9 C.F.R. Subpart C—Certain Animal Semen
Title 9 - Animals and Animal Products
Source: 55 FR 31558, Aug. 2, 1990, unless otherwise noted.
Whenever in this subpart of the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean: Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, to whom authority has been or may be delegated to act in the Administrator's stead. Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service.) Animals. Cattle, sheep, goats, other ruminants, swine, horses, asses, zebras, and poultry. Cattle. Animals of the bovine species. Communicable disease. Any contagious, infectious, or communicable disease of domestic livestock, poultry or other animals. Department. The United States Department of Agriculture (USDA). European Union–15 (EU–15). The organization of Member States consisting of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Portugal, Republic of Ireland, Spain, Sweden, and the United Kingdom (England, Scotland, Wales, the Isle of Man, and Northern Ireland). 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. Horses. Horses, asses, mules, and zebras. Inspector. An employee of the Animal and Plant Health Inspection Service authorized to perform duties required under this subpart. Port veterinarian. A veterinarian employed by the Animal and Plant Health Inspection Service to perform duties required under this part at a port of entry. Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys (including eggs for hatching). 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. Restricted zone for classical swine fever. An area, delineated by the relevant competent veterinary authorities of the region in which the area is located, that surrounds and includes the location of an outbreak of classical swine fever in domestic swine or detection of the disease in wild boar, and from which the movement of domestic swine is prohibited. Ruminants. All animals which chew the cud, such as cattle, buffaloes, sheep, goats, deer, antelopes, camels, llamas 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, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other Territories and Possessions of the United States. [55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991; 61 FR 17242, Apr. 19, 1996; 62 FR 56026, Oct. 28, 1997; 65 FR 56777, Sept. 20, 2000; 71 FR 29071, May 19, 2006] (a) No product subject to the provisions of this subpart shall be brought into the United States except in accordance with the regulations in this subpart and part 94 of this subchapter; nor shall any such product be handled or moved after physical entry into the United States before final release from quarantine or any other form of governmental detention except in compliance with such regulations; Provided, That, except as prohibited by section 306 of the Act of June 17, 1930, as amended (19 U.S.C. 1306), the Administrator may upon request in specific cases permit products to be brought into or through the United States under such conditions as he or she may prescribe, when he or she determines in the specific case that such action will not endanger the livestock or poultry of the United States. (b) Animal semen may not be imported into the United States from any region other than the region in which it was collected. [55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991, and amended at 58 FR 37643, July 13, 1993; 59 FR 26596, May 23, 1994; 62 FR 56026, Oct. 28, 1997] (a) Inspection: All aircraft and other means of conveyance (including shipping containers thereon) moving into the United States from any foreign region are subject to inspection without a warrant by properly identified and designated inspectors to determine whether they are carrying any animal, carcass, product or article regulated or subject to disposal under any law or regulation administered by the Secretary of Agriculture for prevention of the introduction or dissemination of any communicable animal disease. (b) Unloading requirements: Whenever in the course of any such inspection at any port in the United States the inspector has reason to believe that the means of conveyance or container is contaminated with material of animal (including poultry) origin, such as, but not limited to, meat, organs, glands, extracts, secretions, fat, bones, blood, lymph, urine, or manure, so as to present a danger of the spread of any communicable animal disease, the inspector may require the unloading of the means of conveyance and the emptying of the container if he or she deems it necessary to enable him or her to determine whether the means of conveyance or container is in fact so contaminated. The principal operator of the means of conveyance and his or her agent in charge of the means of conveyance shall comply with any such requirement under the immediate supervision of, and in the time and manner prescribed by, the inspector. (c) Cleaning and disinfection: Whenever, upon inspection under this section, an inspector determines that a means of conveyance or shipping container is contaminated with material of animal origin so as to present a danger of the spread of any communicable animal disease, he or she shall notify the principal operator of the means of conveyance or his or her agent in charge, of such determination and the requirements under this section. The person so notified shall cause the cleaning and disinfection of such means of conveyance and container under the immediate supervision of, and in the time and manner prescribed by, the inspector. (d) For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved. [55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991; 62 FR 56026, Oct. 28, 1997; 68 FR 6345, Feb. 7, 2003] (a) Air