[Federal Register Volume 78, Number 221 (Friday, November 15, 2013)]
[Notices]
[Pages 68852-68853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27362]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0715]
Draft Guidance for Industry on Acrylamide in Foods; Availability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availability of a draft guidance entitled ``Guidance for Industry:
Acrylamide in Foods.'' The draft guidance is intended to provide
information that may help growers, manufacturers, and food service
operators reduce acrylamide in certain foods. Acrylamide is a chemical
that can form in some foods during certain types of high-temperature
cooking. The draft guidance is intended to suggest a range of possible
approaches to acrylamide reduction and not to identify specific
recommended approaches.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider your comment on the draft
guidance before we begin work on the final version of the guidance,
submit either electronic or written comments on the draft guidance by
January 14, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Food Safety, Center for Food Safety and
Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive
labels to assist that office in processing your request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
[[Page 68853]]
FOR FURTHER INFORMATION CONTACT: Lauren Posnick Robin, Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1639.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a draft guidance entitled
``Guidance for Industry: Acrylamide in Foods.'' We are issuing this
draft guidance as a Level 1 draft guidance consistent with our good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent our current thinking on acrylamide in foods.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.
The draft guidance is intended to provide information that may help
growers, manufacturers, and food service operators reduce acrylamide in
certain foods. Acrylamide is a chemical that can form in some foods
during certain types of high-temperature cooking, and is a concern
because it can cause cancer in laboratory animals at high doses, and is
reasonably anticipated to be a human carcinogen. Reducing acrylamide in
foods may mitigate potential human health risks from exposure to
acrylamide. The draft guidance is intended to suggest a range of
possible approaches to acrylamide reduction and not to identify
specific recommended approaches.
In particular, the draft guidance is intended to give information
to manufacturers on selecting and handling raw materials, modifying
processing practices, and choosing ingredients, so as to reduce
acrylamide in potato-based foods (such as fries, sliced potato chips,
and fabricated potato chips) and cereal-based foods (such as cookies,
crackers, and breads). The draft guidance also discusses acrylamide
reduction in coffee. The draft guidance also is intended to give
information to manufacturers for placing preparation and cooking
instructions on frozen French fry packages. Lastly, the draft guidance
is intended to give information for food service operations on
preparation of potato-based and cereal-based foods.
II. Paperwork Reduction Act of 1995
This draft guidance contains proposed information collection
provisions that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44
U.S.C. 3501-3520). ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Federal law at 44 U.S.C.
3506(c)(2)(A) requires Federal Agencies to publish a 60-day notice in
the Federal Register for each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, we will publish a 60-day notice of the proposed collection
of information in a future issue of the Federal Register.
III. Comments
Interested persons may submit either electronic comments regarding
the draft guidance to http://www.regulations.gov or written comments to
the Division of Dockets Management (see ADDRESSES). 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.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the draft guidance.
Dated: November 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27362 Filed 11-14-13; 8:45 am]
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