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November 5, 2003

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

*RE: Docket No. 2003N-0312 Animal Feed Safety System*

The National Grain and Feed Association submits this statement in
response to the Food and Drug Administration's request for comments
regarding the potential development of a comprehensive, risk-based
animal feed safety system.

The NGFA, established in 1896, consists of 1,000 grain, feed,
processing, exporting and other grain-related companies that operate
about 5,000 facilities that handle more than two-thirds of all U.S.
grains and oilseeds. With more than 300 member companies operating feed
manufacturing and integrated livestock and poultry operations, the NGFA
is the nation's largest trade association representing commercial feed
manufacturer and integrator interests.

The NGFA's membership encompasses all sectors of the industry, including
country, terminal and export elevators; feed mills; cash grain and feed
merchants; end users of grain and grain products, including processors,
flour millers, and livestock and poultry integrators; commodity futures
brokers and commission merchants; and allied industries, such as
railroads, barge lines, banks, grain exchanges, insurance companies,
computer software firms, and engineering and design/construct companies.
The NGFA also consists of 36 affiliated state and regional U.S. grain
and feed associations, as well as two international affiliated
associations. The NGFA has strategic alliances with the Grain Elevator
and Processing Society and the Pet Food Institute, and a joint operating
and services agreement with the North American Export Grain Association.

The NGFA commends the agency for organizing the September 23-24 public
meeting to explore the concept of developing a comprehensive, risk-based
animal feed safety system. The NGFA was an active participant in FDA's
public meeting, with 10 members representing NGFA's Animal Agriculture
Committee, Feed Legislative and Regulatory Affairs Committee, and Feed
Manufacturing and Technology Committee, as well as staff members, in
attendance. We believe the forum resulted in a constructive exchange of
views by a significant cross section of the commercial feed ingredient,
rendering, feed manufacturing and pet food sectors, federal and state
government officials, academicians, and consumer interests, although we
wish that more representation had been present from the producer/on-farm
and transportation sectors. We believe the public meeting succeeded in
giving participants an opportunity to begin framing the myriad and
complex issues involved in considering a comprehensive, risk-based
approach to animal feed safety.

Conceptually and in principle, the NGFA believes that taking a
risk-based approach to food and feed safety makes sense from a
scientific, public health and resource-allocation standpoint. But as FDA
evaluates whether and how to proceed, there are two major overarching
factors that the NGFA believes strongly need to be uppermost in the
agency's deliberations:

-   First and foremost, the NGFA believes that as FDA considers whether
    to proceed with the development of a federal animal feed safety
    system -- in whatever form that eventually may take -- the agency
    needs to embrace a much more comprehensive approach that is
    inclusive of all sectors of the animal feeding industry. FDA has
    promulgated a comprehensive set of current good manufacturing
    practices (CGMPs) for both licensed and non-licensed medicated feed
    manufacturers, which establish a recognized feed regulatory
    compliance bar for the production and distribution of medicated
    feeds. Ensuing federal and state feed regulatory programs have
    focused almost exclusively on [commercial]{.underline} medicated
    feed manufacturers, even though such establishments represent only a
    fraction of the feed and feed ingredient tonnage produced in the
    United States. Several incidents of concern involving various
    hazards and contaminants (e.g., dioxin, microbial concerns, mineral
    excesses, mycotoxins, pesticides and residues of other unsafe
    substances in transport conveyances) have generated increased
    awareness about the role of other sectors and the importance of FDA
    adopting a more inclusive approach to feed safety that recognizes
    the diversity of the industry.

