Vol. 78 Wednesday, No. 233 December 4, 2013

Part II

Department of Agriculture

Animal and Plant Health Inspection Service 9 CFR Parts 92, 93, 94, et al. Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Products; Final Rule

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DEPARTMENT OF AGRICULTURE Center for Import and Export, VS, Summary of the Major Provisions of the APHIS, 4700 River Road, Unit 39, Regulatory Action Animal and Plant Health Inspection Riverdale, MD 20737–1231; 301–851– The current regulations prohibit the Service 3300. importation of live ruminants and most For information regarding ruminant ruminant products from regions that 9 CFR Parts 92, 93, 94, 95, 96, and 98 products and for other information have BSE or that present an undue risk regarding this rule, contact Dr. [Docket No. APHIS–2008–0010] for BSE. The regulations are less Christopher Robinson, Assistant restrictive for ruminants and ruminant RIN 0579–AC68 Director, Technical Trade Services, products from BSE minimal-risk regions Animal Products, National Center for (currently only Canada). Additionally, Bovine Spongiform Encephalopathy; Import and Export, VS, APHIS, 4700 the regulations allow the importation of Importation of Bovines and Bovine River Road, Unit 38, Riverdale, MD boneless beef from Japan even though Products 20737–1231; 301–851–3300. Japan is listed as a region that has BSE. AGENCY: Animal and Plant Health SUPPLEMENTARY INFORMATION: We are replacing the current BSE Inspection Service, USDA. I. Executive Summary regulations that apply to bovines (cattle ACTION: Final rule. and bison) with import conditions based Need for the Regulatory Action on the inherent risk of BSE infectivity SUMMARY: We are amending the The conditions we are adopting for regulations that govern the importation in specified commodities, as well as on the importation of specified bovine of animals and animal products to the BSE risk status of the region in commodities are based on revise the conditions for the importation which the commodities originate. We internationally accepted scientific of live bovines and products derived are establishing a system for classifying literature and are, in general, consistent from bovines with regard to bovine regions as to BSE risk that is consistent with World Organization for Animal spongiform encephalopathy (BSE). We with the system employed by the OIE, Health (OIE) guidelines. We are making are basing importation conditions on the the international standard-setting these amendments after conducting a inherent risk of BSE infectivity in organization for guidelines related to thorough review of relevant scientific specified commodities, as well as on the animal health. We are also classifying literature and a comprehensive BSE risk status of the region in which certain specified countries as to BSE evaluation of the issues and concluding the commodities originate. We are risk. We are also removing BSE that the changes we are making to the establishing a system for classifying restrictions on the importation of regulations will continue to guard regions as to BSE risk that is consistent cervids and camelids and products against the introduction of bovine with the system employed by the World derived from such animals. spongiform encephalopathy (BSE) into Organization for Animal Health (OIE), the United States, while allowing the Costs and Benefits the international standard-setting importation of additional animals and Consumers benefit from imports to organization for guidelines related to animal products into this country. the extent that consumer choice is animal health. The conditions we are The OIE recognizes three broadened and the increased supply of adopting for the importation of specified classifications of countries for BSE: the imported commodity leads to a price commodities are based on Negligible risk, controlled risk, and decline. We anticipate that the rule will internationally accepted scientific undetermined risk. The OIE guidelines have little impact on consumer choice literature, and are, in general, consistent recommend that countries allow trade or import volumes, and therefore little with guidelines set out in the OIE’s in certain bovine commodities from all or no impact on U.S. businesses as well. Terrestrial Animal Health Code. We are three classifications under conditions Although the impact of this rule on U.S. also classifying certain specified commensurate with their BSE risk. This consumers and producers is expected to countries as to BSE risk and are final rule generally aligns U.S. be minimal, the benefits of the rule are removing BSE restrictions on the regulations with the OIE guidelines and expected to justify its costs. importation of cervids and camelids and demonstrates to the international products derived from such animals. We community the commitment of the II. Background are making these amendments after United States to base its BSE regulations In order to guard against the conducting a thorough review of on internationally accepted scientific introduction and spread of animal relevant scientific literature and a literature. diseases, APHIS, an agency of the U.S. comprehensive evaluation of the issues Department of Agriculture (USDA or and concluding that the changes to the Legal Authority for the Regulatory Department), regulates the importation regulations will continue to guard Action of animals and animal products into the against the introduction of BSE into the Under the Animal Health Protection United States. The regulations in 9 CFR United States, while allowing the Act (AHPA, 7 U.S.C. 8301 et seq.), the parts 92, 93, 94, 95, 96, and 98 (referred importation of additional animals and Secretary of Agriculture has the to below as the regulations) govern the animal products into this country. authority to issue orders and promulgate importation of certain animals, meat, DATES: This rule is effective March 4, regulations to prevent the introduction other animal products and byproducts, 2014. The incorporation by reference of into the United States and the hay, and straw into the United States in the material described in the rule is dissemination within the United States order to prevent the introduction of approved by the Director of the Federal of any pest or disease of livestock. The various animal diseases. Register as of March 4, 2014. Animal and Plant Health Inspection On March 16, 2012, we published in FOR FURTHER INFORMATION CONTACT: For Service’s (APHIS’) regulations in title 9 the Federal Register (77 FR 15848– information concerning live ruminants, of the Code of Federal Regulations, 15913, Docket No. APHIS–2008–0010) a contact Dr. Betzaida Lopez, Import subchapter D, govern the exportation proposal 1 to amend the regulations that Animal Staff Veterinarian, Technical and importation of animals (including Trade Services, Animals, Organisms and poultry) and animal products from and 1 To view the proposed rule, supporting Vectors, and Select Agents, National into the United States. documents, and the comments we received, go to

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govern the importation of animals and number of questions and concerns about The terminology regarding ‘‘cattle of animal products to revise the conditions the proposed rule. These comments and any age’’ that we used in our September for the importation of live bovines and concerns are discussed below by topic. 2008 request for comments was products derived from bovines with consistent with that which we used in General Concerns regard to BSE. Specifically, we proposed the risk analysis for our January 2005 to base our importation conditions on One commenter stated that APHIS did final rule. The commenter stated that the inherent risk of BSE infectivity in not give appropriate consideration to, this terminology was not consistent specified commodities, as well as the and in some cases did not address at all, with the risk assessment which BSE risk status of the region in which some of the concerns raised by the supported the January 2005 final rule. the commodities originate, consistent public on the notice requesting We note that the risk analysis that with the OIE’s Terrestrial Animal Health comment on the delay of applicability of accompanied the January 2005 final rule Code. We proposed to establish a system certain provisions of the rule titled stated: ‘‘It is important to note the for classifying regions as to BSE risk that ‘‘BSE; Minimal-Risk Regions and following change in the final rule. In its is consistent with the system employed Importation of Meat, Meat Byproducts, proposed rule, APHIS restricted beef by the OIE. The conditions we proposed and Meat Food Products Derived from imported from Canada to meat derived for the importation of specified Bovines 30 Months of Age or Older’’ from cattle under 30 months of age. This commodities are based on (the OTM [i.e., over 30 months] rule) (73 requirement has been removed in the internationally accepted scientific FR 54083–54089, Docket No. APHIS– final rule, and beef from animals of any literature and, are, in general, consistent 2008–0093). age will be allowed to be imported from with the guidelines set out in the OIE’s APHIS disagrees. In the proposed a Minimal Risk region.’’ In the January Terrestrial Animal Health Code. We also rule, we responded to comments on our 2005 final rule, we explained that we proposed to classify certain specified removal of the delay of applicability of did not believe this requirement was countries as to BSE risk and proposed provisions of our January 2005 final necessary, provided that measures to remove BSE restrictions on the rule. We are confident that we equivalent to those of FSIS regarding importation of cervids and camelids and responded to all the comments. specified risk material (SRM) removal are in place in the exporting region and products derived from such animals. The commenter stated that in the In the same document we also other such measures as are necessary September 2008 request for comments, affirmed the position we took in (e.g., a prohibition on the use of air APHIS mischaracterized its document removing the delay of applicability of injection stunning devices and controls published in the Federal Register on certain provisions of the rule titled to prevent cross-contamination) are in March 8, 2004 (69 FR 10633–10636, ‘‘Bovine Spongiform Encephalopathy; place. We believe that this clearly lays Docket No. 03–080–2), as proposing to Minimal-Risk Regions and Importation out the intent that APHIS did not apply allow the importation from BSE of Commodities,’’ published in the any specific age limitation to the import minimal-risk regions of beef derived Federal Register on January 4, 2005 (70 of beef. from cattle of any age. The March 2004 FR 460–553, Docket No. 03–080–3). The One commenter stated that, despite document reopened a comment period delay of applicability was removed in a the fact that APHIS stated in the final rule titled ‘‘Bovine Spongiform for a proposed rule published on proposed rule that it is not necessary to Encephalopathy; Minimal Risk Regions; November 4, 2003 (68 FR 62386–62405, revise any provisions in the OTM rule, Importation of Live Bovines and Docket No. 03–080–1) and invited the proposed rule makes substantive Products Derived from Bovines,’’ public comment on changing that revisions to the OTM rule, including published in the Federal Register on proposed rule to allow the importation revisions to the provisions that APHIS September 18, 2007 (72 FR 53314– of beef from bovines 30 months of age stated were essential to its affirmation of 53379, Docket No. APHIS–2006–0041). and older based on new requirements the OTM rule. However, as ordered by the U.S. District issued by USDA’s Food Safety and The commenter is correct in noting Court on July 3, 2008, APHIS provided Inspection Service (FSIS). The that this rule revises the existing additional opportunity for public commenter stated that the March 2004 regulations, including the existing comment on this action in a notice document contained no reference to the regulations that addressed the published in the Federal Register on importation of beef from cattle of any importation of animals and products September 18, 2008 (73 FR 54083– age and instead continued to propose a from BSE minimal risk regions. As 54089, Docket No. APHIS–2008–0093). restriction on the age of cattle by described in the proposed rule, APHIS We responded to comments received on retaining the requirement contained in noted that the existing regulations that notice in our March 2012 proposed the November 2003 proposed rule that contain provisions that are not yet fully rule. the beef be derived from animals that consistent with the latest scientific We solicited comments concerning are not known to have been fed literature. APHIS regulations have our proposal for 60 days ending May 15, ruminant protein, other than milk changed over time, as we gain increased 2012. We reopened and extended the protein, during their lifetime. understanding of the science of BSE and deadline for comments until June 14, When we stated in our September conduct further risk assessments. The 2012, in a document published in the 2008 request for comments that our changes we proposed reflected Federal Register on May 21, 2012 (77 March 2004 document proposed to internationally accepted scientific FR 29914, Docket No. APHIS–2008– allow the importation of beef derived literature and, in general, are consistent 0010). We received 60 comments by that from cattle of any age, we meant that the with the OIE Code. date. They were from private citizens, derivation of beef from bovines 30 We assume that the commenter is domestic and foreign industry months of age or older when referring to the specific issue of whether associations, importers, exporters, and slaughtered would not in itself preclude or not certification about a feed ban is representatives of State and foreign the commodities from being imported. necessary in the conditions for beef governments. The commenters raised a We stated further that we were not imports. APHIS initially imposed such referring to any effect the feed ban a certification requirement, noted in http://www.regulations.gov/ requirement might have on the import both the 2003 proposed rule and the #!docketDetail;D=APHIS-2008-0010. eligibility of the commodities. January 2005 final rule. This

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requirement was not amended in our disease events, and presenting mitigations for a period of at least 7 or 2007 final rule when we lifted the delay guidelines and recommendations on 8 years. In addition, the region must of applicability on certain imports from sanitary measures relating to animal show that the likelihood of release and Canada. In contrast, our regulations for health. As an OIE Member country, the exposure to the BSE agent is negligible. the importation of boneless beef from United States reviews and, where As we explained above, BSE Japan do not include any certification appropriate, comments on all draft OIE surveillance provides information about the feeding practices for the chapters and revisions. As part of the regarding prevalence, changes in the animals from which the beef was United States’ consideration of OIE epidemiology of the disease, and derived. In both instances, however, we drafts, APHIS distributes these drafts to effectiveness of the BSE risk mitigation considered the significant overall risk the U.S. livestock and aquaculture measures. reduction achieved in each country by industries, veterinary experts in various One commenter stated that the United their respective feed bans. Such feed U.S. academic institutions, and other States typically imports more than 2 bans decrease the overall prevalence of interested persons for review and million head of cattle each year. The BSE and therefore reduce the risk that comment. Furthermore, the United commenter asked how APHIS supported any individual animal may be exposed States, represented by APHIS, has been the statement that imported cattle to potentially infected feed. They actively involved in the development of represent only a small portion of cattle continue to be a crucial risk mitigation the OIE Code and fully supports the OIE in U.S. feedlots. measure that is considered in any position that gradations in BSE risk According to data from the National overall risk assessment for BSE. among regions should be recognized Agricultural Statistics Service (NASS), However, since they are crucial to the and that trade should be commensurate of the approximately 2.2 million bovine consideration of the overall status of the with risk. animals imported annually for the years country, requiring specific certification One commenter stated that 2009–2011, about 1.3 million were to that effect for individual animals surveillance for BSE in the United feeder cattle. NASS data also show that from which meat for export is derived States is inadequate. The commenter an average of 25.8 million cattle was is redundant. The feed ban requirement stated that U.S. surveillance has marketed annually by feedlots in the is covered in that consideration of the decreased 90 percent since 2005, and years 2009–2011. Based on this country’s BSE risk. Therefore, in line that the United States only tests cattle information, APHIS estimates that with OIE recommendations, we did not showing symptoms of BSE. The approximately 5 percent of cattle in U.S. include that specific certification commenter stated that all cattle should feedlots were imported. statement in the proposed requirements be tested for BSE at slaughter and that One commenter stated that APHIS did for beef imports from controlled risk such testing would not be prohibitively not address the lack of reported BSE regions. Such certification is, however, expensive. cases in regions where cattle are required for beef imports from APHIS disagrees with the commenter. primarily grass-fed, nor did APHIS undetermined risk regions. For these BSE surveillance programs in the evaluate the import and export regions, either no information is United States focus on obtaining quality standards of these countries. available about any feed ban samples from targeted subpopulations Under Chapter 11.5.2 of the OIE Code, requirements or other risk mitigation rather than looking at the entire adult a release assessment must be conducted measures, or they have not maintained cattle population. Targeted animals are as the first step in determining the BSE the relevant risk mitigation measures cattle older than 30 months of age that risk status of a region. The release sufficient to meet the standards for exhibit signs of central nervous assessment considers the likelihood that controlled or negligible risk. Therefore, disorders or any other signs associated the BSE agent has either been we cannot rely on the overall country with BSE, such as emaciation or injury. introduced into the region via evaluation to ensure that a feed ban is Dead cattle and non-ambulatory cattle commodities potentially contaminated in place and will require certification are also targeted. The experience in the with it, or is already present in the that the animals from which the meat United Kingdom (UK) has shown that region. The elements considered was derived were never fed meat-and- those populations are most likely to test include production of meat-and-bone bone meal or greaves derived from positive for BSE in the event that the meal or greaves from the indigenous ruminants. These requirements are animals were exposed to the agent and ruminant population, imported meat- consistent with our risk assessments lived long enough to develop the and-bone meal or greaves, and imported that demonstrate that an effective feed disease. We note that surveillance is not animal feed and feed ingredients in a ban is a critical risk mitigation measure a BSE mitigation; that is, it does not region. Furthermore, if the release that must be in place in regions that provide a level of protection against the assessment identifies a risk factor, an have a potential risk of BSE. disease. It only allows us to understand exposure assessment is conducted, One commenter stated that the OIE disease trends such as prevalence and which considers the likelihood of cattle Code is not universally recognized as evolution of the disease, and to evaluate being exposed to the BSE agent by the international standard for BSE the effectiveness of risk mitigation reviewing such elements as recycling prevention, mitigation, and measures. The removal of SRMs and the and amplification of the BSE agent surveillance. The commenter noted that ruminant-to-ruminant feed ban are the through consumption by cattle of meat- some countries, such as Japan and primary safeguards to human and and-bone meal or greaves of ruminant Australia, have established their own animal health. origin, or other feed or feed ingredients standards, which are stricter than those One commenter stated that the contaminated with these; the use of of the OIE. The commenter stated that proposed testing rates are too low. The ruminant carcasses (including from APHIS should provide better commenter asked how a region can be fallen stock), by-products, and justification for adopting OIE standards. considered negligible risk if only a small slaughterhouse waste; the parameters of As we explained in the proposed rule, percentage of cattle are tested for BSE. the rendering processes and the the World Trade Organization Surveillance is only one part of the methods of animal feed manufacture; recognizes the OIE as the international evaluation. A region applying for and the feeding or not of ruminants with forum for setting animal health negligible risk status must show meat-and-bone meal and greaves standards, reporting global animal compliance with BSE-related derived from ruminants, including

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measures to prevent cross- forms of certification, such as paper and least one indigenous case of BSE, but contamination of animal feed. APHIS electronic certification. the BSE-positive animal was born more notes that those countries where cattle In the proposed rule, we provided for than 11 years ago, is officially are primarily raised on grass, such as certificates to be signed either by a full- identified, is controlled in its Argentina and Brazil, are considered time salaried veterinary officer of the movements, and completely destroyed negligible risk in part because livestock national government of the exporting at slaughter or death. The commenter practices in those regions contribute a region or issued by a veterinarian also asked for an explanation of the 11- very low likelihood of exposure to designated or accredited by the national year limitation. ruminant materials through bovine feed. government of the exporting region and To achieve negligible risk status, the One commenter stated that the endorsed by a full-time salaried country must comply with stringent proposed rule is full of exceptions that veterinary officer. When evaluating a criteria, including the requirement that would allow importation of live cattle country we consider whether or not it the youngest case reported by the and bovine products from all three risk has the infrastructure and veterinary country has to be older than 11 years. categories, which presents an authority to comply with the APHIS This requirement relates to the unacceptable amount of risk to certification requirements. If, as a result likelihood that contaminated feed that consumers. of our evaluation, we conclude that the the BSE case was potentially exposed to The commenter is incorrect that country has the necessary infrastructure, 11 years ago (during its first year of life) under the provisions of the proposed and if the competent veterinary will no longer be circulating. This is in rule, live cattle could be imported from authority can attest to APHIS that the line with classical BSE data showing regions of all three risk categories. Only competent official has oversight over that cattle developed disease between cattle born after the date of effective certifying a process or product, then 4.5 and 6 years of age following the enforcement of a ruminant-to-ruminant APHIS can accept that signature. We 1990–early 2000 European BSE feed ban would be allowed entry from have amended the requirements in experience. By year 11 after exposure, controlled risk regions, and live cattle §§ 94.18, 94.19, 94.20, and 94.21 to over 95 percent of the BSE cases in from regions of undetermined risk require that certificates must be issued Europe experienced disease. Therefore would be allowed only on a case-by- and signed by a full-time salaried we expect most cases would be detected case basis when the Administrator veterinary officer of the national within 11 years. determines that they do not present a government of the exporting region or One commenter stated that the risk of introducing BSE into the United signed by a person authorized to issue definitions of ‘‘negligible risk’’ and States. While the rule provides for the such certificates by the veterinary ‘‘controlled risk’’ status in the proposed importation of deboned skeletal meat services of the national government of rule are substantively the same as those from all regions, that provision, as well the exporting region. APHIS recognizes of the OIE, and are therefore superfluous as the provisions for the importation of the need to move to electronic in the proposed rule. The commenter other products, is closely aligned with certification in the trade environment, stated that OIE classification and international standards, particularly as and is working to find ways to interpretation should be sufficient. they require SRM removal and steps to implement it in the future. The OIE Code consists of guidelines prevent the contamination of the for international trade in live animals products with SRMs. Regions of Negligible Risk, Controlled and their parts and products. While Four commenters noted that the Risk, and Undetermined Risk for BSE these guidelines are recognized as phrase ‘‘full-time salaried veterinary One commenter stated that OIE’s risk international standards, they do not officer of the national government of the categorizations of regions are based on have the force or effect of law within the exporting region’’ is used throughout self-reported data, and that a scientific United States. For this reason we need the rule. One commenter stated that the committee assesses applications for to establish these definitions in our phrase was not in alignment with the compliance with OIE standards only regulations. provisions in Chapter 5.2.2 of the OIE after a recommendation for a risk One commenter stated that in the Code. The commenter asked if a designation is made. The commenter proposed rule, we proposed to establish veterinarian employed part-time as a stated that this process is inherently a notice-based approach for recognizing government veterinary officer would be unreliable and not subject to rigorous OIE risk categorization for countries, but excluded from signing the required verification. then we also solicited comment on certificates. Another commenter asked The OIE recommendation for a certain countries before the process was that we consider eliminating the region’s BSE risk categorization is based established. The commenter opposed requirement, noting that in the joint on the decision reached by the recognizing the OIE risk categorization initial action plan for the Regulatory Scientific Commission after receiving a for the countries listed before the notice- Cooperation Council announced by recommendation from the OIE BSE ad based approach was established in the Canadian Prime Minister Harper and hoc group. The members of both groups regulations. President Obama on December 7, 2011, are aware of BSE trends and geographic In the proposed rule, we announced the current requirement for a veterinary impacts related to trade among regions. that we were giving preliminary signature for meat export certificates Consequently, the scientific concurrence to the OIE risk was cited as an example of a commission’s decision is based not only classifications of several countries and requirement which creates a burden for on the country’s self-reported data, but gave the public opportunity to regulators as well as for industry. A also on the potential impact on the comment, just as we would have done third commenter stated that APHIS country’s BSE status of its trading in a rulemaking. We received no should build in suitable flexibility to partners’ BSE status, the country’s comments that opposed this allow certificates to be signed by historical trade in specific commodities, concurrence for any of the countries we inspectors who are under the and the impact of BSE-related risk discussed in the proposed rule. supervision of the official veterinarian. mitigation in the region. Several commenters noted that the This commenter also suggested that One commenter asked what the OIE recognizes Singapore and India as APHIS ensure there is sufficient justification was for considering a countries of negligible risk for BSE, and flexibility to allow for the use of various region to be ‘‘negligible risk’’ if it has at Taiwan as a region of controlled risk,

