[Federal Register Volume 79, Number 242 (Wednesday, December 17, 2014)]
[Proposed Rules]
[Pages 75073-75076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29605]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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 

  Federal Register / Vol. 79, No. 242 / Wednesday, December 17, 2014 / 
Proposed Rules  

[[Page 75073]]



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: Proposed rule.

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SUMMARY: USDA's Food Safety and Inspection Service (FSIS) is proposing 
to add the Republic of Lithuania (Lithuania) to the list of countries 
eligible to export meat and meat products to the United States. FSIS's 
review of Lithuania's laws, regulations, and inspection implementation 
show that its meat inspection system requirements are equivalent to the 
Federal Meat Inspection Act (FMIA) and its implementing regulations.
    Under this proposal, meat from cattle, sheep, swine, and goats 
slaughtered in Lithuania, or parts or other products thereof, processed 
in certified Lithuanian establishments, would be eligible for export to 
the United States. All such products would be subject to reinspection 
at United States ports-of-entry by FSIS inspectors.

DATES: Comments must be received on or before February 17, 2015.

ADDRESSES: FSIS invites interested persons to submit comments on this 
rule. Comments may be submitted by one of the following methods:
     Federal eRulemaking Portal: This Web site 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 http://www.regulations.gov. Follow the online instructions at that site for 
submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, Patriots 
Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163A, 
Washington, DC 20250-3700.
     Hand- or courier-delivered submittals: Deliver to Patriots 
Plaza 3, 355 E Street SW., Room 8-163A, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2014-0040. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel Engeljohn, Assistant 
Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495.

SUPPLEMENTARY INFORMATION: 

Background

    FSIS is proposing to amend the Federal 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)). Lithuania is not 
currently listed as eligible to export such products to the United 
States.

Statutory Basis for Proposed Action

    Under the FMIA and the regulations that implement it, meat and meat 
products imported into the United States must be produced under 
standards for safety, wholesomeness, and labeling accuracy 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) of 9 CFR 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 legal authority 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)).
    A foreign country's inspection system must be evaluated by FSIS 
before eligibility to export meat and meat products to the United 
States can be granted. 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. FSIS requests that 
countries provide information about their inspection systems through 
its self-reporting tool (SRT).\1\ Through the SRT, FSIS collects

[[Page 75074]]

information on practices and procedures in six areas, known as 
equivalence components: (1) Government Oversight, (2) Statutory 
Authority and Food Safety Regulations, (3) Sanitation, (4) HACCP 
Systems, (5) Chemical Residue Testing Programs, and (6) Microbiological 
Testing 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 
onsite 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 Web site at: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/equivalence/equivalence-process-overview.
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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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    The FMIA and implementing regulations require that foreign 
countries be listed in the CFR as eligible to import meat and meat 
products into the United States. FSIS must engage in rulemaking to list 
a country as eligible. Countries found eligible to import meat or meat 
products into the United States are listed in the meat inspection 
regulations at 9 CFR 327.2(b). Once listed, the government of an 
eligible country must certify to FSIS that establishments that wish to 
export meat products to the United States are operating under 
requirements equivalent to those of the United States (9 CFR 
327.2(a)(3)). Countries must renew certifications of establishments 
annually.
    Section 20 of the FMIA (21 U.S.C. 620) prohibits importing into the 
United States adulterated or misbranded carcasses, parts of carcasses, 
meat, or meat products of amenable species, which are capable of use as 
human food. To verify that products imported into the United States are 
not adulterated or misbranded, FSIS reinspects and randomly samples 
those products at import, before they enter U.S. commerce.

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. After 
several consultations and FSIS visits to Lithuania, the country amended 
its request to include only meat and meat products in January 2012. If 
approved, Lithuania stated its immediate intent to export canned, 
dried, or smoked meat products of beef and pork to the United States. 
However, if approved, Lithuania would not be precluded from exporting 
other meat products in the future provided the products meet all 
applicable requirements for those products established by the USDA's 
Animal and Plant Health Inspection Service (APHIS) as well as by FSIS.
    FSIS conducted a document review of Lithuania's meat (slaughter and 
processing) inspection system through information provided through the 
SRT to determine whether that system is equivalent to the United 
States' meat inspection system. Based on that review, FSIS concluded 
that Lithuania's laws, regulations, control programs, and procedures 
were sufficient to achieve the level of public health protection 
required by FSIS.
    Accordingly, FSIS proceeded with an initial on-site audit of 
Lithuania's meat inspection system from September 10 to 26, 2012, to 
verify whether Lithuania's State Food and Veterinary Service (SFVS), 
which is Lithuania's central competent authority in charge of food 
inspection, effectively implemented a meat inspection system equivalent 
to that of the United States. FSIS concluded that Lithuania's meat 
inspection system met each equivalence component except sanitation. 
FSIS found that Lithuania had modified its inspection requirements 
since the document review, and no longer required written standard 
operating procedures for sanitation (Sanitation SOPs) from 
establishments. Additionally, the sanitation programs at all of the 
establishments visited by the audit team lacked measures to prevent 
recurring deficiencies that could result in direct product 
contamination or adulteration.
    The initial on-site audit revealed other issues of concern, but 
none that resulted in a failure to meet the other five equivalence 
components. SFVS 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. The initial audit report contains a full 
discussion of the corrective actions proffered by SFVS: http://www.fsis.usda.gov/wps/wcm/connect/600646a6-75fb-4d24-b82e-02361c06f3db/Lithuania-2012.pdf?MOD=AJPERES.
    FSIS conducted a second on-site audit from September 16 to 24, 
2013, to verify that Lithuania had satisfactorily implemented all the 
laws, regulations, and instructions to the field that FSIS found to be 
equivalent during the document analysis and to verify that all 
outstanding issues identified during the previous audit had been 
resolved. FSIS concluded, based on this audit, that Lithuania had 
satisfactorily addressed all audit findings and had met the FSIS 
equivalence criteria for all six components. For example, during the 
audit, FSIS verified that Lithuania had reestablished a regulatory 
requirement that establishments develop and maintain written Sanitation 
SOPs as a condition for gaining certification to export meat products 
to the U.S. FSIS also verified that Lithuania's inspection system has 
established official procedures to verify that each establishment has 
an effective sanitation program that meets the regulatory requirements, 
including development and maintenance of Sanitation SOPs.
    Similarly, FSIS previously found that the SFVS did not ensure that 
establishments' HACCP corrective actions included preventive measures, 
or that establishments were documenting their monitoring or 
verification activities. During the most recent audit, FSIS verified 
that inspection program personnel are now effectively performing 
verification activities designed to ensure that establishments are 
properly documenting their monitoring and verification activities and 
are documenting preventive measures in response to HACCP system 
deviations.
    In summary, FSIS has completed the document review, on-site audit, 
and verification of corrective actions as part of the equivalence 
process, and all outstanding issues have been resolved. FSIS has 
determined that, as implemented, Lithuania's meat inspection system 
(slaughter and processing) is equivalent to the United States' meat 
inspection system. The full report on Lithuania's meat inspection 
system (slaughter and processing) can be found on the FSIS Web site at: 
http://www.fsis.usda.gov/wps/wcm/connect/87776212-0dec-44c3-8ee4-155ad0a02b15/Lithuania_2013_FAR.pdf?MOD=AJPERES.
    Should this rule become final, the Government of Lithuania must 
certify to FSIS that those establishments that wish to export meat or 
meat products to the United States are operating in accordance with 
requirements equivalent to those of the United States. FSIS will verify 
that the establishments certified by Lithuania's government are

