS INFORMATION
Saudi Arabia.—Sabic plans to construct an acids complex
in Jubail. The complex will produce 250,000 tons per year of
phosphoric acid, as well as sulfuric acid and aluminum fluoride.
Plant construction was scheduled to begin in 1997, and was
expected to be completed by 1999 (Green Markets, 1996s).
Senegal.—In September, Compagnie Sénégalese Des
Phosphate de Taïba announced plans to merge with Industries
Chimiques de Sénégal (ICS), its principal customer; the merger
will be retroactive to January 1, 1996. The Senegalese
Government would have 25% to 30% ownership in the new
company, compared with the current ownership of 50% in Taïba
and 37.5% in ICS. Taïba produces 1.5 million tons per year of
phosphate rock, of which about 1 million tons per year is
exported. The remainder is shipped to ICS’ 385,000-ton-per-
year P O phosphoric acid plant. After the merger, the new
2 5
company plans to increase annual mine production capacity to
about 3 million tons, which would support a doubling of
phosphoric acid production capacity (Phosphorus & Potassium,
1996b).
Togo.—The Togolese Government announced plans to sell
40% of its holdings in Office Togolais de Phosphates (OTP), the
country’s only producer of phosphate rock. A committee from
the World Bank was assessing OTP’s asset value, and an offer
for the sale is expected to be made in March 1997. Production
capacity at OTP’s mine is estimated to be 3.4 million tons per
year of rock, and all of the production is exported (Phosphorus
& Potassium, 1996c).
Vietnam.—Japan’s Tomen Corp. reportedly plans to build
a 330,000-ton-per-year phosphate plant near Hanoi. The $180
million plant would be fed by domestic phosphate rock deposits
and would be built as a joint venture with the Vietnam National
Chemical Corp. (Green Markets, 1996t).
Outlook
U.S. and world annual capacity to mine and beneficiate
phosphate ore into marketable phosphate rock continued to
exceed domestic and world demand by an estimated 11% and
19%, respectively, in 1996. U.S. phosphoric acid output was
very near usable capacity, and world phosphoric acid production
was about 94% of available capacity. Fertilizer consumption
and plant operating rates in the countries of the FSU remained
well below the levels reported prior to the dissolution of the
U.S.S.R.
Demand for phosphate rock in the United States is driven
primarily by the fertilizer sector, which supplies North
America’s needs and is the major supplier to world markets;
more than one-half the P O in finished fertilizers manufactured
2 5
in the United States is contained in exported materials. With the
changes in U.S. farm policy and “Freedom to Farm,” the ahead: Green Markets, v. 20, no. 39, September 30, p. 1, 9.
expectation is that more acres will come into production
beginning in 1997; the increase in area, however, is relatively
small compared to the total. If export sales are maintained, then
the expectation is that the U.S. phosphate industry should have
results very similar to those of 1996 (that is, phosphate rock
production and consumption of about 45 million tons and P O
2 5
in fertilizer sales in the United States of about 4.5 million tons
and in exports of finished products of 5.2 million tons) through
the remainder of the century. Exports of phosphate rock are
expected to decline again in 1997, and the United States will be
a net importer as long as the contracts for rock imports from
Morocco remain in force.
On a global basis, new mining operations will probably come
on-stream in the next 5 years in Australia and Saudi Arabia and
possibly in China and Bolivia. An expansion in Morocco is also
probable. The biggest mining question remaining is the future
of operations on the Kola Peninsula in Russia and operations in
Kazakstan, which continue to operate well below the output
levels of the late 1980’s. Some new fertilizer production
capacity will probably be added in Africa, the Middle East, and
Southeast Asia. Future fertilizer plant capacity utilization in the
countries of the FSU is very uncertain.
Because of the nutritional needs of an expanding population,
world fertilizer demand should also increase. The expectation
is that world phosphate demand will grow by an estimated 1.2%
to 1.5% annually through 2000. If many of the areas being
farmed today received fertilizers for proper crop nutrition, then
demand would increase substantially and the increased yields
would allow a reduction in total acres planted.

References Cited
Fertilizer Markets, 1996a, Brazilian fert production capacity is being
concentrated in fewer hands: Fertilizer Markets, v. 7, no. 7, September 9, p.
3.
———1996b, Fertifos to spend $80 million on P O , sulphuric acid production:
2 5
Fertilizer Markets, v. 7, no. 6, September 2, p. 2-3.
———1996c, IBE plans for Kazak phosrock include purchase option: Fertilizer
Markets, v. 6, no. 48, July 1, p. 2-3.
———1996d, Morocco: Fertilizer Markets, v. 7, no. 17, November 18, p. 9.
———1996e, Russian phosrock producer to cut production by 1.5 million
mt/y: Fertilizer Markets, v. 6, no. 51, July 22, p. 3.
———1996f, Serrana to boost share of phosphate market with planned
purchase of Brazil’s Fertisul: Fertilizer Markets, v. 7, no. 5, August 26, p.
1-2.
Fertilizer Week, 1996a, Agrium agrees stock swap for Viridian: Fertilizer
Week, v. 10, no. 24, October 28, p. 1.
———1996b, IBE to refinance revamp of Kara Tau mines: Fertilizer Week, v.
10, no. 23, October 21, p. 2.
———1996c, Indonesian phos mine inaugurated: Fertilizer Week, v. 10, no.
23, October 21, p. 2.
———1996d, Mulberry moving to reopen Piney Point plant: Fertilizer Week,
v. 10, no. 32, December 23, p. 1.
Green Markets, 1996a, Canadian resource company to study China’s second-
largest P deposit: Green Markets, v. 20, no. 40, October 7, p. 8-9.
———1996b, Earth Sciences gets permit for phos plant: Green Markets, v. 20,
no. 42, October 21, p. 11.
———1996c, Emaphos purified phosacid plant is inaugurated: Green Markets,
v. 20, no. 16, April 15, p. 10.
———1996d, FACT chooses Incro to expand fert output: Green Markets, v.
20, no. 26, June 24, p. 12.
———1996e, Fall season off launching pad, analysts see good season, year
———1996f, Godavari to switch production line away from DAP: Green
Markets, v. 20, no. 16, April 15, p. 10.
———1996g, IMC-Agrico adds to Florida rock reserves with buy of CMI’s
Pine Level holding: Green Markets, v. 20, no. 41, October 14, p. 1, 12.
———1996h, IMC-Agrico brings New Wales back to capacity production:
Green Markets, v. 20, no. 28, July 8, p. 1.
———1996i, IMC-Agrico, Chinese will jointly explore phosphate reserves in
U.S. GEOLOGICAL SURVEY—MINERALS INFORMATION 7
Yunnan province: Green Markets, v. 20, no. 39, September 30, p. 1, 9. U.S. Environmental Protection Agency, 1996, National emission standards for
———1996j, IMC-Agrico closes unprecedented two-year DAP supply contract hazardous air pollutants; National emission standard for radon emissions
with Sinochem: Green Markets, v. 20, no. 50, December 16, p. 1. from phosphogypsum stacks: Federal Register, v. 61, no. 50, May 8, p.
———1996k, IMC-Agrico idles Taft, La., plant: Green Markets, v. 20, no. 39, 20775-20779.
September 30, p. 8.
———1996l, IMC-Agrico resumes DAP production at Taft, agrees new sales
to China for second-half 1996: Green Markets, v. 20, no. 30, July 22, p. 1,
12.
———1996m, IMC-Agrico to end phosrock export sales: Green Markets, v.
20, no. 24, June 10, p. 8.
———1996n, Mobil closes Cargill deal for $283 million, earmarks Nichols
mine and tolling pact for group: Green Markets, v. 20, no. 1, January 1, p.
1, 11.
———1996o, North American firms look at Peruvian P reserves: Green
Markets, v. 20, no. 41, October 14, p. 10.
———1996p, OCP outlines expansion plans through end of century: Green
Markets, v. 20, no. 7, February 12, p. 10.
———1996q, OCP to build fert plant in Pakistan: Green Markets, v. 20, no.
41, October 14, p. 10-11.
———1996r, OCP to sell Grande Paroisse 600 K mt/y of phosrock: Green
Markets, v. 20, no. 2, January 8, p. 9.
———1996s, Sabic to build large acids complex in Jubail: Green Markets, v.
20, no. 13, March 25, p. 11.
———1996t, Tomen eyeing Vietnam phosphate plant: Green Markets, v. 20,
no. 47, November 25, p. 12
———1996u, US Ag’s new MAP plant at Fort Meade nearly complete: Green
Markets, v. 20, no. 37, September 16, p. 1.
———1996v, WMC to mine P reserves in Australia, to produce finished
phosphates by 2000: Green Markets, v. 20, no. 51, December 23, p. 9-10.
Kirschner, E.M., 1997, Fertilizer makers gear up to grow: Chemical &
Engineering News, v. 75, no. 13, March 31, p. 13-15.
North American Mineral News, 1996, R-P upgrades phos acid capacity: North
American Mineral News, no. 16, p. 4.
Phosphorus & Potassium, 1996a, Philippine government proposes foreclosure
on Philphos’ assets: Phosphorus & Potassium, no. 205, p. 11-12.
———1996b, Taïba and ICS to merge: Phosphorus & Potassium, no. 205, p.
10-11.
———1996c, Togolese government to sell 40% stake in OTP: Phosphorus &
Potassium, no. 205, p. 10.
———1996d, Yunnan Phosphate commissions new phosacid and TSP units:
Phosphorus & Potassium, no. 205, p. 12-13.
U.S. Department of Commerce, Bureau of the Census, 1997, Inorganic fertilizer
materials and related products (MA28B), first quarter 1997: (Accessed on
the World Wide Web on May 3, 1997 at http://www.census.gov/
cir/www/mq28b.html)
SOURCES OF INFORMATION
U.S. Geological Survey Publications
Phosphate deposits. Ch. in United States Mineral
Resources, USGS Professional Paper 820, 1973.
Phosphate Rock. Ch. in Mineral Commodities Summaries,
annual.
1
Phosphate Rock. Reported monthly in Mineral Industry
Surveys.
1
Sedimentary phosphate resource classification system of the
U.S. Bureau of Mines and the U.S. Geological Survey, U.S.
Geological Survey Circular 882, 1982.
Other
The Fertilizer Institute, Washington, DC.
IMC Global Co. World Wide Web site at URL
http://www.imc-agrico.com
Inorganic Fertilizer Materials, U.S. Bureau of the Census,
quarterly and annual.
International Fertilizer Development Center, Muscle Shoals,
AL.
Office Cherifien des Phosphates, Casablanca, Morocco.
Phosphate Rock. Ch. in Minerals Facts and Problems, U.S.
Bureau of Mines Bulletin 675, 1985.
Stanford Research Institute, Menlo Park, CA.
U.S. Department of Agriculture, Economic Research
Service, Washington, DC.
———
Prior to January 1996, published by the U.S. Bureau of Mines.
1
TABLE 1
SALIENT PHOSPHATE ROCK STATISTICS 1/
(Thousand metric tons and thousand dollars unless otherwise specified)
1993 1992 1993 1994 1995 1996
United States:
Mine production (crude ore) 155,000 107,000 157,000 165,000 179,000
Marketable production 47,000 35,500 41,100 43,500 45,400
P2O5 content 14,100 10,700 12,100 12,800 13,300
Value $1,060,000 $759,000 $869,000 $947,000 $1,060,000
Average per metric ton 2/ $22.53 $21.38 $21.14 $21.75 $23.40
Sold or used by producers 3/ 45,100 40,100 43,900 43,700 43,500
P2O5 content 13,500 11,900 13,100 13,000 12,900
Value 4/ $1,020,000 $856,000 $929,000 $950,000 $1,020,000
Average, dollars per metric ton $22.53 $21.38 $21.14 $21.75 $23.40
Exports 5/ 3,720 3,200 2,800 2,990 1,570 6/
P2O5 content 1,200 1,020 886 875 NA
Value $120,000 $91,200 $71,700 $78,300 NA
Average, dollars per metric ton $32.29 $28.51 $25.60 $28.35 $35.82
Imports for consumption 1,530 534 620 7/ 1,080 e/ 7/ 1,800 e/ 7/
C.i.f. value $56,200 $32,300 $30,200 $55,200 e/ $104,000 e/
Average, dollars per metric ton $36.71 $60.45 $48.76 $51.01 $51.01 $57.91
Consumption 8/ 42,900 38,300 42,900 e/ 42,000 e/ 43,700 e/
Stocks, Dec. 31: Producers 12,600 9,220 5,980 5,710 6,390
World: Production 139,000 119,000 128,000 130,000 r/ 133,000 e/
e/ Estimated. r/ Revised. NA Not available.
1/ Data are rounded to three significant digits.
2/ Average value based on the sold or used values.
3/ Includes domestic sales and exports.
4/ Total value of all domestic and export sales.
5/ Exports reported to the U.S. Geological Survey by companies.
6/ Source: Bureau of the Census.
7/ Some phosphate rock import tonnage and value were suppressed by the Bureau of the Census.
8/ Expressed as sold or used plus imports minus exports. Includes some estimated phosphate rock tonnage imported from Morocco not
reported by the Bureau of the Census in 1994, 1995, and 1996.
TABLE 2
PRODUCTION OF PHOSPHATE ROCK IN THE UNITED STATES, BY REGION 1/
(Thousand metric tons and thousand dollars)
Marketable production
Mine production
(crude ore) Beneficiated Ending
P2O5 P2O5 stocks,
Period/region Rock content Rock content Value 2/ rock
1995 165,000 25,300 43,500 12,800 947,000 5,710
1996:
January-June:
Florida and North Carolina 84,600 11,900 19,900 5,890 464,000 4,730
Idaho and Utah 4,960 1,130 2,790 733 58,000 2,150
Total 89,500 13,100 22,700 6,630 522,000 6,880
July-December:
Florida and North Carolina 85,100 9,740 19,300 5,680 464,000 4,700
Idaho and Utah 3,880 997 3,430 997 77,200 1,690
Total 89,000 10,700 22,700 6,680 541,000 6,390
Grand total 179,000 23,800 45,400 13,300 1,060,000 XX
XX Not applicable.
1/ Data are rounded to three significant digits; may not add to totals shown.
2/ Average value based on the sold or used values.
TABLE 3
PHOSPHATE ROCK SOLD OR USED BY PRODUCERS
IN THE UNITED STATES, BY GRADE AND REGION 1/
(Thousand metric tons and thousand dollars)
U.S. total
Period and grade P2O5
(percent BPL 2/ content Rock content Value 3/
January-June 1995 22,100 6,530 452,000
July-December 1995 21,600 6,440 498,000
Total 43,700 13,000 950,000
January-June 1996:
66 to less than 70 13,900 4,200 310,000
60 to less than 66 5,520 1,560 118,000
Other 4/ 1,800 559 58,100
Total 21,200 6,320 486,000
July-December 1996:
66 to less than 70 W W W
60 to less than 66 18,600 5,460 439,000
Other 4/ 3,780 1,150 92,600
Total 22,400 6,610 532,000
Grand total 43,500 12,900 1,020,000
Florida and North Carolina 38,100 11,300 902,000
Idaho and Utah 5,460 1,620 116,000
W Withheld to avoid disclosing company proprietary data; included
with "Other."
1/ Data are rounded to three significant digits; may not add to totals
shown.
2/ 1.0% BPL (bone phosphate of lime or tricalcium phosphate) =
0.458% P2O5.
3/ F.o.b. mine.
4/ Includes below 60 and 70 to greater than 74% BPL content.
TABLE 4
PHOSPHATE ROCK SOLD OR USED BY PRODUCERS
IN THE UNITED STATES, BY USE AND REGION 1/
(Thousand metric tons)
Region United States
Florida and
North Carolina Idaho and Utah Total
P2O5 P2O5 P2O5
Period and use Rock content Rock content content Rock content
1995 38,100 11,400 5,620 1,600 43,700 13,000
1996:
January-June:
Domestic:
Agricultural 17,600 5,270 1,530 442 19,100 5,720
Industrial 36 12 1,010 287 1,050 299
Subtotal 17,600 5,290 2,530 729 20,200 6,020
Exports: 2/ 955 302 -- -- 955 302
Total 18,600 5,590 2,530 729 21,200 6,320
July-December:
Domestic:
Agricultural 18,900 5,560 1,560 523 20,500 6,080
Industrial W W 1,370 368 W W
Subtotal W W 2,930 891 W W
Exports: 2/ W W -- -- W W
Total 19,400 5,720 2,930 891 22,400 6,610
Grand total 38,100 11,300 5,460 1,620 43,500 12,900
W Withheld to avoid disclosing company proprietary data; included in "Total."
1/ Data are rounded to three significant digits; may not add to totals shown.
2/ Exports reported to the U.S. Geological Survey by companies.
TABLE 5
VALUE OF U.S. PHOSPHATE ROCK, BY GRADE
(Dollars per metric ton, f.o.b. mine)
Grade 1995 1996
(percent BPL 1/ content) Domestic Export Average Domestic Export Average
74 or more -- -- -- W -- W
72 to less than 74 30.40 32.97 31.30 W W W
70 to less than 72 22.88 29.74 26.64 W W W
66 to less than 70 20.90 25.55 21.15 22.29 30.14 22.62
60 to less than 66 22.15 -- 22.15 23.00 W 23.14
Less than 60 17.02 -- 17.02 W -- W
Weighted average 21.29 28.35 21.75 22.90 35.82 23.40
W Withheld to avoid disclosing company proprietary data.
1/ 1.0% BPL (bone phosphate of lime or tricalcium phosphate) = 0.458% P2O5.
TABLE 6
U.S. EXPORTS OF GROUND AND
UNGROUND PHOSPHATE ROCK 1/
(Thousand metric tons)
Quantity
Country 1995 1996
Australia 211 132
Belgium 268 --
Canada 137 12
India 359 223
Japan 463 269
Korea, Republic of 993 724
Netherlands 270 57
New Zealand 128 71
Other 161 81
Total 2,990 1,570
1/ Data are rounded to three significant digits;
may not add to totals shown.
Source: Bureau of the Census.
TABLE 7
U.S. EXPORTS OF SUPERPHOSPHATES
(CONCENTRATED)
(Thousand metric tons)
Quantity
Country 1995 1996
Argentina 19 1
Australia 202 267
Bangladesh 21 --
Brazil 34 76
Canada 18 19
Chile 108 141
Japan 58 38
Peru -- 18
Uruguay 15 13
Other 239 109
Total 714 681
Source: Bureau of the Census.
TABLE 8
U.S. EXPORTS
OF DIAMMONIUM PHOSPHATE
(Thousand metric tons)
Quantity
Country 1995 1996 2/
Argentina 232 402
Australia 438 599
Belgium 103 --
Brazil 59 29
Canada 80 119
Chile 41 51
China 5,600 3,880
Colombia 130 68
Dominican Republic 47 37
Ecuador 69 32
France 35 --
Germany 53 32
Guatemala 9 24
India 1,110 245
Iran 270 --
Japan 501 421
Kenya 11 54
Mexico 40 149
New Zealand 182 181
Pakistan 194 569
Thailand 160 244
Turkey 157 17
Uruguay 69 107
Other 474 660
Total 10,100 7,920
1/ Data are rounded to three significant digits; may
not add to totals shown.
2/ Data under review by Bureau of the Census.
Source: Bureau of the Census.
TABLE 9
U.S. EXPORTS OF
MONOAMMONIUM PHOSPHATE 1/
(Thousand metric tons)
Quantity
Country 1995 1996
Australia 182 318
Brazil 77 166
Canada 505 542
Chile 44 59
Colombia 74 69
Guatemala 27 24
Japan 131 104
Mexico 52 101
New Zealand 14 --
Thailand 8 44
Other 90 84
Total 1,200 1,510
1/ Data are rounded to three significant digits; may
not add to totals shown.
Source: Bureau of the Census.
TABLE 10
U.S. EXPORTS OF
PHOSPHORIC ACID 1/
(Thousand metric tons)
Quantity
Country 1995 1996
Australia 1 122
Canada 137 73
India 157 130
Indonesia 36 --
Venezuela 61 60
Other 183 185
Total 575 570
1/ Excludes superphosphoric acid tonnage.
Source: Bureau of the Census as adjusted by
the U.S. Geological Survey.
TABLE 11
U.S. EXPORTS OF ELEMENTAL PHOSPHORUS 1/
1995 1996
Quantity Value 2/ Quantity Value 2/
Country (metric tons) (thousands) (metric tons) (thousands)
Brazil 98 $202 3 $5
Canada 682 1,230 1,250 2,370
Japan 7,310 13,600 4,760 9,570
Korea, Republic of 194 432 30 57
Mexico 5,280 8,130 6,250 12,500
Netherlands 40 99 40 108
Other 149 345 281 948
Total 13,700 24,100 12,600 25,500
1/ Data are rounded to three significant digits; may not add to totals shown.
2/ F.a.s. values.
Source: Bureau of the Census.
TABLE 12
U.S. IMPORTS FOR CONSUMPTION OF PHOSPHATE ROCK AND
PHOSPHATIC MATERIALS 1/
(Thousand metric tons and thousand dollars)
1995 1996
Phosphatic materials Quantity Value 2/ Quantity Value 2/
Natural calcium phosphates, unground 618 32,800 575 33,100
Natural calcium phosphates, ground 56 3,140 (3/) 117
Dicalcium phosphate 3 4,660 4 5,530
Phosphorus 2 r/ 3,920 r/ 1 3,280
Normal superphosphate (3/) 57 (3/) 33
Triple superphosphate 25 4,720 83 7,650
Diammonium phosphate 21 6,010 77 18,300
Fertilizer containing nitrates and phosphates 51 6,490 69 12,300
Phosphoric acid 1 548 32 7,010
r/ Revised.
1/ Data are rounded to three significant digits.
2/ Declared c.i.f values.
3/ Less than 1/2 unit.
Source: Bureau of the Census as adjusted by the U.S. Geological Survey.
TABLE 13
PHOSPHATE ROCK ANNUAL
WORLD PRODUCTION CAPACITY,
DECEMBER 31, 1996
(Thousand metric tons per year)
Region/country Capacity Percent
United States 51,000 31
Africa 45,700 28
Asia 28,800 17
Western Europe and
the Former U.S.S.R. 20,900 13
Middle East 12,400 8
Latin America 5,300 3
Oceania 1,300 1
World total 1/ 165,000 100
1/ Data may not add to totals shown because of
independent rounding.
Sources: International Fertilizer Industry Association
and the U.S. Geological Survey.
TABLE 14
PHOSPHATE ROCK, BASIC SLAG, AND GUANO: WORLD PRODUCTION, BY COUNTRY 1/ 2/
(Thousand metric tons)
Commodity and Gross weight P2O5 content
country 3/ 1992 1993 1994 1995 1996 e/ 1992 1993 1994 1995 1996 e/
Phosphate rock:
Albania e/ 2 2 2 2 2 (4/) (4/) (4/) (4/) (4/)
Algeria 1,136 718 738 757 760 340 e/ 220 e/ 226 232 230
Australia 2 2 2 e/ 2 e/ 2 (4/) (4/) (4/) e/ (4/) e/ (4/)
Brazil 2,825 r/ 3,419 r/ 3,937 r/ 3,590 r/ 3,600 650 700 700 700 e/ 700
Chile 18 15 10 10 e/ 10 5 4 3 3 e/ 3
China e/ 21,400 21,200 24,100 r/ 19,300 r/ 21,000 6,400 6,350 7,430 r/ 5,790 r/ 6,300
Colombia e/ 32 5/ 45 5/ 48 5/ 50 50 7 9 10 11 11
Egypt e/ 2,000 5/ 1,585 5/ 1,500 1,500 1,500 500 390 390 390 390
Finland 555 628 647 671 600 201 227 236 244 216
India e/ 488 5/ 969 5/ 1,176 5/ 1,250 1,300 132 262 318 338 351
Indonesia e/ 8 7 7 8 8 2 2 2 2 2
Iraq e/ 6/ 600 800 1,000 1,000 1,000 180 240 300 300 300
Israel 6/ 3,595 3,680 3,961 4,063 3,800 1,130 e/ 1,148 1,232 1,264 1,140
Jordan 4,296 4,129 4,217 4,984 5,350 1,410 e/ 1,367 1,399 1,655 1,820
Kazakstan e/ 7,000 4,000 2,000 2,200 500 1,750 1,000 500 550 125
Korea, North e/ 500 510 510 520 520 160 163 163 164 164
Mexico 7/ 515 237 533 622 r/ 625 160 e/ 72 156 180 183
Morocco 8/ 19,145 18,193 19,764 20,200 20,800 6,180 e/ 5,778 6,274 6,381 6,550
Nauru 747 634 613 496 510 5/ 288 244 233 190 194 5/
Netherlands
Antilles e/ 15 10 15 -- r/ -- 5 3 5 -- r/ --
Pakistan e/ 20 5/ 14 5/ 15 5/ 10 r/ 5/ 10 6 4 3 r/ 2 r/ 2
Peru 37 37 37 37 e/ 37 12 12 12 12 e/ 12
Philippines e/ 5 5/ 92 5/ 20 20 20 2 31 7 7 7
Russia e/ 11,500 9,400 8,000 8,800 8,500 4,000 3,300 2,800 3,000 2,900
Senegal e/ 9/ 2,284 5/ 1,667 5/ 1,587 r/ 5/ 1,500 r/ 1,600 830 606 576 r/ 545 r/ 600
South Africa 3,080 2,466 2,545 2,790 2,700 1,170 e/ 962 995 1,087 1,000
Sri Lanka e/ 26 5/ 36 5/ 32 5/ 32 32 6 12 11 11 11
Syria 1,266 931 1,203 1,551 2,000 395 e/ 286 371 477 615
Tanzania e/ 5 r/ 5/ 4 r/ 5/ -- r/ -- r/ -- 2 r/ e/ 1 r/ e/ -- r/ -- r/ --
Thailand 8 11 8 r/ 9 r/ 9 2 3 2 r/ 3 3
Togo e/ 2,083 5/ 1,794 r/ 5/ 2,149 r/ 5/ 2,560 r/ 2,600 760 540 5/ 800 720 720
Tunisia 6,400 5,500 5,699 7,241 7,100 1,890 e/ 1,647 1,712 2,182 2,080
Turkey 65 78 -- r/ -- r/ -- 20 24 -- r/ -- r/ --
United States 47,000 35,500 41,100 43,500 45,400 14,100 10,700 12,100 12,800 13,300
Venezuela 10 -- 99 r/ 86 r/ 203 p/ 3 -- 27 r/ 23 r/ 55 p/
Vietnam e/ 290 5/ 363 5/ 470 5/ 480 480 93 116 144 145 145
Zimbabwe,
concentrate 142 153 151 154 r/ 123 5/ 42 45 45 45 e/ 39
Total 139,000 119,000 128,000 130,000 r/ 133,000 42,800 36,500 39,200 r/ 39,400 r/ 40,200
See footnotes at end of table.
TABLE 14--Continued
PHOSPHATE ROCK, BASIC SLAG, AND GUANO: WORLD PRODUCTION, BY COUNTRY 1/ 2/
(Thousand metric tons)
Commodity and Gross weight P2O5 content
country 3/ 1992 1993 1994 1995 1996 e/ 1992 1993 1994 1995 1996 e/
Basic (Thomas
converter) slag:
Egypt e/ 8 8 8 8 8 2 2 2 2 2
France 356 253 155 140 r/ e/ 150 64 46 28 18 r/ e/ 27
Germany 120 110 134 125 e/ 125 18 16 20 19 e/ 19
Luxembourg e/ 519 5/ 555 5/ 472 5/ 500 500 93 100 85 75 75
Total 1,000 926 769 773 r/ e/ 783 177 164 135 114 r/ e/ 123
Guano:
Chile (4/) -- -- -- -- (4/) e/ -- -- -- --
Philippines e/ (4/) 5/ 5 5/ 5 5 5 (4/) 2 2 2 2
Total e/ 1 5/ 5 5/ 5 5 5 (4/) 2 2 2 2
e/ Estimated. p/ Preliminary. r/ Revised.
1/ Table includes data available through May 8, 1997. Data for major phosphate rock-producing countries derived in part from the International Fertilizer Industry Association; other figures are from official country
sources where available.
2/ World totals, U.S. data, and estimated data are rounded to three significant digits; may not add to totals shown.
3/ In addition to the countries listed, Belgium may have produced small quantities of phosphate rock and Namibia may have produced small quantities of guano, but output is not officially reported; available
information is inadequate for formulation of reliable estimates of output levels.
4/ Less than 1/2 unit.
5/ Reported figure.
6/ Beneficiated.
7/ Includes only output used to manufacture fertilizers.
8/ Production from Western Sahara area is included.
9/ Does not include aluminum phosphate production, gross weight estimated at 75,000 metric tons per year.
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Health Effects of Drinking Water Contamination


About 14.1 million Americans routinely consume drinking water containing pesticides,
including the weed killers, atarzine, alachlor, and simazine. People in 121 Midwestern
towns and cities face an elevated risk of cancer as a result of drinking water containing
five farm pesticides.
Drinking Water in Midwest Has Pesticides, report says, The New York Times, October
18, 1994. "This study is another in a series of wake-up calls that tells us we can no longer
take for granted that our drinking water is safe all the time," says Carol M. Browner,
Administrator, USEPA.
Water is the foundation that human survival is built on. Therefore, we must take all
threats to our drinking water supply seriously. Farm runoff containing agricultural
chemicals and manure may lead to contamination of drinking water supplies with
fungicide, insecticides, herbicides, and fertilizers, containing phosphorous and nitrogen.
David Ozonoff, Chairman, Environmental Health Department, Boston University:" I
think the problem today is that turning on your tap is an act of faith, and I'm not sure that
that act of faith is particularly well- placed." If you drink from the tap, there are several
recent studies you should know about because they may change the way you think about
your water.
Emerging evidence Indicates that fertilizers in water supplies may cause cancer. Studies
in China involving populations exposed to nitrates in their drinking water have suggested
links between nitrate contamination and stomach and liver cancer. Further study of this
potential carcinogen is strongly indicated. A study in New Jersey found evidence of
association between volatile organic compounds in drinking water and leukemia. A
national study, found evidence of increased rates of cancer in the vicinity of hazardous
waste sites. Another study in Woburn, Massachusetts, associated hazardous waste
disposal with increased rates of leukemia.
Effects Drinking Water Distribution Systems on Cancer Rates
The chemicals used in pipes, and joints, may contaminate drinking water after it has been
treated. The many different materials used in these delivery systems result in varied
contamination sources. Copper, tar, asphalt iron, zinc, coal, polyethylene, concrete,
polyvinyl chloride, vinyl, asbestos and lead are all possible sources of post-treatment,
contamination. Another recent study showed an association between leukemia and
trichlorethylene, which came from plastics used in the drinking water delivery system. A
1979 study of several water systems demonstrated an increase in the cancer causing
properties of drinking water after passing through the water delivery system.
A new book, "Our Stolen Future", deals with the disastrous health effects from chemicals
present in large numbers in pesticides, plastics, and industrial processes. The book,
contains a foreword by Vice President Al Gore. It discusses the various and serious
effects these industrial chemicals have on humans and the environment. The book shifts
the debate from the chemicals' potential of causing cancer to their effect on the bodies
hormone systems. "The evidence is here, and the weight of evidence is powerful. This is
enough to wake people up," Theo Colburn, a scientist with the World Wildlife Fund and
co-author of the book, told Reuters News Service. Ten scientists from universities and
hospitals, the Centers for Disease Control and Prevention, the National Academy of
Science called for an intense research effort on these chemicals that seem to lower sperm
counts in men. Evidence shows that men's sperm counts have dropped worldwide since
these chemicals were introduced in the late 1930s. These chemicals also seem to disrupt
other human reproductive and metabolic functions, "Given the environmental, economic
and biological impact of endocrine- disrupting chemicals, difficult decisions regarding
the abatement of health hazards are necessary," Christopher DeRosa, director of the
Health and Human Services Department's Division of Toxicology.
Another area of current concern is centered on the potential for micropollutants to cause
cancer through chemicals that mimic naturally occurring, biologically active compounds.
These substances appear to disrupt intercellular communications. For Example: Nonyl-
phenol, a common chemical , increases proliferation in breast tumor cell cultures.
Zoologist Theo Colborn of the World Wildlife Fund and her co-workers have compiled a
list of 42 chemicals or classes of chemicals that have been reported to affect the
reproductive or hormone system.
Studies were performed in the mid-1980's after high levels of a common industrial
chemical solvent called tetrachloroethylene, or perc was found in the water supplies of
several Massachusetts towns. The studies found the chemical increased the risk of
leukemia and bladder cancer by up to 9 times normal. This same chemical has been
showing up, at lower levels, in a quarter of the water samples around the country.
Even if a city's water passes muster, residential supplies can be contaminated in houses
with lead pipes or plastic pipes that emit volatile compounds or in homes supplied by
private well water that is taken near a landfill site.
The contamination of water is directly related to the degree of contamination of our
environment. Rainwater flushes airborne pollution from the skies, and then washes over
the land before running into the, rivers, aquifers, and lakes that supply our drinking-
water. All of the chemicals generated by man will eventually end up in our water
supplies.
Under conditions of average temperature, humidity, and activity, the human body loses
and, therefore, must replace about 2.3 liters of water each day. Two-thirds of this
consumption is in the form of water or some otherbeverage. Concerns about the health
risks or taste of drinking water may induce those who consume tap water to shift to
bottled water, or other beverages. These beverages may include sweetened soft drinks
and alcoholic beverages, which can pose health risks greater than those associated with
drinking water. In addition, the production and disposal of containers for alternative
beverages, including bottled water, may lead to the release of carcinogens.
According to a report sponsored by Ralph Nader, at least 2,110 contaminants have been
identified in the nation's drinking water supplies. The contaminants not regulated may be
present in drinking water. Further, contaminants such as Lead, Asbestos, and
Trihalomethanes could occur in your water supply after the water leaves the public water
treatment plant. For these reasons, millions of people throughout the world are looking
for alternatives to drinking tap water.

August, 2008 (Revised)
1
RULES
OF
TENNESSEE DEPARTMENT OF ENVIRONMENT AND CONSERVATION
BUREAU OF ENVIRONMENT
DIVISION OF WATER SUPPLY

CHAPTER 1200-5-1
PUBLIC WATER SYSTEMS

TABLE OF CONTENTS

1200-5-1-.01 Authority 1200-5-1-.23 Reserved
1200-5-1-.02 Purpose 1200-5-1-.24 Sodium Monitoring
1200-5-1-.03 Scope 1200-5-1-.25 Volatile Organic Chemicals
1200-5-1-.04 Definitions 1200-5-1-.26 Volatile Organic Chemical Sampling Analytical
1200-5-1-.05 Supervision of Design and Construction and Other Requirements
1200-5-1-.06 Maximum Contaminant Levels 1200-5-1-.27 Reserved
1200-5-1-.07 Monitoring and Analytical Requirements 1200-5-1-.28 Reserved
1200-5-1-.08 Turbidity Sampling and Analytical Requirements 1200-5-1-.29 Use of Non-Centralized Treatment Devices
1200-5-1-.09 Inorganic Chemical Sampling and Analytical 1200-5-1-.30 Reserved
Requirements 1200-5-1-.31 Filtration and Disinfection
1200-5-1-.10 Organic Chemical Sampling and Analytical 1200-5-1-.32 Fees for Public Water Systems
Requirements 1200-5-1-.33 Control of Lead and Copper
1200-5-1-.11 Radionuclide Sampling 1200-5-1-.34 Drinking Water Source Protection
1200-5-1-.12 Secondary Drinking Water Regulations 1200-5-1-.35 Consumer Confidence Reports
1200-5-1-.13 Alternative Analytical Techniques 1200-5-1-.36 Disinfectant Residuals, Disinfection Byproducts,
1200-5-1-.14 Laboratory Certification and Disinfection Byproduct Precursors
1200-5-1-.15 Monitoring of Consecutive Public Water Systems 1200-5-1-.37 Stage 2 Initial Distribution System Evaluation For
1200-5-1-.16 Siting Requirements Disinfection Byproducts
1200-5-1-.17 Operation and Maintenance Requirements 1200-5-1-.38 Stage 2 Disinfection Byproducts Requirements
1200-5-1-.18 Reporting Requirements (LRAA)
1200-5-1-.19 Notification of Customers 1200-5-1-.39 Enhanced Treatment For Cryptosporidium
1200-5-1-.20 Record Maintenance 1200-5-1-.40 Ground Water Rule
1200-5-1-.21 Monitoring For Corrosivity Chacteristics
1200-5-1-.22 Reserved

1200-5-1-.01 AUTHORITY.

(1) These Rules and Regulations are issued under the authority of Public Acts of 1983, Chapter
324.

(2) The Division of Water Supply is responsible for the supervision of public water systems.

Authority: T.C.A. §§ 4-5-201 et seq. and 68-221-701 et seq. Administrative History: Original rule
certified June 7, 1974. Repeal and new rule filed June 30, 1977; effective August 1, 1977. Amendment
filed February 3, 1984; effective February 12, 1985. Amendment filed September 26, 1988; effective
November 10, 1988.

1200-5-1-.02 PURPOSE.

(1) The purpose of these Rules and Regulations is to provide guidelines for the interpretation of
§68-221-701 et seq. of the Tennessee Code Annotated and to set out the procedures to be
followed by the Department in carrying out the State’s primary enforcement responsibility
under the Federal Safe Drinking Water Act. These Rules and Regulations set out the
requirements which agents, employees or representatives of public water systems must meet
in the following areas: in the preparation and submission of plan documents for public water
systems; in the supervision of all phases of construction; in supplying safe drinking water
meeting all applicable maximum contaminant levels or treatment technique requirements; in
providing adequate operation and maintenance of the system; and in complying with
procedural requirements for appealing orders issued by the Commissioner of the Tennessee
Department of Health and Environment against a public water system.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

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August, 2008 (Revised)
2

(2) Where the terms shall and must are used, practice and usage is sufficiently standardized to
indicate a mandatory requirement, insofar as any complaint action by the Department is
concerned. Other items, such as should, recommend, preferred, and the like, indicate
desirable procedures or methods.

Authority: T.C.A. §§4-5-201 et seq., 4-5-202, and 68-221-701 et seq. Administrative History: Original
rule certified June 7, 1974. Repeal and new rule filed June 30, 1977; effective August 1, 1977.

1200-5-1-.03 SCOPE.

These rules will apply to all public water supply systems that provide water for human consumption
through pipes or other constructed conveyances, if such system has at least fifteen (15) service
connections or regularly serves an average of at least twenty–five (25) individuals daily at least sixty (60)
days out of the year. A public water supply system is either a community water system or a non–
community water system. A community water system is a public water supply system which serves at
least fifteen (15) service connections used by year-round residents or regularly serves at least twenty–five
(25) year–round residents. A non–community water system is a public water supply system that is not a
community water system and which generally serves a transient population such as hotels, motels,
restaurants, camps, service stations churches, industry, etc. A Non-Transient Non–Community Water
System is a non–community water system that regularly serves at least 25 of the same persons over six
(6) months per year. These rules do not apply to public water systems which meet all of the following
criteria:

(1) consists only of distribution and storage facilities (and does not have any collection and
treatment facilities);

(2) obtains all of its water from, but is not owned or operated by, a public water system to which
such regulations apply;

(3) does not sell water to any person; and

(4) is not a carrier which conveys passengers in interstate commerce.

Authority: T.C.A. §§4-5-202, 68-221-701 et seq., and 68-221-704. Administrative History: Original
rule certified June 7, 1974. Repeal and new rule filed June 30, 1977; effective August 1, 1977.
Amendment filed February 3, 1984; effective February 12, 1985. Amendment filed September 26, 1988;
effective November 10, 1988. Repeal and new rule filed August 15, 2005; effective October 29, 2005.

1200-5-1-.04 DEFINITIONS.

(1) "Action level" is the concentration of lead or copper in water which may determine the
treatment requirements that a water system is required to complete.

(2) “Bag Filters” are pressure-driven separation devices that remove particulate matter larger
than 1 micrometer using an engineered porous filtration media. They are typically
constructed on a non-rigid fabric filtration media housed in a pressure vessel in which the
direction of flow is from the inside of the bag to outside.

(3) “Bank Filtration” is a water treatment process that uses a well to recover surface water that
has naturally infiltrated into ground water through a river bed or bank(s). Infiltration is
typically enhanced by the hydraulic gradient imposed by nearby pumping water supply or
other wells.

(4) “Benchmark” A disinfection benchmark is the lowest monthly average value of the monthly
logs of Garidia Lamblia inactivation.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

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August, 2008 (Revised)
3

(5) “Business Plan” means a document which identifies source(s) of income or revenue
sufficient to meet expenses over a three (3) year period. The business plan will identify
costs related to retaining a certified operator, estimated annual infrastructure repair costs,
depreciation, facility maintenance fees, estimated annual monitoring costs, estimated costs
of providing public notices, estimated administrative costs, and any and all other
operational, treatment, and related costs (e.g. chemicals and other supplies used to treat
water, etc.). The business plan must include the re-payment of borrowed and amortized
funds.

(6) “Capacity Development Plan” means a document(s) identifying what actions a public water
system is taking or shall take to become a “viable water system.” Such plan shall include
information concerning retention of a Certified Operator in direct charge; system ownership
and accountability; staffing and organizational structure; fiscal management and controls,
source water assessment and protection plan; “business plan;” and any and all other
information identifying any further action that shall be taken.

(7) “Cartridge filters” are pressure-driven separation devices that remove particulate matter
larger than 1 micrometer using an engineered porous filtration media. They are typically
constructed a rigid or semi-rigid self-supporting filter elements housed in pressure vessels in
which flow is from the outside of the cartridge to the inside.

(8) "Coagulation" means a process using coagulant chemicals and mixing by which colloidal
and suspended materials are destabilized and agglomerated into flocs.

(9) “Combined distribution system” is the interconnected distribution system consisting of the
distribution systems of wholesale systems and of the consecutive systems that receive
finished water.

(10) "Community Water System" means a public water system which serves at least fifteen (15)
service connections used by year-round residents or regularly serves at least twenty-five
(25) year-round residents.

(11) "Compliance cycle" means the nine-year calendar year cycle during which public water
systems must monitor for certain contaminants. Each compliance cycle consists of three
three-year compliance periods. The first calendar year cycle begins January 1, 1993 and
ends December 31, 2001; the second begins January 1, 2002 and ends December 31,
2010; the third begins January 1, 2011 and ends December 31, 2019.

(12) "Compliance period" means a three year calendar year period within a compliance cycle.
Each compliance cycle has three three-year compliance periods. Within the first
compliance cycle, the first compliance period runs from January 1, 1993 to December 31,
1995; the second from January 1, 1996 to December 31, 1998; the third from January 1,
1999 to December 31, 2001.

(13) “Comprehensive performance evaluation (CPE)” is a thorough review and analysis of a
treatment plant’s performance-based capabilities and associated administrative, operation
and maintenance practices. It is conducted to identify factors that may be adversely
impacting a plant’s capability to achieve compliance and emphasizes approaches that can
be implemented without significant capital improvements. For purposes of compliance, the
comprehensive performance evaluation must consist of at least the following components:
assessment of plant performance; evaluation of major unit processes; identification and
prioritization of performance limiting factors; assessment of the applicability of
comprehensive technical assistance; and preparation of a CPE report.

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.04, continued)
August, 2008 (Revised)
4
(14) "Confluent growth" means a continuous bacterial growth covering the entire filtration area of
a membrane filter, or a portion thereof, in which bacterial colonies are not discrete.

(15) "Connection" means the point at which there is a meter or service tap if no meter is present.

(16) “Consecutive system is a public water system that receives some or all of its finished water
from one or more wholesale systems. Delivery may be through a direct connection or
through the distribution system of one or more consecutive systems.

(17) "Contaminant" means any physical, chemical, biological, or radiological substance or matter
in water.

(18) "Conventional filtration treatment" means a series of processes including coagulation,
flocculation, sedimentation, and filtration resulting in substantial particulate removal.

(19) "Corrosion inhibitor" means a substance capable of reducing the corrosivity of water toward
metal plumbing materials, especially lead and copper, by forming a protective film on the
interior surface of those materials.

(20) "CT" or "CTcalc" is the product of "residual disinfectant concentration" (C) in mg/1
determined before or at the first customer, and the corresponding "disinfectant contact time"
(T) in minutes, i.e., "C" x "T". If a public water system applies disinfectants at more than one
point prior to the first customer, it must determine the CT of each disinfectant sequence
before or at the first customer to determine the total percent inactivation or "total inactivation
ratio". In determining the total inactivation ratio, the public water system must determine the
residual disinfectant concentration of each disinfection sequence and corresponding contact
time before any subsequent disinfection application point(s). "CT
99.9
" is the CT value
required for 99.9 percent (3-log) inactivation of Giardia lamblia cysts. CT
99.9
for a variety of
disinfectants and conditions appear in Tables 1.1-1.6, 2.1, and 3.1 of 1200-5-1-.31(5)(b)3.

CTcalc
CT
99.9

is the inactivation ratio. The sum of the inactivation ratios, or total inactivation ratio shown
as

(CTcalc)
(CT
99.9
)

is calculated by adding together the inactivation ratio for each disinfection sequence. A total
inactivation ratio equal to or greater than 1.0 is assumed to provide a 3-log inactivation of
Giardia lamblia cyst. Disinfectant concentrations must be determined by tracer studies or
an equivalent demonstration approved by the Department.

(21) "Department" when used in these regulations shall mean the Division of Water Supply,
Tennessee Department of Environment and Conservation, or one of the Division's Field
Offices. The terms "State," "Department," and "Division" are often used interchangeably in
these Rules and Regulations.

(22) "Diatomaceous earth filtration" means a process resulting in substantial particulate removal
in which (1) a precoat cake of diatomaceous earth filter media is deposited on a support
membrane (septum), and (2) while the water is filtered by passing through the cake on the
septum, additional filter media known as body feed is continuously added to the feed water
to maintain the permeability of the filter cake.

