Notice2022-19894
Eligibility of Lithuania To Export Egg Products to the United States
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Published
September 15, 2022
Issuing agencies
Agriculture DepartmentFood Safety and Inspection Service
Abstract
FSIS is announcing that Lithuania is eligible to export egg products to the United States. FSIS has reviewed Lithuania's laws, regulations, and inspection system, as implemented, and has determined that Lithuania's egg products inspection system is equivalent to the food safety inspection system for egg products that the United States has established under the Egg Products Inspection Act (EPIA) and its implementing regulations. Therefore, egg products produced in certified Lithuanian establishments are eligible for export to the United States. All such products will be subject to reinspection at U.S. points-of- entry by FSIS inspectors.
Full Text
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<title>Federal Register, Volume 87 Issue 178 (Thursday, September 15, 2022)</title>
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[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56621-56624]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19894]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2021-0001]
Eligibility of Lithuania To Export Egg Products to the United
States
AGENCY: Food Safety and Inspection Service (FSIS), U.S. Department of
Agriculture (USDA).
ACTION: Notice and response to comments.
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SUMMARY: FSIS is announcing that Lithuania is eligible to export egg
products to the United States. FSIS has reviewed Lithuania's laws,
regulations, and inspection system, as implemented, and has determined
that Lithuania's egg products inspection system is equivalent to the
food safety inspection system for egg products that the United States
has established under the Egg Products Inspection Act (EPIA) and its
implementing regulations. Therefore, egg products produced in certified
Lithuanian establishments are eligible for export to the United States.
All such products will be subject to reinspection at U.S. points-of-
entry by FSIS inspectors.
DATES: Applicable: Lithuania's egg products eligible for import to the
United States will be added to the FSIS Import Library (<a href="https://www.fsis.usda.gov/inspection/import-export/import-export-library">https://www.fsis.usda.gov/inspection/import-export/import-export-library</a>) on
September 15, 2022. Lithuania will be eligible to export to the United
States egg products produced in the country on or after September 15,
2022.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant
Administrator, Office of Policy and Program Development, telephone
(202) 205-0495.
SUPPLEMENTARY INFORMATION:
Background
On December 28, 2021, FSIS published a notice in the Federal
Register (86 FR 73721) that announced that FSIS intended to add
Lithuania to the list of countries eligible to export egg products to
the United States. As explained in the notice, the EPIA prohibits the
importation of egg products capable of use as human food into the
United States unless they were processed under an approved inspection
system of the government of the foreign country of origin and are
labeled and packaged in accordance with, and otherwise comply with, the
standards of the EPIA and regulations issued thereunder applicable to
such articles within the United States (21 U.S.C. 1046(a)(2)). The
regulatory requirements for foreign countries to become eligible to
export egg products to the United States are provided in 9 CFR
590.910(a).
Section 590.910(a) requires a foreign country's inspection system
to be authorized by a legal authority that imposes requirements
equivalent to those of the United States, specifically with respect to
labeling, packaging, sanitation, processing, facility requirements, and
Government inspection. The foreign country's inspection system must
ensure that establishments preparing egg products for export to the
United States comply with requirements equivalent to those of the EPIA
and the regulations promulgated by FSIS under the authority of that
statute. The foreign country is required to certify establishments as
having met the required standards and to notify FSIS of those
establishments that are either certified as eligible to export to the
United States or removed from eligibility.
As part of the FSIS initial equivalence review process, FSIS
evaluated the country's food safety inspection system for egg products
to determine whether it is equivalent to FSIS', and therefore, eligible
to export egg products to the United States. This evaluation consisted
of two processes: A document review and an onsite review. The document
review is an evaluation of the laws, regulations, and other written
materials used by the country to affect its inspection program (9 CFR
327.2(a)(2)(iii), 381.196(a)(2)(iii), and 590.910(a)). The onsite
review is an FSIS audit to verify the implementation of the country's
food safety inspection system. These comprehensive processes are
described more fully on the FSIS website at <a href="https://www.fsis.usda.gov/inspection/import-export/equivalence">https://www.fsis.usda.gov/inspection/import-export/equivalence</a>.
FSIS regulations (9 CFR 590.910(b)) provide that a list of
countries eligible to export egg products to the United States be
maintained at <a href="https://www.fsis.usda.gov/inspection/import-export/import-export-library">https://www.fsis.usda.gov/inspection/import-export/import-export-library</a>. To verify that products imported into the United
States are not adulterated or misbranded, FSIS reinspects all product
imported under FSIS jurisdiction and samples a subset of those products
for pathogens and residues at points-of-entry before they enter U.S.
commerce.
