[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Pages 83030-83034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28112]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2018-0034]


Availability of FSIS Guideline for Industry Response to Customer 
Complaints

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of an updated version of the guideline for industry on 
how to respond to customer complaints of meat and poultry products 
contaminated with foreign materials. FSIS originally published the 
guideline in March 2019. Additionally, FSIS is responding to comments 
received on the March 2019 guideline.

ADDRESSES: A downloadable version of the guideline is available to view 
and print at https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index. No hard copies of the 
guideline have been published.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant 
Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    The Food Safety and Inspection Service (FSIS) administers a 
regulatory program under the Federal Meat Inspection Act (FMIA) (21 
U.S.C. 601 et seq.), the Poultry Products Inspection Act (PPIA) (21 
U.S.C. 451 et seq.), and the Egg Products Inspection Act (EPIA) (21 
U.S.C. 1031 et seq.) to protect the health and welfare of consumers. 
The Agency is responsible for ensuring that meat, poultry, and egg 
products are safe, wholesome, and correctly labeled and packaged.

Updated Guideline

    On March 11, 2019, FSIS announced the availability of a guideline 
to assist all FSIS-regulated establishments that slaughter, or further 
process inspected meat and poultry products to develop and implement 
procedures for responding to customer complaints of adulterated and 
misbranded meat and poultry products (84 FR 8662).
    FSIS has updated the guideline based on comments received. 
Specifically, FSIS revised and reorganized the guideline to improve 
readability; further clarified that a customer complaint program is not 
required; included methods for establishments to demonstrate control of 
products; added information on when establishments must notify FSIS 
that adulterated or misbranded products have entered commerce; added 
and clarified when establishments are required to address foreign 
material contamination in their Hazard Analysis and Critical Control 
Point (HACCP) plan; and clarified applicable regulatory requirements 
for corrective actions, reassessments, and recall procedures.
    While FSIS specifically developed this document to address foreign 
material customer complaints, establishments can apply the information 
to other customer complaints of adulterated or misbranded products in 
commerce. FSIS encourages establishments that may receive customer 
complaints regarding adulterated or misbranded meat and poultry 
products to follow this guideline. This document does not present or 
describe any new regulatory requirements. This guideline represents 
current FSIS thinking, and FSIS will update it as necessary to reflect 
comments received and any additional information that becomes 
available.

Comments and Responses

    FSIS received public comments from six trade associations, a 
poultry products producer, a pork products producer, a consumer 
advocacy organization, a HACCP consulting group, and an equipment 
manufacturer. A summary of the comments and the Agency's responses 
follows:

Foreign Material Adulteration

    Comment: Several trade associations stated that the guidelines 
applied an overreaching and overly broad concept of the term 
``adulteration'' by suggesting that any amount of foreign material, 
regardless of size or nature, adulterates meat and poultry products. 
The comments asserted that not all contaminants are food safety hazards 
and that the guidelines should reflect a risk-based approach to foreign 
material adulteration, taking into account whether the foreign material 
would present a health hazard.
    Response: The FMIA and the PPIA (21 U.S.C. 601 and 453) and FSIS 
regulations (9 CFR 301.2, 381.1, and 531.1) state that the term 
``adulterated'' applies, among other circumstances, to meat or poultry 
products:

    --If it bears or contains any poisonous or deleterious substance 
which may render it injurious to health;
    --if it consists in whole or in part of any filthy, putrid, or 
decomposed substance or is for any other reason unsound, unhealthful, 
unwholesome, or otherwise unfit for human food;
    --if it has been prepared, packed, or held under insanitary 
conditions whereby it may have become contaminated with filth, or 
whereby it may have been rendered injurious to health.

