[Federal Register Volume 89, Number 210 (Wednesday, October 30, 2024)]
[Rules and Regulations]
[Pages 86239-86241]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25122]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 175, 176, 177, and 178

[Docket No. FDA-2018-F-3757]


Indirect Food Additives: Adhesives and Components of Coatings; 
Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, 
and Sanitizers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; response to objection; confirmation of effective 
date.

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SUMMARY: The Food and Drug Administration (FDA or we) is responding to 
the objection that we received from the Environmental Defense Fund, 
Breast Cancer Prevention Partners, Environmental Protection Network, 
Environmental Working Group, and Healthy Babies Bright Futures on the 
final rule that amended the food additive regulations to no longer 
provide for the use of 25 plasticizers that the petition identified as 
ortho-phthalates because these food additive uses have been permanently 
abandoned. After reviewing the objection, FDA has concluded that the 
objection does not provide a basis for modifying FDA's final rule 
amending the food additive regulations.

DATES: The effective date of May 20, 2022, for the final rule published 
on May 20, 2022 (87 FR 31080), is confirmed.

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, 
240-402-7500.

FOR FURTHER INFORMATION CONTACT: Stephen DiFranco, Office of Food 
Chemical Safety, Dietary Supplements, and Innovation (HFS-275), Human 
Foods Program, Food and Drug Administration, 5001 Campus Dr., College 
Park, MD 20740-3835, 240-402-2710; or Lauren Kleinman, Human Foods 
Program, Office of Policy, Regulations and Information (HFS-024), Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-2378.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 14, 2018 (83 FR 56750), we 
announced that we filed a food additive petition (FAP 8B4820) 
(Petition) submitted by The Flexible Vinyl Alliance (FVA or 
Petitioner), c/o Keller and Heckman, LLP, 1001 G St. NW, Suite 500 
West, Washington, DC 20001. The Petition requested that we amend our 
food additive regulations in parts 175, 176, 177, and 178 (21 CFR parts 
175, 176, 177, and 178) to no longer provide for the use of 26 
plasticizer substances that the Petition identified as ortho-
phthalates. (FAP 8B4820 submitted by FVA claimed that the food additive 
uses of di(2-ethylhexyl) hexahydrophthalate and diphenylguanidine 
phthalate are abandoned. We note that these substances are not 
chemically classified as ortho-phthalates and that characterization as 
such is incorrect.) The Petition requested that we revoke the approvals 
on the basis that the food additive uses have been permanently 
abandoned.
    One of the 26 plasticizers identified in the Petition was diallyl 
phthalate (Chemical Abstract Services number (CAS Reg No.) 131-17-9). 
The filing document indicated that this substance may be used as a food 
additive under Sec. Sec.  175.105, 176.180, 176.300, and 177.1210 (21 
CFR 175.105, 176.180, 176.300, and 177.1210) (see 83 FR 56750). 
However, upon further review, we determined that the use of diallyl 
phthalate is only authorized for use in these regulations as a monomer 
to produce polymers and not as a plasticizer. FVA made no claims in 
their Petition that the use of polymers produced with diallyl phthalate 
for food contact applications have been abandoned. Thus, after FDA 
followed up with the Petitioner, diallyl phthalate was no longer 
subject to this Petition (87 FR 31080). In the Federal Register of May 
20, 2022 (87 FR 31080), FDA issued a final rule amending the food 
additive regulations in parts 175, 176, 177, and 178 to no longer 
provide for the use of 25 plasticizers in various food contact 
applications (final rule). We gave interested persons until June 21, 
2022, to file objections and requests for a hearing on the final rule.

II. Objection and Comments

    Section 409(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21

[[Page 86240]]

U.S.C. 348(f)(1)) 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 
relating to food additive regulations are governed by 21 CFR part 12. 
Under Sec.  12.22(a) (21 CFR 12.22(a)), each objection must: (1) be 
submitted on or before the 30th day after the date of publication of 
the final rule; (2) be separately numbered; (3) specify with 
particularity the provision of the regulation or proposed order 
objected to; (4) 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) 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.
    Following the publication of the final rule in which we granted the 
Petition asserting abandonment of the 25 plasticizers in various food 
contact uses, we received a submission from the Environmental Defense 
Fund, Breast Cancer Prevention Partners, Environmental Protection 
Network, Environmental Working Group, and Healthy Babies Bright Futures 
(Objectors) containing one objection and two comments (see submission 
from Tom Neltner, Senior Director for Safer Chemicals, Environmental 
Defense Fund, et al., submitted to the Dockets Management Staff, Food 
and Drug Administration, dated June 19, 2022 (Submission) (Ref. 1). The 
Submission does not contain a request for a hearing.

III. Analysis of Objections and Comments

    The Submission contains one numbered objection and two numbered 
comments. We address each objection and comment below.