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but that those countries were not outcomes of the evaluations and will designation will be required to submit included on the list of regions for which have the necessary documentation to any particular information to APHIS in APHIS concurred with the OIE support or defend recognition decisions. order to receive concurrence. classification. The process we will use is described in In order to determine whether we Singapore was omitted from the list the regulatory text in this document for concur with OIE’s classification, APHIS by mistake. In the cases of India and § 92.5. Taiwan, we were not able to complete One commenter asked if APHIS will review publicly available our review of information in support of would proactively update its lists of information. If sufficient information is concurrence with the OIE designation regions of negligible and controlled risk not publicly available, we will ask before the publication of the proposed according to future changes in the OIE countries to provide us with the rule. We have since concluded our lists, or if APHIS would act only after documentation submitted to the OIE review of information for Taiwan and receiving an official request from the when that country requested official are announcing preliminary country. recognition of its BSE risk status. We concurrence with the OIE designations APHIS will automatically look to will then review the documentation for Singapore and Taiwan in a notice concur with future OIE recognitions of provided and make our evaluation published today in the Federal Register a region’s BSE status. available to the public for comment. in accordance with the process we are One commenter asked if APHIS Four commenters noted that we adopting in this final rule. The OIE intends to actually reassess each dossier would require regions evaluated by recommendations regarding Singapore before proposing to concur with OIE APHIS for BSE risk to submit updated and Taiwan can be viewed at http:// classification. information every year. Some of these It is not APHIS’ intention to do a www.oie.int/en/animal-health-in-the- commenters asked whether APHIS will separate evaluation apart from the OIE’s world/official-disease-status/bse/list-of- rely on OIE’s annual review for bse-risk-status/. This notice will also evaluation. Rather, APHIS will confirm countries originally classified by OIE, or announce preliminary concurrence with that there is information available to whether we would expect these the most recent OIE designations for support our concurrence with the OIE Austria, Belgium, Bulgaria, Brazil, classification. countries to provide updated Colombia, Costa Rica, Croatia, Israel, One commenter asked if APHIS will information to APHIS on a yearly basis. Italy, Japan, the Netherlands, Nicaragua, accept dossiers written in languages One commenter expressed concern that and Slovenia. other than English. if APHIS requires this information from Our review of information in support No, APHIS will not accept dossiers in trading partners classified by OIE, it of concurrence with the OIE designation languages other than English. may set a precedent for other trading for India is ongoing. When our review Two commenters expressed concern partners to ask for the same information, is complete, if the findings support that APHIS plans to determine the BSE which would undermine OIE’s concurrence with the OIE designation, risk designation of any country or region categorization process. via a rulemaking process. One we will publish a notice in the Federal We proposed to allow for APHIS commenter stated that the length of the Register announcing our preliminary recognition of a region as a region of rulemaking process is unpredictable and concurrence with the OIE’s designation negligible risk or controlled risk in one that use of a rulemaking process would for India and provide the public with an of two ways. The first way would be for introduce uncertainty. The other opportunity to comment. APHIS to concur with the OIE One commenter asked if we intended commenter suggested that APHIS classification of the region of either to announce in the final rule the maintain a list on a Web site and negligible or controlled risk. The second concurrence decision for countries that harmonize notification with that of the have already received OIE classification. OIE. way would be for a region that has not Yes. Those regions for which we Since this final rule establishes our been classified by the OIE as either announced preliminary concurrence system for classifying regions as to BSE negligible or controlled risk for BSE to will be recognized accordingly. risk be consistent with the OIE’s BSE submit a request to the Administrator Two commenters stated that the risk categorization of regions, APHIS for either classification, along with United States should accept OIE risk does not plan to use a rulemaking documentation sufficient to allow the classification without conducting process to announce concurrence with USDA to evaluate whether the region duplicative reviews. One of these stated OIE recognition of BSE status. Instead, meets the criteria for either that the United States, as a member of when we concur with the OIE decision classification. The requirement that the OIE, should give automatic on the BSE status of a region, we will updated information be submitted every recognition to the OIE risk publish a notice in the Federal Register year would apply only to countries that classification. announcing our intention to concur and APHIS has evaluated for BSE risk upon APHIS will not be conducting to solicit public comment. If we do not the request of those countries and not to duplicative reviews, but will verify that receive comments that require us to countries that have already been the information is provided or is reconsider our decision to concur, we classified as negligible or controlled risk publicly available to support our will publish a subsequent notice to by the OIE. concurrence with the OIE classification. announce our concurrence with the OIE One commenter noted that in APHIS’ intention is to follow the OIE’s classification and we will update our proposed § 93.436(b)(2)(iii), the BSE guidelines while ensuring that OIE- Web site. Announcing our concurrence proposed regulatory text mentions ‘‘BSE recognized countries apply adequate through this notice process, which minimal risk regions.’’ The commenter BSE risk mitigation measures assuring includes obtaining and evaluating suggested correcting this to ‘‘region of that bovines and bovine commodities public comments, among other negligible risk for BSE in which there destined for export pose a negligible risk information, before making a final has been an indigenous case of BSE/ for BSE, and that the country complies decision on our concurrence, is an with OIE requirements for the specific appropriate process to use. region of controlled risk for BSE.’’ BSE country recognition. APHIS will One commenter asked if countries The commenter is correct. We have thus have greater confidence in the that have received an OIE risk corrected this error in the final rule.

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Conditions for Importation of following the discovery.3 It appears proposal, we will publish it in the Commodities unlikely that much of this year-on-year Federal Register for public comment. quantity decline can be attributed to the One commenter asked that APHIS Live Animals BSE discovery when one compares reconsider its policy on importation of One commenter stated that adopting average monthly U.S. beef export levels zoo ruminants from Canada. The the changes in the proposed rule could during the 2 months before and 2 commenter stated that, since zoo result in BSE-infected cattle entering the months after the BSE discovery. The ruminants cannot be imported from United States and cause the loss of quantity of beef exported by the United Canada, U.S. zoos are reluctant to send export markets. Another commenter States in March and April, 2012, animals to Canada on breeding loans expressed concern that detection of BSE averaged about 63,800 MT per month, because they cannot get them back. The in imported cattle could cause domestic valued at about $384 million, compared commenter stated that zoo ruminants consumers to lose confidence in beef, to an average for May and June 2012 of have no history of BSE and will never resulting in economic harm to the U.S. 65,700 MT per month, valued at about come into contact with any domestic cattle industry. $394 million. livestock in the United States food We disagree with the commenters. We U.S. monthly cattle exports averaged chain, and therefore they pose little, if will be conducting our own evaluations about 16,700 head, valued at $32.4 any, risk to U.S. agriculture. The of the date of effective enforcement of million, during the year preceding the commenter stated further that North the feed ban in any region that would 2012 BSE discovery, compared to a American zoos are losing tremendous export live cattle to the United States, monthly average of about 15,100 head, genetic resources due to the inability to and we will accept exports of live cattle valued at $30.9 million, during the year exchange hoofstock across the U.S. from regions of undetermined risk for following the BSE discovery. Again, this border. The commenter stated that this BSE only on a case-by-case basis when small difference falls well within the could lead to the collapse of valuable the Administrator determines that they range of monthly variation. Considering captive ruminant populations. The commenter is incorrect that zoo do not present a risk of introducing BSE only the 2 months before and 2 months ruminants have no history of BSE. BSE into the United States. We are confident after the BSE discovery, exports for has been reported in several species of that these and the other risk mitigation March and April 2012 averaged about exotic ruminants, including nyala measures in this rule will be effective at 12,100 head per month, valued at $20.9 (Tragelaphus angasi), kudu preventing BSE-infected cattle from million, compared to about 17,900 head (Tragelaphus strepsiceros), gemsbok being imported into the United States. per month for May and June 2012, valued at $39.0 million. (Oryx gazella), eland (Taurotragus oryx), Additionally, we note that economic Arabian oryx (Oryx leucoryx), scimitar- effects of the most recent BSE case in One commenter stated that it was unclear if the provisions of the proposed horned oryx (Oryx dammah), Ankole the United States, confirmed on April cattle, and bison (Bison bison). As we 24, 2012, in a dairy cow in California, rule would be applicable to domesticated water buffaloes (Bubalus explained above, we are in the process were not significant, as evidenced by of developing a proposal to amend the U.S. beef price levels and beef and cattle bubalis). The commenter stated that the definition of ‘‘bovines’’ should be BSE regulations as they affect the exports. Monthly retail prices of choice importation of ovines and caprines and beef averaged $4.93 per pound for the extended to include the domesticated water buffalo, which is commonly products derived from those animals. 12 months between April 2011 and That proposal will also address the March 2012.2 For the following 12 raised as a farmed animal in some European Union (EU) Member States. importation of zoo ruminants. Upon months, April 2012 through March completion of that proposal, we will 2013, the average monthly retail price of APHIS disagrees with the commenter that the domesticated water buffalo publish it in the Federal Register for choice beef was $5.03 per pound. public comment. Comparing narrower time frames, for should be included in the definition of bovines. Current trade in water buffalo One commenter requested that APHIS the 4-month period January 2012 add the ear tag system as established in through April 2012, the average products is primarily in semen and embryos and in dairy products; this rule the EU as an acceptable means of monthly retail price was $5.04 per permanent identification. pound, compared to an average monthly will not affect trade in these articles. Three commenters noted that the While APHIS could recognize an ear price of $4.96 per pound for the 4 proposed rule addressed only bovines tag system like the one used in the EU months between May 2012 and August and bovine products, and that BSE- as an official identification method, for 2012; that is, choice beef prices over the related restrictions on ovines and live bovines imported from BSE-affected 4 months following the BSE discovery caprines were not addressed in the countries we also require a permanent were less than 2 percent lower than proposal. The commenters stated that identification such as a brand or tattoo. prices during the 4 months preceding b APHIS should publish a rule lifting For example, we require a C N brand the discovery. A variety of marketing BSE-related restrictions on ovines and or tattoo on cattle imported from factors influence price movements, and caprines as soon as possible. One Canada. This permanent identification this small percentage decline in 4- commenter specifically requested that allows APHIS to trace an animal back to month average price levels is well APHIS remove BSE-related import the country of origin in the event that within normal market fluctuations. restrictions on ovine casings. the animal shows symptoms of a With respect to U.S. beef exports, for As we explained in the proposed rule, transmissible spongiform the 12 months before the BSE discovery, we are in the process of developing a encephalopathy. One commenter noted that the monthly exports averaged about 71,500 proposal to amend the BSE regulations proposed rule maintains the current metric tons (MT), valued at about $383 as they affect the importation of ovines policy that any cattle imported from million, compared to a monthly average and caprines and products derived from Canada be born after March 31, 1999. of about 64,300 MT, valued at about those animals. Upon completion of the $391 million, during the 12 months The commenter stated that when this requirement was implemented in 2007, 3 U.S. Census Bureau, as reported by Global 2 http://www.ers.usda.gov/data-products/meat- Information Services, Inc. This is the source of all it was estimated that 11 percent of the price-spreads.aspx. trade data reported here. cattle in Canada were born before that

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date, but that according to a January States that are under State inspection imported. The commenter suggested 2012 inventory of cattle in Canada, that rather than Federal inspection. Facilities that allowing the importation of live number is now approximately 2 percent. in the United States that receive cattle too soon after the date of effective The commenter stated that because this imported animals for slaughter must enforcement could result in BSE- number will continue to decline, and operate under the provisions of the exposed cattle entering the United because classical BSE is mostly found in Federal Meat Inspection Act, and States. The commenter also stated that cattle between the ages of 4 and 7 years, overseas facilities approved to export to it was unclear whether the proposal to and is rare in cattle aged over 9 years, the United States must be approved by require documentation of effective APHIS should consider eliminating this USDA’s FSIS. enforcement of feed bans would actually requirement, either by adoption in the provide greater protection against a BSE final rule or by incorporating a Feed Bans introduction. reasonable sunset provision in the final One commenter stated that APHIS has The feed ban requirements apply to rule. been inconsistent in how it animals born at any time after the date APHIS disagrees with the commenter. characterizes the usefulness of the feed of effective enforcement. APHIS notes We believe that we should keep the date ban. The commenter stated that APHIS that at present, the certification in the regulations because this rule now argues that the feed ban serves a statement must only say that the recognizes Canada as a controlled risk different role in BSE mitigation than animals were born after the effective region. Live cattle may be safely does SRM removal, and denies that its enforcement of a feed ban; by requiring imported from controlled risk regions current requirement that animals from documentation of the date of effective provided that the cattle were born after which eligible beef exports are derived enforcement, we will be better able to the date the ruminant-to-ruminant feed must be subject to a feed ban is to verify that the bovines were in fact born ban was effectively enforced. In 2007, prevent the importation of products after that date. after a thorough evaluation of several derived from Canadian cattle that had One commenter stated that our factors contributing to enforcement and been exposed to BSE infectivity. The proposed standards for determining the compliance of the feed ban, APHIS commenter stated that APHIS is positing date of effective enforcement of a feed concluded that the Canadian feed ban either that the feed ban serves no role ban represent an unnecessary burden was effectively enforced by March 31, in protecting human health, or that the because the effectiveness of feed ban 1999. feed ban’s effectiveness in ensuring that enforcement is already assessed as part One commenter noted that while the food entering the food chain is not of the OIE procedure for determining rule removes BSE-related import derived from infected animals is the risk status of a country. The restrictions on in vivo-derived embryos, nonessential to human health. commenter suggested that instead of it does not address restrictions on in APHIS believes that the ruminant-to- using a rulemaking process, APHIS vitro-derived embryos. The commenter ruminant feed ban serves an important should either accept the dates stated that, consistent with international role in ensuring that live animals are not recognized by the EU, or allow, without standards, there should be no BSE- exposed to the BSE agent, which helps a rulemaking for the determination of related restrictions on either in vivo- or ensure that the disease does not appear the date of effective enforcement of a in vitro-derived embryos and that in the U.S. cattle population. SRM feed ban, cattle born after the date of APHIS should revise the provisions for removal mitigates risk in meat products. classification of the country. In the event that an EU Member State embryos accordingly. Our BSE risk assessments examine the The commenter is correct that the OIE wishes to export live cattle to the United five barriers that must be compromised does not recommend restrictions on in States, APHIS will consider using the before BSE could be introduced into the vitro-derived embryos with respect to date recognized by the EU of effective U.S. cattle population: U.S. import BSE. Our regulations in § 98.3(h) enforcement of the feed ban in that restrictions; slaughter controls; currently require that ruminant and Member State after evaluating publicly rendering inactivation factors; feed swine embryos have an intact zona available data or data provided by the manufacturing controls; and dose pellucida, which effectively prohibits EU Member State to support such response. We consider that any feed ban the importation of in-vitro derived and recognition. If the data supports the EU- may not have perfect compliance but if processed embryos. This restriction is recognized date of enforcement, then the risk of release were to be negligible, not related to BSE risk, but to the risks APHIS will accept such date as the date the likelihood of amplification or of other livestock diseases, such as the ruminant-to-ruminant feed ban was perpetuation within the system would bovine viral diarrhea, foot-and-mouth effectively enforced in the region. For also be considered insignificant. As no disease, infectious bovine other regions, APHIS will make a indigenous cases of classical BSE 4 have rhinotracheitis, leptospirosis, leukosis, determination based on the information ever been detected in the United States, and mycoplasmosis. received from the country, which can APHIS remains confident that the risk of One commenter noted that APHIS also include the specific date of feed release and exposure to BSE in the proposed to amend the definition of ban enforcement considered by the United States remains negligible. ‘‘recognized slaughter establishment’’ to country or region. mean a slaughtering establishment One commenter stated that the feed One commenter stated that operating under the provisions of the ban requirements do not specify how determination of the date of effective Federal Meat Inspection Act or a State long after the date of effective enforcement of the ruminant-to- meat inspection act. The commenter enforcement live cattle may be ruminant feed ban should be a matter asked for clarification of whether for the OIE, not for the United States. 4 Immunohistochemistry and Western blot tests at ‘‘State’’ refers only to States of the USDA’s National Veterinary Services Laboratories The OIE ad hoc group evaluation does United States or to territories or nations confirmed that the most recent case of BSE in the not determine the date of feed ban as well. United States was atypical BSE, not classical BSE. enforcement. The OIE assesses whether The word ‘‘State’’ in this definition The report of the case investigation can be viewed the feed ban was effectively enforced on the APHIS Web site at http:// refers to a State of the United States. www.aphis.usda.gov/animal_health/animal_ through audit and compliance for a The definition specifically addresses diseases/bse/downloads/BSE_Summary_ particular period of time. For controlled slaughter establishments in the United Report.pdf. risk countries, this time period is for