Evaluation of the Lithuanian Egg Products Inspection System
FSIS explained in the December 28, 2021, Federal Register notice
that FSIS conducted an onsite audit from October 24 to November 2,
2016, to verify that Lithuania's State Food and Veterinary
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Service (SFVS), the central competent authority (CCA) in charge of food
inspection, effectively implemented an egg products inspection system
equivalent to that of the United States (86 FR 73721). Details
regarding that audit and subsequent actions resulting from it,
including a follow-up audit conducted from July 15 to July 24, 2019,
can be found in the December 28, 2021, notice. In the follow-up audit,
FSIS evaluated the corrective action plans and Lithuania's inspection
verification activities, based on the information Lithuania submitted,
and determined that Lithuania had satisfactorily addressed all the
audit findings and was able to meet FSIS requirements and equivalence
criteria related to all six components (86 FR 73721).
FSIS' Equivalence Determination
After considering the comments received on the notice, discussed
below, FSIS has concluded that Lithuania's egg products inspection
system is equivalent to the United States' inspection system for egg
products. FSIS has added Lithuania to its list of eligible countries to
export egg products to the United States on its website at: <a href="https://www.fsis.usda.gov/inspection/import-export/import-export-library">https://www.fsis.usda.gov/inspection/import-export/import-export-library</a>.
Lithuania is eligible to export to the United States egg products
produced in certified Lithuanian establishments produced on or after
September 15, 2022. FSIS maintains a country specific web page \1\ on
FSIS' website with a link to the country's certified establishments and
a list of the process categories, product categories, and the product
groups Lithuania is eligible to export to the United States. Although a
foreign country may be listed on FSIS' website as eligible to export
egg products to the United States, the exporting country's products
must also comply with all other applicable requirements of the United
States, including those of USDA's Animal and Plant Health Inspection
Service (APHIS). These requirements include restrictions under 9 CFR
part 94 of the APHIS regulations, which regulate the importation of egg
products from foreign countries into the United States to control the
spread of specific animal diseases. All egg products exported to the
United States from Lithuania will be subject to reinspection by FSIS at
United States points-of-entry for, but not limited to, transportation
damage, product and container defects, labeling, proper certification,
general condition, and accurate count. FSIS also will conduct other
types of reinspection activities, such as physical inspection of
products to ensure product safety and taking product samples for
laboratory analysis to detect any drug or chemical residues or
pathogens that may render the product unsafe or other violations that
would render the product economically adulterated. Products that pass
reinspection will be stamped with the official mark of inspection and
allowed to enter United States commerce. If a product does not meet
United States requirements, it will be refused entry and within 45 days
will have to be returned to the country of origin, destroyed, or
converted to animal food (subject to approval of the Food and Drug
Administration (FDA)), depending on the violation. The import
reinspection activities can be found on the FSIS website at: <a href="https://www.fsis.usda.gov/inspection/import-export/import-guidance">https://www.fsis.usda.gov/inspection/import-export/import-guidance</a>. Finally,
within one year of the publication date of this Federal Register
notice, FSIS intends to conduct an onsite audit of Lithuania's egg
products inspection system to verify ongoing equivalence. During the
audit, FSIS auditors will verify that Lithuania's CCA has implemented
its food safety inspection system as described in the Self-Reporting
Tool \2\ and supporting documentation. FSIS will audit government
offices, establishments, and laboratories to verify that the CCA has
implemented its inspection system as documented and verify that the
country's system of controls remains equivalent to the U.S. inspection
system.
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\1\ See: <a href="https://www.fsis.usda.gov/inspection/import-export/import-export-library/lithuania">https://www.fsis.usda.gov/inspection/import-export/import-export-library/lithuania</a>.
\2\ The Self-Reporting Tool (SRT) is a standardized
questionnaire that FSIS provides to foreign governments to gather
information that characterizes foreign inspection systems. Through
the SRT, FSIS collects information on practices and procedures in
six areas, known as equivalence components. The SRT template can be
found on the FSIS website at <a href="https://www.fsis.usda.gov/guidelines/2022-0003">https://www.fsis.usda.gov/guidelines/2022-0003</a>.