    Thus, under the FMIA and PPIA and the regulations, the presence of 
foreign materials adulterates meat and poultry products. Examples of 
foreign materials found in meat and poultry products include: Glass or 
metal fragments, which are deleterious substances that may injure 
health; machinery pieces, such as rubber or plastic, which are filthy, 
or unwholesome, or unfit for food; or sand or rocks, which typically 
contaminate food products because of preparation under insanitary 
conditions. FSIS disagrees that the Agency's interpretation of 
``adulteration'' is overly broad.
    FSIS assesses the public health concern or hazard presented when a 
recall action is initiated for products adulterated with foreign 
materials. FSIS categorizes the recall as Class I (reasonable 
probability that the use of the products will cause serious, adverse

[[Page 83031]]

health consequences or death), Class II (remote probability of adverse 
health consequences from the use of the products), or Class III 
(products will not cause adverse health consequences). FSIS Directive 
8080.1, Recall of Meat and Poultry Products, provides further 
information on recall classifications: FSIS Directive 8080.1.
    In response to these comments and related concerns raised, FSIS 
intends to revise and update the recall directive to clarify recall 
classification issues and instructions to FSIS personnel concerning 
recalls as necessary. In addition, FSIS intends to review recalls of 
meat and poultry products associated with foreign materials over the 
past several years to determine whether the Agency should make 
additional changes to this guidance or instructions to inspection 
program personnel to prevent or reduce related recalls.
    Comment: One FSIS-regulated company comment agreed that the 
presence of any foreign object meets the definition of adulteration and 
requested that the Agency clarify that objects inherent to the product, 
such as bones and feathers, would not render the product adulterated.
    Response: Objects inherent to a product are not ``foreign 
material,'' however, the presence of these objects can render meat or 
poultry products adulterated. The FMIA and PPIA definition of 
``adulterated,'' states that, ``. . . in case the substance is not an 
added substance, such article shall not be considered adulterated under 
this clause if the quantity of such substance in or on such article 
does not ordinarily render it injurious to health'' (21 U.S.C. 
601(m)(1) and 453(g)(1)). Thus, for example, if the size and amount of 
bone in a product would present a health hazard, the product is 
adulterated. When bone or other materials inherent to products, such as 
feathers or hair, do not present a health hazard, they may make the 
products unwholesome or unfit for human food, and therefore, 
adulterated, depending on the amount of these materials and the nature 
of the products. For example, boneless skinless chicken breast with 
noticeable amounts of bone or feathers may be unwholesome and unfit for 
consumers.

Hazard Analysis and Critical Control Point (HACCP) Systems and Food 
Safety Hazards

    Comment: Several trade associations and the consulting group 
commented that not all foreign materials are food safety hazards, and 
therefore, do not have to be addressed in an establishment's HACCP 
system.
    Response: An establishment may not find in its hazard analysis that 
foreign material contamination is reasonably likely to occur in its 
meat or poultry products. Further, some foreign material contamination 
may not cause meat or poultry to be unsafe for human consumption. If 
establishments can support that foreign material contamination is not 
reasonably likely to occur, or if it has occurred, the contamination 
has not caused the products to be unsafe for human consumption, 
establishments would not need to address foreign material contamination 
in its HACCP plan.
    However, if direct product contamination or product adulteration 
has occurred, the establishment must address the event in the HACCP 
system (e.g., the HACCP plan, Sanitation Standard Operating Procedures 
(SOPs), and prerequisite programs) and take applicable corrective 
actions. If the presence of foreign material is a deviation from a 
critical limit, the establishment is required to take the corrective 
actions in the establishment's HACCP plan. If foreign material 
contamination has occurred, has caused products to become unsafe, and 
the establishment has not addressed the hazard in its HACCP plan, the 
establishment would be required to take corrective actions in 9 CFR 
417.3(b), which would include reassessing its HACCP plan to determine 
whether the establishment needs to address foreign materials in its 
HACCP plan. If the establishment has found that foreign material 
contamination has occurred but does not constitute a food safety 
hazard, the establishment would need to assess whether it needs to make 
changes to its Sanitation SOP (9 CFR 416.14 and 416.15). An 
establishment should address any foreign material contamination issues 
related to sanitation in its Sanitation SOP. FSIS recognizes there may 
be foreign material contamination not related to sanitation issues or 
public health hazards. Establishments may be able to support addressing 
those foreign material contamination issues in other prerequisite 
programs under the HACCP system.