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less than 8 years, and for negligible risk allow the importation of gelatin derived Vectors,5 and the uses would have to be countries, it is for at least 8 years. from hides and skins regardless of BSE stated on the permit application. The The commenter stated that there are risk classification of the region of origin. importation of gelatin and collagen dates generally accepted for the effective The commenter asked why, then, in intended solely for human use must still enforcement of the feed ban in the UK §§ 94.23(e) and 95.7(e), that the meet the requirements established by (August 1, 1996) and the EU (January 1, certificate accompanying these other agencies that regulate for public 2001). The commenter asked if APHIS commodities is required to indicate the health. will accept these dates. BSE risk category for the exporting One commenter stated that the As we explained above, in the event region. The commenter also asked what definition of ‘‘offal’’ in § 95.1 leads the that an EU Member State wishes to a region not yet classified should reader to believe that offal is exclusively export live cattle to the United States, indicate on the certificate. The inedible in the United States and will APHIS will consider using the date of commenter suggested using the not be allowed to be imported for effective enforcement of the feed ban language of § 95.8(e) for tallow with 0.15 human consumption. The commenter recognized by the EU after evaluating percent of insoluble impurities. stated that this is not true and that it is publicly available data or data provided well known that liver, tripe, and other by the EU Member State to support such As we explained in the proposed rule, organ meats are found on the U.S. recognition. If the data supports the EU- gelatin and collagen derived from hides market. The commenter asked that we recognized date of enforcement, then and skins do not present a risk for the clarify that meat by-products may APHIS will accept that date as the date transmission of BSE. We believe, include edible parts of a butchered the ruminant-to-ruminant feed ban was however, that additional risk animal, including brains, thymus, effectively enforced in the Member mitigations are warranted for gelatin pancreas, liver, heart, and kidneys. The State. For other regions, APHIS will and collagen derived from bones, based commenter also asked that we define in make a determination based on the on the risk classification of the region of § 94.0 what products are included in information received from the country, origin. For this reason we are requiring ‘‘meat by-products’’ and amend the which can also include the specific date gelatin and collagen imported into the definition of offal in § 95.1 to make it of feed ban enforcement considered by United States be accompanied by an clear that the parts mentioned, when the region. original certificate that indicates the edible, are not covered by the definition. Edible and Inedible Products BSE risk classification of the exporting FSIS, which has the primary authority region and that states that the required for regulating meat and meat products One commenter asked if the conditions have been met. Regions not intended for human consumption, does conditions applying to deboned skeletal yet classified for BSE risk are not define offal but does refer to muscle in § 94.18(b)(2) would also apply considered to be regions of products such as organ meats as ‘‘meat to meat food products and byproducts undetermined risk. We agree with the by-products’’ when used for human made from deboned skeletal meat and commenter, however, that requiring consumption. However, we agree with containing no restricted commodities. hide-derived gelatin and collagen to the commenter that the definition of The conditions for deboned skeletal indicate the BSE risk category for the ‘‘offal’’ in § 95.1 may be confusing and muscle will apply to meat food products exporting region is unwarranted if the have revised it to read ‘‘the inedible made from such, but, as we explained products can be demonstrated to be parts of a butchered animal.’’ in the proposed rule, imported products One commenter noted that the must meet all relevant agency hide-derived and have amended §§ 94.23(e) and 95.7(e) accordingly. proposed rule says that APHIS concurs requirements, including those of FSIS with OIE’s recommendations regarding The commenter asked APHIS to and the U.S. Food and Drug trade of dicalcium phosphate. The elaborate on the circumstances where Administration (FDA). Each agency has commenter stated that Article 11.5.17 of the provision for gelatin and collagen the capability to deny imports based on the OIE Code recommends the same from bones that will have no contact their individual authorities and conditions for dicalcium phosphate concerns. with ruminants in the United States originating in regions of controlled or One commenter stated that the could be imported, and under what undetermined risk, and that APHIS proposed rule reaffirms in § 94.25(a)(2) conditions the gelatin or collagen would should justify its reasons for prohibiting that ovine or caprine meat can derive be allowed importation. dicalcium phosphate from regions of only from animals that were less than 12 APHIS believes that the rule is clear undetermined risk. months of age when slaughtered. The in what the criteria are for importing The commenter is correct that the OIE commenter stated that the OIE Code gelatin and collagen; specifically, such Code recommends no BSE-related does not recommend any restrictions on products may be imported if the restrictions for dicalcium phosphate the import of sheep and goat meat with Administrator determines that the that is free of protein or fat. However, respect to BSE or scrapie. The gelatin and collagen will not come into the OIE Code does recommend that commenter asserted that the restriction contact with ruminants in the United dicalcium phosphate that is not free of is unjustified and asked APHIS to States and that the conditions under protein or fat should originate only in confirm that it will be removed in a which it will be imported will prevent negligible risk or controlled risk regions, future rulemaking. As we explained above, we are in the the introduction of BSE into the United and that, if the material originates in a process of developing a proposal to States. Examples of these uses would region of controlled risk for BSE, include products for human or amend the BSE regulations as they affect 5 the importation of ovines and caprines industrial use, such as film, cosmetics, Application for a permit must be filed on VS manufacturing for glue purposes, and so Form 16–3 (available from APHIS, Veterinary and products derived from those Services, National Center for Import and Export, animals. Upon completion of that on. Persons wishing to import gelatin 4700 River Road Unit 38, Riverdale, MD 20737– and collagen would also need to obtain 1231, or electronically at http:// proposal, we will publish it in the _ Federal Register for public comment. a United States Veterinary Permit for the www.aphis.usda.gov/animal health/permits/). The Importation and Transportation of application must state the intended use of the One commenter noted that in material and the name and address of the consignee proposed § 94.23(b), we proposed to Controlled Materials and Organisms and in the United States.

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additional risk mitigation measures be processed animal protein from regions from regions of negligible or controlled applied. Furthermore, as we explained of controlled risk for BSE unless it can risk for BSE, respectively, and, in the in the proposed rule, there is evidence be demonstrated that the product has case of processed animal proteins, that that dicalcium phosphate produced not been commingled or contaminated the commodity has not been from bones under normal manufacturing with ruminant meat and bone meal or commingled or contaminated with meat processes can contain a small residual greaves. The commenter stated that the and bone meal or greaves from a region proteinaceous fraction, and would second and third options presented in of controlled or undetermined risk for therefore present a risk of transmission § 95.5(a) are compatible with an export BSE. for BSE. For these reasons we proposed region of controlled and even In the proposed rule, we noted that, to limit the importation of dicalcium undetermined risk, but that the of the types of animal products derived phosphate that is not free of traces of certificate required in § 95.5(b) must from bovines, processed ruminant protein or fat from regions of state that the exporting region is of protein that either contains or has been undetermined risk to a case-by-case negligible risk. The commenter asked contaminated by the BSE agent is the basis when the Administrator APHIS to clarify what risk statuses are means of transmission of BSE. determines that the dicalcium allowed for both the exporting regions Therefore, in conducting an assessment phosphate will not come into contact and the regions in which the ruminants of the BSE risk in a country, it is with ruminants in the United States and from which the processed animal important to know the origin of can be imported under conditions that protein is derived are born and raised, processed animal protein, or feedstuffs will prevent the introduction of BSE. and what the restrictions are in each containing processed animal protein, We have amended the regulatory text in case. The commenter also stated that the that have been imported into the § 95.10 to make these requirements certificate should be able to country. Processed animal protein clearer. accommodate each available option. originating from high-risk countries for One commenter stated that the OIE APHIS agrees with the commenter. BSE presents a higher release risk than Code does not provide any conditions Our intention is to allow processed that originating from low-risk countries. for the importation of tallow from animal protein from all regions if it can One commenter asked for clarification regions of undetermined risk other than be demonstrated that the products are of the term feedstuffs, and asked tallow with a maximum level of not contaminated with prohibited specifically if it applies only to feed insoluble impurities of 0.15 percent in material, i.e. ruminant meat-and-bone intended for livestock or is used in a weight and derivatives made from this meal and greaves or SRMs. Most of broader sense to apply to pet foods as tallow, which are considered safe these products, if not all, would need an well. commodities. The commenter stated import permit once it has been that APHIS’ proposed prohibition on demonstrated to APHIS that these Yes, the term feedstuffs could apply tallow other than tallow with maximum products do not contain prohibited to pet foods as well as livestock feed. It level of insoluble impurities of 0.15 material. We have amended § 95.5(a) is possible that pet foods could be used percent in weight from regions of and (b) to clarify this. We have also for cattle feed, either by accidental undetermined risk would not make amended § 95.13 and § 95.14(g) to misfeeding of pet foods to cattle or by sense from a technical point of view. require that nonruminant processed misusing salvage pet food for cattle. The commenter stated that APHIS animal proteins imported from any Farms that raise multiple species (e.g. should either apply the same conditions region would have to be accompanied dogs, swine, and cattle) present a for the same product from regions of by an original certificate and an import particular risk for misfeeding. We would controlled risk or justify why it intends permit that indicates that the material is consider both the origin of pet food and to prohibit the importation of tallow of nonruminant origin. pet food ingredients, and the likelihood other than tallow with maximum level In addition, we have amended of exposure through misfeeding or the of insoluble impurities of 0.15 percent §§ 94.19, 94.20, and 95.5 to remove the likelihood of misuse of salvage pet food in weight from regions of undetermined requirement that the commodities be when evaluating a region for BSE risk. risk. derived from bovines that were born Specified Risk Materials While the OIE Code does recommend and raised in regions of negligible or unrestricted trade in tallow with a controlled risk for BSE, respectively. Three commenters expressed concern maximum level of insoluble impurities The OIE risk assessment evaluation that while the OIE requires removal of of 0.15 percent, the Code also takes into consideration the risk of SRMs from animals older than 30 recommends that tallow with more than release (importation of cattle and cattle months of age, the proposed rule calls 0.15 percent of insoluble impurities by products for a particular time period) for removal of SRMs from animals 30 weight requires certification that it is and the exposure (likelihood that months of age or older. The commenters sourced from a negligible risk country potentially contaminated/infected cattle stated that while this may not appear to or, if it is sourced from a controlled risk derived product contain the BSE agent be a significant difference, it will still country, that it is derived from cattle could be recycled into the system). OIE have a major impact on trade. One that have passed ante-mortem and post- importation standards for countries commenter noted that the EU uses the mortem inspections and does not recognized as either negligible or OIE wording and would not be able to contain SRMs. We will allow all tallow controlled risk for BSE take into guarantee compliance with the if it is determined that it will not come consideration that the risk of importing proposed rule. Another commenter in contact with ruminants, for example, particular commodities (including live noted that the use of ‘‘thirty months of if the tallow is intended for use in cattle) has already been mitigated and as age or older’’ is consistent with FDA manufacturing candles and soaps. The such contributed to an insignificant risk. regulations and with the rules of Canada importation of tallow intended solely For this reason, we do not believe the and Mexico, and stated that adopting for human use must still meet the requirement that the products be the OIE’s language in this rulemaking requirements established by other derived from bovines born and raised in would be helpful only if the FDA, agencies that regulate for public health. regions of negligible or controlled risk is Canada, and Mexico also adopted it. One commenter noted that we necessary. Instead, we will only require The commenter suggested that a proposed to prohibit the importation of that these commodities be exported possible solution would be for USDA

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and FDA to develop an equivalency that, during their first year of life, were and asked APHIS to explain why the agreement with the OIE/EU. reared with a bovine determined to be trigeminal ganglia were included. The commenter is correct that the use infected with BSE during its first year of As we explained in the proposed rule of ‘‘thirty months of age or older’’ is life. and in supporting scientific consistent with FSIS and FDA We agree with the commenter and documentation, APHIS is adopting the regulations as well as with Canadian have made those suggested changes in definition of SRMs already established regulations. We note that anyone this final rule. by FSIS. FSIS has designated as SRMs wishing to import bovine products into One commenter stated that the the brain, skull, eyes, trigeminal ganglia, the United States would have to meet requirements in proposed § 94.23 for the spinal cord, vertebral column FSIS or FDA requirements as well as importation of bone-derived gelatin are (excluding the vertebrae of the tail, the APHIS requirements. We do not different from the requirements in transverse process of the thoracic and anticipate that this difference will have FDA’s interim final rule ‘‘Use of lumbar vertebrae, and the wings of the a significant impact on trade. Materials Derived From Cattle in sacrum), and dorsal root ganglia of cattle One commenter expressed concern Human Food and Cosmetics’’ (70 FR 30 months of age or older, and the that the definitions of SRMs in the 53063–53069 and 73 FR 20785–20794, tonsils and distal ileum of the small proposed rule are not consistent with Docket No. FDA–2004–N–0188) and intestine of all cattle because these those in the FDA interim rule ‘‘Use of also the provisions in FDA’s proposed tissues have demonstrated BSE Materials Derived from Cattle in Human rule ‘‘Use of Materials Derived From infectivity. Food and Cosmetics’’ (69 FR 42256– Cattle in Medical Products Intended for One commenter stated that APHIS’ 42274, Docket No. 2004N–0081) and the Use in Humans and Drugs Intended for list of SRMs is stricter than FSIS’ list FDA proposed rule ‘‘Use of Materials Use in Ruminants’’ (72 FR 1582–1619, with respect to regions of undetermined derived from Cattle in Medical Products Docket No. 2005N–0373). The risk in that the SRM list applies at 12 Intended for Use in Humans and Drugs commenter stated that under the months instead of 30. The commenter Intended for Use in Ruminants’’ (72 FR provisions of our proposed rule, gelatin asked if this list would supersede FSIS’ 1582–1619, Docket No. 2005N–0373). imported from regions of controlled or for commodities imported from regions The commenter stated that while the undetermined BSE risk would have to APHIS’ proposed rule would allow for be manufactured from bovine bones free of undetermined risk. the importation of some bovine gelatins, from skulls of animals of all ages, but The list of SRMs in our proposed rule the same bovine gelatins would be that FDA’s SRM definition allows the is consistent with FSIS’ list; however, prohibited on the U.S. market under the use of skulls of animals below 30 the commenter is correct that we FDA rules, or could not further be months of age. The commenter was proposed that the SRM removal exported outside the United States due concerned that some gelatin that could requirements apply to cattle 12 months to the inconsistency between the be imported under APHIS’ regulations of age and older from undetermined risk regulations. could not be used within the United regions. This requirement is consistent As we explained in the proposed rule, States under the provisions of FDA’s with the OIE recommendations for the APHIS is adopting the definition of requirements. importation of meat and meat products SRMs already established by FSIS. The commenter is correct that under from regions of undetermined risk. If an APHIS and FSIS carry out their FDA’s interim final rule pertaining to undetermined risk region wants to programs in close coordination with the human food and cosmetics, imported export beef to the United States then the FDA. The USDA coordinates with gelatin must not be manufactured from product must meet the requirements of FDA’s Center for Veterinary Medicine skulls and vertebral columns from cattle this rule for removal of SRMs. regarding animal feed and veterinary 30 months of age or older, regardless of Blood and Blood Products pharmaceuticals; the Center for Food the OIE BSE risk categorization of the Safety and Applied Nutrition regarding exporting country. FDA’s regulations Three commenters raised concerns foods other than meat, poultry, and egg that govern the manufacture of gelatin about the proposed requirements for products; and other Centers regarding and collagen are found at 21 CFR 189.5 blood and blood products. The drugs, biologics, and devices containing and 21 CFR 700.27. FDA’s regulations in commenters stated that neither OIE nor bovine material. These agencies § 189.5(e) do allow a process for EU regulations require that blood be collaborate, issuing regulations under designating countries as exempt from collected in a hygienic manner. The their respective authorities. Imported the restrictions contained in the commenters also stated that the OIE products must meet all relevant agency regulations. A country seeking recommendation that blood be collected requirements. Each agency has the designation must send a written request from cattle which were not subject to a capability to deny imports based on to the Office of the Center Director, stunning process, prior to slaughter, their individual authorities and Center for Food Safety and Applied with a device injecting compressed air concerns. Nutrition. FDA will respond in writing or gas into the cranial cavity, or to a One commenter suggested that in the to any such request and may impose pithing process is meant to prevent the proposed definitions for ‘‘region of conditions in granting any such request. contamination of the blood with SRMs. controlled risk for bovine spongiform The medical products proposed rule One commenter stated that the encephalopathy (BSE)’’ and ‘‘region of that FDA published in 2007 would have additional requirement that blood be negligible risk for bovine spongiform the same restrictions for gelatin in collected in a hygienic manner was encephalopathy (BSE)’’ in § 92.1, the medical products intended for use in therefore unjustified and that APHIS wording ‘‘the same feed that potentially humans, and drugs intended for use in should either remove the requirement or contained SRM material’’ be rephrased ruminants. FDA has not finalized the provide further justification and details as ‘‘the same potentially contaminated medical products proposed rule. regarding what the Administrator would feed.’’ The commenter stated that this One commenter expressed concern consider a hygienic manner to collect rephrasing would more closely align that APHIS’ list of SRMs differs from the blood at slaughter. The other two with international standards the OIE list and the EU list. The commenter commenters stated that the inclusion of provisions for identifying and noted especially the inclusion of the dried plasma and blood products in the controlling the movements of bovines trigeminal ganglia in the list of SRMs definition of ‘‘processed animal

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proteins’’ was inconsistent with Chapter We note that these provisions actually prohibited articles transiting air and 11.5 of the OIE Code. appear in § 95.14(c), not § 95.15(b), and ocean ports in the United States for While we agree with the OIE disagree that they are contradictory. immediate export. We are making these recommendations, we also recognize APHIS wants to ensure that changes in order to be consistent with that there are various methods that can nonruminant processed animal protein the existing requirements for meat and be used for blood collection. It is not our mixed with products derived from other products of ruminants and swine intent to dictate which methods can be ruminant blood meets the requirements in § 94.15(d). used, but it must be demonstrated that we have for blood and blood products Issues Outside the Scope of the the method used in any given case does derived from bovines. not result in contamination of the blood Rulemaking/Outside APHIS Authority with SRMs. We recognize blood being Date of Effective Enforcement of Feed One commenter stated that the collected in a closed system as one such Ban in Mexico Geographical BSE Risk rating (GBR) for method. In the proposed rule, we announced the United States should be raised APHIS included dried plasma and that we had conducted an evaluation to because there are many different prion other blood products in the definition of determine the date of effective strains present in North America and ‘‘processed animal proteins’’ to allow enforcement of a feed ban in Mexico, those strains are spreading and the agency to address the potential of and that based on that evaluation, we mutating. such products to be commingled with consider the date of effective The GBR is a qualitative indicator of materials that would be prohibited. enforcement of a feed ban in Mexico to the likelihood of the presence of one or One commenter stated that APHIS be November 30, 2007. We received no more cattle within the native population should provide details regarding what comments on either the evaluation or on of a country being infected with BSE, the Administrator would consider to be the date of effective enforcement on the pre-clinically as well as clinically, at a a hygienic manner to collect blood from feed ban in Mexico. Therefore, we are given point in time. Where its presence live donors. recognizing November 30, 2007, as the is confirmed, the GBR gives an The risk with blood collection at date of effective enforcement of the feed indication of the level of infection. The slaughter is potential contamination of ban in Mexico in this document. GBR methodology was developed, and the blood with SRMs through brain is used, by the European Commission as emboli or cross-contamination after Miscellaneous Changes the basis for trade legislation rules for slaughter. While these risks are not One commenter noted that proposed cattle and their products. APHIS is not associated with the collection of blood § 95.4(c)(7) refers to ‘‘the conditions of involved with this process. from live donors, we want to ensure that paragraphs (d)(1) through (d)(5) of this One commenter stated that under there is no cross-contamination in the section.’’ The commenter asked if the APHIS’ proposed rule, no bovine tissues collection process with blood from reference should be to paragraphs (c)(1) from a negligible risk region are slaughtered animals that was not through (c)(5) of the section instead. considered to be SRMs. The commenter collected via a closed system or some The commenter is correct. We have asked why a negligible risk region other hygienic method. In our corrected the reference in this final rule. willing to export products other than September 2007 final rule, we We proposed in § 92.7 to incorporate skeletal meat should have to recognized a closed system as one by reference Article 11.6.22 of the OIE demonstrate to FSIS that its BSE risk hygienic method of blood collection Code, effective 2009. This article of the status can be reasonably expected to from live donors. OIE Code sets out guidelines for provide the same level of protection One commenter stated that proposed surveillance activities related to BSE. from human exposure to the BSE agent § 95.5 appears internally inconsistent We are updating this to incorporate by as prohibiting SRMs for use as human with proposed § 95.12 on the subject of reference Article 11.5.22 of the OIE food does in the United States. The blood and blood products. Code, effective 2013. In 2013, the OIE commenter stated that this provision The commenter is mistaken. Section updated these guidelines to adjust the should be removed or amended to bring 95.5 refers to processed animal proteins surveillance points required for risk the regulations in line with derived from ruminants. Section 95.12 status recognition of countries with international standards, and that APHIS refers to bovine blood and products small populations of cattle. The OIE should coordinate with FSIS toward derived from bovine blood. These are made these changes at the request of the that end. The commenter also asked different commodities and represent a BSE ad hoc group, supported by the what information should be provided to different risk with respect to BSE. scientific commission and endorsed by FSIS, and what would be the decision One commenter asked why, in the OIE member states. procedure, should the provision remain § 95.15(b), which contains provisions We proposed in § 94.27(a) to require unchanged. The commenter asked if this for processed animal proteins from that, meat, meat products, and other demonstration would be required even nonruminants, it was necessary to edible products derived from bovines, if the exported cuts do not include any exempt eligible blood meal, blood ovines, or caprines that are otherwise of the tissues considered as SRMs in plasma, and other blood products from prohibited importation into the United regions of controlled or undetermined the prohibition. The commenter stated States may transit ports in the United risk. that it seemed contradictory for States for immediate export, or transit The FSIS regulations in 9 CFR 327.2 processed animal proteins derived from the United States by overland transport provide that, to be eligible to export nonruminants to possibly contain if certain conditions were met. We have meat and meat products to the United protein from ruminant blood. The decided to remove the requirement that States for human consumption, a foreign commenter stated that either the the person moving these articles must country must be able to certify that it product is a processed animal protein obtain a United States Veterinary Permit meets FSIS requirements. Therefore, from nonruminants and does not for Importation and Transportation of prior to exporting meat and meat include any ruminant origin protein, or Controlled Materials and Organisms and products to the United States, countries it should be designated as a mixed Vectors. We have also amended the are required to be approved by FSIS as processed animal protein from transit shipment requirements in § 95.15 having an inspection system equivalent nonruminants and ruminants. to remove the permit requirement for to that in the United States. FSIS

