48494

Proposed Rules Federal Register Vol. 70, No. 159

Thursday, August 18, 2005

This section of the FEDERAL REGISTER • Federal eRulemaking Portal: Go to inadequate surveillance for BSE. contains notices to the public of the proposed http://www.regulations.gov and follow Paragraph (a)(3) of § 94.18 lists regions issuance of rules and regulations. The the instructions for locating this docket that present a minimal risk of purpose of these notices is to give interested and submitting comments. introducing BSE into the United States. persons an opportunity to participate in the Other Information: All comments Except for certain controlled transit rule making prior to the adoption of the final rules. submitted in response to this proposal, movements, § 94.18(b) prohibits the as well as analyses for this proposal, are importation of meat, meat products, and available at the EDOCKET Web site most other edible products of ruminants DEPARTMENT OF AGRICULTURE shown above and our reading room. The that have been in any region listed in reading room is located in room 1141 of § 94.18(a)(1) or (a)(2) and restricts the Animal and Plant Health Inspection the USDA South Building, 14th Street importation of those commodities from Service and Independence Avenue, SW., any region listed in § 94.18(a)(3). Washington, DC. Normal reading room In an interim rule published in the 9 CFR Part 94 hours are 8 a.m. to 4:30 p.m., Monday Federal Register on October 16, 2001 through Friday, except holidays. To be (66 FR 52483–52484, Docket No. 01– [Docket No. 05–004–1] sure someone is there to help you, 094–1), and effective on September 10, 2001, we amended the regulations by RIN 0579–AB93 please call (202) 690–2817 before coming. You may also view APHIS adding Japan to the list in § 94.18(a)(1) Importation of Whole Cuts of Boneless documents published in the Federal of regions where BSE exists. That action Beef from Japan Register and related information on the was prompted by the confirmation of Internet at http://www.aphis.usda.gov/ BSE in a native-born animal in Japan. AGENCY: Animal and Plant Health ppd/rad/webrepor.html. The effect of the interim rule was to Inspection Service, USDA. FOR FURTHER INFORMATION CONTACT: Dr. prohibit the importation of ruminants ACTION: Proposed rule. Gary Colgrove, Director, National Center that have been in Japan, as well as meat, for Import and Export, VS, APHIS, 4700 meat products, and most other products SUMMARY: We are proposing to amend River Road Unit 38, Riverdale, MD and byproducts of ruminants that have the regulations governing the 20737–1231; (301) 734–4356. been in Japan. importation of meat and other edible Immediately following the detection animal products by allowing, under SUPPLEMENTARY INFORMATION: of the BSE-infected cow, the certain conditions, the importation of Background Government of Japan initiated an whole cuts of boneless beef from Japan. epidemiological investigation and took a The Animal and Plant Health We are proposing this action in series of measures to detect and control Inspection Service (APHIS) of the response to a request from the BSE in Japan, including measures to United States Department of Agriculture Government of Japan and after ensure that tissues that have the (USDA or the Department) regulates the conducting an analysis of the risk that potential to carry infectious levels of the importation of animals and animal indicates that such beef can be safely BSE agent are removed from cattle at products into the United States to guard imported from Japan under the slaughter, a ban on the feeding of against the introduction of animal conditions described in this proposal. mammalian protein to ruminants is in diseases. The regulations in 9 CFR parts DATES: We will consider all comments place, and increase BSE surveillance. 93, 94, 95, and 96 (referred to below as The Government of Japan has that we receive on or before September the regulations) govern the importation 19, 2005. requested that APHIS consider allowing of certain animals, birds, poultry, meat, the resumption of trade in beef from ADDRESSES: You may submit comments other animal products and byproducts, Japan to the United States. Prior to the by any of the following methods: hay, and straw into the United States in • 2001 ban on the importation of EDOCKET: Go to http:// order to prevent the introduction of ruminants and ruminant products from www.epa.gov/feddocket to submit or various animal diseases, including Japan, Japan primarily exported to the view public comments, access the index bovine spongiform encephalopathy United States boneless cuts of beef from listing of the contents of the official (BSE), a chronic degenerative disease cattle born, raised and slaughtered in public docket, and access those affecting the central nervous system of Japan. Therefore, in response to Japan’s documents in the public docket that are cattle. request, we considered allowing the available electronically. Once you have Section 94.18 of the regulations importation of whole cuts of boneless entered EDOCKET, click on the ‘‘View prohibits or restricts the importation beef derived from cattle that were born, Open APHIS Dockets’’ link to locate this into the United States of meat and raised, and slaughtered in Japan and document. certain other edible products due to analyzed the animal health risks • Postal Mail/Commercial Delivery: BSE. Paragraph (a)(1) of § 94.18 lists associated with that product.1 For a Please send four copies of your regions in which BSE is known to exist. consideration of the risks to human comment (an original and three copies) Paragraph (a)(2) of § 94.18 lists regions to Docket No. 05–004–1, Regulatory that present an undue risk of 1 In this proposal, we use the term ‘‘whole cuts Analysis and Development, PPD, introducing BSE into the United States of boneless beef’’ to refer to meat derived from the APHIS, Station 3C71, 4700 River Road because their import requirements are skeletal muscle of a bovine carcass, excluding all parts of the animal’s head and diaphragm. Meat that Unit 118, Riverdale, MD 20737–1238. less restrictive than those that would be has been ground, flaked, shaved, or otherwise Please state that your comment refers to acceptable for import into the United processed, comminuted, or mechanically separated Docket No. 05–004–1. States and/or because the regions have would not be whole cuts of boneless beef.

