81 FR 38984 - Styrene Information and Research Center; Filing of Food Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 115 (June 15, 2016)

Page Range		38984-38986
FR Document		2016-14107

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Styrene Information and Research Center (SIRC), requesting that we amend our food additive regulations to no longer provide for the use of styrene as a synthetic flavoring substance and adjuvant in food because these uses of styrene have been abandoned.

Federal Register, Volume 81 Issue 115 (Wednesday, June 15, 2016)

[Federal Register Volume 81, Number 115 (Wednesday, June 15, 2016)]
[Proposed Rules]
[Pages 38984-38986]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-14107]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2016-F-1444]

Styrene Information and Research Center; 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 Styrene Information and
Research Center (SIRC), requesting that we amend our food additive
regulations to no longer provide for the use of styrene as a synthetic
flavoring substance and adjuvant in food because these uses of styrene
have been abandoned.

DATES: The food additive petition was filed on May 16, 2016. Submit
either electronic or written comments by August 15, 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-2016-F-1444 for ``Styrene Information and Research Center; 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/

[[Page 38985]]

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 6A4817), submitted by SIRC, c/o
Keller and Heckman LLP, 1001 G Street NW., Suite 500 West, Washington,
DC 20001. The petition proposes to amend Sec. 172.515 (21 CFR 172.515)
to no longer provide for the use of styrene (CAS Reg. No. 100-42-5) as
a synthetic flavoring substance and adjuvant in food because these uses
of styrene have been permanently abandoned.

II. Abandonment

Under section 409(i) of the FD&C Act, we ``shall by regulation
prescribe the procedure by which regulations under the foregoing
provisions of this section may be amended or repealed, and such
procedure shall conform to the procedure provided in this section for
the promulgation of such regulations.'' Our regulations specific to
administrative actions for food additives provide that the Commissioner
of Food and Drugs, on his own initiative or on the petition of any
interested person, under 21 CFR part 10, may propose the issuance of a
regulation amending or repealing a regulation pertaining to a food
additive or granting or repealing an exception for such additive (Sec.
171.130(a) (21 CFR 171.130(a))). These regulations further provide that
any such petition shall include an assertion of facts, supported by
data, showing that new information exists with respect to the food
additive or that new uses have been developed or old uses abandoned,
that new data are available as to toxicity of the chemical, or that
experience with the existing regulation or exemption may justify its
amendment or appeal. New data must be furnished in the form specified
in 21 CFR 171.1 and 171.100 for submitting petitions (Sec.
171.130(b)). Under these regulations, a petitioner may propose that we
amend a food additive regulation if the petitioner can demonstrate that
there are ``old uses abandoned'' for the relevant food additive. Such
abandonment must be complete for any intended uses in the U.S. market.
While section 409 of the FD&C Act and Sec. 171.130 also provide for
amending or revoking a food additive regulation based on safety, an
amendment or revocation based on abandonment is not based on safety,
but is based on the fact that regulatory authorization is no longer
necessary because the use of that food additive has been abandoned.
Abandonment may be based on the abandonment of certain authorized
food additive uses for a substance (e.g., if a substance is no longer
used in certain product categories), or on the abandonment of all
authorized food additive uses of a substance (e.g., if a substance is
no longer being manufactured). If a petition seeks an amendment to a
food additive regulation based on the abandonment of certain uses of
the food additive, such uses must be adequately defined so that both
the scope of the abandonment and any amendment to the food additive
regulation are clear.
The petition submitted on behalf of SIRC contains public
information and information collected from companies that produce
styrene to support the petitioner's claim that styrene is no longer
being manufactured, imported, or otherwise marketed for use as a
synthetic flavoring substance and adjuvant in food in the U.S. market
and that the manufacturers have abandoned the use of styrene for these
uses. SIRC surveyed its membership, which contains over 95 percent of
the current North American styrene industry, to verify that their
members do not:
Currently manufacture styrene for use as a synthetic
flavoring substance and adjuvant in food in the United States;
currently import styrene for use as a synthetic flavoring
substance and adjuvant in food into the United States;
intend to manufacture or import styrene for use as a
synthetic flavoring substance and adjuvant in food in the United States
in the future; and
currently maintain any inventory of styrene for sale or
distribution into commerce that is intended to be marketed for use as a
synthetic flavoring substance and adjuvant in food in the United
States.