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maintains a list of countries eligible to Amending our other import minimal. Potential impacts of the rule export meat to the United States on its regulations for consistency with OIE on U.S. export markets, by influencing Web site at http://www.fsis.usda.gov/ standards is outside the scope of this trading partners’ import policies, are not wps/portal/fsis/topics/international- rulemaking. considered in this analysis. affairs/importing-products/eligible- Therefore, for the reasons given in the Live Bovines (Cattle and Bison) countries-products-foreign- proposed rule and in this document, we establishments/eligible-foreign- are adopting the proposed rule as a final Essentially all U.S. imports of cattle establishments. In the affirmation of its rule, with the changes discussed in this and bison are from Canada and Mexico. SRM interim rule, published in the document. Additionally, we are Over the 10 years 2002–2011, the only Federal Register on July 13, 2007 (72 FR adopting as final our preliminary BSE live bovine imports that did not come 38700–38730, Docket No. 03–025F), risk classifications of countries that from Canada or Mexico were 33 animals FSIS stated that it will also consider were announced in the proposed rule, from Australia, 12 from New Zealand, whether APHIS or FDA imposes any and we are recognizing November 30, and 1 from Guatemala. APHIS is BSE-related restrictions on imports from 2007, as the date of effective classifying Canada and Mexico as the country and, if so, the basis for those enforcement of a feed ban in Mexico. countries of controlled risk for BSE restrictions when developing Executive Orders 12866 and 13563 and (their classification by the OIE). equivalence criteria. Regulatory Flexibility Act Imports from Canada will be One commenter stated that APHIS unaffected by this rule because the This final rule has been determined to should adopt the same standards requirements will cause no change in be significant for the purposes of required by the EU and Japan, including the number or type of animals that are Executive Order 12866 and, therefore, mandatory testing for all cattle brought has been reviewed by the Office of eligible for importation, based on to slaughter and banning the feeding of Management and Budget. Canada’s status as a BSE minimal-risk blood, manure, and slaughterhouse We have prepared an economic region under APHIS’ existing waste to animals. analysis for this rule. The economic regulations. Imports from Mexico also As we explained above, BSE analysis provides a cost-benefit analysis, will be essentially unaffected, since surveillance programs in the United as required by Executive Orders 12866 nearly all cattle imported from Mexico States focus on obtaining quality and 13563, which direct agencies to (98 to 99 percent) are estimated to be samples from targeted subpopulations assess all costs and benefits of available less than 24 months of age; with this rather than looking at the entire adult regulatory alternatives and, if regulation rule APHIS is establishing November cattle population. Cattle typically only is necessary, to select regulatory 30, 2007, as the date of effective test positive for BSE when they are in approaches that maximize net benefits enforcement of a ruminant-to-ruminant the last few months of what can be a (including potential economic, feed ban in Mexico (the earliest date very long incubation period. Testing all environmental, public health and safety that bovines imported from Mexico animals at slaughter would not improve effects, and equity). Executive Order could be born). our understanding of disease trend 13563 emphasizes the importance of Products Derived From Bovines because not all the exposed cattle will quantifying both costs and benefits, of be infected, nor would all infected cattle reducing costs, of harmonizing rules, Six countries, Argentina, Australia, test positive. We continue to believe and of promoting flexibility. The Brazil, Canada, New Zealand, and that FDA’s BSE feed regulations are economic analysis also provides a final Uruguay, accounted for 91 percent of all science based and appropriate for the regulatory flexibility analysis that U.S. bovine product import volume (and BSE risk in the United States. examines the potential economic effects 90 percent of the import value) over the One commenter stated that the United of this rule on small entities, as required 5-year period 2007–2011. Imports from States is covering up the scope of BSE by the Regulatory Flexibility Act. The each of the six countries should and variant Creutzfeldt-Jakob disease economic analysis is summarized continue essentially unchanged and (vCJD) in the United States by not below. Copies of the full analysis are without interruption under the rule, requiring medical professionals to available on the Regulations.gov Web because the protocols in place in these report vCJD cases and not allowing site (see footnote 1 in this document for countries are already in full compliance individual producers to test for BSE. a link to Regulations.gov) or by with the rule’s criteria. Argentina, Requiring medical professionals to contacting the person listed under FOR Australia, New Zealand, and Uruguay report vCJD cases is outside of APHIS’ FURTHER INFORMATION CONTACT. will be classified by APHIS as negligible statutory authority. With respect to This rule will make our bovine and risk regions for BSE; they have never individual producers testing for BSE, we bovine product import restrictions reported a case of BSE. Canada and note that for a diagnostic test to be related to BSE more reflective of current Brazil, which will be classified by considered valid anywhere in the world, scientific thinking while continuing to APHIS as controlled risk regions for it must be done by the competent guard against the introduction of BSE. BSE, already satisfy FSIS inspection veterinary authority of the national The process for classifying regions with requirements and prohibitions on government of the region where the respect to BSE risk will be based on the certain animal stunning or pithing and animals are kept. Furthermore, as we comprehensive review of relevant, mechanically separated meat. explained above, increased testing internationally accepted scientific Imports allowed by the rule from the would not provide better understanding literature and will be consistent with 36 (primarily European) countries listed of disease trend, nor would it provide the process employed by the OIE. The in 9 CFR 94.18 as prohibited from better protection against the spread of rule will also remove BSE-related shipping bovine products to the United the disease. restrictions on the importation of live States likely will be insignificant. In Three commenters stated that APHIS cervids and camelids and their none of the years from 1990 through should also harmonize its other import products. 1996, that is, prior to the prohibition on regulations, especially those for foot- While benefits of the rule are ruminant product imports from all of and-mouth disease (FMD), with OIE expected to justify its costs, effects on Europe in 1997, did the volume of U.S. standards. U.S. imports are expected to be bovine product imports from the 36

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countries account for more than 0.6 annual value averaged less than $50,000 Executive Order 12988 percent of imports of these products. over the 5-year period 2006–2010 (most This final rule has been reviewed Nor does recent EU trade in bovine recent data available), and 90 percent of under Executive Order 12988, Civil products suggest a significant volume of those imports were supplied by Canada Justice Reform. This rule: (1) Preempts imports from the 36 countries in the and China. all State and local laws and regulations future, at least in the near term. While that are inconsistent with this rule; (2) the nominal value of bovine product Benefits, Costs, and Alternatives has no retroactive effect; and (3) does exports by the European Union (EU–27) Consumers benefit from imports to not require administrative proceedings increased more than four-fold in 5 years, the extent that consumer choice is before parties may file suit in court from $0.36 billion in 2007 to nearly broadened and the increased supply of challenging this rule. $1.57 billion in 2011, the value of the imported commodity leads to a price bovine product imports by EU–27 decline. We anticipate that the rule will National Environmental Policy Act Member States in 2011 ($2.42 billion) have little impact on consumer choice An environmental assessment and exceeded the value of their bovine or import volumes, and therefore little finding of no significant impact have product exports by more than $850 or no impact on U.S. businesses as well. been prepared for this final rule. The million. The EU–27 continues to be a Although the impact of this rule on environmental assessment provides a large net importer of bovine products U.S. consumers and producers is basis for the conclusion that the overall. Emerging markets, such as expected to be minimal, the benefits of importation of live bovines and bovine Russia, are likely to take a growing share the rule are expected to justify its costs. products under the conditions specified of Europe’s bovine product exports. Leaving the bovine regulations Bovine product imports from other in this rule will not have a significant unchanged would be unsatisfactory impact on the quality of the human countries that are not currently subject because it would perpetuate the current to BSE-related restrictions are not environment. Based on the finding of no situation in which our BSE-related expected to be significantly affected. significant impact, the Administrator of import conditions are not consistent Over the 5 years 2007–2011, annual the Animal and Plant Health Inspection with current scientific evidence. imports from such countries as a group Service has determined that an Additionally, by maintaining the status averaged 8 to 9 percent of all U.S. environmental impact statement need quo APHIS would forgo the opportunity bovine product imports by volume (10 not be prepared. to establish a process for classifying a to 11 percent by value), with over 95 The environmental assessment and region’s BSE risk status in a more timely percent of these products coming from finding of no significant impact were fashion than is possible under current Mexico, Nicaragua, and Costa Rica. prepared in accordance with: (1) The regulations. Imports from Mexico already meet the National Environmental Policy Act of requirements of a region of controlled Another alternative, amending the 1969 (NEPA), as amended (42 U.S.C. risk for BSE largely by way of FSIS BSE regulations related to the 4321 et seq.), (2) regulations of the requirements. The potential impact on importation of bovines and bovine- Council on Environmental Quality for imports from Nicaragua and Costa Rica, derived products to match precisely the implementing the procedural provisions which APHIS is classifying as regions of OIE Code would also be unsatisfactory of NEPA (40 CFR parts 1500–1508), (3) undetermined risk for BSE, should be because it would not allow APHIS to USDA regulations implementing NEPA minimal at most. Almost all imports independently interpret the scientific (7 CFR part 1b), and (4) APHIS’ NEPA from those two countries are of boneless literature and findings that underlie OIE Implementing Procedures (7 CFR part beef that already satisfy the rule’s risk categorization recommendations. 372). requirements, again, largely by way of Making no changes to the regulations The environmental assessment and FSIS requirements. that govern the importation of cervids finding of no significant impact may be and camelids would also be viewed on the Regulations.gov Web Live Cervids and Camelids and Their unsatisfactory because it would site.6 Copies of the environmental Products perpetuate an unnecessary constraint on assessment and finding of no significant Removal of the prohibition on the trade in those commodities. impact are also available for public importation of live cervids and camelids inspection at USDA, room 1141, South Effects on Small Entities and their products from the 36 countries Building, 14th Street and Independence listed in 9 CFR 94.18 will likely have Small entities prevail among the Avenue SW., Washington, DC, between little or no economic impact on the industries that may be affected by this 8 a.m. and 4:30 p.m., Monday through United States. The United States has not rule, including cow-calf producers, Friday, except holidays. Persons imported any live cervids or camelids cervid and camelid producers, feedlot wishing to inspect copies are requested from these countries since at least 1990. establishments, slaughtering to call ahead on (202) 799–7039 to In none of the years from 1990 through establishments, meat packing and facilitate entry into the reading room. In 1996, before the prohibition of ruminant processing establishments, meat addition, copies may be obtained by meat, meat products, and other edible wholesalers, importers and exporters, writing to the individual listed under products from all of Europe in 1997, did grocery stores and meat markets, and FOR FURTHER INFORMATION CONTACT. the volume of U.S. imports of meat and manufacturers of cosmetics and Paperwork Reduction Act edible offal of deer from the 36 pharmaceuticals. However, as has been countries account for more than 3.3 described, any changes because of this In accordance with section 3507(d) of percent of total imports. Over the 5 rule in U.S. imports of live bovines, the Paperwork Reduction Act of 1995 years 2007–2011, more than 99 percent cervids, camelids, or their products are (44 U.S.C. 3501 et seq.), the information of U.S. imports of meat and edible offal expected to be minor. U.S. small entities collection or recordkeeping of deer have come from New Zealand, are unlikely to be significantly affected. and that country’s dominance of this This rule contains no mandatory 6 Go to http://www.regulations.gov/ #!docketDetail;D=APHIS-2008-0010. The market is unlikely to change as a result reporting, recordkeeping, or other environmental assessment and finding of no of this rule. The volume of U.S. imports compliance requirements for U.S. significant impact will appear in the resulting list of camelid products is very small. Their entities. of documents.

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requirements included in this final rule, Authority: 7 U.S.C. 1622 and 8301–8317; necessary to be classified as a region of which were filed under 0579–0393, 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 negligible risk for BSE. have been submitted for approval to the CFR 2.22, 2.80, and 371.4. (2) Is a region in which it can be Office of Management and Budget ■ 2. In § 92.1, definitions of approved demonstrated through an appropriate (OMB). When OMB notifies us of its laboratory, bovine, exporting region, control and audit that neither meat-and- decision, if approval is denied, we will OIE, OIE Code, OIE Terrestrial Manual, bone meal nor greaves derived from publish a document in the Federal processed animal protein, region of ruminants has been fed to ruminants. Register providing notice of what action controlled risk for BSE, region of (3) Has demonstrated that Type A we plan to take. negligible risk for BSE, region of surveillance in accordance with Article 11.5.22 of the OIE Code, incorporated by E-Government Act Compliance undetermined risk for BSE, specified risk materials (SRMs) from regions of reference in § 92.7, or with equivalent The Animal and Plant Health controlled risk for BSE, and specified guidelines recognized by the Inspection Service is committed to risk materials (SRMs) from regions of Administrator is in place and the compliance with the E-Government Act undetermined risk for BSE are added in relevant points target, in accordance to promote the use of the Internet and alphabetical order to read as follows: with Table 1 of Article 11.5.22 of the other information technologies, to OIE Code, or with equivalent guidelines provide increased opportunities for § 92.1 Definitions. recognized by the Administrator has citizen access to Government * * * * * been met. Type B surveillance in information and services, and for other Approved laboratory. A properly accordance with Article 11.5.22 of the purposes. For information pertinent to equipped institution in the exporting OIE Code, or with equivalent guidelines E-Government Act compliance related region, approved by the official recognized by the Administrator, is to this rule, please contact Mrs. Celeste authority who is responsible for animal sufficient in place of Type A Sickles, APHIS’ Information Collection health matters in that region, that is surveillance or its equivalent once the Coordinator, at (301) 851–2908. staffed by technically competent relevant points target for Type A personnel under the control of a surveillance or its equivalent has been List of Subjects specialist in veterinary diagnostic met. 9 CFR Part 92 methods who is responsible for the (4) Meets one of the following results. conditions: Animal diseases, Imports, Bovine. Bos taurus, Bos indicus, and (i) Has had no case of BSE in the Incorporation by reference, Livestock, Bison bison. region or every case has been Poultry and poultry products, Region, * * * * * demonstrated to have been imported Reporting and recordkeeping Exporting region. A region from and has been completely destroyed; or (ii) Has had at least one indigenous requirements. which shipments are sent to the United case, and all bovines described in either States. 9 CFR Part 93 paragraph (4)(ii)(A) or (4)(ii)(B) of this Animal diseases, Imports, Livestock, * * * * * definition, if still alive, are officially Poultry and poultry products, OIE. The World Organization for identified with unique individual Quarantine, Reporting and Animal Health. identification that is traceable to the recordkeeping requirements. OIE Code. The Terrestrial Animal premises of origin of the animal, have Health Code of the World Organization their movements controlled, and, when 9 CFR Part 94 for Animal Health. slaughtered or at death, are completely OIE Terrestrial Manual. The Manual Animal diseases, Imports, Livestock, destroyed: of Diagnostic Tests and Vaccines for Meat and meat products, Milk, Poultry (A) All bovines that, during their first Terrestrial Animals of the World and poultry products, Reporting and year of life, were reared with a bovine Organization for Animal Health. recordkeeping requirements. determined to be infected with BSE * * * * * during its first year of life, and that 9 CFR Part 95 Processed animal protein. Meat meal, investigation showed consumed the Animal feeds, Hay, Imports, bone meal, meat-and-bone meal, blood same potentially contaminated feed as Livestock, Reporting and recordkeeping meal, dried plasma and other blood the infected animal during that period; requirements, Straw, Transportation. products, hydrolyzed protein, hoof or meal, horn meal, poultry meal, feather (B) If the investigation was unable to 9 CFR Part 96 meal, fish meal, and any other similar determine whether the feed source that products. was used to feed the bovine known to Imports, Livestock, Reporting and be infected was also used to feed other recordkeeping requirements. * * * * * Region of controlled risk for bovine bovines in the herd of the infected 9 CFR Part 98 spongiform encephalopathy (BSE).1 A animal, all bovines born in the same herd as a BSE-infected bovine either Animal diseases, Imports. region for which a risk assessment has been conducted sufficient to identify the within 12 months before or 12 months Accordingly, we are amending 9 CFR historical and existing BSE risk factors after the birth of the infected animal. parts 92, 93, 94, 95, 96, and 98 as in the region and that: (5) Meets the conditions in one of or follows: (1) Has demonstrated that appropriate both paragraphs (5)(i) or (5)(ii) of this mitigations are being taken to manage definition: PART 92—IMPORTATION OF ANIMALS all identified risks, but may not have (i) Has met the following conditions, AND ANIMAL PRODUCTS: been taken for the periods of time but not for at least the past 7 years: PROCEDURES FOR REQUESTING (A) Conducted an ongoing awareness RECOGNITION OF REGIONS program for veterinarians, farmers, and 1 A list of regions classified by APHIS as regions of controlled risk for BSEs is available at http:// workers involved in transportation, ■ 1. The authority citation for part 92 www.aphis.usda.gov/import_export/animals/ marketing, and slaughter of bovines to continues to read as follows: animal_disease_status.shtml. encourage reporting of bovines showing

