Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Proposed Rules 1857 

1. Ethylene dichloride (CAS No. 107– 

06–2); 

2. Methylene chloride (CAS No. 75– 

09–2); and 

3. Trichloroethylene (CAS No. 79–01– 

6). 

II. Request To Amend 21 CFR Part 73 

In accordance with the procedure in 

section 721(d) of the FD&C Act for 

issuance, amendment, or repeal of 

regulations, the petition asks us to 

amend §§ 73.1, 73.30, 73.345, and 

73.615 to remove ethylene dichloride, 

methylene chloride, and 

trichloroethylene. Specifically, the 

petitioners state these substances have 

been found to induce cancer in humans 

or animals and, therefore, are not safe 

pursuant to section 721(b)(5)(B) of the 

FD&C Act (also referred to as the 

‘‘Delaney Clause’’). The Delaney Clause 

provides, in relevant part, that no color 

additive shall be deemed safe for any 

use which will or may result in 

ingestion of all or part of such additive, 

if the additive is found by the Secretary 

of Health and Human Services 

(Secretary) to induce cancer when 

ingested by man or animal, or if it is 

found by the Secretary, after tests which 

are appropriate for the evaluation of the 

safety of additives for use in food, to 

induce cancer in man or animal. 

The petition is available in the docket. 

We invite comments, additional 

scientific data, and other information 

related to the issues raised by this 

petition. If we determine that the 

available data justify amending §§ 73.1, 

73.30, 73.345, and 73.615 to remove 

ethylene dichloride, methylene 

chloride, and trichloroethylene, we will 

publish our decision in the Federal 

Register in accordance with 21 CFR 

71.20. 

The petitioners have claimed that this 

action is categorically excluded under 

21 CFR 25.32(m), which applies to an 

action to prohibit or otherwise restrict 

or reduce the use of a substance in food, 

food packaging, or cosmetics. In 

addition, the petitioners have stated 

that, to their knowledge, no 

extraordinary circumstances exist (see 

21 CFR 25.21). If FDA determines a 

categorical exclusion applies, neither an 

environmental assessment nor an 

environmental impact statement is 

required. If FDA determines a 

categorical exclusion does not apply, we 

will request an environmental 

assessment and make it available for 

public inspection. 

Dated: January 8, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00410 Filed 1–10–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 172 and 173 

[Docket No. FDA–2023–F–5684] 

Filing of Food Additive Petition From 

Environmental Defense Fund, et al.; 

Request To Amend the Food Additive 

Regulations To Remove the Solvents 

Benzene, Ethylene Dichloride, 

Methylene Chloride, and 

Trichloroethylene 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of petition. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that we have filed a food 

additive petition, submitted by 

Environmental Defense Fund, et al., 

proposing that the food additive 

regulations be amended to remove four 

specified solvents. 

DATES: The food additive petition was 

filed on December 21, 2023. Submit 

either electronic or written comments 

on the filing notice by March 11, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

March 11, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received 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– 

2023–F–5684 for ‘‘Filing of Food 

Additive Petition from Environmental 

Defense Fund, et al.; Request To Amend 

the Food Additive Regulations To 

Remove the Solvents Benzene, Ethylene 

Dichloride, Methylene Chloride, and 

Trichloroethylene.’’ Received 

comments, those filed in a timely 

manner (see DATES), 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 

comment 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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
1858 Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Proposed Rules 

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: 

Paulette M. Gaynor, Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–1192. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under section 409(b)(5) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

348(b)(5)), we are giving notice that we 

have filed a food additive petition (FAP 

4A4839), submitted by Environmental 

Defense Fund, Breast Cancer Prevention 

Partners, Center for Environmental 

Health, Environmental Working Group, 

and Lisa Lefferts, c/o Lisa Lefferts, 

Nellysford, VA 22958. The petition 

proposes that we amend §§ 172.560 (21 

CFR 172.560, ‘‘Modified hop extract’’), 

172.710 (21 CFR 172.710, ‘‘Adjuvants 

for pesticide use dilutions’’), 173.230 

(21 CFR 173.230, ‘‘Ethylene 

dichloride’’), 173.255 (21 CFR 172.255, 

‘‘Methylene chloride’’), 173.290 (21 CFR 

173.290, ‘‘Trichloroethylene’’), and 

173.315 (21 CFR 173.315, ‘‘Chemicals 

used in washing or to assist in the 

peeling of fruits and vegetables’’) to 

remove the use of four specified 

solvents. 

