[Federal Register Volume 85, Number 186 (Thursday, September 24, 2020)]
[Notices]
[Pages 60126-60129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21061]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2020-0016]


Availability of FSIS Import Guidance

AGENCY: Food Safety and Inspection Service, Agriculture (USDA).

ACTION: Notice of availability and response to comments.

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SUMMARY: In July 2017, FSIS published and requested comment on guidance 
for importing meat, poultry, and egg products into the United States. 
FSIS is announcing updates to this guidance and responding to comments 
received on the guidance. FSIS intends for this guidance to help U.S. 
importers, customs brokers, official import inspection establishments, 
and other interested persons understand and comply with FSIS import 
requirements. The guidance represents current FSIS thinking, and FSIS 
will update it as necessary to reflect comments received and any 
additional information that becomes available.

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

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

SUPPLEMENTARY INFORMATION:

Background

    The U.S. Department of Agriculture's (USDA) Food Safety and 
Inspection Service (FSIS) is the public health regulatory agency 
responsible for ensuring that domestic and imported meat, poultry, and 
egg products are safe, wholesome, and correctly labeled and packaged. 
FSIS inspects imported meat, poultry, and egg products under the 
authority of 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) (15 U.S.C. 1031 et 
seq.). Imported meat, poultry, and egg products must originate from 
eligible countries and from establishments or plants (for egg products) 
that are certified to export to the United States (21 U.S.C. 620, 466, 
and 1046). A country becomes eligible following an equivalence 
determination process completed by FSIS in coordination with the 
country's central competent authority (CCA). Foreign establishments or 
plants become eligible when the CCA certifies to FSIS that the 
establishments or plants meet requirements that are equivalent to FSIS 
requirements. All imported shipments of meat, poultry, and egg products 
must be presented to FSIS for inspection, with certain exceptions, as 
detailed in the guidance (i.e., a meat, poultry, or dried egg products 
shipment that does not exceed 50 pounds, or a liquid egg products 
shipment that does not exceed

[[Page 60127]]

30 pounds, for personal consumption only).

Updated Guidance

    On July 7, 2017, FSIS announced the availability of and requested 
comments on import guidance that summarized existing requirements for 
importing meat, poultry, and egg products into the U.S. and best 
practices for complying with those requirements (82 FR 31549). FSIS has 
updated the guidance based on comments received. Specifically, FSIS 
revised and reorganized a section on industry supply chain best 
practices; clarified approaches to levels of reinspection; added 
information about generic labeling approvals, food defense, slaughter 
dates on import certification, and barcoding; and made minor editorial 
changes to improve the guidance's clarity.
    This guidance represents current FSIS thinking, and FSIS will 
update it as necessary to reflect comments received and any additional 
information that becomes available. The updated guidance is posted at: 
https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/guidelines.

Comments and Responses

    FSIS received public comments from one trade association and two 
non-profit consumer groups. The following is a summary of the comments 
and the Agency's responses.

Product Lot Grouping & Certification

    Comment: The trade association asked that FSIS use an updated FSIS 
import application and ``physical manifest'' as a cross-reference when 
lots on the foreign inspection certificate and import inspection 
application misalign.
    Response: FSIS regulations require that foreign inspection 
certificates accompany each consignment of meat, poultry, or egg 
products offered for import into the United States and thoroughly 
identify the product (by species, process category, number of units, 
lot weight, etc.) certified by the foreign CCA as meeting all 
applicable FSIS requirements (9 CFR 327.4, 381.197, 557.4, and 
590.915). Thus, the foreign inspection certificate is the primary 
lotting reference for FSIS import inspectors. FSIS acknowledges the 
importance of complete import documentation for meeting all commercial 
and government requirements, but the import inspection application and 
a ``physical manifest'' are not adequate to rectify misaligned lotting.

Barcoding

    Comment: A trade association requested that the guidance reference 
the use of barcodes as an alternative identifier when shipping marks 
are missing or illegible and recommended that the guidance include a 
link to FSIS instructions on this topic.
    Response: FSIS agrees with this recommendation. The use of barcodes 
is currently an option when shipping marks are missing or completely 
illegible and FSIS has updated the guidance to note this option. To use 
the barcode option, countries must first submit a barcoding plan to 
FSIS to be approved for this process, so that FSIS can verify that 
imported products meet requirements. FSIS is currently engaging with 
countries and industry to develop and verify alternative identification 
(e.g., barcode) processes. FSIS is also implementing a pilot to apply 
the official import mark of inspection to imported product (currently 
for raw meat shipments exported to the United States from participating 
establishments in Australia) using barcodes instead of shipping marks 
on shipping containers.