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clinical signs that could be indicative of determined to be infected with BSE lumbar vertebrae, and the wings of the BSE; during its first year of life, and that sacrum), and the dorsal root ganglia. (B) Required notification and investigation showed consumed the * * * * * investigation of all bovines showing same potentially contaminated feed as ■ 3. Subpart A, consisting of existing clinical signs consistent with BSE; and the infected animal during that period; §§ 92.2 through 92.4, is added under the (C) Has carried out the examination, or following heading: in accordance with internationally (B) If the investigation was unable to accepted diagnostic tests and determine whether the feed source that Subpart A—Procedures for Requesting procedures and in approved was used to feed the bovine known to Recognition of Regions Other Than for laboratories, of brain or other tissues be infected was also used to feed other BSE collected as part of the surveillance and bovines in the herd of the infected monitoring described in paragraphs (3) animal, all bovines born in the same ■ 4. Subpart B, consisting of §§ 92.5, and (5)(i)(A) and (5)(i)(B) of this herd as a BSE-infected bovine either 92.6, and 92.7, is added to read as definition; or within 12 months before or 12 months follows: (ii) Has prohibited the feeding to after the birth of the infected animal. Subpart B—Procedures for Requesting BSE ruminants in the region of meat-and- (4) Has, for at least the past 7 years: Risk Status Classification With Regard to bone meal and greaves derived from (i) Conducted an ongoing awareness Bovines ruminants, but it cannot be program for veterinarians, farmers, and Sec. demonstrated through an appropriate workers involved in transportation, 92.5 Determination of the BSE risk level of control and audit that the marketing, and slaughter of bovines to classification of a region. prohibited materials have not been fed encourage reporting of bovines showing 92.6 Determination of the date of effective to ruminants in the region for at least clinical signs that could be indicative of enforcement of a ruminant-to-ruminant the past 8 years. BSE; feed ban. Region of negligible risk for bovine (ii) Required notification and 92.7 Incorporation by reference. spongiform encephalopathy (BSE).2 A investigation of all bovines showing Subpart B—Procedures for Requesting region for which a risk assessment has clinical signs consistent with BSE; and BSE Risk Status Classification With been conducted sufficient to identify the (iii) Carried out the examination, in Regard to Bovines historical and existing BSE risk factors accordance with internationally in the region and that: accepted diagnostic tests and § 92.5 Determination of the BSE risk (1) Has demonstrated that appropriate procedures and in approved classification of a region. mitigations to manage all identified laboratories, of brain or other tissues All countries of the world are risks have been taken for each relevant collected as part of the required considered by APHIS to be in one of period of time to meet each identified surveillance and monitoring described three BSE risk categories—negligible risk, as set forth in this definition. in paragraphs (2) and (4)(i) and (4)(ii) of risk, controlled risk, or undetermined (2) Has demonstrated that Type B this definition. risk. These risk categories are defined in surveillance in accordance with Article (5) Has demonstrated through an § 92.1. Any region that is not classified 11.5.22 of the OIE Code, incorporated by appropriate level of control and audit by APHIS as presenting either negligible reference in § 92.7, or with equivalent that, for at least the past 8 years, neither risk or controlled risk for BSE is guidelines recognized by the meat-and-bone meal nor greaves derived considered to present an undetermined Administrator is in place and the from ruminants have been fed to risk. The listing of those regions relevant points target, in accordance ruminants in the region. classified by APHIS as having either with Table 1 of Article 11.5.22 of the Region of undetermined risk for negligible risk or controlled risk can be OIE Code, or with equivalent guidelines bovine spongiform encephalopathy accessed on the APHIS Web site at recognized by the Administrator has (BSE). Any region that is not classified http://www.aphis.usda.gov/import_ been met. as either a region of negligible risk for export/animals/animal_disease_ (3) Meets one of the following BSE or a region of controlled risk for status.shtml. The listing can also be conditions: BSE. obtained by writing to APHIS at (i) Has had no case of BSE in the * * * * * National Import Export Services, 4700 region or every case has been Specified risk materials (SRMs) from River Road Unit 38, Riverdale, MD demonstrated to have been imported regions of controlled risk for BSE. Those 20737. APHIS may classify a region for and has been completely destroyed; or bovine parts considered to be at BSE according to either paragraph (a) or (ii) Has had at least one indigenous particular risk of containing the BSE paragraph (b) of this section. case, but every indigenous case was agent in infected animals, as listed in (a) BSE risk classification based on born more than 11 years ago, and all the FSIS regulations at 9 CFR 310.22(a). OIE classification. If the OIE has bovines described in either paragraph Specified risk materials (SRMs) from classified a country as either BSE (3)(ii)(A) or (3)(ii)(B) of this definition, regions of undetermined risk for BSE. negligible risk or BSE controlled risk, if still alive, are officially identified Those bovine parts considered to be at APHIS will seek information to support with unique individual identification particular risk of containing the BSE concurrence with the OIE classification. that is traceable to the premises of origin agent in infected animals, as listed in This information could be publicly of the animal, have their movements the FSIS regulations at 9 CFR 310.22(a), available information, or APHIS could controlled, and, when slaughtered or at except that the following bovine parts request that countries supply the same death, are completely destroyed: from regions of undetermined risk for information given to the OIE. APHIS (A) All bovines that, during their first BSE are considered SRMs if they are will announce in the Federal Register, year of life, were reared with a bovine derived from bovines over 12 months of subject to public comment, each intent age: Brain, skull, eyes, trigeminal to concur with an OIE classification. 2 A list of regions classified by APHIS as regions of negligible risk for BSEs is available at http:// ganglia, spinal cord, vertebral column APHIS will also post the summary of www.aphis.usda.gov/import_export/animals/ (excluding the vertebrae of the tail, the the BSE OIE ad hoc group conclusions animal_disease_status.shtml. transverse processes of the thoracic and for review during the comment period.

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The summaries would be available for (i) Relevant changes in BSE be classified regarding BSE risk. The review on the APHIS Web site at legislation, compared to the previous information APHIS will consider will http://www.aphis.usda.gov/import_ year; include, but not be limited to: export/animals/reg_request.shtml. (ii) The importation into the region (1) Policies and infrastructure for feed Following review of any comments during the year of cattle, processed ban enforcement, including an received, the Administrator will animal protein, and products containing awareness program for producers and announce his or her final determination processed animal protein; farmers; regarding classification of the country in (iii) Audit findings in rendering (2) Livestock husbandry practices; the Federal Register, along with a plants and feed mills that process (3) Disposition of processed animal discussion of and response to pertinent ruminant material or material from protein produced from domestic issues raised by commenters. If APHIS mixed species that contains ruminant bovines, including the feeding of such recognizes a country as either negligible material, related to the prohibition of material to any animal species; risk or controlled risk for BSE, the the feeding to ruminants of processed (4) Measures taken to control cross- Agency will include that country in a animal protein; contamination and mislabeling of feed; list of regions of negligible risk or (iv) Audit findings in rendering plants and controlled risk for BSE, as applicable, and feed mills that process nonruminant (5) Monitoring and enforcement of the that APHIS will make available to the material, related to the prohibition of ruminant-to-ruminant feed ban, public on the Agency’s Web site at the feeding to ruminants of processed including audit findings in rendering http://www.aphis.usda.gov/import_ animal protein; plants and feed mills that process export/animals/animal_disease_ (v) Infractions at the types of facilities ruminant material. status.shtml. listed above; (b) After conducting its evaluation, (b) Regions seeking classification as (vi) If and why, in light of the audit APHIS will announce in the Federal negligible or controlled risk that have findings, there has been no significant Register for public comment the date not been classified by the OIE. A region exposure of cattle to the BSE agent APHIS considers to be the date of that has not received classification by through consumption of processed effective enforcement of a ruminant-to- OIE as either negligible risk or animal protein of bovine origin; ruminant feed ban in the requesting controlled risk for BSE and that wishes (vii) Surveillance efforts; region, and will make available to the to be classified by APHIS as negligible (viii) All clinical BSE suspects; and public the evaluation conducted by risk or controlled risk must submit to (ix) Any new cases of BSE. APHIS, as well as the supporting the Administrator a request for (2) If APHIS at any time determines documentation. Following review of any classification, along with that a region no longer meets the criteria comments received, the Administrator documentation sufficient to allow for the risk classification it had will announce his or her final APHIS to conduct an evaluation of previously received, APHIS will remove determination in the Federal Register, whether the region meets the criteria for the region from its list of regions so along with a discussion of and response classification. A list of the classified. If the OIE determines the to pertinent issues raised by documentation required can be accessed region no longer meets the criteria for commenters. on the APHIS Web site at http:// the risk classification it had previously www.aphis.usda.gov/import_export/ received, APHIS may concur with the § 92.7 Incorporation by reference. animals/reg_request.shtml. If, following OIE determination or may request (a) Certain material is incorporated by evaluation of the information submitted, updated information from the region reference into this part with the the Administrator determines that the and determine whether to concur with approval of the Director of the Federal region meets the criteria for the OIE decision APHIS will announce Register under 5 U.S.C. 552(a) and 1 classification as negligible risk or its intent in the Federal Register and CFR part 51. To enforce any edition controlled risk, APHIS will announce accept public comment regarding that other than that specified in this section, that determination in the Federal intent. Following review of any USDA must publish notice of change in Register and will make available to the comments received, the Administrator the Federal Register and the material public on the APHIS Web site the will announce in the Federal Register must be available to the public. All evaluation conducted by APHIS, as well his or her final determination regarding approved material is available for as the information provided by the classification of the region, along with a inspection at the Animal and Plant requesting region. APHIS will accept discussion of and response to pertinent Health Inspection Service (APHIS), and public comment on its intent. Following issues raised by commenters. is available from the sources listed below. For information about the review of any comments received, the (Approved by the Office of Management and Administrator will announce his or her Budget under control number 0579–0393) availability of this material at APHIS, final determination regarding call 301–851–3300 or write to National classification of the region in the § 92.6 Determination of the date of Import Export Services, 4700 River Road Federal Register, along with a effective enforcement of a ruminant-to- Unit 38, Riverdale, MD 20737. It is also discussion of and response to pertinent ruminant feed ban. available for inspection at the National issues raised by commenters. (a) In order for APHIS to determine Archives and Records Administration (c) Retention of classification as either the eligibility of live bovines for (NARA). For information on the negligible risk or controlled risk. (1) As importation from a region classified as availability of this material at NARA, required by the OIE for countries BSE negligible risk or BSE controlled call 202-741-6030 or go to http:// classified as either negligible risk or risk, APHIS must determine the date www.archives.gov/federal_register/ controlled risk by the OIE, regions from which a ban on the feeding of code_of_federal_regulations/ibr_ evaluated by APHIS and classified as ruminant material to ruminants has locations.html. negligible or controlled risk would need been effectively enforced in the region. (b) World Organization for Animal to submit updated information to APHIS APHIS will base its determination of the Health (OIE), 12, rue de Prony 75017 each year. The required information date of effective enforcement on the Paris, France, or email [email protected], includes documentation of the information included in the dossier the http://www.oie.int/eng/normes/Mcode/ following: region submitted when it requested to en_sommaire.htm.

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(1) Terrestrial Animal Health Code, regions in § 94.18(a)(3) of this (B) A tattoo with the letters ‘‘CN’’ Chapter 11.5–Bovine Spongiform subchapter’’ and adding the words applied to the inside of one ear of the Encephalopathy, Article 11.5.22 ‘‘sheep or goats from Canada’’ in their animal; or (Surveillance activities), 22nd Edition, place and by removing the words ‘‘and (C) Other means of permanent 2013. 93.436(a)(3) and (b)(4)’’; and identification upon request if deemed (2) [Reserved] ■ b. In the OMB citation at the end of adequate by the Administrator to (Approved by the Office of Management and the section, by removing the words humanely identify the animal in a Budget under control number 0579–0393) ‘‘numbers 0579–0040, 0579–0165, and distinct and legible way as having been 0579–0234’’ and adding the words imported from Canada. PART 93—IMPORTATION OF CERTAIN ‘‘numbers 0579–0040, 0579–0165, (3) The bovines are accompanied by a ANIMALS, BIRDS, FISH, AND 0579–0234, and 0579–0393’’ in their certificate issued in accordance with POULTRY, AND CERTAIN ANIMAL, place. § 93.405 that states, in addition to the BIRD, AND POULTRY PRODUCTS; ■ 9. Section 93.418 is amended as statements required by § 93.405, that the REQUIREMENTS FOR MEANS OF follows: conditions of paragraph (d)(2) of this CONVEYANCE AND SHIPPING ■ a. By revising the section heading; section, as applicable, have been met. CONTAINERS ■ b. By adding paragraph (d); and (Approved by the Office of Management and ■ Budget under control number 0579–0393) ■ 5. The authority citation for part 93 c. By adding an OMB citation to the continues to read as follows: end of the section. ■ 10. Section § 93.420 is revised to read The revision and additions read as as follows: Authority: 7 U.S.C. 1622 and 8301–8317; follows: 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 § 93.420 Ruminants from Canada for CFR 2.22, 2.80, and 371.4. § 93.418 Cattle and other bovines from immediate slaughter other than sheep and ■ 6. Section 93.400 is amended by Canada. goats. adding definitions of exporting region * * * * * (a) General requirements. The and processed animal protein in (d) In addition to meeting the requirements for the importation of alphabetical order and revising the requirements of paragraphs (a) through sheep and goats from Canada for definition of recognized slaughtering (c) of this section, bovines may be immediate slaughter are contained in establishment to read as follows: imported from Canada only under the § 93.419. There are no BSE-related following conditions: restrictions on the importation of § 93.400 Definitions. (1) The bovines are imported for cervids or camelids from Canada. All * * * * * immediate slaughter under § 93.420; or other ruminants imported from Canada Exporting region. A region from (2) The bovines are imported for other for immediate slaughter, in addition to which shipments are sent to the United than immediate slaughter under the meeting all other applicable States. following conditions: requirements of this part, may be * * * * * (i) The bovines were born after March imported only under the following Processed animal protein. Meat meal, 1, 1999, the date determined by APHIS conditions: bone meal, meat-and-bone meal, blood to be the date of effective enforcement (1) The ruminants must be imported meal, dried plasma and other blood of a ruminant-to-ruminant feed ban in only through a port of entry listed in products, hydrolyzed protein, hoof Canada; § 93.403(b) or as provided for in meal, horn meal, poultry meal, feather (ii) The bovines are imported only § 93.403(f) and be inspected at the port meal, fish meal, and any other similar through a port of entry listed in of entry and otherwise handled in products. § 93.403(b) or as provided for in accordance with § 93.408. * * * * * § 93.403(f); (2) The ruminants must be moved Recognized slaughtering (iii) The bovines were officially directly from the port of entry to a establishment. Any slaughtering identified prior to arriving at the port of recognized slaughtering establishment establishment operating under the entry in the United States with unique in conveyances that are sealed with provisions of the Federal Meat individual identification that is seals of the U.S. Government at the port Inspection Act (21 U.S.C. 601 et seq.) or traceable to each bovine’s premises of of entry. The seals may be broken only a State meat inspection act.2 origin. No person may alter, deface, at the recognized slaughtering * * * * * remove, or otherwise tamper with the establishment by an authorized USDA official identification while the animal representative. 2 See footnote 1. is in the United States or moving into (3) The ruminants must be or through the United States, except that accompanied from the port of entry to § 93.401 [Amended] the identification may be removed at the recognized slaughtering ■ 7. In § 93.401, paragraph (a), the slaughter; and establishment by APHIS Form VS 17– second sentence is amended by adding (iv) The bovines are permanently and 33, which must include the location of the word ‘‘non-bovine’’ before the word humanely identified using one of the the recognized slaughtering ‘‘ruminant’’ and by removing the following additional methods: establishment. citation ‘‘§ 94.18(a)(1) or (a)(2)’’ and (A) A ‘‘CbN’’ mark properly applied (b) Bovines. In addition to meeting the adding the citation ‘‘§ 94.24(a)’’ in its with a freeze brand, hot iron, or other requirements of paragraph (a) of this place. method, and easily visible on the live section, bovines may be imported from animal and on the carcass before Canada for immediate slaughter only § 93.405 [Amended] skinning. Such a mark must be not less under the following conditions: ■ 8. Section 93.405 is amended as than 2 inches nor more than 3 inches (1) The bovines must have been born follows: high, and must be applied to each after March 1, 1999, the date determined ■ a. In paragraph (a)(4), by removing the animal’s right hip, high on the tail-head by APHIS to be the date of effective words ‘‘bovines, sheep, or goats from (over the junction of the sacral and first enforcement of a ruminant-to-ruminant regions listed as BSE minimal-risk coccygeal vertebrae); or feed ban in Canada;

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(2) Before the animal’s arrival at the the identification may be removed at government of the exporting region, or port of entry into the United States, each slaughter. issued by a veterinarian designated or bovine imported into the United States (3) The bovines, if sexually intact, are accredited by the national government from Canada must be officially permanently and humanely identified of the exporting region and endorsed by identified with unique individual using one of the following additional a full-time salaried veterinary officer of identification that is traceable to the methods: the national government of the premises of origin of the animal. No (i) An ‘‘MX’’ mark properly applied exporting region, representing that the person may alter, deface, remove, or with a freeze brand, hot iron, or other veterinarian issuing the certificate was otherwise tamper with the official method, and easily visible on the live authorized to do so, and the certificate identification while the animal is in the animal and on the carcass before attests that the exporting region of the United States or moving into or through skinning. Such a mark must be not less bovines is classified by APHIS as a the United States, except that the than 2 inches nor more than 3 inches negligible-risk region for BSE in which identification may be removed at high, and must be applied to each there has been no indigenous case of slaughter; and animal’s right hip, high on the tail-head BSE. (3) The bovines must be accompanied (over the junction of the sacral and first (b) Bovines from a region of negligible by a certificate issued in accordance coccygeal vertebrae); or risk for BSE in which there has been an with § 93.405 that states, in addition to (ii) A tattoo with the letters ‘‘MX’’ indigenous case of BSE and bovines the statements required by § 93.405, that applied to the inside of one ear of the from a region of controlled risk for BSE. the conditions of paragraphs (b)(1) and animal; or Bovines from a region of negligible risk (b)(2) of this section have been met. (iii) Other means of permanent for BSE, as defined in § 92.1 of this identification upon request if deemed subchapter, in which there has been an (Approved by the Office of Management and adequate by the Administrator to indigenous case of BSE, and bovines Budget under control numbers 0579–0234 and 0579–0393) humanely identify the animal in a from a region of controlled risk for BSE, distinct and legible way as having been as defined in § 92.1 of this subchapter, ■ 11. In § 93.423, paragraph (e) is added imported from Mexico. may be imported only under the to read as follows: (4) The bovines are accompanied by a following conditions: § 93.423 Ruminants from Central America certificate issued in accordance with (1) Prior to importation into the and the West Indies. § 93.405 that states, in addition to the United States, each bovine is officially * * * * * statements required by § 93.405, that the identified with unique individual (e) In addition to meeting all other conditions of paragraphs (e)(1) through identification that is traceable to the applicable requirements of this part, (e)(3) of this section have been met. premises of origin of the animal. No bovines from Central America and the (Approved by the Office of Management and person may alter, deface, remove, or West Indies may be imported only in Budget under control number 0579–0393) otherwise tamper with the official accordance with § 93.436. ■ 13. In § 93.432, the section heading is identification while the animal is in the United States or moving into or through * * * * * revised and paragraph (e) is added to read as follows: the United States, except that the ■ 12. Section 93.427 is amended as identification may be removed at follows: § 93.432 Cattle and other bovines from the slaughter. ■ a. By revising the section heading; Republic of Ireland. (2) The bovines are permanently and ■ b. By adding paragraph (e); and * * * * * humanely identified before arrival at the ■ c. By adding an OMB citation at the (e) In addition to meeting all other port of entry with a distinct and legible end of the section. applicable requirements of this part, mark identifying the exporting country. The revision and additions read as bovines from the Republic of Ireland Acceptable means of permanent follows: may be imported only in accordance identification include the following: with § 93.436. (i) A mark properly applied with a § 93.427 Cattle and other bovines from freeze brand, hot iron, or other method, Mexico. ■ 14. Section § 93.436 is revised to read as follows: and easily visible on the live animal and * * * * * on the carcass before skinning. Such a (e) BSE. In addition to meeting the § 93.436 Bovines from regions of mark must be not less than 2 inches nor requirements of paragraphs (a) through negligible risk, controlled risk, and more than 3 inches high, and must be (d) of this section and all other undetermined risk for BSE. applied to each animal’s right hip, high applicable requirements of this part, The importation of bovines is on the tail-head (over the junction of the bovines may be imported from Mexico prohibited, unless the conditions of this sacral and first coccygeal vertebrae); only under the following conditions: section and any other applicable (ii) A tattoo with letters identifying (1) The bovines were born after conditions of this part are met. Once the the exporting country must be applied November 30, 2007, the date determined bovines are imported, if they do not to the inside of one ear of the animal; by APHIS to be the date of effective meet the conditions of this section, they or enforcement of a ruminant-to-ruminant must be disposed of as the (iii) Other means of permanent feed ban in Mexico. Administrator may direct. identification upon request if deemed (2) The bovines were officially (a) Bovines from a region of negligible adequate by the Administrator to identified prior to arriving at the port of risk for BSE in which there has been no humanely identify the animal in a entry in the United States with unique indigenous case of BSE. Bovines from a distinct and legible way as having been individual identification that is region of negligible risk for BSE, as imported from a region of negligible risk traceable to each bovine’s premises of defined in § 92.1 of this subchapter, in for BSE in which there has been an origin. No person may alter, deface, which there has been no indigenous indigenous case of BSE or from a region remove, or otherwise tamper with the case of BSE, may be imported only if the of controlled risk for BSE. official identification while the animal bovines are accompanied by an original (3) The bovines were born after the is in the United States or moving into certificate issued by a full-time salaried date from which the ban on the feeding or through the United States, except that veterinary officer of the national of ruminants meat-and-bone meal or

