73905

Rules and Regulations Federal Register Vol. 70, No. 239

Wednesday, December 14, 2005

This section of the FEDERAL REGISTER the regulations) govern the importation of foreign governments, and private contains regulatory documents having general of certain animals, birds, poultry, meat, citizens. applicability and legal effect, most of which other animal products and byproducts, A number of commenters supported are keyed to and codified in the Code of hay, and straw into the United States in the rule in general but recommended Federal Regulations, which is published under order to prevent the introduction of certain changes to the proposed 50 titles pursuant to 44 U.S.C. 1510. various animal diseases, including provisions. Others comments consisted The Code of Federal Regulations is sold by bovine spongiform encephalopathy only of recommended changes, the Superintendent of Documents. Prices of (BSE), a chronic degenerative disease objections to the rule in general or to new books are listed in the first FEDERAL affecting the central nervous system of specific provisions, or requests for REGISTER issue of each week. cattle. clarification. In general, the comments On August 18, 2005, we published in we received on the proposed rule can be the Federal Register (70 FR 48494– categorized as follows: DEPARTMENT OF AGRICULTURE 48500, Docket No. 05–004–1) a • Comments on the risk analysis; proposed rule to amend the regulations • Comments on the economic Animal and Plant Health Inspection governing the importation of meat and analysis; Service other edible animal products by • Comments on the environmental allowing, under certain conditions, the analysis; • 9 CFR Part 94 importation of whole cuts of boneless Comments on the proposed [Docket No. 05–004–2] beef from Japan. In that document, we standards for the importation of whole explained that the proposed rule was cuts of boneless beef from Japan; and RIN 0579–AB93 • developed in response to a request from Comments on miscellaneous issues the Government of Japan and after related to the proposed rule. Importation of Whole Cuts of Boneless We discuss these comments by topic Beef From Japan conducting an analysis of the risk that indicated that whole cuts of boneless below. AGENCY: Animal and Plant Health beef that are derived from cattle born, Risk Analysis for the Rulemaking Inspection Service, USDA. raised, and slaughtered in Japan, could ACTION: Final rule. be imported into the United States, Incubation Period and Distribution of provided that the following conditions BSE in Cattle SUMMARY: We are amending the have been met: Issue: One commenter stated that the regulations governing the importation of • The beef is prepared in an APHIS risk analysis relied on outdated meat and other edible animal products establishment that is eligible to have its and incomplete scientific evidence to by allowing, under certain conditions, products imported into the United conclude that BSE infectivity is the importation of whole cuts of States under the Federal Meat confined only to certain tissues and that boneless beef from Japan. We are taking Inspection Act (FMIA) (21 U.S.C. 601 et infectivity in such tissues does not this action in response to a request from seq.) and the regulations in 9 CFR 327.2 occur until cattle reach the age of 32 the Government of Japan and after and the beef meets all other applicable months. The commenter requested that, conducting a risk analysis and requirements of the FMIA and before APHIS proceeds with this considering public comments. This regulations thereunder (9 CFR chapter rulemaking, the Agency explain: (1) action will allow the importation of beef III), including the requirements for Why cattle under 30 months of age do from Japan while continuing to protect removal of specified risk materials not present a risk of BSE, (2) why it is against the introduction of bovine (SRMs) and the prohibition on the use appropriate to base risk management spongiform encephalopathy into the of air-injection stunning devices prior to strategies on equivocal science, (3) why United States. slaughter on cattle from which the beef additional risk mitigation measures are EFFECTIVE DATE: December 12, 2005, is derived. not needed to address the equivocal 11:30 a.m. • The beef is derived from cattle that nature of the science, and (4) why FOR FURTHER INFORMATION CONTACT: Dr. were not subjected to a pithing process APHIS is not imposing additional Gary Colgrove, Director, National Center at slaughter. measures to address the potential risk of for Import and Export, VS, APHIS, 4700 • An authorized veterinary official of BSE infectivity in tissues that have not River Road Unit 38, Riverdale, MD the Government of Japan certifies on an been designated by the USDA’s Food 20737–1231; (301) 734–4356. original certificate that the above Safety and Inspection Service (FSIS) as SUPPLEMENTARY INFORMATION: conditions have been met. SRMs. In our August 2005 proposed rule we Response: We consider the BSE Background explained that these conditions would research upon which we based the The Animal and Plant Health continue to protect against the proposed rule and this final rule to be Inspection Service (APHIS) of the introduction of BSE into the United substantial and current, and consider United States Department of Agriculture States. the mitigation measures in this rule to (USDA or the Department) regulates the We solicited comments concerning be appropriate based on the research. importation of animals and animal the proposed rule and supporting risk We discussed the research upon which products into the United States to guard analysis for 30 days ending September we based this rulemaking in the risk against the introduction of animal 19, 2005. We received 28 comments by document we made available with our diseases. The regulations in 9 CFR parts that date. They were from cattlemen’s August 2005 proposed rule. The key 93, 94, 95, and 96 (referred to below as associations, producers, representatives points are as follows:

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The scope of this rulemaking is Peripheral Nerves not directly applicable to cattle limited to whole cuts of boneless beef Issue: Two commenters stated that the naturally infected with BSE. Therefore, derived from cattle born, raised, and underlying assumption of the proposed we do not consider it necessary to make slaughtered in Japan. BSE infectivity has rule, that whole cuts of boneless beef any adjustments to the risk analysis for never been demonstrated in the muscle from Japan will not contain tissues that this rulemaking or to extend the tissue of cattle experimentally or may carry the BSE agent, is no longer comment period to solicit additional naturally infected with BSE at any stage valid because researchers have found public comment on this issue. of the disease. In tissues that have peripheral nervous system tissues, Blood demonstrated BSE infectivity, including facial and sciatic nerves, that Issue: Two commenters expressed pathogenesis studies have illustrated contain BSE infectivity.2 One of these concern that there has been a limited that levels of infectious BSE agent in commenters requested APHIS to explain amount of research conducted on BSE certain tissues vary with the age of an whether and what additional mitigation measures are needed to reduce the risks infectivity in blood. One of these animal. Infectivity was not detected in commenters cited a report that most tissues in cattle until at least 32 that these tissues may be present in Japanese beef. This commenter further discussed, among other things, the months post-exposure. The exception to detection of infectivity in sheep this is the distal ileum (a part of the requested an additional comment period to obtain public comment regarding the experimentally infected with BSE via intestines), where infectivity was 4 manner by which APHIS intends to treat blood transfusions. This commenter confirmed in experimentally infected this new scientific finding. also stated that the agent that causes cattle as early as 6 months post- Response: APHIS is familiar with the Creutzfeldt-Jakob disease (CJD), a exposure, and the tonsils, where results of the study mentioned by the chronic and fatal neurodegenerative infectivity was confirmed at 10 months commenters in which mice, genetically disease of humans, was detected in post-exposure. Consistent with engineered to be highly susceptible to blood, and questioned whether the BSE requirements established by FSIS and BSE and to overexpress the bovine prion agent could be detected in blood as contained in 9 CFR part 310, we protein, were inoculated with tissues well. The other commenter cited a study proposed to require the removal of from a BSE-infected cow. This study that detected infectivity in hamsters tissues that have demonstrated BSE demonstrated low levels of infectivity in experimentally infected with scrapie.5 infectivity. (FSIS is the public health the mouse assay in the facial and sciatic This commenter requested that APHIS agency within USDA responsible for nerves of the peripheral nervous system. ban the use of blood in cattle feed. ensuring the food safety of beef.) These APHIS has evaluated these findings in Response: As stated in our risk tissues (referred to as specified risk the context of the potential occurrence analysis, the pathogenesis studies of materials or SRMs) are the brain, skull, of infectivity in the peripheral nerves of naturally and experimentally infected eyes, trigeminal ganglia, spinal cord, cattle and the corresponding risks of the cattle have not detected BSE infectivity in blood. vertebral column (excluding the presence of infectivity in such tissues The first study mentioned by the vertebrae of the tail, the transverse resulting in cattle or human exposure to the BSE agent. The results from these commenter above demonstrated process of the thoracic and lumbar transmission of disease from sheep vertebrae, and the wings of the sacrum), experiments in genetically engineered mice should be interpreted with experimentally infected with BSE to and dorsal root ganglia of cattle 30 caution, as the findings may be another sheep via blood transfusions. months of age and older, and the tonsils influenced by the overexpression of We note that there are widely and distal ileum of the small intestine prion proteins and may not accurately acknowledged differences between the of all cattle. In addition to requiring the predict the natural distribution of BSE distribution of BSE infectivity in the removal of SRMs, we proposed infectivity in cattle. Further, the tissues of cattle and sheep. In addition, mitigation measures to address the overexpression of prion proteins in there is a significant difference in potential risk of cross-contamination of transgenic mice may not accurately susceptibility to infection based on the the beef with SRMs. These requirements mimic the natural disease process route of transmission. Infection via oral are based on currently available science because the transgenic overexpressing consumption may be 10,000 times less and are consistent with the international mice have been shown to develop efficient than infection via intravenous guidelines on BSE established by the spontaneous lethal neurological disease injection, such as a blood transfusion. World Organization for Animal Health involving spongiform changes in the Both the United Kingdom’s (formerly known as the Office brain and muscle degeneration.3 In Department for Environment, Food and International des Epizooties (OIE)), addition, the route of administration to Rural Affairs’ Spongiform which is recognized by the World Trade the mice was both intraperitoneal and Encephalopathy Advisory Committee Organization (WTO) as the international intracerebral, which are two very (SEAC) and the European Commission’s organization responsible for the efficient routes of infection as compared Scientific Steering Committee (SSC), development of standards, guidelines, to oral consumption. Given these which are scientific advisory and recommendations with respect to factors, APHIS has determined that the committees, evaluated the findings of animal health and zoonoses (diseases finding of BSE infectivity in facial and transmission of infectivity via blood that are transmissible from animals to sciatic nerves of the transgenic mice is transfusions in sheep experimentally humans).1 For these reasons, we are not infected with BSE and concluded that making any changes to the rule based on 2 Bushmann, A., and Gruschup, M.; Highly Bovine Spongiform Encephalopathy-Sensitive 4 Pattison, J., et al.; UK Strategy for Research and this comment. Transgenic Mice Confirm the Essential Restriction Development on Human and Animal Health of Infectivity to the Nervous System in Clinically Aspects of Transmissible Spongiform 1 The OIE guidelines for trade in terrestrial Diseased Cattle. The Journal of Infectious Diseases, Encephalopathies, 2005–2008. Available at http:// animals (mammals, birds, and bees) are detailed in 192: 934–42, September 1, 2005. www.mrc.ac.uk/pdf-about- the Terrestrial Animal Health Code (available on 3 Westaway, D., et al.; (1994) Degeneration of tse_uk_strategy_june2005.pdf. the Internet at http://www.oie.int). The guidelines Skeletal Muscle, Peripheral Nerves, and the Central 5 Castilla, J., et al.; Detection of Prions in Blood. on BSE are contained in Chapter 2.3.13 of the Code Nervous System in Transgenic Mice Overexpressing Nature Medicine, doi: 10.1038/nm1286, August 28, and supplemented by Appendix 3.8.4 of the Code. Wild-type Prion Proteins. Cell 76, 117–129. 2005, at 3.

