[Federal Register Volume 81, Number 1 (Monday, January 4, 2016)]
[Proposed Rules]
[Pages 42-44]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-33011]
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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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of petition.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, 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.
DATES: The food additive petition was filed on August 17, 2015. Submit
either electronic or written comments by March 4, 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,
[[Page 43]]
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:
I. Background
Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 348(b)(5)), we are giving notice that we have
filed 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 Thomas Neltner, 1875
Connecticut Ave. NW., Suite 600, Washington, DC 20009. The petition
proposes to amend Sec. 172.515 (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.
The seven food additives that are the subject of this petition are
as follows:
Benzophenone (also known as diphenyl ketone) (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
Styrene (CAS No. 100-42-5).
II. Amendment of Sec. 172.515
In accordance with the procedures for amending or revoking a food
additive regulation in Sec. 171.130 (21 CFR 171.130), the petition
asks us to amend Sec. 172.515 to no longer provide for the use of
these seven food additives as synthetic flavoring substances.
Specifically, the petitioners contend that new data establish that
these substances are carcinogenic and are, therefore, not safe for use
in food under the Delaney Clause (section 409(c)(3)(A) of the FD&C
Act), 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
petitioners cite, as evidence, conclusions by the National Toxicology
Program, the International Agency for Research on Cancer, and the
California Environmental Protection Agency's Office of Environmental
Health Hazard Assessment. The petitioners also include results from an
observational epidemiology study in humans exposed to styrene and a
number of long-term, animal feeding studies conducted on each of the
seven additives to support their request. If we determine new data are
available that establish these food additives induce cancer, then FDA
will amend Sec. 172.515 to no longer provide for their use by
publishing an amendment to the regulation in the Federal Register, as
set forth in Sec. Sec. 171.130 and 171.100 (21 CFR 171.100).
Although the petition proposes to amend only Sec. 172.515 to no
longer provide for the use of these seven synthetic flavoring
substances, our action in response to the petition could affect other
regulations which provide specifically for the use of these additives.
Specifically, benzophenone is also approved for use as an indirect food
additive, i.e., a plasticizer (21 CFR 177.2600(c)(4)(iv) diphenyl
ketone). We note that some of these flavoring substances (e.g., ethyl
acrylate, pyridine, styrene) are permitted for use by other food
additive regulations and food contact notifications as reactants or
manufacturing aids. Such uses are not the subject of these food
additive regulations and food contact notifications, and as such, may
not necessarily be affected if this petition results in a regulation.
III. Establish a Zero Tolerance
The petition also requests that FDA explicitly establish a zero
tolerance for these seven substances in Sec. 172.515. There is no
statutory or regulatory provision for establishing a zero tolerance
standard for flavoring food additives in Sec. 172.515. We note,
however, that 21 CFR part 189 permits FDA to prohibit by rulemaking the
use of substances in human foods because of a determination that they
present a potential risk to the public health or have not been shown by
adequate scientific data to be safe for use in human foods. To the
extent that a rulemaking under part 189 to prohibit the use of these
seven substances in food satisfies the petitioner's request for a zero
tolerance, we will consider, to the extent appropriate, whether such a
rulemaking is necessary if this petition results in a regulation.
We also are reviewing the potential environmental impact of the
petitioners' requested action. The petitioners have claimed a
categorical exclusion from preparing an environmental assessment or
environmental impact statement
[[Page 44]]
under 21 CFR 25.32(m). In accordance with regulations issued under the
National Environmental Policy Act (40 CFR 1506.6(b)), we are placing
the environmental document submitted with the subject petition on
public display at the Division of Dockets Management (see ADDRESSES) so
that interested persons may review the document. If we determine that
the petitioners' claim of categorical exclusion is warranted and that
neither an environmental assessment nor an environmental impact
statement is required, we will announce our determination in the
Federal Register if this petition results in a regulation. If we
determine that the claim of categorical exclusion is not warranted, we
will place the environmental assessment on public display at the
Division of Dockets Management and provide notice in the Federal
Register announcing its availability for review and comment.
Dated: December 29, 2015.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2015-33011 Filed 12-31-15; 8:45 am]
BILLING CODE 4164-01-P