[Federal Register Volume 74, Number 229 (Tuesday, December 1, 2009)]
[Notices]
[Page 62795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28756]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Compliance Policy Guide Sec. 527.300 Dairy Products--
Microbial Contaminants and Alkaline Phosphatase Activity (Compliance 
Policy Guide 7106.08); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of draft Compliance Policy Guide Sec. 527.300 Dairy 
Products--Microbial Contaminants and Alkaline Phosphatase Activity (CPG 
7106.08) (the draft CPG). The draft CPG, when finalized, will provide 
guidance for FDA staff on its enforcement policies for pathogens and 
other indicators of inadequate pasteurization or post-pasteurization 
contamination of dairy products.

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 
written or electronic comments on the draft CPG by February 1, 2010.

ADDRESSES: 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. Submit electronic comments 
on the draft CPG to http://www.regulations.gov. Submit written requests 
for single copies of the draft 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.

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

    The draft CPG is intended to provide guidance for FDA staff 
regarding pathogens and indicators of inadequate pasteurization or 
post-pasteurization contamination of dairy products. The draft 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 micro-
organism (i.e., Salmonella species, enterohemorrhagic Escherichia coli 
(EHEC) O157:H7, 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 draft CPG also contains information that may be useful 
to the regulated industry and to 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 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) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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 
http://www.fda.gov/ora/compliance_ref/cpg/default.htm or http://www.regulations.gov.

    Dated: November 24, 2009.
Michael A. Chappell,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. E9-28756 Filed 11-30-09; 8:45 am]
BILLING CODE 4160-01-S