Σ
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.04, continued)
August, 2008 (Revised)
5
(23) "Direct filtration" means a series of processes including coagulation and filtration but
excluding sedimentation resulting in substantial particulate removal.

(24) "Disinfectant" means any oxidant, including but not limited to chlorine, chlorine dioxide,
chloramines, and ozone added to water in any part of the treatment or distribution process,
that is intended to kill or inactivate pathogenic microorganisms.

(25) "Disinfectant contact time" ("T" in CT calculations) means the time in minutes that it takes
for water to move from the point of disinfectant application or the previous point of
disinfectant residual measurement to a point before or at the point where residual
disinfectant concentration ("C") is measured. Where only one "C" is measured, "T" is the
time in minutes that it takes for water to move from the point of disinfectant application to a
point before or at where residual disinfectant concentration ("C") is measured. Where more
than one "C" is measured, "T" is (a) for the first measurement of "C", the time in minutes
that it takes for water to move from the first or only point of disinfectant application to a point
before or at the point where the first "C" is measured and (b) for subsequent measurements
of "C", the time in minutes that it takes for water to move from the previous "C"
measurement point to the "C" measurement point for which the particular "T" is being
calculated. Disinfectant contact time in pipelines must be calculated based on "plug flow" by
dividing the internal volume of the pipe by the maximum hourly flow rate through that pipe.
Disinfectant contact time within mixing basins and storage reservoirs must be determined by
tracer studies or an equivalent demonstration.

(26) "Disinfection" means a process which inactivates pathogenic organisms in water by
chemical oxidants or equivalent agents.

(27) “Disinfection profile” is a summary of daily Giardia lamblia inactivation through the treatment
plant. The procedure for developing a disinfection profile is contained in 40CFR141.172.

(28) "Distribution System" means all water lines up to the point of a meter. For unmetered
systems distribution system includes all lines up to the customer's service tap.

(29) "Domestic or other non-distribution system plumbing problem" means a coliform
contamination problem in a public water system with more than one service connection that
is limited to the specific service connection from which the coliform-positive sample was
taken.

(30) "Dose Equivalent" means the product of the absorbed dose from ionizing radiation and such
factors as account for differences in biological effectiveness due to the type of radiation and
its distribution in the body as specified by the International Commission on Radiological
Units and Measurements (ICRU).

(31) “Dual sample set” is a set of two samples collected at the same time and same location,
with one sample analyzed for TTHM and the other sample analyzed for HAA5. Dual sample
sets are collected for the purposes of conducting an IDSE under the provisions of 1200-5-1-
.37 and determining compliance with the TTHM and HAA5 MCLs under the provisions of
1200-5-1-.38.

(32) "Effective corrosion inhibitor residual" for the purpose of the lead and copper rules only,
means a concentration sufficient to form a passivating film on the interior walls of a pipe.

(33) "Engineer" means the person or firm who designed the public water system and conceived,
developed, executed or supervised the preparation of the plan documents.

(34) “Enhanced coagulation” means the addition of sufficient coagulant for improved removal of
disinfection byproduct precursors by conventional filtration treatment
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.04, continued)
August, 2008 (Revised)
6

(35) “Enhanced softening” means the improved removal of disinfection byproduct precursors by
precipitative softening.

(36) “Filter profile” is a graphical representation of individual filter performance, based on
continuous turbidity measurements or total particle counts versus time for an entire filter run,
from startup to backwash inclusively, that includes an assessment of filter performance
while another filter is being backwashed.

(37) "Filtration" means a process for removing particulate matter from water by passage through
porous media.

(38) “Finished water” is water that is introduced into the distribution system of a public water
system and is intended for distribution and consumption without further treatment, except as
treatment necessary to maintain water quality in the distribution system (e.g., booster
disinfection, addition of corrosion control chemicals).

(39) "First draw sample" means a one-liter sample of tap water, for the purposes of the lead and
copper rules, that has been standing in plumbing pipes at least 6 hours and is collected
without flushing the tap.

(40) “Flocculation" means a process to enhance agglomeration or collection of smaller floc
particles into larger, more easily settleable particles through gentle stirring by hydraulic or
mechanical means.

(41) “Flowing stream” is a course of running water flowing in a definite channel.

(42) “GAC10” means granular activated carbon filter beds with an empty-bed contact time of 10
minutes based on average daily flow and a carbon reactivation frequency of every 180
days, except that the reactivation frequency for GAC10 used as best available technology
for compliance with disinfection byproducts shall be 120 days.

(43) “GAC20” means granular activated carbon filter beds with an empty-bed contact time of 20
minutes based on average daily flow and a carbon reactivation frequency of every 240
days.

(44) "Gross Alpha Particle Activity" means the total radioactivity due to alpha particle emission as
inferred from measurements on a dry sample.

(45) "Gross Beta Particle Activity" means the total radioactivity due to beta particle emission as
inferred from measurements on a dry sample.

(46) “Ground water under the direct influence of surface water” means any water beneath the
surface of the ground with significant occurrence of insects or other macroorganisms, algae,
or large-diameter pathogens such as Giardia lamblia or Cryptosporidium, or significant and
relatively rapid shifts in water characteristics such as turbidity, temperature, conductivity, or
pH which closely correlate to climatological or surface water conditions. Direct influence
must be determined for individual sources in accordance with criteria established by the
State. The State determination of direct influence may be based on site-specific
measurements of water quality and/or documentation of well construction characteristics
and geology with field evaluation.

(47) “Haloacetic acids (five) (HAA5)” mean the sum of the concentrations in milligrams per liter of
the haloacetic acid compounds (monochloroacetic acid, dichloroacetic acid, trichloroacetic
acid, monobromoacetic acid, and dibromoacetic acid), rounded to two significant figures
after addition.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.04, continued)
August, 2008 (Revised)
7

(48) "Halogen" means one of the chemical elements chlorine, bromine or iodine.

(49) “Human Consumption” - means the use of water that involves any drinking or ingestion of
the water by humans, any human skin contact or food preparation where the food is not
brought to boiling temperatures after contact with the water..

(50) "Initial compliance period" means the first full three-year compliance period which begins
January 1, 1993. For public water systems having fewer than 150 service connections initial
compliance period shall be January 2, 1996, for the following contaminants:

(a) Antimony (m) endrin
(b) Beryllium (n) glyphosate
(c) Cyanide (o) oxamyl
(d) Nickel (p) picloram
(e) Thallium (q) simazine
(f) dichloromethane (r) benzo(a)pyrene
(g) 1,2,4-trichlorobenzene (s) di(2ethylhexyl)adipate
(h) 1,1,2-trichloroethane (t) di(2ethylhexyl)phthalate
(i) dalapon (u) hexachlorobenzene
(j) dinoseb (v) hexachlorocyclopentadiene
(k) diquat (w) 2,3,7,8 TCDD
(l) endothall

(51) “Lake/reservoir” refers to a natural or man made basin or hollow on the earth’s surface in
which water collects or is stored that may or may not have a current or single direction of
flow.

(52) "Large water system" for the purpose of lead and copper rule, means a water system that
serves more than 50,000 persons.

(53) "Lead service line" means a service line made of lead which connects the water main to the
building inlet and any lead pigtail, gooseneck or other fitting which is connected to such lead
line.

(54) "Legionella" means a genus of bacteria, some species of which have caused a type of
pneumonia called Legionnaires Disease.

(55) “Locational running annual average (LRAA)” is the average of sample analytical results for
samples taken at a particular monitoring location during the previous four calendar quarters.

(56) "Man-Made Beta Particle and Photon Emitter" means all radionuclides emitting beta
particles and/or photons listed in "Maximum Permissible Body Burdens and Maximum
Permissible Concentration of Radionuclides in Air or Water for Occupational Exposure, NBS
Handbook 69", except the daughter products of thorium-232, uranium-235 and
uranium-238.

(57) "Maximum Contaminant Level" means the maximum permissible level of a contaminant in
water which is delivered at the free flowing outlet of the ultimate user of a public water
system, except in the case of turbidity where the maximum permissible level is measured at
the point of entry to the distribution system. Contaminants added to the water under
circumstances controlled by the user, except those resulting from corrosion of piping and
plumbing caused by water quality, are excluded from this definition.

(58) “Maximum residual disinfectant level (MRDL)” means a level of a disinfectant added for
water treatment that may not be exceeded at the consumer’s tap without an unacceptable
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.04, continued)
August, 2008 (Revised)
8
possibility of adverse health effects. For chlorine and chloramines, a PWS is in compliance
with the MRDL when the running annual average of monthly averages of samples taken in
the distribution system, computed quarterly, is less than or equal to the MRDL. For chlorine
dioxide, a PWS is in compliance with the MRDL when daily samples are taken at the
entrance to the distribution system and no two consecutive daily samples exceed the
MRDL. MRDLs are enforceable in the same manner as maximum contaminant levels under
Section 1412 of the Safe Drinking Water Act. There is convincing evidence that addition of
a disinfectant is necessary for control of waterborne microbial contaminants.
Notwithstanding the MRDLs, operators may increase residual disinfectant levels of chlorine
or chloramines (but not chlorine dioxide) in the distribution system to a level and for a time
necessary to protect public health to address specific microbiological contamination
problems caused by circumstances such as distribution line breaks, storm runoff events,
source water contamination, or cross-connections.

(59) "Maximum Total Trihalomethane Potential (MTP)" means the maximum concentration of
total trihalomethanes produced in a given water containing a disinfectant residual after 7
days at a temperature of 25°C or above.

(60) "Medium-size water system" for the purpose of the lead and copper rule means a water
system that serves greater than 3,300 and less than or equal to 50,000 persons.

(61) “Membrane filtration” is a pressure or vacuum driven separation process in which particulate
matter larger than 1 micrometer is rejected by an engineered barrier, primarily through a
size exclusion mechanism, and which has a measurable removal efficiency of a target
organism that can be verified through the application of a direct integrity test. This definition
includes the common membrane technologies of microfiltration, ultrafiltration, nanofiltration,
and reverse osmosis.

(62) "Near the first service connection" means at one of the twenty percent of all service
connections in the entire system that are nearest the water supply treatment facility, as
measured by the water transport time within the distribution system.

(63) "Non-Community Water System" means a public water system that is not a community
water system.

(64) "Non-Transient Non-Community Water System" or NTNCWS" means a non-community
water system that regularly serves at least twenty-five (25) of the same persons over six (6)
months per year.

(65) "Optimal corrosion control treatment" for the purpose of lead and copper rule only means
the corrosion control treatment that minimizes the lead and copper concentrations at user's
taps while insuring that the treatment does not cause the water system to violate any
primary drinking water regulation.

(66) "Person" means any individual, corporation, company, association, partnership, State,
municipality, utility district, water cooperative, or Federal agency.

(67) "Picocurie" (pCi) means that quantity of radioactive material producing 2.22 nuclear
transformations per minute.

(68) "Plan Documents" mean reports, proposals, preliminary plans, survey and basis of design
data, general and detailed construction plans, profiles, specifications and all other
information pertaining to public water system planning.

(69) “Plant intake” refers to the works or structures at the head of a conduit through which water
is diverted from a source (e.g., river or lake) into the treatment plant.
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(70) "Point of disinfectant application" is the point where the disinfectant is applied and water
downstream of that point is not subject to recontamination by surface water runoff.

(71) "Point-of-Entry Treatment Device" (POE) means a device applied to the drinking water
entering a house or building for the purpose of reducing contaminants in the drinking water
distributed throughout the house or building.

(72) "Point-of-Use Treatment Device" (POU) means a treatment device applied to a single tap
used for the purpose of reducing contaminants in drinking water at that one tap.

(73) ‘Presedimentation” is a preliminary treatment process used to remove gravel, sand and
other particulate material from the source water through settling before the water enters the
primary clarification and filtration processes in a treatment plant.

(74) "Primary Drinking Water Regulation" means a regulation promulgated by the Department
which:

(a) applies to public water systems;

(b) specifies contaminants which, in the judgment of the Department, may have any
adverse effect on the health of persons;

(c) specified for each such contaminant either;

1. a maximum contaminant level, if, in the judgment of the Department, it is
economically and technologically feasible to ascertain the level of such
contaminant in water in public water systems, or

2. if, in the judgment of the Department, it is not economically or technologically
feasible to so ascertain the level of such contaminant, each treatment
technique known to the Department which leads to a reduction in the level of
such contaminant sufficient to satisfy the requirements of Regulations
1200-5-1-.06; and

(d) contains criteria and procedures to assure a supply of drinking water which
dependably complies with such maximum contaminant levels; or treatment
techniques including quality control and testing procedures to insure compliance
with such levels and to insure proper operation and maintenance of the system, and
requirements to (i) the minimum quality of water which may be taken into the
system and (ii) siting for new facilities for public water systems.

(75) “Public Water System” means a system for the provision of piped water for human
consumption if such serves 15 or more connections or which regularly serves 25 or more
individuals daily at least 60 days out of the year and includes:

(a) any collection, treatment, storage or distribution facility under control of the operator of
such system and used primarily in connection with such system; and

(b) any collection or pre-treatment storage facility not under such control which is used
primarily in connection with such system,

The population of a water system shall be determined by actual count or by multiplying the
household factor by the number of connections in the system. The household factor shall be
taken from the latest federal census for that county or city. Water systems serving multi-
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

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10
family residences such as apartment complexes and mobile home parks shall include each
individual residence unit as a connection in determining the population for the system.

(76) "Rem" means the unit of dose equivalent from ionizing radiation to the total body or any
internal organ or organ system. A "millerem (mrem)" is 1/1000 of a rem.

(77) "Repeat compliance period" means any subsequent compliance period after the initial
compliance period.

(78) "Residual disinfectant concentration" ("C" in CT calculations) means the concentration of
disinfectant measured in mg/l in a representative sample of water.

(79) "Safe Drinking Water Act" means the Federal law codified in 42 United States Code 300f et.
seq., Public Law 93-523, dated December 16, 1974 and subsequent amendments..

(80) "Sanitary Survey" means an on-site review of the water source, facilities, equipment,
operation and maintenance of a public water system for the purpose of evaluating the
adequacy of such sources, facilities, equipment, operation and maintenance for producing
and distributing safe drinking water.

(81) "Secondary Drinking Water Regulation" mean a regulation promulgated by the Department
which applies to public water systems and which specifies the maximum contaminant levels
which, in the judgment of the Department are requisite to protect the public welfare. Such
regulations may apply to any contaminant in drinking water

(a) which may adversely affect the odor or appearance of such water and
consequently may cause the persons served by the public water system providing
such water to discontinue its use, or

(b) which may otherwise adversely affect the public welfare. Such regulations may
vary according to geographic and other circumstances.

(82) "Sedimentation" means a process for removal of solids before filtration by gravity or
separation.

(83) "Service line sample" means a one-liter sample of water collected in accordance with
1200-5-1-.33(7)(b)3., that has been standing for at least 6 hours in a service line.

(84) "Single family structure" for the purpose of lead and copper rules means a building
constructed as a single-family residence that is currently used as either a residence or a
place of business.

(85) "Slow sand filtration" means a process involving passage of a raw water through a bed of
sand at low velocity (generally less than 0.4 m/h) resulting in substantial particulate removal
by physical and biological mechanisms.

(86) "Small water system" for the purpose of the lead and copper rules only, means a water
system that serves 3,300 or fewer persons.

(87) “Subpart H systems” means public water systems using surface water or ground water
under the direct influence of surface water as a source that are subject to the requirements
1200-5-1-.31, .39 and 1200-5-1-.17.

(88) "Supplier of Water" means any person who owns or operates a public water system.

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(89) "Surface water" means all water which is open to the atmosphere and subject to surface
runoff.

(90) “SUVA” means Specific Ultraviolet Absorption at 254 nanometers (nm), an indicator of the
humic content of water. It is a calculated parameter obtained by dividing a sample’s
ultraviolet absorption at a wavelength of 254 nm (UV 254/ (in m) by its concentration of
dissolved organic carbon (DOC) (in mg/L).

(91) "System with a single service connection" means a system which supplies drinking water to
consumers via a single service line.

(92) "Too numerous to count" means that the total number of bacterial colonies exceeds 200 on
a 47 millimeter diameter membrane filter used for coliform detection.

(93) “Total Organic Carbon (TOC)” means total organic carbon in mg/L measured using heat,
oxygen, ultraviolet irradiation, chemical oxidants, or combinations of these oxidants that
convert organic carbon to carbon dioxide, rounded to two significant figures.

(94) "Total trihalomethane" (TTHM) means the sum of concentration in milligrams per liter of the
trihalomethane compounds-trihalomethane (chloroform), dibromochloromethane,
bromodichloro-methane and tribomomethane (bromoform), rounded to two significant
figures.

(95) “Transient Non-Community Water System” or “TNCWS” means a non-community water
system that regularly serves at least twenty-five (25) individuals daily at least sixty (60) days
out of the year. A transient non-community water system is a public water supply system
that generally serves a transient population such as hotels, motels, restaurants, camps,
service stations churches, industry, and rest stops.

(96) "Trihalomethane" (THM) means one of the family of organic compounds, named as
derivatives of methane, wherein three of the four hydrogen atoms in methane are each
substituted by a halogen atom in the molecular structure.

(97) “Two-stage lime softening” is a process in which chemical addition and hardness
precipitation occur in each of two distinct unit clarification processes.

(98) “Uncovered finished water storage facility” is a tank, reservoir, or other facility used to store
water that will undergo no further treatment except residual disinfection and is open to the
atmosphere.

(99) “Viable Water System” means a public water system which has the commitment and the
financial, managerial and technical capacity to consistently comply with the Tennessee Safe
Drinking Water Act and these regulations.

(100) "Virus" means a virus of fecal origin which is infectious to humans by waterborne
transmission.

(101) “Waterborne disease outbreak" means a significant occurrence of acute infectious illness,
epidemiologically associated with the ingestion of water from a public water system which is
deficient in treatment, as determined by the appropriate local or State agency.

(102) “Wholesale system” is a public water system that treats source water as necessary to
produce finished water and then delivers some or all of that finished water to another public
water system. Delivery may be through a direct connection or through the distribution
system of one or more consecutive systems.

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August, 2008 (Revised)
12
Authority: T.C.A. § 68-221-704 and 4-5-202. Administrative History: Original rule certified June 7,
1974. Repeal and new rule filed June 30, 1977; effective August 1, 1977. Amendment filed February 3,
1984; effective February 12, 1985. Amendment filed September 26, 1988; effective November 10, 1988.
Amendment filed November 26, 1990; effective January 10, 1991. Amendment filed August 24, 1992;
effective October 8, 1992. Amendment filed October 22, 1993, effective January 5, 1994. Amendment
filed April 12, 1996; effective June 26, 1996. Amendment filed February 17, 1999; effective May 3, 1999.
Amendment filed October 31, 2000; effective January 14, 2001. Amendment filed July 15, 2002; effective
September 28, 2002. Amendment filed December 30, 2002; effective March 15, 2003. Amendment filed
July 31, 2006; effective October 14, 2006. Amendment filed June 12, 2008; effective August 26, 2008.

1200-5-1-.05 SUPERVISION OF DESIGN AND CONSTRUCTION.

(1) Engineering - Plan documents for public water systems shall be submitted to the Department
at least thirty (30) days prior to the date on which action by the Department is desired.

(2) Expiration of Approval - Approval of engineering reports, proposals, preliminary plans, survey
and basis of design data shall be null and void after a period of one year from the date
stamped on the documents, unless the general and detailed plan documents have been
submitted to the Department. Approval of all other plan documents by the Department shall
be null and void after a period of one year from the date stamped on the plan documents,
unless the construction is either underway or completed.

(3) General Practice - All plan documents for public water system design and construction shall
present all information in conformance with accepted engineering practices and the “Design
Criteria for community Public Water Systems” as published by the Department.

(4) Revisions to Plan Documents - Any deviations from plan documents approved by the
Department, which affect location, sanitary and/or mineral quality, capacity, hydraulic
conditions, operating units, or the function of unit processes or distribution and storage, must
be approved in writing before such changes are made. Any revisions must be made on the
master work, i.e., the original tracings. Revised plan documents must be submitted in time to
permit the review and approval of such revisions before any construction which will be
affected by such revisions is begun.

(5) Copies of Plan Documents - Generally, only two copies of the engineering report and two
sets of the preliminary plans shall be required by the Department for review and/or approval.
At least four complete sets of the detailed plan documents shall be required for final review.
Upon the granting by the Department of its approval for construction the documents shall be
so stamped and two sets returned to the engineer’s office, one set forwarded to the
appropriate Field Office for filing or use in field inspection of construction, and one set
retained for the Department files. Upon completion of the project, one set of “As Built” plans
and one copy of the executed contract documents shall be submitted to the Department and
one set each to the owner. In addition, shop drawings, instruction manuals, etc., on all
equipment furnished by the project shall be compiled into one or more documents and given
to the owner.

(6) Supervision of Construction - One set of the plan document stamped “APPROVED FOR
CONSTRUCTION” shall be available at the job sites at all times during construction. The
engineer or a person qualified other than the contractor or his representative, and approved
by the public water system shall provide continuous adequate inspection during construction
to assure that all work is done in accordance with approved plan documents. The
Department’s representative shall have access to the project at any time during construction.
If the Department’s representative observes work being done in a manner that does not
conform to the approved plan documents, he shall have the authority, through the engineer’s
representative, the water system’s agent or directly to the contractor, to order the cessation
of all work affected by the nonconformity until such discrepancies are rectified.
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(7) Engineer’s Seal - Plan documents for non-transient non-community and community public
water systems shall be prepared by a person qualified under Section 62-2-101 et seq.,
Tennessee Code Annotated, and shall have the necessary professional seal affixed as
required by Section 62-2-306 of the Code.

(8) (a) Ownership and Operational Organization – No person shall operate a public water
system without notifying the Division of Water Supply prior to placing the new system in
operation. Any person operating a public water system other than an individual, a
municipality, any agency or instrumentality of the United States, any facility owned and
operated by the State of Tennessee, or any organization otherwise exempt by law must
have a charter or appropriate authorization lawfully issued as set forth in one or more of
the following:

Utility District – T.C.A. 7-82-101 et seq.
General Corporation Act – T.C.A. 48 -1-101 et seq.
Tennessee Regulatory Authority – T.C.A. 65-4-101 et seq.
Urban Type Public Facilities – T.C.A. 5-16-101 et seq.

(b) All public water systems shall comply with all laws, rules and regulations, and policies
of the Department. Construction modification and treatment processes must be
approved in accordance with all federally designated best available technologies and
Tennessee Laws. Every public water system shall, within thirty (30) days following any
change in ownership or operation of the system, file a written report of such change in
ownership or operation with the Department. Such report shall, at a minimum, contain
the name, home address, business address, and home and business phone numbers
of the person assuming ownership or operation of the system, and the date such
change of ownership or operation became effective.

(c) All persons owning or operating a public water system shall keep the Department
advised of their current address and must readily accept all mail sent to them by the
Department. For purposes of this Rule, registered or certified mail sent with proper
postage to the registered owner or operator’s last known address shall be considered
adequate notification regardless of whether is accepted or returned unclaimed.

(d) Because of the Department’s statutory duty to supervise the construction, operation,
and maintenance of public water systems, and because written communication is a
necessary aspect of such supervision, an owner or operator’s refusal to accept mail or
failure to claim registered or certified mail is a violation of this Chapter and may result
in enforcement action.

(9) Interconnection of Systems - Insofar as feasible, public water systems shall be connected
with a municipal, county, regional or other existing approved water system capable of
supplying the demand. Where such connection is not feasible, other approved sources may
be considered. Each public water system shall be designed in such a manner as will
facilitate the connection of the system at an appropriate time to an expanding municipal,
county or regional system. Each public water system shall be designed to provide service to
all service areas anticipated or projected by the owner.

(10) System Capacity - Whenever a public water system reaches eighty (80) per cent of the
design capacity based on average day usage, the supplier of water shall immediately obtain
the services of a competent engineer to prepare plan documents for expansion of said
system.

(11) Turbidimeters – All community water systems using ground water formations under the direct
influence of surface water, and serving more than 50 connections or 150 individuals, shall be
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14
required to install turbidity monitoring equipment with power cutoff ability and recording unit.
Those systems not included in the above may be required to install turbidity monitoring
devices if the Department finds that the system cannot meet the microbiological standard, the
turbidity can be seen without an instrument, or there is an outbreak of illness that may be
water related. All filter plants serving community water systems shall be required to have
continuous recording turbidimeters on the filter effluent line(s). Such instrumentation may be
pen and ink, digital, computerized or other record keeping or recording devices approved by
the Division. If pen and ink recorders are used they shall be limited to two pens and two
filters and shall use a scale of 0 to 2.0 NTU unless specific alternatives are approved in
writing by the Division.

(12) Monitoring of new sources - All new surface or ground water sources added to an existing
water system or proposed for use by a new water system shall have the required biological
and chemical water quality monitoring completed prior to being placed in service. The
parameters to be monitored shall be those required for drinking water for the specific type of
system involved.

(13) Delegation of Plans Review Authority – Under Section 68–221–706 of the Tennessee Code
Annotated, any unit of local government may petition the Commissioner for certification to
review and approve plans for water distribution facilities within its jurisdiction. The unit of
local government must have adequate experience and expertise in water distribution and
must adopt standards and impose requirements which are at least as stringent as the
Department’s. The request for certification must be in writing and contain at least the
following:

(a) The names of the individual(s) responsible for the review and approval together with
his/her experience and education. This person(s) must be employed by the unit of
local government and be a registered professional engineer in Tennessee.

(b) A copy of the standards, requirements and design criteria legally adopted and
enforceable by the unit of local government.

(c) The type of projects the unit of local government wishes to receive certification to
review. This may include but is not limited to water lines, distribution pumping stations
and distribution storage tanks.

(d) Procedures for maintaining records of all projects reviewed and approved by the unit of
local government.

(e) The wording to be used on the approval stamp.

(f) Plans review authority fee.

The Division of Water Supply will be responsible for reviewing the application for certification
and shall have up to 60 days from the receipt of the complete application to make a written
response. Units of local government will not be certified to review projects involving state or
federal funds, raw water pump stations, new water sources, treatment facilities, sludge
handling facilities, or any project designed by the staff of the local government. Any unit of
local government which receives certification for plans review shall submit one copy of any
plan documents it has approved to the Division of Water Supply. This shall be done within 10
days of the local government’s approval. The commissioner may periodically review the unit
of local government’s plans review program and prescribe changes as deemed appropriate.
The Division of Water Supply may execute a written agreement with a unit of local
government which has received plans review certification. Failure to comply with the terms of
the agreement may result in revocation of the plans review certification.

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(Rule 1200-5-1-.05, continued)
August, 2008 (Revised)
15
Authority: T.C.A. §§4-5-201 et seq., 4-5-202, 68-221-701 et seq., and 68-221-704. Administrative
History: Original rule certified June 7, 1974. Repeal and new rule filed June 30, 1977; effective August
1, 1977. Amendment filed February 3, 1984; effective February 12, 1985. Amendment filed August 24,
1992; effective October 8, 1992. Amendment filed April 12, 1996; effective June 26, 1996. Amendment
filed October 31, 2000; effective January 14, 2001. Amendments filed August 15, 2005; effective October
29, 2005.

1200-5-1-.06 MAXIMUM CONTAMINANT LEVELS.

(1) Inorganic Chemicals

(a) The maximum contaminant level for fluoride applies to community water systems. The
maximum contaminant levels for nitrate, nitrite and total nitrate and nitrite are
applicable to both community water systems and non-community water systems. The
maximum contaminant levels for the remaining inorganic chemicals apply only to
community water systems and non-transient non-community systems. The effective
date for antimony, beryllium, cyanide, nickel and thallium shall be January 1, 1993, or
the effective date of this rule whichever is later. The arsenic maximum contaminant
level listed in subparagraph (b)2 is effective for the purpose of compliance January 23,
2006. Until January 23, 2006, the arsenic MCL is 0.05 mg/L.

(b) The following are the maximum contaminant levels for inorganic chemicals:

CONTAMINANT LEVEL, MILLIGRAMS PER LITER

1. Antimony 0.006
2. Arsenic 0.010
3. Asbestos 7 million fibers/liter
(longer than 10 microns)
4. Beryllium 0.004
5. Barium 2.0
6. Cadmium 0.005
7. Chromium 0.1
8. Cyanide (as free cyanide) 0.2
9. Fluoride 4.0
10. Mercury 0.002
11. Nickel 0.1
12. Nitrate 10.0 (as Nitrogen)
13. Nitrite 1.0 (as Nitrogen)
14. Total nitrate and nitrate 10.0 (as Nitrogen)
15. Selenium 0.05
16. Thallium 0.002

(2) Organic Chemicals - The following are the maximum contaminant levels for organic
chemicals.

(a) The following maximum contaminant levels for organic contaminants apply to
community water systems and non-transient non-community water systems. The
effective date of these MCLs shall be the effective date of this regulation.
CONTAMINANT LEVEL, MILLIGRAMS PER LITER

1. Alachlor 0.002
2. Atrazine 0.003
3. Carbofuran 0.04
4. Chlordane 0.002
5. Dibromo chloropropane (DBCP) 0.0002
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6. 2,4 Dichlorophenoxyacetic acid 0.07
7. Ethylene dibromide 0.00005
8. Heptachlor 0.0004
9. Heptachlor epoxide 0.0002
10. Lindane 0.0002
11. Methoxychlor 0.04
12. Polychlorinated biphenyls 0.0005
13. Toxaphene 0.003
14. 2,4,5 Trichlorophenoxyproprionic
acid 0.05
15. Pentachlorophenol 0.001
16. Benzo(a)pyrene 0.0002
17. Dalapon 0.2
18. Di(2-ethylhexyl) adipate 0.4
19. Di(2-ethylhexyl)phthalate 0.006
20. Dinoseb 0.007
21. Diquat 0.02
22. Endothall 0.1
23. Glyphosate 0.7
24. Hexachlorobenzene 0.001
25. Hexachlorocyclopentadiene 0.05
26. Oxamyl (Vydate) 0.2
27. Picloram 0.5
28. Simazine 0.004
29. 2,3,7,8-TCDD (Dioxin) 0.00000003
30. Endrin 0.002

(3) Turbidity - The requirements of 1200-5-1-.06(3) apply to filtered surface systems until June
29, 1993. The requirements in this section apply to unfiltered systems that the State has
determined, in writing, must install filtration until June 29, 1993, or until filtration is installed,
whichever is later.

The maximum contaminant level for turbidity is applicable to public water systems using
surface water source(s) in whole or in part. Furthermore, the maximum contaminant level for
turbidity is applicable to those systems using ground water which are required to install
turbidimeters pursuant to Regulation 1200-5-1-.05(11). The maximum contaminant levels for
turbidity in drinking water, measured at a representative entry point(s) to the distribution
system are:

(a) One (1.0) turbidity unit, as determined by monthly average pursuant to Regulation
1200-5-1-.08.

(b) Two (2.0) turbidity units based on an average for two consecutive days pursuant to
Regulation 1200-5-1-.08.

To meet the maximum contaminant level for turbidity, a public water system must meet both
(a) and (b).

(4) Microbiological - The maximum contaminant levels for microbiologicals are applicable to both
community water systems and non-community water systems.

(a) The maximum contaminant level (MCL) is based on the presence or absence of total
coliforms in a sample, rather than coliform density.

The number of total coliform positive samples shall not exceed any of the following:

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1. For a system which collects at least 40 samples per month, if no more than 5.0
percent of the samples collected during a month are total coliform-positive, the
system is in compliance with the MCL for total coliforms.

2. For a system which collects fewer than 40 samples/month, if no more than one
sample collected during a month is total coliform-positive, the system is in
compliance with the MCL for total coliforms.

3. A public water system which has exceeded the MCL for total coliforms must
report the violation to the State no later than the end of the next business day
after it learns of the violation and notify the public in accordance with the
schedule of 1200-5-1-.19 using the language specified in 1200-5-1-.19.

4. A public water system which has failed to comply with the coliform monitoring
requirements, including a sanitary survey requirement must report the monitoring
violation to the State within ten (10) days after the system discovers the violation
and notify the public in accordance with 1200-5-1-.19.

(b) Any fecal coliform-positive repeat sample or E-coli-positive repeat sample, or any total
coliform-positive repeat sample following a fecal coliform positive or E-coli positive
routine sample constitutes a violation of the MCL for total coliforms. For purposes of
the public notification requirements in 1200-5-1-.19 this is a tier 1 violation that may
pose an acute risk to health.

(c) Fecal coliforms/Escherichia coli (E. coli) testing

1. If any routine or repeat sample is total coliform-positive, the system must analyze
that total coliform-positive culture medium to determine if fecal coliforms are
present, except that the system may test for E. coli in lieu of fecal coliforms. If
fecal coliforms or E. coli are present, the system must notify the State by the end
of the day when the system is notified of the test result, unless the system is
notified of the result after the Department office is closed, in which case the
system must notify the State before the end of the next business day.

2. The State has the discretion to allow a public water system, on a case-by-case
basis, to forgo fecal coliform or E. coli testing on a total coliform-positive sample
if that system assumes that the total coliform-positive sample is fecal coliform-
positive or E. coli-positive. Accordingly, the system must notify the State as
specified in paragraph (c)(1) of this section and the provisions of 1200-5-1-
.06(4)(b) apply.

(d) A public water system must determine compliance with the MCL for total coliforms in
(a) and (b) of this section for each month in which it is required to monitor for total
coliforms.

(e) No variance or exemptions from the maximum contaminant level for total coliforms are
permitted.

(5) Radionuclides-

(a) The following maximum contaminant levels for radium-226, radium-228, and gross
alpha particle radioactivity are applicable to all community water systems:

1. Combined radium-226 and radium-228: The maximum contaminant level for
combined radium-226 and radium-228 is 5 pCi/L. The combined radium-226 and
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

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radium-228 value is determined by the addition of the results of the analysis for
radium-226 and the analysis for radium-228.

2. Gross alpha particle activity (including radium-226 but excluding radon and
uranium): The maximum contaminant level for gross alpha particle activity
(including radium-226 but excluding radon and uranium) is 15 pCi/L.

(b) Maximum contaminant levels for beta particle and photon radioactivity from man-made
radionuclides in community water systems shall be as follows:

1. The average annual concentration of beta particle and photon radioactivity from
man-made radionuclides in drinking water shall not produce an annual dose
equivalent to the total body or any internal organ greater than four (4)
millirem/year.

2. Except for the radionuclides listed in Table A, the concentration of man-made
radionuclides causing four (4) mrem total body or organ dose equivalents shall
be calculated on the basis of a two (2) liter per day drinking water intake using
the 168 hour data listed in “Maximum Permissible Body Burdens and Maximum
Permissible Concentration of Radionuclides in Air or Water for Occupational
Exposure,” NBS Handbook 69 as amended August, 1963, U.S. Department of
Commerce. If two or more radionuclides are present, the sum of their annual
dose equivalent to the total body or to any organ shall not exceed four (4)
millirem/year.


Table A
Average Annual Concentrations Assumed
to Produce a Total Body or Organ Dose of a 4 mrem/yr.

Radionuclide Critical Organ pCi per Liter

Tritium Total Body 20,000
Strontium-90 Bone Marrow 8


(c) MCL for uranium. The maximum contaminant level for uranium is 30 micrograms per
liter.

(d) Compliance dates.

1. Compliance dates for combined radium-226 and -228, gross alpha particle
activity, gross beta particle and photon radioactivity, and uranium: Community
water systems must comply with the MCLs listed in subparagraphs (a), (b), and
(c), beginning December 8, 2003 and compliance shall be determined in
accordance with the requirements of 1200-5-1-.11. Compliance with reporting
requirements for the radionuclides under appendix A to Consumer Confidence
Reports (1200-5-1-.35) and Appendices A and B to Public Notification (1200-5-1-
.19) is required on December 8, 2003.

(e) Best Available Technologies

The Department hereby identifies as indicated in the following table the best technology
available for achieving compliance with the maximum contaminant levels for combined
radium-226 and -228, uranium, gross alpha particle activity, and beta particle and
photon radioactivity.
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(Rule 1200-5-1-.06, continued)
August, 2008 (Revised)
19

Table B.-BAT for Combined Radium-226 and Radium-228, Uranium, Gross
Alpha Particle Activity, and Beta Particle and Photon Radioactivity

Contaminant BAT
1. Combined radium-226 and radium-
228

Ion exchange, reverse osmosis, lime
softening.

2. Uranium Ion exchange, reverse osmosis, lime
softening, coagulation/filtration
3. Gross alpha particle activity(
excluding Radon and Uranium)
Reverse osmosis
4. Beta particle and photon radioactivity Ion exchange and reverse osmosis


(f) No variance or exemption for compliance with the MCLs listed in 1200-5-1-.06(5) are
allowed.

(g) Small systems compliance technologies list for radionuclides.

Table C.-List of Small Systems Compliance Technologies for Radionuclides
and Limitations to Use

Unit Technologies Limitations
(see foot-
notes)
Operator skill level
required
1
Raw water quality
range
and considerations.
1
1. Ion Exchange (IE) (a) Intermediate All ground waters.
2. Point of use (POU
2
) IE (b) Basic All ground waters.
3. Reverse osmosis (RO) (c) Advanced Surface waters usually
require pre-filtration.
4. POU
2
RO (b) Basic Surface waters usually
require pre-filtration.
5. Lime softening (d) Advanced All waters.
6. Green sand filtration (e) Basic
7. Co-precipitation with
Barium Sulfate
(f) Intermediate to
Advanced
Ground waters with
suitable water quality.
8.
Electrodialysis/electrodialys
is reversal
Basic to imtermediate All ground waters.
9. Pre-formed hydrous
Manganese oxide filtration
(g) Intermediate All ground waters.
10. Activated alumia (a)(h) Advanced All ground waters;
competing anion
concentrations may
affect regeneration
frequency.
11. Enhanced
coagulation/filtration
(i) Advanced Can treat a wide range
of water qualities

1
National Research Council (NRC). Safe Water from Every Tap: Improving Water Service to Small
Communities. National Academy Press. Washington, D.C. 1997.
2
A POU, or “point-of-use” technology is a treatment device installed at a single tap used for the purpose
of reducing contaminants in drinking water at that one tap. POU devices are typically installed at the
kitchen tap. See the April 21, 2000 NODA for more details.
Limitations Footnotes: Technologies for Radionuclides:
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.06, continued)
August, 2008 (Revised)
20
a
The regeneration solution contains high concentrations of the contaminant ions. Disposal options
should be carefully considered before choosing this technology.
b
When POU devices are used for compliance, programs for long-term operation, maintenance, and
monitoring must be provided by water utility to ensure proper performance.
c
Reject water disposal options should be carefully considered before choosing this technology. See
other RO limitations described in the SWTR Compliance Technologies Table.
d
The combination of variable source water quality and the complexity of the water chemistry involved
may make this technology too complex for small surface water systems.
e
Removal efficiencies can vary depending on water quality.
f
This technology may be very limited in application to small systems. Since the process requires static
mixing, detention basins, and filtration, it is most applicable to systems with sufficiently high sulfate levels
that already have a suitable filtration treatment train in place.
g
This technology is most applicable to small systems that already have filtration in place.
h
Handling of chemicals required during regeneration and pH adjustment may be too difficult for small
systems without an adequately trained operator.
i
Assumes modification to a coagulation/filtration process already in place.

Table D.-Compliance Technologies by System Size Category for Radionuclide NPDWR's

Contaminant Compliance Technologies
1
for system size categories
(population served)
25-500 501-3,300 3301-10,000
1. Combined radium-
226 and radium-228
1,2,3,4,5,6,7,8,9 1,2,3,4,5,6,7,8,9 1,2,3,4,5,6,7,8,9

2. Gross alpha
particle activity
3.4 3.4 3,4
3. Beta particle
activity and photon
acivity
1,2,3,4 1,2,3,4 1,2,3,4
4. Uranium 1,2,4,10,11 1,2,3,4,5,10,11 1,2,3,4,5,10,11

Note:
1
Numbers correspond to those technologies found listed in table C.

(6) Disinfectant Residuals and Disinfectant Byproducts

(a) Bromate and chlorite. The maximum contaminant levels (MCLs) for bromate and
chlorite are as follows:

Disinfection by-product MCL (mg/L)
Bromate 0 .010
Chlorite 1 .0

1. Compliance dates for CWSs and NTNCWSs. Subpart H systems serving 10,000
or more persons must comply with this paragraph (a) beginning January 1, 2002.
Subpart H systems serving fewer than 10,000 persons and systems using only
ground water not under the direct influence of surface water must comply with
this paragraph (a) beginning January 1, 2004.

2. The Administrator, pursuant to section 1412 of the Act, hereby identifies the
following as the best technology, treatment techniques, or other means available
for achieving compliance with the maximum contaminant levels for bromate and
chlorite identified in this paragraph (a):


Disinfection Best available technology
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.06, continued)
August, 2008 (Revised)
21
by-product
Bromate Control of ozone treatment process to reduce production of
bromate
Chlorite Control of treatment processes to reduce disinfectant demand
and control of disinfection treatment processes to reduce
disinfectant levels

(b) TTHM and HAA5.

1. Subpart L— Running Annual Average compliance (1200-5-1-.36)

(i) Compliance dates. Subpart H systems serving 10,000 or more persons
must comply with subparagraph (b)1 beginning January 1, 2002. Subpart
H systems serving fewer than 10,000 persons and systems using only
ground water not under the direct influence of surface water must comply
with this subparagraph (b)1 beginning January 1, 2004. All systems must
comply with these MCLs until the date specified for Locational Running
Annual Average (subpart V) compliance in 1200-5-1-.38.

Disinfection by-product MCL (mg/L)
Total trihalomethanes (TTHM) 0.080
Haloacetic acids (five) (HAA5) 0.060

(ii) The Administrator, pursuant to section 1412 of the Act, hereby identifies
the following as the best technology, treatment techniques, or other means
available for achieving compliance with the maximum contaminant levels
for TTHM and HAA5 identified in this subparagraph (b)1.

Disinfection by-product Best available technology
Total trihalomethanes (TTHM) and
Haloacetic acids (five) (HAA5)
Enhanced coagulation or enhanced softening
or GAC10, with chlorine as the primary and
residual disinfectant

2. Subpart V—LRAA compliance (1200-5-1-.38)
.
(i) Compliance dates. The subpart V MCLs for TTHM and HAA5 must be
complied with as a locational running annual average (LRAA) at each
monitoring location beginning the date specified for subpart V compliance
in 1200-5-1-.38(1)(c).

Disinfection by-product MCL (mg/L)
Total trihalomethanes (TTHM) 0.080
Haloacetic acids (five) (HAA5) 0.060

(ii) The Administrator, pursuant to section 1412 of the Act, hereby identifies
the following as the best technology, treatment techniques, or other means
available for achieving compliance with the maximum contaminant levels
for TTHM and HAA5 identified in subparagraph (b)2 for all systems that
disinfect their source water:

Disinfection by-product Best available technology
Total trihalomethanes (TTHM) and
Haloacetic acids (five) (HAA5)
Enhanced coagulation or enhanced softening
or GAC10; nanofiltration and with a molecular
weight cutoff of equal to or less than 1000
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.06, continued)
August, 2008 (Revised)
22
Daltons; or GAC20

(iii) The Administrator, pursuant to section 1412 of the Act, hereby identifies
the following as the best technology, treatment techniques, or other means
available for achieving compliance with the maximum contaminant levels
for TTHM and HAA5 identified in subparagraph (b)2 for consecutive
systems and applies only to the disinfected water that consecutive systems
buy or otherwise receive:

Disinfection by-product Best available technology
Total trihalomethanes (TTHM) and Haloacetic
acids (five) -(HAA5).
Systems serving 10,000 or more: Improved
distribution system and storage tank
management to reduce residence time, plus
the use of chloramines for disinfectant residual
maintenance

Systems serving <10,000: Improved
distribution system and storage tank
management to reduce residence time

(c) Maximum residual disinfectant levels.

1. Maximum residual disinfectant levels (MRDLs) are as follows:

Disinfectant residual MRDL (mg/L)
Chlorine........................………..…….. 4.0 (as Cl
2
).
Chloramines........................……..….... 4.0 (as Cl
2
).
Chlorine dioxide.....................……..…. 0.8 (as ClO
2
).

(d) Compliance dates.

1. CWSs and NTNCWSs. Subpart H systems serving 10,000 or more persons must
comply with MRDLs beginning January 1, 2002. Subpart H systems serving
fewer than 10,000 persons and systems using only ground water not under the
direct influence of surface water must comply with MRDLs beginning January 1,
2004.

2. Transient NCWSs. Subpart H systems serving 10,000 or more persons and
using chlorine dioxide as a disinfectant or oxidant must comply with the chlorine
dioxide MRDL beginning January 1, 2002. Subpart H systems serving fewer
than 10,000 persons and using chlorine dioxide as a disinfectant or oxidant and
systems using only ground water not under the direct influence of surface water
and using chlorine dioxide as a disinfectant or oxidant must comply with the
chlorine dioxide MRDL beginning January 1, 2004.

(e) Best Available Control Technology

1. The following are identified as the best technology, treatment technology or other
means available for achieving compliance with the maximum residual
disinfectant level:

(i) Control of the treatment processes to reduce disinfectant demand and
control of disinfection treatment processes to reduce disinfectant levels.

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.06, continued)
August, 2008 (Revised)
23
Authority: T.C.A. §68-221-704. Administrative History: Original rule certified June 7, 1974. Repeal
and new rule filed June 30, 1977; effective August 1, 1977. Amendment filed February 3, 1984; effective
February 12, 1985. Amendment filed September 26, 1988; effective November 10, 1988. Amendment
filed November 26, 1990; effective January 10, 1991. Amendment filed August 24, 1992; effective
October 8, 1992. Amendment filed October 22, 1993; effective January 5, 1994. Amendment filed
October 31, 2000; effective January 14, 2001. Amendment filed November 21, 2001; effective February
4, 2002. Amendment filed April 12, 2002; effective June 26, 2002. Amendment filed July 15, 2002;
effective September 28, 2002. Amendment filed April 19, 2004; effective July 3, 2004. Amendment filed
July 31, 2006; effective October 14, 2006.

