Inyx USA, Ltd.’s response to Section 114 letter regarding CFC stocks owned.

Confidential Business Information located at EPA headquarters 1310 L St NW.


[Federal Register Volume 85, Number 21 (Friday, January 31, 2020)]
[Notices]
[Page 5680]
[FR Doc No: 2020-01887]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4469-DR; Docket ID FEMA-2019-0001]

South Dakota; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of South Dakota (FEMA-4469-DR), dated November 18, 2019,
and related determinations.

DATES: This amendment was issued January 8, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of South Dakota is hereby amended to include the
following area among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of November 18, 2019.

    Aurora County for Individual Assistance (already designated for
Public Assistance).
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-01887 Filed 1-30-20; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 78, Number 88 (Tuesday, May 7, 2013)]
[Proposed Rules]
[Pages 26558-26559]
[FR Doc No: 2013-10163]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-0770; Airspace Docket No. 12-ASW-6]

Proposed Establishment of Class E Airspace; Presidio, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E airspace at
Presidio, TX. Controlled airspace is necessary to accommodate new
Standard Instrument Approach Procedures (SIAP) at Presidio Lely
International Airport. The FAA is taking this action to enhance the
safety and management of Instrument Flight Rules (IFR) operations for
SIAPs at the airport.

DATES: Comments must be received on or before June 21, 2013.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2012-0770/Airspace Docket No. 12-
ASW-6, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9:00 a.m. and
5:00 p.m., Monday through Friday, except Federal holidays. The Docket
Office (telephone 1-800-647-5527), is on the ground floor of the
building at the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: 817-321-
7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2012-0770/
Airspace Docket No. 12-ASW-6.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Central Service Center, 2601
Meacham Blvd., Fort Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by establishing Class E airspace extending upward
from 700 feet above the surface within a 6.5-mile radius, with an
extension to the east, and extending upward from 1,200 feet above the
surface within a 62.5-mile radius, to accommodate new standard
instrument approach procedures at Presidio Lely International Airport,
Presidio, TX. Controlled airspace is needed for the safety and
management of IFR operations at the airport.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9W, dated August 8, 2012 and effective September 15, 2012, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation

listed in this document would be published subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would establish controlled airspace at Presidio Lely
International Airport, Presidio, TX.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9W,
Airspace Designations and Reporting Points, dated August 8, 2012, and
effective September 15, 2012, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASW TX E5 Presidio, TX [New]

Presidio Lely International Airport, TX
    (Lat. 29[deg]38'03'' N., long. 104[deg]21'41'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Presidio Lely International Airport, and
within 2 miles each side of the 070[deg] bearing from the airport
extending from the 6.5-mile radius to 13.4 miles east of the
airport; and that airspace extending upward from 1,200 feet above
the surface within a 62.5 mile radius of the airport, excluding that
airspace within Mexico.

    Issued in Fort Worth, TX, on April 11, 2013.
David P. Medina,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2013-10163 Filed 5-6-13; 8:45 am]
BILLING CODE 4910-13-P


LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 9 1 9.0 Second Stage Filtration 9.1 Introduction The LT2ESWTR 40 CFR 141.728( c) describes second stage filtration as the use of a rapid sand, dual media, granular activated carbon ( GAC), or other fine grain media unit process applied in a separate stage following rapid sand or dual media filtration. Applying an additional layer of media, such as a GAC cap, on an existing single stage filtration unit does not qualify for this credit.

This chapter is organized as follows:

9.2 LT2ESWTR Compliance Requirements  discusses criteria and reporting requirements that systems must meet to receive Cryptosporidium removal.

9.3 Toolbox Selection Considerations  discusses issues specific to second stage filtration that water systems should consider when selecting toolbox options.

9.4 Design and Operational Considerations  discusses hydraulic issues, backwashing, and turbidity monitoring for systems that integrate a second stage filtration in their treatment train.

9.2 LT2ESWTR Compliance Requirements 9.2.1 Credits Under the LT2ESWTR, a system that employs a second, separate filtration stage meeting the following criteria may receive 0.5 log credit for Cryptosporidium removal ( 40 CFR 141.728( c)).

° The first stage of filtration is preceded by a coagulation step ° The second stage of filtration is comprised of rapid sand, dual media, GAC, or other fine grain media ° Both filtration stages treat 100 percent of plant flow Chapter 9  Second Stage Filtration LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 9 2 Under the LT2ESWTR, a system integrating a slow sand filtration process for the second stage of filtration meeting the following criteria can receive 2.5 log credit for Cryptosporidium removal ( 40 CFR 141.728( d)).

° No disinfectant residual is present in the influent to the slow sand filtration process ° Both filtration stages treat 100 percent of plant flow 9.2.2 Reporting Requirements To receive Cryptosporidium removal credit for compliance with the LT2ESWTR, systems must report the following monthly ( 40 CFR 141.730):

$ Verification that 100 percent of finished water was treated by two stages of filtration. Actual data or information required to report is determined by the State. EPA recommends plant piping schematics be initially reported followed by monthly operator certification.

Reporting for LT2ESWTR does not take the place of the IESWTR and LT1ESWTR reporting requirements. Specifically, the turbidity of the combined and individual filter effluent from the first filtration stage must be reported as required by the IESWTR and LT1ESWTR ( 40 CFR 141.74, 40 CFR 141.174( a), 40 CFR 141.551, and 40 CFR 141.560).

9.3 Toolbox Selection Considerations Plants already employing a second unit process that meets the requirements for this toolbox option ( e. g., GAC columns to meet dissolved organic or taste and odor treatment goals) are in the ideal position to seek credit. Other plants that have enough excess filtration capacity or unused filter beds ( e. g., built in anticipation of unrealized plant expansions), may be able to convert piping to enable these filters to operate in series for relatively low cost. However, many plants will find that integrating second stage filtration into an existing treatment train poses significant additional space, capital, and hydraulic requirements. These systems may want to consider this option if the additional treatment provides other benefits. For example, systems that use chloramination and/ or ozone could run the second stage under biological filtration conditions to reduce assimilable organic carbon ( AOC), which promotes biofilm growth and nitrification ( for chloraminating systems) in the distribution system.

Additionally, plants experiencing taste and odor problems or dissolved organic contaminants in their raw water might consider installing GAC columns to alleviate these problems and also receive the Cryptosporidium removal credit. Chapter 9  Second Stage Filtration LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 9 3 Slow sand filtration plants who wish to consider this toolbox option should either have sufficient excess filtration capacity to allow filters to operate in series ( with possible piping modifications) or have sufficient land area to build additional filters.

9.3.1 Advantages The advantages of a second stage filtration process are the same for both rapid and slow sand plants and include operator familiarity with the process, ease of operation, and potential to reduce disinfection byproducts. For plants with existing processes and infrastructure meeting the two stage requirements, implementation costs are likely to be relatively low.

