Rule2025-18655
Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions
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Published
September 25, 2025
Effective
October 27, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its prior notice regulation to add a requirement that prior notice and food facility registration information be submitted within a certain timeframe after certain notices of refusal or hold have been issued ("post-refusal" and "post-hold" submission) or responses to requests for FDA review have been issued and beginning October 1, 2026, add a requirement that the prior notice for articles of food arriving by international mail include the name of the mail service and a mail tracking number. The rule will also finalize certain technical changes, including those that reflect expanded capabilities of the Automated Broker Interface/Automated Commercial Environment/International Trade Data System (ABI/ACE/ITDS) and the Prior Notice Systems Interface (PNSI). These amendments will improve program efficiency and better enable FDA to protect the U.S. food supply and public health.
Full Text
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<title>Federal Register, Volume 90 Issue 184 (Thursday, September 25, 2025)</title>
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[Federal Register Volume 90, Number 184 (Thursday, September 25, 2025)]
[Rules and Regulations]
[Pages 46045-46056]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18655]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA-2011-N-0179]
RIN 0910-AI75
Prior Notice: Adding Requirement To Submit Mail Tracking Number
for Articles of Food Arriving by International Mail and Timeframe for
Post-Refusal and Post-Hold Submissions
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a final rule to amend its prior notice regulation to add a
requirement that prior notice and food facility registration
information be submitted within a certain timeframe after certain
notices of refusal or hold have been issued (``post-refusal'' and
``post-hold'' submission) or responses to
[[Page 46046]]
requests for FDA review have been issued and beginning October 1, 2026,
add a requirement that the prior notice for articles of food arriving
by international mail include the name of the mail service and a mail
tracking number. The rule will also finalize certain technical changes,
including those that reflect expanded capabilities of the Automated
Broker Interface/Automated Commercial Environment/International Trade
Data System (ABI/ACE/ITDS) and the Prior Notice Systems Interface
(PNSI). These amendments will improve program efficiency and better
enable FDA to protect the U.S. food supply and public health.
DATES: This rule is effective October 27, 2025.
ADDRESSES: For access to the docket to read background documents or
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 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: Christopher Henderson, Office of
Inspections and Investigations, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20852, 240-402-8186,
<a href="/cdn-cgi/l/email-protection#9bd8f3e9f2e8eff4ebf3fee9b5d3fef5fffee9e8f4f5dbfdfffab5f3f3e8b5fcf4ed"><span class="__cf_email__" data-cfemail="febd968c978d8a918e969b8cd0b69b909a9b8c8d9190be989a9fd096968dd0999188">[email protected]</span></a>.
Regarding the information collection: Amber Sanford, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#08585a495b7c696e6e486e6c692660607b266f677e"><span class="__cf_email__" data-cfemail="7a2a283b290e1b1c1c3a1c1e1b54121209541d150c">[email protected]</span></a>.
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. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. Need for the Regulation
B. History of This Rulemaking
C. Summary of Comments to the Proposed Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
A. Introduction
B. General Comments and FDA Response
C. Comments on Proposal To Require Post-Refusal and Post-Hold
Submissions of Registration Within 30 Calendar Days and FDA Response
(Proposed Sec. 1.285(i)(1))
D. Comments on Proposal To Require Post-Refusal and Post-Hold
Submissions of Prior Notice Within 10 Calendar Days and FDA Response
(Proposed Sec. 1.283(c))
VI. Effective/Compliance Date(s)
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose of the Final Rule
FDA is issuing a final rule to amend the prior notice regulation as
follows: (1) amend Sec. 1.281(b)(10) (21 CFR 1.281(b)(10)) to add a
requirement, beginning October 1, 2026, for people submitting prior
notice for articles of food arriving by international mail to provide
the name of the mail service and the mail tracking number; \1\ (2)
amend Sec. 1.283 (21 CFR 1.283) to add a requirement that prior notice
be submitted within 10 calendar days from the date a notice of refusal
or hold was issued or 10 calendar days from the date the response to a
request for FDA review under Sec. 1.283(d) was issued; (3) amend Sec.
1.285 (21 CFR 1.285) to add a requirement that Food Facility
Registration (FFR) be submitted within 30 calendar days from the date a
notice of refusal or hold was issued or 30 calendar days from the date
the response to a request for FDA review under Sec. 1.285(j) was
issued; and (4) make certain technical amendments.
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\1\ Note that FDA generally intends to exercise enforcement
discretion when there is no prior notice if the food is offered for
import for non-commercial purposes with a non-commercial shipper.
See Compliance Policy Guide ``Sec. 110.310 Prior Notice of Imported
Food Under the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002,'' announced in the Federal Register on May
6, 2009 (74 FR 20955).
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To effectively carry out its responsibility to detect food articles
offered for import that are adulterated or pose a public health risk,
FDA must be able to identify and inspect food items that are imported
by international mail. Receiving the name of the mail service and a
mail tracking number for articles of food arriving by international
mail will enable FDA to better coordinate with the U.S. Postal Service
(USPS), U.S. Customs and Border Protection (CBP), and other Agencies to
track and inspect articles that have been identified as a possible
bioterrorism risk. Currently, FDA does not receive the name of the mail
service or tracking numbers for articles of food arriving by
international mail. This makes it difficult for FDA to stop articles
from being delivered to U.S. recipients that FDA believes pose a
bioterrorism risk. Having the name of the mail service and tracking
numbers for articles of food arriving by international mail will help
FDA better plan its operations and stop such articles from being
delivered.
Many foods are regularly imported by international mail, and in
FDA's experience, these foods can present similar risks to the U.S.
food supply as other imported foods. Further, based on FDA's experience
at international mail facilities, people are increasingly using the
mail system to import foods, including foods that could pose a
significant risk to public health. The use of the mail system to import
foods highlights the need for FDA to have the name of the mail service
and tracking number to adequately monitor, inspect, and refuse or hold
specific food shipments.
Additionally, requiring a reasonable timeframe for post-refusal and
post-hold submissions of prior notice and FFR may reduce the amount of
time articles subject to refusal or holds are held at ports of entry,
thus reducing associated monetary charges. It will also enable FDA to
utilize its resources more effectively by delineating the post-refusal
and post-hold submission timeframe. Without a date by which such
submissions must be made, FDA has spent long periods of time (e.g.,
weeks and months) reviewing multiple replacement non-compliant prior
notice or registration submissions.
In addition, the final rule amends Sec. 1.280(a)(2) (21 CFR
1.280(a)(2)) to remove the requirement that prior notice of foods
arriving by international mail be submitted exclusively through FDA
PNSI. This amendment enables prior notice for food arriving by
international mail to be submitted through the PNSI or through the U.S.
