Ruminant and swine embryos may be imported from a region where foot-and-mouth disease exists only if all of the following conditions are met:

(a) The donor dam is determined to be free of communicable diseases based on tests, examinations, and other requirements, as follows, except that, with regard to bovine spongiform encephalopathy, the following does not apply to bovines, cervids, or camelids.

(1) During the year before embryo collection, no case of the following diseases occurred in the embryo collection unit or in any herd in which the donor dam was present:

(i) Ruminant: Bovine spongiform encephalopathy, contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley fever, or vesicular stomatitis; or

(ii) Swine: African swine fever, foot-and-mouth disease, classical swine fever, pseudorabies, swine vesicular disease, or vesicular stomatitis.

(2) During the year before embryo collection, no case of the following diseases occurred within 5 kilometers of the embryo collection unit or in any herd in which the donor dam was present:

(i) Ruminant: Bovine spongiform encephalopathy, contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley fever, or vesicular stomatitis; or

(ii) Swine: African swine fever, foot-and-mouth disease, classical swine fever, pseudorabies, swine vesicular disease, or vesicular stomatitis.

(3) During the 60 days before embryo collection, the donor dam did not receive a vaccination for foot-and-mouth disease.

(4) During the 60 days before the donor dam was required to be in the embryo collection unit, in accordance with §98.17(a) of this subpart, the donor dam remained in the same herd, and no ruminants or swine were added to that herd.

(5)

(i) On the day of embryo collection, and again not less than 30 days nor more than 120 days afterward, one sample of at least 10 ml of serum was collected from the donor dam, frozen, and sent to the Foreign Animal Disease Diagnostic Laboratory for testing.

(ii) The donor dam was determined to be free of foot-and-mouth disease based upon tests of the pair of serum samples. In addition, if any of the following diseases exist in the region of origin, the donor dam was determined to be free of these diseases based upon additional tests of the serum samples:

(A) Ruminant: Contagious bovine pleuropneumonia, Rift Valley fever, or vesicular stomatitis; or

(B) Swine: African swine fever, classical swine fever, pseudorabies, swine vesicular disease, or vesicular stomatitis.

(iii) If the donor dam was in any herd during the year before embryo collection that was not certified free of brucellosis by the national government of the region of origin, the donor dam was determined to be free of brucellosis based on tests of the serum samples.

(iv) The only official test results will be those provided by the Foreign Animal Disease Diagnostic Laboratory.

(6) If the donor dam was in any herd during the year before embryo collection that was not certified free of tuberculosis by the national government of the region of origin, the donor dam was determined to be free of tuberculosis by an official veterinarian based on an intradermal tuberculin test. The test must have been administered to the donor dam by an official veterinarian not less than 30 days nor more than 120 days after embryo collection, and not less than 60 days after any previously administered intradermal test for tuberculosis.

(7)

(i) Not less than 30 days nor more than 120 days after embryo collection, the donor dam was examined by an official veterinarian and found free of clinical evidence of the following diseases:

(A) Ruminant: Bovine spongiform encephalopathy, brucellosis, contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley fever, tuberculosis, and vesicular stomatitis; or

(B) Swine: African swine fever, brucellosis, foot-and-mouth disease, classical swine fever, pseudorabies, swine vesicular disease, tuberculosis, and vesicular stomatitis.

(ii) All signs of any other communicable disease must be listed on the health certificate that accompanies the embryos to the United States.

(8)

(i) Between the time the embryos were collected and all examinations and tests required by this subpart were completed, no animals in the embryo collection unit with the donor dam, or in the donor dam's herd of origin, exhibited any clinical evidence of:

(A) Ruminant: Bovine spongiform encephalopathy, brucellosis, contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley fever, tuberculosis, and vesicular stomatitis; or

(B) Swine: African swine fever, brucellosis, foot-and-mouth disease, classical swine fever, pseudorabies, swine vesicular disease, tuberculosis, and vesicular stomatitis.

(ii) All signs of any other communicable disease must be listed on the health certificate that accompanies the embryos to the United States.

(b) The donor dam or donor sire is determined to be free of communicable diseases based on other testing or certifications if required by the Administrator. The Administrator may require additional testing or certifications if he or she determines that they are necessary to determine either the donor dam's or the donor sire's freedom from communicable diseases. Circumstances that may result in additional testing or certifications include, but are not limited to:

(1) The existence of communicable diseases of livestock, other than those diseases specifically listed, in the region of origin;

(2) A high prevalence or an increase in the incidence of a communicable disease in the region of origin;

(3) The use of natural breeding, rather than artificial insemination to conceive the embryos;

(4) The use of fresh, rather than frozen semen, for artificial insemination; and

(5) The use of semen collected at a site other than an artificial insemination center approved by the national government of the region of origin.

(c) Embryos produced by any donor dam or sire that dies before being examined and tested as required under this subpart will not be eligible for importation into the United States.

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15183, Apr. 5, 1996; 62 FR 56025, Oct. 28, 1997; 68 FR 16940, Apr. 7, 2003; 78 FR 73008, Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018]