9.3.2 Disadvantages The disadvantages associated with second stage filtration apply primarily to those plants that do not have existing processes in place or cannot easily convert built in infrastructure. In addition to the capital cost for new filters, these plants may need the following improvements to integrate a second stage of filtration:

° Space if there is currently no room for expansion in the existing plant grounds ° Additional pumping to compensate for head loss associated with an additional filtration process ° Increased backwash supply and treatment For those plants that have existing infrastructure available for a second stage of filtration, they still may have to account for an increased volume of backwash and loss of head due to the second stage.

Systems with rapid sand filtration plants that are considering integrating slow sand filtration into their treatment process should be aware of the following differences in operation and performance of slow sand plants compared to rapid sand plants:

° More space required for slow sand plants ° Decreased filtering performance with cold temperatures ° Maintenance of filters requires draining and scraping a thin layer off the top of the filter Chapter 9  Second Stage Filtration LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 9 4 9.4 Design and Operational Considerations The design of the second stage is site specific and depends on existing infrastructure ( e. g., some systems may have enough filtration capacity to operate filters in series) and space and hydraulic requirements. EPA does not specify or restrict certain configurations, beyond the requirement that all flow must be treated by both stages. Systems that have existing filters not in use or not used to capacity may reconfigure the piping to operate in series. Media sizing for the second stage is also not specified; however, typical design standards for regular or deep bed filters should be followed. If the filter effluent from the first stage is not combined prior to second stage, the turbidity monitoring for IESWTR and LT1ESWTR may have to be conducted on individual filters. For these cases, systems need to consult with the State to develop a new IESWTR or LT1ESWTR filter effluent monitoring plan.

9.4.1 Hydraulic Requirements Additional pumps may be needed to provide the necessary head between the first and second stages of filtration. The number of pumps and total number of filters should allow for redundancy, to ensure that sufficient treatment capacity is in place to treat all the plant flow in the event of equipment breakdown or maintenance. However, the filter loading rate to the second stage does not necessarily need to be the same as for the first stage. The water influent to the second stage should be significantly cleaner, and may enable higher loadings. Final design loading rates should be determined in consultation with the State.

If the filter effluent from the first stage filters is not combined and sent to the second stage filters via a distribution box or other flow equalization device, plant operation may be more complex. For example, if the effluent from one first stage filter is sent to just one second stage filter, then as the flow from first filter decreases ( or headloss through it increases), flow through the second filter will also decrease, unless automatic effluent control valves are installed on the second stage filter. Also, in this case, whenever the first stage filter is backwashed, the second stage filter will also be out of service.

9.4.2 Backwashing Consistent with the Filter Backwash Recycling Rule, the filter backwash from the second stage ( as well as the first stage) must be recycled to the head of the plant if it is recycled. The existing backwashing capacity may be limited and need to be increased. There may be insufficient finished water storage to supply backwash water or there may need to be additional pumping capacity, depending upon the design of the additional filtration stage ( e. g., if the existing filters have a small area and the new filters are significantly larger, the existing backwash pumps may not be able to supply water at a high enough flow to properly expand the filter bed). It is likely that the second stage filters would need to be backwashed less frequently than the first stage ones, due to the lower solids loading. Chapter 9  Second Stage Filtration LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 9 5 Filter ripening and/ or filter to waste times for the second filtration stage will most likely differ from the first stage.

9.4.3 Turbidity Monitoring EPA recommends monitoring the turbidity of the individual filters in the second stage in order to be able to identify any possible filter upset situations. Depending on the first filtration stage effluent quality, it may be difficult to see a significant difference in the second stage effluent. If the combined second stage filter effluent is the only process stream monitored, it is unlikely that an upset in one second stage filter could be detected.


[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)]
[Notices]
[Page 27943]
[FR Doc No: 2017-12681]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: National
Flight Data Center Web Portal

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew a previously approved
information collection. National Flight Data Center (NFDC) Web Portal
forms are used to collect aeronautical information, detailing the
physical description and operational status of all components of the
National Airspace System (NAS).

DATES: Written comments should be submitted by July 19, 2017.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW.,
Washington, DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

FOR FURTHER INFORMATION CONTACT: Ronda Thompson by email at:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0754.
    Title: National Flight Data Center Web Portal.
    Form Numbers: FAA Form 7900-1, 7900-2, 7900-3, 7900-4, 7900-5,
7900-6, 7900-7.
    Type of Review: Renewal of an information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on April 5, 2017 (82 FR 16658). There were no comments.
The National Flight Data Center (NFDC) is the authoritative government
source for collecting, validating, storing, maintaining, and
disseminating aeronautical data concerning the United States and its
territories to support real-time aviation activities. The information
collected ensures the safe and efficient navigation of the national
airspace. The information collected is maintained in the National
Airspace System Resources (NASR) database which serves as the official
repository for NAS data and is provided to government, military, and
private producers of aeronautical charts, publications, and flight
management systems.
    Respondents: Approximately 7,318 representatives of U.S. public
airports, U.S. privately-owned instrument landing systems, and non-
Federal weather systems.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 25 minutes.
    Estimated Total Annual Burden: 1,296 hours.

    Issued in Washington, DC, on June 13, 2017.
Ronda L. Thompson,
FAA Information Collection Clearance Officer, Performance, Policy &
Records Management Branch, ASP-110.
[FR Doc. 2017-12681 Filed 6-16-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 217 (Thursday, November 10, 2022)]
[Notices]
[Pages 67969-67972]
[FR Doc No: 2022-24509]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96241; File No. SR-FINRA-2022-030]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Extend Temporary Supplementary Material .17
(Temporary Relief To Allow Remote Inspections for Calendar Years 2020
and 2021, and Through December 31 of Calendar Year 2022) Under FINRA
Rule 3110 (Supervision)

November 4, 2022.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'' or ``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on October 31, 2022, the Financial Industry
Regulatory Authority, Inc. (``FINRA'') filed with the Securities and
Exchange Commission (``SEC'' or ``Commission'') the proposed rule
change as described in Items I, II, and III below, which Items have
been prepared by FINRA. FINRA has designated the proposed rule change
as constituting a ``non-controversial'' rule change under paragraph
(f)(6) of Rule 19b-4 under the Act,\3\ which renders the proposal
effective upon receipt of this filing by the Commission. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to extend temporary Supplementary Material .17
(Temporary Relief to Allow Remote Inspections for Calendar Years 2020
and 2021, and Through December 31 of Calendar Year 2022) under FINRA
Rule 3110 (Supervision) to include calendar year 2023 inspection
obligations through the earlier of the effective date of the pilot
program proposed in File No. SR-FINRA-2022-021, if approved, or
December 31, 2023 within the scope of the supplementary material.\4\
The proposed extension of Rule 3110.17 would alleviate the ongoing
operational challenges resulting from the COVID-19 pandemic that many
member firms may continue to face in planning for and timely conducting
the on-site inspection component of Rule 3110(c) (Internal Inspections)
at locations requiring inspection in calendar year 2023.\5\
---------------------------------------------------------------------------