and ocean ports. The following air and ocean ports are designated as having inspection facilities for the entry of animal semen: Los Angeles, California; Miami, Florida; and Newburgh, New York. (b) Canadian border ports. The following land border ports are designated as having inspection facilities for the entry of animal semen from Canada: Eastport, Idaho; Houlton and Jackman, Maine; Detroit, Port Huron, and Sault Ste. Marie, Michigan; Baudette, Minnesota; Opheim, Raymond, and Sweetgrass, Montana; Alexandria Bay, Buffalo, and Champlain, New York; Dunseith, Pembina, and Portal, North Dakota; Derby Line and Highgate Springs, Vermont; Oroville and Sumas, Washington. (c) Mexican border ports. The following land border ports are designated as having inspection facilities for the entry of animal semen from Mexico: Douglas, Naco, Nogales, San Luis, and Sasabe, Arizona; Calexico and San Ysidro, California; Antelope Wells, Columbus, and Santa Teresa, New Mexico; Brownsville, Del Rio, Eagle Pass, El Paso, Hidalgo, Laredo, and Presidio, Texas. (d) Limited ports. The following limited ports are designated as having inspection facilities for the entry of animal semen: Anchorage and Fairbanks, Alaska; San Diego, California; Jacksonville, St. Petersburg-Clearwater, and Tampa, Florida; Atlanta, Georgia; Honolulu, Hawaii; Chicago, Illinois; New Orleans, Louisiana; Portland, Maine; Baltimore, Maryland; Boston, Massachusetts; International Falls and Minneapolis, Minnesota; Great Falls, Montana; Portland, Oregon; San Juan, Puerto Rico; Memphis, Tennessee; Galveston and Houston, Texas; Seattle, Spokane, and Tacoma, Washington. (e) Designation of other ports. The Secretary of the Treasury has approved the designation as quarantine stations of the ports specified in this section. In special cases other ports may be designated as quarantine stations under this section by the Administrator, with the concurrence of the Secretary of the Treasury. [55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991, and amended at 58 FR 37643, July 13, 1993; 60 FR 16045, Mar. 29, 1995; 60 FR 25120, May 11, 1995; 64 FR 23179, Apr. 30, 1999; 65 FR 38178, June 20, 2000; 67 FR 68022, November 8, 2002] (a) Application for permit; reservation required. (1) For poultry semen and animal semen, intended for importation from any part of the world, except as otherwise provided for in §98.36, the importer shall first apply for and obtain from APHIS an import permit. The application shall specify the name and address of the importer; the species, breed, quantity of animal semen to be imported; the purpose of the importation; individual animal identification (except poultry) which includes a description of the animal, name, age, markings, if any, registration number, if any, and tattoo or eartag; the region of origin; the name and address of the exporter; the port of embarkation in the foreign region; the mode of transportation, route of travel, and the port of entry in the United States; the proposed date of arrival of the animal semen to be imported; and the name of the person to whom the animal semen will be delivered and the location of the place in the United States to which delivery will be made from the port of entry. Additional information may be required in the form of certificates concerning specific diseases to which the animals are susceptible, as well as vaccinations or other precautionary treatments to which the animals or animal semen have been subjected. Notice of any such requirements will be given to the applicant in each case. (2) An application for permit to import will be denied for semen from ruminants or swine from any region where it has been declared, under section 306 of the Act of June 17, 1930, that foot-and-mouth disease or rinderpest has been determined to exist, except as provided in paragraph (c) of this section. (3) An application for permit to import poultry semen or animal semen may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the animals or animal semen; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; or any other circumstances which the Administrator believes require such denial to prevent the dissemination of any communicable disease of livestock or poultry into the United States. (b) Permit. When a permit is issued, the original and two copies will be sent to the importer. It shall be the responsibility of the importer to forward the original permit and one copy to the shipper in the region of origin, and it shall also be the responsibility of the importer to insure that the shipper presents the copy of the permit to the carrier and makes proper arrangements for the original permit to accompany the shipment to the specified U.S. port of entry for presentation to the collector of customs. Animal semen intended for importation into the United States for which a permit has been issued, will be received at the specified port of entry within the time prescribed in the permit which shall not exceed 14 days from the first day that the permit is effective for all permits. Poultry semen and animal semen for which a permit is required by these regulations will not be eligible for entry if a permit has not been issued; if unaccompanied by such a permit; if shipment is from any port other than the one designated in the permit; if arrival in the United States is at any port other than the one designated in the permit; if the animal semen offered for entry differs from that described in the permit; or if the animal semen is not handled as outlined in the application for the permit and as specified in the permit issued. (c) Animal semen from regions where rinderpest or foot-and-mouth disease