Document ID: FDA-2013-D-0715-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on Acrylamide in Foods; Availability
Posted Date: 2013-11-15T05:00Z

[Federal Register Volume 78, Number 221 (Friday, November 15, 2013)]
[Notices]
[Pages 68852-68853]
From the Federal Register Online via the Government Printing 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Draft Guidance for Industry on Acrylamide in Foods; Availability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availability of a draft guidance entitled ``Guidance for Industry: 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 The draft guidance is intended to provide 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 The draft guidance is intended to suggest a range of possible 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10.115(g)(5)), to ensure that we consider your comment on the draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Food Safety, Center for Food Safety and 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SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 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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