1200-5-1-.07 MONITORING AND ANALYTICAL REQUIREMENTS.

(1) Microbiological Contaminant Sampling

(a) Reserved

(b) Reserved

(c) The supplier of water for a community water system shall take coliform samples at
regular time intervals and in number proportional to the population served by the
system during the reporting period as set forth below:

TOTAL COLIFORM MONITORING FREQUENCY FOR COMMUNITY WATER
SYSTEMS

Minimum Number of
Population Served Samples Per Month

25 to 1,000
1..................................................................................................
1
1,001 to 2,500...............................................................................................2
2,501 to 3,300...............................................................................................3
3,301 to 4,100...............................................................................................4
4,101 to 4,900...............................................................................................5
4,901 to 5,800...............................................................................................6

Minimum Number of
Population Served Samples Per Month

5,801 to 6,700...............................................................................................7
6,701 to 7,600...............................................................................................8
7,601 to 8,500...............................................................................................9
8,501 to 12,900...........................................................................................10
12,901 to 17,200.........................................................................................15
17,201 to 21,500.........................................................................................20
21,501 to 25,000.........................................................................................25
25,001 to 33,000.........................................................................................30
33,001 to 41,000.........................................................................................40
41,001 to 50,000.........................................................................................50
50,001 to 59,000.........................................................................................60
59,001 to 70,000.........................................................................................70
70,001 to 83,000.........................................................................................80
83,001 to 96,000.........................................................................................90
96,001 to 130,000................................................................................................ 100
130,001 to 220,000.............................................................................................. 120
220,001 to 320,000.............................................................................................. 150
320,001 to 450,000.............................................................................................. 180
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.07, continued)
August, 2008 (Revised)
24
450,001 to 600,000.............................................................................................. 210
600,001 to 780,000.............................................................................................. 240
780,001 to 970,000.............................................................................................. 270
970,001 to 1,230,000........................................................................................... 300
1,230,001 to 1,520,000........................................................................................ 330
1,520,001 to 1,850,000........................................................................................ 360
1,850,001 to 2,270,000........................................................................................ 390
2,270,001 to 3,020,000........................................................................................ 420
3,020,001 to 3,960,000........................................................................................ 450
3,960,001 or more................................................................................................ 480

1
Includes public water systems which have at least 15 service connections, but serve
fewer than 25 persons.

1. Coliform samples shall be collected at sites which are representative of water
throughout the distribution system according to a written sample siting plan.

2. Sample siting plans shall be made available to the Department on request.
Plans determined to be deficient by the Department shall be revised by the
system on the basis of the Department’s findings.

3. Microbiological sampling shall be conducted in accordance with the approved
sampling plan.

(d) The monitoring frequency for total coliforms for non-community water systems is as
follows:

1. A non-community water system using only ground water (except ground water
under the direct influence of surface water) and serving 1,000 persons or fewer
must monitor each calendar quarter that the system provides water to the public.

2. A non-community water system using only ground water (except ground water
under the direct influence of surface water) and serving more than 1,000 persons
during any month must monitor at the same frequency as a like-sized community
water system, as specified in Rule 1200-5-1-.07(1)(c). For systems using ground
water under the direct influence of surface water, rule 1200-5-1-.07(1)(d)4.
applies.

3. A non-community water system using surface water, in total or in part, must
monitor at the same frequency as a like-sized community water system, as
specified in 1200-5-1-.07(1)(c), regardless of the number of persons it serves.

4. A non-community water system using ground water under the direct influence of
surface water must monitor at the same frequency as a like-sized community
water system, as specified in 1200-5-1-.07(1)(c). The system must begin
monitoring at this frequency beginning six months after the determination that the
ground water is under the direct influence of surface water.

5. A non-community water system must collect total coliform samples at sites which
are representative of water throughout the distribution system according to a
written sample site plan. These plans are subject to state review and revision.

(e) Public water systems must collect samples at regular time intervals throughout the
monitoring period. Those public water systems that use only ground water (except
ground water under the direct influence of surface water) and serve 4,900 or fewer
persons may collect all required samples on a single day if they are taken from different
sites.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.07, continued)
August, 2008 (Revised)
25

(f) A public water system that uses surface water or ground water under the direct
influence of surface water, and does not practice filtration in compliance with Rule
1200-5-1-.31 must collect at least one sample near the first service connection each
day the turbidity level of the source water exceeds 1 NTU. This sample must be
analyzed for the presence of total coliforms. When one or more turbidity
measurements in any day exceed 1 NTU, the system must collect this coliform sample
within 24 hours of the first exceedance, unless the Department determines that the
system, for reasons outside the system’s control cannot have the sample analyzed
within 30 hours of collection. Sample results from this coliform monitoring must be
included in determining compliance with the MCL for total coliforms in 1200-5-1-.06(4).

(g) Special purpose samples, such as those taken to determine whether disinfection
practices are sufficient following pipe placement, replacement, or repair, shall not be
used to determine compliance with the MCL for total coliforms in Rule 1200-5-1-.06(4)
provided the water is not served to customers before negative analytical results are
obtained. Samples representing water served to customers prior to obtaining analytical
results shall not be special purpose samples and shall count toward compliance with
the MCL for total coliforms in Rule 1200-5-1-.06(4). Repeat samples taken pursuant to
paragraph (2) of this Rule are not considered special purpose samples, and must be
used to determine compliance with the MCL for total coliforms in Rule 1200-5-1-.06(4).

(2) Repeat Monitoring

(a) If a routine sample is total coliform-positive, the public water system must collect a set
of repeat samples within 24 hours of being notified of the positive result. A system
which collects more than one routine sample per month must collect no fewer than
three repeat samples for each total coliform-positive sample found. A system which
collects one routine sample per month or fewer must collect no fewer than four repeat
samples for each total coliform-positive sample found. The Department may extend
the 24-hour limit on a case-by-case basis if the system has a problem in collecting the
repeat samples within 24 hours that is beyond its control. In the case of an extension,
the Department must specify how much time the system has to collect the repeat
samples.

(b) The system must collect at least one repeat sample from the sampling tap where the
original total coliform-positive sample was taken, and at least one repeat sample at a
tap within five service connections upstream and at least one repeat sample at a tap
within five service connections downstream of the original sampling site. If a total
coliform-positive sample is at the end of the distribution system, or one away from the
end of the distribution system, the State may waive the requirement to collect at least
one repeat sample upstream or downstream of the original sampling site.

(c) The system must collect all repeat samples on the same day and within 24 hours of
being notified of a positive result, except that the State may allow a system with a
single service connection to collect the required set of repeat samples over a four
consecutive day period or to collect a larger volume repeat sample(s) in one or more
sample containers of any size, as long as the total volume collected is at least 400 ml
(300 ml for systems which collect more than one routine sample per month.)

(d) If one or more repeat samples in the set is total coliform-positive, the public water
system must collect an additional set of repeat samples in the manner specified in
paragraphs 1200-5-1-.07(2)(a), (b), and (c) of this section. The additional samples
must be collected within 24 hours of being notified of the positive result, unless the
State extends the limit as provided in 1200-5-1-.07(2)(a). The system must repeat this
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.07, continued)
August, 2008 (Revised)
26
process until either total coliforms are not detected in one complete set of repeat
samples or the system determines that the MCL for total coliforms in 1200-5-1-.06(4)
has been exceeded and notifies the State.

(e) If a system normally collecting fewer than five routine samples per monitoring period
has one or more total coliform-positive samples and the Department does not
invalidate the sample(s) under 1200-5-1-.07(3), it must collect at least five routine
samples during the next month the system serves water to the public.

(f) After a system collects a routine sample and before it learns the results of the analysis
of that sample, if it collects another routine sample(s) from within five adjacent service
connections of the initial sample, and the initial sample, after analysis, is found to
contain total coliforms, then the system may count the subsequent sample(s) as a
repeat sample instead of as a routine sample.

(g) Results of all routine and repeat samples not invalidated by the State must be included
in determining compliance with the MCL for total coliforms in 1200-5-1-.06(4).

(3) Invalidation of Total Coliform Samples. A total coliform-positive sample invalidated under
1200-5-1-.07(3) does not count towards meeting the minimum monitoring requirement for
microbiological contaminants.

(a) The state may invalidate a total coliform-positive sample only if the conditions of 1200-
5-1-.07(3)(a) 1., 2., or 3. are met.

1. The laboratory establishes that improper sample analysis caused the total
coliform-positive result;

2. The Department, on the basis of the results of repeat samples collected as
required by 1200-5-1-.07(2)(a), (b), (c), and (d), determines that the total
coliform-positive sample resulted from a domestic or other non-distribution
system plumbing problem. The Department cannot invalidate a sample on the
basis of repeat sample results unless all repeat sample(s) collected at the same
tap as the original total coliform-positive are also total coliform-positive, and all
repeat samples collected within five service connections of the original tap are
total coliform-negative (e.g., the Department cannot invalidate a total coliform-
positive sample on the basis of repeat samples if all the repeat samples are total
coliform-negative, or if the public water system has only one service connection).

3. The State has substantial grounds to believe that a total coliform-positive result is
due to a circumstance or condition which does not reflect water quality in the
distribution system. In this case, the system must still collect all repeat samples
required under 1200-5-1-.07(2)(a), (b), (c), and (d) and use them to determine
compliance with the MCL for total coliforms in 1200-5-1-.06(4). To invalidate a
total coliform-positive sample under this paragraph, the decision with the
rationale for the decision must be documented in writing, and approved and
signed by the supervisor of the Departmental official who recommended the
decision. The Department must make this document available to EPA and the
public. The written documentation must state the specific cause of the total
coliform-positive sample, and what action the system has taken, or will take, to
correct this problem. The Department may not invalidate a total coliform-positive
sample solely on the grounds that all repeat samples are total coliform-negative.

(b) A laboratory must invalidate a total coliform sample (unless total coliforms are
detected) if the sample produces a turbid culture in the absence of gas production
using an analytical method where gas formation is examined (e.g., the Multiple-Tube
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.07, continued)
August, 2008 (Revised)
27
Fermentation Technique), produces a turbid culture in the absence of an acid reaction
in the Presence-Absence (P-A) Coliform Test, or exhibits confluent growth or produces
colonies too numerous to count with an analytical method using a membrane filter
(e.g., Membrane Filter Technique). If a laboratory invalidates a sample because of
such interference, the system must collect another sample from the same location as
the original sample within 24 hours of being notified of the interference problem, and
have it analyzed for the presence of total coliforms. The system must continue to re-
sample within 24 hours and have the samples analyzed until it obtains a valid result.
The Department may waive the 24-hour time limit on a case-by-case basis.

(4) Sanitary Surveys

(a) Public water systems which do not collect five or more routine samples per month must
undergo an initial sanitary survey by June 29, 1994 for community public water
systems and June 29, 1999 for non-community water systems. Thereafter, systems
must undergo another sanitary survey every five years, except that non-community
water systems using only protected and disinfected ground water, as defined by the
Department, must undergo subsequent sanitary surveys at least every ten years after
the initial sanitary survey. The Department must review the results of each sanitary
survey to determine whether the existing monitoring frequency is adequate and what
additional measures, if any, the system needs to undertake to improve drinking water
quality.

(b) In conducting a sanitary survey of a system using ground water having an EPA-
approved wellhead protection program under section 1428 of the Federal Safe Drinking
Water Act, information on sources of contamination within the delineated wellhead
protection area that was collected in the course of developing and implementing the
program should be considered instead of collecting new information, if the information
was collected since the last time the system was subject to a sanitary survey.

(c) Public water systems which do not collect five or more routine samples per month must
undergo a sanitary survey performed by the state at least once every five years. The
system is responsible for ensuring the survey takes place by informing the state within
30 days of the expiration of the 5-year period.

(d) Sanitary surveys conducted by the Department pursuant to Rule 1200-5-1-.40 may be
used to meet the sanitary survey requirements of Rule 1200-5-1-.07(4).

(e) A public water system may request a sanitary survey re-inspection of its water system
provided the public water system requests the re-inspection within sixty (60) days of
the receipt of the results of the initial sanitary survey. The public water system
requesting the sanitary survey re-inspection shall pay the costs of the re-inspection
incurred by the Department.

Authority: T.C.A. §§4-5-201 et seq., 4-5-202, 68-221-701 et seq., and 68-221-704 et seq.
Administrative History: Original rule certified June 7, 1974. Repeal and new rule filed June 30, 1977;
effective August 1, 1977. Amendment filed February 3, 1984; effective February 12, 1985. Amendment
filed November 26, 1990; effective January 10, 1991. Amendment filed August 24, 1992; effective
October 8, 1992. Amendment filed October 22, 1993, effective January 5, 1994. Amendment filed April
12, 1996, effective June 26, 1996. Amendment filed October 31, 2000; effective January 14, 2001.
Amendments filed August 15, 2005; effective October 29, 2005. Amendments filed June 12, 2008;
effective August 26, 2008.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1


August, 2008 (Revised)
28

1200-5-1-.08 TURBIDITY SAMPLING AND ANALTICAL REQUIREMENTS.

(1) Ground water sampling – Samples shall be taken by suppliers of water that serve more than
50 connections or that have been directed to conduct monitoring under Rule 1200-5-1-
.05(11) for both community water systems and non–community water system at a
representative entry point(s) to the water distribution system at least once per day for the
purpose of making turbidity measurements to determine compliance with Regulation 1200–
5–1–.06(3). Public water systems using water from a source not under the direct influence of
surface water are not required to monitor turbidity unless directed to do so under the
provisions of 1200-5-1-.05(11).

(2) Turbidity measurements of surface water and ground water under the direct influence that
employs filtration - The minimum sampling requirements for systems using filtration treatment
shall be as follows:

(a) Turbidity measurements must be performed on representative samples of the system’s
filtered water every four hours, (or more frequently, as authorized by the rules) that the
system serves water to the public. A public water system may substitute continuous
turbidity monitoring for grab samples if approved in writing by the Department. For
systems serving 500 or fewer persons per day, the Department may allow the sampling
frequency to be reduced to once per day if it determines that less frequent monitoring is
sufficient to indicate effective filtration performance. Systems filtering surface water
and ground water under the direct influence of surface water shall comply with the
treatment technique standards found in 1200-5-1-.31(4).

(3) Ground water systems under the direct influence of surface water and do not filter and have
qualified to avoid filtration - The minimum sampling requirements for ground water systems
under the direct influence of surface water and not employing filtration shall be as follows:

(a) Turbidity measurements must be performed on representative grab samples of source
water immediately prior to the first or only point of disinfectant application every four
hours (or more frequently, as authorized by the rules) that the system serves water to
the public. A public water system may substitute continuous turbidity monitoring for
grab sample monitoring if it validates the continuous measurement for accuracy on a
regular basis using a protocol approved by the State. Turbidity must comply with the
limits specified in 1200-5-1-.31(2)(a)2.

(4) Reporting

(a) Ground water systems - All community water systems using a ground water source
with turbidity removal facilities and not designated as ground water under the direct
influence of surface water shall be required, if the results of a turbidity analysis indicate
that the maximum allowable limit has been exceeded, to confirm by resampling as
soon as practicable and preferably within one (1) hour. If the repeat sample confirms
that the maximum allowable limit has been exceeded, the supplier of water shall report
to the Department within forty-eight (48) hours. The repeat sample shall be the sample
used for the purpose of calculating the monthly average. If the monthly average of the
daily samples exceeds the maximum allowable limit, or if the average of two samples
taken on consecutive days exceeds two (2) NTU, the supplier of water shall report to
the Department and notify the public as directed in Regulation 1200-5-1-.18 and 1200-
5-1-.19. All non-community water systems using ground water formations, other than
approved sand and gravel formations, may be required to monitor turbidity if the
Department finds a system cannot meet the microbiological standard, the turbidity limit
is exceeded, or if other health related problems exist.

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.08, continued)
August, 2008 (Revised)
29
(b) Surface water systems and ground water systems under the direct influence of surface
water -Turbidity measurements must be reported within 10 days after the end of each
month the system serves water to the public. Information that must be reported
includes but is not limited to:

1. The total number of filtered water turbidity measurements taken during the
month.

2. The number and percentage of filtered water turbidity measurements taken
during the month which are less than or equal to the applicable limits specified in
1200-5-1-.31(4).

3. The date and value of any turbidity measurements taken during the month which
exceed 5 NTU.

(c) Ground water systems under the direct influence of surface water that have qualified to
avoid filtration - Information that must be reported includes but is not limited to :

1. The maximum turbidity level measured during the month, the date(s) of
occurrence for any measurement(s) which exceeded 5 NTU, and the date(s) the
occurrence(s) was reported to the State.

2. For the first 12 months of recordkeeping, the dates and cumulative number of
events during which the turbidity exceeded 5 NTU, and after one year of
recordkeeping for turbidity measurements, the dates and cumulative number of
events during which the turbidity exceeded 5 NTU in the previous 12 months the
system served water to the public.

3. For the first 120 months of recordkeeping, the dates and cumulative number of
events during which the turbidity exceeded 5 NTU, and after 10 years of
recordkeeping for turbidity measurements, the dates and cumulative number of
events during which the turbidity exceeded 5 NTU in the previous 120 months
the system served water to the public.

(d) Ground water systems under the direct influence of surface water that has been
directed to install filtration but has not yet done so shall monitor as specified in Rule
1200-5-1-.08(4)(a).

Authority: T.C.A. §§68-221-701 et seq. and 4-5-202. Administrative History: Original rule certified
June 7, 1974. Repeal and new rule filed June 30, 1977; effective August 1, 1977. Amendment filed
February 3, 1984; effective February 12, 1985. Amendment filed November 26, 1990; effective January
10, 1991. Amendment filed April 12, 1996; effective June 26, 1996. Amendment filed August 15, 2005;
effective October 29, 2005. Amendment filed June 12, 2008; effective August 26, 2008.

1200-5-1-.09 INORGANIC CHEMICAL SAMPLING AND ANALYTICAL REQUIREMENTS.

(1) Monitoring and analysis for the purpose of determining compliance with the maximum
contaminant level for antimony, arsenic, asbestos, barium, beryllium, cadmium, chromium,
cyanide, fluoride, mercury, nickel, nitrate, nitrite, total nitrate and nitrite, thallium, and
selenium shall be conducted as follows:

(a) Groundwater systems shall take a minimum of one sample at every entry point to the
distribution system which is representative of each well after treatment (hereafter called
a sampling point) beginning in the compliance period starting January 1, 1993. The
system shall take such sample at the same sampling point unless conditions make
another sampling point more representative of each source or treatment plant.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.09, continued)
August, 2008 (Revised)
30

(b) Surface water systems shall take a minimum of one sample at every entry point to the
distribution system after any application of treatment, or in the distribution system at a
point which is representative of each source after treatment (hereafter called a
sampling point), beginning in the compliance period starting January 1, 1993. The
systems shall take each sample at the same sampling point unless conditions make
another sampling point more representative of each source or treatment plant. Surface
water systems include systems with a combination of surface and ground sources.

(c) If the system draws water from more than one source and the sources are combined
before distribution, the system must sample at an entry point to the distribution system
during periods when water representative of all sources is being used.

(d) The State may reduce the total number of analyses by allowing the use of composite
sampling. Composite samples from a maximum of five sampling points are allowed,
provided that the detection limit of the method used for analysis is less than one-fifth of
the MCL. Compositing of sample must be done in the laboratory.

1. If the concentration in the composite sample is greater than or equal to one-fifth
of the MCL of an inorganic chemical, then a follow-up sample must be taken
within 14 days at each sampling point included in the composite. These samples
must be analyzed for the contaminants which were detected in the composite
sample.

2. If duplicates of the original samples taken from each sampling point used in the
composite are available, the system may use these instead of resampling. The
duplicates must be analyzed and the results reported to the State within 14 days
of collection.

3. If the population served by the system is greater than 3,300 persons, then
compositing may only be permitted by the State at sampling points within a
single system. In systems serving 3,300 or less persons, the state may permit
compositing among different systems provided the 5-sample limit is maintained.

(e) All new systems or systems that use a new source of water that begin operation after
the effective date of this rule must demonstrate compliance with the MCL within a
period of time specified by the State. The system must also comply with the initial
sampling frequencies specified by the state to ensure a system can demonstrate
compliance with the MCL. Routine and increased monitoring frequencies shall be
conducted in accordance with the requirements of this rule.

(2) Compliance with the maximum contaminant level for inorganics shall be determined as
specified in paragraph (7) of this rule. The frequency of monitoring for asbestos shall be in
accordance with paragraph (3) of this rule. The frequency of monitoring antimony, arsenic,
barium, beryllium, cadmium, cyanide, chromium, fluoride, mercury, nickel, selenium and
thallium shall be in accordance with paragraph (4) of this rule. The frequency of monitoring
for nitrate shall be in accordance with paragraph (5) of this rule. The frequency of monitoring
for nitrite shall be in accordance with paragraph (6) of this rule.

(3) The frequency of monitoring required to determine compliance with the maximum
contaminant level for asbestos shall be as follows:

(a) Each community and non-transient, non-community water system is required to
monitor for asbestos during the first three-year compliance period of each nine-year
compliance cycle beginning in the compliance period starting January 1, 1993.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.09, continued)
August, 2008 (Revised)
31

1. All community water systems and non-transient non-community water systems
serving more than 10,000 people shall complete initial sampling by
December 31, 1993. All community water systems and non-transient non-
community water systems serving from 3,300 to 10,000 people shall complete
initial sampling by December 31, 1994. All other community water systems and
non-transient non-community water systems shall complete monitoring by
December 31, 1995. Repeat samples shall be collected thereafter on a nine
year cycle.

(b) If the system believes it is not vulnerable to either asbestos contamination in its source
water or due to corrosion of asbestos-cement pipe, or both, it may apply to the Division
to be excluded from the monitoring requirement in paragraph (3)(a). If the Division
agrees to exclude the system, the system is not required to monitor.

(c) The Division may exclude a system from asbestos monitoring provided the public water
system provides the state with a sworn statement by the superintendent, manager or
chief operator of the system that no asbestos materials have been used in its treatment
plant and distribution system and that no asbestos containing materials will be used in
the system after the date of the system requests to be excluded.

(d) An asbestos monitoring waiver if issued by the state remains in effect for three years or
until the system installs asbestos containing materials in the system. Systems shall
notify the state within 48 hours of using any asbestos containing materials. Systems
not receiving a waiver shall monitor in accordance with subparagraph (a) of this
paragraph.

(e) A system vulnerable to asbestos contamination due solely to corrosion of asbestos-
cement pipe shall take one sample at a tap served by asbestos-cement pipe and under
conditions where asbestos contamination is most likely to occur.

(f) A system vulnerable to asbestos contamination due solely to source water shall
monitor in accordance with the provision of paragraph (2) of this rule.

(g) A system vulnerable to asbestos contamination due both to its source water supply and
corrosion of asbestos-cement pipe shall take one sample at a tap served by asbestos–
cement pipe and one sample at the entry point to the distribution system under
conditions where asbestos contamination is most likely to occur.

(h) A system which exceeds the maximum contaminant level at any sampling point shall
monitor quarterly beginning in the next quarter after the violation occurred.

(i) The State may decrease the quarterly monitoring requirement to the frequency
specified in paragraph (3)(a) of this rule provided the State has determined a ground
water system has collected two consecutive quarterly samples and a surface (or
combined surface/ground water system) has four consecutive samples below the MCL.

(j) If monitoring data collected after January 1, 1990 comply with the requirements of
1200-5-1-.09(3), then the State may allow systems to use that data to satisfy the
monitoring requirement for the initial compliance period beginning January 1, 1993.

(4) The frequency of monitoring conducted to determine compliance with the maximum
contaminant levels for antimony, arsenic, barium, beryllium, cadmium, chromium, cyanide,
fluoride, mercury, nickel, selenium and thallium shall be as follows:

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.09, continued)
August, 2008 (Revised)
32
(a) Groundwater systems shall take one sample at each sampling point during each three
year compliance period starting January 1, 1993. Surface water systems and
combined surface/ground systems shall take one sample annually at each sampling
point beginning January 1, 1993.

(b) Systems which exceed the maximum contaminant levels shall monitor quarterly
beginning in the next quarter after the violation occurred.

(c) The State may decrease the quarterly monitoring requirement to the frequencies
specified in paragraph (4)(a) of this section provided a ground water system has
collected two consecutive quarterly samples and a surface water system has a
minimum of four consecutive quarterly samples below the MCL.

(d) The system may apply to the State for a waiver from the monitoring frequencies
specified in subparagraph (4)(a). States may grant a public water system a waiver for
monitoring cyanide, provided that the state determines that the system is not
vulnerable due to the lack of any industrial source of cyanide.

(e) A condition of the waiver shall require that a system shall take a minimum of one
sample while the waiver is effective. The term during which the waiver is effective shall
not exceed one compliance cycle (i.e., nine years).

(f) The State may grant a waiver provided surface water systems have monitored annually
for at least three years and groundwater systems have conducted a minimum of three
rounds of monitoring. (At least one sample shall have been taken since January 1,
1990). Both surface and groundwater systems shall demonstrate that all previous
analytical results were less than the maximum contaminant level. Systems that use a
new water source are not eligible for a waiver until three rounds of monitoring from the
new source have been completed.

(g) In determining the appropriate reduced monitoring frequency, the State shall consider:

1. Reported concentrations from all previous monitoring;

2. The degree of variation in reported concentrations; and

3. Other factors which may affect contaminant concentrations such as changes in
groundwater pumping rates, changes in the system's configuration, changes in
the system's operating procedures, or changes in stream flows or characteristics.

(h) A decision by the State to grant a waiver shall be made in writing and shall set forth the
basis for the determination. The determination may be initiated by the State or upon an
application by the public water system. The public water system shall specify the basis
for its request. The State shall review and, where appropriate, revise its determination
of the appropriate monitoring frequency when the system submits new monitoring data
or when other data relevant to the system's appropriate monitoring frequency become
available.

(5) All public water systems (community, non-transient non-community, and transient non-
community systems) shall monitor to determine compliance with the maximum contaminant
level for nitrate.

(a) Community and non–transient non–community water systems served by ground water
system shall monitor annually beginning January 1, 1993. Community and non–
transient systems served by surface water shall monitor quarterly beginning January 1,
1993.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.09, continued)
August, 2008 (Revised)
33

(b) For community and non–transient non–community water systems, the repeat
monitoring frequency for ground water systems shall be quarterly for at least one year
following any one sample in which the concentration is greater than or equal to 50
percent of the MCL. The State may allow a groundwater system to reduce the
sampling frequency to annually after the results of four consecutive quarterly samples
are below the MCL.

(c) For community and non-transient non-community water systems, the State may allow a
surface water system to reduce the sampling frequency to annually if all analytical
results from four consecutive quarters are less than 50 percent of the MCL. A surface
water system shall return to quarterly monitoring if any one sample is greater than or
equal to 50 percent of the MCL.

(d) Each transient non-community water system shall monitor annually beginning January
1, 1993.

(e) After the initial round of quarterly sampling is completed, each community and non-
transient non-community system which has been allowed to reduce its monitoring to
annually shall take subsequent samples during the quarter(s) which previously resulted
in the highest analytical result.

(6) All public water systems (community, non-transient non-community, and transient non-
community systems) shall monitor to determine compliance with the maximum contaminant
level for nitrite.

(a) All public water systems shall take one sample at each sampling point during the
compliance period beginning January 1, 1993, and ending December 31, 1995.

(b) After the initial sample, systems where an analytical result for nitrite is less than 50
percent of the MCL shall monitor at the frequency determined by the State in
accordance with the criteria in subparagraph (4)(g).

(c) For community, non-transient non-community, and transient non-community water
systems, the repeat monitoring frequency for any water system shall be quarterly for at
least one year following any one sample in which the concentration is greater than or
equal to 50 percent of the MCL. The State may allow a system to reduce the sampling
frequency to annually after determining the system has four consecutive quarters of
data less than the MCL.

(d) Systems which are monitoring annually shall take each subsequent sample during the
quarter(s) which previously resulted in the highest analytical result.

(7) Confirmation samples:

(a) Where the results of sampling for asbestos, antimony, arsenic, barium, beryllium,
cadmium, chromium, cyanide, fluoride mercury, nickel, selenium or thallium indicate an
exceedance of the maximum contaminant level, the state may require that one
additional sample be collected as soon as possible after the initial sample was taken
(but not to exceed two weeks after the date of the initial sample analysis) at the same
sampling point.

(b) Where nitrate or nitrite sampling results indicate an exceedance of the maximum
contaminant level, the system shall take a confirmation sample within 24 hours of the
system's receipt of notification of the analytical results of the first sample. Systems
unable to comply with the 24-hour sampling requirement must immediately notify the
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.09, continued)
August, 2008 (Revised)
34
consumers served by the public water system in accordance with 1200-5-1-.19.
Systems that give public notice rather than collect a confirmation sample within 24-
hours must take and analyze a confirmation sample within two weeks of notification of
the analytical results of the first sample.

(c) If confirmation samples are taken for any contaminant, then the results of the initial and
confirmation sample shall be averaged. The resulting average shall be used to
determine the system's compliance in accordance with paragraph (10). Results of
documented sampling errors may be deleted if approved by the State.

(8) The State may require more frequent monitoring than specified in paragraphs (3), (4), (5),
and (6) of this rule or may require confirmation samples for positive and negative results.

(9) Systems may conduct more frequent monitoring than the minimum monitoring frequencies
specified in this section.

(10) Compliance with the MCLs for inorganic chemicals listed in 1200-5-1-.06 shall be determined
based on the analytical result(s) obtained at each sampling point.

(a) For systems which are conducting monitoring at a frequency greater than annual,
compliance with the maximum contaminant levels for antimony, arsenic, asbestos,
barium, beryllium, cadmium, chromium, cyanide, fluoride, mercury, nickel, selenium
and thallium is determined by a running annual average at each sampling point. If the
average at any sampling point is greater than the MCL, then the system is out of
compliance. If any one sample would cause the annual average to be exceeded, then
the system is out of compliance immediately. Any sample below the detection limit
shall be calculated at zero for the purpose of determining the annual average. If a
system fails to collect the required number of samples, compliance (average
concentration) will be based on the total number of samples collected.

(b) For systems which are monitoring annually, or less frequently, the system is out of
compliance with the maximum contaminant levels for antimony, arsenic, asbestos,
barium, beryllium, cadmium, chromium, cyanide, fluoride, mercury nickel, selenium and
thallium if the level of a contaminant at any sampling point is greater than the MCL. If
confirmation samples are required by the State, the determination of compliance will be
based on the annual average of the initial MCL exceedance and any state required
confirmation samples. If a system fails to collect the required number of samples,
compliance (average concentration) will be based on the total number of samples
collected.

(c) Compliance with the maximum contaminant levels for nitrate and nitrite is determined
based on one sample if the levels of these contaminants are below the MCLs. If the
levels of nitrate and/or nitrite exceed the MCLs in the initial sample, a confirmation
sample is required in accordance with paragraph (7)(b) of this rule, and compliance
shall be determined based on the average of the initial and confirmation samples.

(d) If a public water system has a distribution system separate and distinct from other parts
of the distribution system with no interconnections, the State may allow the system to
give public notice to only the area served by that portion of the system which is out of
compliance.

(e) Arsenic sampling results will be reported to the nearest 0.001 mg/L

(11) The state may establish specific times during each compliance periods for public water
systems to complete its monitoring.

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.09, continued)
August, 2008 (Revised)
35
Authority: T.C.A. §§4-5-202, 68-221-701 et seq., and 68-221-704. Administrative History: Original
rule filed June 30, 1977; effective August 1, 1977. Amendment filed February 3, 1984; effective February
12, 1985. Amendment filed August 24, 1992; effective October 8, 1992. Amendment filed October 22,
1993; effective January 5, 1994. Amendment filed April 12, 1996; effective June 26, 1996. Amendment
filed February 17, 1999; effective May 3, 1999. Amendment filed July 15, 2002; effective September 28,
2002. Amendment filed August 15, 2005; effective October 29, 2005. Amendments filed June 12, 2008;
effective August 26, 2008.

1200-5-1-.10 ORGANIC CHEMICAL SAMPLING AND ANALYTICAL REQUIREMENTS.

(1) Beginning January 1, 1993, or the effective date of these regulations whichever is later,
analysis of the contaminants listed in 1200-5-1-.06(2)(a) for the purposes of determining
compliance with the maximum contaminant level shall be conducted as follows:

(a) Groundwater systems shall take a minimum of one sample at every entry point to the
distribution system which is representative of each well after treatment (hereafter called
a sampling point). Each sample must be taken at the same sampling point unless
conditions make another sampling point more representative of each source, treatment
plant, or within the distribution system.

(b) Surface water systems shall take a minimum of one sample at points in the distribution
system that are representative of each source or at each entry point to the distribution
system after treatment (hereafter called a sampling point). Each sample must be taken
at the same sampling point unless conditions make another sampling point more
representative of each source, treatment plant or within the distribution system.
Surface water systems include systems with a combination of surface and ground
sources.

(c) If the system draws water from more than one source and the sources are combined
before distribution, the system must sample at an entry point to the distribution system
during periods when water representative of all sources is being used.

(d) Monitoring frequency:

1. Each community and non-transient non-community water system shall take four
consecutive quarterly samples for each contaminant listed in 1200-5-1-.06(2)
during each compliance period beginning with the initial compliance period.

2. Systems serving more than 3,300 persons which do not detect a contaminant in
the initial compliance period, may reduce the sampling frequency to a minimum
of two quarterly samples in one year during each repeat compliance period.

3. Systems serving 3,300 or less persons which do not detect a contaminant in the
initial compliance period may reduce the sampling frequency to a minimum of
one sample during each repeat compliance period.

4. All new systems or systems that use a new source of water that begin operation
after the effective date of this rule must demonstrate compliance with the MCL
within a period of time specified by the State. The system must also comply with
the initial sampling frequencies specified by the state to ensure a system can
demonstrate compliance with the MCL. Routine and increased monitoring
frequencies shall be conducted in accordance with the requirements of this rule.

(e) Each community and non-transient water system may apply to the State for a waiver
from the requirement of subparagraph (1)(d) of this rule. A system must reapply for a
waiver for each compliance period.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.10, continued)
August, 2008 (Revised)
36

(f) A State may grant a waiver after evaluating the following: Knowledge of previous use
(including transport, storage, or disposal) of the contaminant within the watershed or
zone of influence of the system. If a determination by the State reveals no previous
use of the contaminant within the watershed or zone of influence, a waiver may be
granted. If previous use of the contaminant is unknown or it has been used previously,
then the following factors shall be used to determine whether a waiver is granted.

1. Previous analytical results.

2. The proximity of the system to a potential point or non-point source of
contamination. Point sources include spills and leaks of chemicals at or near a
water treatment facility or at manufacturing, distribution, or storage facilities, or
from hazardous and municipal waste landfills and other waste handling or
treatment facilities. Non-point sources include the use of pesticides to control
insect and weed pests on agricultural areas, forest lands, home and gardens,
and other land application uses.

3. The environmental persistence and transport of the pesticide or PCBs.

4. How well the water source is protected against contamination due to such factors
as depth of the well and the type of soil and the integrity of the well casing.

5. Elevated nitrate levels at the water supply source.

6. Use of PCBs in equipment used in the production, storage, or distribution of
water (i.e., PCBs used in pumps transformers, etc.).

7. Any other information required by the Department.

(g) If an organic contaminant listed in 1200-5-1-.06(2) is detected (as defined by
subparagraph (1)(r) of this rule) in any sample, then:

1. Each system must monitor quarterly at each sampling point which resulted in a
detection.

2. The State may decrease the quarterly monitoring requirement specified in
paragraph (1)(g)1. of this section provided it has determined that the system is
below the maximum contaminant level. In no case shall the State make this
determination unless a groundwater system takes a minimum of two quarterly
samples and a surface water system takes a minimum of four quarterly samples.

3. After the State determines the system is below the maximum contaminant level
the State may allow the system to monitor annually. Systems which monitor
annually must monitor during the quarter that previously yielded the highest
analytical result.

4. If monitoring results in detection of one or more of certain related contaminants
(aldicarb, aldicarb sulfone, aldicarb sulfoxide and heptachlor, heptachlor
epoxide), then subsequent monitoring shall analyze for all related contaminants.

(h) Systems which violate the maximum contaminant levels for organics must monitor
quarterly. After a minimum of four quarterly samples show the system is in compliance
and the State determines the system is below the MCL, the system shall monitor at the
frequency specified in paragraph (1)(g)3. of this rule.

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.10, continued)
August, 2008 (Revised)
37
(i) The State may require a confirmation sample for positive or negative results. If a
confirmation sample is required by the State, the result must be averaged with the first
sampling result and the average used for the compliance determination. The State has
discretion to delete results of documented sampling errors from this calculation.

(j) The State may reduce the total number of analyses a system must conduct by allowing
the use of composite sampling. Composite samples from a maximum of five sampling
points are allowed, provided that the detection limit of the method used for analysis is
less than one-fifth of the MCL. Compositing of samples must be done in the laboratory
and analyzed within 14 days of sample collection.

(k) Compliance with 1200-5-1-.06(2) shall be determined based on the analytical results
obtained at each sampling point. If one sampling point is in violation of the MCL, the
system is in violation of the MCL.

1. For systems which are conducting monitoring at a frequency greater than annual,
compliance is determined by a running annual average of all samples taken at
each sampling point. If the annual average of any sampling point is greater than
the MCL, then the system is out of compliance. If the initial sample or a
subsequent sample would cause the annual average to be exceeded, then the
system is out of compliance immediately.

2. Systems monitoring annually or less frequently whose sample result exceeds the
regulatory detection level must begin quarterly sampling. The system will not be
considered in violation of the MCL until it has completed one year of quarterly
sampling.

3. If any sample result will cause the running annual average to exceed the MCL, at
any sampling point, the system is out of compliance with the MCL immediately.

4. If a system fails to collect the required number of samples, compliance will be
based on the total number of samples collected.

5. If a sample result is less than the detection limit, zero will be used to calculate the
annual average.

(l) Reserved

(m) Reserved

(n) If monitoring data collected after January 1, 1990, are generally consistent with the
requirements of 1200-5-1-.10(1), then the State will allow systems to use that data to
satisfy the monitoring requirement for the initial compliance period beginning January
1, 1993.

(o) The State may increase the required monitoring frequency, where necessary, to detect
variations within the system (e.g., fluctuations in concentration due to seasonal use,
changes in water source), as determined by the criteria described in 1200-5-1-
.09(3)(a).

(p) The State has the authority to determine compliance or initiate enforcement action
based upon analytical results and other information compiled by their representatives
and agencies.

(q) The state may pursuant to these rules establish specific times during each compliance
period for public water systems to complete its monitoring.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.10, continued)
August, 2008 (Revised)
38

(r) Detection as used in this paragraph shall be defined as greater than or equal to the
following concentrations for each contaminant.

TABLE 1200-5-1-.10(1)(r)

CONTAMINANT DETECTION LIMIT (mg/L)

Alachlor 0.0002
Aldicarb 0.0005
Aldicarb sulfoxide 0.0005
Aldicarb sulfone 0.0008
Atrazine 0.0001
Benzo(a)pyrene 0.00002
Carbofuran 0.0009
Chlordane 0.0002
Dalapon 0.001
Dibromochloropropane (DBCP) 0.00002
Di(2-ethyl hexyl) adipate 0.0006
Di(2-ethyl hexyl) phthalate 0.0006
Dinoseb 0.0002
Diquat 0.0004
2,4-D 0.0001
Endothall 0.009
Endrin 0.00001

CONTAMINANT DETECTION LIMIT (mg/L)

Ethylene dibromide (EDB) 0.00001
Glyphosate 0.006
Heptachlor 0.00004
Heptachlor epoxide 0.00002
Hexachlorobenzene 0.0001
Hexachlorocyclopentadiene 0.0001
Lindane 0.00002
Methoxychlor 0.0001
Oxamyl 0.002
Picloram 0.0001
Polychlorinated biphenyls (PCBs) 0.0001
(as decachlorobiphenyl)
Pentachlorophenol 0.00004
Simazine 0.00007
Toxaphene 0.001
2,3,7,8 TCDD (Dioxin) 0.000000005
2,4,5-TP (Silvex) 0.0002

Authority: T.C.A. §§4-5-201 et seq., 4-5-202, 68-221-701 et seq., and 68-221-704. Administrative
History: Original rule filed June 30, 1977; effective August 1, 1977. Amendment filed February 3, 1984;
effective February 12, 1985. Amendment filed August 24, 1992; effective October 8, 1992. Amendment
filed October 22, 1993; effective January 5, 1994. Amendment filed April 12, 1996; effective June 26,
1996. Amendment filed February 17, 1999; effective May 3, 1999. Amendment filed November 21, 2001;
effective February 4, 2002. Amendment filed July 15, 2002; effective September 28, 2002. Amendment
filed August 15, 2005; effective October 29, 2005. Amendments filed June 12, 2008; effective August 26,
2008.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1


August, 2008 (Revised)
39

1200-5-1-.11 RADIONUCLIDE SAMPLING.

(1) For the purpose of monitoring radioactivity concentrations in drinking water, the required
sensitivity of the radioanalysis is defined in terms of a detection limit. The detection limit shall
be that concentration which can be counted with a precision of plus or minus 100 percent at
the 95 percent confidence level (1.96 sigma where sigma is the standard deviation of the net
counting rate of the sample.)

(a) To determine compliance with gross alpha particle activity, radium-226, radium-228
and uranium the detection limit shall not exceed the concentration in the Table to this
subparagraph.

Detection Limits for Gross Alpha Particle
Activity, Radium-226, Radium-228, and Uranium

Contaminant Detection Limit
Gross alpha particle
activity
3pCi/L
Radium-226 1pCi/L
Radium-228 1pCi/L
Uranium 1/10 the MCL

(b) To determine compliance with beta particle and photon activity the detection limit shall
not exceed the concentrations listed in the following table.

Detection Limits for Man-made Beta Particle
and Photon Emitters
Radionuclide Detection Limit
Tritium 1000pCi/L
Strontium-89 10pCi/L
Strontium-90 2pCi/L
Iodine-131 1pCi/L
Cesium-134 10pCi/L
Gross beta 4pCi/L
Other radionuclides 1/10 of the applicable limit

(2) To judge compliance with the maximum contaminant levels listed in Rule 1200-5-1-.06(5)
averages of data shall be used and shall be rounded to the same number of significant
figures as the maximum contaminant level for the substance in question.

(3) The state has the authority to determine compliance or initiate enforcement action based
upon analytical results or other information compiled by their sanctioned representatives and
agencies.

(4) Monitoring and compliance requirements for gross alpha particle activity, radium -226, radium
228, and uranium.

(a) Community water systems (CWSs) must conduct initial monitoring to determine
compliance with radium-226 and 228, gross alpha particle activity and uranium activity
by December 31, 2007. For the purposes of monitoring for gross alpha particle activity,
radium-226, radium-228, and uranium and beta particle activity and photon activity in
drinking water “detection limit” is defined as in Rule 1200-5-1-.11(3).

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.11, continued)
August, 2008 (Revised)
40
1. Applicability and sampling location for existing community water systems or
sources. All existing CWSs using ground water, surface water or systems using
both ground and surface water (hereafter referred to as systems) must sample at
every entry point to the distribution system that is representative of all sources
being used (hereafter called a sampling point) under normal operating
conditions. The system must take each sample at the same sampling point
unless conditions make another sampling point more representative of each
source or the State has designated a distribution system location, in accordance
with Rule 1200-5-1-.11(4)(a)2(ii)(III).

(i) Applicability and sampling location for new community water systems or
sources. All new CWSs or CWSs that use a new source of water must
begin to conduct initial monitoring for the new source within the first quarter
after initiating use of the source. CWSs must conduct more frequent
monitoring when ordered by the State in the event of possible
contamination or when changes in the distribution system or treatment
processes occur which may increase the concentration of radioactivity in
finished water.

2. Initial monitoring: Systems must conduct initial monitoring for gross alpha particle
activity, radium-226, radium-228, and uranium as follows:

(i) Systems without acceptable historical data, as defined below, must collect
four consecutive quarterly samples at all sampling points before December
31, 2007.

(ii) Grandfathering of data: The Department may allow historical monitoring
data collected at a sampling point to satisfy the initial monitoring
requirements for that sampling point, for the following situations.

(I) To satisfy initial monitoring requirements, a community water system
having only one entry point to the distribution system may use the
monitoring data from the last compliance monitoring period that
began between June 2000 and December 8, 2003.

(II) To satisfy initial monitoring requirements, a community water system
with multiple entry points and having appropriate historical
monitoring data for each entry point to the distribution system may
use the monitoring data from the last compliance monitoring period
that began between June 2000 and December 8, 2003.

(III) To satisfy initial monitoring requirements, a community water system
with appropriate historical data for a representative point in the
distribution system may use the monitoring data from the last
compliance monitoring period that began between June 2000 and
December 8, 2003, provided that the Department finds that the
historical data satisfactorily demonstrates that each entry point to the
distribution system is expected to be in compliance based upon the
historical data and reasonable assumptions about the variability of
contaminant levels between entry points. The Department must
make a written finding indicating how the data conforms to these
requirements.

(iii) For gross alpha particle activity, uranium, radium-226, and radium-228
monitoring, the Department may waive the final two quarters of initial
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monitoring for a sampling point if the results of the samples from the
previous two quarters are below the detection limit.

(iv) If the average of the initial monitoring results for a sampling point is above
the MCL, the system must collect and analyze quarterly samples at that
sampling point until the system has results from four consecutive quarters
that are at or below the MCL, unless the system enters into another
schedule as part of a formal compliance agreement with the Department.