CBP ABI/ACE/ITDS. Further, Sec. 1.281(a)(5)(iv), (b)(4)(iv), and
(c)(5)(iv) are amended to cross-reference product coding requirements
for infant formula under Sec. 106.80 (21 CFR 106.80). These
regulations currently cross-reference Sec. 106.90 (21 CFR 106.90) when
referring to lot or code number requirements for infant formula.
Section 106.90 establishes requirements related to current good
manufacturing practice, while Sec. 106.80 establishes product coding
requirements for infant formula. Therefore, Sec. 1.281(a)(5)(iv),
(b)(4)(iv), and (c)(5)(iv) are amended to refer to Sec. 106.80 instead
of Sec. 106.90.
[[Page 46047]]
B. Summary of the Major Provisions of the Final Rule
This final rule amends Sec. Sec. 1.281(b)(10), 1.283(a)(6) and
(c), 1.285(g) and (i), and 1.280(a)(2). Currently, Sec. 1.281(b)(10),
which applies to articles arriving by international mail, requires only
the submission of the anticipated date of mailing. This rule amends
Sec. 1.281(b)(10) to include an additional requirement, beginning
October 1, 2026, to submit the name of the mail service and mail
tracking number in the prior notice to FDA for food articles arriving
by international mail.
Sections 1.283(a)(6) and (c) and 1.285(g) and (i), with few
exceptions and if other requirements are met, require an article of
food that has been refused under section 801(m) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(m)) (no prior notice
or inaccurate prior notice) or held under section 801(1) of the FD&C
Act (importation from unregistered foreign facility that is required to
register) to be treated as general order merchandise under CBP
regulations if no prior notice is submitted or resubmitted, prior
notice is not adequate, or no registration is provided. However, these
sections do not provide a timeframe within which such submissions must
be made. This final rule amends Sec. 1.283(c)(1) and (2) to require
submission or resubmission of prior notice within 10 calendar days from
the date the notice of refusal was issued or 10 calendar days from the
date the response to a request for FDA review under Sec. 1.283(d) was
issued. We believe that 10 days is an appropriate timeframe because it
allows sufficient time to submit or resubmit prior notice if necessary.
In addition, the final rule amends Sec. 1.285(i)(1) to require
submission of a valid FFR within 30 calendar days from the date a
notice of hold was issued or 30 calendar days from the date the
response to a request for FDA review under Sec. 1.285(j) was issued.
We believe that 30 days is an appropriate timeframe because it allows
time to obtain the information needed to submit a valid registration.
If a prior notice is not submitted or resubmitted, or a registration is
not provided within the required timeframe, these changes will require
the article to be dealt with as set forth in CBP regulations relating
to general order merchandise. Unless otherwise agreed to by CBP and
FDA, the article may only be sold for export or destroyed.
This final rule removes the requirement that only the FDA PNSI be
used for the submission of prior notice for articles of food arriving
by international mail and amends Sec. 1.280(a)(2) to allow prior
notice of articles of food imported or offered for import by
international mail to be submitted through the FDA PNSI or the ABI/ACE/
ITDS.
Finally, this final rule amends Sec. 1.281(a)(5)(iv), (b)(4)(iv),
and (c)(5)(iv) to refer to Sec. 106.80 instead of Sec. 106.90.
C. Legal Authority
Section 801(m) of the FD&C Act directs FDA to issue regulations
requiring prior notice to FDA of an article of food that is imported or
offered for import into the United States for the purpose of enabling
such article to be inspected at ports of entry into the United States.
Section 801(l) of the FD&C Act requires that an article of food that is
imported or offered for import into the United States and that is from
a foreign facility for which a registration has not been submitted to
FDA under section 415 of the FD&C Act (21 U.S.C. 350d) be held at the
port of entry for the article until the foreign facility is so
registered. Additionally, section 701(b) of the FD&C Act (21 U.S.C.
371(b)) authorizes FDA and CBP to prescribe regulations for the
efficient enforcement of section 801 of the FD&C Act.\2\
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\2\ In 2003, the U.S. Treasury Department transferred to the
Department of Homeland Security its regulatory authority relating to
the requirements for prior notice. See Department of Treasury Order
No. 100-16.
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D. Costs and Benefits
We estimate the costs of the final rule, as accrued to submitters
or transmitters of prior notices to read and understand the rule, and
to gather and provide international mail tracking information, to be
negligible. Therefore, this final rule will not significantly increase
costs to small entities. See the Economic Analysis of Impacts for a
detailed cost and benefit analysis.
II. Table of Abbreviations/Commonly Used Acronyms in This Document
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Abbreviation What it means
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ABI.................................... Automated Broker Interface.
ACE.................................... Automated Commercial
Environment.
CBP.................................... U.S. Customs and Border
Protection.
CDC.................................... Centers for Disease Control and
Prevention.
CPG.................................... Compliance Policy Guide.
DUNS................................... Dun & Bradstreet Data Universal
Numbering System.
FDA.................................... Food and Drug Administration.
FD&C Act............................... Federal Food, Drug, and
Cosmetic Act.
FFR Number............................. Food Facility Registration
Number.
FSMA................................... FDA Food Safety Modernization
Act.
ITDS................................... International Trade Data
System.
OMB.................................... Office of Management and
Budget.
PNSI................................... Prior Notice System Interface.
UFI.................................... Unique Facility Identifier.
USPS................................... U.S. Postal Service.
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III. Background
A. Introduction
FDA is issuing a final rule to amend the prior notice regulation in
21 CFR part 1, subpart I, as follows: (1) amend Sec. 1.281(b)(10) to
add a requirement, beginning October 1, 2026, to provide the name of
the mail service and mail tracking number for articles of food imported
or offered for import by international mail; \3\ (2) amend Sec.
1.283(c) to require submission or resubmission of prior notice within
10 calendar days from the date the notice
[[Page 46048]]
of refusal under section 801(m) of the FD&C Act was issued or 10
calendar days from the date the response to a request for FDA review
under Sec. 1.283(d) was issued; (3) amend Sec. 1.285(i) to require
submission of FFR within 30 calendar days from the date the notice of
hold under section 801(l) of the FD&C Act was issued or 30 calendar
days from the date the response to a request for FDA review under Sec.
1.285(j) was issued; (4) amend Sec. 1.280(a)(2) to remove the
requirement that articles of food imported or offered for import by
international mail, and other transaction types that cannot be made
through ACE,\4\ be submitted through FDA PNSI; and (5) amend Sec.
1.281(a)(5)(iv), (b)(4)(iv), and (c)(5)(iv) to cross-reference Sec.
106.80 instead of Sec. 106.90. Section 307 of the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (the
Bioterrorism Act) (Pub. L. 107-188) added section 801(m) to the FD&C
Act and requires FDA to establish regulations requiring the submission
of prior notice of food that is imported or offered for import into the
United States.