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health, we consulted with the Food known as cellular prion protein. The control measures were in place. To date, Safety and Inspection Service (FSIS) of BSE agent does not evoke a traditional approximately 170 probable and USDA, which is the public health immune response or inflammatory confirmed cases of vCJD have been agency that is responsible for ensuring reaction in host animals. BSE is identified worldwide. The majority of the food safety of this product. The risk confirmed by post-mortem microscopic these cases have either been identified analysis is available on EDOCKET and examination of an animal’s brain tissue in the United Kingdom or were linked in the APHIS reading room. or by detection of the abnormal form of to exposure that occurred in the United (Information on accessing EDOCKET as the prion protein in an animal’s brain Kingdom, and all cases have been well as the location and hours of the tissues. The pathogenic form of the linked to exposure in countries with APHIS reading room may be found at protein is both less soluble and more native cases of BSE. Some studies the beginning of this document under resistant to degradation than the normal estimate that more than 1 million cattle ADDRESSES.) You may also request paper form. The BSE agent is resistant to heat may have been infected with BSE copies of the analysis by calling or and to normal sterilization processes. throughout the epidemic in the United writing the person listed under FOR BSE is not a contagious disease; Kingdom. This number of infected cattle FURTHER INFORMATION CONTACT. Please according to internationally accepted could have introduced a significant refer to Docket No. 05–004–1 when research, the only confirmed, natural amount of infectivity into the human requesting copies of the risk analysis. route of transmission of BSE in cattle is food supply. Yet, the low number of Under the Animal Health Protection the consumption of animal feed cases of vCJD identified to date Act (7 U.S.C. 8301 et seq.), the Secretary containing protein from ruminants indicates that there is a substantial of Agriculture may prohibit the infected with BSE. species barrier that protects humans importation of any animal or article if BSE was first documented in the from widespread illness due to exposure the Secretary determines that the United Kingdom in 1986 and has since to the BSE agent. prohibition is necessary to prevent the been confirmed in native-born cattle in introduction into or dissemination 22 European countries in addition to the Factors Considered in the Development within the United States of any pest or United Kingdom, and in some non- of the Proposed Import Conditions disease of livestock. The Secretary has European countries, including Japan, BSE Infectivity determined that it is not necessary to Israel, Canada, and the United States. Examination of naturally-occurring continue to prohibit the importation of Since November 1986, there have been whole cuts of boneless beef derived more than 186,000 confirmed cases of BSE cases and extensive well-controlled from cattle that were born, raised, and BSE in cattle worldwide. As of July BSE challenge studies have clearly slaughtered in Japan, provided that the 2005, Japan had reported a total of 20 demonstrated that the primary site for conditions described in this proposal cases of BSE, including the initial case BSE accumulation in cattle is the central are met. This determination is based on of BSE in September 2001 and two cases nervous system (brain, spinal cord, a number of factors, including research that are currently under further trigeminal ganglia, dorsal root ganglia 3 on BSE and the risk analysis prepared investigation.2 (DRG), and eye). Small amounts of BSE for this rulemaking. In the United States, there have been infectivity accumulate in the distal In this proposed rule, we will first two confirmed cases of BSE, one an ileum, and only trace amounts have provide some background on BSE. Next, imported cow and one a native cow. been found in tonsil samples. we discuss the scientific evidence that The first case of BSE in the United Importantly, BSE studies in cattle to provides a basis for the proposed States was identified in a dairy cow in date have not detected infectivity in any conditions, then discuss the proposed Washington State on December 23, other tissues than those listed above. conditions in further detail. Finally, we 2003. The epidemiological investigation These studies also have found that the will briefly discuss the proposed and DNA test results confirmed that the level of infectious agent in these tissues conditions as they relate to international infected cow was not indigenous to the varies with the age of the animal, with guidelines on BSE. United States, but rather was born and the highest levels of infectivity detected most likely became infected in Alberta, in the brain and spinal cord at the end Bovine Spongiform Encephalopathy Canada, before Canada’s 1997 stages of disease. BSE is a progressive and fatal implementation of a ban on feeding BSE has a long incubation period. neurological disorder of cattle that most mammalian protein to ruminants, Research demonstrates that the results from an unconventional which prevents the use of most incubation period for BSE in cattle is transmissible agent. BSE belongs to the mammalian protein in cattle feed. The linked to the infectious dose received— family of diseases known as second case of BSE in the United States i.e., the larger the infectious dose transmissible spongiform was confirmed in an approximately 12- received, the shorter the incubation encephalopathies (TSEs). All TSEs year-old beef cow in Texas on June 29, period. Cattle typically develop clinical affect the central nervous system of 2005. This animal was born well before signs after an average incubation of 4 to infected animals. However, the the United States instituted a 6 years post-infection. distribution of infectivity in the body of mammalian-to-ruminant feed ban in This research on BSE has been used the animal and mode of transmission August 1997. to develop effective, proven strategies differ according to the species and TSE Variant Creutzfeldt-Jakob disease for removal of these tissues from agent. In addition to BSE, TSEs include, (vCJD), a chronic and fatal animals of appropriate age so that these among other diseases, scrapie in sheep neurodegenerative disease of humans, tissues do not enter the food chain. In and goats, chronic wasting disease has been linked since 1996 through the United States, the FSIS regulations (CWD) in deer and elk, and variant epidemiological, neuropathological, and contained in 9 CFR 310.22 designate the Creutzfeldt-Jakob disease in humans. experimental data to exposure to the brain, spinal cord, vertebral column The agent that causes BSE has yet to BSE agent, most likely through be fully characterized. The theory that is consumption of cattle products 3 DRG are clusters of nerve cells attached to the spinal cord that are contained within the bones of most accepted in the international contaminated with the agent before BSE the vertebral column. Trigeminal ganglia are scientific community is that the agent is clusters of nerve cells connected to the brain that an abnormal form of a normal protein 2 See the risk analysis for further information. lie close to the exterior of the skull.

