[Federal Register: November 15, 2007 (Volume 72, Number 220)]
[Rules and Regulations]
[Page 64126-64129]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15no07-3]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 98
[Docket No. APHIS-2006-0120]
RIN 0579-AC58
Importation of Sheep and Goat Semen
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are amending the regulations regarding the importation of
animal germplasm by removing specific restrictions on sheep semen from
regions where scrapie exists and requiring the inclusion of additional
information on the international health certificate accompanying sheep
and goat semen. Experience and research have convinced us that sheep
and goat semen pose a minimal risk of transmitting scrapie. This action
will relieve restrictions on imported sheep semen while continuing to
provide safeguards against the introduction and dissemination of
scrapie.
DATES: Effective Date: December 17, 2007.
FOR FURTHER INFORMATION CONTACT: Dr. James P. Davis, Senior Staff
Veterinarian, Technical Trade Services, National Center for Import and
Export, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231;
(301) 734-0694.
SUPPLEMENTARY INFORMATION:
Background
On August 9, 2006, we published a proposed rule in the Federal
Register (71 FR 45444-45447) in which we proposed to amend the
regulations in 9 CFR part 98 regarding the importation of animal
germplasm by removing specific restrictions on sheep semen from regions
where scrapie exists and requiring the inclusion of additional
information on the international health certificate accompanying sheep
and goat semen. This action would relieve restrictions on imported
sheep semen while continuing to provide safeguards against the
introduction and dissemination of scrapie.
Comments were required to be received by October 10, 2006. We
received seven comments by that date, from the Canadian Food Inspection
Agency, a sheep industry association, sheep breeders, and private
citizens. One commenter supported the proposed rule as written. Another
commenter stated that there should be a ban on all imports of animal
semen into the United States, but did not offer specific comments on
the provisions of the proposed rule. The remaining commenters were
generally supportive of the proposed rule but made suggestions or
raised issues about its provisions.
The Canadian Food Inspection Agency stated that it believed
Canada's scrapie program is equivalent to the United States' program
and, therefore, sheep semen from Canada should be allowed to be
imported without restrictions. The commenter stated that the risk of
new strains of scrapie being introduced into the United States from
Canada is minimal.
As we stated in the proposed rule, in 1996, when the regulations
allowing semen to be imported from Canada without restrictions were
established, Canada had a scrapie control program that we regarded as
equivalent to that in the United States. In 2001, however, the United
States went from a control program to an eradication program which is
now in full implementation. Canada has not conducted a scrapie
prevalence study and does not conduct national slaughter surveillance
for the disease. To fully evaluate Canada's program we would need a
complete description of the program, including numbers and geographic
representation of their surveillance and efforts to monitor for unusual
strains. We are making no changes to the rule as a result of this
comment.
One commenter stated that semen imported from any country should be
distributed only to flocks listed in the Scrapie National Database to
provide for better traceability in the event of a disease outbreak.
APHIS notes that semen imported from regions not recognized as
scrapie-free--at this time, everywhere in the world except Australia
and New Zealand--will still be required to be distributed only to
listed flocks. We believe the new recordkeeping requirements for first
generation (F1) progeny resulting from imported semen will provide
sufficient information to conduct traceback investigations in the event
of a disease outbreak. We are making no changes as a result of this
comment.
One commenter stated that the requirement that only flocks in the
Scrapie Flock Certification Program may receive imported semen should
be eliminated entirely.
The intent of the proposed rule is to allow all flocks listed in
the Scrapie National Database to use semen imported from anywhere in
the world; there will be no restrictions on distribution of semen
imported from regions recognized as scrapie-free. This does not
unreasonably limit distribution of imported semen since there is a high
compliance rate for flock premises listing through the National Scrapie
Eradication Program, and because any flock may be listed by making a
toll-free phone call. To further facilitate distribution of imported
semen, we have added a provision in this final rule that allows
imported semen to be further distributed to any other listed flock with
written notification to the Veterinary Services area office.