3. Reduced monitoring: The Department may allow community water systems to
reduce the future frequency of monitoring from once every three years to once
every six or nine years at each sampling point, based on the following criteria:

(i) If the average of the initial monitoring results for each contaminant (i.e.,
gross alpha particle activity, uranium, radium-226, or radium-228) is below
the detection limit specified in Rule 1200-5-1-.11, the system must collect
and analyze for that contaminant using at least one sample at that
sampling point every nine years.

(ii) For gross alpha particle activity and uranium, if the average of the initial
monitoring results for each contaminant is at or above the detection limit
but at or below 1/2 the MCL, the system must collect and analyze for that
contaminant using at least one sample at that sampling point every six
years. For combined radium-226 and radium-228, the analytical results
must be combined. If the average of the combined initial monitoring results
for radium-226 and radium-228 is at or above the detection limit but at or
below 1/2 the MCL, the system must collect and analyze for that
contaminant using at least one sample at that sampling point every six
years.

(iii) For gross alpha particle activity and uranium, if the average of the initial
monitoring results for each contaminant is above 1/2 the MCL but at or
below the MCL, the system must collect and analyze at least one sample
at that sampling point every three years. For combined radium-226 and
radium-228, the analytical results must be combined. If the average of the
combined initial monitoring results for radium-226 and radium-228 is above
1/2 the MCL but at or below the MCL, the system must collect and analyze
at least one sample at that sampling point every three years.

(iv) Systems must use the samples collected during the reduced monitoring
period to determine the monitoring frequency for subsequent monitoring
periods (e.g., if a system's sampling point is on a nine year monitoring
period, and the sample result is above 1/2 MCL, then the next monitoring
period for that sampling point is three years).

(v) If a system has a monitoring result that exceeds the MCL while on reduced
monitoring, the system must collect and analyze quarterly samples at that
sampling point until the system has results from four consecutive quarters
that are below the MCL, unless the system enters into another schedule as
part of a formal compliance agreement with the Department.

4. Compositing: To fulfill quarterly monitoring requirements for gross alpha particle
activity, radium-226, radium-228, or uranium, a system may composite up to four
consecutive quarterly samples from a single entry point if analysis is done within
a year of the first sample. The Department will treat analytical results from the
composite as the average analytical result to determine compliance with the
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42
MCLs and the future monitoring frequency. If the analytical result from the
composited sample is greater than 1/2 MCL, the Department may direct the
system to take additional quarterly samples before allowing the system to sample
under a reduced monitoring schedule.

5. A gross alpha particle activity measurement may be substituted for the required
radium-226 measurement provided that the measured gross alpha particle
activity does not exceed 5 pCi/L. A gross alpha particle activity measurement
may be substituted for the required uranium measurement provided that the
measured gross alpha particle activity does not exceed 15 pCi/L. The gross
alpha measurement shall have a confidence interval of 95% (1.65 sigma, where
sigma is the standard deviation of the net counting rate of the sample) for
radium-226 and uranium. When a system uses a gross alpha particle activity
measurement in lieu of a radium- 226 and/or uranium measurement, the gross
alpha particle activity analytical result will be used to determine the future
monitoring frequency for radium-226 and/or uranium. If the gross alpha particle
activity result is less than detection, 1/2 the detection limit will be used to
determine compliance and the future monitoring frequency.

(b) Monitoring and compliance requirements for beta particle and photon radioactivity. To
determine compliance with the maximum contaminant levels for beta particle and
photon radioactivity, a system must monitor at a frequency as follows:

1. Community water systems (both surface and ground water) designated by the
Department as vulnerable must sample for beta particle and photon radioactivity.
Systems must collect quarterly samples for beta emitters and annual samples for
tritium and strontium-90 at each entry point to the distribution system (hereafter
called a sampling point), beginning within one quarter after being notified by the
Department. Systems already designated by the Department must continue to
sample until the Department reviews and either reaffirms or removes the
designation.

(i) If the gross beta particle activity minus the naturally occurring potassium-
40 beta particle activity at a sampling point has a running annual average
(computed quarterly) less than or equal to 50 pCi/L (screening level), the
Department may reduce the frequency of monitoring at that sampling point
to once every 3 years. Systems must collect all samples required in Rule
1200-5-1-.11(4)(b)1 during the reduced monitoring period.

(ii) For systems in the vicinity of a nuclear facility, the Department may allow
the CWS to utilize environmental surveillance data collected by the nuclear
facility in lieu of monitoring at the system's entry point(s), where the
Department determines if such data is applicable to a particular water
system. In the event that there is a release from a nuclear facility, systems
which are using surveillance data must begin monitoring at the community
water system's entry point(s) in accordance with Rule 1200-5-1-.11(4)(b)1.

2. Community water systems (both surface and ground water) designated by the
Department as utilizing waters contaminated by effluents from nuclear facilities
must sample for beta particle and photon radioactivity. Systems must collect
quarterly samples for beta emitters and iodine-131 and annual samples for
tritium and strontium-90 at each entry point to the distribution system (hereafter
called a sampling point), beginning within one quarter after being notified by the
Department. Systems already designated by the Department as systems using
waters contaminated by effluents from nuclear facilities must continue to sample
until the Department reviews and either reaffirms or removes the designation.
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(i) Quarterly monitoring for gross beta particle activity shall be based on the
analysis of monthly samples or the analysis of a composite of three
monthly samples. The former is recommended.

(ii) For iodine-131, a composite of five consecutive daily samples shall be
analyzed once each quarter. As ordered by the Department, more frequent
monitoring shall be conducted when iodine-131 is identified in the finished
water.

(iii) Annual monitoring for strontium-90 and tritium shall be conducted by
means of the analysis of a composite of four consecutive quarterly
samples or analysis of four quarterly samples. The latter procedure is
recommended.

(iv) If the gross beta particle activity beta minus the naturally occurring
potassium-40 beta particle activity at a sampling point has a running
annual average (computed quarterly) less than or equal to 15 pCi/L, the
Department may reduce the frequency of monitoring at that sampling point
to every 3 years. Systems must collect all samples required in Rule 1200-
5-1-.11(4)(b)2 during the reduced monitoring period.

(v) For systems in the vicinity of a nuclear facility, the Department may allow
the CWS to utilize environmental surveillance data collected by the nuclear
facility in lieu of monitoring at the system's entry point(s), where the
Department determines if such data is applicable to a particular water
system. In the event that there is a release from a nuclear facility, systems
which are using surveillance data must begin monitoring at the community
water system's entry point(s) in accordance with Rule 1200-5-1-.11(4)(b)2.

3. Community water systems designated by the Department to monitor for beta
particle and photon radioactivity can not apply to the Department for a waiver
from the monitoring frequencies specified in Rule 1200-5-1-.11(4)(b)1 or 2.

4. Community water systems may analyze for naturally occurring potassium-40
beta particle activity from the same or equivalent sample used for the gross beta
particle activity analysis. Systems are allowed to subtract the potassium-40 beta
particle activity value from the total gross beta particle activity value to determine
if the screening level is exceeded. The potassium-40 beta particle activity must
be calculated by multiplying elemental potassium concentrations (in mg/L) by a
factor of 0.82.

5. For community water systems, if the gross beta particle activity minus the
naturally occurring potassium-40 beta particle activity exceeds the screening
level, an analysis of the sample must be performed to identify the major
radioactive constituents present in the sample and the appropriate doses must
be calculated and summed to determine compliance with Rule 1200-5-1-
.06(5)(b)1, using the formula in Rule 1200-5-1-.06(5)(b)2. Doses must also be
calculated and combined for measured levels of tritium and strontium to
determine compliance.

6. Community water systems must monitor monthly at the sampling point(s) which
exceed the maximum contaminant level in Rule 1200-5-1-.06(5)(c) beginning the
month after the exceedance occurs. Systems must continue monthly monitoring
until the system has established, by a rolling average of 3 monthly samples, that
the MCL is being met. Community water systems who establish that the MCL is
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(Rule 1200-5-1-.11, continued)
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44
being met must return to quarterly monitoring until they meet the requirements
set forth in Rule 1200-5-1-.11(4)(b)1(ii) or 2(i).

(c) General monitoring and compliance requirements for radionuclides.

1. The Department may require more frequent monitoring than specified in
subparagraphs (a) and (b) of this paragraph, or may require confirmation
samples at its discretion. The results of the initial and confirmation samples will
be averaged for use in compliance determinations.

2. Each public water systems shall monitor at the time designated by the
Department during each compliance period.

3. Compliance: Compliance the radionuclide MCLs will be determined based on the
analytical result(s) obtained at each sampling point. If one sampling point is in
violation of an MCL, the system is in violation of the MCL.

(i) For systems monitoring more than once per year, compliance with the
MCL is determined by a running annual average at each sampling point. If
the average of any sampling point is greater than the MCL, then the
system is out of compliance with the MCL.

(ii) For systems monitoring more than once per year, if any sample result will
cause the running average to exceed the MCL at any sample point, the
system is out of compliance with the MCL immediately.

(iii) Systems must include all samples taken and analyzed under the provisions
of this Rule in determining compliance, even if that number is greater than
the minimum required.

(iv) If a system does not collect all required samples when compliance is
based on a running annual average of quarterly samples, compliance will
be based on the running average of the samples collected.

(v) If a sample result is less than the detection limit, zero will be used to
calculate the annual average, unless a gross alpha particle activity is being
used in lieu of radium-226 and/or uranium. If the gross alpha particle
activity result is less than detection, 1/2 the detection limit will be used to
calculate the annual average.

4. The Department has the discretion to delete results of obvious sampling or
analytic errors.

5. If the MCL for radioactivity set forth in Rule 1200-5-1-.06(5) is exceeded, the
operator of a community water system must give notice to the Department
pursuant to Rule 1200-5-1-.20 and to the public as required by Rule 1200-5-1-
.19.

Authority: T.C.A. §§4-5-201 et seq., 4-5-202, 53-2002, 53-2003; 68-221-701 et seq., 68-221-704, and
Public Acts of 1983, Chapter 324. Administrative History: Original rule filed June 30, 1977; effective
August 1, 1977. Amendment filed February 3, 1984; effective February 12, 1985. Amendment filed
August 24, 1992; effective October 8, 1992. Amendment filed November 21, 2001; effective February 4,
2002. Amendment filed April 12, 2002; effective June 26, 2002. Amendment filed August 15, 2005;
effective October 29, 2005. Amendments filed June 12, 2008; effective August 26, 2008.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1


August, 2008 (Revised)
45

1200-5-1-.12 SECONDARY DRINKING WATER REGULATIONS.

(1) The following maximum contaminant levels are established to provide a water that is
aesthetically pleasing to the consumer. These standards will apply to all community water
systems and to those non-community water systems as may be deemed necessary by the
Department. Monitoring for these contaminants will be set in the Monitoring Program for
each system, but in no event less than once every year for a surface and surface/ground
supply and once every three years for a ground water supply.

Maximum Contaminant Level

Milligrams
Contaminant per Liter (unless otherwise indicated)

(a) Chloride 250
(b) Color 15 (Color Units)
(c) Copper 1
(d) MBAS (Methyl Blue Active Substance) 0.5
(e) Iron 0.3
(f) Manganese 0.05
(g) Odor 3 (Threshold Odor Number)
(h) pH 6.5-8.5
(i) Sulfate 250
(j) TDS (Total Dissolved Solids) 500
(k) Zinc 5
(l) Fluoride 2.0
(m) Aluminum 0.2
(n) Silver 0.1

(2) The system may apply for monitoring waivers from the monitoring frequency specified in
paragraph (1). The Department may issue monitoring waivers after considering: historical
data, whether or not there have been customer complaints concerning the contaminant to be
waived, any corrective action taken by the water supplier to correct the secondary
contaminant problem, and whether or not the system routinely monitors for the contaminant
as part of its treatment process monitoring program. The Department shall determine the
frequency, if any, a system must monitor after considering the historical data available, the
number and nature of customer complaints and other factors that may affect the contaminant
concentration, and specify the decision in writing to the system.

Authority: T.C.A. §§4-5-201 et seq., 4-5-202, 68-221-701 et seq, and 68-221-704. Administrative
History: Original rule filed June 30, 1977; effective August 1, 1977. Amendment filed February 3, 1984;
effective February 12, 1985. Amendment filed September 26, 1988; effective November 10, 1988.
Amendment filed August 24, 1992; effective October 8, 1992. Amendment filed April 12, 1996; effective
June 26, 1996. Amendment filed February 17, 1999; effective May 3, 1999. Amendment filed June 12,
2008; effective August 26, 2008.

1200-5-1-.13 ALTERNATIVE ANALYTICAL TECHNIQUES.

If an alternative analytical technique is acceptable to the Administrator of the U.S. Environmental
Protection Agency as being substantially equivalent to the prescribed test in both precision and
accuracy as it relates to the determination of compliance with any maximum contaminant level,
they shall become a part of these Rules and Regulations by inference.

Authority: T.C.A. §§4-5-201 et seq., 4-5-202, and 68-221-701 et seq. Administrative History: Original
rule filed June 30, 1977; effective August 1, 1977.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1


August, 2008 (Revised)
46

1200-5-1-.14 LABORATORY CERTIFICATION.

(1) General

(a) For the purpose of determining compliance with physical, chemical, biological and
radiological constituents and maximum contaminant levels set forth in this rule chapter,
analyses of samples may be considered only if they have been analyzed by a
laboratory certified by the Department. Laboratories which are certified by the
Department are designated "state-certified laboratories." Analysis for turbidity, free
chlorine residual, temperature, pH, alkalinity, calcium, conductivity, orthophosphate,
daily chlorite, and silica may be performed by persons approved by the Department.
Approved methodology must be used.

(b) The Tennessee Laboratory Certification Program is established for the purpose of
evaluating laboratories to determine technical capability to analyze for one or more
groups of the contaminants, disinfectant residuals, disinfection byproducts and
disinfectant precursors listed in Rules 1200-5-1-.06 through 1200-5-1-.10,
1200-5-1-.12, 1200-5-1-.21, 1200-5-1-.24 through 1200-5-1-.26, and 1200-5-1-.36
through .40 of this rule chapter. Designation of Department laboratory certification
officer(s) shall be from those experienced professional staff members assigned to the
Department of Environment and Conservation, Division of Water Supply and certified
by the U.S. Environmental Protection Agency. Certification Officer(s) shall supervise
the certification program.

(c) A laboratory desiring certification in microbiological and/or chemical analysis shall
make written application to the Department of Environment and Conservation, Division
of Water Supply. The applicant shall indicate those group(s) of contaminants for which
it seeks certification:

Chemistry

1. General (wet)
2. Inorganic
3. Organic Chemicals
4. Disinfection Byproducts
5. Polychlorinated Biphenyls (PCBs)
6. Radiochemistry

7. Microbiology

(i) Enzyme Substrate Coliforms
(ii) Membrane Filter Coliforms
(iii) Heterotrophic Plate Count
(iv) Enterococci

(d) The laboratory shall upon request supply to the Department all information requested
concerning its equipment, facilities, data, and the qualifications of its laboratory staff.
Certified laboratories must have an on-site audit conducted every three years by the
certification officer or his/her designee.

(e) A laboratory desiring certification will arrange for an American Association for
Laboratory Accreditation (A2LA) approved vendor to send performance evaluation
samples to the laboratory for testing pursuant to its proficiency testing program. A2LA
approved Performance Evaluation venders can be viewed at:
http://www.a2la.org/dirsearchnew/nelacptproviders.cfm. The laboratory's performance
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(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
47
in correctly evaluating such sample(s) will be sent to both the laboratory and to the
certification officer. All direct costs for the performance evaluation samples will be
borne by the laboratory requesting certification.

(f) The certification officer shall review the written report of the laboratory performance
evaluation and together with his review of requirements set forth in this Rule shall
determine the certification ranking.

(g) Certified laboratories must maintain all records and correspondence used to determine
compliance with the requirements of these Rules for a period of not less than six (6)
years. Adequate information must be available to reconstruct results for compliance
and performance evaluation (PE) samples. This includes all raw data, calculations,
and quality control data. Electronic data must be backed up by protected tape, hard
disk, or other method approved by the Department. Water system clients should be
notified before disposing of any records so that they may request copies if needed.
Performance evaluation samples shall be analyzed annually.

(h) Certified Laboratories shall comply with all requirements set forth in the latest edition of
EPA Manual for the Certification of Laboratories Analyzing Drinking Water except
where those requirements differ from the requirements set forth in this rule chapter.

(2) In order for a laboratory to be certified by the Department:

(a) It must have a written quality assurance (QA) plan which addresses the following parts:

1. Laboratory organization and responsibility.
2. Process used to identify clients' Data Quality Objectives.
3. Standard Operating Procedures with dates of last revision.
4. Field sampling procedures.
5. Laboratory sample receipt and handling procedures.
6. Instrument calibration procedures
7. Analytical procedures.
8. Data reduction, validation, reporting and verification.
9. Type of quality control (QC) checks and the frequency of their use.
10. List schedules of internal and external system and data quality audits and inter -
laboratory comparisons.
11. Preventive maintenance procedures and schedules.
12. Corrective action contingencies.
13. Record keeping procedures.

(i) If a particular part is not relevant, the QA plan should state this and provide
a brief explanation.

(ii) All laboratories analyzing drinking water compliance samples must adhere
to any required QC procedures specified in the approved method.
Documentation for many of the listed QA plan parts may be made by
reference to appropriate sections of the latest edition of EPA Manual for
the Certification of Laboratories Analyzing Drinking Water, the laboratory's
standard operating procedures (SOPs), or other literature (e.g.,
promulgated methods, Standard Methods for the Examination of Water
and Wastewater, etc.). The QA Plan should be updated at least annually.

(b) It must complete the performance evaluation samples as described in Rule 1200-5-1-
.14(9).

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(c) On an annual basis and with each application for certification or recertification, all
laboratories except Tennessee Public Water Systems shall convey to the Department,
Division of Water Supply, payment for the activities necessary for each group of
contaminants it desires certification or recertification. All laboratories except
Tennessee Public Water Systems shall pay annually an administrative certification fee
as listed in the fee schedule. The fee schedule is as follows:

Fee Type Fee in Dollars

1. Administrative In-State $1000.00
2. Administrative Out of State $750.00
3. General Chemistry-Turbidity, Corrosivity, pH $500.00
4. Inorganics- Trace Metals, Sodium, Nitrite, Nitrate, $500.00
Fluoride, Sulfate, Cyanide, Asbestos, Chlorite,
and Bromate
5. Organics $500.00
6. Disinfection Byproducts-Trihalomethanes $500.00
and Haloacetic acids
7. Polychlorinated Biphenyls (PCB) $500.00
8. Radiochemistry $500.00
9. Enzyme Substrate-Total Coliform and E.-Coli $500.00
10. Membrane Filter- Total Coliform, $500.00
Fecal Coliform, E.-Coli
11. Heterotrophic Plate Count $500.00
12. Enterococci $500.00

(i) Certification fees shall be retained by the state even if the laboratory
applying for certification does not qualify for certification.

(ii) If the certification fee is not paid within 30 days after the receipt of the
invoice, certification of the laboratory is automatically revoked.

(iii) The reinstatement fee for a laboratory that fails to pay its certification fee
by the invoice due date shall be $500.00 in addition to the fees specified in
this subparagraph.

(3) Ranking Scheme of Laboratories - Based upon a review of the written application, the facts
determined from any inspection, and the results of a laboratory performance evaluation, a
certification officer may classify a laboratory as follows for the particular group(s) of
contaminants for which it seeks certification:

(a) Certified - A laboratory that meets the minimum requirements as set forth in these
Rules.

(b) Provisionally Certified - A laboratory which has deficiencies but can still produce valid
analytical data.

(c) Not Certified - A laboratory which possesses major deficiencies such that it cannot
consistently produce valid analytical data in order to determine compliance with the
maximum contaminant level. Analytical data will not be accepted from a laboratory
with this ranking.

(d) Interim Certification - Interim certification may be granted in certain circumstances
when it is impossible or unnecessary to perform an on-site audit. Interim certification
status may be granted if, for example, the Certification Officer determines that the
laboratory has the appropriate instrumentation, is using the approved methods, has
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August, 2008 (Revised)
49
adequately trained personnel to perform the analyses, and has satisfactorily analyzed
PE samples, if available, for the contaminants in question. The Certification Officer
should perform an on-site audit as soon as possible but no later than three years. An
example of a situation where this type of certification is warranted would be a
laboratory that has requested certification for the analysis of additional analytes that
involve a method for which it already has certification.

(4) Downgrading Certification Status - A laboratory certified to perform analyses may be
downgraded to a Provisionally Certified status for a particular parameter, or for one or more
groups of contaminants for which it has been certified for any one of the following reasons:

(a) Failure to analyze a set of performance evaluation samples within established
acceptance limits described in paragraph (9) of this rule. If more than one
concentration of a particular contaminant was provided for analysis, the laboratory
must analyze all concentrations provided except where otherwise stated.

(b) Failure to notify the Department within 30 days of any changes either in personnel,
equipment, or laboratory location which may impair analytical capability.

(c) Failure to maintain the minimum required standard of quality as contained in the most
recent version of the EPA Manual for the Certification of Laboratory Analyzing Drinking
Water as determined by an on-site evaluation by a Department representative.

(d) During a provisional status period, which may last for up to one year plus any extension
period pending proceedings for revocation of its certification, the laboratory may
continue to analyze samples for compliance purposes, but it must notify its clients of its
downgraded status in writing on all reports.

(e) Failure to report compliance data to the public water system or the state in a timely
manner. Data that may cause the system to exceed a MCL shall be reported as soon
as possible to the system and to the state.

(5) Revoking Certification Status - A laboratory certified to perform analyses may be downgraded
from a Certified or a Provisionally Certified status to a Not Certified status for a particular
parameter, or for one or more groups of contaminants for which it has been certified,
including but not limited to any of the reasons listed in subparagraphs below. Commercial
laboratories must notify their public water system customers of the change in certification
status by mail within 45 days of a downgrade in status by the Department and retain copies
of such notice for six years.

(a) Failure to analyze an initial and a follow-up or cross check performance evaluation
sample within established acceptance limits.

(b) Failure to correct identified deviations (including continued use of unapproved methods
and equipment) within the time specified by the Department.

(c) Reporting as data derived from its own laboratory analysis, that data obtained from
analyses of the sample(s) performed by another laboratory.

(d) Falsification or inaccurate reporting of analytical data.

(e) Failure to report to the Department on Departmental forms analytical results as
specified by Rule 1200-5-1-.18. Forms may be obtained from the Division of Water
Supply. A certified laboratory shall submit results of its analyses to both the
appropriate Department's field office and the Department's central office on forms
furnished by the Department.
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(f) Failure to perform the analysis within the time period prescribed by the analytical
procedure. However, the time period shall not be more than thirty (30) days from the
sample collection date, except for lead and copper tap samples collected pursuant to
Rule 1200-5-1-.33.

(g) Failure to notify its drinking water customers of any downgrade or revocation of its
certification status and to keep records of the notice to customers.

(h) Failure of the laboratory to reject any sample taken for compliance purposes that does
not meet acceptable criteria for the type container and preservative, maximum holding
time, chain of custody, proper sample collection and transport, and sample report form
that contains the location, date, time of collection, collector's name, preservative added,
and other special remarks concerning the sample. Indelible ink shall be used for
completing the sample report form.

(i) Failure of the Laboratory Director to give timely notice to the party responsible for
collecting the sample that improper sampling technique, container, transport, holding
time, method preservative or documentation was used.

(j) Failure to provide written sampling procedures with sample containers sent to
customers for collecting drinking water samples.

(k) Failure to meet the method detection limits.

(l) Failure to maintain all data necessary to reconstruct analytical results reported for
compliance samples.

(m) Failure to pay certification fees as listed in subparagraph (2)(c) of this rule.

(6) Procedure for Revocation

(a) The State, Department, Division of Water Supply or the certification officer shall notify
the laboratory by certified mail of its intent to revoke certification.

(b) If the local laboratory objects to the determination to revoke certification, the laboratory
shall submit a written notice of appeal to the Department within thirty (30) days after
issuance of the notice of intent to revoke certification. The notice of appeal will be
referred to the Tennessee Water Quality Control Board. The Board will set a hearing
date and conduct proceedings in accordance with the Uniform Administrative
Procedures Act, Chapter 5 of Title 4. If no notice of appeal is so filed, certification will
be revoked.

(c) The notice of appeal shall set forth the grounds and reasons for objection and shall ask
for a hearing before the Tennessee Water Quality Control Board. It shall be signed by
a duly authorized representative of the laboratory such as the president/owner of a
commercial laboratory, or the mayor, utility manager, president, or laboratory
supervisor in the case of a municipal or utility district laboratory.

(d) If the Water Quality Control Board modifies or sets aside the determination of the
Department, the Department will reevaluate the local laboratory within sixty (60) days
of issuance of the decision by the Board.

(7) Reinstatement of Certification - Certification of a laboratory will be reinstated when it
demonstrates to the Department that the deficiencies which resulted in provisional
certification or revocation have been corrected. Such demonstration may result from an
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
51
on-site evaluation and/or a successful analysis of samples on the next regularly scheduled
performance evaluation.

(8) Reciprocity of Certified Laboratories - The Department may authorize acceptance of analyses
from laboratories certified by other states or by the U. S. Environmental Protection Agency.
Authorization will be granted on a reciprocal basis for laboratories from those states which
accept Tennessee laboratory certification. Laboratories desiring Department approval of
their certification from the U.S. E.P.A. or from another state must submit to the Department
copies of all correspondence pertaining to the grant of certification, including the results of
any performance evaluation sample analyses.

(9) Proficiency Evaluation (PE) Samples or Performance Test (PT) Samples

(a) In order to receive and maintain full certification for an analyte, the following are
required for each analyte for which a laboratory is certified:

(i) The laboratory must analyze PE samples (if available) acceptable to the
Department at least once a year for each analyte and by each method
used to analyze compliance samples. PE samples are also referred to as
Performance Test (PT) samples.

(ii) Results from analysis of the PE samples must be within the acceptable
limits set forth in this chapter.

(iii) The laboratory must document the corrective actions taken when a PE
sample is analyzed unsuccessfully. A copy of this documentation must be
available for review by the certification officer.

(iv) A make up PE sample must be successfully analyzed within three months
of being notified that a PE sample was not acceptable.

(b) Excluding vinyl chloride, the laboratory may be certified for all VOCs if they successfully
analyze at least 80% of the regulated VOCs. The 80% Rule does not apply to the
regulated trihalomethanes (THM) or haloacetic acids (HAAs). Laboratories are certified
for total THMs and HAA5 but each regulated THM and HAA concentration must be
reported, evaluated and passed individually to pass the PE sample. If a laboratory fails
one of the regulated THMs or HAAs, it cannot be certified for total THMs or HAA5, but
must analyze another PE sample and pass all of the regulated THMs or HAAs in a PE
sample to be certified to analyze compliance monitoring samples for total
trihalomethanes or total haloacetic acids.

The following table summarizes the 80% Rule.
Analyte(s) PE Success Requirement
Vinyl Chloride 100%
20 VOCs 80% *
4 Regulated THMs 100%
5 Regulated HAA5s 100%

*A lab will not maintain certification for analyte(s) which it repeatedly fails.

(c) Acceptable PE studies for the determination of total coliforms and E. coli shall be part
of a drinking water study. Each study shall contain a set of ten samples in various
combinations of total coliforms, E. coli, non-coliforms, and at least one blank. To be
certified, laboratories must successfully analyze nine of the ten samples with no false
negatives.

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
52
(10) Analytical Requirements

(a) Microbiology

1. Suppliers of water for community water systems and non-community water
systems shall analyze for coliform bacteria for the purpose of determining
compliance with Rule 1200-5-1-.06(4). The standard sample volume required for
total coliform analysis, regardless of the analytical method used is 100 milliliters.
Analyses shall be conducted in accordance with one of the analytical methods in
following table:

Table 1200-5-1-.14(10)(a)1.

Organism Methodology Citation
1

Total Coliform Fermentation Technique
3,4,5
9221A, B
Total Coliform Membrane Filter Technique
6
9222 A, B, C
Presence-Absence (P-A) Coliform Test
5,7
9221
Total Coliforms
2
ONPG-MUG Test
8

Colisure Test
9
E*Colite
®
Test
10

m-ColiBlue24
®
Test
11
Readycult
®
Coliforms 100 Presence/Absence Test
12
Membrane Filter Technique using Chromocult
®
Coliform Agar
13

Colitag
®
Test
14

9223

Footnotes
1 Methods 9221 A, B; 9222 A, B, C; 9221 D and 9223 are contained in Standard Methods for the Examination of Water
and Wastewater, 18th edition (1992) and 19th edition (1995) American Public Health Association, 1015 Fifteenth Street
NW, Washington, D.C. 20005; either edition may be used. In addition, the following online versions may also be used:
9221 A, B, D-99, 9222 A, B, C-97 and 9223 B-97. Standard Methods Online are available at
http://www.standardmethods.org. The year in which each method was approved by the Standard Methods Committee
is designated by the last two digits in the method number. The methods listed are the only online versions that may be
used.
2 The time from sample collection to initiation of analysis may not exceed 30 hours. Systems are encouraged but not
required to hold samples below 10 °C during transit.
3 Lactose broth, as commercially available, may be used in lieu of lauryl tryptose broth, if the system conducts at least 25
parallel tests between this medium and lauryl tryptose broth using the water normally tested, and this comparison
demonstrates that the false-positive rate and false-negative rate for total coliform, using lactose broth, is less than 10
percent.
4 If inverted tubes are used to detect gas production, the media should cover these tubes at least one-half to two-thirds
after the sample is added.
5 No requirement exists to run the completed phase on 10 percent of all total coliform-positive confirmed tubes.
6 MI agar also may be used. Preparation and use of MI agar is set forth in the article, ‘‘New medium for the simultaneous
detection of total coliform and Escherichia coli in water’’ by Brenner, K.P., et al., 1993, Appl. Environ. Microbiol.
59:3534–3544. Also available from the Office of Water Resource Center (RC–4100), 401 M. Street SW, Washington,
DC 20460, EPA/600/J–99/225.
7 Six-times formulation strength may be used if the medium is filter-sterilized rather than autoclaved.
8 The ONPG-MUG Test is also known as the Autoanalysis Colilert System.
9 A description of the Colisure Test, Feb 28, 1994, may be obtained from IDEXX Laboratories, Inc., One IDEXX Drive,
Westbrook, Maine 04092. The Colisure Test may be read after an incubation time of 24 hours.
10 A description of the E*Colite
®
Test, ‘‘Presence/Absence for Coliforms and E. Coli in Water,’’ Dec 21, 1997, is available
from Charm Sciences, Inc., 36 Franklin Street, Malden, MA 02148–4120.
11 A description of the m-ColiBlue24
®
Test, Aug 17, 1999, is available from the Hach Company, 100 Dayton Avenue,
Ames, IA 50010.
12 The Readycult
®
Coliforms 100 Presence/Absence Test is described in the document, “Readycult
®
Coliforms 100
Presence/Absence Test for the Detection and Identification of Coliform Bacteria and Escherichla coli in finished water”,
November 2000, Version 1.0, available from EM Science (an affiliate of Merck KggA, Darmstadt Germany), 480 S.
Democrat Road, Gibbstown, NJ 08027-1297. Telephone number is (800) 222-0342, e-mail address is:
adellenbusch@emscience.com.
13 Membrane Filter Technique using Chromocult
®
Coliform Agar is described in the document, “Chromocult
®
Coliform
Presence/Absence Membrane Filter Test Method for Detection and Identification of Coliform Bacteria and Escherichla
coli in finished water”, November 2000, Version 1.0, available from EM Science (an affiliate of Merck KggA, Darmstadt
Germany), 480 S. Democrat Road, Gibbstown, NJ 08027-1297. Telephone number is (800) 222-0342, e-mail address
is: adellenbusch@emscience.com.
14 Colitag
®
product for the determination of the presence/absence of total coliforms and E. coli is described in “Colitag
®

Product as a Test for Detection and Identification of Coliforms and E. coli Bacteria in Drinking Water and Source Water
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
53
as required in National Primary Drinking Water Regulations,” August 2001, available from CPI International, Inc., 5580
Skylane Blvd., Santa Rosa, CA, 95403 telephone (800) 878-7654, Fax (707) 545-7901, Internet address
http://www.cpiinternational.com.


2. Where a determination of fecal coliform density is not required, public water
systems must conduct fecal coliform analysis in accordance with the following
procedure:

(i) When the MTF Technique or Presence-Absence (P-A) Coliform Test is
used to test for total coliforms, shake the lactose-positive presumptive tube
or P-A bottle vigorously and transfer the growth with a sterile 3-mm loop or
sterile applicator stick into brilliant green lactose bile broth and EC medium
to determine the presence of total and fecal coliforms, respectively.

(ii) For EPA-approved analytical methods which use a membrane filter,
remove the membrane containing the total coliform colonies from the
substrate with a sterile forceps and carefully curl and insert the membrane
into a tube of EC medium (The laboratory may first remove a small portion
of selected colonies for verification), swab the entire surface with a sterile
cotton swab and transfer the inoculum to EC medium (do not leave the
cotton swab in the EC medium), or inoculate individual total coliform-
positive colonies into EC Medium. Gently shake the inoculated EC tubes
to insure adequate mixing and incubate in a waterbath at 44.5 + 0.2°C for
24 + 2 hours. Gas production of any amount in the inner fermentation tube
of the EC medium indicates a positive fecal coliform test. The preparation
of EC medium is described in Method 9221E in Standard Methods for the
Examination of Water and Wastewater, 18th Edition (1992), 19th Edition
(1995), and 20th Edition (1998); the cited method in any one of these three
editions may be used.

3. Public Water Systems choosing to test for E. coli in lieu of fecal coliform must
use the following methods:

(i) EC medium supplemented with 50 ug/ml of
4-methylumbelliferyl-beta-D-glucuronide (MUG) (final concentration), as
described in Method 9222 G in Standard Methods for the Examination of
Water and Wastewater, 19th edition (1995) and 20th edition (1998). Either
edition may be used. Alternatively, the 18th edition (1992) may be used if
at least 10 ml of EC medium, as described in part 2 of this subparagraph,
is supplemented with 50 ug/ml of MUG before autoclaving. The inner
inverted fermentation tube may be omitted. If the 18th edition is used,
apply the procedure in part 2 of this subparagraph for transferring a total
coliform-positive culture to EC medium supplemented with MUG, incubate
the tube at 44.5 + 0.2
o
C for 24 + 2 hours, and then observe fluorescence
with an ultraviolet light (366nm) in the dark. If fluorescence is visible, E.
coli are present.

(ii) Nutrient agar supplemented with 100 μg/ml of 4methylumbelliferyl-beta-D-
glucuronide (MUG) (final concentration), as described in Method 9222G in
Standard Methods for the Examination of Water and Wastewater, 19th
edition (1995) and 20th edition (1998). Either edition may be used for
determining if a total coliform-positive sample, as determined by a
membrane filter technique, contains E. coli Alternatively, the 18th edition
(1992) may be used if the membrane filter containing a total coliform-
positive colony(ies) is transferred to nutrient agar, as described in Method
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
54
9221B (paragraph 3) of Standard Methods (18th edition), supplemented
with 100 ug/ml of MUG. If the 18th edition is used, incubate the agar plate
at 35 °C for 4 hours and then observe the colony(ies) under ultraviolet light
(366 nm) in the dark for fluorescence. If fluorescence is visible, E. coli are
present.

(iii) Minimal Medium ONPG-MUG (MMO-MUG) Test, as set forth in the article
"National Field Evaluation of Defined Substrate Method for the
Simultaneous Detection of Total Coliforms and Escherichia coli from
Drinking Water; Comparison with Presence-Absence Techniques" (Edberg
et al.), Applied and Environmental Microbiology, Volume 55, pp.
1003-1008, April 1989. (Note: The Autoanalysis Colilert System is an
MMO-MUG test). If the MMO-MUG test is total coliform-positive after a
24-hour incubation, test the medium for fluorescence with a 366-nm
ultraviolet light (preferably with a 6-watt lamp) in the dark. If fluorescence
is observed, the sample is E. coli-positive. If fluorescence is questionable
(cannot be definitively read) after 24 hours incubation, incubate the culture
for an additional four hours (but not to exceed 28 hours total) and again
test the medium for fluorescence. The MMO-MUG Test with hepes buffer
in lieu of phosphate buffer is the only approved formulation for the
detection of E. coli.

(iv) The Colisure Test. A description of the Colisure Test may be obtained from
the Millipore Corporation, Technical Services Department, 80 Ashby Road,
Bedford, MA 01730.

(v) The membrane filter method with MI agar, a description of which is cited in
footnote 6 to Table 1200-5-1-.14(10)(a)1.

(vi) E*Colite
®
Test, a description of which is cited in footnote 10 to Table 1200-
5-1-.14(10)(a)1.

(vii) m-ColiBlue24
®
Test, a description of which is cited in footnote 11 to Table
1200-5-1-.14(10)(a)1.

(viii) Readycult
®
Coliforms 100 Presence/Absence Test, a description of which
is cited in footnote 12 to the Table 1200-5-1-.14(10)(a)1.

(ix) Membrane Filter Technique using Chromocult
®
Coliform Agar, a
description of which is cited in footnote 13 to Table 1200-5-1-.14(10)(a)1.

(x) Colitag
®
, a description of which is cited in footnote 14 to Table 1200-5-1-
.14(10)(a)1.

(xi) As an option to subpart (iii) of this part, a system with a total
coliform-positive, MUG-negative, MMO-MUG test may further analyze the
culture for the presence of E. coli by transferring a 0.1 ml. 28-hour
MMO-MUG culture to EC Medium + MUG with a pipet. The formulation
and incubation conditions of EC Medium + MUG, and observation of the
results are described in subpart (i) of this part.

4. Public Water systems required to monitor under Rule 1200-5-1-.31(2)(a)1 and
1200-5-1-.31(5)(b)2 for total coliforms, fecal coliforms, or heterotrophic bacteria
must use one of the methods listed in the following table.

Table 1200-5-1-.14(10)(a)4.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
55

Organism Methodology Citation
1

Total Coliform
2
Total Coliform Fermentation Technique
3,4,5
9221 A, B, C
Total Coliform Membrane Filter Technique
6
9222 A, B, C
ONPG-MUG Test
7
9223
Fecal Coliforms
2
Fecal Coliform Procedure
8
9221 E
Fecal Coliform Filter Procedure 9222 D
Heterotrophic bacteria
2
Pour Plate Method 9215 B
SimPlate
9


Footnotes
1. Except where noted, all methods refer to Standard Methods for the Examination of Water and Wastewater, 18th edition
(1992), 19th edition (1995), or 20th edition (1998), American Public Health Association, 1015 Fifteenth Street, NW.,
Washington, DC 20005. The cited methods published in any of these three editions may be used. In addition, the
following online versions may also be used: 2130 B–01, 9215 B–00, 9221 A, B, C, E–99, 9222 A, B, C, D–97, and 9223
B–97. Standard Methods Online are available http://www.standardmethods.org. The year in which each method was
approved by the Standard Methods Committee is designated by the last two digits in the method number. The methods
listed are the only Online versions that may be used.
2. The time from sample collection to initiation of analysis may not exceed 8 hours. Systems must hold samples below
10 deg. C during transit. {8 hour holding time only applies to Rule 1200-5-1-.31(2)(a)1 and (5)(b)2}
3. Lactose broth, as commercially available, may be used in lieu of lauryl tryptose broth, if the system conducts at least 25
parallel tests between this medium and lauryl tryptose broth using the water normally tested, and this comparison
demonstrates that the false-positive rate and false-negative rate for total coliform, using lactose broth, is less than 10
percent.
4. Media should cover inverted tubes at least one-half to two-thirds after the sample is added.
5. No requirement exists to run the completed phase on 10 percent of all total coliform-positive confirmed tubes.
6. MI agar also may be used. Preparation and use of MI agar is set forth in the article, ‘‘New medium for the
simultaneous detection of total coliform and Escherichia coli in water’’ by Brenner, K.P., et. al., 1993, Appl. Environ.
Microbiol. 59:3534-3544. Also available from the Office of Water Resource Center (RC-4100T), 1200 Pennsylvania
Avenue, NW., Washington DC 20460, EPA/600/J-99/225. Verification of colonies is not required.
7. The ONPG-MUG Test is also known as the Autoanalysis Colilert System.
8. A-1 Broth may be held up to seven days in a tightly closed screw cap tube at 4 deg. C.
9. A description of the SimPlate method, ‘‘IDEXX SimPlate TM HPC Test Method for Heterotrophs in Water’’, November
2000, can be obtained from IDEXX Laboratories, Inc., One IDEXX Drive, Westbrook, Maine 04092, telephone (800)
321-0207.

5. Public water systems required to enumerate E. coli in source water as required
by Rule 1200-5-1-.39 must use one of the approved methods in the following
table:

Table 1200-5-1-.14(10)(a)5.

Parameter
and units Method
1
EPA
Standard methods
18th,19th, 20th
Ed.
Standard methods
online
AOAC,
ASTM,
USGS Other
E. coli,
number per
100 ml
16

MPN
2,3,4
multiple
tube, 9221B / 9221F
6,8
9221B-99 / 9221F
6,8


multiple
tube/multiple well 9223B
7
9223B–97
7
991.155
Colilert
®7,10

Colilert-18
®7,9,10
MF two step 1103.1
13

9222B/9222G
12
,
9213D 9222B–97 / 9222G
12
D5392–93
4

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
56
MF single step 1603
14
, 1604
15
mColiBlue-24
®11

Footnotes
1 The method must be specified when results are reported.
2 Tests must be conducted to provide organism enumeration (density). Select the appropriate configuration of
tubes/filtrations and dilutions/volumes to account for the quality, character, consistency, and anticipated organism density
of the water sample.
3 To assess the comparability of results obtained with individual methods, it is suggested that side-by-side tests be
conducted across seasons of the year with the water samples routinely tested in accordance with the most current
Standard Methods for the Examination of Water and Wastewater or EPA alternate test procedure (ATP) guidelines.
4 ASTM. 2000, 1999, 1996. Annual Book of ASTM Standards—Water and Environmental Technology. Section 11.02.
ASTM International. 100 Barr Harbor Drive, West Conshohocken, PA 19428.
5 AOAC. 1995. Official Methods of Analysis of AOAC International, 16th Edition, Volume I, Chapter 17. Association of
Official Analytical Chemists International. 481 North Frederick Avenue, Suite 500, Gaithersburg, MD 20877–2417.
6 The multiple-tube fermentation test is used in 9221B.1. Lactose broth may be used in lieu of lauryl tryptose broth (LTB), if
at least 25 parallel tests are conducted between this broth and LTB using the water samples normally tested, and this
comparison demonstrates that the false-positive rate and false-negative rate for total coliform using lactose broth is less
than 10 percent. No requirement exists to run the completed phase on 10 percent of all total coliform-positive tubes on a
seasonal basis.
7 These tests are collectively known as defined enzyme substrate tests, where, for example, a substrate is used to detect
the enzyme b-glucuronidase produced by E. coli.
8 After prior enrichment in a presumptive medium for total coliform using 9221B.1, all presumptive tubes or bottles showing
any amount of gas, growth or acidity within 48 h ± 3 h of incubation shall be submitted to 9221F. Commercially available
EC–MUG media or EC media supplemented in the laboratory with 50 μg/mL of MUG may be used.
9 Descriptions of the Colilert
®
, Colilert-18
®
, Quanti-Tray
®
, and Quanti-Tray
®
/2000 may be obtained from IDEXX
Laboratories, Inc., 1 IDEXX Drive, Westbrook, ME 04092.
10 Descriptions of the Colilert , Colilert-18
®
, Quanti-Tray
®
, and Quanti-Tray
®
/2000 may be obtained from IDEXX
Laboratories, Inc., 1 IDEXX Drive, Westbrook, ME 04092.
11 A description of the mColiBlue24
®
test, Total Coliforms and E. coli, is available from Hach Company, 100 Dayton Ave.,
Ames, IA 50010.
12 Subject total coliform positive samples determined by 9222B or other membrane filter procedure to 9222G using NA MUG
media.
13 USEPA. 2002. Method 1103.1: Escherichia coli (E. coli) In Water By Membrane Filtration Using membrane-
Thermotolerant Escherichia coli Agar (mTEC). U.S. Environmental Protection Agency, Office of Water, Washington, DC,
EPA–821–R–02–020.
14 USEPA. 2002. Method 1603: Escherichia coli (E. coli) In Water By Membrane Filtration Using Modified membrane-
Thermotolerant Escherichia coli Agar ( modified mTEC). U.S. Environmental Protection Agency, Office of Water,
Washington, DC, EPA–821–R–02–023.
15 Preparation and use of MI agar with a standard membrane filter procedure is set forth in the article, Brenner et al. 1993.
‘‘New Medium for the Simultaneous Detection of Total Coliform and Escherichia coli in Water.’’ Appl. Environ. Microbiol.
59:3534–3544 and in USEPA. 2002. Method 1604: Total Coliforms and Escherichia coli (E. coli) in Water by Membrane
Filtration by Using a Simultaneous Detection Technique (MI Medium).U.S. Environmental Protection Agency, Office of
Water, Washington, DC, EPA 821–R–02–024.
16 Recommended for enumeration of target organism in ambient water only.

(i) The time from sample collection to initiation of analysis may not exceed 30
hours unless the system meets the condition of subpart (ii) of this part.

(ii) The Department may approve on a case-by-case basis the holding of an E.
coli sample for up to 48 hours between sample collection and initiation of
analysis if the Department determines that analyzing an E. coli sample
within 30 hours is not feasible. E. coli samples held between 30 to 48
hours must be analyzed by the Colilert reagent version of Standard Method
9223B as listed in Table 1200-5-1-.14(10) (a)5.

(iii) Systems must maintain samples between 0°C and 10°C during storage
and transit to the laboratory.

6. Ground water systems must analyze all ground water source samples collected
under Rule 1200-5-1-.40(3) using one of the analytical methods listed in the
following table for the presence of E. coli or enterococci.

