83 FR 50487 - Food Additives Permitted for Direct Addition to Food for Human Consumption; Styrene
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 195 (October 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 195 (October 9, 2018)
| Page Range | 50487-50490 | |
| FR Document | 2018-21808 |
[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)] [Rules and Regulations] [Pages 50487-50490] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21808] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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.thefederalregister.org/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; [[Page 50489]] 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
![Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Rules and Regulations 50487
V. The Repeal of the Rule Is Not the anticipated economic impact of the DEPARTMENT OF HEALTH AND
Intended To Preempt State Action for amendment of a rule on small entities. HUMAN SERVICES
Deceptive or Unfair Acts or Practices The purpose of a regulatory flexibility
Regarding Television Screen Size analysis is to ensure that an agency Food and Drug Administration
To prevent what CTA characterized as considers the impacts on small entities
the potential for ‘‘a complicated and examines regulatory alternatives 21 CFR Part 172
patchwork quilt of inconsistent [state that could achieve the regulatory [Docket No. FDA–2016–F–1444]
law] mandates,’’ 42 it asked the purpose while minimizing burdens on
Commission to issue an affirmative small entities. Section 605 of the RFA, Food Additives Permitted for Direct
statement that by repealing the Rule it 5 U.S.C. 605, provides that such an Addition to Food for Human
intends to preempt any state regulatory analysis is not required if the agency Consumption; Styrene
or enforcement actions regarding head certifies that the regulatory action
representations of television screen AGENCY: Food and Drug Administration,
will not have a significant economic
size.43 The Commission declines to HHS.
impact on a substantial number of small
issue such a statement. entities. The Commission concludes ACTION: Final rule.
While the Commission concludes that
that the repeal of the Rule will not have SUMMARY: The Food and Drug
a trade regulation rule for television
screen measurement is no longer a significant economic impact upon Administration (FDA, the Agency, or
necessary, it retains its authority to small entities because the Rule’s repeal we) is amending the food additive
address future unfair or deceptive will eliminate any costs associated with regulations to no longer provide for the
practices relating to television screen complying with the Rule. Therefore, in use of styrene as a flavoring substance
measurement on a case-by-case basis.44 the Commission’s view, the repeal of the and adjuvant for use in food because
Similarly, states have authority under Rule will not have a significant or these uses have been abandoned. We are
analogous state laws. Therefore, the disproportionate impact on the costs of taking this action in response to a food
Commission’s repeal of the Rule is not small entities that sell televisions. These additive petition submitted by the
intended to preempt the states from entities appear to provide consumers Styrene Information and Research
taking regulatory or enforcement actions with the screen size as measured by a Center (SIRC).
to prevent deception or unfairness television’s manufacturer and that DATES: This rule is effective October 9,
concerning television screen typically appears on a television’s 2018. See section VIII for further
measurement. packaging. In addition, the Commission information on the filing of objections.
VI. Regulatory Flexibility Act and is not aware of any existing federal laws Submit either electronic or written
Regulatory Analysis or regulations that address the objections and requests for a hearing on
measurement of television screens and the final rule by November 8, 2018.
Under Section 22 of the FTC Act, 15
that would conflict with the repeal of ADDRESSES: You may submit objections
U.S.C. 57b–3, the Commission must
issue a final regulatory analysis for a the Rule. Therefore, based on available and requests for a hearing as follows.
proceeding to amend a rule only when information, the Commission certifies Please note that late, untimely filed
it: (1) Estimates that the amendment that repealing the Rule will not have a objections will not be considered.
will have an annual effect on the significant economic impact on a Electronic objections must be submitted
national economy of $100 million or substantial number of small entities. on or before November 8, 2018.
more; (2) estimates that the amendment Objections received by mail/hand
VII. Repeal of Rule delivery/courier (for written/paper
will cause a substantial change in the
cost or price of certain categories of submissions) will be considered timely
For the reasons stated in the
goods or services; or (3) otherwise if they are postmarked or the delivery
preamble, and under the authority of 15
determines that the amendment will service acceptance receipt is on or
U.S.C. 57a, the Commission removes 16 before that date.
