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Electronic Code of Federal Regulations

e-CFR data is current as of December 12, 2019

Title 9Chapter ISubchapter D → Part 92


Title 9: Animals and Animal Products


PART 92—IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS: PROCEDURES FOR REQUESTING RECOGNITION OF REGIONS


Contents
§92.1   Definitions.

Subpart A—Procedures for Requesting Recognition of Regions Other Than for BSE

§92.2   Application for recognition of the animal health status of a region.
§92.3   Movement restrictions.
§92.4   Reestablishment of a region's disease-free status.

Subpart B—Procedures for Requesting BSE Risk Status Classification With Regard to Bovines

§92.5   Determination of the BSE risk classification of a region.
§92.6   Determination of the date of effective enforcement of a ruminant-to-ruminant feed ban.
§92.7   Incorporation by reference.

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. Sample collection using a systematic or statistically designed survey methodology to actively seek out and find cases of animals with a restricted disease agent, or to determine the prevalence of the restricted disease agent in the population.

Adjacent region. Any geographic land area, whether or not identifiable by geological, political or surveyed boundaries, that shares common boundaries with any region.

Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, delegated to act in the Administrator's stead.

Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.

Animals. All species of the animal kingdom, except man, including: Cattle, sheep, goats, other ruminants, swine, horses, asses, mules, zebras, dogs, poultry, and birds that are susceptible to communicable diseases of livestock and poultry or capable of being carriers of those diseases or their arthropod vectors.

Approved laboratory. A properly equipped institution in the exporting region, approved by the official authority who is responsible for animal health matters in that region, that is staffed by technically competent personnel under the control of a specialist in veterinary diagnostic methods who is responsible for the results.

Bovine. Bos taurus, Bos indicus, and Bison bison.

Communicable disease. Any contagious or infectious disease of animals. It can be transmitted either directly or indirectly to a susceptible animal from an infected animal, vector, inanimate source, or other sources.

Contagious disease. Any communicable disease transmitted from one animal to another by direct contact or by feed, water, aerosol, or contaminated objects.

Disease agent. A virus, bacterium, or other organism that causes disease in animals.

Exporting region. A region from which shipments are sent to the United States.

European Union. The organization of Member States consisting of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Republic of Ireland, Spain, Sweden, and the United Kingdom (England, Scotland, Wales, the Isle of Man, and Northern Ireland).

Import (imported, importation) into the United States. To bring into the territorial limits of the United States.

OIE. The World Organization for Animal Health.

OIE Code. The Terrestrial Animal Health Code of the World Organization for Animal Health.

OIE Terrestrial Manual. The Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organization for Animal Health.

Passive surveillance. A surveillance system that does not depend on active participation by the responsible agency to seek out and monitor a restricted disease agent. The system relies on mandatory reporting, a pool of trained investigators, diagnostic submission procedures and laboratory support, and periodic public information and continuing education programs on diseases.

Prevalence. The number of cases of a disease in existence at a given time in a designated area.

Processed animal protein. Meat meal, bone meal, meat-and-bone meal, blood meal, dried plasma and other blood products, hydrolyzed protein, hoof meal, horn meal, poultry meal, feather meal, fish meal, and any other similar products.

Region. Any defined geographic land region identifiable by geological, political or surveyed boundaries. A region may consist of any of the following:

(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).1 A region for which a risk assessment has been conducted sufficient to identify the historical and existing BSE risk factors in the region and that:

1A list of regions classified by APHIS as regions of controlled risk for BSEs is available at 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).2 A region for which a risk assessment has been conducted sufficient to identify the historical and existing BSE risk factors in the region and that:

2A list of regions classified by APHIS as regions of negligible risk for BSEs is available at 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). Any region that is not classified as either a region of negligible risk for BSE or a region of controlled risk for BSE.

Restricted disease agent. Any communicable disease agent or its vector not known to exist in the United States or that is subject to a Federal or cooperative Federal/State control or eradication program within the United States.

Specified risk materials (SRMs) from regions of controlled risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a).

Specified risk materials (SRMs) from regions of undetermined risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a), except that the following bovine parts from regions of undetermined risk for BSE are considered SRMs if they are derived from bovines over 12 months of age: Brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and the dorsal root ganglia.

Surveillance. Systems to find, monitor, and confirm the existence or absence of a restricted disease agent or agents in livestock, poultry and other animals. Surveillance may be passive or active.

United States. All of the States of the United States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.

Vector-borne disease. A disease transmitted to an animal through an intermediate arthropod vector, including ticks or insects.

[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]

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.

(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.1 Such requests must be made in English and must be sent to the Administrator, c/o National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231. (Where possible, include a copy of the request and accompanying information in electronic format.)

1Additionally, APHIS may choose to initiate an evaluation of the animal health status of a foreign region on its own initiative. In such cases, APHIS will follow the same evaluation and notification procedures set forth in this section.

(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 following information 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 http://www.aphis.usda.gov/import__export/animals/reg__request.shtml or by contacting the Director, Sanitary Trade Issues Team, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737.

(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 following information 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 http://www.aphis.usda.gov/import__export/animals/reg__request.shtml or by contacting the Director, Sanitary Trade Issues Team, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737. For a region to be considered historically free of a disease, the disease must not have been reported in domestic livestock for at least the past 25 years and must not have been reported in wildlife for at least the past 10 years.