SIRC also has confirmed that no foreign manufacturers appear to be
using or marketing styrene for use as a synthetic flavoring agent or
adjuvant in food.
We expressly request comments on SIRC's request to amend Sec.
172.515 of the food additive regulations to no longer permit the use of
styrene as a synthetic flavoring substance and adjuvant in food. As
noted, the basis for the proposed amendment is that the uses of styrene
as a synthetic flavoring substance and adjuvant in food have been
permanently abandoned. Accordingly, we request comments that address
whether these uses of styrene have been completely abandoned, such as
information on whether food containing styrene used as a synthetic
flavoring substance and adjuvant are currently being introduced or
delivered for introduction into the U.S. market. We are not currently
aware of information that suggests continued use of styrene as a
synthetic flavoring substance and adjuvant in food. We are providing
the public with 60 days to submit comments. We anticipate that some
interested persons may wish to provide us with certain information they
consider to be trade secret or confidential commercial information
(CCI) that would be exempt under Exemption 4 of the Freedom of
Information Act (5 U.S.C. 552). Interested persons may claim
information that is submitted to us as CCI or trade secret by clearly
marking both the document and the specific information as
``confidential.'' Information so marked will not be disclosed except in
accordance with the Freedom of Information Act and our disclosure
regulations (21 CFR part 20). For electronic submissions to http://www.regulations.gov, indicate in the ``comments'' box of the
appropriate docket that your submission contains confidential
information. Interested persons must also submit a copy of the comment
that does not contain the information claimed as confidential for
inclusion in the public version of the official record. Information not
marked confidential will be included in the public version of the
official record without prior notice.
We are not requesting comments on the safety of these uses of
styrene because such information is not relevant to abandonment, which
is the basis of the proposed action. We will not consider any comments
addressing the safety of styrene or containing safety information on
styrene in our evaluation of this petition.
We have determined under 21 CFR 25.32(m) that this action is of a
type that does not individually or cumulatively

[[Page 38986]]

have a significant effect on the human environment. Therefore, neither
an environmental assessment nor an environmental impact statement is
required.

Dated: June 9, 2016.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2016-14107 Filed 6-14-16; 8:45 am]
BILLING CODE 4164-01-P