    \4\ See infra note 15, and accompanying text for further
discussion of the pilot program proposed in File No. SR-FINRA-2022-
021. The proposed rule change will automatically sunset on the
earlier of the effective date of SR-FINRA-2022-021, if approved, or
December 31, 2023. FINRA will submit a separate rule filing if it
seeks to extend the duration of the temporary proposed rule beyond
December 31, 2023.
    \5\ SEC staff and FINRA have stated in guidance that inspections
must include a physical, on-site review component. See SEC National
Examination Risk Alert, Volume I, Issue 2 (November 30, 2011) and
Regulatory Notice 11-54 (November 2011) (joint SEC and FINRA
guidance stating, a ``broker-dealer must conduct on-site inspections
of each of its office locations; [OSJs] and non-OSJ branches that
supervise non-branch locations at least annually, all non-
supervising branch offices at least every three years; and non-
branch offices periodically.'') (footnote defining an OSJ omitted).
See also SEC Division of Market Regulation, Staff Legal Bulletin No.
17: Remote Office Supervision (March 19, 2004) (stating, in part,
that broker-dealers that conduct business through geographically
dispersed offices have not adequately discharged their supervisory
obligations where there are no on-site routine or ``for cause''
inspections of those offices).
---------------------------------------------------------------------------

    Below is the text of the proposed rule change. Proposed new
language is in italics; proposed deletions are in brackets.
* * * * *
3000. SUPERVISION AND RESPONSIBILITES RELATING TO ASSOCIATED PERSONS
3100. SUPERVISORY RESPONSIBILITIES
3110. Supervision
    (a) through (f) No Change.
       Supplementary Material: --------------
    .01 through .16 No Change.
    .17 Temporary Relief to Allow Remote Inspections for Calendar Years
2020, [and] 2021, 2022, and [Through December 31 of Calendar Year
2022]2023.
    (a) Use of Remote Inspections. Each member obligated to conduct an
inspection of an office of supervisory jurisdiction, branch office or
non-branch location in the calendar years [2020, 2021 and
2022]specified in this supplementary material pursuant to, as
applicable, paragraphs (c)(1)(A), (B) and (C) under Rule 3110 may,
subject to the requirements of this Rule 3110.17, satisfy such
obligation by conducting the applicable inspection remotely, without an
on-site visit to the office or location. In accordance with Rule
3110.16, inspections for calendar year 2020 must be completed on or
before March 31, 2021. [and] [i]Inspections for calendar year 2021 must
be completed on or before December 31, 2021 and inspections for
calendar year 2022 must be completed on or before December 31, 2022.
With respect to a member's obligation to conduct an inspection of an
office or location in calendar year [2022]2023, a member has the option
to conduct those inspections remotely through the earlier of the
effective date of the pilot program proposed in File No. SR-FINRA-2022-
021, if approved, or December 31, [2022]2023. Notwithstanding Rule
3110.17, a member shall remain subject to the other requirements of
Rule 3110(c).
    (b) Written Supervisory Procedures for Remote Inspections.
Consistent with a member's obligation under Rule 3110(b)(1), a member
that elects to conduct its inspections remotely for any of the calendar
years specified in this supplementary material must amend or supplement
its written supervisory procedures to provide for remote inspections
that are reasonably designed to assist in detecting and preventing
violations of and achieving compliance with applicable securities laws
and regulations, and with applicable FINRA rules. Reasonably designed
procedures for conducting remote inspections of offices or locations
should include, among other things: (1) a description of the
methodology, including

technologies permitted by the member, that may be used to conduct
remote inspections; and (2) the use of other risk-based systems
employed generally by the member firm to identify and prioritize for
review those areas that pose the greatest risk of potential violations
of applicable securities laws and regulations, and of applicable FINRA
rules.
    (c) Effective Supervisory System. The requirement to conduct
inspections of offices and locations is one part of the member's
overall obligation to have an effective supervisory system and
therefore, the member must continue with its ongoing review of the
activities and functions occurring at all offices and locations,
whether or not the member conducts inspections remotely. A member's use
of a remote inspection of an office or location will be held to the
same standards for review as set forth under Rule 3110.12. Where a
member's remote inspection of an office or location identifies any
indicators of irregularities or misconduct (i.e., ``red flags''), the
member may need to impose additional supervisory procedures for that
office or location or may need to provide for more frequent monitoring
of that office or location, including potentially a subsequent
physical, on-site visit on an announced or unannounced basis when the
member's operational difficulties associated with COVID-19 abate,
nationally or locally as relevant, and the challenges a member is
facing in light of the public health and safety concerns make such on-
site visits feasible using reasonable best efforts. The temporary
relief provided by this Rule 3110.17 does not extend to a member's
inspection requirements beyond the earlier of the effective date of the
pilot program proposed in File No. SR-FINRA-2022-021, if approved, or
December 31, [2022]2023, and such inspections must be conducted in
compliance with Rule 3110(c).
    (d) Documentation Requirement. A member must maintain and preserve
a centralized record for [each of calendar years 2020 and 2021] the
calendar years specified in this supplementary material[, and for
calendar year 2022 through December 31, 2022] that separately
identifies: (1) all offices or locations that had inspections that were
conducted remotely; and (2) any offices or locations for which the
member determined to impose additional supervisory procedures or more
frequent monitoring, as provided in Rule 3110.17(c). A member's
documentation of the results of a remote inspection for an office or
location must identify any additional supervisory procedures or more
frequent monitoring for that office or location that were imposed as a
result of the remote inspection.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    In response to the COVID-19 global health crisis and the
corresponding need to restrict in-person activities, FINRA provided
temporary relief to member firms from certain regulatory requirements,
including those set forth under Rule 3110. To help alleviate the
attendant logistical challenges member firms were encountering to
satisfy the on-site inspection component of their Rule 3110(c)
requirements, FINRA adopted Rule 3110.16 (Temporary Extension of Time
to Complete Office Inspections) to extend the time by which member
firms were required to complete their calendar year 2020 inspection
obligations under Rule 3110(c) to March 31, 2021 with the expectation
that the extension did not relieve firms from the on-site portion of
the inspections of their offices and locations.\6\ However, health and
safety concerns remained unabated and with many restrictive measures
still in place as calendar year 2020 was ending, FINRA adopted Rule
3110.17 to provide member firms the option, subject to specified
requirements under the supplementary material, to complete remotely
their calendar year inspection obligations without an on-site visit to
the office or location.\7\ This relief has been extended and currently,
Rule 3110.17 is set to automatically sunset on December 31, 2022.\8\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 89188 (June 30,
2020), 85 FR 40713 (July 7, 2020) (Notice of Filing and Immediate
Effectiveness of File No. SR-FINRA-2020-019).
    \7\ See Securities Exchange Act Release No. 90454 (November 18,
2020), 85 FR 75097 (November 24, 2020) (Notice of Filing and
Immediate Effectiveness of File No. SR-FINRA-2020-040).
    \8\ See Securities Exchange Act Release No. 93002 (September 15,
2021), 86 FR 52508 (September 21, 2021) (Notice of Filing and
Immediate Effectiveness of File No. SR-FINRA-2021-023); and
Securities Exchange Act Release No. 94018 (January 20, 2022), 87 FR
4072 (January 26, 2022) (Notice of Filing and Immediate
Effectiveness of File No. SR-FINRA-2022-001).
---------------------------------------------------------------------------

