1856 Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Proposed Rules 

YIKUK, NV FIX (Lat. 41°59′05.16′′ N, long. 114°51′49.12′′ W) 

BROPH, ID WP (Lat. 42°43′15.71′′ N, long. 114°52′31.80′′ W) 

* * * * * 

Issued in Washington, DC, on January 2, 

2024. 

Frank Lias, 

Manager, Rules and Regulations Group. 

[FR Doc. 2024–00085 Filed 1–10–24; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket No. FDA–2023–C–5679] 

Filing of Color Additive Petition From 

Environmental Defense Fund, et al.; 

Request To Amend the Color Additive 

Regulations To Remove the Solvents 

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 color 

additive petition, submitted by 

Environmental Defense Fund, et al., 

proposing that the color additive 

regulations be amended to remove three 

specified solvents. 

DATES: The color additive petition was 

filed on December 21, 2023. Either 

electronic or written comments must be 

submitted 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 

comment, 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 instructions 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 objection, 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–C–5679 for ‘‘Filing of Color 

Additive Petition From Environmental 

Defense Fund, et al.; Request To Amend 

the Color Additive Regulations To 

Remove the Solvents 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 

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 721(d)(1) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 379e(d)(1)), we are 

giving notice that we have filed a color 

additive petition (CAP 4C0327), 

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 §§ 73.1 (21 CFR 

73.1, ‘‘Diluents in color additive 

mixtures for food use exempt from 

certification’’), 73.30 (21 CFR 73.30, 

‘‘Annatto extract’’), 73.345 (21 CFR 

73.345, ‘‘Paprika oleoresin’’), and 73.615 

(21 CFR 73.615, ‘‘Turmeric oleoresin’’) 

to remove the use of three specified 

solvents. 

The three solvents that are the subject 

of this petition are: 


ddrumheller on DSK120RN23PROD with PROPOSALS1
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