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1225 New York Avenue, NW/#400

Washington, DC 20005

P: 202-898-0100

F: 202-898-0203

November 25, 2002

Dockets Management

Branch (HFA 305), Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852.

RE: Docket No. 98D-1146

The National Turkey Federation appreciates the opportunity to review and
comment on the draft Guidance for Industry #152, Docket No. 98D-1146
"Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to
Their Microbiological Effects on Bacteria of Human Health Concern." NTF
is the only national trade association representing the turkey industry
exclusively. NTF represents more than 98 percent of the United States
turkey industry, including processors, growers, breeders, hatchery
owners, and allied industry.

Healthy animals are important to a safe and wholesome food supply. Food
borne illness rates in the U.S., already among the lowest in the world,
are decreasing. Antibiotics have been used in animal husbandry for more
than 40 years to treat, control and prevent disease and to maintain the
health of animals. Observation of judicious use principles, the use of
risk assessment, surveillance, and local intervention have all worked to
enable producers to safely use these products while minimizing the
threat of antibiotic resistance from food borne pathogens.

The turkey industry welcomes this guidance as the first step in bringing
predictability back into the review process and allowing CVM to again
begin timely reviews of new and innovative antimicrobial products.
However, the document seems to be in the direction of the precautionary
principle, not striking an objective balance between actual risk to
human safety and benefits to both producers and consumers of judicious
use of animal health products. Subjective inputs into the risk model
could make the approval hurdle so high that no animal health tools would
be available for turkey growers. Manufacturers of animal health products
will be discouraged from submitting new animal drug applications because
the process will be too uncertain or too costly for the return expected
for a food animal health product. The end result will be a lack of
animal health tools for producers causing increased animal disease and
compromising human food safety while not adding to public health.

In the model considering risk to human health via foods of animal
origin, there is no recognition of the risk between fresh and further
processed foods. Further processed foods are those that have been
subjected to food safety interventions and pose a very low risk of
transferring enteric food borne pathogens to consumers. In addition,
microbiological loads on raw poultry have been reduced dramatically in
recent years. A recent NTF chiller study shows salmonella incidence
rates reduced 50% from the year 2000 (Texas A&M study, publications in
progress). This indicates that the risk to humans of using
antimicrobials in animals would be overestimated in most cases by the
proposed models.

The risk ranking of the antimicrobials is arbitrary and oversimplified.
It is not a comprehensive quantitative risk assessment. This should be
required on such an important issue, and the assessment should be
rigorously validated. There should be a way to challenge a ranking and
to change a ranking over time depending on usage of an antimicrobial and
of types of food products consumed by humans. The guidance does not
appear to provide for an appeal process. A sponsor should be able to
defend their safety package against the subjective risk assessment
outlined in the document.

We appreciate the opportunity to comment on the agency's proposed
guidance and look forward to working closely with the agency in the
future.

Respectfully submitted,

David L. Meeker, Ph.D., MBA

Vice President, Scientific and Regulatory Affairs

National Turkey Federation