[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: 9CFR54.10]

[Page 179-180]
 
                  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. 54.10  Tests for scrapie.

    (a) The Administrator may approve new tests for the diagnosis of 
scrapie conducted on live or dead animals for use in the Scrapie 
Eradication Program. The Administrator 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.
    (b) To be approved, a scrapie test must be able to be replicated at 
the National Veterinary Services Laboratories, or another reliable, 
timely, and cost effective method of check testing must be available to 
APHIS.
    (c) A test or combination of tests may be approved for the 
identification of suspect animals, for the identification of scrapie-
positive animals, or for other purposes such as flock certification. For 
a test to be approved for the identification of scrapie-positive

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animals, the test must have a specificity comparable to the specificity 
of the currently approved tests. For a test to be approved as a live 
animal screening test for the identification of suspect animals, the 
test must be usually reliable but need not be definitive for diagnosing 
scrapie.
    (d) Specific guidelines for use of approved scrapie tests within the 
Scrapie Eradication Program or Scrapie Flock Certification Program will 
be added to this part as tests are approved and will also be contained 
in the Scrapie Eradication UM&R and the Scrapie Flock Certification 
Program standards based on the characteristics of the test, including 
specificity, sensitivity, and predictive value.
    (e) If an owner elects to have an unofficial test conducted on an 
animal for scrapie, or for the proteinase resistant protein associated 
with scrapie, and that animal tests positive to such a test, the animal 
will be designated a suspect animal, unless:
    (1) The test was run as part of a bona fide research protocol 
designed to evaluate an unapproved test in which the owner is not 
informed of the test result; or
    (2) The test protocol includes appropriate measures to prevent the 
spread of scrapie.