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(excluding the vertebrae of the tail, the BSE Risk Factors for Whole Cuts of into the cranial cavity of a stunned transverse process of the thoracic and Boneless Beef animal to further lacerate the CNS lumbar vertebrae, and the wings of the The most significant risk management tissue. This process could cause sacrum), DRG, trigeminal ganglia, skull, strategy for ensuring the safety of whole dissemination of CNS tissue throughout and eyes of cattle 30 months of age and cuts of boneless beef is the prevention the body of the animal during slaughter. older, and the tonsils and the distal of cross-contamination of the beef with This stunning method is banned in the ileum of cattle of any age as SRMs and SRMs during stunning and slaughter of European Union and has never been prohibit their use as human food.4 the animal. Control measures that used in the United States. BSE infectivity has never been prevent contamination of such beef Carcass Splitting. During processing, demonstrated in the muscle tissue of involve the establishment of procedures infectivity could contaminate muscle cattle experimentally or naturally for the removal of SRMs, prohibitions tissue in cattle if tissue debris, infected with BSE at any stage of the on air-injection stunning and pithing, specifically spinal cord, accumulates in disease. Studies performed using TSEs and splitting of carcasses. These the carcass splitting saw and is other than BSE in non-bovine animals potential pathways for contamination transferred to subsequent carcasses. have detected prions in muscle tissue. and the control measures that prevent This potential means of cross- However, the international scientific contamination are described in detail in contamination is very unlikely, community largely considers that these the risk analysis for this rulemaking. however, provided that the SRMs of the studies cannot be directly extrapolated SRM Removal. Research has cattle are effectively removed and to BSE in cattle because of the demonstrated that SRMs from infected cleaning and sanitation procedures that significant interactions between the host cattle may contain BSE infectivity. reduce the likelihood of cross- species and the prion strain involved. Because infectivity has not been contamination from splitting saws are in Pathogenesis studies of naturally and demonstrated in muscle tissue, the most place. experimentally infected cattle have not important mitigation measure for whole To mitigate these risk factors, we are detected BSE infectivity in blood. cuts of boneless beef is the careful proposing to require the conditions However, transmission of BSE was removal and segregation of SRMs. discussed below to ensure that whole demonstrated in sheep that received a Removal of SRMs in a manner that cuts of boneless beef exported to the transfusion of a large volume of blood avoids contamination of the beef with United States from Japan are free of BSE drawn from other sheep that were SRMs minimizes the risk of exposure to contamination. experimentally infected with the BSE materials that have been demonstrated Proposed Import Conditions agent. The United Kingdom’s to contain the BSE agent in cattle. Department for Environment, Food and Air-Injection Stunning. Generally This proposal would allow the Rural Affairs’ Spongiform speaking, there are two types of captive importation of whole cuts of boneless Encephalopathy Advisory Committee bolt stunners used worldwide on beef that are derived from cattle born, (SEAC) and the European Commission’s livestock at slaughter: penetrative and raised, and slaughtered in Japan, Scientific Steering Committee (SSC), non-penetrative. Penetrative captive bolt provided that the following conditions which are scientific advisory stun guns render cattle unconscious, have been met: committees, evaluated the implication quickly and painlessly, prior to • The beef is prepared in an of this finding in relation to food slaughter. Penetrative captive bolt stun establishment that is eligible to have its safety.5 The SEAC concluded that the guns have steel bolts, powered by either products imported into the United finding did not represent grounds for compressed air or a blank cartridge, States under the Federal Meat recommending any changes to the which are driven into the animal’s Inspection Act (FMIA) (21 U.S.C. 601 et current control measures for BSE. The brain. Captive bolt stun guns built or seq.) and the regulations in 9 CFR 327.2 SSC determined that the research results modified to inject compressed air into and the beef meets all other applicable do not support the hypothesis that the cranium of cattle have been shown requirements of the FMIA and bovine blood or muscle meat constitute to force pieces of brain and other CNS regulations thereunder (9 CFR chapter a risk to human health.6 tissue into the circulatory system of III), including the requirements for Based on this information, APHIS stunned cattle, thereby potentially removal of specified risk materials concludes that whole cuts of boneless spreading CNS tissue throughout the (SRMs) and the prohibition on the use beef do not present a BSE risk, provided carcass. These studies prompted a of air-injection stunning devices prior to that certain measures are in place to prohibition on the use of air-injection slaughter on cattle from which the beef avoid contamination of the beef with stunning in the United States.7 Other is derived. potentially infectious tissues. types of penetrative captive bolt • The beef is derived from cattle that stunners include pneumatically were not subjected