[[Page 75075]]

meeting the United States' requirements through periodic, regularly 
scheduled audits of Lithuania's meat inspection system. Certified 
establishments may export to the United States any meat or meat 
products from cattle, sheep, swine, and goats (9 CFR 327.2(b)).
    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. These requirements include 
restrictions under 9 CFR part 94 of APHIS' regulations, which also 
regulate the export of meat products from foreign countries to the 
United States.
    If this proposed rule is adopted, all meat and meat products 
exported to the United States from Lithuania will be subject to 
reinspection at U.S. ports-of-entry for, but not limited to, 
transportation damage, product and container defects, labeling, proper 
certification, general condition, and accurate count.
    In addition, 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 for the 
detection of drug and chemical residues, pathogens, species, and 
product composition. Products that pass reinspection will be stamped 
with the official USDA 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 they must be returned to the country of 
origin, destroyed, or converted to animal food (subject to approval by 
the Food and Drug Administration), 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/fsis-import-reinspection/CT_Index9.

Executive Orders 12866 and 13563, and the Regulatory Flexibility Act

    Executive Orders 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). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This proposed rule has been designated a ``non-
significant'' regulatory action under section 3(f) of Executive Order 
(E.O.) 12866. Accordingly, the rule has not been reviewed by the Office 
of Management and Budget (OMB) under E.O. 12866.

Expected Cost of the Proposed Rule

    If this rule is finalized, Lithuania intends to start with 
exporting canned, dried, or smoked beef and pork products to the United 
States. As noted above, if this rule is finalized, Lithuania would not 
be precluded from exporting other meat products in the future if the 
products meet all applicable APHIS and FSIS requirements for those 
products. Lithuania, however, will not be limited to the export of 
canned, dried, or smoked beef and pork products only. 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.
    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 metric tons (MT), worth of 
beef,\2\ mainly to the European Union and Russia.
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    \2\ 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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    Based on analysis of Lithuania's exports to Russia,\3\ 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.
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    \3\ Ibid.
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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 CY 2013 \5\ shows that this country has 
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 (CY 2013),\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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    The above cost analysis is 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, adopting this proposed rule would lead 
to no negative effects on U.S. consumers.
    Lithuanian companies that export product to the U.S. or U.S. 
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, however, because of 
the anticipated financial benefits associated with marketing their 
products in the United States.

Expected Benefits of the Proposed Rule

    Adoption of this proposed rule will increase trade between the 
United States and Lithuania. The volume of trade stimulated by the 
proposed 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 seek to export commercially 
sterile meat products, including canned meat products and ready-to-eat 
products like salamis and other dried and smoked meats to the United 
States. The proposed rule would, therefore, expand choices for U.S. 
consumers and promote economic competition.

Regulatory Flexibility Act Assessment

    The FSIS Administrator has made a preliminary determination that 
this proposed rule would not have a significant economic impact on a 
substantial number of small entities in the United States, as defined 
by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).

[[Page 75076]]

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.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this proposed 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 retroactive proceedings will be required before parties may file 
suit in court challenging this rule.

Executive Order 13175

    This proposed rule has been reviewed in accordance with the 
requirements of Executive Order 13175, Consultation and Coordination 
with Indian Tribal Governments. The review reveals that this regulation 
will not have substantial and direct effects on Tribal governments and 
will not have significant Tribal implications.

USDA Non-Discrimination 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.
    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).

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 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.

List of Subjects in 9 CFR Part 327

    Imported products.

    For the reasons set out in the preamble, FSIS is proposing to amend 
9 CFR part 327 as follows:

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. Section 327.2 is amended in paragraph (b) by adding ``Lithuania'' in 
alphabetical order to the list of countries.

    Done at Washington, DC, on: December 12, 2014.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2014-29605 Filed 12-16-14; 8:45 am]
BILLING CODE 3410-DM-P