80 FR 52375 - Eligibility of Lithuania To Export Meat and Meat Products to the United States

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

Federal Register Volume 80, Issue 168 (August 31, 2015)

Page Range		52375-52379
FR Document		2015-21510
The Food Safety and Inspection Service (FSIS) is amending the Federal meat inspection regulations to add the Republic of Lithuania (Lithuania) to the list of countries eligible to export meat and meat products to the United States. FSIS has reviewed Lithuania's laws, regulations, and inspection system, as implemented, and has determined that they are equivalent to the Federal Meat Inspection Act (FMIA), the regulations implementing this statute, and the United States food safety system for meat and meat products. Under this final rule, meat from cattle, sheep, swine, and goats slaughtered in Lithuania, or parts or other products thereof, processed in certified Lithuanian establishments, will be eligible for export to the United States. All such products will be subject to reinspection at United States ports of entry by FSIS inspectors.
Federal Register, Volume 80 Issue 168 (Monday, August 31, 2015)
[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)]
[Rules and Regulations]
[Pages 52375-52379]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21510]



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Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Rules 
and Regulations

[[Page 52375]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 327

[Docket No. FSIS-2014-0040]
RIN 0583-AD57


Eligibility of Lithuania To Export Meat and Meat Products to the 
United States

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
Federal meat inspection regulations to add the Republic of Lithuania 
(Lithuania) to the list of countries eligible to export meat and meat 
products to the United States. FSIS has reviewed Lithuania's laws, 
regulations, and inspection system, as implemented, and has determined 
that they are equivalent to the Federal Meat Inspection Act (FMIA), the 
regulations implementing this statute, and the United States food 
safety system for meat and meat products.
    Under this final rule, meat from cattle, sheep, swine, and goats 
slaughtered in Lithuania, or parts or other products thereof, processed 
in certified Lithuanian establishments, will be eligible for export to 
the United States. All such products will be subject to reinspection at 
United States ports of entry by FSIS inspectors.

DATES: Effective: October 30, 2015.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel L. Engeljohn, Assistant 
Administrator, Office of Policy and Program Development, Food Safety 
and Inspection Service, U.S. Department of Agriculture, 1400 
Independence Avenue SW., Washington, DC 20250-3700; Telephone: (202) 
205-0495.

SUPPLEMENTARY INFORMATION:

Background

    On December 17, 2014, FSIS published a proposed rule in the Federal 
Register (79 FR 75073) to add Lithuania to the list of countries 
eligible to export meat and meat products to the United States (9 CFR 
327(b)). This final rule is consistent with the proposed rule.
    As is explained in the proposed rule, under the FMIA and 
implementing regulations, meat and meat products imported into the 
United States must be produced under standards for safety, 
wholesomeness, and labeling that are equivalent to those of the United 
States (21 U.S.C. 620). The FMIA also requires that the livestock from 
which such imports are produced be slaughtered and handled in 
connection with slaughter in a manner that is consistent with the 
Humane Methods of Slaughter Act (7 U.S.C. 1901-1906).
    Section 327.2 of Title 9 of the Code of Federal Regulations (CFR) 
sets out the procedures by which foreign countries may become eligible 
to export meat and meat products to the United States. Paragraph 
327.2(a) requires that a foreign country's meat inspection system 
provide standards equivalent to those of the United States and to 
provide legal authority for the inspection system and its implementing 
regulations that is equivalent to that of the United States. 
Specifically, a country's laws and regulations must impose requirements 
equivalent to those of the United States with respect to: (1) Ante-
mortem inspection, humane methods of slaughter and handling, and post-
mortem inspection by, or under the direct supervision of, a 
veterinarian; (2) official controls by the national government over 
establishment construction, facilities, and equipment; (3) direct and 
continuous official supervision of slaughtering and preparation of 
product by inspectors to ensure that product is not adulterated or 
misbranded; (4) complete separation of establishments certified to 
export from those not certified; (5) maintenance of a single standard 
of inspection and sanitation throughout certified establishments; (6) 
requirements for sanitation and for sanitary handling of product at 
establishments certified to export; (7) official controls over 
condemned product; (8) a Hazard Analysis and Critical Control Point 
(HACCP) system; and (9) any other requirements found in the FMIA and 
its implementing regulations (9 CFR 327.2(a)(2)(ii)).
    The country's inspection system must also impose requirements 
equivalent to those of the United States with respect to: (1) 
Organizational structure and staffing to ensure uniform enforcement of 
the requisite laws and regulations in all certified establishments; (2) 
national government control and supervision over the official 
activities of employees or licensees; (3) qualified inspectors; (4) 
enforcement and certification authority; (5) administrative and 
technical support; (6) inspection, sanitation, quality, species 
verification and residue standards; and (7) any other inspection 
requirements (9 CFR 327.2(a)(2)(i)).

Evaluation of the Lithuanian Meat Inspection System

    In 2004, the government of Lithuania initially requested approval 
to export meat, poultry, and egg products to the United States. In 
January 2012, Lithuania amended its request to include only meat and 
meat products. FSIS then began to evaluate Lithuania's inspection 
system to determine whether it is equivalent to the United States' 
system.
    FSIS conducted a document review of Lithuania's meat inspection 
system through information provided on FSIS's Self-Reporting Tool (SRT) 
\1\ to determine whether its system is equivalent to that of the United 
States. FSIS examined the information submitted by Lithuania to verify 
that the following equivalence components were addressed satisfactorily 
with respect to standards, activities, resources, and enforcement: (1) 
Government Oversight; (2) Statutory Authority and Food Safety 
Regulations; (3) Sanitation; (4) Hazard Analysis and Critical Control 
Point Systems; (5) Chemical Residue Testing Programs; and (6) 
Microbiological Testing Programs. From that review, FSIS concluded that 
Lithuania's laws, regulations, control programs, and procedures were 
sufficient to achieve