exists. Importation of semen of ruminants or swine, originating in any region designated in paragraph (a) of §94.1 of this subchapter as a region where rinderpest or foot-and-mouth disease is determined to exist, is prohibited, except that semen from ruminants or swine originating in such a region may be offered for entry into the United States at the port of New York and later released from such port provided the following conditions have been fulfilled: (1) The importer has applied for and obtained an import permit for the semen in accordance with the provisions of this section and related requirements concerning application therefor, which permit is in effect at the time of importation, and has deposited with the Department prior to the issuance of the permit sufficient funds so as to be available for defraying estimated expenses to be incurred in connection with the proposed semen importation and following the issuance of the permit has deposited such other amounts as may be required from time to time to defray unanticipated costs or increased expenses. Such an import permit may be denied for the reasons specified in paragraph (a)(3) of this section. Furthermore, an import permit will be revoked unless the following conditions have been complied with: (i) The donor animal shall have been inspected on the farm of origin or on another premises (the inspection may be on another premises only if a veterinarian of the Department has traced the donor animal back to its farm of origin) by a veterinarian of the United States Department of Agriculture who, in cooperation with the veterinary service of the region of origin of the donor animal, shall have determined, insofar as possible, that the donor animal was never infected with rinderpest or foot-and-mouth disease; that the donor animal was never on a farm or other premise where rinderpest or foot-and-mouth disease then existed; that the donor animal has not been on a premise that had an animal that was susceptible to the virus of rinderpest or foot-and-mouth disease and that was exposed to either disease during the 12 months immediately prior to the date of inspection of the donor animal; that the donor animal, if a ruminant, has never been vaccinated against rinderpest; that the donor animal, if a swine, has never been vaccinated against rinderpest or foot-and-mouth disease; and that the donor animal was free from evidence of other communicable disease; (ii) The donor animal shall have been permanently identified in a manner satisfactory to a veterinarian of this Department; a blood sample and an oesophageal-pharyngeal tissue sample (O-P sample) from such a donor ruminant and a blood sample from such a donor swine for tests as specified in paragraph (c)(1)(iv) of this section or other tests shall have been collected by a veterinarian of the United States Department of Agriculture and transported by air to the New York Port Veterinarian for delivery to the Foreign Animal Disease Diagnostic Laboratory, Greenport, New York, in containers approved by a veterinarian of this Department, sealed in the region of origin by a veterinarian of this Department; and pending the results of the tests, the donor animal shall have been kept in isolation on the farm of origin or other acceptable location under the supervision of a veterinarian of this Department, and during such isolation period no animal susceptible to rinderpest or foot-and-mouth disease shall have been permitted to enter such farm or location and no other source of exposure to rinderpest or foot-and-mouth disease shall have been present; (iii) The blood samples from the donor animal shall have been negative to the tests specified in paragraph (c)(1)(iv) of this section made at the Foreign Animal Disease Diagnostic Laboratory, Greenport, New York, and to any other test for rinderpest, foot-and-mouth disease or other communicable disease prescribed by the Administrator. (iv) In the case of a ruminant, each blood sample collected pursuant to paragraph (c)(1)(ii) or (vi) of this section shall have been tested for foot-and-mouth disease using the virus infection associated (VIA) test and each O-P sample collected pursuant to paragraph (c)(1)(ii) or (iv) of this section shall have been tested for foot-and-mouth disease using the virus isolation test. In the case of a swine, each blood sample collected pursuant to paragraph (c)(1)(ii) or (vi) of this section shall have been tested for foot-and-mouth disease using the virus infection associated (VIA) test and the virus neutralization test.”1 1 The test procedures for the virus infection associated (VIA) test, the virus isolation test, and the virus neutralization test are available from the Chief, Foreign Animal Disease Diagnostic Laboratory, National Veterinary Services Laboratories, P.O. Box 848, Greenport, NY 11944. (v) Following isolation, preliminary veterinary inspection, and testing while the donor animal was on the farm of origin or other acceptable location, the donor animal shall have been transported, under such conditions as the Department veterinarian prescribed to prevent exposure of the animal to the virus of rinderpest or foot-and-mouth disease, to an isolation facility properly equipped for the necessary care and maintenance of the donor animal and for the proper collection and handling of semen, approved by a veterinarian of this Department and under the direct supervision of such veterinarian; (vi) The semen of the donor animal shall have been collected at the approved isolation facility under the direct supervision of a veterinarian of this Department (any number of collections may be made); such veterinarian shall take a 0.5 ml sample of