The four solvents that are the subject 

of this petition are: 

1. Benzene (CAS No. 71–43–2); 

2. Ethylene dichloride (CAS No. 107–06– 

2); 

3. Methylene chloride (CAS No. 75–09–2); 

and 

4. Trichloroethylene (CAS No. 79–01–6). 

II. Request To Amend 21 CFR Parts 172 

and 173 

In accordance with the procedures for 

amending or repealing a food additive 

regulation in § 171.130 (21 CFR 

171.130), the petition asks us to amend 

§§ 172.560, 172.710, 173.230, 173.255, 

173.290, and 173.315 to remove 

benzene, ethylene dichloride, 

methylene chloride, and 

trichloroethylene. Specifically, the 

petitioners state that these substances 

have been found to induce cancer in 

humans or animals and, therefore, are 

not safe pursuant to section 409(c)(3)(A) 

of the FD&C Act (also referred to as the 

‘‘Delaney Clause’’). The Delaney Clause 

provides that no food additive shall be 

deemed to be safe if it is found to induce 

cancer when ingested by man or animal, 

or if it is found after tests which are 

appropriate for the evaluation of the 

safety of food additives, to induce 

cancer in man or animal. 

The petition is available in the docket. 

We invite comments, additional 

scientific data, and other information 

related to the issues raised by this 

petition. If we determine that the 

available data justify amending 

§§ 172.560, 172.710, 173.230, 173.255, 

173.290, and 173.315 to remove 

benzene, ethylene dichloride, 

methylene chloride, and 

trichloroethylene, we will publish our 

decision in the Federal Register in 

accordance with § 171.130. 

The petitioners have claimed that this 

action is categorically excluded under 

21 CFR 25.32(m), which applies to an 

action to prohibit or otherwise restrict 

or reduce the use of a substance in food, 

food packaging, or cosmetics. In 

addition, the petitioners have stated 

that, to their knowledge, no 

extraordinary circumstances exist (see 

21 CFR 25.21). If FDA determines a 

categorical exclusion applies, neither an 

environmental assessment nor an 

environmental impact statement is 

required. If FDA determines a 

categorical exclusion does not apply, we 

will request an environmental 

assessment and make it available for 

public inspection. 

Dated: January 8, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00411 Filed 1–10–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 and 301 

[REG–118492–23; REG–113064–23; REG– 

120080–22] 

RIN 1545–BQ99; RIN 1545–BQ86; RIN 1545– 

BQ52 

Section 30D Excluded Entities; 

Transfer of Clean Vehicle Credits 

Under Section 25E and Section 30D; 

Section 30D New Clean Vehicle Credit; 

Hearing 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Notice of proposed rulemaking; 

notice of hearing. 

SUMMARY: This document provides a 

notice of public hearing on proposed 

regulations that would provide guidance 

regarding the proposed regulations 

under sections 25E, 30D, and 6213 with 

respect to the clean vehicle credits as 

amended by the Inflation Reduction Act 

of 2022. 

DATES: The public hearing on these 

proposed regulations has been 

scheduled for Wednesday, January 31, 

2024, at 10 a.m. ET. The IRS must 

receive speakers’ outlines of the topics 

to be discussed at the public hearing by 

Thursday, January 18, 2024. If no 

outlines are received by Thursday, 

January 18, 2024, the public hearing 

will be cancelled. 

ADDRESSES: The public hearing is being 

held in the Auditorium, at the Internal 

Revenue Service Building, 1111 

Constitution Avenue NW, Washington, 

DC. Due to security procedures, visitors 

must enter at the Constitution Avenue 

entrance. In addition, all visitors must 

present a valid photo identification to 

enter the building. Because of access 

restrictions, visitors will not be 

admitted beyond the immediate 

entrance area more than 30 minutes 

before the hearing starts. Participants 

may alternatively attend the public 

hearing by telephone. 

Send Submissions to CC:PA:01:PR 

(REG–130080–22, REG–113064–23, and 

REG–118492–23), Room 5205, Internal 

Revenue Service, P.O. Box 7604, Ben 

Franklin Station, Washington, DC 

20044. Submissions may be hand 

delivered Monday through Friday to 

CC:PA:01:PR (REG–130080–22, REG– 

113064–23, and REG–118492–23), 

Couriers Desk, Internal Revenue 

Service, 1111 Constitution Avenue NW, 

Room 5205, Washington, DC 20224 or 

sent electronically via the Federal 

eRulemaking Portal at 


ddrumheller on DSK120RN23PROD with PROPOSALS1