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\3\ The prior notice regulation specifies that ``international
mail'' means foreign national mail services and does not include
express consignment operators or carriers or other private delivery
services unless such service is operating under contract as an agent
or extension of a foreign mail service (21 CFR 1.276(b)(8)).
\4\ There are no longer any transaction types that cannot be
made through ACE.
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B. Need for the Regulation
The information in a prior notice enables FDA to target import
inspections more effectively, thereby helping to protect our nation's
food supply against terrorist acts and other public health emergencies.
FDA regulations require that specific information about articles of
food imported or offered for import into the United States be submitted
in advance of arrival of the food.
Currently, FDA does not require submission of the name of the
international mail service or the mail tracking number for food
articles imported by international mail; therefore, FDA has limited
ability to track or locate the movement of food articles imported by
international mail, which could pose a public health risk. Receiving
the name of the mail service and the mail tracking number for food
articles imported by international mail will assist FDA in conducting
investigations and surveillance operations in response to a food-
related emergency. Access to the name of the mail service and the
tracking number will also enable FDA to act quickly to identify the
affected food articles and prevent contamination of the food supply. It
will also help to improve emergency response time, as FDA and other
agencies will be better equipped to identify, alert, and secure those
facilities or entities that could be potentially impacted by a
bioterrorism incident. Requiring the submission of this information
will bolster FDA's efforts to prevent violative and potentially
dangerous food shipments from entering the United States at
international mail facilities, and will also help FDA to track,
identify, inspect, and contain such shipments. With this information
available, FDA will be able to better utilize its resources and plan
its operations, given its knowledge of the movement, location, and time
of the food's arrival to the U.S. port of entry.
Providing the name of the international mail service and the
tracking number in the prior notice will also enable FDA to effectively
coordinate a quicker response with other agencies in the event of any
suspected act of bioterrorism or public health emergency. For instance,
if FDA receives information indicating that a particular international
mail package contains a food article that could be affected by a
bioterrorist incident or other food-related public health emergency,
FDA alerts CBP and USPS about the food article and the potential risk
it may pose. Knowing the tracking number of that suspected contaminated
food and the mail service will help FDA, CBP, and USPS to track the
origin and location of the international mail. The mail package can
then be more easily identified and separated from other foods or
incoming mail to safely conduct inspection to determine the degree of
risk the article of food poses. This will enable FDA to more swiftly
prevent the article of food from entering the U.S. food supply chain.
Moreover, articles of food imported or offered for import without a
prior notice or with inadequate prior notice are subject to refusal of
admission or hold under section 801(m) of the FD&C Act. Articles of
food imported or offered for import from an unregistered foreign food
facility that is required to register are subject to being held under
section 801(l) of the FD&C Act. If an article of food is refused
admission under section 801(m) or held under section 801(l), certain
persons may submit a request, within five calendar days of the refusal
or hold, asking FDA to review whether the article is subject to the
prior notice requirements, whether the information submitted in a prior
notice is complete and accurate, or whether the facility associated
with the article is subject to FFR requirements (Sec. Sec. 1.283(d)
and 1.285(j)). FDA will review and respond within five calendar days of
receiving the review request (Sec. Sec. 1.283(d) and 1.285(j)).
Submitters or transmitters can also attempt to come into compliance by
submitting or resubmitting prior notice after refusal of admission
(Sec. 1.283(c)), or by obtaining and providing a registration number
for post-hold submissions (Sec. 1.285(i)). Requests for review under
Sec. Sec. 1.283(d) and 1.285(j) may not be used to submit or resubmit
prior notice or obtain a registration number.
Currently, FDA regulations do not require a timeframe within which
an article of food must be brought into compliance by submitting or
resubmitting prior notice or submitting a registration number if the
article of food is refused or held. As a result, when articles of food
are refused or held under section 801(m)(1) or section 801(l) of the
FD&C Act, they may be refused or held for several weeks while
submitters or transmitters resubmit multiple replacement non-compliant
prior notice or registration submissions to be reviewed by FDA. Setting
a timeline for submission or resubmission of prior notice or
registration following a hold or refusal will help to reduce the amount
of time and resources FDA spends on processing post-hold or post-
refusal resubmissions and may reduce cost to importers by decreasing
the amount of demurrage charges (i.e., monetary charges due to a
failure of goods to leave the port).
C. History of the Rulemaking
The Bioterrorism Act amended the FD&C Act and created the
requirement that FDA receive certain information about imported foods
before their arrival in the United States. On February 3, 2003, FDA,
and the Department of Treasury (U.S. Customs Service) \5\ issued a
joint notice of proposed rulemaking (68 FR 5428) requiring submission
to FDA of prior notice of human and animal food that is imported or
offered for import into the United States. On October 10, 2003, FDA
issued an interim final rule (68 FR 58974) that required the submission
to FDA of prior notice of food, including animal food, that is imported
or offered for import into the United States. In 2008, 2011, and 2017,
FDA finalized and issued amendments to the prior notice regulation (see
73 FR 66294, November 7, 2008, as amended at 76 FR 25542, May 5, 2011;
82 FR 15627, March 30, 2017) to further improve the implementation of
the prior notice
[[Page 46049]]
requirement. On November 1, 2023, FDA published a proposed rule
entitled ``Prior Notice: Adding Requirement to Submit Mail Tracking
Number for Articles of Food Arriving by International Mail and
Timeframe for Post-Refusal and Post-Hold Submissions'' (proposed rule)
(88 FR 74939).
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\5\ In March 2003, U.S. Customs Service was subsumed by the
newly formed CBP (see Homeland Security Act of 2002, Public Law 107-
296 (2002)) (https://www.cbp.gov/about/
history#:~:text=On%20March%201%2C%202003%2C%20U.S.,boundaries%20and%2
0ports%20of%20entry).
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For articles not arriving by international mail, the prior notice
rule requires the submission of anticipated arrival information and
planned shipment information to provide FDA with information necessary
for planning examinations and communicating with CBP for enforcement
and examination purposes (see Sec. 1.281(a)(11) and (17), 68 FR 58974
at 59009 and 59011). Further, FDA requires the identification of the
carrier because the information is necessary to enable FDA and CBP to
identify the appropriate article of food for inspection or holding when
the food arrives in the United States (see Sec. 1.281(a)(16), 68 FR
58974 at 59011). The 2008 final rule added the ability, under Sec.
1.281(a)(11), to submit the tracking number for food articles arriving
by express consignment operator or carrier, as part of the anticipated
arrival information of the food or planned shipment information (73 FR
66294 at 66297). In the 2017 amendment to the prior notice regulation,
we removed certain limitations regarding the submission of a tracking
number (82 FR 15627 at 15628). In doing so, we reiterated the
importance of the tracking number to learn the information that FDA
needs to make entry determinations, such as port, date, and time of
arrival. In the 2017 amendment, we also eliminated some requirements
for submitting prior notice due to the expanded capabilities of ACE,
such as the requirement to submit articles that have been refused under
section 801(m)(1) of the FD&C Act or subpart I in FDA PNSI. ACE can now
accommodate this type of entry and others it previously could not, such
as articles of food arriving through international mail and baggage
entries. The amendments described in this final rule will further align
the prior notice regulation with requirements that exist for food not
arriving by international mail and better reflect ACE's expanded
capabilities.
