[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR54.11]

[Page 186-187]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 54_CONTROL OF SCRAPIE--Table of Contents
 
                Subpart A_Scrapie Indemnification Program
 
Sec. 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:

[[Page 187]]

    (1) Employs personnel assigned to supervise 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;
    (4) Meets check test proficiency requirements;
    (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 for 5 years;
    (7) Will allow APHIS to inspect the laboratory without notice during 
normal business hours; and
    (8) Will report all test results to State and Federal animal health 
officials within agreed timeframes. An inspection may include, but is 
not limited to, review and copying of records, examination of slides, 
observation of the test being conducted, and interviewing of personnel.
    (b) A laboratory may request approval to conduct one or more types 
of 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 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 proposed 
withdrawal to the director of the laboratory and shall give the director 
an opportunity to respond. If there are conflicts as to any material 
fact concerning the reason for withdrawal, a hearing will be held to 
resolve the conflicts.