[[Page 52376]]

the level of public health protection required by FSIS.
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    \1\ The SRT is a standardized questionnaire that FSIS provides 
to foreign governments to gather information that characterizes 
foreign inspection systems according to the six equivalence 
components and as required by 9 CFR 327.2(a)(2)(iii). FSIS asks 
foreign governments to submit documentation, such as their 
inspection system laws, regulations, and policy issuances, that 
supports their responses to the SRT questions.
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    FSIS then proceeded with an initial on-site audit of Lithuania's 
meat inspection system in September 2012 and concluded that Lithuania's 
system met each equivalence component except sanitation. Lithuania's 
State Food and Veterinary Service (SFVS), which is Lithuania's central 
competent authority in charge of food inspection, took immediate 
corrective actions to address the audit team's findings and provided a 
corrective action plan, which included new regulations, procedures, 
implementation measures, and verification activities. FSIS reviewed the 
plan and concluded that it addressed all of the audit findings.
    FSIS conducted a second on-site audit in September 2013 to verify 
that all outstanding issues identified during the previous audit had 
been resolved and that Lithuania had satisfactorily implemented all of 
the laws, regulations, and instructions to the field that FSIS found to 
be equivalent during the document review and previous audit. FSIS 
concluded, on the basis of this audit, that Lithuania had 
satisfactorily implemented the corrective action plan that it had 
submitted in response to the 2012 audit.
    Consequently, on December 17, 2014, FSIS published a proposed rule 
to find that Lithuania's meat inspection system is equivalent to the 
United States' system and, therefore, to add Lithuania to the list of 
countries eligible to export meat and meat products to the United 
States. For more detailed information on FSIS's evaluation of the 
Lithuanian meat inspection system, see the proposed rule (79 FR 75073), 
and for the full audit reports, go to: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/foreign-audit-reports.

Final Rule

    After considering the comments received on the proposed rule, 
discussed below, FSIS concludes that Lithuania's meat inspection system 
is equivalent to the United States' inspection system for meat and meat 
products. Therefore, FSIS is amending its meat inspection regulations 
to add Lithuania to the list of countries eligible to export meat and 
meat products to the United States (9 CFR 327.2(b)). Under FSIS's 
import regulations, the government of Lithuania must certify to FSIS 
that those establishments that wish to export meat and meat products to 
the United States are operating under requirements equivalent to those 
of the United States (9 CFR 327.2(a)).
    Although a foreign country may be listed in FSIS's regulations as 
eligible to export meat and meat 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 meat and meat products from countries into 
the United States to control the spread of specific animal diseases.
    Also, under this final rule, all meat and meat products exported to 
the United States from Lithuania will be subject to reinspection by 
FSIS at United States ports of entry for, but not limited to, 
transportation damage, product and container defects, labeling, proper 
certification, general condition, and accurate count.
    FSIS will conduct other types of reinspection activities, such as 
incubation of canned 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 any species 
or product composition 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 U.S. 
commerce. If they do not meet U.S. requirements, they 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 Web site 
at: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/port-of-entry-procedures.
    In addition, Lithuanian meat and meat products will be eligible for 
importation into the United States only if they are from animals 
slaughtered on or after the effective date of this final rule.

Summary of Comments and Responses

    FSIS received seven comments in response to the proposed rule. One 
individual supported the proposed rule. Two individuals, a consumer 
advocacy organization, and three trade associations representing the 
pork industry, opposed it. After review and consideration of these 
comments, FSIS is finalizing the regulation as proposed. The following 
is a brief summary of the relevant issues raised in the comments and 
FSIS's responses.

1. Animal Diseases

    Comment: One individual opposed importing Lithuanian meat and meat 
products, stating that animal feeding practices in Lithuania would not 
effectively prevent bovine spongiform encephalopathy (BSE). Three pork 
industry groups opposed the rule, stating that several cases of African 
Swine Fever (ASF) reported over the past year in domestic and feral 
swine populations in Lithuania and adjacent countries would lead to 
problems in the United States. A consumer advocacy organization stated 
that allowing Lithuanian products into the United States could lead to 
the transmission of certain animal diseases into the United States 
because Lithuania shares common borders with countries that are not 
free of ASF, Foot-and-Mouth Disease (FMD), Classical Swine Fever (CSF), 
or Swine Vesicular Disease (SVD) and has trade practices with these 
countries that are less restrictive than those of the United States.
    Agency Response: To export meat and meat products to the United 
States, countries need to meet the APHIS requirements for animal 
disease prevention and control. APHIS uses several methods to ensure 
that harmful animal diseases do not enter the United States. These 
include actively monitoring the animal disease status of foreign 
countries and maintaining lists of countries and regions considered to 
be free (or not free) of certain diseases. If an animal disease is 
found to exist in a country (or a region within a country) that exports 
meat, poultry, or egg products to the United States, APHIS requires 
specific processing steps to ensure that any product from that country 
or region will not cause the disease to be transmitted to the United 
States (see 9 CFR part 94).
    In addition to these monitoring and processing provisions, APHIS 
requires imported meat, poultry, and egg products to have accompanying 
documentation regarding their origin, animal disease status, degree of 
processing, and intended use. At the U.S. border, CBP officials verify 
that such documentation is accurate and that the products do not pose 
an animal disease transmission risk. These steps take place before FSIS 
reinspects imported product for food safety and other regulatory 
compliance. All meat and meat products that APHIS restricts from 
entering the United States because of animal disease concerns will be

[[Page 52377]]

