[Federal Register Volume 86, Number 246 (Tuesday, December 28, 2021)]
[Notices]
[Pages 73721-73724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28119]


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

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, USDA.

ACTION: Notice and request for comments.

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

SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
that it intends to list Lithuania as a country eligible to export egg 
products to the United States. FSIS has reviewed Lithuania's laws, 
regulations, and documents concerning their egg products inspection 
system, audited the system as implemented, and determined that 
Lithuania's egg products inspection system is equivalent to the system 
that the United States has established under the Egg Products 
Inspection Act (EPIA) and its implementing regulations. Should FSIS 
make a final determination to list Lithuania as eligible to ship egg 
products to the United States, only egg products produced in certified 
Lithuanian establishments would be eligible for export to the United 
States. All such products would continue to be subject to re-inspection 
at U.S. points-of-entry by FSIS inspectors. FSIS is requesting comment 
before it makes a final determination concerning Lithuania's 
equivalence for egg products. FSIS will announce its final 
determination in a subsequent Federal Register notice.

DATES: Comments must be received on or before February 28, 2022.

ADDRESSES: FSIS invites interested persons to submit comments on this 
notice. Comments may be submitted by any of the following methods:
     Federal eRulemaking Portal: This website provides the 
ability to type short comments directly into the comment field on this 
web page or attach a file for lengthier comments. Go to https://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
     Mail: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 1400 Independence 
Avenue SW, Mailstop 3758, Washington, DC 20250-3700.
     Hand- or Courier-Delivered Submittals: Deliver to 1400 
Independence Avenue SW, Jamie L. Whitten Building, Room 350-E, 
Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2021-0001. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to https://www.regulations.gov.
    Docket: For access to background documents or comments received, 
call (202) 205-0495 to schedule a time to visit the FSIS Docket Room at 
1400 Independence Avenue SW, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant 
Administrator, Office of Policy and Program Development, telephone 
(202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    FSIS is announcing that it intends to list Lithuania as a country 
eligible to export egg products to the United States. Lithuania is 
currently eligible to export processed beef and pork to the United 
States.

Statutory and Regulatory Basis for Action

    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 Act 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

[[Page 73722]]

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 or removed from certification.
    Before the foreign country can export egg products to the United 
States, FSIS needs to evaluate the country's 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 
consists of two processes: A document review and an on-site review. The 
document review is an evaluation of the laws, regulations, and other 
written materials used by the country to effect its inspection program 
(9 CFR 327.2(a)(2)(iii), 381.196(a)(2)(iii), and 590.910(a)). FSIS 
requests that countries provide information about their inspection 
systems through the Self Reporting Tool (SRT).\1\ The 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: (1) Government Oversight 
(e.g., Organization and Administration, Enforcement Authority, 
Government Inspection Personnel-Training/Staffing), (2) Government 
Verification of Food Safety and Other Consumer Protection Requirements 
(e.g., Humane Handling, Ante-Mortem Inspection, Post-Mortem Inspection, 
Product Standards and Labeling), (3) Government Sanitation 
Verification, (4) Government Hazard Analysis and Critical Control Point 
(HACCP) Systems Verification, (5) Government Chemical Residue Programs, 
and (6) Government Microbiological Pathogen and Process Control 
Programs. FSIS evaluates the information submitted to verify that the 
critical points in the six equivalence components are addressed 
satisfactorily with respect to standards, activities, resources, and 
enforcement. If the document review is satisfactory, an on-site review 
is scheduled using a multidisciplinary team to evaluate all aspects of 
the country's inspection program. This comprehensive process is 
described more fully on the FSIS website at https://www.fsis.usda.gov/inspection/import-export/equivalence.
---------------------------------------------------------------------------

    \1\ The SRT template can be found on the FSIS website at https://www.fsis.usda.gov/sites/default/files/import/srt.pdf.
---------------------------------------------------------------------------

    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/importlibrary. Once listed, the 
government of an eligible country certifies to FSIS that establishments 
that wish to export egg products to the United States are operating 
under requirements equivalent to those of the United States. 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, as 
discussed in more detail below.