Level of Reinspection (LOR) Applicability

    Comment: The trade association requested clarification on whether 
levels of reinspection (LOR), such as normal, increased, or 
intensified, apply to lab sampling only, or other types of inspection 
(TOI) also (physical exams, container condition, etc.).
    Response: Normal, increased, and intensified LORs can apply to any 
TOI. FSIS clarified this in the guidance.

Sampling

    Comment: The trade association asked whether imported products 
shipped after a related shipment fails a specific lab analysis would be 
subject only to intensified sampling for the same lab analysis, or the 
full range of TOI (e.g., product exam, condition of container, 
sampling, etc.).
    Response: Future associated shipments are subject only to the 
specific TOI failed in the original shipment. FSIS has clarified this 
in the guidance.

Generic Labeling

    Comment: A trade association and non-profit consumer group 
requested guidance about how generic labeling approval (i.e., labeling 
that does not need to be submitted to FSIS for review) would be applied 
to imported shipments.
    Response: Any entity responsible for designing or modifying meat or 
poultry labels may use generic approval of labels, including foreign 
exporters and U.S. importers, provided the label is eligible for 
generic labeling approval. In August 2017, FSIS published a compliance 
guide on generic labeling to assist industry in realizing the 
efficiencies of generic labeling. The guideline is available at 
https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling. 
FSIS also held a webinar for trading partners, foreign 
exporters, and U.S. importers in February 2018 to provide guidance on 
generic labeling (https://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/newsletters/constituent-updates/archive/2018/ConstUpdate011218). 
FSIS updated the import guidance to indicate that 
the generic labeling approval process applies to labels from foreign 
establishments, provided the label is eligible for generic labeling 
approval.

Tray Packs and Palletized Shipments

    Comment: A non-profit consumer group requested information on 
labeling requirements for imported tray packs and single pallets in the 
guidance document, and a trade association requested that FSIS consider 
expanding its policy of permitting application of shipping marks to the 
outside of pallets in certain cases to include shipments destined for 
processing as an intact unit. The trade association noted that, 
currently, palletized, consumer-packaged, fully marked and labeled 
products may be presented with the shipping mark and shipping container 
label applied to the outside of the pallet, rather than to individual 
tray packs or cartons, when only one type and size of product is 
presented as a lot, and the entire pallet will be distributed to retail 
or the end user as an intact unit.
    Response: This proposal is currently under consideration within 
FSIS but is outside the scope of this guidance. Imported tray packs are 
subject to immediate container labeling requirements found in 9 CFR 
327.14. Pallets are subject to labeling requirements if the pallets 
themselves are the outside or shipping container (e.g., shrink-wrapped 
pallet) of the shipment (9 CFR 327.15, 9 CFR 301.2). Regarding an 
expansion of the policy allowing the shipping or identification mark 
and label on pallets of the products referenced above, FSIS is 
considering the proposal for the shipping or identification mark and 
label to be applied to the outside of pallets of product destined for 
further processing as an intact unit.

[[Page 60128]]

Cooked Meat/Poultry Requirements

    Comment: A non-profit consumer group requested that FSIS include 
requirements for imported cooked meat and poultry from countries with 
exotic animal disease outbreaks in the guidance document.
    Response: Animal disease restrictions are under the jurisdiction of 
the Animal and Plant Health Inspection Service (APHIS) and can be found 
in 9 CFR part 94. Since announcing the draft import guidance, FSIS has 
published a new Import Library on its website. The Import Library 
provides links to country-specific pages for equivalent countries that 
can export to the United States detailing the eligible species, process 
categories, product categories, and product groups the country can 
export. The information detailed on the country-specific pages aligns 
with the FSIS product categorization guide and the Public Health 
Information System (PHIS) (https://www.fsis.usda.gov/wps/wcm/connect/abbf595d-7fc7-4170-b7be-37f812882388/Product-Categorization.pdf?MOD=AJPERES).
    Each eligible country page will also list any applicable APHIS 
animal disease restrictions, and includes direct, disease-specific 
links to APHIS' website and regulations. FSIS has updated the import 
guidance to include reference to the Import Library, which can be found 
online at 
https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/eligible-countries-and-products.

