[Federal Register Volume 89, Number 57 (Friday, March 22, 2024)]
[Rules and Regulations]
[Pages 20306-20317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05802]


=======================================================================
-----------------------------------------------------------------------

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, Department of Health and Human 
Services (HHS).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is amending its 
regulations relating to the procedures for determining that a premarket 
notification for a food contact substance (FCN) is no longer effective. 
The final rule provides additional reasons that could form the basis 
for FDA to determine that an FCN is no longer effective. The final rule 
also ensures that manufacturers or suppliers have the opportunity to 
provide input before we determine that an FCN is no longer effective. 
We are making these changes to allow FDA to respond better to new 
information on the safety and use of food contact substances (FCSs), as 
well as manufacturers' business decisions, and also improve the 
efficiency of the premarket notification program.

DATES: This rule is effective May 21, 2024.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule 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: 
    With regard to the final rule: Sharon Koh-Fallet, Center for Food 
Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 301-796-7732; or Carrol 
Bascus, 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; 
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
    C. General Overview of the Final Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Description of General Comments
    C. Comments on a Change to the Process for Obtaining Data or 
Other Information To Demonstrate the Intended Use of a Food Contact 
Substance Is No Longer Safe
    D. Comments on Determining a Premarket Notification for a Food 
Contact Substance Is No Longer Effective Due to Abandonment
    E. Comments on Determining a Premarket Notification for a Food 
Contact Substance Is No Longer Effective Because It Is Authorized by 
a Food Additive Regulation or Is the Subject of an Issued Threshold 
of Regulation Exemption
    F. Comments on Confidentiality of Information Related to 
Premarket Notification for a Food Contact Substance
    G. Miscellaneous Comments
    H. Nonsubstantive Changes
V. Effective/Compliance Date(s)
VI. Economic Analysis of Impacts
    A. Introduction
    B. Summary of Cost and Benefits
VII. Analysis of Environmental Impact

[[Page 20307]]

VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. Reference

I. Executive Summary

A. Purpose of the Final Rule

    We are amending our regulations to provide additional reasons that 
may be the basis for FDA to determine that an FCN is no longer 
effective and to provide the manufacturer or supplier of the substance 
an opportunity to provide input before we make such a determination. 
These changes will create administrative mechanisms to improve the 
efficiency of the premarket notification program for food contact 
substances (FCSs). We are also amending related confidentiality of 
information regulations.

B. Summary of the Major Provisions of the Final Rule

    The final rule provides reasons other than safety as the basis on 
which we may determine that an FCN is no longer effective. These 
reasons include instances where the production, supply, or use of the 
FCS for its intended use by the manufacturer or supplier has ceased or 
will cease (referred to in this rule as ``abandonment''), or where the 
use of an FCS identified in an FCN is either authorized by a food 
additive regulation or is the subject of an issued Threshold of 
Regulation (TOR) exemption. The final rule also provides 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 the use no longer being authorized. 
Additionally, the final rule amends the confidentiality of information 
provisions to provide for the disclosure of certain information 
relating to our determination that an FCN is no longer effective.

C. Legal Authority

    We are issuing the final rule 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)).

D. Costs and Benefits

    The final rule amends the food additive regulations relating to 
premarket notifications for FCSs also known as Food Contact 
Notifications (FCNs) and the procedures by which we determine that an 
FCN is no longer effective. The final rule will allow manufacturers or 
suppliers of FCSs to request that FDA determine that an FCN is longer 
effective for reasons other than safety. We expect that cost savings of 
the final rule take the form of a reduced time burden to FCS 
manufacturers and suppliers responding to FDA's safety concerns with 
information that they no longer produce, use, or supply the FCS for the 
intended use. The final rule will also reduce the time burden to FDA 
for the review of such information. We estimate that cost savings of 
the final rule to manufacturers and suppliers and FDA range from zero 
to $0.4 million, with a central estimate of $0.1 million, annualized 
over 10 years at a 2 percent discount rate. We estimate that there will 
be little to no costs associated with the final rule.

II. Background

A. Need for the Regulation/History of This Rulemaking

    Our regulations at Sec.  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 an FCS is no longer safe. Presently, our regulations do 
not provide reasons other than safety as the basis for FDA to determine 
that an FCN is no longer effective. Also, our regulations do not 
provide manufacturers or suppliers the opportunity to show why an FCN 
should continue to be effective prior to FDA making a determination 
that the FCN is no longer effective. Rather, manufacturers and 
suppliers must respond to FDA after we provide notice of our 
determination that the FCN is no longer effective.
    In the Federal Register of January 26, 2022 (87 FR 3949), we 
published a proposed rule that would amend Sec.  170.105 to address 
these issues and better enable FDA to respond to new information on the 
safety and use of FCSs. We proposed additional reasons to permit us to 
make a determination that an FCN is no longer effective for reasons 
other than safety. We proposed that a manufacturer or supplier could 
request that we determine an FCN to no longer be effective because it 
has ceased (or intends to cease) producing, supplying, or using an FCS 
for the intended use. To reduce confusion created by duplicative 
authorizations, we proposed to remove effective FCNs for intended uses 
already authorized by food additive regulations or the subject of an 
issued TOR exemption. We proposed to provide the manufacturer or 
supplier of an FCS an opportunity to provide information before FDA 
makes a determination that an FCN is no longer effective. Additionally, 
we explained that the proposed changes to Sec.  170.105 would create 
administrative efficiencies in the FCN program. We also proposed to 
amend the confidentiality of information provisions in Sec.  170.102 to 
address the disclosure of certain information related to FDA's 
determination that an FCN is no longer effective.

