Importation of Fresh Beef From Paraguay, 18077-18086 [2023-05889]

Download as PDF Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Proposed Rules (1) How spot prices are estimated are not expected to be impacted by this action; (2) Business practices of the U.S. cotton industry are not expected to change as a result of this action; (3) Costs associated with providing market news services will not be significantly changed by this action; (4) Market news services are paid for by appropriated funds; therefore, users are not charged fees for the provision of the services. West Texas, Kansas, and Oklahoma All counties in Kansas and Oklahoma, all Texas counties not included in the East Texas, South Texas, and Desert Southwest Markets and the New Mexico counties of Union, Quay, Curry, Roosevelt, and Lea. * * * * * ■ 3. In § 27.94, paragraph (a) is revised to read as follows: § 27.94 Spot markets for contract settlement purposes. * Paperwork Reduction Act In compliance with OMB regulations (5 CFR part 1320), which implement the Paperwork Reduction Act (PRA) (44 U.S.C. 3501), the information collection requirements contained in the provisions to be amended by this proposed rule have been previously approved by OMB and were assigned OMB control number 0581–0009, Cotton Classification and Market News Service. AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. AMS has not identified any relevant Federal rules that duplicate, overlap, or conflict with this proposed rule. List of Subjects in 7 CFR Part 27 * * * * (a) For cotton delivered in settlement of any No. 2 contract on the Intercontinental Exchange (ICE); Southeastern; North and South Delta; East Texas and South Texas; West Texas, Kansas, and Oklahoma; and Desert Southwest. * * * * * Melissa Bailey, Associate Administrator, Agricultural Marketing Service. [FR Doc. 2023–06231 Filed 3–24–23; 8:45 am] BILLING CODE P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 94 [Docket No. APHIS–2018–0007] Commodity futures, Cotton. RIN 0579–AE73 For the reasons set forth in the preamble, the Agricultural Marketing Service proposes to amend 7 CFR part 27 as follows: Importation of Fresh Beef From Paraguay Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule. AGENCY: PART 27—COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION We are proposing to amend the regulations governing the importation of certain animals, meat, and other animal products by allowing, under certain conditions, the importation of fresh (chilled or frozen) beef from Paraguay. Based on the evidence from a risk analysis, we have determined that fresh beef can safely be imported from Paraguay, provided certain conditions are met. This action would provide for the importation of fresh beef from Paraguay into the United States while continuing to protect the United States against the introduction of foot-and-mouth disease. DATES: We will consider all comments that we receive on or before May 26, 2023. SUMMARY: 1. The authority citation for 7 CFR part 27 continues to read as follows: ■ Authority: 7 U.S.C. 15b, 7 U.S.C. 473b, 7 U.S.C. 1622(g). 2. In § 27.93, the definitions of the ‘‘East Texas and Oklahoma,’’ and ‘‘West Texas’’ markets are revised to read as follows: ■ ddrumheller on DSK120RN23PROD with PROPOSALS1 § 27.93 * * Bona fide spot markets. * * * East Texas and South Texas Texas counties east of and including Montague, Wise, Parker, Erath, Comanche, Mills, San Saba, Mason, Sutton, Edwards, Kinney, Maverick, Webb, Zapata, Star and Hidalgo counties. * * * * * VerDate Sep<11>2014 19:07 Mar 24, 2023 Jkt 259001 You may submit comments by either of the following methods: ADDRESSES: PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 18077 • Federal eRulemaking Portal: Go to www.regulations.gov. Enter APHIS– 2018–0007 in the Search Field. Select the Documents tab, then select the Comment button in the list of documents. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2018–0007, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road, Unit 118, Riverdale, MD 20737–1238. Supporting documents and any comments we receive on this docket may be viewed at www.regulations.gov or in our reading room, which is located in room 1620 of the USDA South Building, 14th Street and Independence Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799–7039 before coming. FOR FURTHER INFORMATION CONTACT: Dr. Ingrid Kotowski, Import Risk Analyst, Regionalization Evaluation Services, VS, APHIS, 920 Main Campus Drive, Suite 200, Raleigh, NC 27606; (919) 855–7732; email: AskRegionalization@usda.gov. SUPPLEMENTARY INFORMATION: Background The regulations in 9 CFR part 94 (referred to below as the regulations) prohibit or restrict the importation of certain animals and animal products into the United States to prevent the introduction of various animal diseases, including foot-and-mouth disease (FMD), African swine fever, classical swine fever, and swine vesicular disease. These are dangerous and destructive communicable diseases of ruminants and swine. Under most circumstances, § 94.1 of the regulations prohibits the importation of live ruminants and swine and fresh (chilled or frozen) meat derived from ruminants and swine originating in, or transiting through, a region where FMD exists. Section 94.11 restricts the importation of ruminants and swine and their meat and certain other products from regions that are declared free of FMD but that nonetheless present a disease risk because of the regions’ proximity to or trading relationships with regions affected with FMD. Regions that the Animal and Plant Health Inspection Service (APHIS) has declared free of FMD and regions declared free of FMD that are subject to the restrictions in § 94.11 are listed on the APHIS website at https://www.aphis.usda.gov/import_ export/animals/animal_disease_ status.shtml. The regulations do allow for certain exceptions to the prohibitions contained E:\FR\FM\27MRP1.SGM 27MRP1 18078 Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS1 in § 94.1. These exceptions include allowing the importation of fresh (chilled or frozen) beef and ovine meat from Uruguay and fresh beef from certain regions of Argentina and a region of Brazil, subject to certain conditions. While there have been FMD outbreaks in the past in those regions, the disease is not currently known to exist in any of them. We do not recognize those exporting regions as FMD-free, however, because the Argentine, Brazilian, and Uruguayan governments all require that cattle be vaccinated for FMD.1 The conditions for the importation of beef and ovine meat from Uruguay and beef from the exporting regions of Argentina and Brazil are set out in § 94.29 of the regulations and include the following: • The meat is derived from animals born, raised, and slaughtered in the exporting region. • FMD has not been diagnosed in the exporting region within the previous 12 months. • The meat comes from bovines or sheep that originated from premises where FMD has not been present during the lifetime of any bovines and sheep slaughtered for the export of meat to the United States. • The meat comes from bovines or sheep that were moved directly from the premises of origin to the slaughtering establishment without any contact with other animals. • The meat comes from bovines or sheep that received ante-mortem and post-mortem veterinary inspections, paying particular attention to the head and feet, at the slaughtering establishment, with no evidence found of vesicular disease. • The meat consists only of bovine parts or ovine parts that are, by standard practice, part of the animal’s carcass that is placed in a chiller for maturation after slaughter and before removal of any bone, blood clots, or lymphoid tissue. The bovine and ovine parts that may not be imported include all parts of the head, feet, hump, hooves, and internal organs. 1 The position of the United States is that a country that vaccinates for FMD is not free of the disease. Vaccination of cattle against FMD introduces risks related to the immunological response within the vaccinated herd. While a large percentage of individual animals in the herd may fully respond to FMD vaccination, some individual animals in the herd may have a limited response, resulting in partial or no immunity. Therefore, socalled herd immunity may not always reflect individual animal immunity, and the disease may still be present in certain animals in a vaccinated population. As a result, importation of beef from areas in which cattle are vaccinated for FMD could result in importation of beef derived from infected animals. VerDate Sep<11>2014 18:58 Mar 24, 2023 Jkt 259001 • All bone and visually identifiable blood clots and lymphoid tissue have been removed from the meat to be exported (bone-in ovine meat from Uruguay may be imported under certain conditions listed in the regulations, however). • The meat has not been in contact with meat from regions other than those listed in accordance with § 94.1(a). • The meat came from carcasses that were allowed to maturate at 40 to 50 °F (4 to 10 °C) for a minimum of 24 hours after slaughter and that reached a pH below 6.0 in the loin muscle at the end of the maturation period. Measurements for pH must be taken at the middle of both longissimus dorsi muscles. Any carcass in which the pH does not reach less than 6.0 may be allowed to maturate an additional 24 hours and be retested, and, if the carcass still has not reached a pH of less than 6.0 after 48 hours, the meat from the carcass may not be exported to the United States. • An authorized veterinary official of the government of the exporting region certifies on the foreign meat inspection certificate that the above conditions have been met. • The establishment in which the bovines and sheep are slaughtered allows periodic on-site evaluation and subsequent inspection of its facilities, records, and operations by an APHIS representative. Historically, trade in fresh (chilled or frozen) beef from Paraguay has not been allowed because APHIS has considered Paraguay to be a country affected with FMD. In response to a request from the Government of Paraguay that we allow fresh (chilled or frozen) beef to be imported into the United States from that country, we conducted a risk analysis, which can be viewed on the internet on the Regulations.gov website or in our reading room.2 APHIS gathered data to support this analysis from records of the Servicio Nacional de Calidad y Salud Animal (SENACSA), from publicly available information, and from published scientific literature. In addition, APHIS conducted site visits to Paraguay in December 2008 and July 2014 to verify the information submitted by SENACSA and to collect additional data. We concluded that the overall risk associated with importing fresh beef from Paraguay is low and that Paraguay has the infrastructure and emergency 2 Instructions on accessing Regulations.gov and information on the location and hours of the reading room may be found at the beginning of this document under ADDRESSES. You may also request paper copies of the risk analysis by calling or writing the person listed under FOR FURTHER INFORMATION CONTACT. PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 response capabilities needed to effectively report, contain, and eradicate FMD in the event of an outbreak and to do so in a timely manner. We further concluded that Paraguay is able to comply with U.S. import restrictions on the specific products from affected areas. Based on the evidence documented in our risk analysis, we believe that fresh (chilled or frozen) beef can be safely imported from Paraguay, provided certain conditions are met. Accordingly, we are proposing to amend the regulations in § 94.29 to provide for the importation of fresh beef from Paraguay. Under this proposed rule, fresh beef from Paraguay would be subject to the same import conditions applicable to fresh beef and ovine meat from Uruguay (other than bone-in ovine meat imported under § 94.29(g)(1) through (3)) and fresh beef from the exporting regions of Argentina and Brazil. Risk Analysis Our risk analysis was conducted according to the eight factors identified in 9 CFR 92.2, ‘‘Application for recognition of the animal health status of a region or a compartment’’: The scope of the evaluation being requested, veterinary control and oversight, disease history and vaccination practices, livestock demographics and traceability, epidemiological separation from potential sources of infection, surveillance, diagnostic laboratory capabilities, and emergency preparedness and response. A summary evaluation of each factor is discussed below. Based on our analysis of these factors, we have determined that fresh (chilled or frozen) beef can be safely imported into the United States from Paraguay, under the conditions specified in § 94.29. Scope of the Evaluation Being Requested In addition to reviewing records submitted by SENACSA, publicly available information, and published scientific literature, APHIS conducted site visits in December 2008 and July 2014 to verify the information we reviewed and to collect additional data. The site visits focused on the veterinary and legal infrastructure of SENACSA, its FMD control program, border control procedures, disease control measures, laboratory and diagnostic capabilities, biosecurity procedures on cattle farms and in slaughter facilities, animal health recordkeeping systems, movement controls, and disease surveillance systems. The 2014 visit included an evaluation of FMD outbreaks that occurred in 2011 and 2012 and the E:\FR\FM\27MRP1.SGM 27MRP1 Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Proposed Rules effectiveness of SENACSA’s response to the outbreaks. ddrumheller on DSK120RN23PROD with PROPOSALS1 Veterinary Control and Oversight Based on our analysis of the data submitted by SENACSA and observations made during our site visits to Paraguay, we concluded that the competent veterinary authority of Paraguay is well-organized and has the legal authority and technical infrastructure in place to carry out official control, eradication, and quarantine activities at the central, regional, and local levels. SENACSA is also an active collaborator with neighboring countries in diseaseeradication efforts. SENACSA has a system of official veterinarians and support staff in place for carrying out FMD field programs and for import controls and animal quarantines. It also has a training program for animal health professionals, frequently in collaboration with the veterinary medical faculty of the National University. The overall structure and resources of SENACSA have significantly increased and been strengthened in reaction to the FMD outbreak in 2012. Following feedback from the World Organization for Animal Health (WOAH) and the European Union (EU), SENACSA is also hiring new personnel to expand its workforce. A very strong partnership exists between the competent authority and the livestock industry. A large proportion of SENACSA’s funding comes from the private sector in the form of user fees paid by stakeholders associated with sales of animals or movement permits. While this funding method allows SENACSA to operate autonomously and with little political interference, it also makes SENACSA’s budget dependent on user fees. SENACSA is addressing the issue and has increased its operational budget to U.S. $36 million. Although the contribution of the treasury department compared to that of the private sector is small, APHIS found no evidence suggesting that resources from the private sector could change in the future or that available resources for FMD control programs would be reduced. Disease History and Vaccination Practices APHIS observed that SENACSA has an established program for the control and prevention of FMD which includes a well-organized vaccination strategy. The vaccine used in Paraguay has been assessed by international FMD reference laboratories to be appropriate for the strains that have been found in the region in the