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

Filing 59

DECLARATION of Mitchell S. Bernard in Support re: 56 MOTION for Summary Judgment on Plaintiffs Third Claim for Relief.. 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)(Bernard, Mitchell)

EXHIBIT E
TO THE DECLARATION OF MITCHELL S. BERNARD

August 26, 2010
Division of Dockets Management (HFV12)
Center for Veterinary Medicine
Food and Drug Administration
7519 Standish Pl.
Rockville, MD 20855
Re: Draft Guidance 209 – The Judicious Use of Medically Important Antimicrobial
Drugs in Food-Producing Animals
(Docket No. FDA2010D0094)
Dear Sir or Madam:
The American Farm Bureau Federation (AFBF) submits these comments in response to
the notice of availability of a draft guidance (#209) on the use of medically important
antimicrobial drugs in food-producing animals, published by the Food and Drug Administration
(FDA) in the June 29, 2010 Federal Register. AFBF is the nation’s largest agriculture
organization. Our members encompass every type of livestock and poultry production across the
country.
The availability of antibiotics for the livestock industry is critical. Farm Bureau shares
FDA’s interest in ensuring that all animal health products, including antibiotics, continue to be
safe and effective. Furthermore, we agree that human antibiotic resistance is a growing
healthcare problem. The development of bacterial resistance to certain antibiotics poses a
serious public health threat.
Developing strategies for reducing antimicrobial resistance is important for protecting
both public and animal health. However, it is imperative that any new policy relative to
antibiotics be grounded in data and reflect the reality of modern animal agriculture production.
In repeated comments and conversations with FDA, particularly over the last 14 months, Farm
Bureau has expressed serious concern about the detrimental impact of eliminating approved
animal health products and uses.
Further limiting or eliminating animal antibiotic use for livestock will have negative
economic and animal health consequences. Therefore, we oppose restricting antibiotic use for
the livestock and dairy industries that is not based on peer-reviewed, scientific information.
Current Practice and Procedures
While Guidance 209 is not a statement about the safety of current products, a review of
historical and modern safeguards is appropriate. Antimicrobial drugs are critical to address the
health needs of animals. They have been widely used in human and veterinary medicine for

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more than 50 years with benefits to both public and animal health. Published, scientific work
over the past decade has demonstrated the role healthy food animals play in producing meat,
milk and eggs that are free from bacteria that cause human illness. The judicious use of
antibiotics approved by FDA plays an important role in food safety by keeping animals healthy.
Antibiotics in livestock are used carefully by producers in a process that is highly
regulated by FDA. Veterinary medicines are approved by FDA. They are held to the same strict
standards for safety and efficacy as human medicines and are assessed for safety to people who
consume animal-derived food. In 2003, FDA implemented an additional safety measure that
consists of a comprehensive, evidence-based approach to prevent antimicrobial resistance that
may result from the use of antimicrobial drugs in animals.
There are also post-market monitoring programs, such as the National Antimicrobial
Resistance Monitoring System (NARMS), which is conducted jointly by the Centers for Disease
Control and Prevention (CDC), FDA and the Department of Agriculture (USDA). NARMS data
show that resistance in animal products has been steady or declining in recent years.
Farm Bureau has long supported efforts to promote the judicious use of antibiotics.
Each livestock and poultry species has quality production/assurance programs, most FDAreviewed, that educate producers about the responsible use of antibiotics. We expect our
members to participate in these industry programs and adhere to the guidelines instituted for the
judicious use of antimicrobial drugs. Antibiotics are given to livestock strategically, when
animals are sick, susceptible or exposed to illness. They are an integral part of comprehensive
management plans that provide animals with an environment designed to keep them safe, healthy
and comfortable.
FDA has the authority to review every animal health product, including antibiotics, prior
to approval and at periodic intervals after the product is on the market. FDA can and will deny
or limit products that are shown to produce resistance in either animals or people. Layers of
regulatory and industry protections are based on years of data collection. Products available to
livestock caretakers today have gone through rigorous and continuous scientific testing.
Facts About Antibiotic Use and Resistance
We are concerned by recent FDA actions that appear to indicate the agency is basing
complex animal health policies on theory rather than sound scientific studies. Guidance 209
appears to propose action without fully evaluating the resulting benefits and consequences. This
has the potential for a tremendous negative impact on animal health and, ultimately, food safety.
Healthy animals produce safe food, and every available tool is needed to protect animal health.
There are no peer-reviewed scientific studies that establish that judicious use of
antibiotics in livestock increases antibiotic resistance in human infections. Consequently, it is
notable that the actions proposed in Guidance 209 are not based on demonstrated safety risk.
Additionally, there are no data to indicate that limiting antibiotic use in livestock decreases
human health problems with antibiotic resistance. The Danish experience, which many

