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Electronic Code of Federal Regulations

e-CFR data is current as of March 26, 2020

Title 9Chapter ISubchapter DPart 98 → Subpart B


Title 9: Animals and Animal Products
PART 98—IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN


Subpart B—Ruminant and Swine Embryos From Regions Where Foot-and-Mouth Disease Exists


Contents
§98.11   Definitions.
§98.12   General prohibitions.
§98.13   Import permit.
§98.14   Health certificate.
§98.15   Health requirements.
§98.16   The embryo collection unit.
§98.17   Procedures.
§98.18   Shipment of embryos to the United States.
§98.19   Arrival and inspection at the port of entry.
§98.20   Embryos refused entry.
§98.21   Embryos from sheep in regions other than Australia, Canada, and New Zealand.

Source: 56 FR 55809, Oct. 30, 1991, unless otherwise noted.

§98.11   Definitions.

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

Camelid. All species of the family Camelidae, including camels, guanacos, llamas, alpacas, and vicunas.

Cervid. All members of the family Cervidae and hybrids, including deer, elk, moose, caribou, reindeer, and related species.

Collection of embryos. Embryos removed from a single donor dam in one operation.

Embryo. The initial stages of development of an animal, after collection from the natural mother and while it is capable of being transferred to a recipient dam, but not after it has been transferred to a recipient dam.

Embryo collection unit. Area or areas where the donor dam will be bred to produce embryos for importation into the United States, and where the embryos will be collected, processed, and stored pending shipment to the United States.

Foreign Animal Disease Diagnostic Laboratory. The Foreign Animal Disease Diagnostic Laboratory of the Animal and Plant Health Inspection Service.

Herd of origin. The herd in which the donor dam is kept during the 60 days before the donor dam is required to be housed in an embryo collection unit, in accordance with §98.17(a) of this subpart.

Import. To bring into the territorial limits of the United States.

Inspector. An employee of the Animal and Plant Health Inspection Service who is authorized to perform the function involved.

Official veterinarian. A full-time salaried veterinarian of the national government of the country of origin or a veterinarian employed by the Animal and Plant Health Inspection Service (APHIS), and designated by APHIS to supervise or conduct procedures required by this subpart, and to certify that requirements of this subpart have been met.

Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or 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.

Region of origin. The region in which the embryo is conceived and collected and from which the embryo is imported into the United States.

Ruminant. All animals which chew the cud, including cattle, buffaloes, camelids, cervids (deer, elk, moose, and antelope), sheep, goats, and giraffes.

Swine. The domestic hog and all varieties of wild hogs.

United States. All of the 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.

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15183, Apr. 5, 1996; 62 FR 56025, Oct. 28, 1997; 78 FR 73008, Dec. 4, 2013]

§98.12   General prohibitions.

(a) Ruminant and swine embryos may not be imported from regions where foot-and-mouth disease exists except in accordance with this subpart.

(b) Ruminant and swine embryos may not be imported into the United States from any region other than the region in which they were conceived and collected.

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15183, Apr. 5, 1996; 62 FR 56025, Oct. 28, 1997; 83 FR 15494, Apr. 11, 2018]

§98.13   Import permit.

(a) Ruminant and swine embryos and all test samples required by this subpart may be imported into the United States from regions where foot-and-mouth disease exists only if accompanied by import permits issued by the Animal and Plant Health Inspection Service (APHIS).

(b) An application for the import permits must be submitted to the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. Application forms also may be obtained at this same address. The application for a permit to import embryos will also serve as the application for a permit to import test samples for those embryos; separate applications are not required. The application must include the following information:

(1) The name and address of the exporter;

(2) The name and address of the importer;

(3) The name and address of the place where the donor dam will be bred and where the embryo(s) will be collected;

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

(5) The purpose of the importation;

(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; and

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

(Approved by the Office of Management and Budget under control number 0579-0040)

[56 FR 55809, Oct. 30, 1991, as amended at 59 FR 67616, Dec. 30, 1994; 61 FR 15183, Apr. 5, 1996; 62 FR 56025, Oct. 28, 1997; 83 FR 15494, Apr. 11, 2018]

§98.14   Health certificate.

