2010-32232. Compliance Policy Guide Sec. 527.300 Dairy Products-Microbial Contaminants and Alkaline Phosphatase Activity; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of Compliance Policy Guide Sec. 527.300 Dairy Products—Microbial Contaminants and Alkaline Phosphatase Activity (the CPG). The CPG provides guidance for FDA staff on its enforcement policies for pathogens and other indicators of inadequate pasteurization or post-pasteurization contamination of dairy products.

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 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, or fax your request to 240-632-6861. See the SUPPLEMENTARY INFORMATION section for electronic access to the CPG.

Submit electronic comments 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:

Monica Metz, Center for Food Safety and Applied Nutrition (HFS-316), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2041.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of December 1, 2009 (74 FR 62795), FDA made available draft CPG Sec. 527.300 Dairy Products—Microbial Contaminants and Alkaline Phosphatase Activity and gave interested parties an opportunity to submit comments by February 1, 2010. The agency reviewed and evaluated these comments and has modified the CPG where appropriate.

The CPG provides guidance for FDA staff regarding pathogens and indicators of inadequate pasteurization or post-pasteurization contamination of dairy products. The CPG outlines regulatory enforcement policies for FDA staff to use to initiate legal action recommendations based on analytical determinations that a dairy product contains a pathogenic microorganism (i.e., Salmonella species, enterohemorrhagic Escherichia coli (EHEC) O157:H7 and other enterohemorrhagic Escherichia coli, Campylobacter jejuni, Yersinia enterocolitica, or Clostridium botulinum); toxins produced by Clostridium botulinum, enterotoxigenic Staphylococcus, or Bacillus cereus; Staphylococcus aureus; Bacillus cereus; nontoxigenic Escherichia coli; or alkaline phosphatase. The CPG also contains information that may be useful to the regulated industry and to the public.

FDA is issuing the CPG as level 1 guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The CPG represents FDA's current thinking on pathogens and indicators of inadequate pasteurization or post-pasteurization contamination of dairy products. 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 CPG. It is only necessary to submit one set of comments. It is no longer necessary to send two paper 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 CPG from FDA's Office of Regulatory Affairs history page. It may be accessed at http://www.fda.gov/​ora/​compliance_​ref/​cpg/​default.htm.

Dated: December 16, 2010.

Dara Corrigan,

Associate Commissioner for Regulatory Affairs.