HACCP Preshipment Review

    Comment: Many of the trade associations stated that the guideline 
expands the definition of a HACCP System to include any programs 
associated with a production lot, and that the expanded definition 
would impact the documents included in the preshipment review. The 
comments also stated that the preshipment review should only encompass 
corrective actions and documents related to monitoring and verification 
of critical control points (CCPs).
    Response: The HACCP system includes the HACCP plan and all 
prerequisite programs associated with the HACCP plan (78 FR 32184). The 
HACCP regulations (9 CFR 417.5(c)) state that, ``Prior to shipping 
product, the establishment shall review the records associated with the 
production of that product, documented in accordance with this 
section.'' This regulation encompasses all records and does not limit 
the preshipment review to only CCP and corrective action records. When 
an establishment completes a preshipment review, it indicates that the 
establishment takes full and final responsibility for applying its 
HACCP controls to the products that it has produced.

HACCP Reassessment

    Comment: Many trade associations requested clarification on when a 
HACCP plan reassessment is required. The consumer advocacy group 
commented that establishments should be compelled to reassess their 
HACCP plans to identify those points in production where there is a 
possibility of extraneous material contamination. One trade association 
commented that HACCP reassessment is only required and appropriate when 
the adulterant results from an unforeseen food safety hazard.
    Response: An establishment is required to reassess the HACCP plan 
whenever changes occur that could affect the hazard analysis or alter 
the HACCP plan (9 CFR 417.4(a)(3)(i)). For example, if there is an 
equipment change that could result in contaminated products if the 
equipment is not properly maintained. In addition, as is noted above, 
whenever an establishment determines an unforeseen hazard has occurred, 
it must perform a reassessment as part of the corrective actions to 
determine if the hazard should be incorporated into the HACCP plan 9 
CFR 417.3(b)(4)). Establishments are not required to reassess the HACCP 
plan after every customer complaint. For example, an establishment is 
not required to reassess its HACCP plan after receiving a customer 
complaint if:
    <bullet> The establishment determines that the complaint is not 
valid or the complaint is unsubstantiated;
    <bullet> The complaint concerns a hazard already addressed in the 
establishment's HACCP plan;
    <bullet> The complaint does not describe contamination that posed a 
risk to human health; or

[[Page 83032]]

    <bullet> The complaint does not concern a problem with the hazard 
analysis or HACCP plan, e.g., misbranding unrelated to allergens.
    When the establishment addresses foreign material contamination in 
its HACCP plan and a customer complaint represents a deviation from an 
existing critical limit, the establishment must perform corrective 
actions (9 CFR 417.3(a)) but is not required to perform a reassessment.
    FSIS does not agree that an additional requirement that 
establishments reassess their HACCP plans specifically for extraneous 
material is necessary.

Sanitation Standard Operating Procedures (SOPs) Corrective Actions

    Comment: One trade association requested more information on the 
regulatory requirements for Sanitation SOP corrective actions (9 CFR 
416.15) and recordkeeping requirements (9 CFR 416.16) if no food safety 
hazard exists.
    Response: The Sanitation SOP regulations (9 CFR 416.11-416.17) 
require that an establishment identify the procedures sufficient to 
prevent the direct contamination or adulteration of products (9 CFR 
416.12(a)). When an establishment's Sanitation SOPs fail to prevent 
adulteration of products, including contamination by foreign materials, 
it must take appropriate corrective actions, including appropriate 
reevaluation and modification of the Sanitation SOPs (9 CFR 416.15) and 
document those actions (9 CFR 416.16). An establishment must address 
the Sanitation SOP corrective actions and recordkeeping requirements, 
even when a food safety hazard does not exist in that product. FSIS 
Sanitation SOP regulations do not provide for an ``allowance'' of 
direct contamination that is acceptable, the establishment must 
identify the procedures to prevent direct contamination or adulteration 
of products.

