[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