Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants; Confirmation of Effective Date, 5555-5557 [2020-01060]

Download as PDF 5555 Rules and Regulations Federal Register Vol. 85, No. 21 Friday, January 31, 2020 This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. The Code of Federal Regulations is sold by the Superintendent of Documents. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 172 and 177 [Docket No. FDA–2015–F–4317] Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants; Confirmation of Effective Date AGENCY: Food and Drug Administration, HHS. Final rule; confirmation of effective date. ACTION: The Food and Drug Administration (FDA or we) is responding to the submission styled as an objection submitted by Earthjustice on behalf of Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Defense Fund, Environmental Working Group, and the Natural Resources Defense Council, on the final rule that amended the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food. The final rule also amended the food additive regulations to no longer provide for the use of benzophenone as a plasticizer in rubber articles intended for repeated use in contact with food. After reviewing the submission, we have concluded that the submission we received is not an objection and consequently does not provide a basis for modifying the regulations. DATES: Effective date of final rule published in the Federal Register of October 9, 2018 (83 FR 50490) confirmed: October 9, 2018. ADDRESSES: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov and insert the docket number found in brackets in the jbell on DSKJLSW7X2PROD with RULES SUMMARY: VerDate Sep<11>2014 15:45 Jan 30, 2020 Jkt 250001 heading of this final rule 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: Mical Honigfort, Center for Food Safety and Applied Nutrition (HFS–265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740–3835, 240– 402–1278. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 4, 2016 (81 FR 42), we announced the filing of a food additive petition (FAP 5A4810) (‘‘petition’’) submitted jointly by the Center for Science in the Public Interest; Natural Resources Defense Council; Center for Food Safety; Consumers Union; Improving Kids’ Environment; Center for Environmental Health; Environmental Working Group; Environmental Defense Fund, and Mr. James Huff (collectively, ‘‘petitioners’’) c/o Thomas Neltner, 1875 Connecticut Ave. NW, Suite 600, Washington, DC 20009. Subsequently, the Breast Cancer Fund (now known as the Breast Cancer Prevention Partners) and WE ACT for Environmental Justice joined as copetitioners. The petition proposed that we take two separate regulatory actions: (1) Amend the food additive regulations in § 172.515 Synthetic flavoring substances and adjuvants (21 CFR 172.515) to no longer authorize the use of seven listed synthetic flavoring food additives and (2) to establish zero tolerances in § 172.515 for these additives. As FDA explained in the filing notice (81 FR 42 at 42 through 43) and the final rule (83 FR 50490 at 50491) for this petition, the food additive regulation is not the appropriate section for a ‘‘zero tolerance,’’ and this request is not the proper subject of a food additive petition. A food additive petition must either propose the issuance of a regulation prescribing the conditions under which a food additive may be safely used (see section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348(b)(1)), or propose the amendment or repeal of an existing food additive regulation (see section 409(i) of the FD&C Act). As we explained in the final rule, we interpreted the petitioners’ request to establish zero tolerances for these PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 additives as a request to issue a regulation prohibiting a substance from human food under part 189 (21 CFR part 189), a request that is not the proper subject of a food additive petition (83 FR 50490 at 50491). Therefore, because the petitioners’ request to establish zero tolerances fell outside the scope of a food additive petition, we focused solely on the request in the petition to amend the food additive regulations pertaining to these seven synthetic flavoring food additives. The seven food additives that were the subject of the petition are: 1. Benzophenone (also known as diphenylketone) (CAS No. 119–61–9); 2. Ethyl acrylate (CAS No. 140–88–5); 3. Eugenyl methyl ether (also known as 4allylveratrole or methyl eugenol) (CAS No. 93–15–2); 4. Myrcene (also known as 7-methyl-3methylene-1,6-octadiene) (CAS No. 123–35– 3); 5. Pulegone (also known as p-menth-4(8)en-3-one) (CAS No. 89–82–7); 6. Pyridine (CAS No. 110–86–1); and 7. Styrene (CAS No. 100–42–5) Related to FAP 5A4810, in the Federal Register of June 15, 2016 (81 FR 38984), we announced that we filed a food additive petition (FAP 6A4817) proposing