
[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,

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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

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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


