The following terms, when used in this subpart, shall be construed as defined. Those terms used in the singular form in this subpart shall be construed as the plural form and vice versa, as the case may demand.

Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.

Animal. Any cattle, sheep, goats, other ruminants, swine, horses, or asses.

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS).

Approved artificial insemination center. A facility approved or licensed by the national government of the region in which the facility is located to collect and process semen under the general supervision of such government.

Approved embryo transfer unit. A facility approved or licensed by the national government of the region in which the facility is located for the artificial insemination of donor dams or for conception as a result of artificial breeding by a donor sire and for collecting and processing embryos for export under the general supervision of such government.

Department. The United States Department of Agriculture.

Embryo. The initial stage of an animal's development after collection from the natural mother, while it is capable of being transferred to a recipient dam, but not including an embryo that has been transferred to a recipient dam.

Enter (entered, entry) into the United States. To introduce into the commerce of the United States after release from governmental detention at the port of entry.

Flock. A herd.

Herd. All animals maintained on any single premises; and all animals under common ownership or supervision on two or more premises which are geographically separated, but among which there is an interchange or movement of animals.

Import (imported, importation) into the United States. To bring into the territorial limits of the United States.

Inspector. An employee of APHIS who is authorized to perform the function involved.

Oocyte. The first and second maturation stages of a female reproductive cell prior to fertilization.

Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or any other legal entity.

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

Transmissible spongiform encephalopathies (TSEs). A family of progressive and generally fatal neurodegenerative disorders thought to be caused by abnormal proteins, called prions, typically producing characteristic microscopic changes, including, but not limited to, noninflammatory neuronal loss, giving a spongiform appearance to tissues in the brains and nervous systems of affected animals.

United States. All of the several States of the United States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States and all other territories and possessions of the United States.

Except as provided in subpart B of this part, an animal embryo shall not be imported into the United States unless it is from a region listed under § 94.1(a) of this chapter as being free of foot-and-mouth disease, and:

(a) The embryo is exported to the United States from the region in which it was conceived;

(b) The embryo was conceived as a result of artificial insemination with semen collected from a donor sire at an approved artificial insemination center, or the embryo as conceived as a result of natural breeding by a donor sire at an approved embryo transfer unit;

(c) If artificially inseminated, the donor dam conceived the embryo after being inseminated in an approved embryo transfer unit with semen collected at an approved artificial insemination center;

(d) At the time of collection of the semen used to conceive the embryo or at the time of natural breeding, the donor sire met all requirements the donor sire would have to meet under part 93 of this chapter for a health certificate required as a condition of importation into the United States; except that, for sheep and goats only, the donor sire must meet the scrapie requirements in § 98.35 instead of the requirements in § 93.435 of this chapter;

(e) At the time of collection of the embryo from the donor dam, the donor dam met all requirements the donor dam would have to meet under part 93 of this chapter for a health certificate required as a condition of importation into the United States; except that, for sheep and goats only, the donor dam must meet the requirements for embryo donors in § 98.10(a) instead of the requirements in § 93.435 of this chapter;

(f) There is no basis for denying an import permit for the donor sire or donor dam under § 93.304(a)(2) for horses, § 93.404(a)(3) or (4) for ruminants, and § 93.504(a)(2) or (3) for swine of this chapter;

(g) The embryo is collected and maintained under conditions determined by the Administrator to be adequate to protect against contamination of the embryo with infectious animal disease organisms; and

(h) The embryo was determined, based on microscopic examination, to have an intact zona pellucida at the time the embryo was placed into its immediate container (straw or ampule) for shipping.

(i) The embryo is contained in a shipping container which at the time of offer for entry is sealed with an official seal which was affixed to the shipping container by a full-time salaried veterinarian of the national animal health service of the region of origin or by a veterinarian authorized to do so by the national animal health service of the region of origin.

