Federal Register / Vol. 87, No. 17 / Wednesday, January 26, 2022 / Proposed Rules 3949 

Bulletin 737–53A1401, dated April 27, 2021, 

which is referred to in Boeing Alert 

Requirements Bulletin 737–53A1401 RB, 

dated April 27, 2021. 

(h) Exceptions to Service Information 

Specifications 

(1) Where the Compliance Time column of 

the tables in the ‘‘Compliance’’ paragraph of 

Boeing Alert Requirements Bulletin 737– 

53A1401 RB, dated April 27, 2021, uses the 

phrase ‘‘the original issue date of 

Requirements Bulletin 737–53A1401 RB,’’ 

this AD requires using ‘‘the effective date of 

this AD.’’ 

(2) Where Boeing Alert Requirements 

Bulletin 737–53A1401 RB, dated April 27, 

2021, specifies contacting Boeing for repair 

instructions: This AD requires doing the 

repair using a method approved in 

accordance with the procedures specified in 

paragraph (i) of this AD. 

(i) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Seattle ACO Branch, 

FAA, has the authority to approve AMOCs 

for this AD, if requested using the procedures 

found in 14 CFR 39.19. In accordance with 

14 CFR 39.19, send your request to your 

principal inspector or responsible Flight 

Standards Office, as appropriate. If sending 

information directly to the manager of the 

certification office, send it to the attention of 

the person identified in paragraph (j)(1)of 

this AD. Information may be emailed to: 9- 

ANM-Seattle-ACO-AMOC-Requests@faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the responsible Flight Standards Office. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any repair, 

modification, or alteration required by this 

AD if it is approved by The Boeing Company 

Organization Designation Authorization 

(ODA) that has been authorized by the 

Manager, Seattle ACO Branch, FAA, to make 

those findings. To be approved, the repair 

method, modification deviation, or alteration 

deviation must meet the certification basis of 

the airplane, and the approval must 

specifically refer to this AD. 

(j) Related Information 

(1) For more information about this AD, 

contact Courtney Tuck, Aerospace Engineer, 

Cabin Safety and Environmental Systems 

Section, FAA, Seattle ACO Branch, 2200 

South 216th St., Des Moines, WA 98198; 

phone and fax: 206–231–3986; email: 

courtney.k.tuck@faa.gov. 

(2) For service information identified in 

this AD, contact Boeing Commercial 

Airplanes, Attention: Contractual & Data 

Services (C&DS), 2600 Westminster Blvd., 

MC 110–SK57, Seal Beach, CA 90740–5600; 

telephone 562–797–1717; internet https://

www.myboeingfleet.com. You may view this 

referenced service information at the FAA, 

Airworthiness Products Section, Operational 

Safety Branch, 2200 South 216th St., Des 

Moines, WA. For information on the 

availability of this material at the FAA, call 

206–231–3195. 

Issued on December 22, 2021. 

Lance T. Gant, 

Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2022–01408 Filed 1–25–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 170 

[Docket No. FDA–2021–N–0403] 

RIN 0910–AI01 

Food Additives: Food Contact 

Substance Notification That Is No 

Longer Effective 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

proposing to amend its regulations 

relating to the procedures by which we 

determine that a premarket notification 

for a food contact substance (FCN) is no 

longer effective. The proposed rule, if 

finalized, would, among other things, 

ensure that manufacturers or suppliers 

have the opportunity to provide input 

before we could determine that an FCN 

is no longer effective. The proposed rule 

also would provide additional reasons 

that could be the basis for FDA to 

determine that an FCN is no longer 

effective. We are proposing these 

changes to better enable FDA to respond 

to new information on the safety and 

use of food contact substances, as well 

as manufacturers’ business decisions, 

which would also improve our FCN 

program’s efficiency. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by April 11, 2022. Submit written 

comments (including recommendations) 

on the collection of information under 

the Paperwork Reduction Act of 1995 by 

March 28, 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 April 11, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 11, 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– 

2021–N–0403 for ‘‘Food Additives: 

Food Contact Substance Notification 

That Is No Longer Effective.’’ 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 


khammond on DSKJM1Z7X2PROD with PROPOSALS
3950 Federal Register / Vol. 87, No. 17 / Wednesday, January 26, 2022 / Proposed Rules 

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. 

Submit comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 to the Office of 

Management and Budget (OMB) at 

https://www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. The title of this 

proposed collection is Food Contact 

Substance Notification Program. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the proposed rule: 

Paulina Piotrowski, Center for Food 

Safety and Applied Nutrition (HFS– 

275), Food and Drug Administration, 

5001 Campus Dr., College Park, MD 

20740, 301–796–8649, 

paulina.piotrowski@fda.hhs.gov; or 

Lauren Baham, Center for Food Safety 

and Applied Nutrition (HFS–024), Food 

and Drug Administration, 5001 Campus 

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

2378. 

With regard to the information 

collection: Domini Bean, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

5733, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Proposed Rule 

B. Summary of the Major Provisions of the 

Proposed Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Background 

A. Need for the Regulation 

B. FDA’s Current Regulatory Framework 

for Food Contact Substances 

III. Legal Authority 

IV. Description of the Proposed Rule 

A. Data or Other Information Demonstrate 

That the Intended Use of the Food 

Contact Substance Is No Longer Safe 

B. Manufacturer or Supplier No Longer 

Produces, Supplies, or Uses the Food 

Contact Substance for the Intended Use 

C. The Intended Use of the Food Contact 

Substance Is Authorized by a Food 

Additive Regulation 

D. The Intended Use of the Food Contact 

Substance Is Covered by a Threshold of 

Regulation Exemption 

E. Publication of FDA’s Determination That 

an FCN Is No Longer Effective 

F. Future Submissions Following 

Determination That FCN Is No Longer 

Effective 

G. Confidentiality of Information 

V. Proposed Effective Date 

VI. Economic Analysis of Impacts 

A. Introduction 

B. Summary of Benefits and Costs of the 

Proposed Rule 

VII. Analysis of Environmental Impact 

XIII. Paperwork Reduction Act of 1995 

IX. Federalism 

X. Consultation and Coordination With 

Indian Tribal Governments 

XI. References 

I. Executive Summary 

A. Purpose of the Proposed Rule 

We are proposing to amend our 

regulations at § 170.105 (21 CFR 

170.105) to provide additional reasons 

which may be the basis for FDA to 

determine that a FCN is no longer 

effective and to provide the 

manufacturer or supplier of the 

substance an opportunity to provide 

input before we could make such a 

determination. These changes to 

§ 170.105 would create administrative 

mechanisms to improve the efficiency of 

the premarket notification program for 

food contact substances. 

We also are proposing to clarify our 

confidentiality of information regulation 

at § 170.102 (21 CFR 170.102). 

B. Summary of the Major Provisions of 

the Proposed Rule 

FDA’s current regulations at § 170.105 

provide the process by which we may 

determine that an FCN is no longer 

effective based on data or other 

information available to us that 

demonstrate that the intended use of the 

food contact substance is no longer safe. 