refused entry by U.S. Customs and Border Protection (CBP).
    In the case of BSE, APHIS takes into consideration the risk status 
recognition as determined by the World Organization for Animal Health 
(OIE), or conducts its own BSE risk determination upon request. OIE 
designates countries as having a negligible or controlled BSE risk. 
Countries that do not meet those designations are considered to have an 
undetermined risk. OIE and APHIS currently designate Lithuania as a 
country with controlled BSE risk. The review of Lithuania's food safety 
system for potential BSE contamination also indicated that SFVS employs 
effective measures to prevent Specified Risk Materials (SRM) (materials 
from cattle that scientific studies have demonstrated can contain the 
BSE agent in cattle infected with the disease) from contaminating the 
food supply. Removal of SRMs decreases the risk of introduction of BSE 
to a negligible level. Therefore, FSIS has determined that Lithuania's 
measures to remove SRMs from its food supply adequately address the 
potential risk that the BSE agent could contaminate products destined 
for the United States.
    APHIS currently considers Lithuania to be free of SVD, rinderpest, 
and FMD. APHIS, however, has placed Lithuania in a ``special category'' 
because of its common land border with countries that have not been 
identified to be free of these diseases, and because Lithuania's trade 
practices are less restrictive than those of the United States. 
Lithuania's trade practices could, therefore, result in a Lithuanian 
meat supply that is supplemented with animal products from neighboring 
countries. Establishments in ``special category'' countries must 
certify compliance with specific APHIS regulations, which ensure that 
animals and animal products received by these establishments, and the 
products produced by them, are not contaminated through contact with 
regions where these diseases exist (see 9 CFR 94.11(c)(2) and 
94.13(c)(2)).
    APHIS recognizes that ASF outbreaks have occurred in wild boar and 
domestic swine in Lithuania. Lithuania has imposed controls, consistent 
with European Union legislation, to prevent the spread of this disease. 
These controls restrict the movement of pigs and pig products, 
including pork, from areas where the disease has occurred. Were APHIS 
to add any geographic area of Lithuania to the list of ASF-affected 
regions, Lithuania would be required to comply with 9 CFR 94.8(b)-(d), 
which mandates cooking, sealing, cleaning, processing, packing, 
certification, transportation, and handling requirements.
    Under the final rule, Lithuania will be eligible to export meat and 
meat products to the United States, but will be required to meet 
APHIS's requirements. Because Lithuania's disease status may change 
with respect to any animal disease, FSIS will coordinate with APHIS and 
consider how any change may affect Lithuania's eligibility to export 
certain types of products to the United States.

2. Domestic Production

    Comment: One individual argued that increasing demand for goat meat 
in the United States should be met through increased local goat 
production rather than imports. Another individual opposed the rule 
because the United States already has thousands of meat products in 
commerce.
    Agency Response: The final rule will list Lithuania as eligible to 
export meat and meat products derived from cattle, swine, sheep, and 
goats to the United States (9 CFR 327.2(b)). Although Lithuania will be 
listed as eligible, it is unlikely to export significant quantities of 
goat meat or meat products to the United States. Lithuania is a net 
importer of goat meat and does not have export capacity in this area. 
In 2014, Lithuania imported about $3,000 worth of such products, less 
than one metric ton (MT), and did not export any such products. 
Currently, the United States imports about 19,000 MT of goat meat per 
year, of which 98% comes from Australia. Lithuania must be export-
capable and price-competitive to compete in this market. As is 
discussed in the economic analysis below, Lithuania has stated that it 
intends to export only canned, dried, smoked beef and pork products to 
the United States at this time.

3. Adequate Regulation

    Comment: One individual stated that the FDA was unqualified to 
certify Lithuanian establishments seeking to export meat or meat 
products to the United States.
    Agency Response: Under 9 CFR 327.2(a)(3), the government of 
Lithuania must certify to FSIS that those establishments that wish to 
export meat and meat products to the United States are operating under 
requirements equivalent to those of the United States. These 
certifications are subject to review by FSIS. FSIS also conducts 
periodic equivalence audits of countries eligible to export meat, 
poultry, or egg products to the United States and will do so for 
Lithuania. Every imported meat or meat product must enter the United 
States through an official import inspection establishment and be 
reinspected by an FSIS import inspector.

4. Audit Report Findings

    Comment: A consumer advocacy organization expressed several 
concerns regarding the two audits of Lithuania's meat inspection 
system. The organization stated that: (1) The reports are incomplete 
because they fail to include establishment checklists used by the FSIS 
auditor to evaluate how well the Lithuanian inspection program enforced 
food safety laws and regulations at the plant level; (2) the first 
audit found that Lithuania's SFVS had inexplicably dropped a 
requirement that establishments seeking to export to the United States 
maintain written Sanitation Standard Operating Procedures; (3) the 
second audit noted that improvement was still needed in Lithuania's 
inspectors' verification of establishments' compliance with zero 
tolerance requirements for fecal material, ingesta, and milk on 
carcasses and meat parts; (4) in the second audit report, audit staff 
were concerned about the ability of Lithuanian inspection personnel to 
recognize potential sanitation issues in ready[hyphen]to[hyphen]eat 
processing facilities; and (5) neither audit report mentioned what 
precautions the Lithuanian food safety authorities would take as a 
consequence of the 2013 horse meat scandal in the European Union, in 
which Lithuanian products were implicated.
    Agency Response: FSIS's evaluation of all the data collected 
before, during, and after the on-site audits supports the conclusion 
that the Lithuanian meat regulatory system achieves a level of 
protection equivalent to that of the United States. FSIS evaluated how 
well Lithuania's inspection program enforced food safety laws and 
regulations at the plant level, including audit checklists for specific 
establishments. The Lithuania establishment checklists are posted at 
the following link: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/foreign-audit-reports.
    The follow-up audit of Lithuania's meat inspection system confirmed 
that SFVS adequately and effectively addressed all the findings related 
to the previous FSIS initial equivalence on-site audit conducted from 
September 10-26, 2012. The FSIS auditor attested that all corrective 
actions were implemented in a manner consistent with FSIS's inspection 
requirements. Additionally,

[[Page 52378]]

SFVS responded adequately to two areas in need of improvement: 
Verifying that establishments' HACCP systems ensure that all portions 
of carcasses were free of visible contamination with fecal material, 
milk, or ingesta, and requiring that establishments control the 
movement of personnel and materials in establishments producing Ready-
to-Eat (RTE) products. SFVS required immediate adjustments to 
establishments' HACCP systems and sanitation programs, introduced 
correlation sessions to reinforce supervisors' understanding of food 
safety tasks related to export to the United States, and implemented 
on-going training programs for the inspection program personnel. SFVS 
implemented its corrective action plan and provided supporting 
documents during and after its exit meeting with FSIS. These corrective 
actions improved the performance of official verification activities 
and demonstrated SFVS's commitment to consistently meeting the 
requirements for exporting meat and meat products to the United States.
    In 2013, a variety of meat products in the European Union were 
found to contain meat which was not declared on the label, including 
horse meat and pork. In response, the European Commission and EU Member 
States, including Lithuania, have pursued efforts to ensure the proper 
labeling of meat products, including increased communication among food 
safety agencies regarding food fraud, DNA monitoring, revised 
registration and identification procedures for horses in the EU, 
increased penalties for fraudulent activity, and stricter origin 
labeling. Lithuania, as a Member of the EU, is bound by the EU 
Regulations under which these actions have been taken.
    FSIS also verified that SFVS conducts species verification testing 
of meat and meat products intended for both domestic production and 
export, in accordance with the SFVS Director Order No B1-23. This 
testing will ensure that only eligible species will be exported to the 
United States. Furthermore, the FSIS auditor verified that Lithuanian 
establishments are required to ensure that food intended for human 
consumption is adequately labeled or identified to facilitate its 
traceability in accordance with Article 18 for Regulation (EC) No 178/
2002. The identification and labeling requirements include, at least, 
the source of food, animal byproduct, or ingredients in a manner that 
supports effective investigation and traceability. FSIS is confident 
that the Lithuanian measures in place, along with its reinspection and 
verification activities at United States ports of entry, will ensure 
that fraudulently labeled Lithuanian meat products will not enter 
United States commerce.