One commenter suggested that the identification and recordkeeping
requirements for F1 progeny resulting from imported semen should be
made a condition of the import permit rather than a separate agreement.
The commenter further stated that APHIS should distribute special
eartags for identifying F1 progeny at the time the permit is approved.
The commenter stated that these suggestions would reduce the burden on
both producers and APHIS.
We agree with this commenter and have made changes in this final
rule to incorporate these suggestions. Since there will be no written
agreement separate from the permit, this final rule also includes a
provision that APHIS
[[Page 64127]]
may view and copy records of F1 progeny during normal business hours.
One commenter stated that any imported semen should be accompanied
by a certificate of genetic testing of the donor ram for resistance to
scrapie.
While we agree that information from genetic testing may be useful
to sheep breeders, we do not believe that requiring genetic testing of
donor rams as a condition for importing semen into the United States is
warranted because it would put excessive restrictions on the
importation of semen for some breeds in which the scrapie-resistant
genotypes do not exist. If an importer wants to see results of genetic
testing from a donor ram, that individual should request it from the
seller.
One commenter asked that the restriction of selling rams born as a
result of artificial insemination using imported semen only to listed
flocks be relaxed. The commenter stated that sheep breeders currently
are too limited as to whom they may sell such rams.
Although there will be identification and recordkeeping
requirements for F1 progeny resulting from the use of imported semen,
the proposed rule, when finalized, will remove other restrictions on
the sale of F1 progeny. This will apply both to existing F1 progeny
from imported semen as well as to F1 lambs born after the new
regulations take effect.
One commenter questioned the accuracy of the statement in the
proposed rule's economic analysis that only 114 farms of the estimated
43,891 engaged in sheep and goat farming in 2002 had a market value of
$500,000 or more per year in agricultural products sold and Government
payments.
APHIS believes this estimate to be accurate. The figures were
obtained from the 2002 Census of Agriculture, which is the most recent
year for which we have data.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
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.
The regulations in Sec. 98.37 have restricted the importation of
sheep semen from regions other than Australia, Canada, and New Zealand
due to scrapie concerns. These restrictions have included provisions
requiring the semen to be transferred only to females in a United
States flock that participates in the Scrapie Flock Certification
Program (SFCP), the semen originates from a donor animal participating
in a program equivalent to the United States SFCP and that the semen is
accompanied by a certificate attesting to the above conditions.
Additionally, the regulations have required the importer to provide
APHIS with information regarding control programs, surveillance, and
disease incidence in the exporting region, as well as information on
the health status of other ruminants in the region in order to export
sheep semen to the United States.
All these restrictions on imports of sheep and goat semen were put
in place due to scrapie concerns and with the goal of preventing the
spread of scrapie in domestic animals. However, further scientific
research, as well as experience, has demonstrated to APHIS that sheep
and goat semen pose a minimal risk of transmitting scrapie. Therefore,
this final rule will eliminate restrictions on sheep semen being
imported from regions other than Australia, Canada, and New Zealand by
removing the provisions of Sec. 98.37 from our regulations. In their
place, we will require that sheep or goat semen from scrapie-affected
regions be accompanied by an international veterinary certificate as
recommended in the World Organization for Animal Health's (OIE)
Terrestrial Animal Health Code. Consequently, this final rule will
bring the United States' import standards for sheep and goat semen in
harmony with recognized international standards, while still protecting
against scrapie introduction into the United States.