(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) A list of those regions that have requested APHIS' recognition of their animal health status, the disease(s) under evaluation, and, if available, the animal(s) or product(s) the region wishes to export, is available at http://www.aphis.usda.gov/import__export/animals/reg__request.shtml.

(e) If, after review and evaluation of the information submitted in accordance with paragraph (b) or (c) 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.

(f) 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.

(g) If a region is granted animal health status under the provisions of this section, that region 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 to maintain its animal health status.

(Approved by the Office of Management and Budget under control number 0579-0219)

[62 FR 56012, Oct. 28, 1997, as amended at 68 FR 50054, Aug. 20, 2003; 77 FR 1389, Jan. 10, 2012; 77 FR 44109, July 27, 2012]

§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's disease-free status.

This section applies to regions that are designated under this subchapter as free of a specific animal disease and then experience an outbreak of that disease.

(a) Interim designation. If a region recognized as free of a specified animal disease in this subchapter experiences an outbreak of that disease, APHIS will take immediate action to prohibit or restrict imports of animals and animal products from that region. The prohibitions or restrictions may be imposed on only a portion of the region previously recognized as free of a disease. In these cases, APHIS will inform the public as soon as possible through notice in the Federal Register of the basis for its decision to prohibit or restrict imports from the smaller area of that region previously recognized as free.

(b) Reassessment of the disease situation. (1) Following removal of disease-free status from all or part of a region, APHIS may reassess the disease situation in that region to determine whether it is necessary to continue the interim prohibitions or restrictions. In reassessing a region's disease status, APHIS will take into consideration the standards of the World Organization for Animal Health (OIE) for reinstatement of disease-free status, as well as all relevant information obtained through public comments or collected by or submitted to APHIS through other means.

(2) Prior to taking any action to relieve prohibitions or restrictions, APHIS will make information regarding its reassessment of the region's disease status available to the public for comment. APHIS will announce the availability of this information in the Federal Register.

(c) Determination. Based on the reassessment conducted in accordance with paragraph (b) of this section, including comments regarding the reassessment information, APHIS will take one of the following actions:

(1) Publish a notice of its decision to reinstate the disease-free status of the region, or a portion of the region;

(2) Publish a notice of its decision to continue the prohibitions or restrictions on the imports of animals and animal products from that region; or

(3) Publish another document in the Federal Register for comment.

[77 FR 1389, Jan. 10, 2012]

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. The listing can also be obtained by writing to APHIS at National Import Export Services, 4700 River Road Unit 38, Riverdale, MD 20737. APHIS may classify a region for BSE according to either paragraph (a) or paragraph (b) of this section.

(a) BSE risk classification based on OIE classification. If the OIE has classified a country as either BSE negligible risk or BSE controlled risk, APHIS will seek information to support concurrence with the OIE classification. This information could be publicly available information, or APHIS could request that countries supply the same information given to the OIE. APHIS will announce in the Federal Register, subject to public comment, each intent to concur with an OIE classification. APHIS will also post the summary of the BSE OIE ad hoc group conclusions for review during the comment period. The summaries would be available for review on the APHIS Web site at http://www.aphis.usda.gov/import__export/animals/reg__request.shtml. Following review of any comments received, the Administrator will announce his or her final determination regarding classification of the country in the Federal Register, along with a discussion of and response to pertinent issues raised by commenters. If APHIS recognizes a country as either negligible risk or controlled risk for BSE, the Agency will include that country in a list of regions of negligible risk or controlled risk for BSE, as applicable, that APHIS will make available to the public on the Agency's Web site at 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. A region that has not received classification by OIE as either negligible risk or controlled risk for BSE and that wishes to be classified by APHIS as negligible risk or controlled risk must submit to the Administrator a request for classification, along with documentation sufficient to allow APHIS to conduct an evaluation of whether the region meets the criteria for classification. A list of the documentation required can be accessed on the APHIS Web site at http://www.aphis.usda.gov/import__export/animals/reg__request.shtml. If, following evaluation of the information submitted, the Administrator determines that the region meets the criteria for classification as negligible risk or controlled risk, APHIS will announce that determination in the Federal Register and will make available to the public on the APHIS Web site the evaluation conducted by APHIS, as well as the information provided by the requesting region. APHIS will accept public comment on its intent. Following review of any comments received, the Administrator will announce his or her final determination regarding classification of the region in the Federal Register, along with a discussion of and response to pertinent issues raised by commenters.

(c) Retention of classification as either negligible risk or controlled risk. (1) As required by the OIE for countries classified as either negligible risk or controlled risk by the OIE, regions evaluated by APHIS and classified as negligible or controlled risk would need to submit updated information to APHIS each year. The required information includes documentation of the following:

(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 and accept public comment regarding that intent. Following review of any comments received, the Administrator will announce in the Federal Register his or her final determination regarding classification of the region, along with a discussion of and response to pertinent issues raised by commenters.

(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 for public comment the date APHIS considers to be the date of effective enforcement of a ruminant-to-ruminant feed ban in the requesting region, and will make available to the public the evaluation conducted by APHIS, as well as the supporting documentation. Following review of any comments received, the Administrator will announce his or her final determination in the Federal Register, along with a discussion of and response to pertinent issues raised by commenters.

§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 and the material must be available to the public. All approved material is available for inspection at the Animal and Plant Health Inspection Service (APHIS), and is available from the sources listed below. For information about the availability of this material at APHIS, call 301-851-3300 or write to National Import Export Services, 4700 River Road Unit 38, Riverdale, MD 20737. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to 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 oie@oie.int, 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)

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