B. Summary of Comments to the Proposed Rule

    The proposed rule provided a 60-day comment period. We received 
fewer than 20 comments on the proposed rule. The comments were from 
individuals, a consumer advocacy group, a law firm, and an industry 
trade association. The comments addressed topics including: (1) 
improved efficiency and the reduced burden on industry; (2) FDA's 
authority to provide additional reasons for determining that an FCN is 
no longer effective; (3) the circumstances under which FDA would make a 
determination based on abandonment; (4) providing manufacturers or 
suppliers the opportunity to respond to FDA's safety questions before 
determining an FCN is no longer effective; (5) the confidentiality 
provisions; (6) providing an opportunity for affected parties to 
comment on the timeframe for food packaging to clear the market; and 
(7) requesting an additional basis for declaring an FCN no longer 
effective.

C. General Overview of the Final Rule

    The final rule establishes procedures to enable FDA to respond 
better to new information on the safety and use of FCSs. The final rule 
ensures that a manufacturer or supplier has the opportunity to provide 
relevant information to FDA before we make a safety determination. The 
final rule also permits us to make a determination that an FCN is no 
longer effective for reasons other than safety. FDA can reduce 
duplicative authorizations by removing effective FCNs for intended uses 
authorized by food additive regulations or the subject of an issued TOR 
exemption. In addition, the final rule will allow FDA to determine that 
an FCN is no longer effective based on abandonment either: (1) in 
response to a request from a manufacturer or supplier because it has 
ceased (or intends to cease) producing, supplying, or using an FCS for 
the intended use or (2) based on other information available to FDA 
that a manufacturer or supplier has stopped producing, supplying, or 
using an FCS for the intended use.
    We anticipate that a manufacturer or supplier may make such a 
request

[[Page 20308]]

because it no longer needs the authorization or because abandonment 
could be less burdensome than addressing potential safety concerns. 
Further, because the FCS would no longer be produced, supplied, or used 
for the intended use, declaring an FCN as no longer effective based on 
abandonment rather than based on safety may be a more effective and 
efficient use of FDA's resources. However, we may decline such a 
request if we determine there is a safety concern that would be more 
appropriately addressed by FDA making a declaration that an FCN is no 
longer effective based on a determination that the intended use of the 
FCS is no longer safe. We would not declare an FCN no longer effective 
based on abandonment if the manufacturer or supplier temporarily ceases 
production or marketing and informs us of their intention to resume 
producing, supplying, or using the FCS for the intended use in the 
future. Additionally, the final rule amends the confidentiality of 
information provisions to provide for the disclosure of certain 
information relating to our determination that an FCN is no longer 
effective.

III. Legal Authority

    We are issuing this final rule consistent with our authority in 
sections 201, 409, and 701(a) of the FD&C Act. The final rule provides 
reasons other than safety as the basis for which we may determine that 
an FCN is no longer effective. The final rule modifies the procedures 
by which FDA determines that an FCN is no longer effective and amends 
the regulation relating to confidentiality of information.
    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 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 
there is an FCN submitted under section 409(h) of the FD&C Act 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. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received fewer than 20 comments on the proposed rule. The 
comments were from individuals, a consumer advocacy group, a law firm, 
and an industry trade association.
    We describe and respond to the comments in sections B through G of 
this document. We have numbered each comment to help distinguish 
between different comments. We have grouped similar comments together 
under the same number, and, in some cases, we have separated different 
issues discussed in the same comment and designated them as distinct 
comments for purposes of our responses. The number assigned to each 
comment or comment topic is purely for organizational purposes and does 
not signify the comment's value or importance or the order in which 
comments were received.

B. Description of General Comments

    Several comments made general remarks supporting or opposing the 
proposed rule without focusing on a particular proposed provision.
    (Comment 1) Some comments expressed general support for the 
proposed rule. One comment stated that the proposed rule ``would make 
FDA more efficient as well as putting less strain on manufacturers.'' 
Another comment said that ``there are cost savings to both 
manufacturers and suppliers as well as the FDA.'' Another comment 
stated that the rule would ``be an overall help to public health.''
    (Response 1) We agree that the final rule will improve the 
efficiency of FDA's oversight of FCSs. This improved efficiency may 
benefit public health in helping FDA to use its resources better on 
oversight of the FCN program and FCS regulation.

C. Comments on a Change to the Process for Obtaining Data or Other 
Information To Demonstrate the Intended Use of a Food Contact Substance 
Is No Longer Safe

    The proposed rule, at Sec.  170.105(a)(1)(i), stated that we would 
inform the manufacturer or supplier specified in the FCN, in writing, 
of our concerns regarding the safety of the intended use of the FCS. We 
proposed that we would specify a date by which the manufacturer or 
supplier must provide data or other information to address the safety 
concerns. The proposed rule, at Sec.  170.105(a)(1)(ii), stated that 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.
    (Comment 2) One comment questioned the need for a procedural change 
allowing a manufacturer or supplier to provide data or other 
information to respond to our safety concerns, given the current 
authorities provided by Sec.  170.105. The comment stated that 
manufacturers already have the opportunity to provide input before FDA 
makes a determination that an FCN is no longer effective based on 
safety.
    (Response 2) We agree that a manufacturer or supplier already has 
the opportunity to provide input to FDA; however, presently, we are not 
required to provide a manufacturer or supplier an opportunity to 
address safety concerns until after FDA has made a determination. We 
proposed a procedural change to the existing regulation at Sec.  
170.105(b) to help ensure that we have all the relevant information 
before making a determination on whether an FCN should remain 
effective. In the final rule, if the manufacturer or supplier fails to 
supply either the data or other information necessary to address our 
safety concerns, by the specified date, we may make a determination 
that the FCN is no longer effective. However, we will make the 
determination only after we have given the manufacturer or supplier an 
opportunity to provide data or other information to respond to our 
safety questions.
    (Comment 3) Two comments opposed giving a manufacturer or supplier 
the opportunity to respond to safety concerns. One comment stated that 
a manufacturer or supplier should not

[[Page 20309]]

have a say in whether an FCN is effective and making a safety 
determination. One comment asserted that this would ``give 
manufacturers more room for exemptions from safety precautions.''
    (Response 3) The final rule provides manufacturers and suppliers 
the opportunity to demonstrate whether an FCN should remain effective, 
including by providing information pertaining to safety. The 
manufacturer or supplier has the responsibility to demonstrate that the 
intended use of the FCS is safe. FDA will evaluate the information 
provided by manufacturers and suppliers before making a determination 
about the status of an FCN or the safety of an FCS use. The final rule 
continues to provide that we can declare an FCN no longer effective if 
the manufacturer or supplier fails to supply the necessary data or 
information to address our safety concerns.

