
[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Pages 80826-80827]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32232]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0466]


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

[[Page 80827]]

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.
[FR Doc. 2010-32232 Filed 12-22-10; 8:45 am]
BILLING CODE 4160-01-P


