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From: TSS ()
Subject: [Docket No. APHIS-2006-0120] Importation of Sheep and Goat Semen
Date: August 9, 2006 at 10:32 am PST


[Federal Register: August 9, 2006 (Volume 71, Number 153)]
[Proposed Rules]
[Page 45444-45447]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09au06-33]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 98

[Docket No. APHIS-2006-0120]


Importation of Sheep and Goat Semen

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend 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 would relieve restrictions on
imported sheep semen while continuing to provide safeguards against the
introduction and dissemination of scrapie.

DATES: We will consider all comments that we receive on or before
October 10, 2006.

ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov
and, in the lower ``Search Regulations and Federal

Actions'' box, select ``Animal and Plant Health Inspection Service''
from the agency drop-down menu, then click on ``Submit.'' In the Docket
ID column, select APHIS-2006-0120 to submit or view public comments and
to view supporting and related materials available electronically.
Information on using Regulations.gov, including instructions for
accessing documents, submitting comments, and viewing the docket after
the close of the comment period, is available through the site's ``User
Tips'' link.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. APHIS-
2006-0120, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. APHIS-2006-0120.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room is located in room 1141 of
the USDA South Building, 14th Street and Independence Avenue, SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.


FOR FURTHER INFORMATION CONTACT: Dr. Arnaldo Vaquer, Senior Staff
Veterinarian, Technical Trade Services, National Center for Import and
Export, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231;
(301) 734-8074.

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 98 govern the importation of animal
germplasm 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 (Sec. Sec. 98.30 through
98.38, referred to below as the regulations) applies to animal semen.
Currently, the regulations in Sec. 98.37 restrict, due to scrapie
concerns, the importation of sheep semen into the United States from
any region of the world other than Australia, Canada, and New Zealand.
These restrictions include provisions that the semen must be
transferred only to females in a U.S. flock that is participating in
the voluntary Scrapie Flock Certification Program (SFCP), that the
semen must originate from a donor animal participating in a program
equivalent to the SFCP or the SFCP flock status must be lowered, and
that the semen must be accompanied by a certificate attesting to the
above conditions. The importer is also required to provide the Animal
and Plant Health Inspection Service (APHIS) with information concerning
control programs, surveillance, and disease incidence in the exporting
region, as well as information concerning the health status of other
ruminants in the region.
The regulations in Sec. 98.35 deal with declarations, health
certificates, and other documents required for the importation of all
animal semen into the United States. All animal semen

[[Page 45445]]