D. Comments on Determining a Premarket Notification for a Food Contact 
Substance Is No Longer Effective Due to Abandonment

    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 ceased, or intends to cease by a 
specified date, producing, supplying, or using an FCS for the intended 
food contact use in the United States (see proposed Sec.  
170.105(a)(2)(i)(A)). It also proposed that if other data or 
information available to FDA demonstrate that a manufacturer or 
supplier no longer produces, supplies, or uses an FCS for the intended 
use in the United States, we would inform, in writing, the manufacturer 
or supplier specified in the FCN and provide them an opportunity to 
respond before we could determine that the FCN is no longer effective 
(see proposed Sec.  170.105(a)(2)(ii)(A)).
    (Comment 4) One comment disagreed with our proposal but stated that 
there is a need for clarity regarding the status of an FCN after a 
manufacturer or supplier notifies FDA of its intent to withdraw 
products from the market that are the subject of such an FCN. The 
comment recommended an alternate amendment. The comment's proposed 
amendment would require a manufacturer or supplier--if it previously 
notified FDA in writing of its intent to cease introduction into 
interstate commerce and delivery for introduction into interstate 
commerce of any FCS that is the subject of an effective FCN--to submit 
a new FCN before reintroducing the FCS for the same intended use into 
interstate commerce.
    (Response 4) We do not agree with the amendment offered by the 
comment because it would create duplicate authorizations. Under our 
existing regulations, if a manufacturer or supplier notifies us of 
their intent to cease production, supply, or use of an FCS for reasons 
other than a determination by FDA that an FCN is no longer effective 
due to safety concerns, the FCN remains effective for its intended use. 
In the proposal submitted in the comment, an FCN would remain effective 
after the listed manufacturer or supplier informs FDA of their intent 
to cease introduction of the FCS into interstate commerce. The proposal 
would also require a new FCN to be submitted if the manufacturer or 
supplier would reintroduce the FCS into interstate commerce; however, 
the original FCN is still effective. Therefore, the proposed amendment 
would create duplicative authorizations. In contrast, FDA's final rule 
will allow us to declare that an FCN is no longer effective for reasons 
other than safety. If a manufacturer or supplier decides to reintroduce 
the FCS into interstate commerce after we determined it no longer 
effective, they would be required to submit a new FCN.
    (Comment 5) One comment stated that a manufacturer or supplier may 
withdraw products covered by FCNs from the market for any reason, and 
that it can also ``voluntarily withdraw the FCN and dispose of the 
notification if it so desires.'' The comment noted that under the 
statute such companies ``may'' file an FCN and therefore withdrawal of 
an FCN should also be permitted. The comment provided as example that 
under section 6(f) of the Federal Insecticide, Fungicide, and 
Rodenticide Act [Pub. L. 80-104] an applicant may initiate cancellation 
of a registration. The comment stated that it is ``not appropriate for 
manufacturers/suppliers of FCSs covered by effective FCNs to be 
constrained by FDA in their business decisions.''
    (Response 5) We agree that a company may remove products covered by 
FCNs from the market. The final rule does not regulate a company's 
decision to stop the production, supply, or use of FCSs that are 
authorized under effective FCNs. However, we disagree that a 
manufacturer or supplier may withdraw an effective FCN under the 
current regulation. Furthermore, the comment does not explain what the 
regulatory status of the FCS would be under such a scenario. Section 
409 of the FD&C Act does not provide for withdrawal of an effective FCN 
and directs FDA to prescribe, by regulation, the procedure by which we 
are to deem an FCN to no longer be effective. Consistent with the 
statute, we are amending our procedural regulations to provide for 
abandonment as a basis for determining that an FCN is no longer 
effective. Under the final rule, a manufacturer or supplier will be 
able to request that we determine that an FCN is no longer effective 
based on abandonment.
    (Comment 6) A few comments opposed the provision to allow FDA to 
declare an FCN no longer effective for reasons of abandonment and 
asserted that FDA does not have this authority. The comments asserted 
that, under section 409 of the FD&C Act, we can only determine an FCN 
to no longer be effective based on safety. One comment stated that it 
would be appropriate to grant a request based on abandonment from the 
manufacturer or supplier. Another comment asserted that the FD&C Act 
limits FDA's food additive review to safety. The comment also referred 
to our regulation at 21 CFR 171.130, which allows for food additive 
regulations to be repealed or amended for reasons other than safety. 
The comment asserted that section 409(i) of the FD&C Act, which states 
that FDA shall, by regulation, prescribe the procedure by which FDA may 
deem an FCN to no longer be effective, means that FCNs are to be 
treated differently from food additive regulations and that FDA is 
bound by the safety standard in section 409(c)(3)(A) of the FD&C Act 
for FCNs.
    (Response 6) We disagree with the comments. The final rule is 
consistent with our authority in sections 201, 409, and 701(a) of the 
FD&C Act. Section 201(s) of the FD&C Act defines ``food additive.'' 
Section 409(h) of the FD&C Act specifies the procedures for the FCN 
program. Food additives include ``food contact substances,'' which are 
defined in section 409(h)(6) of the FD&C Act as any substance intended 
for use as a component of materials used in manufacturing, packing, 
packing, transporting, or holding food if such uses is not intended to 
have any technical effect in such food. 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. In addition, section 701(a) 
of the FD&C Act gives FDA the authority to issue regulations for the 
efficient enforcement of the FD&C Act. These provisions provide us 
authority to establish and modify administrative procedures to ensure 
the efficiency of the food contact notification program. As one comment 
noted, FDA has already established a