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these findings did not indicate that disease agent that causes BSE may be Response: APHIS reviewed the study additional mitigation measures were reached through the accumulation of referred to by the commenter. The study necessary to protect public health.6 subinfectious doses over time.7 The authors present results that show that Therefore, based on currently available commenter expressed concern that this chronic lymphocytic inflammation information, APHIS considers it finding undercuts the risk analysis enabled prion accumulation in certain unlikely that the experimental prepared for this rulemaking, which, otherwise prion-free organs. The study observations in sheep reflect a according to the commenter, discussed authors postulate that chronic biologically significant event for cattle evidence that BSE infectivity is caused inflammatory condition may act to or affect the safety of whole cuts of by the consumption of a single dose of modify natural and iatrogenic prion boneless beef derived from cattle born, infected tissue and that a low dose transmission by expanding tissue raised, and slaughtered in Japan. exposure has a longer incubation distribution of prions. According to the The study on scrapie-infected period. This commenter requested authors, in the inflammatory conditions hamsters noted by the commenter APHIS to explain the impact of these studied, expression in two specific describes a process by which the findings on its assessment of the risk types of lymphotoxins and a secondary abnormal prion protein can be amplified posed by the importation of boneless lymphoid organ chemokine in certain and detected using current testing beef from Japan. tissues was enough to establish methods, such as a Western blot. In this Response: Our risk analysis does not ‘‘unexpected’’ prion reservoirs. APHIS study, blood from hamsters state, as stated by the commenter, that reviewed the findings from this study, experimentally infected with a scrapie ‘‘BSE infectivity is caused by the which used transgenic mice, in the strain was collected when the animals consumption of a single dose of infected context of the potential occurrence in demonstrated clinical signs of disease. tissue.’’ Our risk analysis states that cattle. We do not believe that the study These blood samples were incubated results can be extrapolated to cattle ‘‘the incubation period [of the BSE with excess normal prion protein from naturally infected with BSE. First, the agent] is inversely related to dose (i.e., brain tissue for multiple cycles. If study used several transgenic and low dose exposures have a long abnormal protein is present in blood, it spontaneous mouse models of chronic incubation period before clinical signs will convert the normal brain prion to inflammation that were inoculated with of disease become apparent).’’ This abnormal prion, yielding an increased scrapie infectivity rather than BSE statement is based on research amount of abnormal prion that can be infectivity. The pathogenesis and conducted on BSE and is not meant to more easily detected. In this manner, infectivity distribution of the scrapie make a statement about the number of the presence of abnormal prion protein agent in mice is different from the BSE doses necessary for cattle to become in the initial blood samples, which was agent in cattle. Second, the mice in this present in levels too low to detect using affected by the BSE agent. Further, the study were injected with scrapie prions routine test methods, was demonstrated. findings noted by the commenter would through intraperitoneal and/or While this finding has many not affect the critical evaluation of risk intracerebral routes of inoculation, possibilities related to the development on which our mitigation measures are which are much more efficient routes of diagnostic tests, it does not based. This rule will allow the than oral consumption of a disease demonstrate BSE infectivity in blood. importation of whole cuts of boneless agent, the natural route for exposure of We also note that the international beef derived from cattle. Regardless of cattle to the BSE agent. Finally, the community largely considers that the infective dose or period of study authors themselves did not claim studies using transmissible spongiform incubation, BSE infectivity has never that the mouse models and results encephalopathies (TSEs) other than BSE been demonstrated in the muscle tissue obtained in the study represent a model in non-bovine animals cannot be of cattle experimentally or naturally for the pathogenesis of BSE in cattle. directly extrapolated to BSE in cattle infected with BSE at any stage of the They stated that direct evidence from because of the significant interactions disease. Therefore, we are not making similar studies using the BSE agent in between the host species and the prion any changes to the rule based on this cattle are needed prior to concluding strain involved. comment. that chronic inflammatory conditions in Feed regulations in the United States Findings Related to Tissue cattle can alter the distribution of the are under the authority of the Food and Inflammation BSE agent. Therefore, we are making no Drug Administration (FDA), not APHIS. changes in the rule in response to this Therefore, the commenter’s request that Issue: One commenter requested that comment. APHIS ban the use of blood in cattle APHIS discuss the implications of a feed falls outside the scope of this recent study 8 indicating that TSE Working Group rulemaking. For these reasons, we are inflammation may act as a modifier of Issue: One commenter stated that the not making any changes to the rule natural and iatrogenic (experimental) proposed rule and supporting risk based on these comments. prion transmission to other organs and analysis should be evaluated by APHIS’ TSE Working Group. The commenter Low Dose Exposure tissues not presently listed as SRMs and whether those findings necessitate the further requested that APHIS make Issue: One commenter cited new implementation of additional risk available to the public a report of the research indicating that infection by the mitigation measures to reduce the risk TSE Working Group’s evaluation of the of introducing BSE into the United risk of BSE arising from the proposed 6 Spongiform Encephalopathy Advisory States from Japan. rule along with the Group’s Committee, Oct. 19, 2000, Summary of SEAC recommendations regarding the actions Committee Meeting 29 September 2000. Available at http://www.defra.gov.uk/news/seac/seac500.htm. 7 Jacquemot, C., et al.; High Incidence of Scrapie that should be taken in response to European Commission Scientific Steering Induced by Repeated Injections of Subinfectious these risks. Committee; The Implications of the Recent Papers Prion Doses. Journal of Virology, July 2005, p. Response: APHIS has proceeded in a on Transmission of BSE by Blood Transfusion in 8904–8908. thorough and deliberative manner, in Sheep (Houston et al., 2000; Hunter et al., 2002), 8 Heikenwalder, M., et al.; Chronic Lymphocytic Adopted by the SSC at its Meeting of 12–13 Inflammation Specifies the Organ Tropism of cooperation with FSIS and FDA, to September. Available at http://europa.eu.int/comm/ Prions. Science, Vol. 37, February 18, 2005, 1107– define the steps necessary to protect food/fs/sc/ssc/out280_en.pdf. 1110. animal and public health. The APHIS

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TSE Working Group consists of APHIS Issue: One commenter expressed meat will introduce BSE into the United employees with expertise in veterinary concern about the Harvard-Tuskegee States. The Harvard-Tuskegee Study is science, epidemiology, import/export Study. In our risk analysis, we refer to referenced in the risk analysis only to issue management, pathobiology, the Harvard-Tuskegee Study in our address this already remote risk. veterinary biologics, and TSE program discussion of the risks associated with APHIS considers the assumptions management. The group has met in the plate waste. The commenter disagreed underpinning the study to be valid and past to assist and make with the study’s conclusion that the risk based on currently available science. As recommendations to the Deputy of BSE becoming established in the mentioned above, the USDA Administrator for APHIS’ Veterinary United States is ‘‘extremely unlikely.’’ commissioned the HCRA and the Center Services, as well as other managers, Specifically, this commenter noted that, for Computational Epidemiology at regarding animal health programs. The with respect to the United States’ Tuskegee University to conduct what TSE Working Group is not solely potential exposure to BSE before the we now refer to as the Harvard- responsible for evaluating information 1989 import ban and 1997 feed ban, the Tuskegee Study in 1998. The objective and data regarding BSE/TSE import Harvard-Tuskegee Study stated that, of the Harvard-Tuskegee Study was to regulations. That said, members of the ‘‘Exposure to infectivity among U.S. analyze and evaluate the measures TSE Working Group who have special cattle could not have been substantial implemented by the U.S. Government to expertise in BSE participated in the because in the years prior to the 1997 prevent the spread of BSE in the United development of the risk analysis, either FDA feed ban, such exposure would States and to reduce the potential as contributing writers or reviewers of have eventually resulted in a substantial exposure of Americans to the BSE agent. the document. Their input was, number of clinical cases, a prediction The Harvard-Tuskegee Study reviewed therefore, considered by the Agency that is inconsistent with the fact that available scientific information related during development of the proposed BSE has not been identified in the to BSE and other TSEs, assessed rule. Under these circumstances, we do United States to date. There is therefore, pathways by which BSE could not believe it would be appropriate for a small chance that BSE could have potentially spread in the United States, the TSE Working Group to take on the been introduced into the U.S. and and identified measures that could be role suggested by the commenter. remained undetected.’’ The commenter taken to protect human and animal stated that the detection of a 12-year-old health in the United States. The Harvard-Tuskegee Investigation of BSE Harvard-Tuskegee Study concluded Risk in the United States BSE-positive cow native to the United States in June 2005 proves that the that, if introduced, BSE is extremely In April 1998, USDA contracted with Harvard-Tuskegee Study’s assumption unlikely to become established in the the Harvard Center for Risk Analysis was in error, and that the chance that United States. The Harvard-Tuskegee (HCRA) at Harvard University and the BSE could have been introduced into Study also concluded that, should BSE Center for Computational Epidemiology the United States was not small. The enter the United States, only a small at Tuskegee University to conduct a commenter also stated that, until and amount of potentially infective tissues comprehensive investigation of BSE risk unless the Secretary revises the would likely reach the human food in the United States. The report,9 widely Harvard-Tuskegee Study to correct the supply and be available for human referred to as the Harvard Risk known, erroneous assumptions consumption. The HCRA recently Assessment or the Harvard Study, is underpinning the study, the Harvard- revised its model using updated referred to in this document as the estimates for some of the model Tuskegee Study is an inappropriate tool Harvard-Tuskegee Study. It was parameters, based on new data about for accurately ascertaining the degree of completed in 2001 and released by the compliance with feed restrictions. The increased risk the United States would USDA. Following a peer review of the results are even lower estimates of risk be subject to under the proposed rule. Harvard-Tuskegee Study in 2002, the than previously predicted. authors responded to the peer review Response: We disagree with this comments and released a revised risk commenter’s interpretation of the Risk of BSE in General assessment in 2003.10 Harvard-Tuskegee Study’s conclusion Issue: Several commenters expressed regarding the risk of BSE establishment concern regarding the risk posed by 9 Harvard Center for Risk Analysis, Harvard in the United States. First, the text boneless beef imported into the United School of Public Health, and Center for extracted from the Harvard-Tuskegee States from Japan. One commenter Computational Epidemiology, College of Veterinary Study and quoted by the commenter asked why the U.S. Government would Medicine, Tuskegee University; Evaluation of the Potential for Bovine Spongiform Encephalopathy in states that ‘‘ * * * such exposure propose to allow the importation of the United States. Available at http:// would have eventually resulted in a boneless beef from Japan if there is any www.aphis.usda.gov/lpa/issues/bse/ substantial number of clinical _ risk that it could introduce BSE into the risk assessment/mainreporttext.pdf, 2001. cases***.’’ We do not consider one United States. One commenter stated 10 Research Triangle Institute; Review of the Evaluation of the Potential for Bovine Spongiform native case of BSE to constitute a that APHIS failed to provide a basis for Encephalopathy in the United States. Accessed substantial number. In addition, the its conclusion that this increased risk is online at http://www.aphis.usda.gov/lpa/issues/bse/ model used by the Harvard-Tuskegee acceptable. BSE_Peer_Review.pdf, 2002. Study did not rely on a zero probability Response: Zero risk is virtually, if not Harvard Center for Risk Analysis, Harvard School of Public Health; Evaluation of the Potential for of BSE incidence in the United States. absolutely, impossible to achieve. If we Bovine Spongiform Encephalopathy in the United The detection of BSE in a 12-year-old were to make trade dependent on zero States: Response to Reviewer Comments Submitted cow does not invalidate the conclusions risk, foreign, as well as interstate, trade by Research Triangle Institute. Available at http:// of the study nor our conclusions about in animals and animal products would www.aphis.usda.gov/lpa/issues/bse/ ResponsetoComments.pdf, 2003. the level of risk posed by the cease. Consistent with international Harvard Center for Risk Analysis, Harvard School importation of beef from Japan under trade agreements, such as the WTO’s of Public Health, and Center for Computational the proposed conditions. Furthermore, ‘‘Agreement on the Application of Epidemiology, College of Veterinary Medicine, because this rule applies only to whole Sanitary and Phytosanitary Measures’’ Tuskegee University; Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United cuts of boneless beef, and muscle tissue (WTO–SPS Agreement) and the North States. Available at http://www.aphis.usda.gov/lpa/ of cattle has never demonstrated BSE American Free Trade Agreement, APHIS issues/bse/madcow.pdf, 2003. infectivity, it is highly unlikely that this agrees that measures to protect human,

