Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al

Filing 91

DECLARATION of Jennifer A. Sorenson in Support re: 89 Memorandum of Law in Opposition,. Document filed by Center For Science In The Public Interest, Food Animal Concerns Trust, Natural Resources Defense Council, Inc., Public Citizen, Inc., Union Of Concerned Scientists, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I)(Sorenson, Jennifer)

EXHIBIT D
TO THE THIRD DECLARATION
OF JENNIFER A. SORENSON

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine

ANNUAL REPORT - FISCAL YEAR 2003
October 1, 2002 - September 30, 2003

Contents
A MESSAGE FROM THE DIRECTOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I
A MESSAGE FROM THE DEPUTY DIRECTOR . . . . . . . . . . . . . . . . . . . . . . . III
ABOUT CENTER FOR VETERINARY MEDICINE . . . . . . . . . . . . . . . . . . . . . 1

Our Mission and Guiding Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Our Strategic Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Our Organization and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Our Sphere of Influence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Our Stakeholders and Partners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
FISCAL YEAR 2003 CHALLENGES AND
ACCOMPLISHMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Increasing the Availability of Safe and Effective Drugs . . . . . . . . . . . . . . . . . . . . . . . 10
Increasing Drug Availability for Aquaculture and Other
Minor Uses/Minor Species . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Reducing Risk From Antimicrobial Resistance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Controlling Risk From Bovine Spongiform
Encephalopathy (BSE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Avoiding Unsafe Drug Residues in Human Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Assuring Feed Safety: The Animal Feed Safety
System (AFSS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

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Protecting Against Bioterrorism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Assuring the Safety of Animals Produced By
Biotechnology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Additional Surveillance and Compliance Actions to Protect
Public and Animal Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Enhancing Productivity Through Results-Oriented
Initiatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Leveraging Productivity Through Partnerships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
OUR GOALS FOR FISCAL YEAR 2004 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
STAFFING, SPACE AND BUDGET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Appendices
A. AWARDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
B. PUBLICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
C. BUDGET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

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A Message From the Director…
Progress in Our Efforts To Meet Health Needs
We present this, our first
annual report, in an effort to
reach out to our stakeholders
with a summary of our
activities and accomplishments
during Fiscal Year 2003 to
protect human and
animal health.
Dr. Stephen F. Sundlof, D.V.M., Ph.D.
Director, Center for Veterinary Medicine

T

his has been a watershed year for the
Center for Veterinary Medicine – an
appropriate year for our first annual
report. Some of the most important
accomplishments during FY 2003 laid the
foundation for collecting animal drug user fees
in 2004 and beyond. Building on our “Back to
Basics” strategic plan, we aligned our business
processes with results-oriented management to
expedite the review of animal drug applications
while controlling costs.

CENTER FOR VETERINARY MEDICINE

The Animal Drug User Fee Act is now a reality. The new law will improve access to
animal health care products, benefiting consumers, pet owners and food animal producers
– as well as the animals to which drugs are administered. The user fees to be paid by the
animal health industry will be dedicated to expediting the animal drug application review
process, as we focus on performance goals developed in consultation with the industry.
We turned another corner this year in our efforts to address an important public health
issue, antimicrobial resistance. For the first time, we have outlined a comprehensive,
evidence-based approach to minimizing the emergence and spread of resistant bacteria
that result from the use of antimicrobial drugs in food animals. Guidance for Industry
#152 provides a scientific risk-based process for assessing the likelihood that an
antimicrobial drug used to treat an animal may lead to infections in humans by bacteria
resistant to treatment with antimicrobial drugs. This risk information will enable CVM to
assess the likelihood that antimicrobial resistance might result from use of a drug in food
animals, and to manage those risks to avoid resistance before it develops.
We reached historic milestones in the enforcement of our regulation that is intended to
prevent the establishment and spread of Bovine Spongiform Encephalopathy (BSE).
FDA adopted the BSE feed regulation in 1997 to avoid the public health risks and
economic disasters that have resulted from BSE outbreaks in other countries. Due largely
to the efforts of state regulatory agencies and FDA field offices, we reached two goals
during the past year that represent unprecedented regulatory achievements: inspection of
100 percent of the firms that are at the top of the chain in feed manufacture and distribution – and greater than 99 percent compliance by those firms. What’s more, we made
significant strides during the year toward development of practical tests for detecting
illicit ingredients in ruminant feed.

I

A Message from the Director - Center for Veterinar y Medicine

There is more. As part of our contribution to the nation’s effort to
counter bioterrorism, we took the first steps toward development of a
comprehensive animal feed safety system. We also completed a lengthy
administrative hearing as part of our effort to withdraw approval of the
poultry drug enrofloxacin (a fluoroquinolone) on the grounds that its use
results in an unacceptable level of antimicrobial resistance.
We approved 44 percent more original, supplemental and generic animal drug applications than
in the previous fiscal year. As just one example, we approved a breakthrough drug for chemical
sterilization of male puppies that will help control the growing dog population. And we made
significant progress in the development of methods to detect illegal residues of the harmful
drugs chloramphenicol and nitrofurans in imported seafood.
We continued to work closely with our international regulatory partners, particularly within
the Veterinary International Conference on Harmonization (VICH) to harmonize safety and
efficacy requirements to support drug approvals. We also worked within the Codex
Committee on Residues of Veterinary Drugs in Food (CCRVDRF) to harmonize residue
tolerances among more than 150 countries. We worked within other international fora, both
bilaterally and multilaterally, to further our public health goals and our strategic plan goals, and
to support U.S. Government trade agencies such as the Office of the U.S. Trade Representative.
We present more details on these and many other activities in this annual report. The following
pages set out the challenges we face, the achievements accomplished during the past year, and
our plans for the future. Where we reached our performance goals for FY 2003, we so indicate.
Where we fell short of the goals, we indicate this also. We believe we best serve the public by
reporting our shortcomings along with our accomplishments.
The achievements we report resulted from the hard work of a competent and dedicated staff.
This report also documents continued expansion of collaborative activities with many of our
stakeholders. These arrangements provide mutual benefit and allow us to fulfill our role in
protecting the public health more effectively and efficiently. We are grateful for the support of
our stakeholders as we work together for the public good.
With the passage of the Animal Drug User Fee Act, Congress passed the fourth major law for
animal drugs during the past 15 years. We will work diligently during Fiscal Year 2004 to
implement the latest law, just as we have worked hard to turn Congressional directives into
results relating to generic drugs, extralabel use and drug availability. Above all, we value the
trust the public bestows on us, and we will continue to earn that trust by upholding these and
other laws for which we have responsibility.

II

A Message From the Deputy Director…
Internal Growth To Support External Benefit
Dr. Linda Tollefson, D.V.M., MPH

I

have the privilege of following Dr. Sundlof’s summary of our substantive FY 2003
achievements with a report on developments in the organization that is behind the
accomplishments.
Our “Back to Basics” strategic plan commits us to take actions that enable us to
accomplish our mission of protecting public and animal health through the efficient
use of resources. During the past year, we took several major steps toward enhancing
productivity through results-oriented initiatives. These include activity-based costing,
project management and other measures intended to help us target limited resources for
maximum public health benefit. We believe that these efforts will result in greater consumer safety, healthier animals and increased satisfaction on the part of our stakeholders.
We describe these and related initiatives in detail in this report.
CVM’s Senior Management Team* collaborates on day-to-day management and policy
decisions facing the Center, as well as long-range planning, budgeting and policy development. In making its decisions, the team considers scientific, economic, international,
and social issues and their impact on the Center. A project manager documents action
items and decisions to assure that these actions and decisions are implemented.
The Senior Management Team members work to make CVM a high performance
organization, modeling the values and behaviors of the organization, with an emphasis on
continuous learning and 360 degree feedback to improve performance and behavior. In
its quest for continued higher performance in CVM, the team works with the other
members of the Center to develop the CVM strategic plan and prioritize important
projects to better use resources to meet short and long term goals.
CVM’s Senior Management Team members are as follows:

*

Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine
Dr. Linda Tollefson, Deputy Director, Center for Veterinary Medicine
Dr. Andrew J. Beaulieu, Associate Director for Animal Health Policy & Regulations
Ms. Catherine Beck, Associate Director for Executive Programs and Acting Associate Director for Policy and Regulations
Dr. David Grau, Senior Management Consultant
Dr. William Flynn, Deputy Associate Director for Policy and Regulations
Dr. Daniel G. McChesney, Director, Office of Surveillance and Compliance
Mr. Don Peterson, Director, Office of Management
Mr. David Wardrop, Director, Office of Management (replacing Mr. Peterson on December 8, 2003)
Dr. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation
Dr. Linda Youngman, Director, Office of Research

III

A Message from the Deputy Director - Center for Veterinar y Medicine

We made some organizational changes that will facilitate implementation of the
management initiatives. Building on the establishment of an Office of Executive
Programs in FY 2002, we formalized a Project Management Staff to guide the application
of the project management concept for improved organizational performance. And
we established an Executive Secretariat to improve the quality and timeliness of
our responses to inquiries from our stakeholders. We also reorganized the Office of
Management, to accommodate FDA’s consolidation of administrative services and to
organize more efficiently around like functions.
Appointments of individuals to serve in key positions are essential to the success of any
organization; we made several such selections during the year. These include the choice
of Bill Flynn, D.V.M., M.S., as Deputy Associate Director for Policy and Regulations;
Steve Vaughn, D.V.M., as Director, Office of New Animal Drug Evaluation; Linda
Youngman, M.S., Ph.D., and Marlene Wekell, Ph.D., as Director and Deputy Director,
respectively, of the Office of Research; Dan McChesney, Ph.D., as Director, Office of
Surveillance and Compliance; Bernadette Dunham, D.V.M., Ph.D., as Deputy Director,
Office of New Animal Drug Evaluation; and Al Montgomery, D.V.M., as our first
Counterterrorism Coordinator.
The accomplishments of an organization are often reflected in the public recognition of
its people. CVM and its people were recognized with a number of awards during the
year. Dr. Andy Beaulieu received the 2003 Meritorious Presidential Rank Award for
scientific and policy leadership during his 30 years with CVM. Several CVM staff
members received the HHS Secretary’s Award for Distinguished Service for the innovative program – organized in collaboration with the government of Mexico – to monitor
resistance in pathogens that could contaminate food imported into the United States.
Our Staff College was recognized as having the best practice government-wide for its
Competency Model and Learning Management System. We have included a complete list
of FY 2003 awards in Appendix A.
The professional productivity of our scientists is evidenced by the large number of articles they published during the year. We have included a complete list in Appendix B.
It’s been a busy, productive year – made possible by our staff of motivated, talented
people. Their contributions cause our Senior Management Team to be optimistic about
the challenges of FY 2004 and beyond. And there will be plenty of challenges – for
example, hiring a number of scientists as reviewers and otherwise implementing the
requirements of the Animal Drug User Fee Act. We look forward to working with others
in the FDA and our stakeholders as we face the tasks ahead of us.
IV

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ABOUT

The Center for
Veterinary Medicine Our Mission and Guiding Principles
OUR MISSION…
The Center for Veterinary Medicine is a consumer protection
organization. We foster public and animal health by approving
safe and effective products for animals and by enforcing other
applicable provisions of the Federal Food, Drug and Cosmetic
Act and other authorities.
OUR GUIDING PRINCIPLES…
We are committed to:
Health Protection. We honor our role in protecting the health
of people and animals, and value the principles and spirit of the
supporting laws and regulations.
Integrity. We conduct ourselves with honesty and integrity,
recognizing that upholding the public trust requires the highest
standards of moral and ethical conduct.
Quality. We achieve excellence through the ongoing development of our competencies and continuous quality improvement
in all our processes. In particular, we recognize the value and
importance of science and law in reaching quality and timely
regulatory decisions.
Teamwork. Everyone’s contribution is important. Working
together, we place the mission of the Center first and align our
contributions, whether individual or in teams, toward that end.
We conduct ourselves in accordance with the principles of
consultative and participative decision-making.

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Communication. We communicate information, ideas, decisions, and provide feedback,
internally and external to the organization, in a candid, timely, constructive, and clear
manner.
Equity. We treat our customers and each other with fairness, courtesy, respect and
compassion while fostering an atmosphere of mutual trust.
Diversity. We promote workforce diversity to strengthen and enrich the Center.
Innovation. We apply new concepts, ideas, and creative approaches to improve current
operations and to meet the challenges of the future.
Safety and Health. We seek to ensure a safe and healthful workplace.
Quality of Worklife. We create and use programs that enhance our quality of worklife to
improve our ability to carry out the mission of the organization.

Our Strategic Plan
CVM’s strategic plan reflects the principles set forth in the President’s Management
Agenda, the “one HHS” initiative of the Secretary of Health and Human Services, and the
Food and Drug Administration’s Strategic Action Plan.
Our plan, “CVM’s Back to Basics Approach for Carrying Out Our Public and Animal
Health Mission,” commits us to focus on our core functions of:
•

Animal drug review (premarket activities)

•

Compliance-related actions

•

Post-approval monitoring

•

Animal feed safety

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To help us focus on the basics, our plan establishes the following goals. We will:
•

Set priorities (reviewed annually) and say “no” to lower priority items.

•

Improve, and bring discipline to and through, our business practices.

•

Support and use good science in establishing solid regulatory policy.

•

Improve the capacity of the organization to meet current and future demands on
the Center.

•

Develop revenue enhancing programs for core services.

