[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Notices]
[Pages 50013-50015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19264]
[[Page 50013]]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS 2020-0031]
Mandatory Inspection of Egg Substitutes and Freeze-Dried Egg
Products Imported Into the United States
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: On October 29, 2020, the Food Safety and Inspection Service
(FSIS) published the final rule, ``Egg Products Inspection
Regulations,'' which, among other things, announced that FSIS would
begin exercising jurisdiction over plants that produce egg substitutes
and freeze-dried egg products on October 30, 2023. This notice provides
information to foreign countries that already export these products to
the United States, as well as countries interested in exporting these
products to the United States, about submitting their equivalence
documentation to FSIS so that the Agency can begin assessing their
eligibility before October 30, 2023.
DATES: Foreign countries currently exporting egg substitutes and/or
freeze-dried egg products to the U.S. without an egg products
inspection system equivalence determination by FSIS, as well as foreign
countries not exporting that are interested in exporting such products
to the United States under FSIS jurisdiction:
Must notify FSIS of their intention to export egg
substitutes and freeze-dried egg products to the United States
(Phase 1) by October 30, 2021.
Must submit a complete Self-Reporting Tool (SRT),
including supporting documentation that demonstrates how a country's
egg products inspection system achieves an equivalent level of
public health protection to FSIS' egg products inspection system
(Phase 2), by April 30, 2022.
Must have submitted complete SRT responses and
supporting documentation to FSIS, and FSIS must have determined that
the SRT submission demonstrates that the country maintains an
equivalent documented egg products inspection system to FSIS' egg
products inspection system (Phase 3) by October 30, 2023.
Foreign countries that currently maintain equivalent egg products
inspection systems to FSIS' inspection system for egg products
inspection (i.e., Canada and the Netherlands) must submit an updated
certified establishment list to include egg substitutes and/or freeze-
dried egg products product groups by October 1, 2023, if these
countries are currently exporting these products or wish to begin
exporting them to the United States after October 30, 2023.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant
Administrator, Office of Policy and Program Development, telephone
(202) 205-0495.
SUPPLEMENTARY INFORMATION: By October 30, 2023, foreign countries that
already export egg substitutes and freeze-dried egg products to the
United States and wish to continue doing so must have submitted their
equivalence documentation to FSIS, and FSIS must have determined that
the country maintains an equivalent documented egg products inspection
system to FSIS' egg products inspection system. If a country does not
submit the required documentation or FSIS has determined that the
country does not maintain an equivalent documented egg products
inspection system, the foreign country will not be eligible to export
egg substitutes and freeze-dried egg products to the U.S. after October
30, 2023. Foreign countries not exporting egg substitutes and freeze-
dried egg products that are interested in exporting such products to
the United States under FSIS jurisdiction will not be able to begin
exporting them until October 30,2023, after FSIS has determined that
the country maintains an equivalent documented egg products inspection
system.
On October 30, 2023, egg substitutes and freeze-dried egg products
will no longer be regulated by the U.S. Food and Drug Administration
(FDA) but instead by FSIS, as they will be recognized as egg products
under FSIS' jurisdiction, and FSIS will begin to enforce its
regulations regarding the inspection of domestically produced and
imported egg substitutes and freeze-dried egg products (85 FR 68640).
Egg substitutes are similar in formulation, if not identical in
some cases, to egg products. Their processing also is like other egg
products. The contamination risks associated with these types of
products also are identical. For these reasons, FSIS determined that
the processing of egg substitutes must take place within the framework
of FSIS' Hazard Analysis and Critical Control Point System and
Sanitation Standard Operating Procedures framework. Similarly, the food
safety risks associated with freeze-dried egg products are like those
associated with frozen egg products, as freeze-dried egg products are
pasteurized liquid egg products flash frozen and placed in a vacuum
chamber where ice particles are removed.
Foreign countries exporting egg substitutes and freeze-dried egg
products to the United States, or countries interested in doing so,
will need to demonstrate that their documented egg products inspection
systems are equivalent to the U.S. system. Foreign countries already
exporting egg substitute and freeze-dried egg products to the U.S. may
continue to export these products, provided they actively work with
FSIS while seeking an initial equivalence determination from the
Agency. If they do not submit the required documentation, they will
have to stop shipping such products to the United States. The FSIS
equivalency process is described fully on the FSIS website at: https://www.fsis.usda.gov/inspection/import-export/equivalence.
Under 9 CFR 590.910(a), whenever it is determined by the
Administrator that the system of egg products inspection maintained by
any foreign country is such that the egg products produced in such
country are processed, labeled, and packaged in accordance with, and
otherwise comply with, the standards of the Act and the regulations
including, but not limited to the sanitary, processing, facility, and
Government inspection requirements in 9 CFR 590.500 through 590.590,
notice of that fact will be given according to 9 CFR 590.910(b).
In determining whether a foreign country maintains an equivalent
egg products food safety inspection system, the Administrator will
review the inspection regulations of the foreign country to determine
how the inspection systems are administered in the foreign country.
After approval of the inspection system, the Administrator may, as
often and to the extent deemed necessary, authorize representatives of
the Department to review the foreign inspection system to determine
whether it is implemented in a manner equivalent to the U.S. inspection
system.