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animal, and plant health should be no never been demonstrated in muscle the livestock in the United States from more trade restrictive than necessary to tissue in cattle. In fact, we clearly stated the introduction of BSE, the FDA must achieve an appropriate level of that the primary barriers limiting the first modify the U.S. feed ban to prevent protection. Under these agreements, likelihood that whole cuts of boneless the possible recycling of any BSE participating nations, including the beef imported from Japan would expose infectivity imported from Japan. United States and U.S. trading partners, the U.S. cattle population to BSE are the According to the commenter, the U.S. have agreed to base their measures, such inherently low risk of the product, the feed ban includes exceptions for the as conditions for importation, on mitigation measures included in this feeding of blood, poultry litter, and science-based risk assessments and rule to prevent contamination, and the plate waste, the feeding of SRMs to international standards. fact that the product is unlikely to be farmed animals, and does not require As discussed in our risk analysis, BSE fed to cattle. We further stated that segregated facilities in the infectivity has never been demonstrated although the product is not intended for manufacturing of animal feed. This in the muscle tissue of cattle animal consumption, we evaluated commenter stated that these elements of experimentally or naturally infected pathways by which some small fraction the feed ban must be eliminated before with BSE at any stage of the disease. or amount of the product might APHIS begins accepting beef or cattle Therefore, if BSE is present in a inadvertently be fed to cattle. from any country where BSE is known country’s cattle population, as it is in The amount of boneless beef that to exist, including Japan. Japan, the most significant risk would be imported from Japan is mitigation measure for ensuring the relatively small and the amount of Response: The model used by the safety of whole cuts of boneless beef is material likely to be disposed of is even Harvard-Tuskegee Study included the prevention of cross-contamination of smaller, given that household and assumptions about the types of the beef with SRMs during stunning and restaurant food waste are rarely, if ever, rendering processes used in the United slaughter of cattle. The proposed rule fed to cattle or rendered. These types of States, and the amount of material and this final rule include mitigation waste become municipal garbage and subjected to these processes. There are measures that address such risks and are are disposed of in landfills. Further, only a limited number of rendering consistent with the international because the FDA requires that plate processes in use, and research has guidelines on BSE established by the waste be further heat processed before it demonstrated that, with one exception, OIE. can be incorporated into ruminant feed, these processes inactivate significant any potential plate waste derived from levels of the BSE agent. The one type of U.S. Feed Ban boneless beef from Japan would most rendering system that does not Issue: One commenter stated that the likely be subject to rendering processes inactivate significant levels of the BSE level of risk posed by beef imported that would inactivate significant levels agent, the low-temperature vacuum from Japan is unacceptable because the of the BSE agent, thereby further system, is not widely used in the United U.S. feed ban could potentially result in reducing the level of infectivity in the States, if at all. In fact, the Harvard- the recycling of BSE in the United feed. Therefore, our risk analysis Tuskegee Study assumed that only 5 States. This commenter requested that concluded that it is extremely unlikely percent of cattle carcasses rendered in APHIS define ‘‘small fraction’’ and that imported material containing an the United States may be subject to this ‘‘highly diluted’’ in our statements in infectious level of the BSE agent will process. APHIS does not rely solely on the risk analysis about the amount of enter the ruminant feed chain. Because this inactivation, however, in the imported beef that might, we do not consider these pathways to be analysis. A series of barriers, of which hypothetically, be fed to cattle, and the epidemiologically significant for inactivation at rendering is only one, potential concentration of any BSE exposure of the U.S. cattle population to must each be crossed in sequence for agent, if present, that might be available. BSE infectivity in products imported transmission of BSE to occur. In fact, The commenter further questioned under this rule, we do not believe it is inactivation by rendering would only be whether these terms describe an necessary to quantify a level of relevant if BSE-contaminated beef infectious level below 0.001 gram, infectious material that is theoretically entered the United States and entered which is the amount of infected tissue possible, but highly unlikely, to be the ruminant feed supply. Our analysis research has shown to cause BSE present. For these reasons, we are shows that neither event is likely. infectivity. In addition, the commenter making no changes to the rule in asked how many doses may be expected response to this comment. With regard to the commenter’s to enter the animal food chain, if the With regard to the commenter’s statement that the FDA must modify dose is greater than 0.001 gram. request for APHIS to define ‘‘small and broaden the U.S. feed ban to Response: We disagree that the fraction’’ and ‘‘highly diluted,’’ in our prevent the possible recycling of any current feed regulations could result in statements in the risk analysis about the BSE infectivity imported from Japan, the the recycling of BSE if introduced into amount of imported beef that might, Harvard-Tuskegee Study demonstrates the United States by whole cuts of hypothetically, be fed to cattle, these that with the existing feed ban, even boneless beef from Japan. In our risk terms were used to describe a small with incomplete compliance, the level analysis, we considered possible direct amount of material and a small amount of transmission of BSE from infected and indirect pathways by which whole of material that is not concentrated, animals is minimal, if it occurs at all. cuts of boneless beef imported from respectively. This rule only allows the importation of Japan might expose U.S. cattle to BSE if Issue: One commenter stated that whole cuts of boneless beef, a product the product contained the BSE agent. APHIS’ reliance upon heat-processed that presents a very low risk of BSE We discussed these pathways in the rendering to inactivate BSE infectivity is infectivity. Even if beef were imported context of barriers that exist to prevent misplaced because the Harvard- with infectivity, all of the sequential these types of exposures. Our discussion Tuskegee Study makes no definitive barriers to transmission-of which the of these barriers was specifically finding that the rendering processes feed ban is only one-must be crossed in prefaced by the fact that whole cuts of used in the United States will inactivate order for transmission to occur. boneless beef are an inherently low risk the BSE agent. This commenter stated Therefore, we are making no changes to commodity because BSE infectivity has that, in order to meet its duty to protect the rule in response to this comment.

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Cross-Contamination slaughter mitigations applied in both prohibited under this rule). This Issue: One commenter expressed systems would work similarly to reduce commenter cited a report by the concern that the current FSIS the potential for contamination of whole European Commission’s TSE BSE Ad regulations and policies do not fully cuts of boneless beef. For example, the Hoc Group that noted a theoretical risk address the possibility of cross- Japanese establishments, like U.S. that, when a healthy animal that contamination between SRMs and establishments, remove the vertebral nevertheless has infectivity in the brain edible product in plants that column as a unit to reduce the is stunned using a penetrative method, predominately slaughter cattle over 30 likelihood of potentially infective there is the possibility that the bolt of months of age. This commenter stated tissues contaminating the beef. The the gun could be contaminated and establishments also remove spinal cord that, although the current policies could introduce that infectivity into one dura matter and wash the dressed address the use of separate equipment or more sequentially stunned animals, if carcasses after splitting, and inspectors 11 in cattle under 30 months versus those stunned with the same gun. The confirm that the carcasses are free of all that are over this age, they do not commenter requested APHIS to visually detectable evidence of specifically address the issue of specifically address what measures it contamination by spinal cord fragments. dedicated equipment for the removal will put in place to address this risk. Some establishments in Japan carry out and trim of SRMs in plants slaughtering Response: We acknowledge the suction removal of spinal cords prior to over-30-month-old cattle. The theoretical possibility that infectivity in carcass splitting, which further reduces commenter urged the USDA to include the brain of a BSE-infected bovine could the risk of contamination. Finally, it more specific requirements in its potentially be transferred from the head should be noted that the whole cuts of of one animal to the head of another regulations to prevent cross boneless beef that will be imported into contamination between SRMs and animal through the use of penetrating the United States from Japan are stunning methods. However, there is edible products. The commenter stated trimmed further, which again reduces that these should include, but not be currently no evidence that such any potential for contamination. contamination occurs during the limited to, requiring the use of separate Issue: One commenter stated that the equipment, such as knives and blades, slaughter process. Further, as discussed proposed rule is arbitrary and in the background section of our August and utilizing effective TSE disinfection capricious because APHIS has not procedures for equipment used to 2005 proposed rule, we use the term, quantified the number of infectious ‘‘whole cuts of boneless beef,’’ to refer handle SRMs. doses of BSE-infected material that can Response: The FSIS regulations to meat derived from the skeletal muscle be expected to contaminate boneless of a bovine carcass, excluding all parts contained in 9 CFR part 310 require that beef based on the scientifically known establishments that slaughter/process of the animal’s head and diaphragm. occurrence of contamination resulting These restrictions ensure that cattle develop, implement, and maintain from carcass splitting. This commenter written procedures for the removal, penetrative stunning methods not stated that APHIS provides no basis for prohibited under this rule are not a risk segregation, and disposition of SRMs. its conclusion that the increased risk These procedures address appropriately factor for whole cuts of boneless beef associated with importing meat from from Japan. potential cross-contamination of edible Japan that may be contaminated with product with SRMs. FSIS inspectors are high risk tissues is acceptable. BSE Incidence in Japan responsible for verifying the Response: We disagree with the Issue: One commenter stated that the effectiveness of the establishment’s comment. Our proposed rule and the proposed rule did not take into procedures. If FSIS personnel determine risk analysis are scientifically sound. consideration the present and future that an establishment’s procedures are Many regulatory decisions do not BSE incidence rate in Japan. This not effective in preventing cross- depend on numerical calculations or commenter stated that the rule should contamination, the inspectors will take quantifications. What is important is a require that Japan demonstrate that the appropriate action. careful, comprehensive characterization incidence of BSE is declining and that Issue: One commenter expressed and evaluation of the risk involved. no new cases are discovered in animals concern that infective tissue could Such an evaluation has been born after the implementation of the potentially contaminate additional accomplished by APHIS and is feed ban. The commenter stated that carcasses via the use of saws in carcass consistent with the methodology used sufficient time has not yet lapsed since splitting. This commenter stated that in the risk analysis for this rulemaking. Japan implemented its feed ban and this risk is too great for consumers and With respect to the commenter’s other risk mitigation measures to the U.S. cattle industry. Another specific concern, i.e., the quantification determine whether such measures have commenter requested that APHIS of infectious doses of BSE-infected effectively arrested the spread of BSE. explain the risk of introducing BSE into material that can be expected to Another commenter stated that Japanese the United States that may result from contaminate whole cuts of boneless beef is not safe based on the incidence the potential for boneless beef to be beef, there currently is no reliable of BSE in Japan. Finally, one commenter contaminated with BSE-infected tissues information to support a precise stated that Japan should be proven to be during the carcass-splitting process. quantification of a human infectious free from BSE for 7 years before the Response: As discussed in our risk dose. However, there is a wide body of United States should consider importing analysis, cross-contamination events independently verifiable scientific from Japan. represent potential pathways to evidence regarding BSE, including how Response: We concur that at present contaminate whole cuts of boneless to control and eliminate the disease. it is not possible to know with certainty beef. One potential event for such beef This rule requires mitigation measures whether any additional animals in Japan is cross-contamination of carcasses with consistent with that information. are infected with BSE. However, as Issue: One commenter expressed spinal cord during carcass splitting, as documented in our risk analysis, we the saw cuts the carcass in half. concern that the proposal did not FSIS has determined that the Japanese address the risk of acceptable methods 11 Scientific Report on Stunning Methods and meat inspection system is equivalent to of stunning (other than air-injection BSE Risks, TSE BSE Ad Hoc Group, European that of the United States, and that the stunning and pithing, which are Commission, December 13, 2001, at 41.

