[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