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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 9 - Animals and Animal Products |
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Chapter I - Animal and Plant Health Inspection Service, Department of Agriculture |
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SubChapter B - Cooperative Control and Eradication of Livestock or Poultry Diseases |
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Part 54 - Control of Scrapie |
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Subpart A - Scrapie Indemnification Program |
§ 54.10 - Program approval of tests for scrapie.
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§ 54.10 Tests Program approval of tests for scrapie.
(a) The Administrator may approve new tests or test methods for the diagnosis of scrapie conducted on live or dead animals for use in the Scrapie Eradication Program and/or the Scrapie Free Flock Certification 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 reproducibilityrepeatability, that is, the ability to reproduce the same result repeatedly on a given sample;
(3) Data to support suitabilityreproducibility, that is, data to show that similar results can be produced when the test is run at other laboratories;
(4) Data to support the diagnostic and in the case of assays the analytical sensitivity and specificity of the test; and
(5) Any other data or information requested by the Administrator to determine the suitability of the test for program use. This may include but is not limited to past performance, cost of test materials and equipment, ease of test performance, generation of waste, and potential use of existing equipment.
(b) To be approved for program use, a scrapie test must be able to be replicated readily and successfully performed at the National Veterinary Services Laboratories, or another .
check testing must be available to APHIS.(c) The test must have a reliable, timely, and cost effective method of
(cproficiency testing.
(d) The Administrator may decline to evaluate any test kit for program approval that has not been licensed for the intended use and may decline to evaluate any test or test method for program use unless the requester can demonstrate that the new method offers a significant advantage over currently approved methods.
for the identification of(e) A test or combination of tests may be approved for the identification of suspect animals,
haveor scrapie-positive animals, or for other purposes such as flock certification. For a test to be approved for the identification of scrapie-positive animals, the test must
the specificity of the currently approved testsdemonstrate a diagnostic specificity comparable to
as a live animalthat of current program-approved tests, and the sensitivity of the test will also be considered in determining the approved uses of the test within the program. For a test to be approved
for the removal of high-risk, exposed, or suspect animal designations the test must have a diagnostic sensitivity at least comparable to that of current program-approved tests used for this purpose. Since the purpose of a screening test is usually to identify a subset of animals for further testing, for a test to be approved as a screening test for the identification of suspect animals, the test must be usually reliable but need not be definitive for diagnosing scrapie.
d(
scrapief) Specific guidelines for use of program-approved
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 standardstests within the Scrapie Eradication Program or Scrapie Free Flock Certification Program will be
made available on the scrapie website at http://www.aphis.usda.gov/animal-health/scrapie. Guidelines will be based on the characteristics of the test, including specificity, sensitivity, and predictive value in defined groups of animals.
e(
: (1) The test was rung) 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
bona fidethe test is conducted as part of a
designed to evaluate an unapproved test in which the owner is not informed of the test result; orresearch protocol
(2) The test protocol includes appropriate measures to prevent the spread of scrapie.
and the protocol includes appropriate measures to prevent the spread of scrapie.
(h) The Administrator may withdraw or suspend approval of any test or test method if the test or method does not perform at an acceptable level following approval or if a more effective test or test method is subsequently approved. The Administrator shall give written notice of the suspension or proposed withdrawal to the director of the laboratories using the test or method or in the case of test kits to the manufacturer and shall give the director or manufacturer 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.
(Approved by the Office of Management and Budget under control number 0579-0469)
[84 FR 11185, Mar. 25, 2019]