[Federal Register Volume 88, Number 210 (Wednesday, November 1, 2023)]
[Proposed Rules]
[Pages 74939-74947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24086]
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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: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to amend its prior notice regulations to 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
and 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). We are also proposing 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, if finalized, will improve
program efficiency and better enable FDA to protect the U.S. food
supply and public health.
DATES: Either electronic or written comments on the proposed rule must
be submitted by January 30, 2024. Submit written comments (including
recommendations) on the collection of information under the Paperwork
Reduction Act of 1995 (PRA) by January 2, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 30, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Comments
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
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 below (see ``Written/Paper Submissions'' and
``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
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.
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-2011-N-0179 for ``Information Required in Prior Notice of Imported
Food.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, at 240-402-7500.
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 submission. You
should submit two copies total. One copy will include the
[[Page 74940]]
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
Submit comments on the information collection under the PRA to the
Office of Management and Budget (OMB) at https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by
selecting ``Currently under Review--Open for Public Comments'' or by
using the search function. The title of this proposed collection is
``Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002.''
FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule:
Peter Ajuonuma, Office of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr., Rockville, MD 20852, 301-796-2277,
[email protected].
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, 301-706-5733,
[email protected].
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. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. Introduction
B. Need for the Regulation
C. History of the Rulemaking
IV. Legal Authority
V. Description of the Proposed Rule
VI. Proposed Effective Date
VII. Preliminary Economic Analysis of Impacts
A. Introduction
B. Summary of Costs and Benefits
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. Reference
I. Executive Summary
A. Purpose of the Proposed Rule
FDA uses prior notice information to, among other things, determine
what products should be inspected upon arrival into the United States.
The proposed rule, if finalized, would: (1) amend Sec. 1.281(b)(10)
(21 CFR 1.281(b)(10)) to add a requirement 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. Sec. 1.283 and 1.285 (21 CFR 1.283 and 1.285) to add a
requirement that prior notice be submitted within 10 calendar days from
the date a notice of refusal or hold was issued and that food facility
registration be submitted within 30 calendar days from the date a
notice of refusal or hold was issued; and (3) make certain technical
amendments.
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\1\ Note that FDA intends to consider 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 would 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 would help
FDA better plan its operations and stop such articles from being
delivered.
Many foods are regularly imported by mail, and in FDA's experience,
these foods can present similar risks to the U.S. food supply as other
imported foods. Further, FDA's presence at international mail
facilities supports that 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 food highlights the
need for FDA to have the name of the mail service and tracking number
to adequately monitor and refuse or hold specific food shipments.
Additionally, requiring a reasonable timeframe for post-refusal and
post-hold submissions of prior notice and food facility registration
may reduce the amount of time articles subject to refusal or holds are
held at ports of entry, thus reducing associated monetary charges. It
would 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
longer periods of time (e.g., weeks and months) reviewing multiple
replacement non-compliant prior notice or registration submissions.
Finally, regarding the technical changes to the regulations, FDA's
PNSI was developed to receive prior notice information for import
submissions that could not be accommodated in the Automated Commercial
System (ACS), mainly mail and baggage submissions, and prior notice for
foods refused under section 801(m) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 381(m)). ACE, ACS's successor
system, can now accommodate such submissions. Therefore, we also
propose to amend 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 through FDA PNSI. If finalized as proposed, prior notice
for food arriving by international mail can be submitted through the
PNSI or through the U.S. CBP ABI/ACE/ITDS. Further, we propose to amend
Sec. 1.281(a)(5)(iv),
[[Page 74941]]
(b)(4)(iv), and (c)(5)(iv) 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, if finalized as
proposed, Sec. 1.281(a)(5)(iv), (b)(4)(iv), and (c)(5)(iv) will be
amended to refer to Sec. 106.80 instead of Sec. 106.90.