Executive Orders 12866 and 13563, and the Regulatory Flexibility Act

    Executive Orders (E.O.) 12866 and 13563 direct agencies to assess 
all costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). E.O. 
13563 emphasizes the importance of quantifying both costs and benefits, 
of reducing costs, of harmonizing rules, and of promoting flexibility. 
This final rule was designated a ``non-significant'' regulatory action 
under section 3(f) of E.O. 12866. Accordingly, this rule was not 
reviewed by OMB under E.O. 12866.

Economic Impact Analysis

    FSIS is adopting, in its entirety, the proposed regulatory impact 
analysis from the proposed rule.\2\ Lithuania expressed an intent to 
export canned, dried, or smoked beef and pork products to the United 
States. Lithuania, however, will not be precluded from exporting other 
meat products in the future if the products meet all applicable APHIS 
and FSIS requirements for those products. Given the limited market in 
the United States for Lithuanian meat products and Lithuania's low 
projected export volume, there is likely to be little, if any, impact 
on the United States economy.
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    \2\ 79 FR 75075.
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    Lithuania is a small beef producer with limited beef export 
capacity. Its maximum beef export to the world was achieved in 2011, 
when it exported $130 million, or 25,000 MT, worth of beef, mainly to 
the European Union and Russia. Based on analysis of Lithuania's exports 
to Russia, FSIS estimates that Lithuania has an excess beef export 
capacity of $26 million ($130 million - $104 million = $26 million) in 
value, or 3,000 MT (25,000 MT - 22,000 MT = 3,000 MT) in volume, that 
could be exported to the United States.\3\
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    \3\ This data is from Eurostat, the statistical office of the 
European Union, and is based on Lithuania's official statistics. It 
is also available at the Global Trade Atlas database at: http://www.gtis.com/gta/secure/gateway.cfm.
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    Accordingly, allowing Lithuanian beef exports to enter the 
13,050,000-MT \4\ United States beef market is expected to have minimal 
effect (3,000 MT represents a 0.023% increase), leaving the total 
United States beef supply almost unchanged. Because importing beef from 
Lithuania is not expected to greatly alter the United States beef 
supply, it will not contribute to any price change in that market.
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    \4\ Source: Foreign Agricultural Service (FAS) Production, 
Supply and Distribution (PSD) data, available at: https://apps.fas.usda.gov/psdonline/psdQuery.aspx.
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    Lithuanian data from CY2013 \5\ shows that this country reached its 
maximum pork export capacity, meaning it will export little, if any, 
pork to the United States. Considering that the United States pork 
supply is 11,212,000 MT (CY2013),\6\ it is unlikely that imports from 
Lithuania will result in price changes in the United States pork 
market.
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    \5\ This data is from Eurostat, based on Lithuania's official 
statistics. It is also available at the Global Trade Atlas database 
at: http://www.gtis.com/gta/secure/gateway.cfm.
    \6\ Source: FAS PSD data, available at: https://apps.fas.usda.gov/psdonline/psdQuery.aspx.
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    This cost analysis was based on Lithuania's full export capacity. 
Currently, however, only six Lithuanian establishments intend to export 
product to the United States. Four are meat processors only, one is a 
slaughter facility, and one conducts both meat slaughter and 
processing. Of the four processing facilities, three process beef and 
pork, and one processes pork only. The slaughter-only facility and the 
facility that conducts both slaughter and processing both handle beef 
and pork. The combined export capacity of these six establishments is 
much less than Lithuania's total export capacity. With no price change 
expected in U.S. meat markets, the final rule would not lead to any 
negative effects on U.S. consumers.
    Lithuanian companies that export product to the United States and 
domestic companies that import products from Lithuania to the United 
States will incur standard costs such as export fees and freight and 
insurance costs. They will be willing to bear these costs because of 
the anticipated financial benefits associated with marketing their 
products in the United States.
    The final rule will increase trade between the United States and 
Lithuania. The volume of trade stimulated by this rule is likely to be 
small and is expected to have little or no effect on U.S. meat supplies 
or meat prices. U.S. consumers, however, are expected to enjoy more 
choices when purchasing meat and meat products. Lithuanian 
establishments will export commercially sterile meat products, 
including canned meat products and ready-to-eat products like salamis 
and

[[Page 52379]]

other dried and smoked meats to the United States. The final rule 
expands choices for U.S. consumers and promotes economic competition.

Regulatory Flexibility Act Assessment

    The FSIS Administrator certifies that, for the purposes of the 
Regulatory Flexibility Act (5 U.S.C. 601-602), this final rule will not 
have a significant impact on a substantial number of small entities in 
the United States.

Executive Order 12988, Civil Justice Reform

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this rule: (1) All State and local laws and 
regulations that are inconsistent with this rule will be preempted; (2) 
no retroactive effect will be given to this rule; and (3) no 
administrative proceedings will be required before parties may file 
suit in court challenging this rule.

Paperwork Reduction Act

    No new paperwork requirements are associated with this proposed 
rule. Foreign countries wanting to export meat and meat products to the 
United States are required to provide information to FSIS certifying 
that their inspection systems provide standards equivalent to those of 
the United States, and that the legal authority for the system and 
their implementing regulations are equivalent to those of the United 
States. FSIS provided Lithuania with questionnaires asking for detailed 
information about the country's inspection practices and procedures to 
assist that country in organizing its materials. This information 
collection was approved under OMB number 0583-0153. The proposed rule 
contains no other paperwork requirements.

E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things, 
promoting the use of the Internet and other information technologies 
and providing increased opportunities for citizen access to Government 
information and services, and for other purposes.