The proposed rule, if finalized, would 

include reasons other than safety as the 

basis on which we may determine that 

an FCN is no longer effective and the 

process under which we would make 

determinations based on these other 

reasons. These reasons would include 

instances in which the production, 

supply, or use of the food contact 

substance for its intended use has 

ceased or will cease, or the use of a food 

contact substance identified in an FCN 

is authorized by a food additive 

regulation or covered by a threshold of 

regulation exemption. We also propose 

to provide the manufacturer or supplier 

who submitted an FCN the opportunity 

to address our safety concerns or to 

otherwise show why an FCN should 

continue to be effective before we could 

determine that an FCN is no longer 

effective, resulting in this use no longer 

being authorized. 

C. Legal Authority 

FDA is proposing to modify the 

procedures by which FDA determines 

that an FCN is no longer effective. These 

modifications would include additional 

reasons as the basis for FDA to 

determine that an FCN is no longer 

effective and to amend the regulation 

pertaining to confidentiality of 

information to address, among other 

things, data and information related to 

FDA’s determination that an FCN is no 

longer effective. These changes are 

consistent with our authority in sections 

201, 409, and 701(a) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 321, 348, and 371(a)). 

We discuss our legal authority in greater 

detail in part III below. 

D. Costs and Benefits 

The proposed changes to § 170.105 

are expected to result in cost savings 

and other benefits to manufacturers and 

suppliers of food contact substances, as 

well as to FDA. We expect the costs of 

the proposed rule to be minimal and, 

therefore, do not believe that the 

proposed rule will have a significant 

economic impact on a substantial 

number of small entities. For further 

discussion, see Section VI, ‘‘Economic 

Analysis of Impacts.’’ 


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II. Background 

A. Need for the Regulation 

Our regulations at § 170.105 set forth 

the process by which FDA may 

determine that an FCN is no longer 

effective. This determination currently 

only applies when data or other 

information demonstrating the intended 

use of a food contact substance is no 

longer safe. Our regulations currently do 

not provide reasons other than safety as 

the basis for FDA to determine that an 

FCN is no longer effective, nor do our 

regulations provide manufacturers or 

suppliers the opportunity to show why 

an FCN should continue to be effective 

before we make our determination. The 

proposed rule would establish new 

procedures to address these issues, 

which would better enable FDA to 

respond to new information on the 

safety and use of food contact 

substances. The proposed rule would 

ensure that a manufacturer or supplier 

has the opportunity to provide 

information relevant for FDA to make a 

safety determination before we could 

make such a determination. The 

proposed rule would also permit FDA to 

make a determination that an FCN is no 

longer effective for reasons other than 

safety. For example, FDA could reduce 

confusion created by duplicative 

authorizations by removing effective 

FCNs for intended uses authorized by 

food additive regulations or covered by 

a Threshold of Regulation (TOR) 

exemption. In addition, the proposed 

rule would allow a manufacturer or 

supplier to request that an FCN be 

determined to no longer be effective 

because it has ceased (or intends to 

cease) producing, supplying, or using a 

food contact substance for the intended 

use. This may be less burdensome for 

both FDA and the manufacturer or 

supplier than addressing potential 

safety concerns. We may decline this 

request if we determine there is a safety 

issue that serves as the basis for FDA’s 

determination. This would improve the 

efficiency of the FCN program, which in 

turn may reduce the burden on 

manufacturers or suppliers, as well as 

FDA. The proposed rule will also 

improve the transparency of the FCN 

program. 

B. FDA’s Current Regulatory Framework 

for Food Contact Substances 

A food additive (see section 201(s) of 

the FD&C Act for the definition of a food 

additive) is subject to premarket review 

by FDA (see section 409 of the FD&C 

Act). The use of a food additive not in 

compliance with section 409 of the 

FD&C Act is deemed unsafe (section 

409(a) of the FD&C Act). A food is 

deemed to be adulterated if it is or if it 

bears or contains an unsafe food 

additive (section 402(a)(2)(C) of the 

FD&C Act). 

A food additive may be a food contact 

substance. A food contact substance is 

any substance that is intended for use as 

a component of materials used in 

manufacturing, packing, packaging, 

transporting, or holding food if such use 

of the substance is not intended to have 

any technical effect in such food (see 

section 409(h)(6) of the FD&C Act and 

§ 170.3(e)(3)). Accordingly, food contact 

substances that are food additives 

require FDA premarket authorization 

(id.). 

Certain uses of food contact 

substances (often described as indirect 

food additives) are authorized through 

FDA’s food additive regulations (see 21 

CFR parts 173 through 177, and 180). 

FDA has also established procedures set 

forth in § 170.39 to exempt from 

regulation as food additives certain 

substances used in food-contact articles 

that migrate or may be expected to 

migrate into food at levels that are 

below the threshold of regulation. 

Manufacturers and suppliers can review 

our food additive regulations and TOR 

exemptions to determine which food 

contact substances are already 

authorized by regulation or exempted 

from regulation for a specific foodcontact use. 

Section 409 of the FD&C Act (21 

U.S.C. 348) establishes a premarket FCN 

process as the primary method by which 

FDA reviews the use of food additives 

that are food contact substances and by 

which such uses are authorized as safe. 

Our regulations in part 170, Subpart D, 

set forth the procedures for the FCN 

process. The FD&C Act establishes that 

a manufacturer or supplier of a food 

contact substance may, at least 120 days 

before introducing or delivering into 

interstate commerce, notify us of the 

identity and intended use of the 

substance and of the manufacturer’s 

determination that it is safe for such 

intended use (see section 409(h) of the 

FD&C Act and § 170.100). An FCN is 

effective only for the substance, its 

intended use, and the manufacturer or 

supplier identified in the FCN 

submission (see section 409(h)(1)(C) of 

the FD&C Act and § 170.100(a)). If 

another manufacturer or supplier 

wishes to market the same food contact 

substance for the same use, they must 

submit an FCN to FDA (see 

§ 170.100(a)). 

Our regulations, at § 170.105, 

establish the process by which we may 

determine that an FCN is no longer 

effective. We may determine that the 

FCN is no longer effective if data or 

other information available to us, 

including data not submitted by the 

manufacturer or supplier, demonstrate 

that the intended use of the food contact 

substance is no longer safe (see 

§ 170.105(a)). Further, if we determine 

that an FCN is no longer effective, we 

inform the manufacturer or supplier in 

writing of the basis for that 

determination and provide a time by 

which the manufacturer or supplier may 

show why the FCN should continue to 

be effective (see § 170.105(b)). Finally, if 

the manufacturer or supplier fails to 

respond adequately to the safety 

concerns regarding the notified use, we 

will publish a notice of our 

determination that the FCN is no longer 

effective in the Federal Register (see 

§ 170.105(c)). The notice states that a 

detailed summary of the basis for our 

determination that the FCN is no longer 

effective has been placed on public 

display and that copies are available 

upon request (id.). The date that the 

notice publishes in the Federal Register 

is the date on which the notification is 

no longer effective (id.). Our 

determination that an FCN is no longer 

effective constitutes final agency action 

that is subject to judicial review (see 

§ 170.105(d)). 