In addition, in the 2003 interim final rule, we stated that under
Sec. 1.283(a)(6), if no prior notice, correction (i.e., prior notice
resubmission), or request for FDA review is submitted in a timely
fashion, following a refusal under section 801(m) of the FD&C Act, the
food will be dealt with as set forth in CBP regulations relating to
general order merchandise, except that it may only be sold for export
or destroyed as agreed to by CBP and FDA (68 FR 58974 at 59020 and
59021). Similarly, we stated that under Sec. 1.285(g), if an article
of food is placed under hold under section 801(l) of the FD&C Act and
no registration or request for FDA review is submitted in a timely
fashion, the food will be dealt with as set forth in CBP regulations
relating to general order merchandise, except that it may only be sold
for export or destroyed as agreed to by CBP and FDA (68 FR 58974 at
59076).
In the 2008 final rule, we made a minor change in the text of Sec.
1.283(a)(6) by replacing the phrase, ``in a timely fashion,'' with the
phrase, ``in accordance with paragraph (d) [of Sec. 1.283],'' to
clarify that the timeliness of a request for FDA review is found at
Sec. 1.283(d); we made a similar change in Sec. 1.285(g) (73 FR 66294
at 66370). These changes require requests for FDA review under
Sec. Sec. 1.283(d) and 1.285(j) to be submitted within five calendar
days of the refusal or hold and remove the requirement that post-
refusal and post-hold submissions be submitted in a timely fashion or
be subject to any timeframe. However, Sec. Sec. 1.283(a)(6) and
1.285(g) state that, if an article of food is refused or held under
section 801(m) or 801(l) of the FD&C Act, and no prior notice is
submitted or resubmitted, or no registration is provided, the food must
be dealt with as set forth in CBP regulations relating to general order
merchandise.
It is difficult for FDA to administer these provisions without a
requirement for when the prior notice must be submitted or resubmitted
or for when registration must be provided. There is currently no
uniform and predictable date by which such submissions must be made
before the article is treated as CBP general order merchandise. As
such, there have been instances where articles are refused or held for
prolonged periods of time (e.g., weeks and months) while submitters or
transmitters submit multiple replacement non-compliant prior notice or
registration submissions that must be reviewed by FDA. This is not an
effective use of FDA resources and personnel and can lead to the
accumulation of large demurrage charges for those articles that are
subject to hold or refusal. This final rule amends these provisions by
imposing a timeframe for post-refusal and post-hold submissions.
D. Summary of Comments to the Proposed Rule
Most of the comments we received on the proposed rule are generally
supportive of our proposed amendments to Sec. Sec. 1.280, 1.281,
1.283, and 1.285. Many comments agree that these amendments to the
prior notice regulation will help FDA and other agencies improve food
safety and increase consumer confidence in imported food arriving
through international mail. Comments agree that requiring only the
anticipated date of mailing for international mail provides limited
information for effective tracking. They state that requiring
submitters of prior notice for articles of food arriving by
international mail to provide the name of the mail service and the mail
tracking number is a positive step towards improving the safety of
imported food and that these proposed amendments align with the
evolving landscape of international trade and the increasing use of the
mail system to import various food products. Comments further note that
agencies such as FDA having the name of the mail service and tracking
number allows for real-time and specific tracking ability that can be
more effectively utilized to mitigate potential risks, and that the
practical utility of the information is likely to enable a faster and
more proactive response.
Regarding the proposal to require specific timeframes for
submitting prior notice and FFR following a notice of refusal or hold,
multiple comments believe that imposing the timeframes is a sensible
approach. Some comments state that the proposed 10-calendar day
timeframe for prior notice and the 30-calendar day timeframe for FFR
strikes a balance between FDA's regulatory process and providing
submitters with a reasonable timeframe. They add that this not only
facilitates a quicker response to potential risks but also aligns with
the need for efficient resource utilization. One comment says that the
30-calendar day timeframe for post-hold registration may not be
sufficient due to several procedures needed to complete an FDA food
facility registration. The comment suggests that a 45-calendar day or
60-calendar day timeframe would better accommodate the potential need
to obtain the unique facility identifier (UFI) to complete the FDA FFR
process. The comment bases its estimation of time on how long it could
take to obtain a Dun & Bradstreet Data Universal Numbering System
(DUNS) number since that number serves as the UFI. One comment asks how
the proposed amendments would impact laboratory samples of tea or
coffee for analysis that are sent to the United States by a courier
mailing service. Another comment commends
[[Page 46050]]
FDA's collaboration with the USPS and CBP and recommends expanding its
collaboration to include the Centers for Disease Control and Prevention
(CDC) and other Federal agencies.
IV. Legal Authority
We are issuing this final rule under section 801(m) of the FD&C
Act, which directs FDA to implement a regulation requiring prior
notification to FDA of food that is imported or offered for import into
the United States; section 801(l) of the FD&C Act, which requires that
a food article being imported or offered for import into the United
States that is from a foreign facility for which a registration has not
been submitted under section 415 of the FD&C Act be held at the port of
entry until the foreign facility is so registered; and section 701(b)
of the FD&C Act, which authorizes FDA and CBP to jointly issue
regulations for the efficient enforcement of section 801 of the FD&C
Act.
In the 2003 interim final rule, we stated that the planned shipment
information is necessary to ensure the effective enforcement of section
801(m) of the FD&C Act (68 FR 58974 at 59012). The tracking information
is considered part of the planned shipment information as it is
currently allowed to be submitted under Sec. 1.281(a)(17). In both the
2003 and 2008 final rules, we explained that certain information not
explicitly mentioned in section 801(m) of the FD&C Act is required for
the efficient enforcement of the Bioterrorism Act (68 FR 58974 at 59001
and 73 FR 66294 at 66340). We determine that, for articles of food
arriving by international mail, the name of the mail service and the
mail tracking number is necessary for the efficient enforcement of
section 801(m) of the FD&C Act. Additionally, we determine that
imposing a timeframe on post-refusal and post-hold submissions of prior
notice and FFR is necessary for the efficient enforcement of sections
801(m) and 801(l) of the FD&C Act.
