ENVIRONMENTAL HEALTH

RISK ASSESSMENTS
SCIENCE OR VOODOO?

Ron Pearson, M.S., CIH

Environmental Health & Safety, Inc.
St. Paul MN
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 The Nature of Risk

 200 people die annually in U.S. from

electrocution (risk level 10-6 per year)
 should I replace the wiring in my old
house?

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 The Nature of Risk

 7000 people die annually in U.S. from

falls in their homes
 but ... most are over age 65, so should
the rest of us ignore this?
 It's all about CHOICES

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 Estimating Risk

 Probabilities are fine until it happens to

me
 Some of the uncertainty is due to
chance, some of it isn't

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 Estimating Risk

 Historical risks are easily understood -

e.g. car accidents
 What kind of car do you drive?
 Does it have airbags?
 Do you drive fast?

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 Comparing Risks
 action annual risk uncertainty
 all cancers 3 in 1,000 10%
 pack-a-day 4 in 1,000 150%
smoker
 mountain 6 in 10,000 50%
climber
 car accident 24 in 10,000 10%
 drinking MCL 6 in 1,000,000 1,000%
of chloroform
in water
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 Comparing Risks

 Human nature dictates that we tend to

worry more about risks that are severe
and abrupt, as opposed to something
that has some "probability" of occurring
down the road
 Many say that we “can’t” compare
unlike risks, but in fact, we do it all the
time

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 The Costs of Risk Reduction

 Location Risk Reduction Cost per

(geog.) means life saved
 Indonesia Death Immunization $100
countries (infection)
 U.S./ Cancer Pollution $1,000,000
other prevention

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 Why do we need Risk
Assessment?
 "Emerging" risks - e.g. hormonal
analogues
 Shifts in perception
– information overload - the "health studies"
results that we are bombarded with daily
– ability to measure minute amounts of
substances
 many traditionally severe health risks
(e.g. smallpox) are gone
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 Environmental Health Risk
Assessment
 health risk = the likelihood that an
adverse effect will occur to a person (or
group of persons) in a chemical
exposure situation
 Usually, a higher exposure causes more
serious effects or makes them more
likely
 At some low exposure level, the risks
become insignificant
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 Estimates of Risk

 Estimates of risk are needed to assist in

making decisions
 Only in extreme cases will risks
estimates alone drive decision making
 zero risk compels no action, while a
great risk may compel immediate action
 IN REALITY, risk estimates lie
somewhere in between

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 Environmental Health Risk
Assessments use two types of
Risk Estimates:
 for carcinogens, the increased
probability of individuals' getting
cancer from a particular exposure
 for other toxicants, a comparison of
expected exposure to an exposure that
is assumed to be insignificant

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 Environmental Health Risk
Assessments use two types of
Risk Estimates
 Why? Because they are most often used
in USEPA risk assessments
 In general, effects on systems such as
the reproductive or immune system are
not scrutinized nearly as much as
carcinogenic effects

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 What DON’T risk assessments
estimate?
 total number of people affected
 relative incidence of an adverse effect in
populations known to be exposed with
those not exposed
 the ratio of the expected risk with the
exposure to that expected without it
 reduced life expectancy associated with
the effect
 lost income potential, costs to society

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 Uncertainties in Risk
Assessments
 Dose Effect = relationship between the
amount of a chemical exposure and the
nature and/or severity of the toxic
effect
 Data on toxic chemicals usually come
from:
– laboratory experiments on animals NOT
epidemiology studies of humans
– moreover, many are inferences based on
bacterial and/or human cells
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 Uncertainties in Risk
Assessments
 Dr. Bruce Ames, (Ames salmonella
microsomal screening test developer),
stated repeatedly that he never
intended for his "tool" to be applied as it
is today

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 Uncertainties in Risk
Assessments
both of these sources of data cause
problems because:
 an animal or cell is not a human being
 most animal toxicity data is short-
term
 relatively high exposures are used
experimentally, to cause statistically
significant effects

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 Uncertainties in Risk
Assessments
 many species are
homogeneous
(purposely, to limit – genetic make up
variability in – age
response) – habits
 By contrast, humans – occupation
are diverse in their – health status
response to – diet, etc.
chemicals due to:

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 Uncertainties in Risk
Assessments
 some argue that extrapolations from
animals to humans are more reliable
than epidemiology studies, due to:
 small study populations (lack of
"statistical significance")
 confounding variables
 lack of exposure data
 differences between study populations
and the population to be protected
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 Uncertainties in Risk
Assessments
 When no effect is seen in lab animals, is
there negligible risk to humans exposed
at such a level?
 a 1% incidence of any disease would be
impossible to detect in a study of 25
animals, but would represent more than
2 million cases if the entire U.S.
population were exposed
 HOW DO WE ANSWER THIS
QUESTION???
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 Uncertainties in Risk
Assessments
 In risk assessment, it is often assumed
that:
 for cancer: there is no safe dose, and;
 at low doses, the relationship between
dose-effect is directly proportional
(linear)
 for other health effects: there is a safe
dose

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 Public Perception and Public
Demands
 The "vicious circle":
 public perception ->
media reporting ->
congressional action ->
agency regulation in response to public
demands

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 Public Perception and Public
Demands
 Are we (in the U.S.) better off now than
before the "skyrocketing" industrial use
of chemicals?
 Since 1940 - life expectancy has
increased nearly 15 years
 Since 1970 - infant mortality has
decreased by 1/2
 Since 1970 - heart disease has dropped
by nearly 1/3
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 Public Perception and Public
Demands
 Cancer deaths have increased...or have
they?
 Many feel the this is due simply to:
– smoking (increases lung, pharyngeal,
pancreatic and bladder cancer incidence)
– sun exposure (malignant melanoma has
increased eight-fold)
– the increase in life expectancy (you have to
die of something...)
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 Where has this all brought us?

