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January/February 2002

Vol. XVII, No. I

STATEMENT BY HHS SECRETARY TOMMY G. THOMPSON


Regarding Release of Harvard BSE Risk Assessment

A Harvard University study released rules are a strong firewall

Photo by Scott Bauer


today has found that thanks to against the spread of BSE
the joint efforts of the Department of in American herds.
Health and Human Services and the Since these measures
Department of Agriculture, Bovine were put in place in 1997,
Spongiform Encephalopathy (BSE)— FDA has gone to great
or “Mad Cow Disease”—poses only lengths to impress on all
an “extremely low” risk to our con- renderers, feed mills and
sumers and agriculture. similar establishments in
The study shows that even if the this country that these
disease should appear in the United rules are vital for the
States, it would be contained by the health of our consumers,
safeguards already put in place by agriculture, and eco- FDA feed rules play a critical role in protecting our herds
the Food and Drug Administration nomy. As part of the pro- from BSE.
and USDA. This is a reassuring find- gram, FDA and its state feed inspec- There are still some components of
ing, but it also means that we can- tor colleagues have developed a the animal feed industry that are fail-
not let those safeguards down, and special guidance for the animal feed ing to live up to the FDA standards. I
that we must constantly keep improv- industry, held public meetings with want it to be clear that we intend to
ing them. stakeholders, and conducted more enforce FDA’s rules with increased
Protecting our country against BSE than 12,000 inspections and re-in- vigor.
has been among my top concerns spections of the more than 10,000 FDA, USDA, and our state and pri-
since I took my present post. One of renderers and feed mills in the U.S. vate sector partners deserve to be
my first initiatives was the launching These inspections will continue. congratulated on their performance
of an action plan to protect this coun- Support for FDA’s measures has in combating BSE. But we cannot rest
try against BSE. been gratifying. Industry and govern- on our success to date. As the
Today, I want to join the Harvard ment agree: American consumers Harvard assessment makes clear,
researchers in emphasizing the criti- can and must be protected. Today, we continued vigilance and concern are
cal importance of FDA rules that pro- are well on the way to achieving full essential.
tect our herds from BSE. As the compliance, and we must not settle This statement was issued Friday,
Harvard study demonstrates, these for less. November 30, 2001.

VMAC MEETING SCHEDULED FOR JANUARY 2002

T he FDA Veterinary Medicine Ad-


visory Committee (VMAC) will
meet on January 22, 23, and 24, 2002,
recommendations to the Agency on
FDA’s regulatory issues. At the Janu-
ary meeting, VMAC will seek recom-
ess of new animal drug applications
(NADAs). Information concerning the
(Continued, next page)
from 8:30 a.m. to 5 p.m., at the mendations on the issues of import In This Issue
DoubleTree Hotel, Plaza Rooms I, II, tolerances under the provisions of
NRSP-7 Committee Meeting ..... 2
and III, 1750 Rockville Pike, Rockville, the Animal Drug Availability Act of Surveying Feed Commodities
MD. This FDA public advisory com- 1996 (ADAA), and on the antimicro- for Antibiotic Resistance ......... 6
mittee meeting will be open to the bial drug effects on pathogen load in Antimicrobials in Hatcheries .... 8
public. The general function of the food-producing animals as pathogen CVM Establishes New
committee is to provide advice and load relates to the pre-approval proc- Project Management Staff ...... 11

U.S DEPARTMENT OF HEALTH AND HUMAN SERVICES


PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION CENTER FOR VETERINARY MEDICINE
2 VMAC MEETING SCHEDULED FOR JANUARY 2002 (Continued)
discussion of import tolerances can 3), Food and Drug Administration, dresses of proposed participants, and
be found in an August 13, 2001 CVM 7519 Standish Place, Rockville, MD an indication of the approximate time
UPDATE and in a Federal Register 20855. Written comments must be requested to make their presentation.
notice of August 10, 2001. submitted by January 4, 2002. Oral They will be notified of their allotted
Information concerning the issues presentations from the public will be time prior to the meeting. Their en-
of pathogen load will be made pub- scheduled between approximately tire statements should be submitted
licly available to the VMAC members 1:30 p.m. and 4:15 p.m. on January for the record.
and the public in advance of the 22, and 8:45 a.m. and 11:00 a.m. on Additional information about the
meeting and posted on CVM’s Home January 24, 2002. The time allotted VMAC meeting will be included on
Page. A limited number of paper cop- for each presentation may be limited. the FDA/Center for Veterinary Medi-
ies of the background information Individuals wishing to make oral pre- cine Home Page. Up-to-date informa-
will be available at the meeting. sentations should notify Aleta tion on the VMAC meeting is also
Interested persons may present Sindelar (telephone number 301-827- available on the FDA Advisory Com-
data, information, or views, orally or 4515 or address above) before Janu- mittee Information Line, 1-800-741-
in writing, on the issues pending be- ary 4, 2002. They should submit a 8138 (301-443-0572 in the Washing-
fore the committee. Written submis- brief statement of the general nature ton, DC area), code 12546.
sions may be made to Aleta Sindelar, of the evidence or arguments they
Center for Veterinary Medicine (HFV- wish to present, the names and ad-

NRSP-7 HOLDS SEMI-ANNUAL COMMITTEE MEETING


by Meg Oeller, D.V.M.

