[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]



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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.

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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

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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].

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    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