[[Page 20310]]

regulation under which we may repeal a food additive regulation based 
on abandonment. Likewise, nothing in section 409(i) of the FD&C Act 
precludes FDA from establishing procedures by regulation to deem an FCN 
no longer effective based on reasons other than safety.
    (Comment 7) Some comments opposed the proposed revisions that would 
allow FDA to determine that an FCN is no longer effective because 
production, supply, or use of the FCS has stopped or will stop. One 
comment expressed concerns that FDA would determine that an FCN is no 
longer effective without considering whether a manufacturer or supplier 
or their customer has significant stock of an FCS on hand. The comment 
questioned whether FDA would make the determination without regard to 
whether the manufacturer or supplier intends to resume production, at a 
future date, based on market conditions. Another comment expressed 
concerns about the reasons third parties might provide information and 
data to FDA to support a determination that an FCN is no longer 
effective based on abandonment. For example, the commenter stated, ``if 
any third party can provide FDA with information that a product that is 
the subject of an effective FCN is not now being manufactured for food-
contact applications, such substances could be targeted for removal 
without demonstrating a safety concern.''
    (Response 7) We expect that, in most cases, a determination based 
on abandonment will be in response to a request from a manufacturer or 
supplier, rather than based on information from a third party. However, 
to address the concerns raised by the comments with respect to 
information provided by a third party, we have amended the provision 
for abandonment that is based on other data or information available to 
FDA. We have added ``or intends to continue in the future'' to make 
clear that FDA would not make a determination based on abandonment if 
the manufacturer or supplier informs us that it intends to resume in 
the future the production, supply, or use of an FCS for the intended 
use in the United States (see Sec.  170.105(a)(2)(ii)(A) and (B)). If 
we receive information from a third party or through other means, as 
outlined in Sec.  170.105(a)(2)(ii)(A), we will inform, in writing, the 
affected manufacturer or supplier specified in the FCN before we could 
determine that the FCN is no longer effective. In cases where a 
manufacturer or supplier informs us that its suspension of the 
production, supply, or use is only temporary, we will not declare an 
FCN no longer effective on the basis of abandonment. This information 
must be provided to FDA in writing, within the specified timing, as 
required under Sec.  170.105(a)(2)(ii).
    With respect to the comments about supplies of an FCS held by a 
manufacturer or supplier, or its customers, the final rule provides for 
compliance dates to address these situations. When a manufacturer or 
supplier requests that we determine that an FCN is no longer effective 
because it has ceased or plans to cease producing, supplying, or using 
an FCS, we will confirm with the manufacturer or supplier the date it 
has ceased or that it intends to cease production, supply, or use. 
Under the final rule, if we determine that an FCN is no longer 
effective, we will publish a notice announcing the determination in the 
Federal Register. The FCN will no longer be effective on the date of 
publication of the notice. If the manufacturer or supplier informs us 
that it intends to cease production, supply, or use at a future date, 
we will provide for a separate compliance date that is the future date 
specified by the manufacturer or supplier, and this compliance date 
will be reflected in the Federal Register. To take into consideration 
inventory held by downstream customers, as provided in Sec.  
170.105(b), FDA may also include a separate compliance date in the 
Federal Register for the use of the FCS in food contact articles.
    (Comment 8) One comment opposed the provision to allow FDA to 
determine an FCN is no longer effective based on abandonment, absent a 
request by the manufacturer or supplier, because, according to the 
comment, it would cause potential harm to a business.
    (Response 8) We anticipate that a determination that an FCN is no 
longer effective based on abandonment will not cause potential harm to 
businesses because the majority of these actions will be in response to 
a manufacturer or supplier's specific request because it has ceased or 
plans to cease production of the FCS. However, there may be rare cases 
where the manufacturer or supplier is not available because the 
business no longer exists. In such instances, we may determine that an 
FCN is no longer effective based on abandonment. We note that Sec.  
170.100(d) (21 CFR 170.100(d)) requires a manufacturer or supplier for 
which a notification is effective to keep a current address on file 
with FDA.
    (Comment 9) One comment stated that the proposed rule does not 
assure that a manufacturer or supplier will have adequate time to 
respond to our request for data and information to demonstrate that 
they continue to produce, supply, or use the FCS for the intended use 
in the United States. The comment stated that a ``manufacturer or 
supplier may be forced to comply with an arbitrary or inadequate 
deadline'' to provide information to FDA.
    (Response 9) In response to this comment, we revised Sec.  
170.105(a)(2)(ii), which describes the response of a manufacturer or 
supplier to FDA, to remove the reference to providing ``data and 
information to demonstrate'' a continued use, and instead are requiring 
that the manufacturer or supplier respond in writing indicating whether 
it continues, or intends to continue in the future, to produce, supply, 
or use an FCS for the intended use in the United States. We anticipate 
that there will be minimal burden on a manufacturer and supplier to 
provide us with such a statement. We will provide an appropriate amount 
of time for manufacturers and suppliers to respond, based on the 
information available to us at that time. We will consider a request 
for additional time from a manufacturer or supplier.
    (Comment 10) One comment stated that if an FCN is declared no 
longer effective based on abandonment, a ``substantially-delayed 
compliance deadline would be appropriate, to assure that lawfully 
manufactured food packaging has a sufficient opportunity to work its 
way through channels of trade.'' The comment further stated that 
affected parties must be provided with an opportunity to provide 
comments to FDA on the length of time that will be required for food 
contact articles to clear channels of trade.
    (Response 10) As provided in Sec.  170.105(b), if we determine it 
would be protective of public health, we may include a separate 
compliance date for the use of the FCS in food contact articles. We 
believe the manufacturer or supplier is in a position to estimate the 
time it will take for the affected FCS and food contact articles to 
clear the U.S. market. We expect that the manufacturer or supplier will 
confer with its downstream customers to ascertain the time it will take 
to exhaust their inventory and clear the U.S. market. Therefore, in 
response to the comment, we revised Sec.  170.105(a)(2)(i)(A) to 
require that the request from a manufacturer or supplier include 
information or a basis to support the estimated date for the FCS, as 
well as food contact articles that contain such FCS, produced, 
supplied, or used by the manufacturer or supplier, to clear the U.S. 
market. This

[[Page 20311]]

information will help to inform a separate compliance date for the use 
of an FCS in food contact articles.

