[Federal Register Volume 65, Number 183 (Wednesday, September 20, 2000)]
[Rules and Regulations]
[Pages 56775-56779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24134]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 98

[Docket No. 99-023-2]


Importation of Animal Semen

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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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.

[[Page 56776]]

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.

[[Page 56777]]

    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 Sec. 98.30, the definition of Animals is revised to read as 
follows:


Sec. 98.30  Definitions.

* * * * *
    Animals. Cattle, sheep, goats, other ruminants, swine, horses, 
asses, zebras, and poultry.
* * * * *

    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).


Sec. 98.35  Declaration, health certificate, and other documents for 
animal semen.

* * * * *
    (d) * * *
    (7) The seal number on the shipping container;
* * * * *
    (f) All shipping containers carrying animal semen for importation 
into the United States must be sealed with an

[[Page 56778]]

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.
* * * * *

    4. Immediately before Sec. 98.36, the heading ``Canada'' is 
removed.

    5. Section 98.36 is revised to read as follows:


Sec. 98.36  Animal semen from Canada.

    (a) General importation requirements for animal semen from Canada.

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   If the product is . . .                     Then . . .
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(1) Equine semen.............  There are no importation requirements
                                under this part.
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(2) Sheep or goat semen......  The importer or his agent, in accordance
                                with Secs.  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.
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(3) Animal semen other than    See paragraph (b) of this section.
 equine, sheep, or goat semen.
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    (b) Importation requirements for animal semen other than equine, 
sheep, or goat semen from Canada.

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  If the product is offered for
         entry at a . . .                  And . . .                  Or . . .                 Then . . .
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(1) Canadian land border port      The donor animal was born  The donor animal was      The importer or his
 listed in Sec.  98.33(b) of this   in Canada or the United    legally imported into     agent, in accordance
 part.                              States and has never       Canada, released to       with Sec.  98.35 of
                                    been in a region other     move freely in Canada,    this part, must
                                    than Canada or the         and has been released     present:
                                    United States.             in Canada for no less    (i) Two copies of a
                                                               than 60 days.             declaration; and
                                                                                        (ii) A health
                                                                                         certificate.
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(2) Canadian land border port      The donor animal does not                            The importer or his
 listed in Sec.  98.33(b) of this   meet the special                                     agent, in accordance
 part.                              conditions listed above                              with Secs.  98.34 and
                                    in paragraph (b)(1) of                               98.35 of this part,
                                    this table.                                          must present:
                                                                                        (i) An import permit;
                                                                                        (ii) Two copies of a
                                                                                         declaration; and
                                                                                        (iii) A health
                                                                                         certificate.
(3) Port not listed in Sec.                                                             The importer or his
 98.33(b) of this part.                                                                  agent, in accordance
                                                                                         with Secs.  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.
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[[Page 56779]]

    Done in Washington, DC, this 14th day of September 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-24134 Filed 9-19-00; 8:45 am]
BILLING CODE 3410-34-U