[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\
---------------------------------------------------------------------------
\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