Title 9

SECTION 54.11

54.11 Approval of laboratories to run official scrapie tests and official genotype tests.

§ 54.11 Approval of laboratories to run official scrapie tests and official genotype tests.

(a) State, Federal, and university laboratories, or in the case of genotype tests, private laboratories will be approved by the Administrator when he or she determines that the laboratory:

(1) Employs personnel assigned to supervise and conduct the testing who are qualified to conduct the test based on education, training, and experience and who have been trained by the National Veterinary Services Laboratories (NVSL) or who have completed equivalent training approved by NVSL;

(2) Has adequate facilities and equipment to conduct the test;

(3) Follows standard test protocols that are approved or provided by NVSL;

(4) Meets check test proficiency requirements and consistently produces accurate test results as determined by NVSL review;

(5) Meets recordkeeping requirements;

(6) Will retain records, slides, blocks, and other specimens from all cases for at least 1 year and from positive cases and DNA from all genotype tests for at least 5 years and will forward copies of records and any of these materials to NVSL within 5 business days of request; Except that, NVSL may authorize a shorter retention time in a standard operating procedure or contract;

(7) Will allow APHIS to inspect the laboratory without notice during normal business hours. An inspection may include, but is not limited to, review and copying of records, examination of slides, review of quality control procedures, observation of sample handling/tracking procedures, observation of the test being conducted, and interviewing of personnel;

(8) Will report all test results to State and Federal animal health officials and record them in the National Scrapie Database within timeframes and in the manner and format specified by the Administrator; and

(9) Complies with any other written guidance provided to the laboratory by the Administrator.

(b) A laboratory may request approval to conduct one or more types of program-approved scrapie test or genotype test on one or more types of tissue. To be approved, a laboratory must meet the requirements in paragraph (a) of this section for each type of test and for each type of tissue for which they request approval.

(c) The Administrator may suspend or withdraw approval of any laboratory for failure to meet any of the conditions required by paragraph (a) of this section. The Administrator shall give written notice of the suspension or the proposed withdrawal to the director of the laboratory and shall give the director an opportunity to respond. Such action shall become effective upon oral or written notification, whichever is earlier, to the laboratory or manufacturer. If there are conflicts as to any material fact concerning the reason for withdrawal, a hearing may be requested in accordance with the procedure in § 79.4(c)(3) of this chapter. The action under appeal shall continue in effect pending the final determination of the Administrator, unless otherwise ordered by the Administrator. The Administrator's final determination constitutes final agency action.

(d) The Administrator may require approved laboratories to reimburse APHIS for part or all of the costs associated with the approval and monitoring of the laboratory.

(Approved by the Office of Management and Budget under control numbers 0579-0101 and 0579-0469) [84 FR 11185, Mar. 25, 2019]

---