V. Comments on the Proposed Rule and FDA Response
A. Introduction
We received five comment submissions on the proposed rule by the
close of the comment period, each containing one or more comments on
one or more issues. We received comments from regulatory specialists
representing industry, food and consumer safety advocates, a trade
association, and other individuals. After considering these comments,
we are revising the proposed provisions in Sec. Sec. 1.283(c) and
1.285(i) to require the clock for the 10 calendar days for submission
of post-refusal prior notice and the clock for the 30 calendar days for
submission of post-hold registration to start from the date FDA issues
the response to a request for FDA review under Sec. Sec. 1.283(d) or
1.285(j), respectively, for those that file a request for review. In
addition, we are delaying the requirements to submit the name of mail
service and tracking number until October 1, 2026, to allow for
adequate time for the PNSI and ACE systems to become ready to receive
such information.
We describe and respond to the comments in sections B through E of
this document. We have numbered each comment and response 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. General Comments and FDA Response
(Comment 1): Multiple comments express support for the proposed
rule change to Sec. 1.281. They state that requiring the international
mail prior notice submitter to provide the name of the mail service and
the tracking number, in addition to the already provided anticipated
date of mailing, is a commonsense action that would improve food safety
and increase consumer confidence in their food deliveries. One comment
supports the overarching goals of the proposed rule to enhance FDA's
ability to monitor and regulate imported food effectively. The comment
believes that the current requirement under Sec. 1.281(b)(10) provides
limited information for effective tracking and that the proposed
amendments demonstrate a thoughtful approach to adapting regulatory
frameworks to evolving trends in international trade and technological
capabilities. The comment suggests, given the gravity of a bioterrorist
event, that leveraging CDC and other agencies dedicated to protecting
public health may help to bolster compliance with the regulation. It
suggests that FDA should consider expanding its collaboration to other
agencies not mentioned in the proposed rule preamble.
(Response 1): We agree that requiring the submitter to provide the
name of the mail service and the tracking number, in addition to the
already provided anticipated date of mailing, will help FDA and other
agencies to improve food safety and may increase consumer confidence in
food importation through international mail. We further agree that our
final rule, which amends Sec. 1.281(b), will provide additional
information to help FDA to effectively track and inspect articles of
food arriving by international mail and that the amendments in the rule
will help to bolster efficient regulatory oversight of imported food,
improve food safety, and mitigate public health risk. Regarding the
prior notice and FFR requirements for articles of food imported by
international mail, FDA most often collaborates with CBP and USPS.
However, FDA collaborates with multiple federal and state entities,
including CDC, to facilitate its regulatory oversight and enforcement
obligations related to food.
(Comment 2): One comment asks whether samples for laboratory
analysis shipped through a courier mail service from around the world
would be subject to the requirement to submit an international mail
tracking number.
(Response 2): The final rule to require prior notice submission of
an international mail tracking number applies to shipments of articles
of food arriving by international mail. International mail means
foreign national mail services. International mail does not include
express consignment operators, carriers, or other private delivery
services, unless such service is operating under contract as an agent
or extension of a foreign mail service (Sec. 1.276(b)(8) (21 CFR
1.276(b)(8))).
Regarding prior notice requirements for laboratory samples, as
stated in the 2008 Prior Notice final rule, many samples of food are
``articles of food imported or offered for import,'' as stated in
section 801(m) of the FD&C Act. If, however, the samples are items that
are in such early stages of research and development that they cannot
yet be considered food under Sec. 1.276(b)(5), they would not be
subject to prior notice requirements. In addition, if the sample is in
a form that is not an article of food, then prior notice requirements
would not apply. But where a sample is food, as defined under prior
notice, the sample is not excluded from the final rule even if it is
imported or offered for import for quality assurance, research or
analysis purposes only, not for human or animal consumption, and not
for resale (73 FR 66294 at 66315). However, as discussed in the Prior
Notice final
[[Page 46051]]
rule compliance policy guide (CPG),\6\ FDA and CBP may consider not
taking any regulatory action when there is no prior notice and the food
is a sample not intended for human or animal consumption.
---------------------------------------------------------------------------
\6\ CPG Sec.110.301 Prior Notice of Imported Food Under the
Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 (May 2009).
---------------------------------------------------------------------------
(Comment 3): One comment expresses concern about placing a hold on
perishable food and asks if FDA would reimburse shippers for spoiled
food, given that consumers may often find it not to be worthwhile to
pursue a claim in small claims court for spoiled food.
(Response 3): Neither FDA nor CBP are liable for transportation,
storage, or other expenses resulting from refusal or any hold
(Sec. Sec. 1.283(a)(4) and 1.285(e)). However, FDA has procedures in
place to prioritize and expedite the review of emergency and perishable
shipments (see generally FDA's Investigation Operations Manual, Chapter
6, Imports). In addition, FDA has a process for holding food arriving
by international mail. If an article of food arrives by international
mail with inadequate prior notice or the prior notice confirmation
number is not affixed as required, the parcel will be held by CBP for
72 hours for FDA inspection and disposition. If FDA refuses the article
under section 801(m)(1) of the FD&C Act and there is a return address,
the parcel may be returned to sender marked ``No Prior Notice--FDA
Refused.'' If the article is refused and there is no return address or
FDA determines that the article of food in the parcel appears to
present a hazard, FDA may dispose of or destroy the parcel (Sec.
1.283(e)).
As it pertains to this final rule, the comment does not specify any
perceived effect that the rule will have on the time that articles of
food are held. As we stated in the proposed rule, we believe that the
rule may reduce the amount of time articles subject to refusal or holds
are held at ports of entry, thus reducing associated monetary charges
(88 FR 74939 at 74940). We note that any potential legal dispute
between private parties arising from a hold on a food shipment is
outside the scope of this rule.
(Comment 4): One comment believes the proposed requirements to
submit the name of the mail service and tracking number would not be a
concern since the information should be readily available to submitters
or transmitters, but asks that the requirements not be implemented
until the relevant information technology systems are updated and able
to accept the newly required information.
(Response 4): We agree that the name of the mail service and mail
tracking number should be readily available to submitters or
transmitters, and we did not receive comments that indicate otherwise.
Our research indicates that a tracking number is available for
international mail in most major countries that export food to the
United States. Therefore, we are finalizing the requirements to submit
the name of the mail service and tracking number for articles arriving
by international mail in Sec. 1.281(b)(10).
In response to the comment, and to provide adequate time for PNSI
and ACE to be updated to accommodate the newly required information, we
are delaying the requirements to submit the name of the mail service
and the tracking number for articles of food arriving by international
mail until October 1, 2026. If we receive information to indicate that
PNSI and/or ACE will not be ready to receive the name of the mail
service and tracking number by October 1, 2026, we will consider the
appropriate means to address this, including whether the temporary
exercise of enforcement discretion for the requirements to submit the
name of the mail service and tracking number would be appropriate until
the time that PNSI and ACE can receive such information.
