[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56621-56624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19894]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 (https://www.fsis.usda.gov/inspection/import-export/import-export-library) 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 https://www.fsis.usda.gov/inspection/import-export/equivalence.
    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 https://www.fsis.usda.gov/inspection/import-export/import-export-library. 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

[[Page 56622]]

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: https://www.fsis.usda.gov/inspection/import-export/import-export-library.
    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: https://www.fsis.usda.gov/inspection/import-export/import-guidance. 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.
---------------------------------------------------------------------------

    \1\ See: https://www.fsis.usda.gov/inspection/import-export/import-export-library/lithuania.
    \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 https://www.fsis.usda.gov/guidelines/2022-0003.
---------------------------------------------------------------------------

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,

[[Page 56623]]

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\
---------------------------------------------------------------------------

    \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 http://www.fao.org/faostat/en/#data/FBS. 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 https://comtrade.un.org/data/.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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: https://quickstats.nass.usda.gov/results/B6EC799A-D857-338C-82DC-73C74B27755B.
    \6\ U.S. Production and Consumption Data accessed from USDA/
World Agricultural Supply and Demand Estimates (WASDE): https://usda.library.cornell.edu/concern/publications/3t945q76s?locale=en. 
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 https://www.ams.usda.gov/sites/default/files/media/Shell_Egg_Standard%5B1%5D.pdf.
    \7\ U.S. Import and Export Data accessed from USDA Foreign 
Agricultural Service: Global Agricultural Trade System: https://apps.fas.usda.gov/GATS/default.aspx. Egg products are based on 
Harmonized System (HS) codes 040811, 040819, 040891, 040899, 350211, 
and 350219.
---------------------------------------------------------------------------

    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: 
https://www.fsis.usda.gov/policy/federal-register-rulemaking. 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: https://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.

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

[[Page 56624]]

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].
    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