T he USDA’s Minor Use Animal


Drug Program, National Research
Support Project #7 (NRSP-7) held its
(University of California, Davis), Dr.
Alistair Webb (University of Florida),
Dr. Robert Holland (Iowa State Uni-
explained that the coming year looks
very promising for the Center with a
proposed budget increase. He
semi-annual meeting of the techni- versity), and Dr. Paul Bowser (Cornell pointed out that CVM was still work-
cal committee and administrative ad- University). The Administrative Advi- ing under a continuing resolution
visors on October 22 and 23 in sors are Dr. Kirklyn Kerr (University pending passage of the budget. In the
Rockville, MD and Washington, DC. of Connecticut), Dr. John Nielson next year, a high priority will be on-
The spring meeting is hosted each (University of Florida), Dr. David farm and feed mill inspections based
year by one of the four regions, but Thawley (University of Nevada), and on Bovine Spongiform Encephalopa-
the fall meeting is always held in the Dr. Don Robertson (Kansas State thy (Mad Cow) concerns.
Washington area to provide an oppor- University). The USDA representative Strategic planning at CVM is start-
tunity for input from members of FDA’s is Dr. Larry Miller (Washington, DC) ing again with an emphasis on “back
Center for Veterinary Medicine (CVM). and the FDA liaison is Dr. Meg Oeller to basics”. Some items of special in-
The purpose of the NRSP-7 Minor (Rockville, MD). This meeting was terest include controlling internet
Use Animal Drug Program is to ad- also attended by the National NADA (Continued, next page)
dress the shortage of minor use ani- coordinator for Aquaculture, Rosalie
mal drugs by funding and oversee- “Roz” Schnick and Dr. Mark
FDA Veterinarian
ing the efficacy, animal safety, and Feldlaufer of the USDA Bee lab in
Bernard A. Schwetz, D.V.M. , Ph.D.
human food safety research and en- Beltsville, MD, as well as by review- Acting Principal Deputy Commissioner of
vironmental assessment required for ers and managers from FDA/CVM. Food and Drugs
drug approval. The scope of the pro- This meeting was postponed from Stephen F. Sundlof, D.V.M., Ph.D.
gram includes minor species of agri- its originally scheduled dates in Sep- Director
Center for Veterinary Medicine
cultural importance, and generally tember due to the upheaval in travel
excludes companion animals. arrangements following September Karen A. Kandra, Editor
11. Because of the change, three of
Attendance the four administrative advisors were Published bi-monthly.
The technical committee is made unable to attend. Dr. Don Robertson Home Page: http://www.fda.gov/cvm/
Articles are free of copyright and may be
up of a National Coordinator, 4 Re- was their sole representative at this
printed.
gional Coordinators, 4 Regional Ad- meeting.
Comments are invited.
ministrative Advisors, and liaisons Phone (301) 827-3800
from USDA and FDA. The National Welcoming Remarks From Dr. FAX (301) 827-4065 or write to:
Coordinator is Dr. John Babish Sundlof FDA Veterinarian (HFV-12)
7519 Standish Place
(Cornell University). The Regional The Director of CVM, Dr. Stephen
Rockville, MD 20855
Coordinators are Dr. Arthur Craigmill Sundlof, welcomed everyone and
FDA Veterinarian January/February 2002
NRSP-7 HOLDS SEMI-ANNUAL COMMITTEE MEETING (Continued) 3
pharmacies, reduction of the applica- brochure before they are distributed. lasalocid for deer and goats,
tion backlog through the use of con- The brochure includes a description fenbendazole, nitarsone, and zoalene
sultants to find efficiencies, and the of the program’s mission, back- for gamebirds, and carp pituitary ex-
development of tolerances & testing ground, and organization as well as tract for fish.
for residues in imported foodstuffs. a list of the contact information for Most discussion centered on Dr.
A contract has been awarded to ICF the members of the technical com- Kelly’s (Mississippi State University)
Consulting to identify medications mittee and administrative advisors. proposal to complete the carp pitu-
used in aquaculture around the On the back of the brochure is an itary extract target animal safety
world. The U.S. is concerned about abbreviated Animal Drug Request work. Dr. Kelly proposed both exten-
a competitive disadvantage com- form so that interested persons may sion of species covered as well as an
pared to overseas producers, espe- suggest new projects for the program extensive list of tissues for histopa-
cially in the case of seafood from to pursue. thology. NRSP-7 has provided admin-
Southeast Asia. Some of this may be istrative assistance, but has not
corrected by the requirement for ex- Administrative Advisors’ funded this work previously. The con-
porters to have Hazard Analysis Criti- Report sensus at the meeting was that it is a
cal Control Point (HACCP) plans in Dr. Don Robertson said that John needed production tool and should
place, since such plans require dis- Babish sent NRSP-7 update letters to be supported.
closure of medications used on major stakeholders in the sheep, goat,
farmed fish. gamebird, and aquaculture industries. NORTH CENTRAL REGION: Dr. Robert
Antimicrobial resistance develop- He advised that we should make an Holland
ment remains a major concern. A effort to maintain and expand such re- The major current project is the
new guidance document is planned lationships. CIDR-G intravaginal progesterone
for publication in the Spring. Dr. device for sheep. There have been
Sundlof noted that there are still USDA Representative’s Report
numerous complications of the
problems enforcing prudent use of Dr. Miller related that the USDA project resulting from the sale of the
antibiotics. Links are being estab- budget is on hold. The House bud- device from the original New Zealand
lished with State veterinary boards get is the same as last year but the manufacturer. We hope to resolve
to assist with enforcement in the ar- Senate shows an increase. He de- these problems so that this approval
eas of prudent use of antibiotics, scribed the plan for the next day’s can be pursued. The U.S. sheep in-
compounding, and catalog sales. Dr. meeting with administrators at USDA dustry lists this product as its num-
Sundlof also said that CVM has re- and the order of presentations that ber one need.
ceived a special allotment of $3 mil- we should give.
lion for studies on subtherapeutic WESTERN REGION: Dr. Arthur Craigmill
Regional Coordinators’ Reports
drug use. He was questioned about Dr. Craigmill reported on several
the advisability of NRSP-7 pursuing NORTHEAST REGION: Dr. Paul Bowser. completed and inactivated projects.
a project for florfenicol in sheep. He Although many of these projects Those completed include a pharma-
answered that antimicrobial resis- are intended to support species cokinetic study for ceftiofur in alpacas
tance requirements should not be grouping, the data will be accumu- and llamas and another on pharma-
sufficient to discourage such a lated to support individual drug ap- cokinetics and residue depletion of
project. provals for the drugs under study. oxytetracycline in sheep.
Current projects include hydrogen (Continued, next page)
National Coordinator’s Report peroxide for bacterial gill
Photo by Scott Bauer

Dr. Babish reported on his meeting disease in finfish, oxytet-


with the North Eastern Experimental racycline for finfish, sulfa-
Station Directors. He was encouraged dimethoxine/ormetoprim
to make visits to other regions to (Romet-30TM) for finfish
make sure they are aware of the pro- and sulfadimethoxine/
gram. The Southern region will need ormetoprim (RofenaidTM)
special attention as they face the fu- for pheasants.
ture retirement of Administrative
Advisor John Neilson and select his S OUTHERN R EGION : Dr.
replacement. Alistair Webb
The new NRSP-7 brochures have Dr. Webb reported that
been printed but the web site address current projects include
was inadvertently omitted. A label ivermectin for rabbits,
with the address will be affixed to the fenbendazole for deer,

FDA Veterinarian January/February 2002


4 NRSP-7 HOLDS SEMI-ANNUAL COMMITTEE MEETING (Continued)
Current projects include ivermectin
Active NRSP-7 Projects
pour-on for bison, strontium chloride
in salmonids, and pirlimycin for dairy Drug Route of Species Indication Region
goats. The bee projects were dis- Administration
cussed later by Dr. Feldlaufer. Some
IVERMECTIN ....................... injection rabbits ear mites S
species grouping work is underway
in gamebirds. TYLOSIN ............................ soluble powder honey bees American foulbrood W
LASALOCID ........................ oral (feed) pheasant coccidiosis S
New Projects
TILMICOSIN ....................... injection veal calves respiratory infections NC
NORTHEAST REGION – A new project is
planned for goats, although the de- PROGESTERONE ................. CIDR sheep estrus synchronization NC
tails are not yet determined. HYDROGEN PEROXIDE ......... topical various fish bacterial gill disease NE
SOUTHERN REGION – A new project CARP PITUITARY ................ injection various fish spawning aid S
with imidocarb for babesiosis in
SULFADIMETHOXINE/
cattle is projected, but not certain ORMETOPRIM .................... oral (feed) pheasants bacterial infections NE
pending sponsor agreement. and coccidiosis
NORTH CENTRAL REGION – Three new NITARSONE ........................ oral (feed) partridge blackhead S
projects have been proposed. Final
ZOAMIX ............................. oral (feed) pheasants coccidiosis S
decisions are pending additional in-
formation. The proposed projects are FENBENDAZOLE .................. oral (feed) pheasants, gapeworm, capillaria S
for Apitol for bees to treat varroa partridges &
mites, florfenicol for mycoplasma in- quail
fections in veal calves, and a treat- OXYTETRACYCLINE ............. oral (feed) finfish bacterial infections NE
ment for mastitis in ewes.
LASALOCID ........................ oral (feed) deer coccidiosis S
WESTERN REGION – A new project will STRONTIUM CHLORIDE ....... immersion finfish otolith marking W
be started in the coming year for
florfenicol in sheep & goats for bac- LASALOCID ........................ oral (feed) goats coccidiosis S
terial respiratory infections and pos- PIRLIMYCIN ....................... intramammary goats mastitis W
sibly also for a foot rot claim.
LINCOMYCIN ...................... soluble powder honey bees American foulbrood W
Other Reports SULFADIMETHOXINE/
ORMETOPRIM .................... Oral (feed) finfish Bacterial infections NE
Dr. Mark Feldlaufer of the USDA
bee lab in Beltsville discussed his
work in support of New Animal Drug hydrogen peroxide, and oxytetracy- reclassified as ‘inactive’ for the time
Applications for lincomycin and ty- cline. This group is also conducting being. The committee discussed Inves-
losin for American foulbrood in hon- studies to support species grouping. tigational New Animal Drug (INAD) in-
eybees. The target animal safety vestigators who are not producing or
study data have been submitted, the FDA’S NRSP-7 Liaison Report submitting their data. In some cases,
residue depletion studies are done, The Minor Use/Minor Species Ani- producers/collaborators might more
and effectiveness studies are under- mal Health Act of 2001 (the MUMS appropriately get the drugs under the
way. Dr. Oeller has obtained letters Bill) has been introduced in both new Compliance Policy Guide on
from CVM agreeing that antimicrobial houses of Congress and is continu- (Continued, next page)
resistance studies will not be needed ing to add co-sponsors. If
Photo by Peggy Greb

