[Federal Register Volume 71, Number 99 (Tuesday, May 23, 2006)]
[Notices]
[Page 29651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0056]


Draft Compliance Policy Guide; Guidance Levels for 3-MCPD (3-
chloro-1,2-propanediol) in Acid-Hydrolyzed Protein and Asian-Style 
Sauces; 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 a draft compliance policy guide (CPG) entitled ``Sec. 
500.500 Guidance Levels for 3-MCPD (3-chloro-1,2-propanediol) in Acid-
Hydrolyzed Protein and Asian-Style Sauces.'' The draft CPG establishes 
regulatory action guidance for FDA personnel for 3-MCPD in acid-
hydrolyzed protein (acid-HP) and Asian-style sauces.

DATES: Submit written or electronic comments regarding the draft CPG by 
July 24, 2006.

ADDRESSES: Submit written requests for single copies of the draft CPG 
entitled ``Sec. 500.500 Guidance Levels for 3-MCPD (3-chloro-1,2-
propanediol) in Acid-Hydrolyzed Protein and Asian-Style Sauces'' 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 
document.
    Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Judith L. Kidwell, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1071, FAX: 
301-436-2972.

SUPPLEMENTARY INFORMATION:

I. Background

    The draft CPG is intended to provide clear policy and regulatory 
guidance for FDA's field and headquarters staff with regard to 3-MCPD 
in acid-HP and Asian-style sauces. In particular, the draft CPG sets 
forth guidance levels for 3-MCPD in acid-HP and Asian-style sauces. FDA 
would use these levels to help determine whether acid-HP and Asian-
style sauces are unsafe. The levels adopted in the draft CPG are not 
binding on FDA, the regulated industry, or the courts. In any given 
case, FDA may decide to initiate an enforcement action against acid-HP 
and Asian-style sauces with concentrations below these levels or decide 
not to initiate an enforcement action against acid-HP and Asian-style 
sauces with concentrations that meet or exceed the levels. The draft 
CPG also contains information that may be useful to the regulated 
industry and to the public.
    FDA has adopted good guidance practices (GGPs) that set forth the 
agency's policies and procedures for the development, issuance, and use 
of guidance documents (21 CFR 10.115). The draft CPG is being issued as 
a Level 1 draft guidance consistent with GGPs. This draft CPG 
represents the agency's current thinking on 3-MCPD in acid-HP and 
Asian-style sauces. 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 the draft CPG. 
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 and the draft CPG 
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 under ``Compliance References.''

    Dated: May 12, 2006.
David Horowitz,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. E6-7796 Filed 5-22-06; 8:45 am]
BILLING CODE 4160-01-S