
[Federal Register Volume 77, Number 217 (Thursday, November 8, 2012)]
[Notices]
[Page 67013]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27225]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0848]


Draft Compliance Policy Guide Sec. 550.050 Canned Ackee, Frozen 
Ackee, and Other Ackee Products--Hypoglycin A Toxin; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft Compliance Policy Guide entitled ``Compliance 
Policy Guide Sec. 550.050 Canned Ackee, Frozen Ackee, and Other Ackee 
Products--Hypoglycin A Toxin (the draft CPG).'' The draft CPG, when 
finalized, will provide guidance for FDA staff on our enforcement 
criteria for canned ackee, frozen ackee, and other ackee products that 
contain hypoglycin A.

DATES: Although you can comment on any CPG at any time (see 21 CFR 
10.115(g)(5)), to ensure that FDA considers your comment on the draft 
CPG before it begins work on the final version of the CPG, submit 
electronic or written comments on the draft CPG by January 7, 2013.

ADDRESSES: 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, 12420 Parklawn Dr., 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 draft 
CPG.
    Submit electronic comments on the draft CPG to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Yinqing Ma, Center for Food Safety and 
Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 240-402-1700.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of the draft CPG entitled 
``Compliance Policy Guide Sec. 550.050 Canned Ackee, Frozen Ackee, and 
Other Ackee Products--Hypoglycin A Toxin.'' The draft CPG is intended 
to provide guidance for FDA staff regarding hypoglycin A in canned 
ackee, frozen ackee, and other ackee products. We have concluded that 
canned ackee, frozen ackee, and other ackee products containing 
concentrations of hypoglycin A above 100 parts per million (ppm) have 
not been processed properly, and that the finished product may be 
injurious to health. As stated in the draft CPG, canned ackee, frozen 
ackee, and other ackee products may be considered adulterated within 
the meaning of section 402(a)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342(a)(4)) when hypoglycin A is present in the 
food at levels greater than 100 ppm. The draft CPG also contains 
information that may be useful to the regulated industry and to the 
public.
    The draft CPG is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The draft CPG, when finalized, 
will represent our current thinking on hypoglycin A in ackee 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 either written comments regarding the 
draft CPG to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of 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, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the draft CPG either 
from FDA's Office of Regulatory Affairs history page at http://www.fda.gov/ora/compliance_ref/cpg/default.htm or from http://www.regulations.gov. Always access an FDA guidance document by using 
FDA's Web site listed in the previous sentence to find the most current 
version of the guidance.

    Dated: November 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27225 Filed 11-7-12; 8:45 am]
BILLING CODE 4160-01-P