Currently, our regulations do not 

provide reasons other than safety as the 

basis for FDA to determine that an FCN 

is no longer effective, nor do our 

regulations provide manufacturers or 

suppliers the opportunity to show why 

an FCN should continue to be effective 

before we make our determination. 

III. Legal Authority 

FDA is proposing to modify the 

procedures by which FDA determines 

that an FCN is no longer effective and 

to include additional reasons as the 

basis for FDA to determine that an FCN 

is no longer effective. Given these 

proposed changes, FDA also is 

proposing to amend the regulation 

pertaining to confidentiality of 

information. These changes are 

consistent with our authority in sections 

201, 409, and 701(a) of the FD&C Act. 

The FD&C Act defines ‘‘food 

additive,’’ in relevant part, as any 

substance, the intended use of which 

results or may reasonably be expected to 

result, directly or indirectly, in its 

becoming a component of food or 

otherwise affecting the characteristics of 

any food (including any substance 

intended for use in producing, 

manufacturing, packing, processing, 

preparing, treating, packaging 

transporting, or holding food; and 

including any source of radiation 

intended for any such use), if such 

substance is not generally recognized by 


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3952 Federal Register / Vol. 87, No. 17 / Wednesday, January 26, 2022 / Proposed Rules 

experts as safe under its intended use 

(section 201(s) of the FD&C Act). Food 

additives include ‘‘food contact 

substances,’’ which are defined as any 

substance intended for use as a 

component of materials used in 

manufacturing, packing, packaging, 

transporting, or holding food if such use 

is not intended to have any technical 

effect in such food (section 409(h)(6) of 

the FD&C Act). 

A food additive is deemed unsafe 

unless that substance and its use 

conform with a regulation issued under 

section 409 of the FD&C Act or unless 

there is an FCN submitted under section 

409(h) that is effective (section 409(a) of 

the FD&C Act)). Section 409(h) of the 

FD&C Act sets forth the procedure for 

FCNs. 

Under section 409(i) of the FD&C Act, 

FDA must prescribe by regulation the 

procedure by which FDA may deem an 

FCN to no longer be effective (sections 

409(i) and 1003(d) of the FD&C Act) (21 

U.S.C. 348(i) and 393(d)). Section 701(a) 

of the FD&C Act gives us the authority 

to issue regulations for the efficient 

enforcement of the FD&C Act. 

IV. Description of the Proposed Rule 

Our regulations, at § 170.105, provide 

safety as the only basis for FDA to 

determine that an FCN is no longer 

effective and provides an opportunity 

for the manufacturer or supplier to 

respond to our safety concerns only 

after we have made our determination. 

Based on our experience in 

administering the FCN program, we 

have concluded that FDA could better 

respond to new information about the 

safety and use of food contact 

substances if FDA were not limited only 

to determining that an FCN is no longer 

effective based on safety. The proposed 

rule would amend § 170.105 by 

including additional reasons which may 

be the basis for us to determine that an 

FCN is no longer effective. The 

proposed rule also would give the 

manufacturer or supplier the 

opportunity to respond to our safety 

concerns or to otherwise show why an 

FCN should continue to be effective 

before we could determine that an FCN 

is no longer effective. 

We are proposing to provide 

additional reasons which may be the 

basis for FDA to determine that an FCN 

is no longer effective. These additional 

reasons include: (1) Information 

available to FDA that demonstrate that 

the manufacturer or supplier specified 

in the FCN has stopped or intends to 

stop producing, supplying, or using a 

food contact substance for the intended 

use; (2) the intended use of the food 

contact substance identified in the FCN 

is authorized by a food additive 

regulation; or (3) the intended use of the 

food contact substance identified in the 

FCN is covered by a TOR exemption. 

After FDA has determined that an FCN 

is no longer effective, a manufacturer or 

supplier would not be precluded from 

submitting a new FCN for the same food 

contact substance, including for the 

same intended use, unless the intended 

use of the food contact substance is 

authorized by a food additive regulation 

or covered by a TOR exemption. 

We also are proposing to amend our 

confidentiality of information regulation 

at § 170.102 to address the data and 

information that is related to a 

notification, including data and 

information related to FDA’s 

determination that an FCN is no longer 

effective. 

A. Data or Other Information 

Demonstrate That the Intended Use of 

the Food Contact Substance Is No 

Longer Safe 

Our current regulations state that if 

data or other information available to 

us, including data not submitted by a 

manufacturer or supplier, demonstrate 

that the intended use of a food contact 

substance is no longer safe, we may 

determine that the FCN is no longer 

effective (see § 170.105(a)). This 

regulation also sets forth the process 

whereby we will inform a manufacturer 

or supplier of our determination and 

give the manufacturer or supplier an 

opportunity to show why the FCN 

should continue to be effective for that 

use and specifies the time for the 

manufacturer or supplier to respond 

(see § 170.105(b)). 

The proposed rule would change the 

process for determining that an FCN is 

no longer effective based on safety 

concerns in one key respect. Under the 

proposed rule, we would make a 

determination that the FCN is no longer 

effective only after we have given the 

manufacturer or supplier an opportunity 

to provide data or other information to 

respond to our safety concerns. We 

could determine an FCN is no longer 

effective if a manufacturer or supplier 

fails to respond by the specified date, or 

to provide the data and information that 

is necessary to address the safety 

concerns regarding the notified use. 

Giving manufacturers and suppliers the 

opportunity to provide data and 

information will help inform our safety 

reviews before we make a 

determination. 

In brief, the proposed rule, at 

§ 170.105(a)(1)(i), would state that we 

will inform the manufacturer or 

supplier specified in the FCN, in 

writing, of our concerns regarding the 

safety of the intended use of the food 

contact substance. FDA will specify a 

date by which the manufacturer or 

supplier must provide data or other 

information to address the safety 

concerns (see proposed 

§ 170.105(a)(1)(i)). Under proposed 

§ 170.105(a)(1)(ii), if the manufacturer or 

supplier fails, by the specified date, to 

supply the data or other information 

necessary to address the safety concerns 

regarding the notified use, we may 

determine that the FCN is no longer 

effective because there is no longer a 

basis to conclude that the intended use 

is safe. 

