[Federal Register Volume 77, Number 46 (Thursday, March 8, 2012)]
[Notices]
[Pages 14022-14023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-5628]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0091]
Guidance for Industry: Testing for Salmonella Species in Human
Foods and Direct-Human-Contact Animal Foods; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a guidance entitled ``Guidance for
Industry: Testing for Salmonella Species in Human Foods and Direct-
Human-Contact Animal Foods.'' The document provides guidance to firms
that manufacture, process, pack, or hold human foods or direct-human-
contact animal foods intended for distribution to consumers,
institutions, or food processors. This guidance does not apply to egg
producers and other persons who are covered by FDA's final rule
``Prevention of Salmonella Enteritidis in Shell Eggs During Production,
Storage, and Transportation.'' The guidance addresses testing
procedures for Salmonella species (spp.) in human foods (except shell
eggs) and direct-human-contact animal foods, and the interpretation of
test results, when the presence of Salmonella spp. in the food may
render the food injurious to human health.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Food Safety, Center for Food Safety and Applied
Nutrition, (HFS-317), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels
to assist that office in processing your request. See the
[[Page 14023]]
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2022.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 23, 2011 (76 FR 16425), FDA made
available a draft guidance entitled ``Testing for Salmonella Species in
Human Foods and Direct-Human-Contact Animal Foods'' and gave interested
parties an opportunity to submit comments by June 21, 2011. The Agency
reviewed and evaluated these comments and has modified the guidance
where appropriate.
This guidance is intended for firms that manufacture, process,
pack, or hold human foods or direct-human-contact animal foods intended
for distribution to consumers, institutions, or food processors. The
guidance does not apply to egg producers and other persons who are
covered by FDA's final rule ``Prevention of Salmonella Enteritidis in
Shell Eggs During Production, Storage, and Transportation'' (21 CFR
part 118; the shell egg final rule). The guidance addresses testing
procedures for Salmonella spp. in human foods (except shell eggs) and
direct-human-contact animal foods, and the interpretation of test
results, when the presence of Salmonella spp. in the food may render
the food injurious to human health. FDA issued separate guidances in
December 2011 and July 2011, respectively, entitled ``Guidance for
Industry: Prevention of Salmonella Enteritidis in Shell Eggs During
Production, Storage and Transportation,'' which provides guidance to
egg producers on how to comply with certain provisions contained in the
shell egg final rule, including provisions for environmental and egg
testing for Salmonella Enteritidis; and ``Draft Guidance for Industry:
Questions and Answers Regarding the Final Rule, Prevention of
Salmonella Enteritidis in Shell Eggs During Production, Storage, and
Transportation,'' which responds to questions FDA has received on the
shell egg final rule since its publication and includes guidance on
environmental and egg testing for Salmonella Enteritidis.
II. Significance of Guidance
The final guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the Agency's current thinking on testing for Salmonella spp. in human
foods and direct-human-contact animal foods. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternate approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding the
guidance. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov.
Always access an FDA document using the FDA Web site listed previously
to find the most current version of the guidance.
Dated: March 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5628 Filed 3-7-12; 8:45 am]
BILLING CODE 4160-01-P