that we amend § 172.515 to no longer provide for the use of styrene as a synthetic flavoring substance and adjuvant in food because the use has been abandoned. We later issued a final rule in the Federal Register of October 9, 2018 (83 FR 50487) granting the petition and amending § 172.515 to no longer authorize the use of styrene as a synthetic flavoring substance and adjuvant in food because its use under § 172.515 had been permanently and completely abandoned. Additionally, in the Federal Register of October 9, 2018 (83 FR 50490), we published a final rule partially granting FAP 5A4810 to amend the food additive regulations in § 172.515 to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food. We also amended the food additive regulation in 21 CFR 177.2600 to no longer provide for the use of benzophenone as a plasticizer in rubber articles intended for repeated use in contact with food. We denied as moot the portions of the petition proposing that the food additive regulations be amended to no longer authorize the use E:\FR\FM\31JAR1.SGM 31JAR1 5556 Federal Register / Vol. 85, No. 21 / Friday, January 31, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES of styrene as a synthetic flavoring substance because this use has been permanently and completely abandoned (83 FR 50490 at 50492 through 50493). As discussed in detail in section III, we explained in the final rule that we declined to act on the petitioners’ request to establish a zero tolerance for the use of these synthetic flavoring substances in food because that issue is not the proper subject of a food additive petition. The final rule advised that objections and requests for a hearing on the final rule were due by November 8, 2018. II. Objections and Requests for Hearing Section 409(f)(1) of the FD&C Act provides that, within 30 days after publication of an order relating to a food additive regulation, any person adversely affected by such order may file objections, specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds therefor, and requesting a public hearing upon such objections. Under 21 CFR 171.110, objections and requests for a hearing are governed by 21 CFR part 12 of FDA’s regulations. Under 21 CFR 12.22(a), each objection must meet the following conditions: (1) Must be submitted on or before the 30th day after the date of publication of the final rule; (2) must be separately numbered; (3) must specify with particularity the provision of the regulation or proposed order objected to; (4) must specifically state each objection on which a hearing is requested; failure to request a hearing on an objection constitutes a waiver of the right to a hearing on that objection; and (5) must include a detailed description and analysis of the factual information to be presented in support of the objection if a hearing is requested; failure to include a description and analysis for an objection constitutes a waiver of the right to a hearing on that objection. Within the 30-day objection period following publication of the final rule, we received approximately 50 comments concerning the final rule. With the exception of one submission, the comments did not purport to raise objections and did not provide or identify any relevant new evidence. We will not address these comments further. However, we received one submission that stated it was noting several concerns and raising one ‘‘objection.’’ Earthjustice, on behalf of Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Center for Science in the Public VerDate Sep<11>2014 15:45 Jan 30, 2020 Jkt 250001 Interest, Environmental Defense Fund, Environmental Working Group, and the Natural Resources Defense Council, wrote to ‘‘share our objection and concerns’’ about the final rule (see Letter from Peter Lehner, Senior Attorney, and Carrie Apfel, Staff Attorney, Earthjustice, to Dockets Management Staff, Food and Drug Administration, dated November 8, 2018). (For the purposes of this document, we will refer to these entities as ‘‘parties.’’) The submission stated that the parties ‘‘applaud[ed] FDA for acknowledging that it ‘cannot consider these synthetic substances to be safe as a matter of law,’’’ but indicated that it objected to our ‘‘failure to indicate expressly that these substances no longer qualify in any way as ‘safe’ for use in food, which amounts to an arbitrary and unlawful failure to protect the safety of food’’ (id. at page 1). The submission also noted two concerns about our analyses of the substances (id.). The parties also stated in their submission that they waived their right to a hearing (id.). As discussed in detail in section III, the provision for objections and a hearing under section 409(f) of the FD&C Act does not apply to this ‘‘objection.’’ For the purposes of this document, our use of the term ‘‘objection’’ does not mean that the provision for objections under section 409(f) of the FD&C Act applies. III. Analysis of Objection The submission’s ‘‘objection’’ is not subject to the objections and hearing procedure in section 409(f) of the FD&C Act. Therefore, we will not address the arguments detailed in the submission. The submission asserts that FDA’s failure to indicate expressly in the final rule that substances found to induce cancer cannot qualify in any way as ‘‘safe’’ for use in food is arbitrary and unlawful (Earthjustice submission at pages 2 through 3). The submission further states that, ‘‘To correct this deficiency, FDA must explain that substances found to induce cancer cannot qualify as ‘‘safe’’ for use in food, regardless of whether those substances purport to be food additives, GRAS substances, or both’’ (id. at page 3). A substance is generally recognized as safe (GRAS) if there is general recognition, among qualified experts, to be safe under the conditions of its intended use. A substance that is GRAS under the conditions of its intended use is excluded from the statutory definition of food additive under section 201(s) of the FD&C Act (21 U.S.C. 321(s)). Thus, given a substance is, by definition, not a food additive if it is GRAS, whether PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 the status of a substance is GRAS is outside the scope of the food additive petition process and the related provision for objections and public hearing. Section 409(f)(1) of the FD&C Act states that within 30 days after publication of an order made pursuant to section 409(c) or (d) of the FD&C Act, any person adversely affected by such an order may file objections, specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds therefor. In the final rule, we stated that we partially granted the petition and partially denied the petition, completely responding to the food additive petition submitted by the petitioners (83 FR 50490 at 50492). FDA partially granted the petition by amending the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food based on data provided by the petitioners that demonstrated these additives induce cancer in laboratory animals, and, as a result of this finding in animals, FDA cannot as a matter of law maintain the listing of these synthetic flavoring substances in the food additive regulations (21 U.S.C. 348(c)(3)(A)). We further amended the food additive regulations to no longer provide for the use of benzophenone as a plasticizer in rubber articles intended for repeated use in contact with food because of evidence that benzophenone causes cancer in animals. FDA denied as moot the portions of the petition proposing that the food additive regulations be amended to no longer authorize the use of styrene as a synthetic flavoring substance because this use has been permanently and completely abandoned. Further, and most relevant here, FDA denied the petitioners’ request to establish zero tolerances for these additives because such a request fell outside the scope of the food additive petition process (83 FR 50490 at 50491). As a result of responding to these two food additive petitions, FDA revoked the uses of all seven synthetic flavoring substances either: (1) As a matter of law because data demonstrated that six of the seven synthetic flavoring substances have been shown to cause cancer in animals or (2) based on a determination that the use had been completely and permanently abandoned; we further made clear that the petitioners’ ‘‘zero tolerance’’ request was not the proper subject of a food additive petition (83 FR 50487; 83 FR 50490). E:\FR\FM\31JAR1.SGM 31JAR1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 85, No. 21 / Friday, January 31, 2020 / Rules and Regulations Thus, when the parties state in their ‘‘objection’’ that FDA’s ‘‘failure to indicate expressly that these substances no longer qualify in any way as ‘safe’ for use in food.. . . amounts to an arbitrary and unlawful failure to protect the safety of food,’’ it does not appear the parties have stated with particularity a specific provision of the synthetic flavoring substances order that they deem objectionable. The parties do not object to our determination to revoke the uses of the synthetic flavoring substances, and in fact in their submission, the parties stated they ‘‘applaud FDA for acknowledging that it ‘cannot consider these synthetic flavoring substances to be safe as a matter of law’ ’’ (Earthjustice submission, page 1). Rather, by asserting in their submission that FDA is being arbitrary and unlawful by failing to indicate expressly in the final rule that substances found to induce cancer cannot qualify in any way as ‘‘safe’’ for use in food, we interpret the parties’ ‘‘objection’’ to be related to the petitioners’ request to establish zero tolerances for these synthetic flavoring additives, a request we declined to