Our Organization and Responsibilities
We carry out our mission through the efforts of people who are organized into five
offices: the Office of the Director; the Office of New Animal Drug Evaluation; the Office
of Surveillance and Compliance; the Office of Research; and the Office of Management.
All of our offices are located in Rockville, Maryland, except the Office of Research,
whose facilities are located in Laurel, Maryland.
OFFICE OF THE DIRECTOR (OD)
The Office of the Director directs overall Center activities, coordinates and establishes
Centerwide policy, and provides guidance for the implementation of the Center’s “Back
to Basics” strategic plan. The Center Director serves as CVM’s representative and
spokesperson concerning our activities, interacting with the general public, industry, the
media, other government agencies, and national and international organizations.
The Director approves animal drug applications and exercises other statutory authority
that has been delegated to him. Other functions are performed through a Deputy Director
and associate directors for executive programs, policy and regulations, and animal health
policy and operations. The office conducts communication and education programs,
provides project management support for the Center, offers the services of the CVM
Ombudsman, manages a program to promote drugs for minor uses and minor species,
manages the Veterinary Medicine Advisory Committee, and coordinates international
activities in the Center.

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OFFICE OF NEW ANIMAL DRUG EVALUATION (ONADE)
ONADE’s mission is to protect the public health by ensuring the availability of an
adequate number of safe and effective animal drugs to meet the therapeutic and production needs of animals. ONADE administers the core function of drug review – it directs
the approval process for animal drugs. FDA must review an animal drug for safety,
effectiveness and quality before the drug can be legally marketed in interstate commerce.
CVM approves drugs intended to benefit the health and productivity of food animals, and
the health of companion animals.
Drug sponsors must submit clinical tests to establish drug safety and effectiveness.
Sponsors of drugs intended for food animals must also prove that food products derived
from treated animals do not contain unsafe drug residues, and that the food products are
acceptable with respect to microbial safety. The sponsors must develop analytical methods to detect and measure drug residues in edible animal products. The Federal Food,
Drug and Cosmetic Act provides for approval of both pioneer and generic animal drugs,
and for FDA-granted authority to use investigational animal drugs. CVM classifies the
animal drugs it approves, for distribution and use purposes, as over-the-counter, prescription, or veterinary feed directive.
OFFICE OF SURVEILLANCE AND COMPLIANCE (OS&C)
This office has primary responsibility for three of CVM’s core functions: compliancerelated actions, post-approval monitoring and animal feed safety. OS&C monitors the
safety and effectiveness of approved drugs after they enter the market. This includes
surveillance for development of antibiotic resistance that could compromise human and
animal therapy, and for adverse reactions in treated animals. Working with the U.S.
Department of Agriculture and state agencies, OS&C monitors the occurrence of unsafe
drug residues in meat and poultry products, and guides efforts to protect consumers
through educational and enforcement activities related to drug residues. The office
coordinates enforcement actions against unapproved drugs that are on the market and that
threaten public and animal health, and we utilize epidemiological skills to protect public
and animal health.
OS&C conducts surveillance and compliance programs to protect animal feed from
contamination by toxic materials such as mycotoxins, pesticides, heavy metals and industrial chemicals. The office administers the feed mill licensing program, approves feed
additives and coordinates biennial inspections of feed manufacturers. OS&C coordinates
the Center’s counterterrorism efforts. The office’s Bioresearch Monitoring staff oversees
inspections of both nonclinical (laboratory) and clinical studies, to provide assurance of

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the integrity of data submitted in support of animal drug applications. OS&C also
coordinates the Center’s administrative actions involving approved drugs, such as actions
to withdraw drug approvals.
OFFICE OF RESEARCH (OR)
The Office of Research conducts applied research in support of regulatory decisionmaking related to each of CVM’s core functions. OR operates from a state-of-the-art
research complex containing offices, laboratories, animal buildings and pastures.
In support of the drug review function, OR conducts studies in animal drug safety and efficacy, antimicrobial resistance mechanisms, metabolism, standardization of test methods,
and pharmcokinetics/pharmacodynamics. The goal of these efforts is to provide a science
base for guideline development. OR supports the compliance program of the Center
through the development of analytical methods and evaluation of screening tests for detection of drug residues in imported and domestic food products. The office is responsible
for the post-approval monitoring of retail meats for drug resistant foodborne pathogens
under the National Antimicrobial Resistance Monitoring System, and molecular typing
of those pathogens as part of the national PulseNet program. OR conducts research to
understand the microbiology of animal feeds, and the dissemination of resistant organisms
via livestock feeds. The office is also developing methods to detect material, prohibited by
the BSE feed regulation, that could compromise animal feed safety.
OR prepares a detailed annual report; for a copy, write to Center for Veterinary Medicine,
Office of Research, 8401 Muirkirk Road, Laurel, MD 20708, attention Denise Strekal.
OFFICE OF MANAGEMENT (OM)
The Office of Management has primary responsibility in four program areas: budget and
finance; management services; planning, procurement and facilities; and information
resources management. OM plans, develops and implements Center management policies.
OM provides leadership and direction for the planning, development and execution of the
CVM budget. This includes analysis, formulation and presentation of budget issues. The
office serves as the focal point for management and administrative interaction with other
FDA offices to assist in the efficient delivery of administrative services to the Center’s
employees. OM provides liaison services for activities that include space and workplace
planning, facilities management and operations, and workplace safety. OM represents
management on Center issues that involve the National Treasury Employees’ Union and

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the implementation of the FDA/NTEU Collective Bargaining Agreement. OM also serves
as liaison with the Agency’s Office of Information Technology Shared Services to ensure
efficient and effective IT development management, and website development. OM also
manages the financial activities associated with the Center’s user fee program.
OM directs the development and implementation of the competency-based Staff College
and accompanying curriculum. OM sets the Center’s expectations with regard to
required competencies through the Staff College Knowledge Center.

Our Sphere of Influence
CVM’s efforts to help assure that domestic and imported animal food products are safe
affect millions of consumers. American consumers eat – on the average – 115 pounds
of meat, 67 pounds of poultry, 15 pounds of fish, 595 pounds of dairy products and 30
pounds of eggs each year. Besides protecting the health of consumers, CVM works to
safeguard the health of food-producing animals in the United States: 97 million cattle,
59 million pigs, 8.8 billion chickens, 272 million turkeys and 7 million sheep. The U.S.
produces about $100 billion worth of livestock and livestock products each year.
CVM approvals are now in effect for 727 drugs for use in food-producing animals. We
have approved many of these drugs for administration through animal feed. CVM has
licensed approximately 1,200 firms that manufacture medicated feeds, under a law passed
by Congress several years ago. And we have published regulations that authorize use of
more than 50 food (feed) additives.
More than 600 currently approved drugs are available to maintain the health of our
nation’s growing pet population, which now numbers 60 million dogs and 70 million
cats, in addition to 5.5 million horses.
Altogether, we regulate activities of some 6,600 feed manufacturers and related firms,
more than 150 animal drug manufacturers and other sponsors of animal drug applications,
many thousands of livestock and poultry producers, and firms in a variety of specialized
industry groups. The drugs we approve help the nation’s 69,000 veterinarians accomplish
their task of maintaining the health of the nation’s animals.

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Our Stakeholders and Partners
A key goal in our strategic
action plan is better
information to empower
consumers.
From the FDA Strategic
Action Plan

We communicate information, ideas, decisions, and
provide feedback, internally
and external to the organization, in a candid, timely,
constructive and clear manner. We treat our customers
and each other with fairness,
courtesy, respect and compassion while fostering an
atmosphere of mutual trust.
From CVM’s Guiding Principles

OUR STAKEHOLDERS
Many organizations, and millions of individuals, have
a stake in the outcome of CVM’s work. They include
consumers, animal owners, veterinarians, and firms in the
regulated industries – companies that market the drugs,
feeds and other products that we regulate. Our stakeholders
also include trade associations; consumer organizations;
state, federal and foreign regulatory agencies; international
standard-setting organizations; and others.
We use a variety of methods to keep stakeholders informed,
and to seek their advice and opinions about our policies
and programs. These methods include public meetings;
requests for comment on proposed regulations and guidance
documents; the CVM website; and a variety of informal
means such as letters, phone calls and e-mails.

OUR PARTNERS

Our success in promoting and protecting the public
health depends not only on the active involvement of our
stakeholders, but also on the formation of partnerships
with those whose goals align with ours. Government
downsizing, a changing economy, technical advances and
other factors have prompted FDA and CVM increasingly
to seek out partnering opportunities to maximize the use of
our resources.

It makes good business
sense to engage in
relationships where
collaborators work
synergistically to achieve
goals that neither party
could achieve on its own.
From the FDA Veterinarian
July/August 2002

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The concept of collaboration and partnership is generally known as leveraging, and we
are working to make it one of the foundations of our day-to-day operations. Our partners
include:
•

Other federal agencies with whom we share related regulatory responsibilities, such
as the U.S. Department of Agriculture’s Food Safety and Inspection Service (e.g.,
surveillance for animal drug residue and antimicrobial resistance) and Animal and
Plant Health Inspection Service (e.g., BSE), and the U.S. Environmental Protection
Agency (e.g., pesticides). For example, the Interagency Residue Control Group,
with members from FDA, USDA and EPA, coordinates information on residues of
animal drugs, pesticides and environmental contaminants in animal food products.

•

Centers for Disease Control and Prevention, National Center for Infectious Diseases
(e.g., surveillance for antimicrobial resistance).

•

USDA’s Agricultural Research Service and Cooperative State Research, Education
and Extension Service.

•

State agencies, who partner with us to conduct inspections for compliance with the
BSE feed regulation and other feed inspections, and to carry out other regulatory
and surveillance functions.

•

Veterinarians, who share with us numerous public and animal health goals such as
testing and surveillance of animal drugs for safety and effectiveness, avoiding drug
residues in food products, minimizing the development of antimicrobial resistance
through prudent drug use practices, and educating producers and related industries
as to their public health responsibilities.

•

Foreign regulatory agencies who have responsibility and authority for controlling
animal drugs and feeds in their countries; we leverage such international work
through our participation and leadership in VICH, CCRVDF and other multilateral
organizations.

We partner through cooperative agreements, cost-sharing contracts, cooperative research
and development agreements (CRADAs), interagency agreements (IAGs), cosponsorship
agreements and informal agreements. We hold joint workshops, cosponsor training sessions,
work with scientists on mission-related research, and cooperate with others in many ways.
We include a number of examples of current partnership arrangements in this annual report.

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FISCAL YEAR
2003
Challenges and
Accomplishments

Introduction
Although we are organized into five separate offices,
our Guiding Principles call for the staff of the Center for
Veterinary Medicine to work together, placing the mission of
the Center first. In fact, most of our significant accomplishments involve the efforts of people from two or more offices,
through teams, committees and day-to-day coordination.
Thus, we organize our presentation of FY 2003 accomplishments not according to office structure, but according to
crosscutting topics. These topics reflect issues of significant
public interest. We introduce each of these areas of concern
with a statement of the challenges that we face as we attempt
to meet our “Back to Basics” goals.
To help us achieve our strategic goals in FY 2003, we
established targets for the year – a number of specific performance goals. Individual offices have primary responsibility
for achieving some of the performance goals, but two or
more offices share many of the performance goals because
the goals relate to activities that require collaborative efforts.
We highlight our performance goals in the appropriate
sections and mark them with a for goal accomplished, and
an for goal not accomplished.
We have worked during the past year to focus on the
priorities stated in FDA’s Strategic Action Plan: efficient risk
management, empowering consumers, improving patient
and consumer safety, protecting America from terrorism, and
more effective regulation through a stronger workforce. We
have indicated below some examples of how our FY 2003
accomplishments responded to the agency’s priorities.

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Increasing the Availability of
Safe and Effective Animal Drugs
THE CHALLENGE

FY 2003 Performance Goals
Goal Achieved

Complete review and
action on 90 percent of all
animal drug applications
and supplements received
in FY 2003 within 275 days,
and complete review and
action on 90 percent of all
investigational animal drug
submissions received in FY
2003 within 325 days.
Goal Achieved

Reduce pending overdue
animal drug submissions by
15 percent.

Statutory standards and the needs of our stakeholders – and especially the needs of the billions of
animals whose health we seek to protect – require
that we make the right preapproval decisions, and do
so efficiently and expeditiously.
CVM’s challenge is to protect the public health by
assuring that there is an adequate supply of animal
drugs to meet therapeutic and production needs.
To accomplish this challenge, CVM must consider
the public health, including human, animal and
environmental health; employ applicable science to
make high quality decisions; understand the economics of the animal health industry; and conduct
quality reviews efficiently to help keep unsafe and
ineffective drugs off of the market.
FY 2003 ACCOMPLISHMENTS
We responded to the challenges in a number of
ways, as described below. In general, these actions
were directed toward achieving the FDA strategic
plan priority of increased productivity in new drug
development, and the strategic plan’s objective of
providing a timely, high quality and cost-effective
process for review of pre-market submissions.

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PRODUCTIVITY ACCOMPLISHMENTS IN THE
ANIMAL DRUG EVALUATION PROCESS
We improved productivity in the pre-market review of animal drugs without the addition
of new resources. The Office of New Animal Drug Evaluation approved 44 percent more
original, supplemental and generic animal drug applications during FY 2003 than in the
previous fiscal year:

Application

FY 2002

FY 2003

Animal Drug
Applications

16

18

Supplemental
Animal Drug
Applications

312

450

Abbreviated Animal
Drug Applications
(generic)

14

26

Supplemental
Abbreviated Animal
Drug Applications

67

95

Total Applications

409

589

During the year, we completed review of 95 percent of all animal drug applications
within 275 days, and 99 percent of all investigational animal drug submissions within
325 days. This exceeded our goals of completing 90 percent of the reviews within the
indicated time frames.
In addition, we had a performance goal to reduce the number of pending overdue
submissions by 15 percent. CVM exceeded the goal by reducing the number of overdue
submissions by 38 percent.