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analyzed the likelihood that whole cuts impact on that segment of the beef the beef imported under the conditions of boneless beef imported from Japan industry. described in the rule will pose no would: (1) Contain infectious levels of Response: Our assessment of the greater level of risk as products the BSE agent; and (2) present a risk of rule’s potential impact on U.S. produced for human consumption in exposing U.S. consumers or cattle to producers of Wagyu beef was as the United States. Matters relating to BSE, if the imported beef product was thorough as possible given the available country of origin labeling are beyond contaminated with BSE. Based on the data. In the proposed rule, we stated the scope of this rule. potential pathways, we then determined that we did not have all of the data Environmental Assessment appropriate mitigation measures to necessary for a comprehensive analysis, address the risks associated with whole and invited the public to provide Issue: One commenter stated that cuts of boneless beef imported from information that would enable us to APHIS should prepare an Japan. BSE infectivity has never been better assess the rule’s potential impact, environmental impact statement (EIS) demonstrated in the muscle tissue of including information on the number of that shows the effects of a range of cattle infected with BSE at any stage of domestic Wagyu producers and their potential risks including low risk, the disease. Therefore, the most production. None of the comments moderate risk, and high risk. significant risk management strategy for received from the public in response to Response: APHIS prepared an ensuring the safety of whole cuts of the proposed rule included that environmental assessment in order to boneless beef is the prevention of cross- information. determine whether or not there could be contamination of the beef with SRMs Issue: One commenter stated that significant environmental impacts during stunning and slaughter of the domestic producers will lose associated with allowing the animal. Mitigation measures that economically from this rule because the importation of whole cuts of boneless prevent contamination of such beef initial regulatory flexibility analysis beef from Japan based upon conditions involve procedures for the removal of noted that consumers may benefit if the specified in the rulemaking. The SRMs and carcass splitting and price of domestic Wagyu beef goes purpose of an environmental assessment prohibitions on air-injection stunning down due to the resumption of trade in is to provide sufficient information and and pithing. This rule requires such Japanese boneless beef. analysis to agency decisionmakers to mitigation measures. While our risk Response: The economic impact of allow them to determine whether a analysis considered the incidence of the rule on domestic Wagyu producers proposed agency action will have a BSE in Japan in its discussion of the OIE is unclear. This is because the extent to significant effect on the human recommendations on BSE, it did not which Wagyu beef imports from Japan environment, including public health play a central role in our evaluation of and domestically produced Kobe-style and safety. The decisionmaker reviews the risk posed by whole cuts of boneless beef compete for the same group of the environmental assessment and any beef. Our evaluation was based on the buyers is not known. It is conceivable associated public comments and then nature of the commodity and the that demand for, and prices of, domestic makes a determination on whether there potential pathways for exposure. Kobe-style beef could decline if will be adverse impacts significantly consumers switched to Wagyu beef from affecting the human environment. This Economic Analysis Japan once that product becomes determination is based on the Issue: One commenter asked what available in the U.S. market. On the consequences of associated risks and on assurances there are in the rule that other hand, it is possible that the safeguards that are designed to prevent Wagyu beef will be the only beef importation of Wagyu beef from Japan those risks from occurring and causing exported, since Japan also produces could stimulate additional interest in, significant adverse impacts on the Holstein beef, which appears to be and demand for, high-end beef in human environment. If a determination where Japan is experiencing the highest general, thereby benefitting U.S. is made that a proposed action would rate of BSE. producers of Kobe-style beef. That have a significant effect on the human Response: This rule allows the domestic Kobe-style beef will likely sell environment, the agency is obligated to importation of whole cuts of boneless at a lower average price than Wagyu prepare an EIS. If a determination is beef from all cattle breeds, including beef from Japan suggests that the two made that the action will not have a Holstein, provided that certain commodities are not perfect substitutes. significant effect on the human conditions are met. These conditions, Issue: One commenter expressed environment, a finding of no significant which include removal of SRMs and concern that the most serious economic impact is issued in connection with any prohibitions on the use of air-injection impact of the rule has not been final rule and an environmental impact stunning and pithing, will continue to addressed, that is, the possibility of an statement is unnecessary. That is the protect against the introduction of BSE American consumer contracting variant case with this rulemaking. into the United States, regardless of the CJD (vCJD), which has been linked via Issue: The same commenter stated breed of cattle from which the beef is scientific and epidemiological studies to that the proposed rule should be derived. As a practical matter, the exposure to the BSE agent. The afforded even greater scrutiny from an export of Holstein beef to the United commenter stated that this rule would environmental perspective than APHIS States is unlikely, since it is unlikely unfairly reduce demand for beef from afforded the minimal risk region rule that Japan will try to compete in the American cattle producers because because of the cumulative effects of the U.S. import market for lower-grade beef country of origin labeling has not yet two rules. from culled dairy cattle against such been enforced and consumers will not Response: The minimal-risk region established suppliers as Australia and be able to differentiate Japanese beef rule (see 70 FR 360–553, Docket No. 03– New Zealand. We expect only Wagyu from American beef. 080–3, January 4, 2005) allows the beef to be imported under the rule. Response: The possibility of an importation of live bovines less than 30 Issue: One commenter stated that the American consumer contracting vCJD months of age when imported and when impact of the rule on the domestic from infected meat imported from Japan slaughtered, sheep and goats less than Wagyu beef industry should be is extremely unlikely. FSIS, which 12 months of age when imported and thoroughly analyzed because this rule assessed the human health risks when slaughtered, and certain bovine has the potential to have the most associated with the rule, concluded that meat, meat byproducts, and meat food