to a pithing process 4 The skull and vertebral column (excluding the operated stunners that do not inject air at slaughter. vertebrae of the tail, the transverse processes of the and standard cartridge-fired captive bolt • An authorized veterinary official of thoracic and lumbar vertebrae, and the wings of the stunners. In general, studies do not the Government of Japan certifies on an sacrum) of cattle 30 months of age and older were indicate that these other types of designated as SRMs in the FSIS regulations because original certificate that the above they contain high-risk tissues such as the brain and penetrative captive bolt stunners pose a conditions have been met. spinal cord. significant risk of causing CNS tissue to Following is a further description of 5 Spongiform Encephalopathy Advisory be forced into the circulatory system of and rationale for each of these proposed Committee, Oct 19, 2000, Summary of SEAC cattle. conditions. Committee Meeting 29 September 2000. Available Pithing. Pithing involves the insertion at http://www.defra.gov.uk/news/seac/seac500.htm. Establishment Eligibility 6 European Commission Scientific Steering of an elongated rod-shaped instrument Committee. ‘‘The Implications of the Recent Papers This proposal would require that the on Transmission of BSE by Blood Transfusion in 7 See FSIS’ interim final rule entitled, beef be prepared in an establishment Sheep (Houston et al, 2000); Hunter et al, 2002), ‘‘Prohibition of the Use of Certain Stunning Devices Adopted by the SSC at its Meeting of 12–13 Used To Immobilize Cattle During Slaughter’’ that is eligible to have its products September.’’ Available at http://europa.eu.int/ (Docket No. 01–033IF, 69 FR 1885–1891), published imported into the United States under comm/food/fs/sc/ssc/out280_en.pdf. on January 12, 2004, for further information. the Federal Meat Inspection Act (FMIA)

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(21 U.S.C. 601 et seq.) and the other prerequisite program. (HACCP is a respect to animal health and zoonoses regulations in 9 CFR 327.2. process control system designed to (diseases that are transmissible from As required under the FMIA, FSIS identify and prevent microbial and animals to humans). The OIE guidelines ensures that imported meat in the U.S. other hazards in food production.) for trade in terrestrial animals marketplace is safe, wholesome, These procedures and requirements (mammals, birds, and bees) are detailed unadulterated, and properly labeled by help to ensure that SRMs are effectively in the Terrestrial Animal Health Code (1) Determining if foreign countries and removed and handled in a manner to (available on the internet at http:// their establishments have implemented avoid contamination of the carcass. www.oie.int). The guidelines on BSE food safety system and inspection As mentioned above, one potential are contained in Chapter 2.3.13 of the requirements equivalent to those in the pathway for cross-contamination of Code and supplemented by Appendix United States and (2) reinspecting muscle tissue of cattle is if potentially 3.8.4 of the Code. imported meat and poultry products infectious tissue debris accumulates in The 2005 OIE guidelines on BSE from those countries through random the carcass splitting saw and is provide for three possible BSE sampling of shipments. The FSIS transferred to subsequent carcasses. classifications for an exporting country, regulations in 9 CFR 327.2 provide that FSIS has developed procedures to verify zone, or compartment (referred to below countries eligible to export meat to the that cross-contamination of edible tissue as a region): Negligible risk, controlled United States must have a meat with SRMs is reduced to the maximum risk, and undetermined risk. inspection system determined by FSIS extent practical in facilities that The OIE guidelines for negligible risk to be equivalent to the U.S. meat slaughter cattle, or process carcasses or regions apply to those regions where inspection system. The FSIS parts of carcasses of cattle.9 This either (1) there has been no indigenous equivalency determination is based on a includes verification of sanitization cases of BSE or any imported cases of review of the foreign country’s relevant procedures for equipment used to cut BSE have been completely destroyed, or laws and regulations and an on-site through SRMs. (2) the last indigenous case of BSE was audit of the foreign country’s inspection Air-injection Stunning. The FSIS reported more than 7 years ago. In system. FSIS has determined that regulations in 9 CFR part 313 prohibit addition, a region may be considered a Japan’s meat inspection system is the use of captive bolt stunners that negligible risk for BSE if it has equivalent and that Japan is eligible to deliberately inject compressed air into demonstrated, through an appropriate export meat and meat products to the the cranium of cattle at the end stage of level of control and audit, that meat- United States. the penetration cycle. This requirement and-bone meal and greaves derived from Once a country is listed as eligible to addresses the potential risk posed by the ruminants have not been fed to export meat and meat products to the use of air-injection stunning devices, ruminants for at least 8 years, among United States, it is responsible for which may force pieces of brain and other criteria. Controlled risk regions, in certifying individual exporting other CNS tissue into the circulatory contrast, include regions where an establishments to FSIS and for system of stunned cattle. indigenous case of BSE was reported providing annual