Analytical Methods for Source Water
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
57
Monitoring
Fecal Indicator
1
Methodology Method citation
E. coli Colilert
3
Colisure
3
Membrane Filter Method with MI Agar
m-ColiBlue24 Test
5

E*Colite Test
6

EC-MUG
7

NA-MUG
7

9223 B.
2

9223 B.
2

EPA Method 1604.
4




9221 F.
2

9222 G.
2

Enterococci Multiple-Tube Technique
Membrane Filter Technique
Membrane Filter Technique
Enterolert
9

9230B.
2
9230C.
2

EPA Method 1600.
8


Analyses must be conducted in accordance with the documents listed below. The Director of the Federal Register
approves the incorporation by reference of the documents listed in footnotes 2-11 in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. Copies of the documents may be obtained from the sources listed below. Copies may be inspected at
EPA’s Drinking Water Docket, EPA West, 1301 Constitution Avenue, NW., EPA West, Room B102, Washington DC
20460 (Telephone: 202-566-2426); or at the National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Footnotes
1 The time from sample collection to initiation of analysis may not exceed 30 hours. The ground water system is
encouraged but not required to hold samples below 10
o
C during transit.
2 Methods are described in Standard Methods for the Examination of Water and Wastewater 20
th
edition (1998)
and copies may be obtained from the American Public Health Association, 1015 Fifteenth Street, NW.,
Washington DC 20005-2605.
3 Medium is available through IDEXX Laboratories, Inc., One IDEXX Drive, West Brook, Maine 04092.
4 EPA Method 1604: Total Coliforms and Escherichia coli in Water by Membrane Filtration Using a Simultaneous
Detection Technique (MI Medium); September 2002, EPA 821-R-02-024. Method is available at
http://www.epa.gov/nerlccwww/1604sp02.pdf or from EPA’s Water Resource Center (RC-4100T), 1200
Pennsylvania Avenue, NW., Washington DC 20460.
5 A description of the m-ColiBlue24 Test, “Total Coliforms and E. coli Membrane Filtration Method with m-
ColiBlue24 Broth,” Method No. 10029 Revision 2, August 17, 1999, is available from Hach Company, 100
Dayton Ave., Ames IA 50010 or from EPA’s Water Resource Center (RC-4100T), 1200 Pennsylvania Avenue,
NW., Washington DC 20460.
6 A description of the E*Colite Test, “Charm E*Colite Presence/Absence Test for Detection and Identification of
Coliform Bacteria and Escherichia coli in Drinking Water, January 9, 1998, is available from Charm Sciences,
Inc., 659 Andover St., Lawrence, MA 01843-1032 or from EPA’s Water Resource Center (RC-4100T), 1200
Pennsylvania Avenue, NW., Washington DC 20460.
7 EC-MUG (Method 9221F) or NA-MUG (Method 9222G) can be used for E. coli testing step as described in
141.21(f)(6)(i) or (ii) after use of Standard Methods 9221 B, 9221 D, 9222 B, or 9222 C.
8 EPA Method 1600: Enterococci in Water by Membrane Filtration Using membrane-Enterococcus Indoxyl-b-D-
Glucoside Agar (mEI) EPA 821-R-02-022 (September 2002) is an approved variation of Standard Method
9230C. The method is available at http://www.epa.gov/nerlcwww/1600sp02.pdf or EPA’s Water Resource
Center (RC-4100T), 1200 Pennsylvania Avenue, NW., Washington DC 20460. The holding time and
temperature for ground water samples are specified in footnote 1 above, rather than as specified in Section 8 of
EPA Method 1600.
9 Medium is available through IDEXX Laboratories, Inc., One IDEXX Drive, Westbrook, Maine 04092.
Preparation and use of the medium is set forth in the article “Evaluation of Enterolert for Enumeration of
Enterococci in Recreational Waters,” by Budnick, G.E., Howard, R.T, and Mayo, D.R., 1996, Applied and
Environmental Microbiology, 62:3881-3884.

(b) Public Water system required to monitor for turbidity by this Rule Chapter must use one
of the methods listed in the following table:

Table 1200-5-1-.14(10)(b)
Turbidity
4
Nephelometric Method 2130 B
NephelometricMethod 180.1
1

Great Lakes Instruments Method 2
2

Hach FilterTrak 10133
3

Footnotes
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
58
1 ‘‘Methods for the Determination of Inorganic Substances in Environmental Samples’’, EPA/600/R-93/100, August 1993.
Available at NTIS, PB94-121811.
2 GLI Method 2, ‘‘Turbidity’’, November 2, 1992, Great Lakes Instruments, Inc., 8855 North 55
th
Street, Milwaukee,
Wisconsin 53223.
3 A description of the Hach FilterTrak Method 10133, ‘‘Determination of Turbidity by Laser Nephelometry,’’ January 2000,
Revision 2.0, can be obtained from; Hach Co., P.O. Box 389, Loveland, CO 80539–0389, telephone: 800–227–4224.
4 Styrene divinyl benzene beads (e.g. AMCO-AEPA–1 or equivalent) and stabilized formazin (e.g. Hach StablCal TM or
equivalent) are acceptable substitutes for formazin.

(c) Public water systems required to monitor by this Rule Chapter for any Inorganic
contaminants listed in the following table must utilize one of the approved methods for
that contaminant listed in the following table:

Inorganic Contaminants Analytical Methods
Table 1200-5-1-.14(10)(c)


Contaminant Methodology
13
EPA ASTM
3

SM
4
(18th,
19th ed.)
SM
4
(20th
ed.)
SM Online
22
Other
1. Alkalinity Titrimetric
D1067-92, 02
B 2320 B 2320 B 2320 B-97
Electrometric titration I-1030-85
5

2. Antimony
Inductively Coupled
Plasma 200.8
2


(ICP)—Mass
Spectrometry

Hydride-Atomic
Absorption D3697-92, 02

Atomic
Absorption;Platform 200.9
2


Atomic Absorption;
Furnace 3113 B 3113 B-99
3. Arsenic ICP-Mass Spectrometry 200.8
2


Atomic
Absorption;Platform 200.9
2


Atomic Absorption;
Furnace
D2972-97, 03
C 3113 B 3113 B-99

Hydride Atomic
Absorption
D2972-97, 03
B 3114 B 3114 B-97
4. Asbestos Transmission Electron 100.1
9

Microscopy
Transmission Electron 100.2
10

Microscopy
5. Barium
Inductively Coupled
Plasma 200.7
2
3120 B 3120 B 3120 B-99
ICP-Mass Spectrometry 200.8
2

Atomic Absorption; Direct 3111D 3111 D-99

Atomic Absorption;
Furnace 3113 B 3113 B-99
6. Beryllium
Inductively Coupled
Plasma 200.7
2
3120 B 3120 B 3120 B-99
ICP-Mass Spectrometry 200.8
2


Atomic
Absorption;Platform 200.9
2


Atomic Absorption;
Furnace
D3645-97, 03
B 3113 B 3113 B-99
7. Cadmium
Inductively Coupled
Plasma 200.7
2

ICP-Mass Spectrometry 200.8
2

Atomic 200.9
2

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
59
Absorption;Platform

Atomic Absorption;
Furnace 3113 B 3113 B-99
8. Calcium EDTA titrimetric D511-93, 03 A 3500-Ca D 3500-Ca B
3500-Ca B-
97
Atomic Absorption; Direct D511-93, 03 B 3111 B 3111 B-99
Aspiration.

Inductively Coupled
Plasma 200.7
2
3120 B 3120 B 3120 B-99
Ion Chromatography D6919-03
9. Chromium
Inductively Coupled
Plasma 200.7
2
3120 B 3120 B 3120 B-99
ICP-Mass Spectrometry 200.8
2


Atomic
Absorption;Platform 200.9
2


Atomic Absorption;
Furnace 3113 B 3113 B-99
10. Copper
Atomic Absorption;
Furnace
D1688-95, 02
C 3113 B 3113 B-99
Atomic Absorption; Direct
D1688-95, 02
A 3111 B 3111 B-99
Aspiration.

Inductively Coupled
Plasma 200.7
2
3120 B 3120 B 3120 B-99
ICP-Mass spectrometry 200.8
2


Atomic
Absorption;Platform 200.9
2

11.Conductivit
y Conductance 2510 B 2510 B 2510 B-97

D1125-95
(Reapproved
1999) A

12. Cyanide Manual Distillation D2036-98 A 4500-CN⎯ C
4500-CN⎯
C
followed by
Spectrophotometric, D2036-98 B 4500-CN⎯ G
4500-
CN⎯G 4500-CN⎯ G-
Amenable. 99
Spectro-photometric D2036-98 A 4500-CN⎯E
4500-CN⎯
E 4500-CN⎯ E- I-3300-85
5
Manual. 99
Spectro-photometric 335.4
6

Semi-automated.
Selective Electrode 4500-CN⎯ F
4500-CN⎯
F 4500-CN⎯ F-
99
UV, Distillation,
Kelada-01
16

Spectrophotometric.
Micro Distillation, Flow
Injection,
Spectrophotometric.
QuikChem
10-
204-00-1-
X
17

Ligand Exchange and D6888-04 OIA-1677,
Amperometry
19
DW
19

13. Fluoride Ion Chromatography 300.0
6
, D4327-97, 03 4110 B 4110 B 4110 B-00
300.1
18

Manual Distill; Color. 4500-F⎯ B, D 4500-F⎯ B,
4500-F⎯ B,
D-
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
60
SPADNS. D 97
Manual Electrode
D1179-93, 99
B 4500-F⎯ C 4500-F⎯ C 4500-F⎯ C-97
Automated Electrode
380-75WE
11

Automated Alizarin 4500-F⎯ E 4500-F⎯ E 4500-F⎯ E-97 129-71W
11

Capillary Ion
Electrophoresis
D6508,
Rev. 2
22

14. Lead
Atomic Absorption;
Furnace
D3559-96, 03
D 3113 B 3113 B-99
ICP-Mass spectrometry 200.8
2


Atomic
Absorption;Platform 200.9
2



Differential Pulse Anodic
Stripping Voltametry
Method
1001
15

15.
Magnesium Atomic Absorption D511-93, 03 B 3111 B 3111 B-99
ICP 200.7
2
3120 B 3120 B 3120 B-99
Complexation Titrimetric D511-93, 03 A 3500-Mg E 3500-Mg B
3500-Mg B-
97
Methods
Ion Chromatography D6919-03
16. Mercury Manual, Cold Vapor 245.1
2
D3223-97, 02 3112 B 3112 B-99
Automated, Cold Vapor 245.2
1

ICP-Mass Spectrometry 200.8
2

17. Nickel
Inductively Coupled
Plasma 200.7
2
3120 B 3120 B 3120 B-99
ICP-Mass Spectrometry 200.8
2


Atomic
Absorption;Platform 200.9
2

Atomic Absorption; Direct 3111 B 3111 B-99

Atomic Absorption;
Furnace 3113 B 3113 B-99
18. Nitrate Ion Chromatography 300.0
6
D4327-97, 03 4110 B 4110 B 4110 B-00 B-1011
8

300.1
2

Automated Cadmium 353.2
6
D3867-90 A 4500-NO
3
⎯ F
4500-
NO
3
⎯F
4500-NO
3
⎯ F-
00
Reduction
Ion Selective Electrode 4500-NO
3
⎯ D
4500-
NO
3
⎯D
4500-NO
3
⎯ D
-00 601
7

Manual Cadmium D3867-90 B 4500-NO
3
⎯ E
4500-
NO
3
⎯E
4500-NO
3

E-00
Reduction
Capillary Ion
D6508, Rev
2
22

Electrophoresis
19. Nitrite Ion Chromatography 300.0
6
D4327-97, 03 4110 B 4110 B 4110 B-00 B-1011
8

300.1
2

Automated Cadmium 353.2
6
D3867-90 A 4500-NO
3
⎯ F
4500-
NO
3
⎯F
4500-NO
3
⎯ F
-00
Reduction

Manual Cadmium
Reduction D3867-90 B 4500-NO
3
⎯E
4500-
NO
3
⎯E
4500-N O
3

E-00
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
61
Spectrophotometric 4500-NO
2
⎯B
4500-
NO
2
⎯B
4500-NO
2
⎯B-
00
Capillary Ion
D6508,
Rev.
Electrophoresis 2
22

20. Ortho-
phos- Colorimetric, Automated, 365.1
6
4500-P F 4500-P F
phate
12
Ascorbic Acid.
Colorimetric, ascorbic D515-88 A 4500-P E 4500-P E
acid, single reagent.
Colorimetric I-1601-85
5
Phosphomolybdate;
Automated-seg- I-2601-90
5
mented flow;
Automated Discrete I-2598-85
5
Ion Chromatography 300.0
6
D4327-97, 03 4110 B 4110 B 4110 B-00
300.1
18

Capillary Ion Electro-
D6508,
Rev.
phoresis. 2
22

21. pH Electrometric 150.1, D1293-95, 99 4500-H
+
B 4500-H
+
B
4500-H
+
B -
00
150.2
1

22. Selenium
Hydride-Atomic
Absorption
D3859-98, 03
A 3114 B 3114 B-97
ICP-Mass Spectrometry 200.8
2


Atomic
Absorption;Platform 200.9
2


Atomic Absorption;
Furnace
D3859-98, 03
B 3113 B 3113 B-99

23. Silica Colorimetric, Molybdate I-1700-85
5
Blue

Automated-
segmentedFlow I-2700-85
5
Colorimetric D859-94, 00.
Molybdosilicate . 4500-Si D
4500-SiO2
C
4500-SiO2
C-
97
4500-Si E

Heteropoly blue


4500-SiO2
D
4500-SiO2
D-
97
Automated for Molyb- 4500-Si F
4500-SiO2
E
4500-SiO2
E-
date-reactive Silica. 97

Inductively Coupled
Plasma 200.7
2
3120 B 3120 B 3120 B-99
24. Sodium
Inductively Coupled
Plasma 200.7
2

Atomic Absorption; Direct 3111 B 3111 B-99
Aspiration.
Ion Chromatography D6919-03
25.
Temperature Thermometric 2550 2550 2550-00
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
62
26. Thallium ICP-Mass Spectrometry 200.8
2


Atomic
Absorption;Platform 200.9
2


Footnotes
1. ‘‘Methods for Chemical Analysis of Water and Wastes,’’ EPA/600/4-79/020, March 1983. Available at NTIS, PB84-
128677.
2. ‘‘Methods for the Determination of Metals in Environmental Samples—Supplement I,’’ EPA/600/R-94/111, May 1994.
Available at NTIS, PB95-125472.
3. Annual Book of ASTM Standards, 1994, 1996, 1999, or 2003, Vols. 11.01 and 11.02, ASTM International; any year
containing the cited version of the method may be used. The previous versions of D1688-95A, D1688-95C (copper),
D3559-95D (lead), D1293-95 (pH), D1125-91A (conductivity) and D859-94 (silica) are also approved. These previous
versions D1688-90A, C; D3559-90D, D1293-84, D1125-91A and D859-88, respectively are located in the Annual Book of
ASTM Standards, 1994, Vol. 11.01. Copies may be obtained from ASTM International, 100 Barr Harbor Drive, West
Conshohocken, PA 19428.
4. Standard Methods for the Examination of Water and Wastewater, 18th edition (1992), 19th edition (1995), or 20th edition
(1998). American Public Health Association, 1015 Fifteenth Street, NW., Washington, DC 20005. The cited methods
published in any of these three editions may be used, except that the versions of 3111 B, 3111 D, 3113 B and 3114 B in
the 20th edition may not be used.
5. Method I-2601-90, Methods for Analysis by the U.S. Geological Survey National Water Quality Laboratory—Determination
of Inorganic and Organic Constituents in Water and Fluvial Sediment, Open File Report 93-125, 1993; For Methods I-
1030-85; I-1601-85; I-1700-85; I-2598-85; I-2700-85; and I-3300-85 See Techniques of Water Resources Investigation of
the U.S. Geological Survey, Book 5, Chapter A-1, 3rd edition., 1989; Available from Information Services, U.S. Geological
Survey, Federal Center, Box 25286, Denver, CO 80225-0425.
6. ‘‘Methods for the Determination of Inorganic Substances in Environmental Samples,’’ EPA/600/R-93/100, August 1993.
Available at NTIS, PB94-120821.
7. The procedure shall be done in accordance with the Technical Bulletin 601 ’’ Standard Method of Test for Nitrate in
Drinking Water,’’ July 1994, PN 221890-001, Analytical Technology, Inc. Copies may be obtained from ATI Orion, 529
Main Street, Boston, MA 02129.
8. Method B-1011, ‘‘Waters Test Method for Determination of Nitrite/Nitrate in Water Using Single Column Ion
Chromatography,’’ August 1987. Copies may be obtained from Waters Corporation, Technical Services Division, 34
Maple Street, Milford, MA 01757, Telephone: 508/482-2131, Fax: 508/482-3625.
9. Method 100.1, ‘‘Analytical Method For Determination of Asbestos Fibers in Water,’’ EPA/600/4-83/043, EPA, September
1983. Available at NTIS, PB83-260471.
10. Method 100.2, ‘‘Determination of Asbestos Structure Over 10-µm In Length In Drinking Water,’’ EPA/600/R-94/134, June
1994. Available at NTIS, PB94-201902.
11. Industrial Method No. 129-71W, ‘‘Fluoride in Water and Wastewater,’’ December 1972, and Method No. 380-75WE,
‘‘Fluoride in Water and Wastewater,’’ February 1976, Technicon Industrial Systems. Copies may be obtained from Bran &
Luebbe, 1025 Busch Parkway, Buffalo Grove, IL 60089.
12. Unfiltered, no digestion or hydrolysis.
13. Because MDLs reported in EPA Methods 200.7 and 200.9 were determined using a 2x preconcentration step during
sample digestion, MDLs determined when samples are analyzed by direct analysis (i.e., no sample digestion) will be
higher. For direct analysis of cadmium and arsenic by Method 200.7, and arsenic by Method 3120 B, sample
preconcentration using pneumatic nebulization may be required to achieve lower detection limits. Preconcentration may
also be required for direct analysis of antimony, lead, and thallium by Method 200.9; antimony and lead by Method 3113
B; and lead by Method D3559-90D, unless multiple in-furnace depositions are made.
14. If ultrasonic nebulization is used in the determination of arsenic by Methods 200.7, 200.8, or SM 3120 B, the arsenic must
be in the pentavalent state to provide uniform signal response. For Methods 200.7 and 3120 B, both samples and
standards must be diluted in the same mixed acid matrix concentration of nitric and hydrochloric acid with the addition of
100 µL of 30% hydrogen peroxide per 100 mL of solution. For direct analysis of arsenic with Method 200.8 using
ultrasonic nebulization, samples and standards must contain 1 mg/L of sodium hypochlorite.
15. The description for Method Number 1001 for lead is available from Palintest, LTD, 21 Kenton Lands Road, P.O. Box
18395, Erlanger, KY 41018. Or from the Hach Company, P.O. Box 389, Loveland, CO 80539.
16. The description for the Kelada-01 Method, ‘‘Kelada Automated Test Methods for Total Cyanide, Acid Dissociable Cyanide,
And Thiocyanate,’’ Revision 1.2, August 2001, EPA # 821-B01-009 for cyanide is available from the National Technical
Information Service (NTIS), PB 2001-108275, 5285 Port Royal Road, Springfield, VA 22161. The toll free telephone
number is 800-553-6847. Note: A 450-W UV lamp may be used in this method instead of the 550-W lamp specified if it
provides performance within the quality control (QC) acceptance criteria of the method in a given instrument. Similarly,
modified flow cell configurations and flow conditions may be used in the method, provided that the QC acceptance criteria
are met.
17. The description for the QuikChem Method 10-204-00-1-X, ‘‘Digestion and distillation of total cyanide in drinking and
wastewaters using MICRO DIST and determination of cyanide by flow injection analysis,’’ Revision 2.1, November 30,
2000, for cyanide is available from Lachat Instruments, 6645 W. Mill Rd., Milwaukee, WI 53218. Telephone: 414-358-
4200.
18. ‘‘Methods for the Determination of Organic and Inorganic Compounds in Drinking Water,’’ Vol. 1, EPA 815-R-00-014,
August 2000. Available at NTIS, PB2000-106981.
19. Method OIA-1677, DW ‘‘Available Cyanide by Flow Injection, Ligand Exchange, and Amperometry,’’ January 2004. EPA-
821-R-04-001, Available from ALPKEM, A Division of OI Analytical, P.O. Box 9010, College Station, TX 77842-9010.
20. Sulfide levels below those detected using lead acetate paper may produce positive method interferences. Test samples
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
63
using a more sensitive sulfide method to determine if a sulfide in-terference is present, and treat samples accordingly.
21. Standard Methods Online are available at http://www.standardmethods.org. The year in which each method was
approved by the Standard Methods Committee is designated by the last two digits in the method number. The methods
listed are the only online versions that may be used.
22. Method D6508, Rev. 2, ‘‘Test Method for Determination of Dissolved Inorganic Anions in Aqueous Matrices Using
Capillary Ion Electrophoresis and Chromate Electrolyte,’’ available from Waters Corp, 34 Maple St, Milford, MA, 01757,
Telephone: 508/482-2131, Fax: 508/482-3625.

(d) Detection Limits for Inorganic methodology specified below must be equal to or less
than the requirements in the following:

Table 1200-5-1-.14(10)(d)
Detection Limits for Inorganic Contaminants
MCL Detection
Contaminant (mg/l) Methodology limit (mg/1)

Antimony 0.006 Atomic Absorption Furnace 0.003
Atomic Absorption: Platform 0.0008
5

ICP-Mass Spectrometry 0.0004
Hydride-Atomic Absorption 0.001
Arsenic 0.01
6
Atomic Absorption Furnace 0.001
Atomic Absorption: Platform
Stabilized Temperature
7
0.0005
Atomic Absorption: Gaseous Hydride 0.001
ICP-Mass Spectrometry
8
0.0014
Asbestos 7 MFL
1
Transmission Electron Microscopy 0.01 MFL
Barium 2 Atomic Absorption; furnace technique 0.002
Atomic Absorption; Direct Aspiration 0.1
Inductively Coupled Plasma 0.002(0.001)

Beryllium 0.004 Atomic Absorption; Furnace 0.0002
Atomic Absorption; Platform 0.00002
5
Inductively Coupled Plasma
2
0.0003
ICP-Mass Spectrometry 0.0003
Cadmium 0.005 Atomic Absorption; furnace technique 0.0001
Inductively Coupled Plasma 0.001

Chromium 0.1 Atomic Absorption; furnace technique 0.001
Inductively Coupled Plasma 0.007(0.001)

Cyanide 0.2 Distillation, Spectrophotometric
3
0.02
Distillation, Automated Spectrophotometric
3
0.005
Distillation, Selective Electrode
3
0.05
Distillation, Amenable, Spectrophotometric
4
0.02
Mercury 0.002 Manual Cold Vapor Technique 0.0002
Automated Cold Vapor Technique 0.0002
Nickel 0.1 Atomic Absorption; Furnace 0.001
Atomic Absorption; Platform 0.0006
5
Inductively Coupled Plasma
2
0.005
ICP-Mass Spectrometry 0.0005
Nitrate 10 (as N) Manual Cadmium Reduction 0.01
Automated Hydrazine Reduction 0.01
Automated Cadmium Reduction 0.05
Ion Selective Electrode 1
Ion Chromatography 0.01
Nitrite 1 (as N) Spectrophotometric 0.01
Automated Cadmium Reduction 0.05
Manual Cadmium Reduction 0.01
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
64
Ion Chromatography 0.004
Selenium 0.05 Atomic Absorption; furnace 0.002
Atomic Absorption; gaseous hydride 0.002
Thallium 0.002 Atomic Absorption; Furnace 0.001
Atomic Absorption; Platform 0.0007
5
ICP-Mass Spectrometry 0.0003
___________________________________________________________________________________________
Footnotes
1 MFL = million fibers per liter > 10 microns.
2 Using a 2X preconcentration step as noted in Method 200.7 Lower method detection limits (MDLs) may be achieved
using a 4X preconcentration.
3 Screening method for total cyanides.
4 Measures "free" cyanides.
5 Lower MDLs are reported using stabilized temperature graphite furnace atomic absorption.
6 The value for arsenic is effective January 23, 2006. Until then the MCL is 0.05 mg/L.
7. The MDL reported for EPA method 200.9 (Atomic Absorption; Platform-Stabilized Temperature) was determined using
a 2X concentration step during sample digestion. The MCL determined for samples analyzed using direct analyses (i.e,
no sample digestion) will be higher. Using multiple depositions, EPA 200.9 is capable of obtaining MDL of 0.0001
mg/L.
8 Using selective ion monitoring, EPA Method 200.8 (ICP-MS) is capable of obtaining a MDL of 0.0001 mg/L.


1. Laboratories must achieve the method detection limit for lead of 0.001 mg/l
according to the procedures in appendix B of part 136 of 40 CFR. This need
only be accomplished if the laboratory will be processing source water composite
samples under Rule 1200-5-1-.33(9)(a)1(iii).

(i) Lead: 0.001 mg/l (only if source water compositing is done under Rule
1200-5-1-.09); and

(ii) Copper: 0.001 mg/l or 0.020 mg/l when atomic absorption direct aspiration
is used (only if source water compositing is done under Rule
1200-5-1-.09).

2. The Department has the authority to allow the use of previously collected
monitoring data, if the data were collected and analyzed in accordance with the
requirements of this rule.

3. All lead levels measured between the PQL and the MDL must be either reported
as measured or they can be reported as one-half the PQL (0.0025 mg/l). All
levels below the lead MDL must be reported as zero; and

4. All copper levels measured between PQL and the MDL must be either reported
as measured or they can be reported as one-half the PQL (0.025 mg/l). All
levels below the copper MDL must be reported as zero.

(e) Laboratories must analyze PE samples within the following acceptance criteria:

Contaminant Acceptance limit
Antimony ±30 at ≥0.006 mg/1
Arsenic ±30 at ≥0.003 mg/l
Asbestos
2 standard deviations based on
study statistics
Barium ±15% at ≥0.15 mg/1
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
65
Beryllium ±15% at ≥0.001 mg/1
Cadmium ±20% at ≥0.002 mg/1
Chromium ±15% at ≥0.01 mg/1
Cyanide ±25% at ≥0.1 mg/1
Fluoride ±10% at ≥1 to 10 mg/1
Mercury ±30% at ≥0.0005 mg/1
Nickel ±15% at ≥0.01 mg/1
Nitrate ±10% at ≥0.4 mg/1
Nitrite ±15% at ≥0.4 mg/1
Selenium ±20% at ≥0.01 mg/1
Thallium ±30% at ≥0.002 mg/1

(f) Sample collection for antimony, arsenic, asbestos, barium, beryllium, cadmium,
chromium, cyanide, fluoride, mercury, nickel, nitrate, nitrite, selenium, and thallium
under this Rule shall be conducted using the sample preservation, container, and
maximum holding time procedures specified in the table below:

Table 1200-5-1-.14(10)(f)

Contaminant Preservative
1
Container
2
Time
3

Antimony HNO
3
P or G 6 months
Arsenic Conc HNO
3
to pH <2 P or G 6 months
Asbestos 4°C P or G 48 hours
4

Barium HNO
3
P or G 6 months
Beryllium HNO
3
P or G 6 months
Cadmium HNO
3
P or G 6 months
Chromium HNO
3
P or G 6 months
Cyanide 4°C, NaOH P or G 14 days
Fluoride None P or G 1 month
Mercury HNO
3
P or G 28 days
Nickel HNO
3
P or G 6 months
Nitrate 4°C P or G 48 hours
5

Nitrate-Nitrite 6 H
2
SO
4
P or G 28 days
Nitrite 4°C P or G 48 hours
Selenium HNO
3
P or G 6 months
Thallium HNO
3
P or G 6 months

Footnotes
1 For cyanide determinations samples must be adjusted with sodium hydroxide to pH 12 at the time off collection.
When chilling is indicated the sample must be shipped and stored at 4 °C or less. Acidification of nitrate or metals
samples may be with a concentrated acid or a dilute (50% by volume) solution of the applicable concentrated acid.
Acidification of samples for metals analysis is encouraged and allowed at the laboratory rather than at the time of
sampling provided the shipping time and other instructions in Section 8.3 of EPA Methods 200.7 or 200.8 or 200.9
are followed.
2 P=plastic, hard or soft; G=glass, hard or soft.
3 In all cases samples should be analyzed as soon after collection as possible. Follow additional (if any) information on
preservation, containers or holding times that is specified in method.
4 Instructions for containers, preservation procedures and holding times as specified in Method 100.2 must be adhered
to for all compliance analyses including those conducted with Method 100.1.
5 If the sample is chlorinated, the holding time for an unacidified sample kept at 4 °C is extended to 14 days.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
66
6 Nitrate-Nitrite refers to a measurement of total nitrate.


(g) Certified Laboratories performing analyses for Public Water Systems as required by
this rule chapter must utilize an approved method for Organic contaminants listed in the
following table:

Table 1200-5-1-.14(10)(g)

Contaminant EPA method
1
Standard
Methods
ASTM Other
1. Benzene 502.2, 524.2
2. Carbon tetrachloride 502.2, 524.2, 551.1
3. Chlorobenzene 502.2, 524.2
4. 1,2-Dichlorobenzene 502.2, 524.2
5. 1,4-Dichlorobenzene 502.2, 524.2
6. 1,2-Dichloroethane 502.2, 524.2
7. cis-Dichloroethylene 502.2, 524.2
8. trans-Dichloroethylene 502.2, 524.2
9. Dichloromethane 502.2, 524.2
10. 1,2-Dichloropropane 502.2, 524.2
11. Ethylbenzene 502.2, 524.2
12. Styrene 502.2, 524.2
13. Tetrachloroethylene 502.2, 524.2, 551.1
14. 1,1,1-Trichloroethane 502.2, 524.2, 551.1
15. Trichloroethylene 502.2, 524.2, 551.1
16. Toluene 502.2, 524.2
17. 1,2,4-Trichlorobenzene 502.2, 524.2
18. 1,1-Dichloroethylene 502.2, 524.2
19. 1,1,2-Trichloroethane 502.2, 524.2, 551.1
20. Xylenes (total) 502.2, 524.2
21. Vinyl chloride 502.2, 524.2
22. 2,3,7,8-TCDD (dioxin) 1613
23. 2,4-D
4
(as acid, salts and
esters)
515.2, 555, 515.1, 515.3, 515.4 D5317–93,98
(Reapproved
2003)

24. 2,4,5-TP
4
(Silvex) 515.2, 555, 515.1, 515.3, 515.4 D5317–93,98
(Reapproved
2003)

25. Alachlor
2
507, 525.2, 508.1, 505, 551.1
26. Atrazine
2
507, 525.2, 508.1, 505, 551.1 Syngenta
5
AG–
625
27. Benzo(a)pyrene 525.2, 550, 550.1
28. Carbofuran 531.1, 531.2 6610
29. Chlordane 508, 525.2, 508.1, 505
30. Dalapon 552.1, 515.1, 552.2, 515.3, 515.4,
552.3

31. Di(2-ethylhexyl)adipate 506, 525.2
32. Di(2-ethylhexyl)phthalate 506, 525.2
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
67
33. Dibromochloropropane (DBCP) 504.1, 551.1
34. Dinoseb
4
515.2, 555, 515.1, 515.3, 515.4
35. Diquat 549.2
36. Endothall 548.1
37. Endrin 508, 525.2, 508.1, 505, 551.1
38. Ethylene dibromide (EDB) 504.1, 551.1
39. Glyphosate 547 6651
40. Heptachlor 508, 525.2, 508.1, 505, 551.1
41. Heptachlor Epoxide 508, 525.2, 508.1, 505, 551.1
42. Hexachlorobenzene 508, 525.2, 508.1, 505, 551.1
43. Hexachlorocyclopentadiene 508, 525.2, 508.1, 505, 551.1
44. Lindane 508, 525.2, 508.1, 505, 551.1
45. Methoxychlor 508, 525.2, 508.1, 505, 551.1
46. Oxamyl 531.1, 531.2 6610
47. PCBs
3
(as decachlorobiphenyl) 508A
48. PCBs
3
(as Aroclors) 508.1, 508, 525.2, 505
49. Pentachlorophenol 515.2, 525.2, 555, 515.1, 515.3,
515.4
D5317–93,98
(Reapproved
2003)

50. Picloram
4
515.2, 555, 515.1, 515.3, 515.4 D5317–93,98
(Reapproved
2003)

51. Simazine
2
507, 525.2, 508.1, 505, 551.1
52. Toxaphene 508, 508.1, 525.2, 505

Footnotes
1. Previously approved EPA methods remain available for compliance monitoring until June 1, 2001. EPA methods 502.2
Rev. 2.0, 505 Rev. 2.0, 507 Rev. 2.0, 508 Rev. 3.0, 531.1 Rev. 3.0 are in ``Methods for the Determination of Organic
Compounds in Drinking Water'', December 1988, revised July 1991; methods 506 and 551 are in ``Methods for the
Determination of Organic Compounds in Drinking Water--Supplement I'', July 1990; methods 515.2 Rev. 1.0 and 524.2
Rev. 4.0 are in ``Methods for the Determination of Organic Compounds in Drinking Water--Supplement II,'' August 1992;
and methods 504.1 Rev. 1.0, 508.1 Rev. 1.0, 525.2 Rev.1.0 are available from US EPA NERL, Cincinnati, OH 45268
2. Substitution of the detector specified in Method 505, 507, 508, or 508.1 for the purpose of achieving lower detection limits
is allowed as follows: Either an electron capture or nitrogen phosphorus detector may be used provided all regulatory
requirements and quality control criteria are met.
3. PCBs are qualitatively identified as Aroclors and measured for compliance purposes as decachlorobiphenyl. Users of
Method 505 may have more difficulty in achieving the required detection limits than users of Methods 508.1, 525.2 or 508.
4. Accurate determination of the chlorinated esters requires hydrolysis of the sample as described in EPA Methods 515.1,
515.2, 515.3, 515.4, and 555 and ASTM Method D 5317–93, 98 (Reapproved 2003).
5. This method may not be used for the analysis of atrazine in any system where chlorine dioxide is used for drinking water
treatment. In samples from all other systems, any result for atrazine generated by Method AG–625 that is greater than
one-half the maximum contaminant level (MCL) (in other words, greater than 0.0015mg/L or 1.5 μg/L) must be confirmed
using another approved method for this contaminant and should use additional volume of the original sample collected for
compliance monitoring. In instances where a result from Method AG–625 triggers such confirmatory testing, the
confirmatory result is to be used to determine compliance.


1. To obtain certification for contaminants 1 through 20 listed in Table 1200-5-1-
.14(10)(g) laboratories must:

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
68
(i) Successfully analyze 80% of the contaminants included in the PE sample.
To successfully analyze a contaminant a laboratory must achieve
quantitative results which are: within ±40% of the actual amount in the PE
sample when the actual amount is less than 0.010 mg/l, within ±20% of the
actual amount in the PE sample when the actual amount is greater than or
equal to 0.010 mg/l.

(ii) Achieve a method detection limit of 0.0005 mg/l, according to the
procedures in 40 CFR part 136 Appendix B.

2. To obtain certification for vinyl chloride a laboratory must:

(i) Achieve quantitative results on PE samples which are within ±40% of the
actual amount of vinyl chloride in the PE sample.

(ii) Achieve a method detection limit of 0.0005 mg/l, according to the
procedures in 40 CFR part 136 Appendix B.

(iii) Achieve certification for contaminants 1 through 20 listed in Table 1200-5-
1-.14(10)(g).

3. To obtain certification for contaminants 22 through 52 listed in Table 1200-5-1-
.14(10)(g) certified laboratories must achieve quantitative results on PE samples
within the following acceptance limits:

Table 1200-5-1-.14(10)(g)3.
_________________________________________________________________________________________
Contaminant Acceptance limits
(percent)
_________________________________________________________________________________________

DBCP + 40
EDB + 40
Alachlor + 45
Atrazine + 45
Benzo[a]pyrene 2 standard deviations
Carbofuran + 45
Chlordane + 45
Dalapon 2 standard deviations
Di(2-ethylhexyl)adipate 2 standard deviations
Di(2-ethylhexyl)phthalate 2 standard deviations
Dinoseb 2 standard deviations
Diquat 2 standard deviations
Endothall 2 standard deviations
Endrin + 30
Glyphosate 2 standard deviations
Heptachlor + 45
Heptachlor Epoxide + 45
Hexachlorobenzene 2 standard deviations.
Hexachlorocyclopentadiene 2 standard deviations
Lindane + 45
Methoxychlor + 45
Oxamyl 2 standard deviations
PCBs (as Decachlorobiphenyl) 0 - 200
Picloram 2 standard deviations
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
69
Simazine 2 standard deviations
Toxaphene + 45
Aldicarb 2 standard deviations
Aldicarb sulfoxide 2 standard deviations
Aldicarb sulfone 2 standard deviations.
Pentachlorophenol + 50
2,3,7,8-TCDD (Dioxin) 2 standard deviations
2,4-D + 50
2,4,5-TP (Silvex) + 50

4. Analysis for PCBs shall be conducted as follows:

(i) Each system which monitors for PCBs shall analyze each sample using
either Methods 508.1, 525.2, 508, or 505. Users of Method 505 may have
more difficulty in achieving the required Aroclor detection limits than users
of Methods 508.1, 525.2 or 508.

(ii) If PCBs (as one of seven Aroclors) are detected (as designated by Table
1200-5-1-.14(10)(e)4.(ii) in any sample analyzed using Methods 505 or
508, the system shall reanalyze the sample using Method 508A to
quantitate PCBs (as decachlorobiphenyl).

Table 1200-5-1-.14 (10)(g)4.(ii)

Aroclor Detection Limit (mg/l)

1016 0.00008
1221 0.02
1232 0.0005
1242 0.0003
1248 0.0001
1254 0.0001
1260 0.0002

(iii) Compliance with the PCB MCL shall be determined based upon the
quantitative results of analyses using Method 508A.

(h) Analytical methods used to determine compliance with Rule 1200-5-1-.06(5) shall be in
accordance with Table 1200-5-1-.14(10)(h).
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
70
Table 1200-5-1-.14(10)(h)

Reference (method or page number)
Contaminant Methodology EPA
1
EPA
2
EPA
3
EPA
4
SM
5
ASTM
6
USGS
7
DOE
8
Other
Naturally occurring:
Gross alpha
11
and beta. Evaporation 900.0 p 1 00-01 p 1 302, 7110 B R-1120-76
Gross alpha
11
Co-precipitation 00-02 7110 C
Radium 226 Radon emanation 903.1 p 16 Ra-
04
p 19 7500-Ra C D 3454-91 R-1141-76 Ra-05 N.Y.
9

Radio chemical 903.0 p 13 Ra-
03
304, 305, 7500-Ra B D 2460-91 R-1140-76 GA
14
Radium 228 Radio chemical 904.0 p 24 Ra-
05
p 19 304, 7500-Ra D R-1142-76 N. Y.
9
N. J.
10

Uranium
12
Radio chemical 908.0 7500-U B
Fluorometric 908.1 7500-U C (17
th
Ed.) D 2907-91 R-1180-76 R-1181-
76
U-04
ICP-MS 200.8
1
3
3125 D 5673-03
Alpha spectrometry 00-07 P 33 7500-U C (18
th
or 19
th

Ed.)
D 3972-90 R-1182-76 U-02
Laser Phosophorimetry D 5174-91
Man-made
Radioactive cesium.
Radio chemical 901.0 p 4 7500-Cs B D 2459-72 R-1111-76
Gamma ray
spectrometry.
901.1 p 92 7120 (19
th
Ed.) D 3649-91 R-1110-76 4.5.2.3
Radioactive iodine Radio chemistry 902.0 p 6
p 9
7500-I B
7500-I C
7500-I D
D 3649-91
Gamma ray
spectrometry.
901.1 p 92 7120 (19
th
Ed.) D 4785-88 4.5.2.3
Radioactive Strontium 89,
90.
Radio chemical 905.0 p 29 Sr-04 p 65 303, 7500-Sr B R-1160-76 Sr-01
Sr-02

Tritium Liquid scintillation 906.0 p 34 H-02 p 87 306, 7500-3H B D 4107-91 R-1171-76
Gamma emitters Gamma ray 901.1 p 92 7120 (19
th
Ed.) D 3649-91 R-1110-76 4.5.2.3
Spectrometry 902.0
901.0
7500-Cs B
7500-I B
D 4785-88
The procedures shall be done in accordance with the documents listed below. The incorporation by reference of documents 1 through 10 was approved by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the documents may be obtained from the sources listed below. Information reguarding obtaining these
documents can be obtained from the Safe Drinking Water Hotline at 800-426-4691. Documents may be inspected at EPA’s Drinking Water Docket, 401 M Street, SW., Washington, DC
20460 (Telephone: 202-260-3027); or at the Office of Federal Register, 800 North Capitol Street, NW., Suite 700, Washington, DC.
Footnotes
1 “Prescribed Procedures for Measurement of Radioactivity in Drinking Water”, EPA 600/4-80-032, August 1980. Available at U. S. Department of Commerce, National
Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161 (Telephone 800-553-6847), PB 80-224744.
2 “Interim Radiochemical Methodology for Drinking Water”, EPA 600/4-75-008(revised), March 1976. Available at NTIS, ibid. PB 253258.
3 “Radiochemistry Procedures Manual”, EPA 520/5-84-006, December 1987. Available at NTIS, ibid. PB 84-215581.
4 “Radiochemical Analytical Procedures for Analysis of Environmental Samples”, March 1979. Available at NTIS, ibid. EMSL LV 053917.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
71
5 “Standard Methods for the Examination of Water and Wastewater”, 13
th
, 17
th
, 18
th
, 19
th
Editions, 1971, 1989, 1992, 1995. Available at American Public Health Association,
1015 Fifteenth Street N. W., Washington, D. C. 20005. All methods are in the 17
th
, 18
th
, and 19
th
editions except 7500-U C Fluorometric Uranium was discontinued after the
17
th
Edition, 7120 Gamma Emitters is only in the 19
th
Edition, and 302, 303, 304, 305 and 306 are only in the 13
th
Edition.
6 Annual Book of ASTM Standards, Vol. 11.02, 1994. Available at American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428.
7 “Methods for Determination of Radioactive Substances in Water and Fluvial Sediments”, Chapter A5 in Book 5 of Techniques of Water-Resources Investigations of the United
States Geological Survey, 1977. Available at U. S. Geological Survey (USGS) Information Services, Box 25286, Federal Center, Denver, CO 80225-0425.
8 “EML Procedures Manual”, 27
th
Edition, Volume 1, 1990. Available at the Environmental Measurements Laboratory, U. S. Department of Energy (DOE), 376 Hudson Street,
New York, NY 10014-3621.
9 “Determination of Ra-226 and Ra-228 (Ra-02)”, January 1980, Revised June 1982. Available at Radiological Sciences Institute Center for Laboratories and Research, New
York State Department of Health, Empire State Plaza, Albany, NY 12201.
10 “Determination of Radium 228 in Drinking Water”, August 1980. Available at State of New Jersey, Department of Environmental Protection, Division of Environmental Quality,
Bureau of Radiation and Inorganic Analysis Services, 9 Ewing Street, Trenton, NJ 08625.
11 Natural uranium and thorium-230 are approved as gross alpha calibration standards for gross alpha with co-precipitation and evaporation methods; americium-241 is
approved with co-precipitation methods.
12 If uranium (U) is determined by mass, a 0.67 pCi/ug of uranium conversion factor must be used. This conservative factor is based on the 1:1 activity ratio of U-234 to U-238
that is characteristic of naturally occurring uranium.
13 ‘‘Determination of Trace Elements in Waters and Wastes by Inductively Coupled Plasma-Mass Spectrometry,’’ Revision 5.4, which is published in ‘‘Methods for the
Determination of Metals in Environmental Samples—Supplement I,’’ ’ EPA 600–R–94–111, May 1994. Available at NTIS, PB 95–125472.
14 ‘‘The Determination of Radium-226 and Radium-228 in Drinking Water by Gamma-ray Spectrometry Using HPGE or Ge(Li) Detectors,’’ Revision 1.2, December 2004.
Available from the Environmental Resources Center, Georgia Institute of Technology, 620 Cherry Street, Atlanta, GA 30332–0335, USA, Telephone: 404–894–3776. This
method may be used to analyze for radium-226 and radium-228 in samples collected after January 1, 2005 to satisfy the radium-226 and radium-228 monitoring requirements
specified at 40 CFR 141.26.


PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised) 72

1. When the identification and measurement of radionuclides other than those listed
in Table 1200-5-1-.11(1), the following references are to be used, except in
cases where alternative methods have been approved by the Department.

(i) Procedures for Radiochemical Analysis of Nuclear Reactor Aqueous
Solutions, H. L. Krieger and S. Gold, EPA-RA-73-014, USEPA, Cincinnati,
Ohio, May, 1973.

(ii) HASL Procedure Manual, Edited by John H. Harley, HASL 300, ERDA
Health and Safety Laboratory, New York, NY., 1973.

(i) Public Water Systems required to monitor disinfectant residuals by this Rule Chapter
must utilize one of the methods in the following table. In addition Water Systems may
use of the ITS free chlorine test strip for the determination of free chlorine. Use of the
test strips is described in Method D99–003, ‘‘Free Chlorine Species (HOCl- and OCl-)
by Test Strip,’’ Revision 3.0, November 21, 2003, available from Industrial Test
Systems, Inc., 1875 Langston St., Rock Hill, SC 29730. Free and total chlorine
residuals may be measured continuously by adapting a specified chlorine residual
method for use with a continuous monitoring instrument provided the chemistry,
accuracy, and precision remain the same. Instruments used for continuous monitoring
must be calibrated with a grab sample measurement at least every five days, or with a
protocol approved by the Department.