Additional Public Notification

    FSIS will officially notify the World Trade Organization's 
Committee on Sanitary and Phytosanitary Measures (WTO/SPS Committee) in 
Geneva, Switzerland, of this rule and will announce it online through 
the FSIS Web page located at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/interim-and-final-rules.
    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 Web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of this publication available 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 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

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at: http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410.
    Fax: (202) 690-7442.
    Email: [email protected].
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

List of Subjects in 9 CFR Part 327

    Imported products.

    For the reasons set out in the preamble, FSIS amends 9 CFR part 327 
as follows:

9 CFR PART 327--IMPORTED PRODUCTS

0
1. The authority citation for part 327 continues to read as follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.


Sec.  327.2  [Amended]

0
2. Amend Sec.  327.2(b) by adding ``Lithuania'' in alphabetical order 
to the list of countries.

    Done at Washington, DC, on: August 13, 2015.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2015-21510 Filed 8-28-15; 8:45 am]
BILLING CODE 3410-DM-P
52375

Rules and Regulations Federal Register
Vol. 80, No. 168

Monday, August 31, 2015

This section of the FEDERAL REGISTER Background requirements found in the FMIA and its
contains regulatory documents having general implementing regulations (9 CFR
On December 17, 2014, FSIS
applicability and legal effect, most of which 327.2(a)(2)(ii)).
are keyed to and codified in the Code of published a proposed rule in the
Federal Regulations, which is published under Federal Register (79 FR 75073) to add The country’s inspection system must
50 titles pursuant to 44 U.S.C. 1510. Lithuania to the list of countries eligible also impose requirements equivalent to
to export meat and meat products to the those of the United States with respect
The Code of Federal Regulations is sold by United States (9 CFR 327(b)). This final to: (1) Organizational structure and
the Superintendent of Documents. Prices of rule is consistent with the proposed staffing to ensure uniform enforcement
new books are listed in the first FEDERAL rule. of the requisite laws and regulations in
REGISTER issue of each week. As is explained in the proposed rule, all certified establishments; (2) national
under the FMIA and implementing government control and supervision
regulations, meat and meat products over the official activities of employees
DEPARTMENT OF AGRICULTURE imported into the United States must be or licensees; (3) qualified inspectors; (4)
produced under standards for safety, enforcement and certification authority;
Food Safety and Inspection Service
wholesomeness, and labeling that are (5) administrative and technical
equivalent to those of the United States support; (6) inspection, sanitation,
9 CFR Part 327
(21 U.S.C. 620). The FMIA also requires quality, species verification and residue
[Docket No. FSIS–2014–0040] that the livestock from which such standards; and (7) any other inspection
imports are produced be slaughtered requirements (9 CFR 327.2(a)(2)(i)).
RIN 0583–AD57 and handled in connection with
slaughter in a manner that is consistent Evaluation of the Lithuanian Meat
Eligibility of Lithuania To Export Meat with the Humane Methods of Slaughter Inspection System
and Meat Products to the United States Act (7 U.S.C. 1901–1906). In 2004, the government of Lithuania
Section 327.2 of Title 9 of the Code initially requested approval to export
AGENCY: Food Safety and Inspection
of Federal Regulations (CFR) sets out the meat, poultry, and egg products to the
Service, USDA.
procedures by which foreign countries United States. In January 2012,
ACTION: Final rule. may become eligible to export meat and Lithuania amended its request to
SUMMARY: The Food Safety and meat products to the United States. include only meat and meat products.
Inspection Service (FSIS) is amending Paragraph 327.2(a) requires that a FSIS then began to evaluate Lithuania’s
the Federal meat inspection regulations foreign country’s meat inspection inspection system to determine whether
to add the Republic of Lithuania system provide standards equivalent to it is equivalent to the United States’
(Lithuania) to the list of countries those of the United States and to system.
eligible to export meat and meat provide legal authority for the
FSIS conducted a document review of
products to the United States. FSIS has inspection system and its implementing
Lithuania’s meat inspection system
reviewed Lithuania’s laws, regulations, regulations that is equivalent to that of
through information provided on FSIS’s
and inspection system, as implemented, the United States. Specifically, a
Self-Reporting Tool (SRT) 1 to determine
and has determined that they are country’s laws and regulations must
whether its system is equivalent to that
equivalent to the Federal Meat impose requirements equivalent to those
of the United States. FSIS examined the
Inspection Act (FMIA), the regulations of the United States with respect to: (1)
information submitted by Lithuania to
implementing this statute, and the Ante-mortem inspection, humane
verify that the following equivalence
United States food safety system for methods of slaughter and handling, and
components were addressed
meat and meat products. post-mortem inspection by, or under the
satisfactorily with respect to standards,
Under this final rule, meat from cattle, direct supervision of, a veterinarian; (2)
activities, resources, and enforcement:
sheep, swine, and goats slaughtered in official controls by the national
(1) Government Oversight; (2) Statutory
Lithuania, or parts or other products government over establishment
Authority and Food Safety Regulations;
thereof, processed in certified construction, facilities, and equipment;
(3) Sanitation; (4) Hazard Analysis and
Lithuanian establishments, will be (3) direct and continuous official
Critical Control Point Systems; (5)
eligible for export to the United States. supervision of slaughtering and
Chemical Residue Testing Programs;
All such products will be subject to preparation of product by inspectors to
and (6) Microbiological Testing
reinspection at United States ports of ensure that product is not adulterated or
Programs. From that review, FSIS
entry by FSIS inspectors. misbranded; (4) complete separation of
concluded that Lithuania’s laws,
establishments certified to export from
DATES: Effective: October 30, 2015. regulations, control programs, and
those not certified; (5) maintenance of a
FOR FURTHER INFORMATION CONTACT: Dr. procedures were sufficient to achieve
single standard of inspection and
Daniel L. Engeljohn, Assistant sanitation throughout certified 1 The SRT is a standardized questionnaire that
Administrator, Office of Policy and establishments; (6) requirements for
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FSIS provides to foreign governments to gather
Program Development, Food Safety and sanitation and for sanitary handling of information that characterizes foreign inspection
Inspection Service, U.S. Department of product at establishments certified to systems according to the six equivalence
Agriculture, 1400 Independence Avenue export; (7) official controls over components and as required by 9 CFR
SW., Washington, DC 20250–3700; 327.2(a)(2)(iii). FSIS asks foreign governments to
condemned product; (8) a Hazard submit documentation, such as their inspection
Telephone: (202) 205–0495. Analysis and Critical Control Point system laws, regulations, and policy issuances, that
SUPPLEMENTARY INFORMATION: (HACCP) system; and (9) any other supports their responses to the SRT questions.

