PART 92—IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS: PROCEDURES FOR REQUESTING RECOGNITION OF REGIONS AND COMPARTMENTS Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4. Source: 62 FR 56012, Oct. 28, 1997, unless otherwise noted. § 92.1 Definitions. Active surveillance. Adjacent region. Administrator. Animal and Plant Health Inspection Service Animals. Approved laboratory. Bovine. Bos taurus, Bos indicus, Bison bison. Communicable disease. Compartment. Contagious disease. Disease agent. Exporting region. European Union. 1 1 Import (imported, importation) into the United States. OIE. OIE Code. OIE Terrestrial Manual. Passive surveillance. Prevalence. Processed animal protein. Region. (1) A national entity (country); (2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.); (3) Parts of several national entities combined into an area; or (4) A group of national entities (countries) combined into a single area. Region of controlled risk for bovine spongiform encephalopathy (BSE). 2 2 http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml. (1) Has demonstrated that appropriate mitigations are being taken to manage all identified risks, but may not have been taken for the periods of time necessary to be classified as a region of negligible risk for BSE. (2) Is a region in which it can be demonstrated through an appropriate control and audit that neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants. (3) Has demonstrated that Type A surveillance in accordance with Article 11.5.22 of the OIE Code, incorporated by reference in § 92.7, or with equivalent guidelines recognized by the Administrator is in place and the relevant points target, in accordance with Table 1 of Article 11.5.22 of the OIE Code, or with equivalent guidelines recognized by the Administrator has been met. Type B surveillance in accordance with Article 11.5.22 of the OIE Code, or with equivalent guidelines recognized by the Administrator, is sufficient in place of Type A surveillance or its equivalent once the relevant points target for Type A surveillance or its equivalent has been met. (4) Meets one of the following conditions: (i) Has had no case of BSE in the region or every case has been demonstrated to have been imported and has been completely destroyed; or (ii) Has had at least one indigenous case, and all bovines described in either paragraph (4)(ii)(A) or (4)(ii)(B) of this definition, if still alive, are officially identified with unique individual identification that is traceable to the premises of origin of the animal, have their movements controlled, and, when slaughtered or at death, are completely destroyed: (A) All bovines that, during their first year of life, were reared with a bovine determined to be infected with BSE during its first year of life, and that investigation showed consumed the same potentially contaminated feed as the infected animal during that period; or (B) If the investigation was unable to determine whether the feed source that was used to feed the bovine known to be infected was also used to feed other bovines in the herd of the infected animal, all bovines born in the same herd as a BSE-infected bovine either within 12 months before or 12 months after the birth of the infected animal. (5) Meets the conditions in one of or both paragraphs (5)(i) or (5)(ii) of this definition: (i) Has met the following conditions, but not for at least the past 7 years: (A) Conducted an ongoing awareness program for veterinarians, farmers, and workers involved in transportation, marketing, and slaughter of bovines to encourage reporting of bovines showing clinical signs that could be indicative of BSE; (B) Required notification and investigation of all bovines showing clinical signs consistent with BSE; and (C) Has carried out the examination, in accordance with internationally accepted diagnostic tests and procedures and in approved laboratories, of brain or other tissues collected as part of the surveillance and monitoring described in paragraphs (3) and (5)(i)(A) and (5)(i)(B) of this definition; or (ii) Has prohibited the feeding to ruminants in the region of meat-and-bone meal and greaves derived from ruminants, but it cannot be demonstrated through an appropriate level of control and audit that the prohibited materials have not been fed to ruminants in the region for at least the past 8 years. Region of negligible risk for bovine spongiform encephalopathy (BSE). 3 3 http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml. (1) Has demonstrated that appropriate mitigations to manage all identified risks have been taken for each relevant period of time to meet each identified risk, as set forth in this definition. (2) Has demonstrated that Type B surveillance in accordance with Article 11.5.22 of the OIE Code, incorporated by reference in § 92.7, or with equivalent guidelines recognized by the Administrator is in place and the relevant points target, in accordance with Table 1 of Article 11.5.22 of the OIE Code, or with equivalent guidelines recognized by the Administrator has been met. (3) Meets one of the following conditions: (i) Has had no case of BSE in the region or every case has been demonstrated to have been imported and has been completely destroyed; or (ii) Has had at least one indigenous case, but every indigenous case was born more than 11 years ago, and all bovines described in either paragraph (3)(ii)(A) or (3)(ii)(B) of this definition, if still alive, are officially identified with unique individual identification that is traceable to the premises of origin of the animal, have their movements controlled, and, when slaughtered or at death, are completely destroyed: (A) All bovines that, during their first year of life, were reared with a bovine determined to be infected with BSE during its first year of life, and that investigation showed consumed the same potentially contaminated feed as the infected animal during that period; or (B) If the investigation was unable to determine whether the feed source that was used to feed the bovine known to be infected was also used to feed other bovines