Table 1200-5-1-.14(10)(i)

Methodology SM (19th
or 20th ed)
SM
Online
2

Other Residual measured
1

O
3
Free Cl
2
Combined
Cl
2

Total Cl
2
ClO
2

Amperometric
Titration
4500-Cl D 4500-Cl-
D-00
D 1253-03
3
X X X
Low Level
Amperometric
Titration
4500-Cl E 4500-Cl-E-
00
X
DPD Ferrous
Titrimetric
4500-Cl F 4500-Cl-F-
00
X X X
DPD Colorimetric 4500-Cl G 4500-Cl-
G-00
X X X
Syringaldazine
(FACTS)
4500-Cl H 4500-Cl-
H-00
X
Iodometric
Electrode
4500-Cl I 4500-Cl-I-
00
X
DPD 4500-ClO
2
D
X
Amperometric
Method II
4500-ClO
2
E
4500 ClO
2

E-00
X
Spectrophotometr
ic
327.0 Rev
1.1
4
X
Indigo Method 4500-O
3
B 4500-O
3

B-97
X


Footnotes
1 X indicates method is approved for measuring specified disinfectant residual. Free chlorine or total chlorine may be
measured for demonstrating compliance with the chlorine MRDL and combined chlorine, or total chlorine may be
measured for demonstrating compliance with the chloramine MRDL.
2 The Standard Methods Online version that is approved is indicated by the last two digits in the method number which is
the year of approval by the Standard Method Committee. Standard Methods Online are available at
http://www.standardmethods.org.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
73
3 Annual Book of ASTM Standards, Vol. 11.01, 2004 ; ASTM International; any year containing the cited version of the
method may be used. Copies of this method may be obtained from ASTM International, 100 Barr Harbor Drive, P.O. Box
C700 West Conshohocken, PA 19428–2959.
4 EPA Method 327.0, Revision 1.1, ‘‘Determination of Chlorine Dioxide and Chlorite Ion in Drinking Water Using Lissamine
Green B and Horseradish Peroxidase with Detection by Visible Spectrophotometry,’’ USEPA, May 2005, EPA 815–R–05–
008. Available online at http://www.epa.gov/safewater/methods/sourcalt.html.


(j) Analysis conducted to determine compliance with Rule 1200-5-1-.12 shall be made in
accordance with the methods described in the following table:

Table 1200-5-1-.14(10)(j)

Contaminant EPA ASTM
3

SM
4
18th and 19th
ed. SM
4
20th ed. SM
7
Online Other
1. Aluminum 200.7
2
3120 B 3120 B 3120 B-99
200.8
2
3113 B 3113 B-99
200.9
2
3111 D 3111 D-99
2. Chloride 300.0
1
D4327–97, 03 4110 B 4110 B 4110 B-00
300.1
6
D512–89
Reapproved
1999) B 4500–Cl

D 4500–Cl

D 4500–Cl

D-97
4500–Cl

B 4500–Cl

B 4500–Cl

B-97



D6508, Rev.
2
8

3. Color 2120 B 2120 B 2120 B-01
4. Foaming Agents 5540 C 5540 C 5540 C-00
5. Iron 200.7
2
3120 B 3120 B 3120 B-99
200.9
2
3111 B 3111 B-99
3113 B 3113 B-99
6. Manganese 200.7
2
3120 B 3120 B 3120 B-99
200.8
2
3111 B 3111 B-99
200.9
2
3113 B 3113 B-99
7. Odor 2150 B 2150 B 2150 B-97
8. Silver 200.7
2
3120 B 3120 B 3120 B-99 I-3720-85
5

200.8
2
3111 B 3111 B-99
200.9
2
3113 B 3113 B-99
9. Sulfate 300.0
1
D4327–97, 03 4110 B 4110 B 4110 B-00
300.1
6

375.2
1
D516–90, 02 4500–SO
4
2–
F

4500–SO
4
2–
F


4500–SO
4
2–
C,D 4500–SO
4
2–
C,D
4500–SO
4
2–
E

4500–SO
4
2–
E



D6508, Rev.
2
8

10. Total Dissolved
Solids 200.7
2
2540 C 2540 C 2540 C-97
11. Zinc 200.8
2
3120 B 3120 B 3120 B-99
3111 B 3111 B-99

Footnotes
1 ‘‘Methods for the Determination of Inorganic Substances in Environmental Samples,’’ EPA/600/R–93–100, August 1993.
Available at NTIS, PB94–120821.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
74
2 ‘‘Methods for the Determination of Metals in Environmental Samples—Supplement I,’’ EPA/600/R–94–111, May 1994.
Available at NTIS, PB 95–125472.
3 Annual Book of ASTM Standards, 1994, 1996, 1999, or 2004, Vols. 11.01 and 11.02, ASTM International; any year
containing the cited version of the method may be used. Copies may be obtained from the ASTM International, 100 Barr
Harbor Drive, West Conshohocken, PA 19428.
4 Standard Methods for the Examination of Water and Wastewater, 18th edition (1992), 19th edition (1995), or 20th edition
(1998). American Public Health Association, 1015 Fifteenth Street, NW., Washington, DC 20005. The cited methods
published in any of these three editions may be used, except that the versions of 3111 B, 3111 D, and 3113 B in the 20th
edition may not be used.
5 Method I–3720–85, Techniques of Water Resources Investigation of the U.S. Geological Survey, Book 5, Chapter A–1,
3rd ed., 1989. Available from Information Services, U.S. Geological Survey, Federal Center, Box 25286, Denver, CO
80225–0425.
6 ‘‘Methods for the Determination of Organic and Inorganic Compounds in Drinking Water,’’ Vol. 1, EPA 815-R–00–014,
August 2000. Available at NTIS, PB2000–106981.
7 Standard Methods Online are available at http://www.standardmethods.org. The year in which each method was
approved by the Standard Methods Committee is designated by the last two digits in the method number. The methods
listed are the only online versions that may be used.
8 Method D6508, Rev. 2, ‘‘Test Method for Determination of Dissolved Inorganic Anions in Aqueous Matrices Using
Capillary Ion Electrophoresis and Chromate Electrolyte,’’ available from Waters Corp, 34 Maple St., Milford, MA, 01757,
Telephone: 508/482–2131, Fax: 508/482–3625.


(k) Disinfection byproducts

1. Systems required to monitor by this Rule Chapter for disinfection byproducts
must utilize the approved methods in the following table:

Table 1200-5-1-.14(10)(k)1.
Approved Methods for Disinfection Byproduct Compliance Monitoring
Contaminant and methodology
1
EPA method Standard method
2
SM online
9
ASTM method
3

TTHM
P&T/GC/ElCD & PID 502.2
4

P&T/GC/MS 524.2
LLE/GC/ECD 551.1

HAA5
LLE (diazomethane)/GC/ECD 6251 B
5
6251 B–94
SPE (acidic methanol)/GC/ECD 552.1
5

LLE (acidic methanol)/GC/ECD 552.2, 552.3

Bromate
Ion chromatography 300.1 D 6581–00
Ion chromatography & post
column reaction
317.0 Rev 2.0
6
,
326.0
6


IC/ICP–MS 321.8
6,7


Chlorite
Amperometric titration 4500–ClO
2
E
8
4500–ClO
2
E–00
8

Spectrophotometry 327.0 Rev 1.1
8

Ion chromatography 300.0, 300.1,
317.0 Rev 2.0,
326.0.
D 6581–00

1
P&T = purge and trap; GC = gas chromatography; ElCD = electrolytic conductivity detector; PID = photoionization detector; MS =
mass spectrometer; LLE = liquid/liquid extraction; ECD = electron capture detector; SPE = solid phase extraction; IC = ion
chromatography; ICP–MS = inductively coupled plasma/mass spectrometer.
2
19th and 20th editions of Standard Methods for the Examination of Water and Wastewater, 1995 and 1998, respectively, American
Public Health Association; either of these editions may be used.
3
Annual Book of ASTM Standards, 2001 or any year containing the cited version of the method, Vol 11.01.
4
If TTHMs are the only analytes being measured in the sample, then a PID is not required.
5
The samples must be extracted within 14 days of sample collection.
6

Ion chromatography & post column reaction or IC/ICP-MS must be used for monitoring of bromate for purposes of demonstrating
eligibility of reduced monitoring, as prescribed in Rule 1200-5-1-.36(6)(b)3(ii).
7

Samples must be preserved at the time of sampling with 50 mg ethylenediamine (EDA)/L of sample and must be analyzed within
28 days.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.14, continued)
August, 2008 (Revised)
75
8
Amperometric titration or spectrophotometry may be used for routine daily monitoring of chlorite at the entrance to the distribution
system, as prescribed in Rule 1200-5-1-.36(6)(b)2(i)(I). Ion chromatography must be used for routine monthly monitoring of chlorite
and additional monitoring of chlorite in the distribution system, as prescribed in Rules 1200-5-1-.36(6)(b)2(i)(II) and (b)2(ii).
9
The Standard Methods Online version that is approved is indicated by the last two digits in the method number which is the year of
approval by the Standard Method Committee. Standard Methods Online are available at http://www.standardmethods.org.


2. Laboratories must achieve quantitative results on the PE sample analyses that
are within the following acceptance limits:

DBP Acceptance limits
(percent of true
value)
Comments
TTHM
Chloroform ±20 Laboratory must meet all 4 individual THM acceptance
limits in order to successfully pass a PE sample for
TTHM
Bromodichloromethane ±20
Dibromochloromethane ±20
Bromoform ±20

HAA5
Monochloroacetic Acid ±40 Laboratory must meet the acceptance limits for all 5 of
the HAA5 compounds in order to successfully pass a
PE sample for HAA5
Dichloroacetic Acid ±40
Trichloroacetic Acid ±40
Monobromoacetic Acid ±40
Dibromoacetic Acid ±40

Chlorite ±30

Bromate ±30


3. Laboratories must report quantitative data for concentrations at least as low as
the ones listed in the following table for all DBP samples analyzed for compliance
with Rules 1200-5-1-.06, .36, .37, and .38:

DBP Minimum reporting
level (mg/L)
1

Comments
TTHM
2

Chloroform 0.0010
Bromodichloromethane 0.0010
Dibromochloromethane 0.0010
Bromoform 0.0010

HAA5
2

Monochloroacetic Acid 0.0020
Dichloroacetic Acid 0.0010
Trichloroacetic Acid 0.0010
Monobromoacetic Acid 0.0010
Dibromoacetic Acid 0.0010

Chlorite 0.020 Applicable to monitoring as prescribed in Rules 1200-5-
1-.36(6)(b)2(i)(II) and (b)2(ii).

Bromate 0.0050 or 0.00010 Laboratories that use EPA Methods 317.0 Revision 2.0,
326.0 or 321.8 must meet a 0.0010 mg/L MRL for
bromate.

1
The calibration curve must encompass the regulatory minimum reporting level (MRL) concentration. Data may be reported for
concentrations lower than the regulatory MRL as long as the precision and accuracy criteria are met by analyzing an MRL check
standard at the lowest reporting limit chosen by the laboratory. The laboratory must verify the accuracy of the calibration curve at the
MRL concentration by analyzing an MRL check standard with a concentration less than or equal to 110% of the MRL with each
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

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batch of samples. The measured concentration for the MRL check standard must be ±50% of the expected value, if any field sample
in the batch has a concentration less than 5 times the regulatory MRL. Method requirements to analyze higher concentration check
standards and meet tighter acceptance criteria for them must be met in addition to the MRL check standard requirement.

2
When adding the individual trihalomethane or haloacetic acid concentrations to calculate the TTHM or HAA5 concentrations,
respectively, a zero is used for any analytical result that is less than the MRL concentration for that DBP, unless otherwise specified
by the State.

4. Additional analytical methods. Systems required to analyze parameters not
included in subparagraph (i) and part (k)1 of this paragraph must use the
following methods. A party approved by the EPA or the Department must
measure these parameters.

(i) Alkalinity. All methods allowed in subparagraph (c) of this paragraph for
measuring alkalinity.

(ii) Bromide. EPA Methods 300.0, 300.1, 317.0 Revision 2.0, 326.0, or ASTM
D 6581–00.

(iii) Total Organic Carbon (TOC). Standard Method 5310 B or 5310 B–00
(High-Temperature Combustion Standard Method) or Standard Method
5310 C or 5310 C–00 (Persulfate-Ultraviolet or Heated-Persulfate
Oxidation Method) or Standard Method 5310 D or 5310 D–00 (Wet-
Oxidation Method) or EPA Method 415.3 Revision 1.1. Inorganic carbon
must be removed from the samples prior to analysis. TOC samples may
not be filtered prior to analysis. TOC samples must be acidified at the time
of sample collection to achieve pH less than or equal to 2 with minimal
addition of the acid specified in the method or by the instrument
manufacturer. Acidified TOC samples must be analyzed within 28 days.

(iv) Specific Ultraviolet Absorbance (SUVA). SUVA is equal to the UV
absorption at 254 nm (UV254) (measured in m
-1
divided by the dissolved
organic carbon (DOC) concentration) (measured as mg/L). In order to
determine SUVA, it is necessary to separately measure UV254 and DOC.
When determining SUVA, systems must use the methods stipulated in
Rule 1200-5-1-.14(10)(k)4(iv)(I) to measure DOC and the method
stipulated in Rule 1200-5-1-.14(10)(k)4(iv)(II) to measure UV254. SUVA
must be determined on water prior to the addition of disinfectants/oxidants
by the system. DOC and UV254 samples used to determine a SUVA
value must be taken at the same time and at the same location.

(I) Dissolved Organic Carbon (DOC). Standard Method 5310 B or 5310
B–00 (High-Temperature Combustion Method) or Standard Method
5310 C or 5310 C–00 (Persulfate-Ultraviolet or Heated-Persulfate
Oxidation Method) or Standard Method 5310 D or 5310 D–00 (Wet-
Oxidation Method) or EPA Method 415.3 Revision 1.1. DOC
samples must be filtered through the 0.45 μm pore-diameter filter as
soon as practical after sampling, not to exceed 48 hours. After
filtration, DOC samples must be acidified to achieve pH less than or
equal to 2 with minimal addition of the acid specified in the method
or by the instrument manufacturer. Acidified DOC samples must be
analyzed within 28 days of sample collection. Inorganic carbon must
be removed from the samples prior to analysis. Water passed
through the filter prior to filtration of the sample must serve as the
filtered blank. This filtered blank must be analyzed using procedures
identical to those used for analysis of the samples and must meet
the following criteria: DOC < 0.5 mg/L.

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(II) Ultraviolet Absorption at 254 nm (UV254). Standard Method 5910 B
or 5910 B–00 (Ultraviolet Absorption Method) or EPA Method 415.3
Revision 1.1. UV absorption must be measured at 253.7 nm (may be
rounded off to 254 nm). Prior to analysis, UV254 samples must be
filtered through a 0.45 μm pore-diameter filter. The pH of UV254
samples may not be adjusted. Samples must be analyzed as soon
as practical after sampling, not to exceed 48 hours.

(v) pH. All methods allowed in Table 1200-5-1-.14(10)(c) for measuring pH.

(vi) Magnesium. All methods allowed in Table 1200-5-1-.14(10)(c) for
measuring magnesium.

(l) Cryptosporidium. Systems must analyze for Cryptosporidium using Method 1623:
Cryptosporidium and Giardia in Water by Filtration/IMS/FA, 2005, United States
Environmental Protection Agency, EPA–815-R–05–002 or Method 1622:
Cryptosporidium in Water by Filtration/IMS/FA, 2005, United States Environmental
Protection Agency, EPA–815–R–05–001, which are incorporated by reference. The
Director of the Federal Register approves this incorporation by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of these methods
online from http:// www.epa.gov/safewater/disinfection/lt2 or from the United States
Environmental Protection Agency, Office of Ground Water and Drinking Water, 1201
Constitution Ave., NW, Washington, DC 20460 (Telephone: 800–426–4791). You may
inspect a copy at the Water Docket in the EPA Docket Center, 1301 Constitution Ave.,
NW, Washington, DC, (Telephone: 202–566–2426) or at the National Archives and
Records Administration (NARA). For information on the availability of this material at
NARA, call 202–741–6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html

1. Systems must analyze at least a 10 L sample or a packed pellet volume of at
least 2 ml as generated by the methods listed in Rule 1200-5-1-.14(10)(l).
Systems unable to process a 10 L sample must analyze as much sample volume
as can be filtered by two filters approved by EPA for the methods listed in Rule
1200-5-1-.14(10)(l), up to a packed pellet volume of at least 2 ml.

2. (i) Matrix spike (MS) samples, as required by the methods in Rule 1200-5-1-
.14(10)(l), must be spiked and filtered by a laboratory approved for
Cryptosporidium analysis under Rule 1200-5-1-.14(10)(l)4.

(ii) If the volume of the MS sample is greater than 10 L, the system may filter
all but 10 L of the MS sample in the field, and ship the filtered sample and
the remaining 10 L of source water to the laboratory. In this case, the
laboratory must spike the remaining 10 L of water and filter it through the
filter used to collect the balance of the sample in the field.

3. Flow cytometer-counted spiking suspensions must be used for MS samples and
ongoing precision and recovery (OPR) samples.

4. Systems must have Cryptosporidium samples analyzed by a laboratory that is
approved under EPA’s Laboratory Quality Assurance Evaluation Program for
Analysis of Cryptosporidium in Water or a laboratory that has been certified for
Cryptosporidium analysis by an equivalent State laboratory certification program.

Authority: T.C.A. §§68-13-704 and 4-5-202. Administrative History: Original rule filed June 30, 1977;
effective August 1, 1977. Amendment filed February 3, 1984; effective February 12, 1985. Amendment
filed September 26, 1988; effective November 10, 1988. Amendment filed November 26, 1990; effective
January 10, 1991. Amendment filed August 24, 1992; effective October 8, 1992. Amendment filed
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

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November 21, 2001; effective February 4, 2002. Amendment filed July 31, 2006; effective October 14,
2006. Repeal of and new rule filed June 12, 2008; effective August 26, 2008.

1200-5-1-.15 MONITORING OF CONSECUTIVE PUBLIC WATER SYSTEMS.

(1) Each public water system is required to provide monitoring data to the Department as
required by Rules 1200-5-1-.07 through 1200-5-1-.12, 1200-5-1-.21, 1200-5-1-.24, 1200-5-1-
.26 and unregulated contaminant monitoring and reporting as required by the Environmental
Protection Agency. Those public water systems which do not practice disinfection and which
purchase all of their water from one or more public water systems that treats water may
utilize the monitoring results obtained under Rules 1200-5-1-.08 through 1200-5-1-.12, 1200-
5-1-.24, 1200-5-1-.26 and unregulated contaminant monitoring and reporting as required by
the Environmental Protection Agency to demonstrate compliance if the public water system
that treats water is subject to the referenced monitoring requirements. Consecutive systems
that do not disinfect will be required to collect and analyze all samples that must be collected
at the tap including asbestos. Those systems purchasing water and which practice
disinfection shall not use the monitoring results obtained by another system for contaminants
to be monitored in unregulated contaminant monitoring and reporting as required by the
Environmental Protection Agency.

(2) Those public water systems which purchase all of their water and elect to perform the
monitoring required by Rules 1200-5-1-.08 through 1200-5-1-.12, 1200-5-1-.21, 1200-5-1-.24,
1200-5-1-.26 and unregulated contaminant monitoring and reporting as required by the
Environmental Protection Agency will have compliance with the MCL determined on the
analytical results of its sampling.

(3) Those public water systems which purchase all their water and elect to use the analytical
results of the system from which it purchases water shall be deemed to be in compliance with
the monitoring and MCL requirements provided the seller of water is in compliance. Any
violation of an MCL or monitoring requirement by the seller of water will constitute a violation
for all systems which purchase water unless samples are taken as described in Paragraph
(2) of this section.

(4) All public notification requirements as contained in Section 1200-5-1-.19 are the responsibility
of the individual public water system regardless of which public water system conducts the
analysis.

(5) All public water systems must maintain records as required by Section 1200-5-1-.20 of all
analytical results which pertain to the system regardless of which system actually did the
analysis.

Authority: T.C.A. §§4-5-201 et seq., 4-5-202, 68-13-704, and 68-221-701 et seq. Administrative
History: Original rule filed June 30, 1977; effective August 1, 1977. Amendment filed September 26,
1988; effective November 10, 1988. Amendment filed August 24, 1992; effective October 8, 1992.
Amendments filed June 12, 2008; effective August 26, 2008.

1200-5-1-.16 SITING REQUIREMENTS.

(1) Before a person may enter into a financial commitment for or initiate construction of a new
public water system or increase capacity of an existing public water system, he shall notify
the Department and, to the extent practicable, avoid locating part or all of the new or
expanded facility at a site which:

(a) Is subject to a significant risk from earthquakes, floods, fires, or other disasters which
could cause a breakdown of the public water system or a portion thereof; or

(b) Except for intake structures, is within the flood plain of a 100-years flood.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

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79

(2) All other siting requirements shall be in accordance with those set forth in “Design Criteria for
Public Water Systems” as published by the Department.

Authority: T.C.A. §§4-5-201 et seq. and 68-221-701 et seq. Administrative History: Original rule filed
June 30, 1977; effective August 1, 1977. Amendment filed April 12, 1996; effective June 26, 1996.

1200-5-1-.17 OPERATION AND MAINTENANCE REQUIREMENTS.

(1) All community water systems which are designated as a surface supply and classified as a
filtration system and all iron removal plants which use gravity filters must have an operator in
attendance and responsible for the treatment process when the plant is in operation. Gravity
iron removal plants which have installed continuous monitoring equipment including
equipment for turbidity and chlorine residual with alarms and/or shutdown ability may seek
approval from the Department to operate the treatment plant in an automated mode without
an operator in attendance. All iron removal plants with pressure filters and using a ground
water source from an approved sand and gravel formation will not be required to have an
operator in attendance during all periods of operation provided suitable protection,
acceptable to the Department, is provided.

Non–community water systems which are classified as a surface supply will be required to
have a full time operator in attendance unless certain continuous monitoring equipment is
installed.

Pursuant to Tennessee Code Annotated 68–221–904, all operators in direct responsible
charge of a water supply system, including the treatment plant and/or distribution system,
must be certified by the Department as competent to operate same.

Because the proper operation and maintenance of water systems is critical to a system’s
ability to provide safe water to the public and to comply with these rules, all water supply
systems must comply with the provisions of Rule 1200-5-3. A violation of those rules is a
violation of this rule as well.

(2) All community water systems and those non-community water systems classified as a
surface source shall compile and maintain accurate daily operating records of the water
works system on forms prepared and furnished by the Department. The daily operating
records shall be submitted in a timely manner so they are received by the Department no
later than ten days after the end of the reporting month. Any special reports, deemed
necessary by the Department to assure continuous satisfactory operation of the water
system, shall be submitted to the Department.

Water systems which desire to use their own forms to report the daily operating results to the
Department must have prior approval of the form from the Department.

(3) All water quality tests, other than those listed in Regulation 1200-5-1-.06 shall be made in
accordance with the latest edition of “Standard Methods for the Examination of Water and
Wastewater” or alternate methods acceptable to the Department. The schedule of laboratory
tests followed in controlling the operation of a waterworks system will vary with the character
of the water; therefore, all waterworks systems must have the equipment necessary to
perform all laboratory tests pertinent to the control of the plant or system operation, and the
equipment shall be maintained in good working order at all times. Laboratory tests pertinent
to proper operation shall be prescribed by the Department for each community water system.

(4) Chlorine is the recommended disinfection agent. Other agents will be considered by the
Department provided they are effective and testing procedures for their effectiveness are
recognized in the latest edition of “Standard Methods for the Examination of Water and
Wastewater”. All community water systems, using ground water as a raw water source and
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.17, continued)
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80
serving more than 50 connections or 150 persons shall continuously chlorinate (unless other
disinfection methods are approved) and shall maintain a free chlorine residual in all parts of
the distribution system in the amount of not less than 0.2 mg/l. Public Water Systems using
surface water shall continuously chlorinate and maintain a free chlorine residual of 0.2 mg/l in
all parts of the distribution system. The residual disinfectant concentration specified by this
rule shall not be less than 0.2 mg/l in more than 5 percent of the samples each month, for
any two consecutive months the system serves water to the public. All public water systems
serving 50 or fewer connections that do not disinfect shall install continuous disinfection if the
system fails to comply with the maximum contaminant level for coliform, experiences a
disease outbreak or is directed to install disinfection by the department. All public water
systems serving 50 or fewer connections that do not disinfect shall install continuous
disinfection if the system fails to comply with the maximum contaminant level for coliform,
experiences a disease outbreak or is directed to install disinfection by the department.

(5) All systems submitting samples for microbiological examination to the State laboratory must
submit said sample in the bottle(s) provided by the State and return the samples to the
proper State laboratory in the shipping carton provided by the State. The cost of postage for
shipping the sample to the proper State laboratory shall be paid by the supplier of water. All
samples submitted for microbiological examination must be collected and mailed to arrive at
the proper State laboratory not later than Thursday noon of any week. Thirty hours is the
limit allowed from the time of collection to the time of examination at the proper State
laboratory.

(6) Pursuant to Section 68–221–711(6) the installation, allowing the installation, or maintenance
of any cross–connection, auxiliary intake, or bypass is prohibited unless the source and
quality of water from the auxiliary supply, the method of connection, and the use and
operation of such cross–connection, auxiliary intake, or bypass has been approved by the
Department. The arrangement of sewer, soil, or other drain lines or conduits carrying
sewage or other wastes in such a manner that the sewage or waste may find its way into any
part of the public water system is prohibited.

All community water systems must adopt an ordinance or policy prohibiting all of the above
and submit a copy of the executed ordinance or policy to the Department for approval. All
community water systems shall develop a written plan for a cross–connection control
program to detect and eliminate or protect the system from cross–connections. The written
plan must be approved by the Department.

After adoption and approval of the cross–connection ordinance or policy and plan, each
community water system must establish an ongoing program for the detection and
elimination of hazards associated with cross–connections. Records of the cross–connection
control program must be maintained by the water supplier and shall include such items as
date of inspection, person contacted, recommendations, follow–up, and testing results.

(a) Public water systems must develop and implement an ongoing cross-connection
program. Cross-connection plans and policies shall present all information in
conformance with the “Design Criteria for Community Public Water Systems” as
published by the Department.

(b) The public water system shall ensure that cross-connections between the distribution
system and a consumer’s plumbing are surveyed and/or inspected and determined not
to exist or contain a significant risk or are eliminated or controlled by the installation of
an approved backflow preventer commensurate with the degree of hazard.

(7) Within one year after the effective date of these regulations all community water system shall
prepare an emergency operations plan in order to safeguard the water supply and to alert the
public of unsafe drinking water in the event of natural or man-made disasters. Emergency
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.17, continued)
August, 2008 (Revised)
81
operation plans shall be consistent with guidelines established by the State and shall be
reviewed and approved by the Department.

(8) (a) General-Public water systems, construction contractors and engineers shall follow and
document sanitary practices used in inspecting, constructing or repairing water lines,
finished water storage facilities, filters and wells. In lieu of writing their own disinfection
standard operating procedures, public water systems, engineers and contractors may
chose to follow the latest edition of the AWWA standards C-651, C-652 or equivalent
methods provided the method has been approved in writing by the department and is
available during the inspection, construction, maintenance or repair activity. The
documentation shall include bacteriological sample results, construction logs, standard
operating procedures and may include photographs where appropriate. All pipes,
tanks, filters, filter media and other materials shall be properly disinfected prior to being
placed in service. Any disinfectant used to disinfect shall be NSF approved or plain
household bleach and used in a manner that assures sufficient contact time and
concentration to inactivate any pathogens present. Bacteriological results including line
repair records indicating adequacy of disinfection shall be maintained on file by the
water system for five years. All public water systems, contractors, and engineers shall
prepare and follow standard disinfection procedures approved by the state when
inspecting, maintaining, repairing or constructing lines, tanks, filters and wells.
Procedures to ensure that water containing excessive concentrations of disinfectant is
not supplied to the customers or discharged in such manner as to harm the
environment shall be implemented.

All materials used for new or repaired water lines, storage facilities, filters, filter media,
and wells will be inspected prior to use for any evidence of gross contamination. Any
contamination observed shall be removed and the materials protected during
installation.

(b) Disinfection of New Facilities-Bacteriological samples will be collected and analyzed to
verify the effectiveness of the disinfection practices prior to placing new facilities in
service. Bacteriological samples shall be collected to determine the effectiveness of
the installation process including protecting the pipe material during storage,
installation, and disinfection. This can be demonstrated by collecting two sets of
microbiological samples 24 hours apart or collecting a single set of microbiological
samples 48 hours or longer after flushing the highly chlorinated water from the lines. In
either case microbiological samples in each set will be collected at approximately
2,500-foot intervals with samples near the beginning point and at the end point unless
alternate sampling frequency and distance between sampling points approval has been
obtained from the state. Where sanitary conditions were not maintained before, during
or after construction, an additional bacteriological sample shall be collected from a
location representing the water from the contaminated area. Unsanitary conditions
include failure to document the sanitary handling of materials, to conduct construction
inspections and to maintain records, and to document sanitary practices during
construction and other hazards such trench flooding during construction. If the
constructed facility yields positive bacterial samples, additional flushing, disinfection
and bacteriological sampling shall be repeated until the water is coliform free.

(c) Disinfection of Existing Facilities-Drinking water mains, storage facilities and filters that
have been partially dewatered during inspection or repair shall, after the repair or
inspection is completed, be disinfected, and flushed prior to placing it back in service.
Bacteriological samples shall be collected immediately or as soon as possible after the
repair is completed and from a location representing the water contained in the
repaired line, tank or filter. The repaired facility may be returned to service prior to
obtaining bacteriological results. If the repaired facility yields positive bacterial
samples, additional flushing, disinfection and bacteriological sampling shall be
repeated until the water is coliform free.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.17, continued)
August, 2008 (Revised)
82

1. If one-half or more of either the original or repeat bacteriological samples
collected from the repaired or renovated facility are total coliform positive, the
system shall notify the state within 30 days that it has reviewed its disinfection
and sampling practices in an attempt to identify why the positive samples
occurred and revise its disinfection and sampling plans accordingly.

2. If any public water system collects a fecal coliform positive repeat sample or e-
coli positive repeat sample or a total coliform positive repeat sample following an
initial positive fecal coliform or e-coli sample collected from the repaired or
renovated facility, the system shall notify the state within 24-hours and issue a
tier 1 public notice using the language specified in Appendix B of Rule 1200-5-1-
.19.

(d) Inspectors, contractors, operators, public water systems or engineers that fail to
document and follow adequate disinfection procedures, and fail to collect
bacteriological samples during repairs, inspections or maintenance activities that
potentially would compromise the microbial quality of the water shall issue a boil water
advisory to the customers served by that portion of the public water system prior to
returning the facility to service. The boil water advisory shall remain in effect until
satisfactory microbial tests results are obtained.

(9) All community water systems shall be operated and maintained to provide minimum positive
pressure of twenty (20) psi throughout the distribution system. No person shall install or
maintain a water service connection to any premises where a booster pump has been
installed unless such booster pump is equipped with a low pressure cut-off mechanism
designed to cut off the booster pump when the pressure on the suction side of the pump
drops to twenty (20) psi gauge.

(10) All community water systems having more than 50 service connections shall establish and
maintain an adequate flushing program. The flushing program established shall help ensure
that dead end and low usage mains are flushed periodically, drinking water standards are
met, sediment and air removal and the free chlorine residual specified under Rule 1200-5-
1.17(4) is maintained. Records of each flushing are to be maintained by the water system.
These records shall include date, time, location, persons responsible and length of flushing.
In addition to the above information, the free chlorine residual will have to be measured and
recorded on the end of dead end mains after being flushed.

(11) All community public water systems serving more than 50 connections and which have their
own source of water shall be required to install, operate and maintain duplicate disinfection
equipment. Duplicate disinfection equipment means at least two chlorine cylinders
connected to at least two chlorinators. Each set of chlorine cylinders consists of one or more
cylinders which may be connected together by an automatic switchover valve. The two sets
of chlorine cylinders may tee in to a common feed line leading to the chlorinators, but may
not be connected together by an automatic switchover valve. The two sets of chlorine
cylinders must be weighed independently and operated simultaneously. At least two
chlorinators must be operated at all times with each feeding a part of the required dosage.
The chlorinators may discharge to a common manifold piping network to allow multiple
injection points. Facilities may be exempt from simultaneously operating duplicate
disinfection equipment if the facility has a reliable chlorine residual analyzer with an alarm
notifying a manned control center capable of immediately shutting down the treatment facility.
Facilities, which are staffed during the time water is treated, can use one set of chlorine
cylinders with the automatic switchover device provided the free chlorine residual is checked
at the facility every two hours. A reliable free chlorine residual analyzer with an alarm system
to a manned control center may be used for unmanned facilities that desire to use one set of
chlorine cylinders with the automatic switchover device.

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.17, continued)
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83
All public water systems which use a hypochlorinator shall be required to have two solution
pumps, two tanks for bleach solution and operate both units at the same time.

(12) All public water systems which utilize a filtration system shall use the following bed
specifications and not exceed the following rates of filtration.

(a) Rapid Sand Filtration - 2.0 gallons per minute per square foot for turbidity removal, 3.0
gallons per minute per square foot for iron removal.

There must be 30 inches of sand media with an effective size of 0.35 mm to 0.55 mm
and a uniformity coefficient not greater than 1.70

(b) High Rate Filtration - 4.0 gallons per minute per square foot for turbidity removal, 4.0
gallons per minute per square foot for iron removal.

There must be 30 inches of dual media with 10 to 12 inches of sand and 18 to 20
inches of anthracite. The sand shall have an effective size of 0.35 mm to 0.55 mm and
a uniformity coefficient not greater than 1.70. The anthracite shall have an effective
size of 0.8 mm to 1.2 mm with a uniformity coefficient not greater than 1.85.

(c) Existing water systems with rapid sand filters and approved for higher rates of filtration
by the Department will be allowed to continue at that rate provided the drinking water
standards are met. The water supplier must be able to document that the Department
approved the system for the higher rate.

(d) All mixed media filter beds will be at least 30 inches in depth and approved by the
Department.

(e) Filtration rates above 4.0 gallons per minute per square foot will be considered on an
individual basis. The Department will take into account the raw water characteristics,
the treatment units, operational history, and operating personnel.

(13) All community water systems serving 50 connections or more shall install duplicate pumps for
the raw water, finished water, and distribution pumping stations. A water system will not be
required to have duplicate pumps in a distribution pumping station under the following
conditions: limited number of service connections, availability of replacement pumps,
maintaining adequate flows and pressures without the pumping station, and for emergency
use only. All community public water systems using ground water supplies and having more
than 50 service connections must have duplicate wells and/or duplicate pumps in a spring
supply unless fed by gravity flow.

(14) All community water systems serving 50 connections or more are required to have 24 hours
of distribution storage based on the average daily demand for the past twelve months.
Distribution storage must be located so that the instantaneous demand can be met in all
areas at any time.

(a) Systems which purchase water for resale may utilize the storage of the supplier
provided the supplier has adequate distribution storage. Water systems that have
large ground storage tanks will be given credit for distribution storage provided auxiliary
power is available to pump water to the distribution system.

(b) Systems which have more than three (3) treatment facilities, have more than one
source of water, and which have special power arrangements so that it is unlikely that
all units would be down at the same time are not required to have distribution storage
provided the peak demand can be met.

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(Rule 1200-5-1-.17, continued)
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84
(c) Water systems which have an average daily demand of 10 million gallons or more are
not required to have 24 hours of distribution storage provided the system has adopted
a contingency plan for emergencies that has been approved by the Department. The
contingency plan must demonstrate the water system is able to provide residential
service to all customers for a 24 hour period during any emergency involving the shut
down of the treatment facility.

(d) Public water systems which utilize wells and provide only disinfection, pH adjustment,
corrosion inhibitor and/or fluoridation as treatment, may use the capacity of the wells
and the plant as part of the distribution storage under the following conditions:

1. The existing distribution storage tank(s) are adequate to meet the peak demands
on the system,

2. The well(s), disinfection equipment and other pumping facilities needed to supply
water to the distribution storage tank are equipped with an auxiliary power source
with automatic controls, and

3. The well field capacity is determined by removing the largest well from
consideration.

(e) Public water systems may take into account private distribution storage facilities in the
following manner:

1. Private distribution storage may be counted as water system storage provided
the private storage tank floats on the water utility’s system and the water used
serves both the private and utility system demand.

2. The water utility may reduce the amount of needed distribution storage by
subtracting the average daily volume of any water user that has its own storage
tank. This can be done provided the private storage tank is used on a daily
basis.

3. Private distribution storage tanks used strictly for fire protection by the private
owner cannot be in the water systems distribution storage capacity.

(15) All community water systems serving 50 or more service connections must have and
maintain up-to-date maps of the distribution system. These maps must show the locations of
the water mains, sizes of mains, valves, blow-offs or flush hydrants, air-release valves, and
fire hydrants. One up-to-date copy of the overall system distribution map(s) is to be
submitted to the Division of Water Supply every five years.

(16) All vents on wells, springs, storage tanks, overflows and clearwells shall be properly
screened. All overflows on springs and tanks shall be screened and protected.

(17) All buildings and equipment used in and for the production and distribution of water (to
include chemical and other storage buildings) must be well maintained and be reliable and fit
for the purpose for which they are used. This includes, but is not limited to:

(a) When a water treatment plant is not producing water and an operator is not in
attendance, plant entrances must be locked.

(b) Equipment such as chemical feeders, pumps, turbidimeters, pumpage meters, alarm
systems, and air tanks shall be maintained and in good working condition. Pumps,
tanks, hoses, and other equipment used by system personnel shall be disinfected and
dedicated to its use if it comes into contact with water that may be consumed by
humans.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

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85

(c) Duplicate or backup equipment shall be available as necessary to maintain the
production of water meeting drinking water standards. Backup equipment or alternate
treatment means shall be available for feeding all chemicals critical for adequate water
treatment.

(18) All community water systems planning to or having installed hydrants must protect the
distribution system from contamination. All water mains designed for fire protection must be
six inches or larger and be able to provide 500 gallons per minute with 20 pounds per square
inch residual pressure. Fire hydrants shall not be installed on water mains less than six
inches in diameter or on water mains that cannot produce 500 gpm at 20 psi residual
pressure unless -the tops are painted red. Out of service hydrants shall have tops painted
black or covered with a black shroud or tape..

Existing Class C hydrants (hydrants unable to deliver a flow of 500 gallons per minute at a
residual pressure of 20 pounds per square inch (psi) shall have their tops painted red by
January 1, 2008.

The water system must provide notification by certified mail at least once every five years
beginning January 1, 2008, to each fire department that may have reason to utilize the
hydrants, that fire hydrants with tops painted red (Class C hydrants) cannot be connected
directly to a pumper fire truck. Fire Departments may be allowed to fill the booster tanks on
any fire apparatus from an available hydrant by using the water system’s available pressure
only (fire pumps shall not be engaged during refill operations from a Class C hydrant).

(19) Before any new or modified community water treatment facility can be placed in service, it
must be inspected and approved in writing by the Department.

(20) Public water systems which adjust the fluoride content of the water supply shall maintain the
concentration of fluoride in the finished water between 0.9 mg/l and 1.3 mg/l based on the
monthly average. Each water system adjusting the fluoride content to the finished water
must monitor for fluoride as required by the system’s individual monitoring program
established by the Department.

(21) New or modified turbidity removal facilities may not be placed into operation until the facility
and the operator have been approved by the Department for the turbidity analysis.

(22) All pipe, solder, or flux which is used in the installation or repair of any public water system
shall be lead free. This shall not apply to lead joints necessary for the repair of cast iron
pipes. The term “lead free” in this section is defined as follows:

(a) When used with respect to solders and flux shall mean solders and flux containing not
more than two-tenths of one percent (0.2%) lead and

(b) When used with respect to pipes and pipe fittings shall mean pipes and pipe fittings
containing not more than eight percent (8.0%) lead.

(23) All dead end water mains and all low points in water mains shall be equipped with a blow-off
or other suitable flushing mechanism capable of producing velocities adequate to flush the
main.

(24) All community water systems must establish and maintain a file for customer complaints.
This file shall contain the name of the person with the complaint, date, nature of complaint,
date of investigation and results or actions taken to correct any problems.

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(Rule 1200-5-1-.17, continued)
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86
(25) The Department may, upon written notice, require confirmation of any sampling results and
also may require sampling and analysis for any contaminant when deemed necessary by the
Department to protect the public health or welfare.

(26) Those public water systems required to monitor for turbidity and chlorine residual must have
the laboratory approved by the Department before the results of these analyses can be
accepted for compliance purposes.

(27) By December 30, 1991, or 18 months after the determination that a ground water system is
influenced by surface water, all public water systems classified as a ground water system
impacted by surface water shall utilize treatment techniques which achieve:

(a) At least 99.9 percent (3 log) removal and/or inactivation of Giardia lamblia cysts
between a point where the raw water is not subject to recontamination by surface water
runoff and a point downstream before or at the first customer.

(b) At least 99.99 percent (4 log) removal and/or inactivation of viruses between a point
where the raw water is not subject to recontamination by surface water runoff and a
point downstream before or at the first customer.

(28) All public water systems using surface water shall provide disinfection to control the biological
quality of the water. Due consideration shall be given to the contact time of the disinfectant in
the water with relation to pH, ammonia, taste producing substances, temperature, presence
and type of pathogens, and trihalomethane formation potential. All disinfection basins must
be designed to prevent water short-circuiting the system. The disinfectant will be applied in
the manner needed to provide adequate contact time.

(29) All community water systems using ground water as the raw water source serving water to
more than 50 connections or 150 people will apply the disinfectant in the manner needed for
adequate contact time. Contact time for ground water systems shall not be less than 15
minutes prior to the first customer.

(30) Any surface supplied public water system or ground water systems under the direct influence
of surface water required to filter shall employ filtration in combination with disinfection that
will achieve 99.9% (3 log) and 99.99% (4 log) inactivation of Giardia lamblia and viruses
respectively between a point where the raw water is not subject to recontamination by
surface water runoff and a point downstream before or at the first customer. For the
purposes of determining removal or inactivation efficiencies for Giardia lamblia and viruses
Table 1200-5-1-.17(30)1 and 1200-5-1-.17(30)2 shall apply. The free residual disinfectant
concentration in the water entering the distribution system cannot be less than 0.2 mg/l for
more than four hours.

TABLE 1200-5-1-.17(30)1

ASSUMED LOG REMOVALS BY FILTRATION METHOD
AND REQUIRED LEVELS OF DISINFECTION
____________________________________________________________________________________
Treatment Assumed Log Removal Required minimum level
of disinfection


Giardia Viruses Giardia Viruses
Conventional filtration 2.5 2.0 0.5 2.0
Direct filtration 2.0 1.0 1.0 3.0
Slow Sand filtration 2.0 2.0 1.0 2.0
Diatomaceous Earth
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

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87
filtration 2.0 1.0 1.0 3.0
____________________________________________________________________________________

TABLE 1200-5-1-.17(30)2

CT VALUES FOR ACHIEVING 1-LOG INACTIVATION OF
GIARDIA CYSTS
1
____________________________________________________________________________________
pH Temperature
______________ 0.5°C 5°C 10°C 15°C________
Free Chlorine
2,3
6 55 39 29 19
7 79 55 41 26
8 115 81 61 41
9 167 118 88 59
Ozone 0.97 0.63 0.48 0.32
Chlorine dioxide 1270 735 615 500
____________________________________________________________________________________

1
Values to achieve 0.5 log inactivation are one half those shown in the table.

2
CT values are for 2.0 mg/l free chlorine.

3
CT values for other concentrations of free chlorine may be taken from Appendix E of
the guidance manual for Compliance with the “Filtration and Disinfection Requirements
For Public Water Systems Using Surface Water Sources,” October, 1989, Edition,
Science and Technology Branch Criteria and Standards Division, Office of Drinking
Water, USEPA, Washington, D.C.

(31) Each public water system must certify annually in writing to the State that when acrylamide
and epichlorohydrin are used in drinking water systems, the combination (or product) of dose
and monomer level does not exceed the levels specified as follows:

Acrylamide = 0.05% dosed at 1 ppm (or equivalent)
Epichlorohydrin = 0.01% dosed at 20 ppm (or equivalent)

Public water systems can rely on manufacturer’s or third parties certification for complying
with this requirement.

(32) New service taps on existing mains that must be uncovered to make the tap, shall be flushed
and the free chlorine residual measured and recorded prior to connecting the service lines.
These records shall be retained until the next sanitary survey or for three years.

(33) All public water systems shall properly maintain their distribution system finished water
storage tanks. Each community water system shall establish and maintain a maintenance
file on each of its finished water and distribution storage tanks. These maintenance files
must be available for inspection by Department personnel. These files must include the
dates and results of all routine water storage tank inspections by system personnel, any
reports of detailed professional inspections of the water storage tanks by contractor
personnel, dates and details of routine tank cleanings and surface flushings, and dates and
details of all tank maintenance activities. The tank inspection records shall include dates of
the inspections; the sanitary, coating and structural conditions of the tank; and all
recommendations for needed maintenance activities. Community Water Systems shall have
a professional inspection performed and a written report produced on each of their finished
water and distribution storage tanks at least once every five years. Non-community water
systems shall have a professional inspection and written report performed on each of their
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88
atmospheric pressure finished water and distribution storage tanks no less frequently than
every five years. Records of these inspections shall be available to the Department
personnel for inspection. Persons conducting underwater inspections of finished water
storage tanks shall comply with AWWA standard C652-92 or later versions of the standard.

(34) Paints and coatings for the interior of potable water storage facilities must be acceptable to
the Department. Paints and coatings accepted by the Environmental Protection Agency
(EPA) and/or the National Sanitation Foundation (NSF) for potable water contact are
generally acceptable to the Department. Paint systems for steel tanks shall be consistent
with AWWA Standard D102-78. Factory coated bolted steel tanks shall be in accordance
with AWWA D103-87. Wire-wound circular prestressed concrete tanks shall be in
accordance with AWWA D110-86.

