[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)]
[Rules and Regulations]
[Pages 50487-50490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21808]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

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


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Styrene

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
amending the food additive regulations to no longer provide for the use 
of styrene as a flavoring substance and adjuvant for use in food 
because these uses have been abandoned. We are taking this action in 
response to a food additive petition submitted by the Styrene 
Information and Research Center (SIRC).

DATES: This rule is effective October 9, 2018. See section VIII for 
further information on the filing of objections. Submit either 
electronic or written objections and requests for a hearing on the 
final rule by November 8, 2018.

ADDRESSES: You may submit objections and requests for a hearing as 
follows. Please note that late, untimely filed objections will not be 
considered. Electronic objections must be submitted on or before 
November 8, 2018. Objections received by mail/hand delivery/courier 
(for written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is on or before 
that date.

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Objections submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your objection will be 
made public, you are solely responsible for ensuring that your 
objection 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

[[Page 50488]]

objection, that information will be posted on https://www.regulations.gov.
     If you want to submit an objection with confidential 
information that you do not wish to be made available to the public, 
submit the objection 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Dockets 
Management Staff, FDA will post your objection, 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 ``Food Additives Permitted for Direct Addition to 
Food for Human Consumption; Styrene.'' Received objections, those filed 
in a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit an objection with 
confidential information that you do not wish to be made publicly 
available, submit your objections 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 Dockets Management 
Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 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, 5001 
Campus Dr., College Park, MD 20740-3835, 240-402-1071.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 15, 2016 (81 FR 38984), we 
announced that we 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 proposed to amend 
Sec. [thinsp]172.515 Synthetic flavoring substances and adjuvants (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 abandoned. Any use of styrene 
other than as a synthetic flavoring substance and adjuvant in food in 
accordance with Sec.  172.515 was considered outside the scope of this 
petition.

II. Evaluation of Abandonment

    Section 409(i) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 348(i)) states that we must by regulation establish the 
procedure for amending or repealing a food additive regulation and that 
this procedure must conform to the procedure provided in section 409 of 
the FD&C Act for the issuance 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))). The regulations 
further provide that any such petition must 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 repeal. New data must be furnished in the 
form specified in Sec. Sec.  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 United States 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 should 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 information 
collected from its members to support the petitioner's claim that 
styrene is no longer manufactured, imported, or otherwise marketed for 
use as a synthetic flavoring substance and adjuvant in food in the U.S. 
market and that industry has abandoned such use of styrene. 
Specifically, the petition contained information SIRC collected through 
surveying its membership, which contains over 95 percent of the current 
North American styrene industry, to verify that its members:
     Do not currently manufacture styrene for use as a 
synthetic flavoring substance and adjuvant in food in the United 
States;
     do not currently import styrene for use as a synthetic 
flavoring substance and adjuvant in food into the United States;

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     do not 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
     do not 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 confirmed that no foreign manufacturers appear to be 
using or marketing styrene for use as a synthetic flavoring substance 
or adjuvant in food, based on information received from the Japan 
Styrene Industry Association, the European Chemical Industry Council, 
and contacts in China.
    Additionally, SIRC consulted with the Flavor and Extract 
Manufacturers Association of the Unites States and received a 
determination confirming that the Flavor and Extract Manufacturers 
Association members no longer use or produce styrene as a synthetic 
flavoring substance or adjuvant in food. The Flavor and Extract 
Manufacturers Association also submitted to the docket for this 
petition data and information in support of the petition, which FDA 
reviewed and evaluated in making its decision on this petition. The 
Flavor and Extract Manufacturers Association is a national association 
of the U.S. flavor industry whose members include flavor manufacturers, 
flavor users, flavor ingredient suppliers, and others. Based on 
information provided from Flavor and Extract Manufacturers Association, 
its members manufacture more than 95 percent of all flavoring 
substances sold in the United States.

