Styrene Information and Research Center; Filing of Food Additive Petition, 38984-38986 [2016-14107]

Download as PDF 38984 Federal Register / Vol. 81, No. 115 / Wednesday, June 15, 2016 / Proposed Rules proposed to require modification of the FQIS: • Docket No. FAA–2016–6140, Directorate Identifier 2015–NM–059– AD, for certain The Boeing Company Model 777 airplanes. • Docket No. FAA–2016–6141, Directorate Identifier 2015–NM–048– AD, for certain The Boeing Company Model 767 airplanes. • Docket No. FAA–2016–6143, Directorate Identifier 2015–NM–028– AD, for certain all Airbus Model A300 B4–600, B4–600R, and F4–600R series airplanes, and Model A300 C4–605R Variant F airplanes (collectively called Model A300–600 series airplanes), and Model A310 series airplanes. • Docket No. FAA–2016–6144, Directorate Identifier 2015–NM–088– AD, for certain Airbus Model A318, A319, A320, and A321 airplanes. • Docket No. FAA–2016–6145, Directorate Identifier 2015–NM–056– AD, for certain The Boeing Company Model 747 airplanes. ehiers on DSK5VPTVN1PROD with PROPOSALS Actions Since Previous NPRM Was Issued Since we issued the NPRM, we have received a request from Airlines for America (A4A) to extend the comment period for some of the NPRMs referenced above. A4A stated that the NPRMs are controversial and could drive substantial costs, especially for cargo airlines. To be able to prepare informed and meaningful comments with coordinated consensus among its members, A4A requested a longer comment period to understand a number of factors, including related service information, data and safety analysis of the unsafe condition, and potential costs. We agree with the request, and have determined that it is appropriate to extend the comment period for all the NPRMs referenced above to give all interested persons additional time to examine the proposed requirements and submit comments. We have determined that extending the comment period until September 19, 2016, will not compromise the safety of the affected airplanes. The comment period for Docket No. FAA–2016–6139 closes September 19, 2016. Because no other portion of the proposal or other regulatory information has been changed, the entire proposal is not being republished. VerDate Sep<11>2014 14:37 Jun 14, 2016 Jkt 238001 Issued in Renton, Washington, on June 8, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. 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’’). [FR Doc. 2016–14114 Filed 6–14–16; 8:45 am] 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 https://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 https:// 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: https://www.fda.gov/ BILLING CODE 4910–13–P 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. 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: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://www.regulations.gov. • If you want to submit a comment with confidential information that you PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 E:\FR\FM\15JNP1.SGM 15JNP1 Federal Register / Vol. 81, No. 115 / Wednesday, June 15, 2016 / Proposed Rules regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// 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 § 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. ehiers on DSK5VPTVN1PROD with PROPOSALS 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 (§ 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. VerDate Sep<11>2014 14:37 Jun 14, 2016 Jkt 238001 New data must be furnished in the form specified in 21 CFR 171.1 and 171.100 for submitting petitions (§ 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 § 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. PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 38985 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 § 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 https:// 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 E:\FR\FM\15JNP1.SGM 15JNP1 38986 Federal Register / Vol. 81, No. 115 / Wednesday, June 15, 2016 / Proposed Rules 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 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R04–OAR–2015–0449; FRL–9947–62– Region 4] Air Plan Approval; North Carolina; Regional Haze Progress Report Environmental Protection Agency. ACTION: Proposed rule. AGENCY: The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of North Carolina through the North Carolina Division of Air Quality (NC DAQ) on May 31, 2013. North Carolina’s May 31, 2013, SIP revision (Progress Report) addresses requirements of the Clean Air Act (CAA or Act) and EPA’s rules that require each state to submit periodic reports describing progress towards reasonable progress goals (RPGs) established for regional haze and a determination of the adequacy of the state’s existing SIP addressing regional haze (regional haze plan). EPA is proposing to approve North Carolina’s Progress Report on the basis that it addresses the progress report and adequacy determination requirements for the first implementation period for regional haze. DATES: Comments must be