last 15 years. VerDate Sep<11>2014 18:58 Mar 24, 2023 Jkt 259001 Serosurveillance has demonstrated adequate levels of immunity in cattle previously immunized. Following the 2011/2012 FMD outbreak, SENACSA instituted changes to its vaccination program. Audits of vaccinators and the vaccine cold chain were conducted. Vaccination cycles were increased from two to three annually. The training provided by SENACSA and industry-based Animal Health Commissions (AHC) prior to each vaccination cycle also appears to have increased the level of awareness of good vaccination practices among AHC vaccinators. Livestock Demographics and Traceability Paraguay’s animal identification system is similar to, and meets the requirements of, the EU and Chilean markets, both of which have stringent traceability requirements. Paraguay has two traceability systems: A mandatory system under SENACSA and an industry-based, voluntary program called the System for the Identification and Traceability of Rural Holdings in Paraguay (SITRAP). Under SITRAP, there have been initiatives undertaken to facilitate and enhance traceability at slaughter. Movement controls were well organized and coordinated. Internal control posts visited were wellequipped with access to telecommunications and information technology systems. Staff at these control posts were well aware of movement requirements and followed established procedures related to movement control. The staff had an organized and consistent way of assessing each animal transport and movement. Records at the control posts were well organized, and manuals of procedures were readily available. We concluded that Paraguay has a sound system for animal identification and traceability, premises registration, and animal movement controls. The system is adequate to provide assurance that the U.S. import requirements for animals to be born, raised, and slaughtered in Paraguay can be met. Epidemiological Separation From Potential Sources of Infection Many natural barriers, such as large rivers and forest areas, exist along Paraguay’s international and internal borders. These barriers restrict both animal movement and human traffic and prevent the spread of disease. Movement of FMD-susceptible species or products into Paraguay could occur through international borders where sufficient physical barriers do not PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 18079 exist, e.g., along some areas bordering Brazil and Argentina. However, the international borders are actively monitored, and Paraguay collaborates effectively with neighboring countries to minimize the risk of introduction of FMD. Border control agreements between Paraguay and its neighbors have been in place since the 1970s, and efforts continue to strengthen and harmonize border activities. Sufficient controls exist at the airports for interdiction of prohibited material and for prevention of the recycling of confiscated products and international waste. With the exception of Chile, APHIS does not consider the countries of South America to be free of FMD. Coordinated regional FMD control efforts have been effective in decreasing the incidence of FMD and limiting it to certain regions, however. Based on the history of the disease on the continent, Paraguay’s veterinary infrastructure, and SENASCA’S prompt response to the outbreaks in Argentina (2006), Brazil (2005–2006), and Bolivia (2007), APHIS concluded that it is unlikely that disease would be introduced from adjacent areas. However, at the time the risk analysis was prepared, Colombia had just eradicated an FMD outbreak. As long as FMD is endemic in certain areas in South America, there is a potential risk of reintroduction of the disease into the export area. Surveillance Practices Our evaluation led us to conclude that Paraguay has a good epidemiological surveillance system. The surveillance activities conducted and the use of sound statistical methodologies increase the likelihood of detection of FMD if it exists in the population. Paraguay’s surveillance system combines both active surveillance and passive surveillance. Active surveillance consists of annual seroepidemiological sampling at the national level to verify the absence of circulating FMD virus. The active surveillance strategy is updated based on the surveillance objectives for the year. Extensive serological surveys were also conducted following FMD outbreaks 2003 and 2011/2012 to ensure the absence of circulating FMD virus. Passive surveillance is based on the notification of vesicular disease by producers who are required by law to report any suspect cases to their Local Veterinary Unit, which must then respond within 12 hours of notification. Indemnification is predicated on this notification by the producer. Paraguay’s passive surveillance efforts are enhanced by the extensive awareness of E:\FR\FM\27MRP1.SGM 27MRP1 18080 Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS1 the clinical signs of FMD among the animal health field staff and within the industry, as well as the mandatory reporting requirement for suspect cases of vesicular diseases. SENACSA, producers, and the AHCs in particular all have a role in passive surveillance efforts. Additional surveillance comes from herd immunity studies, which are conducted frequently. Enhanced epidemiological surveillance occurs in High Surveillance Zones, which were established by Paraguay in coordination with neighboring countries. SENACSA has a manual of procedures that provides the field veterinarians with guidelines for sample collection, animal identification, aging by dentition, communications, and measures to be taken in case of reactors or suspect cases. The manual ensures consistency in surveillance activities and responses to suspects among field offices. Diagnostic Laboratory Capabilities The Directorate General for Laboratories (DIGELAB) is the official laboratory in Paraguay and is located in the SENACSA headquarters. Responsibilities include the diagnosis of SENACSA’s program diseases such as FMD, bovine spongiform encephalopathy, tuberculosis, brucellosis, classical swine fever, and Newcastle disease. DIGELAB’s FMD laboratory is the only laboratory in Paraguay authorized to conduct diagnostic testing for vesicular diseases, including FMD. Relative to the FMD program, DIGELAB’s Vesicular Diseases Department is responsible for conducting FMD diagnostic testing of animals as required under SENACSA’s active and passive surveillance strategy, including surveillance sampling at fairs and shows, as well as testing of animals for import or export. APHIS concluded that Paraguay has the diagnostic capabilities to adequately test samples for the presence of FMD virus. DIGELAB’s FMD laboratory has the necessary infrastructure, equipment, and personnel. The laboratory staff are well-trained in the diagnosis of vesicular diseases. Diagnostic test methodologies used in the identification of vesicular diseases are consistent with WOAH guidelines. All laboratory standard operating procedures are thorough and systematic, and documentation is good. The laboratory conducts quality control on all FMD vaccines, both nationally produced and imported. SENACSA has an organized recordkeeping system for laboratory data and the ability to complete and report test results in a timely manner. VerDate Sep<11>2014 18:58 Mar 24, 2023 Jkt 259001 Emergency Preparedness and Response SENACSA has established procedures for rapidly detecting and responding to FMD emergencies. SENACSA has surveillance and laboratory programs for early detection of FMD and the necessary infrastructure for carrying out emergency eradication programs, including an FMD contingency plan supported by a legal framework and a sufficient budget. If FMD is confirmed in Paraguay through diagnostic testing, the National Animal Health Emergency System (SINAESA) is immediately activated, and a Director of Emergency is appointed to head up the emergency response effort. SINAESA is responsible for establishing a chain of command and for identifying and obtaining the necessary resources to carry out the activities needed to eradicate the disease. In responding to outbreaks in neighboring countries, as well as during the 2011/2012 outbreak in Paraguay, SENACSA demonstrated its capacity for rapid and effective emergency response. The above findings are detailed in the risk analysis document. The risk analysis explains the factors that have led us to conclude that fresh (chilled or frozen) beef may be safely imported from Paraguay under the conditions enumerated above. It also establishes that Paraguay has adequate veterinary infrastructure in place to prevent, control, report, and manage FMD outbreaks. Therefore, we are proposing to amend § 94.29 to allow the importation of fresh beef from Paraguay under the conditions described above. Executive Orders 12866, 13563, and Regulatory Flexibility Act This proposed rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget (OMB). We have prepared an economic analysis for this rule. The economic analysis provides a cost-benefit analysis, as required by Executive Orders 12866 and 13563, which 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, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The economic analysis also provides an initial regulatory flexibility analysis that examines the potential economic effects PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 of this rule on small entities, as required by the Regulatory Flexibility Act. Based on the information we have, there is no reason to conclude that adoption of this proposed rule would result in any significant economic effect on a substantial number of small entities. However, we do not currently have all of the data necessary for a comprehensive analysis of the effects of this proposed rule on small entities. Therefore, we are inviting comments on potential effects. In particular, we are interested in determining the number and kind of small entities that may incur benefits or costs from the implementation of this proposed rule. Introduction This analysis examines potential economic impacts of a proposed rule that would allow fresh (chilled or frozen) beef from Paraguay to be imported into the United States provided certain conditions are met. APHIS currently considers the whole territory of Paraguay to be a region where FMD exists. With few exceptions, APHIS’ regulations in part 94 prohibit the importation of fresh (chilled or frozen) meat of ruminants or swine that originates in or transits a region where FMD is considered to exist. APHIS does not consider Paraguay as free of FMD because Paraguay vaccinates against FMD. As explained in detail earlier in this document, the vaccination requirement could result in infected animals being imported into the United States. This document provides a benefit-cost analysis, as required by Executive Orders 12866 and 13563, which 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, 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 document also examines the potential economic effects of the rule on small entities, as required by the Regulatory Flexibility Act. Overview of the Action and Affected Entities U.S. Beef Production and Trade The United States is the largest beef producer in the world and produces E:\FR\FM\27MRP1.SGM 27MRP1 Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Proposed Rules primarily grain-fed beef for the domestic and export markets. Over the period 2016 to 2020, U.S. beef production averaged 12 million metric tons (MT); 18081 exports 1.4 million MT; and imports 1.3 million MT (Table 1). TABLE 1—U.S. BEEF PRODUCTION, EXPORTS, AND IMPORTS [2016 to 2020] Year Production Imports Exports Metric tons 2016 2017 2018 2019 2020 ............................................................................................................................................. ............................................................................................................................................. ............................................................................................................................................. ............................................................................................................................................. ............................................................................................................................................. 11,468,481 11,904,762 12,216,780 12,346,485 12,355,556 1,365,986 1,357,370 1,359,637 1,386,848 1,515,646 1,159,637 1,296,599 1,433,107 1,372,336 1,338,322 5-year average ..................................................................................................................... 12,058,413 1,397,098 1,320,000 Source: U.S. Department of Agriculture (USDA), World Agricultural Outlook Board, ‘‘World Agricultural Supply and Demand Estimates’’ and supporting materials; U.S. Department of Commerce, Bureau of Economic Analysis (population); and USDA, Economic Research Service. Most U.S. beef imports are grass-fed beef that is processed together with higher-fat trimmings from U.S. grain-fed beef to produce ground beef. Canada, Australia, New Zealand, and Mexico historically have been the largest sources of U.S. beef imports (Table 2). Entry of beef from Paraguay into the U.S. beef market would result in a change in market shares. In terms of exports, between 2016 and 2020 the top destinations for U.S. beef were Japan (362,071 MT); South Korea (264,780 MT); Mexico (181,982 MT); Hong Kong (156,025 MT); and Canada (133,316 MT). TABLE 2—U.S. BEEF IMPORTS FROM PRINCIPAL SUPPLY COUNTRIES [2016 to 2020; 1,000 MT] Country 2016 2017 2018 2019 2020 Average 1,000 Metric tons, carcass weight equivalent Canada ..................................................... Australia ................................................... Mexico ...................................................... New Zealand ............................................ Brazil ........................................................ Nicaragua ................................................. Uruguay .................................................... Other Countries ........................................ 325.37 347.74 223.67 277.67 69.22 50.43 54.72 16.42 336.01 315.02 259.99 252.48 62.39 60.44 54.61 15.81 358.91 305.08 230.36 259.54 63.92 71.07 51.91 18.20 384.31 324.85 262.90 181.77 74.01 82.83 53.89 21.57 374.15 300.50 295.25 233.73 100.20 85.83 66.73 58.39 355.75 318.64 254.44 241.04 73.95 70.12 56.37 26.07 Total .................................................. 1,365.24 1,356.75 1,358.99 1,386.13 1,514.78 1,396.38 Source: USDA ERS carcass weight equivalent calculations using data from U.S. Department of Commerce, Bureau of the Census. Note: Quantities include some processed beef and veal. ddrumheller on DSK120RN23PROD with PROPOSALS1 Paraguay’s Beef Production and Trade Historically, beef cattle production has been one of the major agricultural activities in Paraguay with beef and soybeans being the leading exports. Paraguay recently surpassed Argentina for eighth place among the world’s largest beef exporters. The Paraguayan beef industry is focused on exports with about 40 percent of the production consumed domestically. Paraguay ships roughly 90 percent of its beef to just five markets: Chile, Russia, Israel, Taiwan VerDate Sep<11>2014 18:58 Mar 24, 2023 Jkt 259001 and Brazil. Today, cattle are being displaced from traditional production areas in Paraguay because of a steady increase in soybean acreage. Since the 1990s, there has also been increased grain supplementation of beef cattle feeding regimes in Paraguay. For the period 2016 to 2020, Paraguay’s average annual production was 582,000 MT, with domestic consumption averaging 224,000 MT, or about 40 percent of production (Table 3). Exports averaged 372,000 MT per year. Paraguay’s average exports of PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 372,000 MT for the 2016 to 2020 period is equivalent to approximately 26 percent of U.S. fresh beef imports for the same period. The quantity of fresh beef expected to be imported into the United States from Paraguay, ranging from 3,250 to 6,500 MT, is equivalent to about 0.05 percent of U.S. average annual fresh beef production, about 0.05 percent of U.S. average annual imports of fresh beef, and about 0.50 percent of average annual exports of fresh beef, 2016 to 2020. E:\FR\FM\27MRP1.SGM 27MRP1 18082 Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Proposed Rules TABLE 3—PARAGUAY’S BEEF PRODUCTION, EXPORTS, AND IMPORTS [2016 to 2020] Year Production Consumption Imports Exports 1,000 Metric tons 2013 2014 2015 2016 2017 ................................................................................................................. ................................................................................................................. ................................................................................................................. ................................................................................................................. ................................................................................................................. 