intended for importation to the United States must be accompanied by a
health certificate that provides certain specific information about the
origin and handling of the semen. Paragraph (e) lists additional
requirements for the health certificate accompanying sheep and goat
semen, which must include an attestation that 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, that the semen donor showed no evidence of scrapie at the time
of collection, and that the parents of the semen donor are not, nor
were not, affected with scrapie.
These requirements are more restrictive than those recommended by
the World Organization for Animal Health (OIE) in Chapter 2.4.8,
Article 2.4.8.8 of the Terrestrial Animal Health Code. The OIE
standards for importing sheep and goat semen from a region not free
from scrapie state that importing countries should require an
international veterinary certificate attesting that in the region of
origin, scrapie is compulsorily notifiable, a surveillance and
monitoring system is in place, affected sheep and goats are slaughtered
and completely destroyed, and the feeding of sheep and goats with meat-
and-bone meal or greaves potentially contaminated with an animal
transmissible spongiform encephalopathy (TSE) has been banned and the
ban effectively enforced in the whole region. The certificate should
also attest that donor animals are permanently identified to enable
traceback to their establishment of origin, have been kept since birth
in establishments in which no case of scrapie has been confirmed during
their residency, and showed no clinical sign of scrapie at the time of
semen collection.
Experience and research have convinced APHIS that sheep semen poses
a minimal risk of transmitting and disseminating scrapie in the United
States. Through the SFCP, flocks using imported semen from scrapie-
affected regions have been monitored and no first generation (F1)
progeny resulting from the imported semen have been implicated in
scrapie outbreaks. Furthermore, research studies, though limited in
scope, have not revealed transmission through semen or detected the
infective agent in semen, testes, or seminal vesicles of affected
rams.\1\
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\1\ See L.A. Detwiler and M. Baylis, ``The Epidemiology of
Scrapie,'' Rev. sci. tech. Off. int. Epiz. 2003, 22 (1), 131.
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Therefore, we are proposing to ease the restrictions on the
importation of sheep semen by removing the provisions of Sec. 98.37
from our regulations. In lieu of these regulations, we would amend
Sec. 98.35(e) to require that imported sheep or goat semen be
accompanied by an international veterinary certificate consistent with
the OIE standards describe above. In Sec. 98.35, paragraph (e) already
contains some certificate requirements for imported sheep and goat
semen; the changes we are proposing would bring them further into
alignment with international standards.
Specifically, we would amend Sec. 98.35(e) to require imported
sheep and goat semen to be accompanied by an international veterinary
certificate attesting that in the region where the semen originates
certain conditions are met. These conditions would include that scrapie
is a compulsorily notifiable disease and that there is an effective
surveillance and monitoring system for scrapie in the region where the
semen originates. In addition, the region where the semen originates
would have to require that affected sheep and goats are slaughtered and
completely destroyed. The region where the semen originates must also
enforce a ruminant-to-ruminant feed ban; that is, the feeding of sheep
and goats with meat-and-bone meal or greaves derived from ruminants
must also be banned and the ban effectively enforced in the whole
region. The certificate would have to attest that the donor animals are
permanently identified to enable traceback to their premises of origin,
have been kept since birth on premises in which no case of scrapie had
been confirmed during their residency, showed no clinical sign of
scrapie at the time of semen collection, and did not subsequently
develop scrapie between the time of collection and the time the semen
was exported to the United States. The certificate would also have to
attest that donor animals were not the offspring of scrapie-affected
dams.
This certificate would be required for all sheep and goat semen
imported into the United States. In addition, the distribution of
imported semen within the United States could be limited, depending on
the status of the region of origin of the semen. Semen from regions
free of scrapie could be distributed throughout the United States, but
semen from regions not scrapie free could only be distributed to a
flock that is listed as a flock/herd premises in the Scrapie National
Database as part of either the regulatory or voluntary flock
certification scrapie programs described in 9 CFR part 79 and 9 CFR
part 54 subpart B, respectively. Flock owners would also be required to
sign a written agreement that all first generation (F1) progeny
resulting from imported semen from a region that is not free of scrapie
would be identified with a permanent official identification consistent
with the provisions in Sec. 79.2, and records of any sale of F1
progeny, including the name and address of the buyer, would be kept for
a period of 5 years. This would ease some restrictions on where
imported semen may be used while still enabling traceback of the
progeny resulting from the imported semen. While the risk of scrapie
transmission from sheep semen is believed to be minimal, no studies
have been done regarding the transmissibility through semen of other
animal TSEs and certain other diseases in small ruminants. For this
reason, traceback of progeny is essential.
Under the proposed rule, we would recognize Australia and New
Zealand as regions free of scrapie. The regulations in Sec. 98.37
currently allow imported sheep semen from Australia, Canada, and New
Zealand to be distributed to any flock in the United States. When these
regulations were established in 1996, Canada was included in the list
of regions from which semen could be imported without additional
restrictions even though Canada is not scrapie free. At that time,
Canada had a scrapie control program equivalent to the one in the
United States, and it was determined to be unlikely that new strains of
scrapie would be spread into the United States from Canada. In 2001,
the United States went from a control program to an eradication
program, which is now in full implementation. However, Canada's scrapie
program has not advanced at the same speed as the one in the United
States. For these reasons, under the proposed rule semen imported from
Canada would be subject to the same restrictions as semen from all
other regions except Australia and New Zealand, i.e, it could be
distributed only to females in a flock that is listed as a flock/herd
premises in the Scrapie National Database, as described above.