semen from each semen collection; and all handling procedures, such as examination, dilution, refrigeration, and preparation of the semen for shipment, shall have been under the direct supervision of a veterinarian of this Department. In the case of a ruminant, a blood sample and an O-P sample shall have been taken from the donor animal by a veterinarian of the Department within 7 days after the final semen collection, and between 21 to 28 days after the taking of these samples another blood sample shall have been taken from the donor animal by a veterinarian of the Department. In the case of a swine, a blood sample shall have been taken from the donor animal by a veterinarian of the Department within 7 days after the final semen collection, and between 21 to 28 days after the taking of the sample, another blood sample shall have been taken from the donor animal by a veterinarian of the Department. (2) The semen collected at the approved isolation facility shall have been at all times, except during air transportation to New York, in the custody of a veterinarian of this Department. (3) The semen for which an import permit has been issued shall have been transported by air to the port of New York in liquid nitrogen containers approved by a veterinarian of this Department; sealed in the region of origin by a veterinarian of this Department; and accompanied by a statement by such veterinarian showing the identification of the donor animal and the dates the semen was collected, along with a certificate regarding the health status of the donor animal as of the date of shipment of the semen to the port of New York. All semen received at the port of New York shall be held under quarantine in liquid nitrogen storage at such port in the custody of APHIS until released or otherwise disposed of as provided in this section. (4) The donor animal shall have been retained at the approved isolation facility in the region where the semen was collected until all of the applicable samples referred to in paragraph (c)(1)(vi) of this section have been collected by a veterinarian of the Department for tests as specified in paragraph (c)(1)(iv) of this section at the Foreign Animal Disease Diagnostic Laboratory, Greenport, New York, and any other tests as required by the Administrator. (5) The semen sample from each collection shall have consisted of unprocessed semen without any added substances, and shall have been tested at the Foreign Animal Disease Diagnostic Laboratory, Greenport, New York. Such tests shall have been performed by injecting the semen samples into test animals which are susceptible to rinderpest or foot-and-mouth disease. The semen collected at the approved isolation facility, other than the semen samples, may be held in the region of origin or at the port of New York, at the option of the importer, until all of the testing required to be conducted under this section is completed. (6) If it is determined that the requirements set forth in this paragraph have been complied with and there are no indications that the donor animal or the semen from the donor animal harbors the virus of rinderpest or foot-and-mouth disease or any other communicable disease and if the donor animal, blood samples from the donor animal, O-P samples (if applicable) from the donor animal, and semen samples from the donor animal are negative to all other tests required, the semen shall be released for shipment to the consignee listed by the importer; otherwise the semen shall be destroyed or disposed of as the Administrator, may direct. (7) Porcine semen from the People's Republic of China. In addition to the other requirements of this part, porcine semen may be imported into the United States from the People's Republic of China (PRC) only after the official veterinary organization (OVO) of the PRC has certified that the PRC is free of African swine fever, rinderpest, and Teschen's disease, and after the following conditions have been fulfilled: (i) The donor boars must pass a 60-day isolation/collection period in a facility jointly approved by the OVO of the PRC and the USDA as adequate to prevent exposure of the donor boars to infectious diseases. Any other swine at the isolation facility, such as teaser animals, must also meet the requirements of this paragraph. No animals may be added to the group after the start of the 60-day isolation/collection period. The Department will permit collection of semen to be initiated at the beginning of the isolation/collection period. The facility shall be cleaned and disinfected with a 4 percent sodium carbonate solution used in accordance with applicable label instructions in the presence of OVO quarantine personnel prior to the start of the isolation. During the isolation/collection period, personnel handling the animals shall not have contact with other domestic farm livestock (this term does not include pets such as dogs and cats). Raw animal food wastes (garbage) shall not be fed to the donor boars while in isolation. At the start of the isolation/collection period, and again after 14 days of isolation, all animals offered for collection of semen must be given an intramuscular injection of dihydrostreptomycin at a rate of 25 mg/kg dosage as a precautionary treatment for leptospirosis. Feed and bedding used during the isolation/collection period shall not originate from areas infected with epizootic diseases and must meet veterinary hygienic requirements established by the OVO of the PRC concerning freedom of the feed and bedding from contamination that could transmit diseases. During the isolation/collection period the swine at the collection center shall not have direct contact