for these projects. The environmen- enacted, this legislation


tal assessments are in progress. would make incentives
Roz Schnick distributed her hand- available to pharmaceuti-
out, “Update on the Activities of the cal sponsors, allow for
National Coordinator for Aquaculture conditional approvals of
New Animal Drug Applications.” She MUMS drugs, and allow
described the progress of the active legal marketing of some
projects of the Federal-State Aqua- products for non-food-
culture Drug Approval Partnership producing animals under
Project. These projects include claims an indexing system.
for Aqui-STM (anesthetic), Chlora- Current projects were
mine-T, Copper Sulfate, Florfenicol, reviewed and some were

FDA Veterinarian January/February 2002


NRSP-7 HOLDS SEMI-ANNUAL COMMITTEE MEETING (Continued) 5
extralabel use of drugs in feed for DAY TWO

Photo by Jack Dykinga


minor species (CPG 615.115). The second day of the meet-
Those groups should either con- ing was held at the USDA Wa-
tinue to submit effectiveness terfront Offices. This meeting
data whenever they use the was attended by the NRSP-7
drug under the INAD, or they members and Roz Schnick.
should use the CPG to acquire Midmorning, the group was
needed medicated feeds. Other joined by USDA administrators.
groups that are studying drugs
under an NRSP-7 INAD and not International Workshop
submitting data at all must either The NRSP-7 program tradi-
submit the data as promised, or tionally hosted a workshop on
have the INAD file inactivated. strategy in the pursuit of rational spe- a minor species concern every 2
It is important that NRSP-7 follow the cies grouping. They are studying years. The last workshop was held in
rules that allow unapproved uses of multiple species (trout, tilapia, cat- 1996 on the topic of “Drug Approval
these drugs under its INADs. It is im- fish, yellow perch, toadfish, salmon); for Minor Species in the 21st Cen-
perative that this data, including No- under varying conditions (warm & tury”. After 1996, resources were di-
tice of Claimed Investigational Exemp- cold/fresh & sea water); using mul- rected toward activities other than
tion forms, be submitted in a timely tiple drugs (albendazole, ivermectin, the sponsorship of workshops. The
manner so that inspections can be flumequine). They are looking at drug program planned to hold a workshop
scheduled, and slaughter authoriza- levels in muscle. Badaruddin Shaikh next September or October at a ho-
tions can be kept up to date. CVM can presented data for albendazole in trout tel in the Dulles airport area.
take regulatory action against sponsors and tilapia (the sulfoxide and sulfone The committee decided to postpone
and investigators who fail to comply are the metabolites measured). the workshop until September 2003 in
with these requirements. NRSP-7 must Dr. John Babish also discussed his view of overseas travel fears. Dr. Webb
administer its INAD files in full compli- species grouping approach. He is look- and Dr. Craigmill are co-chairing the
ance with the laws and regulations. ing at characterizing species by drug meeting. They circulated a draft pro-
metabolism ability with emphasis on gram outline. The current plan is to
Species Grouping P450 & CYP families. He is character- have the workshop center on interna-
This concept involves demonstrat- izing these with western blot & enzy- tional issues for minor species and
ing, usually through pharmacokinet- matic analysis. The fish species he minor uses. The meeting will be held
ics, that similar species may be and Dr. Bowser are studying are rain- in cooperation with Global FARAD (the
grouped for the purposes of demon- bow trout, tilapia, walleye, yellow Food Animal Residue Avoidance Data-
strating effectiveness, target animal perch, summer flounder, hybrid striped bank). The committee will investigate
safety, and human food safety. One bass, and channel catfish. The human holding the workshop in Baltimore.
outcome may be that a representa- based enzyme antibody assays cross-
tive species can be studied to provide react with fish and gamebirds (quail). Meeting with USDA
data to support the inclusion of simi- Administrators
lar species on the label of a new ani- GLP Discussion The group then met with Gary
mal drug. This is probably most This discussion centered on inspec- Cunningham, Ted Wilson, Bill
needed in aquaculture where there tions and the mechanism of a data Wagner, Gary Jensen, and Dave Morris
are literally hundreds of species and audit. Dr. Lynn Friedlander, of CVM, of USDA. Several members of the
it is not practical to test the drug on explained the requirements for in- committee gave presentations on the
them all. Other groups also could spections, mechanisms for data au- NRSP-7 program, including, back-
benefit from such research. This in- dits, and information that should be ground on the program, species
cludes gamebirds (pheasants, par- included in human food safety data grouping efforts, species project
tridges, and quail), deer (white tail, red submissions. It was a very useful dis- summaries, and the role of FDA/CVM.
deer, elk, etc.), and ratites (ostriches, cussion. A productive discussion followed.
emus, and rheas). It may be that the
research will show that the species are Spring 2002 Meeting NRSP-7 Website
not similar, or are not similar for some The Spring meeting of the NRSP-7 Dr. Webb provided an overview of
classes of drugs. Learning what is and Technical Committee and Administra- the new and improved NRSP-7
is not suitable for grouping will be very tive Advisors will be held in Davis, website: http://www.nrsp7.org . The
valuable in making drug approval for California on April 29 and 30, 2002. website currently provides links to
minor species more efficient. There will be a tour of the University’s minor species group websites,
Dr. Renate Reimschuessel ex- sheep dairy followed by the business updated names and addresses of
plained the CVM’s Office of Research meeting. (Continued, bottom of next page)
FDA Veterinarian January/February 2002
6 SURVEYING FEED COMMODITIES FOR ANTIBIOTIC RESISTANCE
by David Wagner, Ph.D.

