Proposed Rule2022-01527
Food Additives: Food Contact Substance Notification That Is No Longer Effective
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Published
January 26, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
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<title>Federal Register, Volume 87 Issue 17 (Wednesday, January 26, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 <a href="https://www.fda.gov/food/chemicals/authorized-uses-pfas-food-contact-applications">https://www.fda.gov/food/chemicals/authorized-uses-pfas-food-contact-applications</a>.) 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 <a href="https://www.fda.gov/food/packaging-food-contact-substances-fcs/threshold-regulation-exemptions-substances-used-food-contact-articles">https://www.fda.gov/food/packaging-food-contact-substances-fcs/threshold-regulation-exemptions-substances-used-food-contact-articles</a>).
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 <a href="https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm">https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm</a>.
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 <a href="http://reginfo.gov">reginfo.gov</a> (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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm">https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm</a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 26, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.