Determination of the BSE risk classification of a region.

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§ 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)


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