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proponents of restricting antibiotic use in livestock cite as a “success,” does not show any
improvement in the antibiotic resistance concerns in humans.
On the contrary, peer-reviewed studies have shown that antibiotic use on farms does not
significantly increase resistant bacteria in humans. Since antibiotics have been used in livestock
for half a century, resistance related to antibiotic use in agriculture would have occurred by now.
The fact that it has not means that antibiotic use in animals is not a major risk to human health.
Top scientists with the CDC and the National Institutes of Health (NIH) told a
congressional committee earlier this year that there is no scientific study linking antibiotic use in
food animal production with antibiotic resistance. At an April 28 hearing, CDC Director Dr.
Thomas Frieden stated, “I am not aware of evidence in this country that has documented the
spread from animals to humans, feed animals to humans.” Similarly, when asked by a
congressional subcommittee on July 14 to identify the scientific studies that indicate a public
health benefit of removing antibiotics approved for growth promotion, USDA could not cite any
peer-reviewed U.S. research. At the same hearing last month, Congress inquired of FDA what
decreases in the level of human antibiotic resistance are expected to result from Guidance 209 as
currently proposed. The agency responded that it had not quantified the intended human health
impact. The data cited to verify any reduction in human resistance was a 2003 report from the
Institute of Medicine which was not a study, but rather a literature review of multiple opinions
on the topic.
It is important to calculate both the benefits and costs of proposed action before
implementation.
Issues in Guidance 209
Despite the FDA’s own scientific data and rigorous safety testing and approval
procedures already in place, Guidance 209 indicates the FDA intends to take two actions to
decrease antibiotic use in livestock:
1) Eliminate growth promotion as an acceptable antibiotic use in livestock production.
2) Require antibiotics to be used under the oversight of, or in consultation with, a
veterinarian.
Guidance 209 calls for antibiotics that are “medically important” to humans to be used in
animals only when necessary to assure their health. It also says those antibiotics should be
administered with veterinary “oversight or consultation.” These key terms are not fully defined.
An overly-broad interpretation could eliminate certain antibiotics that are extremely important to
livestock health, animal welfare, and food safety.
We support veterinary oversight, defined as a working relationship with a licensed
veterinarian. The medical importance to humans of antibiotics must be evaluated on a specific
case-by-case basis, using thorough risk assessments. All steps in the causal pathway should be
quantified, examining the relationship of a livestock antibiotic first to the development of
resistance in the animal and subsequently the transfer of that specific resistant bacteria through
the food chain to a consumer who seeks treatments for symptoms from the bacteria and receives