W idespread dissemination of re-


sistance to antibiotics resulting
from the selective effect of drug use
dering industry reported the produc-
tion of 8.8 billion pounds of protein
meals in 2000. A large portion of
feed commodities to assess their role
in antibiotic resistance dissemination.
Poultry by-product meal, meat and
in food animals may have important these products is incorporated into bone meal, blended animal proteins,
ramifications for both human and animal feeds. It is therefore not unrea- and whole cereal grains (corn and oats)
animal health. A critical question rel- sonable to view the feed industry as a were the first products cultured. En-
evant to this ecological issue is: What recycling business that utilizes by-prod- terococcus spp. were isolated, iden-
is the source of the resistance deter- ucts of high nutritional value from tified to species, and tested for sus-
minants? Are they always present in other industries, to provide complex ceptibilities to 17 antibiotics using a
the environment at low, virtually un- nutrient sources for animal production. broth microdilution assay. The anti-
detectable levels or are they introduced Recently, the issue of antibiotic re- biotics are incorporated in a custom-
from outside? Are there management sistance resulting from the use of ized Gram positive panel that is used
practices that could minimize or elimi- antibiotics in animal production has in the National Antimicrobial Resis-
nate resistance development? Answers once again become a significant con- tance Monitoring System (NARMS)
to these questions could lead to im- cern to the Center for Veterinary and produced by TREK Diagnostics,
provements in our ability to control Medicine (CVM) and other national Inc. Eleven of the antibiotics are ei-
development and dissemination of and international health agencies. ther used directly in the feed or wa-
resistance to antibiotics and thereby The potential for resistance develop- ter of animals or they are members
optimize their efficacy, extend their ment in animal production settings to of drug classes used in these ways.
useful lifespan, and minimize pos- negatively impact human therapeutic A total of 175 samples were cul-
sible negative health consequences. efficacy is being revisited. The role that tured. All were positive for entero-
Animal feeds and feed commodi- feed may play in the dynamics of anti- cocci except for corn (41%, 24/58) and
ties may serve as vectors for the dis- biotic resistance development and dis- poultry meal (95%, 19/20). Enterococ-
semination and maintenance of resis- semination in the animal production cus faecium was by far the most
tance determinants in the animal environment is essentially unknown. prevalent Enterococcus species, ac-
production environment and thereby The possibility that feed may serve not counting for 72% (167/232) of the iso-
in the food supply. The commercial only as a vector for resistance but also lates recovered. Enterococcus
feed industry, during 2000, supplied may function to maintain and concen- faecalis was rarely recovered from
an estimated 119 million tons of feed trate resistance due to its recycling any of the samples tested. Nine of the
that were required to support inten- characteristic may be important. There twelve isolates recovered came from
sive integrated animal production in are essentially no data available to as- corn. This is interesting because E.
the United States. This figure does sess the potential role of animal feed faecalis is the most common cause
not include the millions of tons of to serve as a vector for the transmis- of human infections accounting for
feed mixed on farms. With the excep- sion and/or maintenance of antibiotic more than 80% of reported cases. It
tion of the cereal grains and grasses, resistant bacteria or resistance deter- is also the species most commonly
virtually all other commodities that minants in the animal environment. isolated from animal production en-
comprise animal feeds are by-prod- During FY 2000, CVM’s Division of vironments and from the intestinal
ucts of other industries including the Animal and Food Microbiology initi- contents of animals including hu-
animal production industry. The ren- ated a preliminary survey of animal mans. All of the samples of oats were
positive for enterococci (36) but no
E. faecalis were isolated. The results
NRSP-7 HOLDS SEMI-ANNUAL COMMITTEE thus far show that enterococci are
MEETING (Continued) widely disseminated in the environ-
ment and can readily be isolated
from feed commodities.
committee members, interactive Ani- update on the status of all aspects of Resistance to antibiotics used in
mal Drug Request Forms for new the program as well as an opportu- human therapy was primarily seen in
project requests, and a “Frequently nity to expand partnerships with isolates recovered from meat and
Asked Questions” section. Plans are other organizations. bone meal and was observed for tet-
underway to implement features in- For more information about NRSP- racycline, streptomycin, and erythro-
cluding “Breaking News”, feature 7, please visit our website http:// mycin. Reduced susceptibilities to
articles, a searchable database of www.nrsp7.org or call Dr. Meg Oeller antibiotics used only in animal pro-
animal drugs, and a searchable da- at (301) 827-3067. duction were observed in significant
tabase of NRSP-7 activities. Please Dr. Oeller is a Veterinary Medical proportions of the isolates from all the
visit the site. Officer in CVM’s Office of the Director. rendered animal by-products tested
The day-and-a-half meeting was an especially bacitracin susceptibility.
excellent opportunity to provide an (Continued, top of next page)

FDA Veterinarian January/February 2002


SURVEYING FEED COMMODITIES FOR COMMENT PERIOD 7
ANTIBIOTIC RESISTANCE (Continued) EXTENDED FOR
IMPORT TOLERANCES
Resistance to ciprofloxacin was de- whereas, isolates recovered from ANPRM
tected, but only in the isolates recov- poultry production houses are very
ered from the cereal grains. None of resistant with 75% and 65% of the
the 167 isolates of Enterococcus faeci-
um were determined to have minimum
isolates being resistant to the two
drugs respectively. One question of
T he Food and Drug Administration
(FDA) is extending to March 11,
2002, the comment period for the
inhibitory concentrations (MIC) for interest resulting from these data is:
Synercid above the NCCLS breakpoint Why are the isolates associated with advance notice of proposed
of 4 ug/ml. This observation stands in poultry meal not resistant when those rulemaking (ANPRM) that appeared
stark contrast to E. faecium isolates re- from live poultry are? The apparent in the August 10, 2001, Federal Reg-
covered from litter taken from poultry decrease in susceptibility of isolates ister. The ANPRM stated that FDA in-
production houses where about 65% recovered from feed to the commonly tends to propose a regulation for es-
of E. faecium are resistant to Synercid used production drugs bacitracin, ty- tablishing import tolerances, and
at concentrations up to 32ug/ml. This losin, and lincomycin may be an is- solicited comments on issues related
difference between feed and produc- sue of concern to animal production. to the implementation of the import
tion environmental isolates probably This survey activity is continuing tolerances provision in section 4 of
demonstrates the selective effect elic- and will be expanded during 2002 the Animal Drug Availability Act of
ited by virginiamycin use in feed. No with the involvement of the FDA’s 1996 (ADAA). The ADAA authorizes
resistance to Linezolid or penicillin, Office of Regulatory Affairs which FDA to establish drug residue toler-
drugs of critical importance to human will conduct a national sampling pro- ances (import tolerances) for im-
therapy was observed in any of the gram of rendered feed commodities. ported food products of animal ori-
feed isolates tested. These samples will be submitted to gin for drugs that are used in other
What seems to be most remarkable CVM’s Office of Research for cultur- countries, but that are unapproved
about the data collected to date is the ing and analysis. In addition to En- new animal drugs in the U.S. Food
limited amount of antibiotic resis- terococcus, E. coli, salmonellae, and products of animal origin that are in
tance associated with isolates from Campylobacter will be selectively cul- compliance with the import tolerance
feed commodities relative to that tured and tested for antibiotic sus- will not be considered adulterated
seen in animal production environ- ceptibility profiles. under the Federal Food, Drug, and
ments. For example, Enterococcus Dr. Wagner is a Research Animal Cosmetic Act and may be imported
isolates from poultry by-product Scientist in CVM’s Division of Animal into the United States. FDA is extend-
meal are very susceptible to drugs and Food Microbiology. ing the comment period to provide
such as penicillin and Synercid; stakeholders sufficient opportunity to
comment at the January 22-24, 2002,
public advisory committee meeting
NEW CVM OFFICIAL FOR INTERNATIONAL and within sixty days thereafter.
ACTIVITIES Written or electronic comments on
the ANPRM should be submitted to the

