[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