510 570 590 610 610 186 183 210 222 223 2 2 1 2 1 326 389 381 390 380 Average .................................................................................................... 578 231 2 373 Source: Compiled from various GAIN Reports of the USDA Foreign Agricultural Service using carcass weight equivalent data. Expected Benefits and Costs of the Rule For this analysis, we use a nonspatial, net trade, partial equilibrium approach to welfare analysis to compute expected impacts of the rule on U.S. producers and consumers of fresh beef. In this section, we describe assumptions and parameters of the welfare analysis, including the baseline price and quantities, projected imports from Paraguay, and domestic price elasticities of demand and supply. We then discuss the modeling results. The model evaluates how domestic market prices and quantities may adjust to the policy change, and how producers and consumers may potentially be impacted. We assume that demand and supply functions are approximately linear near the initial equilibrium point. For small parallel shifts in supply and demand, this assumption results in reasonably accurate measures of consumer and producer surplus changes. Beef imports from Paraguay will affect prices and quantities of fresh beef on the U.S. market, and therefore result in welfare impacts as reflected in changes in consumer and producer surplus. Consumer surplus is the difference between what the consumer pays for a unit of a good or service and the maximum price that the consumer would be willing to pay for that unit. Producer surplus is the difference between the price a producer is paid for supplying a unit of a good or service and the minimum price that the producer would be willing to accept to supply that unit. Our analysis is non-spatial in that the price and quantity effects obtained from the model are assumed to be average effects across geographically separate markets. Partial equilibrium means that the model results are based on maintaining a commodity-price equilibrium in a limited portion of the overall economy. All other economic sectors not explicitly included in the model are assumed to have a negligible influence on the model results. A partial equilibrium analysis is appropriate because the rule is specific to imports of fresh beef from Paraguay and is therefore expected to have only limited effects on other sectors of the economy. Baseline data for fresh beef are shown in Tab1e 4. Baseline quantities are based on 5-year averages, 2016 through 2020. Domestic supply is equated to fresh beef production minus exports, where fresh beef exports are set equal to zero. In a net trade model, such as the one applied in this analysis, a country is identified as either a net exporter or a net importer of a particular commodity. In this instance, U.S. fresh beef exports are not included as part of domestic supply in the baseline in order to quantify the effects of permitting fresh beef imports from Paraguay. Domestic demand for fresh beef is equated to fresh production less exports plus imports. The baseline price is the 5-year average U.S. custom import value for fresh beef, 2016 through 2020.3 TABLE 4—U.S. FRESH BEEF BASELINE DATA: PRODUCTION, IMPORTS, EXPORTS, DOMESTIC CONSUMPTION, AND PRICE IN 2016 DOLLARS [2016 to 2020] Year Production Imports Exports Domestic supply Price per MT Metric tons ddrumheller on DSK120RN23PROD with PROPOSALS1 2016 2017 2018 2019 2020 ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... 11,468,481 11,904,762 12,216,780 12,346,485 12,355,556 1,365,986 1,357,370 1,359,637 1,386,848 1,515,646 1,159,637 1,296,599 1,433,107 1,372,336 1,338,322 11,674,830 11,965,533 12,143,311 12,360,998 12,532,880 6,988 7,092 7,248 7,533 8,063 5 year average .............................................................. 12,058,413 1,397,098 1,320,000 12,135,510 7,385 Source: USDA, World Agricultural Outlook Board, ‘‘World Agricultural Supply and Demand Estimates’’ and supporting materials; U.S. Department of Commerce, Bureau of Economic Analysis (population); and USDA, Economic Research Service. For this analysis, we use price elasticities of demand and supply for fresh beef of ¥1.52 and 0.34, respectively.4 In the short run, beef producers’ responsiveness is inelastic due to limitations in adjusting supply to 3 The custom import value is defined as the price actually paid or payable for merchandise when sold for exportation, excluding import duties, freight, insurance, and other charges incurred in bringing the merchandise to the importing country. 4 Paarlberg, Philip L., Ann Hillberg Seitzinger, John G. Lee, and Kenneth H. Mathews, Jr. Economic Impacts of Foreign Animal Disease. Economic Research Report Number 57. USDA ERS, May 2008. VerDate Sep<11>2014 18:58 Mar 24, 2023 Jkt 259001 PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 E:\FR\FM\27MRP1.SGM 27MRP1 Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Proposed Rules market changes. In the long run, producers are better able to respond to changes in price associated with increased market supply. Likewise, a more price-elastic long-run demand would be indicative of increased price responsiveness of consumers over time. As a measure of possible impacts of fresh beef imports from Paraguay, we consider import volumes of 3,250 to 6,500 MT (5 to 10 percent of the other countries tariff rate quota of 65,005 5). For each of the three annual import levels, we modeled changes in U.S. consumption, production, price, consumer welfare, producer welfare, and net social welfare gain (Table 5). In each case, consumer welfare gains outweigh producer welfare losses with 18083 positive net welfare impacts. Producer welfare losses under the three import levels range between $12 and $23 million. Consumer welfare gains range between $13 and $26 million with net welfare gains of between $1.3 and $3.0 million. Beef imports from Paraguay may displace imports from other countries. TABLE 5—MODELED IMPACTS FOR U.S. FRESH BEEF PRODUCTION, CONSUMPTION, PRICE, AND CONSUMER AND PRODUCER WELFARE, ASSUMING FRESH BEEF IMPORTS FROM PARAGUAY [Of 3,250 MT, 4,875 MT, and 6,500 MT] ddrumheller on DSK120RN23PROD with PROPOSALS1 Assumed annual fresh beef imports from Paraguay ................................................. Change in U.S. consumption, MT ............................................................................. Change in U.S. production, MT ................................................................................. Change in domestic price of fresh beef, dollars per MT ........................................... % Change in domestic price ..................................................................................... Change in consumer welfare ..................................................................................... Change in producer welfare ...................................................................................... Annual net benefit ...................................................................................................... 3,250 2,715 ¥535 ($1.09) ¥0.0147 $13,179,777 ($11,660,864) $1,518,913 4,875 4,072 ¥803 ($1.63) ¥0.0221 $19,770,771 ($17,491,078) $2,279,694 6,500 5,430 ¥1,070 ($2.17) ¥0.0294 $26,362,502 ($23,321,146) $3,041,356 Alternatives to the Rule We considered alternatives to the chosen course of action, including maintaining the current prohibition on imports of fresh beef from Paraguay and using the WOAH recommendations to determine import requirements. Continuing to prohibit fresh beef imports from Paraguay is not defensible, given that a complete restriction on imports is unnecessary for safeguarding the U.S. cattle industry provided certain conditions are met. We therefore reject the status quo alternative. A second alternative considered by APHIS would be to allow fresh beef to enter from Paraguay under trade recommendations established by the WOAH. The WOAH recommendations, however, do not meet the acceptable level of protection of the United States. FMD is a highly contagious disease caused by a resilient virus readily transmitted to all cloven-hoofed animals. There are few effective mitigation measures to guard against the risk of exposure of susceptible U.S. livestock if FMD-infected animals or products contaminated with the FMD virus were imported into the United States. APHIS has determined therefore that a cautious approach to allowing fresh beef imports from regions that vaccinate for FMD is warranted. As noted earlier, the position of the United States is that a country that vaccinates for FMD is not free of the disease. Vaccination of cattle against FMD introduces risks related to the immunological response within the vaccinated herd. While a large percentage of individual animals in the herd may fully respond to FMD vaccination, some individual animals in the herd may have a limited response, resulting in partial or no immunity. Therefore, so-called herd immunity may not always reflect individual animal immunity, and the disease may still be present in certain animals in a vaccinated population. As a result, importation of beef from areas in which cattle are vaccinated for FMD could result in importation of beef derived from infected animals. Under the World Trade Organization Sanitary and Phytosanitary Agreement, Member Countries are encouraged to base their import requirements on international recommendations but maintain the right to adopt additional measures provided that they are based on science, are transparent in the way they are developed and implemented, and do not arbitrarily or unjustifiably discriminate among members. APHIS does not recognize a country that vaccinates for FMD as free of the disease because vaccination may mask clinical signs. The virus can remain present but undetected in vaccinated populations. APHIS regulations allow for the importation of meat and meat products from regions that vaccinate for FMD provided that these products are processed in such a way as to ensure the inactivation of the FMD virus. If APHIS were to follow the WOAH recommendations, we expect that fresh beef imports from Paraguay would tend toward the upper end of the 3,250 to 6,500 MT range; more cattle and larger quantities of beef would likely qualify for export to the United States because the import sanitary requirements would be less stringent. Fresh beef imports from Paraguay exceeding 6,500 MT would enter under a higher tariff rate. Under the modeled 6,500 MT scenario, wholesale beef price would decrease by 0.03 percent. U.S. beef production would decline by approximately 1,000 MT or less than a percent of total U.S beef production. We reject this alternative to the rule for reasons other than disproportionate economic impact and because it does not meet APHIS’ determination of necessary sanitary requirements for the importation of fresh beef from Paraguay. The preferred alternative has been analyzed using the limited information available. We cannot certify that this rule would have no disproportionate impact on small entities, but at this time have found no evidence that it would have such impacts. 5 Harmonized Tariff Schedule of the United States (2018) Revision 4, Chapter 2, Meat and Edible Meat Offal. The tariff rate quota provides preferential- duty access for certain named countries and a category of countries grouped as Other Countries or Areas. The combined annual quantity of beef allowed to be imported from Other Countries or Areas is limited to 65,005 MT. VerDate Sep<11>2014 18:58 Mar 24, 2023 Jkt 259001 PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 Initial Regulatory Flexibility Analysis The Regulatory Flexibility Act requires agencies to evaluate the potential effects of their proposed and final rules on small businesses, small organizations and small governmental jurisdictions. This initial regulatory flexibility analysis describes expected impacts of this proposed rule on small entities, as required by section 603 of the Act. E:\FR\FM\27MRP1.SGM 27MRP1 18084 Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS1 Reasons Action Is Being Considered In response to a request from the Government of Paraguay that fresh (chilled or frozen) beef be allowed to be imported into the United States from Paraguay, APHIS conducted a risk analysis to enable APHIS to develop appropriate regulatory conditions with mitigations to address potential risks of FMD disease introduction following any initiation of trade in fresh beef from Paraguay. In the analysis APHIS considered the epidemiological characteristics of FMD that are relevant to the risk of importing fresh and frozen beef under certain conditions into the United States and described appropriate mitigations to reduce that risk. The mitigations to be applied include restrictions on the origin of animals, requirements for maturation and pH testing of carcasses, ante-mortem and post-mortem inspections, and verification by Paraguayan officials that the various mitigations were applied appropriately. APHIS concluded from the assessments that the surveillance, prevention, and control measures implemented by the Government of Paraguay are sufficient and that fresh beef imported from Paraguay under the additional mitigation measures imposed by the proposed action will be safe. It is highly unlikely that such imports from Paraguay will introduce or disseminate FMD within the United States. As of 2020, there are more than 70 markets opened to Paraguayan beef. Cattlemen in Paraguay and the Government of Paraguay aim at opening in the future important markets such as China, NAFTA countries, and South Korea.6 Objectives of and Legal Basis for the Rule With a few exceptions, APHIS regulations in 9 CFR part 94 prohibit the importation of fresh (chilled or frozen) meat of ruminants or swine that originates in or transits a region where FMD is considered to exist. APHIS does not consider Paraguay free of FMD because Paraguay vaccinates against FMD. The proposed rule would allow the importation of fresh (chilled or frozen) beef from Paraguay under certain conditions designed to ensure beef exported to the United States will not harbor FMD virus. In accordance with the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the Secretary of Agriculture has the authority to promulgate regulations and take measures to prevent the introduction of 6 Paraguay Beef & Cattle Outlook 2020: https:// beef2live.com/story-paraguay-beef-cattle-annual-0206336. VerDate Sep<11>2014 18:58 Mar 24, 2023 Jkt 259001 contagious animal diseases into the United States by means of import restrictions. Potentially Affected Small Entities Entities that could be primarily affected by the proposed rule are beef and cattle producers, as well as feedlots and slaughter facilities. Of the 882,692 farms 7 in the United States with cattle and calves, 711,827 sold cattle and calves, 729,0466 were classified as beef cow farms, and 54,599 had milk cows.8 Based on data from the 2017 Census of Agriculture and Small Business Administration (SBA) standards,9 we expect a majority of these entities to be small. Entities in the categories beef cattle ranching and farming (NAICS 112111) and dairy cattle and milk production (NAICS 112120) are considered small if their total annual sales do not exceed $1 million. The 2017 Census of Agriculture indicates that 99 percent of beef cattle operations are classified as small; of the 582,380 (farms with sales) farms classified under the beef cattle ranching and farming category, 99 percent had annual sales of less than $1 million. Of the 47,237 dairy operations, 95 percent are classified as small. Entities in the category cattle feedlots (NAICS 112112) are considered small if they have total annual sales of not more than $8 million. Sales were not available for farms operating as feedlots. Entities classified as animal (except poultry) slaughtering (NAICS 311611) with not more than 1,000 employees are considered small by SBA standards. The 2012 Economic Census reports 1,494 establishments in this category. Of this number, 1,357 establishments (96 percent) had fewer than 1,000 employees.10 Thus, the majority of slaughter establishments are considered small by SBA standards. Projected Reporting, Recordkeeping, and Other Compliance Requirements Reporting and recordkeeping requirements associated with the proposed rule are discussed in the 7 Represents all farms that held cattle inventory whether or not they sold cattle. 