with, or exposure to, any other animals not included in the group at the isolation facility. Exposure consists of contact with yards, pens, or other facilities or vehicles that have been in contact with animals and have not been cleaned and disinfected. (ii) Donor boars shall be selected from premises which are solely swine breeding operations. These premises must be located at the center of an area with a 16 km radius that was free of foot-and-mouth disease (FMD), swine vesicular disease (SVD), and classical swine fever for three years prior to semen collection. Donor boars shall not have been vaccinated against these diseases. There shall have been no cases of these diseases on these premises for five years prior to the collection of semen. There shall have been no animal introduced into these premises from farms affected with these diseases for three years prior to the collection of semen. There shall have been no evidence of brucellosis, tuberculosis, or pseudorabies on these premises or on premises adjacent to these premises for one year prior to the collection of semen. (iii) During the 60-day isolation/collection period, the boars offered for collection of semen shall be subjected to the following tests,2 2 Technical information on laboratory methods and procedures for these tests may be obtained from the Administrator, c/o Director, National Veterinary Services Laboratories, P.O. Box 844, Ames, IA 50010. (A) Foot-and-mouth disease: (1) Microtiter virus neutralization (VN) test for types, A, O, C, and Asia. (The PRC will test for types A and O, and the United States will test for types C and Asia at the USDA Foreign Animal Disease Diagnostic Laboratory (FADDL)). (2) Agar gel immunodiffusion (AGID) test using virus infection associated antigen (VIAA) in serum. (Animals having responses to the AGID test or reacting to the VN test at 1:10 dilution or greater shall be eliminated as semen donors, and all other swine in contact with them shall be retested within 30 days. If the whole group does not have the above responses and there is no clinical evidence of FMD, the group shall be eligible for collection of semen with respect to FMD. Otherwise, none of the group shall qualify as donors of semen for export.) (B) Brucellosis: Standard tube test (STT) at less than 30 IU/ml, and card test (antigen and protocol to be supplied by USDA). (C) Swine vesicular disease: Virus neutralization test at 1:40 dilution (serums to be tested at FADDL). (D) Classical swine fever: Fluorescent antibody neutralization (FAN) test at 1:16 dilution. (E) Japanese B encephalitis: Hemagglutination inhibition (HI) test, negative according to PRC standards. (F) Pseudorabies: Virus neutralization at 1:4 dilution. (G) Tuberculosis: Intradermal test using bovine PPD tuberculin (Positive animals will be necropsied. If there are lesions of TB in the test positive pigs, the whole group will be ineligible as semen donors. If no lesions are found, the rest of the pigs will be eligible as semen donors with respect to tuberculosis. All samples of the above tests, except as noted for FMD, SVD, and TB, will be submitted to laboratories designated by the OVO of the PRC. At least 21 days after the final collection of semen for exportation, the donor animals will be retested for the diseases listed above, with the exception of tuberculosis and Japanese encephalitis. In addition, aliquots of each ejaculate of semen collected shall be submitted to FADDL for pathogen isolation tests for FMD, brucellosis, swine vesicular disease, classical swine fever, Japanese encephalitis, and pseudorabies. (iv) The semen will not be eligible for release in the United States until all tests in paragraph (c)(7)(iii) of this section have been completed with negative results. (v) Each semen straw or ampule for export must be identified with the name or identification number of the donor boar and with the date of collection. A USDA veterinarian shall certify that he or she has supervised the collection and processing of the semen and its storage until the time it is shipped to the United States. Each shipment will be accompanied by a USDA veterinarian unless the semen is shipped directly to the port of New York, with no stops en route. Shipment to the United States will be in accordance with the terms of a USDA import permit. Semen imported in accordance with this section shall be released by USDA to the importer only after all requirements of this section have been met. [55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991, and amended at 58 FR 37644, July 13, 1993; 59 FR 26596, May 23, 1994; 62 FR 56026, Oct. 28, 1997; 68 FR 16940, Apr. 7, 2003] (a) The certificates, declarations, and affidavits required by the regulations in this subpart shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of animal semen at such port, for the use of the veterinary inspector at the port of entry. (b) For all animal semen offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the animal semen, the number, breed, species, and purpose of the importation, the name of the person to whom the animal semen will be delivered, and the location of the place to which such delivery will be made. (c) All animal semen intended for importation into the United States shall be accompanied by a health 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. (d) The health certificate must state: (1) The name and address of the place where the semen was collected; (2) The name and address of the veterinarian who supervised the collection of the semen; (3) The date of semen collection; (4) The identification and breed of the donor animal; (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 