31090 Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Notices 

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. 

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 orthophthalates 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: 

• 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. 

• 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: 

• 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. 

• 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. 

• 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 orthophthalates 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 orthophthalates. The petitioners based their 

petition on the claim that new evidence 

demonstrates the use of these orthophthalates in food contact applications 

is unsafe. Elsewhere in this issue of the 

Federal Register, we have published a 


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

§ 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 (§ 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 (§ 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 § 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 orthophthalates 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 orthophthalates 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 orthophthalates 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 


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