``In-Commerce'' Clarification

    Comment: Many comments requested clarification on when adulterated 
products are considered ``in commerce'' and whether products on 
premises owned by the producing establishment, such as warehouses or 
other facilities, demonstrates that there is control of the products.
    Response: FSIS stated in the guideline that, in general, products 
are considered to be ``in commerce,'' or having ``entered commerce,'' 
when they have left the direct control of the producing establishment 
and are in distribution, freely moving to consignees and customers. 
FSIS does not want to limit an establishment's flexibility and 
innovation for moving products by providing a strict definition of 
``direct control.'' Common methods that establishments use to 
demonstrate that they are maintaining direct control include written 
procedures, programs, or agreements that describe their process for 
maintaining control. For example, an establishment may have physical 
control over products, through a company seal on a trailer or tamper 
evident tape on containers. Products may move between two 
establishments or facilities owned by the same corporation under direct 
control, provided the control is sufficiently documented and HACCP 
system decisions are consistent with the expressed control. The 
guideline was revised to include questions establishments can consider 
in determining if they have direct control and methods they can use to 
demonstrate control.

Reporting Adulterated Product in Commerce

    Comment: Several trade associations requested clarification of the 
timeframe for establishments to notify the FSIS District Office when 
learning or determining that adulterated products have entered 
commerce. Commenters questioned whether an establishment is required to 
notify the District Office as soon as it has learned or has reason to 
believe adulterated products have entered commerce or instead when the 
establishment has completed its investigation and has determined that 
adulterated products have entered commerce. One industry comment 
suggested that the District Office be required to respond to the 
establishment within a specific time limit and provide the 
establishment information concerning whether the issue has been 
resolved, is pending review, or has been passed to an FSIS recall 
committee. The commenter also suggested that the District Office be 
required to provide guidance on whether the establishment would be 
required to take corrective actions or reassess their HACCP plan under 
the HACCP regulations.
    Response: The notification regulation (9 CFR 418.2) requires an 
establishment to notify the District Office within 24 hours of learning 
or determining that an adulterated or misbranded meat or poultry 
product received by or originating from the establishment has entered 
commerce, if the establishment believes or has reason to believe this 
has happened. FSIS is not able to pinpoint a ``start time'' of the 24-
hours, since every case is different. In many cases, the establishment 
will learn of a complaint and need to investigate the validity. During 
the investigation, the point at which the establishment ``believes, or 
has reason to believe'' adulterated product has entered commerce is 
when the establishment must report the event within 24 hours. The 
investigation does not have to be completed before the establishment 
believes, or has reason to believe, that adulterated product entered 
commerce.
    The District Office will work with the establishment, but FSIS does 
not believe that providing detailed information will be necessary in 
all cases. District Offices will determine what information is 
appropriate and possible to provide to an establishment on a case-by-
case basis. Official establishments should be familiar enough with the 
regulatory requirements in 9 CFR parts 416 and 417 to determine when 
corrective actions are required, what actions will meet the regulatory 
requirements, when a reassessment is required, how a reassessment is 
documented, and when the establishment should implement recall 
procedures. FSIS has clarified reassessment, notification, and 
corrective action regulatory requirements in the updated guidance. 
Establishments can contact FSIS field personnel or headquarters 
personnel if they have additional questions about a specific situation. 
The Agency recognizes that establishments need timely communication 
with the District Office and will ensure this communication continues.
    Comment: A member of industry requested that FSIS clarify in the 
guideline what action domestic establishments should take if they 
shipped product adulterated by foreign material to a foreign country. 
The same commenter asked for clarification about what an establishment 
should do if they receive adulterated product from a foreign country.
    Response: Official establishments are required to notify the 
District Office if they ship or receive adulterated products (9 CFR 
418.2 and U.S.C. 612 and 459(b)). The notification requirement applies 
to domestic establishments that ship products to another country (i.e., 
export). FSIS has added language in the guideline in the 
``Responsibilities at the Producing Establishment'' section to clarify 
this requirement.