    Even though it has been more than two years since the World Health
Organization declared COVID-19 a pandemic,\9\ member firms' in-person
staff requirements, which were first developed in response to COVID-19-
related health concerns, have remained in flux. This reflects, in part,
ongoing staff health concerns; according to the CDC, the number of new
deaths from COVID-19 in the United States in September 2022 ranged from
approximately 2,900 to 3,200 deaths per week,\10\ and approximately 20
percent of counties in the United States have a medium or high COVID-19
Community Level based on the CDC's most recent calculations.\11\ While
CDC guidance on managing the risks related to COVID-19 has become more
streamlined,\12\ dissimilar vaccination rates through the U.S.\13\ and
the uncertainty about whether there will be a significant increase in
the number of COVID-19 cases in light of the presence of COVID-19
variants, including Omicron and its lineages,\14\ continues to raise
staff health concerns, particularly with regard to inspections of their
home activities.
---------------------------------------------------------------------------

    \9\ See Centers for Disease Control and Prevention (``CDC''),
International Classification of Diseases, Tenth Revision, Clinical
Modification, https://www.cdc.gov/nchs/data/icd/Announcement-New-ICD-code-for-coronavirus-3-18-2020.pdf. See also WHO Director-
General, Opening Remarks at the Media Briefing on COVID-19 (March
11, 2020), https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020.
    \10\ See CDC, COVID Data Tracker--Trends in Number of COVID-19
Cases and Deaths in the US Reported to CDC, by State/Territory,
https://covid.cdc.gov/covid-data-tracker/#trends_weeklydeaths_select_00 (last visited October 27, 2022).
    \11\ See CDC, COVID Data Tracker--COVID-19 Integrated County
View, https://covid.cdc.gov/covid-data-tracker/#county-view?list_select_state=all_states&data-type=CommunityLevels (last
visited October 27, 2022).
    \12\ See generally CDC Press Release, CDC streamlines COVID-19
guidance to help the public better protect themselves and understand
their risk, https://www.cdc.gov/media/releases/2022/p0811-covid-guidance.html (August 11, 2022).
    \13\ A state-by-state comparison of vaccination rates is
available at https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additionaldose-totalpop.
    \14\ Variants of concern include BA.5, BA.4.6, and BQ.1.1, among
others. See CDC, COVID Data Tracker--Variant Proportions, https://covid.cdc.gov/covid-data-tracker/#variant-proportions (last visited
October 27, 2022).
---------------------------------------------------------------------------

    As year 2022 is in its fourth quarter, firms need to establish
their inspection

schedules for calendar year 2023 and ensure there is adequate,
experienced staff available to travel and conduct on-site inspections
safely within the context of fluid work locations. This situation
presents complexity for many firms in terms of planning and deploying
resources. Even with increased availability of vaccines, FINRA
understands that many firm personnel are still working at least part
time from alternative work locations (e.g., private residences), while
taking incremental steps to resume in-person activities in some fashion
amid the current environment. With these considerations alone, FINRA
believes there is a continued need for temporary relief beyond December
31, 2022.
    FINRA has also filed with the Commission File No. SR-FINRA-2022-
021, a proposed rule change to adopt a voluntary, remote inspections
pilot program that is currently pending Commission review. The review
period may extend well into 2023.\15\ Given the potential length of
that review period, and the pilot program's significant planning
requirements and varying limitations applicable to specific firms and
office locations, FINRA believes that firms that intend to participate
in the pilot program, if approved, will need a significant number of
months to prepare appropriately for the pilot program. Moreover,
further FINRA guidance may be needed to guide implementation in various
circumstances.\16\ Firms that are not eligible, or do not intend, to
participate in the pilot program, if approved, will also need the time
to make any operational adjustments to schedule and conduct the on-site
component of their upcoming inspections once Rule 3110.17 expires on
the effective date of the pilot program, which could come before
December 31, 2023. For these reasons, and to avoid overlapping
provisions, under the proposed rule change herein, temporary Rule
3110.17 would expire on the earlier of the effective date of the pilot
program proposed in File No. SR-FINRA-2022-021 or December 31,
2023.\17\ If the Pilot Proposal is not approved, member firms should
use the time provided in proposed Rule 3110.17 to prepare to fulfill
their Rule 3110(c) obligations through on-site inspections of their
offices and locations.\18\
---------------------------------------------------------------------------

    \15\ On July 28, 2022, FINRA filed a proposed rule change to
adopt proposed Supplementary Material .18 under Rule 3110 that would
set forth the terms of a voluntary, three-year remote inspections
pilot program to allow member firms to elect to fulfill their
obligation under Rule 3110(c) by conducting inspections of some or
all branch offices and locations remotely without an on-site visit
to such office or location. See Securities Exchange Act Release No.
95452 (August 9, 2022), 87 FR 50144 (August 15, 2022) (Notice of
Filing of File No. SR-FINRA-2022-021) (``Pilot Proposal''). The
Pilot Proposal is currently pending Commission review and under
Section 19(b)(2) of the Exchange Act, the last day for the
Commission to issue an order of approval or disapproval of File No.
SR-FINRA-2022-021 is April 12, 2023. See 15 U.S.C. 78s(b)(2).
    \16\ As part of the implementation of the remote inspections
pilot program, FINRA intends to publish a Regulatory Notice or other
guidance about the operational aspects of the pilot program.
    \17\ Proposed Rule 3110.18 would expressly provide that if Rule
3110.17 has not already expired by its own terms, it would
automatically sunset on the effective date of the pilot program. See
Pilot Proposal.
    \18\ See note 5, supra.
---------------------------------------------------------------------------

