[Federal Register: September 20, 2000 (Volume 65, Number 183)]
[Rules and Regulations]
[Page 56775-56779]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se00-3]
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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
1830363