2010-18873. Draft Compliance Policy Guide Sec. 690.800 Salmonella

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for FDA staff entitled “Compliance Policy Guide Sec. 690.800 Salmonella in Animal Feed” (the draft CPG). The draft CPG, when finalized, is intended to provide guidance for FDA staff on regulatory policy relating to animal feed or feed ingredients that come in direct contact with humans, such as pet food and pet treats, contaminated with Salmonella and also on regulatory policy relating to animal feed or feed ingredients contaminated with a Salmonella serotype that is pathogenic to the target animal for the animal feed.

DATES:

Although you can comment on any CPG at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on the draft CPG before it begins work on the final version of the CPG, submit either electronic or written comments on the draft CPG by November 1, 2010.

ADDRESSES:

Submit written requests for single copies of the CPG to the Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 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 CPG.

Submit electronic comments on the draft CPG to http://www.regulations.gov. Submit written comments on the draft 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, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-276-9200.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for FDA staff entitled “Compliance Policy Guide Sec. 690.800 Salmonella in Animal Feed.” The draft CPG provides guidance for FDA staff regarding the contamination of animal feed and feed ingredients with Salmonella. The draft CPG proposes criteria that should be considered in recommending enforcement action against animal feed or feed ingredients that are adulterated due to the presence of Salmonella. In particular, the draft CPG proposes regulatory action guidance relating to animal feed or feed ingredients that are contaminated with Salmonella and (1) come in direct contact with humans, such as pet food and pet treats, or (2) are contaminated with a Salmonella serotype that is pathogenic to the target animal for which the animal feed is intended. The draft CPG also contains information that may be useful to regulated industry and the public.

FDA is issuing the draft CPG as Level 1 draft guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft CPG, when finalized, will represent the agency's current thinking on enforcement recommendations for certain circumstances where animal feed or feed ingredients are contaminated with Salmonella. 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 the draft CPG. 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 CPG at either http://www.fda.gov/​ora/​compliance_​ref/​cpg/​default.htm or http://www.regulations.gov.

Dated: July 23, 2010.

Michael A. Chappell,

Acting Associate Commissioner for Regulatory Affairs.