In response to our potential safety 

concerns with the intended use of a 

food contact substance, we have 

received voluntary commitment letters 

from certain manufacturers that they 

have ceased or intend to cease the 

introduction into interstate commerce of 

food contact substances for food contact 

use in the United States; however, these 

FCNs remain effective. (See ‘‘Market 

Phase-Out of Certain Short-Chain 

PFAS’’ and also at ‘‘Market Phase-Out 

and Revocation of Authorization of 

Long-Chain PFAS’’ at https://

www.fda.gov/food/chemicals/ 

authorized-uses-pfas-food-contactapplications.) Accordingly, we also 

propose allowing a manufacturer or 

supplier to respond to FDA, by the date 

specified for providing data or other 

information, by requesting that we 

determine that an FCN is no longer 

effective because the manufacturer or 

supplier no longer produces, supplies, 

or uses the food contact substance for 

the intended use in the United States, or 

intends to stop producing, supplying, or 

using a food contact substance for the 

intended use in the United States by a 

specified date (see proposed 

§ 170.105(a)(2)(i)(A)). 

Depending on the circumstances, we 

may deny such a request if it is 

insufficient to protect the public health, 

for example, because of the public 

health risk from continued exposure to 

the food contact substance. If FDA 

denies such a request, and we had 

previously informed the manufacturer 

or supplier of our concerns regarding 

the safety of the intended use of the 

food contact substance, we may 

determine that an FCN is no longer 

effective because there is no longer a 

basis to conclude that the intended use 

is safe (see proposed 

§ 170.105(a)(1)(iii)). Alternatively, FDA 

may provide the manufacturer or 

supplier with additional time to provide 

us with data or other information to 

respond to the safety concerns (id.). If 

the manufacturer or supplier fails, by 

the specified date, to supply the data or 


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Federal Register / Vol. 87, No. 17 / Wednesday, January 26, 2022 / Proposed Rules 3953 

other information necessary to address 

the safety concerns regarding the 

notified use, we may determine that the 

FCN is no longer effective because there 

is no longer a basis to conclude that the 

notified use is safe (id.). 

B. Manufacturer or Supplier No Longer 

Produces, Supplies, or Uses the Food 

Contact Substance for the Intended Use 

Our current regulations do not 

provide a basis for determining that an 

FCN is no longer effective for reasons 

other than safety. Based on our 

experience, manufacturers have stopped 

manufacturing certain food contact 

substances that are authorized for use 

under effective FCNs; however, there is 

no provision for the manufacturers to 

request that an FCN be determined to be 

no longer effective based on reasons 

other than safety. For example, a 

manufacturer may choose, for business 

reasons, to stop production of the food 

contact substance to the specifications 

in the FCN and sale of the food contact 

substance into food contact 

applications, while continuing to sell 

the same substance for use in non-food 

contact applications. 

The proposed rule would provide that 

a manufacturer or supplier may request 

in writing that FDA determine that an 

FCN is no longer effective on the basis 

that it has stopped, or intends to stop by 

a specified date, producing, supplying, 

or using a food contact substance for the 

intended food contact use in the United 

States (see proposed 

§ 170.105(a)(2)(i)(A)). As detailed above, 

the manufacturer or supplier also may 

provide this information when given the 

opportunity to respond to our safety 

concerns (see proposed 

§ 170.105(a)(1)(ii)). We would then 

notify the manufacturer or supplier 

whether we are granting this request 

(see proposed § 170.105(a)(2)(i)(A)). 

If FDA grants the request, we may 

determine that the FCN is no longer 

effective on the basis that the 

manufacturer or supplier has stopped 

producing, supplying, or using a food 

contact substance for the intended use 

in the United States or that it intends to 

stop producing, supplying, or using a 

food contact substance for the intended 

use in the United States by a specified 

date (see proposed § 170.105(a)(2)(i)(B)). 

When such a request is based on the 

intent to stop producing, supplying, or 

using a food contact substance for the 

intended use in the United States at a 

future date, FDA will include the date 

specified in the request (i.e., the date by 

which the manufacturer or supplier 

intends to stop producing, supplying, or 

using a food contact substance) as the 

compliance date to stop producing, 

supplying, or using the food contact 

substance for the intended use in the 

United States (id.). 

The proposed rule also would provide 

that if other data or information 

available to FDA demonstrate that a 

manufacturer or supplier no longer 

produces, supplies, or uses a food 

contact substance for the intended use 

in the United States, we will inform, in 

writing, the manufacturer or supplier 

specified in the FCN before we could 

determine that the FCN is no longer 

effective (see proposed 

§ 170.105(a)(2)(ii)(A)). For example, we 

may learn from persons other than the 

manufacturer or supplier listed in the 

FCN that the manufacturer or supplier 

is no longer producing, supplying, or 

using the food contact substance for its 

intended use in the United States, such 

as when the listed manufacturer or 

supplier has ceased operations and has 

not been acquired by another company. 

The proposal also would state that we 

will include a specified time period by 

which the manufacturer or supplier 

must provide us with data or other 

information that demonstrate that the 

manufacturer or supplier continues to 

produce, supply, or use a food contact 

substance for the intended use in the 

United States (id.). 

If the manufacturer or supplier fails, 

by the specified date, to provide data or 

other information that demonstrate that 

the manufacturer or supplier continues 

to produce, supply, or use a food 

contact substance for the intended use 

in the United States, or if the 

manufacturer or supplier confirms that 

it has stopped producing, supplying, or 

using the food contact substance for the 

intended food contact use in the United 

States, FDA may determine that the FCN 

is no longer effective (see proposed 

§ 170.105(a)(2)(ii)(B)). 

C. The Intended Use of the Food Contact 

Substance Is Authorized by a Food 

Additive Regulation 

The proposed rule would create a new 

provision by which we may determine 

that an FCN is no longer effective 

because the intended use of the food 

contact substance is authorized by a 

food additive regulation (see proposed 

§ 170.105(a)(3)). Issuing a food additive 

regulation can be more efficient than 

reviewing multiple FCNs for the same 

food contact substance and for the same 

use. FCNs are effective only for a 

specific manufacturer or supplier to 

produce, supply, or use the subject food 

contact substance for the intended use 

described in the FCN notification. 

Multiple manufacturers or suppliers 

often request FCNs for the same 

intended use of a food contact 

substance. In contrast, a food additive 

regulation can authorize the use of a 

food contact substance for any 

manufacturer or supplier who meets the 

provisions of the relevant food additive 

regulation (see section 409(a)(3) of the 

FD&C Act). 

Therefore, if a food additive 

regulation exists for a substance that is 

the subject of an FCN for the same 

intended use, proposed § 170.105(a)(3) 

would enable us to determine that this 

FCN is no longer effective because the 

food contact substance is authorized by 

a food additive regulation. This would 

enable us to remove the duplicative 

authorization specific to the 

manufacturer or supplier listed in each 

FCN. Removing these FCNs from the 

inventory of effective FCNs when such 

authorization is unnecessary because 

the intended use of the food contact 

substance is authorized under a food 

additive regulation may avoid confusion 

by other manufacturers and suppliers on 

whether they would also need to obtain 

authorization through an FCN for that 

use. 

