§ 98.10a - Sheep and goat embryos and oocytes.

§ 98.10a Embryos from sheep in regions other than Australia, Canada, and New Zealand.

Cross Reference

Link to an amendment published at 86 FR 68863, Dec. 3, 2021.

(a) Except for embryos from sheep in Australia, Canada, or New Zealand, embryos from sheep may only be imported into the United States if they comply with all applicable provisions of this subpart and one of

Sheep and goat embryos and oocytes.

(a) Sheep and goat embryos or oocytes collected from donors located in, or originating from, regions recognized by APHIS as free of classical scrapie, or from a flock or herd having certified status in a scrapie flock certification program recognized by APHIS as acceptable, may be imported in accordance with §§ 98.3 through 98.8. In addition to the requirements of § 98.5, the health certificate must indicate that the embryos or oocytes were collected, processed, and stored in conformity with the requirements in § 98.3(g).

(b) In vivo-derived sheep and goat embryos or oocytes collected from donors located in, or originating from, regions or flocks not recognized by APHIS as free of classical scrapie, may be imported in accordance with §§ 98.3 through 98.8 and the following conditions:

(1) The embryos

are transferred to females in a flock in the United States that participates in the Voluntary Scrapie Flock Certification Program (see 9 CFR part 54, subpart B) and qualifies as a “Certified” flock; or

(2) The embryos are transferred to females in a flock in the United States that participates in the Voluntary Scrapie Flock Certification Program (see 9 CFR part 54, subpart B) and the flock owner has agreed, in writing, to maintain the flock, and all first generation progeny resulting from embryos imported in accordance with this section, in compliance with all requirements of the Voluntary Scrapie Flock Certification Program until the flock, including all first generation progeny resulting from embryos imported in accordance with this section, qualifies as a “Certified” flock.

(b) Sheep embryos may be imported under paragraph (a) of this section only if the importer provides the Voluntary Scrapie Flock Certification Program identification number of the receiving flock as part of the application for an import permit.

(c) Sheep embryos may be imported under paragraph (a)(1) of this section only if they are the progeny of a dam and sire that are part of flocks in the region of origin that participate in a program determined by the Administrator to be equivalent to the Voluntary Scrapie Flock Certification Program, and the flocks have been determined by the Administrator to be at a level equivalent to “Certified” in the Voluntary Scrapie Flock Certification Program.

(d) Sheep embryos may be imported under paragraph (a)(2) of this section only if they are transferred to animals in a Certifiable Class C flock participating in the Voluntary Scrapie Flock Certification Program; except, that if the embryos are the progeny of a dam and sire whose flock in the region of origin participates in a program determined by the Administrator to be equivalent to the Voluntary Scrapie Flock Certification Program, then the embryos may be placed in a flock in the United States which would be classified at a level equivalent to or lower (i.e., at a greater risk) than the certification level, as determined by the Administrator, of either the flock of the dam or the flock of the sire, whichever one presents the greater risk.

(e) The flock to which the sheep embryos are transferred pursuant to paragraph (a)(2) of this section must be monitored for scrapie disease until the flock, and all first generation progeny resulting from the embryos imported in accordance with this section, qualifies as a “Certified” flock.

(f) Except for sheep embryos being placed in Certifiable Class C flocks, the certificate accompanying sheep embryos imported under paragraph (a) of this section must contain the following statement: “The embryos identified on this certificate are the progeny of a dam and sire that have been monitored by a salaried veterinary officer of [name of region of origin], for [number of months], in the same source flock which had been determined by the Administrator, APHIS, prior to the exportation of these embryos to the United States, to be equivalent to [certification level (of dam or sire) presenting greater risk] of the Voluntary Scrapie Flock Certification Program authorized under 9 CFR part 54, subpart B.”

(1) The Administrator will determine, based upon information supplied by the importer, whether the flock of the embryos' dam and sire participates in a program in the region of origin that is equivalent to the Voluntary Scrapie Flock Certification Program, and if so, at what level the source flock would be classified.

(2) In order for the Administrator to make a determination, the importer must supply the following information with the application for an import permit, no less than 1 month prior to the anticipated date of importation:

(i) The name, title, and address of a knowledgeable official in the veterinary services of the region of origin;

(ii) The details of scrapie control programs in the region of origin, including information on disease surveillance and border control activities and the length of time such activities have been in effect;

(iii) Any available information concerning additions, within the 5 years immediately preceding collection of the embryos, to the flock of the embryos' sire and dam;

(iv) Any available data concerning disease incidence, within the 5 years immediately preceding collection of the embryos, in the flock of the embryos' sire and dam, including, but not limited to, the results of diagnostic tests, especially histopathology tests, conducted on any animals in the flock;

(v) Information concerning the health, within the 5 years immediately preceding collection of the embryos, of other ruminants, flocks, and herds with which the embryos' sire and dam and the flock of the embryos' sire and dam might have had physical contact, and a description of the type and frequency of the physical contact; and

(vi) Any other information requested by the Administrator in specific cases as needed to make a determination.