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52376 Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Rules and Regulations

the level of public health protection requirements equivalent to those of the The following is a brief summary of the
required by FSIS. United States (9 CFR 327.2(a)). relevant issues raised in the comments
FSIS then proceeded with an initial Although a foreign country may be and FSIS’s responses.
on-site audit of Lithuania’s meat listed in FSIS’s regulations as eligible to
export meat and meat products to the 1. Animal Diseases
inspection system in September 2012
and concluded that Lithuania’s system United States, the exporting country’s Comment: One individual opposed
met each equivalence component except products must also comply with all importing Lithuanian meat and meat
sanitation. Lithuania’s State Food and other applicable requirements of the products, stating that animal feeding
Veterinary Service (SFVS), which is United States, including those of practices in Lithuania would not
Lithuania’s central competent authority USDA’s Animal and Plant Health effectively prevent bovine spongiform
in charge of food inspection, took Inspection Service (APHIS). These encephalopathy (BSE). Three pork
immediate corrective actions to address requirements include restrictions under industry groups opposed the rule,
the audit team’s findings and provided 9 CFR part 94 of the APHIS regulations, stating that several cases of African
a corrective action plan, which included which regulate the importation of meat Swine Fever (ASF) reported over the
new regulations, procedures, and meat products from countries into past year in domestic and feral swine
implementation measures, and the United States to control the spread populations in Lithuania and adjacent
verification activities. FSIS reviewed the of specific animal diseases. countries would lead to problems in the
plan and concluded that it addressed all Also, under this final rule, all meat United States. A consumer advocacy
of the audit findings. and meat products exported to the organization stated that allowing
United States from Lithuania will be Lithuanian products into the United
FSIS conducted a second on-site audit
subject to reinspection by FSIS at States could lead to the transmission of
in September 2013 to verify that all
United States ports of entry for, but not certain animal diseases into the United
outstanding issues identified during the
limited to, transportation damage, States because Lithuania shares
previous audit had been resolved and
product and container defects, labeling, common borders with countries that are
that Lithuania had satisfactorily
proper certification, general condition, not free of ASF, Foot-and-Mouth
implemented all of the laws, and accurate count.
regulations, and instructions to the field Disease (FMD), Classical Swine Fever
FSIS will conduct other types of
that FSIS found to be equivalent during (CSF), or Swine Vesicular Disease (SVD)
reinspection activities, such as
the document review and previous and has trade practices with these
incubation of canned products to ensure
audit. FSIS concluded, on the basis of countries that are less restrictive than
product safety and taking product
this audit, that Lithuania had those of the United States.
samples for laboratory analysis to detect
satisfactorily implemented the any drug or chemical residues or Agency Response: To export meat and
corrective action plan that it had pathogens that may render the product meat products to the United States,
submitted in response to the 2012 audit. unsafe or any species or product countries need to meet the APHIS
Consequently, on December 17, 2014, composition violations that would requirements for animal disease
FSIS published a proposed rule to find render the product economically prevention and control. APHIS uses
that Lithuania’s meat inspection system adulterated. Products that pass several methods to ensure that harmful
is equivalent to the United States’ reinspection will be stamped with the animal diseases do not enter the United
system and, therefore, to add Lithuania official mark of inspection and allowed States. These include actively
to the list of countries eligible to export to enter U.S. commerce. If they do not monitoring the animal disease status of
meat and meat products to the United meet U.S. requirements, they will be foreign countries and maintaining lists
States. For more detailed information on refused entry and within 45 days will of countries and regions considered to
FSIS’s evaluation of the Lithuanian have to be returned to the country of be free (or not free) of certain diseases.
meat inspection system, see the origin, destroyed, or converted to If an animal disease is found to exist in
proposed rule (79 FR 75073), and for the animal food (subject to approval of the a country (or a region within a country)
full audit reports, go to: http:// Food and Drug Administration (FDA)), that exports meat, poultry, or egg
www.fsis.usda.gov/wps/portal/fsis/ depending on the violation. The import products to the United States, APHIS
topics/international-affairs/importing- reinspection activities can be found on requires specific processing steps to
products/eligible-countries-products- the FSIS Web site at: http:// ensure that any product from that
foreign-establishments/foreign-audit- www.fsis.usda.gov/wps/portal/fsis/ country or region will not cause the
reports. topics/international-affairs/importing- disease to be transmitted to the United
products/port-of-entry-procedures. States (see 9 CFR part 94).
Final Rule
In addition, Lithuanian meat and In addition to these monitoring and
After considering the comments meat products will be eligible for processing provisions, APHIS requires
received on the proposed rule, importation into the United States only imported meat, poultry, and egg
discussed below, FSIS concludes that if they are from animals slaughtered on products to have accompanying
Lithuania’s meat inspection system is or after the effective date of this final documentation regarding their origin,
equivalent to the United States’ rule. animal disease status, degree of
inspection system for meat and meat processing, and intended use. At the
products. Therefore, FSIS is amending Summary of Comments and Responses U.S. border, CBP officials verify that
its meat inspection regulations to add FSIS received seven comments in such documentation is accurate and that
Lithuania to the list of countries eligible response to the proposed rule. One the products do not pose an animal
to export meat and meat products to the individual supported the proposed rule. disease transmission risk. These steps
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United States (9 CFR 327.2(b)). Under Two individuals, a consumer advocacy take place before FSIS reinspects
FSIS’s import regulations, the organization, and three trade imported product for food safety and
government of Lithuania must certify to associations representing the pork other regulatory compliance. All meat
FSIS that those establishments that wish industry, opposed it. After review and and meat products that APHIS restricts
to export meat and meat products to the consideration of these comments, FSIS from entering the United States because
United States are operating under is finalizing the regulation as proposed. of animal disease concerns will be

