[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Notices]
[Page 16425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-6793]



[[Page 16425]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0091]


Draft Guidance for Industry: Testing for Salmonella Species in 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) is announcing the 
availability of a draft guidance for industry entitled ``Testing for 
Salmonella Species in Human Foods and Direct-Human-Contact Animal 
Foods.'' The draft guidance, when finalized, is intended for firms that 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 The draft guidance does not apply to egg producers and 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 The draft guidance addresses testing procedures for 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: Although you can comment on any guidance at any time (see 21 CFR 
10.115 (g)(5)), to ensure that the Agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments concerning the 
draft guidance by June 21, 2011.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit written requests for single copies of the draft guidance to the 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 SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance.

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 20740,301-436-2022.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Testing for Salmonella Species in Human Foods and Direct-
Human-Contact Animal Foods.'' The draft guidance, when finalized, 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 draft 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 draft 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 intends to issue a separate guidance document 
responding to questions FDA has received on the shell egg final rule 
since its publication and include in that document guidance on 
environmental and egg testing for Salmonella Enteritidis.
    Salmonella spp. can cause serious and sometimes fatal infections in 
young children, frail or elderly people, and others with weakened 
immune systems. Healthy persons infected with Salmonella spp. often 
experience fever, diarrhea (which may be bloody), nausea, vomiting, and 
abdominal pain. In rare circumstances, infection with Salmonella spp. 
can result in the organism getting into the blood stream and producing 
more severe illnesses such as arterial infections (i.e., infected 
aneurysms), endocarditis, and arthritis. In addition, direct-human-
contact animal foods contaminated with Salmonella spp. pose a 
significant health risk to humans who have direct contact with the 
foods at homes, petting zoos, agricultural fairs, or similar venues.
    The draft 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.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Always access an FDA guidance document by using 
the Web sites listed previously to find the most current version of the 
guidance.

    Dated: March 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6793 Filed 3-22-11; 8:45 am]
BILLING CODE 4160-01-P