C VM is pleased to announce that


Dr. Merton V. Smith has been se-
lected to fill the position as Special
in the Executive Office of the Presi-
dent for a year (’93-’94) and worked
to finalize both the North American
Dockets Management Branch (HFA-
305), Food and Drug Administration,
5630 Fishers Lane, Room 1061,
Assistant for International Activities, Free Trade Agreement and the Uru- Rockville, MD 20852, by March 11,
Office of the Director, CVM. guay Round of Multilateral Trade 2002. Electronic comments should be
Dr. Smith comes from FDA’s Office Negotiations, the latter establishing submitted to http://www.fda.gov/
of International Programs (OIP) in the the World Trade Organization. dockets/ecomments . Comments
Office of the Commissioner. For the Dr. Smith received his B. A. degree
should reference Docket No. 01N-0284.
past 16 years, Dr. Smith has held a from the University of Virginia, and
Additional information on the
number of positions in OIP and its M. S. and Ph.D. degrees in food sci-
ANPRM is included in the August 10
predecessor unit, the International ence and nutrition from Virginia Poly-
and December 7, 2001, Federal Reg-
Affairs Staff, including the Africa and technic Institute, completing research
ister ( http://www.fda.gov/OHRMS/
Near East Desk Officer, the Americas in the area of food-borne infections
Desk Officer, the Multilateral Pro- and intoxications. He also received
DOCKETS/98fr/081001a.htm and
grams Desk Officer, and the Interna- his J. D. degree at Catholic Univer- http://www.fda.gov/OHRMS/DOCK-
tional Harmonization and Trade Af- sity, focusing on environmental, ETS/98fr/120701c.htm ,) and from
fairs Desk Officer. Most recently, he trade, and administrative law. Dr. Frances Pell, Center for Veterinary
has been the Acting Director, Inter- Smith is currently a member of the Medicine (HFV-235), Food and Drug
national Agreements Staff, OIP. District of Columbia Bar. He may be Administration, 7500 Standish Place,
Dr. Smith was detailed to the Of- reached at 301-827-6239. Rockville, MD 20855, 301-827-0188, E-
fice of the U.S. Trade Representative mail: fpell@cvm.fda.gov.

FDA Veterinarian January/February 2002


8 USE OF ANTIMICROBIALS IN HATCHERIES: A FIELD ASSIGNMENT
by Linda E. Silvers, D.V.M., M.P.H. and
Charlotte D. Spires, D.V.M., M.P.H., D.A.C.V.P.M.

R ecently, the Centers for Disease


Control and Prevention (CDC) re-
ported the emergence of domesti-
of food or by direct contact, the ex-
act magnitude of the human health
impact has been difficult to quantify.3
gene, and eleven blaCMY variants have
been described to date. Recent re-
search conducted in the Office of Re-
cally acquired ceftriaxone-resistant Some human bacterial infections ac- search at CVM identified plasmid-
Salmonella in humans in the U.S. quired from food animal sources may mediated AmpC-like-lactamases in E.
This antimicrobial resistance was not respond to antimicrobial drugs coli and Salmonella isolated from
detected by the routine surveillance chosen for treatment because a simi- food animals and retail meats. These
of the National Antimicrobial Resis- lar drug was given to the food ani- blaCMY genes were further shown to
tance Monitoring System (NARMS). mal and resulted in the development be transferred between different bac-
Because ceftriaxone-resistant Salmo- of resistant organisms. teria.5
nella has become a public health con- Approximately 1.4 million cases of The Assignment Memorandum in-
cern, the Center for Veterinary Medi- salmonellosis occur in the U.S. each cluded a six-page questionnaire to
cine (CVM) Office of Surveillance and year, most in children and the elderly, identify hatchery compliance with 21
Compliance issued a high priority and an estimated 600 of these cases CFR Part 530, which addresses
assignment directed at identifying are fatal.4 Ceftriaxone, a third genera- extralabel drug use in animals.
the use of ceftiofur and other antimi- tion cephalosporin, is the drug of Extralabel drug use is legal if require-
crobial drugs in a nationally repre- choice for treating invasive Salmo- ments in the regulation are satisfied
sentative sample of poultry hatcher- nella infections. Resistance to this (e.g., use of the drug by or on the
ies in the United States. drug is a concern, particularly in chil- lawful order of a licensed veterinar-
Historically, populations of bacte- dren, since fluoroquinolones, an al- ian within the context of a valid vet-
ria have impacted human and animal ternative treatment, are not approved erinary-client-patient relationship).
health, without facing much of a chal- for use in children.4 Prior notice was not given to person-
lenge to their own well-being. That Because of cross-resistance be- nel at inspected sites. The Assign-
situation changed in the early 1940’s, tween the veterinary drug ceftiofur ment Memorandum, which was sent
as antimicrobial drugs, the first sig- and the human drug ceftriaxone, and to District Directors, Directors of In-
nificant weapons in the fight against because food animals are the pre- vestigation Branches, and FDA Dis-
bacterial illnesses, were widely mar- dominant source of domestically ac- trict Offices, required the following
keted. While antimicrobial drugs quired Salmonella infections, actions: Inspection of the hatchery to
have been an extremely effective ceftiofur use may be contributing to determine compliance with 21 CFR
treatment, over time, bacteria that are ceftriaxone-resistant Salmonella 530, completion of all inspections
resistant to antimicrobial drugs have which are subsequently acquired by during FY01, coordination of follow-
emerged. people via food consumption or by ups by Districts so that as many vis-
Today, almost all bacteria that were direct contact. Ceftiofur is the only its as possible could be conducted on
universally susceptible to antibiotics expanded spectrum cephalosporin the same day and collaboration with
are now resistant to at least some of drug approved for systemic use in CVM so that a representative from
these drugs, and some bacteria are food animals in the U.S. This drug is the Division of Epidemiology could
resistant to many different antibiot- currently approved for therapeutic work with Field Personnel during
ics.1 Selective pressure exerted by use in cattle, swine and poultry. The each inspection. Directions to Field
antimicrobial drug use can result in majority of cephalosporin-resistant Personnel included: 1) Review all
the development of antimicrobial re- Salmonella express an extended- medication/treatment records to
sistance.2 The use of antimicrobials spectrum -lactamase, which is able identify antimicrobials used by the
in human medicine as well as in food to hydrolyze oxyimino cephalospor- firm, 2) Review labels on the drugs
animal production may promote this ins and monobactams, but not the found at each site to ensure that use
type of selection. cephamycins. However, recent re- is per approved label directions, and
Antimicrobial drugs are used in ports indicate that several organisms 3) Evaluate any extralabel use to de-
animal agriculture to treat disease, to of Enterobacteriaceae have obtained termine if the drug was prescribed by
prevent disease, and to promote plasmids encoding AmpC-like-lac- a veterinarian within the context of a
growth/feed efficiency. While it is tamases that hydrolyze the cepha- valid veterinary-client-patient rela-
known that the administration of an- losporins as well as the cephamycins tionship and satisfied other require-
timicrobials to food animals can se- such as cefoxitin and ceftriaxone. ments of 21 CFR Part 530.
lect for resistance among bacteria Resistance to ceftriaxone and ceftio- The hatcheries inspected were ran-
which may subsequently be passed fur is mediated by a cephalomy- domly selected in an effort to focus
to humans through the consumption cinase (CMY) encoded by the blaCMY (Continued, next page)