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SIGNIFICANT NEW APPROVALS
We considered 63 of the FY 2003 approvals to be significant. These significant approvals
included:
New chemical entities. These are chemical substances that we have not previously
approved for use in animals. We approved original animal drug applications for four
new chemical entities during the year:
Neutersol Injectable Solution, for chemical castration of young male dogs. This
product is the first FDA-approved alternative to surgical castration of young
dogs. The drug may prove to be a valuable aid in efforts to control the growing
dog population; animal shelters are likely to have a veterinarian administer the
product to dogs on site rather than relying on owners to take adopted dogs to a
veterinarians for surgical sterilization.
Zubrin Rapidly-Disintegrating Tablets
Metacam Oral Suspension
Both products are nonsteroidal anti-inflammatory drugs for treatment of
osteoarthritis in dogs.
CelerinTM, a microencapsulated product for increased weight gain and improved
feed efficiency in steers and heifers fed in confinement.
Supplemental applications for new species. These included approvals for
Neo-Sol in turkeys; Optaflexx (the first non-hormonal, non-antimicrobial growth
promoter) for increased rate of weight gain and improved feed efficiency in cattle
fed in confinement; Matrix, for synchronization of estrus in gilts; and several drug
products for treatment of osteoarthritis, post-operative pain, dermatitis and pruritus in
dogs.
New combinations. These approvals included Zimectrin Gold and Equimax, and
Quest Plus, for anthelmintic use in horses; and an approval for concurrent uses of
Program and Capstar for flea management in dogs.
New Strength/Concentration. We approved new strengths of Naxcel XT Sterile
Suspension and Tetradure 300 for treatment of Bovine Respiratory Disease.

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ACTIONS TO INCREASE THE EFFICIENCY AND REDUCE THE
COST OF THE REVIEW PROCESS
The Office of New Animal Drug Evaluation achieved significant progress on a number
of strategic initiatives designed to improve the effectiveness of the pre-market review
process, including:
•

Establishing a working group, in collaboration with the Animal Health Institute,
whose goal is to improve the quality of data submissions so that the number of
review cycles can be reduced.

•

Publishing guidance documents in connection with the FDA’s Drug Quality
Initiative, as part of the agency’s Strategic Action Plan. This included guidance
to sponsors for electronic records, dispute resolution, protocols, sterile drug
products, and a framework for innovative pharmaceutical manufacturing and
quality assurance.

•

Completing about 90 percent of the scope of the Veterinary Establishment and
Production Formulation sections of our Submission Tracking and Reporting
System (STARS). The benefits of these sections will include, for example,
expediting the search for formulation information, and associating manufacturing
facilities with approved applications.

•

Developing and implementing a robust project management system for work
assignments that are not included in STARS, and developing standardized
procedures for final actions that have STARS controls.

•

Developing strategies for planning work by predicting incoming submissions.

•

Developing guidance on drug application regulatory and quality assurance
requirements, including “Refuse to File” and “Refuse to Review” policies.

•

Developing guidance and other proactive strategies designed to better educate
sponsors during the pre-submission stage

Working with industry and international regulatory partners within VICH to harmonize
preapproval guidance to further assure the submission of adequate studies, and to support
the efficient use of industry resources. This included progress in completing guidance
documents on toxicity testing and microbial safety.

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RESEARCH TO SUPPORT ANIMAL DRUG APPROVALS
Drug sponsors are responsible for submitting studies to prove that their drugs are safe
and effective. Complementary work – accomplished by CVM, its contractors and
collaborators – may alter the type and number of studies required for approvals, thus
improving the efficiency of the drug approval process. During FY 2003, CVM conducted
or sponsored research with aquatic and terrestrial animals to develop models for
conducting safety and effectiveness studies. Studies with aquatic species are described
in the next section. Other work included studies involving drug metabolism in swine and
induction of rumen function in calves.
Immunopharmacology studies identify factors affecting drug safety and efficacy in target
animals, and human food safety. One such study involved the kinetics of a prostaglandin
in cattle. Pharmacokinetics/pharmacodynamics help assess the effects of drugs in
diseased animals, an important contribution because most data submitted to CVM are
generated in healthy animals. An example is a study involving the use of enrofloxacin in
both healthy and diseased cattle.
ASSISTANCE IN THE PASSAGE OF USER FEE LEGISLATION
We provided leadership and technical support for legislative efforts that resulted in the
passage of the Animal Drug User Fee Act of 2003. Many of our efforts during FY 2003
to improve efficiency, cost-effectiveness and accountability in the drug approval process
were undertaken to facilitate implementation of ADUFA.

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Increasing Drug Availability for
Aquaculture and Other Minor Uses/
Minor Species
THE CHALLENGE
Because the potential sales volume
is low, animal drug manufacturers
lack economic incentive to seek
animal drug approvals for minor
uses (diseases that are rare) or
minor species (any animal species
other than cattle, horses, pigs,
chickens, turkeys, dogs or cats).
The problem is particularly acute
in aquaculture.
The harvest of wild-caught fish is declining rapidly. As a
result, aquaculture is becoming an increasingly important
source of fish for human consumption. The U.S. aquaculture
industry is expanding – approaching $1 billion in annual
sales – and the need for therapeutic and production drugs
is growing as well. For example, aquaculture producers
and veterinarians need drugs to treat fungal infections in
trout, several bacterial and mycobacterial infections in fish,
internal parasitic infections in fish, and diseases in shrimp
and abalone.
FY 2003 ACCOMPLISHMENTS
We continued our efforts to increase the availability and
diversity of drugs for use in aquaculture, including the
following actions.

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RESEARCH TO SUPPORT DRUG APPROVALS
Office of Research scientists conducted research on several aquatic animal diseases for
which no drugs are currently approved. These included a study on the effectiveness of
formalin for treating fungal infections, a serious disease of rainbow trout and other fish
species, particularly those raised in aquaculture facilities. We also made progress in the
development of a model internal parasite infection in largemouth bass for studying the
effectiveness of antiparasitic drugs.
We continued studies to determine whether it is possible to group fish species (based
on criteria such as salt vs. freshwater, warm vs. cold water species) so that drugs can
be approved for groups of fish species after being tested in one representative species.
For example, we completed a study of the metabolism and depletion of albendazole,
an anthelmintic drug, in rainbow trout, tilapia and Atlantic salmon. The results suggest
that there is a potential for species grouping of cold and warm water fish for drugs of
this type. These studies are a good example of how we are working to achieve the FDA
strategic plan priority of greater productivity in new drug development.
ACTIONS TO ENHANCE OUR AUTHORITY TO APPROVE DRUGS
FOR AQUACULTURE AND OTHER USES
The specific challenge to increase the availability and diversity of drugs for use in
aquaculture is part of the larger challenge of meeting the need for animal drug approvals
for minor uses and minor species. Some of these needs include drugs that can be
administered in feed to control parasitic infections and other diseases in farm-raised
pheasants; a more concentrated formulation of a drug used in darts to tranquilize zoo
animals so veterinarians do not have to dart animals multiple times; an effective drug
for treatment of liver flukes in elk; and products for manipulation of reproduction in
sheep, goats and other small ruminants to allow U.S. producers to compete with foreign
producers who are allowed to use such products.

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This situation parallels the need for “orphan
drugs” in human medicine, a need that
Congress has responded to through legislation. Recognizing the similar problem
in animal medicine, Congress included a
provision in the Animal Drug Availability
Act of 1996 that required the Secretary of
Health and Human Services to develop
proposals to facilitate the approval of animal
drugs intended for minor uses and minor
species. The FDA published the proposals
in 1998. During FY 2003 we provided
technical assistance and briefings related
to legislative proposals concerning minor
uses and minor species. Very similar bills
have been approved by a committee in the
Senate and will be considered by the House
of Representatives during its 2004 session
– major milestones in the passage of this
much-needed legislation.

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Reducing Risk From
Antimicrobial Resistance
THE CHALLENGE
FY 2003 Performance Goals
Goal Achieved

Publish final guidance
for industry (GFI # 152)
that outlines the strategy
for assuring the safety of
antimicrobial animal drugs
with regard to their microbiological effects on bacteria
of human health concern.
Goal Achieved

Participate in the cooperative agreement with four
sites in Mexico to determine
prevalence of Salmonella, E.
coli, and Campylobacter in
symptomatic and asymptomatic humans.

Scientific evidence demonstrates that the use of
antimicrobial drugs in food-producing animals can
result in the development of resistant bacteria. The
resistant bacteria can then be transferred to humans
through food. These bacteria may not be pathogenic
to the animals, but may cause illness in humans.
Two examples are Salmonella and Campylobacter,
which can cause severe, even fatal, foodborne illness
in humans.
If the resistant bacteria cause an illness in a
consumer who needs drug treatment, that treatment
may be compromised because the drugs of choice
may be ineffective. Resistance to the antimicrobial
drugs needed to treat human illness is a serious
public health threat, whether the resistance develops
from inappropriate use of antibiotics in people, use
of antimicrobials in food-producing animals, or
other sources.

Goal Achieved

Continue to enhance the National Antimicrobial Resistance Monitoring
System (NARMS) on an international basis through support of an advanced
WHO training course in Mexico and a beginning course in Central Asia.

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Goal Achieved

Continue to support the
WHO global Salmonella
surveillance program with
funding and trainers.
(ongoing)
Goal Achieved

Expand the human arm
of NARMS to include all 50
states.

FY 2003 ACCOMPLISHMENTS
In cooperation with other agencies, CVM has
undertaken proactive risk assessment and risk
management, surveillance, research and education programs to reduce the risk to human health
that can result from the use of antimicrobials in
food-producing animals. We reached significant
milestones in this effort during the past year, as
described in the following paragraphs. These
efforts respond to the FDA strategic plan priority
of reducing foodborne illness, a major public
health threat.

Goal Achieved

Hold a hearing on our proposal to remove
fluoroquinolone from use in poultry.
Goal Achieved

Continue to review penicillin and tetracycline approvals
for microbial food safety concerns, to be supplemented by
external research literature review and analysis.
Complete the data collection from the field and
laboratory studies related to Virginiamycin. Complete the
draft Virginiamycin risk assessment.

NOT Achieved

The risk assessment could not be completed until the data had
been generated from the extramural research, and this was not
done in time to finish the report during the fiscal year.
Goal Achieved

Conduct research to identify food animal species causing
human drug resistance.

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ASSESSING RISK AND TAKING APPROPRIATE RISK
MANAGEMENT ACTION
Guidance for assessing risk. Following publication of a draft for comment
and a public meeting, the Center has issued guidance that for the first time outlines a
comprehensive evidence-based approach to preventing antimicrobial resistance resulting
from the use of antimicrobial drugs in animals. The guidance, designated Guidance for
Industry (GFI) #152,1 provides a scientific risk-based process for assessing the likelihood
that an antimicrobial drug used to treat an animal may cause an antimicrobial resistance
problem in humans. The guidance is intended to avoid the problem before it can develop,
since it applies in the drug approval process. However, its principles will also be applied
in determining whether to remove approved products from the market.
Revocation of obsolete regulations. Consistent with the development of GFI
#152, the FDA in August 2003 proposed removal of regulations that required drug
sponsors to submit safety and effectiveness data related to subtherapeutic feed uses
of certain antibiotics, nitrofuran and sulfonamide drugs. This includes 21 C.F.R. §
558.15, published in 1973 to provide a framework for the now obsolete requirements.
The August publication also announced the effective conditions of use for certain drug
products and use combinations listed in the regulations that are to be revoked.
Penicillin and tetracycline review. As a follow-up to long-standing proposals
to withdraw approvals of subtherapeutic feed uses of penicillin and tetracycline,
CVM during FY 2003 completed microbiological food safety reviews for five out of
seven approved penicillin and penicillin combination products, and the first of several
tetracycline products. These reviews are using GFI #152 to develop an overall estimate
of the risk to humans from the continued use of these drugs.
Proposed withdrawal of fluoroquinolone approval. In 2000, CVM took the first
steps toward withdrawing the approval for the use of the fluoroquinolone enrofloxacin
in poultry. We based this initiative on several findings. First, the use of fluoroquinolones
causes the development of fluoroquinolone-resistant Campylobacter in poultry. Second,
the resistant Campylobacter is transferred to humans and is a significant cause of
the development of resistant Campylobacter infections in humans. Third, resistant
Campylobacter infections are a human health hazard. We accompanied our proposal to
withdraw the enrofloxacin approval with a risk assessment focused on the resistancedeveloping properties of fluoroquinolones used in poultry.
Guidance for Industry (GFI) #152, “Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to
Their Microbiological Effects on Bacteria of Human Health Concern.”
1

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Enrofloxacin is comparable to ciprofloxacin, a fluoroquinolone used widely in human
medicine. Fluoroquinolones are one of the most valuable antimicrobial drug classes
available to treat human infections. They are effective against a wide range of human
diseases that have major public health impacts in the United States. Therefore the public
would benefit if we remove from the market any drug that causes the development of
organisms that resist fluoroquinolone treatment in humans.
The law specifies certain procedures that are to be followed before an approved animal
drug can be withdrawn from the market. CVM completed one of those processes, a
lengthy administrative hearing concerning enrofloxacin, during FY 2003. We provided
scientific expertise for the hearing, based on extensive literature reviews and
expert testimony.
Virginiamycin risk assessment. In accordance with a plan to evaluate risks
associated with use of approved antimicrobials, we initiated a risk assessment for
Virginiamycin use in animals. We will use information from the risk assessment to
determine what risk management measures we should take, if any. The Center continued
to develop the risk assessment during FY 2003.
MONITORING FOR THE DEVELOPMENT OF RESISTANCE
Federal/state monitoring program. We collaborate with the U.S. Department of
Agriculture (USDA) and the Centers for Disease Control and Prevention (CDC) in the
operation of the National Antibiotic Resistance Monitoring System (NARMS). This
program tracks changes in susceptibilities to a number of antimicrobial drugs of animal
pathogens that can cause disease in humans. NARMS monitors for resistance using three
testing sites (or arms): humans (CDC), animal (USDA), and retail meat (FDA/CVM).
Data from the program provides timely information to veterinarians and physicians,
prolonging the useful lives of approved drugs by promoting prudent use.
During FY 2003, our partners in the human data arm of NARMS expanded to include
public health laboratories in all 50 states and local health departments in three major
cities. The retail meat arm of NARMS completed plans to expand from eight to ten the
number of states included in data collection. Integration of the data from the NARMS
segments (human, animal, retail meat) continued, so that we can track changes in
susceptibility among isolates from all three arms. In addition, each NARMS testing site
now has the expertise of a molecular biologist to facilitate analytical microbiological
research associated with the surveillance activities.