have a significant effect upon covered CFR part 410.
entities or upon consumers. The Electronic Submissions
Commission determines that the repeal List of Subjects in 16 CFR Part 410
of the Rule will not have such effects on Submit electronic objections in the
the national economy; on the cost of Advertising, Electronic funds transfer, following way:
televisions; or on covered parties or Television, and Trade practices. • Federal eRulemaking Portal:
consumers. The Rule repeal, rather than By direction of the Commission,
https://www.regulations.gov. Follow the
imposing any costs on covered parties Commissioner Wilson not participating.
instructions for submitting comments.
or consumers, will eliminate any costs Objections submitted electronically,
Donald S. Clark,
associated with complying with the including attachments, to https://
Secretary. www.regulations.gov will be posted to
Rule. Accordingly, the repeal of the
Rule is exempt from Section 22’s final the docket unchanged. Because your
PART 410—[REMOVED] objection will be made public, you are
regulatory analysis requirements.
The Regulatory Flexibility Act solely responsible for ensuring that your
■ Accordingly, under the authority of 15 objection does not include any
(‘‘RFA’’), 5 U.S.C. 601–612, requires that
the Commission conduct an analysis of U.S.C. 57a, the Commission removes 16 confidential information that you or a
CFR part 410. third party may not wish to be posted,
[FR Doc. 2018–21803 Filed 10–5–18; 8:45 am] such as medical information, your or
amozie on DSK3GDR082PROD with RULES
enforcement, the Commission stated that should it
find any future deception of the type that the Rule BILLING CODE 6750–01–P anyone else’s Social Security number, or
was intended to prevent, the Commission could confidential business information, such
address this deception through case-by-case
enforcement). as a manufacturing process. Please note
42 CTA–II at 9. that if you include your name, contact
43 CTA–II at 9–11. information, or other information that
44 See n. 41, supra. identifies you in the body of your
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![50490 Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Rules and Regulations
VII. Paperwork Reduction Act of 1995 Dated: October 2, 2018. FDA is declining to act on the
Leslie Kux, petitioners’ request to issue a regulation
This final rule contains no collection Associate Commissioner for Policy. to prohibit the use of these synthetic
of information. Therefore, clearance by flavoring substances in food because
[FR Doc. 2018–21808 Filed 10–5–18; 8:45 am]
the Office of Management and Budget that issue is not the proper subject of a
BILLING CODE 4164–01–P
under the Paperwork Reduction Act of food additive petition.
1995 is not required.
DATES: This rule is effective October 9,
VIII. Objections DEPARTMENT OF HEALTH AND 2018. See section IX for further
HUMAN SERVICES information on the filing of objections.
If you will be adversely affected by Submit either electronic or written
one or more provisions of this Food and Drug Administration objections and requests for a hearing on
regulation, you may file with the the final rule by November 8, 2018.
Dockets Management Staff (see 21 CFR Parts 172 and 177
ADDRESSES: You may submit objections
ADDRESSES) either electronic or written [Docket No. FDA–2015–F–4317] and requests for a hearing as follows.
objections. You must separately number
Please note that late, untimely filed
each objection, and within each Food Additive Regulations; Synthetic objections will not be considered.
numbered objection you must specify Flavoring Agents and Adjuvants Electronic objections must be submitted
with particularity the provision(s) to
AGENCY: Food and Drug Administration, on or before November 8, 2018.
which you object and the grounds for
HHS. Objections received by mail/hand
your objection. Within each numbered
ACTION: Final rule; notification of partial delivery/courier (for written/paper
objection, you must specifically state
denial of petition. submissions) will be considered timely
whether you are requesting a hearing on
if they are postmarked or the delivery
the particular provision that you specify SUMMARY: The Food and Drug service acceptance receipt is on or
in that numbered objection. If you do Administration (FDA, the Agency, or before that date.