 Many times, the science of

epidemiology simply confirms the
obvious - rarely has an epidemiological
study drawn attention to an agent that
was not already recognized by an astute
observer in the field (e.g. Fen-Phen)

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 Where has this all brought us?

 We fear carcinogens in our drinking

water ... but what about Milwaukee's
public water supply and an outbreak of
cryptosporidium? Would we better off
taking some of our money from the
former and spending it on the latter?
 Asbestos: we won't even get into it ...

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 Regulatory “Reform”

 What agencies conduct health risk

assessments?
 OSHA
 EPA
 FDA
 USDA

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 Regulatory “Reform”

 1983 - the NAS published the "Red

Book" - "Risk Assessment in the Federal
Government: Managing the Process"
 defined four steps of risk assessment,
but more importantly, discussed how to
separate the "science" from the "policy"

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 Regulatory “Reform”
 1987: EPA published "Unfinished
Business" - ranked items such as
pesticides in food and radon as higher
health risks than items such as
groundwater contaminants or
hazardous waste sites BUT...failed to
rank airborne lead as a high risk - again,
it was driven by
carcinogens....essentially we have no
scientific methods for comparing cancer
with non-cancer risks
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 Regulatory “Reform”
 1991 - Federal Focus, Inc. called for an
executive order (16 CRR 171),
essentially prohibiting the use of overly
conservative assumptions
 Risk Assessment has been represented
by many as a "value free" process, when
in fact it is full of judgements
 Risk Assessment and Risk Management
are, and should remain, separate
processes
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 Regulatory “Reform”
 Risk Assessment produces very precise
numbers of questionable accuracy

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 Regulatory “Reform”

 Federal Trend: legislators pursuing risk

assessment as means of telling us what
the "real" risks are, so we can spend our
money accordingly - represents another
easy answer for attacking what ails us -
after all, what politician in their right
mind would outright oppose legislation
that is supposedly "good for the
environment"?
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 Regulatory “Reform”
 State Trends: decreasing funding for
public health/environmental health
programs but increasing environmental
regulatory spending - in 1994 we spent
$4.09 per capita on the former and
$18.87 per capita on the latter
 In the Republican party's "Contract
with America" a bill called the "Job
Creation and Wage Enhancement Act"
bolstered risk assessment and cost
benefit analyses requirements
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 Cost-Benefit Analysis

 A good example of cost-benefit analysis

and the fallacies that can be put forth:
 OSHA's proposed IAQ rule estimated
that a facility manager would spend an
average of 15 minutes documenting
each complaint

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 "Advancements" in the Science
of Environmental Health Risk
Assessment
 ASTM RBCA - Risk Based Closure
Assessment methodology
 many states have jumped on the
bandwagon for this approach to
screening UST sites, especially as state
funds have become more scarce

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  ASTM RBCA - Risk Based Closure
Assessment methodology
 uses a tiered approach
 Tier I: "lookup tables"
 Tiers 2 - 4: incorporate more site specific
values for:
– ground water
– soil types
– specific information on receptors
 Still, much of the conclusions depend
on mathematically modeled results -
"garbage in - garbage out" still applies
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 Conclusion: Where do we go
from here?
 Most environmental problems are
extremely complicated technically

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 Conclusion: Where do we go
from here?
 We live in the age of entitlement: we
want the government to provide us a
risk-free society, and we want it now!
 We MUST decide how much minuscule
reductions in risk we are willing to pay
for
 We MUST question our legislators
AND regulators motives and actions

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 Conclusion: Where do we go
from here?
 We live in the age of technology, and
science can solve all of our ills: modern
science has it's limitations, particularly
when it comes to the analysis of living
systems - it may never suffice in
accurately predicting health effects or
their potential from low level exposures
 We MUST decide how much
uncertainty we are willing to tolerate
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 Conclusion: Where do we go
from here?
 We live in the age of the sound byte:
most of the public gets the lion's share
of this information from the media
 We MUST improve communication of
these issues dramatically

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 Conclusion: Where do we go
from here?
 We live in the age of cancer paranoia:
most of the EPA's regulatory efforts
focus on cancer
 We MUST shift the emphasis equally to
non-cancer endpoints

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  "Security is mostly a superstition. It
does not exist in nature, nor do the
children of men as a whole experience
it. Avoidance of danger is no safer in
the long run than outright exposure.
Life is either a daring adventure, or
nothing."... Helen Keller
 “DON'T WORRY - BE HAPPY” ...
Bobby McFerrin

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