38986 Federal Register / Vol. 81, No. 115 / Wednesday, June 15, 2016 / Proposed Rules

have a significant effect on the human considered the official comment and EPA approved that SIP revision on May
environment. Therefore, neither an should include discussion of all points 13, 2016, resulting in a full approval of
environmental assessment nor an you wish to make. EPA will generally North Carolina’s regional haze plan.
environmental impact statement is not consider comments or comment Each state is also required to submit
required. contents located outside of the primary a progress report in the form of a SIP
Dated: June 9, 2016. submission (i.e., on the web, cloud, or revision every five years that evaluates
Dennis M. Keefe,
other file sharing system). For progress towards the RPGs for each
additional submission methods, the full mandatory Class I Federal area within
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
EPA public comment policy, the state and for each mandatory Class
information about CBI or multimedia I Federal area outside the state which
[FR Doc. 2016–14107 Filed 6–14–16; 8:45 am]
submissions, and general guidance on may be affected by emissions from
BILLING CODE 4164–01–P
making effective comments, please visit within the state. See 40 CFR 51.308(g).
http://www2.epa.gov/dockets/ Each state is also required to submit, at
commenting-epa-dockets. the same time as the progress report, a
ENVIRONMENTAL PROTECTION
FOR FURTHER INFORMATION CONTACT: determination of the adequacy of its
AGENCY
Sean Lakeman, Air Regulatory existing regional haze plan. See 40 CFR
40 CFR Part 52 Management Section, Air Planning and 51.308(h). The first progress report is
Implementation Branch, Air, Pesticides due five years after submittal of the
[EPA–R04–OAR–2015–0449; FRL–9947–62– and Toxics Management Division, U.S. initial regional haze plan.
Region 4] Environmental Protection Agency, On May 31, 2013, as required by 40
Air Plan Approval; North Carolina; Region 4, 61 Forsyth Street SW., CFR 51.308(g), NC DAQ submitted to
Regional Haze Progress Report Atlanta, Georgia 30303–8960. Mr. EPA, in the form of a revision to North
Lakeman can be reached by phone at Carolina’s SIP, a report on progress
AGENCY: Environmental Protection (404) 562–9043 and via electronic mail made towards the RPGs for Class I areas
Agency. at lakeman.sean@epa.gov. in the State and for Class I areas outside
ACTION: Proposed rule. SUPPLEMENTARY INFORMATION: the State that are affected by emissions
SUMMARY: The Environmental Protection I. Background from sources within the State. This
Agency (EPA) is proposing to approve a submission also includes a negative
Under the Regional Haze Rule,1 each declaration pursuant to 40 CFR
State Implementation Plan (SIP) state was required to submit its first
revision submitted by the State of North 51.308(h)(1) that the State’s regional
implementation plan addressing haze plan is sufficient in meeting the
Carolina through the North Carolina regional haze visibility impairment to
Division of Air Quality (NC DAQ) on requirements of the Regional Haze Rule
EPA no later than December 17, 2007. (40 CFR 51.300 et seq.). EPA is
May 31, 2013. North Carolina’s May 31, See 40 CFR 51.308(b). North Carolina
2013, SIP revision (Progress Report) proposing to approve North Carolina’s
submitted its regional haze plan on that Progress Report on the basis that it
addresses requirements of the Clean Air date, and like many other states subject
Act (CAA or Act) and EPA’s rules that satisfies the requirements of 40 CFR
to the Clean Air Interstate Rule (CAIR), 51.308(g) and (h) now that EPA has fully
require each state to submit periodic relied on CAIR to satisfy best available
reports describing progress towards approved the State’s regional haze plan.
retrofit technology (BART) requirements
reasonable progress goals (RPGs) for emissions of sulfur dioxide (SO2) II. Requirements for the Regional Haze
established for regional haze and a and nitrogen oxides (NOX) from electric Progress Report and Adequacy
determination of the adequacy of the generating units (EGUs) in the State. On Determinations
state’s existing SIP addressing regional June 7, 2012, EPA finalized a limited
haze (regional haze plan). EPA is A. Regional Haze Progress Report
disapproval of North Carolina’s
proposing to approve North Carolina’s December 17, 2007 regional haze plan Under 40 CFR 51.308(g), states must
Progress Report on the basis that it submission because of deficiencies submit a regional haze progress report
addresses the progress report and arising from the State’s reliance on CAIR as a SIP revision every five years and
adequacy determination requirements to satisfy certain regional haze must address, at a minimum, the seven
for the first implementation period for requirements. See 77 FR 33642. In a elements found in 40 CFR 51.308(g). As
regional haze. separate action taken on June 27, 2012, described in further detail in section III
DATES: Comments must be received on EPA finalized a limited approval of below, 40 CFR 51.308(g) requires: (1) A
or before July 15, 2016. North Carolina’s December 17, 2007, description of the status of measures in
ADDRESSES: Submit your comments, regional haze plan submission, as the approved regional haze plan; (2) a
identified by Docket ID No. EPA–R04– meeting some of the applicable regional summary of emissions reductions
OAR–2015–0449 at http:// haze requirements as set forth in achieved; (3) an assessment of visibility
www.regulations.gov. Follow the online sections 169A and 169B of the CAA and conditions for each Class I area in the
instructions for submitting comments. in 40 CFR 51.300–51.308. See 77 FR state; (4) an analysis of changes in
Once submitted, comments cannot be 38185. On October 31, 2014, the State emissions from sources and activities
edited or removed from Regulations.gov. submitted a regional haze plan revision within the state; (5) an assessment of
EPA may publish any comment received to correct the deficiencies identified in any significant changes in
to its public docket. Do not submit anthropogenic emissions within or
ehiers on DSK5VPTVN1PROD with PROPOSALS

the June 27, 2012, limited disapproval
electronically any information you by replacing reliance on CAIR with outside the state that have limited or
consider to be Confidential Business reliance on the State’s Clean impeded progress in Class I areas
Information (CBI) or other information Smokestacks Act (CSA) as an alternative impacted by the state’s sources, (6) an
whose disclosure is restricted by statute. to NOX and SO2 BART for BART- assessment of the sufficiency of the
Multimedia submissions (audio, video, eligible EGUs formerly subject to CAIR. approved regional haze plan; and (7) a
etc.) must be accompanied by a written review of the state’s visibility
comment. The written comment is 1 40 CFR part 51, subpart P. monitoring strategy.

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Document Created: 2016-06-15 02:21:33
Document Modified: 2016-06-15 02:21:33

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notice of petition.
Dates		The food additive petition was filed on May 16, 2016. Submit either electronic or written comments by August 15, 2016.
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.
FR Citation		81 FR 38984

81 FR 38984 - Styrene Information and Research Center; Filing of Food Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 115 (June 15, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration