
[Federal Register Volume 78, Number 136 (Tuesday, July 16, 2013)]
[Notices]
[Pages 42526-42527]
From the Federal Register Online via the Government Printing 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, kim.young@fda.hhs.gov.

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]
BILLING CODE 4160-01-P


