[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]
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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, Department of Health and Human
Services (HHS).
ACTION: Final rule.
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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