[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.

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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