[Federal Register Volume 87, Number 17 (Wednesday, January 26, 2022)]
[Proposed Rules]
[Pages 3949-3958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01527]


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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.

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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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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

[[Page 3950]]

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, <a href="/cdn-cgi/l/email-protection#34445541585d5a551a445d5b40465b43475f5d745250551a5c5c471a535b42"><span class="__cf_email__" data-cfemail="becedfcbd2d7d0df90ced7d1caccd1c9cdd5d7fed8dadf90d6d6cd90d9d1c8">[email protected]</span></a>; 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, 
<a href="/cdn-cgi/l/email-protection#431311021037222525032527226d2b2b306d242c35"><span class="__cf_email__" data-cfemail="613133203215000707210705004f0909124f060e17">[email protected]</span></a>.

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 Sec.  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 Sec.  
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 Sec.  170.102 (21 CFR 170.102).

B. Summary of the Major Provisions of the Proposed Rule

    FDA's current regulations at Sec.  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 Sec.  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.''

[[Page 3951]]

II. Background

A. Need for the Regulation

    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 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 Sec.  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 Sec.  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 food-contact 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 Sec.  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 Sec.  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 Sec.  170.100(a)).
    Our regulations, at Sec.  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 Sec.  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 Sec.  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 Sec.  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 
Sec.  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

[[Page 3952]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  170.105(a)(1)(i)). 
Under proposed Sec.  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-contact-applications.) 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 
Sec.  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 Sec.  
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

[[Page 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 
Sec.  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 Sec.  
170.105(a)(1)(ii)). We would then notify the manufacturer or supplier 
whether we are granting this request (see proposed Sec.  
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 Sec.  
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 Sec.  
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 Sec.  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 Sec.  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 Sec.  
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 Sec.  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 Sec.  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 Sec.  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

[[Page 3954]]

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 food-processing 
equipment) is so trivial as not to require regulation of the substance 
as a food additive (see Sec.  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 Sec.  
170.39(a)). We list current TOR exemptions on our website (see https://www.fda.gov/food/packaging-food-contact-substances-fcs/threshold-regulation-exemptions-substances-used-food-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 Sec.  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 Sec.  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 Sec.  
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 Sec.  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 Sec.  
170.105(c)).
    The proposed rule would retain the provision but renumber it as 
Sec.  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 Sec.  
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 Sec.  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 Sec.  170.105(b).

F. Future Submissions Following Determination That an FCN Is No Longer 
Effective

    Currently, Sec.  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 Sec.  
170.105(c)). The new submission would be made under Sec. Sec.  170.100 
and 170.101 (id.).

G. Confidentiality of Information

    Currently, our regulation at Sec.  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 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. The 
proposed rule would amend Sec.  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 Sec.  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

[[Page 3955]]

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 Sec.  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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                   Units
                                                                                   ------------------------------------
                   Category                       Primary       Low        High                  Discount     Period                  Notes
                                                 estimate    estimate    estimate      Year        rate       covered
                                                                                      dollars    (percent)    (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:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 3956]]

    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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
    21 CFR section; activity         Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses        (hours)
----------------------------------------------------------------------------------------------------------------
170.105(a); Manufacturer or                    2               1               2              75             150
 supplier responds to FDA by
 providing additional data or
 information to demonstrate that
 the FCN should continue to be
 effective......................
170.105 (a)(2)(i); Manufacturer                5               1               5               2              10
 or supplier requests that FDA
 determine that the FCN should
 no longer be effective based on
 non-safety reasons.............
                                 -------------------------------------------------------------------------------
    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.
    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 x 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

[[Page 3957]]

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 
x 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

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 title, paragraph (e) 
introductory text and paragraphs (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 FCN is withdrawn 
under Sec.  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 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 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

[[Page 3958]]

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 Sec. Sec.  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


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