Executive Order 12866 and Regulatory Flexibility Act

This proposed 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 restrict the importation of sheep
semen from regions other than Australia, Canada, and New Zealand due to
scrapie

[[Page 45446]]

concerns. These restrictions include provisions requiring the semen to
be transferred only to females in a United States flock that
participates in the 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 require 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 of 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 proposed rule would 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 would require that sheep or goat semen from scrapie-affected
regions be accompanied by an international veterinary certificate as
recommended in OIE's Terrestrial Animal Health Code. Consequently, this
proposed rule would bring the United States' import standards for sheep
semen in harmony with recognized international standards, while still
protecting against scrapie introduction to the United States.
These proposed changes in the regulations would 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 production is
tracked by the U.S. Census Bureau. In 2001, the latest available year,
there were 3,999 establishments in the North American Industry
Classification System (NAICS) subsector 1152, which comprises
establishments primarily engaged in performing support activities
related to raising livestock.\2\ 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's (SBA) size standard for this particular sector is $6
million or less in annual receipts.\3\ Unfortunately, the Census data
do not include annual receipts for these establishments; however, based
on the average annual payroll per establishment, it is reasonable to
conclude that the majority of these businesses would be considered
small by SBA definitions.
---------------------------------------------------------------------------

\2\ Statistics of U.S. Businesses: 2001: Support Activities for
Animal Production--United States. Washington, DC: U.S. Census
Bureau.
\3\ Table of Size Standards based on NAICS 2002. Washington, DC:
U.S. 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 or 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. APHIS
welcomes public comment that would support or contradict this
understanding.
Additionally, it is possible the proposed 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.\4\ The SBA size
standard for sheep and goat farming (NAICS 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 of agricultural products sold is $10,815.\5\ 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.
---------------------------------------------------------------------------

\4\ USDA, 2002 Census of Agriculture-United States Data, Table
50. Washington, DC: National Agricultural Statistics Service.
\5\ 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 proposed rule would lift some of the import restrictions on
imported semen from regions that are not considered scrapie-free, there
would be a reduction in compliance requirements. In place of current
requirements, imported sheep or goat semen would have to be accompanied
by an international veterinary certificate consistent with OIE
standards. This certificate would 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 proposed
changes. 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.\6\ It is possible that the proposed changes would
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 would be over the long run because currently there is
not a large demand for sheep semen in the United States, as is
evidenced by the number of imports. In fact, domestic sheep and goat
producers rarely rely on artificial insemination as a means for
breeding animals, as 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.\7\
---------------------------------------------------------------------------

\6\ Elizabeth McKenna, Data Manager (APHIS).
\7\ Susan Schoenian, Area Agent, Sheep & Goats Western Maryland
Research & Education Center, University of Maryland Cooperative
Extension; via e-mail 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 the proposed changes 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

[[Page 45447]]

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 2.1 million head of breeding 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 would
not have a significant economic impact on a substantial number of small
entities.

Executive Order 12988

This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required 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.

Accordingly, we propose to amend 9 CFR part 98 as follows:

PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN

1. The authority citation for part 98 would continue 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.

2. In Sec. 98.35, paragraphs (e)(1), (e)(2), and (e)(3) would be
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 trace back 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 export of the 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 as a
flock/herd premises in the Scrapie National Database as part of the
Scrapie Program in the United States, and the flock owner has agreed,
in writing, that:
(i) All first generation (F1) progeny resulting from imported semen
will be identified with a permanent official identification consistent
with the provisions in Sec. 79.2 of this chapter; and
(ii) Records of any sale of F1 progeny, including the name and
address of the buyer, will be kept for a period of 5 years.
* * * * *


Sec. 98.37 [Removed and reserved]

3. Section 98.37 would be removed and reserved.

Done in Washington, DC, this 3rd day of August 2006.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E6-12934 Filed 8-8-06; 8:45 am]

BILLING CODE 3410-34-P


http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-12934.htm

TSS




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