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45444 Federal Register / Vol. 71, No.

153 / Wednesday, August 9, 2006 / Proposed Rules

PART 95—SANITARY CONTROL OF Done in Washington, DC, this 3rd day of 20737–1238. Please state that your
ANIMAL BYPRODUCTS (EXCEPT August 2006. comment refers to Docket No. APHIS–
CASINGS), AND HAY AND STRAW, Elizabeth E. Gaston, 2006–0120.
OFFERED FOR ENTRY INTO THE Acting Administrator, Animal and Plant Reading Room: You may read any
UNITED STATES Health Inspection Service. comments that we receive on this
[FR Doc. E6–12944 Filed 8–8–06; 8:45 am] docket in our reading room. The reading
8. The authority citation for part 95 BILLING CODE 3410–34–P room is located in room 1141 of the
would continue to read as follows: USDA South Building, 14th Street and
Authority: 7 U.S.C. 8301–8317; 21 U.S.C. Independence Avenue, SW.,
136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, DEPARTMENT OF AGRICULTURE Washington, DC. Normal reading room
2.80, and 371.4. hours are 8 a.m. to 4:30 p.m., Monday
Animal and Plant Health Inspection through Friday, except holidays. To be
9. Section 95.4 would be amended as Service sure someone is there to help you,
follows: please call (202) 690–2817 before
9 CFR Part 98 coming.
a. Paragraph (c)(2) would be revised to
read as set forth below. [Docket No. APHIS–2006–0120] Other Information: Additional
information about APHIS and its
b. Paragraphs (c)(3) through (c)(7) Importation of Sheep and Goat Semen programs is available on the Internet at
would be redesignated as paragraphs
AGENCY: Animal and Plant Health
(c)(4) through (c)(8), respectively.
c. A new paragraph (c)(3) would be Arnaldo Vaquer, Senior Staff
added to read as set forth below. ACTION: Proposed rule.
Veterinarian, Technical Trade Services,
d. Newly designated paragraph (c)(7) SUMMARY: We are proposing to amend National Center for Import and Export,
would be revised to read as set forth the regulations regarding the VS, APHIS, 4700 River Road Unit 39,
below. importation of animal germplasm by Riverdale, MD 20737–1231; (301) 734–
removing specific restrictions on sheep 8074.
§ 95.4 Restrictions on the importation of semen from regions where scrapie exists
processed animal protein, offal, tankage, SUPPLEMENTARY INFORMATION:
fat, glands, certain tallow other than tallow
and requiring the inclusion of
additional information on the Background
derivatives, and serum due to bovine
spongiform encephalopathy. international health certificate The regulations in 9 CFR part 98
accompanying sheep and goat semen. govern the importation of animal
(c) * * * Experience and research have germplasm to prevent the introduction
(2) Except for material processed or convinced us that sheep and goat semen of contagious diseases of livestock and
stored in regions listed in § 94.18(a)(3) pose a minimal risk of transmitting poultry into the United States. Subparts
of this subchapter, all steps of scrapie. This action would relieve A and B of part 98 apply to animal
processing and storing the material are restrictions on imported sheep semen embryos, and subpart C (§§ 98.30
carried out in a facility that has not been while continuing to provide safeguards through 98.38, referred to below as the
used for the processing and storage of against the introduction and regulations) applies to animal semen.
materials derived from ruminants that dissemination of scrapie. Currently, the regulations in § 98.37
have been in any region listed in DATES: We will consider all comments restrict, due to scrapie concerns, the
§ 94.18(a) of this subchapter. that we receive on or before October 10, importation of sheep semen into the
(3) For material processed or stored in 2006. United States from any region of the
regions listed in § 94.18(a)(3) of this ADDRESSES: You may submit comments world other than Australia, Canada, and
subchapter, all steps of processing and by either of the following methods: New Zealand. These restrictions include
storing the material are carried out in a • Federal eRulemaking Portal: Go to provisions that the semen must be
facility that has not been used for the and, in the transferred only to females in a U.S.
processing and storage of materials lower ‘‘Search Regulations and Federal flock that is participating in the
derived from ruminants that have been Actions’’ box, select ‘‘Animal and Plant voluntary Scrapie Flock Certification
in any region listed in § 94.18(a)(1) or Health Inspection Service’’ from the Program (SFCP), that the semen must
(a)(2) of this subchapter. agency drop-down menu, then click on originate from a donor animal
‘‘Submit.’’ In the Docket ID column, participating in a program equivalent to
* * * * *
select APHIS–2006–0120 to submit or the SFCP or the SFCP flock status must
(7) Each shipment to the United States view public comments and to view be lowered, and that the semen must be
is accompanied by an original certificate supporting and related materials accompanied by a certificate attesting to
signed by a full-time, salaried available electronically. Information on the above conditions. The importer is
veterinarian of the government agency using, including also required to provide the Animal and
responsible for animal health in the instructions for accessing documents, Plant Health Inspection Service (APHIS)
region of export certifying that the submitting comments, and viewing the with information concerning control
conditions of paragraphs (c)(1) through docket after the close of the comment programs, surveillance, and disease
(c)(4) of this section have been met; period, is available through the site’s incidence in the exporting region, as
except that, for shipments of animal ‘‘User Tips’’ link. well as information concerning the
feed from a region listed in § 94.18(a)(3) • Postal Mail/Commercial Delivery: health status of other ruminants in the
of this subchapter, the certificate may be Please send four copies of your region.
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signed by a person authorized to issue comment (an original and three copies) The regulations in § 98.35 deal with
such certificates by the veterinary to Docket No. APHIS–2006–0120, declarations, health certificates, and
services of the national government of Regulatory Analysis and Development, other documents required for the
the region of origin. PPD, APHIS, Station 3A–03.8, 4700 importation of all animal semen into the
* * * * * River Road Unit 118, Riverdale, MD United States. All animal semen