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Summary of Comments and Responses
FSIS received three comments in response to the notice, one from a
trade association representing U.S. egg farmers, one from a trade
association representing U.S. egg products producers, and one from an
individual. The two trade associations opposed the declaration of
equivalence for Lithuania for the reasons discussed below. The
individual asked about the importation of shell eggs from Lithuania.
Because this notice does not deal with the importation of shell eggs
from Lithuania, the comment is outside the scope of this notice and is
not addressed. The following is a brief summary of the relevant issues
raised in the comments and FSIS' responses.
Continuous Inspection
Comments: The trade association representing U.S. egg farmers and
the trade association representing U.S. egg products producers
questioned how FSIS will verify that continuous inspection, including
the inspection of shell eggs prior to breaking, will be provided in a
foreign egg products processing plant, as required by the EPIA. The
trade association representing U.S. egg products producers noted that
under the final rule ``Egg Products Inspection Regulations'' (85 FR
68640), ``continuous inspection'' was interpreted to provide for the
presence of inspectors at official plants at the same frequency that
meat and poultry processing establishments have inspectors, i.e., at
least once per production shift (daily inspection).
Response: FSIS will verify through Lithuania's (and other
countries') documented foreign inspection procedures submitted to FSIS
through the SRT and FSIS audits of the inspection systems that
``continuous inspection'' in foreign egg products establishments,
including the inspection of shell eggs prior to breaking, is conducted
by government inspectors who are present at the establishment at least
once per production shift.
Hazard Analysis and Critical Control Point (HACCP) Implementation
Comments: The trade association representing U.S. egg products
producers asked if equivalence procedures would be implemented in
Lithuania when the HACCP system requirements are implemented on October
31, 2022.
Response: FSIS has verified through Lithuania's SRT responses and
documentation reviews that Lithuania has a documented inspection
system, including requirements for Sanitation Performance Standards,
Sanitation Standard Operating Procedures and HACCP, equivalent to FSIS'
egg products inspection system under the new requirements of the final
egg rule (see 85 FR 68640). Implementation of these requirements will
be verified during the next audit.
Failure To Provide Government Oversight
Comments: The trade association representing U.S. egg producers
argued that Lithuania is unable to demonstrate adequate government
oversight of its egg products inspection system. According to the trade
association, the country may have shown that its laws, regulations,
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control programs, and procedures were equivalent to those of the United
States in 2014, but Lithuania was unable to demonstrate adequate
government oversight over its egg products inspection system in 2016
and 2019, considering the documentation reviews and onsite audits
conducted by FSIS. The commenter noted that in 2016, FSIS concluded
that the Lithuanian government was unable to demonstrate adequate
government oversight regarding implementation and verification of its
sanitation requirements. The commenter noted that in 2019, FSIS
conducted a second onsite audit and found that actions to correct the
2016 deficiencies in the egg products plant were implemented and
effective; however, the commenter further noted that in 2019, the
Agency found that Lithuania could not demonstrate adequate government
oversight regarding implementation and verification of its egg products
requirements.
Response: FSIS' equivalence review process for Lithuania was not
unique. Many countries submit multiple series of corrective actions to
FSIS and undergo more than one onsite audit before they are found
eligible to export meat, poultry, or egg products to the United States.
As FSIS explained in the December 28, 2021, notice, the Lithuanian
government addressed past concerns both with the egg products
inspection system and with other products that they are eligible to
export to the United States. The corrective actions provided indicated
that the country has addressed FSIS concerns (86 FR 73721). As is
stated above, FSIS will follow up with an audit of Lithuania's egg
products inspection system within one year of granting equivalence,
which is standard policy for all countries granted new equivalence.
Economic Impact Analysis
As explained above, FSIS is listing Lithuania as a country eligible
to export egg products to the United States. Given the limited market
in the United States for Lithuania's egg products and Lithuania's
projected low export volume, there is likely to be little, if any,
impact on the United States economy.
In comparison to the United States, Lithuania is a small egg and
egg products producer with limited capacity to export egg products.
