(a) Request for regional classification; requirements. A representative of the national government(s) of any country or countries who has the authority to make such a request may request that APHIS classify a region for tuberculosis. Requests for classification or reclassification must be submitted to APHIS electronically or through the mail as provided at http://www.aphis.usda.gov/import__export/animals/live__animals.shtml. Guidance regarding how to complete a request in a manner that will allow APHIS to review it expeditiously is available at http://www.aphis.usda.gov/import__export/animals/reg__request.shtml, and may also be obtained by contacting the National Director, Regionalization Evaluation Services, Strategy and Policy Unit, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737. At a minimum, in order for APHIS to consider the request complete, it must define the boundaries of the region, specify the prevalence level for tuberculosis within the region, and demonstrate the following:

(1) That there is effective veterinary control and oversight within the region;

(2) That tuberculosis is a notifiable disease within the region; and

(3) That the region has a program in place for tuberculosis that includes, at a minimum:

(i) Epidemiological investigations following the discovery of any infected animals or affected herds, or any animals or herds that have had non-negative test results following a test for tuberculosis, and documentation of these investigations;

(ii) Management of affected herds in a manner designed to eradicate tuberculosis from those herds in a timely manner, and documentation regarding this management;

(iii) Regulatory controls on the movement of livestock into, within, and from the region that correspond to the risk of dissemination of tuberculosis associated with such movement; and

(iv) Access to, oversight of, and quality controls for diagnostic testing for tuberculosis within the region.

(4) That the region has surveillance in place that is equivalent to or exceeds Federal standards for surveillance within the United States.

(b) APHIS evaluation. If, after reviewing and evaluating the request for classification, APHIS believes the region can be accurately classified for tuberculosis, APHIS will publish a notice in the Federal Register proposing to classify the region according to §93.437, and making the information upon which this proposed classification is based available to the public for review and comment. The notice will request public comment.

(c) APHIS determination.

(1) If no comments are received on the notice, or if comments are received but do not affect APHIS' proposed classification, APHIS will publish a subsequent notice in the Federal Register announcing that classification to be final and adding the region to the appropriate list on the APHIS website.

(2) If comments received on the notice suggest that the region be classified according to a different tuberculosis classification, and APHIS agrees with the comments, APHIS will publish a subsequent notice in the Federal Register making the information supplied by commenters available to the public, and proposing to classify the region according to this different classification. The notice will request public comment.

(3) If comments received on the notice suggest that insufficient information was supplied on which to base a tuberculosis classification, and APHIS agrees with the comments, APHIS will publish a subsequent notice in the Federal Register specifying the additional information needed before APHIS can classify the region.

(d) Maintaining classification and reclassification initiated by APHIS. If a region is classified under the provisions of this section, that region may be required to submit additional information or allow APHIS to conduct additional information collection activities in order for that region to maintain its classification. Moreover, if APHIS determines that a region's classification for tuberculosis is no longer accurate, APHIS will publish a notice in the Federal Register announcing the revised classification and setting forth the reasons for this reclassification.

(Approved by the Office of Management and Budget under control number 0579-0442)

[85 FR 57953, Sept. 17, 2020]