C. Comments on Proposal To Require Post-Refusal and Post-Hold
Submissions of Registration Within 30 Calendar Days and FDA Response
(Proposed Sec. 1.285(i)(1))
FDA sought comment on whether 30 calendar days from the date the
notice of hold was issued would be an appropriate timeframe to require
for post-hold registration submission or if a different timeframe would
be more appropriate.
(Comment 5): One comment opines that the 30-calendar day period
strikes a balance between the regulatory process and providing
submitters with a reasonable timeframe. Another comment expresses
concern about the proposed amendment that requires that a valid FFR
number be obtained and submitted to the Agency within 30 calendar days.
The comment suggests that 30 calendar days is not enough time to obtain
and submit a valid facility registration number, considering the amount
of time it could take to file a request for review by FDA, receive a
response of the review decision, and submit the required information,
if necessary. The comment contends that FDA failed to account for the
time necessary for a firm to obtain a UFI, if needed. The comment
explains that, currently, a DUNS number assigned by Dun & Bradstreet
serves as the UFI. The comment claims that, because a food facility
cannot complete the facility registration process until the DUNS number
has been assigned, it may not be possible for a firm to provide the
registration information within 30 calendar days according to the Dun &
Bradstreet website, which states that it may take up to 30 business
days to obtain a new DUNS number.\7\ The comment further contends that
given the fact that the key step in the registration process is not
under the firm's control, the timeframe should be extended to 45 or 60
calendar days to allow firms that do not currently have a DUNS number
to be able to obtain a DUNS number and complete the FFR process.
---------------------------------------------------------------------------
\7\ See <a href="https://www.dnb.com/duns/get-a-duns.html">https://www.dnb.com/duns/get-a-duns.html</a>.
---------------------------------------------------------------------------
(Response 5): We disagree that the required timeframe should be
extended to 45 or 60 calendar days from the date a notice of hold was
issued and believe that 30 calendar days is a sufficient timeframe to
submit a post-hold FDA food facility registration in most cases.
Additionally, we considered the timeframe between when a request for
FDA review is filed and when FDA issues a review decision and have
revised our proposal so that the 30-calendar day timeframe for those
who file a request for FDA review will start from the time FDA issues a
review decision. As the comment explains, the process of completing FFR
involves obtaining a UFI. Domestic and foreign facilities are required
to submit a UFI recognized as acceptable by FDA as part of FFR (21 CFR
1.232(a)(2)). The UFI currently recognized as acceptable by FDA is a
DUNS number, which is a unique nine-digit number assigned and managed
by Dun & Bradstreet. After a DUNS number is obtained and submitted to
FDA, FDA will verify the accuracy of the UFI and that the facility-
specific address associated with the UFI is the same address associated
with the registration (see 21 CFR 1.231(a)(3)). If there are no
discrepancies between the FFR system and the DUNS data, the FFR system
will automatically accept and issue an FFR number (i.e., on the same
day).
Regarding comments' contention that a DUNS number may take up to 30
business days to obtain, the recent data we received from Dun &
Bradstreet on the length of time it takes to process and issue a DUNS
number indicates that the vast majority of DUNS applications (97.3
percent in recent months) are completed, and a DUNS number is
[[Page 46052]]
issued, in less than 10 business days, and even more (99.69 percent)
are completed in less than 20 business days. For example, from
September 1, 2023, to February 29, 2024, 97.3 percent of global
applications for a DUNS number were completed in less than 10 business
days, and 99.69 percent of DUNS applications were completed in less
than 20 business days of submitting the application. From March 2021 to
March 2023, 71.31 percent of global applications were completed in less
than 10 business days, and 95.70 percent were completed in less than 20
business days. This trend reflects an increase in the average amount of
global applications completed in less than 10 or 20 business days.
Moreover, the data show that, from September 2023 to February 2024,
99.81 percent of DUNS applications were completed in less than 30 days.
Based on this information, we do not believe that extending the
timeline to submit registration (such as by 15 or 30 days, as suggested
by the comment) is necessary. The trend in recent years is that DUNS
applications are completed in less time and the vast majority are
completed in less than 30 days. For these reasons, we have determined
that the 30 calendar-day timeframe for a post-hold submission of an FFR
number is sufficient and we decline to extend the timeframe to submit
registration beyond 30 days. Therefore, we are finalizing the rule as
proposed, requiring a timeframe of 30 calendar days for a post-hold
submission of an FFR number.
However, the comment also mentions that the 30-day timeframe is not
enough time to obtain and submit a valid FFR number, considering the
amount of time it could take to file a request for review by FDA,
receive a response of the review decision, and submit the required
information, if necessary. We recognize that the process for requesting
FDA review of a hold under Sec. 1.285(j) may impact the ability to
meet the timeframes for submitting a post-hold submission under Sec.
1.285(i). For example, if a submitter or transmitter requests FDA
review of a hold under Sec. 1.285(j), receives a response of the
review decision, and then must obtain a DUNS number to complete the FFR
process, the submitter or transmitter may not be able to meet the 30-
day timeframe as proposed, which would start the clock from the date a
notice of hold was issued. Therefore, we are revising the rule by
adding language in Sec. 1.285(i) to clarify that the clock for the 30-
day timeframe will start from the date the response to a request for
FDA review under Sec. 1.285(j) is issued, for those that file a
request for review.
D. Comments on Proposal To Require Post-Refusal and Post-Hold
Submissions of Prior Notice Within 10 Calendar Days and FDA Response
(Proposed Sec. 1.283(c))
FDA sought comment on whether 10 calendar days from the date the
notice of refusal or hold was issued would be an appropriate timeframe
to require for post-refusal and post-hold prior notice resubmission, or
if a different timeframe would be more appropriate.
(Comment 6): The comments we received on this proposal were
supportive. Comments think that the timeframe is reasonable and strikes
a balance between the regulatory process and providing the submitter
with a reasonable timeframe. We did not receive comments that disagreed
or raised issues with this proposed amendment.
(Response 6): We agree that 10 calendar days is an appropriate
timeframe to require for post-refusal and post-hold resubmission of
prior notice. However, similar to the process for requesting FDA review
of a hold under Sec. 1.285(j), we also recognize that the process for
requesting FDA review of a hold under Sec. 1.283(d) may impact the
ability to meet the timeframe for submitting a post-refusal submission
under Sec. 1.283(c). For example, a submitter or transmitter may
request review of a hold under Sec. 1.283(d), receive a response of
the review decision, and then need to obtain additional information to
complete prior notice submission. Accordingly, and for consistency with
Sec. 1.285(i), we revised the language in Sec. 1.283(c) to clarify
that the clock for the 10-day timeframe will start from the date the
response to a request for FDA review is issued, for those that file a
request for review.
VI. Effective Date
This final rule will become effective 30 days after the date of
publication in the Federal Register.
VII. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 14192, the
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review
Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801,
Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4).
