[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Notices]
[Pages 31090-31091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10532]



Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Notices

[[Page 31090]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0571]


Ortho-phthlates for Food Contact Use; Request for Information

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice; request for information.

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SUMMARY: The Food and Drug Administration (FDA or we) is opening a 
docket to obtain data and information on the use of ortho-phthalates 
(or ``phthalates'') for food contact applications. Specifically, FDA is 
seeking scientific data and information on current uses, use levels, 
dietary exposure, and safety data of certain ortho-phthalates. The 
purpose of this request is to provide FDA with all sources of relevant 
information to support our review of the current use levels and safe 
use of these ortho-phthalates in food contact applications.

DATES: Submit either electronic or written comments and scientific data 
and information by July 19, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before July 19, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 19, 2022. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2022-N-0571 for ``Ortho-phthalates for Food Contact Use; Request 
for Information.'' Received comments, those filed in a timely manner 
(see ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Jessica Urbelis, Center for Food 
Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-5187; or Meadow Platt, 
Office of Regulations and Policy (HFS-024), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

I. Background

A. Introduction

    Ortho-phthalates may be used as plasticizers for polymers, most 
commonly poly (vinyl chloride), to make the polymers less brittle or to 
soften them. These polymers are then used in a wide range of products, 
such as toys, vinyl flooring and wall covering, detergents, lubricating 
oils, food packaging, pharmaceuticals, blood bags and tubing, and 
personal care products. Our food additive regulations at parts 175, 
176, 177, 178, and 181 (21 CFR parts 175, 176, 177, 178, and 181) 
provide for the safe use of certain ortho-phthalates as plasticizers 
for packaging used to contact food and for other food contact 
applications, such as components of adhesives, resins, lubricants, and 
sealants.

B. Recent Petitions

    In the Federal Register of May 20, 2016 (81 FR 31877), we announced 
that we had filed a food additive petition (FAP 6B4815) in accordance 
with 21 CFR 171.130. The food additive petition (FAP 6B4815) proposed 
that we amend or revoke certain food additive regulations under parts 
175, 176, 177, and 178 to no longer provide for the food contact use of 
specified ortho-phthalates. The petitioners based their petition on the 
claim that new evidence demonstrates the use of these ortho-phthalates 
in food contact applications is unsafe. Elsewhere in this issue of the 
Federal Register, we have published a

[[Page 31091]]

final rule in response to FAP 6B4815 denying that petition.
    On April 20, 2016, we received a citizen petition (Docket No. FDA-
2016-P-1171) requesting that we initiate rulemaking to remove the prior 
sanctions in part 181 for the following five ortho-phthalates: di(2-
ethylhexyl) phthalate (CAS No. 117-81-7), diethyl phthalate (CAS No. 
84-66-2), ethyl phthalyl ethyl glycolate (CAS No. 84-72-0), butyl 
phthalyl butyl glycolate (CAS No. 85-70-1), and diisooctyl phthalate 
(CAS No. 27554-26-3). FDA defined the term ``prior sanction'' in Sec.  
170.3(l) (21 CFR 170.3(l)) as an explicit approval granted with respect 
to use of a substance in food prior to September 6, 1958, by FDA or the 
United States Department of Agriculture (USDA), pursuant to the FD&C 
Act, the Poultry Products Inspection Act, or the Meat Inspection Act. 
The term ``prior sanction'' derives from section 201(s)(4) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(s)(4)), 
which excepts from the definition of a food additive any substance used 
in accordance with a sanction or approval granted before September 6, 
1958, the date of enactment of the Food Additives Amendment to the FD&C 
Act. Before that date, we had approved specific uses of various food-
contact materials or food ingredients by issuing letters and other 
statements that, in FDA's view, these substances were ``not considered 
unsafe,'' that they did ``not present a hazard,'' or that we ``did not 
object to their use.'' The existence of a prior sanction exempts 
sanctioned uses from the food additive provisions of the FD&C Act but 
not from the other adulteration or the misbranding provisions of the 
FD&C Act (Sec.  181.5(b)). The prior sanction exists only for a 
specific use of a substance in food and delineates level(s), 
condition(s), and product(s) set forth by explicit approval by FDA or 
USDA before September 6, 1958 (Sec.  181.5(a)). Some prior sanctioned 
substances are codified in part 181. The citizen petition also 
requested that we add a new section to 21 CFR part 189 prohibiting the 
use of the following eight ortho-phthalates: diisobutyl phthalate (CAS 
No. 84-69-5), di-n-butyl phthalate (CAS No. 84-74-2), butyl benzyl 
phthalate (CAS No. 85-68-7), dicyclohexyl phthalate (CAS No. 84-61-7), 
di-n-hexyl phthalate (CAS No. 84-75-3), diisooctyl phthalate (CAS No. 
27554-26-3), di(2-ethylhexyl) phthalate (CAS No. 117-81-7), and 
diisononyl phthalate (CAS No. 28553-12-0). We are denying this citizen 
petition.
    In the Federal Register of November 14, 2018 (83 FR 56750), we 
announced that we had filed a food additive petition (FAP 8B4820) 
submitted in accordance with Sec.  171.130. That FAP (8B4820) proposed 
to amend parts 175, 176, 177, and 178 to no longer provide for certain 
uses of ortho-phthalates on the basis that the use of those ortho-
phthalates in food contact applications has been abandoned. Elsewhere 
in this issue of the Federal Register, we have published a final rule 
in response to FAP 8B4820 granting that petition and amending parts 
175, 176, 177, and 178 to no longer authorize the uses of the subject 
ortho-phthalates in food contact applications because those uses have 
been permanently and completely abandoned.
    FAP 8B4820 includes the ortho-phthalates that are addressed in FAP 
6B4815 except for the following: Diisononyl phthalate (DINP) (CAS No. 
28553-12-0), diisodecyl phthalate (DIDP) (CAS No. 26761-40-0), di(2-
ethylhexyl) phthalate (DEHP) (CAS No. 117-81-7), and dicyclohexyl 
phthalate (DCHP) (CAS No. 84-61-7). These four phthalates are not 
included in the final rule for FAP 8B4820 because the petition does not 
claim that their uses have been abandoned. In addition, FAP 8B4820 does 
not include diallyl phthalate (CAS No.) 131-17-9. Diallyl phthalate is 
only authorized for use in these regulations as a monomer in the 
manufacture of polymers and not as a plasticizer.