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the antibiotic initially given to the animal. Given the demonstrated complexity of this chain of
events, the risk assessment process is not easy but it is the only way to determine true risk as
opposed to unsubstantiated concern. To simplify the number of necessary risk assessments,
antibiotics or other animal health products not used in human medicine should not be classified
as medically important, alleviating the need for costly and time-consuming comprehensive
assessment of antimicrobials utilized solely for animal health.
It appears that antibiotics currently used for growth promotion but not currently labeled
for the other three approved claims (preventing, treating or controlling diseases) could continue
to be used if, after undergoing a second rigorous FDA approval process, one of those label
claims is proved. But the approval process typically takes seven to 10 years and can cost
millions of dollars.
We recognize the public health importance of issues concerning all antibiotic use,
whether human or livestock, and strongly encourage FDA to base future policy and regulatory
decisions regarding such use on objective, substantive scientific evidence obtained through valid
research. As a general farm organization, we do not claim to be scientific experts in the field of
veterinary medicine or epidemiology. However, we do understand the daily practicalities of
raising healthy animals in a manner which respects the welfare of the animals, the safety of the
workers, and the impact on the overall environment. Ultimately, our goal is to continue
providing safe, high-quality, abundant, affordable meat, milk, and eggs for a growing population.
In order to achieve that goal, we must have the full use and range of animal health and herd/flock
management tools.
Role of Veterinarians and the Veterinary Feed Directive (VFD)
The animal agriculture industry relies on the veterinary community to assist witih and
oversee animal health. Our members work closely with their veterinarians on a range of
management issues. Producers utilize veterinary expertise to develop animal health plans that
include the judicious use of antibiotics. We support veterinarian oversight of the administration
of antibiotics, rather than limitations on or elimination of these critical animal health and food
safety protection tools.
Requiring that all antibiotics be accompanied by feed directives would be problematic
given the country’s severe shortage of large animal veterinarians. Currently approved VFD
drugs have a record of safe use in animals under this process. However, we are concerned that
the VFD process – even if improved dramatically – may be ill-suited to serve as a vehicle for
providing increased veterinary oversight for a larger number of currently approved
antimicrobials. We question whether the VFD can be expanded to apply to the number of
antimicrobials previously approved by FDA for feed use, as envisioned by the agency under
draft Guidance 209.
Farm Bureau recommends that the agency undertake significant discussions with
stakeholders in the animal feed, animal health, veterinary, and producer sectors to determine
whether the VFD process can be improved to the extent necessary to be workable for these

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currently approved, non-VFD animal health products. The current system would have to be
substantively altered if it is to be applied to a large number of products, and we question whether
this is the most efficient approach given the other influencing factors with which to contend.
The Animal Drug Availability Act of 1996, which established the VFD category, states
that a VFD is not a prescription under state or federal law. Were this not the case, feed mills
handling and/or dispensing “prescription” medicated feeds would need a veterinarian or
pharmacist on staff, and to comply with other state pharmacy board requirements. This is
significant given the staffing issues prevalent in the food animal industry today.
Farm Bureau and other animal health, livestock and poultry organizations have
documented the severe shortage of veterinarians in many geographic areas. A study
commissioned by the American Veterinary Medical Association (AVMA) last year indicates that
the demand for food supply veterinarians will increase by about 13 percent over the next several
years, while the supply will have a short fall of about 4-5 percent annually. Meanwhile, the
number of veterinary school graduates entering food supply medicine remains stagnant.
Although we are pursuing all avenues to increase veterinary capacity, the situation will not be
corrected easily or quickly.
This shortage would create a significant hindrance if FDA were to attempt to expand the
list of currently approved animal drugs whose distribution and use in food-producing animals is
subjected to the VFD process. The issue of an insufficient supply of veterinarians must be
recognized as FDA contemplates possible changes to the regulatory requirements for medicated
feeds containing VFD drugs. It would be counterproductive to the health of animals and the
safety of the food supply to make drastic, fundamental changes to a 14 year-old functioning
system, including replacing it with a new system requiring a substantially larger veterinarian
force when those professionals are currently unavailable.
We appreciate FDA’s consideration of our comments. Farm Bureau believes stakeholder
collaboration is critical and welcomes a constructive discussion of production practices, including the
use of antibiotics in livestock. We look forward to continuing our long-standing partnership to
protect and improve animal health.
Sincerely,

Mark Maslyn
Executive Director, Public Policy