
[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)]
[Proposed Rules]
[Pages 8867-8869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03708]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2015-F-4317]


Center for Science in the Public Interest, Natural Resources 
Defense Council, Center for Food Safety, Consumers Union, Improving 
Kids' Environment, Center for Environmental Health, Environmental 
Working Group, Environmental Defense Fund, and James Huff; Filing of 
Food Additive Petition; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of comment period.

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[[Page 8868]]

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the notice of filing that appeared in the Federal 
Register of January 4, 2016. In the notice, FDA requested comments on a 
filed food additive petition (FAP 5A4810), submitted by the Center for 
Science in the Public Interest, Natural Resources Defense Council, 
Center for Food Safety, Consumers Union, Improving Kids' Environment, 
Center for Environmental Health, Environmental Working Group, 
Environmental Defense Fund, and James Huff, proposing that the food 
additive regulations be amended to no longer authorize the use of seven 
listed synthetic flavoring food additives and to establish zero 
tolerances for the additives. We are taking this action in response to 
a request for an extension to allow interested persons additional time 
to submit comments.

DATES: We are extending the comment period on the notice of filing of a 
food additive petition published on January 4, 2016 (81 FR 42). Submit 
either electronic or written comments by May 3, 2016.

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-2015-F-4317 for ``Center for Science in the Public Interest, 
Natural Resources Defense Council, Center for Food Safety, Consumers 
Union, Improving Kids' Environment, Center for Environmental Health, 
Environmental Working Group, Environmental Defense Fund, and James 
Huff, Filing of Food Additive Petition.'' 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.

FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1071.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 4, 2016 
(81 FR 42), we published a notice of filing of a food additive petition 
(FAP 5A4810) submitted by the Center for Science in the Public 
Interest, Natural Resources Defense Council, Center for Food Safety, 
Consumers Union, Improving Kids' Environment, Center for Environmental 
Health, Environmental Working Group, Environmental Defense Fund, and 
James Huff, c/o Mr. Thomas Neltner, 1875 Connecticut Ave. NW., Suite 
600, Washington, DC 20009. The notice also invited comments on the 
petition. The petition proposes to amend 21 CFR 172.515, Synthetic 
flavoring substances and adjuvants, to no longer provide for the use of 
seven listed synthetic flavoring food additives and to establish zero 
tolerances for these additives. Specifically, the petitioners contend 
that new data establish that these substances are carcinogenic and are, 
therefore, not safe for use in food pursuant to the Delaney Clause 
(section 409(c)(3)(A) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 348(c)(3)(A))), which provides that no food additive shall be 
deemed to be safe if it is found to induce cancer when ingested by man 
or animal, or if it is found, after tests which are appropriate for the 
evaluation of the safety of food additives, to induce cancer in man or 
animal.
    The seven food additives which are the subject of the petition are:
     Benzophenone (also known as diphenylketone) (CAS No. 119-
61-9);
     Ethyl acrylate (CAS No. 140-88-5);
     Eugenyl methyl ether (also known as 4-allylveratrole or 
methyl eugenol) (CAS No. 93-15-2);
     Myrcene (also known as 7-methyl-3-methylene-1,6-octadiene) 
(CAS No. 123-35-3);
     Pulegone (also known as p-menth-4(8)-en-3-one) (CAS No. 
89-82-7);
     Pyridine (CAS No. 110-86-1); and

[[Page 8869]]

     Styrene (CAS No. 100-42-5).
    We have received a request for a 60-day extension of the comment 
period for the petition. The request conveyed concern that the current 
60-day comment period does not allow sufficient time to collect and 
provide data and information and develop a meaningful and thoughtful 
response to the assertions set forth in the petition.
    We have considered the request and are extending the comment period 
for the petition for an additional 60 days, until May 3, 2016. We 
believe that a 60-day extension allows adequate time for interested 
persons to submit comments without significantly delaying rulemaking on 
these important issues.

    Dated: February 18, 2016.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2016-03708 Filed 2-22-16; 8:45 am]
 BILLING CODE 4164-01-P