Executive Orders 12866 and 13563 direct us to assess all benefits
and costs of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits.
Rules are ``significant'' under Executive Order 12866 Section 3(f)(1)
if they ``have an annual effect on the economy of $100 million or more;
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, or tribal governments or
communities.'' The Office of Information and Regulatory Affairs (OIRA)
has determined that this final rule is not a significant regulatory
action under Executive Order 12866.
Executive Order 14192 requires that any new incremental costs
associated with certain significant regulatory actions ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least 10 prior regulations.'' This final rule is not
an Executive Order 14192 regulatory action because this rule is not
significant under Executive Order 12866.
Because this rule is not likely to result in an annual effect on
the economy of $100 million or more or to meet other criteria specified
in the Congressional Review Act/Small Business Regulatory Enforcement
Fairness Act, OIRA has determined that this rule does not fall within
the scope of 5 U.S.C. 804(2).
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the change to prior notice requirements will not
significantly increase costs to 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 estimates 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 $187
million, using the most current (2024) Implicit Price Deflator for the
Gross Domestic Product. This final rule will not result in an
expenditure in any year that meets or exceeds this amount.
B. Summary of Benefits, Costs, and Transfers
This rule would amend existing prior notice regulation to require
the submission of the name of the mail
[[Page 46053]]
service and tracking number for food articles imported using
international mail. The rule would also require transmitters to
resubmit prior notice within 10 calendar days from the date a notice of
refusal or hold is issued or 10 calendar days from the date the
response to a request for FDA review is issued, and to submit FFR
within 30 calendar days from the date a notice of refusal or hold is
issued or 30 days from the date the response to a request for FDA
review is issued. The rule also makes other technical changes.
To estimate costs and benefits associated with the rule, we assume
that the appropriate baseline is the state of the world with current
prior notice regulation. We then compare the likely impacts of the rule
against this baseline. The costs of the rule accrue to submitters or
transmitters of prior notices for reading and understanding the rule
and the additional time needed to gather and provide the tracking
information. When annualized over a period of 10 years, we estimate
these costs range from approximately $0.04 million to $0.44 million at
a 3 percent rate of discount. At a 7 percent rate of discount, these
costs range from approximately $0.04 million to $0.43 million. Our
primary annualized estimates are approximately $0.24 million at both
the 3 and 7 percent rates of discount.
We estimate benefits in the form of cost-savings which accrue to
transmitters of prior notices and to FDA. These cost-savings range in
annualized value from approximately $0.03 million to $0.14 million at
the 3 and 7 percent rates of discount. The primary annualized value for
both discount rates is $0.07 million. These estimates are summarized in
table 1. Other benefits, and resulting impacts on social welfare, are
highly uncertain. These benefits may include improvements in public
health from a decreased incidence in outbreaks of foodborne illness or
bioterrorism events. However, because it is difficult to forecast the
likelihood and magnitude of such events, we do not quantify their
benefits.
Table 1--Summary of Benefits, Costs, and Distributional Effects of the Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/year..... $0.07 $0.03 $0.14 2023 7 10
0.07 0.03 0.14 2023 3 10
Annualized Quantified................... .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
-----------------------------------------------------------------------------------------------------------
Qualitative............................. Unquantified improvements to .......... .......... .......... ..................................
public health from better
surveillance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized millions/year...... 0.24 0.04 0.43 2023 7 10
0.24 0.04 0.44 2023 3 10
Annualized Quantified................... .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
Qualitative............................. .......... .......... .......... .......... .......... .......... ..................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized Monetized millions/ .......... .......... .......... .......... 7 ..........
year. .......... .......... .......... .......... 3 ..........
-----------------------------------------------------------------------------------------------------------
From/To................................. From:
To: ..........
-----------------------------------------------------------------------------------------------------------
Other Annualized Monetized millions/year .......... .......... .......... .......... 7
.......... .......... .......... .......... 3
-----------------------------------------------------------------------------------------------------------
From/To................................. From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: None.............................................................................................................
Small Business: None................................................................................................................................
Wages:..............................................................................................................................................
Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
In line with Executive Order 14192, in table 2 we estimate present
and annualized values of costs, cost savings, and net costs over a
perpetual time horizon. We estimate that this rule will generate $0.16
million in annualized net costs at a 7 percent discount rate,
discounted relative to year 2024, over a perpetual time horizon.
Table 2--Executive Order 14192 Summary Table
[Millions of 2024 dollars, discounted over a perpetual time horizon relative to year 2024 at a 7 percent
discount rate]
----------------------------------------------------------------------------------------------------------------
Primary estimate Low estimate High estimate
----------------------------------------------------------------------------------------------------------------
Present Value of Costs.................................... $3.40 $0.40 $6.41
Present Value of Cost Savings............................. 1.05 0.53 2.10
Present Value of Net Costs................................ 2.35 (0.12) 4.31
Annualized Costs.......................................... 0.24 0.03 0.45
Annualized Cost Savings................................... 0.07 0.04 0.15
[[Page 46054]]
Annualized Net Costs...................................... 0.16 (0.01) 0.30
----------------------------------------------------------------------------------------------------------------
Note: Values in parentheses denote net negative costs (i.e., net cost savings).
We have developed an Economic Analysis of Impacts that assesses the
impacts of the final rule (Ref. 1). The full analysis of economic
impacts is available in the docket for this final rule (FDA-2011-N-
0179) and at <a href="https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria">https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria</a>.
VIII. 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.
IX. Paperwork Reduction Act of 1995
This 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 (PRA) (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: Prior Notice of Imported Food Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (0910-
0923)
Description: FDA is amending its regulation governing notification
requirements for articles of food being imported or offered for import
into the United States and is making corresponding changes to the
information collection. Specifically, we are revising the data elements
required in prior notice notifications under section 801(m) of the FD&C
Act to include mail service name and mail tracking number.
FDA intends to use the information to better identify, track,
contain, and inspect articles of food sent through international mail
that it has reason to believe present a bioterrorism threat or public
health concern. We believe having the name of the mail service and the
mail tracking number will improve our ability to identify and prevent
such food articles from entering the U.S. food supply, as well as
reduce challenges associated with locating articles without this
information.
Description of Respondents: Persons submitting prior notice for
articles of food imported or offered for import into the United States.