B. Summary of the Major Provisions of the Proposed Rule
FDA proposes to amend 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. If this amendment is
finalized as proposed, Sec. 1.281(b)(10) will include an additional
requirement 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 FD&C Act (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, or no
registration is provided. However, these sections do not provide a
timeframe within which such submissions must be made. If this amendment
is finalized as proposed, Sec. 1.283(c)(1) and (2) will require
submission or resubmission of prior notice within 10 calendar days from
the date the notice of refusal was issued. We believe that 10 days is
an appropriate timeframe because it allows time for certain persons who
want to file a request for FDA review pursuant to Sec. 1.283(d), to
file their request, receive a response of the review decision, and
submit or resubmit prior notice if necessary.
In addition, if finalized as proposed, Sec. 1.285(i)(1) will
require submission of a valid registration within 30 calendar days from
the date a notice of hold was issued. We believe that 30 days is an
appropriate timeframe in this context because it allows time to obtain
and submit a valid registration if necessary. It also allows time to
file a request for FDA review pursuant to Sec. 1.285(j), receive a
response of the review decision, and submit or resubmit registration if
necessary. If a prior notice is not submitted or resubmitted, or a
registration is not provided within the 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.
FDA also proposes to amend Sec. 1.280(a)(2). This regulation
currently requires prior notice of articles of food imported or offered
for import by international mail, and other transaction types that
cannot be made through ABI/ACE/ITDS, to be submitted through FDA PNSI.
At this time, there are no longer any transaction types that cannot be
made through ABI/ACE/ITDS. Therefore, this proposed amendment would
remove the requirement that only the FDA PNSI be used for the
submission of prior notice for articles of food arriving by
international mail. Finally, FDA proposes to amend 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 proposed 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. The proposed rule, if finalized, would
not significantly increase costs to small entities. See the Preliminary
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/ acronym What it means
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ABI................................. Automated Broker Interface.
ACE................................. Automated Commercial Environment.
CBP................................. U.S. Customs and Border
Protection.
CPG................................. Compliance Policy Guide.
E.O................................. Executive Order.
FD&C Act............................ Federal Food, Drug, and Cosmetic
Act.
FSMA................................ FDA Food Safety Modernization Act.
GMP................................. Good Manufacturing Practice.
OMB................................. Office of Management and Budget.
PNSI................................ Prior Notice System Interface.
USPS................................ U.S. Postal Service.
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III. Background
A. Introduction
FDA proposes to amend the prior notice regulation as follows: (1)
amend Sec. 1.281(b)(10) to add a requirement 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 of refusal under section
801(m) of the FD&C Act was issued and Sec. 1.285(i) to require
submission of food facility registration within 30 calendar days from
the date the notice of hold under section 801(l) of the FD&C Act was
issued; and (3) 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 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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[[Page 74942]]
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 food articles
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 carrier and the mail tracking number for food
articles imported by international mail would 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 would also enable FDA to act quickly to identify the
affected food articles and prevent contamination of the food supply. It
would also help to improve emergency response time, as FDA and other
Agencies would 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
would bolster FDA's efforts to prevent violative and potentially
dangerous food shipments from entering the United States at
international mail facilities, and also could help FDA to track,
identify, inspect, and contain such shipments. With this information
available, FDA could 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 emergencies,
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 carrier would help FDA, CBP, and USPS to
track the origin and location of the international mail. The mail
package could 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 would enable FDA to
prevent the article of food from entering the U.S. food supply chain
more swiftly.
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 5 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 food facility registration requirements
(Sec. Sec. 1.283(d) and 1.285(j)). Alternatively, submitters or
transmitters can 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 submit multiple replacement non-compliant
prior notice or registration submissions to be reviewed by FDA. This
practice consumes significant amounts of FDA reviewers' time and may
lead to importers incurring large demurrage charges (i.e., monetary
charges due to a failure of goods to leave 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 requires 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 requirement.
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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, Pub. L. 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 rule, 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
[[Page 74943]]
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 proposed rule would further align the prior notice rule 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
paragraph (d) [of that section]. We made a similar change in Sec.