(a) Ruminant and swine embryos shall not be imported into the United States unless they are 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.

(b) The health certificate must state:

(1) The name and address of the place where the embryos were collected;

(2) The name and address of the veterinarian who collected the embryos;

(3) The date of embryo collection;

(4) The identification and breed of the donor dam and donor sire;

(5) The number of ampules or straws covered by the health certificate and the identification number or code on each ampule or straw;

(6) The dates, types, and results of all examinations and tests performed on the donor dam and donor sire as a condition for importing the embryos;

(7) The dates and results of all tests performed on unfertilized eggs, nontransferrable embryos, and embryo collection and wash fluids;

(8) The names and addresses of the consignor and consignee;

(9) That the embryos are being imported into the United States in accordance with subpart B of 9 CFR part 98.

(c) If any of the information required by paragraph (b) of this section is provided in code, deciphering information must be attached to the health certificate.

(d) The health certificate accompanying sheep or goat embryos intended for importation from any part of the world shall, in addition to the statements required by paragraph (b) of this section, state that:

(1) The embryos' sire and dam have not been in any flock or herd nor had contact with sheep or goats which have been in any flock or herd where scrapie has been diagnosed or suspected during the 5 years prior to the date of collection of the embryos;

(2) The embryos' sire and dam showed no evidence of scrapie at the time the embryos were collected;

(3) Scrapie has not been suspected nor confirmed in any progeny of the embryos' donor dam; and

(4) The parents of the embryos' sire and dam are not, nor were not, affected with scrapie.

(e) There must be a separate health certificate for each collection of embryos.

(Approved by the Office of Management and Budget under control number 0579-0040)

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15183, Apr. 5, 1996; 61 FR 17242, Apr. 19, 1996; 62 FR 56025, Oct. 28, 1997]

§98.15   Health requirements.

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]

§98.16   The embryo collection unit.

Ruminant and swine embryos may be imported into the United States from a region where foot-and-mouth disease exists only if they were conceived, collected, processed, and stored prior to importation at an embryo collection unit. The embryo collection unit may be located on the premises where the donor dam's herd of origin is kept, or at any other location, provided that the embryo collection unit has been inspected and approved by an APHIS veterinarian and that the following requirements are met:

(a) Animal holding and breeding area(s). The embryo collection unit must have an area or areas for holding the donor dams and for breeding them (either natural breeding or artificial insemination).

(b) Embryo collection area. The embryo collection must have a room or outdoor area for collection of embryos that contains a device or devices for restraining embryo donors during embryo collection. If a room, the floor, walls, and ceiling must be impervious to moisture and constructed of materials that can withstand repeated cleaning and disinfection. If an outdoor area, the area must have a floor that is impervious to moisture and is constructed of materials that can withstand repeated cleaning and disinfection. If the outdoor area also has walls or a roof, the walls or roof also must be impervious to moisture and be constructed of materials that can withstand repeated cleaning and disinfection.

(c) Embryo processing area. The embryo collection unit must have an enclosed room, which may be mobile, that is used only for processing embryos. The walls, floor, and ceiling of the room must be impervious to moisture and constructed of materials that can withstand repeated cleaning and disinfection. The room must contain a work surface for handling the embryos, such as a table or countertop that is impervious to moisture. The room also must contain a microscope with a minimum of 50x magnification, and equipment for freezing the embryos.

(d) Embryo storage area. The embryo collection unit must have one lockable area that is used only for storing frozen embryos intended for importation into the United States.

(e) Area for cleaning and disinfecting or sterilizing equipment. The embryo collection unit must have an enclosed room used for cleaning and disinfecting or sterilizing equipment used for artificial insemination or for collection, processing, or storage of embryos. The walls, floor, and ceiling of the room must be impervious to moisture and constructed of materials that can withstand repeated cleaning and disinfection.

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15184, Apr. 5, 1996; 62 FR 56025, Oct. 28, 1997; 83 FR 15494, Apr. 11, 2018]

§98.17   Procedures.

(a) Housing of the donor dam. (1) Beginning at least 24 hours before a donor dam is bred to produce embryos for importation to the United States, the donor dam must be housed at an embryo collection unit.