E. Comments on Determining a Premarket Notification for a Food Contact 
Substance Is No Longer Effective Because It Is Authorized by a Food 
Additive Regulation or Is the Subject of an Issued 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 FCS is authorized by a food additive regulation (see proposed 
Sec.  170.105(a)(3)). We explained that issuing a food additive 
regulation can be more efficient than reviewing multiple FCNs for the 
same FCS and for the same use.
    Additionally, 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 Sec.  170.105(a)(4)). We explained that FCNs 
are effective only for a specific manufacturer or supplier, and 
multiple manufacturers or suppliers often request FCNs for the same 
intended use of an FCS. In contrast, a TOR exemption can cover the use 
of an FCS for any manufacturer or supplier who meets the requirements 
of the TOR. We also explained that we 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 food processing 
equipment) is so trivial as not to require regulation of the substance 
as a food additive (see 21 CFR 170.39).
    (Comment 11) One comment opposed the new provisions. The comment 
stated that the existing FCN program does not accept FCNs for review 
when the proposed use of the substance is authorized through a food 
additive regulation or the subject of an issued TOR exemption. The 
comment said that the new provision would therefore only be applicable 
to FDA-initiated authorizations for the purpose of determining that an 
existing effective FCN is no longer effective. The comment stated that 
section 409(h)(3)(A) of the FD&C Act requires that the FCN process be 
used except when we determine that submission and review of a petition 
is necessary to provide adequate assurance of safety. The comment said 
that we may not determine that an FCN is no longer effective because 
the intended use is authorized by a food additive regulation or the 
subject of an issued TOR exemption because the process ``runs counter 
to Congressional intent'' and ``contravenes Congress' explicit 
requirement that the FCN process shall be used for authorizing the 
marketing of a food-contact substance . . .''
    (Response 11) We disagree with the comment. Section 409 of the FD&C 
Act establishes an FCN process as the primary means by which FDA 
regulates food additives that are FCSs. However, it does not preclude 
us from relying on authorizations provided under food additive 
regulations or issued TOR exemptions as a basis to determine that an 
FCN authorization is duplicative and may be declared no longer 
effective. Section 409(i) of the FD&C Act gives FDA authority to 
prescribe by regulation the procedure by which FDA may determine an FCN 
to no longer be effective. Further, section 701(a) of the FD&C Act 
gives FDA the authority to issue regulations for the efficient 
enforcement of the FD&C Act. Through these provisions, Congress 
provided FDA with the discretion and authority to establish and modify 
administrative procedures to ensure the efficiency of the authorization 
of the safe use of FCSs. The TOR exemption provides an alternative to 
regulate food additives that are FCSs. As described in the Senate 
report associated with the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115), the legislation by which Congress 
amended the FD&C Act to add the FCN program, explicitly left in place 
TOR exemptions and food additive regulations for FCSs (S. Rep. No. 105-
43, at 46 (1997)).
    Furthermore, authorizations of FCSs through food additive 
regulations or TOR exemptions, rather than through FCNs, may improve 
efficiency of our premarket programs because they are not specific to 
one manufacturer or supplier. As such, having these authorizations may 
reduce administrative burdens on FDA and on new manufacturers and 
suppliers of FCS for uses that we already determined are safe when 
manufactured or supplied for uses that comply with the listed 
limitations and specifications. Because an FCN would be duplicative of 
these authorizations, removing a duplicative FCN may help avoid 
confusion from other manufacturers or suppliers about whether they 
would also need to obtain authorization through the FCN program. 
Therefore, under the final rule we may determine that an FCN is no 
longer effective and remove the duplicate FCN from the inventory of 
effective FCNs, if it is the subject of a food additive regulation or 
the subject of an issued TOR exemption.
    FDA would only take action after we inform the manufacturer or 
supplier specified in the FCN, in writing, that the intended use of the 
FCN is authorized by a food additive regulation or the subject of an 
issued TOR exemption. As explained in the proposed rule, the 
manufacturer or supplier would have the opportunity to demonstrate that 
the intended use is not authorized by a food additive regulation or the 
subject of an issued TOR exemption (87 FR 3949 at 3952 through 3954).
    (Comment 12) One comment opposed the provision in the proposed rule 
that would allow us to determine that an FCN is no longer effective if 
it is the subject of an issued TOR exemption. The comment expressed 
concern about the process for granting TOR exemptions.
    (Response 12) Our FCN regulations (see Sec.  170.100(b)(2)) provide 
that FDA may choose not to accept an FCN if there is an issued TOR 
exemption for the intended use. Unlike an authorization provided under 
an effective FCN, which is specific to the manufacturer or supplier 
specified in the notification, a TOR exemption can be relied on for 
uses that comply with the limitations and specifications listed in the 
TOR exemption. The final rule, at Sec.  170.105(a)(4), provides a 
corresponding provision that would allow FDA to declare an FCN no 
longer effective on the basis that this use is covered by an issued TOR 
exemption.
    As for the comment pertaining to the process for granting a TOR 
exemption, we note that the process for granting a TOR exemption is not 
the subject of this rulemaking.
    (Comment 13) One comment asserted that promulgating food additive 
regulations or issuing a TOR exemption to replace FCNs would result in 
the loss of manufacturer-specific information because new manufacturers 
would come to market without notification to FDA and that FDA would no 
longer have the benefit of the ``knowledge of which food contact 
substances have entered the market, who manufactured such substances, 
and in what amount.'' The comment said that this lack of notice and 
information would result in the loss of public safety benefits.
    (Response 13) FDA would conduct research, gather and evaluate all 
relevant data, and complete the necessary analysis of an FCS before 
promulgating a food additive regulation or issuing a TOR exemption. We 
expect that we would have significant data or other information to 
support proposing a new food additive regulation or TOR exemption 
before doing so. Therefore, we do not agree that the loss of 
manufacturer-specific information would negatively affect public 
health.