(35) By January 1, 1996, public water systems using surface water and ground water systems
under the direct influence of surface water that filter shall have rewash capability. Such
systems shall perform a rewash cycle, or filter to waste each time a filter is backwashed. The
rewash cycle shall be conducted in a way and manner necessary to prevent the introduction
of contaminants such as pathogens and turbidity trapped in the filter into the clear well or
distribution system.

Existing filter plants may be approved to operate without rewash (filter-to-waste provisions) if
existing operational and backwash practices prevent water of unacceptable quality from
entering the clearwell or distribution system. To operate without rewash the water system
must demonstrate to the Department that filtered water turbidity after backwashing is reliably
and consistently below 0.5 NTU immediately after backwashing each filter. Approval to
operate without rewash must be approved in writing and approval must be renewed if any
modifications are made to the operation or design of the plant. Each filter that operates
without rewash must have a continuous recording turbidimeter and retain the records for a
period of five years.

(36) By January 1, 1995, all chemicals, additives, coatings or other materials used in the
treatment, conditioning and conveyance of drinking water must have been approved by the
National Sanitation Foundation (NSF) or American National Standards Institute (ANSI)
certified parties as meeting NSF product standard 60 and 61. Until 1995, products used for
treatment, conditioning and conveyance of drinking water shall have been listed as approved
by the US EPA or NSF.

(37) Any new Community Water System or Non-Transient Non-Community Water System
commencing operation after September 30, 1999 shall have a “Capacity Development Plan”
and be a “viable water system.”

(38) Public Water Systems identified as not complying or potentially not complying with the
requirements of the Safe Drinking Water Act and in accordance with the priorities established
in the State’s Capacity Development Strategy shall prepare a “Capacity Development Plan”
and demonstrate viability.

(39) Public water systems are not permitted to construct uncovered finished water reservoirs after
the effective date of this subparagraph.

(40) Benchtop and continuous turbidimeters used to determine compliance with limits set forth in
this rule chapter must be calibrated at least every three months with primary standards and
documented. Documentation shall be maintained for a period not less than five years.
Primary standards are Formazin, AMCO clear, Stablcal, or alternatives approved in writing by
the Division. Dilute Formazin solutions are unstable and must be prepared on the day of
calibration. Manufacturers’ recommendations on calibration procedure must be followed.

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89
(41) Verifications for benchtop turbidimeters are comparisons to approved reference materials.
Verifications for continuous turbidimeters are comparisons to approved reference materials or
comparisons to a properly calibrated benchtop turbidimeter. Secondary reference materials
are assigned a value immediately after acceptable primary calibration has been completed.
Acceptable verifications for turbidity measurements greater than 0.5 NTU must agree within
±10% from the reading assigned to the reference material after primary calibration.
Acceptable verifications for measurements 0.5 NTU or less must be within ±0.05 NTU or less
from the reading assigned to the reference material after primary calibration. When
comparisons are made from a continuous turbidimeter to a benchtop turbidimeter, the
continuous measurement must be within ±10% of the benchtop reading for measurements
above 0.5 NTU and ±0.05 NTU for reading 0.5 NTU or less. When acceptable verifications
are not achieved the instrument must be re-calibrated with primary standards according to
paragraph (40) of this rule. Approved reference materials for benchtop turbidimeters are
primary standards and materials suggested by the manufacturer such as sealed sample cells
filled with metal oxide particles in a polymer gel. The 0.5 NTU ICE-PIC
TM
from Hach is an
approved reference material for secondary turbidity verifications for Hach continuous
turbidimeters when utilized as per Manufacturers’ recommendations. All other reference
materials for turbidimeter verifications must be approved in writing by the Division.
Verifications for turbidimeters must be performed according to the following:

(a) Verification of benchtop turbidimeters must be performed daily and documented.
Verifications must include a sample in the expected working range of the instrument or
as close to the working range as possible. Documentation must include: assigned
reference material value after calibration, recorded daily reading for all reference
standards, instrument identification, and date.

(b) Combined filter effluent turbidimeters as required by Rule 1200-5-1-.31(5)(c)1. must be
verified daily and documented. When reference material is utilized documentation
must include: instrument identification, date, assigned reference material value after
calibration, and daily value for reference material. When comparisons to benchtop
turbidimeters are utilized documentation must include: instrument identification, date,
continuous turbidimeter value, and benchtop turbidimeter value.

(c) Individual filter turbidimeters as required by Rule 1200-5-1-.31(5)(c)4. must be verified
weekly.

Authority: T.C.A. §§4-5-201 et seq., 4-5-202, 68-221-701 et seq., and 68-221-704. Administrative
History: Original rule filed June 30, 1977; effective August 1, 1977. Amendment filed February 3, 1984;
effective February 12, 1985. Amendment filed September 26, 1988; effective November 10, 1988.
Amendment filed November 26, 1990; effective January 10, 1991. Amendment filed August 24, 1992;
effective October 8, 1992. Amendment filed October 22, 1993; effective January 5, 1994. Amendment
filed April 12, 1996; effective June 26, 1996. Amendment filed February 17, 1999; effective May 3, 1999.
Amendment filed October 31, 2000; effective January 14, 2001. Amendment filed November 21, 2001;
effective February 4, 2002. Amendment filed December 30, 2002; effective March 15, 2003.
Amendments filed August 15, 2005; effective October 29, 2005. Amendments filed June 12, 2008;
effective August 26, 2008.

1200-5-1-.18 REPORTING REQUIREMENTS.

(1) Except where a shorter period is specified in this Chapter, the supplier of water shall report to
the Department the results of any test measurement or analysis required by this part within
(A) the first ten days following the month in which the result is received or (B) the first ten
days following the end of the required monitoring period as stipulated by the Department,
which ever of these is shortest.

(2) All systems shall report to the Department within forty-eight (48) hours of the failure to comply
with Departmental drinking water regulations or other requirements (including failure to
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.18, continued)
August, 2008 (Revised)
90
comply with monitoring, maximum contaminant level or treatment technique requirements)
set forth in these Rules and Regulations, and in case of any of the following events shall
immediately notify the Department and responsible local officials:

(a) any major breakdown or failure of equipment in water treatment process which affects
the quality or quantity of the water leaving the treatment plant;

(b) any serious loss of water service due to a failure of transmission or distribution
facilities; or

(c) any situation with the water system which presents or may present an imminent and
substantial endangerment to health.

(3) Systems are not required to report analytical results to the Department in cases where a
State laboratory performs the analysis and reports the results to the Department.

(4) The public water system, within 10 days of completing the public notification requirements
under 1200-5-1-.19 for the initial public notice and any repeat notices, must submit to the
department a certification that it has fully complied with the public notification regulations.
The public water system must include with this certification a representative copy of each
type of notice distributed, published, posted and made available to the persons served by the
system and to the media.

(5) The water supply system shall submit to the Department, within the time stated in the
request, copies of any records required to be maintained under Section 1200-5-1-.20 hereof
or copies of any documents then in existence which the Department is entitled to inspect
pursuant to the authority of Public Acts of 1983, Chapter 324.

(6) The owner or operator of a community water system or non-transient non-community water
system who is required to monitor under unregulated contaminant monitoring and reporting
as required by the Environmental Protection Agency shall send a copy of the results of such
monitoring and any public notice issued under 1200-5-1-.19 to the Department within 30 days
of receipt of the results or issuance of the notice.

(7) The community water system or non-transient non-community water system shall furnish the
following information on forms provided by the Department to the Department for each
sample analyzed under unregulated contaminant monitoring and reporting as required by the
Environmental Protection Agency:

(a) Results of all analytical methods, including negatives,
(b) Name and address of the system that supplied the sample,
(c) Contaminant(s),
(d) Analytical method(s) used,
(e) Date of sample,
(f) Date of analysis.

(8) It shall be a violation of these regulations for any person, public water system, engineer,
operator or certified laboratory to:

(a) Record data or information and/or report any inaccurate, misleading, false or
information known or that should be known to be false; or

(b) Report any data or information that is inaccurate, misleading or false because the
person reporting has not used reasonable care, judgment or the application of his
knowledge in the preparation of the report.

(c) Provide inaccurate or false statements to the State.
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.18, continued)
August, 2008 (Revised)
91

Authority: T.C.A. §§4-5-201 et seq., 4-5-202, 68-13-704, 68-221-701 et seq., and 68-221-704.
Administrative History: Original rule. filed June 30, 1977; effective August 1, 1977. Amendment filed
February 3, 1984; effective February 12, 1985. Amendment filed September 26, 1988; effective
November 10, 1988. Amendment filed August 24, 1992; effective October 8, 1992. Amendment filed
November 21, 2001; effective February 4, 2002. Amendments filed June 12, 2008; effective August 26,
2008.

1200-5-1-.19 NOTIFICATION OF CUSTOMERS.

(1) Each owner and operator of a public water system including community, non-transient non-
community, and non-community water systems must comply with this rule.

(a) Each owner or operator of a public water system must give public notice for all
violations of national primary drinking water regulations and for other situations as
listed in Table 1200-5-1-.19(1). The term national primary drinking water regulation is
used in this rule to include violations of the maximum contaminant level (MCL),
maximum residual disinfectant level (MRDL), treatment technique (TT), monitoring
requirements, and testing procedures described in these regulations. Appendix A to
this rule identifies the tier assignment for each specific violation or situation requiring a
public notice.

Table 1200-5-1-.19(1)
Violation Categories and Other Situations
Requiring a Public Notice
----------------------------------------------------------------------------------------------------------------------------
1. NPDWR violations:

(i) Failure to comply with an applicable maximum contaminant level (MCL) or maximum
residual disinfectant level (MRDL).
(ii) Failure to comply with a prescribed treatment technique (TT).
(iii) Failure to perform water quality monitoring, as required by the drinking water regulations.
(iv) Failure to comply with testing procedures as prescribed by a drinking water regulation.

2. Variance and exemptions under sections 1415 and 1416 of SDWA:

(i) Operation under a variance or an exemption.
(ii) Failure to comply with the requirements of any schedule that has been set under a
variance or exemption.

3. Special public notices:

(i) Occurrence of a waterborne disease outbreak or other waterborne emergency.
(ii) Exceedance of the alternate MCL for nitrate by non-community water systems (NCWS),
where the non-community system has been granted an alternate standard by the
department.
(iii) Exceedance of the secondary maximum contaminant level (SMCL) for fluoride.
(iv) Availability of unregulated contaminant monitoring data.
(v) Other violations and situations determined by the department to require a public notice
under this rule, not already listed in Appendix A.
---------------------------------------------------------------------------------------------------------------------

(b) Public notice requirements are divided into three tiers to take into account the
seriousness of the violation or situation and any potential adverse health effects that
may be involved. The public notice requirements for each violation or situation listed in
Table 1 of this section are determined by the tier to which it is assigned. Table 1200-5-
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.19, continued)
August, 2008 (Revised)
92
1-.19(1)(b)2 of this paragraph provides the definition of each tier. Appendix A of this
rule identifies the tier assignment for each specific violation or situation.

Table 1200-5-1-.19(1)(b)2
Definition of Public Notice Tiers
--------------------------------------------------------------------------------------------------------------------------------
1. Tier 1 public notice--required for NPDWR violations and situations with significant potential to
have serious adverse effects on human health as a result of short-term exposure.

2. Tier 2 public notice--required for all other NPDWR violations and situations with potential to have
serious adverse effects on human health.

3. Tier 3 public notice--required for all other NPDWR violations and situations not included in Tier 1
and Tier 2.
--------------------------------------------------------------------------------------------------------------------------------

(c) Who must be notified?

1. Each public water system must provide public notice to persons served by the
water system, in accordance with this rule. Public water systems that sell or
otherwise provide drinking water to other public water systems (i.e., to
consecutive systems) are required to give public notice to the owner or operator
of the consecutive system; the consecutive system is responsible for providing
public notice to the persons it serves.

2. If a public water system has a violation in a portion of the distribution system that
is physically or hydraulically isolated from other parts of the distribution system,
the Division may allow the system to limit distribution of the public notice to only
persons served by that portion of the system which is out of compliance.
Permission by the department for limiting distribution of the notice must be
granted in writing.

3. A representative copy of the each type of the notice distributed, published,
posted and/or made available to the persons served by the system and/or to the
media must also be sent to the Division within ten days of completion of each
public notification.

(2) Tier 1 Public Notice--Form, manner, and frequency of notice.

(a) Which violations or situations require a Tier 1 public notice? Table 1200-5-1-.19(2) of
this paragraph lists the violation categories and other situations requiring a Tier 1 public
notice. Appendix A to this rule identifies the tier assignment for each specific violation
or situation.

Table 1200-5-1-.19(2) Violation Categories and Other Situations
Requiring a Tier 1 Public Notice
-------------------------------------------------------------------------------------------------------------------------------
1. Violation of the MCL for total coliforms when fecal coliform or E. coli are present in the water
distribution system as specified in 1200-5-1-.06, or when the water system fails to test for fecal
coliforms or E. coli when any repeat sample tests positive for coliform as specified in 1200-5-1-
.07;

2. Violation of the MCL for nitrate, nitrite, or total nitrate and nitrite, as defined in 1200-5-1-.06, or
when the water system fails to take a confirmation sample within 24 hours of the system's receipt
of the first sample showing an exceedance of the nitrate or nitrite MCL, as specified in 1200-5-1-
.09;

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(Rule 1200-5-1-.19, continued)
August, 2008 (Revised)
93
3. Exceedance of the alternate MCL for nitrate by non-community water systems (NCWS), where
the non-community system has been granted an alternate standard by the department;

4. Violation of the MRDL for chlorine dioxide, as defined in 1200-5-1-.36, when one or more
samples taken in the distribution system the day following an exceedance of the MRDL at the
entrance of the distribution system exceed the MRDL, or when the water system does not take
the required samples in the distribution system, as specified in 1200-5-1-.36;

5. Violation of the turbidity MCL under 1200-5-1-.06, where the department determines after
consultation that a Tier 1 notice is required or where consultation does not take place within 24
hours after the system learns of the violation;

6. Violation of the Surface Water Treatment Rule (SWTR) 1200-5-1-.31, Interim Enhanced Surface
Water Treatment Rule (IESWTR) or Long Term 1 Enhanced Surface Water Treatment Rule
(LT1ESWTR) treatment technique requirement resulting from a single exceedance of the
maximum allowable turbidity limit (as identified in Appendix A) where the department determines
after consultation that a tier 1 notice is required or where consultation does not take place within
24 hours after the system learns of the violation;

7. Occurrence of a waterborne disease outbreak, as defined in 1200-5-1-.04, or other waterborne
emergency (such as a failure or significant interruption in key water treatment processes, a
natural disaster that disrupts the water supply or distribution system, or a chemical spill or
unexpected loading of possible pathogens into the source water that significantly increases the
potential for drinking water contamination);

8. Other violations or situations with significant potential to have serious adverse effects on human
health as a result of short-term exposure, as determined by the Division either in its regulations or
on a case-by-case basis.

9. Detection of E. coli or enterococci in source water samples as specified in Rule 1200-5-1-.40(3).
------------------------------------------------------------------------------------------------------------------------------

(b) When is the Tier 1 public notice to be provided? What additional steps are required?
Public water systems must:

1. Provide a public notice as soon as practical but no later than 24 hours after the
system learns of the violation;

2. Initiate consultation with the Division agency as soon as practical, but no later
than 24 hours after the public water system learns of the violation or situation, to
determine additional public notice requirements; and

3. Comply with any additional public notification requirements (including any repeat
notices or direction on the duration of the posted notices) that are established as
a result of the consultation with the Division. Such requirements may include the
timing, form, manner, frequency, and content of repeat notices (if any) and other
actions designed to reach all persons served.

(c) What is the form and manner of the public notice? Public water systems must provide
the notice within 24 hours in a form and manner reasonably calculated to reach all
persons served. The form and manner used by the public water system are to fit the
specific situation, but must be designed to reach residential, transient, and non-
transient users of the water system. In order to reach all persons served, water
systems are to use, at a minimum, one or more of the following forms of delivery:

1. Appropriate broadcast media (such as radio and television);

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.19, continued)
August, 2008 (Revised)
94
2. Posting of the notice in conspicuous locations throughout the area served by the
water system;

3. Hand delivery of the notice to persons served by the water system; or

4. Another delivery method approved in writing by the department.

(3) Tier 2 Public Notice--Form, manner, and frequency of notice.

(a) Which violations or situations require a Tier 2 public notice? Table 1200-5-1-.19(3) of
this paragraph lists the violation categories and other situations requiring a Tier 2 public
notice. Appendix A to this rule identifies the tier assignment for each specific violation
or situation.

Table 1200-5-1-.19(3) Violation Categories and Other Situations
Requiring a Tier 2 Public Notice
-------------------------------------------------------------------------------------------------------------------------------
1. All violations of the MCL, MRDL, and treatment technique requirements, except where a Tier 1
notice is required under subparagraph (2)(a) or where the department determines that a Tier 1
notice is required;

2. Violations of the monitoring and testing procedure requirements, where the department
determines that a Tier 2 rather than a Tier 3 public notice is required, taking into account potential
health impacts and persistence of the violation; and

3. Failure to comply with the terms and conditions of any variance or exemption in place.

4. Failure to take corrective action or failure to maintain at least 4-log treatment of viruses (using
inactivation, removal, or a Department-approved combination of 4-log virus inactivation and
removal) before or at the first customer under Rule 1200-5-1-.40(4)(a).
------------------------------------------------------------------------------------------------------------------------------

(b) When is the Tier 2 public notice to be provided?

1. Public water systems must provide the public notice as soon as practical, but no
later than 30 days after the system learns of the violation. If the public notice is
posted, the notice must remain in place for as long as the violation or situation
persists, but in no case for less than seven days, even if the violation or situation
is resolved. The department may, in appropriate circumstances, allow additional
time for the initial notice of up to three months from the date the system learns of
the violation. The department will not grant an extension to the 30-day deadline
for any unresolved violation or to allow across-the-board extensions by rule or
policy for other violations or situations requiring a Tier 2 public notice. Extensions
granted by the department must be in writing.

2. The public water system must repeat the notice every three months as long as
the violation or situation persists, unless the department determines that
appropriate circumstances warrant a different repeat notice frequency. In no
circumstance may the repeat notice be given less frequently than once per year.
The department will not allow less frequent repeat notice for an MCL violation
under the Total Coliform Rule or a treatment technique violation under the 1200-
56-1-.31. The department will not through its rules or policies permit across-the-
board reductions in the repeat notice frequency for other ongoing violations
requiring a Tier 2 repeat notice. Departmental determinations allowing repeat
notices to be given less frequently than once every three months must be in
writing.

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.19, continued)
August, 2008 (Revised)
95
3. For the turbidity violations specified in this paragraph, public water systems must
consult with the division agency as soon as practical but no later than 24 hours
after the public water system learns of the violation, to determine whether a Tier
1 public notice under 1200-5-1-.19(2)(a) is required to protect public health.
When consultation does not take place within the 24-hour period, the water
system must distribute a Tier 1 notice of the violation within the next 24 hours
(i.e., no later than 48 hours after the system learns of the violation), following the
requirements under 1200-5-1-.19(2)(b) and (c). Consultation with the
department is required for:

(i) Violation of the turbidity MCL under 1200-5-1-.06; or

(ii) Violation of the SWTR, IESWTR or LT1ESWTR treatment technique
requirement (1200-5-1-.31) resulting from a single exceedance of the
maximum allowable turbidity limit.

(c) What is the form and manner of the Tier 2 public notice? Public water systems must
provide the initial public notice and any repeat notices in a form and manner that is
reasonably calculated to reach persons served in the required time period. The form
and manner of the public notice may vary based on the specific situation and type of
water system, but it must at a minimum meet the following requirements:

1. Unless directed otherwise by the department in writing, community water
systems must provide notice by:

(i) Mail or other direct delivery to each customer receiving a bill and to other
service connections to which water is delivered by the public water system;
and

(ii) Any other method reasonably calculated to reach other persons regularly
served by the system, if they would not normally be reached by the notice
required in subparagraph (c)1(i) of this paragraph. Such persons may
include those who do not pay water bills or do not have service connection
addresses (e.g., house renters, apartment dwellers, university students,
nursing home patients, prison inmates, etc.). Other methods may include:
publication in a local newspaper; delivery of multiple copies for distribution
by customers that provide their drinking water to others (e.g., apartment
building owners or large private employers); posting in public places
served by the system or on the Internet; or delivery to community
organizations.

2. Unless directed otherwise by the department in writing, non-community water
systems must provide notice by:

(i) Posting the notice in conspicuous locations throughout the distribution
system frequented by persons served by the system, or by mail or direct
delivery to each customer and service connection (where known); and

(ii) Any other method reasonably calculated to reach other persons served by
the system if they would not normally be reached by the notice required in
subparagraph (c)2(i). Such persons may include those served who may
not see a posted notice because the posted notice is not in a location they
routinely pass by. Other methods may include: publication in a local
newspaper or newsletter distributed to customers; use of E-mail to notify
employees or students; or, delivery of multiple copies in central locations
(e.g., community centers).

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.19, continued)
August, 2008 (Revised)
96
(4) Tier 3 Public Notice--Form, manner, and frequency of notice.

(a) Which violations or situations require a Tier 3 public notice? Table 1200-5-1-.19(4) of
this paragraph lists the violation categories and other situations requiring a Tier 3 public
notice. Appendix A to this subpart identifies the tier assignment for each specific
violation or situation.

Table 1200-5-1-.19(4)
Violation Categories and Other Situations Requiring a Tier 3 Public Notice
--------------------------------------------------------------------------------------------------------------------------------
1. Monitoring violations for the primary drinking water contaminants, except where a Tier 1 notice is
required under 1200-5-1-.19(2)(a) or where the department determines that a Tier 2 notice is
required;

2. Failure to comply with an approved departmental or EPA testing procedure, except where a Tier
1 notice is required under 1200-5-1-.19(2)(a) or where the department determines that a Tier 2
notice is required;

3. Operation under a variance granted under Section 1415 or an exemption granted under Section
1416 of the Safe Drinking Water Act;

4. Availability of unregulated contaminant monitoring results, as required under 1200-5-1-.19(7), and

5. Exceedance of the fluoride secondary maximum contaminant level (SMCL), as required under
1200-5-1-.19(8).
--------------------------------------------------------------------------------------------------------------------------------

(b) When is the Tier 3 public notice to be provided?

1. Public water systems must provide the public notice not later than one year after
the public water system learns of the violation or situation or begins operating
under a variance or exemption. Following the initial notice, the public water
system must repeat the notice annually for as long as the violation, variance,
exemption, or other situation persists. If the public notice is posted, the notice
must remain in place for as long as the violation, variance, exemption, or other
situation persists, but in no case less than seven days (even if the violation or
situation is resolved).

2. Instead of individual Tier 3 public notices, a public water system may use an
annual report detailing all violations and situations that occurred during the
previous twelve months, as long as the timing requirements of subparagraph (b)1
of this paragraph are met.

(c) What is the form and manner of the Tier 3 public notice? Public water systems must
provide the initial notice and any repeat notices in a form and manner that is
reasonably calculated to reach persons served in the required time period. The form
and manner of the public notice may vary based on the specific situation and type of
water system, but it must at a minimum meet the following requirements:

1. Unless directed otherwise by the division in writing, community water systems
must provide notice by:

(i) Mail or other direct delivery to each customer receiving a bill and to other
service connections to which water is delivered by the public water system;
and

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.19, continued)
August, 2008 (Revised)
97
(ii) Any other method reasonably calculated to reach other persons regularly
served by the system, if they would not normally be reached by the notice
required in subparagraph (c)1(i) of this paragraph. Such persons may
include those who do not pay water bills or do not have service connection
addresses (e.g., house renters, apartment dwellers, university students,
nursing home patients, prison inmates, etc.). Other methods may include:
Publication in a local newspaper; delivery of multiple copies for distribution
by customers that provide their drinking water to others (e.g., apartment
building owners or large private employers); posting in public places or on
the Internet; or delivery to community organizations.

2. Unless directed otherwise by the division in writing, non-community water
systems must provide notice by:

(i) Posting the notice in conspicuous locations throughout the distribution
system frequented by persons served by the system, or by mail or direct
delivery to each customer and service connection (where known); and

(ii) Any other method reasonably calculated to reach other persons served by
the system, if they would not normally be reached by the notice required in
subparagraph (c)2(i) of this paragraph. Such persons may include those
who may not see a posted notice because the notice is not in a location
they routinely pass by. Other methods may include: Publication in a local
newspaper or newsletter distributed to customers; use of E-mail to notify
employees or students; or, delivery of multiple copies in central locations
(e.g., community centers).

(d) In what situations may the Consumer Confidence Report be used to meet the Tier 3
public notice requirements? For community water systems, the Consumer Confidence
Report (CCR) may be used as a vehicle for the initial Tier 3 public notice and all
required repeat notices, as long as:

1. The CCR is provided to persons served no later than 12 months after the system
learns of the violation or situation as required under 1200-5-1-.19(4)(b);

2. The Tier 3 notice contained in the CCR follows the content requirements under
1200-5-1-.19(5); and

3. The CCR is distributed following the delivery requirements under 1200-5-1-
.19(4)(c).

(5) Content of the public notice.

(a) What elements must be included in the public notice for violations of National Primary
Drinking Water Regulations (NPDWR) or other situations requiring a public notice?
When a public water system violates a NPDWR or has a situation requiring public
notification, each public notice must include the following elements:

1. A description of the violation or situation, including the contaminant(s) of concern,
and (as applicable) the contaminant level(s);

2. When the violation or situation occurred;

3. Any potential adverse health effects from the violation or situation, including the
standard language under subparagraph (d)1 or (d)2 of this section, whichever is
applicable;

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(Rule 1200-5-1-.19, continued)
August, 2008 (Revised)
98
4. The population at risk, including subpopulations particularly vulnerable if exposed
to the contaminant in their drinking water;

5. Whether alternative water supplies should be used;

6. What actions consumers should take, including when they should seek medical
help, if known;

7. What the system is doing to correct the violation or situation;

8. When the water system expects to return to compliance or resolve the situation;

9. The name, business address, and phone number of the water system owner,
operator, or designee of the public water system as a source of additional
information concerning the notice; and

10. A statement to encourage the notice recipient to distribute the public notice to
other persons served, using the standard language under subparagraph (d)3 of
this paragraph, where applicable.

(b) What elements must be included in the public notice for public water systems operating
under a variance or exemption?

1. If a public water system has been granted a variance or an exemption, the public
notice must contain:

(i) An explanation of the reasons for the variance or exemption;

(ii) The date on which the variance or exemption was issued;

(iii) A brief status report on the steps the system is taking to install treatment,
find alternative sources of water, or otherwise comply with the terms and
schedules of the variance or exemption; and

(iv) A notice of any opportunity for public input in the review of the variance or
exemption.

2. If a public water system violates the conditions of a variance or exemption, the
public notice must contain the ten elements listed in subparagraph (a) of this
paragraph.

(c) How is the public notice to be presented?

1. Each public notice required by this section:

(i) Must be displayed in a conspicuous way when printed or posted;

(ii) Must not contain overly technical language or very small print;

(iii) Must not be formatted in a way that defeats the purpose of the notice;

(iv) Must not contain language which nullifies the purpose of the notice.

2. Each public notice required by this section must comply with multilingual
requirements, as follows:

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.19, continued)
August, 2008 (Revised)
99
(i) For public water systems serving a twenty-five percent or more of non-
English speaking consumers, the public notice must contain information in
the appropriate language(s) regarding the importance of the notice or
contain a telephone number or address where persons served may contact
the water system to obtain a translated copy of the notice or to request
assistance in the appropriate language.

(d) What standard language must public water systems include in their public notice?
Public water systems are required to include the following standard language in their
public notice:

1. Standard health effects language for MCL or MRDL violations, treatment
technique violations, and violations of the condition of a variance or exemption.
Public water systems must include in each public notice the health effects
language specified in Appendix B to this rule corresponding to each MCL, MRDL,
and treatment technique violation listed in Appendix A to this rule, and for each
violation of a condition of a variance or exemption.

2. Standard language for monitoring and testing procedure violations. Public water
systems must include the following language in their notice, including the
language necessary to fill in the blanks, for all monitoring and testing procedure
violations listed in Appendix A to this rule:

We are required to monitor your drinking water for specific contaminants on a
regular basis. Results of regular monitoring are an indicator of whether or not
your drinking water meets health standards. During [compliance period], we ``did
not monitor or test'' or ``did not complete all monitoring or testing'' for
[contaminant(s)], and therefore cannot be sure of the quality of your drinking
water during that time.

3. Standard language to encourage the distribution of the public notice to all
persons served. Public water systems must include in their notice the following
language (where applicable):

Please share this information with all the other people who drink this water,
especially those who may not have received this notice directly (for example,
people in apartments, nursing homes, schools, and businesses). You can do
this by posting this notice in a public place or distributing copies by hand or mail.

(6) Notice to new billing units or new customers.

(a) What is the requirement for community water systems? Community water systems
must give a copy of the most recent public notice for any continuing violation, the
existence of a variance or exemption, or other ongoing situations requiring a public
notice to all new billing units or new customers prior to or at the time service begins.

(b) What is the requirement for non-community water systems? Non-community water
systems must continuously post the public notice in conspicuous locations in order to
inform new consumers of any continuing violation, variance or exemption, or other
situation requiring a public notice for as long as the violation, variance, exemption, or
other situation persists.

(7) Special notice of the availability of unregulated contaminant monitoring results.

(a) When is the special notice to be given? The owner or operator of a community water
system of a non-transient, non-community water system required to monitor for
unregulated contaminant monitoring and reporting by the Environmental Protection
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.19, continued)
August, 2008 (Revised)
100
Agency must notify persons served by the system of the availability of the results of
such sampling no later than 12 months after the monitoring results are known.

(b) What is the form and manner of the special notice? The form and manner of the public
notice must follow the requirements for a Tier 3 public notice prescribed in paragraph
(4)(c), (d)1, and (d)3. The notice must also identify a person and provide the telephone
number to contact for information on the monitoring results.

(8) Special notice for exceedance of the SMCL for fluoride.

(a) When is the special notice to be given? Community water systems that exceed the
fluoride secondary maximum contaminant level (SMCL) of 2 mg/l as specified in 1200-
5-1-.12 (determined by the last single sample taken in accordance with 1200-5-1-.09,
but do not exceed the maximum contaminant level (MCL) of 4 mg/l for fluoride (as
specified in 1200-5-1-.06, must provide the public notice in subparagraph (c) of this
paragraph to persons served. Public notice must be provided as soon as practical but
no later than 12 months from the day the water system learns of the exceedance. A
copy of the notice must also be sent to all new billing units and new customers at the
time service begins and to the department and State public health officer. The public
water system must repeat the notice at least annually for as long as the SMCL is
exceeded. If the public notice is posted, the notice must remain in place for as long as
the SMCL is exceeded, but in no case less than seven days (even if the exceedance is
eliminated). On a case-by-case basis, the department may require an initial notice
sooner than 12 months and repeat notices more frequently than annually.

(b) What is the form and manner of the special notice? The form and manner of the public
notice (including repeat notices) must follow the requirements for a Tier 3 public notice
in paragagh(4)(c) and (d)1 and (d)3.

(c) What mandatory language must be contained in the special notice? The notice must
contain the following language, including the language necessary to fill in the blanks:

This is an alert about your drinking water and a cosmetic dental problem that might
affect children under nine years of age. At low levels, fluoride can help prevent cavities,
but children drinking water containing more than 2 milligrams per liter (mg/l) of fluoride
may develop cosmetic discoloration of their permanent teeth (dental fluorosis). The
drinking water provided by your community water system [name] has a fluoride
concentration of [insert value] mg/l.

Dental fluorosis, in its moderate or severe forms, may result in a brown staining and/or
pitting of the permanent teeth. This problem occurs only in developing teeth, before
they erupt from the gums. Children under nine should be provided with alternative
sources of drinking water or water that has been treated to remove the fluoride to avoid
the possibility of staining and pitting of their permanent teeth. You may also want to
contact your dentist about proper use by young children of fluoride-containing products.
Older children and adults may safely drink the water.

Drinking water containing more than 4 mg/L of fluoride (the U.S. Environmental
Protection Agency's drinking water standard) can increase your risk of developing bone
disease. Your drinking water does not contain more than 4 mg/l of fluoride, but we're
required to notify you when we discover that the fluoride levels in your drinking water
exceed 2 mg/l because of this cosmetic dental problem.

For more information, please call [name of water system contact] of [name of
community water system] at [phone number]. Some home water treatment units are
also available to remove fluoride from drinking water. To learn more about available
home water treatment units, you may call NSF International at 1-877-8-NSF-HELP.'

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.19, continued)
August, 2008 (Revised)
101
(9) Special notice for nitrate exceedances above MCL by non- community water systems
(NCWS), where granted permission by the department under 40CFR141.11(d).

(a) When is the special notice to be given? The owner or operator of a non-community
water system granted permission by the department under 40CFR141.11(d) to exceed
the nitrate MCL must provide notice to persons served according to the requirements
for a Tier 1 notice under 1200-5-1-.19(2)(a) and (b).

(b) What is the form and manner of the special notice? Non-community water systems
granted permission by the department to exceed the nitrate MCL under
40CFR141.11(d) must provide continuous posting of the fact that nitrate levels exceed
10 mg/l and the potential health effects of exposure, according to the requirements for
Tier 1 notice delivery under 1200-5-1-.19(2)(c) and the content requirements under
1200-5-1-.19(5).

(10) Notice by department on behalf of the public water system.

(a) May the department give the notice on behalf of the public water system? The
department may give the notice required by this rule on behalf of the owner and
operator of the public water system if the department complies with the requirements of
this rule.

(b) What is the responsibility of the public water system when notice is given by the
department? The owner or operator of the public water system remains responsible for
ensuring that the requirements of this rule are met and civil penalties assessed against
the system for failure to give the notice and for damages and expenses incurred by the
department.

(11) Special notice for repeated failure to conduct monitoring of the source water for
Cryptosporidium and for failure to determine bin classification or mean Cryptosporidium level.

(a) When is the special notice for repeated failure to monitor to be given? The owner or
operator of a community or non-community water system that is required to monitor
source water under 1200-5-1-.39(2) must notify persons served by the water system
that monitoring has not been completed as specified no later than 30 days after the
system has failed to collect any 3 months of monitoring as specified in 1200-5-1-
.39(2)(c). The notice must be repeated as specified in 1200-5-1-.19(3)(b).

(b) When is the special notice for failure to determine bin classification or mean
Cryptosporidium level to be given? The owner or operator of a community or non-
community water system that is required to determine a bin classification under 1200-
5-1-.39(11), or to determine mean Cryptosporidium level under 1200-5-1-.39(13), must
notify persons served by the water system that the determination has not been made
as required no later than 30 days after the system has failed report the determination
as specified in 1200-5-1-.39(11)(e) or 1200-5-1-.39(13)(a), respectively. The notice
must be repeated as specified in 1200-5-1-.19(3)(b). The notice is not required if the
system is complying with a State-approved schedule to address the violation.

(c) What is the form and manner of the special notice? The form and manner of the public
notice must follow the requirements for a Tier 2 public notice prescribed in 1200-5-1-
.19(3)(c). The public notice must be presented as required in 1200-5-1-.19(5)(c).

(d) What mandatory language must be contained in the special notice? The notice must
contain the following language, including the language necessary to fill in the blanks.

1. The special notice for repeated failure to conduct monitoring must contain the
following language:
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.19, continued)
August, 2008 (Revised)
102

We are required to monitor the source of your drinking water for Cryptosporidium.
Results of the monitoring are to be used to determine whether water treatment at
the (treatment plant name) is sufficient to adequately remove Cryptosporidium
from your drinking water. We are required to complete this monitoring and make
this determination by (required bin determination date). We ‘‘did not monitor or
test’’ or ‘‘did not complete all monitoring or testing’’ on schedule and, therefore,
we may not be able to determine by the required date what treatment
modifications, if any, must be made to ensure adequate Cryptosporidium
removal. Missing this deadline may, in turn, jeopardize our ability to have the
required treatment modifications, if any, completed by the deadline required,
(date).

For more information, please call (name of water system contact) of (name of
water system) at (phone number).

2. The special notice for failure to determine bin classification or mean
Cryptosporidium level must contain the following language:

We are required to monitor the source of your drinking water for Cryptosporidium
in order to determine by (date) whether water treatment at the (treatment plant
name) is sufficient to adequately remove Cryptosporidium from your drinking
water. We have not made this determination by the required date. Our failure to
do this may jeopardize our ability to have the required treatment modifications, if
any, completed by the required deadline of (date). For more information, please
call (name of water system contact) of (name of water system) at (phone
number).

2. Each special notice must also include a description of what the system is doing
to correct the violation and when the system expects to return to compliance or
resolve the situation.

APPENDIX A TO 1200-5-1-.19.---NPDWR VIOLATIONS AND OTHER SITUATIONS REQUIRING PUBLIC NOTICE
1

MCL/MRDL/TT violations
2
Monitoring & testing procedure
violations
Contaminant Tier of public
notice
required
Citation Tier of public
notice
required
Citation
I. Violations of National Primary Drinking Water
Regulations (NPDWR):
3


A. Microbiological Contaminants
1. Total coliform 2 1200-5-1-.06(4)(a) 3 1200-5-1-.07(1)-(2)
2. Fecal coliform/E.coli 1 1200-5-1-.06(4)(b)
4
1,3 1200-5-1-.07(1)-(2)
3. Turbidity MCL 2 1200-5-1-.06(4)(a) 3 1200-5-1-.08
4. Turbidity MCL(average of 2 days’ samples
> 2 NTU)
5
2,1 1200-5-1-.06(3)(b) 3 1200.-5-1-.08
5. Turbidity (for TT violations resulting from a
Single exceedance of maximum allowable
turbidity level)
6
2,1 1200-5-1-.31(2)(a)
1200-5-1-.31(2)(a)
1200-5-1-.31(4)(a)2.
1200-5-1-.31(4)(b)2.
1200-5-1-.31(4)(b)2.
1200-5-1-.31(4)(b)2.
3 1200-5-1-.31
1200-5-1-.31
1200-5-1-.31
1200-5-1-.31
6. Surface Water Treatment Rule violations
other than violations resulting from single
exceedance of max. allowable turbidity level
(TT) [1200-5-1-.31(4)]
2 1200-5-1-.31(1)-(4) 3 1200-5-1-.31(4)
7. Interim Enhanced Surface Water
Treatment Rule violations, other than
violations resulting from single exceedance of
max turbidity level (TT) [1200-5-1-.31(4)
7
2 1200-5-1-.31(1)-(4) 3 1200-5-1-.31(4)®
8. Filter Backwash Recycling Rule Violations

2 1200-5-1-.31(9)® 3 1200-5-1-/31(9)(b)
and (d)
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.19, continued)
August, 2008 (Revised)
103
9.Long term 1 Enhanced Surface Water
Treatment Rule Violations
2 1200-5-1-.31(4) 3 1200-5-1-.31(6)
10. LT2ESWTR violation 2 1200-5-1-.39(11)-(21)
22
2,3 1200-5-1-.39(2)-(6)
1200-5-1-.39(9)-(10)
11. Ground Water Rule violations 2 Rule 1200-5-1-.40(5) 3 1200-5-1-.40(3)(m)
1200-5-1-.40(4)(d)
B. Inorganic Chemicals (IOCs)
1. Antimony 2 1200-5-1-.06(1)(b)1. 3 1200-5-1-.09
2. Arsenic 2
8
1200-5-1-.06(1)(b)2. 3
11
1200-5-1-.09
3. Asbestos (fibers >10 µm) 2 1200-5-1-.06(1)(b)3. 3 1200-5-1-.09
4. Barium 2 1200-5-1-.06(1)(b)5. 3 1200-5-1-.09
5. Beryllium 2 1200-5-1-.06(1)(b)4. 3 1200-5-1-.09
6. Cadmium 2 1200-5-1-.06(1)(b)6. 3 1200-5-1-.09
7. Chromium (total) 2 1200-5-1-.06(1)(b)7. 3 1200-5-1-.09
8. Cyanide 2 1200-5-1-.06(1)(b)8. 3 1200-5-1-.09
9. Fluoride 2 1200-5-1-.06(1)(b)9. 3 1200-5-1-.09
10. Mercury (inorganic) 2 1200-5-1-.06(1)(b)10. 3 1200-5-1-.09
11. Nickel 2 1200-5-1-.06(1)(b)11. 3 1200-5-1-.09
12. Nitrate 1 1200-5-1-.06(1)(b)12.
12
1,3 1200-5-1-.09
13. Nitrite 1 1200-5-1-.06(1)(b)13.
12
1,3 1200-5-1-.09
14. Total Nitrate and Nitrite 1 1200-5-1-.06(1)(b)14. 3 1200-5-1-.09
15. Selenium 2 1200-5-1-.06(1)(b)15. 3 1200-5-1-.09
16. Thallium 2 1200-5-1-.06(1)(b)16. 3 1200-5-1-.09
C. Lead and Copper Rule (Action Level for lead
is 0.015 mg/L, for copper is 1.3 mg/L)

1. Lead and Copper Rule (TT) 2 1200-5-1-.33(1)-(6) 3 1200-5-1-.33
D. Synthetic Organic Chemicals (SOCs)
1. 2,4-D 2 1200-5-1-.06(2)(a)6. 3 1200-5-1-.10
2. 2,4,5-TP (Silvex) 2 1200-5-1-.06(2)(a)14. 3 1200-5-1-.10
3. Alachlor 2 1200-5-1-.06(2)(a)1. 3 1200-5-1-.10
4. Atrazine 2 1200-5-1-.06(2)(a)2. 3 1200-5-1-.10
5. Benzo(a)pyrene (PAHs) 2 1200-5-1-.06(2)(a)16. 3 1200-5-1-.10
6. Carbofuran 2 1200-5-1-.06(2)(a)3. 3 1200-5-1-.10
7. Chlordane 2 1200-5-1-.06(2)(a)4. 3 1200-5-1-.10
8. Dalapon 2 1200-5-1-.06(2)(a)17. 3 1200-5-1-.10
9. Di (2-ethylhexyl) adipate 2 1200-5-1-.06(2)(a)18. 3 1200-5-1-.10
10. Di (2-ethylhexyl) phthalate 2 1200-5-1-.06(2)(a)19. 3 1200-5-1-.10
11. Dibromochloropropane 2 1200-5-1-.06(2)(a)20. 3 1200-5-1-.10
12. Dinoseb 2 1200-5-1-.06(2)(a)20. 3 1200-5-1-.10
13. Dioxin (2,3,7,8-TCDD) 2 1200-5-1-.06(2)(a)29. 3 1200-5-1-.10
14. Diquat 2 1200-5-1-.06(2)(a)21. 3 1200-5-1-.10
15. Endothall 2 1200-5-1-.06(2)(a)22. 3 1200-5-1-.10

16. Endrin 2 1200-5-1-.06(2)(a)30. 3 1200-5-1-.10
17. Ethylene Dibromide 2 1200-5-1-.06(2)(a)7. 3 1200-5-1-.10
18.Glyphospate 2 1200-5-1-.06(2)(a)23. 3 1200-5-1-.10
19. Heptachlor 2 1200-5-1-.06(2)(a)8. 3 1200-5-1-.10
20. Heptachlor epoxide 2 1200-5-1-.06(2)(a)9. 3 1200-5-1-.10
21. Hexachlorobenzene 2 1200-5-1-.06(2)(a)24. 3 1200-5-1-.10
22. Hexachlorocyclo-pentadiene 2 1200-5-1-.06(2)(a)25. 3 1200-5-1-.10
23. Lindane 2 1200-5-1-.06(2)(a)10. 3 1200-5-1-.10
24. Methoxchlor 2 1200-5-1-.06(2)(a)11. 3 1200-5-1-.10
25. Oxamyl (Vydate) 2 1200-5-1-.06(2)(a)26. 3 1200-5-1-.10
26. Pentachlorophenol 2 1200-5-1-.06(2)(a)15. 3 1200-5-1-.10
27. Picloram 2 1200-5-1-.06(2)(a)27. 3 1200-5-1-.10
28. Polychlorinated biphenyls (PCBs) 2 1200-5-1-.06(2)(a)12. 3 1200-5-1-.10
29. Simazine 2 1200-5-1-.06(2)(a)28. 3 1200-5-1-.10
30. Toxaphene 2 1200-5-1-.06(2)(a)13. 3 1200-5-1-.10
E. Volatile Organic Chemicals (VOCs)
1. Benzene 2 1200-5-1-.25(2)(e) 3 1200-5-1-.26
2. Carbon tetrachloride 2 1200-5-1-.25(2)(b) 3 1200-5-1-.26
3. Chlorobenzene (monochlorbenzene) 2 1200-5-1-.25(2)(1) 3 1200-5-1-.26
4. o-Dichlorobenzene 2 1200-5-1-.25(2)(m) 3 1200-5-1-.26
5. p-Dichlorobenzene 2 1200-5-1-.25(2)(h) 3 1200-5-1-.26
6. 1,2-Dichloroethane 2 1200-5-1-.25(2)(d) 3 1200-5-1-.26
7. 1,1-Dichloroethylene 2 1200-5-1-.25(2)(f) 3 1200-5-1-.26
8. cis-1,2-Dichloroethylene 2 1200-5-1-.25(2)(i) 3 1200-5-1-.26
9. trans-1,2-Dichloroethylene 2 1200-5-1-.25(2)(q) 3 1200-5-1-.26
10. Dichloromethane 2 1200-5-1-.25(2)(s) 3 1200-5-1-.26
11. 1,2-Dichloropropane 2 1200-5-1-.25(2)(j) 3 1200-5-1-.26
12. Ethylbenzene 2 1200-5-1-.25(2)(k) 3 1200-5-1-.26
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August, 2008 (Revised)
104
13. Styrene 2 1200-5-1-.25(2)(n) 3 1200-5-1-.26
14. Tetrachloroethylene 2 1200-5-1-.25(2)(o) 3 1200-5-1-.26
15. Toluene 2 1200-5-1-.25(2)(p) 3 1200-5-1-.26
16. 1,2,4-Trichlorobenzene 2 1200-5-1-.25(2)(t) 3 1200-5-1-.26
17. 1,1,1-Trichloroethane 2 1200-5-1-.25(2)(g) 3 1200-5-1-.26
18. 1,1,2-Trichloroethane 2 1200-5-1-.25(2)(w) 3 1200-5-1-.26
19. Trichloroethylene 2 1200-5-1-.25(2)(a) 3 1200-5-1-.26
20. Vinyl chloride 2 1200-5-1-.25(2)(c) 3 1200-5-1-.26
21. Xylenes (total) 2 1200-5-1-.25(2)(r) 3 1200-5-1-.26
F. Radioactive Contaminants
1. Beta/photon emitters 2 1200-5-1-.06(5)(b) 3 1200-5-1-.11
2. Alpha emitters 2 1200-5-1-.06(5)(a) 3 1200-5-1-.11
3. Combined radium (226 & 228) 2 1200-5-1-.06(5)(a)2. 3 1200-5-1-.11
4. Uranium
9
2 1200-5-1-.06(5)(c)
10-
3 1200-5-1-.11
G. Disinfection Byproducts (DBPs), Byproduct
Precursors, Disinfectant Residuals. Where
Disinfection is used in the treatment of drinking
water, disinfectants combine with organic and
inorganic matter present in water to form
chemicals called disinfection byproducts (DBPs).
EPA sets standards for controlling the levels of
disinfectants and DBPs in drinking water
including trihalomethanes (THMs) and haloacetic
acids (HAAs).
13