Evaluation of Lithuania's Egg Products Inspection System

    In November 2014, the government of Lithuania requested approval to 
export egg products to the United States. FSIS conducted a document 
review of Lithuania's egg products inspection system and concluded, on 
the basis of that review, that Lithuania's laws, regulations, control 
programs, and procedures were equivalent to those of the United States.
    Accordingly, from October 24, 2016, to November 2, 2016, FSIS 
proceeded with an on-site audit of Lithuania's egg products inspection 
system to verify that Lithuania's State Food and Veterinary 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. FSIS audited the SFVS 
headquarters, one territorial office, and one local inspection office, 
the single establishment that was to be certified to export egg 
products to the United States, and the National Food and Veterinary 
Risk Assessment Institute (NFVRAI), the national government laboratory. 
During the visit, the establishment was not producing egg products for 
export to the United States. However, the FSIS auditor was able to 
conduct observations of SFVS's inspection at the establishment and to 
verify information that was provided during the document review.
    The 2016 on-site audit of Lithuania's egg products inspection 
system found that SFVS was unable to demonstrate adequate government 
oversight regarding implementation and verification of its sanitation 
requirements as evidenced by the establishment's failure to conduct 
candling procedures and washing, sanitizing, and drying dirty eggs. The 
FSIS auditors observed that dirty eggs were in direct contact with each 
other and other eggs on the conveyor and that the establishment's 
employees were not removing those eggs prior to the breaking operation. 
In addition, the FSIS auditors observed after the breaking step an 
accumulation of intact shell eggs or large fragments of broken shells 
in the egg products containers, resulting in direct product 
contamination. Lastly, FSIS auditors observed beaded condensate, dust 
on overhead structures, and pooling water on the establishment's floor. 
SFVS responded with its proposed corrective actions for the 
deficiencies identified during the 2016 audit.
    On April 25, 2017, FSIS sent its audit report to SFVS. In the 
letter accompanying the report, FSIS advised SFVS that as the next step 
in the review process, the Agency would evaluate SFVS's proposed 
corrective actions identified during the 2016 audit and would schedule 
a verification audit in the near future. Additionally, after further 
assessment of the country's written program, FSIS determined that 
Lithuania needed to submit updated supporting documentation and to 
clarify some of the information previously provided to FSIS as part of 
its initial equivalence request for egg products. Throughout 2018 and 
2019, the SFVS continued to provide supporting documents in response to 
FSIS requests.
    From July 15 to July 24, 2019, FSIS conducted an on-site audit to 
verify whether the food safety system governing egg products was 
implemented as described in the FSIS SRT and is effective in providing 
an equivalent level of public health protection as achieved in the 
United States. Specifically, the audit was intended to determine 
whether Lithuania's corrective actions in response to the prior 
findings were implemented and effective. FSIS audited the SFVS 
headquarters, two territorial offices, and four local inspection 
offices, and the one establishment that was to be certified to export 
egg products to the United States.
    The FSIS auditors found that the corrective actions for the 2016 
Government Sanitation component findings were implemented and effective 
in resolving the findings. However, they also determined that the 2016 
Government Oversight finding was not resolved and that SFVS was still 
unable to demonstrate adequate government oversight regarding 
implementation and verification of its egg products requirements. For 
example, the government inspection personnel failed to identify several 
deficiencies at the establishment and

[[Page 73723]]

