§ 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.

§ 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.

Cross Reference

Link to an amendment published at 84 FR 11195, Mar. 25, 2019.

(a) Designation. A Based on a classification investigation as defined in § 79.1, including testing of animals, if needed, a designated scrapie epidemiologist will designate a flock to be an exposed flock, an infected flock, a source flock, a flock under investigation, and/or a non-compliant flock, or 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 § 79.1.

(1) A State or APHIS veterinarian will designate an animal to be

genetically susceptible exposed animal, genetically resistant exposed sheep, genetically less susceptible exposed sheep, low-risk exposed animal, and/or a suspect animal after determining that the flock or animal meets the criteria of the relevant definition in § 79.1.

(

2

b)

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

Redesignation. A reclassification investigation as defined in § 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 § 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 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

may be conducted to determine whether the current designated status of a flock or animal may be changed or removed. Reclassification investigations will be initiated and conducted, and redesignation decisions will be made, in accordance with procedures approved by the Administrator. These procedures are available at http://www.aphis.usda.gov/animal-health/scrapie.

(c) Testing and notification procedures. Any animal that may be a high-risk animal, any animal that may have been exposed to the lambing of a high-risk animal, any suspect animal, and any animal that was born in the flock after a high-risk animal may have lambed may be selected for testing by the DSE or an APHIS or State representative working under the direction of a DSE or the Administrator. Which animals are selected and the method of testing selected animals will be based on the risk associated with the flock and the type and number of animals available for test. When flock records are adequate to determine that all high-risk animals that lambed in the flock are available for testing,

may limit

the testing may be limited to

all exposed

postmortem testing of all high-risk and suspect animals. Testing may also include an official genotype test, 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, postmortem examination of other animals, 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.

Animals may not be tested for scrapie to establish the designation of the flock until they are test eligible. Animals are generally considered test eligible when the animals are over 14 months of age if born after the exposure or are 18 months post exposure. If testing these animals is necessary to establish the status of a flock they must be held for later testing unless sent directly to slaughter or a terminal feedlot.

(1) Noncooperation. If an owner does not make his or her animals available for testing within 60 days of notification by an APHIS or State representative, within 60 days of becoming test eligible, or as mutually agreed in writing by the Administrator and the owner, 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

will be designated a source, infected, or exposed flock, whichever definition applies and a noncompliant flock.

(2) Notice to owner. As soon as possible after making

such

a designation or redesignation 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

or animal(s) in writing of the designation.

(3) Appeal. The owner of an animal may appeal the designation of an animal as 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.

genetically susceptible exposed animal, genetically resistant exposed sheep, genetically less susceptible exposed sheep, low-risk exposed animal, or a suspect animal. The owner of a flock may appeal the designation of the flock as an exposed flock, an infected flock, a source flock, a flock under investigation, or a non-compliant flock. The owner of a laboratory or test manufacturing facility may appeal the suspension or withdrawal of approval for a laboratory or a test. To do so, the owner must appeal by writing to the Administrator within 10 days after being informed of the reasons for the proposed action. The appeal must include all of the facts and reasons upon which the owner relies to show that the proposed action is incorrect or is not supported. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator. The action under appeal shall continue in effect pending the final determination of the Administrator, unless otherwise ordered by the Administrator. The final determination of the Administrator shall become effective upon oral or written notification, whichever is earlier, to the owner. In the event of oral notification, written confirmation shall be given as promptly as circumstances allow. The Administrator's final determination constitutes final agency action.

(Approved by the Office of Management and Budget under control number 0579-0101)

[84 FR 11195, Mar. 25, 2019]