(a) Except as provided in subpart B of this part, an animal embryo shall not be imported into the United States unless accompanied by an import permit issued by APHIS and unless imported into the United States within 14 days after the proposed date of arrival stated in the import permit.

(b) An application for an import permit must be submitted to the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. An application form for an import permit may be obtained from this staff.

(c) The completed application shall include the following information:

(1) The name and address of the person intending to export an embryo from the region of origin,

(2) The name and address of the person intending to import an embryo,

(3) The species, breed, and number of embryos to be imported,

(4) The purpose of the importation,

(5) The region in which the embryo is conceived,

(6) The port of embarkation,

(7) The mode of transportation,

(8) The route of travel,

(9) The port of entry in the United States,

(10) The proposed date of arrival in the United States,

(11) The name and address of the person to whom the embryo will be delivered in the United States, and

(12) The measures to be taken to ensure that the embryo is collected and maintained under conditions adequate to protect against contamination of the embryo with infectious animal disease organisms.

(d) Applications for a permit to import sheep and goat embryos and oocytes must include the flock identification number of the receiving flock and the premises or location identification number assigned in the APHIS National Scrapie Database; or, in the case of embryos or oocytes moving to a storage facility, the premises or location identification number must be included.

(e) After receipt and review of the application by APHIS, an import permit indicating the applicable conditions under this subpart for importation into the United States shall be issued for the importation of embryos described in the application if such embryos appear to be eligible to be imported. Even though an import permit has been issued for the importation of an embryo, the embryo may be imported only if all applicable requirements of this subpart are met.

(a) Except as provided in subpart B of this part, an animal embryo shall not be imported into the United States unless it is accompanied by a certificate issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so. The certificate shall state:

(1) The dates, places, types, and results of all examinations and tests performed on the donor sire and donor dam as a condition for importation of the embryo, and the names and addresses of persons or laboratories conducting the examinations or tests, and a statement that any other requirements established by § 98.3 have been complied with,

(2) The name and address of the consignor and consignee,

(3) The name and address of the approved artificial insemination center where the semen for the embryo was collected, if applicable,

(4) The name and address of the approved embryo transfer unit where the donor dam was inseminated or bred and the embryo was collected, and

(5) The measures taken to ensure that the embryo was collected and maintained under conditions adequate to protect against contamination of the embryo with infectious animal disease organisms.

(b) [Reserved]

An embryo shall not be imported into the United States unless at a port of entry listed in § 93.303 for horses, § 93.403 for ruminants, or § 93.503 for swine of this chapter.

Upon arrival of an embryo at a port of entry, the importer or the importer's agent shall notify APHIS of the arrival by giving an inspector a document stating:

(a) The port of entry,

(b) The date of arrival,

(c) Import permit number,

(d) Carrier, and identification of the means of conveyance,

(e) The name and address of the importer,

(f) The name and address of the broker,

(g) The region of origin of the embryo,

(h) The number, species, and purpose of importation of the embryo, and

(i) The name and address of the person to whom the embryo will be delivered.

Any embryo offered for entry into the United States in accordance with this subpart and documents accompanying the embryo shall be subject to inspection by an inspector at the time the embryo is offered for entry in order to determine whether the embryo is eligible for entry. The import permit and the health certificate shall be given to the inspector.

Any embryo refused entry into the United States for noncompliance with the requirements of this subpart shall be removed from the United States within a time period specified by the Administrator or abandoned by the importer for destruction, and pending such action shall be subject to such safeguards as the inspector determines necessary to prevent the possible introduction into the United States of infectious animal diseases. If such embryo is not removed from the United States within such time period, or abandoned for destruction, it may be seized, destroyed, or otherwise disposed of as the inspector determines necessary to prevent the possible introduction into the United States of infectious animal diseases.

Notwithstanding other provisions in this part, the Administrator may in specific cases allow the importation and entry into the United States of embryos other than as provided for in this part under such conditions as the Administrator may prescribe to prevent the introduction into the United States of infectious animal diseases.

(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 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.