1.285(g)'' (73 FR 66294 at 66370). That change requires requests for
FDA review under Sec. Sec. 1.283(d) and 1.285(j) to be submitted
within 5 calendar days of the refusal or hold and removes 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 (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 proposed rule would amend such
provisions by imposing a timeframe for post-refusal and post-hold
submissions.
IV. Legal Authority
We are issuing this proposed 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 now tentatively 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
tentatively determine that imposing a timeframe on post-refusal and
post-hold submissions of prior notice and food facility registration is
necessary for the efficient enforcement of sections 801(m) and 801(l)
of the FD&C Act.
V. Description of the Proposed Rule
The proposed rule, if finalized, will amend Sec. Sec. 1.281(b)(10)
to require the submission of the name of the mail service and mail
tracking number in the prior notice for articles of food sent by
international mail. Currently, Sec. 1.281(b)(10) requires only the
submission of the anticipated date of mailing. If the proposed rule is
finalized, Sec. 1.281(b)(10) will include an additional requirement to
submit the name of the international mail service used in mailing the
article and the mail tracking number in the prior notice of the article
to FDA, for food articles arriving by international mail. We believe
international mail packages usually bear tracking numbers that could be
used to track the mail or identify its country of origin. We welcome
comments regarding any country where a tracking number is not issued
for international mail.
The proposed rule will also amend Sec. Sec. 1.283(a)(6) and (c),
and 1.285(g) and (i)(1) to require post-refusal and post-hold
submissions of prior notice to be submitted within 10 calendar days and
post-refusal and post-hold submissions of registration be submitted
within 30 calendar days from the date the notice of refusal or hold was
issued. If the prior notice or registration requirements are not met
within these timeframes, the article shall 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. We believe that 30 calendar days is an appropriate
timeframe for registration submissions because it gives time to obtain
and submit a valid registration, as well as time to file a request for
review by FDA and receive a response of the review decision, and to
submit the required information, if necessary. However, we are willing
to consider other timeframes. Therefore, FDA invites public comment on
whether 30 calendar days would be an appropriate timeframe for
registration submission or if a different timeframe would be more
appropriate. For comments suggesting a timeframe, we request an
explanation of the reason.
If finalized, the proposed change to Sec. 1.280(a)(2) will remove
the requirement that articles of food arriving by international mail be
submitted in FDA PNSI. This change will allow a prior notice submitter
to use CBP's ABI/ACE/ITDS as an alternative to FDA PNSI to submit prior
notice of articles of food imported or offered for import by
international mail.
This proposal would also make technical amendments to Sec.
1.281(a)(5)(iv), (b)(4)(iv), and (c)(5)(iv) to correct a cross-
reference in the regulation to Sec. 106.80 instead of Sec. 106.90.
[[Page 74944]]
VI. Proposed Effective Date
FDA is proposing that the final rule based on this proposal become
effective 30 days after the date of publication in the Federal
Register.
VII. Preliminary Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 14094, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
Executive Orders 12866, 13563, and 14094 direct us to assess all
benefits, costs, and transfers of available regulatory alternatives
and, when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). Rules are ``significant'' under Executive Order 12866
Section 3(f)(1) (as amended by Executive Order 14094) if they ``have an
annual effect on the economy of $200 million or more (adjusted every 3
years by the Administrator of [the Office of Information and Regulatory
Affairs (OIRA)] for changes in gross domestic product); or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, territorial, or tribal governments or
communities.'' OIRA has determined that this proposed rule is not a
significant regulatory action under Executive Order 12866 Section
3(f)(1).
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the proposed change to prior notice requirements
would not significantly increase costs to small entities, we propose to
certify that the 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 estimates of
anticipated impacts, 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 $177
million, using the most current (2022) Implicit Price Deflator for the
Gross Domestic Product. This proposed rule would not result in an
expenditure in any year that meets or exceeds this amount.