The proposed rule also would state 

that, before we could determine that an 

FCN is no longer effective, we would 

inform the manufacturer or supplier 

specified in the FCN, in writing, that the 

intended use of the food contact 

substance identified in the FCN is 

authorized by a food additive regulation 

(see proposed § 170.105(a)(3)(i)). FDA 

would include a specified time period 

by which the manufacturer or supplier 

must provide FDA with data or other 

information about whether the intended 

use of the food contact substance is 

authorized by a food additive 

regulation, and we would not make a 

determination until after the time period 

expires (id). If the manufacturer or 

supplier fails, by the specified date, to 

supply data or other information that 

demonstrate that the intended use of the 

food contact substance is not authorized 

by a food additive regulation, FDA may 

determine that the FCN is no longer 

effective (see proposed 

§ 170.105(a)(3)(ii)). 

D. The Intended Use of the Food 

Contact Substance Is Covered by a 

Threshold of Regulation Exemption 

The proposed rule would create a new 

provision by which we may determine 

that an FCN is no longer effective 

because the intended use of the food 

contact substance is covered by a TOR 

exemption (see proposed 

§ 170.105(a)(4)). As noted earlier, FCNs 

are effective only for a specific 

manufacturer or supplier, and multiple 

manufacturers or suppliers often request 

FCNs for the same intended use of a 


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food contact substance. In contrast, a 

TOR exemption can cover the use of a 

food contact substance for any 

manufacturer or supplier who meets the 

requirements of the TOR. FDA will 

grant a TOR exemption only if the 

likelihood or extent of migration to food 

of a substance used in a food-contact 

article (e.g., food-packaging or foodprocessing equipment) is so trivial as 

not to require regulation of the 

substance as a food additive (see 

§ 170.39). As such, the substance used 

in a food-contact article becomes a 

component of food at levels that are 

below the threshold of regulation. FDA 

may grant a TOR exemption only if: (1) 

The substance is not, or is not suspected 

to be, a carcinogen in humans or 

animals; (2) the substance presents no 

other health or safety concern because 

the use results in a dietary 

concentration of 0.5 parts per billion or 

less or a dietary exposure of 1 percent 

or less of the acceptable daily intake for 

the substance and the substance is 

currently regulated for direct addition to 

food; (3) the substance has no technical 

effect in or on the food itself; and (4) the 

substance use has no significant adverse 

impact on the environment (see 

§ 170.39(a)). We list current TOR 

exemptions on our website (see https:// 

www.fda.gov/food/packaging-foodcontact-substances-fcs/thresholdregulation-exemptions-substances-usedfood-contact-articles). 

If there is an FCN for a use of a food 

contact substance that is also covered by 

a TOR exemption, the proposed rule 

would enable us to remove an FCN for 

that same substance for the same 

intended use. Removing these FCNs 

from the inventory of effective FCNs 

may avoid confusion by other 

manufacturers and suppliers on whether 

they need to obtain authorization under 

the FCN process for the use of a food 

contact substance that is covered under 

a TOR exemption. Therefore, if a TOR 

exemption exists for a substance that is 

the subject of an FCN for the same 

intended use, proposed § 170.105(a)(4) 

would enable us to determine that this 

FCN is no longer effective because the 

use of the food contact substance is 

covered by a TOR exemption. This 

process would enable us to remove the 

duplicative authorization specific to the 

manufacturer or supplier listed in each 

FCN and would increase efficiency for 

the food industry and FDA. 

The proposed rule also would state 

that, before we determine that an FCN 

is no longer effective, we would inform 

the manufacturer or supplier specified 

in the FCN, in writing, that the intended 

use of the food contact substance 

identified in the FCN is covered by a 

TOR exemption (see proposed 

§ 170.105(a)(4)(i)). FDA would include a 

specified time period by which the 

manufacturer or supplier must provide 

FDA with data or other information 

about whether the intended use of the 

food contact substance is covered by a 

TOR exemption, and we would not 

make a determination until after the 

time period expired (id). 

If a manufacturer or supplier fails, by 

the specified date, to supply data or 

other information that demonstrate that 

the intended use of the food contact 

substance identified in the FCN is not 

covered by a TOR exemption, FDA may 

determine that the FCN is no longer 

effective on the basis that the intended 

use of the food contact substance is 

covered under a threshold of regulation 

exemption (see proposed 

§ 170.105(a)(4)(ii)). 

E. Publication of FDA’s Determination 

That an FCN Is No Longer Effective 

Our current regulation states that, if 

the manufacturer or supplier fails to 

respond adequately to the safety 

concerns regarding the notified use, 

FDA will publish a notice of its 

determination that the FCN is no longer 

effective (see § 170.105(c)). FDA will 

publish the notice in the Federal 

Register, stating that a detailed 

summary of the basis for FDA’s 

determination that the FCN is no longer 

effective has been placed on public 

display and that copies are available 

upon request (id). The date that the 

notice publishes in the Federal Register 

is the date on which the FCN is no 

longer effective (see § 170.105(c)). 

The proposed rule would retain the 

provision but renumber it as 

§ 170.105(b) and extend this provision 

to the proposed provisions in this 

proposed rule under which FDA will 

determine an FCN is no longer effective. 

FDA may include a separate compliance 

date for the use of the food contact 

substance in food contact articles, if 

FDA determines it would be protective 

of public health, for the time-limited use 

of the food contact substance (see 

proposed § 170.105(b)). For example, 

food contact articles that contain the 

food contact substance for its intended 

use may still be in the supply chain 

after a manufacturer has stopped 

manufacturing the food contact 

substance. FDA may set a compliance 

date in the future for the continued use 

of the food contact substance if FDA 

determines that its intended use during 

this timeframe would not pose a risk to 

public health. 

Additionally, our current regulation, 

at § 170.105(d), states that our 

determination that an FCN is no longer 

effective constitutes final agency action 

and is subject to judicial review. The 

proposed rule would renumber the 

provision as proposed § 170.105(b). 

F. Future Submissions Following 

Determination That an FCN Is No 

Longer Effective 

Currently, § 170.105 does not state 

that a manufacturer or supplier may 

submit a new FCN for the same food 

contact substance for the same intended 

use. The proposed rule would state that 

our determination that an FCN is no 

longer effective does not preclude any 

manufacturer or supplier from 

submitting a new FCN for the same food 

contact substance, including for the 

same intended use, after we have 

determined that an FCN is no longer 

effective, unless the intended use of the 

food contact substance is authorized by 

a food additive regulation or is covered 

by a TOR exemption (see proposed 

§ 170.105(c)). The new submission 

would be made under §§ 170.100 and 

170.101 (id.). 