Isolated Events Versus Systemic Foreign Material Contamination

    Comment: Several trade associations stated that the guideline 
failed to address the difference between an isolated foreign material 
contamination event and systemic foreign material

[[Page 83033]]

contaminations. One commenter stated that reporting an isolated event, 
with no evidence of other product in commerce, is premature and serves 
little purpose. Another commenter proposed notification only when an 
isolated event posed a public health risk, or when there were two or 
more foreign contamination issues of a similar nature or on-going 
findings of the same root cause.
    Response: The notification requirement allows the Agency to quickly 
determine whether a recall action is necessary. If an establishment has 
evidence that the event is isolated, the establishment is still 
required to report the event to the District Office and should present 
this evidence to the District Office.

Recall Notification (9 CFR 418.2) and Notice of Receipt of Adulterated 
or Misbranded Product (FSIS Form 8140-1)

    Comment: Many commenters questioned whether Form 8140-1 was 
necessary, given the regulatory requirement of 9 CFR 418.2. Many 
comments also suggested that the notification process needed to be 
consolidated, streamlined, and standardized among District Offices. 
Many comments suggested that all District Offices have a designated 
email account posted on the FSIS web page so that establishments can 
report shipment or receipt of adulterated or misbranded products. A 
separate comment was submitted recommending that establishments utilize 
the Agency's Public Health Information System (PHIS)to report 
incidents.
    Response: FSIS is in the process of modernizing inspector reporting 
methods and replacing the paper-based reporting with electronic 
reporting in PHIS. FSIS is also developing an optional industry 
interface in PHIS that will provide a centralized location for 
establishments to report to the applicable District Office that they 
have shipped or received adulterated or misbranded products. 
Establishments may continue to notify the District Offices through 
traditional methods, such as phone calls, and each District Office 
lists a 24-hour phone number that is available for reporting listed at 
https://www.fsis.usda.gov/wps/portal/informational/districtoffices.

Consumer Complaint Program Requirement

    Comment: Many trade associations requested that the guideline 
clarify that there is no requirement that an establishment develop or 
implement a consumer complaint program and no requirement that a 
complaint handling program, if one exists, be incorporated into the 
HACCP plan or Sanitation SOPs. The consumer advocacy group commented 
that there should be a requirement for a consumer complaint program for 
all establishments.
    Response: The guideline has been revised to further clarify that a 
customer complaint program is not required and, if one is developed, 
there is no requirement to incorporate the program into the HACCP 
system.
    FSIS's regulatory requirements for HACCP (9 CFR part 417) and 
Sanitation SOPs (9 CFR part 416) address the requirements to prevent 
adulteration. As noted above, if changes occur that affect the hazard 
analysis or HACCP plan, including consumer complaints, or if hazardous 
foreign materials are found in the products and the HACCP plan does not 
address the hazard, the establishment is required to reassess the HACCP 
plan (9 CFR 417.4(a)(3)(i) and 417.4(b)) and make necessary changes to 
address the hazard. Based on the reassessment, the establishment may 
incorporate a new CCP into its HACCP plan to address foreign materials, 
or it may develop a prerequisite program (including the Sanitation SOP, 
as discussed below) to prevent the hazard that would be part of the 
HACCP system.
    FSIS regulations require that an establishment's Sanitation SOPs 
describe all procedures sufficient to prevent adulteration of products 
(9 CFR 416.12(a)). When Sanitation SOPs, which are prerequisite to the 
HACCP plan, fail to prevent adulteration of products through 
contamination with foreign materials, the establishment is required to 
take corrective actions (9 CFR 416.15). Corrective actions include 
ensuring appropriate disposition of products, restoring sanitary 
conditions, preventing the recurrence of direct contamination or 
adulteration of products, and evaluating and making necessary 
modification of the Sanitation SOPs to prevent future adulteration with 
foreign materials.