recertification within the last 7 years and regions that documentation. FSIS regularly conducts Pithing cannot demonstrate that a ruminant-to- on-site audits of the eligible foreign This proposal would prohibit the use ruminant feed ban has been in place for inspection systems to ensure they of pithing processes on the cattle from at least 8 years. The OIE guidelines for remain equivalent to the U.S. system. which the beef is derived. This undetermined risk regions apply to requirement addresses the potential risk those regions that do not meet the Other Applicable Requirements Under recommended criteria for any other the FMIA posed by pithing, which may force pieces of brain and other CNS tissue category. This proposal would also require that into the circulatory system of stunned The export conditions contained in the beef meet all other applicable cattle. the OIE guidelines grow increasingly requirements of the FMIA and stringent as the status of a region moves regulations thereunder (9 CFR chapter Certification from negligible risk through controlled III), including the requirements for We conclude that whole cuts of risk to undetermined risk. For removal of SRMs and the prohibition on boneless beef derived from cattle born, controlled risk regions, the OIE the use of air-injection stunning devices raised, and slaughtered in Japan can be guidelines recommend that meat and prior to slaughter on cattle from which safely imported from Japan into the meat products not contain SRMs and the beef is derived. United States, provided the above- mechanically separated meat from the SRM Removal. The FSIS regulations mentioned mitigation measures are met, skull and vertebral column from cattle contained in 9 CFR 310.22 provide that as certified to on an original certificate over 30 months of age, and that the meat establishments are responsible for issued by an authorized veterinary and meat products be derived from ensuring that SRMs are completely official of the Government of Japan. cattle that received ante-mortem and removed from the carcass, segregated post-mortem inspections and that the from edible products, and disposed of in International Guidelines on BSE cattle were not subjected to an air- an appropriate manner.8 Under the FSIS International guidelines for trade in injection stunning or pithing process at regulations, an establishment must animal and animal products are slaughter, among other criteria. incorporate such procedures into its developed by the World Organization The proposed import conditions for Hazard Analysis and Critical Control for Animal Health (formerly known as whole cuts of boneless beef from Japan, Point (HACCP) plan or in its sanitation the Office International des Epizooties including the requirements that the beef standard operating procedures (SOPs) or (OIE)), which is recognized by the come from an establishment eligible to World Trade Organization (WTO) as the export meat to the United States under 8 See FSIS’ interim final rule entitled, international organization responsible the FMIA and FSIS regulations, are ‘‘Prohibition of the Use of Specified Risk Materials for the development of standards, consistent with the criteria for for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle’’ guidelines, and recommendations with controlled risk regions. We believe this (Docket No. 03–025IF, 69 FR 1862–1874), published is appropriate, given that Japan has on January 12, 2004, for further information. 9 See FSIS Notice 10–04. reported indigenous cases of BSE within

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the last 7 years and has measures in This proposal would allow the Wagyu beef is a high-priced specialty place to control BSE risks, but these importation of whole cuts of boneless meat widely acclaimed for its flavor and measures have not been in place long beef derived from cattle that were born, tenderness. ‘‘Kobe beef’’ refers to Wagyu enough for Japan to be considered a raised, and slaughtered in Japan, beef that is produced in the Kobe area negligible risk region. More details on provided that certain conditions are of Japan.) Japan also produces Holstein the BSE situation in Japan and Japan’s met. We expect that this proposal would breed dairy cattle, but it is unlikely that actions to protect animal and human have little or no economic impact on the Japan would try to compete in the U.S. health are contained in the risk analysis. majority of consumers and beef import market for lower-grade beef from producers in the United States because culled dairy cattle. Accordingly, we Executive Order 12866 and Regulatory the volume of beef imported from Japan expect only Wagyu beef to be imported Flexibility Act is likely to be small and have only a under the proposed rule. This proposed rule has been reviewed minor impact on the overall domestic We expect that Japan would continue under Executive Order 12866. The rule beef market. to be a minor supplier of beef to the has been determined to be significant In 2001, APHIS placed a ban on the United States if this proposal were for the purposes of Executive Order importation of ruminants and most adopted. We estimate that the volume of 12866 and, therefore, has been reviewed ruminant products from Japan following imports is likely to range between about by the Office of Management and the confirmation of one case of BSE in 8 metric tons and 15 metric tons per Budget. a native-born animal in that country. year, a quantity aligned with import Under the Animal Health Protection Prior to that ban, U.S. imports of levels in the years immediately prior to Act of 2002 (7 U.S.C. 8301 et seq.), the