G. Confidentiality of Information 

Currently, our regulation at § 170.102 

discusses the confidentiality of 

information in a premarket notification 

for a food contact substance. The 

proposed rule would amend our 

regulation to address the confidentiality 

of data and information that is related 

to a notification, including data and 

information related to FDA’s 

determination that an FCN is no longer 

effective. Specifically, the proposed rule 

would amend § 170.102(e) to address 

the disclosure of certain information 

related to a notification, including 

information related to FDA’s 

determination that an FCN is no longer 

effective. The proposed rule would 

amend § 170.102(e)(1) to include all 

safety and functionality data and 

information submitted with or 

incorporated by reference into the 

notification, or submitted in reference to 

an effective FCN. The proposed rule 

also would amend § 170.102(e)(5) to 

include all correspondence and written 

summaries of oral discussions relating 

to the notification or to FDA’s 

determination that an FCN is no longer 

effective. 

V. Proposed Effective Date 

We intend that any final rule resulting 

from this rulemaking become effective 

60 days after the date of publication of 

the final rule in the Federal Register. 

VI. Economic Analysis of Impacts 

A. Introduction 

We have examined the impacts of the 

proposed rule under Executive Order 


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12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612) and the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4). 

Executive Orders 12866 and 13563 

direct us to assess all costs and benefits 

(both quantitative and qualitative) of 

available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). We 

have developed a comprehensive 

economic analysis of impacts that 

assesses the impacts of the proposed 

rule. We believe that the proposed rule 

will not be an economically significant 

regulatory action as defined by 

Executive Order 12866. 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because of the minimal costs to 

manufacturers and suppliers that would 

be affected by this proposed rule, we 

propose to certify that this proposed 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before proposing 

‘‘any rule that includes any Federal 

mandate that may result in the 

expenditure by state, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

one year.’’ The current threshold after 

adjustment for inflation is $158 million, 

using the most current (2020) Implicit 

Price Deflator for the Gross Domestic 

Product. We do not expect this 

proposed rule to result in any 1-year 

expenditure that will meet or exceed 

this amount. 

B. Summary of Benefits and Costs of the 

Proposed Rule 

The proposed rule is expected to lead 

to benefits in the form of cost savings to 

manufacturers and suppliers who have 

effective food contact notifications and 

to FDA. The proposed rule would revise 

FDA’s current process of determining 

whether an FCN is no longer effective. 

The proposed rule would give 

manufacturers and suppliers the 

opportunity to demonstrate why an FCN 

should continue to be effective before 

we could make a determination. 

Additionally, the proposed rule would 

amend § 170.105 to include reasons 

other than safety as the basis for FDA to 

determine that an FCN is no longer 

effective. This would include instances 

in which the production, supply, or use 

of the food contact substance for its 

intended use has ceased or will cease by 

a specified date, or the use of a food 

contact substance identified in an FCN 

is authorized by a food additive 

regulation or TOR exemption. Cost 

savings would be accrued by 

manufacturers and suppliers who may 

wish to cease manufacturing a food 

contact substance and to request that 

FDA determine that an FCN is no longer 

effective for reasons other than safety. 

This may enable manufacturers to 

resolve the regulatory status of a food 

contact substance without acquiring and 

submitting data or other information 

addressing the safety of the intended 

use. We also would realize cost savings 

as we would be able to act more 

efficiently upon an FCN request by the 

manufacturer or supplier to determine 

that an FCN is no longer effective for 

reasons other than safety. Because the 

proposed rule would reduce the burden 

for both industry and FDA and would 

not require significant additional action 

to be taken, we expect the costs of the 

proposed rule to be minimal. 

The estimated total cost savings of the 

proposed rule are estimated in 2020 

U.S. dollars and range from zero to $0.5 

million, with a central estimate of $0.1 

million, annualized at 7 percent over 10 

years. Discounted at 3 percent, 

annualized cost savings range from zero 

to $0.4 million, with a central estimate 

of $0.1 million. We estimate that the 

costs of the proposed rule are minimal. 

The estimated cost savings and costs of 

the proposed rule are summarized in 

table 1. 

TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(percent) 

Period 

covered 

(years) 

Cost Savings: 

One-time Monetized millions/year ............ .................. .................. .................. .................. .................. ..................

Annualized ................................................ $0.1M $0 $0.5M 2020 7 10 

Quantified .................................................. 0.1M 0 0.4M 2020 3 10 

Qualitative ................................................. .................. .................. .................. .................. .................. ..................

Costs: 

Annualized ................................................ .................. .................. .................. .................. .................. ..................

Monetized millions/year ............................ .................. .................. .................. .................. .................. ..................

Annualized ................................................ .................. .................. .................. .................. .................. ..................

Quantified .................................................. .................. .................. .................. .................. .................. ..................

Qualitative ................................................. .................. 0 .................. 2020 .................. 10 

Transfers: 

Federal Annualized ................................... .................. .................. .................. .................. .................. ..................

Monetized $millions/year .......................... .................. .................. .................. .................. .................. ..................

From: To: 

Other Annualized ...................................... .................. .................. .................. .................. .................. ..................

Monetized $millions/year .......................... .................. .................. .................. .................. .................. ..................

From: To: 

Effects: 

State, Local or Tribal Government: 

Small Business: Increased cost savings of zero to $144.25 per affected small entity 

Wages: 

Growth: 


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The full analysis of economic impacts 

is available in the docket for this 

proposed rule (Ref. 1) and at https://

www.fda.gov/AboutFDA/ 

ReportsManualsForms/Reports/ 

EconomicAnalyses/default.htm. 

VII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.30(h) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

VIII. Paperwork Reduction Act of 1995 

This proposed rule contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3521). A description of 

these provisions is given in the 

Description section of this document 

below with an estimate of the annual 

reporting burden. Included in the 

estimate is the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing each collection of 

information. 

We invite comments on these topics: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of FDA’s functions, 

including whether the information will 

have practical utility; (2) the accuracy of 

FDA’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Food Contact Substance 

Notification System; OMB Control 

Number 0910–0495—Revision 

Description: Section 409(h) of the 

FD&C Act establishes a premarket 

notification process for food contact 

substances. Section 409(h)(6) of the 

FD&C Act defines a ‘‘food contact 

substance’’ as any substance intended 

for use as a component of materials used 

in manufacturing, packing, packaging, 

transporting, or holding food if such use 

is not intended to have any technical 

effect in such food. Section 409(h)(3) of 

the FD&C Act requires that the 

notification process be used for 

authorizing the marketing of food 

contact substances except when: (1) The 

Secretary determines that the 

submission and premarket review of a 

food additive petition (FAP) under 

section 409(b) of the FD&C Act is 

necessary to provide adequate assurance 

of safety or (2) the Secretary and the 

manufacturer or supplier agree that an 

FAP should be submitted. Section 

409(h)(1) of the FD&C Act requires that 

a notification include: (1) Information 

on the identity and the intended use of 

the food contact substance and (2) the 

basis for the manufacturer’s or 

supplier’s determination that the food 

contact substance is safe under the 

intended use. FDA regulations at part 

170 specify the information that a 

notification must contain. 

The proposed rule would amend the 

procedure by which we determine that 

an FCN is no longer effective. The 

information collection would cover 

situations that entail the potential 

reporting of additional data or other 

information by manufacturers or 

suppliers of food contact substances. 