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greaves derived from ruminants has PART 94—RINDERPEST, FOOT-AND- (excluding the vertebrae of the tail, the been effectively enforced. MOUTH DISEASE, NEWCASTLE transverse processes of the thoracic and (4) The bovines are accompanied by DISEASE, HIGHLY PATHOGENIC lumbar vertebrae, and the wings of the an original certificate issued by a full- AVIAN INFLUENZA, AFRICAN SWINE sacrum), and the dorsal root ganglia. time salaried veterinary officer of the FEVER, CLASSICAL SWINE FEVER, * * * * * national government of the exporting SWINE VESICULAR DISEASE, AND BOVINE SPONGIFORM § 94.1 [Amended] region, or issued by a veterinarian ENCEPHALOPATHY: PROHIBITED ■ 17. In § 94.1, paragraphs (b)(4) and (d) designated or accredited by the national AND RESTRICTED IMPORTATIONS are amended by removing the citation government of the exporting region and ‘‘§ 94.22’’ both times it appears and endorsed by a full-time salaried ■ 15. The authority citation for part 94 adding the citation ‘‘§ 94.29’’ in their veterinary officer of the national continues to read as follows: place. government of the exporting region, Authority: 7 U.S.C. 450, 7701–7772, 7781– § 94.9 [Amended] representing that the veterinarian 7786, and 8301–8317; 21 U.S.C. 136 and issuing the certificate was authorized to 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and ■ 18. In § 94.9, paragraph (c) is amended do so, and the certificate attests to the 371.4. by removing the citation ‘‘§ 94.24’’ and BSE risk classification of the exporting ■ 16. Section 94.0 is amended by adding the citation ‘‘§ 94.31’’ in its region and that the conditions of removing the definitions of cervid and place. paragraphs (b)(1) through (b)(3) of this specified risk materials (SRMs) and § 94.10 [Amended] section have been met. adding definitions of exporting region, ■ (5) If there has been an indigenous mechanically separated meat, processed 19. In § 94.10, paragraph (c) is amended by removing the citation case of BSE in the exporting region, the animal protein, specified risk materials ‘‘§ 94.24’’ and adding the citation following restrictions apply: (SRMs) from regions of controlled risk for BSE, and specified risk materials ‘‘§ 94.31’’ in its place. (i) Bovines that, during their first year (SRMs) from regions of undetermined ■ 20. Section 94.18 is revised to read as of life, were reared with a bovine risk for BSE in alphabetical order to read follows: determined to be infected with BSE as follows: during its first year of life, and that an § 94.18 Bovine spongiform investigation showed consumed the § 94.0 Definitions. encephalopathy; importation of edible products derived from bovines. same potentially contaminated feed as * * * * * (a) The importation of meat, meat the infected animal during that period Exporting region. A region from products, and other edible products are not eligible for importation into the which shipments are sent to the United derived from bovines is prohibited with United States; and States. regard to BSE, except as provided in this (ii) If the investigation was unable to * * * * * Mechanically separated meat. A section and in §§ 94.19, 94.20, 94.21, determine whether the feed source that finely comminuted product resulting 94.22, 94.23, and 94.27. was used to feed the bovine known to (b) The following commodities from the mechanical separation and derived from bovines may be imported be infected was also used to feed other removal of most of the bone from into the United States without bovines in the herd of the infected attached skeletal muscle of bovine restriction regarding BSE, provided that animal, all bovines born in the same carcasses that meets the FSIS all other applicable requirements of this herd as a BSE-infected bovine either specifications contained in 9 CFR 319.5. within 12 months before or 12 months part are met: * * * * * after the birth of the infected animal are (1) Milk and milk products; Processed animal protein. Meat meal, (2) Boneless skeletal muscle meat not eligible for importation into the bone meal, meat-and-bone meal, blood (excluding mechanically separated United States. meal, dried plasma and other blood meat) that: (c) Bovines from a region of products, hydrolyzed protein, hoof (i) Is derived from bovines that were undetermined risk for BSE. Importation meal, horn meal, poultry meal, feather not, prior to slaughter, subjected to a of bovines from a region of meal, fish meal, and any other similar pithing process or to stunning with a undetermined risk for BSE, as defined products. device injecting compressed air or gas in § 92.1 of this subchapter, is * * * * * into the cranial cavity, and that passed prohibited; Except that: The Specified risk materials (SRMs) from ante-mortem and post-mortem Administrator may allow such imports regions of controlled risk for BSE. Those inspection; on a case-by-case basis if the live bovine parts considered to be at (ii) Has been prepared in a manner to bovines are imported for specific uses, particular risk of containing the BSE prevent contamination with SRMs; and including, but not limited to, show or agent in infected animals, as listed in (iii) Is accompanied to the United States by an original certificate stating exhibition, and under conditions the FSIS regulations at 9 CFR 310.22(a). that the conditions of paragraphs determined by the Administrator to be Specified risk materials (SRMs) from (b)(2)(i) and (b)(2)(ii) of this section have adequate to prevent the spread of BSE. regions of undetermined risk for BSE. Those bovine parts considered to be at been met. The certificate must be issued (Approved by the Office of Management and particular risk of containing the BSE and signed by a full-time salaried Budget under control number 0579–0234) agent in infected animals, as listed in veterinary officer of the national the FSIS regulations at 9 CFR 310.22(a), government of the exporting region or except that the following bovine parts signed by a person authorized to issue from regions of undetermined risk for such certificates by the veterinary BSE are considered SRMs if they are services of the national government of derived from bovines over 12 months of the exporting region. age: Brain, skull, eyes, trigeminal (Approved by the Office of Management and ganglia, spinal cord, vertebral column Budget under control number 0579–0015)

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■ 21. Section 94.19 is revised to read as comparable to those provided in 9 CFR meat-and-bone meal or greaves derived follows: 301.2 with regard to cattle, and other from ruminants. than boneless skeletal meat that meets (b) The commodities were derived § 94.19 Importation of meat, meat from bovines that passed ante-mortem byproducts, and meat food products the conditions of § 94.18(b)(2)—may be derived from bovines from regions of imported from a region of controlled and post-mortem inspections. negligible risk for BSE. risk for BSE, as defined in § 92.1 of this (c) The commodities were derived from bovines that were not subjected to Meat, meat byproducts, and meat food subchapter, if the following conditions a stunning process, prior to slaughter, products, as defined by FSIS in 9 CFR and all other applicable requirements of with a device injecting compressed air 301.2–except that those terms as applied this part are met: or gas into the cranial cavity, or to a to bison shall have a meaning (a) The commodities were exported pithing process. comparable to those provided in 9 CFR from a region of controlled risk for BSE. (b) The commodities were derived (d) The commodities were produced 301.2 with regard to cattle, and other and handled in a manner that ensured than boneless skeletal meat that meets from bovines that passed ante-mortem and post-mortem inspections. that such commodities do not contain the conditions of § 94.18(b)(2)—may be and are not contaminated with any of imported from a region of negligible risk (c) The commodities were derived from bovines that were not subjected to the following: for BSE, as defined in § 92.1 of this (1) SRMs from regions of subchapter, if the following conditions a stunning process, prior to slaughter, with a device injecting compressed air undetermined risk for BSE; or and all other applicable requirements of (2) Mechanically separated meat from or gas into the cranial cavity, or to a this part are met: the skull and vertebral column from pithing process. (a) The commodities were exported bovines over 12 months of age. from a region of negligible risk for BSE. (d) The commodities were produced (e) The commodities are accompanied (b) If BSE has been diagnosed in one and handled in a manner that ensured by an original certificate stating that the or more indigenous bovines in the that such commodities do not contain exporting region is a region of region of negligible risk, the and are not contaminated with either of undetermined risk for BSE and that the commodities were derived from bovines the following: conditions of this section have been subject to a ban on the feeding to (1) SRMs from regions of controlled met. The certificate must be issued and ruminants of meat-and-bone meal or risk for BSE; or signed by a full-time salaried veterinary greaves derived from ruminants. (2) Mechanically separated meat from officer of the national government of the (c) The commodities were derived the skull and vertebral column from exporting region, or signed by a person from bovines that passed ante-mortem bovines 30 months of age or older. authorized to issue such certificates by and post-mortem inspections. (e) The commodities are accompanied the veterinary services of the national (d) The commodities are accompanied by an original certificate stating that the government of the exporting region. by an original certificate stating that the exporting region is classified by APHIS exporting region is classified by APHIS (Approved by the Office of Management and as a region of controlled risk for BSE, Budget under control number 0579–0393) as a region of negligible risk for BSE and and that the conditions of this section that the conditions of paragraphs (a) have been met. The certificate must be § 94.27 [Removed] through (c) of this section, as applicable, issued and signed by a full-time salaried ■ 24. Section 94.27 is removed. have been met. The certificate must be veterinary officer of the national issued and signed by a full-time salaried government of the exporting region, or §§ 94.22 through 94.26 [Redesignated veterinary officer of the national signed by a person authorized to issue §§ 94.29 through 94.33] government of the exporting region, or such certificates by the veterinary ■ 25. Sections 94.22 through 94.26 are signed by a person authorized to issue services of the national government of redesignated as §§ 94.29 through 94.33, such certificates by the veterinary the exporting region. respectively. services of the national government of ■ 26. New §§ 94.22 through 94.27 are the exporting region. (Approved by the Office of Management and Budget under control numbers 0579–0015 added to read as follows: Note: To be eligible to export meat, meat and 0579–0393) Sec. byproducts, and meat food products under ■ 23. Section 94.21 is added to read as the conditions of this section for human * * * * * consumption, a region must also be one that follows: 94.22 Meat or dressed carcasses of hunter- has demonstrated to FSIS in accordance with § 94.21 Importation of meat, meat harvested bovines. 9 CFR 310.22 that its BSE risk status can byproducts, and meat food products 94.23 Importation of gelatin derived from bovines. reasonably be expected to provide the same derived from bovines from regions of level of protection from human exposure to 94.24 Restrictions on importation of meat undetermined risk for BSE. the BSE agent as does prohibiting specified and edible products from ovines and risk materials for use as human food in the Meat, meat byproducts, and meat food caprines due to bovine spongiform United States. products, as defined by FSIS in 9 CFR encephalopathy. 301.2–except that those terms as applied 94.25 Restrictions on the importation from (Approved by the Office of Management and to bison shall have a meaning Canada of meat and edible products from Budget under control number 0579–0393) comparable to those provided in 9 CFR ovines and caprines other than gelatin. ■ 22. Section 94.20 is revised to read as 301.2 with regard to cattle, and other 94.26 Gelatin derived from horses or swine follows: or from ovines or caprines that have not than boneless skeletal meat that meets been in a region restricted because of § 94.20 Importation of meat, meat the conditions of § 94.18(b)(2)—may be BSE. byproducts, and meat food products imported from regions of undetermined 94.27 Transit shipment of articles. derived from bovines from regions of risk for BSE, as defined in § 92.1 of this * * * * * controlled risk for BSE. subchapter, if the following conditions Meat, meat byproducts, and meat food and all other applicable requirements of § 94.22 Meat or dressed carcasses of products, as defined by FSIS in 9 CFR this part are met: hunter-harvested bovines. 301.2—except that those terms as (a) The commodities were derived The meat or dressed carcass applied to bison shall have a meaning from bovines that have never been fed (eviscerated and the head is removed) is

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derived from a wild bovine that has issuing the certificate was authorized to Permit for Importation and been legally harvested in the wild, as do so. The certificate must state that the Transportation of Controlled Materials verified by proof such as a hunting requirements of paragraph (b), (c), or (d) and Organisms and Vectors by filing a license, tag, or the equivalent that the of this section, as applicable, have been permit application on VS Form 16–3. To hunter must show to the authorized met and, for gelatin other than that apply for a permit, file a permit inspector. described in paragraph (b) of this application on VS Form 16–3 (available (Approved by the Office of Management and section, must indicate the BSE risk from APHIS, Veterinary Services, Budget under control number 0579–0393) classification of the exporting region. National Center for Import and Export, (f) The Administrator determines that 4700 River Road Unit 38, Riverdale, MD § 94.23 Importation of gelatin derived from the gelatin will not come into contact 20737–1231, or electronically at http:// bovines. with ruminants in the United States and www.aphis.usda.gov/animal_health/ (a) The importation of gelatin derived can be imported under conditions that permits/). The application for such a from bovines is prohibited because of will prevent the introduction of BSE permit must state the intended use of BSE, unless: into the United States, and the person the gelatin and name and address of the (1) The gelatin meets the requirements importing the gelatin has obtained a consignee in the United States. of either paragraph (b), (c), or (d), as United States Veterinary Permit for well as the requirements of paragraph Importation and Transportation of § 94.25 Restrictions on the importation (e) of this section and all other Controlled Materials and Organisms and from Canada of meat and edible products applicable requirements of this part; or from ovines and caprines other than Vectors. To apply for a permit, file a gelatin. (2) The gelatin is authorized permit application on VS Form 16–3 The commodities listed in paragraphs importation under paragraph (f) of this (available from APHIS, Veterinary (a) and (b) of this section may be section and meets all other applicable Services, National Center for Import and imported from Canada if the conditions requirements of this part. Export, 4700 River Road Unit 38, of this section are met. (b) The gelatin is derived from hides Riverdale, MD 20737–1231, or (a) Meat, carcasses, meat byproducts, and skins, provided the gelatin has not electronically at http:// and meat food products from ovines or been commingled with materials www.aphis.usda.gov/animal_health/ caprines. (1) The meat, carcass, meat ineligible for entry into the United permits/). The application for such a byproduct, or meat food product, as States. permit must state the intended use of defined by FSIS in 9 CFR 301.2, is (c) The gelatin is derived from the the gelatin and name and address of the derived from ovines or caprines that are bones of bovines and originates in a consignee in the United States. region of negligible risk for BSE. from a flock or herd subject to a (d) The gelatin is derived from the § 94.24 Restrictions on importation of ruminant feed ban equivalent to the bones of bovines, originates in a region meat and edible products from ovines and requirements established by the U.S. of controlled risk or undetermined risk caprines due to bovine spongiform Food and Drug Administration at 21 for BSE, and meets the requirements of encephalopathy. CFR 589.2000, and the ovines or paragraphs (d)(1) through (d)(4) of this (a) Except as provided in paragraph caprines: section: (b) of this section and in § 94.25, the (i) Were less than 12 months of age (1) The bones from which the gelatin importation of meat, meat products, and when slaughtered; was derived were derived from bovines edible products other than meat (ii) Were slaughtered at a facility that that passed ante-mortem and post- (excluding milk and milk products) either slaughters only ovines or caprines mortem inspection. from ovines and caprines that have been less than 12 months of age or complies (2) The bones from which the gelatin in any of the following regions is with a segregation process approved by was derived did not include the skulls prohibited: Albania, Andorra, Austria, the national veterinary authority of the of bovines or the vertebral column of Belgium, Bosnia-Herzegovina, Bulgaria, region of origin and the Administrator bovines 30 months of age or older. Canada, Croatia, the Czech Republic, as adequate to prevent contamination or (3) The bones were subjected to a Denmark, the Federal Republic of commingling of the meat with products process that includes all of the Yugoslavia, Finland, France, Germany, not eligible for importation into the following steps, or to a process at least Greece, Hungary, the Republic of United States; as effective in reducing BSE infectivity: Ireland, Israel, Italy, Japan, (iii) Did not test positive for and were (i) Degreasing; Liechtenstein, Luxembourg, the Former not suspect for a transmissible (ii) Acid demineralization; Yugoslav Republic of Macedonia, spongiform encephalopathy; (iii) Acid or alkaline treatment; Monaco, Norway, Oman, the (iv) Never resided in a flock or herd (iv) Filtration; and Netherlands, Poland, Portugal, Romania, that has been diagnosed with BSE; and (v) Sterilization at 138 °C (280.4 °F) or San Marino, Slovakia, Slovenia, Spain, (v) Were not subject to any movement greater for a minimum of 4 seconds; and Sweden, Switzerland, and the United restrictions within Canada as a result of (4) The gelatin has not been Kingdom. exposure to a transmissible spongiform commingled with materials ineligible (b) The importation of gelatin derived encephalopathy. for entry into the United States. from ovines or caprines that have been (2) The commodities are accompanied (e) The gelatin is accompanied to the in any region listed in paragraph (a) of by an original certificate of such United States by an original certificate this section is prohibited unless the compliance issued by a full-time signed by a full-time salaried veterinary following conditions have been met: salaried veterinary officer of Canada, or officer of the national government of the (1) The gelatin is imported for use in issued by a veterinarian designated by exporting region, or issued by a human food, human pharmaceutical the Canadian government and endorsed veterinarian designated by the national products, photography, or some other by a full-time salaried veterinary officer government of the exporting region and use that will not result in the gelatin of the Government of Canada, endorsed by a full-time salaried coming in contact with ruminants in the representing that the veterinarian veterinary officer of the national United States. issuing the certificate was authorized to government of the exporting region, (2) The person importing the gelatin do so; and if all other applicable representing that the veterinarian obtains a United States Veterinary requirements of this part are met.