Once FSIS has determined that a foreign country maintains an
equivalent egg products food safety inspection system and is eligible
to export egg products to the United States, only establishments that
the country's central competent authority (CCA) has certified as
complying with the requirements equivalent to U.S. requirements would
be eligible to export egg substitutes and freeze-dried egg products to
the United States. To ensure that all foreign countries that export, or
wish to export, egg substitutes or freeze-dried egg products to the
U.S., FSIS is implementing a three-phase plan to assist countries in
demonstrating that
[[Page 50014]]
their documented egg products inspection systems are equivalent to the
U.S. system.
During Phase 1, foreign countries that are currently exporting egg
substitutes or freeze-dried egg products to the U.S. and do not
currently maintain an equivalence determination by FSIS or foreign
countries that are interested in exporting such products to the U.S.
under FSIS jurisdiction should notify FSIS by October 30, 2021, of
their desire to seek an initial equivalence determination for these
products. Foreign countries should submit an official notification by
email to FSIS' Office of International Coordination at
[email protected]. Foreign countries already exporting
such products to the United States will be permitted to continue to
export these products while seeking an initial equivalence
determination from FSIS. In response, FSIS will provide information on
how to report necessary information to FSIS through the SRT, which is a
questionnaire used by FSIS to assess whether a country maintains an
equivalent documented food safety inspection system.
During Phase 2, foreign countries are requested to submit a
complete SRT, including supporting documentation that demonstrates how
a country's egg products inspection system achieves an equivalent level
of public health protection to FSIS' egg products inspection system, no
later than April 30, 2022. FSIS will review the SRT responses and
supporting documentation to determine whether additional information is
needed from the country. If additional information is needed, FSIS will
follow-up with the appropriate CCAs to request additional information.
Also, during Phase 2, between April 30, 2022, and April 30, 2023,
foreign countries should address any requests for additional
information from FSIS and provide updated SRT responses and supporting
documentation. During Phases 1 and 2, FSIS will review the SRT
submissions and may ask foreign countries for additional information,
as needed.
During Phase 3, from April 30 to October 30, 2023, FSIS will
continue to review and assess SRT responses and request additional
information, if necessary. By the end of Phase 3, October 30, 2023,
foreign countries that wish to continue exporting egg substitutes and
freeze-dried egg products to the U.S. must have submitted complete SRT
responses and supporting documentation to FSIS, and FSIS must have
determined that the SRT submission demonstrates that the country
maintains an equivalent documented egg products inspection system to
FSIS' egg products inspection system. If the country does not submit
the required documentation or FSIS has determined that the country does
not maintain an equivalent documented egg products inspection system,
the foreign country will not be eligible to export egg substitutes and
freeze-dried egg products to the U.S. after October 30, 2023.
Based on its review of the information and documentation that the
country submits, FSIS will tentatively decide whether the foreign
country's egg products inspection system and requirements are
equivalent to FSIS', and if so, plan an onsite audit of the country's
egg products inspection system. If FSIS also tentatively finds the
foreign country's egg products inspection system equivalent based on
the audit, FSIS will advance the equivalence determination through the
Federal Register notice process announcing the results of the document
review and onsite audit, proposing to add the country to its list of
eligible exporting countries, and providing an opportunity for public
comment. After analysis of public comments, FSIS will publish a Federal
Register notice announcing its determination on the country's
eligibility and responding to comments.
If a country currently maintains an equivalence determination from
FSIS for their egg products inspection system, FSIS will request an
updated certified establishment list by October 1, 2023, to include
these product groups so that countries can continue to export these
products to the United States after October 30, 2023. These countries
are also required to meet all other requirements of the Egg Products
Final Rule.
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 website located at:
http://www.fsis.usda.gov/federal-register. FSIS will also announce and
provide a link to it 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 option to password protect their accounts.
USDA Nondiscrimination Statement
In accordance with Federal civil rights law and U.S. Department of
Agriculture (USDA) civil rights regulations and policies, the USDA, its
Agencies, offices, and employees, and institutions participating in or
administering USDA programs are prohibited from discriminating based on
race, color, national origin, religion, sex, gender identity (including
gender expression), sexual orientation, disability, age, marital
status, family/parental status, income derived from a public assistance
program, political beliefs, or reprisal or retaliation for prior civil
rights activity, in any program or activity conducted or funded by USDA
(not all bases apply to all programs). Remedies and complaint filing
deadlines vary by program or incident.
Persons with disabilities who require alternative means of
communication for program information (e.g., Braille, large print,
audiotape, American Sign Language, etc.) should contact the responsible
Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or
contact USDA through the Federal Relay Service at (800) 877-8339.
Additionally, program information may be made available in languages
other than English.
To file a program discrimination complaint, complete the USDA
Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and
at any USDA office or write a letter addressed to USDA and provide in
the letter all of the information requested in the form. To request a
copy of the complaint form, call (866) 632-9992. Submit your completed
form or letter to USDA by: (1) Mail: U.S. Department of Agriculture,
Office of the Assistant Secretary for Civil Rights, 1400 Independence
Avenue SW, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3)
email: [email protected].
[[Page 50015]]
USDA is an equal opportunity provider, employer, and lender.
Paul Kiecker,
Administrator.
[FR Doc. 2021-19264 Filed 9-3-21; 8:45 am]
BILLING CODE 3410-DM-P