act on in the final rule because such a request was not the proper subject of a food additive petition. As explained in the final rule (83 FR 50490 at 50491), a food additive petition must either propose the issuance of a regulation prescribing the conditions under which a food additive may be safely used or propose the amendment or repeal of an existing food additive regulation (sections 409(b)(1) and (i) of the FD&C Act). We explained in the final rule that we interpreted the request to establish zero tolerances for these flavoring additives as a request to issue a regulation prohibiting a substance from human food under part 189 and that this request fell outside the scope of a food additive petition because it does not propose the issuance of a new food additive regulation or the amendment or repeal of an existing food additive regulation (id.). Consequently, we did not address the zero tolerance request further in the final rule and thus this issue was not considered part of the order by regulation that revoked the uses for these synthetic flavoring additives, pursuant to section 409(c) of the FD&C Act. Therefore, because the parties failed to identify a provision of the order deemed objectionable and have also failed to raise an objection regarding the order made pursuant to section 409(c) or (d) of the FD&C Act, the provision for objections and public VerDate Sep<11>2014 16:28 Jan 30, 2020 Jkt 250001 hearing under section 409(f) of the FD&C Act does not apply.1 Finally, even though we do not think the parties’ submission legally rises to an objection under 409(f) of the FD&C Act, even if the submission was a properly raised objection, we would deny such an objection because the parties’ request amounts to the same outcome as the petitioners’ zero tolerance request and such a request falls outside the scope of the food additive petition process. IV. Conclusion After evaluating the submission from Earthjustice et al., we have concluded that the ‘‘objection’’ is not within the scope of the objections and hearing provision under section 409(f) of the FD&C Act. Therefore, we do not address the arguments related to this ‘‘objection.’’ We are confirming October 9, 2018, as the effective date of this regulation. FDA still intends to not enforce applicable requirements of the final rule with regard to food products manufactured (domestically and internationally) prior to October 9, 2020, that contain one or more of these six synthetic flavoring substances, to provide an opportunity for companies to reformulate products prior to enforcing the requirements of this final rule. 5557 Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place lasmiditan in schedule V of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing lasmiditan, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule V of the CSA. Dated: January 16, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. The effective date of this rulemaking is January 31, 2020. Interested persons may file written comments on this rulemaking in accordance with 21 U.S.C. 811(j)(3) and 21 CFR 1308.43(g). Electronic comments must be submitted, and written comments must be postmarked, on or before March 2, 2020. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Interested persons may file a request for hearing or waiver of hearing in accordance with 21 U.S.C. 811(j)(3) and 21 CFR 1308.44. Requests for hearing and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before March 2, 2020. [FR Doc. 2020–01060 Filed 1–30–20; 8:45 am] ADDRESSES: BILLING CODE 4164–01–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA–558] Schedules of Controlled Substances: Placement of Lasmiditan in Schedule V Drug Enforcement Administration, Department of Justice. ACTION: Interim final rule with request for comments. AGENCY: On October 11, 2019, the U.S. Food and Drug Administration approved a new drug application for Reyvow (lasmiditan) tablets for oral use. Lasmiditan is chemically known as [2,4,6-trifluoro-N-(6-(1methylpiperidine-4-carbonyl)pyridine2-yl-benzamide]. Thereafter, the SUMMARY: 1 We note that the parties’ submission did not present any argument or evidence that FDA’s determination that the petitioners’ zero tolerance request was not the proper subject of a food additive petition, and was thus outside the scope of section 409 of the FD&C Act, was erroneous. PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 DATES: To ensure proper handling of comments, please reference ‘‘Docket No. DEA–558’’ on all correspondence, including any attachments. • Electronic comments: The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission, you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. • Paper comments: Paper comments that duplicate the electronic submission are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular E:\FR\FM\31JAR1.SGM 31JAR1