could not explain how the egg products pasteurization records presented 
during the audit supported that pasteurization requirements were met. 
The FSIS auditors also identified that the establishment was not able 
to produce a current calibration certificate for one flow rate probe 
used during the pasteurization process and was not monitoring and 
documenting product temperature during heat treatment of each lot of 
dried whites at a supportable frequency. Furthermore, the auditors 
found that the government inspectors had not identified these 
noncompliances.
    Also, during the 2019 audit, the FSIS auditors observed multiple 
blood spots on the yolks of multiple eggs with no actions taken by the 
official government veterinarians or establishment personnel to remove 
the blood spots or reject the affected egg products. FSIS auditors also 
identified blocks of yeast used in the fermentation of egg products 
stored in a refrigerator without any labeling indicating the actual 
product contents. SFVS responded to FSIS with its corrective actions to 
the identified deficiencies.
    FSIS sent its audit report to SFVS on January 7, 2020. SFVS 
addressed the FSIS audit findings through corrective action plans 
presented to FSIS on February 14, 2020 and September 10, 2020. 
Specifically, veterinarians who perform inspections in egg products 
establishments were introduced to the FSIS audit findings and the SFVS 
conducted training on FSIS' egg products training program. The SFVS 
revised the working procedures to incorporate corrective actions to the 
audit findings, including instructions on pasteurization requirements. 
As part of the corrective action plan, the audited egg products 
establishment installed new pasteurization equipment and an inedible 
egg rejection system and purchased a replacement flow meter to have on-
site while one is being calibrated. The SFVS established requirements 
for the establishments to include a once per year calibration frequency 
into their equipment control program and to label every package of 
yeast indicating the original name, product manufacturer, shelf life, 
lot number, and weight. Lithuania also provided documentary evidence to 
demonstrate adequate function of newly installed equipment and for 
government inspection activities verifying implementation of corrective 
actions. 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.
    On October 29, 2020, FSIS published the final rule, Egg Products 
Inspection Regulations (85 FR 68640). The rule established new 
requirements for official plants that process egg products to develop 
and implement Hazard Analysis and Critical Control Point (HACCP) and 
Sanitation Standard Operating Procedures (Sanitation SOPs) and to meet 
other requirements, including sanitation performance standards, 
consistent with FSIS' meat and poultry regulations. On April 15, 2021, 
FSIS sent a letter to SFVS notifying it of the policy changes and 
explaining that some requirements for foreign countries had taken 
effect on December 28, 2020. The letter also stated that the Sanitation 
SOP requirements would become effective on October 29, 2021, while the 
HACCP requirements would take effect on October 31, 2022.
    On May 17, 2021, Lithuania provided FSIS with documentation that 
outlined the changes that were made to the SFVS' egg products 
inspection system to achieve equivalence with the revised U.S. 
regulations related to the requirements for establishments to develop 
and implement HACCP and Sanitation SOPs, including sanitation 
performance standards. FSIS conducted a document review of SFVS's 
updated operating procedure and has determined that Lithuania's egg 
products inspection system is equivalent with the new U.S. regulatory 
requirements for sanitation and HACCP described in the October 29, 2020 
final rule.
    In summary, FSIS has completed the document review, on-site audit, 
follow-up audits with verification of corrective actions as part of the 
equivalence process and determined that all outstanding issues have 
been resolved. FSIS has concluded that, as implemented, Lithuania's 
inspection system for egg products is equivalent to that of the United 
States. All audit reports on Lithuania's egg products inspection system 
can be found on the FSIS website at https://www.fsis.usda.gov/inspection/import-export/international-reports/foreign-audit-reports.
    At this time, Lithuania intends to certify one establishment as 
eligible to export egg products to the United States. After considering 
comments in response to this notice, should FSIS make a final 
determination that Lithuania maintains an equivalent inspection system, 
FSIS will publish a subsequent Federal Register notice announcing that 
Lithuania is eligible to export egg products to the United States. In 
addition, the government of Lithuania would need to certify to FSIS 
those establishments that wish to export egg products to the United 
States and that operate in accordance with requirements equivalent to 
that of the United States (9 CFR 590.510(a)). FSIS would verify that 
the establishments certified by Lithuania's government are meeting the 
United States requirements through additional verification audits of 
Lithuania's egg products inspection system. 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 be found to 
comply with all other applicable requirements of the United States. 
Accordingly, egg products exported from Lithuania would be subject to 
re-inspection at U.S. points-of-entry for, but not limited to, 
transportation damage, product and container defects, labeling, proper 
certification, general condition, and accurate count. In addition, FSIS 
would conduct other types of re-inspection activities, such as taking 
product samples for laboratory analysis for the detection of chemical 
residues and pathogens for a subset of Lithuania's egg products 
imported into the United States. Products that pass re-inspection would 
be stamped with the official mark of inspection and allowed to enter 
U.S. commerce. If they do not meet U.S. requirements, they would be 
refused entry and within 45 days would be exported to the country of 
origin, destroyed, or converted to animal food (subject to approval of 
the U.S. Food and Drug Administration), depending on the violation.

Economic Impact Analysis

    As explained above, FSIS intends to list 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 low volume 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, of which approximately 
50,800 tons were consumed within Lithuania. The remaining eggs were 
exported mainly to the European Union, of which Lithuania is a member. 
Of these exports, approximately 17.2 percent were in the

[[Page 73724]]

form of egg products.\2\ As such, FSIS estimates the total potential 
egg products available for export to be approximately 3,200 tons \3\ 
(17.2 percent of 18,800 tons). 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.
---------------------------------------------------------------------------

    \2\ Detailed data on Lithuanian egg products is limited. We use 
the available egg data to estimate the potential amount of egg 
products Lithuania would be able to export to the United States. 
Lithuania's production, trade and consumptions data are based on the 
Food and Agricultural Organization of the United Nations (FAO, 2021) 
Food Balance Sheet: Available at http://www.fao.org/faostat/en/#data/FBS. The maximum expected exports potential is based on 
production plus imports minus consumption and assuming zero ending 
stock. FSIS calculated 17.2 percent as a five-year average based on 
2015-19 FAO data.
    \3\ Noted that FSIS has jurisdiction over only some egg 
products, not all.
---------------------------------------------------------------------------

    From 2015 to 2019, the U.S. had an annual average of 375 million 
egg laying hens \4\ that produced 6.6 million tons of eggs, of which 
approximately 5.6 million tons were consumed domestically.\5\ While the 
U.S. imports around 11,200 tons of egg products annually, it is a net 
exporter of egg products.\6\
---------------------------------------------------------------------------

    \4\ 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/53032069-6FCE-3AA2-99E7-B33E1C1AD8F2.
    \5\ 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.
    \6\ 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 volume to the U.S. are likely to 
be low 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 preliminary determination that 
this notice will not have a significant economic impact on a 
substantial number of small entities, as defined by the Regulatory 
Flexibility Act (5 U.S.C. 601). 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 on-line 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 not a ``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 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. 2021-28119 Filed 12-27-21; 8:45 am]
BILLING CODE 3410-DM-P