(g) All first generation progeny resulting from embryos imported under this section are subject to the requirements of 9 CFR part 54 and all other applicable regulations

or oocytes must be accompanied by a health certificate meeting the requirements listed in § 98.5, and with the following additional certifications:

(i) The embryos or oocytes were collected, processed and stored in conformity with the requirements in § 98.3(g).

(ii) For in vivo-derived sheep embryos only: The embryo is of the genotype AAQR or AARR based on official testing of the parents or the embryo.

(iii) Certificates for sheep embryos not of the genotype AAQR or AARR, and for all goat embryos, must contain the following additional certifications:

(A) In the country or zone:

(1) TSEs of sheep and goats are compulsorily notifiable to the national veterinary authority of the region;

(2) A scrapie awareness, surveillance, monitoring, and control system is in place;

(3) TSE-affected sheep and goats are killed and completely destroyed; and

(4) The feeding to sheep and goats of meat-and-bone meal of ruminant origin has been banned and the ban is effectively enforced in the whole country.

(B) The donor animals:

(1) Have been kept since birth in flocks or herds where no case of scrapie had been confirmed during their residency; and

(2) Are permanently identified to enable a traceback to their flock or herd of origin, and this identification is recorded on the certificate accompanying the embryo(s) and linked to the embryo container identification; and

(3) Showed no clinical sign of scrapie at the time of embryo/oocyte collection; and

(4) Have not tested positive for, and are not suspect for, a transmissible spongiform encephalopathy; and

(5) Are not under movement restrictions within the country or region of origin as a result of exposure to a transmissible spongiform encephalopathy.

(2) [Reserved]

(c) Any additional certifications or testing requirements established by APHIS, based on genetic susceptibility of the embryo or embryo parents, and/or on scrapie testing of the embryo donor, will be listed in the APHIS import permit. Such certifications or required test results must also be recorded on the health certificate accompanying the embryo(s).

(d) Sheep and goat embryos or oocytes may only be imported for transfer to recipient females in the United States if the flock or herd where the recipients reside is listed in the National Scrapie Database; except APHIS may permit importation of sheep and goat embryos or oocytes to an APHIS-approved storage facility where they may be kept until later transferred to recipient females in a flock or herd in the United States listed in the APHIS National Scrapie Database, and under such conditions as the Administrator deems necessary to trace the movement of the imported embryos or oocytes. Imported sheep or goat embryos or oocytes not otherwise restricted by the conditions of an import permit may be transferred from a listed flock or herd to any other listed flock or herd, or from an embryo storage facility to a listed flock or herd, with written notification to the responsible APHIS Veterinary Services Service Center.

(e) The importer, the owner of a recipient flock or herd where delivery of the embryos or oocytes is made, or the owner of an APHIS-approved embryo or oocyte storage facility must maintain records of the disposition (including destruction) of imported or stored embryos or oocytes for 5 years after the embryo or oocyte is transferred or destroyed. These records must be made available during normal business hours to APHIS representatives on request for review and copying.

(f) For in vitro-derived and manipulated sheep or goat embryos and oocytes, APHIS will make a case-by-case determination or establish conditions in an import permit that includes any additional mitigations deemed necessary to prevent the introduction of disease as provided in § 98.10.

(g) The owner of all sheep or goats resulting from embryos or oocytes imported under this section shall:

(1) Identify them at birth with a permanent official identification number consistent with the provisions of § 79.2 of this chapter; such identification may not be removed except at slaughter and must be replaced if lost;

(2) Maintain a record linking the official identification number to the imported embryo or oocyte including a record of the replacement of lost tags;

(3) Maintain records of any sale or disposition of such animals, including the date of sale or disposition, the name and address of the buyer, and the animal's official identification number; and

(4) Keep the required records for a period of 5 years after the sale or death of the animal. APHIS may view and copy these records during normal business hours.

(Approved by the Office of Management and Budget under control numbers 0579-0040, 0579-0101, and 0579-01010453)

[61 86 FR 1724168863, AprDec. 19, 1996, as amended at 62 FR 56025, Oct. 28, 19973, 2021]