Pet Food

    Comment: One trade association stated that adulterated meat and 
poultry products may be diverted to the pet food industry, specifically 
dog and cat food. The commenter requested that the guideline state that 
FSIS does not allow or condone downgraded human food material that 
presents a health or safety risk be diverted to a by-product stream for 
use in pet food. The comment also requests a statement that any human 
food by-products, including adulterated human food processed at these 
facilities, is subject to FDA regulation under the Food Safety 
Modernization Act (FSMA) once it leaves the facility.
    Response: These comments are generally outside the scope of this 
guideline. Except for the fee-for-service program for certifying 
products for dog and cat food in 9 CFR part 355.29, FSIS does not 
inspect pet food or products intended for pet food. However, FSIS 
revised the guideline to include language recommending that FSIS-
inspected establishments communicate with pet food manufacturers before 
sending products to a pet food facility to ensure that the products are 
eligible under FDA requirements and is acceptable to the pet food 
manufacturer.

Rail Dust

    Comment: A comment from the equipment manufacturer stated rail dust 
and black specks are the most frequent causes of foreign material 
contamination and that the industry should switch to an oil-free 
contamination-free system.
    Response: FSIS regulations (9 CFR part 416) require an 
establishment's sanitation procedures to prevent direct contamination 
of products and for non-food contact surfaces to be cleaned as often as 
necessary to prevent insanitary conditions or the adulteration of 
products. The regulations provide inspected establishments flexibility 
to meet these regulatory requirements and most establishments do. 
Therefore, FSIS disagrees with the need to establish prescriptive, new 
requirements concerning sanitation systems.

Providing Flexibility

    Comment: Many trade associations expressed concern that the 
inflexible approach in the guideline could deter the implementation of 
new foreign material detection methods and encouraged FSIS to adopt 
policies that encourage establishments to identify and address non-
hazardous foreign material before an actual health risk is posed.
    Response: The guideline does not set up any new requirements or 
limit flexibility. The Agency agrees that establishments should be 
encouraged to identify and address non-hazardous foreign material 
before an actual health risk is posed. The changes and clarifications 
the Agency has made to the guidance should encourage establishments to 
develop policies and procedures to better address foreign material 
hazards.

Formatting and Editorial Comments

    Comment: Several comments made recommendations and suggestions for 
reorganizing, reformatting, and

[[Page 83034]]

clarifying the graphics and text in the guideline.
    Response: FSIS appreciates these recommendations and made the 
recommended changes when the suggestions did not conflict with FSIS 
policy.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of this publication available through 
the FSIS Constituent Update, which is used to provide information 
regarding FSIS policies, procedures, regulations, Federal Register 
notices, FSIS public meetings, and other types of information that 
could affect or would be of interest to our constituents and 
stakeholders. The Constituent Update is available on the FSIS web page. 
Through the web page, FSIS provides information to a much broader, more 
diverse audience. In addition, FSIS offers an email subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves and have the option to password protect 
their accounts.

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
    Fax: (202) 690-7442.
    Email: <a href="/cdn-cgi/l/email-protection#0c7c7e636b7e6d61226562786d67694c797f686d226b637a"><span class="__cf_email__" data-cfemail="acdcdec3cbdecdc182c5c2d8cdc7c9ecd9dfc8cd82cbc3da">[email protected]</span></a>.
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

    Done in Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2020-28112 Filed 12-18-20; 8:45 am]
BILLING CODE 3410-DM-P


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