Between 2015 and 2019, Lithuania had an annual average of 3.2 million
egg laying hens that produced 55,300 tons of eggs and imported 14,300
tons of eggs. During this same period, Lithuania consumed approximately
50,800 tons of eggs annually. The remaining eggs were exported as eggs
or egg products, mainly to the European Union, of which Lithuania is a
member. Of these exports, approximately 17.2 percent were in the form
of egg products.\3\ According to the United Nations Comtrade Database,
Lithuania, on average, exported 3,200 tons of egg products during 2017-
2021. Assuming that the European Union will continue to be Lithuania's
largest trading partner, the amount of egg products to be exported to
the U.S. is likely to be less than 3,200 tons.\4\
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\3\ Lithuania's production, trade, and consumptions data are
based on the Food and Agricultural Organization of the United
Nations (FAO, 2021) Food Balance Sheet (FBS): available at <a href="http://www.fao.org/faostat/en/#data/FBS">http://www.fao.org/faostat/en/#data/FBS</a>. FSIS calculated 17.2 percent as a
five-year average based on 2015-19 FAO data (production plus imports
minus consumption and assuming zero ending stock). The latest
available FBS data for Lithuania is 2019.
\4\ United Nations Statistical Division, UN Comtrade Database,
2017-2021: available at <a href="https://comtrade.un.org/data/">https://comtrade.un.org/data/</a>.
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From 2017 to 2021, the U.S. had an annual average of 387 million
egg laying hens \5\ that produced 6.9 million tons of eggs, of which
approximately 5.9 million tons were consumed domestically.\6\ While the
U.S., on average, imported around 7,000 tons of egg products annually
in this period, it was a net exporter of egg products.\7\
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\5\ U.S. Chicken Layers Inventory are based on USDA National
Agricultural Statistics Service (NASS) data for July 1st each year
from 2015-19. The data were accessed from the USDA/NASS Quick Stats
at: <a href="https://quickstats.nass.usda.gov/results/B6EC799A-D857-338C-82DC-73C74B27755B">https://quickstats.nass.usda.gov/results/B6EC799A-D857-338C-82DC-73C74B27755B</a>.
\6\ U.S. Production and Consumption Data accessed from USDA/
World Agricultural Supply and Demand Estimates (WASDE): <a href="https://usda.library.cornell.edu/concern/publications/3t945q76s?locale=en">https://usda.library.cornell.edu/concern/publications/3t945q76s?locale=en</a>.
WASDE's egg data are published in dozen; FSIS converted these data
into tons using Grade A Large Egg Weight based on USDA/Agricultural
Marketing Service conversion rate: accessed from <a href="https://www.ams.usda.gov/sites/default/files/media/Shell_Egg_Standard%5B1%5D.pdf">https://www.ams.usda.gov/sites/default/files/media/Shell_Egg_Standard%5B1%5D.pdf</a>.
\7\ U.S. Import and Export Data accessed from USDA Foreign
Agricultural Service: Global Agricultural Trade System: <a href="https://apps.fas.usda.gov/GATS/default.aspx">https://apps.fas.usda.gov/GATS/default.aspx</a>. Egg products are based on
Harmonized System (HS) codes 040811, 040819, 040891, 040899, 350211,
and 350219.
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With only one establishment intending to export egg products to the
U.S., Lithuanian egg products exports to the U.S. are likely to be
small in comparison to the total U.S. egg products market, and are
expected to have little or no effect on U.S. egg products supplies or
their prices. U.S. consumers, however, are expected to enjoy more
choices when purchasing egg products.
Effect on Small Businesses
The FSIS Administrator has made a determination that this notice
will not have a significant economic impact on a substantial number of
small entities in the United States, as defined by the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.). The trade volume is expected to
have little or no effect on all U.S. establishments, regardless of
size.
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 website located at:
<a href="https://www.fsis.usda.gov/policy/federal-register-rulemaking">https://www.fsis.usda.gov/policy/federal-register-rulemaking</a>. 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: <a href="https://www.fsis.usda.gov/subscribe">https://www.fsis.usda.gov/subscribe</a>. 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.
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 a not ``major rule,'' as defined by 5 U.S.C. 804(2).
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
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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 <a href="https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint">https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint</a> 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: <a href="/cdn-cgi/l/email-protection#a1d1d3cec6d3c0cc8fc8cfd5c0cac4e1d4d2c5c08fc6ced7"><span class="__cf_email__" data-cfemail="1b6b69747c697a763572756f7a707e5b6e687f7a357c746d">[email protected]</span></a>.
USDA is an equal opportunity provider, employer, and lender.
Paul Kiecker,
Administrator.
[FR Doc. 2022-19894 Filed 9-14-22; 8:45 am]
BILLING CODE 3410-DM-P
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