in the herd of the infected animal, all bovines born in the same herd as a BSE-infected bovine either within 12 months before or 12 months after the birth of the infected animal. (4) Has, for at least the past 7 years: (i) Conducted an ongoing awareness program for veterinarians, farmers, and workers involved in transportation, marketing, and slaughter of bovines to encourage reporting of bovines showing clinical signs that could be indicative of BSE; (ii) Required notification and investigation of all bovines showing clinical signs consistent with BSE; and (iii) Carried out the examination, in accordance with internationally accepted diagnostic tests and procedures and in approved laboratories, of brain or other tissues collected as part of the required surveillance and monitoring described in paragraphs (2) and (4)(i) and (4)(ii) of this definition. (5) Has demonstrated through an appropriate level of control and audit that, for at least the past 8 years, neither meat-and-bone meal nor greaves derived from ruminants have been fed to ruminants in the region. Region of undetermined risk for bovine spongiform encephalopathy (BSE). Restricted disease agent. Specified risk materials (SRMs) from regions of controlled risk for BSE. Specified risk materials (SRMs) from regions of undetermined risk for BSE. Surveillance. United States. Vector-borne disease. [62 FR 56012, Oct. 28, 1997, as amended at 68 FR 16938, Apr. 7, 2003; 72 FR 67232, Nov. 28, 2007; 78 FR 72993, Dec. 4, 2013; 85 FR 11835, Feb. 28, 2020; 86 FR 45622, Aug. 16, 2021] Subpart A—Procedures for Requesting Recognition of Regions Other Than for BSE Source: 78 FR 72994, Dec. 4, 2013, unless otherwise noted. § 92.2 Application for recognition of the animal health status of a region or a compartment. (a) The representative of the national government(s) of any country or countries who has the authority to make such a request may request that APHIS recognize the animal health status of a region or a compartment. 1 1 (b) Requests for recognition of the animal health status of a region, other than requests submitted in accordance with paragraph (c) of this section, must include, in English, the information in paragraphs (b)(1) through (8) of this section about the region. More detailed information regarding the specific types of information that will enable APHIS to most expeditiously conduct an evaluation of the request is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request (1) Scope of the evaluation being requested. (2) Veterinary control and oversight. (3) Disease history and vaccination practices. (4) Livestock demographics and traceability. (5) Epidemiological separation from potential sources of infection. (6) Surveillance. (7) Diagnostic laboratory capabilities. (8) Emergency preparedness and response. (c) Requests for recognition that a region is historically free of a disease based on the amount of time that has elapsed since the disease last occurred in a region, if it has ever occurred, must include, in English, the information in paragraphs (c)(1) through (6) of this section about the region. More detailed information regarding the specific types of information that will enable APHIS to most expeditiously conduct an evaluation of the request is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request (1) Scope of the evaluation being requested. (2) Veterinary control and oversight. (3) Disease history and vaccination practices. (4) Disease notification. (5) Disease detection. (6) Barriers to disease introduction. (d) Requests for recognition of the animal health status of a compartment must include, in English, the information in paragraphs (d)(1) through (8) of this section about the compartment. More detailed information regarding the specific types of information that will enable APHIS to most expeditiously conduct an evaluation of the request is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request (1) Scope of the evaluation being requested. (2) Veterinary control and oversight of the compartment. (3) Disease history and vaccination practices. (4) Livestock or poultry commodity movement and traceability. (5) Epidemiologic separation of the compartment from potential sources of infection. (6) Surveillance. (7) Diagnostic laboratory capabilities. (8) Emergency preparedness and response. (e) A list of those regions for which an APHIS recognition of their animal health status has been requested, the disease(s) under evaluation, and, if available, the animal(s) or product(s) the region wishes to export, is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request. (f) A list of countries that have requested an APHIS compartmentalization evaluation, and a description of the requested compartment is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request. (g) If, after review and evaluation of the information submitted in accordance with paragraph (b), (c), or (d) of this section, APHIS believes the request can be safely granted, APHIS will indicate its intent and make its evaluation available for public comment through a document published in the Federal Register (h) APHIS will provide a period of time during which the public may comment on its evaluation. During the comment period, the public will have access to the information upon which APHIS based its evaluation, as well as the evaluation itself. Once APHIS has reviewed all comments received, it will make a final determination regarding the request and will publish that determination in the Federal Register (i) If a region or compartment is granted animal health status under the provisions of this section, the representative of the national government(s) of any country or countries who has the authority to make a regionalization or compartmentalization request may be required to submit additional information pertaining to animal health status or allow APHIS to conduct additional information collection activities in order for that region or compartment to maintain its animal health status. (Approved by the Office of Management and Budget under control numbers 0579-0040 and 0579-0453) [85 