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.

Compartment. Any defined animal subpopulation contained in one or more establishments under a common biosecurity management system for which surveillance, control, and biosecurity measures have been applied with respect to a specific disease.

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, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland (Republic of), Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden. ¹

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. (1) A national entity (country);
2. (2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);
3. (3) Parts of several national entities combined into an area; or

4. (4) A group of national entities (countries) combined into a single area.

   Region of controlled 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:

5. (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.
6. (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.
7. (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.

8. (4) Meets one of the following conditions:

   1. (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

   2. (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:

      1. (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
      2. (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.

9. (5) Meets the conditions in one of or both paragraphs (5)(i) or (5)(ii) of this definition:

   1. (i) Has met the following conditions, but not for at least the past 7 years:

      1. (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;
      2. (B) Required notification and investigation of all bovines showing clinical signs consistent with BSE; and
      3. (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

   2. (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 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:

   3. (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.
   4. (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.

   5. (3) Meets one of the following conditions:

      1. (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

      2. (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:

         1. (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
         2. (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.

   6. (4) Has, for at least the past 7 years:

      1. (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;
      2. (ii) Required notification and investigation of all bovines showing clinical signs consistent with BSE; and
      3. (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.

   7. (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.

¹ For animal health purposes, APHIS considers that Northern Ireland is following European Union regulations and policies and is treating it the same as Member States of the European Union.

² A 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.

³ A 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.

[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]