> The NGFA believes the commercial medicated feed manufacturing sector
> of the animal feed chain has done a commendable job in manufacturing
> and distributing products, and has a proven record of safety. That
> record has been documented through FDA and state inspections and
> enforcement. It also was examined in the September 2000 report on food
> safety by the General Accounting Office (GAO) -- the investigatory arm
> of Congress -- which concluded that, "\[i\]n the United States, only a
> relatively few incidents of human illness have been traced to
> contaminated animal feed."[^1] The GAO report went on to add: "Public
> health officials have identified only two incidences of human illness
> resulting from bacteria-contaminated animal feed in the past 30
> years"[^2] -- both involving *Salmonella* and one of which was still
> under investigation at the time GAO issued the report. The GAO report
> also found that as of July 2000, there had been "no reported cases in
> the United States of human illness resulting from chemically
> contaminated animal feed" and that during fiscal years 1998 and 1999,
> "less than 3 percent of animal feed samples tested for pesticides
> contained residue levels above established tolerances."[^3]

-   Second, when evaluating whether and how to proceed with the
    development of a comprehensive, risk-based approach to animal feed
    safety, we believe it is important for FDA to recognize and factor
    into its deliberations the considerable initiatives that the private
    sector already has taken to adopt a wide range of quality-assurance
    practices. Various sectors of the industry, including organizations
    that consist of commercial feed manufacturers, certain sectors of
    the ingredient industry, and the livestock and poultry industries,
    have developed quality-assurance programs and educational
    initiatives for their respective sectors.

For instance, the NGFA in 1994 developed the commercial feed industry's
first and most comprehensive model feed quality assurance program, and
has conducted 17 educational workshops since that time that have
attracted more than 600 commercial feed manufacturers. Participants in
the NGFA's model feed quality assurance program have included large and
small medicated and non-medicated feed manufacturers, integrators and
allied industries (including representatives of firms providing product
liability insurance to the commercial feed industry).

> The proliferation of private-sector quality-assurance initiatives over
> the past two decades has been spurred by several factors. For one,
> such systems are being adopted because the private sector takes its
> responsibility to produce safe feed seriously. There also are powerful
> market-based incentives for doing so, including customer demand,
> requests for contractual assurances and guarantees, and the need to
> control product liability losses and manage resultant product
> liability insurance costs.

The NGFA believes FDA generally has done a good job in developing a
scientific, risk-based assessment on which to establish tolerances for
animal drug carryover in feed -- as evidenced by its CGMP regulations
that apply to commercial feed mills that manufacture medicated feeds.
The CGMPs for medicated feed represent a set of requirements and a
compliance bar that is recognized and well understood by FDA-regulated
medicated feed facilities. FDA's medicated feed CGMPs also have served a
useful role by providing the foundation for, and encouraging development
of, U.S. industry-based quality-assurance programs, such as the
previously cited ***Model Feed Quality Assurance Program*** developed by
the NGFA.

The medicated feed CGMPs also have served as the basis for developing
draft codes of practice for animal feeding in international fora[^4]
such as the United Nations' Food and Agricultural Organization and the
Codex Alimentarius Commission. The CGMPs also formed the foundation for
the Association of American Feed Control Officials' (AAFCO)
***"Guidance/Framework for Best Management Practices for Manufacturing,
Packaging and Distributing Animal Feeds and Feed Ingredients,"*** a
voluntary guidance document that was finalized in 2002, as well as a
subsequent AAFCO "Checklist" based on the Guidance/Framework document
that was adopted in 2003. We believe more can and should be done by FDA
and others to promote the positive contribution that the medicated feed
CGMPs have played in enhancing feed and food safety.

The NGFA believes that developing and implementing a more comprehensive,
scientific and risk-based approach to animal feed to protect human and
animal health would carry with it several prerequisites that FDA should
acknowledge in advance and incorporate into any such approach:

-   First, FDA would need to have the financial resources to fund much
    more research to determine which -- and what levels of -- substances
    are most critical to feed safety. FDA currently embraces a zero or
    near-zero tolerance for several contaminants (e.g., salmonella,
    dioxin, microbes, etc.) that is not sufficiently grounded in science
    nor risk assessment. One of the disturbing undercurrents at FDA's
    September 2003 public meeting was a misperception -- in our view --
    that the research on which to base a prudent animal feed safety
    system already had been completed. We believe that is an erroneous
    assumption.