boneless beef from Japan were negligible the ban. There are three reasons for the Secretary of Agriculture is authorized to when compared to total imports of that small import volume. First, the demand promulgate regulations that are commodity. Over the 4-year period, for Japanese Wagyu beef in the United necessary to prevent the introduction or 1997–2000, for example, the volume of States would likely be small, because dissemination of any pest or disease of U.S. imports of boneless beef from the beef is expensive. In October 2004, livestock into the United States. Japan—reported to be entirely fresh/ for example, the average actual selling This proposed rule would amend the chilled, as opposed to frozen—averaged price of Wagyu sirloin in Japanese regulations governing the importation of a little less than 9 metric tons per year. supermarkets was just under $50 per 12 meat and other edible animal products This amount was less than 0.005 pound. The price of Japanese Wagyu by allowing, under certain conditions, percent of average annual U.S. imports beef would be higher in the United the importation of whole cuts of of fresh/chilled boneless beef world- States because of transportation and boneless beef derived from cattle born, wide for the same period (202,540 other costs associated with the 11 raised, and slaughtered in Japan. We are metric tons). The average annual value importation of the beef from Japan. Second, Japanese agricultural officials proposing this action in response to a of U.S. imports of boneless beef from have indicated to APHIS staff that they request from the Government of Japan Japan over this 4-year period was would expect the volume of Wagyu and after conducting an analysis of the $808,000, less than 0.2 percent of the 4- exports to the United States to be risk that indicates that such beef can be year average annual value of U.S. imports of fresh/chilled boneless beef approximately 10 metric tons per year. safely imported from Japan under the This quantity aligns with historic conditions described in this proposal. from all regions ($600 million). Including frozen boneless beef in the import levels, as described above, and In accordance with 5 U.S.C. 603, we would be well below the annual tariff have performed an initial regulatory comparison over the same 4-year period diminishes Japan’s annual average rate quota for Japan of 200 metric tons.13 flexibility analysis, which is Over the 10-year period from 1991 to summarized below, regarding the percentage share all the more, to about 0.001 percent of the quantity and about 2000 U.S. imports of boneless beef— impact of this proposed rule on small both fresh/chilled and frozen—from entities.10 This analysis also serves as 0.05 percent of the value of all U.S. boneless beef imports. This impact Japan never exceeded 27.0 metric tons our cost-benefit analysis under in any one year. Executive Order 12866. Based on the would be further reduced if Japan’s share of the U.S. total beef supply Finally, Japan’s boneless beef exports information we have, there is no basis to countries other than the United States to conclude that this rule will result in (domestic production plus imports minus exports, disregarding carryover have also been minor. Over the 4-year any significant economic impact on a period 1997–2000, Japan’s exports of substantial number of small entities. stocks) were considered. Based on the unit price of beef boneless beef to the world—both fresh/ However, we do not currently have all imported into the United States from chilled and frozen—averaged only 81 of the data necessary for a Japan prior to the 2001 ban on the metric tons per year, and the largest comprehensive analysis of the effects of importation of ruminants and most export volume in any one of those years this proposed rule on small entities. ruminant products from Japan, it is was 95 metric tons (in 1999). For fresh/ Therefore, we are inviting comments on assumed that all of the boneless beef chilled boneless beef alone, the 4-year the potential effects. In particular, we imported from Japan prior to the ban annual average was 37 metric tons, with are interested in determining the 14 was Wagyu beef. (The term ‘‘Wagyu,’’ no one year exceeding 47 metric tons. number and kinds of small entities that Because we expect that Japan would which literally translates to Japanese would incur benefits or costs from the export only Wagyu beef if this proposal cattle, refers to purebred Japanese Black implementation of this proposed rule or Japanese Brown breeds of cattle. and the economic effect of those 12 Source: ‘‘Monthly Statistics,’’ January 2005, benefits and costs. Agricultural & Livestock Industries Corporation. 11 Trade statistics, unless otherwise indicated, are The selling price was calculated using an exchange taken from the World Trade Atlas or the Global rate of 105 yen per U.S. dollar and it is the price 10 A copy of the full economic analysis is Trade Atlas (Global Trade Information Services), for Wagyu sirloin from all regions in Japan, available for review on EDOCKET or in our reading which report data from the Department of including Kobe. room. (Information on accessing EDOCKET as well Commerce, U.S. Bureau of the Census. The 13 Harmonized Tariff Schedule of the United as the location and hours of the reading room may Harmonized Tariff Schedule (HTS) 6-digit code for States (2005), Chapter 2, Meat and Edible Meat be found at the beginning of this document under fresh/chilled boneless beef cuts is 020130; the HTS Offal. ADDRESSES.) code for frozen boneless beef is 020230. 14 Foreign Agricultural Service, USDA.

