Federal Register / Vol. 87, No. 131 / Monday, July 11, 2022 / Proposed Rules 41079 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 174, 175, and 177 

[Docket No. FDA–2022–F–1108] 

Environmental Defense Fund, Maricel 

Maffini, Breast Cancer Prevention 

Partners, Clean Water Action/Clean 

Water Fund, Consumer Reports, 

Endocrine Society, Environmental 

Working Group, Healthy Babies Bright 

Futures, Linda Birnbaum, and the 

Nicholas School of the Environment at 

Duke University; Filing of Food 

Additive Petition 

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 

petition, submitted by Environmental 

Defense Fund, Maricel Maffini, Breast 

Cancer Prevention Partners, Clean Water 

Action/Clean Water Fund, Consumer 

Reports, Endocrine Society, 

Environmental Working Group, Healthy 

Babies Bright Futures, Linda Birnbaum, 

and the Nicholas School of the 

Environment at Duke University, 

proposing that the food additive 

regulations be amended to remove or 

restrict authorizations for the use of 

bisphenol A (BPA). 

DATES: The food additive petition was 

filed on May 2, 2022. Submit either 

electronic or written comments on the 

filing notice by September 9, 2022. 

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 

September 9, 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–F–1108 for ‘‘Environmental 

Defense Fund, Maricel Maffini, Breast 

Cancer Prevention Partners, Clean Water 

Action/Clean Water Fund, Consumer 

Reports, Endocrine Society, 

Environmental Working Group, Healthy 

Babies Bright Futures, Linda Birnbaum, 

and the Nicholas School of the 

Environment at Duke University; Filing 

of Food Additive Petition.’’ 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 

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: 

Marissa Santos, Center for Food Safety 

and Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–8160. 

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 

2B4831), submitted by Environmental 

Defense Fund, Maricel Maffini, Breast 

Cancer Prevention Partners, Clean Water 

Action/Clean Water Fund, Consumer 

Reports, Endocrine Society, 

Environmental Working Group, Healthy 

Babies Bright Futures, Linda Birnbaum, 

and the Nicholas School of the 

Environment at Duke University, c/o 

Mr. Thomas Neltner, 1875 Connecticut 

Ave. NW, Washington, DC 20009. The 

petition proposes to amend the food 

additive regulations in §§ 175.105, 

175.300, 177.1440, 177.1580, 177.1585, 

177.2280, and 177.2440 (21 CFR 

175.105, 175.300, 177.1440, 177.1580, 

177.1585, 177.2280, and 177.2440); 

Indirect Food Additives: General (part 

174 (21 CFR part 174)); Indirect Food 

Additives: Adhesives and Components 

of Coatings (21 CFR part 175); and 


khammond on DSKJM1Z7X2PROD with PROPOSALS
41080 Federal Register / Vol. 87, No. 131 / Monday, July 11, 2022 / Proposed Rules 

Indirect Food Additives: Polymers (21 

CFR part 177), to remove authorizations 

for the use of BPA in §§ 175.105, 

175.300, and 177.2440; establish a 

migration limit for BPA from the 

authorized uses of BPA in food contact 

articles in §§ 177.1440, 177.1580, 

177.1585, and 177.2280; and add a new 

provision to part 174 with a restriction 

on the use of BPA, stating that the 

substance is subject to a specific 

migration limit of 0.5 nanograms per 

kilogram of food. The petition is 

available in Docket No. FDA–2022–F– 

1108. 

II. Amendment of §§ 175.105, 175.300, 

177.1440, 177.1580, 177.1585, 177.2280, 

and 177.2440 and Addition of New 

Provision With BPA Restriction 

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 

§§ 175.105, 175.300, 177.1440, 

177.1580, 177.1585, 177.2280, and 

177.2440 to remove authorizations for 

the use of BPA in §§ 175.105, 175.300, 

and 177.2440; establish a migration 

limit for BPA from the authorized uses 

of BPA in food contact articles in 

§§ 177.1440, 177.1580, 177.1585, and 

177.2280; and add a new provision to 

part 174 with a restriction on the use of 

BPA. The petitioners cite, as evidence, 

a draft opinion by the European Food 

Safety Authority (EFSA), which 

analyzed studies related to the health 

effects of dietary BPA exposure that 

were published between January 1, 

2013, through October 15, 2018. EFSA’s 

draft opinion entitled ‘‘Re-evaluation of 

the risks to public health related to the 

presence of bisphenol (BPA) in 

foodstuffs,’’ was published in December 

2021 for public comment. Based on the 

analysis in the draft EFSA opinion, the 

petitioners conclude that the use of BPA 

in food and food contact articles is toxic 

and disrupts the ‘‘proper functioning of 

the immune and reproductive systems.’’ 

