[Federal Register Volume 71, Number 153 (Wednesday, August 9, 2006)]
[Proposed Rules]
[Pages 45444-45447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12934]


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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.
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    \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.
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    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.
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    \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).''
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    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\
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    \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.
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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]
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