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During the year, CVM completed collection of data on the prevalence and antimicrobial
drug susceptibility of foodborne bacteria in retail meat. We also completed a slaughterhouse
survey, which compared bacterial samples from slaughterhouse workers with samples from
a human control group. The study’s purpose was to assess the extent of transfer of antibiotic
resistance to humans from food animals.
Mexican resistance
surveillance. CVM
collaborated with the Mexican
government to establish a
novel surveillance initiative,
ResistVet, in January 2002.
The surveillance system is
designed to identify outbreaks
of foodborne illness, especially
those that are resistant to
more than one drug, in time to
take steps to stop the spread
of resistant pathogens. The
initiative responds to increases in U.S. importation of meat and poultry from Mexico after
passage of the North American Free Trade Agreement.
During FY 2003, we completed the determination of the prevalence of Salmonella and
quinolone-resistant E. coli in humans, animals and food products, and continued the
same work with regard to Campylobacter. Work on the identification and comparison of
susceptibility profiles for Salmonella, Campylobacter and E. coli continued during the year.
Genetic analysis showed a link between Salmonella and E. coli strains in humans and retail
food. The data quantified resistance levels and identified virulence factors, including those
associated with traveler’s diarrhea.
The first report from these efforts was published in Antimicrobial Agents and Chemotherapy
in June 2003. The Secretary of HHS recognized the innovation and achievements in this
program with his Award for Distinguished Service in 2003.

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RESEARCH TO SUPPORT ANTIMICROBIAL RESISTANCE
SURVEILLANCE AND REGULATION
CVM collaborates on – and has initiated a number of – research studies designed to
provide greater understanding of antibiotic resistance mechanisms, so that the prevalence
of antibiotic-resistant bacteria might be reduced throughout the food production
continuum. During FY 2003, CVM made progress in a project to investigate molecular
typing tools to help determine the animal origin of foodborne bacterial pathogens. In a
study done in collaboration
with state veterinary
diagnostic laboratories,
we determined that cattle
and swine are major
reservoirs for Salmonella
Newport. Another study
generated data on the
impact of tetracycline and
fluoroquinolone exposure
on the evolution of
resistance in the important
foodborne pathogen
Campylobacter. Still
another study provided important data on the transfer of resistant Campylobacter jejuni.
Other research provided information on the role that livestock feed plays in the
introduction of resistant pathogens into the animal production environment. One
study provided information on the establishment of E. coli in calves through feed. A
second study provided information on the prevalence of Salmonella and E. coli, and the
antibiotic susceptibilities of the bacterial isolates.

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FY 2003 Performance Goals
Goal Achieved

(With the FDA Office of
Regulatory Affairs) Conduct
targeted BSE inspections of
all known renderers and feed
mills processing products
containing prohibited
material.
Goal Achieved

Develop web-based,
dynamic reports
summarizing the most
current information
concerning the results of
inspections involving all
firms subject to BSE inspections.

Controlling Risk from Bovine
Spongiform Encephalopathy
(BSE)
THE CHALLENGE
BSE, commonly known as “mad cow disease,” is
a chronic, degenerative, always fatal neurological
disease affecting the central nervous system of
cattle. BSE belongs to a family of diseases known as
transmissible spongiform encephalopathies (TSEs)
that include several ruminant and nonruminant
animal diseases. Laboratory and epidemiological
evidence strongly suggests that people can contract
a human TSE, variant Cruetzfeldt-Jakob disease
(vCJD), by consuming food from BSE-infected
cattle. In the absence of adequate controls, BSE
could be spread among the cattle population through
feed ingredients derived from infected cattle.
FY 2003 ACCOMPLISHMENTS

Goal Achieved

Continue to develop and
provide educational outreach
and training to FDA District
and State investigators,
regulated industry, and
the public.

Here are some of our achievements during the year
just ended:
STRENGTHENING THE BSE
FEED REGULATION
FDA acted in 1997 to prevent the establishment
and amplification of BSE in the United States
through feed, and thereby minimize any risk to
animals and humans. We did so by adopting our
BSE feed regulation, which prohibits the feeding of
mammalian protein (with exceptions) – known as
“prohibited material” – to cattle and other ruminants.

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Goal Achieved

Validate DNA-based detection methods. Consult with FDA’s
Office of Regulatory Affairs laboratories to optimize their usage
of the DNA-based detection methods as regulatory methods.
Develop and validate an
Enzyme Linked Immunosorbent
Assay (ELISA)-type assay
that will permit detection of
prohibited material.

NOT Achieved

While researchers at the Office
of Research made significant
progress toward this goal,
they were slowed in isolating
adequate supplies of the target
protein that will be used to
develop antibodies needed for
the ELISA test. The researchers
have concluded that they must
extract the proteins from
rendered material, where
the target protein is far less
prevalent, so that the ELISA
will work properly with
processed feed.

During FY 2003, FDA published an advanced notice of
proposed rulemaking to solicit information and views on
some potential changes to the regulation. We identified
measures that could further reduce the already small risk
that BSE will become established in the United States.
Prohibiting the rendering (processing for animal feed)
of the animal parts that are most likely to carry the BSE
agent is one example. CVM is reviewing the comments
as it considers what changes, if any, to make in the
regulation.
ACHIEVING COMPLIANCE WITH THE
FEED REGULATION
By the end of FY 2003, we had achieved our goal of
inspecting 100 percent of the nation’s renderers, protein
blenders and feed manufacturers – more than 6,600
firms – for compliance with the regulation. We had also
inspected an additional 6,900 firms including ruminant
feeders, on-farm mixers, pet food manufacturers, animal
feed salvagers and animal feed transporters. We issued
seven Warning Letters and instituted 14 recalls for
violations of the regulation during the year.
By the end of FY 2003, we had nearly reached our
goal of 100 percent compliance with the regulation’s
requirements; less than 1 percent of the firms known to
handle prohibited material had violations serious enough
to require official action at their last inspection.

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These achievements were possible only because of partnerships with state regulatory
agencies, which have conducted the majority of the inspections, and through “piggybacking” onto existing surveillance, sampling and enforcement programs for efficient
enforcement of the regulation. These efficiencies reflected the FDA strategic plan
priority of efficient risk management.
We have now made detailed information from the feed rule inspections available on the
CVM website, in the newly designed FDA BSE/Ruminant Feed Inspection Database.
The website contains a variety of other information related to our BSE activities.
DEVELOPING ANALYTICAL METHODS FOR DETECTING
PROHIBITED MATERIAL
The availability of practical, validated methods to detect protein from different animal
species could improve the effectiveness and efficiency of the enforcement of the BSE
feed regulation. The use of such methods would be consistent with the FDA strategic
plan priority of targeting limited resources for maximum protection. Although methods
to detect mammalian protein are available, methods are needed to identify protein from
individual species so that the presence of prohibited material can be detected.
The Office of Research has validated a DNA-based method for detection of bovine-derived material, and has made the method available for routine use by FDA field offices.
OR made progress during FY 2003 in validating a second DNA-based method that will
permit identification of proteins from either cattle or swine, and proteins from deer, elk,
sheep or goats. Work on an Enzyme Linked Immunosorbent Assay (ELISA)-type assay
that will permit detection of prohibited material proceeded far enough in FY 2003 to
permit identification of four unique heat-stable proteins in bovine meat and bonemeal.
Once purified, the proteins will be used to produce antibodies, an important step in the
development of an ELISA assay.
TESTING IMPORTED AND DOMESTIC FEED SAMPLES
CVM has requested the collection and analysis of samples of feed imported from countries known to have BSE, and countries that are at risk for BSE. The purpose is to test
for the presence of mammalian protein, which is prohibited in feed material imported
from those countries. We have also issued an assignment for domestic sample collection, to test for animal protein as a basis for further investigation.

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CONTROL OF CHRONIC WASTING DISEASE (CWD)
CVM issued a guidance document, “Use of Material From Deer and Elk in Animal
Feed,” in May 2003. The document sets out our recommendations regarding the use in
the feed for all animals (ruminants and non-ruminants) of all material from deer and
elk that have Chronic Wasting Disease (CWD), or are considered at high risk for CWD.
This guidance should help avoid uncertainty about how to handle carcasses during the
hunting season.
GUIDANCE AND TRAINING FOR INSPECTORS
We have drafted a BSE Compliance Program Guidance document with the assistance
of a wide range of FDA and state officials, and have held two national meetings to
introduce the guide. The guidance has two purposes: to provide complete instructions
to FDA and state investigators as they conduct domestic BSE inspections, and to assist
in evaluating animal feed products imported from BSE and BSE-at-risk countries.
CVM also conducted five training sessions on the compliance program for federal and
state investigators

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Avoiding Unsafe Drug Residues
in Human Food
THE CHALLENGE
FY 2003 Performance Goals

Modify Compliance
Program Guidance Manual
7371.006 Illegal Residues in
Meat and Poultry to include
residues in domestic seafood.
The program’s name will be
changed to Illegal Residues in
Meat, Poultry and Seafood.

NOT Achieved

The Compliance Program
is in the progress of being
updated and is almost
complete. Competing
priorities (Monkeypox and
prairie dogs) have delayed
completion.

The FDA strategic plan emphasizes the need for
safety oversight to catch up with the rapid growth
in the volume of imports of products that are under
FDA’s jurisdiction. An example is the importation
of seafood; aquaculture is increasing in foreign
countries, and the U.S. is a major market for
products from these operations. Approximately half
of the seafood consumed in the U.S. is obtained
abroad. Some foreign aquaculture operations use
drugs, such as chloramphenicol and nitrofurans, that
are not approved for use in the U.S. As a result,
imported seafood may contain unsafe drug residues.
Similarly, improper use of drugs in domestic animals
can result in unsafe residues in meat and milk.
FY 2003 ACCOMPLISHMENTS
The following summarizes our FY 2003 efforts to
avoid unsafe residues in seafood, meat and milk.
CONTROLLING UNSAFE DRUG RESIDUE IN IMPORTED SEAFOOD
During the past year we collected information
on drugs being used in foreign aquaculture, and
assessed the data to identify possible hazardous
drug residues in food. We used this information
to develop a Center position on chloramphenicol
residue in imported shrimp, which was discovered
through FDA sampling. We also provided evidence
that Southeast Asia was the source of the production
of shrimp with chloramphenicol residues being
imported into the United States

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We are using available data to help prioritize drugs for analytical method development
and drug residue monitoring in seafood. For example, we worked on the development of
an analytical method that would be capable of screening for multiple classes of drugs in
shrimp. The method, which uses generic extraction techniques and mass spectrometry,
would greatly increase the number of drugs that could be detected in imported seafood.
This responds to the FDA priority of efficient use of limited enforcement resources,
especially with respect to imported food products.
The Office of Research developed a validated, sensitive procedure for use by the FDA
Northeast Regional Laboratory to detect illegal residues of chloramphenicol in imported
shrimp and other seafoods. OR also evaluated a commercial screening test for state
regulatory agencies to use for the same purpose, reaching the conclusion that the test is
acceptable for regulatory use.
OR is now focused on adapting the shrimp method for other species, including channel
catfish. We also developed a confirmatory procedure for the marker residue for
chloramine-T, proposed for using in treating bacterial gill disease.
We provided fish tissues with intentionally added drug residues to scientists who are
developing methods to detect residues of drugs such as gentian violet and erythromycin.
This work will be helpful in preventing unsafe seafood from being imported into the
United States, and in the effort to develop import tolerance levels for selected drugs.
ENFORCEMENT TO CONTROL DRUG RESIDUES IN MEAT
CVM’s tissue residue program protects consumers from unsafe meat products. Under
CVM’s direction, FDA investigated 447 tissue residue violations during the year, and
issued 65 tissue residue-related warning letters. Enforcement actions resulted in consent
decrees of injunction against several dairy farms that had marketed cows and calves
whose edible tissues contained illegal residues of penicillin, sulfonamides and other
drugs. Six injunction actions and one criminal prosecution were initiated during the year.
We also provided training on drug residues in cooperation with USDA’s Food Safety and
Inspection Service, and collaborated with FSIS in the production of a video on residues
in meat and poultry. We also initiated an outreach program to educate consumers,
veterinarians and students on how to prevent drug residues in dairy animals.