FDA Veterinarian January/February 2002


USE OF ANTIMICROBIALS IN HATCHERIES: A CVM SCIENTISTS 9
FIELD ASSIGNMENT (Continued) ATTEND
CONFERENCE ON
on use patterns that are representa- was at a university research facility TRANSGENIC
tive of most poultry hatcheries in the which only raised chicks for research ANIMALS
U.S. Epidemiologists and microbiolo- purposes. When possible, alternate
gists from CVM’s Division of Epide- hatcheries in the area were identified. by Wendelyn Warren, Ph.D. and Kevin
Greenlees, Ph.D., DABT
miology collaborated with local FDA A total of 27 commercial hatcheries
field investigators as well as with
members of CVM’s Division of Com-
pliance to inspect 37 chicken and tur-
(22 chicken, 4 turkey, 1 combination)
were actually inspected. The data is
currently being compiled and ana-
S even scientists from the Office of
New Animal Drug Evaluation and
the Office of Surveillance and Com-
key hatcheries. The size of the hatch- lyzed. pliance attended the Transgenic Ani-
eries and the types of operations mal Research Conference III. The con-
varied. A questionnaire that captured References ference was held from September 9
use information for ceftiofur and through September 13, 2001 at the
other antimicrobials such as gentami- 1. Levy SB. The antibiotic paradox. Granlibakken Conference Center in
cin (an aminoglycoside antimicrobial New York: New York; 1992. Tahoe City, California and was hosted
drug approved for use in poultry), 2. American Society of Microbiol- by the University of California at
was administered, and a site inspec- ogy. Report of the ASM Task Force Davis. This was the third in a series
tion was conducted at each hatchery. on Antimicrobial Resistance. of conferences since 1997 that
Data collected included demographic Washington, DC March 1995. uniquely focuses on genetic engi-
information, current and past neering in animal species used in
ceftiofur and gentamicin usage, 3. Smith KE, Bender JB, Osterholm agriculture. It was an international
routes of administration, doses ad- MT. Antimicrobial resistance in meeting intended to bring together
ministered, number of chicks or animals and relevance to human researchers from the leading labora-
poults produced at the facility and the infections. In: Nachamkin I, Blaser tories doing cutting edge research
proportion of chicks or poults treated MJ, editors. Campylobacter. 2nd and development with transgenic
with the antimicrobial drug. ed.Washington, DC: ASM Press; animals.
Biosecurity suits, hats and shoe 2000. P.483-138. The CVM attendees are all part of
covers were necessary in several the Animal Biotechnology Working
4. Fey PD, Safranek TJ, Rupp ME, Group or the Biotechnology Process
hatcheries. In most instances, the
Dunne EF, Ribot E, Iwen PC, Group. These groups identify and
hatcheries supplied the inspectors
Bradford PA, Angulo FJ Hinrichs resolve regulatory policy and scien-
with all of the necessary items that
SH. Ceftriaxone-resistant Salmo- tific issues regarding transgenic ani-
were needed to meet their
nella infection acquired by a child mals. The presentations addressed
biosecurity requirements. These
from cattle. New England Journal cutting-edge methodology, technical
ranged from no precautions to
of Medicine 2000;342(7):1242- improvements, and current progress
shower in-shower out facilities.
1249. towards producing transgenic ani-
On September 11th, when the ter-
rorism attacks occurred, six Division mals for medical, agricultural, and
5. Zhao S, White GD, McDermott FP,
of Epidemiology members were in even industrial applications. Informa-
Friedman S, English L, Ayers S,
travel status due to this field assign- tion was provided on basic and ap-
Meng J, Maurer JJ, Holland R,
ment. As a consequence, several plied research through presentations,
Walker DR. Identification and Ex-
travel itineraries were affected. This posters, and informal discussions.
pression of Cephamycinase blaCMY CVM scientists were very interested
disruption necessitated extension of Genes in Escherichia coli and Sal- in understanding the advances in
the assignment beyond the FY01 monella Isolated from Food Ani- genetic engineering and how they
deadline for completion. mals and Ground Meat. 2001. may impact considerations of safety
Generally, interviewees from the Antimicrob. Agents Chemother. and effectiveness, particularly in food
various hatcheries were very coop- 45: 3647-3650. animals.
erative and provided all of the infor-
Dr. Silvers is a Veterinary Medical The field of transgenic animal re-
mation that was requested. Some
Officer in CVM’s Division of Epidemi- search is rapidly evolving towards
hatcheries were not inspected for
ology. Dr. Spires is an Epidemiologist practical applications for this technol-
various reasons. In some instances,
in CVM’s Division of Epidemiology. ogy. Presentations ranged from dis-
the hatcheries were no longer opera-
cussion on how to spin spider silk
tional. In one instance, the hatchery
produced in the mammary gland of
(Continued, next page)

FDA Veterinarian January/February 2002


10 CVM SCIENTISTS ATTEND CONFERENCE ON TRANSGENIC ANIMALS
(Continued)

bioengineered goats to pharmaceu- FDA’s Center for Biologics, for ex- The shock and grief caused by these
tical production in the semen of ample, regulates products such as attacks was apparent in the discus-
transgenic pigs, to the production of human serum albumin or insulin in- sions among the participants of the
low phosphorus manure in tended for use in human medicine conference. Many attendees experi-
bioengineered pigs. Each of these and harvested from the milk, semen, enced considerable hardships in re-
very different applications of bioengi- or other tissue of the bioengineered turning home. Travel arrangements
neering technology share the key animal. were cancelled, rescheduled, and re-
step of altering the structure and Because of the small size of the scheduled again as airports struggled
function of the bioengineered animal. conference, the nature of the setting, to cope with the events. Although
Information about this conference is and the collegial atmosphere some thoughts were with all those who
available through the University of of the most important stakeholder have been affected by this tragedy,
California at Davis web site at http:// outreach occurred over meals and it was clear that the conference so-
www.biotech.ucdavis.edu/events/ coffee breaks. CVM scientists dis- lidified into a community of scientists
events.htm. cussed the INAD and NADA process that ignored national boundaries and
Altering the structure and function with sponsors and potential sponsors brought together the individuals from
of an animal through the insertion of in this informal setting. There was academia, industry, and government.
the transgenic material, and in some also an opportunity for candid discus- We thank the conference organizers
cases, the resulting expression prod- sions with regulatory scientists from and the Granlibakken Conference
uct are considered to be subject to Health Canada and the Canadian Center for their gracious understand-
FDA’s regulatory authority likely to Food Inspection Service. The confer- ing and support in a very difficult
require the submission of a new ani- ence allowed the CVM scientists to time. We would also like to acknowl-
mal drug application to the Center for expand their breadth of knowledge edge the remarkable support and
Veterinary Medicine (see Office of in this fast-growing field and to in- solidarity expressed by the interna-
Science and Technology Policy, Cen- teract with potential stakeholders and tional attendees.
ter for Environmental Quality Case other government’s agencies as the Dr. Warren is a Pharmacologist in the
Studies of Environmental Regulation tools of genetic engineering find their Residue Chemistry Team in CVM’s Of-
for Biotechnology, http://www.ostp. way into commercial applications. fice of New Animal Drug Evaluation
gov/html/012201.html). Other FDA The 2001 Transgenic Animal Con- (ONADE). Dr. Greenlees is a Toxicolo-
Centers may have a role in the regu- ference was impacted by the terror- gist in the Toxicology Team in ONADE.
lation of this new technology. The ist attacks on September 11, 2001.

