[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]



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 Rules and Regulations
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  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.

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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.
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    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