Agencies

[Federal Register Volume 85, Number 21 (Friday, January 31, 2020)]
[Rules and Regulations]
[Pages 5555-5557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01060]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 

========================================================================


Federal Register / Vol. 85, No. 21 / Friday, January 31, 2020 / Rules 
and Regulations

[[Page 5555]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 172 and 177

[Docket No. FDA-2015-F-4317]


Food Additive Regulations; Synthetic Flavoring Agents and 
Adjuvants; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

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

SUMMARY: The Food and Drug Administration (FDA or we) is responding to 
the submission styled as an objection submitted by Earthjustice on 
behalf of Breast Cancer Prevention Partners, Center for Environmental 
Health, Center for Food Safety, Center for Science in the Public 
Interest, Environmental Defense Fund, Environmental Working Group, and 
the Natural Resources Defense Council, on the final rule that amended 
the food additive regulations to no longer authorize the use of 
benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, 
and pyridine as synthetic flavoring substances for use in food. The 
final rule also amended the food additive regulations to no longer 
provide for the use of benzophenone as a plasticizer in rubber articles 
intended for repeated use in contact with food. After reviewing the 
submission, we have concluded that the submission we received is not an 
objection and consequently does not provide a basis for modifying the 
regulations.

DATES: Effective date of final rule published in the Federal Register 
of October 9, 2018 (83 FR 50490) confirmed: October 9, 2018.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule 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: Mical Honigfort, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740-3835, 240-402-1278.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 4, 2016 (81 FR 42), we announced 
the filing of a food additive petition (FAP 5A4810) (``petition'') 
submitted jointly by the Center for Science in the Public Interest; 
Natural Resources Defense Council; Center for Food Safety; Consumers 
Union; Improving Kids' Environment; Center for Environmental Health; 
Environmental Working Group; Environmental Defense Fund, and Mr. James 
Huff (collectively, ``petitioners'') c/o Thomas Neltner, 1875 
Connecticut Ave. NW, Suite 600, Washington, DC 20009. Subsequently, the 
Breast Cancer Fund (now known as the Breast Cancer Prevention Partners) 
and WE ACT for Environmental Justice joined as co-petitioners.
    The petition proposed that we take two separate regulatory actions: 
(1) Amend the food additive regulations in Sec.  172.515 Synthetic 
flavoring substances and adjuvants (21 CFR 172.515) to no longer 
authorize the use of seven listed synthetic flavoring food additives 
and (2) to establish zero tolerances in Sec.  172.515 for these 
additives. As FDA explained in the filing notice (81 FR 42 at 42 
through 43) and the final rule (83 FR 50490 at 50491) for this 
petition, the food additive regulation is not the appropriate section 
for a ``zero tolerance,'' and this request is not the proper subject of 
a food additive petition. A food additive petition must either propose 
the issuance of a regulation prescribing the conditions under which a 
food additive may be safely used (see section 409(b)(1) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348(b)(1)), or 
propose the amendment or repeal of an existing food additive regulation 
(see section 409(i) of the FD&C Act). As we explained in the final 
rule, we interpreted the petitioners' request to establish zero 
tolerances for these additives as a request to issue a regulation 
prohibiting a substance from human food under part 189 (21 CFR part 
189), a request that is not the proper subject of a food additive 
petition (83 FR 50490 at 50491). Therefore, because the petitioners' 
request to establish zero tolerances fell outside the scope of a food 
additive petition, we focused solely on the request in the petition to 
amend the food additive regulations pertaining to these seven synthetic 
flavoring food additives.
    The seven food additives that were the subject of the petition are:

    1. Benzophenone (also known as diphenylketone) (CAS No. 119-61-
9);
    2. Ethyl acrylate (CAS No. 140-88-5);
    3. Eugenyl methyl ether (also known as 4-allylveratrole or 
methyl eugenol) (CAS No. 93-15-2);
    4. Myrcene (also known as 7-methyl-3-methylene-1,6-octadiene) 
(CAS No. 123-35-3);
    5. Pulegone (also known as p-menth-4(8)-en-3-one) (CAS No. 89-
82-7);
    6. Pyridine (CAS No. 110-86-1); and
    7. Styrene (CAS No. 100-42-5)

    Related to FAP 5A4810, in the Federal Register of June 15, 2016 (81 
FR 38984), we announced that we filed a food additive petition (FAP 
6A4817) proposing that we amend Sec.  172.515 to no longer provide for 
the use of styrene as a synthetic flavoring substance and adjuvant in 
food because the use has been abandoned. We later issued a final rule 
in the Federal Register of October 9, 2018 (83 FR 50487) granting the 
petition and amending Sec.  [thinsp]172.515 to no longer authorize the 
use of styrene as a synthetic flavoring substance and adjuvant in food 
because its use under Sec.  [thinsp]172.515 had been permanently and 
completely abandoned.
    Additionally, in the Federal Register of October 9, 2018 (83 FR 
50490), we published a final rule partially granting FAP 5A4810 to 
amend the food additive regulations in Sec.  [thinsp]172.515 to no 
longer authorize the use of benzophenone, ethyl acrylate, eugenyl 
methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring 
substances for use in food. We also amended the food additive 
regulation in 21 CFR[thinsp]177.2600 to no longer provide for the use 
of benzophenone as a plasticizer in rubber articles intended for 
repeated use in contact with food. We denied as moot the portions of 
the petition proposing that the food additive regulations be amended to 
no longer authorize the use

[[Page 5556]]

of styrene as a synthetic flavoring substance because this use has been 
permanently and completely abandoned (83 FR 50490 at 50492 through 
50493). As discussed in detail in section III, we explained in the 
final rule that we declined to act on the petitioners' request to 
establish a zero tolerance for the use of these synthetic flavoring 
substances in food because that issue is not the proper subject of a 
food additive petition. The final rule advised that objections and 
requests for a hearing on the final rule were due by November 8, 2018.

II. Objections and Requests for Hearing

    Section 409(f)(1) of the FD&C Act provides that, within 30 days 
after publication of an order relating to a food additive regulation, 
any person adversely affected by such order may file objections, 
specifying with particularity the provisions of the order deemed 
objectionable, stating reasonable grounds therefor, and requesting a 
public hearing upon such objections.
    Under 21 CFR 171.110, objections and requests for a hearing are 
governed by 21 CFR part 12 of FDA's regulations. Under 21 CFR 12.22(a), 
each objection must meet the following conditions: (1) Must be 
submitted on or before the 30th day after the date of publication of 
the final rule; (2) must be separately numbered; (3) must specify with 
particularity the provision of the regulation or proposed order 
objected to; (4) must specifically state each objection on which a 
hearing is requested; failure to request a hearing on an objection 
constitutes a waiver of the right to a hearing on that objection; and 
(5) must include a detailed description and analysis of the factual 
information to be presented in support of the objection if a hearing is 
requested; failure to include a description and analysis for an 
objection constitutes a waiver of the right to a hearing on that 
objection.
    Within the 30-day objection period following publication of the 
final rule, we received approximately 50 comments concerning the final 
rule. With the exception of one submission, the comments did not 
purport to raise objections and did not provide or identify any 
relevant new evidence. We will not address these comments further.
    However, we received one submission that stated it was noting 
several concerns and raising one ``objection.'' Earthjustice, on behalf 
of Breast Cancer Prevention Partners, Center for Environmental Health, 
Center for Food Safety, Center for Science in the Public Interest, 
Environmental Defense Fund, Environmental Working Group, and the 
Natural Resources Defense Council, wrote to ``share our objection and 
concerns'' about the final rule (see Letter from Peter Lehner, Senior 
Attorney, and Carrie Apfel, Staff Attorney, Earthjustice, to Dockets 
Management Staff, Food and Drug Administration, dated November 8, 
2018). (For the purposes of this document, we will refer to these 
entities as ``parties.'') The submission stated that the parties 
``applaud[ed] FDA for acknowledging that it `cannot consider these 
synthetic substances to be safe as a matter of law,''' but indicated 
that it objected to our ``failure to indicate expressly that these 
substances no longer qualify in any way as `safe' for use in food, 
which amounts to an arbitrary and unlawful failure to protect the 
safety of food'' (id. at page 1). The submission also noted two 
concerns about our analyses of the substances (id.). The parties also 
stated in their submission that they waived their right to a hearing 
(id.).
    As discussed in detail in section III, the provision for objections 
and a hearing under section 409(f) of the FD&C Act does not apply to 
this ``objection.'' For the purposes of this document, our use of the 
term ``objection'' does not mean that the provision for objections 
under section 409(f) of the FD&C Act applies.