animal as a condition for importing the semen; (7) The seal number on the shipping container; (8) The names and addresses of the consignor and consignee; and (9) That the semen is being imported into the United States in accordance with subpart C of 9 CFR part 98. (e) The certificate accompanying sheep or goat semen intended for importation from any part of the world shall, in addition to the statements required by paragraph (d) of this section, state that: (1) The semen donor has 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 semen; (2) The semen donor showed no evidence of scrapie at the time the semen was collected; and (3) The parents of the semen donor are not, nor were not, affected with scrapie. (f) All shipping containers carrying animal semen for importation into the United States must be sealed with an official seal of the national veterinary service of the region of origin. The health certificate must show the seal number on the shipping container. The semen must remain in the sealed container until arrival in the United States and, at the U.S. port of entry, an inspector determines that either: (1) The seal numbers on the health certificate and shipping container match; or (2) The seal numbers on the health certificate and shipping container do not match, but an APHIS representative at the port of entry is satisfied that the shipping container contains the semen described on the health certificate, import permit, declaration, and any other accompanying documents. [55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991, as amended at 58 FR 37644, July 13, 1993; 61 FR 15184, Apr. 5, 1996; 61 FR 17242, Apr. 19, 1996; 62 FR 56026, Oct. 28, 1997; 65 FR 56777, Sept. 20, 2000] (a) General importation requirements for animal semen from Canada. (b) Importation requirements for animal semen other than equine, sheep, or goat semen from Canada. [65 FR 56778, Sept. 20, 2000] (a) Except for semen from sheep in Australia, Canada, or New Zealand, semen from sheep may only be imported into the United States if it complies with all applicable provisions of this subpart and one of the following conditions: (1) The semen is 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 semen is 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 semen 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 semen imported in accordance with this section, qualifies as a “Certified” flock. (b) Sheep semen 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 semen may be imported under paragraph (a)(1) of this section only if it comes from a donor animal in a flock in the region of origin that participates in a program determined by the Administrator to be equivalent to the Voluntary Scrapie Flock Certification Program, and the flock has been determined by the Administrator to be at a level equivalent to “Certified” in the Voluntary Scrapie Flock Certification Program. (d) Sheep semen may be imported under paragraph (a)(2) of this section only if it is transferred to animals in a Certifiable Class C flock participating in the Voluntary Scrapie Flock Certification Program; except, that if the semen comes from a donor animal 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 semen may be used in a flock in the United States which would be classified at a level equivalent to or lower (i.e., at greater risk) than the certification level, as determined by the Administrator, of the flock of the donor animal. (e) The flock to which the sheep semen is 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 semen imported in accordance with this section, qualifies as a “Certified” flock. (f) Except for sheep semen being placed in Certifiable Class C flocks, the certificate accompanying the sheep semen imported under paragraph (a) of this section must contain the following statement: “The semen identified on this certificate has been collected from a sire that has 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 the semen to the United States, to be equivalent to [certification level] 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 donor animal's flock 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 these activities have been in effect; (iii) Any available information concerning additions, within the 5 years immediately preceding collection of the semen, to the flock of the semen donor; (iv) Any available data concerning disease incidence, within the 5 years immediately preceding collection of the semen in the donor animal's flock, 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 semen, of other ruminants, flocks, and herds with which the donor animal and the donor animal's flock 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 semen imported under this section are subject to the requirements of 9 CFR part 54 and all other applicable regulations. [61 FR 17242, Apr. 19, 1996, as amended at 62 FR 56026, Oct. 28, 1997; 64 FR 23179, April 30, 1999] In addition to meeting all other applicable provisions of this part, swine semen imported from the EU–15 must meet the following conditions, except as noted in paragraph (h) of this section with regard to swine semen imported from Denmark, Finland, the Republic of Ireland, Sweden, or the United Kingdom: (a) The semen must come from a semen collection center approved for export by the competent veterinary authority of the EU–15 Member State. (b) The semen must not have been collected from a donor boar that was in any of the following regions or zones, unless the semen was collected after the periods described: (1) Any region when the region was classified in §§94.9(a) and 94.10(a) of this chapter as one in which classical swine fever is known