Importation of Animal Semen

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Final rule.

SUMMARY:

We are amending our regulations concerning the importation of animal semen by eliminating importation requirements for all canine semen from anywhere in the world and for equine semen from Canada. We believe these changes are warranted because canine semen and equine semen from Canada pose no threat of introducing diseases to U.S. livestock. This action will reduce regulatory requirements for the importation of semen while continuing to protect the health of U.S. livestock.

We are also requiring that other animal semen be imported only in shipping containers that bear the official government seal of the national veterinary service of the region of origin. This action will help prevent the importation of animal semen that does not meet the requirements of our regulations.

EFFECTIVE DATE:

October 20, 2000.

FOR FURTHER INFORMATION CONTACT:

Dr. Roger Perkins, Senior Staff Veterinarian, National Center for Import and Export (NCIE), VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231; (301) 734-8419.

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 98 govern the importation of animal germ plasm to prevent the introduction of contagious diseases of livestock and poultry into the United States. Subparts A and B of part 98 apply to animal embryos, and subpart C (referred to below as “the regulations”) applies to animal semen.

We are amending the regulations by eliminating importation requirements for all canine semen from anywhere in the world and for equine semen from Canada. We believe these changes are warranted because canine semen and equine semen from Canada pose no threat of introducing diseases to U.S. livestock. We are also removing references to mules from the regulations because mule semen is not collected. In addition, we are requiring that other animal semen be imported only in shipping containers that bear the official government seal of the national veterinary service of the region of origin. This action will help prevent the importation of animal semen that does not meet the requirements of our regulations.

We published a proposal for this action in the Federal Register on January 26, 2000 (65 FR 4173-4176, Docket No. 99-023-1). We solicited comments concerning our proposal for 60 days ending March 27, 2000. We received eight comments by that date. They were from representatives of industry and a university. Five commenters supported the proposed rule in its entirety. The remaining commenters expressed concerns about certain provisions of the proposed rule. Their specific concerns are discussed below.

Comment: All imported equine semen, even equine semen from Canada, should be required to be screened for specific pathogens, such as contagious equine metritis (CEM), equine viral arteritis (EVA), vesicular stomatitis, West Nile virus, equine infectious anemia (EIA), equine influenza, and equine herpes virus. Screenings should not be limited to those equine diseases that are exotic to the United States or for which there is a national eradication program. Therefore, you should not eliminate importation requirements for equine semen from Canada.

Response: Canada's disease status for the diseases listed by this commenter is the same as the disease status of the United States. Therefore, in accordance with the standards established by the Office International des Epizooties and international trade agreements entered into by the United States, we have no basis to require testing of equine semen from Canada for these diseases or to impose other regulatory requirements on equine semen from Canada based on Canada's disease status.

Further, it is impractical to require intensive disease screenings for equine semen. The time involved in testing would preclude the importation of fresh semen and may even affect the viability of imported frozen semen.

Therefore, we are making no changes to the proposal in response to this comment.

Comment: If you are considering amending the regulations to require testing of semen from stallions that are serologically positive for EVA, why would you propose to remove requirements for equine semen from Canada?

Response: At this time, our regulations do not require domestic or imported semen to be tested for EVA. If, in the future, we determine that such a requirement is necessary, we will amend the regulations to reflect that change. Until that time, we have no basis for imposing stricter requirements on equine semen from Canada than on domestic equine semen. Therefore, we are making no changes to the proposal in response to this comment.

Comment: There is evidence that EIA can be spread through semen. We require live animals from Canada to be EIA negative. We should also require testing of equine semen from Canada to determine if the semen is negative.

Response: Two research papers, one published in 1942 and the other in 1984, reference the possibility that EIA can be spread through semen. However, we do not know of any more current research that confirms or supports the theory that EIA can be transmitted through semen. Consequently, we believe that, even if EIA were present in equine semen imported into the United States from Canada, there is no sound scientific basis to conclude that disease transmission would occur through insemination of that semen. Therefore, we are making no changes to the proposal in response to this comment.

Comment: Potential pathogens in canine semen pose a threat to Canidae spp. (for example, Brucella canis). Therefore, you should at least require health certification, including a simple set of serologic tests or documentation of sero-negative status prior to vaccination, for canine semen.

Response: The regulations in 9 CFR part 98 govern the importation of animal germ plasm to prevent the introduction of contagious diseases of livestock and poultry into the United States. We do not consider Canidae spp., such as foxes, jackals, coyotes, wolves, and dogs, to be livestock under the regulations, and there is no evidence that diseases that could be transmitted by canine semen would present a threat to livestock. Therefore, we are making no changes to the proposal in response to this comment.

Comment: Your analysis under Executive Order 12866 and the Regulatory Flexibility Act underestimates the effect that this proposal could have on U.S. entities. The analysis should consider the potential for the international movement of both canine and equine semen. In the early years of bovine artificial insemination, the world underestimated the effect this technology would have on the cattle industry and trade of bovine semen. Especially when researchers find an easy way to cryopreserve stallion semen to maintain a high level of fertility, we will see a significant increase in the use of frozen semen, and the dynamics of your “apparently small volume of imports” will change dramatically.