8 U.S. 2017 Agriculture Census, tables 12, 13, 14, 16, https://www.nass.usda.gov/Publications/ AgCensus/2017/Full_Report/Volume_1,_Chapter_1_ US/st99_1_0011_0012.pdf. https:// www.nass.usda.gov/Publications/AgCensus/2017/ Full_Report/Volume_1,_Chapter_1_US/st99_1_ 0013_0014.pdf. https://www.nass.usda.gov/ Publications/AgCensus/2017/Full_Report/Volume_ 1,_Chapter_1_US/st99_1_0015_0016.pdf. 9 Small Business Administration size standards: https://www.sba.gov/document/support-table-sizestandards. 10 U.S. Bureau of Census, 2018 County Business Pattern Survey: https://data.census.gov/cedsci/ tablen=311611&tid=CBP2018.CB1800CBP. PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 proposed rule under the heading ‘‘Paperwork Reduction Act.’’ Duplication, Overlap, or Conflict With Existing Rules and Regulations APHIS has not identified any duplication, overlap, or conflict of the proposed rule with other Federal rules. Alternatives To Minimize Significant Economic Impacts of the Rule For the purposes of this Initial Regulatory Flexibility Analysis, we have used the best data available to examine feasible ways to achieve the desired policy goals. We cannot certify that this rule would have no disproportionate impact on small entities, but at this time have found no evidence that it would have such impacts. We recognize we may not have all relevant information concerning economic impacts at this time. Therefore, we invite public comment on any additional relevant information. We also invite public comments on alternatives that may achieve the objective of this proposed rule. Executive Order 12988 This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (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) administrative proceedings will not be required before parties may file suit in court challenging this rule. Executive Order 13175 This 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 rule will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications. In 2020, APHIS informed Tribal leaders of the proposed action and solicited comments and questions. APHIS did not receive any comments or questions from Tribal leaders in response. APHIS worked with the APHIS Office of the National Tribal Liaison to conduct the outreach in 2020 and also hosted a Tribal listening session on October 17, 2022, about the proposed rule. If a tribe requests consultation in the future, APHIS will work with the Office of Tribal Relations to ensure meaningful consultation is provided. E:\FR\FM\27MRP1.SGM 27MRP1 Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Proposed Rules National Environmental Policy Act To provide the public with documentation of APHIS’ review and analysis of any potential environmental impacts associated with the importation of fresh (chilled or frozen) beef from Paraguay, we have prepared an environmental assessment. The environmental assessment was prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500–1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS’ NEPA Implementing Procedures (7 CFR part 372). The environmental assessment may be viewed on the Regulations.gov website or in our reading room. (A link to Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this proposed rule.) In addition, copies may be obtained by calling or writing to the individual listed under FOR FURTHER INFORMATION CONTACT. ddrumheller on DSK120RN23PROD with PROPOSALS1 Paperwork Reduction Act In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), reporting and recordkeeping requirements included in this proposed rule have been submitted for approval to OMB. Written comments and recommendations for the proposed information collection should be sent within 60 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 60-day Review—Open for Public Comments’’ or by using the search function. Please send a copy of your comments to: (1) Docket No. APHIS–2018–0007, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road Unit 118, Riverdale, MD 20737–1238, and (2) Clearance Officer, OCIO, USDA, Room 404–W, 14th Street and Independence Avenue SW, Washington, DC 20250. APHIS is proposing to amend the regulations in § 94.29 to provide for the importation of fresh (chilled or frozen) beef from Paraguay. Under this proposed rule, fresh beef from Paraguay would be subject to the same import conditions applicable to fresh beef and ovine meat from Uruguay (other than bone-in ovine meat imported under § 94.29(g)(1) through (3)) and fresh beef from the exporting regions of Argentina and Brazil. The importation of fresh beef VerDate Sep<11>2014 18:58 Mar 24, 2023 Jkt 259001 from Paraguay will require information collection activities such as the completion and signature of Foreign Meat Inspection Certificates by an authorized veterinary official of the Government of Paraguay and onsite evaluations and inspections of operations, records, and processing facilities to ensure they are following the procedures necessary to lead to the results listed in the Foreign Meat Inspection Certificate. The certificate, evaluation, and inspection ensure that exported fresh beef from Paraguay poses negligible risk of introducing disease into the United States. If this action is finalized and OMB approves of this information collection package, APHIS plans to merge this information collection into OMB control number 0579–0372, Importation of Beef and Ovine Meat from Uruguay and Beef from Argentina and Brazil. We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us: (1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency’s functions, including whether the information will have practical utility; (2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses). Estimate of burden: Public burden for this collection of information is estimated to average 1.3 hours per response. Respondents: Authorized veterinary officials employed by the Government of Paraguay and beef producers in Paraguay. Estimated annual number of respondents: 2. Estimated annual number of responses per respondent: 1. Estimated annual number of responses: 3. Estimated total annual burden on respondents: 4 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 18085 of responses multiplied by the estimate of burden.) A copy of the information collection may be viewed on the Regulations.gov website or in our reading room. (A link to Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this proposed rule.) Copies can also be obtained from Mr. Joseph Moxey, APHIS’ Paperwork Reduction Act Coordinator, at (301) 851–2483. APHIS will respond to any information collection review-related comments in the final rule. All comments will also become a matter of public record. E-Government Act Compliance The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For trade partners who have fully automated systems, APHIS will accept computer extracts of electronic health certification data. These certificates are included in the government-wide use of the International Trade Data System via the Automated Commercial Environment to improve business operations and further Agency missions. Respondents are free to maintain required records as best suited for their organization. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Mr. Joseph Moxey, APHIS’ Paperwork Reduction Act Coordinator, at (301) 851–2483. List of Subjects in 9 CFR Part 94 Animal diseases, Imports, Livestock, Meat and meat products, Milk, Poultry and poultry products, Reporting and recordkeeping requirements. Accordingly, we propose to amend 9 CFR part 94 as follows: PART 94—FOOT-AND-MOUTH DISEASE, NEWCASTLE DISEASE, HIGHLY PATHOGENIC AVIAN INFLUENZA, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, SWINE VESICULAR DISEASE, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS 1. The authority citation for part 94 continues to read as follows: ■ Authority: 7 U.S.C. 1633, 7701–7772, 7781–7786, and 8301–8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4. E:\FR\FM\27MRP1.SGM 27MRP1 18086 § 94.29 Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Proposed Rules [Amended] 2. Section 94.29 is amended as follows: ■ a. In the introductory text, by adding the words ‘‘fresh (chilled or frozen) beef from Paraguay;’’ after the word ‘‘Tocantins;’’; ■ b. In paragraph (a)(1), by adding the words ‘‘or in Paraguay;’’ after the word ‘‘Brazil’’; and ■ c. In paragraph (b), by adding the words ‘‘in Paraguay (for beef from Paraguay),’’ after the words ‘‘(for beef from Brazil),’’. ■ Done in Washington, DC, this 17th day of March 2023. Jennifer Moffitt, Under Secretary for Marketing and Regulatory Programs. [FR Doc. 2023–05889 Filed 3–24–23; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF ENERGY 10 CFR Part 430 [EERE–2023–BT–STD–0005] RIN 1904–AF51 Energy Conservation Program: Energy Conservation Standards for Fluorescent Lamp Ballasts Office of Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Request for information. AGENCY: The U.S. Department of Energy (‘‘DOE’’) is initiating an effort to determine whether to amend the current energy conservation standards for fluorescent lamp ballasts (‘‘FLB’’). Under the Energy Policy and Conservation Act, as amended, DOE must review these standards no later than three years after making a determination that standards for the product do not need to be amended and publish either a notice of proposed rulemaking (‘‘NOPR’’) to propose new standards for FLB or a notification of determination that the existing standards do not need to be amended. DOE is soliciting the public for information to help determine whether the current standards require amending under the applicable statutory criteria. DOE welcomes written comments from the public on any subject within the scope of this document, including topics not specifically raised. DATES: Written comments and information are requested and will be accepted on or before April 26, 2023. ADDRESSES: Interested persons are encouraged to submit comments using ddrumheller on DSK120RN23PROD with PROPOSALS1 SUMMARY: VerDate Sep<11>2014 18:58 Mar 24, 2023 Jkt 259001 the Federal eRulemaking Portal at www.regulations.gov under docket number EERE–2023–BT–STD–0005. Follow the instructions for submitting comments. Alternatively, interested persons may submit comments may submit comments, identified by docket number EERE–2023–BT–STD–0005, by any of the following methods: Email: FLB2023STD0005@ee.doe.gov. Include the docket number EERE–2023– BT–STD–0005 in the subject line of the message. Postal Mail: Appliance and Equipment Standards Program, U.S. Department of Energy, Building Technologies Office, Mailstop EE–5B, 1000 Independence Avenue SW, Washington, DC 20585–0121. Telephone: (202) 287–1445. Hand Delivery/Courier: Appliance and Equipment Standards Program, U.S. Department of Energy, Building Technologies Office, 950 L’Enfant Plaza, SW, 6th Floor, Washington, DC 20024. Telephone: (202) 287–1445. No telefacsimiles (‘‘faxes’’) will be accepted. For detailed instructions on submitting comments and additional information on this process, see section III of this document. Docket: The docket for this activity, which includes Federal Register notices, comments, and other supporting documents/materials, is available for review at www.regulations.gov. All documents in the docket are listed in the www.regulations.gov index. However, some documents listed in the index, such as those containing information that is exempt from public disclosure, may not be publicly available. The docket web page can be found at www.regulations.gov/docket/EERE2023-BT-STD-0005. The docket web page contains instructions on how to access all documents, including public comments, in the docket. See section III for information on how to submit comments through www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Mr. Bryan Berringer, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE–5B, 1000 Independence Avenue SW, Washington, DC 20585–0121. Telephone: (202) 586– 0371. Email: ApplianceStandardsQuestions@ ee.doe.gov. Mr. Nolan Brickwood, U.S. Department of Energy, Office of the General Counsel, GC–33, 1000 Independence Avenue SW, Washington, DC 20585–0121. Telephone: (202) 586– 4498. Email: Nolan.Brickwood@ hq.doe.gov. PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 For further information on how to submit a comment, or review other public comments and the docket contact the Appliance and Equipment Standards Program staff at (202) 287– 1445 or by email: ApplianceStandardsQuestions@ ee.doe.gov. SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction A. Authority and Background B. Deviation From Appendix A II. Request for Information and Comments A. Products Covered by This Process B. Market and Technology Assessment 1. Product Classes 2. Technology Assessment C. Screening Analysis D. Engineering Analysis 1. Efficiency Analysis 2. Cost Analysis E. Energy Use Analysis 1. Operating Hours 2. Lamp Mixture F. Life-Cycle Cost and Payback Analysis 1. Installation Costs 2. Repair and Maintenance Costs 3. Efficiency Distributions 4. Product Lifetimes G. Shipments H. National Impact Analysis I. Manufacturer Impact Analysis III. Submission of Comments I. Introduction A. Authority and Background The Energy Policy and Conservation Act, Public Law 94–163, as amended (‘‘EPCA’’),1 authorizes DOE to regulate the energy efficiency of a number of consumer products and certain industrial equipment. (42 U.S.C. 6291– 6317) Title III, Part B of EPCA 2 established the Energy Conservation Program for Consumer Products Other Than Automobiles. These products include fluorescent lamp ballasts (‘‘FLBs’’), the subject of this document. (42 U.S.C. 6292(a)(13)) EPCA prescribed energy conservation standards for these products and directed DOE to conduct two cycles of rulemakings to determine whether to amend these standards. (42 U.S.C. 6295(g)(7)(A)–(B)) The energy conservation program under EPCA consists essentially of four parts: (1) testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. Relevant provisions of EPCA specifically include definitions 1 All references to EPCA in this document refer to the statute as amended through the Energy Act of 2020, Public Law 116–260 (Dec. 27, 2020), which reflect the last statutory amendments that impact Parts A and A–1 of EPCA. 2 For editorial reasons, upon codification in the U.S. Code, Part B was redesignated Part A. E:\FR\FM\27MRP1.SGM 27MRP1