[[Page 20312]]

    (Comment 14) One comment stated that declaring an FCN as no longer 
effective based on an issued TOR exemption or food additive regulation 
would create undue burdens for industry because business documentation 
commonly includes references to FCN numbers. The comment stated that if 
FDA deems an FCN no longer effective for nonsafety reasons, this could 
create confusion in the marketplace. In addition, the comment stated 
that the companies who submitted an FCN would bear the burden and cost 
of data development to demonstrate safety, whereas if FDA issues a TOR 
exemption or a food additive regulation for that use, other companies 
will benefit. The comment noted that Congress specifically created a 
manufacturer-specific notification process for FCNs.
    (Response 14) As we explained in response to Comment 12, section 
409 of the FD&C Act does not preclude us from issuing a TOR exemption 
or a food additive regulation for the use of an FCS or from relying on 
these authorizations as a basis to determine that duplicative FCNs may 
be declared no longer effective.
    FDA intends to establish and maintain a list of FCNs that are no 
longer effective (and the reason for the FDA's determination) on its 
website to limit confusion. The list will be available along with the 
current inventory of effective FCNs.

F. Comments on Confidentiality of Information Related to Premarket 
Notification for a Food Contact Substance

    The proposed rule would amend Sec.  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. Specifically, proposed Sec.  170.102(e)(1) would continue to 
make all safety and functionality data and information submitted with 
or incorporated by reference into the notification as well as all 
correspondence and written summaries of oral discussions relating to 
the notification available for public disclosure. Proposed Sec.  
170.102(e)(5) also would make all data, correspondence and written 
summaries of oral discussions relating to FDA's determination that an 
FCN is no longer effective available for public disclosure, unless the 
information is exempt under 21 CFR 20.61 (pertaining to trade secrets 
and commercial or financial information that is privileged or 
confidential).
    (Comment 15) One comment disagreed with the proposed amendments to 
Sec.  170.102. The comment stated that, besides the manufacturer's 
notice of market withdrawal, no new information would be provided to 
the FCN file, and, as such, the proposed amendments are not warranted.
    (Response 15) The amendments to the confidentiality of information 
regulations are necessary to provide for disclosure of information 
related to manufacturer or supplier notifications and FDA's 
determination that an FCN is no longer effective for its intended use. 
Thus, the final rule contains the revisions to Sec.  170.102 from the 
proposed rule with minor editorial changes.
    (Comment 16) One comment supported the proposed change to Sec.  
170.102(e) to make publicly available data and information related to 
our determination that an FCN is no longer effective. The comment 
requested that this public disclosure not be limited to FCNs that are 
deemed no longer effective by FDA and be expanded to include all FCNs. 
The comment also emphasized that the public disclosure should entail 
timely publication to FDA's website, rather than public disclosure in 
response to a request under the Freedom of Information Act (FOIA).
    (Response 16) The comment may have misunderstood our proposed 
change to Sec.  170.102(e), which already addresses the public 
disclosure of information related to FCNs. The proposed rule would 
revise Sec.  170.102(e) to address explicitly FCNs that FDA has 
determined are no longer effective; however, there is no difference in 
the public disclosure of this information. To make this clearer, we are 
further revising Sec.  170.102(e) to include the reference to FCNs that 
are no longer effective in the same sentence as other FCNs. With 
respect to the comment asking FDA to disclose information about FCNs 
proactively on FDA's website instead of in response to a FOIA request, 
decisions about proactive disclosures are based on available resources 
and policy priorities. To ensure transparency, FDA will continue to 
maintain an inventory on its website that lists effective FCNs, and 
intends to maintain a second inventory that will list FCNs that are no 
longer effective (and the reason for FDA's determination).

G. Miscellaneous Comments

    (Comment 17) Some comments stated that there is no need for this 
rule because the U.S. Department of Agriculture (USDA) can ``oversee 
such issues.''
    (Response 17) We disagree. Pursuant to section 409(i) of the FD&C 
Act we, rather than USDA, have authority over FCSs.
    (Comment 18) One comment asked about a pending citizen petition 
related to FDA's evaluation of cumulative effects of related 
substances. The pending citizen petition requests revisions to our 
regulations, including 21 CFR 170.101 (Information in a premarket 
notification for a food contact substance (FCN)).
    (Response 18) The comment is outside of the scope of this 
rulemaking, as the purpose is to amend the process that we use to 
determine that an FCN is no longer effective.
    (Comment 19) Some comments discussed the use of plastic and 
Styrofoam in food packaging generally.
    (Response 19) The comments are outside the scope of this rulemaking 
and so we decline to address them.
    (Comment 20) One comment requested that FDA revise the proposed 
rule to ``include notifiers' failure to systematically identify the 
class of chemically- or pharmacologically-related substances in the 
diet as sufficient for FDA to determine an FCN is no longer 
effective.'' The comment also made several recommendations for a 
``revised proposed rule regarding food contact substance 
notifications.'' The recommendations for a revised proposed rule 
include: (1) requiring FDA to post our evaluation of the FCN as well as 
the FCN itself; (2) requesting periodic updates; (3) requiring 
manufacturers and suppliers to submit samples of their FCSs to FDA upon 
request; (4) including FDA's need for a sample as a reason to determine 
an FCN no longer effective; and (5) that FDA ``sunset an FCN to prompt 
an update.''
    (Response 20) We decline to issue a revised proposed rule at this 
time and are not including these recommendations in the final rule 
because they are outside the scope of our rulemaking. With respect to 
the request that we post our evaluation of an FCN, as discussed in 
response to Comment 16, decisions about proactive disclosures are 
generally based on available resources and policy priorities.