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were adopted, this action has the entities. As discussed above, the APHIS Web site at http:// potential to affect farmers and ranchers proposed rule has the potential to www.aphis.usda.gov/lpa/issues/bse/ in the United States who raise Wagyu primarily affect farmers and ranchers in bse.html. You may request paper copies and Wagyu hybrid cattle for the high- the United States who produce Kobe- of the environmental assessment by end domestic beef market. However, the style beef. The number of these calling or writing to the person listed impact, if any, on these so-called ‘‘Kobe- producers is unknown, but it is believed under FOR FURTHER INFORMATION style’’ beef producers is unclear, to be very small. The American Wagyu CONTACT. Please refer to the title of the without an approximation of the Association, a Wagyu breeder group, environmental assessment when quantity of Kobe-style beef sold in the lists approximately 75 members in the requesting copies. The environmental United States and information on the United States.16 assessment is also available for review extent to which the two products would The size distribution of Kobe-style in our reading room (information on the directly compete. The number of these beef producers in the United States is location and hours of the reading room producers is unknown, but it is believed also unknown, but it is reasonable to is provided under the heading to be very small. assume that most are small, under the ADDRESSES at the beginning of this Cost-Benefit Analysis U.S. Small Business Administration’s notice). (SBA) standards. This assumption is Given the high price and small based on composite data for all beef Paperwork Reduction Act quantity of Wagyu beef expected to be producers in the United States. In 2002, This proposed rule contains no new imported, the proposed rule is likely to there were 664,431 U.S. farms in North information collection or recordkeeping have little impact for most U.S. American Industry Classification requirements under the Paperwork consumers. A relatively small segment System (NAICS) 112111, a classification Reduction Act of 1995 (44 U.S.C. 3501 of beef consumers would benefit comprised of establishments primarily et seq.). because they would be allowed, once engaged in raising cattle. Of the 664,431 Government Paperwork Elimination again, to buy this product in the United farms, 659,009 (or 99 percent) had Act Compliance States. Importers, brokers and others in annual receipts that year of less than the United States who would participate $500,000.17 The SBA’s small entity The Animal and Plant Health in the importation of Wagyu beef from threshold for farms in NAICS 112111 is Inspection Service is committed to Japan also stand to benefit, due to the annual receipts of $750,000. compliance with the Government increased business activity. Paperwork Elimination Act (GPEA), U.S. beef producers, in general, would Executive Order 12988 which requires Government agencies in not be affected by the proposed rule; This proposed rule has been reviewed general to provide the public the option demand is expected to remain low under Executive Order 12988, Civil of submitting information or transacting reflecting pre-ban consumption Justice Reform. If this proposed rule is business electronically to the maximum patterns, with a minor impact on less adopted: (1) All State and local laws and extent possible. For information expensive domestically produced beef. regulations that are inconsistent with pertinent to GPEA compliance related to Any producer impact of the rule would this rule will be preempted; (2) no this proposed rule, please contact Mrs. likely fall upon producers of Kobe-style retroactive effect will be given to this Celeste Sickles, APHIS’ Information beef, and then only to the extent that the rule; and (3) administrative proceedings Collection Coordinator, at (301) 734– commodities would be competing for will not be required before parties may 7477. the same niche market. file suit in court challenging this rule. In general, trade of a commodity List of Subjects in 9 CFR Part 94 increases social welfare. To the extent National Environmental Policy Act Animal diseases, Imports, Livestock, that consumer choice is broadened and To provide the public with Meat and meat products, Milk, Poultry the increased supply of the imported documentation of APHIS’ review and and poultry products, Reporting and commodity leads to a price decline, analysis of any potential environmental gains in consumer surplus will recordkeeping requirements. impacts associated with the proposed Accordingly, we propose to amend 9 outweigh losses in domestic producer importation of whole cuts of boneless 15 CFR part 94 as follows: surplus. Although the rule’s impact on beef from Japan, we have prepared an the relatively small number of U.S. environmental assessment. The PART 94—RINDERPEST, FOOT-AND- producers of Kobe-style beef is environmental assessment was prepared MOUTH DISEASE, FOWL PEST (FOWL uncertain, it is expected to provide in accordance with: (1) The National PLAGUE), EXOTIC NEWCASTLE benefits to consumers (domestic Environmental Policy Act of 1969 DISEASE, AFRICAN SWINE FEVER, importers, wholesalers, retailers, as well (NEPA), as amended (42 U.S.C. 4321 et CLASSICAL SWINE FEVER, AND as final consumers) that would exceed seq.), (2) regulations of the Council on BOVINE SPONGIFORM any potential losses to domestic Environmental Quality for ENCEPHALOPATHY: PROHIBITED producers. The net welfare effect for the implementing the procedural provisions AND RESTRICTED IMPORTATIONS United States of reestablished Wagyu of NEPA (40 CFR parts 1500–1508), (3) beef imports from Japan would be USDA regulations implementing NEPA 1. The authority citation for part 94 positive. (7 CFR part 1b), and (4) APHIS’ NEPA would continue to read as follows: Effects on Small Entities Implementing Procedures (7 CFR part Authority: 7 U.S.C. 450, 7701–7772, and We do not expect that this proposal 372). 8301–8317; 21 U.S.C. 136 and 136a; 31 The environmental assessment may U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4. would have significant economic impact be viewed on the EDOCKET Web site on a substantial number of small 2. In § 94.18, paragraph (b) would be (see ADDRESSES above for instructions revised to read as follows: for accessing EDOCKET) or on the 15 Consumer surplus is the difference between the § 94.18 Restrictions on importation of amount a consumer is willing to pay for a good and meat and edible products from ruminants 16 Source: American Wagyu Association Web site. the amount actually paid. Producer surplus is the due to bovine spongiform encephalopathy. amount a seller is paid for the good minus the 17 2002 Census of Agriculture, National seller’s cost. Agricultural Statistics Service. * * * * *