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DEVELOPMENT OF SCREENING TESTS FOR DRUG
RESIDUES IN MILK
Our scientists played a key role in the development of two new screening tests for residue
of beta-lactam drugs such as penicillin in milk. The National Conference on Interstate
Milk Shipments approved these tests during the past year.
RESEARCH TO SUPPORT REGULATORY EFFORTS TO PREVENT
UNSAFE RESIDUES IN MEAT AND MILK
Research conducted or funded by CVM supports the development and use of analytical
methods for detecting drug residue in meat and milk. During FY 2003, USDA’s
Food Safety and Inspection Service implemented a procedure developed at the CVM
Office of Research for the confirmation of aminoglycoside residues in edible products.
Identification of residues of streptomycin, gentamicin and other drugs using this
procedure has permitted regulatory enforcement action where such action was not
possible in the past.
We also conducted a pilot study to investigate residue resulting from extralabel uses of
florfenicol in lactating dairy cattle, and to assess analytical methods for measuring the
parent compound in raw bovine milk as well as plasma. Another study, which determined
renal clearance of gentamicin in steers, could result in a rapid test for use in decisions to
slaughter antibiotic-treated steers or dairy cows.
CHANGE IN REGULATION OF CARCINOGENIC DRUGS
In December 2002, we proposed to revise the regulation that defines “no residue” for
purpose of approval of carcinogenic animal drugs under the “DES proviso” to the Federal
Food, Drug and Cosmetic Act’s Delaney Clause. The current regulation provides that
CVM may accept a finding that residue is present, but below the “no significant risk”
level, as satisfying the statutory requirement of “no residue.” The proposed revision
would eliminate this definition of “no residue,” replacing it with a standard that a
substance can be approved if no residue can be detected by the approved regulatory
method. However, the Center would continue to use the “no significant risk” level,
determined through appropriate toxicological testing, as a benchmark for assessing the
acceptability of a regulatory method.

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Assuring Feed Safety: The Animal
Feed Safety System (AFSS)
THE CHALLENGE
Threats to the safety of the
nation’s animal feed supply could
come from several sources,
including bioterrorism. Contaminants in animal feed can harm the
animals, as well as humans who
consume animal products – and
adversely affect the nation’s food
and feed supplies.
The United States does not
have a comprehensive system
designed to protect the nation’s
animal feed supply. FDA’s
regulatory effort has targeted
particular health issues,
such as BSE and potentially
unsafe drug residues in edible
animal products (addressed by
medicated feed Good Manufacturing Practices). We have
also implemented measures directed toward particular
aspects of feed or feed production, including evaluating food
(feed) additive petitions and conducting surveillance and
compliance programs regarding feed contaminants. Working
with state regulatory authorities, we have responded on a
case by case basis to incidents involving feed contamination
with such substances as PCBs, dioxins, Salmonella and
mycotoxins, including aflatoxin.

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The Association of American Feed Control Officials has begun work on a model state
regulation for process control, and the feed industry is considering development of
a comprehensive risk-based system. For the most part, however, the current system
emphasizes end-product sampling.
CVM is developing a comprehensive risk-based system that would be preventive – the
Animal Feed Safety System. It would be designed to detect hazards before feed products
are distributed and thus minimize detrimental animal and human health effects. AFSS
would also reduce adverse economic impacts that could be heightened by the influence of
today’s global marketplace on the U.S. feed industry and allied industries.
FY 2003 ACCOMPLISHMENTS
In an effort to develop an umbrella preventive program for the manufacture and
distribution of animal feed, we have organized an AFSS Work Group that includes
representatives from state regulatory agencies and members from other parts of FDA.
The Work Group sponsored a two-day public meeting in September 2003, and gathered
input from representatives of the feed industry and others on the design of an effective
preventive, risk-based program to help minimize risks associated with animal feeds.
The Work Group intends to use the information gathered in public meetings and
written comments to prepare one or more regulations. We also expect to produce other
documents, including guidance materials, education and training programs, enforcement
strategies and compliance programs to assure the safety of the animal feed supply.

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Protecting Against Bioterrorism
THE CHALLENGE
FY 2003 Performance Goals
Goal Achieved

Implement a contract
with the European Union to
develop analytical methods
to detect substances that are
prohibited from ruminant
feed by the BSE feed rule
and that could be introduced
into the U.S. animal feed
supplies by bioterrorists.

There is widespread concern that naturally occurring
pathogens that could spread easily through the food
chain could be used as bioterrorist weapons to harm
human and animal health. There is also concern that
common foodborne pathogens could be genetically
altered to make it more difficult to solve potential
problems. Bioterrorism against the human food
and animal feed supplies would also harm the U.S.
economy. FDA-regulated products such as animal
drugs would play a central role in countering the
effects of such terrorism.

Goal Achieved

Review, assess and take appropriate enforcement action as a result of
inspections conducted/samples collected. This includes follow-up actions as
well as a result of intentional contamination.
Goal Achieved

Develop a database containing a comprehensive inventory of registered
animal drug establishments and listed animal drug products. Use this database to assess the availability or anticipated shortage of animal drug products
that would be needed to deal with terrorist attacks.
Goal Achieved

Conduct a threat analysis of possible terrorist actions that could be taken
to contaminate animal feed.

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FY 2003 ACCOMPLISHMENTS
We are in the early stages of defining our role and goals with respect to bioterrorism. However, we are already working with other federal agencies to help the United States prepare
for a biological emergency, natural disaster or terrorist attack by making sure there are safe
and adequate supplies of animal drug products and animal feeds. We have developed an
Emergency Operations Plan for this purpose. Specific accomplishments during the year, in
addition to the preliminary work on the Animal Feed Safety System, included:
•

Continued funding of a contract for a database of available veterinary diagnostic
and laboratory capabilities throughout the nation. The database will improve the
abilities of state diagnostic laboratories to provide timely information about animal
diseases and chemical poisonings to emergency operations personnel. The contract
is with Iowa State University and also involves the U.S. Department of Energy.

•

Preparing a substantial portion of a draft preliminary assessment of vulnerabilities
in the feed industry using the CARVER/SHOCK process, a method used to evaluate
potential threats to regulated products.

•

Working with animal feed trade associations to develop bio-security awareness
guidelines for the feed manufacturing industry.

•

Assisting in the updating of FDA’s counterterrorism emergency response plan,
including scenarios in which animal feed would transmit infectious organisms.

•

Participating in nationwide bioterrorism exercises, in which CVM personnel had
responsibility for coordinating responses relating to animal drug and feed issues.
This included an “outside the box” component leading to the prevention of animalto-human spread of the plague.

•

Participating in interagency mock exercises on BSE introduction into the United
States.

•

Intensifying the review of products offered for import, and collaborating with the
U.S. Customs Service and FDA field laboratories and offices on safety and security
issues. This involved providing information on taking, preserving and shipping
an appropriate feed or animal product sample to a laboratory for analysis, and on
expediting the sharing of sensitive information with state officials and the feed and
drug industries.

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Assuring the Safety of Animals
Produced by Biotechnology
THE CHALLENGE
FY 2003 Performance Goal
Complete risk assessment
that will define the data
needed to determine safety
of food derived from cloned
animals. If food derived
from cloned animals is
not comparable to food
from conventionally bred
animals, we will devise a
risk management strategy
(e.g. guidance) to reduce or
avoid any risks. Secondarily,
we will assess animal health
risks, both for individual
animals and populations of
domesticated animals, for
cloned animals this year.

NOT Achieved

The application of biotechnology to the production of
animals and their products is expanding rapidly. Animal biotechnology includes both genetic engineering
and cloning. Food-producing animals may be genetically engineered to optimize the nutritional value of
derived food products, increase growth rate or enhance
resistance to disease. Animals may also be genetically
engineered to manufacture a human or veterinary drug,
biologic, food additive, or other product of commercial
value. There is much interest in cloning, the colloquial
term used to describe the process of somatic cell
nuclear transfer (SCNT) with the objective of producing near-identical copies of adult animals that possess
superior production characteristics. Producing animals
through biotechnology raises potential food and animal
safety issues, and CVM needs to have a thorough
understanding of the scientific and risk issues that the
two kinds of animal biotechnology present.
FY 2003 ACCOMPLISHMENTS

Completion of the draft
We are in the early stages of defining our role and goals
report was delayed to acin this area. Following is a summary of CVM’s explorcommodate the analysis of
atory efforts in this area during FY 2003.
a new data set. The team
completed the analysis of
the issue, including a significant new data set that arrived toward the end of
the fiscal year, and concluded that food derived from animal clones posed
no additional risks relative to comparable products from conventional
animals. Completion of the draft report was delayed to accommodate the
analysis of the new data set.

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ANIMAL CLONES
CVM conducted a risk assessment to evaluate the safety of food derived from animal
clones and the risk to animal health from cloning. The risk assessment concludes that the
current weight of evidence suggests that there are no biological reasons to indicate that
consumption of edible products from clones of cattle, pigs, sheep or goats poses a greater
risk than consumption of those products from their non-cloned counterparts. Cloning can
pose an increased frequency of health risks to animals involved in the cloning process,
but these effects do not differ qualitatively from the effects observed in other animal
reproductive technologies or natural breeding. The risk assessment built on the findings
of a National Academy of Sciences report, which found that food products derived from
animal clones and their offspring are likely to be as safe to eat as food from their nonclone counterparts.
DISPOSITION OF INVESTIGATIONAL ANIMALS
The Center has developed an outreach program to inform researchers engaged in
producing genetically engineered animals of their responsibilities with regard to the
disposition of investigational animals. As a first step, we contacted all land grant
universities that are involved in research dealing with genetic engineering in animals to
determine whether they require CVM authorization in the production and disposition
of genetically engineered animals. The Center has been working closely with several
university and private sector investigators to help them through the investigational animal
drug process, including the appropriate disposition of investigational animals.
ANIMAL BIOTECHNOLOGY COMMERCIAL INVENTORY
Building on a project initiated in FY 2002, CVM has developed a database of 250
companies, research organizations and universities conducting animal biotechnologyderived product research and development. Maintaining the database is a dynamic
process, so the activity will continue into the future.

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Additional Surveillance and
Compliance Actions To Protect
Public and Animal Health
THE CHALLENGE
FY 2003 Performance Goals
Goal Achieved

(With ORA) Maintain
biennial inspection coverage
by inspecting 50 percent of
registered animal drug and
feed establishments.
Develop process control
guidance to the feed industry
and model regulations for
state adoption.

NOT Achieved

The guidance was completed
in conjunction with AAFCO,
but the model regulations are
still being developed.

Compliance and surveillance activities are key parts
of our efforts with regard to antimicrobial resistance,
BSE, drug residues, feed safety and other crosscutting
issues described above. We have had challenges
in other areas, related to our core functions of
compliance-related actions, post-approval monitoring
and animal feed safety. These challenges include
surveillance to assess post-approval drug safety,
taking steps to assure proper manufacture of approved
drugs, regulation of the marketing of compounded
drugs and other unapproved drugs, and acting
against other threats to public and animal health.
Accomplishments in these areas are described below.
FY 2003 ACCOMPLISHMENTS
Our FY 2003 accomplishments featured a blend
of new and continuing activities. An example of
the former is our involvement in the control of
Monkeypox, a disease that provides evidence of a
trend toward animal-to-human spread of infection
through exotic animals. The Division of Compliance
is now issuing permits to allow movement of
animals (African rodents, North American prairie
dogs and certain other animals) for reasons other
than those identified in an FDA/CDC Joint Order
on Monkeypox. We also coordinated follow-up to
possible violations of the Order, which was issued
under the authority of the Public Health Service Act.

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We coordinated the investigation and subsequent recall of feed and feed ingredients
containing high levels of dioxin. The dioxin came from a zinc oxide product, a byproduct
of brass production, used in mineral mixes for incorporation into animal feed. The recall
involved over 475 products from 17 firms. CVM worked with FDA field offices and state
regulatory counterparts, as well as the USDA and EPA in the investigation and follow-up.
The action was consistent with FDA’s public health objective of reducing the level of
exposure to dioxins in animal and human food. With cumulative exposure, dioxins are
potential carcinogens and may cause reproductive or developmental health problems.
We issued a Compliance Policy Guide (CPG) on animal drug compounding in August
2003. The document provides guidance to drug compounders, veterinarians and FDA
staff on how the agency intends to address compounding of drugs intended for use in
animals. The CPG focuses on the manufacture and distribution of unapproved drugs
that are clearly outside the bounds of traditional pharmacy practice. Consistent with the
positions established in this policy, we helped obtain an injunction against a firm that
manufactured sterile veterinary products from bulk antibiotics.
We also assisted in obtaining an injunction against a major drug manufacturer, based on
continuing violations of the current good manufacturing practice regulations. As part of
the consent decree, the firm agreed to pay $500 million to the U.S. Treasury, the largest
monetary settlement in FDA history. This case involved both human and animal drugs.
One of the FDA strategic plan priorities calls for increased attention to detection of
adverse events connected with drug use. In our continuing effort to monitor experience
with approved animal drugs, we reviewed nearly 20,000 adverse drug experience reports,
including 1,775 reports of products with manufacturing defects. We reviewed nearly
2,500 promotional labeling and advertising pieces prepared by drug manufacturers and
distributors.
As a result of our pharmacovigilance program, sponsors of a number of drug products
made labeling revisions reflecting post-approval adverse drug experience information,
and notified veterinarians of the changes. The manufacturers of 15 euthanasia drug
products containing pentobarbital added an environmental warning on their labeling, to
minimize injury to wildlife that might feed on the carcasses of euthanized animals.

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We also conducted health hazard evaluations for several marketed veterinary products
and determined their recall classification based on their potential hazard to humans and
animals.
In addition, we participated with FDA’s Center for Drug Evaluation and Research in
evaluating the Current Good Manufacturing Practice (CGMP) regulations for dosage
form drugs. The goal of this initiative is to use a risk-based approach in evaluating the
CGMPs, inspections and enforcement. This work supports the FDA strategic plan in that
it emphasizes the need for greater flexibility and efficiency in drug manufacturing.
We issued nearly 600 export certificates for animal drugs and feeds. The actions certify
that the products may be marketed in, and legally exported from, the United States.