Agencies

[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Proposed Rules]
[Pages 18077-18086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05889]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. APHIS-2018-0007]
RIN 0579-AE73


Importation of Fresh Beef From Paraguay

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the regulations governing the 
importation of certain animals, meat, and other animal products by 
allowing, under certain conditions, the importation of fresh (chilled 
or frozen) beef from Paraguay. Based on the evidence from a risk 
analysis, we have determined that fresh beef can safely be imported 
from Paraguay, provided certain conditions are met. This action would 
provide for the importation of fresh beef from Paraguay into the United 
States while continuing to protect the United States against the 
introduction of foot-and-mouth disease.

DATES: We will consider all comments that we receive on or before May 
26, 2023.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov. 
Enter APHIS-2018-0007 in the Search Field. Select the Documents tab, 
then select the Comment button in the list of documents.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2018-0007, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at www.regulations.gov or in our reading room, which is 
located in room 1620 of the USDA South Building, 14th Street and 
Independence Avenue SW, Washington, DC. Normal reading room hours are 8 
a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure 
someone is there to help you, please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Ingrid Kotowski, Import Risk 
Analyst, Regionalization Evaluation Services, VS, APHIS, 920 Main 
Campus Drive, Suite 200, Raleigh, NC 27606; (919) 855-7732; email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 9 CFR part 94 (referred to below as the 
regulations) prohibit or restrict the importation of certain animals 
and animal products into the United States to prevent the introduction 
of various animal diseases, including foot-and-mouth disease (FMD), 
African swine fever, classical swine fever, and swine vesicular 
disease. These are dangerous and destructive communicable diseases of 
ruminants and swine. Under most circumstances, Sec.  94.1 of the 
regulations prohibits the importation of live ruminants and swine and 
fresh (chilled or frozen) meat derived from ruminants and swine 
originating in, or transiting through, a region where FMD exists. 
Section 94.11 restricts the importation of ruminants and swine and 
their meat and certain other products from regions that are declared 
free of FMD but that nonetheless present a disease risk because of the 
regions' proximity to or trading relationships with regions affected 
with FMD. Regions that the Animal and Plant Health Inspection Service 
(APHIS) has declared free of FMD and regions declared free of FMD that 
are subject to the restrictions in Sec.  94.11 are listed on the APHIS 
website at https://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml.
    The regulations do allow for certain exceptions to the prohibitions 
contained

[[Page 18078]]

in Sec.  94.1. These exceptions include allowing the importation of 
fresh (chilled or frozen) beef and ovine meat from Uruguay and fresh 
beef from certain regions of Argentina and a region of Brazil, subject 
to certain conditions. While there have been FMD outbreaks in the past 
in those regions, the disease is not currently known to exist in any of 
them. We do not recognize those exporting regions as FMD-free, however, 
because the Argentine, Brazilian, and Uruguayan governments all require 
that cattle be vaccinated for FMD.\1\ The conditions for the 
importation of beef and ovine meat from Uruguay and beef from the 
exporting regions of Argentina and Brazil are set out in Sec.  94.29 of 
the regulations and include the following:
---------------------------------------------------------------------------

    \1\ The position of the United States is that a country that 
vaccinates for FMD is not free of the disease. Vaccination of cattle 
against FMD introduces risks related to the immunological response 
within the vaccinated herd. While a large percentage of individual 
animals in the herd may fully respond to FMD vaccination, some 
individual animals in the herd may have a limited response, 
resulting in partial or no immunity. Therefore, so-called herd 
immunity may not always reflect individual animal immunity, and the 
disease may still be present in certain animals in a vaccinated 
population. As a result, importation of beef from areas in which 
cattle are vaccinated for FMD could result in importation of beef 
derived from infected animals.
---------------------------------------------------------------------------

     The meat is derived from animals born, raised, and 
slaughtered in the exporting region.
     FMD has not been diagnosed in the exporting region within 
the previous 12 months.
     The meat comes from bovines or sheep that originated from 
premises where FMD has not been present during the lifetime of any 
bovines and sheep slaughtered for the export of meat to the United 
States.
     The meat comes from bovines or sheep that were moved 
directly from the premises of origin to the slaughtering establishment 
without any contact with other animals.
     The meat comes from bovines or sheep that received ante-
mortem and post-mortem veterinary inspections, paying particular 
attention to the head and feet, at the slaughtering establishment, with 
no evidence found of vesicular disease.
     The meat consists only of bovine parts or ovine parts that 
are, by standard practice, part of the animal's carcass that is placed 
in a chiller for maturation after slaughter and before removal of any 
bone, blood clots, or lymphoid tissue. The bovine and ovine parts that 
may not be imported include all parts of the head, feet, hump, hooves, 
and internal organs.
     All bone and visually identifiable blood clots and 
lymphoid tissue have been removed from the meat to be exported (bone-in 
ovine meat from Uruguay may be imported under certain conditions listed 
in the regulations, however).
     The meat has not been in contact with meat from regions 
other than those listed in accordance with Sec.  94.1(a).
     The meat came from carcasses that were allowed to maturate 
at 40 to 50 [deg]F (4 to 10 [deg]C) for a minimum of 24 hours after 
slaughter and that reached a pH below 6.0 in the loin muscle at the end 
of the maturation period. Measurements for pH must be taken at the 
middle of both longissimus dorsi muscles. Any carcass in which the pH 
does not reach less than 6.0 may be allowed to maturate an additional 
24 hours and be retested, and, if the carcass still has not reached a 
pH of less than 6.0 after 48 hours, the meat from the carcass may not 
be exported to the United States.
     An authorized veterinary official of the government of the 
exporting region certifies on the foreign meat inspection certificate 
that the above conditions have been met.
     The establishment in which the bovines and sheep are 
slaughtered allows periodic on-site evaluation and subsequent 
inspection of its facilities, records, and operations by an APHIS 
representative.
    Historically, trade in fresh (chilled or frozen) beef from Paraguay 
has not been allowed because APHIS has considered Paraguay to be a 
country affected with FMD. In response to a request from the Government 
of Paraguay that we allow fresh (chilled or frozen) beef to be imported 
into the United States from that country, we conducted a risk analysis, 
which can be viewed on the internet on the Regulations.gov website or 
in our reading room.\2\ APHIS gathered data to support this analysis 
from records of the Servicio Nacional de Calidad y Salud Animal 
(SENACSA), from publicly available information, and from published 
scientific literature. In addition, APHIS conducted site visits to 
Paraguay in December 2008 and July 2014 to verify the information 
submitted by SENACSA and to collect additional data.
---------------------------------------------------------------------------

    \2\ Instructions on accessing Regulations.gov and information on 
the location and hours of the reading room may be found at the 
beginning of this document under ADDRESSES. You may also request 
paper copies of the risk analysis by calling or writing the person 
listed under FOR FURTHER INFORMATION CONTACT.
---------------------------------------------------------------------------

    We concluded that the overall risk associated with importing fresh 
beef from Paraguay is low and that Paraguay has the infrastructure and 
emergency response capabilities needed to effectively report, contain, 
and eradicate FMD in the event of an outbreak and to do so in a timely 
manner. We further concluded that Paraguay is able to comply with U.S. 
import restrictions on the specific products from affected areas. Based 
on the evidence documented in our risk analysis, we believe that fresh 
(chilled or frozen) beef can be safely imported from Paraguay, provided 
certain conditions are met. Accordingly, we are proposing to amend the 
regulations in Sec.  94.29 to provide for the importation of fresh beef 
from Paraguay. Under this proposed rule, fresh beef from Paraguay would 
be subject to the same import conditions applicable to fresh beef and 
ovine meat from Uruguay (other than bone-in ovine meat imported under 
Sec.  94.29(g)(1) through (3)) and fresh beef from the exporting 
regions of Argentina and Brazil.

Risk Analysis

    Our risk analysis was conducted according to the eight factors 
identified in 9 CFR 92.2, ``Application for recognition of the animal 
health status of a region or a compartment'': The scope of the 
evaluation being requested, veterinary control and oversight, disease 
history and vaccination practices, livestock demographics and 
traceability, epidemiological separation from potential sources of 
infection, surveillance, diagnostic laboratory capabilities, and 
emergency preparedness and response. A summary evaluation of each 
factor is discussed below. Based on our analysis of these factors, we 
have determined that fresh (chilled or frozen) beef can be safely 
imported into the United States from Paraguay, under the conditions 
specified in Sec.  94.29.

Scope of the Evaluation Being Requested

    In addition to reviewing records submitted by SENACSA, publicly 
available information, and published scientific literature, APHIS 
conducted site visits in December 2008 and July 2014 to verify the 
information we reviewed and to collect additional data. The site visits 
focused on the veterinary and legal infrastructure of SENACSA, its FMD 
control program, border control procedures, disease control measures, 
laboratory and diagnostic capabilities, biosecurity procedures on 
cattle farms and in slaughter facilities, animal health recordkeeping 
systems, movement controls, and disease surveillance systems. The 2014 
visit included an evaluation of FMD outbreaks that occurred in 2011 and 
2012 and the

[[Page 18079]]

effectiveness of SENACSA's response to the outbreaks.

Veterinary Control and Oversight

    Based on our analysis of the data submitted by SENACSA and 
observations made during our site visits to Paraguay, we concluded that 
the competent veterinary authority of Paraguay is well-organized and 
has the legal authority and technical infrastructure in place to carry 
out official control, eradication, and quarantine activities at the 
central, regional, and local levels. SENACSA is also an active 
collaborator with neighboring countries in disease-eradication efforts.
    SENACSA has a system of official veterinarians and support staff in 
place for carrying out FMD field programs and for import controls and 
animal quarantines. It also has a training program for animal health 
professionals, frequently in collaboration with the veterinary medical 
faculty of the National University. The overall structure and resources 
of SENACSA have significantly increased and been strengthened in 
reaction to the FMD outbreak in 2012. Following feedback from the World 
Organization for Animal Health (WOAH) and the European Union (EU), 
SENACSA is also hiring new personnel to expand its workforce.
    A very strong partnership exists between the competent authority 
and the livestock industry. A large proportion of SENACSA's funding 
comes from the private sector in the form of user fees paid by 
stakeholders associated with sales of animals or movement permits. 
While this funding method allows SENACSA to operate autonomously and 
with little political interference, it also makes SENACSA's budget 
dependent on user fees. SENACSA is addressing the issue and has 
increased its operational budget to U.S. $36 million. Although the 
contribution of the treasury department compared to that of the private 
sector is small, APHIS found no evidence suggesting that resources from 
the private sector could change in the future or that available 
resources for FMD control programs would be reduced.