To support their conclusion, the 

petitioners also cite publications 

referred to in comments to EFSA on the 

draft opinion and an epidemiology 

study that petitioners assert show an 

association of in utero exposure to BPA 

with an increased risk of asthma and 

wheezing in school-age girls. 

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 removing 

authorizations for the use of BPA as 

listed under §§ 175.105, 175.300, and 

177.2440; establishing a migration limit 

for BPA from authorized uses of BPA in 

food contact articles as listed under 

§§ 177.1440, 177.1580, 177.1585, and 

177.2280; or adding a new provision 

with a restriction on the use of BPA, 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) because this action 

would prohibit or otherwise restrict the 

use of a substance in food packaging. In 

addition, the petitioners have stated 

that, to their knowledge, no 

extraordinary circumstances exist. 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: July 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14682 Filed 7–8–22; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2021–0342; FRL–9971–01– 

R4] 

Air Plan Approval; Georgia; Vehicle 

Inspection and Maintenance Program 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve 

State Implementation Plan (SIP) 

revisions submitted by the State of 

Georgia through the Georgia Department 

of Natural Resources (GA DNR), 

Environmental Protection Division (GA 

EPD) on April 30, 2021. The revisions 

remove obsolete references and 

provisions, update and clarify the 

State’s inspection and maintenance (I/ 

M) requirements, and update 

terminology, in part to reflect advances 

in test and vehicle technology. EPA has 

evaluated the SIP revisions and has 

preliminarily determined the changes 

will not increase emissions under the 

Georgia 

I/M program. EPA is proposing to 

approve these changes pursuant to the 

Clean Air Act (CAA). 

DATES: Comments must be received on 

or before August 10, 2022. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R04– 

OAR–2021–0342 at 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Once submitted, comments cannot be 

edited or removed from Regulations.gov. 

EPA may publish any comment received 

to its public docket. Do not submit 

electronically any information you 

consider to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Multimedia submissions (audio, video, 

etc.) must be accompanied by a written 

comment. The written comment is 

considered the official comment and 

should include discussion of all points 

you wish to make. EPA will generally 

not consider comments or comment 

contents located outside of the primary 

submission (i.e., on the web, cloud, or 

other file sharing system). For 

additional submission methods, the full 

EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

www2.epa.gov/dockets/commentingepa-dockets. 

FOR FURTHER INFORMATION CONTACT: 

Kelly Sheckler, Air Regulatory 

Management Section, Air Planning and 

Implementation Branch, Air and 

Radiation Division, U.S. Environmental 

Protection Agency, Region 4, 61 Forsyth 

Street SW, Atlanta, Georgia 30303–8960. 

The telephone number is (404) 562– 

9222. Ms. Sheckler can also be reached 

via electronic mail at sheckler.kelly@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. What is the background of Georgia’s 

SIP-approved I/M program? 

The CAA requires areas that are 

designated as moderate, serious, severe, 

or extreme ozone nonattainment areas to 

establish a motor vehicle I/M program to 

ensure regular monitoring of gasoline 

fueled motor vehicle emissions. See 

CAA sections 182(b)(4), (c)(3). The 

required monitoring is performed by 

periodic emissions testing of vehicles. 

See CAA sections 182(a)(2)(B), (c)(3). 

This emissions testing ensures that 

vehicles are well maintained, operating 

as designed, and do not exceed 

established vehicle pollutant limits. A 

basic I/M program is required for 

moderate ozone nonattainment areas, 

and an enhanced I/M program is 

required for serious, severe, or extreme 

ozone nonattainment areas. 

In 1991, EPA classified a 13-county 

area in and around the Atlanta, Georgia, 

metropolitan area as a serious ozone 

nonattainment area for the 1979 1-hour 

ozone national ambient air quality 

standards (NAAQS), triggering the 

requirement for the State to establish an 


khammond on DSKJM1Z7X2PROD with PROPOSALS