B. Summary of Costs and Benefits
This proposed rule would amend existing prior notice regulations to
require the submission of tracking information for food articles
imported using international mail. To estimate costs and benefits
associated with the proposed rule, we assume that the appropriate
baseline is the state of the world with current prior notice
regulations. We then compare the likely impacts of the proposed rule
against this baseline. The costs of the proposed rule, if finalized,
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 $0.50 million at a 3 percent rate of discount. At a 7 percent rate
of discount, these costs range from approximately $0.04 million to
$0.52 million. Our primary annualized estimates are approximately $0.27
million and $0.28 million at 3 and 7 percent rates of discount,
respectively.
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 $0.04 million to $0.18 million for
both 3 and 7 percent rates of discount. The primary annualized value is
$0.09 million for both rates of discount. These estimates are
summarized in table 1.
Table 1--Summary of Benefits, Costs and Distributional Effects of Proposed Rule
----------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
----------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $0.09 $0.04 $0.18 2021 7 10
$millions/year. 0.09 0.04 0.18 2021 3 10
Annualized Quantified.... .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
----------------------------------------------------------------------------------
Qualitative..............
----------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized 0.28 0.04 0.52 2021 7 10
$millions/year. 0.27 0.04 0.50 2021 3 10
Annualized Quantified.... .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
----------------------------------------------------------------------------------
Qualitative..............
----------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized .......... .......... .......... .......... 7 ..........
Monetized $millions/year. .......... .......... .......... .......... 3 ..........
----------------------------------------------------------------------------------
From/To.................. From:
To:
----------------------------------------------------------------------------------
Other Annualized .......... .......... .......... .......... 7 ..........
Monetized $millions/year. .......... .......... .......... .......... 3 ..........
----------------------------------------------------------------------------------
From/To.................. From:
To:
----------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: None.....................................................................
[[Page 74945]]
Small Business: None........................................................................................
Wages:......................................................................................................
Growth:.....................................................................................................
----------------------------------------------------------------------------------------------------------------
We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 1) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
VIII. Analysis of Environmental Impact
We have determined under 21 CFR 25.30(h) that this proposed 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 proposed rule contains information collection provisions that
are subject to review by OMB under the PRA (44 U.S.C. 3501-3521). A
description of these provisions is given in the Description section of
this document with an estimate of the annual reporting. 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.
FDA invites 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: Prior Notice of Imported Food Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002; OMB
Control No. 0910-0520--Revision.
Description: FDA is amending its regulations 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 2--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average one-
Number of Average number Total annual time burden per Average burden Total annual
21 CFR section respondents of responses responses respondent (in per response hours
per respondent minutes) (in minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.281(b)(10)...................................... 5,460 143 781,219 30 4 54,811
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 proposed 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 781,219
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 amounts to 163,800
minutes (5,460 x 30). The total recurring burden for all the 781,219
mail entries is 3,124,876 minutes (781,219 x 4). Therefore, we estimate
the average total annual recurring burden in hours to be 54,811
(163,800 + 3,124,876 / 60).
To ensure that comments on information collection are received, OMB
recommends that written comments be submitted through https://www.reginfo.gov/public/do/PRAMain (see ADDRESSES). All comments should
be identified with the title of the information collection.
In compliance with the PRA (44 U.S.C. 3407(d)), we have submitted
the information collection provisions of this proposed rule to OMB for
review. These
[[Page 74946]]
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.
X. 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 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 proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the 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. FDA solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.
XII. Reference
The following reference is on display in the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m. Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.
1. Preliminary Regulatory Impact Analysis, Requirement for
Submission of Mail Tracking Number or Tracking Code for Food
Articles Arriving by International Mail; available at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
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 proposes
to amend 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 https://www.access.fda.gov/.
* * * * *
0
3. In Sec. 1.281 revise paragraphs (a)(5)(iv), (b)(4)(iv), (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, 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), (c)(1), and (c)(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.
(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.
* * * * *
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. Unless
otherwise agreed to by CBP and FDA, the article may only be sold for
export or destroyed.
* * * * *
(i) * * *
[[Page 74947]]
(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.
* * * * *
Dated: October 26, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-24086 Filed 10-31-23; 8:45 am]
BILLING CODE 4164-01-P