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Enhancing Productivity Through
Results-Oriented Initiatives
THE CHALLENGE
The President’s Management Agenda calls on federal
agencies to focus on results and use their resources wisely.
An expected outcome is that citizens will receive improved
service and performance, and citizen satisfaction will
increase.
FDA’s Strategic Action Plan challenges us to use sciencebased efficient risk management, to obtain “the most public
health bang for our regulatory buck.” This includes targeting
limited resources for maximum protection of the public
health, and increased productivity in new drug development.
FY 2003 ACCOMPLISHMENTS
We believe that efficient, results-oriented management
within the Center will meet the challenges of the President’s
Management Agenda and the FDA Strategic Action Plan.
It will lead to enhanced consumer and animal health and
increased satisfaction on the part of all of our stakeholders.
Following are highlights of what we did this year in our
efforts to achieve these outcomes.
REENGINEERING OUR BUSINESS
PROCESSES
CVM’s “Back to Basics” strategic plan goals call for
reengineering many of our business processes to produce
efficient results. This includes developing new ways to
measure and improve the performance of our core functions.

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To give us data to measure our performance, we implemented an activity-based costing
system. This system relies on data from an activity time reporting system, which
documents time spent by CVM staff on the major activities we perform each day. We
developed and tested the time reporting plan during FY 2003, for implementation
throughout the Center at the start of FY 2004.
When it is fully operational, the activity-based costing system will allow full time
accounting for activities in program areas. This will, in turn, give CVM managers a
key tool for planning and using their resources. It will enable the managers to better
understand, manage, and assign true costs to our business processes, activities, services
and products. In addition, it will communicate the Center’s priorities to front line staff.
Activity-based costing directly supports the FDA Strategic Plan and our “Back to
Basics” approach in several ways, including promoting business process improvement,
prioritization and performance management. It promotes budgetary discipline and the
efficient use of resources to facilitate decision-making.
In addition, CVM during FY 2003 introduced project management as a way of doing
business. The application of project management to the Center’s high priority projects
has already resulted in improved organizational performance through increased
accountability and a focus on results. The Project Management Staff is implementing an
Action Plan for the use of project management Center-wide. Four pilot projects are under
way, using project management principles, tools, processes and methodologies. The
establishment of effective goals and objectives, strategies, assumptions and identification
of project risks through project management resulted in a clearer vision of the project
for the pilot teams, Center management and other stakeholders. The pilot teams received
formal training in project management principles and use of CVM’s standard web-based
project management software.
We also established a formal Executive Secretariat, to improve the quality, timeliness and
consistency of information the Center communicates to our stakeholders. The Executive
Secretariat created a system to log and track correspondence, and a system to facilitate
meetings between the Center and our stakeholders. During the Executive Secretariat’s
first year of operation, the Center eliminated a backlog of overdue correspondence
and responded to 80 requests from associations, 34 from Congressional offices, 41
from consumers, 26 from members of the regulated industry, 24 from international
correspondents and 36 from professionals.

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APPLICATION OF STRATEGIC INITIATIVES
Here are two examples of changes we are making in line with the new results-oriented
initiatives. First, during the past year our Office of Research revised its three-year
plan and annual research report to better align research priorities with the “Back to
Basics” initiative. As a result, the office’s studies are now directly aligned with the four
core functions in CVM’s “Back to Basics” initiative: animal drug review (pre-market
activities), compliance-related actions, post-approval monitoring and animal feed safety.
Concurrently, the Office of New Animal Drug Evaluation integrated its research planning
with that of the Office of Research.
Second, the Office of New Animal Drug Evaluation is applying the results-oriented, costeffective management techniques in the following way. During FY 2002 activity-based
costing exercises, the office mapped the processes it uses in its drug approval activities.
During FY 2003, the office modified some of the processes and began to formalize
them – through the preparation of guidelines and SOPs. Applying project management,
ONADE is now identifying individual projects, assigning timeframes to each, and then
tracking the projects.
Full implementation of activity-based costing will allow ONADE to assign costs to
animal drug applications and supplements. Complete implementation of all the tools of
results-oriented management will provide essential information for resource planning
and other management decisions. One key goal is to reduce the cost of processing
applications and supplements. These initiatives will be especially valuable as we begin to
implement the Animal Drug User Fee Act.
STRATEGIC HUMAN CAPITAL MANAGEMENT
More effective regulation
through a stronger workforce.
FDA Strategic Plan

We achieve excellence through
the ongoing development of
our competencies…
From CVM’s Guiding Principles

This is the first of the government-wide initiatives
listed in the President’s Management Agenda. It is
a vital part of CVM’s results-oriented management
emphasis. We did a number of things during FY
2003 that were directed toward development of
our managerial, scientific and technical skills.
For example, we have started a major workforce
planning initiative, with the initial focus on the
Office of New Animal Drug Evaluation. The
ultimate goal is to identify ONADE’s workforce
needs through FY 2009, and determine recruitment
and retention strategies.

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FY 2003 Performance Goal
Goal Achieved

Continue development,
expansion and integration of
the Staff College by expanding
content of in-house program;
research and development
components and integration
of competency based Learning
Management System
with Center and Agency
information technology
infrastructure.

We continued to develop and expand the CVM
Staff College, which we established in FY
2002. The Staff College is intended to provide a
framework to support development of the scientific,
management, leadership and team competencies
that enable our staff to more effectively carry out
CVM’s mission. During the past year the Staff
College completed a Center-wide assessment
of training needs, and prepared a curriculum
development plan based on the assessment.
Staff from the Staff College and the Office of New
Animal Drug Evaluation have begun to develop
training plans for newly hired reviewers, with the
objective of reducing the amount of time necessary
for reviewers to achieve full performance.

INFORMATION TECHNOLOGY AND ELECTRONIC GOVERNMENT
We are continuing to enhance our management of information technology. This is
consistent with the President’s expanded electronic government initiative. For example,
we extended the scope of electronic submissions by drug sponsors, improved and
broadened several databases, and made more data and information available to the public
through the CVM website. We expanded the accessibility of our website by launching a
Spanish language page in March 2003.
The federal government can
The work of the information technology staff in
secure greater services at
our Office of Management supported many of the
lower cost through electronic
year’s accomplishments that we describe elsewhere
government.
in this report. Here are two more examples.
The IT staff integrated the separate Bioresearch
From the President’s Management Agenda
Monitoring (BIMO) database into the Center’s
existing Submission Tracking and Reporting
System (STARS). This reduces the amount of
data entry that the BIMO staff has to make and makes the bioresearch investigational
data readily available to all throughout the Center. Similarly, the IT staff integrated the
Division of Compliance database on consulting reviews into STARS, making the tracking
of consulting reviews more efficient.

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Leveraging Productivity
Through Partnerships
We will develop revenueenhancing programs for core
services … by leveraged or
otherwise enhanced CVM
or stakeholder resources
for achieving shared
responsibilities.
CVM “Back to Basics” Goal

THE CHALLENGE
Budget tightening and other factors have prompted
FDA and CVM to continuously seek out partnering
opportunities to maximize the use of our resources.
Our success in promoting and protecting the
public health depends in large part not only on
active involvement of our stakeholders, but also
partnerships with those whose goals align with ours.
FY 2003 ACCOMPLISHMENTS
We initiated several partnering arrangements during
the year and continued a number of others. These
mutual-benefit arrangements have influenced CVM
policies and practices, and have enhanced our
research and epidemiological efforts. They are in
line with the FDA strategic plan priority to ensure
effective communication and working relationships
with key external stakeholders.
We have highlighted a number of partnership
agreements in this report. Examples include the
collaborative effort with the U.S. Department of
Agriculture and the Centers for Disease Control
and Prevention in the National Antimicrobial
Resistance Monitoring System; collaboration with
the Mexican government to detect resistance in
pathogens that may contaminate food imported into
the U.S. and also pose a hazard to U.S. travelers;
and arrangements with state regulatory agencies to
conduct BSE feed rule inspections and medicated
feed inspections.

C e n t e r f o r Ve t e r i n a r y M e d i c i n e - 2 0 0 3 A n n u a l Re p o r t

45

There are many partnerships that we have not mentioned in this report. For example,
we continued working with the Joint Institute for Food Safety and Applied Nutrition
(JIFSAN) at the University of Maryland on antimicrobial resistance, aquatic species
grouping and pharmacokinetic modeling. We collaborated with the World Health
Organization on global surveillance for Salmonella, and training in the isolation,
identification and susceptibility testing for Salmonella and Campylobacter. We
participated in an interagency agreement
with the Department of Veterans Affairs
for the evaluation of Mycobacterium
marinum virulence mutants in fish, a
project that may lead to developing a
DNA-vaccine against a major pathogen
in aquaculture-raised fish.
These and other partnerships allow us
to devote our scarce resources to those
activities that we are uniquely qualified
to perform. They provide a means to
expand our capabilities by allowing us to
use our intellects, time, money and other
resources in a manner that maximizes
their value.

C e n t e r f o r Ve t e r i n a r y M e d i c i n e - 2 0 0 3 A n n u a l Re p o r t

46

OUR GOALS

For Fiscal Year
2004

Regulation of animal drugs and feeds present complex challenges. Assuring food safety, for example, requires expertise
with regard to a diversity of issues including antimicrobial
resistance, carcinogenic drugs and toxic residues. We regulate drugs and feeds that are used in a wide range of species,
including companion animals and exotic animals, as well as
food producing animals. New and emerging issues will be
added to these ongoing challenges during FY 2004.
ANIMAL DRUG USER FEE ACT
IMPLEMENTATION
We will place major emphasis during FY 2004 on the
implementation of the Animal Drug User Fee Act. This
includes hiring new personnel, and purchasing, installing and
maintaining new technological management and information
systems.
Our ADUFA goals, for FY 2004 and beyond, are to:
•

Eliminate existing backlogs of animal drug
applications within 2 years.

•

Over a 5-year period, move toward the goal of
completing the review of 90 percent of animal drug
applications within 180 days.

•

Resolve new and emerging scientific issues that affect
CVM’s ability to make approval decisions.

•

Achieve an enhanced and predictable review
performance.

C e n t e r f o r Ve t e r i n a r y M e d i c i n e - 2 0 0 3 A n n u a l Re p o r t

47

OTHER MAJOR GOALS
Other major goals for 2004 include:
Implementing our new guidance on antimicrobial resistance, the risk-based system for
assessing the likelihood that an antimicrobial drug used to treat animals may cause an
antimicrobial resistance problem in humans.
Developing plans for the animal feed safety system. We will review the information
presented during the public meeting in September 2003, analyze the strengths and
weaknesses of the current system, and analyze other innovative programs. We will then
begin to develop regulations, guidance documents and other materials as appropriate.
Continuing our efforts to increase the availability and diversity of drugs for minor uses
and minor species.
Making appropriate decisions with regard to the scope of the BSE feed regulation,
making progress in the development and implementation of analytical methods for
detecting prohibited material, and exploring other alternatives to enhance the efficient
enforcement of the regulation. We will continue the reinspections of the relatively few
firms that were found to be out of compliance at their last inspections.
Expanding our capability to regulate drug residues in imported seafood, and in meat
and milk.
Further defining CVM’s role, goals and program activities with regard to bioterrorism
and animal biotechnology.
Adapting our compliance and surveillance activities to meet the unexpected challenges
in post-approval drug use and animal feed safety.
Further developing our initiatives for enhancing productivity through results-oriented
initiatives. Among other things, we plan to integrate activity-based costing into our
operational planning and budgeting.
Developing new partnership arrangements with our stakeholders, and enhancing
existing partnerships.

C e n t e r f o r Ve t e r i n a r y M e d i c i n e - 2 0 0 3 A n n u a l Re p o r t

48

STAFFING,
SPACE
and BUDGET

STAFF
As of the end of FY 2003, CVM had a total staff of 346.
This included 86 administrative personnel, 85 regulatory
personnel, 180 scientists and 5 others.
SPACE
CVM has received and begun to occupy an additional 5,600
square feet of space on the second floor of Metro Park North
IV. With the passage of ADUFA, new space will be required
for approximately 75 additional personnel over the next three
years.
We now have offices in Metro Park North II, Metro Park
North IV and Metro Park North V in Rockville, Maryland,
in addition to the Office of Research facilities in Laurel,
Maryland. CVM offices are scheduled to move to the FDA
campus at White Oak in Silver Spring, Maryland, by the end
of this decade, with Office of Research facilities remaining in
Laurel, Maryland.
BUDGET
The FY 2003 enacted budget for the Animal Drugs and Feeds
Program was $87,659,000, broken down as follows:
Center $57,115,000 with 341 full-time equivalent (FTE’s)
Field $30,544,000 with 255 FTEs
Budget details are in Appendix C.
The CVM budget increased by 142 percent from 1996 to
2004. These increases were due to Food Safety increases
from 1998 to 2001, and increases for BSE, Imports and
Inspections, and Antibiotic Drugs. Additional increases are
anticipated during FY 2004, due to passage of ADUFA.

Appendix A

AWARDS
CENTER FOR VETERINARY MEDICINE*

Honor Award Recipients
THE PRESIDENT OF THE UNITED STATES
2003 MERITORIOUS
PRESIDENTIAL RANK AWARD
Andrew J. Beaulieu, D.V.M.

For scientific and policy leadership during 30 years with the
Center for Veterinary Medicine.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SECRETARY’S AWARD FOR
DISTINGUISHED SERVICE
The Mexico-U.S. Antimicrobial Resistance Monitoring
System Team
For establishing a program in Mexico to detect antimicrobial
resistance in foodborne pathogens to better assure the safety of
domestic and exported food to the U.S.

Sonya Bodeis
Marcia Headrick, D.V.M., M.P.H.
Patrick F. McDermott, Ph.D.
Linda Tollefson, D.V.M., M.P.H.
Robert Walker, Ph.D.
David G. White, Ph.D.

FDA Counter/Bioterrorism Preparedness Team

For demonstrating outstanding leadership in FDA’s counter/
bioterrorism preparedness efforts to protect the nation’s
public health and food supply from biological, chemical and
radiological threats and to respond more effectively to threats
following the tragic events of September 11, 2001.

Charles E. Eastin, II, D.V.M., Ph.D., M.P.H.