received on or before July 15, 2016. ADDRESSES: Submit your comments, identified by Docket ID No. EPA–R04– OAR–2015–0449 at https:// www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is ehiers on DSK5VPTVN1PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 14:37 Jun 14, 2016 Jkt 238001 considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/ commenting-epa-dockets. FOR FURTHER INFORMATION CONTACT: Sean Lakeman, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303–8960. Mr. Lakeman can be reached by phone at (404) 562–9043 and via electronic mail at lakeman.sean@epa.gov. SUPPLEMENTARY INFORMATION: I. Background Under the Regional Haze Rule,1 each state was required to submit its first implementation plan addressing regional haze visibility impairment to EPA no later than December 17, 2007. See 40 CFR 51.308(b). North Carolina submitted its regional haze plan on that date, and like many other states subject to the Clean Air Interstate Rule (CAIR), relied on CAIR to satisfy best available retrofit technology (BART) requirements for emissions of sulfur dioxide (SO2) and nitrogen oxides (NOX) from electric generating units (EGUs) in the State. On June 7, 2012, EPA finalized a limited disapproval of North Carolina’s December 17, 2007 regional haze plan submission because of deficiencies arising from the State’s reliance on CAIR to satisfy certain regional haze requirements. See 77 FR 33642. In a separate action taken on June 27, 2012, EPA finalized a limited approval of North Carolina’s December 17, 2007, regional haze plan submission, as meeting some of the applicable regional haze requirements as set forth in sections 169A and 169B of the CAA and in 40 CFR 51.300–51.308. See 77 FR 38185. On October 31, 2014, the State submitted a regional haze plan revision to correct the deficiencies identified in the June 27, 2012, limited disapproval by replacing reliance on CAIR with reliance on the State’s Clean Smokestacks Act (CSA) as an alternative to NOX and SO2 BART for BARTeligible EGUs formerly subject to CAIR. 1 40 PO 00000 CFR part 51, subpart P. Frm 00012 Fmt 4702 Sfmt 4702 EPA approved that SIP revision on May 13, 2016, resulting in a full approval of North Carolina’s regional haze plan. Each state is also required to submit a progress report in the form of a SIP revision every five years that evaluates progress towards the RPGs for each mandatory Class I Federal area within the state and for each mandatory Class I Federal area outside the state which may be affected by emissions from within the state. See 40 CFR 51.308(g). Each state is also required to submit, at the same time as the progress report, a determination of the adequacy of its existing regional haze plan. See 40 CFR 51.308(h). The first progress report is due five years after submittal of the initial regional haze plan. On May 31, 2013, as required by 40 CFR 51.308(g), NC DAQ submitted to EPA, in the form of a revision to North Carolina’s SIP, a report on progress made towards the RPGs for Class I areas in the State and for Class I areas outside the State that are affected by emissions from sources within the State. This submission also includes a negative declaration pursuant to 40 CFR 51.308(h)(1) that the State’s regional haze plan is sufficient in meeting the requirements of the Regional Haze Rule (40 CFR 51.300 et seq.). EPA is proposing to approve North Carolina’s Progress Report on the basis that it satisfies the requirements of 40 CFR 51.308(g) and (h) now that EPA has fully approved the State’s regional haze plan. II. Requirements for the Regional Haze Progress Report and Adequacy Determinations A. Regional Haze Progress Report Under 40 CFR 51.308(g), states must submit a regional haze progress report as a SIP revision every five years and must address, at a minimum, the seven elements found in 40 CFR 51.308(g). As described in further detail in section III below, 40 CFR 51.308(g) requires: (1) A description of the status of measures in the approved regional haze plan; (2) a summary of emissions reductions achieved; (3) an assessment of visibility conditions for each Class I area in the state; (4) an analysis of changes in emissions from sources and activities within the state; (5) an assessment of any significant changes in anthropogenic emissions within or outside the state that have limited or impeded progress in Class I areas impacted by the state’s sources, (6) an assessment of the sufficiency of the approved regional haze plan; and (7) a review of the state’s visibility monitoring strategy. E:\FR\FM\15JNP1.SGM 15JNP1

Agencies

[Federal Register Volume 81, Number 115 (Wednesday, June 15, 2016)]
[Proposed Rules]
[Pages 38984-38986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

-----------------------------------------------------------------------

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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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 https://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
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