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products, from regions recognized as the proposal for APHIS’ departure from than in Africa and some countries on minimal-risk for BSE, provided that previous policies to deny the the Arabian Peninsula. Also, in contrast certain conditions are met. The importation of commodities from BSE- to infectious diseases that can be environmental assessment for the affected regions. diagnosed relatively quickly, BSE has an minimal-risk region rule and a review of Response: With regard to trade from extremely long incubation period. the issues raised by public comment BSE-affected regions, § 94.18(a)(1) lists Therefore, our regulations for BSE are provided the basis for a finding of no regions where BSE is known to exist. designed to protect against the significant impact on the quality of the Paragraph (a)(2) of § 94.18 lists regions introduction of BSE from regions where human environment, i.e., public health that present an undue risk of BSE BSE exists or that present an undue risk and safety (see 70 FR 18252–18262, because their import requirements are of introducing BSE. Docket No. 03–080–7, April 8, 2005). less restrictive than those that would be An alternative approach to assigning The rule for Japanese beef will only acceptable for import into the United status to a region is to follow a allow whole cuts of boneless beef, States and/or because the regions have commodity-based approach in which which have not demonstrated BSE inadequate surveillance for BSE. mitigations are defined that are infectivity at any stage of the disease. Additionally, § 94.18(a)(3) lists regions appropriate to the commodity (and the The conditions contained in this rule for that present a minimal risk of region, if relevant). Existing examples of whole cuts of boneless beef, such as the introducing BSE into the United States. this include the regulations in § 94.18(b) appropriate removal of SRMs from the APHIS prohibits the importation of live that allow for the importation of gelatin carcass, address the potential risk for ruminants and certain ruminant and milk under certain conditions from BSE contamination. Thus, it is highly products and byproducts both from any region listed in § 94.18(a). Similarly, unlikely that the importation of such regions where BSE is known to exist this rule will allow the importation of beef from Japan would result in the (and that are not considered BSE whole cuts of boneless beef from Japan, introduction of BSE into the United minimal-risk regions) and from regions under the conditions contained in this States. Therefore, from an of undue risk, even though BSE has not rule, while continuing to protect against environmental perspective, an been diagnosed in a native animal in the the introduction of BSE into the United environmental assessment is the latter regions. The minimal-risk regions States. appropriate level of environmental rule provided the basis for allowing the The import request submitted to documentation. importation of various commodities APHIS by the Government of Japan lent from regions in which BSE has been itself to a commodity-based approach Proposed Regulations detected but that have been evaluated as because it was limited in scope to BSE Regulations (General Approach) minimal-risk regions for BSE. boneless beef from Japanese cattle. With respect to the issue about Japan Because Japan was not requesting the Issue: Several commenters expressed meeting the requirements for a minimal- importation of live animals, we only concern that APHIS’ import policy with risk region as defined in § 94.0, as considered the risk associated with the regard to BSE and, more specifically, mentioned previously, the situation in importation of that commodity, rather BSE-related restrictions for the Japan represents conditions consistent than the risk associated with the importation of whole cuts of boneless with a controlled-risk region as outlined importation of live animals and other beef from Japan, seems to differ from its in the OIE guidelines. We did not commodities from Japan. Because whole regionalization approach found in the evaluate Japan as a minimal-risk region. cuts of boneless beef present a low risk current BSE regulations and the general This rule is commodity-based. The of BSE, we determined that it was not policy with regard to recognition of requirements for importing that necessary to evaluate the country in regions for other foreign animal commodity-whole cuts of boneless beef- light of the minimal-risk region criteria. diseases. One commenter stated that, protect against the introduction of BSE. OIE Recommendations on BSE with most diseases, APHIS does not Other provisions in APHIS’ regulations allow importation until adequate address risks associated with other Issue: Several commenters expressed surveillance has been done to prove diseases. For example, if Japan were to concern that the proposed conditions freedom of a region from the disease. experience an outbreak of foot-and- for whole cuts of boneless beef from However, with regard to BSE, stated the mouth disease, the requirements of Japan are less restrictive than the commenter, APHIS allows imports from § 94.4, which require cooking or curing, recommended export conditions a region until a case of BSE is identified would apply. contained in Article 2.3.13.1 of the in that region. The commenter stated With respect to the approach to BSE OIE’s 2005 Terrestrial Animal Health that APHIS should define standards for differing from the approach to other Code for deboned skeletal muscle meat all levels of trade with various countries diseases, when it was newly discovered, from anywhere. These commenters concerning BSE. The commenter BSE was limited in its geographic pointed out that the proposal did not suggested that APHIS conduct or peer distribution to the United Kingdom and require that the beef be derived from review the proper risk evaluations to certain other countries in Europe. There cattle that are less than 30 months of age determine a country’s BSE risk category was no evidence to suggest the disease and that the cattle be subject to ante- based upon OIE guidance and to classify existed elsewhere in the world. and post-mortem inspections and were all countries that have not been Designating regions as affected could be not suspect or confirmed BSE cases. The evaluated as undetermined risk regions. done quickly by interim rule as cases commenters stated that these conditions Similarly, another commenter were detected. Evaluation of countries are contained in the OIE expressed concern that APHIS does not for lower risk status (e.g., minimal risk recommendations for the export of have a standard for protecting the or unaffected), usually involves a risk deboned skeletal muscle meat from any United States against the introduction analysis as well as a rulemaking. The region. One commenter requested that and spread of BSE, and potentially other BSE approach (i.e., designation as these additional restrictions be added to communicable diseases, because Japan affected) is consistent with our the rule. Finally, one commenter also does not meet the criteria for a minimal- approach to other diseases, such as noted that the proposed rule would risk region. Finally, one commenter African horsesickness, which has never allow for the importation of boneless stated that no reason was provided in been shown to exist in countries other beef from cattle over 30 months of age,

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which is not allowed from minimal-risk Japanese authorities had conducted an the risks associated with whole cuts of regions. appropriate risk assessment to identify boneless beef from Japan. We did not Response: We appreciate the the historical and existing BSE risk attempt to classify Japan as a minimal- commenter’s question regarding factors; the country’s surveillance risk region, nor did we include live consistency with the current OIE program was consistent with Type A animals or other meat and meat recommendations on BSE. As discussed surveillance as defined by OIE in products. Rather, we limited our in the proposed rule and the risk Appendix 3.8.4 of the Code; and the analysis to the BSE risk associated with analysis, the conditions for the BSE conditions for controlled-risk whole cuts of boneless beef. Scientific importation of whole cuts of boneless regions relative to BSE cases, a feed ban, data show that BSE infectivity in the beef from Japan are consistent with the importation of meat-and-bone meal or muscle tissue of cattle examined in recommendations for the export of meat greaves, epidemiological tracing, and either the mouse bioassay or the cattle and meat products from controlled-risk disposition of affected and contact assays have not been demonstrated to regions, which are contained in Article animals were met. date, regardless of the age of the animal. 2.3.13.10 of the OIE’s 2005 Terrestrial It is important to note that, while we For these reasons, we consider whole Animal Health Code, not those considered the OIE recommendations cuts of boneless beef to be inherently recommendations for the export of on BSE in the development of the risk low-risk for BSE and determined that it deboned beef from any region. Unlike analysis, we based our mitigation can be safely traded provided that the OIE recommendations for the free measures on a careful analysis of the measures are taken to prevent cross- trade of deboned beef from any region, risk posed by the importation of whole contamination during processing. Such the OIE recommendations for cuts of boneless beef from Japan. BSE measures are contained in this rule and commodities exported from controlled- infectivity has never been demonstrated an age restriction is not necessary. risk regions do not contain a 30-month- in the muscle tissue of cattle infected age restriction. with BSE at any stage of the disease. County of Origin Labeling The OIE recommendations, as noted Therefore, the most significant risk Issue: A number of commenters by the commenter, include conditions management strategy for ensuring the recommended that country of origin that the commodity be derived from safety of whole cuts of boneless beef is labeling be required in the United States cattle that were subject to ante- and the prevention of cross-contamination of so that beef imported from Japan would post-mortem inspections and were not the beef with SRMs during stunning and be so labeled. Some commenters suspect or confirmed BSE cases. These slaughter of the animal. Mitigation suggested APHIS postpone requirements are consistent with FSIS measures that prevent contamination of implementation of this rule until such requirements under the Federal Meat such beef involve procedures for the labeling is in place in this country. Inspection Act (FMIA). In 9 CFR parts removal of SRMs and carcass splitting Several commenters raised concerns 309 and 310, for example, FSIS requires and prohibitions on air-injection about how the United States would be that all livestock offered for slaughter stunning and pithing. This rule requires able to verify the requirement that the must receive (and pass) ante- and post- such mitigation measures. beef be derived from cattle born, raised, mortem inspections. As part of FSIS’ Age Restriction and slaughtered in Japan without a equivalence determination process, country of origin labeling requirement. Issue: One commenter expressed countries that export commodities to the Finally, one commenter expressed concern that the proposal did not United States must have meat concern that, because the proposal did contain an age limitation on whole cuts inspection systems that provide the not contain a country-of-origin of boneless beef from Japan and stated same level of protection as that requirement, any stigma associated with that there should be such a restriction, provided by systems in the United imported Japanese beef would be States. Because the OIE especially since Japan’s control transferred to the entire U.S. beef supply recommendations noted by the measures for BSE have not been in place if the BSE or vCJD incidence in Japan commenter are already established for a long period of time. Other increases. requirements under FSIS’ regulations, commenters stated that the lack of a 30- Response: Under the Farm Security and are, moreover, requirements that month age restriction on cattle from and Rural Investment Act of 2002 and pertain to all livestock regardless of the which the beef is derived for export the 2002 Supplemental Appropriations BSE risk status of a region, it was not from Japan is inconsistent with APHIS’ Act, USDA is required to implement a necessary to include those same rulemakings, specifically, the age restriction for cattle and cattle products mandatory country of origin labeling requirements in our regulations. 12 Issue: One commenter asked for contained in the minimal-risk rule. program (COOL). USDA’s Agricultural clarification on how APHIS determined Some of these commenters stated that Marketing Service (AMS) published a that Japan could be considered as APHIS provided no justification for proposed rule on the COOL program on having controlled-risk status under the allowing imports of beef from animals October 30, 2003 (68 FR 61944–61985, OIE guidelines. over 30 months of age from Japan or any Docket No. LS–03–04). Under the Response: APHIS personnel requested other country where BSE is known to proposal, retailers would be required to written documentation on the BSE exist. notify their customers of the country of status of and conditions in Japan and Response: Prior to developing the origin of all beef (including veal), lamb, conducted a site visit to verify the proposed rule for this action, we pork, fish, and selected other perishable information and gather additional data. analyzed the likelihood that boneless commodities being marketed in their We then evaluated the country-specific beef imported from Japan would: (1) stores. In addition, the AMS proposal information in the context of the OIE Contain infectious levels of the BSE identified criteria that these recommendations on BSE and found agent; and (2) present a risk of exposing commodities must meet to be that the BSE conditions in Japan are U.S. consumers or cattle to BSE, if the considered of U.S. origin. In November consistent with those conditions for a imported beef was contaminated with 12 AMS USDA; Country of Origin Labeling— controlled-risk region contained in BSE. Based on the potential pathways, Current Status of Country of Origin Labeling. Article 2.3.13.4 of the 2005 Terrestrial APHIS then determined what mitigation Available at http://www.ams.usda.gov/cool/ Animal Health Code. For example, measures should be imposed to address status.htm.

