[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR55.8]

[Page 184-185]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 55--CONTROL OF CHRONIC WASTING DISEASE--Table of Contents
 
       Subpart A--Chronic Wasting Disease Indemnification Program
 
Sec. 55.8  Official CWD tests and approval of laboratories to conduct official CWD tests.

    (a) An official CWD test is:

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    (1) Histopathological examination of central nervous system (CNS) 
tissues from the animal for characteristic microscopic lesions of CWD, 
using test protocols provided by the National Veterinary Services 
Laboratories (NVSL);
    (2) The use of proteinase-resistant protein analysis methods 
including but not limited to immunohistochemistry and/or western 
blotting on CNS and/or peripheral tissue samples from a live or a dead 
animal, using test protocols provided by NVSL; or
    (3) Any other test method approved by the Administrator in 
accordance with this section.
    (b) The Administrator may approve new tests for the diagnosis of CWD 
conducted on live or dead animals, and will base the approval or 
disapproval of a test on the evaluation by APHIS and, when appropriate, 
outside scientists, of:
    (1) A standardized test protocol that must include a description of 
the test, a description of the reagents, materials, and equipment used 
for the test, the test methodology, and any control or quality assurance 
procedures;
    (2) Data to support reproducibility, that is, the ability to 
reproduce the same result repeatedly on a given sample;
    (3) Data to support suitability, that is, data to show that similar 
results can be produced when the test is run at other laboratories;
    (4) Data to support the sensitivity and specificity of the test; and
    (5) Any other data requested by the Administrator to determine the 
suitability of the test for program use.
    (c) Specific protocols for official CWD tests are available upon 
request to NVSL.
    (d) State, Federal, and university laboratories will be approved by 
the Administrator to conduct official CWD tests when he or she 
determines that the laboratory:
    (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 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 \1\ the laboratory without notice 
during normal business hours; and
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    \1\ 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.
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    (8) Will report all test results to State and Federal animal health 
officials within agreed timeframes.
    (e) The Administrator may withdraw approval of any laboratory for 
failure to meet any of the conditions required by paragraph (d) 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. The hearing will be conducted in accordance with 
rules of practice that will be adopted by the Administrator for the 
proceeding.

Subpart B [Reserved]

                           PART 56 [RESERVED]

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