III. Analysis of Objection

    The submission's ``objection'' is not subject to the objections and 
hearing procedure in section 409(f) of the FD&C Act. Therefore, we will 
not address the arguments detailed in the submission.
    The submission asserts that FDA's failure to indicate expressly in 
the final rule that substances found to induce cancer cannot qualify in 
any way as ``safe'' for use in food is arbitrary and unlawful 
(Earthjustice submission at pages 2 through 3). The submission further 
states that, ``To correct this deficiency, FDA must explain that 
substances found to induce cancer cannot qualify as ``safe'' for use in 
food, regardless of whether those substances purport to be food 
additives, GRAS substances, or both'' (id. at page 3). A substance is 
generally recognized as safe (GRAS) if there is general recognition, 
among qualified experts, to be safe under the conditions of its 
intended use. A substance that is GRAS under the conditions of its 
intended use is excluded from the statutory definition of food additive 
under section 201(s) of the FD&C Act (21 U.S.C. 321(s)). Thus, given a 
substance is, by definition, not a food additive if it is GRAS, whether 
the status of a substance is GRAS is outside the scope of the food 
additive petition process and the related provision for objections and 
public hearing.
    Section 409(f)(1) of the FD&C Act states that within 30 days after 
publication of an order made pursuant to section 409(c) or (d) of the 
FD&C Act, any person adversely affected by such an order may file 
objections, specifying with particularity the provisions of the order 
deemed objectionable, stating reasonable grounds therefor. In the final 
rule, we stated that we partially granted the petition and partially 
denied the petition, completely responding to the food additive 
petition submitted by the petitioners (83 FR 50490 at 50492). FDA 
partially granted the petition by amending the food additive 
regulations to no longer authorize the use of benzophenone, ethyl 
acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as 
synthetic flavoring substances for use in food based on data provided 
by the petitioners that demonstrated these additives induce cancer in 
laboratory animals, and, as a result of this finding in animals, FDA 
cannot as a matter of law maintain the listing of these synthetic 
flavoring substances in the food additive regulations (21 U.S.C. 
348(c)(3)(A)). We further amended the food additive regulations to no 
longer provide for the use of benzophenone as a plasticizer in rubber 
articles intended for repeated use in contact with food because of 
evidence that benzophenone causes cancer in animals. FDA denied as moot 
the portions of the petition proposing that the food additive 
regulations be amended to no longer authorize the use of styrene as a 
synthetic flavoring substance because this use has been permanently and 
completely abandoned. Further, and most relevant here, FDA denied the 
petitioners' request to establish zero tolerances for these additives 
because such a request fell outside the scope of the food additive 
petition process (83 FR 50490 at 50491).
    As a result of responding to these two food additive petitions, FDA 
revoked the uses of all seven synthetic flavoring substances either: 
(1) As a matter of law because data demonstrated that six of the seven 
synthetic flavoring substances have been shown to cause cancer in 
animals or (2) based on a determination that the use had been 
completely and permanently abandoned; we further made clear that the 
petitioners' ``zero tolerance'' request was not the proper subject of a 
food additive petition (83 FR 50487; 83 FR 50490).