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2005, President Bush signed Public Law for this disease—the time between of boneless beef from Japan. These 109–197, which includes a provision to initial infection and the manifestation of commenters stated that the export extend a previous delay of clinical signs—is generally very long, on conditions for beef between the two implementation of mandatory COOL for the average of about 5 years. nations should be the same. all covered commodities except wild Accordingly, we know there is a long In addition, one commenter noted and farm-raised fish and shellfish until period during which, using the current that the proposed rule did not address September 2008. The COOL program, methodology, testing an infected animal potential impacts the rule could have on when implemented, will address the that has not demonstrated clinical signs the United States’ ability to restore the labeling concerns raised by commenters of the disease or is not at the end of the export markets that remain closed to the with regard to APHIS’ proposed rule. incubation period would, incorrectly, U.S. cattle and beef industries. This APHIS does not consider it necessary to produce negative results. If, however, commenter asked if APHIS has delay implementation of this rule until the infected animal is already exhibiting consulted with South Korea and other those labeling provisions are some type of clinical signs that could be importing nations that continue to ban implemented. In its October 30, 2004, consistent with BSE, then the test is not U.S. beef and cattle to determine proposal, AMS noted, in discussing likely to produce false negative results. whether the rule would enhance or Section 10816 of Public Law 107–171 (7 BSE infectivity has never been impede the reopening of these markets. U.S.C. 1638–1638d) regarding COOL demonstrated in the muscle tissue of This commenter expressed concern that that the ‘‘intent of the law is to provide cattle experimentally or naturally the rule would be viewed by other consumers with additional information infected with BSE at any stage of the nations as exposing the United States to on which to base their purchasing disease. Therefore, if BSE is present in an unacceptable risk. This commenter decisions. It is not a food safety or a country’s cattle population, the most requested that APHIS provide the public animal health measure. COOL is a retail significant risk mitigation measure for with a list of nations that currently labeling program and as such does not ensuring the safety of whole cuts of allow the importation of Japanese beef address food safety or animal health boneless beef is the prevention of cross- and stated that APHIS should not concerns.’’ contamination of the beef with SRMs proceed with the rule until and unless With respect to the concern expressed during stunning and slaughter of the a firm commitment is obtained from all about verifying that the beef is derived animal. This rule includes such risk countries that formerly accepted U.S. from cattle born, raised, and slaughtered mitigation measures. For example, this beef exports that they will-in a timely in Japan, this rule will require that an rule requires the removal of SRMs and fashion-reopen their borders to U.S. authorized veterinary official of the prohibits the use of air-injection beef, even if the U.S. resumes imports Government of Japan certify on an stunning devices and pithing processes of Japanese beef. original certificate that the conditions on cattle from which the beef is derived. Response: APHIS does not have contained in this rule have been met. For these reasons, we do not consider authority to restrict trade based on its potential market access effects. Under BSE Testing the testing of bovines at slaughter to be scientifically justified or meaningful in its statutory authority, APHIS may Issue: One commenter requested that, the context of either human or animal prohibit or restrict the importation or before proceeding with this rule, APHIS health. Making this a criterion for the entry of any animal or article when the explain why the rule does not require importation of beef from Japan would agency determines it is necessary to BSE testing of cattle slaughtered in not contribute to human or animal prevent the introduction or Japan in the rule. This commenter stated health protection. A statistically and dissemination of a pest or disease of that the use of rapid tests could assist epidemiologically valid surveillance livestock. However, APHIS is actively in eliminating from the food chain plan is crucial to monitoring the success negotiating with trading partners to clinically healthy cattle with PrPsc of risk mitigation measures, such as a reestablish our export markets. (abnormal prion protein) in the central feed ban, but surveillance is not a nervous system. The commenter stated Trade With Other BSE-Affected Regions mitigation measure. that such a mandatory testing Issue: One commenter suggested that requirement must be included in any Miscellaneous Comments APHIS make explicit in its final rule rule to resume imports from BSE- that, based on the logic and reference to affected countries or else the United Harmonized Two-Way Trade the new OIE guidelines in the proposal, States would have no means of ensuring Issue: Many commenters requested the United States is now ready to accept the continuation of current mitigation that APHIS not finalize the proposed safe products from countries that have measures currently practiced in rule until two-way, harmonized trade experienced BSE but have stringent risk countries like Japan. can be resumed between the United mitigation measures in place, following Response: We understand the interest States and Japan. These commenters separate risk analyses to be carried out expressed by some commenters in expressed concern that Japan has not by APHIS. This commenter stated that testing certain cattle for slaughter. provided adequate assurances that U.S. it expects APHIS is now prepared to use However, no live animal tests exist for producers will be allowed to export beef the same approach when evaluating a BSE and the currently available to Japan. Further, several of these specific request to authorize the import postmortem tests, although useful for commenters were concerned that U.S. of whole cuts of boneless beef from the disease surveillance (i.e., in determining producers would be subject to more European Union, in particular. In the rate of disease in the cattle stringent export conditions than those contrast, another commenter expressed population), are not appropriate as food faced by exporters of boneless beef from concern that the rule would establish a safety indicators. Studies have Japan. For example, some commenters precedent for allowing the importation demonstrated that the earliest point at expressed concern that U.S. producers of commodities from other BSE-affected which current testing methods can will only be allowed to export beef to regions that pose a greater risk of detect a positive case of BSE is 2 to 3 Japan if the beef is derived from cattle introducing BSE into the United States months before the animal begins to less than 20 months of age. No such age than does boneless beef from Japan. demonstrate clinical signs. Research restriction was contained in the Response: As mentioned above, under also indicates that the incubation period proposed rule regarding the importation its statutory authority, APHIS may

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prohibit or restrict the importation or Commission. These assessments were estimated that the incidence of deaths entry of any animal or article when the initially begun in the late 1990’s, under from vCJD reached a peak in mid-2000, agency determines it is necessary to the auspices of the European with 28 deaths that year. For prevent the introduction or Commission’s Scientific Steering comparison, the Centers for Disease dissemination of a pest or disease of Committee (SSC). Since the functions of Control (CDC) estimates that foodborne livestock. When we receive a request the former SSC have now been taken up diseases cause approximately 76 million from a country to allow the importation by the European Food Safety Authority illnesses, 350,000 hospitalizations, and of commodities, we carefully and (EFSA), the GBR assessments are done 5,000 deaths in the United States alone thoroughly consider the risk associated under the EFSA. This assessment each year. Of these, known pathogens with the commodity and the country. In process is not a process supervised by account for an estimated 14 million addition, APHIS is currently the USDA or APHIS, and we cannot illnesses, 60,000 hospitalizations, and considering developing a change any assessments previously 1,800 deaths annually. These estimates comprehensive set of regulations done by the European Commission. It is are not attributed to specific food consistent with the OIE not clear what the commenter means by products implicated in each outbreak, recommendations on BSE. requesting that the United States adhere but rather to the specific pathogens. The to the BSE GBRs, as these are Importation of Commodities From variation in number of reported vCJD documents created internally by the Minimal-Risk Regions and/or Canada cases cited in our minimal-risk regions European Union for its purposes. APHIS final rule and the proposed rule for this Issue: One commenter stated that the conducts its own risk assessments as rulemaking and noted by the commenter risk analysis and the OIE guidelines necessary for specific rulemaking is attributable to an update in figures used in support of the proposed rule efforts, incorporating all available obtained by APHIS and not a spike in would also allow the importation of information. Such information may refer the number of vCJD cases reported cattle over 30 months of age and beef to an assessment conducted by the worldwide. from those cattle from any minimal-risk country requesting a regulatory change, Issue: Two commenters raised region. This commenter stated that, as a but it generally would not depend on result, there is no justified reason to questions regarding the origin of CJD in third party assessments. humans. One commenter noted that allow the importation of beef from Japan The United States considers all there are different strains of TSEs being to enter the United States and not animal TSEs in developing regulations discovered in ruminants, and that new provide the same treatment for related to BSE. However, it should be Canadian cattle and beef. The noted that the various animal TSEs are atypical strains of TSE in cattle look commenter stated that Canada and other generally caused by different agents similar to sporadic CJD in humans. minimal-risk regions should be afforded (i.e., scrapie in sheep is different from Another commenter asked if APHIS has treatment consistent with Japan and that chronic wasting disease (CWD) in considered whether sporadic CJD in Canadian cattle over 30 months of age cervids, which is different from BSE in humans might be caused by atypical and beef derived from those cattle cattle) with different routes of cases of TSEs that have been found in should be allowed to be imported by transmission and unique characteristics. animals. This commenter further APHIS. Sometimes these processes may be questioned whether blood and other Response: APHIS recognizes that the similar, but one cannot automatically tissues may carry BSE infectivity in OIE guidelines address the importation assume, for example, that if a country cattle infected with atypical strains of of live cattle over 30 months of age and has identified scrapie in sheep that they the BSE agent or other TSE agents. beef from such cattle from regions of are therefore at significant risk for other Response: Sporadic CJD is the most different status. However, the scope of animal TSEs such as CWD or BSE. common form of CJD. It has been found this rulemaking is limited to whole cuts in every country in the world where it of boneless beef derived from cattle CJD and Domestic Compliance With has been looked for including countries born, raised, and slaughtered in Japan. FSIS’ BSE-Related Regulations that are generally considered by the Therefore, the issue of imports of live Issue: One commenter noted that the international scientific community to be cattle over 30 months of age and beef number of probable and confirmed cases free of BSE and other TSEs (for example, from those cattle from minimal-risk of vCJD cited in the proposed rule was Australia and New Zealand). In general, regions, including Canada, falls outside greater than the number of cases cited it affects about one person per million. the scope of this rulemaking. in the minimal-risk regions final rule No association between sporadic CJD Nevertheless, as noted in the minimal- and raised questions regarding the and consumption of animal products in risk region rule, APHIS is committed to significance of this increase in cases general and/or infected or contaminated dealing with the issue of imports of live over a several month period. This bovine products has ever been bovines 30 months of age and over from commenter requested that APHIS documented. It is currently believed Canada in further rulemaking. provide a comparison between the that sporadic CJD arises through the Issue: One commenter stated that the number of deaths attributable to the spontaneous conversion of PrPC (normal BSE minimal-risk regions rule should be consumption of beef contaminated with cellular prion protein) to PrPSC in an withdrawn, and that the U.S. BSE and the number of deaths individual.13 In contrast, atypical cases geographical BSE risk assessment (GBR) attributable to the consumption of beef of BSE in cattle are rare and have been should immediately be raised to BSE contaminated with other food-borne reported in only few countries that GBR IV. This commenter further contaminates such as Escherichia coli experience BSE, such as Italy, Belgium, requested that the United States adhere (E. coli) in order to place this increase Japan, and France. It has been to the BSE GBR and that USDA work to in vCJD cases in context for the beef and speculated that the spontaneous or enhance those assessments to include cattle industries. sporadic form of BSE could exist in all animal TSEs. Response: To date, there have been a cattle, as well as humans.14 Response: Consideration of changes to total of approximately 170 cases of vCJD the minimal-risk rule are outside the reported worldwide since 1996. Most of 13 Stahl, N. and Prusiner, S.B.; (1991) FASEB–J. scope of this rulemaking. The BSE GBRs these cases have been in the United 5: 2799–807. are conducted by the European Kingdom. In the United Kingdom, it is 14 Biacabe; 2004 EMBO reports, Vol. 5, No. 1.