Disease History and Vaccination Practices

    APHIS observed that SENACSA has an established program for the 
control and prevention of FMD which includes a well-organized 
vaccination strategy. The vaccine used in Paraguay has been assessed by 
international FMD reference laboratories to be appropriate for the 
strains that have been found in the region in the last 15 years. 
Serosurveillance has demonstrated adequate levels of immunity in cattle 
previously immunized.
    Following the 2011/2012 FMD outbreak, SENACSA instituted changes to 
its vaccination program. Audits of vaccinators and the vaccine cold 
chain were conducted. Vaccination cycles were increased from two to 
three annually. The training provided by SENACSA and industry-based 
Animal Health Commissions (AHC) prior to each vaccination cycle also 
appears to have increased the level of awareness of good vaccination 
practices among AHC vaccinators.

Livestock Demographics and Traceability

    Paraguay's animal identification system is similar to, and meets 
the requirements of, the EU and Chilean markets, both of which have 
stringent traceability requirements. Paraguay has two traceability 
systems: A mandatory system under SENACSA and an industry-based, 
voluntary program called the System for the Identification and 
Traceability of Rural Holdings in Paraguay (SITRAP). Under SITRAP, 
there have been initiatives undertaken to facilitate and enhance 
traceability at slaughter.
    Movement controls were well organized and coordinated. Internal 
control posts visited were well-equipped with access to 
telecommunications and information technology systems. Staff at these 
control posts were well aware of movement requirements and followed 
established procedures related to movement control. The staff had an 
organized and consistent way of assessing each animal transport and 
movement. Records at the control posts were well organized, and manuals 
of procedures were readily available.
    We concluded that Paraguay has a sound system for animal 
identification and traceability, premises registration, and animal 
movement controls. The system is adequate to provide assurance that the 
U.S. import requirements for animals to be born, raised, and 
slaughtered in Paraguay can be met.

Epidemiological Separation From Potential Sources of Infection

    Many natural barriers, such as large rivers and forest areas, exist 
along Paraguay's international and internal borders. These barriers 
restrict both animal movement and human traffic and prevent the spread 
of disease.
    Movement of FMD-susceptible species or products into Paraguay could 
occur through international borders where sufficient physical barriers 
do not exist, e.g., along some areas bordering Brazil and Argentina. 
However, the international borders are actively monitored, and Paraguay 
collaborates effectively with neighboring countries to minimize the 
risk of introduction of FMD. Border control agreements between Paraguay 
and its neighbors have been in place since the 1970s, and efforts 
continue to strengthen and harmonize border activities. Sufficient 
controls exist at the airports for interdiction of prohibited material 
and for prevention of the recycling of confiscated products and 
international waste.
    With the exception of Chile, APHIS does not consider the countries 
of South America to be free of FMD. Coordinated regional FMD control 
efforts have been effective in decreasing the incidence of FMD and 
limiting it to certain regions, however. Based on the history of the 
disease on the continent, Paraguay's veterinary infrastructure, and 
SENASCA'S prompt response to the outbreaks in Argentina (2006), Brazil 
(2005-2006), and Bolivia (2007), APHIS concluded that it is unlikely 
that disease would be introduced from adjacent areas. However, at the 
time the risk analysis was prepared, Colombia had just eradicated an 
FMD outbreak. As long as FMD is endemic in certain areas in South 
America, there is a potential risk of reintroduction of the disease 
into the export area.

Surveillance Practices

    Our evaluation led us to conclude that Paraguay has a good 
epidemiological surveillance system. The surveillance activities 
conducted and the use of sound statistical methodologies increase the 
likelihood of detection of FMD if it exists in the population.
    Paraguay's surveillance system combines both active surveillance 
and passive surveillance. Active surveillance consists of annual 
seroepidemiological sampling at the national level to verify the 
absence of circulating FMD virus. The active surveillance strategy is 
updated based on the surveillance objectives for the year. Extensive 
serological surveys were also conducted following FMD outbreaks 2003 
and 2011/2012 to ensure the absence of circulating FMD virus. Passive 
surveillance is based on the notification of vesicular disease by 
producers who are required by law to report any suspect cases to their 
Local Veterinary Unit, which must then respond within 12 hours of 
notification. Indemnification is predicated on this notification by the 
producer. Paraguay's passive surveillance efforts are enhanced by the 
extensive awareness of

[[Page 18080]]

the clinical signs of FMD among the animal health field staff and 
within the industry, as well as the mandatory reporting requirement for 
suspect cases of vesicular diseases. SENACSA, producers, and the AHCs 
in particular all have a role in passive surveillance efforts.
    Additional surveillance comes from herd immunity studies, which are 
conducted frequently. Enhanced epidemiological surveillance occurs in 
High Surveillance Zones, which were established by Paraguay in 
coordination with neighboring countries.
    SENACSA has a manual of procedures that provides the field 
veterinarians with guidelines for sample collection, animal 
identification, aging by dentition, communications, and measures to be 
taken in case of reactors or suspect cases. The manual ensures 
consistency in surveillance activities and responses to suspects among 
field offices.

Diagnostic Laboratory Capabilities

    The Directorate General for Laboratories (DIGELAB) is the official 
laboratory in Paraguay and is located in the SENACSA headquarters. 
Responsibilities include the diagnosis of SENACSA's program diseases 
such as FMD, bovine spongiform encephalopathy, tuberculosis, 
brucellosis, classical swine fever, and Newcastle disease. DIGELAB's 
FMD laboratory is the only laboratory in Paraguay authorized to conduct 
diagnostic testing for vesicular diseases, including FMD. Relative to 
the FMD program, DIGELAB's Vesicular Diseases Department is responsible 
for conducting FMD diagnostic testing of animals as required under 
SENACSA's active and passive surveillance strategy, including 
surveillance sampling at fairs and shows, as well as testing of animals 
for import or export.
    APHIS concluded that Paraguay has the diagnostic capabilities to 
adequately test samples for the presence of FMD virus. DIGELAB's FMD 
laboratory has the necessary infrastructure, equipment, and personnel. 
The laboratory staff are well-trained in the diagnosis of vesicular 
diseases. Diagnostic test methodologies used in the identification of 
vesicular diseases are consistent with WOAH guidelines. All laboratory 
standard operating procedures are thorough and systematic, and 
documentation is good. The laboratory conducts quality control on all 
FMD vaccines, both nationally produced and imported. SENACSA has an 
organized recordkeeping system for laboratory data and the ability to 
complete and report test results in a timely manner.

Emergency Preparedness and Response

    SENACSA has established procedures for rapidly detecting and 
responding to FMD emergencies. SENACSA has surveillance and laboratory 
programs for early detection of FMD and the necessary infrastructure 
for carrying out emergency eradication programs, including an FMD 
contingency plan supported by a legal framework and a sufficient 
budget. If FMD is confirmed in Paraguay through diagnostic testing, the 
National Animal Health Emergency System (SINAESA) is immediately 
activated, and a Director of Emergency is appointed to head up the 
emergency response effort. SINAESA is responsible for establishing a 
chain of command and for identifying and obtaining the necessary 
resources to carry out the activities needed to eradicate the disease. 
In responding to outbreaks in neighboring countries, as well as during 
the 2011/2012 outbreak in Paraguay, SENACSA demonstrated its capacity 
for rapid and effective emergency response.
    The above findings are detailed in the risk analysis document. The 
risk analysis explains the factors that have led us to conclude that 
fresh (chilled or frozen) beef may be safely imported from Paraguay 
under the conditions enumerated above. It also establishes that 
Paraguay has adequate veterinary infrastructure in place to prevent, 
control, report, and manage FMD outbreaks. Therefore, we are proposing 
to amend Sec.  94.29 to allow the importation of fresh beef from 
Paraguay under the conditions described above.

Executive Orders 12866, 13563, and Regulatory Flexibility Act

    This proposed rule has been determined to be significant for the 
purposes of Executive Order 12866 and, therefore, has been reviewed by 
the Office of Management and Budget (OMB).
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by Executive 
Orders 12866 and 13563, which 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, and equity). Executive Order 13563 emphasizes the importance 
of quantifying both costs and benefits, of reducing costs, of 
harmonizing rules, and of promoting flexibility. The economic analysis 
also provides an initial regulatory flexibility analysis that examines 
the potential economic effects of this rule on small entities, as 
required by the Regulatory Flexibility Act.
    Based on the information we have, there is no reason to conclude 
that adoption of this proposed rule would result in any significant 
economic effect on a substantial number of small entities. However, we 
do not currently have all of the data necessary for a comprehensive 
analysis of the effects of this proposed rule on small entities. 
Therefore, we are inviting comments on potential effects. In 
particular, we are interested in determining the number and kind of 
small entities that may incur benefits or costs from the implementation 
of this proposed rule.

Introduction

    This analysis examines potential economic impacts of a proposed 
rule that would allow fresh (chilled or frozen) beef from Paraguay to 
be imported into the United States provided certain conditions are met. 
APHIS currently considers the whole territory of Paraguay to be a 
region where FMD exists. With few exceptions, APHIS' regulations in 
part 94 prohibit the importation of fresh (chilled or frozen) meat of 
ruminants or swine that originates in or transits a region where FMD is 
considered to exist. APHIS does not consider Paraguay as free of FMD 
because Paraguay vaccinates against FMD. As explained in detail earlier 
in this document, the vaccination requirement could result in infected 
animals being imported into the United States.
    This document provides a benefit-cost analysis, as required by 
Executive Orders 12866 and 13563, which 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, 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 document also examines the potential economic effects of the rule 
on small entities, as required by the Regulatory Flexibility Act.

Overview of the Action and Affected Entities

U.S. Beef Production and Trade

    The United States is the largest beef producer in the world and 
produces

[[Page 18081]]

primarily grain-fed beef for the domestic and export markets. Over the 
period 2016 to 2020, U.S. beef production averaged 12 million metric 
tons (MT); exports 1.4 million MT; and imports 1.3 million MT (Table 
1).

                               Table 1--U.S. Beef Production, Exports, and Imports
                                                 [2016 to 2020]
----------------------------------------------------------------------------------------------------------------
                              Year                                  Production        Imports         Exports
----------------------------------------------------------------------------------------------------------------
                                                                                    Metric tons
                                                                 -----------------------------------------------
2016............................................................      11,468,481       1,365,986       1,159,637
2017............................................................      11,904,762       1,357,370       1,296,599
2018............................................................      12,216,780       1,359,637       1,433,107
2019............................................................      12,346,485       1,386,848       1,372,336
2020............................................................      12,355,556       1,515,646       1,338,322
                                                                 -----------------------------------------------
    5-year average..............................................      12,058,413       1,397,098       1,320,000
----------------------------------------------------------------------------------------------------------------
Source: U.S. Department of Agriculture (USDA), World Agricultural Outlook Board, ``World Agricultural Supply and
  Demand Estimates'' and supporting materials; U.S. Department of Commerce, Bureau of Economic Analysis
  (population); and USDA, Economic Research Service.

    Most U.S. beef imports are grass-fed beef that is processed 
together with higher-fat trimmings from U.S. grain-fed beef to produce 
ground beef. Canada, Australia, New Zealand, and Mexico historically 
have been the largest sources of U.S. beef imports (Table 2). Entry of 
beef from Paraguay into the U.S. beef market would result in a change 
in market shares.
    In terms of exports, between 2016 and 2020 the top destinations for 
U.S. beef were Japan (362,071 MT); South Korea (264,780 MT); Mexico 
(181,982 MT); Hong Kong (156,025 MT); and Canada (133,316 MT).