DRAFT GUIDANCE ON PHARMACOVIGILANCE OF VETERINARY


MEDICAL PRODUCTS AVAILABLE FOR COMMENT

T he Food and Drug Administration


(FDA) is announcing the availabil-
ity of a draft guidance for industry
cine (CVM) Home Page on the
Internet at: http://www.fda.gov/cvm/
guidance/published.htm#documents.
comments should be submitted to:
http://www.accessdata.fda.gov/scripts/
oc/dockets/commentdocket.cfm .
(#142) entitled “Pharmacovigilance of Single copies of the guidance may be Comments should be identified with
Veterinary Medicinal Products: Man- obtained by writing to the FDA Vet- the full title of the draft guidance and
agement of Periodic Summary Up- erinarian. Please send one self-ad- Docket number 01D-0501.
date Reports (PSUs).” This draft guid- dressed adhesive label to assist in Additional information about this
ance has been developed by the processing your request. draft guidance document may be
International Cooperation on Harmo- Written or electronic comments on found in the December 13, 2001, Fed-
nisation of Technical Requirements this draft guidance should be submit- eral Register (http://www.fda.gov/
for Registration of Veterinary Medici- ted by January 14, 2002, to ensure OHRMS/DOCKETS/98fr/
nal Products (VICH). It is intended to their adequate consideration in 121301b.htm), and from Dr. William
describe the reporting system for preparation of the final document. C. Keller, Center for Veterinary Medi-
identification of possible adverse General comments on Agency guid- cine (HFV-210), Food and Drug Ad-
events following the use of marketed ance documents are welcome at any ministration, 7500 Standish Place,
veterinary medicinal products sub- time. Submit written comments to Rockville, MD 20855, 301-827-6642, e-
mitted to the European Union, Japan, the Dockets Management Branch mail: wkeller@cvm.fda.gov <mailto:
and the United States. (HFA-305), Food and Drug Adminis- wkeller@cvm.fda.gov>.
Draft guidance #142 is available on tration, 5630 Fishers Lane, Room
the FDA/Center for Veterinary Medi- 1061, Rockville, MD 20852. Electronic
FDA Veterinarian January/February 2002
CVM ESTABLISHES NEW PROJECT MANAGEMENT STAFF 11
by Madeline Van Hoose

G oal II of the Center for Veterinary


Medicine Strategic Plan states
that “We will improve and bring dis-
team members and the organiza-
tions they represent
achieve the goals of the project and
meet several critical and very tight
deadlines.
• Facilitate priority setting for
cipline to and through our business project objectives and tasks I see the initial benefits of a CVM
practices by having . . . created a Cen- Project Management Staff as more
• Facilitate the work of the project
ter level project management func- effective project management for
team in accomplishing the project
tion.” To implement this goal, CVM larger, cross-functional CVM projects,
goals and objectives
has created a new Project Manage- a common project management vo-
ment Staff at the Center level, under • Identify problems and issues early cabulary, a project management in-
the direction of the Deputy Center in the project formation system, well-defined and
Director, Dr. Linda Tollefson. The new • Identify project resource require- repeatable project management
Project Management Staff will de- ments and conflicts early in the processes, and more readily avail-
velop and implement project man- project able project management tools,
agement processes and methodolo- • Facilitate decision-making and mentoring, and training. Over the
gies to bring discipline to the way the problem-solving by the project longer term, this will result in align-
Center manages complex projects, team ment of projects to the CVM Stra-
and provide the support and training tegic Plan, a culture of collaboration
• Improve coordination and com-
necessary to facilitate its effective and accountability, leveraging of
munication among the organiza-
application across the Center. knowledge across the Center, and
tions represented by the project
As Director of the new Project Man- increased internal and external stake-
team members
agement Staff, I will be holding meet- holder satisfaction. At a team level,
ings throughout the Center over the • Improve communication with the benefits include expedited
next few months to describe the func- principals outside the project achievement of project team goals
tions and terminology of project team and deliverables, empowerment of
management as a discipline, and to • Provide project status information project team members through indi-
share the Project Management Staff to senior managers for decision- vidual accountability, and an en-
Strategic Plan. I look forward to get- making hanced framework for critical deci-
ting to know each staff member and One of the goals of the Project sion-making.
learning more about their views of Management Staff is to create con- The CVM Project Management
the critical project management sistency across CVM in the way we Staff will be adding another staff
needs of the various components of approach and implement project member to its ranks this year. In ad-
CVM. management. This will be a long- dition, short-term details will be es-
The vision of the new staff is to term effort that involves terminology, tablished for project managers and
establish project management in methodology and process develop- project coordinators to participate as
CVM as a culture and way of doing ment, standards and metrics devel- specific projects arise. Not only will
business that adds value at all levels opment, mentoring, training, and a this help to incorporate project man-
of the organization. The Project Man- lot of piloting on real projects. agement tools and techniques into
agement Staff Strategic Plan outlines Our first pilot project for applica- organizations that allow these
the goals and strategies for accom- tion of team-based project manage- detailees to participate, but the
plishing this and its Implementation ment is the development of the Anti- knowledge and skills they learn can
Plan creates the roadmap for their microbial Resistance Guidance For be applied to any project—large,
realization. Included in that plan are Industry. I will be working with Dr. Bill small, complex, or simple. Mastering
goals and strategies that will ulti- Flynn, the Team Leader, Mrs. Carole these skills will open up new oppor-
mately reach out to all of CVM. Andres, the Project Manager, and all tunities for individuals to apply them.
Almost anyone, when asked, can of the team members of the Antimi- A CVM Project Management Team
give his or her own version of what crobial Resistance Guidance Group will also be established as a less for-
project management means to them. (ARGG) (Ms. Mary Bartholomew, Dr. mal structure to allow individuals
But for starters, a working definition Kevin Greenlees, Ms. Aleta Sindelar, from throughout CVM to participate
of team-based project management Dr. Charlotte Spires, and Dr. David and learn about what project man-
can be stated as the process of plan- White), to apply the principles and agement is and how it can help in
ning, focusing, coordinating, and tools of project management to this their own organizations.
communicating the activities of a development effort. This project is Madeline Van Hoose is Director of
project team to: very complex and critically important CVM’s Project Management Staff.
• Establish and manage a project to the Center. It is an ideal example
plan that is agreed to by all project where project management can help

FDA Veterinarian January/February 2002


12 REGULATORY ACTIVITIES
by Karen A. Kandra

quired cautionary statement “Do Not selling and shipping a Type A Medi-
Feed to Cattle or Other Ruminants.” cated Article (Lasalocid/Bovatec 68)
For example, the common scoop to the above firm which does not
used to transfer prohibited material possess a valid FDA Medicated Feed
from 50-pound bags to smaller Mill License. As a manufacturer of
brown bags is not cleaned between materials intended for animal feed
prohibited and non-prohibited mate- use, feed mills are responsible for

