Eligibility of Lithuania To Export Meat and Meat Products to the United States, 52375-52379 [2015-21510]

Download as PDF 52375 Rules and Regulations Federal Register Vol. 80, No. 168 Monday, August 31, 2015 This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. The Code of Federal Regulations is sold by the Superintendent of Documents. Prices of new books are listed in the first FEDERAL REGISTER issue of each week. 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 Food Safety and Inspection Service, USDA. ACTION: Final rule. AGENCY: 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: rmajette on DSK7SPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 13:58 Aug 28, 2015 Jkt 235001 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 PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 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 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. E:\FR\FM\31AUR1.SGM 31AUR1 52376 Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Rules and Regulations the level of public health protection required by FSIS. 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/importingproducts/eligible-countries-productsforeign-establishments/foreign-auditreports. rmajette on DSK7SPTVN1PROD with RULES 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 VerDate Sep<11>2014 13:58 Aug 28, 2015 Jkt 235001 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/importingproducts/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. PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 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 E:\FR\FM\31AUR1.SGM 31AUR1 rmajette on DSK7SPTVN1PROD with RULES Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Rules and Regulations 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, VerDate Sep<11>2014 13:58 Aug 28, 2015 Jkt 235001 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 exportcapable 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 PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 52377 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-to-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/importingproducts/eligible-countries-productsforeign-establishments/foreign-auditreports. 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, E:\FR\FM\31AUR1.SGM 31AUR1 rmajette on DSK7SPTVN1PROD with RULES 52378 Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Rules and Regulations 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 ongoing 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 VerDate Sep<11>2014 13:58 Aug 28, 2015 Jkt 235001 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. 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 Accordingly, allowing Lithuanian beef exports to enter the 13,050,000– MT 4 United States beef market is 2 79 FR 75075. 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. 4 Source: Foreign Agricultural Service (FAS) Production, Supply and Distribution (PSD) data, 3 This PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 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. 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. 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 available at: https://apps.fas.usda.gov/psdonline/ psdQuery.aspx. 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. E:\FR\FM\31AUR1.SGM 31AUR1 Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Rules and Regulations 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 EGovernment 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. rmajette on DSK7SPTVN1PROD with RULES 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/ VerDate Sep<11>2014 13:58 Aug 28, 2015 Jkt 235001 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. 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: program.intake@usda.gov. PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 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 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. § 327.2 [Amended] 2. Amend § 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 DEPARTMENT OF THE TREASURY Community Development Financial Institutions Fund 12 CFR Part 1805 RIN 1505–AA92 Community Development Financial Institutions Program Community Development Financial Institutions Fund, Department of the Treasury. ACTION: Interim rule with request for comment. AGENCY: The Department of the Treasury is issuing an interim rule implementing the Community Development Financial Institutions Program (CDFI Program), administered by the Community Development Financial Institutions Fund (CDFI Fund). This interim rule includes revisions necessary to implement the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards published by the Department of the Treasury on December 19, 2014, as well as to make technical corrections and other updates to the current rule. DATES: Effective date: August 31, 2015; all comments must be written and must be received in the offices of the CDFI Fund on or before October 30, 2015. SUMMARY: How To File a Complaint of Discrimination 52379 E:\FR\FM\31AUR1.SGM 31AUR1

Agencies

[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)]
[Rules and Regulations]
[Pages 52375-52379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21510]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
week.

========================================================================


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.

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

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \2\ 79 FR 75075.
---------------------------------------------------------------------------

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

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \4\ Source: Foreign Agricultural Service (FAS) Production, 
Supply and Distribution (PSD) data, available at: https://apps.fas.usda.gov/psdonline/psdQuery.aspx.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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: program.intake@usda.gov.
    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