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-   Second, the agency would need to use these research findings to
    conduct a risk-based hazard analysis to determine which products or
    steps in the process need to be addressed by each respective sector
    (e.g., ingredients, transporters, on-farm mixers, commercial mills,
    etc.), and the degree to which such hazards already are being
    minimized through existing regulations (in the case of commercial
    medicated feed manufacturers) and the use of sector-specific
    quality-assurance practices.

-   Third, once hazards are identified and a risk-assessment performed,
    various industry sectors would need to have access to quick,
    inexpensive and reliable diagnostic tests (such as quick tests and
    assays) to monitor and detect feed safety hazards (e.g., pathogens,
    dioxins, pesticides, mycotoxins, etc.) that are identified. Further,
    these diagnostic tests would need to be validated as yielding
    accurate, and consistently repeatable results.

-   Fourth, to be successful, a comprehensive, risk-based animal feed
    safety system would require "buy-in" from a diverse array of state
    regulatory agencies, producer groups, commercial industry sectors
    and allied industries (such as transporters) to achieve a level
    playing field. It also would require much more coordination on an
    ongoing basis between FDA, state feed control agencies and other
    entities (such as universities and state laboratories) than
    currently exists.

The NGFA respectfully submits that each of the four aforementioned
conditions is a necessary precursor to a prudent, risk-based animal feed
safety approach.

Importantly, the NGFA believes the federal government also should start
by rectifying shortcomings in its implementation of [existing laws and
regulatory authority]{.underline} that are designed to minimize
feed-borne hazards. One glaring example is the failure of the U.S.
Department of Transportation to finalize regulations to implement the
Safe Food Transportation Act of 1990, which is designed to prevent
unsafe backhauling of food or feed products in conveyances that also are
used to haul hazardous substances, such as fertilizer, unless such
conveyances are cleaned properly by the carrier. Another example is the
lack of enforcement at both the federal and state level against
unapproved novel feed ingredients/additives being incorporated into
animal feed and pet food. While AAFCO and FDA are making initial strides
to identify illegal feed ingredients/additives for enforcement action,
unapproved feed additives continue to be advertised and offered for sale
in inter- and intra-state commerce.

As FDA considers components that could be considered for inclusion in a
potential federal animal feed safety system, the NGFA believes:

-   Such an approach should focus on further enhancing the [safety of
    feed for food-producing animals]{.underline}, thereby protecting
    human and animal health and retaining consumer confidence. As such,
    the NGFA believes that FDA should place a [priority]{.underline} on
    those sectors of the industry most directly linked to safe [food
    animal production that -- unlike the commercial medicated feed
    industry -- are not already subject to FDA regulation, guidelines or
    ongoing oversight]{.underline}.

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-   FDA should consider the effectiveness of initiatives already being
    pursued. These include the role played by:

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-   existing private-sector initiatives, including quality-assurance
    programs, voluntary best management practices and industry trade
    rules developed by trade associations and individual companies that
    are being adopted across a wide spectrum of feed and
    feed-ingredient-related sectors;

-   AAFCO's ***"Guidance/Framework for Best Management Practices for
    Manufacturing, Packaging and Distributing Animal Feeds and Feed
    Ingredients"*** and "Checklist" alluded to previously. The NGFA and
    other organizations actively participated in the development of
    these documents, and are actively distributing them to our
    respective industry sectors. These documents may be particularly
    useful models for FDA to consider as it considers whether and how to
    proceed with an animal feed safety system; and

-   the Model National Medicated Feed Program developed through AAFCO.

Each of these initiatives share a common characteristic -- flexibility
and the ability to tailor practices to the specific type, size and
characteristics of each facility. A one-size-fits-all approach will not
work.

-   FDA should incorporate the principles contained in the Voluntary
    Self Inspection Program (VSIP) as a major component, and should
    broaden it to encompass both medicated and non-medicated feed and
    feed ingredients. Doing so would provide an important additional
    incentive to encourage the adoption of quality-assurance programs in
    the private sector, while enabling government to more effectively
    target its scarce inspection, compliance and enforcement resources.
    It is our understanding that FDA currently is considering whether to
    initiate VSIP as a pilot project for medicated feed manufacturing
    establishments for which CGMP regulations already exist.

