[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Draft Guidance for Industry: Testing for Salmonella Species in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availability of a draft guidance for industry entitled ``Testing for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 The draft guidance, when finalized, is intended for firms that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 The draft guidance does not apply to egg producers and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 The draft guidance addresses testing procedures for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this draft guidance before it begins work on the final version of the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draft guidance by June 21, 2011.
ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to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Submit written requests for single copies of the draft guidance to the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]
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