*In cases in which the award recipients included individuals from CVM and other
organizations, only the CVM staff are mentioned.

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Schering-Plough Corporation Injunction Team (FDA)
For outstanding performance in the development, negotiation
and execution of the Schering-Plough Corporation consent
decree of permanent injunction.

Jorge F. Christian
Gloria J. Dunnavan
Elizabeth A. Grove

FOOD AND DRUG ADMINISTRATION
FDA COMMISSIONER’S SPECIAL
CITATION
Veterinary Compounding Injunction
Litigation Group

For exceptional efforts in successfully litigating a complex,
precedent-setting injunction case involving illegal
compounding of veterinary drugs.

Gloria J. Dunnavan
Elizabeth A. Grove

AWARD OF MERIT
John C. Matheson III

For sustained, outstanding leadership of FDA’s efforts in the
area of animal biotechnology.

Elizabeth L. Parbuoni

For outstanding leadership among CVM reviewers and
industry sponsors in the implementation of electronic
submissions leading to improved response times and
communication of review outcomes.

Reengineering Recalls Working Group

For outstanding performance in reengineering FDA recall
procedures to achieve greater efficiency in processing, enhance
customer service and increase availability of information to
stakeholders.

Appendix A

Barbara A. Rodgers

Appendix A

EQUAL OPPORTUNITY ACHIEVEMENT
AWARD
CVM Recruitment and Retention Team

For exemplary service and leadership in the area of
recruitment and retention that promoted inclusion and
diversity within the Center for Veterinary Medicine.

Sherry L. Ayers
Andrew J. Beaulieu, D.V.M.
Monica R. Brown Reid, D.V.M.
Bessie M. Cook
Stephanie W. Dove
Eric S. Dubbin, D.V.M.
Henry E. Ekperigin, D.V.M., Ph.D.
Lowell P. Fried
Kendrick T. Gibbs
Linda A. Grassie
Jo W. Gulley
Treava S. Hopkins
Gwendolyn Jones
Woodrow M. Knight, Ph.D.
Anna B. Nevius, Ph.D.
Isabel W. Pocurull
William D. Price, Ph.D.
Scheryl Y. Sledge-Gonzalez
Elaine A. Walker
Katherine P. Weld, Ph.D.

OUTSTANDING SERVICE AWARD
Amey L. Adams, Ph.D.

For outstanding service as a superior mentor in the
area of biotechnology and for providing outstanding
contributions to the Animal Biotechnology Working
Group.

CVM Staff College Team

For outstanding leadership and service to the Center for
Veterinary Medicine in development of its Staff College.

Stanice L. Cooper
Paula B. Searle
Melissa A. Starinsky
Sherri S. Washington
Faith S. Skordinski, Ed.D.

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Export of U.S. Poultry to Russia Team

For providing both expert scientific knowledge and
effective negotiation skills to resolve an important trade
dispute related to the export of U.S. poultry to Russia.

Steven D. Brynes, Ph.D.
Nicholas E. Weber, Ph.D.

George K. Haibel, D.V.M.

In recognition of outstanding performance resulting in
the timely preparation, processing and maintenance of
regulations and Federal Register documents associated
with new animal drug approvals.

Anita L. Heinrich

For sustained, exceptional service to CVM’s employees
in delivering major administrative management services,
in addition to her many duties as the Center’s Budget
Officer.

Residue Chemistry Team

For elimination of the extensive backlog of methods
submissions and development of a positive cooperative
relationship between INAD sponsors and the CVM.

Steven D. Brynes, Ph.D.
Lynn G. Friedlander, Ph.D.
Wendelyn R. Jones-Warren, Ph.D.
David R. Newkirk, Ph.D.
Julia A. Oriani, Ph.D.
Valerie B. Reeves

Lisa M. Troutman, D.V.M.

For sustained excellence in regulatory review
with significant contributions in the field of animal
biotechnology.

Kimberly A. Worthington

Appendix A

For outstanding performance in managing administrative,
personnel and budget activities during periods of severe
staff shortages in the Office of Research.

BSE Feed Ban Compliance Program Team

Appendix A

GROUP RECOGNITION AWARD
For exceptional effort in enhancing communication and
compliance efforts to ensure a high level of compliance
with the BSE Feed Ban regulation.

Neal Bataller, D.V.M.
Kim E. Bell
Deborah A. Cera
Gloria J. Dunnavan
Mark H. Hackman
Dragan Momcilovic, D.V.M., Ph.D.
Frances M. Pell
Burt A. Pritchett, D.V.M.
Barbara A. Rodgers
Fredda C. Shere-Valenti
Francisca Stone
Toni V. Wooten
Kim R. Young

Division of Animal and Food Microbiology
Support Team

For outstanding support of intramural and extramural
training in microbiology and molecular biology methods
while maintaining effective productivity in active research
programs.

Sherry L. Ayers
Sonya M. Bodeis
Peggy J. Carter
Patti Cullen
Linda L. English
Sharon L. Friedman
Charles M. Gieseker
Althea Glenn
Susannah Hubert
Shawn D. McDermott
Sadaf Qaiyumi
Lisa E. Rojas
Stanley G. Serfling

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Division of Manufacturing Technologies Group

For outstanding achievement in implementing the Center
Strategic Plan by significantly lowering Division backlog
and development of processes to monitor workload and
increase review efficiency.

Laura A. Adam
Dennis M. Bensley, Ph.D.
Mary Beth Borsetti
Jean-Michel Campagne, Ph.D.
Xikui Chen, Ph.D.
Julie V. Conwell, Ph.D.
Anne D. Edelson
Raafat M. Fahmy, Ph.D.
Alem Ghiorghis, Ph.D.
Charles W. Gray, Ph.D.
Norman R. Gregory
Wei Guo, Ph.D.
Gregory W. Hunter, Ph.D.
Mai X. Huynh
Kalatu S. Kamara
Mary G. Leadbetter
June Liang, Ph.D.
William G. Marnane
Angel McLean
James K. Nitao, Ph.D.
Michael Popek
Robin M. Stone
Geoffrey K. Wong

Tissue Residues and Strategies for Case
Development Organization and Training Team

Appendix A

For outstanding contributions and teamwork during
the development and implementation of Federal/State
training on investigations/case development of illegal
residues in meat and poultry.

Deborah A. Cera
Eric S. Dubbin, D.V.M.
Gloria J. Dunnavan
Lynn G. Friedlander, Ph.D.
Joseph C. Paige, D.V.M., MPH
Frances M. Pell
Michael R. Talley, D.V.M.
Toni V. Wooten

1st International Conference on Microbiological
Risk Assessment Foodborne Hazards

Appendix A

GROUP RECOGNITION AWARD

For planning and coordination efforts of the first
International Conference on Microbiological Risk
Assessment Foodborne Hazards, helping focus the world
community of scientific priorities.

Mary J. Bartholomew, Ph.D.

Bioterrorism Act Downlink and Outreach Group

For your contributions to the successful satellite downlink
meeting and the development and distribution of outreach
materials communicating our messages and legislative
proposals within the United States and worldwide.

Aleta M. Sindelar

FDA BSE Emergency Response Group

For exceptional performance and leadership in designing
emergency exercise scenarios for three exercises
testing the FDA BSE Response Plan, which resulted in
development of a more comprehensive response plan for
the Agency.

Gloria J. Dunnavan

Records Access Guidance Workgroup

For outstanding contributions in developing and writing
the FDA Concept Paper, “Bioterrorism Act Proposed
Guidance to Records Access.”

Neal Bataller, D.V.M.

Research Involving Human Subjects Committee

For exceptional performance in assuring that all FDAsponsored research complies with the Federal regulations
and ethical principles for the protection of human
research subjects.

Linda D. Youngman, Ph.D.

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LEVERAGING/COLLABORATION
AWARD
David B. Batson, Ph.D.

For sustained efforts in fostering leveraging and
collaborations in the research program of the Center for
Veterinary Medicine.

CVM Leveraging Education Series Team

For their initiative and perseverance in forming
collaborations with and educating outside parties to more
effectively carry out the mission of CVM.

David B. Batson, Ph.D.
Marilyn N. Martinez-Pelsor, Ph.D.
Melissa A. Starinsky

FDA/CVM Swine Mycoplasmal Pneumonia
Workshop Team

For exceptional performance in organizing and
participating in the FDA/CVM Swine Mycoplasmal
Pneumonia Workshop, Kansas City, MO, March 6-7,
2002.

Nabil A. Anis, D.V.M.
Cindy L. Burnsteel, D.V.M.
Irma M. Carpenter
Gillian A. Comyn, D.V.M., MPH
Naba K. Das, D.V.M., Ph.D.
Janice A. Derr, Ph.D.
Janis R. Messenheimer, D.V.M.
Julia W. Punderson, VMD, DACT
Susan Storey, D.V.M.
Michelle L. Stull, D.V.M.

Toxicologic Pathology Training Team

For providing consultation and training in the discipline
of toxicologic pathology to FDA scientific reviewers.

Donald Prater, D.V.M.

Appendix A

The University of Puerto Rico Memorandum of
Understanding (MOU) Operating Committee
For enhancing the public health through training
programs that improve the scientific and regulatory
expertise for products in the Americas.

Merton V. Smith, II., Ph.D., J.D.

Melanie R. Berson, D.V.M.

Appendix A

QUALITY OF WORK LIFE AWARD
For creating a work environment that encourages
participation, creativity and humor.

IT Productivity Team

For significant contributions to the productivity and
quality of work life in FDA’s Center for Veterinary
Medicine.

Robert Bruce Craig
David Shawn Matheny

David L. Lynch

For leadership and innovation in providing an improved
quality of work life for CVM employees.

PLAIN LANGUAGE AWARD
FDA 2003 Science Forum Organizing Committee
For embracing Plain Language goals and reaching out
beyond the traditional scientific community to bring
information about FDA science to a more diverse
audience.

Sizhuang Stephen Yan, Ph.D.
Linda D. Youngman, Ph.D.

Registration Proposed Rule-Writing Group

For extraordinary contributions in drafting the
registration proposed rule, writing a clear and
understandable bioterrorism proposed rule to ensure the
protection of the United States food supply.

Isabel W. Pocurull

COMMISSIONER’S SPECIAL
RECOGNITION AWARD
Cancer Drug Development Patient Consultant
Program

For exceptional performance with the Patient Consultant
Telephone Lecture Series.

Tracey H. Forfa, Esq.

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58

CBER GROUP RECOGNITION
Countering Bio Terrorism Recruitment Initiative
Group (Swat Team)
For exceptional leadership and teamwork contributing
to the successful completion of the CBER CT/BT hiring
initiative.

Lisa M. Durphy

FDA SCIENTIFIC ACHIEVEMENT AWARD
Excellence In Laboratory Science
CVM LABORATORY RESEARCH
EXCELLENCE AWARD
Campylobacter Working Group

For the development of the NCCLS approved antimicrobial
susceptibility testing method for the fastidious food borne
bacterial pathogen Campylobacter jejuni.

Sonya M. Bodeis
Patrick F. McDermott, Ph.D.
Robert D. Walker, Ph.D.

Excellence in Review Science
CVM REVIEW SCIENTIFIC
EXCELLENCE AWARD
Harlan J. Howard, Ph.D.
For leadership in creating scientific standards, where
none existed previously, in evaluating effectiveness
and animal safety for reproductive agents used in food
animals.

PHS COMMISSIONED CORPS HONOR AWARDS
PHS ACHIEVEMENT MEDAL (AM)

Appendix A

LCDR Minnis Tom Hendricks

For contribution toward the attainment of program
objectives by directing and coordinating emergency support
to CDC by assisting them in triaging relevant technical
documents for FDA.

Appendix A

CVM AWARDS AND RECOGNITION
THE CVM DIRECTOR’S HONOR AWARD
First place recipient – Margaret A. Klock

For exemplary performance, outstanding service, dedication
and commitment to the Center for Veterinary Medicine in all
areas of administrative support.

Second place recipient – William J. Burkholder, D.V.M., Ph.D.

For exemplary work and leadership in Agency precedent setting
policy issues concerning pet food.

CVM ADMINISTRATIVE/COMMUNICATIONS
EXCELLENCE AWARD
Marilyn H. Broderick

For outstanding accomplishments in advising the Center and
the Agency officials about three pivotal information disclosure
issues.

Sherri S. Washington

For her commitment to excellence and outstanding
performance in the development, administration and
maintenance of the CVM Staff College Knowledge Center.

CVM SUPPORT STAFF EXCELLENCE
AWARD
Jean D. Jackson

For your diligence, perseverance and dedication to your family
and profession and the many long hours of service committed to
the pursuit of excellence.

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CVM TEAM EXCELLENCE AWARD
CVM Aquaculture Methods Priority Team

For extraordinary contributions to CVM’s mission
through the identification, transfer and validation of
improved methods for the detection of chloramphenicol
residues in seafood and honey.

Julia A. Oriani, Ph.D.
Kevin J. Greenlees, Ph.D.
Valerie Reeves
Merton V. Smith, II., Ph.D., J.D.
Frances M. Pell
Mary C. Carson, Ph.D.
Pak S. Chu, Ph.D.
David N. Heller
Philip J. Kijak, Ph.D.
Cristina B. Nochetto
Jurgen D. von Bredow, Ph.D.

CVM User Fee Working Group

For outstanding leadership in negotiating a mutually
beneficial user fee program with the animal drug industry.

Andrew J. Beaulieu, D.V.M.
David L. Lynch
William G. Marnane
Jerome J. McDonald, Ph.D.
A. Robert Miller
Steven D. Vaughn, D.V.M.

Electronic Submissions Working Group (ESWG)

Appendix A

For outstanding achievement in facilitating the electronic
submission of information, as a substitute for paper, and
fostering the use and acceptance of electronic signatures.