Under the VSIP approach, developed through AAFCO with active input and
support from the NGFA, establishments would be encouraged to develop and
implement quality-assurance programs that meet federal standards or
guidelines. Among other things, VSIP includes the following concepts: 1)
Establishments would enter into a binding agreement with FDA committing
to develop and implement a written Q/A program that meets FDA standards
or guidelines; 2) participating establishments would conduct annual
self-inspections of their operations and correct deficiencies; 3)
participating establishments would submit summary results of their
inspections to FDA and state feed control authorities; and 4)
participating establishments would be subject to random spot-check
audits by government to ensure the quality-assurance programs are being
implemented. In return, participating establishments would be a low
priority for federal (and the NGFA submits should be for state)
inspections, except for cause.

-   More emphasis needs to be placed on the safety of feed once it
    leaves the commercial feed mill. Feed has the potential to be
    contaminated with salmonella depending upon how it is transported,
    stored and handled once it leaves the control of the commercial
    mill.

-   Given the proliferation of various types of quality-assurance
    methods (e.g., HACCP, HACCP-like, ISO, etc.), it may be beneficial
    for FDA to consider developing basic guidelines concerning the
    elements or components that should be included within each of these
    Q/A methods to enhance the level of understanding about what each
    does -- and doesn't -- encompass. Again, however, it is important
    that the agency not attempt to develop a "model standard" or attempt
    to devise a "one-size-fits-all" approach.

**[If]{.underline}** grounded in sound science that is based upon solid
research and truly risk-based, the NGFA believes that a comprehensive,
risk-based federal feed safety program has the potential to:

-   Establish a baseline and provide a more uniform framework to guide
    activities of federal and state government, and the feed ingredient,
    feed manufacturing, transport, and on-farm and commercial
    mixer-feeder sectors in addressing those hazards most important to
    preserving and enhancing feed safety. In so doing, such a federal
    initiative could provide a more level playing field in the market.

-   Enable government agencies to better focus scarce human and
    financial resources on those areas most critical to feed and food
    safety, while reducing the need to respond to perceived or actual
    feed safety "emergencies."

-   Further enhance consumer confidence in the safety of meat, milk and
    eggs.

The NGFA believes a government-based animal feed safety system will
**[not]{.underline}** have a major impact on the domestic or
international competitiveness of the U.S. feed or animal agriculture
industries, since market forces already have encouraged the development
and implementation of quality-assurance programs by industry sectors in
response to customer preferences. U.S. competitiveness in world markets
is influenced to a far greater degree by the supply and demand for raw
grains and other ingredients (which can be influenced by U.S. farm
policy), the efficiency and cost-competitiveness of the transportation
sector, and other "macro" factors. However, we do believe that a federal
approach to animal feed safety can be of value in overcoming
non-science-based trade barriers, particularly for products for which
regulatory standards or guidelines are not implemented currently. In
addition, commercial firms may request government-based certification
that such firms are adhering to various quality systems implemented in
response to customer demand.

At this conceptual stage -- without knowing what might be encompassed in
a federal animal feed safety system -- it is impossible to estimate the
potential burdens a comprehensive, risk-based approach might impose. But
it is likely that the burdens would take different forms -- in both
human-resource and economic terms -- on government and industry:

-   Potential Burdens for [Government]{.underline}:

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-   [Developing]{.underline} a risk-based federal feed safety program
    would require that FDA: 1) consider whether it is necessary to amend
    the Federal Food, Drug and Cosmetic Act to provide the agency with
    the statutory authority needed to implement such an approach; 2)
    develop a much more seamless ongoing working relationship with other
    federal agencies (e.g., the U.S. Department of Agriculture's
    Agricultural Marketing Service, Department of Transportation, etc.)
    that could be involved in developing guidelines/standards and/or
    certifying private-sector industry quality-assurance initiatives, as
    well as states, which likely would be on the front lines in
    overseeing or encouraging the adoption of such a system; and 3)
    conduct the necessary research to provide the scientific
    underpinning for identifying and setting potential limits for
    feed-borne hazards that [truly]{.underline} affect human or animal
    health.

