[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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