[Federal Register Volume 67, Number 228 (Tuesday, November 26, 2002)]
[Notices]
[Pages 70752-70753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-29925]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 94D-0147]


Guidance for Industry: Studies to Evaluate the Utility of Anti-
Salmonella Chemical Food Additives in Feeds; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance for industry 
([]80) 
entitled ``Guidance for Industry: Studies to Evaluate the Utility of 
Anti-Salmonella Chemical Food Additives in Feeds.'' The guidance 
explains the standards upon which studies to establish the utility of 
anti-Salmonella chemical food additives for maintaining feeds 
Salmonella-negative should be based. The intended effect of this 
guidance is to provide advice on study standards for the establishment 
of anti-Salmonella food additives that will maintain feeds Salmonella-
negative.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the final 
guidance to the Communications Staff (HFV-12), Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your requests. Submit written comments on the final 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
final guidance document.

FOR FURTHER INFORMATION CONTACT: Henry E. Ekperigin, Center for 
Veterinary Medicine (HFV-222), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0174, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In April 1991, FDA publicly discussed its intention to adopt a 
policy requiring feeds and feed ingredients to be Salmonella-free 
(meeting of FDA's Veterinary Medicine Advisory Committee, April 11, 
1991, Bethesda, MD). The agency later adopted a policy requiring feeds 
and feed ingredients to be Salmonella-negative (see 59 FR 33975, July 
1, 1994). This reflected concerns that Salmonella infections cause a 
significant portion of foodborne illnesses, and that animal feeds are a 
significant source of Salmonella infections in food animals and thus in 
humans. After the issuance of the Salmonella-negative policy, 
development began on several products designed to achieve and maintain 
Salmonella-negative levels in animal feeds. Sponsors of these products 
may file food additive petitions to establish the safety and utility of 
the additives. Because sponsors have used a variety of research methods 
to support their petitions, FDA has found it difficult to

[[Page 70753]]

evaluate the petitions in a uniform manner.
    In an effort to achieve more consistency, FDA developed a draft 
guidance entitled ``Utility Studies for Anti-Salmonella Chemical Food 
Additives in Animal Feeds.'' The availability of this draft guidance 
was announced in the Federal Register of June 23, 1994 (59 FR 32442). A 
public workshop on this topic was held on August 8, 1994, in 
conjunction with the annual meeting of the Poultry Science Association 
in Starkville, MS. Comments at the public workshop and the written 
comments received on the draft guidance led FDA to revise the draft 
document. The agency clarified several statements that had caused 
confusion or had raised questions among the respondents. Further, 
following suggestions from the respondents, the agency made several 
changes in the testing methods.
    The purpose of this final guidance is to support consistent 
evaluation of anti-Salmonella food additives and their ability to 
maintain a Salmonella-negative level in previously ``clean'' animal 
feeds through repeated exposure to various Salmonella serotypes. This 
guidance should help ensure that sponsors conduct appropriate studies 
to evaluate the utility of anti-Salmonella food additives, and that FDA 
accomplish uniform review and decisionmaking. In turn, this should 
facilitate the approval process for such food additives.
    This final guidance explains the recommended experimental process 
in detail and references other FDA documents that pertain to general 
experimental practices and procedures recommended by FDA. The guidance 
provides details concerning recommended testing methods.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The final guidance represents the 
agency's current thinking on anti-Salmonella food additives for keeping 
feeds Salmonella-negative. It does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    There are nine or fewer respondents to the information collection 
described in this guidance and therefore no burden analysis is required 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
    Title: Guidance for Industry: Studies to Evaluate the Utility of 
Anti-Salmonella Chemical Food Additives in Feeds.
    Description: In 1990, FDA announced its goal of Salmonella-negative 
animal feed and feed ingredients (see 59 FR 33975, July 1, 1994). The 
policy responds to concerns that Salmonella infections cause a 
significant portion of foodborne illnesses, and that animal feeds serve 
as a significant source of Salmonella infections in food animals and 
consequently in humans. In response, sponsors have developed several 
products designed to achieve and maintain Salmonella-negative levels in 
animals feeds. The sponsors also have filed the requisite food additive 
petitions that prove both the safety and utility of the additive 
products. However, up to this point, it has been difficult for FDA to 
evaluate the petitions in a consistent manner, as the research methods 
supporting the petitions have varied to a significant degree.
    This final guidance document describes standards upon which studies 
to establish the utility of anti-Salmonella chemical food additives for 
maintaining feeds Salmonella-negative should be based. Certain types of 
information should be collected in these studies, as described in the 
final guidance.

IV. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this final guidance 
at any time. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. The guidance and received comments are available for public 
inspection in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cvm.

    Dated: November 15, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-29925 Filed 11-25-02; 8:45 am]
BILLING CODE 4160-01-S