These changes in the regulations will have a direct effect on
importers of sheep semen and those businesses involved in support
activities for animal production, which includes, among other
activities, establishments providing breeding services. The number of
establishments engaged in support activities for animal breeding is
tracked by the U.S. Census Bureau. In 2001, the latest year for which
information is available, there were 3,999 establishments in the North
American Industry Classification System (NAICS) subsector 1152, which
comprises establishments primarily engaged in performing activities
related to raising livestock.\1\ The annual payroll for these 3,999
establishments was $452.3 million, which translates into an average
annual payroll per establishment of $113,106. The U.S. Small Business
Administration (SBA) size standard for this particular sector is $6
million or less in annual receipts.\2\ Unfortunately, the Census data
do not include annual receipts for these establishments; however, based
on the annual payroll per establishment, it is reasonable to conclude
that the majority of these businesses would be considered small by SBA
definitions.
---------------------------------------------------------------------------
\1\ Statistics of U.S. Businesses: 2001: Support Activities for
Animal Production--United States. Washington, DC: U.S. Census
Bureau.
\2\ Table of Size Standards based on NAICS 2002. Washington, DC:
Small Business Administration, 2004.
---------------------------------------------------------------------------
A variety of animal production support activities other than
artificial insemination for sheep are included in NAICS subsector 1152.
APHIS does not have specific information on the number and size of
businesses providing artificial insemination services. Based on the
data for all NAICS 1152 businesses, we believe they are primarily small
entities with annual receipts of not more than $6 million.
Additionally, it is possible this final rule may indirectly affect
domestic sheep and goat producers. The Census of Agriculture for 2002,
the most recent year for which we have data, estimated that there were
43,891 farms engaged in sheep and goat farming.\3\ The SBA size
standard for sheep and goat farming (NAIS subsector 1124) is $750,000
or less in annual receipts. The 2002 Census estimates the total market
value of all agricultural products sold by domestic sheep and goat
farmers to be over $445 million, which translates into an average of
$10,147 per farm. When combined with Government payments, the average
per-farm market value agricultural products sold is $10,815.\4\ Only
114 farms are classified as having $500,000 or more in market value of
agricultural products sold and Government payments. So, at least
43,777, or 99 percent, of farms engaged in sheep and goat farming would
be considered small by SBA standards.
---------------------------------------------------------------------------
\3\ USDA, 2002 Census of Agriculture--United States Data, Table
50, Washington, DC: National Agricultural Statistics Service.
\4\ USDA, 2002 Census of Agriculture, Table 59, under column
heading ``Sheep and Goat Farming (1124).''
---------------------------------------------------------------------------
Foreign exporters of sheep semen from countries other than
Australia, Canada, and New Zealand might also benefit from the removal
of import restrictions on sheep semen. However, as non-U.S. entities,
they lie outside the scope of the Regulatory Flexibility Act and are
not considered in this economic analysis.
As this rule will lift some of the import restrictions on imported
semen from regions that are not considered
[[Page 64128]]
scrapie-free, there will be a reduction in compliance requirements. In
place of the current requirements, imported sheep or goat semen will
have to be accompanied by an international veterinary certificate
consistent with OIE standards. This certificate will have to be
completed by a veterinary officer prior to being exported to the United
States, and as such would not pose any compliance requirements for
domestic entities.
Benefits
Importers of sheep semen, as well as firms engaged in agricultural
support activities, specifically those providing artificial
insemination services, could possibly benefit from the final rule.
Imports of sheep semen are not tracked as a separate line item by
USDA's Foreign Agricultural Service. However, Veterinary Services of
APHIS tracks raw data and estimates there were 2,491 straws of sheep
semen imported in 2004 and only 1 straw in 2003, with Australia being
the primary exporter.\5\ It is possible that the changes to the
regulations will encourage exports of sheep and goat semen to the
United States in response to reduced import restrictions. Laws of
supply and demand dictate that increased supply will result in lower
prices. However, if this happens it will be over the long run because
currently there is not a large demand for sheep semen in the United
States, as evidenced by the number of imports. In fact, domestic sheep
and goat producers rarely rely on artificial insemination as a means of
breeding animals because it is too expensive. Artificial insemination
technology is primarily practiced by the seedstock industry. Thus, the
market for imported sheep semen is small, consisting primarily of
producers that raise less common breeds and desire imported semen to
improve and diversify their genetics.\6\
---------------------------------------------------------------------------
\5\ Elizabeth McKenna, Data Manager (APHIS).