    In sum, proposed Rule 3110.17 would avoid a potential lapse in the
temporary relief while challenges from COVID-19 persist, provide firms
regulatory continuity in meeting their inspection obligations during
the remaining Commission review period of the Pilot Proposal, and allow
firms time to adapt to the pilot program, if approved, and prepare for
conducting on-site inspections, as applicable.
    FINRA is not proposing to amend the other conditions of the
temporary rule. The current conditions of the supplementary material
for firms that elect to conduct remote inspections would remain
unchanged: such firms must amend or supplement their written
supervisory procedures for remote inspections, use remote inspections
as part of an effective supervisory system, and maintain the required
documentation. FINRA continues to believe this temporary remote
inspection option is a reasonable alternative to provide to firms to
fulfill their Rule 3110(c) obligations under current conditions while
the Commission considers the Pilot Proposal. This extension is designed
to maintain the investor protection objectives of the inspection
requirements under these circumstances. Firms should consider whether,
under their particular operating conditions, reliance on remote
inspections would be reasonable under the circumstances. For example,
firms with offices that are open to the public or that are otherwise
doing business as usual should consider whether some in-person
inspections would be feasible and add value to the firms' supervisory
program.
    FINRA has filed the proposed rule change for immediate
effectiveness. FINRA is proposing to make the proposed rule change
operative on January 1, 2023.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\19\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. In recognition of the ongoing impact of COVID-19 on
performing the on-site inspection component of Rule 3110(c), the
proposed rule change is intended to continue providing firms a
temporary regulatory option to conduct inspections of offices and
locations remotely during calendar year 2023. This temporary proposed
supplementary material does not relieve firms from meeting the core
regulatory obligation to establish and maintain a system to supervise
the activities of each associated person that is reasonably designed to
achieve compliance with applicable securities laws and regulations, and
with applicable FINRA rules that directly serve investor protection.
With the ongoing staffing challenges resulting from the lingering
COVID-19 pandemic, FINRA believes that the proposed rule change
provides sensibly tailored relief, while continuing to serve and
promote the protection of investors and the public interest. In
addition, the extended time would give firms clarity around their Rule
3110(c) inspection obligations pending the Commission's review of the
Pilot Proposal.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. The potential economic impacts
of Rule 3110.17 as described in File No. SR-FINRA-2020-040 continue to
have applicability to the proposed rule change herein. The proposed
rule change would extend the temporary relief that provides firms with
the option to fulfill their inspection obligations remotely. The
proposed extension would include calendar year 2023 inspection
obligations through the earlier of the effective date of the pilot
program proposed in File No. SR-FINRA-2022-021, if approved, or
December 31, 2023 within the scope of the supplementary material
without making substantive changes to the other aspects of the
provision. In addition, the proposed temporary extension would avoid a
potential lapse in temporary relief while the Pilot Proposal is pending
Commission action. Further, the

proposed extension would provide regulatory certainty while firms
continue to manage health and safety concerns, work absences, and the
transition to new workforce arrangements. FINRA believes that this
limited extension in temporary relief, together with the requirements
for using the temporary relief in Rule 3110.17, would not diminish
investor protection.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \20\ and Rule 19b-
4(f)(6) thereunder.\21\
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78s(b)(3)(A).
    \21\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-FINRA-2022-030 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2022-030. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of FINRA. All comments received will be
posted without change. Persons submitting comments are cautioned that
we do not redact or edit personal identifying information from comment
submissions.
    You should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-FINRA-2022-030
and should be submitted on or before December 1, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
---------------------------------------------------------------------------

    \22\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-24509 Filed 11-9-22; 8:45 am]
BILLING CODE 8011-01-P


•
All food sent into the country for the personal consumption of the recipient and not for
business use or redistribution;
•
Gifts arriving in the United States from one individual to another in a business setting;
and
•
Consumer-to-consumer shipments.
Some comments state that the requirement to provide the manufacturer’s registration
number in the prior notice is overly burdensome and unreasonable for some segments of the food
industry.  The comments suggest that there are numerous legitimate reasons that food companies
may seek to import food products from manufacturers whose registration number is unknown or
which are not required to register with FDA.
Other comments recommend alternatives to the requirement to submit the manufacturer’s
registration number.  The most commonly recommended alternative to submission of the
manufacturer’s registration number is to allow submitters to identify the manufacturer by
providing the name and address of the facility with an accompanying reason as to why the

222
registration number was not submitted.  One comment specifically recommends a drop-down
menu that allows the submitter to explain the reason for the lack of a registration number, such as
"product was not obtained from the manufacturer."  The comment reasons that this optional
approach allows FDA to continue to require registration numbers, but does not per se invalidate a
prior notice based on the absence of this single piece of information.  Another comment suggests
that the submitter affirm that it believes, to the best of its knowledge, that the manufacturer is
registered with FDA.  One comment recommends that only the manufacturer’s name for a "gray
market" food should be sufficient for the prior notice when the submitter does not know the
manufacturer’s registration number.
Another comment asserts that FDA must consider alternative means for ensuring that all
facilities subject to the Registration of Food Facilities Rule (21 CFR part 1, subpart H) have an
updated registration on file with FDA that has been verified.  The comment further suggests that
taking such action will allow the FDA to ensure that the regulations are not implemented in a
manner that prevents the lawful import of safe and healthy food products based solely upon the
unavailability of the confidential facility registration number.  Several comments assert that
confirmation that a facility is registered can be made without obtaining the registration number
of the facility.
One comment states that, though FDA has indicated that it wants the new facility
registration requirement to be enforced through the prior notice regime, enforcement can be
accomplished without requiring that the facility registration numbers be included in the prior
notice.  With the name and address of the manufacturer included, FDA can look up the
manufacturer in its database of registered manufacturers.  If the manufacturer has not registered,
then the FDA could deny entry to the articles of food in question.  The manufacturers therefore

223
already have a strong incentive to register with the FDA, since that is the only way their products
can gain entry into the United States.
Other comments suggest inspection of a food shipment to ensure its safety when the prior
notice submission lacks the required registration number, rather than refusal of that food as an
acceptable alternative.  The comments state that this approach will avoid situations where
shipments are rejected while still preserving FDA’s regulatory discretion.  Another comment
states that importers who obtain food from parties other than the original food manufacturers are
willing to bear the burden of increased inspections when they do not provide a manufacturer’s
registration number in the prior notice.  Other comments agree that the manufacturer’s
registration number should be required in prior notice submissions, but that the prior notice
should not be deemed inadequate (i.e., the food should not be refused under 801(m)) if the
manufacturer is identified by name and address of the facility and a reason for lack of submission
of the manufacturer’s registration number is provided.
Another comment suggests that the final rule should be amended to provide that the prior
notice only need to include such information about the manufacturers of older vintage wines that
is readily available to the importer, together with registration numbers for all persons who have
owned the wine and all facilities that have stored the wine over the preceding 2 years.
One comment suggests that FDA permit the importation of quality assurance samples that
will be used for taste testing or quality control that includes human consumption without the
facility registration number of the foreign manufacturer or processor. The comment further
suggests that in lieu of the registration number, the prior notice should include the
manufacturer’s name and location along with the identification of the person sending the
samples.

