[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: 9CFR79.4]

[Page 302-303]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 79--SCRAPIE IN SHEEP AND GOATS--Table of Contents
 
Sec. 79.4  Designation of scrapie-positive animals, high-risk animals, exposed animals, suspect animals, exposed flocks, infected flocks, noncompliant flocks, 
          and source flocks; notice to owners.

    (a) Designation. A designated scrapie epidemiologist will designate 
an animal to be a scrapie-positive animal, high-risk animal, exposed 
animal, or suspect animal after determining that the animal meets the 
criteria of the relevant definition in Sec. 79.1.
    (1) A State or APHIS veterinarian will designate an animal to be a 
suspect animal after determining that the animal meets the criteria of 
the relevant definition in Sec. 79.1.
    (2) A designated scrapie epidemiologist will designate a flock to be 
a source, infected, or exposed flock after reviewing sale, movement, and 
breeding records that indicate the flock meets the criteria of the 
relevant definition in Sec. 79.1.
    (i) A designated scrapie epidemiologist may conduct testing of 
animals if he or she determines such testing is needed to properly 
designate a flock to be a source, infected, or exposed flock. The 
designated scrapie epidemiologist will select animals for testing in a 
manner that will provide a 95 percent confidence of detecting scrapie at 
a prevalence of 1 percent or, when flock records are adequate and all 
exposed animals that lambed in the flock are available for testing, may 
limit the testing to all exposed and suspect animals. Flocks meeting the 
definition of infected or source flocks that are designated as exposed 
flocks must complete a post exposure monitoring and management plan. 
Testing may include live-animal testing using a live-animal official 
test, an official genotype test, the culling and postmortem examination 
and testing of genetically susceptible animals in the flock that cannot 
be evaluated by a live animal test, and postmortem examination and 
testing of animals found dead or cull animals at slaughter.
    (ii) If an owner does not make his or her animals available for 
testing within 60 days of notification or as mutually agreed or fails to 
submit required postmortem samples, the flock will be designated a 
source, infected, or exposed flock, whichever definition applies. Any 
flock that is pending designation must comply with the movement 
restrictions for infected flocks.
    (3) A designated scrapie epidemiologist will designate a flock to be 
a noncompliant flock after determining that the flock meets the 
definition of a noncompliant flock in Sec. 79.1.
    (b) Redesignation. (1) A designated scrapie epidemiologist may 
reclassify an animal designated a high-risk animal as an exposed animal 
after receiving negative results from an official test or in accordance 
with an approved Scrapie Control Pilot Project.
    (2) A State or APHIS veterinarian may remove the suspect animal 
designation from an animal that had clinical signs of scrapie and that 
did not test positive for scrapie or for the proteinase resistant 
protein associated with scrapie upon determination that it is alive and 
no longer exhibits such signs, or that the signs are not caused by 
scrapie.
    (3) A designated scrapie epidemiologist may remove the suspect 
animal designation from an animal that has tested positive for scrapie 
or for the proteinase resistant protein associated with scrapie on an 
unofficial test based on knowledge of the test used or based on an 
epidemiologic investigation which may include additional testing of the 
suspect animal and or animals that have been commingled with the suspect 
animal.
    (4) A designated scrapie epidemiologist may remove the suspect 
animal designation from an animal that tested positive on a live-animal 
screening test based on an epidemiologic investigation which includes 
additional official testing of the suspect animal and when appropriate, 
animals that have been commingled with the suspect animal.
    (5) A designated scrapie epidemiologist may remove the exposed flock 
designation after completing an epidemiologic investigation or upon 
completion of a post-exposure management and monitoring plan. As part of 
the epidemiologic investigation the designated scrapie epidemiologist 
may conduct testing of animals if he or she determines such testing is 
needed to properly redesignate the flock. The designated scrapie 
epidemiologist will

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select animals for testing in a manner that will provide a 95 percent 
confidence of detecting scrapie at a prevalence of 1 percent or, when 
flock records are adequate and all exposed animals that lambed in the 
flock are available for testing, may limit the testing to all exposed 
and suspect animals. Testing may include live-animal testing using a 
live-animal official test, an official genotype test, the culling and 
postmortem examination and testing of genetically susceptible animals in 
the flock that cannot be evaluated by a live animal test, and postmortem 
examination and testing of animals found dead or cull animals at 
slaughter. A designated scrapie epidemiologist shall redesignate an 
exposed flock as a noncompliant flock if the owner fails to make his 
animals available for testing within 60 days of notification or as 
mutually agreed or fails to submit required postmortem samples.
    (6) Based on an epidemiologic investigation and testing, a 
designated scrapie epidemiologist may redesignate an infected flock or 
source flock as an exposed flock. The designated scrapie epidemiologist 
may only use this option when the epidemiologic investigation reveals 
that the scrapie exposure was minor or could not be confirmed due to 
inadequate records. The designated scrapie epidemiologist will select 
animals for testing in a manner that will provide a 95 percent 
confidence of detecting scrapie at a prevalence of 1 percent or, when 
flock records are adequate and all exposed animals that lambed in the 
flock are available for testing, may limit the testing to all exposed 
and suspect animals. Testing may include live-animal testing using a 
live-animal official test, an official genotype test, the culling and 
postmortem examination and testing of genetically susceptible animals in 
the flock that cannot be evaluated by a live animal test, and postmortem 
examination and testing of animals found dead or cull animals at 
slaughter. Infected or source flocks that are redesignated as exposed 
flocks must complete a post exposure monitoring and management plan. If 
an owner does not make his or her animals available for testing within 
60 days of notification or as mutually agreed or fails to submit 
required postmortem samples, the flock designation will remain 
unchanged.
    (7) A designated scrapie epidemiologist may remove the noncompliant 
flock designation after reviewing any required testing of the flock and 
determining that the flock has complied with the required testing or no 
longer meets the definition of a noncompliant flock.
    (8) A designated scrapie epidemiologist may redesignate an exposed 
animal, exposed flock, or infected flock by removing that designation 
after completing an epidemiologic investigation and determining that the 
exposure was limited to a scrapie-positive male animal that was not born 
in the flock (the owner must have adequate records and animal 
identification to show that the scrapie-positive male animal was 
purchased).
    (c) Notice to owner. As soon as possible after making such a 
determination, a State or APHIS representative will attempt to notify 
the owner(s) of the flock(s) in writing that their flock contained or 
contains a scrapie-positive animal, a suspect animal, a high-risk animal 
or an exposed animal, or that the flock is an infected, source, exposed, 
or noncompliant flock or that the flock is pending designation as an 
infected, source, exposed, or noncompliant flock. The notice will 
include:
    (1) A description of the interstate movement restrictions and 
identification requirements;
    (2) Reporting requirements;
    (3) Sample submission requirements for suspect and high-risk animals 
contained in this part;
    (4) Options for controlling the spread of scrapie from, and 
eradicating scrapie in, an infected flock or source flock or to reduce 
the risk of the occurrence of scrapie in a flock that contains a high-
risk or an exposed animal; and
    (5) In the case of flocks that are pending designation the 
notification shall include the testing options available to them and the 
designation their flock will receive if they decline to test.

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