This proposal would augment the 

existing information collection that 

covers the food contact substance 

notification program at part 170, subpart 

D. 

Description of Respondents: 

Respondents to the information 

collection are manufacturers and 

suppliers of food contact substances 

sold in the United States. Respondents 

are from the private sector (for-profit 

businesses). 

We estimate the burden of this 

collection of information as follows: 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

(hours) 

Total hours 

170.105(a); Manufacturer or supplier responds to FDA by 

providing additional data or information to demonstrate 

that the FCN should continue to be effective .................. 2 1 2 75 150 

170.105 (a)(2)(i); Manufacturer or supplier requests that 

FDA determine that the FCN should no longer be effective based on non-safety reasons .................................... 5 1 5 2 10 

Total .............................................................................. ........................ ........................ ........................ ........................ 160 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The burden estimates in table 2 are 

based on our experience with our Food 

Contact Substance Notification Program. 

We will inform the affected 

manufacturers or suppliers of the 

specified FCN about data or other 

information that their food contact 

substance may: (1) Not be safe for its 

intended use; or (2) have stopped being 

produced, supplied, or used as a food 

contact substance for its intended use; 

or (3) be authorized by a food additive 

regulation; or (4) be covered by a TOR 

exemption. As such, we may determine 

that the specified FCN may no longer be 

effective for its intended use unless the 

affected manufacturer or supplier 

provides additional data or other 

information to demonstrate that the FCN 

should continue to be effective. In row 

1, we estimate that, annually, 2 

respondents will each spend about 75 

hours preparing a response for a total of 

150 hours (2 respondents × 75 hours). In 

the existing information collection for 

our Food Contact Substance Notification 

Program (OMB control number 0910– 

0495; 84 FR 3468), we estimate that it 

may take up to 150 hours to prepare and 

submit an FCN depending on the 

complexity of the submittal. We assume 

the time to prepare a response will take 

about half the time of the initial 

submittal because the manufacturer or 

supplier should already have compiled 

and have access to most, if not all the 

information demonstrating that their 

FCN should continue to be effective and 

remains safe for its intended use. 

The proposed rule would allow a 

manufacturer or supplier to request that 

FDA determine that their FCN is no 


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longer effective on the basis that the 

manufacturer or supplier no longer 

produces, supplies, or uses the food 

contact substance for the intended use. 

We believe a manufacturer or supplier 

will not need much time to prepare 

such a request as it should already have 

access to information that it has or 

intends to no longer produce, supply, or 

use the food contact substance for the 

intended use. Based on the Preliminary 

Regulatory Impact Analysis, we estimate 

that 5 respondents will voluntarily 

request that FDA determine that their 

FCN is no longer effective (Ref. 1). 

Accordingly, in row 2, we estimate that 

5 respondents will each submit 1 

request to us per year with each request 

taking 2 hours to prepare for a total of 

about 10 hours (2 respondents × 5 

hours). 

To ensure that comments on 

information collection are received, 

OMB recommends that written 

comments be submitted through 

reginfo.gov (see ADDRESSES). All 

comments should be identified with the 

title of the information collection. 

In compliance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3407(d)), we have submitted the 

information collection provisions of this 

proposed rule to OMB for review. These 

information collection requirements 

will not be effective until FDA 

publishes a final rule, OMB approves 

the information collection requirements, 

and the rule goes into effect. FDA will 

announce OMB approval of these 

requirements in the Federal Register. 

IX. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that this proposed rule 

does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

conclude that the proposed rule does 

not contain policies that have 

federalism implications as defined in 

the Executive Order and, consequently, 

a federalism summary impact statement 

is not required. 

X. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13175. We 

have tentatively determined that the 

proposed rule does not contain policies 

that would have a substantial direct 

effect on one or more Indian Tribes, on 

the relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. We 

invite comments from tribal officials on 

any potential impact on Indian Tribes 

from this proposed action. 

XI. Reference 

The following reference is on display 

at the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday; it 

is also available electronically at https:// 

www.regulations.gov. FDA has verified 

the website address, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. FDA, ‘‘Food Additives: Food Contact 

Substance Notification That Is No Longer 

Effective, Preliminary Regulatory Impact 

Analysis, Initial Regulatory Flexibility 

Analysis.’’ Also available at: https://

www.fda.gov/AboutFDA/ 

ReportsManualsForms/Reports/ 

EconomicAnalyses/default.htm. 

List of Subjects in 21 CFR Part 170 

Administrative practice and 

procedure, Food additives, Reporting 

and recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, we propose that 21 

CFR part 170 be amended as follows: 

PART 170—FOOD ADDITIVES 

■ 1. The authority citation for part 170 

continues to read as follows: 

Authority: 21 U.S.C. 321, 341, 342, 346a, 

348, 371. 

■ 2. Amend § 170.102 by revising the 

section title, paragraph (e) introductory 

text and paragraphs (e)(1) and (5) to read 

as follows: 

§ 170.102 Confidentiality of information 

related to premarket notification for a food 

contact substance (FCN). 

* * * * * 

(e) The following data and 

information are available for public 

disclosure, unless extraordinary 

circumstances are shown, on the 121st 

day after receipt of the notification by 

FDA, except that no data or information 

are available for public disclosure if the 

FCN is withdrawn under § 170.103. Data 

and information related to FDA’s 

determination that an FCN is no longer 

effective are available for public 

disclosure as of the date of publication 

in the Federal Register of FDA’s 

determination. 

(1) All safety and functionality data 

and information submitted with or 

incorporated by reference into the 

notification, or submitted in reference to 

an effective FCN. Safety and 

functionality data include all studies 

and tests of a food contact substance on 

animals and humans and all studies and 

tests on a food contact substance for 

establishing identity, stability, purity, 

potency, performance, and usefulness. 

* * * * * 

(5) All correspondence and written 

summaries of oral discussions relating 

to the notification or to FDA’s 

determination that an FCN is no longer 

effective, except information that is 

exempt under § 20.61 of this chapter. 

* * * * * 

■ 3. Revise § 170.105 to read as follows: 

§ 170.105 The Food and Drug 

Administration’s (FDA’s) determination that 

a premarket notification for a food contact 

substance (FCN) is no longer effective. 

(a) FDA may determine that an FCN 

is no longer effective if: 

(1) Data or other information available 

to FDA, including data not submitted by 

the manufacturer or supplier, 

demonstrate that the intended use of a 

food contact substance is no longer safe. 

(i) FDA will inform the affected 

manufacturer or supplier specified in 

the FCN, in writing, of FDA’s concerns 

regarding the safety of the intended use 

of the food contact substance. FDA will 

specify the date by which the 

manufacturer or supplier must provide 

FDA with data or other information to 

respond to FDA’s safety concerns. 