-   [Implementing]{.underline} a comprehensive, risk-based federal feed
    safety program would require that FDA and state governments: 1)
    spread limited human and financial resources across a much broader
    spectrum of the feed ingredient, feed manufacturing and feeding
    industries than has occurred previously; 2) develop a much more
    coordinated and integrated relationship with state feed control
    agencies, which likely will -- and should -- bear much of the
    responsibility for educating and providing oversight of various
    industry sectors with whatever risk-based animal feed safety program
    is developed; 3) fundamentally change the mind-set of federal and
    state feed inspectors to focus on hazards that truly affect human
    and animal health (whereas, the current tendency of some inspectors
    and agencies is to spend significant time on such "economic" issues
    as label guarantees); and 4) improve the training of inspectors
    (both federal and state) to refocus and improve the quality and
    consistency of whatever government-based inspections that are
    eventually incorporated into a risk-based animal feed safety
    approach.

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-   Potential Burdens for [Private Sector]{.underline}:

> Depending upon its scope and nature, [developing and
> implementing]{.underline} a comprehensive, risk-based federal feed
> safety program may entail the "up-front" expenditure of considerable
> human and financial resources for certain establishments or sectors of
> the industry that have not adopted quality-assurance programs yet. But
> the actual additional operating costs imposed on the feed industry to
> meet the demands of additional requirements (e.g., procedure
> modifications, documentation and recordkeeping, etc.) cannot be
> quantified until FDA's approach is known. Likewise, some
> establishments or industry sectors may need to expend human and/or
> financial resources to retool existing quality-assurance programs to
> focus on areas determined through a risk assessment to be critical to
> feed safety.

However, long-term, the NGFA believes that quality-assurance programs
that are truly science- and risk-based have the potential to pay for
themselves through enhanced plant and employee productivity; fewer
reworks/recalls; fewer product liability complaints; and reduced
premiums for product liability insurance.

Finally, as FDA is aware, AAFCO has initiated the development of what it
calls a ***"Model Feed Safety Program"*** that contains elements that
mirror those being considered by FDA as part of the latter's federal
animal feed safety system initiative. Rather than viewing these as
mutually exclusive or parallel efforts, the NGFA encourages FDA and
AAFCO to work together and with affected producer and industry sectors
so that whatever emerges from both pursuits represents a well-reasoned
and consistent approach, and not duplicative.

In closing, the NGFA is confident that FDA -- when analyzing how to
proceed -- will guard against the inevitable attempts by some companies
or organizations seeking to benefit from such an initiative by
advocating proprietary products, services or certifications that do not
address legitimate feed safety risks borne out by sound science or
prudent risk assessment, or which would undermine government-based
inspection programs.

The NGFA appreciates FDA's consideration of its views, and looks forward
to being a fully engaged and constructive participant in future
discussions with the agency and other interested parties on this
important matter.

Sincerely yours,

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Randall C. Gordon

Vice President

Communications and Government Relations

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Joseph Garber

Chairman

Feed Legislative and Regulatory Affairs Committee

[^1]: "Food Safety -- Controls Can be Strengthened to Reduce the Risk of
    Disease Linked to Unsafe Animal Feed." General Accounting Office,
    September 2000. Page 4.

[^2]: IBID. Page 9.

[^3]: IBID. Page 10.

[^4]: Food and Agriculture Organization's Expert Consultation on Animal
    Feeding and Food Safety, Rome, Italy March 10-14, 1997; and Codex
    Alimentarius Commission's *Ad Hoc* Intergovernmental Task Force on
    Animal Feeding, 1999- .