T he following firms/individuals re-


ceived warning letters for offer-
ing animals for slaughter that con-
rial uses. Also, opened bags of pro-
hibited materials were reported to be
stored next to other open feed ingre-
assuring that the overall operation
and the products manufactured and
distributed are in compliance with the
tained illegal drug residues: dient bags. law. This includes assuring that each
• Mike Bidart, Owner, Loyola Dairy, Ray Winn, President, Winn, Inc., site where the firm handles Type A
Chino, CA Smithfield, UT, received a warning Medicated Articles adheres to the re-
• Charles F. Woodward, DVM, letter for manufacturing a free choice quirement not to ship to unlicensed
Concho Dairy Consulting, feed containing the Category II Type or unauthorized parties.
Onalaska, WI A Medicated Article, Lasalocid/Bova- Mr. Louis A. Rodriguez, Vice Presi-
tec 68, for use in cattle and sheep. dent, Pet Magic, Inc., Detroit, MI, re-
• Shaye G. Pope, President, Pope This firm failed to have an approved ceived a warning letter for releasing
Dairy Enterprises, Stetsonville, WI formula, and failed to possess a valid pig ear dog treats that had been de-
• Anthony R. Dinitto, Rome, NY FDA Medicated Feed Mill License. In tained by the Detroit District Office
• Randy J. Winner, Four Star Dairy, addition, the firm’s product labels into commerce without the proper
Yorkshire, OH contained numerous errors. release from the FDA. The samples
Mr. LaMar G. Clements, President, tested positive for Salmonella.
These violations involved illegal
Walton Feeds West, Inc., Cache Junc-
residues of penicillin in a dairy cow;
tion, UT, received a warning letter for
extra-label treatment resulting in
flunixin meglumine residues in a
cow; illegal residues of gentamicin in NEW DOSAGE FORM DRUG APPROVED FOR
a cow; illegal residues of
sulfadimethoxine in two cows; and,
HORSES
neomycin in a cow.

F DA recently announced the first

Photo by Norman Watkins


A warning letter was issued to the
following firms for violations related metered-dose inhaler approved
to 21 CFR Part 589.2000 – Animal Pro- for use in horses. The active ingredi-
teins Prohibited in Ruminant Feed. ent, albuterol, is a new chemical en-
This regulation is intended to prevent tity never before approved for veteri-
the establishment and amplification nary use.
of Bovine Spongiform Encephalopa- Albuterol sulfate is administered to
thy (BSE) through feed. horses intranasally via a metered-
dose inhaler for the immediate relief
• Kenneth Roy Tufly, Owner, Dixon
of bronchospasm and bronchocon-
Feeds, Inc., Dixon, MT
striction associated with reversible
• Gregory M. Sostak, President, airway obstruction [also known as
Finlayson Ag Center, Finlayson, chronic obstructive pulmonary dis-
MN ease (COPD)] in horses.
Violations included failure to sepa- Marketed under the trade name,
rate the receipt, processing, and stor- Torpex, and sponsored by Boehringer
age of the product containing prohib- Ingelheim VetMedica, Inc., the drug
ited material from non-prohibited is supplied in a pressurized alumi-
material; failure to establish a writ- num canister contained within an This aerosol dosage provides an
ten system to avoid commingling actuator system equipped with a de- alternative to the approved drug,
and cross-contamination of common tachable nasal delivery bulb. The na- clenbuterol, an oral syrup. Aerosol al-
equipment; failure to maintain sal bulb is inserted into the horse’s buterol provides relief to affected
records sufficient to track the mate- nostril and when the horse inhales, horses within minutes allowing the
rials throughout the receipt, process- the device is actuated providing a horse to breath easier. Typical adverse
ing, and distribution of products; and, puff of aerosolized albuterol which is reactions are transient sweating,
failure to label products with the re- delivered to the horse’s lungs. muscle tremors, or excitement.
FDA Veterinarian January/February 2002
FDA INVESTIGATOR ATTENDS MILK SEMINAR 13
O n November 7, 2001, Investiga-
tor Karen Robles from FDA’s
San Francisco District Office pre-
Holman, FDA’s Pacific Regional Direc-
tor. There were representatives from
the dairy regulatory programs in 22
residue follow-up inspections, and
the most common causes of illegal
drug residues. Materials provided in-
sented the FDA’s Illegal Drug Resi- States, as well as 130 attendees at the cluded FDA and the Veterinarian
dues in Meat & Poultry Program at tissue residue presentation, including booklets and press releases covering
the Pacific/Southwest Region Milk veterinarians, dairy producers, and recent injunction cases.
Seminar held in Reno, Nevada. Open- State regulatory officials. Topics in-
ing remarks were provided by Brenda cluded program objectives, tissue

SUPPLEMENTAL ABBREVIATED NEW ANIMAL DRUG APPROVALS


Company Generic and (Brand) Names Indications Routes/Remarks
Bimeda, Inc. Oxytetracycline hydrochloride Turkeys, swine. For the treatment ORAL—The ANADA provides for a
(ANADA 200-144) (Tetroxy) of various bacterial diseases. zero-day withdrawal time for use of
oxytetracycline hydrochloride in the
drinking water of turkeys and swine.
Federal Register 11/26/01

Photo by Keith Weller

ABBREVIATED NEW ANIMAL DRUG APPROVALS


Company Generic and (Brand) Names Indications Routes/Remarks
First Priority, Inc. Ivermectin Horses. For treatment and control ORAL—The ANADA is a generic
(ANADA 200-321) (PrimectinTM Equine Oral Liq- of various species of internal and copy of Merial Ltd’s Eqvalan® oral
uid) Rx cutaneous parasites. liquid for horses approved as NADA
140-439.
Federal Register 12/05/01

(Continued, next page)


Photo by Karen Kandra

FDA Veterinarian January/February 2002


14 ABBREVIATED NEW ANIMAL DRUG APPROVALS (Continued)
Company Generic and (Brand) Names Indications Routes/Remarks
Vibrac AH, Inc. Ivermectin Cattle. For treatment and control TOPICAL—The ANADA is a generic
(ANADA 200-318) (Virbamec Pour-On) of various species of external and copy of Merial Ltd’s Ivomec® Pour-
internal parasites. On for Cattle approved as NADA 140-
841.
Federal Register 12/05/01

Photo by Karen Kandra

SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS


Company Generic and (Brand) Names Indications Routes/Remarks
Schering-Plough Animal Diclazuril Turkeys. For prevention of coccidi- MEDICATED FEED—The supple-
Health Corp. (ClinacoxTM) osis. mental NADA provides for use of the
(NADA140-951) approved diclazuril Type A medi-
cated article to make Type B and
Photo by Scott Bauer

Type C medicated turkey feeds used


for prevention of coccidiosis caused
by Eimeria adenoeides, E.
gallopavonis, and E. melagrimitis.
Also, the NADA establishes toler-
ances for diclazuril residues in turkey
liver at 3 ppm, muscle at 0.5 ppm,
and skin with adherent fat at 1 ppm.
Federal Register 12/04/01

(Continued, next page)

FDA Veterinarian January/February 2002


SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS (Continued) 15
Company Generic and (Brand) Names Indications Routes/Remarks
Pfizer, Inc. Carprofen Dogs. For the relief of pain and ORAL—The supplement provides
(NADA 141-053) (Rimadyl® Caplets) Rx inflammation associated with for a once daily, 2 mg/lb dosage of
osteoarthritis. carprofen, by oral caplet.
Federal Register 12/05/01

Photo by Karen Kandra


MoorMan’s, Inc. Monensin Cattle. For prevention and control MEDICATED FEED—The supple-
(NADA 115-581) (MoorMan’s Mintrate Blonde of coccidiosis. ment provides for use of approved
Block RU and MoorMan’s monensin Type A medicated
Mintrate Red Block RU) articles to make free-choice, medi-
cated feed blocks used for prevention
and control of coccidiosis
caused by Eimeria bovis and E.
Photo by Karen Kandra

zuernii in pasture cattle.


Federal Register 12/07/01

FDA Veterinarian January/February 2002


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02-2311