Imported Carcasses

    Comment: A non-profit consumer group requested FSIS include 
requirements for reinspecting imported carcasses in the guidance 
document.
    Response: Section VI of FSIS Directive 9900.2, available at 
https://www.fsis.usda.gov/wps/wcm/connect/e262834a-80f7-4502-bf1d-1a79b03899cd/9900.2.pdf?MOD=AJPERES, 
includes FSIS inspection program 
personnel (IPP) instructions for reinspecting imported carcasses. FSIS 
did not update the import guidance with this information because this 
guidance is intended for importers and foreign countries, not FSIS 
inspection program personnel.

Prohibiting Imports of Beef Derived From Cattle Subject to Certain Pre-
Slaughter Restraints

    Comment: A non-profit consumer group requested that FSIS prohibit 
the import of beef from cattle slaughtered using ``shackle/hoist'' and 
``shackle/drag'' methods, which are not permitted in the United States, 
specifically from South American countries.
    Response: Prohibiting entry of a product derived from a specific 
method of slaughter is a matter of equivalence, not import inspection. 
Equivalence is the process of determining whether a country's food 
safety inspection system achieves FSIS's appropriate level of public 
health protection as applied domestically in the United States. 
Additionally, the foreign food safety inspection system is to provide 
standards equivalent to FSIS to ensure other non-food safety 
requirements (such as humane handling, accurate labeling, and assurance 
that meat, poultry, or egg products are not economically adulterated) 
are met.
    As part of the equivalence process, FSIS completes a review of a 
country's laws, regulations, policies, and procedures pertaining to its 
food safety inspection. This review includes assessment of humane 
handling and slaughter, animal disease restrictions, and postmortem 
inspection. FSIS assesses the supporting documents to determine whether 
each country's food safety inspection system provide standards 
equivalent to FSIS regarding these and other factors of inspection. If 
FSIS concludes that these documents support that the country maintains 
a food safety inspection system that provides an equivalent level of 
protection, then FSIS conducts an on-site verification audit of the 
country's food safety inspection system. The purpose of the audit is to 
verify that the inspection system is implementing its laws, 
regulations, policies, and procedures as described in its documents. 
Information on the equivalence process is available at: 
https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/Equivalence/equivalence-process-overview.
    At the time of this Notice, Argentina, Brazil, Chile, and Uruguay 
are South American countries that maintain equivalence with the United 
States for certain meat products. FSIS auditors have determined that 
slaughter establishments that produce eligible meat products in these 
countries comply with the animal welfare, humane slaughter, and 
postmortem inspection requirements of the government's requirements, 
which are equivalent to FSIS requirements.

FSIS Changes

    Based on further internal review, FSIS has updated the guidance as 
follows:
    Slaughter dates: FSIS added language to reflect that slaughter 
dates may be required on the official inspection certificate when FSIS 
has first determined that a country's system is equivalent to the 
United States, or FSIS reinstates a country's equivalence status.
    Reinspection failures and appeals: FSIS added language to clarify 
the existing policy on intensified rates of reinspection when a 
shipment fails reinspection, to align with current PHIS programming. 
FSIS also added a sub-section for establishment appeals of inspection 
decisions.
    Equivalence page: FSIS has updated links in the guidance to the 
current FSIS equivalence page.
    Food defense: FIS has added a section on food defense.
    Industry Supply Chain Best Practices: FSIS has expanded and revised 
the industry supply chain best practices section.
    Siluriformes: FSIS has added regulatory references for Siluriformes 
throughout the guidance.

Congressional Review Act

    Pursuant to the Congressional Review Act at 5 U.S.C. 801 et seq., 
the Office of Information and Regulatory Affairs has determined that 
this notice is not a ``major rule,'' as defined by 5 U.S.C. 804(2).

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication online 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 is able to provide 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

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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: [email protected].
    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 at Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2020-21061 Filed 9-23-20; 8:45 am]
BILLING CODE 3410-DM-P