III. Comments on the Filing Notice

    We provided 60 days for comments on the filing notice. We received 
two comments. For ease of reading, we preface each comment discussion 
with a numbered ``Comment,'' and the word ``Response'' appears before 
FDA's response. The number assigned is for organizational purposes only 
and does not signify any individual comment's value, importance, or 
order in which it was received. One comment expressed concerns about 
the timing of FDA action on SIRC's abandonment petition. This comment 
is summarized below, followed by FDA's response. The other comment 
supported SIRC's conclusions that the use of styrene as a synthetic 
flavoring substance or adjuvant in food has been abandoned.
    (Comment 1) One comment requested that we not make a final decision 
on the petition until after we make a final decision on a food additive 
petition (FAP 5A4810) submitted in 2015 by several consumer groups 
asking us to remove styrene (and six other additives) from Sec.  
172.515 as a synthetic flavoring substance and adjuvant in food on the 
basis that it is not safe for use in food (Docket No. FDA-2015-F-4317). 
The comment stated that if we make a decision on the petition based on 
abandonment before making a decision on FAP 5A4810 based on safety, a 
company may conclude that the use of styrene is generally recognized as 
safe (GRAS) without notifying us. The comment also stated that making a 
decision based on abandonment ``leaves unresolved the safety issue . . 
. and encourages industry to only consider whether something is 
abandoned in order to preempt a safety decision.'' Further, the comment 
stated that FDA is statutorily required to regulate food additives and 
prevent the use of those that are unsafe and that FDA's failure to make 
a determination based on safety would fall short of FDA's statutory 
duty.
    (Response 1) FDA disagrees. We are not required to make a final 
decision on FAP 5A4810 before the current petition. With regard to the 
assertion that FDA is required to make a safety determination and that 
failure to do so falls short of FDA's statutory duty, FDA has numerous 
responsibilities related to food additives. Each year, FDA receives and 
responds to hundreds of submissions under the various petition and 
notification programs we administer. Therefore, if the use of a food 
additive is no longer authorized in response to an abandonment 
petition, FDA may determine that it is neither necessary nor an 
efficient use of its limited resources to address safety arguments 
related to an abandoned use.
    With regard to the comment's concern that a manufacturer may 
conclude that the use of styrene as a synthetic flavoring substance and 
adjuvant in food is GRAS without notifying us, we note that, for a 
substance to be GRAS based on scientific procedures, the scientific 
data and information about the use of a substance must be generally 
available and there must be general recognition among qualified experts 
that those data and information establish that the substance is safe 
under the conditions of its intended use (21 CFR 170.30). Prior 
approval as a food additive does not mean that the use of a substance 
is GRAS (see 81 FR 54960 at 54976, August 17, 2016). FDA encourages 
firms to seek our evaluation of any conclusion of GRAS status before 
they introduce the substance into the market. In the event that a 
manufacturer later wishes to reinstate the use of styrene as a 
synthetic flavoring substance and adjuvant in food, we would expect the 
manufacturer to seek re-authorization through submission of a food 
additive petition because this intended use was previously authorized 
under section 409 of the FD&C Act.
    With regard to the assertion that an abandonment petition could be 
used by industry to preempt a safety determination by FDA, we have the 
discretion to make a safety determination regardless of whether there 
is an abandonment petition.
    Elsewhere in this issue of the Federal Register we have published a 
final rule in response to FAP 5A4810 amending Sec.  172.515 to no 
longer authorize the use of benzophenone, ethyl acrylate, eugenyl 
methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring 
substances and adjuvants in food.

IV. Conclusion

    FDA reviewed the data and information in the petition and other 
available relevant material to evaluate whether the use of styrene as a 
synthetic flavoring substance and adjuvant in food has been has been 
permanently and completely abandoned. Based on the available 
information, we have determined that the use of styrene as a synthetic 
flavoring substance and adjuvant in food has been abandoned. Therefore, 
we are amending Sec.  172.515 to no longer provide for the use of 
styrene as a synthetic flavoring substance and adjuvant in food.

V. Public Disclosure

    In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that we considered and relied upon in reaching our 
decision to approve the petition will be made available for public 
disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in Sec.  
171.1(h), we will delete from the documents any materials that are not 
available for public disclosure.

VI. Analysis of Environmental Impact

    We previously considered the environmental effects of this rule, as 
stated in the June 15, 2016, Federal Register notice of petition for 
FAP 6A4817 (81 FR 38984). We stated that we had determined, under 21 
CFR 25.32(m), that this action ``is of a type that does not 
individually or cumulatively have a significant effect on the human 
environment'' such that neither an environmental assessment nor an 
environmental impact statement is required. We have not received any 
new information or comments that would affect our previous 
determination.

[[Page 50490]]

VII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VIII. Objections

    If you will be adversely affected by one or more provisions of this 
regulation, you may file with the Dockets Management Staff (see 
ADDRESSES) either electronic or written objections. You must separately 
number each objection, and within each numbered objection you must 
specify with particularity the provision(s) to which you object and the 
grounds for your objection. Within each numbered objection, you must 
specifically state whether you are requesting a hearing on the 
particular provision that you specify in that numbered objection. If 
you do not request a hearing for any particular objection, you waive 
the right to a hearing on that objection. If you request a hearing, 
your objection must include a detailed description and analysis of the 
specific factual information you intend to present in support of the 
objection in the event that a hearing is held. If you do not include 
such a description and analysis for any particular objection, you waive 
the right to a hearing on the objection.
    Any objections received in response to the regulation may be seen 
in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at https://www.regulations.gov.

List of Subjects in 21 CFR Part 172

    Food additives, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

0
1. The authority citation for part 172 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 342, 348, 371, 379e.


Sec.  172.515  [Amended]

0
2. Amend Sec.  172.515(b) by removing the entry for ``Styrene.''

    Dated: October 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21808 Filed 10-5-18; 8:45 am]
 BILLING CODE 4164-01-P