FR 11835, Feb. 28, 2020, as amended at 86 FR 68856, Dec. 3, 2021] § 92.3 Movement restrictions. Whenever the European Commission (EC) establishes a quarantine for a disease in the European Union in a region the Animal and Plant Health Inspection Service recognizes as one in which the disease is not known to exist and the EC imposes prohibitions or other restrictions on the movement of animals or animal products from the quarantined area in the European Union, such animals and animal products are prohibited importation into the United States. [68 FR 16938, Apr. 7, 2003] § 92.4 Reestablishment of a region or compartment's disease-free status. This section applies to regions or compartments that are designated under this subchapter as free of a specific animal disease and then experience an outbreak of that disease. (a) Interim designation. Federal Register (b) Reassessment of the disease situation. (2) Prior to taking any action to relieve prohibitions or restrictions, APHIS will make information regarding its reassessment of the region's or compartment's disease status available to the public for comment. APHIS will announce the availability of this information by means of a notice in the Federal Register (c) Determination. (1) Publish a notice in the Federal Register (2) Publish a notice in the Federal Register (3) Publish another document in the Federal Register [85 FR 11836, Feb. 28, 2020] Subpart B—Procedures for Requesting BSE Risk Status Classification With Regard to Bovines Source: 78 FR 72994, Dec. 4, 2013, unless otherwise noted. § 92.5 Determination of the BSE risk classification of a region. All countries of the world are considered by APHIS to be in one of three BSE risk categories—negligible risk, controlled risk, or undetermined risk. These risk categories are defined in § 92.1. Any region that is not classified by APHIS as presenting either negligible risk or controlled risk for BSE is considered to present an undetermined risk. The listing of those regions classified by APHIS as having either negligible risk or controlled risk can be accessed on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml. (a) BSE risk classification based on OIE classification. Federal Register, http://www.aphis.usda.gov/import_export/animals/reg_request.shtml. Federal Register, http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml. (b) Regions seeking classification as negligible or controlled risk that have not been classified by the OIE. http://www.aphis.usda.gov/import_export/animals/reg_request.shtml. Federal Register Federal Register, (c) Retention of classification as either negligible risk or controlled risk. (i) Relevant changes in BSE legislation, compared to the previous year; (ii) The importation into the region during the year of cattle, processed animal protein, and products containing processed animal protein; (iii) Audit findings in rendering plants and feed mills that process ruminant material or material from mixed species that contains ruminant material, related to the prohibition of the feeding to ruminants of processed animal protein; (iv) Audit findings in rendering plants and feed mills that process nonruminant material, related to the prohibition of the feeding to ruminants of processed animal protein; (v) Infractions at the types of facilities listed above; (vi) If and why, in light of the audit findings, there has been no significant exposure of cattle to the BSE agent through consumption of processed animal protein of bovine origin; (vii) Surveillance efforts; (viii) All clinical BSE suspects; and (ix) Any new cases of BSE. (2) If APHIS at any time determines that a region no longer meets the criteria for the risk classification it had previously received, APHIS will remove the region from its list of regions so classified. If the OIE determines the region no longer meets the criteria for the risk classification it had previously received, APHIS may concur with the OIE determination or may request updated information from the region and determine whether to concur with the OIE decision APHIS will announce its intent in the Federal Register Federal Register (Approved by the Office of Management and Budget under control number 0579-0393) § 92.6 Determination of the date of effective enforcement of a ruminant-to-ruminant feed ban. (a) In order for APHIS to determine the eligibility of live bovines for importation from a region classified as BSE negligible risk or BSE controlled risk, APHIS must determine the date from which a ban on the feeding of ruminant material to ruminants has been effectively enforced in the region. APHIS will base its determination of the date of effective enforcement on the information included in the dossier the region submitted when it requested to be classified regarding BSE risk. The information APHIS will consider will include, but not be limited to: (1) Policies and infrastructure for feed ban enforcement, including an awareness program for producers and farmers; (2) Livestock husbandry practices; (3) Disposition of processed animal protein produced from domestic bovines, including the feeding of such material to any animal species; (4) Measures taken to control cross-contamination and mislabeling of feed; and (5) Monitoring and enforcement of the ruminant-to-ruminant feed ban, including audit findings in rendering plants and feed mills that process ruminant material. (b) After conducting its evaluation, APHIS will announce in the Federal Register Federal Register, § 92.7 Incorporation by reference. (a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, USDA must publish notice of change in the Federal Register http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (b) World Organization for Animal Health (OIE), 12, rue de Prony 75017 Paris, France, or email [email protected], http://www.oie.int/eng/normes/Mcode/en_sommaire.htm. (1) Terrestrial Animal Health Code, Chapter 11.5-Bovine Spongiform Encephalopathy, Article 11.5.22 (Surveillance activities), 22nd Edition, 2013. (2) [Reserved] (Approved by the Office of Management and Budget under control number 0579-0393)