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(b) Meat or dressed carcasses of paragraphs (a) through (c) this section Authority: 7 U.S.C. 8301–8317; 21 U.S.C. hunter-harvested ovines or caprines. (1) are met. Meat, meat products, and other 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, The meat or dressed carcass (eviscerated edible products derived from bovines, 2.80, and 371.4. and the head is removed) is derived ovines, or caprines are eligible to transit ■ 29. Section 95.1 is amended by from a wild ovine or caprine that has the United States by overland removing the definition of specified risk been legally harvested in the wild, as transportation if the requirements of materials (SRMs), by revising the verified by proof such as a hunting paragraphs (a) through (d) of this section definition of offal, and by adding license, tag, or the equivalent that the are met: definitions of exporting region, specified hunter must show to the United States (a) The articles must be sealed in risk materials (SRMs) from regions of Customs and Border Protection official; leakproof containers bearing serial controlled risk for BSE, specified risk and numbers during transit. Each container materials (SRMs) from regions of (2) The animal from which the meat must remain sealed during the entire undetermined risk for BSE, and tallow is derived was harvested within a time that it is in the United States. derivative in alphabetical order to read jurisdiction specified by the (b) The person moving the articles as follows: Administrator for which the game and must notify, in writing, the inspector at wildlife service of the jurisdiction has both the place in the United States § 95.1 Definitions. informed the Administrator either that where the articles will arrive and the * * * * * the jurisdiction conducts no type of port of export before such transit. The Exporting region. A region from game feeding program, or has complied notification must include the: which shipments are sent to the United with, and continues to comply with, a (1) Times and dates of arrival in the States. ruminant feed ban equivalent to the United States; * * * * * requirements established by the U.S. (2) Times and dates of exportation Offal. The inedible parts of a Food and Drug Administration at 21 from the United States; butchered animal. CFR 589.2000. (3) Mode of transportation; and * * * * * (c) Ports. All products to be brought Specified risk materials (SRMs) from into the United States under this section (4) Serial numbers of the sealed containers. regions of controlled risk for BSE. Those must, if arriving at a land border port, bovine parts considered to be at (c) The articles must transit the arrive at one of the following ports: particular risk of containing the BSE United States in Customs bond. Eastport, ID; Houlton, ME; Detroit agent in infected animals, as listed in (Ambassador Bridge), Port Huron, and (d) The commodities must be eligible the FSIS regulations at 9 CFR 310.22(a). Sault St. Marie, MI; International Falls, to enter the United States in accordance Specified risk materials (SRMs) from MN; Sweetgrass, MT; Alexandria Bay, with the provisions of this part and regions of undetermined risk for BSE. Buffalo (Lewiston Bridge and Peace must be accompanied by the Those bovine parts considered to be at Bridge), and Champlain, NY; Pembina certification required by that section. particular risk of containing the BSE and Portal, ND; Derby Line and Additionally, the following conditions agent in infected animals, as listed in Highgate Springs, VT; and Blaine must be met: the FSIS regulations at 9 CFR 310.22(a), (Pacific Highway and Cargo Ops), (1) The shipment must be exported except that the following bovine parts Lynden, Oroville, and Sumas (Cargo), from the United States within 7 days of from regions of undetermined risk for WA. its entry; and BSE are considered SRMs if they are § 94.26 Gelatin derived from horses or (2) The commodities may not be derived from bovines over 12 months of swine or from ovines or caprines that have transloaded while in the United States, age: Brain, skull, eyes, trigeminal not been in a region restricted because of except for direct transloading under the ganglia, spinal cord, vertebral column BSE. supervision of an authorized inspector, (excluding the vertebrae of the tail, the Gelatin derived from horses or swine, who must break the seals of the national transverse processes of the thoracic and or from ovines or caprines that have not government of the region of origin on lumbar vertebrae, and the wings of the been in any region listed in § 94.24(a) the means of conveyance that carried sacrum), and the dorsal root ganglia. must be accompanied at the time of the commodities into the United States * * * * * importation into the United States by an and seal the means of conveyance that Tallow derivative. Any chemical official certificate issued by a will carry the commodities out of the obtained through initial hydrolysis, veterinarian employed by the national United States with seals of the U.S. saponification, or transesterification of government of the region of origin. The Government. tallow; chemical conversion of material official certificate must state the species (Approved by the Office of Management and obtained by hydrolysis, saponification, of animal from which the gelatin is Budget under control number 0579–0393) or transesterification may be applied to derived and, if the gelatin is derived obtain the desired product. § 94.28 [Amended] from ovines or caprines, certify that the * * * * * ■ gelatin is not derived from ovines or 27. In § 94.28, paragraph (c) is ■ 30. Section 95.4 is revised to read as caprines that have been in any region amended by removing the citation follows: listed in § 94.24(a). ‘‘§ 94.28(b)(5)’’ and adding ‘‘paragraph (b)(5) of this section’’ in its place. § 95.4 Restrictions on the importation of § 94.27 Transit shipment of articles. processed animal protein, offal, tankage, Meat, meat products, and other edible PART 95—SANITARY CONTROL OF fat, glands, certain tallow other than tallow products derived from bovines, ovines, ANIMAL BYPRODUCTS (EXCEPT derivatives, and serum due to bovine or caprines that are otherwise CASINGS), AND HAY AND STRAW, spongiform encephalopathy. prohibited importation into the United OFFERED FOR ENTRY INTO THE (a) Except as provided in paragraphs States in accordance with § 94.18 UNITED STATES (c), (d), (e), (f), or (g) of this section or through § 94.26 may transit air and in § 95.15, any of the materials listed in ocean ports in the United States for ■ 28. The authority citation for part 95 paragraph (b) of this section derived immediate export if the conditions of continues to read as follows: from animals, or products containing

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such materials, are prohibited in a facility that has not been used for Center for Import and Export, 4700 importation into the United States if the processing and storage of materials River Road Unit 38, Riverdale, MD paragraph (a)(1), (a)(2), or (a)(3) of this derived from ovines and caprines that 20737–1231, or electronically at http:// section applies: have been in any region other than www.aphis.usda.gov/animal_health/ (1) The animals have been in any Canada that is listed in paragraph (a)(4) permits/.) region listed in paragraph (a)(4) of this of this section. (d) Except as provided in paragraph section; (4) The facility demonstrates to (e) of this section and in § 95.15, serum (2) The materials have been stored, APHIS that the materials intended for from ovines or caprines that have been rendered, or otherwise processed in a exportation to the United States were in any region listed in paragraph (a)(4) region listed in paragraph (a)(4) of this transported to and from the facility in a of this section is prohibited importation section; or manner that would prevent cross- into the United States, except for (3) The materials have otherwise been contamination by or commingling with scientific, educational, or research associated with a facility in a region prohibited materials. purposes if the Administrator listed in paragraph (a)(4) of this section. (5) If the facility processes or handles determines that the importation can be (4) Albania, Andorra, Austria, any material derived from mammals, made under conditions that will prevent Belgium, Bosnia-Herzegovina, Bulgaria, inspection of the facility for compliance the introduction of BSE into the United Canada, Croatia, the Czech Republic, with the provisions of this section is States. Such serum must be Denmark, the Federal Republic of conducted at least annually by a accompanied by a permit issued by Yugoslavia, Finland, France, Germany, representative of the government agency APHIS in accordance with § 104.4 of Greece, Hungary, the Republic of responsible for animal health in the this chapter and must be moved and Ireland, Israel, Italy, Japan, region, unless the region chooses to handled as specified on the permit. Liechtenstein, Luxembourg, the Former have such inspection conducted by (e) The importation of serum albumin, Yugoslav Republic of Macedonia, APHIS. If APHIS conducts the serocolostrum, amniotic liquids or Monaco, Norway, Oman, the inspections required by this section, the extracts, and placental liquids derived Netherlands, Poland, Portugal, Romania, facility has entered into a cooperative from ovines or caprines that have been San Marino, Slovakia, Slovenia, Spain, service agreement executed by the in any region listed in paragraph (a)(4) Sweden, Switzerland, and the United operator of the facility and APHIS. In of this section, and collagen and Kingdom. accordance with the cooperative service collagen products that are derived from (b) Restricted materials: (1) Processed agreement, the facility must be current ovines or caprines and that would animal protein, tankage, offal, and in paying all costs for a veterinarian of otherwise be prohibited under tallow other than tallow derivatives, APHIS to inspect the facility (it is paragraphs (a) and (b) of this section, is unless in the opinion of the anticipated that such inspections will prohibited unless the following Administrator, the tallow cannot be occur approximately once per year), conditions have been met: used in feed; including travel, salary, subsistence, (1) The article is imported for use as (2) Glands, unprocessed fat tissue, administrative overhead, and other an ingredient in cosmetics; and blood and blood products; incidental expenses (including excess (2) The person importing the article (3) Processed fats and oils, and baggage provisions up to 150 pounds). has obtained a United States Veterinary derivatives of processed animal protein, In addition, the facility must have on Permit for Importation and tankage, and offal; or deposit with APHIS an unobligated Transportation of Controlled Materials (4) Derivatives of glands and blood amount equal to the cost for APHIS and Organisms and Vectors by filing a and blood products. personnel to conduct one inspection. As permit application on VS Form 16–3 (c) The import prohibition in funds from that amount are obligated, a (VS Form 16–3 may be obtained from paragraph (a) of this section does not bill for costs incurred based on official APHIS, Veterinary Services, National apply if the following conditions are accounting records will be issued to Center for Import and Export, 4700 met prior to importation: restore the deposit to the original level, River Road Unit 38, Riverdale, MD (1) The material is derived from one revised as necessary to allow for 20737–1231, or electronically at http:// of the following: inflation or other changes in estimated www.aphis.usda.gov/animal_health/ (i) A nonruminant species and the costs. To be current, bills must be paid permits/.); and material is not ineligible for importation within 14 days of receipt. (3) The permit application states the under § 95.13 or § 95.14; (6) The facility allows periodic APHIS intended use of the article and the name (ii) Cervids or camelids; inspection of its facilities, records, and and address of the consignee in the (iii) Bovines, and the material is not operations. United States. ineligible for importation under the (7) Each shipment to the United States (f) Insulin otherwise prohibited under conditions of § 95.5, § 95.6, § 95.7, is accompanied by an original certificate paragraphs (a) and (b) of this section § 95.8, § 95.9, § 95.10, or § 95.12; or signed by a full-time, salaried may be imported if the insulin is for the (iv) Ovines or caprines that have veterinarian of the government agency personal medical use of the person never been in any region listed in responsible for animal health in the importing it and if the person importing paragraph (a)(4) of this section. exporting region certifying that the the shipment has applied for and (2) In any region other than Canada conditions of paragraphs (c)(1) through obtained from APHIS a United States that is listed in paragraph (a)(4) of this (c)(5) of this section have been met. Veterinary Permit for Importation and section, all steps of processing and (8) The person importing the Transportation of Controlled Materials storing the material are carried out in a shipment has applied for and obtained and Organisms and Vectors. To apply facility that has not been used for the from APHIS a United States Veterinary for a permit, file a permit application on processing and storage of materials Permit for Importation and VS Form 16–3 (available from APHIS, derived from ovines or caprines that Transportation of Controlled Materials Veterinary Services, National Center for have been in any region that is listed in and Organisms and Vectors by filing a Import and Export, 4700 River Road paragraph (a)(4) of this section. permit application on VS Form 16–3. Unit 38, Riverdale, MD 20737–1231, or (3) In Canada, all steps of processing (VS Form 16–3 may be obtained from electronically at http:// and storing the material are carried out APHIS, Veterinary Services, National www.aphis.usda.gov/animal_health/

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permits/). The application for such a Sec. government of the exporting region, permit must state the intended use of * * * * * representing that the veterinarian the insulin and the name and address of 95.5 Processed animal protein derived from issuing the certificate was authorized to the consignee in the United States. ruminants. do so. The certificate must state the 95.6 Offal derived from bovines. exporting region and that the Note to paragraph (f): Insulin that is not 95.7 Collagen derived from bovines. prohibited from importation under this requirements of this section, as 95.8 Tallow derived from bovines. applicable, have been met. paragraph may be prohibited from 95.9 Derivatives of tallow derived from importation under other Federal laws, bovines. (d) The person importing the including the Federal Food, Drug, and 95.10 Dicalcium phosphate derived from processed animal protein obtains a Cosmetic Act, 21 U.S.C. 321 et seq. bovines. United States Veterinary Permit for (g) Offal that is otherwise prohibited 95.11 Specified risk materials. Importation and Transportation of under paragraphs (a) and (b) of this 95.12 Blood and blood products derived Controlled Materials and Organisms and section because it is derived from ovines from bovines. Vectors by filing a permit application on or caprines that have been in a region 95.13 Importation from regions of negligible VS Form 16–3. To apply for a permit, listed in paragraph (a)(4) of this section risk for BSE of processed animal protein file a permit application on VS Form may be imported into the United States derived from animals other than ruminants. 16–3 (available from APHIS, Veterinary if the offal is derived from ovines or 95.14 Importation from regions of Services, National Center for Import and caprines from Canada that have not controlled risk or undetermined risk for Export, 4700 River Road Unit 38, been in a region listed in paragraph BSE of processed animal protein derived Riverdale, MD 20737–1231, or (a)(4) of this section other than Canada, from animals other than ruminants. electronically at http:// and the following conditions are met: 95.15 Transit shipment of articles. www.aphis.usda.gov/animal_health/ (1) The offal: * * * * * permits/). The application for such a (i) Is derived from ovines or caprines permit must state the intended use of that were less than 12 months of age § 95.5 Processed animal protein derived the processed animal protein and name when slaughtered and that are from a from ruminants. and address of the consignee in the flock or herd subject to a ruminant feed The importation of ruminant-derived United States. ban equivalent to the requirements processed animal protein, or any established by the U.S. Food and Drug commodities containing such products, (Approved by the Office of Management and Budget under control number 0579–0393) Administration at 21 CFR 589.2000; is prohibited unless the conditions of (ii) Is not derived from ovines or this section are met: § 95.6 Offal derived from bovines. (a) The exporting region is a region of caprines that have tested positive for or Offal derived from bovines is are suspect for a transmissible negligible risk for BSE; and (1) The product has not been prohibited importation into the United spongiform encephalopathy; States unless it meets the requirements (iii) Is not derived from animals that commingled or contaminated with for the importation of meat, meat have resided in a flock or herd that has ruminant meat-and-bone meal or products, and meat byproducts in either been diagnosed with BSE; and greaves from a region of controlled or (iv) Is derived from ovines or caprines undetermined risk for BSE; and § 94.19, § 94.20, or § 94.21, with the whose movement was not restricted in (2) The product must be derived from exception of the requirements in the BSE minimal-risk region as a result ruminants that were subject to a ban on § 94.19(c), § 94.20(b), and § 94.21(b), of exposure to a transmissible the feeding of ruminants with meat-and- respectively. The person importing the spongiform encephalopathy. bone meal or greaves derived from offal must obtain a United States (2) Each shipment to the United States ruminants if it is either: Veterinary Permit for Importation and is accompanied by an original certificate (i) Exported from a region of Transportation of Controlled Materials signed by a full-time salaried veterinary negligible risk for BSE in which there and Organisms and Vectors by filing a officer of the national government of the has been at least one indigenous case of permit application on VS Form 16–3. To exporting region, or issued by a BSE; or apply for a permit, file a permit veterinarian designated by the exporting (ii) Derived from ruminants that were application on VS Form 16–3 (available region and endorsed by a full-time in a region of negligible risk for BSE in from APHIS, Veterinary Services, salaried veterinary officer of the which there has been at least one National Center for Import and Export, national government of the exporting indigenous case of BSE. 4700 River Road Unit 38, Riverdale, MD (b) The exporting region is a region of 20737–1231, or electronically at http:// region, representing that the _ veterinarian issuing the certificate was controlled or undetermined risk, the www.aphis.usda.gov/animal health/ authorized to do so. The certificate must product is ruminant-derived processed permits/). The application for such a state that the requirements of paragraph animal protein other than ruminant permit must state the intended use of (g)(1) of this section have been met; and meat-and-bone meal or greaves, and it the offal and name and address of the (3) The shipment, if arriving at a U.S. has been demonstrated that the product consignee in the United States. has not been commingled or land border port, arrives at a port listed § 95.7 Collagen derived from bovines. in § 94.25(c) of this subchapter. contaminated with ruminant meat-and- bone meal or greaves from a controlled (a) The importation of collagen (Approved by the Office of Management and or undetermined risk region. derived from bovines is prohibited Budget under control numbers 0579–0015, because of BSE unless: 0579–0234, and 0579–0393) (c) Each shipment to the United States is accompanied by an original certificate (1) The collagen meets the §§ 95.5 through 95.30 [Redesignated as signed by a full-time salaried veterinary requirements of either paragraph (b), (c), §§ 95.16 through 95.41] officer of the national government of the or (d), as well as the requirements of ■ 31. Sections 95.5 through 95.30 are exporting region, or issued by a paragraph (e) of this section and all redesignated as §§ 95.16 through 95.41, veterinarian designated by the national other applicable requirements of this respectively. government of the exporting region and part; or ■ 32. New §§ 95.5 through 95.15 are endorsed by a full-time salaried (2) The collagen is authorized added to read as follows: veterinary officer of the national importation under paragraph (f) of this

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section and meets all other applicable Services, National Center for Import and www.aphis.usda.gov/animal_health/ requirements of this part: Export, 4700 River Road Unit 38, permits/). The application for such a (b) The collagen is derived from hides Riverdale, MD 20737–1231, or permit must state the intended use of and skins, provided the collagen has not electronically at http:// the tallow and the name and address of been commingled with materials www.aphis.usda.gov/animal_health/ the consignee in the United States. ineligible for entry into the United permits/). The application for such a (Approved by the Office of Management and States. permit must state the intended use of Budget under control number 0579–0393) (c) The collagen is derived from the the collagen and the name and address bones of bovines that originated from a of the consignee in the United States. § 95.9 Derivatives of tallow derived from bovines. region of negligible risk for BSE. (Approved by the Office of Management and (d) The collagen is derived from the Budget under control number 0579–0393) (a) The importation of derivatives of bones of bovines that originated from a tallow from bovines is prohibited unless region of controlled or undetermined § 95.8 Tallow derived from bovines. the commodity meets the conditions of risk for BSE and meets the requirements (a) The importation of bovine-derived either paragraph (b), (c), (d), or (e) of of paragraphs (d)(1) through (d)(4) of tallow is prohibited unless: this section as well as paragraph (f) of this section: (1) The requirements of either this section, or, alternatively, meets the (1) The bones from which the collagen paragraph (b), (c), or (d), as well as the conditions of paragraph (g) of this was derived were derived from bovines requirements of paragraph (e) of this section. that passed ante-mortem and post- section are met; or (b) The commodity meets the mortem inspection; (2) The requirements of paragraph (f) definition of tallow derivative in § 95.1. (2) The bones from which the collagen of this section are met. (c) The derivative is from tallow was derived did not include the skulls (b) The tallow is composed of a composed of a maximum level of of bovines or the vertebral column of maximum level of insoluble impurities insoluble impurities of 0.15 percent in bovines 30 months of age or older; of 0.15 percent in weight; or weight. (3) The bones were subjected to a (c) The tallow originates from a region (d) The derivative is from tallow that process that includes all of the of negligible risk for BSE; or originates from a region of negligible following steps, or to a process at least (d) The tallow originates from a region risk for BSE. as effective in reducing BSE infectivity: of controlled risk for BSE, is derived (e) The derivative is from tallow that (i) Degreasing; from bovines that have passed ante- originates from a region of controlled (ii) Acid demineralization; mortem and post-mortem inspections, risk for BSE, is derived from bovines (iii) Acid or alkaline treatment; and has not been prepared using SRMs that have passed ante-mortem and post- (iv) Filtration; and as defined for regions of controlled risk mortem inspections, and does not (v) Sterilization at 138 °C (280.4 °F) or for BSE in § 92.1 of this subchapter. contain SRMs as defined for regions of greater for a minimum of 4 seconds; and (e) The tallow is accompanied to the controlled risk for BSE in § 92.1 of this (4) The collagen has not been United States by an original certificate subchapter. commingled with materials ineligible signed by a full-time salaried veterinary (f) The tallow derivative is for entry into the United States. officer of the national government of the accompanied to the United States by an (e) The collagen is accompanied to the exporting region, or issued by a original certificate signed by a full-time United States by an original certificate veterinarian designated by the national salaried veterinary officer of the signed by a full-time salaried veterinary government of the exporting region and national government of the exporting officer of the national government of the endorsed by a full-time salaried region, or issued by a veterinarian exporting region, or issued by a veterinary officer of the national designated by the national government veterinarian designated by the national government of the exporting region, of the exporting region and endorsed by government of the exporting region and representing that the veterinarian a full-time salaried veterinary officer of endorsed by a full-time salaried issuing the certificate was authorized to the national government of the veterinary officer of the national do so. The certificate must state that the exporting region, representing that the government of the exporting region, requirements of paragraph (b), (c), or (d) veterinarian issuing the certificate was representing that the veterinarian of this section, as applicable, have been authorized to do so. The certificate must issuing the certificate was authorized to met and, for tallow other than that state that the requirements of paragraph do so. The certificate must state that the described in paragraph (b) of this (b), (c), (d), or (e) of this section, as requirements of paragraph (b), (c), or (d) section, must indicate the BSE risk applicable, have been met and, for of this section, as applicable, have been classification of the exporting region. tallow derivatives other than those met and, for collagen other than that (f) The Administrator determines that described in paragraph (b) or (c) of this described in paragraph (b) of this the tallow will not come into contact section, must indicate the BSE risk section, must indicate the BSE risk with ruminants in the United States and classification of the exporting region. classification of the exporting region. can be imported under conditions that (g) The Administrator determines that (f) The Administrator determines that will prevent the introduction of BSE the tallow derivative will not come into the collagen will not come into contact into the United States, and the person contact with ruminants in the United with ruminants in the United States and importing the tallow has obtained a States and can be imported under can be imported under conditions that United States Veterinary Permit for conditions that will prevent the will prevent the introduction of BSE Importation and Transportation of introduction of BSE into the United into the United States, and the person Controlled Materials and Organisms and States, and the person importing the importing the collagen has obtained a Vectors. To apply for a permit, file a tallow derivative has obtained a United United States Veterinary Permit for permit application on VS Form 16–3 States Veterinary Permit for Importation Importation and Transportation of (available from APHIS, Veterinary and Transportation of Controlled Controlled Materials and Organisms and Services, National Center for Import and Materials and Organisms and Vectors. Vectors. To apply for a permit, file a Export, 4700 River Road Unit 38, To apply for a permit, file a permit permit application on VS Form 16–3 Riverdale, MD 20737–1231, or application on VS Form 16–3 (available (available from APHIS, Veterinary electronically at http:// from APHIS, Veterinary Services,