Response: It is extremely difficult, at best, to project how a regulatory action, or a new technology, will affect international trade. Therefore, we use current trade and production information to make our best estimates about the potential effect of rules. We believe that the economic analysis in this document is a fair estimate of the potential effect this rule will have on U.S. importers and others. Therefore, we are making no changes to the proposal in response to this comment.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, without change.

Executive Order 12866 and Regulatory Flexibility Act

This rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

We are amending the regulations by eliminating importation requirements for canine semen from anywhere in the world and for equine semen from Canada, and by removing references to mules. This means that canine semen from anywhere in the world, and equine semen from Canada, will no longer need an import permit, declaration, health certificate, or other document and will not have to meet any other requirements in our regulations when imported into the United States. This action will have no affect on the importation of mule semen because mule semen is not collected and, therefore, not imported. We believe these changes are warranted because canine semen from anywhere in the world, as well as equine semen from Canada, pose no threat of introducing diseases to U.S. livestock. This action will reduce requirements while continuing to protect the health of U.S. livestock. This action will benefit U.S. importers of canine semen from anywhere in the world and equine semen from Canada because it will ease the importation of these products. As noted above, importers of canine semen from anywhere in the world and equine semen from Canada will no longer need to obtain an import permit, health certificate, or declaration before importing the semen into the United States. This will slightly reduce the time and money required for the importation of these products. The principal monetary savings to affected importers will be the $39.50 per load fee currently charged for a permit to import animal semen into the United States (see table of user fees in 9 CFR part 130.8).

APHIS will also benefit from this action because we will no longer have to use our resources to issue import permits or perform other duties required by the regulations for the importation of canine semen from anywhere in the world or equine semen from Canada.

However, we believe that the benefits of this action will be small because of the apparently small volume of U.S. imports of canine semen from anywhere in the world and equine semen from Canada. Specific data on the volume of these imports is not available, which leads us to believe that the volume of those imports is relatively small. As a point of reference, the value of U.S. imports of bovine semen from all countries of the world in 1998 amounted to approximately $14 million. That means those imports comprised only 0.1 percent of the value of U.S. imports of all products of animal origin from all countries of the world in 1998. Because the volumes of U.S. imports of canine semen and equine semen were not reported as separate categories for 1998, we expect the value of those imports each amounted to less than $14 million.

We are also requiring that other animal semen from anywhere in the world be imported only in shipping containers that bear an official government seal. The seal number of each shipping container will have to appear on the health certificate that accompanies the shipment. This action will help prevent the importation of animal semen that does not meet the requirements of our regulations.

Because it is standard industry practice to seal containers of animal semen for importation into the United States with official seals, we do not believe this change will have a significant impact on exporters, importers, or APHIS. For veterinarians in the country of export, writing the seal numbers of the shipping containers on the health certificate accompanying the shipment and, for APHIS, checking to see that the seal numbers match will require a small amount of time, but we do not believe that will have a significant impact on affected persons.

The Regulatory Flexibility Act requires us to consider the economic effects of our rules on small entities. The businesses in the United States that will be affected by the proposed rule change are importers of canine semen from anywhere in the world and equine semen from Canada. The number of these businesses is not known, but there are probably few because of the apparently small volume of U.S. imports of canine and equine semen. Therefore, this action will likely not have an economic effect on a substantial number of U.S. businesses, large or small.

The businesses that will be affected are likely small in size, at least by the standards of the Small Business Administration (SBA). This assumption is based on SBA's information for providers of services involving animal semen, or similar services, in the United States. In 1993, there were 1,671 U.S. firms engaged in buying and/or marketing certain farm products, including animal semen. Of those 1,671 firms, 97 percent had fewer than 100 employees, the SBA's small entity threshold for such firms. In addition, in 1993, there were 6,804 U.S. firms engaged in performing certain services for pets, equines, and other animal specialities, including artificial insemination and breeding services. The per firm sales average of those 6,804 firms was $115,290, a figure well below the SBA's small entity threshold for such firms of $5 million. However, as previously discussed, this rule is not expected to have a significant economic effect on affected businesses.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

Executive Order 12988

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

Paperwork Reduction Act

This rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

List of Subjects in 9 CFR Part 98

• Animal diseases
• Imports

Accordingly, we are amending 9 CFR part 98 as follows:

PART 98—IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN

1. The authority citation for part 98 is revised to read as follows:

Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 103-105, 111, 134a, 134b, 134c, 134d, 134f, 136, and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

2. In § 98.30, the definition of Animals is revised to read as follows:

3. Section 98.35 is amended as follows:

a. By redesignating paragraphs (d)(7) and (d)(8) as paragraphs (d)(8) and (d)(9), and by adding a new paragraph (d)(7).

b. By adding a new paragraph (f).

4. Immediately before § 98.36, the heading “Canada” is removed.

5. Section 98.36 is revised to read as follows:

(b) Importation requirements for animal semen other than equine, sheep, or goat semen from Canada.