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Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Rules and Regulations 52377

refused entry by U.S. Customs and processing, packing, certification, meat or meat product must enter the
Border Protection (CBP). transportation, and handling United States through an official import
In the case of BSE, APHIS takes into requirements. inspection establishment and be
consideration the risk status recognition Under the final rule, Lithuania will be reinspected by an FSIS import
as determined by the World eligible to export meat and meat inspector.
Organization for Animal Health (OIE), products to the United States, but will
or conducts its own BSE risk be required to meet APHIS’s 4. Audit Report Findings
determination upon request. OIE requirements. Because Lithuania’s Comment: A consumer advocacy
designates countries as having a disease status may change with respect organization expressed several concerns
negligible or controlled BSE risk. to any animal disease, FSIS will regarding the two audits of Lithuania’s
Countries that do not meet those coordinate with APHIS and consider meat inspection system. The
designations are considered to have an how any change may affect Lithuania’s organization stated that: (1) The reports
undetermined risk. OIE and APHIS eligibility to export certain types of are incomplete because they fail to
currently designate Lithuania as a products to the United States. include establishment checklists used
country with controlled BSE risk. The by the FSIS auditor to evaluate how
2. Domestic Production well the Lithuanian inspection program
review of Lithuania’s food safety system
for potential BSE contamination also Comment: One individual argued that enforced food safety laws and
indicated that SFVS employs effective increasing demand for goat meat in the regulations at the plant level; (2) the
measures to prevent Specified Risk United States should be met through first audit found that Lithuania’s SFVS
Materials (SRM) (materials from cattle increased local goat production rather had inexplicably dropped a requirement
that scientific studies have than imports. Another individual that establishments seeking to export to
demonstrated can contain the BSE agent opposed the rule because the United the United States maintain written
in cattle infected with the disease) from States already has thousands of meat Sanitation Standard Operating
contaminating the food supply. Removal products in commerce. Procedures; (3) the second audit noted
of SRMs decreases the risk of Agency Response: The final rule will that improvement was still needed in
introduction of BSE to a negligible level. list Lithuania as eligible to export meat Lithuania’s inspectors’ verification of
Therefore, FSIS has determined that and meat products derived from cattle, establishments’ compliance with zero
Lithuania’s measures to remove SRMs swine, sheep, and goats to the United tolerance requirements for fecal
from its food supply adequately address States (9 CFR 327.2(b)). Although material, ingesta, and milk on carcasses
the potential risk that the BSE agent Lithuania will be listed as eligible, it is and meat parts; (4) in the second audit
could contaminate products destined for unlikely to export significant quantities report, audit staff were concerned about
the United States. of goat meat or meat products to the the ability of Lithuanian inspection
APHIS currently considers Lithuania United States. Lithuania is a net personnel to recognize potential
to be free of SVD, rinderpest, and FMD. importer of goat meat and does not have sanitation issues in ready-to-eat
APHIS, however, has placed Lithuania export capacity in this area. In 2014, processing facilities; and (5) neither
in a ‘‘special category’’ because of its Lithuania imported about $3,000 worth audit report mentioned what
common land border with countries that of such products, less than one metric precautions the Lithuanian food safety
have not been identified to be free of ton (MT), and did not export any such authorities would take as a consequence
these diseases, and because Lithuania’s products. Currently, the United States of the 2013 horse meat scandal in the
trade practices are less restrictive than imports about 19,000 MT of goat meat European Union, in which Lithuanian
those of the United States. Lithuania’s per year, of which 98% comes from products were implicated.
trade practices could, therefore, result in Australia. Lithuania must be export- Agency Response: FSIS’s evaluation
a Lithuanian meat supply that is capable and price-competitive to of all the data collected before, during,
supplemented with animal products compete in this market. As is discussed and after the on-site audits supports the
from neighboring countries. in the economic analysis below, conclusion that the Lithuanian meat
Establishments in ‘‘special category’’ Lithuania has stated that it intends to regulatory system achieves a level of
countries must certify compliance with export only canned, dried, smoked beef protection equivalent to that of the
specific APHIS regulations, which and pork products to the United States United States. FSIS evaluated how well
ensure that animals and animal at this time. Lithuania’s inspection program enforced
products received by these food safety laws and regulations at the
establishments, and the products 3. Adequate Regulation plant level, including audit checklists
produced by them, are not contaminated Comment: One individual stated that for specific establishments. The
through contact with regions where the FDA was unqualified to certify Lithuania establishment checklists are
these diseases exist (see 9 CFR Lithuanian establishments seeking to posted at the following link: http://
94.11(c)(2) and 94.13(c)(2)). export meat or meat products to the www.fsis.usda.gov/wps/portal/fsis/
APHIS recognizes that ASF outbreaks United States. topics/international-affairs/importing-
have occurred in wild boar and Agency Response: Under 9 CFR products/eligible-countries-products-
domestic swine in Lithuania. Lithuania 327.2(a)(3), the government of Lithuania foreign-establishments/foreign-audit-
has imposed controls, consistent with must certify to FSIS that those reports.
European Union legislation, to prevent establishments that wish to export meat The follow-up audit of Lithuania’s
the spread of this disease. These and meat products to the United States meat inspection system confirmed that
controls restrict the movement of pigs are operating under requirements SFVS adequately and effectively
and pig products, including pork, from equivalent to those of the United States. addressed all the findings related to the
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areas where the disease has occurred. These certifications are subject to previous FSIS initial equivalence on-site
Were APHIS to add any geographic area review by FSIS. FSIS also conducts audit conducted from September 10–26,
of Lithuania to the list of ASF-affected periodic equivalence audits of countries 2012. The FSIS auditor attested that all
regions, Lithuania would be required to eligible to export meat, poultry, or egg corrective actions were implemented in
comply with 9 CFR 94.8(b)–(d), which products to the United States and will a manner consistent with FSIS’s
mandates cooking, sealing, cleaning, do so for Lithuania. Every imported inspection requirements. Additionally,

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52378 Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Rules and Regulations