Daniel A. Benz, Ph.D.
Lesley J. Groves
Mai Huynh
Thomas Letonja, D.V.M., Ph.D.
Jerome J. McDonald, Ph.D.
Julia A. Oriani, Ph.D.
Glenn A. Peterson, Ph.D.
Elizabeth L. Parbuoni
Jeffrey L. Punderson, D.V.M.
Margaret A. Zabriski, Ph.D.

Note: Names of CVM staff members are in bold type

Appendix B

PUBLICATIONS
Altekruse, S.F. and Tollefson, L.K. 2003.
“Human campylobacteriosis: a challenge for the veterinary
profession.” Journal of the American Veterinary Medical
Association. 223(4): 445-452.
Babu, U., Okamura, M., Gaines, D., Raybourne, R., Lillehoj,
H., Myers, M.J., and Heckert, R.A. 2003.
“Impact of live attenuated and killed Salmonella vaccines
of the cell mediated immunity of laying hens.” Veterinary
Immunology and Immunopathology. 91 (1):39-44.
Bartholomew, M.J., Hollinger, K., and Vose, D. 2003.
Chapter 30, “Characterizing the risk of antimicrobial use in
food animals: fluoroquinolone-resistant Campylobacter from
consumption of chicken.” (M.E. Torrence, R.E. Isaacson,
Eds) Microbial Food Safety in Animal Agriculture: Current
Topics. Iowa State University Press.
Bethem, R.A., Boison, J., Gale, J., Heller, D., Lehotay, S.,
Loo, J., Musser, S., Price, P., and Stein, S. 2003.
“Establishing the fitness for purpose of mass spectrometric
methods.” Journal of American Society Mass Spectrometry.
14:528-541.
Ge, B., White, D.G., McDermott, P.F., Girard, W., Zhao,
S., Hubert, S., and Meng, J.. 2003.
“Antimicrobial resistant Campylobacter species from retail
raw meats.” Applied and Environmental Microbiology. 69:
3005 3007.
Hinton, D.M., Farrell, D.E., and Myers, M.J. 2003.
“Impact on cellular immunity following chronic low dose
exposure to aflatoxin B1.” Toxicological Sciences. 73:
362-377.

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Hong, Y., Lui, T., Hofacre, C., Maier, M., White, D.G.,
Ayers, S., Wang, L., and Maurer, J.J. 2003.
“A restriction fragment length polymorphism based polymerase chain reaction as an alternative to serotyping for
identifying Salmonella serotypes.” Avian Dis. 47:387-395.
Kawalek, J.C., Howard, K.D., Myers, M.J., Farrell, D.E.,
Cope, C.V., and Jackson, J.E. 2003.
“Effect of oral administration of low doses of pentobarbital
on the induction of cytochrome P450 isoforms and cytochrome P450-mediated reactions in immature beagles.”
American Journal Veterinary Research. 64:1167-1175.
Kijak, P.J. and Reeves, V.B. 2003.
“The process of development and validation of animal drug
residue methods for U.S. Food and Drug Administration
regulatory use.” In P.W. Lee (Ed.), Handbook of Residue
Analytical Methods for Agrochemicals. John Wiley and
Sons. (pp. 93-96.)
Liu, M., Reimschuessel, R., and Hassel, B.A. 2002.
“Molecular cloning of the fish interferon stimulated gene, 15
kDa (ISG15) ortohologue: a ubiquitin-like gene induced by
nephrotoxic damage.” Gene 298 (2): 129-39.
Martinez, M.N. and McGilveray, I. AAPS/RAPS/CAPRA
Collaborative Program: “Exploring the challenges of drug
regulation in a global environment: clinical concerns.”
AAPS PharmSci. 2003; 5 (4): article 27. DOI: 10.1208/
ps050427.
McDermott, P.F., Bodeis, S.M., and Walker, R.D. 2002.
“Development of a standardized susceptibility testing method for Campylobacter.” FDA Veterinarian 17(4); Jul/Aug.

Appendix B

McDermott, P.F., Walker, R.D., and White, D.G. 2003.
“Antimicrobials: modes of action and mechanisms of resistance.” International Journal of Toxicology, 22:135-143.

Appendix B

Miller, R.A., Walker, R.D., Baya, A., Clemens, K., Coles,
M., Hawke, J.P., Henricson, B.E., Hsu, H.M., Mathers, J.J.,
Oaks, J.L., Papapetropoulou, M., and Reimschuessel, R.
2003.
“Antimicrobial susceptibility testing of aquatic bacteria:
quality control disk diffusion ranges for Escherichia coli
ATCC 25922 and Aeromonas salmonicida subsp. salmonicida ATCC 33658 at 22 degrees C and 28 degrees C.” Journal
of Clinical Microbiology. 41 (9) 4318-4323.
Myers, M.J., Farrell, D.E., Baker, J.K., Evock-Clover,
C.M., and Steele, N.C. 2003.
“Influence of long-term recombinant porcine somatotropin
(PST) treatment on the responses to sub-chronic endotoxemia in swine.” Domestic Animal Endocrinology. 24:
155-170.
Myers, M.J., Yancy, H.F., and Farrell, D.E. 2003.
“Characterization of a PCR-based approach for the simultaneous detection of multiple animal-derived materials in
animal feed.” Journal of Food Protection. 66 (6):10851089.
Myers, M.J., Farrell, D.E., Palmer, D.C., and Post, L.O.
2003.
“Inflammatory mediator production in swine following
endotoxin-challenge with or without co-administration of
dexamethasone.” International Immunopharmacology. 3(4):
571-579.
Paige, J.C. and Tollefson, L. 2003. Chapter 13.
“Veterinary products: residues and resistance pathogens.”
Food Safety. CAB International.
Petersen, A.D., Walker, R.D., Bowman, M.M., Scott II,
H.C., and Rosser Jr., E.J. 2002.
“Frequency of isolation and antimicrobial susceptibility
patterns of Staphylococcus intermedium and Pseudomonas
aeruginosa isolates from canine skin and ear samples over
a 6-year period (1992-1997).” Journal of American Animal
Hospital Association. 38:407-413.

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Post, L.O., Cope, C.V., Farrell, D.E., Baker, J.D., and
Myers, M.J. 2003.
“The effect of endotoxin and dexamethasone on enrofloxacin
pharmacokinetics in swine.” Journal of Pharmacology and
Experimental Therapeutics. 304 (2): 889-895.
Reimschuessel, R., Gieseker, C., Driscoll, C., Baya, A.,
Kane, A.S., Blazer, V.S., Evans, J., Kent, M.L., Moran,
J.D.W., and Poynton, S.L. 2003.
“Kudoa clupeidae spores and myxosporean plasmodial
infection, associated with ulcerative lesions in young Atlantic menhaden Brevoortia tyrannus, (Latrobe) (Clupeidae)
in a tributary of the Chesapeake Bay.” Diseases of Aquatic
Animals. 53:143-166.
Ruley, K, Reimschuessel, R., and Trucksis, M. 2002.
“Goldfish as an animal model system for Mycobacterial
infection.” Methods in Enzymology. 358:29-39.
Schroeder, C.M., White D.G., Ge,B., Zhang, Y., McDermott, P.F., Ayers, S., Zhao, S., and Meng, J.. 2003.
“Isolation of antimicrobial-resistant Escherichia coli from
retail meats purchased in Greater Washington, DC, USA.”
International Journal of Food Microbiology. 85:197-202.
Schroeder, C.M., Meng, J., Zhao, Z., DebRoy, C., Torcolini, J., Zhao, S., McDermott, P.F., Wagner, D. D., Walker,
R. D., and White, D.G. 2003.
“Antimicrobial resistance of Escherichia coli O26, O103,
O111, O128, and O145 from animals and humans.” Emerging Infectious Disease. 8(12):1409-1414.

Appendix B

Schroeder, C.M., Parlor, K.W., Marsh, T.L., Ames, N.K.,
Goeman, A.K., and Walker., R.D. 2003.
“Characterization of the predominant anaerobic bacterium
recovered from digital dermatitis in three Michigan dairy
cows.” Anaerobe. 9:151-155.

Appendix B

Shaikh, B., Rummel, N., and Reimschuessel, R. 2003.
“Determination of Albendazole and its major metabolites in
the muscle tissues of Atlantic salmon, tilapia and rainbow
trout by high performance liquid chromatography with
fluorometric detection.” Journal of Agricultural and Food
Chemistry. 51(11) 3254-3259.
Shaikh, B., Rummel, N., Gieseker, C., Serfling, S., and
Reimschuessel, R. 2003.
“Metabolism and residue depletion of albendazole and its
metabolites in rainbow trout, tilapia and Atlantic salmon.”
Journal of Veterinary Pharmacology Therapeutics. 26: 1-7.
Simjee S., Wagner, D.D., White, D.G., Hayes, J., Meng, J.,
and McDermott, P.F. 2002.
“Prevalence of streptogramin resistance genes among Enterococcus isolates recovered from retail meats.” Journal of
Antimicrobial Chemotherapy. 50(6):877-882.
Simjee S., White, D.G., Wagner, D.D., Meng, J., Qaiyumi,
S., Zhao, S., and McDermott, P.F. 2002.
“Identification of vat(E) in Enterococcus faecalis isolated
from retail poultry and its transferability to Enterococcus
faecium.” Antimicrobial Agents and Chemotherapy. 46(12):
3823-3828.
Tibbetts, R.J., White, D.G., Dyer, N.W., Giddings, C.W. and
Nolan., L.K. 2003.
“Characterization of Escherichia coli isolates incriminated in
mink colisepticemia.” Veterinary Research Communication.
27:341-357.
Tollefson, L. and Flynn, W.T. October 2002.
“Impact of antimicrobial resistance on regulatory policies in
veterinary medicine: status report.” Challenges and Issues
in Veterinary Pharmacology and Animal Health. American
Association of Pharmaceutical Scientists PharmSci 4(4)
article 37 (http://www.aapspharmsci.org).

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Tollefson, L., Flynn, W.T., and Headrick, M.L. 2003.
Chapter 7. “Regulatory activities of the U.S. Food and Drug
Administration designed to control antimicrobial resistance
in foodborne pathogens.” Microbial Food Safety in Animal
Agriculture: Current Topics. (M.E. Torrence, R.E. Isaacson,
Eds.) Iowa State University Press.
White, D. G., Zhao, S., McDermott, P.F., Ayers, S., Friedman, S., Sherwood, J., Breider Foley, M., and Nolan, L.K.
2003.
“Characterization of integron-mediated antimicrobial resistance in Salmonella isolated from diseased swine.” Canadian
Journal of Veterinary Research. 67: 39-47.
White, D.G., Ayers, S., Hofacre, C., Thayer, S.G., and
Maurer, J.J. 2003.
“Antimicrobial susceptibilities of Staphylococcus aureus
isolated from commercial broilers in Northeast Georgia.”
Avian Dis. 47:203-210.
White, D. G., Zhao, S., McDermott, P.F., Ayers, S.,
Gaines, S., Friedman, S., Wagner, D.D., Meng, J.,
Needle, D., Davis, M., and Debroy, C. 2002.
“Characterization of antimicrobial resistance among Shiga
toxin producing Escherichia coli O111 isolates of animal and
human origin.” Microbial Drug Resistance. 8: 139-146.
White, D.G., McDermott, P.F., and Walker, R.D. 2003.
Chapter 5. “Standardization and harmonization of bacterial
antimicrobial susceptibility testing methods.” Microbial
Food Safety in Animal Agriculture: Current Topics. (M.E.
Torrence, R.E. Isaacson, Eds.) Iowa State University Press.

Appendix B

Yaron, S., White, D.G., and Matthews, K.R. 2003.
“Characterization of an Escherichia coli O157:H7 marR
mutant.” International Journal of Food Microbiology. 85:
281-291.

Appendix B

Yazwinski, T.A., Chapman, H.D., Davis, R.B., Letonja, T.,
Pote, L., Maes, L., Vercruysse, J., and Jacobs, D.E. 2003.
“World Association for the Advancement of Veterinary
Parasitology (WAAVP) guidelines for evaluating the effectiveness of anthelmintics in chickens and turkeys.” Vet.
Parasitol. 116: 159-173.
Zaidi, M.B., Zamora, E., Diaz, P., Tollefson, L., FedorkaCray, P.J., and Headrick, M.L. 2003.
“Risk factors for fecal quinolone-resistant Escherichia coli
in Mexican children.” Antimicrobial Agents and Chemotherapy 47(6):1999-2001.
Zhao, S., Datta, A., Ayers, S., Friedman, S., Walker, R.D.,
and White, D.G. 2003.
“Antimicrobial resistant Salmonella serovars isolated from
imported foods.” International Journal of Food Microbiology. 84: 87-92.

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BUDGET
The FY 2003 budget for the Animal Drugs and Feeds Program follows:

Pre-Mmarket

Post-Market

FY 2003 Total

Center

$27,100,000

$30,015,000

$57,115,000

Field

$ 2,237,000

$28,307,000

$30,544,000

Total

$29,337,000

$58,322,000

$87,659,000

The budget amount includes costs for personnel, figured in terms of “Full-Time Equivalents
(FTE),” which is the budget nomenclature for one employee working full time. For FY 2003,
the FTEs were:

Center 341

Field 255

Total 596

The following table provides the trend for the Animal Drugs and Feeds
Program since 1996:
1997

1998

1999

2000

2001

2002

2003

Center

$25,418,000

$25,588,000

$28,612,000

$30,668,000

$36,471,000

$48,440,000

$55,727,000

$57,115,000

Field

Appendix C

1996

$11,396,000

$10,628,000

$12,742,000

$12,585,000

$13,122,000

$15,630,000

$29,916,000

$30,544,000

Total

$36,814,000

$36,216,000

$41,354,000

$43,253,000 $49,593,000

$64,070,000

$85,643,000

$87,659,000