[Federal Register Volume 78, Number 136 (Tuesday, July 16, 2013)]
[Notices]
[Pages 42526-42527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16975]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0378]
Compliance Policy Guide Sec. 690.800 Salmonella in Food for
Animals; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of guidance for our staff entitled ``Compliance Policy
Guide Sec. 690.800 Salmonella in Food for Animals'' (the CPG). The CPG
provides guidance to FDA staff on Salmonella-contaminated food for
animals.
DATES: Submit either electronic or written comments on the CPG at any
time.
ADDRESSES: Submit written requests for single copies of the CPG to the
Food and Feed Policy Staff, Office of Policy and Risk Management,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20850. Send one self-addressed adhesive
label to assist that office in processing your request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the CPG.
Submit electronic comments on the CPG to http://www.regulations.gov. Submit written comments on the CPG to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kim Young, Center for Veterinary
Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9207, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance document entitled
``Compliance Policy Guide Sec. 690.800 Salmonella in Food for Animals''
(the CPG). The CPG provides guidance to FDA staff on Salmonella-
contaminated food for animals. The CPG is being issued consistent with
our good guidance practices regulation (21 CFR 10.115). The CPG
represents FDA's current thinking on Salmonella-contaminated food for
animals. 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.
In the Federal Register of August 2, 2010 (75 FR 45130), we
announced the availability of a draft CPG entitled ``Compliance Policy
Guide Sec. 690.800 Salmonella in Animal Feed,'' and gave interested
persons an opportunity to submit comments by November 1, 2010, for us
to consider before beginning our work on the final version of the CPG.
In the Federal Register of October 29, 2010 (75 FR 66769), we published
a notice extending the comment period until December 31, 2010. We
received numerous comments on the draft CPG and have modified the final
CPG where appropriate. The CPG announced in this notice finalizes the
draft CPG announced on August 2, 2010.
Changes to the CPG include:
The title of the CPG is changed from ``Salmonella in
Animal Feed'' to ``Salmonella in Food for Animals.'' FDA made this
change to clarify that the CPG covers all animal food. The term ``food
for animals'' here includes pet food and animal feed.
The term ``Direct Human Contact Animal Feed'' has been
removed from the CPG, because commenters found the term to be
confusing. The term pet food is now used instead. It is defined to mean
food for pets and includes treats and chews for pets.
The CPG explains criteria that FDA personnel should consider in
recommending enforcement action against food for animals that is
adulterated due to the presence of Salmonella. In particular, the CPG
provides regulatory action guidance relating to pet food or pet food
ingredients that are contaminated with Salmonella. In addition, the CPG
provides regulatory action guidance relating to animal feed and animal
feed ingredients that are contaminated with certain Salmonella
serotypes that are pathogenic to the particular species of animal for
which the animal feed or animal feed ingredients are intended. The CPG
also contains information that may be useful to regulated industry and
the public.
This notice is related to two notices published elsewhere in this
issue of the Federal Register, in which FDA is announcing: (1) The
removal of 21 CFR 500.35 ``Animal feeds contaminated with Salmonella
microorganisms,'' and
[[Page 42527]]
(2) the withdrawal of ``Compliance Policy Guide Sec. 690.700 Salmonella
Contamination of Dry Dog Food.'' The enforcement policy in the CPG
supersedes the policies articulated in 21 CFR 500.35 and CPG Sec.
690.700.
II. Comments
Interested persons may submit either electronic comments regarding
the CPG to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the CPG at either
http://www.fda.gov/ora/compliance_ref/cpg/default.htm or at http://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the CPG.
Dated: July 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16975 Filed 7-15-13; 8:45 am]
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