(ii) If the manufacturer or supplier 

fails, by the specified date, to supply 

either the data or other information 

necessary to address the safety concerns 

regarding the notified use or a request 

described in paragraph (a)(2)(i) of this 

section, FDA may determine that the 

FCN is no longer effective because there 

is no longer a basis to conclude that the 

intended use is safe. 

(iii) If FDA denies a request described 

in paragraph (a)(2)(i) of this section, and 

FDA had previously informed the 

manufacturer or supplier of FDA’s 

concerns regarding the safety of the 

intended use of the food contact 

substance as described in paragraph 

(a)(1)(i) of this section, FDA may 

determine that a FCN is no longer 

effective because there is no longer a 

basis to conclude that the intended use 

is safe. Alternatively, FDA may provide 

the manufacturer or supplier with 

additional time to provide FDA with 

data or other information to respond to 

FDA’s safety concerns. If the 

manufacturer or supplier fails, by the 

specified date, to supply the data or 


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3958 Federal Register / Vol. 87, No. 17 / Wednesday, January 26, 2022 / Proposed Rules 

other information necessary to address 

the safety concerns regarding the 

notified use, FDA may determine that 

the FCN is no longer effective because 

there is no longer a basis to conclude 

that the intended use is safe. 

(2) Data or other information available 

to FDA demonstrate that the 

manufacturer or supplier specified in 

the FCN has stopped or intends to stop 

producing, supplying, or using a food 

contact substance for the intended use. 

Such data or other information includes 

but is not limited to: 

(i) A request from the manufacturer or 

supplier. 

(A) The manufacturer or supplier 

specified in the FCN may request in 

writing that FDA determine that an FCN 

is no longer effective on the basis that 

it has stopped producing, supplying, or 

using a food contact substance for the 

intended food contact use in the United 

States or that it intends to stop 

producing, supplying, or using a food 

contact substance for the intended food 

contact use in the United States by a 

specified date. FDA will notify the 

manufacturer or supplier whether FDA 

is granting the request. 

(B) If FDA grants the request, FDA 

may determine that the FCN is no longer 

effective on the basis that the 

manufacturer or supplier has stopped 

producing, supplying, or using a food 

contact substance for the intended use 

in the United States or that it intends to 

stop producing, supplying, or using a 

food contact substance for the intended 

food contact use in the United States by 

a specified date. When such a request is 

based on the intent to stop producing, 

supplying, or using a food contact 

substance for the intended food contact 

use in the United States at a future date, 

FDA will include in the notice 

described in paragraph (b) of this 

section the date specified in the request 

as the compliance date by which the 

manufacturer or supplier will stop 

producing, supplying, or using the food 

contact substance for the intended food 

contact use in the United States. 

(ii) Other data or information 

available to FDA. 

(A) If other data or information 

available to FDA demonstrate that a 

food contact substance is no longer 

produced, supplied, or used for an 

intended food contact use in the United 

States, FDA will inform the affected 

manufacturer or supplier specified in 

the FCN, in writing. FDA will include 

a specified time period by which the 

manufacturer or supplier must provide 

FDA with data or other information that 

demonstrate that the manufacturer or 

supplier continues to produce, supply, 

or use a food contact substance for the 

intended use in the United States. 

(B) If the manufacturer or supplier 

fails, by the specified date, to provide 

data or other information that 

demonstrate that the manufacturer or 

supplier continues to produce, supply, 

or use a food contact substance for the 

intended use in the United States; or if 

the manufacturer or supplier confirms 

that it has stopped producing, 

supplying, or using the food contact 

substance for the intended food contact 

use in the United States, FDA may 

determine that the FCN is no longer 

effective. 

(3) The intended use of the food 

contact substance identified in the FCN 

is authorized by a food additive 

regulation. 

(i) FDA will inform the manufacturer 

or supplier specified in the FCN in 

writing that the intended use of the food 

contact substance identified in the FCN 

is authorized by a food additive 

regulation. FDA will include a specified 

time period by which the manufacturer 

or supplier must respond to FDA with 

data or other information about whether 

the intended use of the food contact 

substance is authorized by a food 

additive regulation. 

(ii) If a manufacturer or supplier fails, 

by the specified date, to supply data or 

other information that demonstrate that 

the intended use of the food contact 

substance identified in the FCN is not 

authorized by a food additive 

regulation, FDA may determine that the 

FCN is no longer effective on the basis 

that the intended use of the food contact 

substance is authorized under a food 

additive regulation. 

(4) The intended use of the food 

contact substance identified in the FCN 

is covered by a threshold of regulation 

exemption. 

(i) FDA will inform the manufacturer 

or supplier specified in the authorizing 

FCN in writing that the intended use of 

the food contact substance identified in 

the FCN is covered by a threshold of 

regulation exemption. FDA will include 

a specified time period by which the 

manufacturer or supplier must respond 

to FDA with data or other information 

about whether the intended use of the 

food contact substance is covered by a 

threshold of regulation exemption. 

(ii) If a manufacturer or supplier fails, 

by the specified date, to supply data or 

other information that demonstrate that 

the intended use of the food contact 

substance identified in the FCN is not 

covered by a threshold of regulation 

exemption, FDA may determine that the 

FCN is no longer effective on the basis 

that the intended use of the food contact 

substance is covered under a threshold 

of regulation exemption. 

(b) If FDA determines that an FCN is 

no longer effective, FDA will publish a 

notice of its determination in the 

Federal Register stating that a detailed 

summary of the basis for FDA’s 

determination that the FCN is no longer 

effective has been placed on public 

display and that copies are available 

upon request. If FDA determines it 

would be protective of public health, 

FDA may include a separate compliance 

date for the use of the food contact 

substance in food contact articles, 

including food contact substances that 

were produced, supplied, or used by the 

manufacturer or supplier before 

publication of the notice in the Federal 

Register or before the compliance date 

described in paragraph (a)(2)(i)(B) of 

this section. The date that the notice 

publishes in the Federal Register is the 

date on which the notification is no 

longer effective. FDA’s determination 

that an FCN is no longer effective is 

final agency action subject to judicial 

review. 

(c) FDA’s determination that an FCN 

is no longer effective does not preclude 

any manufacturer or supplier from 

submitting a new FCN for the same food 

contact substance, including for the 

same intended use, after FDA has 

determined that an FCN is no longer 

effective, unless the intended use of the 

food contact substance is authorized by 

a food additive regulation or covered by 

a threshold of regulation exemption. 

The new submission must be made 

under §§ 170.100 and 170.101. 

Dated: January 20, 2022. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

[FR Doc. 2022–01527 Filed 1–25–22; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R07–OAR–2021–0932; FRL–9461–01– 

R7] 

Air Plan Approval; Iowa; Determination 

of Attainment by the Attainment Date 

for the 2010 1-Hour Sulfur Dioxide 

Standard 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to determine 

that the Muscatine sulfur dioxide (SO2) 

nonattainment area attained the 2010 1- 


khammond on DSKJM1Z7X2PROD with PROPOSALS