Document ID: FDA-2013-D-0715-0016
Agency: fda
Document Type: Notice
Title: Acrylamide in Foods; Guidance for Industry; Availability
Posted Date: 2016-03-11T05:00Z

[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Pages 12907-12908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05490]

[[Page 12907]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0715]

Acrylamide in Foods; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``Acrylamide in 
Foods.'' The guidance finalizes the ``Draft Guidance for Industry on 
Acrylamide in Foods,'' modified where appropriate in response to 
comments we received on the draft guidance dated November 2013. This 
guidance is intended to provide information that may help growers, 
manufacturers, and food service operators reduce acrylamide levels in 
certain foods, which may mitigate potential human health risks from 
exposure to acrylamide.

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
[FDA-2013-D-0715] for the guidance document. Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to The 
Division of Plant Products and Beverages, Office of Food Safety, Center 
for Food Safety and Applied Nutrition, HFS-317, 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 guidance.

FOR FURTHER INFORMATION CONTACT: Eileen Abt, Center for Food Safety and 
Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 240-402-1529.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Guidance for Industry: Acrylamide in Foods.'' We are issuing 
this guidance consistent with our good guidance practices regulation 
(21 CFR 10.115). The guidance represents our current thinking on this 
topic. It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.
    In the Federal Register of November 15, 2013, (78 FR 68852), we 
made available a draft guidance for Industry entitled ``Draft Guidance 
for Industry on Acrylamide in Foods'' and provided an opportunity for 
comment prior to our work on the final version of the guidance. The 
final guidance has been modified in response to comments. The guidance 
announced in this notice finalizes the draft guidance dated November 
2013.
    This guidance is intended to provide information that may help 
growers, manufacturers, and food service operators reduce acrylamide 
levels in certain foods. Acrylamide is a chemical that can form in some 
foods during certain types of high-temperature cooking. Acrylamide 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 levels in foods may mitigate potential human health risks 
from exposure to

[[Page 12908]]

acrylamide. The guidance is intended to suggest a range of possible 
approaches to reducing acrylamide levels and not to identify specific 
recommended approaches.

II. Electronic Access

    Persons with access to the Internet may obtain the 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 guidance.

    Dated: March 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05490 Filed 3-10-16; 8:45 am]
 BILLING CODE 4164-01-P