(2) The donor dam must remain at the embryo collection unit until the embryos for importation into the United States have been collected.

(3) After collection of embryos, the donor dam must either remain at the embryo collection unit or be returned to the herd of origin and remain there until all examinations and tests required by this subpart have been completed.

(4) During the time the donor dam is in the embryo collection unit, in accordance with paragraphs (a)(1) through (a)(3) of this section, no animals may be in the embryo collection unit with the donor dam unless:

(i) They meet the requirements of §98.15 of this subpart that are applicable to the donor dam at that time;

(ii) They are part of the donor dam's herd of origin; or

(iii) They are serving as donor sires for the production of embryos to be imported into the United States.

(b) Oversight and supervision. (1) All procedures associated with the production of embryos for importation into the United States, including artificial insemination, natural breeding, and cleaning and disinfection, must be performed under the oversight of an APHIS veterinarian. Collecting test samples, and collecting, processing, and storing embryos, must be supervised in person by an APHIS veterinarian.

(2) Officials from the Animal and Plant Health Inspection Service must be given access to all areas of the embryo collection unit and the donor dam's herd of origin during the time the donor dam is housed there, in accordance with paragraphs (a)(1) through (a)(3) of this section.

(c) Personnel. All personnel must put on clean outer garments, including disinfected boots, and must scrub their hands with soap and water each time they enter the embryo collection unit and before entering any room or area listed in §98.16 of this subpart.

(d) Cleaning, disinfection, and sterilization. (1) All equipment that comes in contact with embryos or with media used for their collection or processing must be sterile. Equipment used for embryos from one donor dam, or with associated media, may not be used for embryos or associated media from any other donor dam until it has been resterilized.

(2) All equipment that comes in contact with a donor dam's secretions or excretions must be sterile and may not be used with any other donor dam until it has been resterilized.

(3) Containers used for storing embryos or for shipping embryos to the United States must be examined and found free of any organic matter and then disinfected before the ampules or straws are placed inside.

(4) The floor, ceiling, and walls of any room or outdoor area used for embryo collection, and the restraining device(s) used for this procedure, must be cleaned with soap and water and disinfected before the room or area is used to collect embryos intended for importation to the United States, and at least daily while in use for this purpose.

(5) The room and work surface used for processing embryos must be kept free of insects, rodents, trash, manure, and other animal matter and must be cleaned with soap and water and disinfected before the room is used for embryos intended for importation to the United States, and the work surface must be cleaned and disinfected at least daily while in use for this purpose.

(6) The area of the embryo collection unit used to store embryos intended for importation to the United States must be kept free of insects, rodents, trash, manure, and other animal matter and must be cleaned with soap and water and disinfected before being used to store the embryos.

(7) The room used for cleaning and disinfecting or sterilizing equipment used for artificial insemination or for collection, processing, or storage of embryos must be kept free of insects, rodents, trash, manure, and other animal matter and must be cleaned with soap and water and disinfected before being used to prepare equipment for donors of embryos intended for importation into the United States, and at least daily while in use for this purpose.

(e) Media; cryogenic agent. (1) All media containing products of animal origin and used for embryo collection and processing must be from sources in the United States or Canada.

(2) The liquid nitrogen used to freeze embryos may not have been used previously for any other products of animal origin.

(f) Collection and processing of embryos. (1) If embryos are collected in an outdoor area, they must be collected by using a closed collection system so that the embryos are not exposed to open air until they are inside the embryo processing room.

(2) Embryos from donors that do not meet the requirements of §98.15 of this subpart that are applicable at the time of embryo collection may not be in the processing room at the same time as embryos intended for importation into the United States.

(3) Each embryo must be washed at least 10 times. Each wash must be accomplished by transferring the embryo into an aliquot of fresh medium that is 100 times the volume of the embryo plus any fluid transferred from the previous wash. No more than 10 embryos from the same flush may be washed together. A sterile micropipette must be used for each transfer, and the embryos must be well agitated throughout the entire volume of the wash before the next transfer. Embryos from different donors may not be washed together.

(4) After the last wash, each embryo must be microscopically examined over its entire surface at not less than 50 × magnification. An embryo may not be imported into the United States unless its zona pellucida is found to be intact and free from any adherent material.