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APHIS agrees with the commenter analyses conducted using the best what risk mitigation measures have that reports indicate that some of the scientific information available. These been imposed. Neither USDA nor the atypical BSE cases, in particular the are made available for public comment OIE have strictly defined an ‘‘effectively bovine amyloidotic spongiform in association with regulations enforced ban.’’ The OIE has indicated encephalopathy (BASE), and sporadic implementing these controls. The BSE that it may consider developing such a CJD have similar PrPSC patterns. APHIS surveillance program in the United definition, but this process may take evaluated the findings in the context of States was developed by technical some time. USDA considers effective risk of exposure to cattle and humans. experts to help determine whether BSE enforcement of the feed ban as an Currently, the relevance of the atypical is present in the U.S. cattle population, important measure to control BSE in a cases is unknown, but at this time there and if so, to help estimate at what level. specific region. In previous rulemaking, is no indication that any control The USDA’s OIG is conducting an we noted that determining whether a measures—such as feed bans or SRM ongoing audit of the BSE surveillance feed ban had been effectively enforced requirements—should be modified program. involved a review by APHIS of a based on these cases. Additionally, number of interrelated factors, Other Comments although atypical cases of BSE and including: The existence of a program to sporadic CJD share similarities at this Issue: One commenter stated that gather compliance information and point, there is no evidence that they are there was no background or supporting statistics; whether appropriate linked. information provided along with the regulations are in place in the region; Issue: One commenter expressed proposed rule. the adequacy of enforcement activities concern over the number of citations Response: The background (e.g., whether sufficient resources and issued for various SRM violations information in support of the proposal commitment are dedicated to enforcing during the June 2004 enhanced BSE was provided in our risk analysis and compliance); a high level of facility surveillance program in the United other supporting analyses that were inspections and compliance; States. This commenter questioned made available to the public concurrent accountability of both inspectors and whether these incidents of with the proposal. These documents inspected facilities; and adequate noncompliance may have led to remain available at http:// recordkeeping. infective materials entering the human www.regulations.gov. Therefore, for the reasons given in the or animal food chains. This commenter Issue: Several commenters raised proposed rule and in this document, we cited the case of BSE detected in a 12- issues that fall outside the scope of this are adopting the proposed rule as a final year-old cow in Texas as evidence that rulemaking, including the impact of rule, without change. infective materials may have entered the eating meat on the health of American food chain. The commenter suggested consumers, the relative quality of beef Effective Date that noncompliance reports should be produced in Japan and the United This is a substantive rule that relieves made more easily available to the public States, and the necessity and market restrictions and, pursuant to the in the future. effects of importing beef from Japan provisions of 5 U.S.C. 553, may be made Response: FSIS inspectors are when the United States produces beef effective less than 30 days after responsible for verifying the domestically. publication in the Federal Register. The effectiveness of an establishment’s Response: APHIS does not have Administrator of the Animal and Plant procedures. If FSIS personnel determine authority to restrict trade based on these Health Inspection Service has that an establishment’s procedures are considerations. Under its statutory determined that immediate ineffective in preventing cross- authority, APHIS may prohibit or implementation of this rule is warranted contamination, the inspectors will take restrict the importation or entry of any to relieve certain restrictions on the appropriate action. We note that none of animal or article when the Secretary importation of whole cuts of boneless the meat from the 12-year-old BSE- determines it is necessary to prevent the beef from Japan that are no longer infected cow in Texas mentioned by the introduction or dissemination of a pest necessary. commenter entered the human food or or disease of livestock. While the United animal feed chains. States does not have direct control over Executive Order 12866 and Regulatory Issue: One commenter stated that the the quality of products produced in Flexibility Act domestic BSE mitigation measures, other countries, FSIS requires that the This rule has been reviewed under including the U.S. ruminant feed ban, food it regulates be produced under Executive Order 12866. The rule has border controls, and BSE surveillance conditions that will provide at least an been determined to be significant for the program, must be strengthened in order equivalent level of safety as that purposes of Executive Order 12866 and, to protect public health. The commenter produced in the United States. therefore, has been reviewed by the further requested that USDA’s Office of Therefore, we are not making any Office of Management and Budget. the Inspector General (OIG) hold an changes to the rule based on this Under the Animal Health Protection inquiry into the effectiveness of the BSE comment. Act of 2002 (7 U.S.C. 8301 et seq.), the surveillance program. Issue: One commenter stated that it Secretary of Agriculture is authorized to Response: APHIS considers the would be helpful if the OIE or USDA promulgate regulations that are measures in place to be adequate and would define ‘‘controlled BSE-risk necessary to prevent the introduction or based on the best available science. country’’ and ‘‘effectively enforced dissemination of any pest or disease of First, available evidence suggests that ban.’’ livestock into the United States. the feed ban which FDA implements is Response: Article 2.3.13.4 of the OIE’s This final rule will amend the a critical safeguard against the spread of 2005 Terrestrial Animal Health Code regulations governing the importation of BSE in the United States. FDA has lists recommended conditions that a meat and other edible animal products recently issued a proposed rule to country, zone, or compartment should by allowing, under certain conditions, further strengthen the feed ban (70 FR meet to be considered as controlled BSE the importation of whole cuts of 58570–58601, October 6, 2005). risk. These conditions include a boneless beef derived from cattle born, Domestic BSE mitigation measures for consideration of whether a country has raised, and slaughtered in Japan. This border controls are based on risk identified indigenous cases of BSE and action is taken in response to a request

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from the Government of Japan and after imports. This impact would be further exceeded 27.0 metric tons in any one conducting an analysis of the risk that reduced if Japan’s share of the U.S. total year. indicates that such beef can be imported beef supply (domestic production plus Finally, Japan’s boneless beef exports from Japan under the conditions imports minus exports, disregarding to countries other than the United States described in this final rule. These carryover stocks) were considered. have also been minor. Over the 4-year conditions will continue to protect Based on the unit price of beef period 1997–2000, Japan’s exports of against the introduction of BSE into the imported into the United States from boneless beef to the world—both fresh/ United States. Japan prior to the 2001 ban on the chilled and frozen—averaged only 81 In accordance with 5 U.S.C. 604, we importation of ruminants and most metric tons per year, and the largest have performed a final regulatory ruminant products from Japan, it is export volume in any one of those years flexibility analysis, which is assumed that all of the boneless beef was 95 metric tons (in 1999). For fresh/ summarized below, regarding the imported from Japan prior to the ban chilled boneless beef alone, the 4-year impact of this rule on small entities.15 was Wagyu beef. (The term ‘‘Wagyu,’’ annual average was 37 metric tons, with This analysis also serves as our cost- which literally translates to Japanese no one year exceeding 47 metric tons.19 benefit analysis under Executive Order cattle, refers to purebred Japanese Black Because we expect that Japan will 12866. or Japanese Brown breeds of cattle. export only Wagyu beef under this final We expect that this rule will have Wagyu beef is a high-priced specialty rule, this action has the potential to little or no economic impact on the meat widely acclaimed for its flavor and affect farmers and ranchers in the majority of consumers and beef tenderness. ‘‘Kobe beef’’ refers to Wagyu United States who raise Wagyu and producers in the United States because beef that is produced in the Kobe area Wagyu hybrid cattle for the high-end the volume of beef imported from Japan of Japan.) Japan also produces Holstein domestic beef market. However, the is likely to be small and have only a breed dairy cattle, but it is unlikely that impact, if any, on these so-called ‘‘Kobe- minor impact on the overall domestic Japan would try to compete in the U.S. style’’ beef producers is unclear, beef market. import market for lower-grade beef from without an approximation of the In 2001, APHIS placed a ban on the culled dairy cattle. Accordingly, we quantity of Kobe-style beef sold in the importation of ruminants and most expect only Wagyu beef to be imported United States and information on the ruminant products from Japan following under the final rule. extent to which the two products would the confirmation of one case of BSE in We expect that Japan will continue to directly compete. The number of these a native-born animal in that country. be a minor supplier of beef to the United producers is unknown, but it is believed Prior to that ban, U.S. imports of States after this final rule becomes to be very small. boneless beef from Japan were negligible effective. We estimate that the volume when compared to total imports of that of imports is likely to range between Cost-Benefit Analysis commodity. Over a 4-year period, 1997– about 8 metric tons and 15 metric tons Given the high price and small 2000, for example, the volume of U.S. per year, a quantity aligned with import quantity of Wagyu beef expected to be imports of boneless beef from Japan— levels in the years immediately prior to imported, this final rule is likely to have reported to be entirely fresh/chilled, as the ban. There are three reasons for the little impact for most U.S. consumers. A opposed to frozen—averaged a little less small import volume. First, the demand relatively small segment of beef than 9 metric tons per year. This for Japanese Wagyu beef in the United consumers will benefit because they amount was less than 0.005 percent of States will likely be small, because the would be allowed, once again, to buy average annual U.S. imports of fresh/ beef is expensive. In October 2004, for this product in the United States. chilled boneless beef worldwide for the example, the average actual selling price Importers, brokers and others in the same period (202,540 metric tons).16 of Wagyu sirloin in Japanese United States who will participate in The average annual value of U.S. supermarkets was just under $50 per the importation of Wagyu beef from imports of boneless beef from Japan over pound.17 The price of Japanese Wagyu Japan also stand to benefit, due to the this 4-year period was $808,000, less beef would be higher in the United increased business activity. than 0.2 percent of the 4-year average States because of transportation and U.S. beef producers, in general, will annual value of U.S. imports of fresh/ other costs associated with the not be affected by this final rule; chilled boneless beef from all regions importation of the beef from Japan. demand is expected to remain low ($600 million). Including frozen Second, Japanese agricultural officials reflecting pre-ban consumption boneless beef in the comparison over have indicated to APHIS staff that they patterns, with a minor impact on less the same 4-year period diminishes expect the volume of Wagyu exports to expensive domestically produced beef. Japan’s annual average percentage share the United States to be approximately Any producer impact of the rule will all the more, to about 0.001 percent of 10 metric tons per year. This quantity the quantity and about 0.05 percent of likely fall upon producers of Kobe-style aligns with historic import levels, as the value of all U.S. boneless beef beef, and then only to the extent that the described above, and would be well commodities will be competing for the below the annual tariff rate quota for 15 A copy of the full economic analysis is same niche market. 18 available for review on the Regulations.gov Web Japan of 200 metric tons. Over the 10- In general, trade of a commodity site. Go to http://www.regulations.gov, click on the year period from 1991 to 2000, U.S. increases social welfare. To the extent ‘‘Advanced Search’’ tab and select ‘‘Docket Search.’’ imports of boneless beef—both fresh/ that consumer choice is broadened and In the Docket ID field, enter APHIS–2005–0073 then click on ‘‘Submit.’’ The economic analysis will chilled and frozen—from Japan never the increased supply of the imported appear near the end of the resulting list of commodity leads to a price decline, documents. 17 Source: ‘‘Monthly Statistics,’’ January 2005, gains in consumer surplus will 16 Trade statistics, unless otherwise indicated, are Agricultural & Livestock Industries Corporation. outweigh losses in domestic producer taken from the World Trade Atlas or the Global The selling price was calculated using an exchange 20 Trade Atlas (Global Trade Information Services), rate of 105 yen per U.S. dollar, and it is the price surplus. Although the rule’s impact on which report data from the Department of for Wagyu sirloin from all regions in Japan, Commerce, U.S. Bureau of the Census. The including Kobe. 19 Foreign Agricultural Service, USDA. Harmonized Tariff Schedule (HTS) 6-digit code for 18 Harmonized Tariff Schedule of the United 20 Consumer surplus is the difference between the fresh/chilled boneless beef cuts is 020130; the HTS States (2005), Chapter 2, Meat and Edible Meat amount a consumer is willing to pay for a good and code for frozen boneless beef is 020230. Offal. Continued