to exist, except for the EU–15; (2) A restricted zone in the EU–15 established because of the detection of classical swine fever in domestic swine, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of an EU–15 Member State or until 6 months following depopulation of the swine on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or (3) A restricted zone in the EU–15 established because of the detection of classical swine fever in wild boar, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the EU–15 Member State. (c) The semen must not have been collected from a donor boar that was commingled with swine that at any time were in any of the regions or zones described in paragraphs (b)(1) through (b)(3) of this section, unless the semen was collected after the periods described. (d) The semen must not have been collected from a donor boar that transited any region or zone described in paragraphs (b)(1) through (b)(3) of this section during the periods described, unless the donor boar was moved directly through the region or zone in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination, or unless the semen was collected after the periods described; (e) The donor boar must be held in isolation for at least 30 days prior to entering the semen collection center. (f) No more than 30 days prior to being held in isolation as required by paragraph (e) of this section, the donor boar must be tested with negative results with a classical swine fever test approved by the Office International des Epizooties (World Organization for Animal Health). (g) No equipment or materials used in transporting the donor boar from the farm of origin to the semen collection center may have been used previously for transporting swine that do not meet the requirements of this section, unless such equipment or materials have first been cleaned and disinfected. (h) Except for semen collected from swine in Denmark, Finland, the Republic of Ireland, Sweden, or the United Kingdom, before the semen is exported to the United States, the donor boar must be held at the semen collection center and observed by the center veterinarian for at least 40 days following collection of the semen, and, along with all other swine at the semen collection center, exhibit no clinical signs of classical swine fever. (i) The semen must be accompanied by a certificate issued by a salaried veterinary officer of the competent veterinary authority of the EU–15 Member State, stating that the provisions of paragraphs (a) through (h) of this section have been met.3 3 The certification required may be placed on the certificate required under §98.35(c) or may be contained in a separate document. [71 FR 29072, May 19, 2006]
Title 9: Animals and Animal Products
PART 98—IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN
Subpart C—Certain Animal Semen
§ 98.30 Definitions.
§ 98.31 General prohibitions; exceptions.
§ 98.32 Inspection of certain aircraft and other means of conveyance and shipping containers thereon; unloading, cleaning, and disinfection requirements.
§ 98.33 Ports designated for the importation of certain animal semen.
§ 98.34 Import permits for poultry semen and animal semen.
§ 98.35 Declaration, health certificate, and other documents for animal semen.
§ 98.36 Animal semen from Canada.
------------------------------------------------------------------------ If the product is . . . Then . . .------------------------------------------------------------------------(1) Equine semen............. There are no importation requirements under this part.------------------------------------------------------------------------(2) Sheep or goat semen...... The importer or his agent, in accordance with §§ 98.34 and 98.35 of this part, must present: (i) An import permit; (ii) Two copies of a declaration; and (iii) A health certificate.------------------------------------------------------------------------(3) Animal semen other than See paragraph (b) of this section. equine, sheep, or goat semen.------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- If the product is offered for entry at a . . . And . . . Or . . . Then . . .----------------------------------------------------------------------------------------------------------------(1) Canadian land border port listed The donor animal was The donor animal was The importer or his in § 98.33(b) of this part. born in Canada or the legally imported into agent, in accordance United States and has Canada, released to with § 98.35 of never been in a region move freely in Canada, this part, must other than Canada or and has been released present: the United States. in Canada for no less (i) Two copies of a than 60 days. declaration; and (ii) A health certificate.----------------------------------------------------------------------------------------------------------------(2) Canadian land border port listed The donor animal does The importer or his in § 98.33(b) of this part. not meet the special agent, in accordance conditions listed above with §§ in paragraph (b)(1) of 98.34 and 98.35 of this table. this part, must present: (i) An import permit; (ii) Two copies of a declaration; and (iii) A health certificate.(3) Port not listed in § The importer or his 98.33(b) of this part. agent, in accordance with §§ 98.34 and 98.35 of this part, must present: (i) An import permit; (ii) Two copies of a declaration; and (iii) A health certificate.----------------------------------------------------------------------------------------------------------------
§ 98.37 Semen from sheep in regions other than Australia, Canada, and New Zealand.
§ 98.38 Restrictions on the importation of swine semen from the EU–15.