not request a hearing for any particular we) is partially granting a petition
objection, you waive the right to a submitted by the Breast Cancer Fund Electronic Submissions
hearing on that objection. If you request (now known as the Breast Cancer Submit electronic objections in the
a hearing, your objection must include Prevention Partners), Center for following way:
a detailed description and analysis of Environmental Health, Center for Food • Federal eRulemaking Portal:
the specific factual information you Safety, Center for Science in the Public https://www.regulations.gov. Follow the
intend to present in support of the Interest, Consumers Union, instructions for submitting comments.
objection in the event that a hearing is Environmental Defense Fund, Objections submitted electronically,
held. If you do not include such a Environmental Working Group, including attachments, to https://
description and analysis for any Improving Kids’ Environment, Natural www.regulations.gov will be posted to
particular objection, you waive the right Resources Defense Council, WE ACT for the docket unchanged. Because your
to a hearing on the objection. Environmental Justice, and Mr. James objection will be made public, you are
Any objections received in response Huff, by amending the food additive solely responsible for ensuring that your
to the regulation may be seen in the regulations to no longer authorize the objection does not include any
Dockets Management Staff between 9 use of benzophenone, ethyl acrylate, confidential information that you or a
a.m. and 4 p.m., Monday through eugenyl methyl ether, myrcene, third party may not wish to be posted,
Friday, and will be posted to the docket pulegone, and pyridine as synthetic such as medical information, your or
at https://www.regulations.gov. flavoring substances for use in food. We anyone else’s Social Security number, or
are taking this action because, despite confidential business information, such
List of Subjects in 21 CFR Part 172
FDA’s scientific analysis and as a manufacturing process. Please note
Food additives, Reporting and determination that these substances do that if you include your name, contact
recordkeeping requirements. not pose a risk to public health under information, or other information that
the conditions of their intended use, the identifies you in the body of your
Therefore, under the Federal Food, petitioners provided data demonstrating objection, that information will be
Drug, and Cosmetic Act and under that these additives induce cancer in posted on https://www.regulations.gov.
authority delegated to the Commissioner laboratory animals, and, as a result of • If you want to submit an objection
of Food and Drugs and redelegated to this finding in animals, FDA cannot as with confidential information that you
the Director, Center for Food Safety and a matter of law maintain the listing of do not wish to be made available to the
Applied Nutrition, 21 CFR part 172 is these synthetic flavoring substances in public, submit the objection as a
amended as follows: the food additive regulations. Because of written/paper submission and in the
PART 172—FOOD ADDITIVES evidence that benzophenone causes manner detailed (see ‘‘Written/Paper
PERMITTED FOR DIRECT ADDITION cancer in animals, FDA also is Submissions’’ and ‘‘Instructions’’).
TO FOOD FOR HUMAN amending the food additive regulations
to no longer provide for the use of Written/Paper Submissions
CONSUMPTION
benzophenone as a plasticizer in rubber Submit written/paper submissions as
articles intended for repeated use in follows:
■ 1. The authority citation for part 172
contact with food. FDA is denying as • Mail/Hand delivery/Courier (for
continues to read as follows:
moot the portions of the petition written/paper submissions): Dockets
amozie on DSK3GDR082PROD with RULES
Authority: 21 U.S.C. 321, 341, 342, 348, proposing that the food additive Management Staff (HFA–305), Food and
371, 379e. regulations be amended to no longer Drug Administration, 5630 Fishers
§ 172.515 [Amended] authorize the use of styrene as a Lane, Rm. 1061, Rockville, MD 20852.
synthetic flavoring substance because • For written/paper objections
■ 2. Amend § 172.515(b) by removing this use has been permanently and submitted to the Dockets Management
the entry for ‘‘Styrene.’’ completely abandoned. In addition, Staff, FDA will post your objection, as
VerDate Sep<11>2014 17:30 Oct 05, 2018 Jkt 247001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\09OCR1.SGM 09OCR1](https://thefederalregister.org/doc/83_FR_50682/page/4.svg)
Document Created: 2018-10-06 00:59:29
Document Modified: 2018-10-06 00:59:29
| 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 | Rules and Regulations | |
| Action | Final rule. | |
| 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. | |
| 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. | |
| FR Citation | 83 FR 50487 | |
| CFR Associated | Food Additives and Reporting and Recordkeeping Requirements |
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