C. Current Status of Information

    The original safety assessments that resulted in the authorized 
uses of ortho-phthalates in food contact applications were based on 
exposure and toxicological information and data provided during the 
period of 1961 through 1985. As the food supply and packaging market 
has changed since that time, the use of ortho-phthalates in food 
contact materials has also evolved. Furthermore, the body of available 
toxicological information on phthalates has expanded since the food 
contact uses of ortho-phthalates were authorized. While FDA is 
generally aware of updated toxicological and use information on 
phthalates that is publicly available, we are also aware that 
stakeholders do not always make such information public. As such, we 
request all updated information regarding the food contact uses, use 
levels, and dietary exposure and safety data for the ortho-phthalates 
listed below that are currently in use in food contact applications. We 
may use this information to update the dietary exposure estimates and 
safety assessments for the permitted food contact uses of ortho-
phthalates. While we are responding to the food additive petitions and 
citizen petition based on the information provided in those petitions 
and other relevant and available data, the information we are 
requesting may add to our knowledge of ortho-phthalates that remain 
authorized for use.

II. Request for Information

    FDA is requesting information on the current food contact uses, use 
levels, dietary exposure and safety data on ortho-phthalates currently 
used in food contact applications. FDA is not requesting this 
information for uses that have been abandoned. Specifically, FDA 
requests the following:
    1. Information on any current specific food-contact uses and use 
levels for the following ortho-phthalates found in FDA's regulations 
(as food additives and/or prior sanctioned substances): Diisononyl 
phthalate (DINP, CAS No. 28553-12-0), diisodecyl phthalate (DIDP, CAS 
No. 26761-40-0), di(2-ethylhexyl) phthalate (DEHP, CAS No. 117-81-7), 
dicyclohexyl phthalate (DCHP, CAS No. 84-61-7), butylphthalyl butyl 
glycolate (BPBG, CAS No. 85-70-1), diethyl phthalate (DEP, CAS No. 84-
66-2), ethylphthalyl ethyl glycolate (EPEG, CAS No. 84-72-0) and 
diisooctyl phthalate (DIOP, CAS No. 27554-26-3);
    2. Data, analyses, and any other information related to dietary 
exposure from the use of ortho-phthalates listed in item 1 currently in 
food contact applications;
    3. Safety data for all ortho-phthalates listed in item 1 currently 
used in food contact applications; and/or
    4. Information regarding any prior sanctioned uses of ortho-
phthalates not listed in FDA's regulations. This includes documentation 
to support the prior sanction and the information requested in items 1 
through 3 above on the current use(s), use levels, exposure, and safety 
information for any such prior-sanctioned ortho-phthalates currently in 
use.

    Dated: May 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10532 Filed 5-19-22; 8:45 am]
BILLING CODE 4164-01-P