H. Nonsubstantive Changes

    On our own initiative, to maintain consistency and provide clarity 
with existing FCN program notifications and TOR exemptions, we are 
making nonsubstantive changes to the following:
     In Sec.  170.102(e), we are making clarifying edits to the 
provision.
     In Sec.  170.105(a)(2), we are replacing the words 
``stopped'' and ``stop'' with ``ceased'' or ``cease,'' the terms used 
in

[[Page 20313]]

the FCN program identifying the FCNs that are not in interstate 
commerce.
     In Sec.  170.105(a)(2)(ii)(A), because an FCN is specific 
to a manufacturer or supplier, we are revising the first sentence to 
add a reference to the manufacturer or supplier specified in the FCN.
     In Sec.  170.105(a)(3)(i), we are revising the second 
sentence to clarify the data and information the manufacturer or 
supplier is to provide.
     In Sec.  170.105(a)(4), we are replacing the words 
``covered by a threshold of regulation exemption'' to ``the subject of 
an issued threshold of regulation exemption.''
     Sec.  170.105(a)(4)(i), we are revising the second 
sentence to clarify the data and information the manufacturer or 
supplier is to provide.

V. Effective/Compliance Date(s)

    The preamble to the proposed rule stated that we would make any 
final rule resulting from this rulemaking effective 60 days after its 
date of publication in the Federal Register (87 FR 3949 at 3954).
    We did not receive any comments on the proposed effective date for 
the final rule. Therefore, the final rule will become effective on May 
21, 2024.

VI. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, Executive Order 14094, the 
Congressional Review Act/Small Business Regulatory Enforcement Fairness 
Act (5 U.S.C. 801, Pub. L. 104-121), 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, 13563, and 14094 direct us to assess all 
benefits, costs, and transfers 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). Rules are ``significant'' under Executive Order 12866, 
section 3(f)(1) (as amended by Executive Order 14094), if they ``have 
an annual effect on the economy of $200 million or more (adjusted every 
3 years by the Administrator of [the Office of Information and 
Regulatory Affairs (OIRA)] for changes in gross domestic product); or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, territorial, or tribal governments 
or communities.'' OIRA has determined that this final rule is not a 
significant regulatory action under Executive Order 12866, section 
3(f)(1).
    A rule is ``major'' under the Congressional Review Act/Small 
Business Regulatory Enforcement Fairness Act if it has resulted or is 
likely to result in an annual effect on the economy of $100 million or 
more or meets other criteria specified in the Congressional Review Act. 
OIRA has determined that this final rule is not a major rule under the 
Congressional Review Act/Small Business Regulatory Enforcement Fairness 
Act.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the final rule is unlikely to impose a 
substantial burden on the affected small entities, we certify that the 
final 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 impacts, before issuing ``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 $183 
million, using the most current (2023) Implicit Price Deflator for the 
Gross Domestic Product. We do not expect this final rule to result in 
any 1-year expenditure that will meet or exceed this amount.

B. Summary of Cost and Benefits

    We expect the final rule to lead to cost savings for manufacturers 
and suppliers of FCSs and FDA. The final rule would revise FDA's 
current process of determining whether an FCN is no longer effective. 
The final rule would provide manufacturers and suppliers the 
opportunity to demonstrate why an FCN should continue to be effective 
before we could determine that an FCN is no longer effective. 
Additionally, the final rule would revise the current process to cover 
situations in which it is determined that an FCN is no longer effective 
for reasons other than safety, including that a manufacturer or 
supplier may request that FDA determine that an FCN is no longer 
effective on the basis that the manufacturer or supplier no longer 
produces, supplies, or uses the FCS for the intended use. Cost savings 
will be incurred by manufacturers and suppliers of FCSs who will be 
able to request that FDA determine the FCN is no longer effective for 
reasons other than safety. Cost savings will take the form of a 
decreased time burden to FCS manufacturers and suppliers responding to 
FDA's safety concerns with information that they no longer produce, 
use, or supply the FCN for the intended use. FDA will also experience 
cost savings from being able to act more efficiently upon such a 
request by the manufacturer or supplier. As the revisions in the final 
rule would not require significant additional action to be taken by 
manufacturers and suppliers, we expect the costs of the final rule to 
be minimal.
    The estimated total cost savings of the final rule are estimated in 
2021 U.S. dollars and range from zero to $0.4 million, with a central 
estimate of $0.1 million, annualized at 2 percent over 10 years. We 
estimate that the costs of the final rule are minimal. The cost savings 
and costs of the final rule are summarized in table 1.

                                    Table 1--Summary of Cost Savings, Costs, and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Units
                                                                                    ------------------------------------
                    Category                       Primary       Low        High                               Period                 Notes
                                                  estimate    estimate    estimate      Year      Discount     covered
                                                                                       dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost Savings:
    One-time Monetized millions/year...........  ..........  ..........  ..........  ..........  ..........  ..........  ...............................
    Annualized Quantified......................       $0.1M          $0       $0.4M        2021           2          10
    Qualitative................................  ..........  ..........  ..........  ..........  ..........  ..........
Costs:
    Annualized.................................  ..........  ..........  ..........  ..........  ..........  ..........  ...............................
    Monetized millions/year....................  ..........  ..........  ..........  ..........  ..........  ..........  ...............................