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(b) Except as provided in paragraph DEPARTMENT OF TRANSPORTATION information identified in this proposed (d) of this section or in §§ 94.19 or AD. 94.27, the importation of meat, meat Federal Aviation Administration FOR FURTHER INFORMATION CONTACT: products, and edible products other Todd Thompson, Aerospace Engineer, than meat (except for gelatin as 14 CFR Part 39 International Branch, ANM–116, FAA, provided in paragraph (c) of this [Docket No. FAA–2005–22125; Directorate Transport Airplane Directorate, 1601 section, milk, and milk products) from Identifier 2005–NM–130–AD] Lind Avenue, SW., Renton, Washington 98055–4056; telephone (425) 227–1175; ruminants that have been in any of the RIN 2120–AA64 regions listed in paragraph (a) of this fax (425) 227–1149. section is prohibited. Airworthiness Directives; Empresa SUPPLEMENTARY INFORMATION: * * * * * Brasileira de Aeronautica S.A. Comments Invited (EMBRAER) Model ERJ 170 Airplanes 3. A new § 94.27 would be added to We invite you to submit any relevant read as follows: AGENCY: Federal Aviation written data, views, or arguments Administration (FAA), Department of regarding this proposed AD. Include the § 94.27 Importation of whole cuts of Transportation (DOT). docket number ‘‘FAA–2005–22125; boneless beef from Japan. ACTION: Notice of proposed rulemaking Directorate Identifier 2005–NM–130– Notwithstanding any other provisions (NPRM). AD’’ at the beginning of your comments. of this part, whole cuts of boneless beef We specifically invite comments on the derived from cattle that were born, SUMMARY: The FAA proposes to adopt a overall regulatory, economic, raised, and slaughtered in Japan may be new airworthiness directive (AD) for environmental, and energy aspects of imported into the United States under certain EMBRAER Model ERJ 170 the proposed AD. We will consider all airplanes. This proposed AD would comments received by the closing date the following conditions: require replacing the very high and may amend the proposed AD in (a) The beef is prepared in an frequency (VHF) antenna located in light of those comments. establishment that is eligible to have its position 1 of the fuselage with a new, We will post all comments we products imported into the United improved VHF antenna. This proposed receive, without change, to http:// States under the Federal Meat AD results from a report of the loss of dms.dot.gov, including any personal Inspection Act (21 U.S.C. 601 et seq.) all voice communications due to a information you provide. We will also and the regulations in 9 CFR 327.2 and lightning strike damaging all the VHF post a report summarizing each the beef meets all other applicable antennas. We are proposing this AD to substantive verbal contact with FAA requirements of the Federal Meat prevent the loss of voice personnel concerning this proposed AD. Inspection Act and regulations communication, which when combined Using the search function of that Web thereunder (9 CFR chapter III), with the complexity of the national site, anyone can find and read the including the requirements for removal airspace system, could result in reduced comments in any of our dockets, of SRMs and the prohibition on the use flightcrew situational awareness, including the name of the individual who sent the comment (or signed the of air-injection stunning devices prior to increased flightcrew workload, and comment on behalf of an association, slaughter on cattle from which the beef increased risk of human error, and business, labor union, etc.). You may is derived. consequent reduced ability to maintain safe flight and landing of the airplane. review the DOT’s complete Privacy Act (b) The beef is derived from cattle that Statement in the Federal Register DATES: We must receive comments on were not subjected to a pithing process this proposed AD by September 19, published on April 11, 2000 (65 FR at slaughter. 2005. 19477–78), or you may visit http:// (c) An authorized veterinary official of dms.dot.gov. ADDRESSES: Use one of the following the Government of Japan certifies on an addresses to submit comments on this Examining the Docket original certificate that the above proposed AD. You may examine the AD docket on conditions have been met. • DOT Docket Web site: Go to the Internet at http://dms.dot.gov, or in Done in Washington, DC, this 15th day of http://dms.dot.gov and follow the person at the Docket Management August 2005. instructions for sending your comments Facility office between 9 a.m. and 5 W. Ron DeHaven, electronically. p.m., Monday through Friday, except • Government-wide rulemaking Web Acting Under Secretary for Marketing and Federal holidays. The Docket Regulatory Programs. site: Go to http://www.regulations.gov Management Facility office (telephone and follow the instructions for sending [FR Doc. 05–16422 Filed 8–16–05; 9:43 am] (800) 647–5227) is located on the plaza your comments electronically. level of the Nassif Building at the DOT BILLING CODE 3410–34–P • Mail: Docket Management Facility, street address stated in the ADDRESSES U.S. Department of Transportation, 400 section. Comments will be available in Seventh Street, SW., Nassif Building, the AD docket shortly after the Docket Room PL–401, Washington, DC 20590. Management System receives them. • Fax: (202) 493–2251. • Hand Delivery: Room PL–401 on Discussion the plaza level of the Nassif Building, The Departmento de Aviacao Civil 400 Seventh Street, SW., Washington, (DAC), which is the airworthiness DC, between 9 a.m. and 5 p.m., Monday authority for Brazil, notified us that an through Friday, except Federal holidays. unsafe condition may exist on all Contact Empresa Brasileira de EMBRAER Model ERJ 170 airplanes. Aeronautica S.A. (EMBRAER), P.O. Box The DAC advises that there was a report 343—CEP 12.225, Sao Jose dos of the loss of all voice communications Campos—SP, Brazil for service due to a lightning strike that damaged

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