Burden: FDA estimates the burden of this collection of information
as follows:
Table 3--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Average number Total Total
21 CFR Section Number of of responses annual Average burden per annual
respondents per respondent responses response hours
----------------------------------------------------------------------------------------------------------------
1.281(b)(10)--Information Included in Prior Notice
----------------------------------------------------------------------------------------------------------------
One-Time Burden................ 5,460 1 5,460 0.5 (30 minutes).......... 2,730
Recurring Burden............... ........... 143 780,780 0.07 (4 minutes).......... 54,655
--------------------------------------------------------------------------------
Total...................... ........... .............. .......... .......................... 57,385
----------------------------------------------------------------------------------------------------------------
Based on 2021 fiscal year data from our Online Reporting Analysis
Decision Support System, we estimate that 26,200 persons submit prior
notice through PNSI. We assume 5,460, or roughly 20 percent, are
importing or offering for import articles of food by international
mail. The requirement to submit tracking information applies only to
persons importing or offering for import articles of food by
international mail. The number of prior notices for international mail
entries per respondent per year ranges from 1 to approximately 5,000.
The average number of prior notice submissions for international mail
entries per person per year is approximately 143. Of the more than 18
million prior notices received by FDA per year, approximately 780,780
are identified as ``mail.''
We estimate a one-time average burden of 30 minutes per respondent
to learn the new requirement and coordinate with mail services to
establish best practices for receiving and providing the information.
In addition to the one-time burden, we estimate an average recurring
annual burden of 4 minutes per prior notice mail submission. The one-
time total burden for all the 5,460 respondents totals 2,730, and the
recurring burden amounts to 54,655 hours. Therefore, we estimate the
total annual burden to be 57,385 hours.
Although FDA received comments on the proposed rule, none were
responsive to the four collection of information topics solicited.
Therefore, the estimated PRA burden for this final rule is the same as
the estimated burden in the proposed rule. For clarity, we have
reformatted the burden chart in this final rule. The updated format
differs from the proposed rule by breaking out burden estimates by
activity. These revisions do not alter the nature of the information
being collected.
The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the PRA.
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
[[Page 46055]]
displays a currently valid OMB control number.
X. 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.
XI. 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.
XII. 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>. Although FDA
verified the website address in this document, please note that
websites are subject to change over time.
1. Final Regulatory Impact Analysis, Adding Requirement to Submit
Mail Tracking Number for Articles of Food Arriving by International
Mail and Timeframe for Post-refusal and Post-hold Submissions;
available at <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
List of Subjects in 21 CFR Part 1
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, FDA amends
21 CFR part 1 as follows:
PART 1--GENERAL ENFORCEMENT REGULATIONS
0
1. The authority citation for part 1 continues to read as follows:
Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c,
350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371,
374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216,
241, 243, 262, 264, 271.
0
2. In Sec. 1.280 revise paragraph (a)(2) to read as follows:
Sec. 1.280 How must you submit prior notice?
(a) * * *
(2) The FDA Prior Notice System Interface (FDA PNSI) at <a href="https://www.access.fda.gov/">https://www.access.fda.gov/</a>.
* * * * *
0
3. In Sec. 1.281 revise paragraphs (a)(5)(iv), (b)(4)(iv), (b)(10) and
(11), and (c)(5)(iv) to read as follows:
Sec. 1.281 What information must be in a prior notice?
(a) * * *
(5) * * *
(iv) The lot or code numbers or other identifier of the food if
required by the Act or FDA regulations, e.g., low-acid canned foods, by
Sec. 113.60(c) of this chapter; acidified foods, by Sec. 114.80(b) of
this chapter; and infant formula, by Sec. 106.80 of this chapter;
* * * * *
(b) * * *
(4) * * *
(iv) The lot or code numbers or other identifier of the food if
required by the Act or FDA regulations, e.g., low-acid canned foods, by
Sec. 113.60(c) of this chapter; acidified foods, by Sec. 114.80(b) of
this chapter; and infant formula, by Sec. 106.80 of this chapter;
* * * * *
(10) The anticipated date of mailing, and beginning October 1,
2026, the name of the mail service and the mail tracking number;
(11) The name and address of the U.S. recipient; and
* * * * *
(c) * * *
(5) * * *
(iv) The lot or code numbers or other identifier of the food if
required by the Act or FDA regulations, e.g., low-acid canned foods, by
Sec. 113.60(c) of this chapter; acidified foods, by Sec. 114.80(b) of
this chapter; and infant formula, by Sec. 106.80 of this chapter;
* * * * *
0
4. In Sec. 1.283 revise paragraphs (a)(6) and (c)(1) and (2) to read
as follows:
Sec. 1.283 What happens to food that is imported or offered for
import without adequate prior notice?
(a) * * *
(6) No post-refusal submission or request for review. If an article
of food is refused under section 801(m)(1) of the Act and no prior
notice is submitted or resubmitted in accordance with paragraph (c) of
this section, no request for FDA review is submitted in accordance with
paragraph (d) of this section, or export has not occurred in accordance
with paragraph (a)(5) of this section, the article of food shall be
dealt with as set forth in CBP regulations relating to general order
merchandise (19 CFR part 127), except that, unless otherwise agreed to
by CBP and FDA, the article may only be sold for export or destroyed.
* * * * *
(c) * * *
(1) If an article of food is refused under paragraph (a)(1)(i) of
this section (no prior notice) and the food is not exported, prior
notice must be submitted in accordance with Sec. Sec. 1.280 and
1.281(c) within 10 calendar days from the date the notice of refusal
was issued or 10 calendar days from the date the response to a request
for FDA review under paragraph (d) of this section was issued.
(2) If an article of food is refused under paragraph (a)(1)(ii) of
this section (inaccurate prior notice) and the food is not exported,
the prior notice should be canceled in accordance with Sec. 1.282 and
you must resubmit prior notice in accordance with Sec. Sec. 1.280 and
1.281(c) within 10 calendar days from the date the notice of refusal
was issued or 10 calendar days from the date the response to a request
for FDA review under paragraph (d) of this section was issued.
* * * * *
0
5. In Sec. 1.285 revise paragraphs (g) and (i)(1) to read as follows:
Sec. 1.285 What happens to food that is imported or offered for
import from unregistered facilities that are required to register under
subpart H of this part?
* * * * *
(g) No registration or request for review. If an article of food is
placed under hold under section 801(l) of the Act and no registration
number is submitted in accordance with paragraph (i) of this section,
or no request for FDA review is submitted in accordance with paragraph
(j) of this section, or export has not occurred in accordance with
paragraph (f) of this section, the food shall be dealt with as set
forth in CBP regulations relating to general order merchandise (19 CFR
part 127). Unless
[[Page 46056]]
otherwise agreed to by CBP and FDA, the article may only be sold for
export or destroyed.
* * * * *
(i) * * *
(1) To resolve a hold, if an article of food is held under
paragraph (b) of this section because it is from a foreign facility
that is not registered, the facility must be registered, and a valid
registration number must be obtained and submitted to the FDA Division
of Food Defense Targeting within 30 calendar days from the date the
notice of hold was issued or 30 calendar days from the date the
response to a request for FDA review under paragraph (j) of this
section was issued.
* * * * *
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-18655 Filed 9-24-25; 8:45 am]
BILLING CODE 4164-01-P
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