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National Center for Import and Export, Riverdale, MD 20737–1231, or (1) The blood was collected in a 4700 River Road Unit 38, Riverdale, MD electronically at http:// hygienic manner, as determined by the 20737–1231, or electronically at http:// www.aphis.usda.gov/animal_health/ Administrator, that prevents www.aphis.usda.gov/animal_health/ permits/). The application for such a contamination of the blood with SRMs; permits/). The application for such a permit must state the intended use of and permit must state the intended use of the dicalcium phosphate and the name (2) The donor animal was free of the tallow derivative and the name and and address of the consignee in the clinical signs of disease. address of the consignee in the United United States. (c) The blood and blood products are States. (Approved by the Office of Management and accompanied to the United States by an (Approved by the Office of Management and Budget under control number 0579–0393) original certificate that states that the Budget under control number 0579–0393) conditions of this section have been § 95.11 Specified risk materials. met. The certificate must be issued by § 95.10 Dicalcium phosphate derived from Notwithstanding any other provisions a full-time salaried veterinary officer of bovines. of this part, the importation of specified the national government of the (a) The importation of dicalcium risk materials from controlled-risk exporting region, or issued by a phosphate derived from bovines is regions or undetermined-risk regions for veterinarian designated by the national prohibited unless: BSE, and any commodities containing government of the exporting region and (1) The requirements of either such materials, is prohibited, unless the endorsed by a full-time salaried paragraph (b), (c), or (d) and the Administrator determines that the veterinary officer of the exporting requirements of paragraph (e) of this materials or other commodities will not region, representing that the section are met; or come into contact with ruminants in the (2) The requirements of paragraph (f) veterinarian issuing the certificate was United States and can be imported authorized to do so. of this section are met. under conditions that will prevent the (b) The dicalcium phosphate contains introduction of BSE into the United (Approved by the Office of Management and Budget under control number 0579–0393) no trace of protein or fat; or States, and the person importing the (c) The dicalcium phosphate materials or other commodities has § 95.13 Importation from regions of originates from a region of negligible obtained a United States Veterinary negligible risk for BSE of processed animal risk for BSE; or Permit for Importation and protein derived from animals other than (d) The dicalcium phosphate Transportation of Controlled Materials ruminants. originates from a region of controlled and Organisms and Vectors. To apply risk for BSE, is derived from bovines The importation from regions of for a permit, file a permit application on that have passed ante-mortem and post- negligible risk for BSE of processed VS Form 16–3 (available from APHIS, mortem inspections, and does not animal protein derived from animals Veterinary Services, National Center for contain SRMs as defined for regions of other than ruminants is prohibited Import and Export, 4700 River Road controlled risk for BSE in § 92.1 of this importation into the United States Unit 38, Riverdale, MD 20737–1231, or subchapter. unless the following conditions are met: electronically at http:// (a) The processed animal protein is (e) The dicalcium phosphate is _ accompanied by an original certificate www.aphis.usda.gov/animal health/ not prohibited importation under § 95.4; signed by a full-time salaried veterinary permits/). The application for such a (b) The processed animal protein officer of the national government of the permit must state the intended use of imported into the United States in exporting region, or issued by a the materials and other commodities accordance with this section is veterinarian designated by the national and the name and address of the accompanied by an original certificate government of the exporting region and consignee in the United States. signed by a full-time salaried veterinary endorsed by a full-time salaried § 95.12 Blood and blood products derived officer of the national government of the veterinary officer of the national from bovines. exporting region, or issued by a government of the exporting region, The importation of bovine blood and veterinarian designated by the national representing that the veterinarian products derived from bovine blood is government of the exporting region and issuing the certificate was authorized to prohibited unless the following endorsed by a full-time salaried do so. The certificate must indicate the conditions and the conditions of all veterinary officer of the national BSE risk classification of the exporting other applicable parts of this chapter are government of the exporting region, region and state that the requirements of met: representing that the veterinarian paragraph (b) (c), or (d) of this section, (a) For blood collected at slaughter issuing the certificate was authorized to as applicable, have been met. and for products derived from blood do so, that indicates that the material is (f) The Administrator determines that collected at slaughter: derived from animals other than the dicalcium phosphate will not come (1) The blood was collected in a ruminants. into contact with ruminants in the hygienic manner, as determined by the (c) The person importing the United States and can be imported Administrator, that prevents shipment has applied for and obtained under conditions that will prevent the contamination of the blood with SRMs; from APHIS a United States Veterinary introduction of BSE into the United and Permit for Importation and States, and the person importing the (2) The slaughtered animal passed Transportation of Controlled Materials dicalcium phosphate has obtained a ante-mortem inspection and was not and Organisms and Vectors. To apply United States Veterinary Permit for subjected to a pithing process or to a for a permit, file a permit application on Importation and Transportation of stunning process with a device injecting VS Form 16–3 (available from APHIS, Controlled Materials and Organisms and compressed air or gas into the cranial Veterinary Services, National Center for Vectors. To apply for a permit, file a cavity. Import and Export, 4700 River Road permit application on VS Form 16–3 (b) For blood collected from live Unit 38, Riverdale, MD 20737–1231, or (available from APHIS, Veterinary donor bovines and for products derived electronically at http:// Services, National Center for Import and from blood collected from live donor www.aphis.usda.gov/animal_health/ Export, 4700 River Road Unit 38, bovines: permits/).

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(Approved by the Office of Management and funds from that amount are obligated, a (1) Times and dates of arrival in the Budget under control number 0579–0393) bill for costs incurred based on official United States; § 95.14 Importation from regions of accounting records will be issued to (2) Times and dates of exportation controlled risk or undetermined risk for restore the deposit to the original level, from the United States; and BSE of processed animal protein derived revised as necessary to allow for (3) Serial numbers of the sealed from animals other than ruminants. inflation or other changes in estimated containers. The importation from regions of costs. To be current, bills must be paid (c) The articles must transit the controlled risk or undetermined risk for within 14 days of receipt. United States under Customs bond. BSE of processed animal protein (f) The facility allows periodic APHIS (d) The person moving the articles derived from animals other than inspection of its facilities, records, and must obtain a United States Veterinary operations. ruminants is prohibited importation Permit for Importation and (g) The processed animal protein into the United States unless the Transportation of Controlled Materials imported into the United States in and Organisms and Vectors. To apply following conditions are met: accordance with this section is (a) The processed animal protein is for a permit, file a permit application on accompanied by an original certificate VS Form 16–3 (available from APHIS, not prohibited importation under § 95.4; signed by a full-time, salaried veterinary (b) Except as provided in paragraph Veterinary Services, National Center for officer of the national government of the Import and Export, 4700 River Road (c) of this section, the processed animal exporting region, or issued by a protein does not contain and was not Unit 38, Riverdale, MD 20737–1231, or veterinarian designated by the national electronically at http:// commingled with material derived from government of the exporting region and ruminants originating in a BSE www.aphis.usda.gov/animal_health/ endorsed by a full-time, salaried permits/). controlled- or undetermined-risk region; veterinary officer of the national (e) The commodities must be eligible (c) For blood meal, blood plasma, and government of the exporting region, to enter the United States in accordance other blood products, the material does representing that the veterinarian with §§ 95.4 through 95.14 and must be not contain and was not commingled issuing the certificate was authorized to accompanied by the certification with ruminant blood or blood products do so, that states that the processed required by that section. Additionally, prohibited importation into the United animal protein is not of ruminant origin the following conditions must be met: States under this part. and that conditions of this section have (1) The shipment must be exported (d) Inspection of the facility for been met. compliance with the provisions of this (h) The person importing the from the United States within 7 days of section is conducted at least annually by shipment has applied for and obtained its entry; a competent authority of the from APHIS a United States Veterinary (2) The commodities may not be government agency responsible for Permit for Importation and transloaded while in the United States, animal health in the region, unless the Transportation of Controlled Materials except for direct transloading under the region chooses to have such inspections and Organisms and Vectors. To apply supervision of an authorized inspector, conducted by APHIS. The inspections for a permit, file a permit application on who must break the seals of the national must verify either that: VS Form 16–3 (available from APHIS, government of the exporting region on (1) All steps of processing and storing Veterinary Services, National Center for the means of conveyance that carried the material are carried out in a facility Import and Export, 4700 River Road the commodities into the United States that has not been used for the Unit 38, Riverdale, MD 20737–1231, or and seal the means of conveyance that processing or storage of materials electronically at http:// will carry the commodities out of the derived from ruminants originating in a www.aphis.usda.gov/animal_health/ United States with seals of the U.S. BSE controlled- or undetermined-risk permits/). Government; and region; or (3) A copy of the import permit (2) The material is produced in a (Approved by the Office of Management and required under paragraph (d) of this Budget under control number 0579–0393) manner that prevents contamination of section must be presented to the the processed animal protein with § 95.15 Transit shipment of articles. inspector at the port of arrival and the materials prohibited importation into Articles that are otherwise prohibited port of export in the United States. the United States. importation into the United States in § 95.16 [Amended] (e) If APHIS conducts the inspections accordance with §§ 95.4 through 95.14 required by paragraph (d) of this may transit air and ocean ports in the ■ 33. In newly redesignated § 95.16, section, the facility has entered into a United States for immediate export if footnote 1 is amended by removing the cooperative service agreement executed the conditions of paragraphs (a) through citation ‘‘§ 95.30’’ and adding ‘‘§ 95.41’’ by the operator of the facility and (c) of this section are met. Articles are in its place. APHIS. In accordance with the eligible to transit the United States by § 95.17 [Amended] cooperative service agreement, the overland transportation if the facility must be current in paying all requirements of paragraphs (a) through ■ 34. In newly redesignated § 95.17, the costs for a veterinarian of APHIS to (e) of this section are met. introductory text is amended by inspect the facility (it is anticipated that (a) The articles must be sealed in removing the citation ‘‘§ 95.5’’ and such inspections will occur leakproof containers bearing serial adding the citation ‘‘§ 95.16’’ in its approximately once per year), including numbers during transit. Each container place. travel, salary, subsistence, must remain sealed during the entire § 95.18 [Amended] administrative overhead, and other time that it is in the United States. incidental expenses (including excess (b) Before such transit, the person ■ 35. In newly redesignated § 95.18, the baggage provisions up to 150 pounds). moving the articles must notify, in introductory text is amended by In addition, the facility must have on writing, the inspector at both the place removing the citation ‘‘§ 95.8’’ and deposit with APHIS an unobligated in the United States where the articles adding the citation ‘‘§ 95.19’’ in its amount equal to the cost for APHIS will arrive and the port of export. The place, and footnote 3 to paragraph (c) is personnel to conduct one inspection. As notification must include the: amended by removing the citation

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‘‘§ 95.5’’ and adding the citation § 95.32 [Amended] with, a facility in a region listed in ‘‘§ 95.16’’ in its place. ■ 45. Newly redesignated § 95.32 is § 95.4(a)(4); and (5) The material was never associated § 95.19 [Amended] amended by removing the citation ‘‘§ 95.28’’ and adding the citation with any of the materials listed in ■ 36. In newly redesignated § 95.19, the ‘‘§ 95.39’’ in its place, and by removing paragraph (a) of this section that have introductory text is amended by the citation ‘‘§ 95.22’’ and adding the been in a region listed in § 95.4(a)(4). removing the citation ‘‘§ 95.7’’ and citation ‘‘§ 95.33’’ in its place. (c) The certification required by adding the citation ‘‘§ 95.18’’ in its paragraph (a) of this section must place. § 95.33 [Amended] clearly correspond to the shipment by ■ 46. Newly redesignated § 95.33 is means of an invoice number, shipping § 95.20 [Amended] amended by removing the citation marks, lot number, or other method of identification. ■ 37. In newly redesignated § 95.20, the ‘‘§ 95.28’’ and adding the citation introductory text is amended by ‘‘§ 95.39’’ in its place, and by removing (Approved by the Office of Management and removing the citation ‘‘§ 95.10’’ and the citation ‘‘§ 95.21’’ and adding the Budget under control number 0579–0234) citation ‘‘§ 95.32’’ in its place. adding the citation ‘‘§ 95.21’’ in its PART 96—RESTRICTION OF place, and footnote 4 to paragraph (c) is § 95.36 [Amended] IMPORTATIONS OF FOREIGN ANIMAL amended by removing the citation CASINGS OFFERED FOR ENTRY INTO ■ 47. In newly redesignated § 95.36, ‘‘§ 95.5’’ and adding the citation THE UNITED STATES ‘‘§ 95.16’’ in its place. paragraphs (a) and (b) are amended by removing the citation ‘‘§ 95.26’’ both ■ 49. The authority citation for part 96 § 95.21 [Amended] times it appears and adding the citation continues to read as follows: ‘‘§ 95.37’’ in their place. ■ 38. In newly redesignated § 95.21, the Authority: 7 U.S.C. 8301–8317; 21 U.S.C. ■ introductory text is amended by 48. Newly redesignated § 95.40 is 136 and 136a; 7 CFR 2.22, 2.80, and 371.4. revised to read as follows: removing the citation ‘‘§ 95.9’’ and ■ 50. In § 96.2, paragraph (b) is revised adding the citation ‘‘§ 95.20’’ in its § 95.40 Certification for certain materials. and paragraph (c) is added to read as place. (a) In addition to meeting any other follows: certification or permit requirements of § 95.23 [Amended] § 96.2 Prohibition of casings due to this chapter, the following articles, if ■ 39. In newly redesignated § 95.23, the African swine fever and bovine spongiform derived from ovines or caprines, may be encephalopathy. introductory text is amended by imported into the United States from removing the citation to ‘‘§ 95.11’’ and * * * * * any region not listed in § 95.4(a)(4) only (b) Casings from ovines or caprines. adding the citation ‘‘§ 95.22’’ in its if they are accompanied by a certificate, place. The importation of casings, except as described in paragraph (b) of this stomachs, derived from ovines or § 95.25 [Amended] section: caprines that originated in or were (1) Processed animal protein, tankage, ■ processed in any region listed in 40. In newly redesignated § 95.25, the offal, and tallow other than tallow § 95.4(a)(4) are prohibited, unless the introductory text is amended by derivatives, unless, in the opinion of the following conditions are met: removing the citation ‘‘§ 95.16’’ and Administrator, the tallow cannot be (1) The casings are derived from adding the citation ‘‘§ 95.27’’ in its used in feed; sheep that were slaughtered in Canada place. (2) Glands and unprocessed fat tissue; at less than 12 months of age and that (3) Processed fats and oils, and § 95.26 [Amended] were from a flock subject to a ruminant derivatives of processed animal protein, feed ban equivalent to the requirements ■ 41. Newly redesignated § 95.26 is tankage, and offal; established by the U.S. Food and Drug amended by removing the citation (4) Derivatives of glands; and Administration at 21 CFR 589.2000; and ‘‘§ 95.16’’ and adding the citation (5) Any product containing any of the (2) The casings are accompanied by ‘‘§ 95.27’’ in its place. materials listed in paragraphs (a)(1) an original certificate that meets the through (a)(4) of this section. requirements of § 96.3 and: § 95.27 [Amended] (b) The certificate required by (i) States that the casings meet the paragraph (a) of this section must be an ■ 42. In newly redesignated § 95.27, the conditions of this section; original official certificate, signed by a introductory text is amended by (ii) Is written in English; full-time, salaried veterinarian of the removing the citation ‘‘§ 95.15’’ and (iii) Is signed by an individual eligible agency responsible for animal health in adding the citation ‘‘§ 95.26’’ in its to issue the certificate required under the exporting region, that states the place. § 96.3; and following: (iv) Is presented to an authorized § 95.28 [Amended] (1) The animal species from which the inspector at the port of entry. material was derived; (c) Casings from bovines. The ■ 43. In newly redesignated § 95.28, the (2) The region in which any facility importation of casings derived from introductory text is amended by where the material was processed is bovines is prohibited, unless the removing the citation ‘‘§ 95.18’’ and located; following conditions are met: adding the citation ‘‘§ 95.29’’ in its (3) That the material was derived only (1) If the casings are derived from place. from animals that have never been in bovines from a region of negligible risk § 95.29 [Amended] any region listed in § 95.4(a)(4), with the for BSE, as defined in § 92.1 of this regions listed in § 95.4(a)(4) specifically subchapter, the certificate required ■ 44. Newly redesignated § 95.29 is named; under § 96.3 indicates the APHIS BSE amended by removing the citation (4) That the material did not originate risk classification of the region in which ‘‘§ 95.17’’ and adding the citation in, and was never stored, rendered, or the bovines were slaughtered and the ‘‘§ 95.28’’ in its place. processed in, or otherwise associated casings were collected.

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(2) If the casings are derived from from Canada must state that the casings Cervid. All members of the family bovines from a region of controlled risk meet the requirements of § 96.2(b) and Cervidae and hybrids, including deer, for BSE or a region of undetermined risk the certificate accompanying bovine elk, moose, caribou, reindeer, and for BSE, as defined in § 92.1 of this casings must state that the casings meet related species. subchapter, the casings are not derived the requirements of either § 96.2(c)(1) or * * * * * from the small intestine or, if the (c)(2) as applicable. ■ 54. In § 98.15, the introductory text of casings are derived from the small * * * * * intestine, the casings are derived from paragraph (a) is revised to read as that part of the small intestine that is PART 98—IMPORTATION OF CERTAIN follows: eligible for use as human food in ANIMAL EMBRYOS AND ANIMAL § 98.15 Health requirements. accordance with the requirements SEMEN established by the Food Safety and * * * * * Inspection Service at 9 CFR 310.22 and ■ 52. The authority citation for part 98 (a) The donor dam is determined to be the Food and Drug Administration at 21 continues to read as follows: free of communicable diseases based on CFR 189.5. Authority: 7 U.S.C. 1622 and 8301–8317; tests, examinations, and other (3) The casings are accompanied by 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 requirements, as follows, except that, an original certificate that meets the CFR 2.22, 2.80, and 371.4. with regard to bovine spongiform requirements of § 96.3 and paragraphs encephalopathy, the following does not (b)(2)(i) through (b)(3)(iv) of this section. ■ 53. Section 98.11 is amended by apply to bovines, cervids, or camelids. * * * * * adding definitions of camelid and * * * * * ■ 51. In § 96.3, paragraph (d) is revised cervid, in alphabetical order, to read as follows: Done in Washington, DC, this 19th day of to read as follows: November 2013. § 96.3 Certificate for animal casings. § 98.11 Definitions. Max T. Holtzman, * * * * * * * * * * Acting Deputy Under Secretary for Marketing (d) In addition to meeting the Camelid. All species of the family and Regulatory Programs. requirements of this section, the Camelidae, including camels, guanacos, [FR Doc. 2013–28228 Filed 12–3–13; 8:45 am] certificate accompanying sheep casings llamas, alpacas, and vicunas. BILLING CODE 3410–34–P

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