1. Total trihalomethanes (TTHMs) 2
14
1200-5-1-.06(6)(b) 3 1200-5-1-36,.37,
and 38
2. Haloacetic Acids (HAA5) 2 1200-5-1-.06(6)(b) 3 1200-5-1-.36,.37
and .38
3. Bromate 2 1200-5-1-.06(6)(a) 3 1200-5-1-.36
4. Chlorite 2 1200-5-1-.06(6)(a) 3 1200-5-1-.36
5. Chlorine (MRDL) 2 1200-5-1-.06(6)(c) 3 1200-5-1-.36
6. Chloramine (MRDL) 2 1200-5-1-.06(6)(c) 3 1200-5-1-.36


7. Chlorine dioxide (MRDL), where any 2
consecutive daily samples at entrance to
distribution system only are above MRDL
2 1200-5-1-
.36(7)(c)2.(ii)
2
15
, 3 1200-5-1-.36
8. Chlorine dioxide (MRDL), where sample(s)
in distribution system the next day are also
above MRDL
16
1 1200-5-1-.36(7)(c)2.(i) 1 1200-5-1-.36
9. Control of DBP precursors—TOC (TT) 2 1200-5-1-.36-(7)(d) 3 1200-5-1-.36
10. Bench marking and disinfection profiling N/A N/A 3 1200-5-1-.36
11. Development of monitoring plan N/A N/A 3 1200-5-1-.36
H. Other Treatment Techniques
1. Acrylamide (TT) 2 1200-5-1-.17(31) N/A N/A
2. Epichlorohydrin (TT) 2 1200-5-1-.17(31) N/A N/A
II. Unregulated Contaminant Monitoring:
17

A. Unregulated contaminants N/A N/A 3
B. Nickel 2 1200-5-1-.06(b) 3 1200-5-1-.09

III. Public Notification for Variances and
Exemptions:

A. Operation under a variance or exemption 3
18
1200-5-1-.19(2)(b) N/A N/A
B. Violation of conditions of a variance or
exemption
19
2 1200-5-1-.19(2)(b) N/A N/A

IV. Other Situations Requiring Public
Notification:

A. Fluoride secondary maximum contaminant
Level (SMCL) exceedance
3 1200-5-1-.19(q) N/A N/A
B. Exceedance of nitrate MCL for non-
community systems, as allowed by department
1 1200-5-1-.19(1)(a)3. N/A N/A
C. Availability of unregulated contaminant
monitoring data
3 1200-5-1-.19(10) N/A N/A
D. Waterborne disease outbreak 1 1200-5-1-.31(2)(c)2. N/A N/A
E. Other waterborne emergency
20
1 N/A N/A N/A
F. Other situations as determined by the
department
21
1, 2, 3 N/A N/A N/A
G. Source Water Sample Positive for GWR
Fecal indicators: E. coli or enterococci
1

Rule 1200-5-1-
.40(3)(l)
N/A N/A

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.19, continued)
August, 2008 (Revised)
105
Appendix A –Endnotes

1. Violations and other situations not listed in this table (e.g., failure to prepare Consumer Confidence Reports), do not require
notice, unless otherwise determined by the department. The department may, at its option, also require a more stringent public
notice tier (e.g., Tier 1 instead of Tier 2 or Tier 2 instead of Tier 3) for specific violations and situations listed in this Appendix, as
authorized under 1200-5-1-.19(2)(a) and (3)(a).
2. MCL – Maximum contaminant level, MRDL – Maximum residual disinfectant level, TT-Treatment technique.
3. The term Violations of National Primary Drinking Water Regulations (NPDWR) is used here to include violations of MCL, MRDL,
treatment technique, monitoring, and testing procedure requirements.
4. Failure to test for fecal coliform or E.coli is a Tier 1 violation if testing is not done after any repeat sample tests positive for
coliform. All other total coliform monitoring and testing procedure violations are Tier 3.
5. Systems that violate the turbidity MCL of 2 NTU based on an average of measurements over two consecutive days must consult
with the department within 24 hours after learning of the violation. Based on this consultation, the department may subsequently
decide to elevate the violation to Tier 1. If a system is unable to make contact with the department in the 24-hour period, the
violation is automatically elevated to Tier 1.
6. Systems with treatment technique violations involving a single exceedance of a maximum turbidity limit under the Surface Water
Treatment Rule, Interim Enhanced Surface Water Treatment Rule, or the Long Term 1 Enhanced Surface Water Treatment Rule
(1200-5-1-.31) are required to consult with the Department within 24 hours after learning of the violation. Based on this consultation,
the department may subsequently decide to elevate the violation to Tier 1. If a system is unable to make contact with the
department in the 24-hour period, the violation is automatically elevated to Tier 1.
7. Most of the requirements of the Interim Enhanced Surface Water Treatment Rule 1200-5-1-.31 become effective January 1, 2002
for Subpart H systems (surface water systems and ground water systems under the direct influence of surface water) serving at
least 10,000 persons. The Surface Water Treatment Rule remains in effect for systems serving at least 10,000 persons even after
2002; the Interim Enhanced Surface Water Treatment Rule adds additional requirements and does not in many cases supercede
the SWTR.
8. The arsenic MCL citations are effective January 23, 2006, or the effective date of this rule whichever comes first.
9. The uranium MCL tier 2 violation citations are effective December 8, 2003 for all community water systems.
10. The uranium tier 3 violations are effective December 8, 2003, for all community water systems
11. The arsenic Tier 3 MCL violations are effective January 23, 2006 or the effective date of this rule whichever comes first.
12. Failure to take a confirmation sample within 24 hours for nitrate or nitrite after an initial sample exceeds the MCL is a Tier 1
violation. Other monitoring violations for nitrate are Tier 3.
13. Subpart H community and non-transient non-community systems serving ≥10,000 must comply with new DBP MCLs,
disinfectant MRDLs, and related monitoring requirements beginning January 1, 2002. All other community and non-transient non-
community systems must meet the MCLs and MRDLs beginning January 1, 2004. Subpart H transient non-community systems
serving 10,000 or more persons and using chlorine dioxide as a disinfectant or oxidant must comply with the chlorine dioxide MRDL
beginning January 1, 2002. Subpart H transient non-community systems serving fewer than 10,000 persons and using only ground
water not under the direct influence of surface water and using chlorine dioxide as a disinfectant or oxidant must comply with the
chlorine dioxide MRDL beginning January 1, 2004.
14. 1200-5-1-.06(6), 1200-5-1-36(5(a)-(b) apply until 1200-5-1-.38(1)-(11) take effect under the schedule in 1200-5-1-.38(1)(c)
15. Failure to monitor for chlorine dioxide at the entrance to the distribution system the day after exceeding the MRDL at the
entrance to the distribution system is a Tier 2 violation.
16. If any daily sample taken at the entrance to the distribution system exceeds the MRDL for chlorine dioxide and one or more
samples taken in the distribution system the next day exceed the MRDL, Tier 1 notification is required. Failure to take the required
samples in the distribution system after the MRDL is exceeded at the entry point also triggers Tier 1 notification.
17. Some water systems must monitor for certain unregulated contaminants.
18. This citation refers to §§1415 and 1416 of the Safe Drinking Water Act. §§1415 and 1416 require that “a schedule
prescribed… for a public water system granted a variance [or exemption] shall require compliance by the system…”
19. In addition to §§1415 and 1416 of the Safe Drinking Water Act, 40 CFR 142.307 specifies the items and schedule milestones
that must be included in a variance for small systems.
20. Other waterborne emergencies require a Tier 1 public notice under 1200-5-1-.19(2)(a) for situations that do not meet the
definition of a waterborne disease outbreak given in 1200-5-1-.04 but that still have the potential to have serious adverse effects on
health as a result of short-term exposure. These could include outbreaks not related to treatment deficiencies, as well as situations
that have the potential to cause outbreaks, such as failures or significant interruption in water treatment processes, natural disasters
that disrupt the water supply or distribution system, chemical spills, or unexpected loading of possible pathogens onto the source
water.
21. The department may place other situations in any tier it believes appropriate, based on threat to public health.
22
.
Failure to collect three or more samples for cryptosporidium analysis is a Tier 2 violation requiring special notice as specified in
1200-5-1-.19(11). All other monitoring and testing procedure violations are Tier 3.


APPENDIX B TO 1200-5-1-.19. –STANDARD HEALTH EFFECTS FOR PUBLIC NOTIFICATION
Contaminant MCLG
1
mg/l MCL
2
mg/l Standard health effects language for public notification
National Primary Drinking Water
Regulations (NRDWR):

A. Microbiological Contaminants
1a. Total coliform Zero See foot
note
3

Coliforms are bacteria that are naturally present in the
environment and are used as an indicator that other,
potentially-harmful, bacteria may be present. Coliforms
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

(Rule 1200-5-1-.19, continued)
August, 2008 (Revised)
106
were found in more samples than allowed and this was a
warning of potential problems.
1b. Fecal coliform/E.coli Zero Zero Fecal coliforms and E.coli are bacteria whose presence
indicates that the water may be contaminated with human
or animal wastes. Microbes in these wastes can cause
short-term effects, such as diarrhea, cramps, nausea,
headaches, or other symptoms. They may pose a special
health risk for infants, young children, some of the elderly,
and people with severely compromised immune systems.
1c. Fecal indicators (GWR)
i. E. coli
ii. Enterococci


Zero
None


TT
TT

Fecal indicators are microbes whose presence indicates
that the water may be contaminated with human or animal
wastes. Microbes in these wastes can cause short-term
health effects, such as diarrhea, cramps, nausea,
headaches, or other symptoms. They may pose a special
health risk for infants, young children, some of the elderly,
and people with severely compromised immune systems.
1d. Ground Water Rule (GWR)
TT violations
None TT Inadequately treated or inadequately protected water may
contain disease-causing organisms. These organisms can
cause symptoms such as diarrhea, nausea, cramps, and
associated headaches.
2a. Turbidity (MCL)
4
None 1 NTU
5
/2
NTU
Turbidity has no health effects. However, turbidity can
interfere with disinfection and provide a medium for
microbial growth. Turbidity may indicate the presence of
disease-causing organisms. These organisms include
bacteria, viruses, and parasites that can cause symptoms
such as nausea, cramps, diarrhea and associated
headaches.
2b. Turbidity (SWTR TT)
6

(surface water and ground water
under the direct influence)
None TT
7
Turbidity has no health effects. However, turbidity can
interfere with disinfection and provide a medium for
microbial growth. Turbidity may indicate the presence of
disease-causing organisms. These organisms include
bacteria, viruses, and parasites that can cause symptoms
such as nausea, cramps, diarrhea and associated
headaches.
2c. Turbidity (IESWTR and
LT1ESWTR TT)
8
(surface water
and ground water under the
direct influence of surface water)
None TT Turbidity has no health effects. However, turbidity can
interfere with disinfection and provide a medium for
microbial growth. Turbidity may indicate the presence of
disease-causing organisms. These organisms include
bacteria, viruses, and parasites that can cause symptoms
such as nausea, cramps, diarrhea and associated
headaches.
B. Surface Water Treatment Rule
(SWTR) Long Term 1 (LT1ESWTR)
and Interim Enhanced Surface Water
Treatment Rule (IESWTR) violations:

3. Giardia lamblia (SWTR/
IESWTR/LT1ESWTR)
Zero TT
10
Inadequately treated water may contain disease-causing
organisms. These organisms include bacteria, viruses,
and parasites which can cause symptoms such as nausea,
cramps, diarrhea, and associated headaches.
4. Viruses (SWTR/IESWTR/
LT1ESWTR).
Same as B.3.
5. Heterotrophic plate count
(HPC) bacteria
9

(SWTR/(IESWTR/LT1ESWTR).
Same as B.3.
6. Legionella
(SWTR/IESWTR/LT1ESWTR).
Same as B.3.
7. Cryptosporidium
(IESWTR/LT1ESWTR)
Same as B.3.
C. Inorganic Chemicals
8. Antimony 0.006 0.006 Some people who drink water containing antimony well in
excess of the MCL over many years could experience
increases in blood cholesterol and decreases in blood
sugar.
9. Arsenic
11
0 0.01 Some people who drink water containing arsenic in excess
of the MCL over many years could experiences skin
damage or problems with their circulatory system, and may
have an increased risk of getting cancer.
10. Asbestos (10 µm) 7 MFL
12
7 MFL Some people who drink water containing asbestos in
excess of the MCL over many years may have an
increased risk of developing benign intestinal polyps.

PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

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August, 2008 (Revised)
107

11. Barium 2 2 Some people who drink water containing barium in
excess of the MCL over many years could experience
an increase in their blood pressure.
12. Beryllium 0.004 0.004 Some people who drink water containing beryllium well
in excess of the MCL over many years could develop
intestinal lesions.
13. Cadmium 0.005 0.005 Some people who drink water containing cadmium in
excess of the MCL over many years could experience
kidney damage.
14. Chromium (total) 0.1 0.1 Some people who drink water containing chromium well
in excess of the MCL over many years could experience
allergic dermatitis.
15. Cyanide 0.2 0.2 Some people who drink water containing cyanide well in
excess of the MCL over many years could experience
nerve damage or problems with their thyroid.
16. Fluoride 4.0 4.0 Some people who drink water containing fluoride in
excess of the MCL over many years could get bone
disease, including pain and tenderness of the bones.
Fluoride in drinking water at half the MCL or more may
cause mottling of children’s teeth, usually in children
less than nine years old. Mottling, also known as dental
fluorosis, may include brown staining and/or pitting of
the teeth, and occurs only in developing teeth before
they erupt from the gums.
17. Mercury (inorganic) 0.002 0.002 Some people who drink water containing inorganic
mercury well in excess of the MCL over many years
could experience kidney damage.
18. Nitrate 10 10 Infants below the age of six months who drink water
containing nitrate in excess of the MCL could become
seriously ill and, if untreated, may die. Symptoms
include shortness of breath and blue baby symptoms.
19. Nitrite 1 1 Infants below the age of six months who drink water
containing nitrite in excess of the MCL could become
seriously ill and, if untreated, may die. Symptoms
include shortness of breath and blue baby symptoms.
20. Total Nitrate and Nitrite 10 10 Infants below the age of six months who drink water
containing nitrate and nitrite in excess of the MCL could
become seriously ill and, if untreated, may die.
Symptoms include shortness of breath and blue baby
symptoms.
21. Selenium 0.05 0.05 Selenium is an essential nutrient. However, some
people who drink water containing selenium in excess of
the MCL over many years could experience hair or
fingernail losses, numbness in fingers or toes, or
problems with their circulation.
22. Thallium 0.0005 0.002 Some people who drink water containing thallium in
excess of the MCL over many years could experience
hair loss, changes in their blood, or problems with their
kidneys, intestines, or liver.
D. Lead and Copper Rule:
23. Lead Zero TT
13
Infants and children who drink water containing lead in
excess of the action level could experience delays in
their physical or mental development. Children could
show slight deficits in attention span and learning
abilities.
Adults who drink this water over many years could
develop kidney problems or high blood pressure.

24. Copper 1.3 TT
14
Copper is an essential nutrient, but some people who
drink water containing copper in excess of the action
level over a relatively short amount of time could
experience gastrointestinal distress. Some people who
drink water containing copper in excess of the action
level over many years could suffer liver or kidney
damage. People with Wilson’s disease should consult
their personal doctor.
E. Synthetic Organic Compounds
25. 2,4-D 0.07 0.07 Some people who drink water containing the weed killer
2,4-D well in excess of the MCL over many years could
experience problems with their kidneys, liver or adrenal
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

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August, 2008 (Revised)
108
glands.
26. 2,4,5-TP (Silvex) 0.05 0.05 Some people who drink water containing silvex in
excess of the MCL over many years could experience
liver problems.
27. Alachlor Zero 0.002 Some people who drink water containing alachlor in
excess of the MCL over many years could have
problems with their eyes, liver kidneys, or spleen, or
experience anemia, and may have an increased risk of
getting cancer.
28. Atrazine 0.003 0.003 Some people who drink water containing atrazine well in
excess of the MCL over many years could experience
problems with their cardiovascular system or
reproductive difficulties.
29. Benzo(a)pyrene (PAHs) Zero 0.0002 Some people who drink water containing
benzo(a)pyrene in excess of the MCL over many years
may experience reproductive difficulties and may have
an increased risk of getting cancer.
30. Carbofuran 0.04 0.04 Some people who drink water containing carbofuran in
excess of the MCL over many years could experience
problems with their blood, or nervous or reproductive
systems.
31. Chlordane Zero 0.002 Some people who drink water containing chlordane in
excess of the MCL over many years could experience
problems with their liver or nervous system, and may
have an increased risk of getting cancer.
32. Dalapon 0.2 0.2 Some people who drink water containing dalapon well in
excess of the MCL over many years could experience
minor kidney changes.
33. Di (2-ethylexyl) adipate 0.4 0.4 Some people who drink water containing di (2-ethyhexyl)
adipate well in excess of the MCL over many years
could experience general toxic effects or reproductive
difficulties.
34. Di (2-ethylhexyl) phthalate Zero 0.006 Some people who drink water containing di (2-
ethylhexyl) phthalate in excess of the MCL over many
years may have problems with their liver, or experience
reproductive difficulties, and may have an increased risk
of getting cancer.
35. Dibromochloropropane
(DBCP)
Zero 0.0002 Some people who drink water containing DBCP in
excess of the MCL over many years could experience
reproductive difficulties and may have an increased risk
of getting cancer.
36. Dinoseb 0.007 0.007 Some people who drink water containing dinoseb well in
excess of the MCL over many years could experience
reproductive difficulties.
37. Dioxin (2,3,7,8-TCDD) Zero 3x10
-8
Some people who drink water containing dioxin in
excess of the MCL over many years could experience
reproductive difficulties and may have an increased risk
of getting cancer.

38. Diquat 0.02 0.02 Some people who drink water containing diquat in
excess of the MCL over many years could get cataracts.
39. Endothall 0.1 0.1 Some people who drink water containing endothall in
excess of the MCL over many years could experience
problems with their stomach or intestines.
40. Endrin 0.002 0.002 Some people who drink water containing endrin in
excess of the MCL over many years could experience
liver problems.
41. Ethylene dibromide Zero 0.00005 Some people who drink water containing ethylene
dibromide in excess of the MCL over many years could
experience problems with their liver, stomach,
reproductive system, or kidneys, and may have an
increased risk of getting cancer.
42. Glyphosate 0.7 0.7 Some people who drink water containing glyphosate in
excess of the MCL over many years could experience
problems with their kidneys or reproductive difficulties.
43. Heptachlor Zero 0.0004 Some people who drink water containing heptachlor in
excess of the MCL over many years could experience
liver damage and may have an increased risk of getting
cancer.
44. Heptachlor epoxide Zero 0.0002 Some people who drink water containing heptachlor
epoxide in excess of the MCL over many years could
PUBLIC WATER SYSTEMS CHAPTER 1200-5-1

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August, 2008 (Revised)
109
experience liver damage, and may have an increased
risk of getting cancer.
45. Hexachlorobenzene Zero 0.001 Some people who drink water containing
hexachlorobenzene in excess of the MCL over many
years could experience problems with their liver or
kidneys, or adverse reproductive effects, and may have
an increased risk of getting cancer.
46. Hexachlorocyclopentadiene 0.05 0.05 Some people who drink water containing
hexachlorocyclopentadiene well in excess of the MCL
over many years could experience problems with their
kidneys or stomach.
47. Lindane 0.0002 0.0002 Some people who drink water containing lindane in
excess of the MCL over many years could experience
problems with their kidneys or liver.
48. Methoxychlor 0.04 0.04 Some people who drink water containing methoxychlor
in excess of the MCL over many years could experience
reproductive difficulties.
49. Oxamyl (Vydate) 0.2 0.2 Some people who drink water containing oxamyl in
excess of the MCL over many years could experience
slight nervous system effects.
50. Pentachlorophenol Zero 0.001 Some people who drink water containing
pentachlorophenol in excess of the MCL over many
years could experience problems with their liver or
kidneys, and may have an increased risk of getting
cancer.
51. Picloram 0.5 0.5 Some people who drink water containing picloram in
excess of the MCL over many years could experience
problems with their liver.
52. Polychlorinated biphenyls
(PCBs)
Zero 0.0005 Some people who drink water containing PCBs in
excess of MCL over many years could experience
changes in their skin, problems with their thymus gland,
immune deficiencies, or reproductive or nervous system
difficulties, and may have an increased risk of getting
cancer.
53. Simazine 0.004 0.004 Some people who drink water containing simazine in
excess of the MCL over many years could experience
problems with their blood.

54. Toxaphene Zero 0.003 Some people who drink water containing toxaphene in
excess of the MCL over many years could have
problems with their kidneys, liver, or thyroid, and may
have an increased risk of getting cancer.
F. Volatile Organic Compounds
VOC)

55. Benzene Zero 0.005 Some people who drink water containing benzene in
excess of the MCL over many years could experience
anemia or a decrease in blood platelets, and may have
an increased risk of getting cancer.
56. Carbon tetrachloride Zero 0.005 Some people who drink water containing carbon
tetrachloride in excess of the MCL over many years
could experience problems with their liver and may have
an increased risk of getting cancer.
57. Chlorobenzene (monochloro-
benzene)
0.1 0.1 Some people who drink water containing chlorobenzene
in excess of the MCL over many years could experience
problems with their liver or kidneys.
58. o-Dichlorobenzene 0.6 0.6 Some people who drink water containing o-
dichlorobenzene in excess of the MCL over many years
could experience problems with their liver, kidneys, or
circulatory systems.
59. p-Dichlorobenzene 0.075 0.075 Some people who drink water containing p-
dichlorobenzene in excess of the MCL over many years
could experience anemia, damage to their liver, kidneys,
or spleen, or changes in their blood.
60. 1,2-Dichloroethane Zero 0.005 Some people who drink water containing 1,2-
dichloroethane in excess of the MCL over many years
may have an increased risk of getting cancer.
61. 1,1-Dichloroethylene 0.007 0.007 Some people who drink water containing 1,1-
dichloroethylene in excess of the MCL over many years
could experience problems with their liver.
62. cis-1,2-Dichloroethylene 0.07 0.07 Some people who drink water containing cis-1,2-
dichloroethylene in excess of the MCL over many years
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could experience problems with their liver.
63. trans-1,2-Dichloroethylene 0.1 0.1 Some people who drink water containing trans-1,2-
dichloroethylene well in excess of the MCL over many
years could experience problems with their liver.
64. Dichloromethane Zero 0.005 Some people who drink water containing
dichloromethane in excess of the MCl over many years
could have liver problems and may have an increased
risk of getting cancer.
65. 1,2-Dichloropropane Zero 0.005 Some people who drink water containing 1,2-
dichloropropane in excess of the MCL over many years
may have an increased risk of getting cancer.
66. Ethylbenzene 0.7 0.7 Some people who drink water containing ethylbenzene
well in excess of the MCL over many years could
experience problems with their liver or kidneys.
67. Styrene 0.1 0.1 Some people who drink water containing styrene well in
excess of the MCL over many years could have
problems with their liver, kidneys, or circulatory system.
68. Tetrachloroethylene Zero 0.005 Some people who drink water containing
tetrachloroethylene in excess of the MCL over many
years could have problems with their livers, and may
have an increased risk of getting cancer.
69. Toluene 1 1 Some people who drink water containing toluene well in
excess of the MCL over many years could have
problems with their nervous system, kidneys, or liver.

70. 1,2,4-Trichlorobenzene 0.07 0.07 Some people who drink water containing 1,2,4-
trichlorobenzene well in excess of the MCL over many
years could experience changes in their adrenal glands.
71. 1,1,1-Trichloroethane 0.2 0.2 Some people who drink water containing 1,1,1-
trichloroethane in excess of the MCL over many years
could experience problems with their liver, nervous
system, or circulatory problems.
72. 1,1,2-Trichloroethylene 0.003 0.005 Some people who drink water containing 1,1,2-
trichloroethane well in excess of the MCL over many
years could have problems with their liver, kidneys, or
immune systems.
73. Trichloroethylene Zero 0.005 Some people who drink water containing
trichloroethylene in excess of the MCL over many years
could experience problems with their liver and may have
an increased risk of getting cancer.
74. Vinyl chloride Zero 0.002 Some people who drink water containing vinyl chloride
in excess of the MCL over many years may have an
increased risk of getting cancer.
75. Xylenes (total) 10 10 Some people who drink water containing xylenes in
excess of the MCL over many years could experience
damage to their nervous system.
G. Radioactive Contaminants
76. Beta/photon emitters Zero 4 mrem/yr
15
Certain minerals are radioactive and may emit forms of
radiation known as photons and beta radiation. Some
people who drink water containing beta and photon
emitters in excess of the MCL over many years may
have an increased risk of getting cancer.
77. Alpha emitters Zero 15 pCi/L
17
Certain minerals are radioactive and may emit a form of
radiation known as alpha radiation. Some people who
drink water containing alpha emitters in excess of the
MCL over many years may have an increased risk of
getting cancer.
78. Combined radium (226 &
228).
Zero 5 pCi/L Some people who drink water containing radium 226 or
228 in excess of the MCL over many years may have
an increased risk of getting cancer.
79. Uranium
16
Zero 30ug/L Some people who drink water containing uranium in
excess of the MCL over many years may have an
increased risk of getting cancer and kidney toxicity.
H. Disinfection Byproducts (DBPs),
Byproducts Precursors, and
Disinfectant Residuals: Where
disinfection is used in the treatment
of drinking water, disinfectants
combine with organic and inorganic
matter present in water to form
chemicals called disinfection by-

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products (DBPs). EPA sets
standards for controlling the levels
of disinfectants and DBPs in
drinking water, including
trihalomethanes (THMs) and
haloacetic acids (HAAs):
18

80. Total trihalomethanes
(TTHMs)
N/A 080
19 20
Some people who drink water containing
trihalomethanes in excess of the MCL over many years
may experience problems with their liver, kidneys, or
central nervous system, and may have an increased risk
of getting cancer.
81. Haloacetic Acids (HAA) N/A 0.060
21
Some people who drink water containing haloacetic
acids in excess of the MCL over many years may have
an increased risk of getting cancer.

82. Bromate Zero 0.010 Some people who drink water containing bromate in
excess of the MCL over many years may have an
increased risk of getting cancer.
83. Chlorite 0.08 1.0 Some infants and young children who drink water
containing chlorite in excess of the MCL could
experience nervous system effects. Similar effects may
occur in fetuses of pregnant women who drink water
containing chlorite in excess of the MCL. Some people
may experience anemia.
84. Chlorine 4 (MRDLG)
22
4.0
(MRDL)
23

Some people who use water containing chlorine well in
excess of the MRDL could experience irritating effects to
their eyes and nose. Some people who drink water
containing chlorine well in excess of the MRDL could
experience stomach discomfort.
85. Chloramines 4 (MRDLG) 4.0 (MRDL) Some people who use water containing chloramines
well in excess of the MRDL could experience irritating
effects to their eyes and nose. Some people who drink
water containing chloramines well in excess of the
MRDL could experience stomach discomfort or anemia.
86a. Chlorine dioxide, where any
2 consecutive daily samples
taken at the entrance to the
distribution system are above the
MRDL.
0.8 (MRDLG) 0.8 (MRDL) Some infants and young children who drink water
containing chlorine dioxide in excess of the MRDL could
experience nervous system effects. Similar effects may
occur in fetuses of pregnant women who drink water
containing chlorine dioxide in excess of the MRDL.
Some people may experience anemia.
Add for public notification only: The chlorine dioxide
violations reported today are the result of exceedances
at the treatment facility only, not within the distribution
system which delivers water to consumers. Continued
compliance with chlorine dioxide levels within the
distribution system minimizes the potential risk of these
violations to consumers.
86b. Chlorine dioxide, where one
or more distribution system
samples are above the MRDL.
0.8 (MRDLG) 0.8 (MRDL) Some infants and young children who drink water
containing chlorine dioxide in excess of the MRDL could
experience nervous system effects. Similar effects may
occur in fetuses of pregnant women who drink water
containing chlorine dioxide in excess of the MRDL.
Some people may experience anemia.
Add for public notification only: The chlorine dioxide
violations reported today include exceedances of the
EPA standard within the distribution system which
delivers water to consumers. Violations of the chlorine
dioxide standard within the distribution system may
harm human health based on short-term exposures.
Certain groups, including fetuses, infants, and young
children, may be especially susceptible to nervous
system effects from excessive chlorine dioxide
exposure.
87. Control of DBP precursors
(TOC)
None TT Total organic carbon (TOC) has no health effects.
However, total organic carbon provides a medium for
the formation of disinfection byproducts. These
byproducts include trihalomethanes (THMs) and
haloacetic acids (HAAs). Drinking water containing
these byproducts in excess of the MCL may lead to
adverse health effects, liver or kidney problems, or
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nervous system effects, and may lead to an increased
risk of getting cancer.
I. Other Treatment Techniques:

88. Acrylamide Zero TT Some people who drink water containing high levels of
acrylamide over a long period of time could have
problems with their nervous system or blood, and may
have an increased risk of getting cancer.
89. Epichlorohydrin Zero TT Some people who drink water containing high levels of
epichlorohydrin over a long period of time could
experience stomach problems, and may have an
increased risk of getting cancer.


Appendix B-Endnotes
1. MCLG – Maximum contaminant level goal.
2. MCL – Maximum contaminant level.
3. For water systems analyzing at least 40 samples per month, no more than 5.0 percent of the monthly samples may be
positive for total coliforms. For systems analyzing fewer than 40 samples per month, no more than one sample per month
may be positive for total coliforms.
4. There are various regulations that set turbidity standards for different types of systems, including 1200-5-1-.08 and 1200-
5-1-.31. The MCL for the monthly turbidity average is 1 NTU; the MCL for the 2-day average is 2 NTU for systems that
are required to filter but have not yet installed filtration.
5. NTU – Nephelometric turbidity unit.
6. There are various regulations that set turbidity standards for different types of systems, including 1200-5-1-.08 and 1200-
5-1-.31. Systems subject to the Surface Water Treatment Rule (both filtered and unfiltered) may not exceed 5 NTU. In
addition, in filtered systems, 95 percent of samples each month must not exceed 0.5 NTU in systems using conventional
or direct filtration and must not exceed 1 NTU in systems using slow sand or diatomaceous earth filtration or other
filtration technologies approved by the department.
7. TT – Treatment technique.
8. There are various regulations that set turbidity standards for different types of systems, including 1200-5-1-.08 and 1200-
5-1-.31. For systems subject to the IESWTR (systems serving at least 10,000 people, using surface water or ground
water under the direct influence of surface water), that use conventional filtration or direct filtration, after January 1, 2002,
the turbidity level of a system’s combined filter effluent may not exceed 0.3 NTU in at least 95 percent of monthly
measurements, and the turbidity level of a system’s combined filter effluent must not exceed 1 NTU at any time. For
systems subject to the LT1EWSTR (systems serving fewer than 10,000 people, using surface water or ground water
under the direct influence of surface water), that use conventional filtration or direct filtration, after January 14, 2005, the
turbidity level of a system’s combined filter effluent may not exceed 0.3 NTU in at least 95 percent of monthly
measurements, and the turbidity level of a system’s combined filter effluent must not exceed 1 NTU at any time. Systems
subject to the IESWTR/LT1ESWTR using technologies other than conventional, direct, slow sand, or diatomaceous earth
filtration must meet turbidity limits set by the division.
9. The bacteria detected by heterotrophic plate count (HPC) are not necessarily harmful. HPC is simply an alternative
method of determining disinfectant residual levels. The number of such bacteria is an indicator of whether there is
enough disinfectant in the distribution system.
10. SWTR and IESWTR/LT1ESWTR treatment technique violations that involve turbidity exceedances may use the health
effects language for turbidity instead.
11. These arsenic values are effective January 23, 2006. Until then the MCL is 0.05 mg/L and there is no MCLG.
12. Millions fibers per liter.
13. Action Level = 0.015 mg/L.
14. Action Level = 1.3 mg/L.
15. Millirems per years.
16. The uranium MCL is effective December 8, 2003, for all community water systems.
17. Picocuries per liter.
18. Surface water systems and ground water systems under the direct influence of surface water are regulated under 1200-5-
1-.31. Subpart H community and non-transient non-community systems serving ≥10,000 must comply with DBP MCLs
and disinfectant maximum residual disinfectant levels (MRDLs) beginning January 1, 2002. Subpart H transient non-
community systems serving 10,000 or more persons and using chlorine dioxide as a disinfectant or oxidant must comply
with the chlorine dioxide MRDL beginning January 1, 2002. All other community and non-transient non-community water
systems must meet the MCLs and MRDLs beginning January 1, 2004.
19. Community and non-transient non-community systems must comply with LRAA subpart V TTHM and HAA5 MCLs of
0.080 mg/L and 0.060 mg/L, respectively (with compliance calculated as a locational running annual average) on the
schedule in 1200-5-1-.38(1).
20. The MCL for total trihalomethanes is the sum of the concentrations of the individual trihalomethanes.
21. The MCL for haloacetic acids is the sum of the concentrations of the individual haloacetic acids.
22. MRDLG – Maximum residual disinfectant level goal.
23. MRDL – Maximum residual disinfectant level.




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113
Appendix C to Rule 1200-5-1-.19
List of Acronyms used in Public Notice Regulations

CCR Consumer Confidence Report
CWS Community Water System
DBP Disinfection Byproduct
EPA Environmental Protection Agency
GWR Ground Water Rule
HPC Heterotrophic Plate Count
IESWTR Interim Enhanced Surface Water Treatment
Rule
IOC Inorganic Chemical
LCR Lead and Copper Rule
MCL Maximum Contaminant Level
MCLG Maximum Contaminant Level Goal
MRDL Maximum Residual Disinfectant Level
MRDLG Maximum Residual Disinfectant Level Goal
NPDWR National Primary Drinking Water Regulation
NCWS Non-community Water System
NTNCWS Non-transient non-community Water System
NTU Nephelometric Turbidity Unit
OGWDW Office of Ground Water and Drinking Water
OW Office of Water
PN Public Notification
PWS Public Water System
SDWA Safe Drinking Water Act
SMCL Secondary Maximum Contaminant Level
SOC Synthetic Organic Chemical
SWTR Surface Water Treatment Rule
TCR Total Coliform Rule
TT Treatment Technique
TWS Transient Non-community Water System
VOC Volatile Organic Chemical

Authority: T.C.A. §§68-213-704, 68-221-704 and 4-5-202. Administrative History: Original rule filed
June 30, 1977; effective August 1, 1977. Amendment filed February 3, 1984; effective February 12,
1985. Amendment filed September 26, 1988; effective November 10, 1988. Amendment filed April 10,
1989; effective May 25, 1989. Amendment filed November 26, 1990; effective January 10, 1991.
Amendment filed August 24, 1992; effective October 8, 1992. Amendment filed October 22, 1993,
effective January 5, 1994. Amendment filed May 2, 1994; effective July 16, 1994. Amendment filed April
12, 1996; effective June 26, 1996. Amendment filed October 31, 2000, effective January 14, 2001.
Amendment filed November 21, 2001; effective February 4, 2002. Amendment filed April 12, 2002,
effective June 26, 2002. Amendment filed July 15, 2002, effective September 28, 2002.Amendment filed
August 15, 2005, effective October 29 ,2005. Amendment filed July 31, 2006; effective October 14, 2006.
Amendments filed June 12, 2008; effective August 26, 2008.

1200-5-1-.20 RECORD MAINTENANCE.

(1) Any owner or operator of a public water system subject to the provisions of these rules shall
retain on its premises or at a convenient location near its premises the following records:

(a) Records of bacteriological analysis made pursuant to these rules shall be kept for not
less than five (5) years. Records of chemical analyses made pursuant to these rules
shall be kept for not less than ten (10) years. Actual laboratory reports may be kept, or
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data may be transferred to tabular summaries, provided that the following information is
included:

1. The date, place, and time of sampling, the name of the person who collected the
sample;

2. Identification of the sample as to whether it was a routine distribution system
sample, repeat sample, raw or process water sample or other special purpose
sample;

3. Date of analysis;

4. Laboratory and person responsible for performing analysis;

5. The analytical technique/method used; and

6. The results of the analysis.

(b) Records of action taken by the system to correct violations of primary drinking water
regulations shall be kept for a period not less than three (3) years after the last action
taken with respect to the particular violation involved.

(c) Copies of any written reports, summaries or communications relating to sanitary
surveys of the system conducted by the system itself, by a private consultant, or by any
State or Federal agency, shall be kept for a period not less than ten (10) years after
completion of the sanitary survey involved.

(d) Records concerning a variance or exemption granted to the system shall be kept for a
period ending not less than five (5) years following the expiration of such variance or
exemption.

(e) Any such reports required by the State shall be available for inspection by the public at
the appropriate public water system office during regular business hours.

(f) Records of turbidity analysis shall be maintained for not less than five years. These
records shall include daily worksheets, calibration data and strip charts. The strip
charts shall be labeled each day the system operates with the date, time, place of
collection, operator's initials, and the operating scale of the instrument.

(g) Daily worksheets, strip charts, and shift logs used in the production of monthly
operation reports or operation control of the plant shall be maintained for a minimum of
five years.

(h) Cross-connection plans and inspection records, complaint logs, facility maintenance
records, and storage tank inspection records shall be kept for 5 years.

(i) Copies of the public notices issued and certifications made to the state pursuant to
Rule 1200-5-1-.19 must be kept for three years after issuance.

(j) Any system subject to the requirements of 1200-5-1-.33 shall retain on its premises
original records of all sampling data and analyses, reports, surveys, letters, evaluations,
schedules, State determinations, and any other information required by 1200–5–1–.33(2)
through (9). Each water system shall retain the records required by this section for no
fewer than 12 years.

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(k) Copies of monitoring plans developed pursuant to Chapter 1200-5-1 shall be kept for the
same period of time as the records of analyses taken under the plan are required to be
kept under subparagraph (a) of this paragraph, except as specified elsewhere in this
chapter.

Authority: T.C.A. §§68-221-704 and 4-5-202. Administrative History: Original rule filed June 30,
1977; effective August 1, 1977. Amendment filed February 3, 1984; effective February 12, 1985.
Amendment filed August 24, 1992; effective October 8, 1992. Amendment filed April 12, 1996; effective
June 26, 1996. Amendment filed November 21, 2001; effective February 4, 2002. Amendments filed
August 15, 2005; effective October 29, 2005. Amendment file July 31, 2006; effective October 14, 2006.

1200-5-1-.21 MONITORING FOR CORROSIVITY CHARACTERISTICS.

(1) Community water supply systems shall identify whether the following construction materials
are present in their distribution system and report to the Department.

(a) Piping, solder, caulking, interior lining of distribution mains, service lines, and home
plumbing made of lead;

(b) Piping and alloys, service lines, and home plumbing made of copper;

(c) Galvanized piping, service lines, and home plumbing;

(d) Ferrous piping materials such as cast iron and steel;

(e) Asbestos cement pipe;

(f) Vinyl lined asbestos cement pipe;

(g) Coal tar lined pipes and tanks.

Authority: T.C.A. §§4-5-202, 68-221-701 et seq., and 68-221-704 Administrative History: Original
rule filed June 30, 1977; effective August 1, 1997. Repeal and new rule filed February 3, 1984; effective
February 12, 1985. Repeal and new rule filed August 15, 2005; effective October 29, 2005.

1200-5-1-.22 RESERVED.

Authority: T.C.A. §§4-5-202, 68-221-701 et seq., and 68-221-704. Administrative History: Original
rule filed June 30, 1977; effective August 1, 1997. Repeal and new rule filed February 3, 1984; effective
February 12, 1985. Amendment filed October 31, 2000; effective January 14, 2001. Repeal and new
rule filed August 15, 2005; effective October 29, 2005.

1200-5-1-.23 RESERVED.

Authority: T.C.A. §§4-5-202, 68-221-701 et seq., and 68-221-704. Administrative History: Original
rule filed June 30, 1977; effective August 1, 1997. Repeal and new rule filed February 3, 1984; effective
February 12, 1985. Amendment filed February 17, 1999; effective May 3, 1999. Amendment filed
October 31, 2000; effective January 14, 2001. Repeal and new rule filed August 15, 2005; effective
October 29, 2005.

1200-5-1-.24 SODIUM MONITORING.

(1) Suppliers of water for community public water systems shall collect and analyze one sample
per plant at the entry point of the distribution system for the determination of sodium
concentration levels. Samples must be collected and analyzed annually for systems utilizing
surface water sources in whole or in part, and at least every three years for systems utilizing
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solely ground water sources. The minimum number of samples required to be taken by the
system shall be based on the number of treatment plants used by the system, except that
multiple wells drawing raw water from a single aquifer may be considered one treatment plant
for determining the minimum number of samples. The supplier of water may be required by
the Department to collect the analyze water samples for sodium more frequently in locations
where the sodium content is variable.

(2) The supplier of water shall report to the Department the results of the analyses for sodium
within the first 10 days of the month following the month in which the sample results were
received or within the first 10 days following the end of the required monitoring period
whichever of these is first. If more than annual sampling is required, the supplier shall report
the average sodium concentration within 10 days of the month following the month in which
the analytical results of the last sample used for the annual average was received.

(3) The supplier of water shall notify appropriate local and state public health officials of the
sodium levels by written notice by direct mail within three months. A copy of each notice
required to be provided by this paragraph shall be sent to the Department within 10 days of
its issuance.

(4) Analyses for sodium shall be performed by conducting analysis using inductively coupled
plasma, EPA Method 200.7 or by using Standard Method 3111B.

Authority: T.C.A. §§4-5-201 et seq. and 68-221-701 et seq. Administrative History: Original rule filed
June 30, 1977; effective August 1, 1997. Repeal and new rule filed February 3, 1984; effective February
12, 1985. Amendment filed February 17, 1999; effective May 3, 1999.

1200-5-1-.25 VOLATILE ORGANIC CHEMICALS.

(1) The maximum contaminant levels for Volatile Organic Chemicals (VOC) set forth in 1200-5-1-
.25(2)(a) through (h) became effective on January 9, 1989. The maximum contaminant
levels set forth in 1200-5-1-.25(i) through (r) became effective October 8, 1992. The
maximum contaminant levels set forth in 1200-5-1-.25(r) through (u) shall become effective
January 17, 1994 or the effective date of these rules whichever is earlier.

(2) Volatile Organic Chemicals in community water systems and non-transient non-community
water systems shall not exceed any of the following maximum contaminant levels as
determined by the sampling and analytical requirements of 1200-5-1-.26.

MAXIMUM
CONTAMINANT
LEVEL
CONTAMINANT IN MILLIGRAMS/LITER

(a) Trichloroethylene
0.005
(b) Carbon tetrachloride 0.005
(c) Vinyl chloride 0.002
(d) 1,2-Dichloroethane 0.005
(e) Benzene
0.005
(f) 1,1 Dichloroethylene 0.007
(g) 1,1,1-Trichloroethane 0.20
(h) para-Dichlorobenzene 0.075
(i) cis 1,2-Dichloroethylene 0.07
(j) 1,2-Dichloropropane 0.005
(k) Ethyl benzene 0.7
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(l) Monochlorobenzene 0.1
(m) ortho-Dichlorobenzene 0.6
(n) Styrene 0.1
(o) Tetrachloroethylene 0.005
(p) Toluene 1
(q) trans 1,2-Dichloroethylene
0.1
(r) Xylenes (total) 10
(s) Dichloromethane
0.005
(t) 1,2,4-Trichlorobenzene 0.07
(u) 1,1,2-Trichloroethane 0.005

Authority: T.C.A. §§4-5-201 et seq. and 68-221-701 et seq. Administrative History: Original rule filed
May 17, 1978; effective June 16, 1978. Repeal filed February 3, 1984; effective February 12, 1985.
Amendment filed September 26, 1988; effective November 10, 1988. Amendment filed August 24, 1992;
effective October 8, 1992. Amendment filed October 22, 1993; effective January 5, 1994.

1200-5-1-.26 VOLATILE ORGANIC CHEMICAL SAMPLING, ANALYTICAL AND OTHER
REQUIREMENTS.

(1) Analysis of the contaminants listed in 1200-5-1-.25(2) for the purpose of determining
compliance with the maximum contaminant level shall be conducted as follows:

(a) Groundwater systems shall take a minimum of one sample at every entry point to the
distribution system which is representative of each well after treatment (hereafter