A. Objection 1

    The Submission states that ``The agency [improperly] denied FVA's 
request to remove approval of diallyl phthalate because it was used as 
a monomer to produce polymers and not as a plasticizer'' (Ref. 1 at 
page 1). The Submission states that the FVA survey that FVA submitted 
to provide evidence of abandonment asked survey recipients about food 
contact applications for the listed substances, not about use of the 
listed substances as plasticizers. According to this objection, FVA 
``clearly considered diallyl phthalate as abandoned,'' and therefore 
FDA should have removed diallyl phthalate from its food additive 
regulations on the basis that its use has been abandoned. The 
Submission also states the Objectors are not requesting a hearing on 
this Objection. Therefore, the Objectors have waived any right to a 
hearing on their Objection (see Sec.  12.22(a)(4)). The only remaining 
question under Sec.  12.24(a) is whether the Objection establishes that 
the final rule should be modified or revoked with respect to diallyl 
phthalate. As described below, we conclude that the Objectors have not 
established a basis for modifying or revoking the final rule.
    As FDA stated in the Federal Register document announcing the final 
rule, after following up with the Petitioner, diallyl phthalate was no 
longer subject to the Petition. In an email correspondence dated July 
20, 2018, between FDA and FVA's agent, FVA confirmed that diallyl 
phthalate is not within the scope of the abandonment request (see also 
87 FR 31080 at 31080 through 31081; Ref. 2). Thus, diallyl phthalate 
was removed from the Petition. Because diallyl phthalate was removed 
from the scope of the Petition, when FDA issued the final rule granting 
the Petition, the final rule did not cover diallyl phthalate. Thus, the 
final rule did not impact the regulatory authorizations for diallyl 
phthalate. Accordingly, FDA's actions regarding diallyl phthalate were 
reasonable, and there is no need for FDA to modify or revoke the final 
rule in response to Objection 1.

B. Comment 1

    The Submission asserts that FDA should remove the existing prior 
sanctioned uses of diethyl phthalate (CAS Reg. No. 84-66-2), diisooctyl 
phthalate (CAS Reg. No. 27554-26-3), ethylphthalyl ethyl glycolate (CAS 
Reg No. 84-72-0), and butylphthalyl butyl glycolate (CAS Reg. No. 85-
70-1) as a plasticizer at Sec.  181.27 (Ref. 1 at page 3). The 
Submission states that the survey that FVA used to support the request 
to remove food additive approvals for these substances did not 
differentiate between food additive and prior-sanctioned uses of these 
substances, and so therefore the prior-sanctioned uses should also be 
considered abandoned. The comment states that based on this evidence, 
FDA should have either removed the prior-sanction approvals as part of 
the final rule ``or initiated rulemaking to do so.''
    Prior-sanctioned uses are beyond the scope of food additive 
petitions, which apply only to substances that meet the definition of 
``food additive'' in section 201(s) of the FD&C Act (21 U.S.C. 321(s)). 
Consequently, prior-sanctioned uses are not the subject of the final 
rule (87 FR 31080 at 31081). Furthermore, section 409(f)(1) of the FD&C 
Act permits objections and requests for a hearing only to orders made 
under section 409(c) and (d) of the FD&C Act. Because FDA has not 
issued any orders under section 409(c) or (d) of the FD&C Act taking 
action on the specified prior-sanctioned-uses, the Submission's request 
regarding prior-sanctioned uses is not an objection to an order under 
section 409(c)(1)(B) of the FD&C Act and is not subject to the 
objections and hearing procedure in section 409(f) of the FD&C Act. 
Therefore, we will not address requests related to prior-sanctioned 
uses as part of this objections procedure under section 409(f) of the 
FD&C Act. The appropriate procedure for requesting rulemaking with 
respect to prior-sanctioned uses is to submit a citizen petition in 
accordance with 21 CFR 10.30.

C. Comment 2

    The Submission states that ``we do not object'' to the FVA 
abandonment claim, but states that some of the abandoned substances 
``may be present in food, food packaging and food handling equipment.'' 
According to the Submission, there is a need for FDA to ``clearly 
communicate to food manufacturers and food packaging and handling 
equipment manufacturers that they are not permitted to use [the 
abandoned substances] in food uses that may migrate into food without a 
specific food additive use approval or a specific authorization[.]''
    With respect to the suggestion that FDA needs to further 
communicate about the final rule, we disagree. We have already 
adequately communicated the nature and the scope of this action, in 
accordance with our standard procedures when granting a food additive 
petition. Specifically, we published the final rule in the Federal 
Register, which is the standard way for Agencies to communicate with 
regulated parties about substantive matters. We also posted a 
constituent update on FDA's website on the date the final rule went on 
display, informing industry and the public of the changes to the food 
additive regulations that resulted from the May 20, 2022, final rule 
and the circumstances around the action (Ref. 3). The constituent 
update

[[Page 86241]]

remains available on FDA's website. Furthermore, in the Federal 
Register of May 20, 2022 (87 FR 31090), we issued a notice requesting 
information on the use of some ortho-phthalates still authorized for 
food contact uses. The notice also discusses FAP 8B4820 and provides a 
citation to the final rule (see 87 FR 31090 at 31091).

IV. Summary and Conclusions

    After evaluating the Submission, for the reasons above, we conclude 
that the objection does not provide any basis for us to modify our 
regulations.

V. References

    The following references are on display at the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. Although FDA 
verified the website addresses in this document, please note that 
websites are subject to change over time.

1. Neltner, T., Environmental Defense Fund et. al., to the Dockets 
Management Staff, Food and Drug Administration, dated June 19, 2022.
2. Email from D.W. Hill, Keller and Heckman LLP to S. DiFranco, DPR, 
OFAS, CFSAN, FDA July 20, 2018.
3. ``Phthalates in Food Packaging and Food Contact Applications.'' 
Available at: https://www.fda.gov/food/food-ingredients-packaging/phthalates-food-packaging-and-food-contact-applications.

    Dated: October 22, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-25122 Filed 10-29-24; 8:45 am]
BILLING CODE 4164-01-P