                                               Table 2--U.S. Beef Imports From Principal Supply Countries
                                                                [2016 to 2020; 1,000 MT]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Country                               2016            2017            2018            2019            2020           Average
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                   1,000 Metric tons, carcass weight equivalent
                                                         -----------------------------------------------------------------------------------------------
Canada..................................................          325.37          336.01          358.91          384.31          374.15          355.75
Australia...............................................          347.74          315.02          305.08          324.85          300.50          318.64
Mexico..................................................          223.67          259.99          230.36          262.90          295.25          254.44
New Zealand.............................................          277.67          252.48          259.54          181.77          233.73          241.04
Brazil..................................................           69.22           62.39           63.92           74.01          100.20           73.95
Nicaragua...............................................           50.43           60.44           71.07           82.83           85.83           70.12
Uruguay.................................................           54.72           54.61           51.91           53.89           66.73           56.37
Other Countries.........................................           16.42           15.81           18.20           21.57           58.39           26.07
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................        1,365.24        1,356.75        1,358.99        1,386.13        1,514.78        1,396.38
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: USDA ERS carcass weight equivalent calculations using data from U.S. Department of Commerce, Bureau of the Census.
Note: Quantities include some processed beef and veal.

Paraguay's Beef Production and Trade

    Historically, beef cattle production has been one of the major 
agricultural activities in Paraguay with beef and soybeans being the 
leading exports. Paraguay recently surpassed Argentina for eighth place 
among the world's largest beef exporters. The Paraguayan beef industry 
is focused on exports with about 40 percent of the production consumed 
domestically. Paraguay ships roughly 90 percent of its beef to just 
five markets: Chile, Russia, Israel, Taiwan and Brazil. Today, cattle 
are being displaced from traditional production areas in Paraguay 
because of a steady increase in soybean acreage. Since the 1990s, there 
has also been increased grain supplementation of beef cattle feeding 
regimes in Paraguay.
    For the period 2016 to 2020, Paraguay's average annual production 
was 582,000 MT, with domestic consumption averaging 224,000 MT, or 
about 40 percent of production (Table 3). Exports averaged 372,000 MT 
per year. Paraguay's average exports of 372,000 MT for the 2016 to 2020 
period is equivalent to approximately 26 percent of U.S. fresh beef 
imports for the same period.
    The quantity of fresh beef expected to be imported into the United 
States from Paraguay, ranging from 3,250 to 6,500 MT, is equivalent to 
about 0.05 percent of U.S. average annual fresh beef production, about 
0.05 percent of U.S. average annual imports of fresh beef, and about 
0.50 percent of average annual exports of fresh beef, 2016 to 2020.

[[Page 18082]]



                            Table 3--Paraguay's Beef Production, Exports, and Imports
                                                 [2016 to 2020]
----------------------------------------------------------------------------------------------------------------
                      Year                          Production      Consumption       Imports         Exports
----------------------------------------------------------------------------------------------------------------
                                                                         1,000 Metric tons
                                                 ---------------------------------------------------------------
2013............................................             510             186               2             326
2014............................................             570             183               2             389
2015............................................             590             210               1             381
2016............................................             610             222               2             390
2017............................................             610             223               1             380
                                                 ---------------------------------------------------------------
    Average.....................................             578             231               2             373
----------------------------------------------------------------------------------------------------------------
Source: Compiled from various GAIN Reports of the USDA Foreign Agricultural Service using carcass weight
  equivalent data.

Expected Benefits and Costs of the Rule

    For this analysis, we use a non-spatial, net trade, partial 
equilibrium approach to welfare analysis to compute expected impacts of 
the rule on U.S. producers and consumers of fresh beef. In this 
section, we describe assumptions and parameters of the welfare 
analysis, including the baseline price and quantities, projected 
imports from Paraguay, and domestic price elasticities of demand and 
supply. We then discuss the modeling results. The model evaluates how 
domestic market prices and quantities may adjust to the policy change, 
and how producers and consumers may potentially be impacted.
    We assume that demand and supply functions are approximately linear 
near the initial equilibrium point. For small parallel shifts in supply 
and demand, this assumption results in reasonably accurate measures of 
consumer and producer surplus changes. Beef imports from Paraguay will 
affect prices and quantities of fresh beef on the U.S. market, and 
therefore result in welfare impacts as reflected in changes in consumer 
and producer surplus. Consumer surplus is the difference between what 
the consumer pays for a unit of a good or service and the maximum price 
that the consumer would be willing to pay for that unit. Producer 
surplus is the difference between the price a producer is paid for 
supplying a unit of a good or service and the minimum price that the 
producer would be willing to accept to supply that unit.
    Our analysis is non-spatial in that the price and quantity effects 
obtained from the model are assumed to be average effects across 
geographically separate markets. Partial equilibrium means that the 
model results are based on maintaining a commodity-price equilibrium in 
a limited portion of the overall economy. All other economic sectors 
not explicitly included in the model are assumed to have a negligible 
influence on the model results. A partial equilibrium analysis is 
appropriate because the rule is specific to imports of fresh beef from 
Paraguay and is therefore expected to have only limited effects on 
other sectors of the economy.
    Baseline data for fresh beef are shown in Tab1e 4. Baseline 
quantities are based on 5-year averages, 2016 through 2020. Domestic 
supply is equated to fresh beef production minus exports, where fresh 
beef exports are set equal to zero. In a net trade model, such as the 
one applied in this analysis, a country is identified as either a net 
exporter or a net importer of a particular commodity. In this instance, 
U.S. fresh beef exports are not included as part of domestic supply in 
the baseline in order to quantify the effects of permitting fresh beef 
imports from Paraguay. Domestic demand for fresh beef is equated to 
fresh production less exports plus imports. The baseline price is the 
5-year average U.S. custom import value for fresh beef, 2016 through 
2020.\3\
---------------------------------------------------------------------------

    \3\ The custom import value is defined as the price actually 
paid or payable for merchandise when sold for exportation, excluding 
import duties, freight, insurance, and other charges incurred in 
bringing the merchandise to the importing country.

  Table 4--U.S. Fresh Beef Baseline Data: Production, Imports, Exports, Domestic Consumption, and Price in 2016
                                                     Dollars
                                                 [2016 to 2020]
----------------------------------------------------------------------------------------------------------------
                                                                                     Domestic
              Year                  Production        Imports         Exports         supply       Price per MT
----------------------------------------------------------------------------------------------------------------
                                                                    Metric tons
                                 -------------------------------------------------------------------------------
2016............................      11,468,481       1,365,986       1,159,637      11,674,830           6,988
2017............................      11,904,762       1,357,370       1,296,599      11,965,533           7,092
2018............................      12,216,780       1,359,637       1,433,107      12,143,311           7,248
2019............................      12,346,485       1,386,848       1,372,336      12,360,998           7,533
2020............................      12,355,556       1,515,646       1,338,322      12,532,880           8,063
                                 -------------------------------------------------------------------------------
    5 year average..............      12,058,413       1,397,098       1,320,000      12,135,510           7,385
----------------------------------------------------------------------------------------------------------------
Source: USDA, World Agricultural Outlook Board, ``World Agricultural Supply and Demand Estimates'' and
  supporting materials; U.S. Department of Commerce, Bureau of Economic Analysis (population); and USDA,
  Economic Research Service.

    For this analysis, we use price elasticities of demand and supply 
for fresh beef of -1.52 and 0.34, respectively.\4\ In the short run, 
beef producers' responsiveness is inelastic due to limitations in 
adjusting supply to

[[Page 18083]]

market changes. In the long run, producers are better able to respond 
to changes in price associated with increased market supply. Likewise, 
a more price-elastic long-run demand would be indicative of increased 
price responsiveness of consumers over time.
---------------------------------------------------------------------------

    \4\ Paarlberg, Philip L., Ann Hillberg Seitzinger, John G. Lee, 
and Kenneth H. Mathews, Jr. Economic Impacts of Foreign Animal 
Disease. Economic Research Report Number 57. USDA ERS, May 2008.
---------------------------------------------------------------------------

    As a measure of possible impacts of fresh beef imports from 
Paraguay, we consider import volumes of 3,250 to 6,500 MT (5 to 10 
percent of the other countries tariff rate quota of 65,005 \5\). For 
each of the three annual import levels, we modeled changes in U.S. 
consumption, production, price, consumer welfare, producer welfare, and 
net social welfare gain (Table 5). In each case, consumer welfare gains 
outweigh producer welfare losses with positive net welfare impacts. 
Producer welfare losses under the three import levels range between $12 
and $23 million. Consumer welfare gains range between $13 and $26 
million with net welfare gains of between $1.3 and $3.0 million. Beef 
imports from Paraguay may displace imports from other countries.
---------------------------------------------------------------------------

    \5\ Harmonized Tariff Schedule of the United States (2018) 
Revision 4, Chapter 2, Meat and Edible Meat Offal. The tariff rate 
quota provides preferential-duty access for certain named countries 
and a category of countries grouped as Other Countries or Areas. The 
combined annual quantity of beef allowed to be imported from Other 
Countries or Areas is limited to 65,005 MT.

 Table 5--Modeled Impacts for U.S. Fresh Beef Production, Consumption, Price, and Consumer and Producer Welfare,
                                    Assuming Fresh Beef Imports From Paraguay
                                      [Of 3,250 MT, 4,875 MT, and 6,500 MT]
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
Assumed annual fresh beef imports from Paraguay........              3,250              4,875              6,500
Change in U.S. consumption, MT.........................              2,715              4,072              5,430
Change in U.S. production, MT..........................               -535               -803             -1,070
Change in domestic price of fresh beef, dollars per MT.            ($1.09)            ($1.63)            ($2.17)
% Change in domestic price.............................            -0.0147            -0.0221            -0.0294
Change in consumer welfare.............................        $13,179,777        $19,770,771        $26,362,502
Change in producer welfare.............................      ($11,660,864)      ($17,491,078)      ($23,321,146)
Annual net benefit.....................................         $1,518,913         $2,279,694         $3,041,356
----------------------------------------------------------------------------------------------------------------

Alternatives to the Rule

    We considered alternatives to the chosen course of action, 
including maintaining the current prohibition on imports of fresh beef 
from Paraguay and using the WOAH recommendations to determine import 
requirements. Continuing to prohibit fresh beef imports from Paraguay 
is not defensible, given that a complete restriction on imports is 
unnecessary for safeguarding the U.S. cattle industry provided certain 
conditions are met. We therefore reject the status quo alternative.
    A second alternative considered by APHIS would be to allow fresh 
beef to enter from Paraguay under trade recommendations established by 
the WOAH. The WOAH recommendations, however, do not meet the acceptable 
level of protection of the United States.
    FMD is a highly contagious disease caused by a resilient virus 
readily transmitted to all cloven-hoofed animals. There are few 
effective mitigation measures to guard against the risk of exposure of 
susceptible U.S. livestock if FMD-infected animals or products 
contaminated with the FMD virus were imported into the United States. 
APHIS has determined therefore that a cautious approach to allowing 
fresh beef imports from regions that vaccinate for FMD is warranted.
    As noted earlier, the position of the United States is that a 
country that vaccinates for FMD is not free of the disease. Vaccination 
of cattle against FMD introduces risks related to the immunological 
response within the vaccinated herd. While a large percentage of 
individual animals in the herd may fully respond to FMD vaccination, 
some individual animals in the herd may have a limited response, 
resulting in partial or no immunity. Therefore, so-called herd immunity 
may not always reflect individual animal immunity, and the disease may 
still be present in certain animals in a vaccinated population. As a 
result, importation of beef from areas in which cattle are vaccinated 
for FMD could result in importation of beef derived from infected 
animals.
    Under the World Trade Organization Sanitary and Phytosanitary 
Agreement, Member Countries are encouraged to base their import 
requirements on international recommendations but maintain the right to 
adopt additional measures provided that they are based on science, are 
transparent in the way they are developed and implemented, and do not 
arbitrarily or unjustifiably discriminate among members. APHIS does not 
recognize a country that vaccinates for FMD as free of the disease 
because vaccination may mask clinical signs. The virus can remain 
present but undetected in vaccinated populations. APHIS regulations 
allow for the importation of meat and meat products from regions that 
vaccinate for FMD provided that these products are processed in such a 
way as to ensure the inactivation of the FMD virus.
    If APHIS were to follow the WOAH recommendations, we expect that 
fresh beef imports from Paraguay would tend toward the upper end of the 
3,250 to 6,500 MT range; more cattle and larger quantities of beef 
would likely qualify for export to the United States because the import 
sanitary requirements would be less stringent. Fresh beef imports from 
Paraguay exceeding 6,500 MT would enter under a higher tariff rate. 
Under the modeled 6,500 MT scenario, wholesale beef price would 
decrease by 0.03 percent. U.S. beef production would decline by 
approximately 1,000 MT or less than a percent of total U.S beef 
production.
    We reject this alternative to the rule for reasons other than 
disproportionate economic impact and because it does not meet APHIS' 
determination of necessary sanitary requirements for the importation of 
fresh beef from Paraguay. The preferred alternative has been analyzed 
using the limited information available. We cannot certify that this 
rule would have no disproportionate impact on small entities, but at 
this time have found no evidence that it would have such impacts.