SFVS responded adequately to two verification activities at United States expected to have minimal effect (3,000
areas in need of improvement: Verifying ports of entry, will ensure that MT represents a 0.023% increase),
that establishments’ HACCP systems fraudulently labeled Lithuanian meat leaving the total United States beef
ensure that all portions of carcasses products will not enter United States supply almost unchanged. Because
were free of visible contamination with commerce. importing beef from Lithuania is not
fecal material, milk, or ingesta, and expected to greatly alter the United
requiring that establishments control the Executive Orders 12866 and 13563, and States beef supply, it will not contribute
movement of personnel and materials in the Regulatory Flexibility Act to any price change in that market.
establishments producing Ready-to-Eat Executive Orders (E.O.) 12866 and Lithuanian data from CY2013 5 shows
(RTE) products. SFVS required 13563 direct agencies to assess all costs that this country reached its maximum
immediate adjustments to and benefits of available regulatory pork export capacity, meaning it will
establishments’ HACCP systems and alternatives and, if regulation is export little, if any, pork to the United
sanitation programs, introduced necessary, to select regulatory States. Considering that the United
correlation sessions to reinforce approaches that maximize net benefits States pork supply is 11,212,000 MT
supervisors’ understanding of food (including potential economic, (CY2013),6 it is unlikely that imports
safety tasks related to export to the environmental, public health and safety from Lithuania will result in price
United States, and implemented on- effects, distributive impacts, and changes in the United States pork
going training programs for the equity). E.O. 13563 emphasizes the market.
inspection program personnel. SFVS importance of quantifying both costs This cost analysis was based on
implemented its corrective action plan and benefits, of reducing costs, of Lithuania’s full export capacity.
and provided supporting documents harmonizing rules, and of promoting Currently, however, only six Lithuanian
during and after its exit meeting with flexibility. This final rule was establishments intend to export product
FSIS. These corrective actions improved designated a ‘‘non-significant’’ to the United States. Four are meat
the performance of official verification regulatory action under section 3(f) of processors only, one is a slaughter
activities and demonstrated SFVS’s E.O. 12866. Accordingly, this rule was facility, and one conducts both meat
commitment to consistently meeting the not reviewed by OMB under E.O. 12866. slaughter and processing. Of the four
requirements for exporting meat and processing facilities, three process beef
meat products to the United States. Economic Impact Analysis and pork, and one processes pork only.
In 2013, a variety of meat products in FSIS is adopting, in its entirety, the The slaughter-only facility and the
the European Union were found to proposed regulatory impact analysis facility that conducts both slaughter and
contain meat which was not declared on from the proposed rule.2 Lithuania processing both handle beef and pork.
the label, including horse meat and expressed an intent to export canned, The combined export capacity of these
pork. In response, the European dried, or smoked beef and pork products six establishments is much less than
Commission and EU Member States, to the United States. Lithuania, Lithuania’s total export capacity. With
including Lithuania, have pursued however, will not be precluded from no price change expected in U.S. meat
efforts to ensure the proper labeling of exporting other meat products in the markets, the final rule would not lead to
meat products, including increased future if the products meet all any negative effects on U.S. consumers.
communication among food safety applicable APHIS and FSIS Lithuanian companies that export
agencies regarding food fraud, DNA requirements for those products. Given product to the United States and
monitoring, revised registration and the limited market in the United States domestic companies that import
identification procedures for horses in for Lithuanian meat products and products from Lithuania to the United
the EU, increased penalties for Lithuania’s low projected export States will incur standard costs such as
fraudulent activity, and stricter origin volume, there is likely to be little, if any, export fees and freight and insurance
labeling. Lithuania, as a Member of the impact on the United States economy. costs. They will be willing to bear these
EU, is bound by the EU Regulations Lithuania is a small beef producer costs because of the anticipated
under which these actions have been with limited beef export capacity. Its financial benefits associated with
taken. maximum beef export to the world was marketing their products in the United
FSIS also verified that SFVS conducts achieved in 2011, when it exported States.
species verification testing of meat and $130 million, or 25,000 MT, worth of The final rule will increase trade
meat products intended for both beef, mainly to the European Union and between the United States and
domestic production and export, in Russia. Based on analysis of Lithuania’s Lithuania. The volume of trade
accordance with the SFVS Director exports to Russia, FSIS estimates that stimulated by this rule is likely to be
Order No B1–23. This testing will Lithuania has an excess beef export small and is expected to have little or
ensure that only eligible species will be capacity of $26 million ($130 million ¥ no effect on U.S. meat supplies or meat
exported to the United States. $104 million = $26 million) in value, or prices. U.S. consumers, however, are
Furthermore, the FSIS auditor verified 3,000 MT (25,000 MT ¥ 22,000 MT = expected to enjoy more choices when
that Lithuanian establishments are 3,000 MT) in volume, that could be purchasing meat and meat products.
required to ensure that food intended exported to the United States.3 Lithuanian establishments will export
for human consumption is adequately Accordingly, allowing Lithuanian commercially sterile meat products,
labeled or identified to facilitate its beef exports to enter the 13,050,000– including canned meat products and
traceability in accordance with Article MT 4 United States beef market is ready-to-eat products like salamis and
18 for Regulation (EC) No 178/2002. The
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identification and labeling requirements 2 79 FR 75075. available at: https://apps.fas.usda.gov/psdonline/
include, at least, the source of food, 3 This data is from Eurostat, the statistical office psdQuery.aspx.
animal byproduct, or ingredients in a of the European Union, and is based on Lithuania’s 5 This data is from Eurostat, based on Lithuania’s

manner that supports effective official statistics. It is also available at the Global official statistics. It is also available at the Global
Trade Atlas database at: http://www.gtis.com/gta/ Trade Atlas database at: http://www.gtis.com/gta/
investigation and traceability. FSIS is secure/gateway.cfm. secure/gateway.cfm.
confident that the Lithuanian measures 4 Source: Foreign Agricultural Service (FAS) 6 Source: FAS PSD data, available at: https://

in place, along with its reinspection and Production, Supply and Distribution (PSD) data, apps.fas.usda.gov/psdonline/psdQuery.aspx.

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Document Created: 2018-02-23 11:04:41
Document Modified: 2018-02-23 11:04:41
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		Effective: October 30, 2015.
Contact		Dr. Daniel L. Engeljohn, Assistant Administrator, Office of Policy and Program Development, Food Safety and Inspection Service, U.S. Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 20250-3700; Telephone: (202) 205-0495.
FR Citation		80 FR 52375
RIN Number		0583-AD57
80 FR 52375 - Eligibility of Lithuania To Export Meat and Meat Products to the United States

DEPARTMENT OF AGRICULTUREFood Safety and Inspection Service

Federal Register Volume 80, Issue 168 (August 31, 2015)

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