(5) After washing and examination of the zona pellucida, embryos must be individually packaged in sterile ampules or straws and frozen in liquid nitrogen. The donor dam's and sire's identifications and breed, the date of embryo collection, the name and address of the place where the embryos were collected, and an identification number for the straw or ampule must be recorded with indelible markings on each ampule or straw. If any of this information is provided in code, deciphering information must be attached to the health certificate for the embryos.

(6) The Administrator may require additional measures to be taken in processing embryos after collection (for example, adding trypsin to the washes) if he or she determines that such measures are necessary to ensure the embryos freedom from infectious agents that may cause communicable diseases. Circumstances that may result in such additional measures being required include, but are not limited to:

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

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

(g) Preparation of test samples; tests. (1) All nontransferrable embryos and unfertilized eggs from each collection of embryos intended for importation into the United States must be pooled, frozen in liquid nitrogen, and sent to the Foreign Animal Disease Diagnostic Laboratory for testing under the personal supervision of an APHIS veterinarian. The collection and last two wash fluids from the collection of embryos must be frozen and sent to the Foreign Animal Disease Diagnostic Laboratory for testing under the personal supervision of an APHIS veterinarian. Samples from different collections may not be mixed.

(2) All samples collected in accordance with paragraph (g)(1) of this section must be tested and found negative for viral contamination. The wash fluids also must be found negative for bacterial contamination. The only official results for these tests will be those provided by the Foreign Animal Disease Diagnostic Laboratory.

(h) Storage of embryos. (1) Frozen embryos to be imported into the United States must be stored in a locked area or must remain in the custody of an official veterinarian until they are sealed in accordance with paragraph (h)(2) of this section and released for shipment to the United States in accordance with §98.18(a) of this subpart; except that, the embryos may be moved to a U.S. Department of Agriculture-operated animal import center in either New York, Hawaii, or Florida, under seal and in the custody of that individual, and remain in quarantine there until all tests and examinations required by this subpart have been completed and all test results have been provided by the Foreign Animal Disease Diagnostic Laboratory.

(2) Containers in which embryos will be imported into the United States must be sealed by an official veterinarian with the official seal of the region of origin or, if the official veterinarian is an employee of the Animal and Plant Health Inspection Service, with an official seal of the United States Department of Agriculture. The seal number must be recorded on the health certificate that accompanies the embryos to the United States.

(Approved by the Office of Management and Budget under control number 0579-0040)

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15184, Apr. 5, 1996; 62 FR 56026, Oct. 28, 1997]

§98.18   Shipment of embryos to the United States.

(a) Release from the embryo collection unit. Except as provided in §98.17(h)(1) of this subpart, embryos may not be moved from the embryo collection unit until all tests and examinations required by this subpart have been completed and the Import-Export Animals Staff, Veterinary Services, APHIS, has received written notification of all test results from the Foreign Animal Disease Diagnostic Laboratory.

(b) Route. The sealed shipping containers must be routed directly to the U.S. port of entry designated on the import permit.

(c) Ports of entry. The embryos may be imported into the United States only through a port of entry listed in §93.203(a) of this chapter.

(d) Date of arrival in the United States. Embryos that arrive at the port of entry more than 14 days after the proposed date of arrival stated in the import permit will not be eligible for importation into the United States.

[56 FR 55809, Oct. 30, 1991, as amended at 62 FR 56026, Oct. 28, 1997]

§98.19   Arrival and inspection at the port of entry.

(a) Upon arrival at the port of entry, the importer or the importer's agent must present an inspector at the port with the original health certificate and the original import permit for the embryos.

(b) The shipping container and all straws or ampules containing embryos must be made available to an inspector at the port of entry for inspection, and may not be removed from the port of entry until an inspector determines that the embryos are eligible for entry in accordance with this subpart and releases them.

§98.20   Embryos refused entry.

If any embryos are determined to be ineligible for importation into the United States upon arrival at the port of entry, the importer must remove the embryos from the United States within 30 days, or the embryos will be destroyed.

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

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 with §98.10a.

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

[61 FR 17242, Apr. 19, 1996]

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