[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:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed below (see ``Written/Paper Submissions'' and 
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-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.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper 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, 
<a href="/cdn-cgi/l/email-protection#e3b386978691cda289968c8d968e82a3858782cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="28784d5c4d5a0669425d47465d4549684e4c490640405b064f475e">[email protected]</span></a>.
    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, 
<a href="/cdn-cgi/l/email-protection#c595978496b1a4a3a385a3a1a4ebadadb6eba2aab3"><span class="__cf_email__" data-cfemail="411113001235202727012725206f2929326f262e37">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. 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


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