224
While most comments state that the name and address of the manufacturer could be
submitted in prior notice, one comment states that re-sellers will not normally supply the name of
their supplier or the name of the manufacturer of a particular product to their customers.  The
comment asserts that supplying the name of the manufacturer would allow that customer to
circumvent the re-seller and attempt to make direct contact with the supplier or manufacturer,
thus taking business away from the re-seller.  Another comment states that if only the name of
the manufacturer is submitted in a prior notice, the prior notice should not be considered
inadequate.
Other comments support requiring the registration number of the original processor on
prior notice submissions, particularly when a third-party is exporting the product to the United
States.  One comment further recommends that FDA should revise its rules regarding the use of
registration numbers in general, and in the prior notice rule in particular, to protect legitimate
buyers and distributors from unauthorized “gray market” imports. Several comments suggest
that the manufacturer’s registration number should be required and that only the registration
number be submitted, not the name and country.  Additionally, some comments suggest that if
manufacturer and facility registration numbers are provided and the numbers provided are
specific to a particular facility location, the requirement to complete the address information
should be removed to avoid duplication of information.
(Response) To effectively implement the prior notice and registration provisions in the
Bioterrorism Act, the final rule requires the registration number of the manufacturer or, if the
registration number is not provided, the facility’s full address and reason the registration is not
provided.  Reasons for not providing a registration number include, for example, the
manufacturing facility is out of business; the manufacturing facility is a private residence and

225
thus is not a "facility" for the purposes of the registration requirements; and the submitter is
unable to determine the registration number of the manufacturing facility.
Matching of facilities is vital for making an initial assessment on the accuracy of the prior
notice; assessing the risk of the associated article of food based on the associated manufacturing
facility, its operations, and history of importations; and verifying registration status.  Without the
registration number, PNC reviewers have to conduct this matching using the name and address
submitted in a prior notice.  Due to the potential for human error during data input or deviations
in the spelling or format of a facility’s name, address or city, FDA may incorrectly think it has
found a match between the facility described in the prior notice and a facility in the registration
database.  Similarly, the facility described in the prior notice may be close, but not exact, to
several facilities listed in the registration database, causing uncertainty as to which, if any, is the
correct match.  This is complicated by the fact that the manufacturing facility submitted as part
of prior notice might not be registered.  At best this matching process may take significantly
longer (depending on the number of manufacturers, products, and other factors involved),
impeding FDA’s ability to complete its review within the prior notice timeframes.  At worst, a
facility mismatch will result in FDA conducting its risk assessment based on incorrect
information.
The information provided in a registration thus enables FDA to better assess risk of the
product itself, as it gives the PNC more information upon which to base its assessment.  PNC
reviewers use the registration information to verify whether the articles of food in the shipment
match the food product categories that the owner, operator, or agent-in-charge of the facility
listed in the site-specific facility’s registration with FDA.  The registration information also
provides alternate names for a facility, lists the parent company and subsidiaries of the facility,

226
verifies addresses, and provides the identity of the officers of the facility and/or their U.S.
Agents.  This additional information may identify potential terrorist threats (e.g., a facility and/or
facility official has ties with a terrorist organization). Not providing the registration number in a
prior notice leads to prolonged or incomplete searches, which in turn could lead to additional
cargo delays or examinations at the port of arrival as the PNC completes its intensive review (see
earlier discussion under timeframes). We also note that registered facilities generally do not
make their registration numbers public, so they generally have to be obtained directly from the
manufacturer or its designee during the importation process as part of completing a prior notice.
Thus it is harder to falsify registration information than the facility’s name and address, deterring
the submission of false manufacturer identification information.
In some cases, the registration number of the manufacturer is not available to the
submitter, and therefore, we have revised the rule to provide an alternate means for satisfying the
requirement to provide the identity of the site-specific manufacturer in prior notices.  For
purposes of the prior notice final rule, the identity of the manufacturer is the name of the
manufacturer and either: (1) The registration number, city, and country of the manufacturer or
(2) both the full address of the manufacturer and the reason the registration number is not
provided (see § 1.281(a)(6), (b)(5), (c)(6)).  One of the following reasons may be submitted
when no manufacturer registration number is provided:
•
Situations where the facility is out of business, as stated in § 1.235(a);
•
Private residence, as stated in § 1.227(b)(2);
•
The facility is a restaurant, as defined in § 1.227(b)(10), and qualifies for the
restaurant exemption in § 1.226(d);

227
•
The facility is a retail food establishment, as defined in § 1.227(b)(11), and
qualifies for the retail food establishment exemption in § 1.226(c);
•
The facility is a non-processing fishing vessel, as stated in § 1.226(f);
•
Non-bottled drinking water collection and distribution establishment, as stated in
§ 1.227(b)(2);
•
The manufacturer satisfies the definition of “farm” in § 1.227(b)(3), and qualifies
for the farm exemption in § 1.226(b); or
•
The submitter is unable to determine the registration number of the manufacturer.
The full address of the manufacturer has been provided by the submitter.
The Prior Notice Final Rule Draft CPG that is announced elsewhere in this issue of the
FEDERAL REGISTER lists these reasons to use when the registration number is not provided
and describes our proposed enforcement policies.
As discussed previously, without the registration number, it will be more difficult and/or
may take more time for us to verify the identity of the manufacturing facility and its registration
status and to determine whether the article of food is subject to being held under section 801(l) of
the act.  Thus, it is in the interest of the parties involved in the import to provide the
manufacturer’s name and registration number, and not simply the manufacturer’s name and full
address, since the registration number will help us process the shipment more expeditiously.  The
submitter should exercise a reasonable amount of effort to obtain and provide the registration
number before using the reason “the submitter is unable to determine the registration number of
the manufacturer.
FDA does not agree with the comments asserting that the registration number is sufficient
by itself to “identify” a facility in a prior notice submission.  The additional information is

228
needed to verify that the registration number, which is comprised of eleven digits, is accurate.
Without additional information, there is a significant possibility of typographical errors, leading
to misidentification of facilities, which could lead to foods being stopped at the port for
inadequate prior notice and registration.  There also is the possibility of someone entering data in
an attempt to “guess” at a registration number.  Having identifying information in addition to the
registration number helps prevent such guessing.  Having this confirmatory information also
allows us to notify submitters of a mismatch before the prior notice is accepted and confirmed
for review, which allows them to correct any inadvertent errors before the food arrives at the
port, where it otherwise may be subject to refusal for an inadequate (inaccurate) prior notice.
If the prior notice does not contain either the manufacturer’s registration number or the
reason and name and full address, the food is subject to refusal of admission under section
801(m)(1) of the act for failure to provide adequate prior notice, as the identity of the
manufacturer is incomplete.  The food also may be subject to a hold under section 801(l) of the
act if the food is from a foreign manufacturer that is not registered under section 415 of the act.
In response to comments from those who are importing food from a facility that is not
registered because food manufactured by it is not intended to be consumed in the United States,
FDA notes that these shipments are subject to hold under 801(l) of the act.  Under section 801(l)
of the act, food is subject to being held if it is imported or offered for import into the United
States and it is from a foreign facility that has not registered.  This provision applies regardless of
whether the food was intended for consumption in the United States at the time it was
manufactured, for example where an article of food is made in Country X for consumption in
Country X, but is purchased by a third party who re-labels the product for import and resale in
the United States.