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the relatively small number of U.S. significant impact on the quality of the PART 94—RINDERPEST, FOOT-AND- producers of Kobe-style beef is human environment. Based on the MOUTH DISEASE, FOWL PEST (FOWL uncertain, it is expected to provide finding of no significant impact, the PLAGUE), EXOTIC NEWCASTLE benefits to consumers (domestic Administrator of the Animal and Plant DISEASE, AFRICAN SWINE FEVER, importers, wholesalers, retailers, as well Health Inspection Service has CLASSICAL SWINE FEVER, AND as final consumers) that will exceed any determined that an environmental BOVINE SPONGIFORM potential losses to domestic producers. impact statement need not be prepared. ENCEPHALOPATHY: PROHIBITED The net welfare effect for the United AND RESTRICTED IMPORTATIONS States of reestablished Wagyu beef The environmental assessment and imports from Japan will be positive. finding of no significant impact were I 1. The authority citation for part 94 prepared in accordance with: (1) The continues to read as follows: Effects on Small Entities National Environmental Policy Act of We do not expect that this final rule 1969 (NEPA), as amended (42 U.S.C. Authority: 7 U.S.C. 450, 7701–7772, 7781– will have significant economic impact 7786, and 8301–8317; 21 U.S.C. 136 and 4321 et seq.), (2) regulations of the 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and on a substantial number of small Council on Environmental Quality for 371.4. entities. As discussed above, this rule implementing the procedural provisions has the potential to primarily affect of NEPA (40 CFR parts 1500–1508), (3) I 2. In § 94.18, paragraph (b) is revised farmers and ranchers in the United USDA regulations implementing NEPA to read as follows: States who produce Kobe-style beef. The (7 CFR part 1b), and (4) APHIS’ NEPA § 94.18 Restrictions on importation of number of these producers is unknown, Implementing Procedures (7 CFR part meat and edible products from ruminants but it is believed to be very small. The 372). due to bovine spongiform encephalopathy. American Wagyu Association, a Wagyu breeder group, lists approximately 75 The environmental assessment and * * * * * members in the United States.21 finding of no significant impact may be (b) Except as provided in paragraph The size distribution of Kobe-style viewed on the Internet at http:// (d) of this section or in §§ 94.19 or beef producers in the United States is www.regulations.gov. Go to http:// 94.27, the importation of meat, meat also unknown, but it is reasonable to www.regulations.gov, click on the products, and edible products other assume that most are small, under the ‘‘Advanced Search’’ tab and select than meat (except for gelatin as U.S. Small Business Administration’s ‘‘Docket Search.’’ In the Docket ID field, provided in paragraph (c) of this (SBA) standards. This assumption is enter APHIS–2005–0073 then click on section, milk, and milk products) from based on composite data for all beef ‘‘Submit.’’ The environmental ruminants that have been in any of the producers in the United States. In 2002, assessment and finding of no significant regions listed in paragraph (a) of this there were 664,431 U.S. farms in North impact will appear near the end of the section is prohibited. American Industry Classification resulting list of documents. Copies of * * * * * System (NAICS) 112111, a classification the environmental assessment and I 3. A new § 94.27 is added to read as comprised of establishments primarily finding of no significant impact are also engaged in raising cattle. Of the 664,431 follows: available for public inspection at USDA, farms, 659,009 (or 99 percent) had room 1141, South Building, 14th Street § 94.27 Importation of whole cuts of annual receipts that year of less than boneless beef from Japan. $500,000.22 The SBA’s small entity and Independence Avenue SW., threshold for farms in NAICS 112111 is Washington, DC, between 8 a.m. and Notwithstanding any other provisions annual receipts of $750,000. 4:30 p.m., Monday through Friday, of this part, whole cuts of boneless beef except holidays. Persons wishing to derived from cattle that were born, Executive Order 12988 inspect copies are requested to call raised, and slaughtered in Japan may be This final rule has been reviewed ahead on (202) 690–2817 to facilitate imported into the United States under under Executive Order 12988, Civil entry into the reading room. In addition, the following conditions: Justice Reform. This rule: (1) Preempts copies may be obtained by writing to the (a) The beef is prepared in an all State and local laws and regulations individual listed under FOR FURTHER establishment that is eligible to have its that are inconsistent with this rule; (2) INFORMATION CONTACT. products imported into the United has no retroactive effect; and (3) does Paperwork Reduction Act States under the Federal Meat not require administrative proceedings Inspection Act (21 U.S.C. 601 et seq.) before parties may file suit in court This final rule contains no new and the regulations in 9 CFR 327.2 and challenging this rule. information collection or recordkeeping the beef meets all other applicable National Environmental Policy Act requirements under the Paperwork requirements of the Federal Meat Inspection Act and regulations An environmental assessment and Reduction Act of 1995 (44 U.S.C. 3501 thereunder (9 CFR chapter III), finding of no significant impact have et seq.). including the requirements for removal been prepared for this final rule. The List of Subjects in 9 CFR Part 94 of SRMs and the prohibition on the use environmental assessment provides a of air-injection stunning devices prior to basis for the conclusion that the Animal diseases, Imports, Livestock, slaughter on cattle from which the beef importation of whole cuts of boneless Meat and meat products, Milk, Poultry is derived. beef from Japan under the conditions and poultry products, Reporting and specified in this rule will not have a recordkeeping requirements. (b) The beef is derived from cattle that were not subjected to a pithing process the amount actually paid. Producer surplus is the I Accordingly, we are amending 9 CFR at slaughter. amount a seller is paid for the good minus the part 94 as follows: seller’s cost. (c) An authorized veterinary official of 21 Source: American Wagyu Association Web site. the Government of Japan certifies on an 22 2002 Census of Agriculture, National original certificate that the above Agricultural Statistics Service. conditions have been met.

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Done in Washington, DC, this 12th day of and follow the instructions for sending The service bulletin refers to Rolls- December 2005. your comments electronically. Royce Service Bulletin RB.211–78– Charles D. Lambert, • Mail: Docket Management Facility; C899, Revision 3, dated May 7, 2004, as Acting Under Secretary for Marketing and U.S. Department of Transportation, 400 an additional source of service Regulatory Programs. Seventh Street, SW., Nassif Building, information for modifying the cowl [FR Doc. 05–24057 Filed 12–12–05; 11:30 room PL–401, Washington, DC 20590. assemblies of the left- and right-hand am] • Fax: (202) 493–2251. • thrust reversers. The modification BILLING CODE 3410–34–P Hand Delivery: Room PL–401 on includes related investigative actions, the plaza level of the Nassif Building, and repair if necessary. The related 400 Seventh Street, SW., Washington, investigative actions include certain DEPARTMENT OF TRANSPORTATION DC, between 9 a.m. and 5 p.m., Monday inspections for discrepancies of the through Friday, except Federal holidays. bores, bushings, plug holes, and cavity Contact Airbus, 1 Rond Point Maurice Federal Aviation Administration webs of the thrust reversers. Bellonte, 31707 Blagnac Cedex, France, 14 CFR Part 39 for the service information identified in FAA’s Determination and Requirements this AD. of This AD [Docket No. FAA–2005–23252; Directorate FOR FURTHER INFORMATION CONTACT: Tim Identifier 2004–NM–146–AD; Amendment These airplane models are 39–14414; AD 2005–25–21] Backman, Aerospace Engineer, International Branch, ANM–116, FAA, manufactured in France and are type RIN 2120–AA64 Transport Airplane Directorate, 1601 certificated for operation in the United Lind Avenue, SW., Renton, Washington States under the provisions of section Airworthiness Directives; Airbus Model 98055–4056; telephone (425) 227–2797; 21.29 of the Federal Aviation A330–243, –341, –342, and –343 fax (425) 227–1149. Regulations (14 CFR 21.29) and the Airplanes Equipped with Rolls-Royce SUPPLEMENTARY INFORMATION: applicable bilateral airworthiness RB211 TRENT 700 Engines agreement. Pursuant to this bilateral Discussion airworthiness agreement, the DGAC has AGENCY: Federal Aviation ´ ´ Administration (FAA), Department of The Direction Generale de l’Aviation kept the FAA informed of the situation Transportation (DOT). Civile (DGAC), which is the described above. We have examined the airworthiness authority for France, DGAC’s findings, evaluated all pertinent ACTION: Final rule; request for notified us that an unsafe condition may information, and determined that we comments. exist on certain Airbus Model A330– need to issue an AD for products of this SUMMARY: The FAA is adopting a new 243, –341, –342, and –343 airplanes type design that are certificated for airworthiness directive (AD) for certain equipped with Rolls-Royce RB211 operation in the United States. Airbus Model A330–243, –341, –342, TRENT 700 engines. The DGAC advises Therefore, we are issuing this AD to and –343 airplanes equipped with Rolls- that a review of certification tests of the prevent fatigue cracking of the hinges Royce RB211 TRENT 700 engines. This thrust reverser revealed that certain integrated into the 12 o’clock beam of AD requires modifying the cowl structural components within the C- the thrust reversers, which could result duct need strengthening to meet high assemblies of the left- and right-hand in separation of a thrust reverser from fatigue loads and maintain structural thrust reversers. This AD results from a the airplane, and consequent reduced integrity. Unexpected high loads were review of certification tests of the thrust controllability of the airplane. This AD measured on the hinges integrated into reverser, which revealed that certain requires accomplishing the actions the 12 o’clock beam of the thrust structural components within the C- specified in the Airbus service reverser; the 12 o’clock beam forms the duct need strengthening to meet high information described previously except upper edge of the C-duct of the thrust fatigue loads and maintain structural as discussed under ‘‘Difference Among reverser on Rolls-Royce engines. This integrity. We are issuing this AD to the AD, French Airworthiness Directive, condition, if not corrected, could result prevent fatigue cracking of the hinges and Airbus Service Information.’’ in fatigue cracking of the hinges integrated into the 12 o’clock beam of integrated into the 12 o’clock beam of the thrust reversers, which could result Difference Among the AD, French the thrust reversers, separation of a in separation of a thrust reverser from Airworthiness Directive, and Airbus thrust reverser from the airplane, and the airplane, and consequent reduced Service Information consequent reduced controllability of controllability of the airplane. the airplane. The French airworthiness directive DATES: This AD becomes effective and the service information specify a December 29, 2005. Relevant Service Information modification that involves replacement The Director of the Federal Register Airbus has issued Service Bulletin of certain thrust reverser C-ducts with approved the incorporation by reference A330–78–3010, Revision 03, dated April new ducts at or before specific total of a certain publication listed in the AD 28, 2004. The service bulletin describes flight cycle thresholds. This AD requires as of December 29, 2005. procedures for modifying the cowl you to replace the affected parts before We must receive comments on this assemblies of the left- and right-hand the accumulation of those thresholds or AD by February 13, 2006. thrust reversers. Accomplishing the within 6 months after the effective date ADDRESSES: Use one of the following actions specified in the service of the AD, whichever is later. A table addresses to submit comments on this information is intended to adequately containing those flight cycle thresholds AD. address the unsafe condition. The is specified in paragraph (f) of this AD. • DOT Docket Web site: Go to DGAC mandated the service information We have included a 6-month grace http://dms.dot.gov and follow the and issued French airworthiness period to ensure that any airplane that instructions for sending your comments directive F–2001–528 R2, dated June 23, is close to or has passed its applicable electronically. 2004, to ensure the continued threshold (if imported and placed on the • Government-wide rulemaking Web airworthiness of these airplanes in U.S. Register) is not grounded as of the site: Go to http://www.regulations.gov France. effective date of the AD.

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