[[Page 20314]]

 
    Annualized.................................  ..........  ..........  ..........  ..........  ..........  ..........  ...............................
    Quantified.................................  ..........  ..........  ..........  ..........  ..........  ..........  ...............................
    Qualitative................................  ..........  ..........          $0        2021  ..........          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 $147.31 per affected small entity.................................................................
    Wages:..............................................................................................................................................
    Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. The full analysis of economic 
impacts is available in the docket for this final rule (Ref. 1) and at 
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

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

    The final 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). The title, 
description, and respondent description of the information collection 
provisions are shown in the following paragraphs 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.
    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 FCSs. 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 states 
that the notification process be utilized for authorizing the marketing 
of FCSs except when: (1) the Secretary of HHS (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 FCS and (2) the basis for the 
manufacturer's or supplier's determination that the FCS is safe under 
the intended use. FDA regulations at part 170 (21 CFR part 170) specify 
the information that a notification must contain.
    The final rule amends the procedure by which we determine that an 
FCN is no longer effective. The information collection will cover 
situations that entail the potential reporting of additional data or 
other information by manufacturers or suppliers of FCSs. The final rule 
will augment the existing information collection that covers the FCN 
program at part 170, subpart D.
    Description of Respondents: Respondents to the information 
collection are manufacturers and suppliers of FCSs 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\
----------------------------------------------------------------------------------------------------------------
                                                                                           Average
                                                 Number of      Number of       Total     burden per     Total
           21 CFR section; activity             respondents   responses per    annual      response      hours
                                                               respondent     responses    (hours)
----------------------------------------------------------------------------------------------------------------
170.105(a); Manufacturer or supplier responds             2               1           2           75         150
 to FDA by providing a written response and
 additional data or information to demonstrate
 that the FCN should continue to be effective.
170.105(a)(2)(i); Manufacturer or supplier                5               1           5            2          10
 requests that FDA determine that the FCN
 should no longer be effective based on
 nonsafety reasons............................
                                               -----------------------------------------------------------------

[[Page 20315]]

 
    Total.....................................  ...........  ..............  ..........  ...........         160
----------------------------------------------------------------------------------------------------------------
\1\ There 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 and are unchanged from 
our estimates in the proposed rule.
    We will inform the affected manufacturers or suppliers of the 
specified FCN about data or other information that their FCSs may: (1) 
not be safe for its intended use; (2) have stopped being produced, 
supplied, or used as an FCS for its intended use; (3) be authorized by 
a food additive regulation; or (4) be the subject of an issued 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, two respondents will each spend about 75 
hours preparing a written response followed by submission of additional 
data or information to demonstrate that the FCN should continue to be 
effective for a total of 150 hours (2 respondents x 75 hours). In the 
existing information collection for our Food Contact Substance 
Notification Program (OMB control number 0910-0495; 87 FR 7190 
(February 8, 2022)), 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 final rule will allow a manufacturer or supplier to request 
that FDA determine that their FCN is no longer effective on the basis 
that the manufacturer or supplier no longer produces, supplies, or uses 
the FCS 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 ceased or intends to no longer 
produce, supply, or use the FCS for the intended use. Based on the 
Final Regulatory Impact Analysis, we estimate that five respondents 
will voluntarily request that FDA determine that their FCN is no longer 
effective (Ref. 1). Accordingly, in row 2, we estimate that five 
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 
x 5 hours).
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995. Before the effective date of this 
final rule, FDA will publish a notice in the Federal Register 
announcing OMB's decision to approve, modify, or disapprove the 
information collection provisions in this final rule.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number.

IX. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that the 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 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 rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects 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. Accordingly, we 
conclude that the rule does not contain policies that have Tribal 
implications as defined in the Executive order and, consequently, a 
Tribal summary impact statement is not required.

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/. Although FDA 
verified the website addresses in this document, please note that 
websites are subject to change over time.

1. FDA, ``Food Additives: Food Contact Substance Notification That 
Is No Longer Effective, Final Regulatory Impact Analysis, Regulatory 
Flexibility Analysis.'' Also available at: https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

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, 21 CFR part 
170 is amended as follows:

PART 170--FOOD ADDITIVES

0
1. The authority citation for part 170 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.


0
2. Amend Sec.  170.102 by revising the section heading and paragraphs 
(e) introductory text and (e)(1) and (5) to read as follows:


Sec.  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

[[Page 20316]]

FCN is withdrawn under Sec.  170.103; and on the date of publication in 
the Federal Register of an FDA determination that an FCN is no longer 
effective.
    (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 Sec.  
20.61 of this chapter.
* * * * *

0
3. Revise Sec.  170.105 to read as follows:


Sec.  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 an 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 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 ceased or intends to 
cease 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 ceased producing, supplying, or using a food contact 
substance for the intended food contact use in the United States or 
that it intends to cease producing, supplying, or using a food contact 
substance for the intended food contact use in the United States by a 
specified date. The request must include information or a basis to 
support the estimated date for the food contact substance, as well as 
food contact articles that contain such food contact substance, 
produced, supplied, or used by the manufacturer or supplier to clear 
the U.S. market. 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 
ceased producing, supplying, or using a food contact substance for the 
intended use in the United States or that it intends to cease 
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 cease 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 cease 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 manufacturer or supplier specified in the FCN has ceased producing, 
supplying, or using a food contact substance for the intended use in 
the United States, FDA will inform the affected manufacturer or 
supplier in writing. FDA will include a specified time period by which 
the manufacturer or supplier must respond in writing indicating whether 
the manufacturer or supplier continues, or intends to continue in the 
future, 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 respond in writing indicating that the manufacturer or supplier 
continues, or intends to continue in the future, 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 ceased 
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 food contact substance and its intended use meet the 
identity limitations and specifications authorized by the cited food 
additive regulation.
    (ii) If a manufacturer or supplier fails, by the specified date, to 
supply data or other information that demonstrates 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 the subject of an issued 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 the subject of an issued threshold 
of regulation exemption. FDA will include a specified time period by 
which the manufacturer or supplier

[[Page 20317]]

must respond to FDA with data or other information about whether the 
food contact substance and its intended use meet the identity 
limitations and specifications listed in the cited threshold of 
regulation exemption.
    (ii) If a manufacturer or supplier fails, by the specified date, to 
supply data or other information that demonstrates that the intended 
use of the food contact substance identified in the FCN is not exempt 
through an issued 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 the subject of an issued 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 the subject of an issued threshold of regulation 
exemption. The new submission must be made under Sec. Sec.  170.100 and 
170.101.

    Dated: March 12, 2024.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2024-05802 Filed 3-21-24; 8:45 am]
BILLING CODE 4164-01-P