229
(Comments) One comment recommends that inter-company gifts be exempt from the
requirement to provide the manufacturer’s registration number on the prior notice because these
items have no commercial value and are sent as business gifts.  The comment suggests that FDA
use the same approach for business and non-business gifts, by allowing a listing of the
manufacturer’s name and address as it appears on the product’s label.
(Response) The provisions in the final rule regarding the registration number are being
revised, and these revised provisions apply to both business and non-business shipments.  The
final rule no longer allows for submission of the name and address as it appears on the label in
any situation.  However, the rule also is being changed such that the submitter may submit either
the manufacturer's registration number, city, and country or both the manufacturer's full address
and the reason why the registration number is not provided.
d. Questions seeking clarification.
i. Designation of grower. (Comments) Two comments state that they are exempt from
the registration requirements because they are farms; however, they want guidance regarding the
steps these farms should follow to ensure that their products move through the prior notice
system without delays at the port.
(Response) If the article of food is no longer in its natural state, such that the identity of
the manufacturer is required, the submitter can submit a reason for why the registration number
was not provided; i.e., facility is a grower, meets farm exemption.  These reasons also are listed
in the Prior Notice Final Rule Draft CPG announced elsewhere in this issue of the FEDERAL
REGISTER.  If the article of food is in its natural state, the identity of the manufacturer is not
required and the systems will know that they do not need to verify the manufacturing facility’s
registration status.

230
ii. Manufacturer cancels registration. (Comments) A comment asks what designation is
appropriate for the scenario where at the time of production the manufacturing/processing
facility was legitimately registered with the FDA, but cancelled its registration prior to the
importer submitting prior notice.
(Response) If the manufacturing facility still is operational, but chooses to cancel its
registration with FDA, then the food from this facility is subject to refusal under 801(l) of the
act.  As stated therein, “If an article of food is being imported or offered for import into the
United States, and such article is from a foreign facility for which a registration has not been
submitted to [FDA], such article shall be held at the port of entry for the article, and may not be
delivered to the importer, owner, or consignee of the article, until the foreign facility is so
registered.”  If the facility has canceled its registration because it has gone out of business, then
this reason may be entered on the prior notice.
iii. Identity of Manufacturer for Samples. (Comments) One comment states that there are
some circumstances involving market survey and consumer complaint samples where the
manufacturing facility is unknown to the submitter of prior notice and the manufacturing facility
may not have a registration number because it does not do business in the United States.  One
comment provides the example of when shoppers are hired to collect company trademark
products, package these according to company-established protocol, enclose purchase
information and ship these to designated laboratories in the United States. and the shoppers often
have no way of knowing the identity of the specific manufacturing facility.  One comment states
that it is not likely that a manufacturer’s registration number would be available for competitive
product samples and for finished product samples used for evaluation purposes, as well as for
articles used for research and development purposes.  The comment states that the registration

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number does not fall under the Freedom of Information Act and in some cases, the
manufacturer’s facility may not be required to register since the article of food was not intended
for consumption in the United States.  Another comment provides the example of when a
consumer expresses a concern about either the quality or safety of a purchased food, and the
consumer is instructed to ship that product to the U.S.-based franchise company laboratory for a
timely analytical assessment.
(Response) We have revised the final rule such that the identity of the manufacturer must
include the name of the manufacturer and either the registration number, city, and country of the
manufacturer or both the full address of the manufacturer and the reason the registration number
is not provided.  Relevant to these comments, one of the reasons for not providing the
registration number is that the submitter is unable to determine it.  However, as described above,
if the article of food is from an unregistered facility, it is subject to being held under section
801(l) of the act.  Moreover, without the registration number, it will be more difficult and/or may
take more time for FDA to verify the identity of the manufacturing facility and its registration
status. As a result, the food may be delayed until the verification is completed.
While the final rule requires prior notice, including the identity of the manufacturer, for
shipments of samples, under the enforcement policy proposed in the Prior Notice Final Rule
Draft CPG, FDA and CBP should typically consider not taking any regulatory action with
respect to prior notice violations when an article of food is imported or offered for import for
quality assurance, research or analysis purposes only, not for human or animal consumption
without prior notice.

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iv. U.S. manufacturer of product being imported. (Comments) Two comments express
concern that FDA would reject a prior notice for imported food that contains a U.S.
manufacturing facility and that facility’s registration number.
(Response) Both ABI/ACS and PNSI accept the identity of a manufacturing facility from
any internationally recognized country designation, including the United States.  FDA recognizes
that some food imported into the U.S. is manufactured in the U.S., exported, and then re-
imported.  Prior notice applies to these articles of food and identification of the U.S. facility as
the manufacturer is correct.
v. Require manufacturer to reveal or conceal the registration number.  (Comments) Two
comments recommend that FDA compel manufacturers to divulge their food facility registration
numbers upon inquiry.  Another comment requests that FDA issue guidance stating that: FDA
does not require the registration number on commercial documents; the inclusion of a
registration number on commercial documents will not facilitate clearance by CBP or FDA of
the shipment; and FDA recommends that companies reveal this confidential information once
only in a formal letter and ensure by all possible means that their customer (e.g., distributor,
importer, or customs broker) also respect the confidentiality of this information.  One comment
cautions about reported abusive and misleading declaration of a registration number in a prior
notice for shipments that are unconnected with the food facility that actually owns that
registration number.  Another comment suggests that FDA should revise both the prior notice
and registration rules to clarify that those doing business with the owner of a facility should not
and have no reason to demand the facility registration number.
Several comments suggest that FDA provide a means for importers and others to verify a
facility’s registration, even if such verification does not disclose any information beyond

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affirmation or denial.  One comment suggests that FDA compare Manufacturer Identity (MID)
data submitted through ABI/ACS to the FDA Food Facility Registration database and notify the
transmitter of a MID mismatch while keeping actual registration information secure.  The
comment reasons that this process would give the submitter and transmitter of a prior notice a
noncompliance alert and also would alert the agency of possible additional intensive review
requirements even before the prior notice submission has been completed.  Another comment
encourages the agency to allow American importers to query a database that would do nothing
more than confirm whether the details provided are accurate.  Another comment suggests that
FDA make the registration database available to authorized customs brokers only.
(Response) FDA does not intend to direct registered food facilities to divulge their
registration numbers on documents or upon request.  However, FDA does agree that guidance
regarding divulging registration numbers and prior notice submissions may help to clarify the
process, and provided this guidance in our “Guidance for Industry, Questions and Answers
Regarding Registration of Food Facilities Final Guidance” available at
http://www.cfsan.fda.gov/~dms/ffregui4.html.
vi. Exporting facility. (Comments) One comment requests that FDA accommodate the
importation of previously manufactured food products that were purchased at retail outlets
outside the United States and recommends that FDA require only the registration number of the
exporting facility and information identifying the company responsible for the product.  The
comment reasons that this information, along with other identity information required by prior
notice, should be sufficient for FDA and CBP to make risk decisions about a particular import.
(Response) FDA disagrees.  The Bioterrorism Act requires the identity of the
manufacturer as well as the shipper.  The identity of the shipper or the exporting facility alone is

