[Federal Register: May 23, 2006 (Volume 71, Number 99)]
[Notices]
[Page 29651]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23my06-50]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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