[Federal Register Volume 73, Number 62 (Monday, March 31, 2008)]
[Notices]
[Pages 16861-16862]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-6504]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0143] (formerly Docket No. 2006D-0056)


Compliance Policy Guide Sec. 500.500 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 compliance policy guide (CPG) Sec. 500.500 Guidance 
Levels for 3-MCPD (3-chloro-1, 2-propanediol) in Acid-Hydrolyzed 
Protein and Asian-Style Sauces. The CPG provides regulatory action 
guidance for FDA staff regarding 3-MCPD in acid-hydrolyzed

[[Page 16862]]

protein (acid-HP) and Asian-style sauces.

DATES: Submit written or electronic comments regarding the CPG at any 
time.

ADDRESSES: 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. Submit electronic comments 
to: http://www.regulations.gov.
    Submit written requests for single copies of CPG 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, 240-632-6860. 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.

FOR FURTHER INFORMATION CONTACT: Judith L. Kidwell, Office of Food 
Additive Safety, Center for Food Safety and Applied Nutrition (HFS-
265), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD, 20740-3835, 301-436-1071.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 23, 2006 (71 FR 29651), FDA 
announced the availability of draft CPG Sec. 500.500 Guidance Levels 
for 3-MCPD (3-chloro-1,2-propanediol) in Acid-Hydrolyzed Protein and 
Asian-Style Sauces. FDA received one comment on the draft CPG. The 
International Hydrolyzed Protein Council (IHPC) offered clarification 
for the following sentence found in the BACKGROUND section of the draft 
CPG: ``Since 1996, many countries * * * have recommended or required 
that industry take steps to ensure that 3-MCPD is not detectable in 
acid-HP or Asian-style sauces at levels ranging from 0.01 parts per 
million (ppm) to 1 ppm.'' IHPC suggested that we revise the sentence as 
follows: ``Since 1996, many countries * * * have recommended or 
required that industry take steps to ensure that 3-MCPD in acid-HP or 
Asian-style sauces does not exceed levels ranging from 0.01 parts per 
million (ppm) to 1 ppm.'' IHPC explained that using the phrase ``not 
detectable'' and then listing allowable levels is confusing. We concur 
with the comment and have revised the final CPG accordingly. FDA also 
revised the SPECIMEN CHARGES section in the final CPG to provide 
operational guidance regarding reference to the United States Code 
(U.S.C.) when citing the violation charged in a domestic seizure and 
reference to the Federal Food, Drug, and Cosmetic Act when citing the 
violation charged in an import detention. We also have made other 
editorial changes to the CPG for clarification.
    This CPG is being issued as level 1 guidance consistent with FDA's 
good guidance practices regulations (21 CFR 10.115). The 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 on the CPG at any time. 
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. The CPG and received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only.

III. Electronic Access

    Persons with access to the Internet may obtain the CPG from the 
Office of Regulatory Affairs home page at http://www.fda.gov/ora under 
``Compliance Reference.''

    Dated: March 14, 2008.
Margaret O'K. Glavin,
Associate Commissioner for Regulatory Affairs.
[FR Doc. E8-6504 Filed 3-28-08; 8:45 am]
BILLING CODE 4160-01-S