[[Page 5557]]

    Thus, when the parties state in their ``objection'' that FDA's 
``failure to indicate expressly that these substances no longer qualify 
in any way as `safe' for use in food.. . . amounts to an arbitrary and 
unlawful failure to protect the safety of food,'' it does not appear 
the parties have stated with particularity a specific provision of the 
synthetic flavoring substances order that they deem objectionable. The 
parties do not object to our determination to revoke the uses of the 
synthetic flavoring substances, and in fact in their submission, the 
parties stated they ``applaud FDA for acknowledging that it `cannot 
consider these synthetic flavoring substances to be safe as a matter of 
law' '' (Earthjustice submission, page 1). Rather, by asserting in 
their submission that FDA is being arbitrary and unlawful by failing to 
indicate expressly in the final rule that substances found to induce 
cancer cannot qualify in any way as ``safe'' for use in food, we 
interpret the parties' ``objection'' to be related to the petitioners' 
request to establish zero tolerances for these synthetic flavoring 
additives, a request we declined to act on in the final rule because 
such a request was not the proper subject of a food additive petition.
    As explained in the final rule (83 FR 50490 at 50491), a food 
additive petition must either propose the issuance of a regulation 
prescribing the conditions under which a food additive may be safely 
used or propose the amendment or repeal of an existing food additive 
regulation (sections 409(b)(1) and (i) of the FD&C Act). We explained 
in the final rule that we interpreted the request to establish zero 
tolerances for these flavoring additives as a request to issue a 
regulation prohibiting a substance from human food under part 189 and 
that this request fell outside the scope of a food additive petition 
because it does not propose the issuance of a new food additive 
regulation or the amendment or repeal of an existing food additive 
regulation (id.). Consequently, we did not address the zero tolerance 
request further in the final rule and thus this issue was not 
considered part of the order by regulation that revoked the uses for 
these synthetic flavoring additives, pursuant to section 409(c) of the 
FD&C Act. Therefore, because the parties failed to identify a provision 
of the order deemed objectionable and have also failed to raise an 
objection regarding the order made pursuant to section 409(c) or (d) of 
the FD&C Act, the provision for objections and public hearing under 
section 409(f) of the FD&C Act does not apply.\1\
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    \1\ We note that the parties' submission did not present any 
argument or evidence that FDA's determination that the petitioners' 
zero tolerance request was not the proper subject of a food additive 
petition, and was thus outside the scope of section 409 of the FD&C 
Act, was erroneous.
---------------------------------------------------------------------------

    Finally, even though we do not think the parties' submission 
legally rises to an objection under 409(f) of the FD&C Act, even if the 
submission was a properly raised objection, we would deny such an 
objection because the parties' request amounts to the same outcome as 
the petitioners' zero tolerance request and such a request falls 
outside the scope of the food additive petition process.

IV. Conclusion

    After evaluating the submission from Earthjustice et al., we have 
concluded that the ``objection'' is not within the scope of the 
objections and hearing provision under section 409(f) of the FD&C Act. 
Therefore, we do not address the arguments related to this 
``objection.'' We are confirming October 9, 2018, as the effective date 
of this regulation. FDA still intends to not enforce applicable 
requirements of the final rule with regard to food products 
manufactured (domestically and internationally) prior to October 9, 
2020, that contain one or more of these six synthetic flavoring 
substances, to provide an opportunity for companies to reformulate 
products prior to enforcing the requirements of this final rule.

    Dated: January 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01060 Filed 1-30-20; 8:45 am]
 BILLING CODE 4164-01-P

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