Document ID: FDA-2011-D-0091-0007
Agency: fda
Document Type: Notice
Title: Guidance for Industry; Availability: Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods
Posted Date: 2012-03-08T05:00Z

[Federal Register Volume 77, Number 46 (Thursday, March 8, 2012)]
[Notices]
[Pages 14022-14023]
From the Federal Register Online via the Government Printing 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]
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