\6\ Susan Schoenian, Area Agent, Sheep & Goats Western Maryland
Research & Education Center, University of Maryland Cooperative
Extension; via email communication and article ``An Update on Sheep
A.I.'' Maryland Small Ruminant page. http://www.sheepandgoat.com/articles/ai.html
, Maryland Sheep News, 1999.
---------------------------------------------------------------------------
Costs
It is possible these changes to the regulations could have an
indirect effect on domestic sheep and goat breeders over the long run.
However, a variety of conditions would have to be met for this
situation to materialize. These conditions include, but are not limited
to, artificial insemination technology becoming a more cost effective
approach to sheep and goat production versus using breeding animals.
Essentially, the only way sheep and goat breeders would be affected
over the long run is if the process of artificial insemination becomes
cheaper than purchasing or maintaining replacement breeding animals. As
of January 1, 2005, there were inventories of 4.53 million head of
breeding sheep and goats in the United States. Thus, it is possible
that, as the process of artificial insemination becomes more cost
effective and as imported sheep semen becomes more readily available
and technologies improve, sheep and goat producers will substitute away
from buying replacement breeding animals and use artificial
insemination instead. However, as stated previously, this situation is
long term in nature and highly conditional.
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 proposed 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.
0
Accordingly, we are amending 9 CFR part 98 as follows:
PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN
0
1. The authority citation for part 98 continues to read as follows:
Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
0
2. In Sec. 98.34, a new paragraph (d) is added to read as follows:
Sec. 98.34 Import permits for poultry semen and animal semen.
* * * * *
(d) Sheep and goat semen from regions where scrapie exists.
Importation of semen of sheep and goats is subject to the requirements
in Sec. 98.35(e). Applications for a permit to import sheep and goat
semen must include statements that:
(1) All first generation (F1) progeny resulting from imported semen
will be identified with a permanent official identification consistent
with the provisions of Sec. 79.2 of this chapter; and
(2) Records of any sale of F1 progeny, including the name and
address of the buyer, will be kept for a period of 5 years. APHIS may
view and copy these records during normal business hours.
0
3. In Sec. 98.35, paragraphs (e)(1), (e)(2), and (e)(3) are revised to
read as follows:
Sec. 98.35 Declaration, health certificate, and other documents for
animal semen.
(e) * * *
(1) The donor animals:
(i) Are permanently identified, to enable traceback to their
establishment of origin; and
(ii) Have been kept since birth in establishments in which no case
of scrapie had been confirmed during their residency; and
(iii) Neither showed clinical signs of scrapie at the time of semen
collection nor developed scrapie between the time of semen collection
and the export of semen to the United States; and
(iv) The dam of the semen donor is not, nor was not, affected with
scrapie.
(2) In the region where the semen originates:
(i) Scrapie is a compulsorily notifiable disease; and
(ii) An effective surveillance and monitoring system for scrapie is
in place; and
(iii) Affected sheep and goats are slaughtered and completely
destroyed; and
(iv) The feeding of sheep and goats with meat-and-bone meal or
greaves derived from ruminants has been banned and the ban effectively
enforced in the whole region; and
(3) Semen originating in regions other than Australia and New
Zealand is to be transferred to females in a flock that is listed in
the Scrapie National Database as part of the Scrapie Program in the
United States. Imported semen may be further distributed to any other
listed flock with written notification to the APHIS Veterinary Services
area office.
* * * * *
Sec. 98.37 [Removed]
0
4. Section 98.37 is removed and reserved.
[[Page 64129]]
Done in Washington, DC, this 8th day of November 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-22279 Filed 11-14-07; 8:45 am]
BILLING CODE 3410-34-P