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not sufficient to satisfy the requirements of the statute.  The facility that manufactured the food
must be identified.
vii. Food imported or offered for import for transshipment, storage, and export, or further
manipulation and export. In the IFR, a registration number is not required for a facility
associated with an article of food if the article is imported or offered for import for
transshipment, storage, and export, or further manipulation and export.  We have removed this
exception in the final rule because we have determined that section 801(m) of the act requires the
identity of the manufacturer for food imported or offered for import into the United States,
regardless of whether that food will be consumed in the United States.  Likewise, under section
801(l) of the act, food is subject to being held if it is imported or offered for import into the
United States and it is from a foreign facility that has not registered.  This provision applies even
if the food is not for consumption in the United States.  As noted previously, if the submitter is
unable to determine the registration number of the manufacturer, the submitter may provide a
reason along with the name and full address of the manufacturer.
(Final rule) Section 1.281(a)(6), (b)(5), and (c)(6) of the final rule requires for an article
of food that is no longer in its natural state, the identity of the manufacturer, as follows:  the
name of the manufacturer; and either the registration number, city, and country of the
manufacturer or both the full address of the manufacturer and the reason the registration number
is not provided.
8. The Grower, if Known
The Bioterrorism Act requires the submission of the identity of the grower of the article,
if that identity is known within the specified period of time that notice is required to be provided.
Section 1.281(a)(7), (b)(6), and (c)(7) of the IFR requires for an article of food that is in its

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natural state, submission of the name and growing location address of the grower, if known.  If
the submitter does not know the identity of the grower or, if the article has been consolidated,
and the submitter does not know the identity of any of the growers, the submitter may provide
the name and address of the firm that has consolidated the articles of food from different growers
or different growing locations.
(Comments) One comment asks that the requirement to identify the grower not be
mandatory in the final rule and suggests exempting the growers and providing the information of
growers on a voluntary basis.  Another comment asserts that it is virtually impossible to identify
each grower once grain is commingled at the country elevator.
(Response) The Bioterrorism Act requires the identity of the grower, if known, in the
submission of prior notice.  Therefore, we cannot eliminate the requirement to provide the
identity of the grower in all cases, as suggested by the comment. If the identity of the grower is
not known at the time of submission of the prior notice, and the food has been consolidated, then
the submitter may, but is not required to, provide the name and address of the consolidator (§
1.281(a)(7), (b)(6), and (c)(7)).
(Comments) Another comment states that a single shipment of fresh fruit may represent
hundreds of growers, all of whom are known by the submitter of the prior notice.  The comment
asserts that requiring submission of an individual prior notice for each article represented by a
single grower seems unnecessarily burdensome.  The comment suggests that in lieu of requiring
identification of all known growers in the prior notice, the rule should require the submitter of
the prior notice to retain a complete list of growers and to make this list available to FDA for
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(Response) We do not agree.  Periodic access, inspection, and copying of a complete
listing of all growers of an article of food does not satisfy the requirement to identify the grower
of the article of food, if known, within the specified period of time that notice is required to be
provided.  FDA responded to a similar comment in the prior notice IFR and explained that FDA
does not agree that a list would satisfy the statutory requirement, as it would not tell FDA which
grower was associated with the particular article of food as envisioned by the statute (68 FR
58974 at 59006).  We affirm the view here.
(Comments) One comment requests that FDA reconsider the requirement to submit the
names of multiple growers, if known, in the prior notice.   The comment notes that submitters of
prior notices must provide separate notices for each grower in the case of consolidated shipments
(if the growers are known), which it asserts is onerous and costly for exporters of consolidated
shipments of horticulture products.  The comment believes that the proposed recordkeeping rules
will cause the names of the growers to be recorded and available and the prior notice information
is a duplication of effort.  The comment asks that, for consolidated shipments, FDA permit the
submission of one prior notice providing the name of the consolidator or one notice with the
names of all the growers.
(Response) FDA disagrees.  Adding the capability to accept a list of growers would add
considerable complexity to both the data entry software (PNSI and/or ABI) and the screening
programs.  FDA responded to a similar comment in the prior notice IFR and explained that FDA
does not agree that a list would satisfy the statutory requirement, as it would not tell FDA which
grower was associated with the particular article of food as envisioned by the statute (68 FR
58974 at 59006).  And as we explained in the previous response, periodic access, inspection, and
copying of a complete listing of all growers of an article of food does not satisfy the requirement

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to identify the grower of the article of food, if known, within the specified period of time that
notice is required to be provided.  FDA notes that users of PNSI can create a prior notice for one
grower, copy that prior notice, and edit just the grower information and the quantity and
packaging information, assuming the imports for each grower are distinctly packaged.
(Final rule) Section 1.281(a)(7), (b)(6), and (c)(7) of the final rule requires for an article
of food that is in its natural state, the submission of the name and growing location address of the
grower, if known.  If the submitter does not know the identity of the grower or, if the article has
been consolidated and the submitter does not know the identity of any of the growers, the name
and address of the firm that has consolidated the articles of food from different growers or
different growing locations may be submitted.
9. FDA Country of Production
The Bioterrorism Act requires the submission of the identity of the country from which
the article originates.  The IFR in § 1.281(a)(8), (b)(7) and (c)(8), requires that a prior notice
contain the FDA Country of Production of the article of food being imported or offered for
import into the United States.  As set out in the IFR definition at § 1.276(b)(4), the FDA Country
of Production is, for an article of food in its natural state, the country where the article of food
was grown, including harvested or collected and readied for shipment to the United States.  If,
however, an article of food is wild fish, including seafood, that was caught or harvested outside
the waters of the United States by a vessel that is not registered in the United States, the FDA
Country of Production is the country in which the vessel is registered.  For a food that is no
longer in its natural state, the FDA Country of Production is the country where the article of food
was made.  However, if an article of food is made from wild fish, including seafood, that was
made aboard a vessel, the FDA Country of Production is the country in which the vessel is

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registered.  The IFR also provides that the FDA Country of Production of food grown and
harvested or collected or made in a U.S. Territory is the United States.
(Comments) One comment asks what is required as the country of production in a case
where spirits are exported in bulk to a third-country for local bottling and subsequent export