Initial Regulatory Flexibility Analysis

    The Regulatory Flexibility Act requires agencies to evaluate the 
potential effects of their proposed and final rules on small 
businesses, small organizations and small governmental jurisdictions. 
This initial regulatory flexibility analysis describes expected impacts 
of this proposed rule on small entities, as required by section 603 of 
the Act.

[[Page 18084]]

Reasons Action Is Being Considered

    In response to a request from the Government of Paraguay that fresh 
(chilled or frozen) beef be allowed to be imported into the United 
States from Paraguay, APHIS conducted a risk analysis to enable APHIS 
to develop appropriate regulatory conditions with mitigations to 
address potential risks of FMD disease introduction following any 
initiation of trade in fresh beef from Paraguay. In the analysis APHIS 
considered the epidemiological characteristics of FMD that are relevant 
to the risk of importing fresh and frozen beef under certain conditions 
into the United States and described appropriate mitigations to reduce 
that risk. The mitigations to be applied include restrictions on the 
origin of animals, requirements for maturation and pH testing of 
carcasses, ante-mortem and post-mortem inspections, and verification by 
Paraguayan officials that the various mitigations were applied 
appropriately. APHIS concluded from the assessments that the 
surveillance, prevention, and control measures implemented by the 
Government of Paraguay are sufficient and that fresh beef imported from 
Paraguay under the additional mitigation measures imposed by the 
proposed action will be safe. It is highly unlikely that such imports 
from Paraguay will introduce or disseminate FMD within the United 
States. As of 2020, there are more than 70 markets opened to Paraguayan 
beef. Cattlemen in Paraguay and the Government of Paraguay aim at 
opening in the future important markets such as China, NAFTA countries, 
and South Korea.\6\
---------------------------------------------------------------------------

    \6\ Paraguay Beef & Cattle Outlook 2020: https://beef2live.com/story-paraguay-beef-cattle-annual-0-206336.
---------------------------------------------------------------------------

Objectives of and Legal Basis for the Rule

    With a few exceptions, APHIS regulations in 9 CFR part 94 prohibit 
the importation of fresh (chilled or frozen) meat of ruminants or swine 
that originates in or transits a region where FMD is considered to 
exist. APHIS does not consider Paraguay free of FMD because Paraguay 
vaccinates against FMD. The proposed rule would allow the importation 
of fresh (chilled or frozen) beef from Paraguay under certain 
conditions designed to ensure beef exported to the United States will 
not harbor FMD virus. In accordance with the Animal Health Protection 
Act (7 U.S.C. 8301 et seq.), the Secretary of Agriculture has the 
authority to promulgate regulations and take measures to prevent the 
introduction of contagious animal diseases into the United States by 
means of import restrictions.

Potentially Affected Small Entities

    Entities that could be primarily affected by the proposed rule are 
beef and cattle producers, as well as feedlots and slaughter 
facilities. Of the 882,692 farms \7\ in the United States with cattle 
and calves, 711,827 sold cattle and calves, 729,0466 were classified as 
beef cow farms, and 54,599 had milk cows.\8\ Based on data from the 
2017 Census of Agriculture and Small Business Administration (SBA) 
standards,\9\ we expect a majority of these entities to be small. 
Entities in the categories beef cattle ranching and farming (NAICS 
112111) and dairy cattle and milk production (NAICS 112120) are 
considered small if their total annual sales do not exceed $1 million. 
The 2017 Census of Agriculture indicates that 99 percent of beef cattle 
operations are classified as small; of the 582,380 (farms with sales) 
farms classified under the beef cattle ranching and farming category, 
99 percent had annual sales of less than $1 million. Of the 47,237 
dairy operations, 95 percent are classified as small. Entities in the 
category cattle feedlots (NAICS 112112) are considered small if they 
have total annual sales of not more than $8 million. Sales were not 
available for farms operating as feedlots. Entities classified as 
animal (except poultry) slaughtering (NAICS 311611) with not more than 
1,000 employees are considered small by SBA standards. The 2012 
Economic Census reports 1,494 establishments in this category. Of this 
number, 1,357 establishments (96 percent) had fewer than 1,000 
employees.\10\ Thus, the majority of slaughter establishments are 
considered small by SBA standards.
---------------------------------------------------------------------------

    \7\ Represents all farms that held cattle inventory whether or 
not they sold cattle.
    \8\ U.S. 2017 Agriculture Census, tables 12, 13, 14, 16, https://www.nass.usda.gov/Publications/AgCensus/2017/Full_Report/Volume_1,_Chapter_1_US/st99_1_0011_0012.pdf. https://www.nass.usda.gov/Publications/AgCensus/2017/Full_Report/Volume_1,_Chapter_1_US/st99_1_0013_0014.pdf. https://www.nass.usda.gov/Publications/AgCensus/2017/Full_Report/Volume_1,_Chapter_1_US/st99_1_0015_0016.pdf.
    \9\ Small Business Administration size standards: https://www.sba.gov/document/support-table-size-standards.
    \10\ U.S. Bureau of Census, 2018 County Business Pattern Survey: 
https://data.census.gov/cedsci/tablen=311611&tid=CBP2018.CB1800CBP.
---------------------------------------------------------------------------

Projected Reporting, Recordkeeping, and Other Compliance Requirements

    Reporting and recordkeeping requirements associated with the 
proposed rule are discussed in the proposed rule under the heading 
``Paperwork Reduction Act.''

Duplication, Overlap, or Conflict With Existing Rules and Regulations

    APHIS has not identified any duplication, overlap, or conflict of 
the proposed rule with other Federal rules.

Alternatives To Minimize Significant Economic Impacts of the Rule

    For the purposes of this Initial Regulatory Flexibility Analysis, 
we have used the best data available to examine feasible ways to 
achieve the desired policy goals. We cannot certify that this rule 
would have no disproportionate impact on small entities, but at this 
time have found no evidence that it would have such impacts.
    We recognize we may not have all relevant information concerning 
economic impacts at this time. Therefore, we invite public comment on 
any additional relevant information. We also invite public comments on 
alternatives that may achieve the objective of this proposed rule.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (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) administrative proceedings will not be required before 
parties may file suit in court challenging this rule.

Executive Order 13175

    This 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 rule will not have 
substantial and direct effects on Tribal governments and will not have 
significant Tribal implications.
    In 2020, APHIS informed Tribal leaders of the proposed action and 
solicited comments and questions. APHIS did not receive any comments or 
questions from Tribal leaders in response. APHIS worked with the APHIS 
Office of the National Tribal Liaison to conduct the outreach in 2020 
and also hosted a Tribal listening session on October 17, 2022, about 
the proposed rule. If a tribe requests consultation in the future, 
APHIS will work with the Office of Tribal Relations to ensure 
meaningful consultation is provided.

[[Page 18085]]

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
importation of fresh (chilled or frozen) beef from Paraguay, we have 
prepared an environmental assessment. The environmental assessment was 
prepared in accordance with: (1) The National Environmental Policy Act 
of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of 
the Council on Environmental Quality for implementing the procedural 
provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations 
implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing 
Procedures (7 CFR part 372).
    The environmental assessment may be viewed on the Regulations.gov 
website or in our reading room. (A link to Regulations.gov and 
information on the location and hours of the reading room are provided 
under the heading ADDRESSES at the beginning of this proposed rule.) In 
addition, copies may be obtained by calling or writing to the 
individual listed under FOR FURTHER INFORMATION CONTACT.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), reporting and recordkeeping 
requirements included in this proposed rule have been submitted for 
approval to OMB. Written comments and recommendations for the proposed 
information collection should be sent within 60 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 60-day Review--
Open for Public Comments'' or by using the search function. Please send 
a copy of your comments to: (1) Docket No. APHIS-2018-0007, Regulatory 
Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road 
Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer, OCIO, 
USDA, Room 404-W, 14th Street and Independence Avenue SW, Washington, 
DC 20250.
    APHIS is proposing to amend the regulations in Sec.  94.29 to 
provide for the importation of fresh (chilled or frozen) beef from 
Paraguay. Under this proposed rule, fresh beef from Paraguay would be 
subject to the same import conditions applicable to fresh beef and 
ovine meat from Uruguay (other than bone-in ovine meat imported under 
Sec.  94.29(g)(1) through (3)) and fresh beef from the exporting 
regions of Argentina and Brazil. The importation of fresh beef from 
Paraguay will require information collection activities such as the 
completion and signature of Foreign Meat Inspection Certificates by an 
authorized veterinary official of the Government of Paraguay and onsite 
evaluations and inspections of operations, records, and processing 
facilities to ensure they are following the procedures necessary to 
lead to the results listed in the Foreign Meat Inspection Certificate. 
The certificate, evaluation, and inspection ensure that exported fresh 
beef from Paraguay poses negligible risk of introducing disease into 
the United States. If this action is finalized and OMB approves of this 
information collection package, APHIS plans to merge this information 
collection into OMB control number 0579-0372, Importation of Beef and 
Ovine Meat from Uruguay and Beef from Argentina and Brazil.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public burden for this collection of 
information is estimated to average 1.3 hours per response.
    Respondents: Authorized veterinary officials employed by the 
Government of Paraguay and beef producers in Paraguay.
    Estimated annual number of respondents: 2.
    Estimated annual number of responses per respondent: 1.
    Estimated annual number of responses: 3.
    Estimated total annual burden on respondents: 4 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the estimate of burden.)
    A copy of the information collection may be viewed on the 
Regulations.gov website or in our reading room. (A link to 
Regulations.gov and information on the location and hours of the 
reading room are provided under the heading ADDRESSES at the beginning 
of this proposed rule.) Copies can also be obtained from Mr. Joseph 
Moxey, APHIS' Paperwork Reduction Act Coordinator, at (301) 851-2483. 
APHIS will respond to any information collection review-related 
comments in the final rule. All comments will also become a matter of 
public record.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For trade partners who have fully automated systems, 
APHIS will accept computer extracts of electronic health certification 
data. These certificates are included in the government-wide use of the 
International Trade Data System via the Automated Commercial 
Environment to improve business operations and further Agency missions. 
Respondents are free to maintain required records as best suited for 
their organization. For information pertinent to E-Government Act 
compliance related to this proposed rule, please contact Mr. Joseph 
Moxey, APHIS' Paperwork Reduction Act Coordinator, at (301) 851-2483.

List of Subjects in 9 CFR Part 94

    Animal diseases, Imports, Livestock, Meat and meat products, Milk, 
Poultry and poultry products, Reporting and recordkeeping requirements.

    Accordingly, we propose to amend 9 CFR part 94 as follows:

PART 94--FOOT-AND-MOUTH DISEASE, NEWCASTLE DISEASE, HIGHLY 
PATHOGENIC AVIAN INFLUENZA, AFRICAN SWINE FEVER, CLASSICAL SWINE 
FEVER, SWINE VESICULAR DISEASE, AND BOVINE SPONGIFORM 
ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS

0
1. The authority citation for part 94 continues to read as follows:

    Authority: 7 U.S.C. 1633, 7701-7772, 7781-7786, and 8301-8317; 
21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

[[Page 18086]]

Sec.  94.29  [Amended]

0
2. Section 94.29 is amended as follows:
0
a. In the introductory text, by adding the words ``fresh (chilled or 
frozen) beef from Paraguay;'' after the word ``Tocantins;'';
0
b. In paragraph (a)(1), by adding the words ``or in Paraguay;'' after 
the word ``Brazil''; and
0
c. In paragraph (b), by adding the words ``in Paraguay (for beef from 
Paraguay),'' after the words ``(for beef from Brazil),''.

    Done in Washington, DC, this 17th day of March 2023.
Jennifer Moffitt,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2023-05889 Filed 3-24-23; 8:45 am]
BILLING CODE 3410-34-P


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