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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Proposed Rules 45445

intended for importation to the United Therefore, we are proposing to ease subpart B, respectively. Flock owners
States must be accompanied by a health the restrictions on the importation of would also be required to sign a written
certificate that provides certain specific sheep semen by removing the agreement that all first generation (F1)
information about the origin and provisions of § 98.37 from our progeny resulting from imported semen
handling of the semen. Paragraph (e) regulations. In lieu of these regulations, from a region that is not free of scrapie
lists additional requirements for the we would amend § 98.35(e) to require would be identified with a permanent
health certificate accompanying sheep that imported sheep or goat semen be official identification consistent with
and goat semen, which must include an accompanied by an international the provisions in § 79.2, and records of
attestation that the semen donor has not veterinary certificate consistent with the any sale of F1 progeny, including the
been in any flock or herd nor had OIE standards describe above. In name and address of the buyer, would
contact with sheep or goats which have § 98.35, paragraph (e) already contains be kept for a period of 5 years. This
been in any flock or herd where scrapie some certificate requirements for would ease some restrictions on where
has been diagnosed or suspected during imported sheep and goat semen; the imported semen may be used while still
the 5 years prior to the date of collection changes we are proposing would bring enabling traceback of the progeny
of the semen, that the semen donor them further into alignment with resulting from the imported semen.
showed no evidence of scrapie at the international standards. While the risk of scrapie transmission
time of collection, and that the parents Specifically, we would amend from sheep semen is believed to be
of the semen donor are not, nor were § 98.35(e) to require imported sheep and minimal, no studies have been done
not, affected with scrapie. goat semen to be accompanied by an regarding the transmissibility through
These requirements are more international veterinary certificate semen of other animal TSEs and certain
restrictive than those recommended by attesting that in the region where the other diseases in small ruminants. For
the World Organization for Animal semen originates certain conditions are this reason, traceback of progeny is
Health (OIE) in Chapter 2.4.8, Article met. These conditions would include essential. of the Terrestrial Animal Health that scrapie is a compulsorily notifiable Under the proposed rule, we would
Code. The OIE standards for importing disease and that there is an effective recognize Australia and New Zealand as
sheep and goat semen from a region not surveillance and monitoring system for regions free of scrapie. The regulations
free from scrapie state that importing scrapie in the region where the semen in § 98.37 currently allow imported
countries should require an originates. In addition, the region where sheep semen from Australia, Canada,
international veterinary certificate the semen originates would have to and New Zealand to be distributed to
attesting that in the region of origin, require that affected sheep and goats are any flock in the United States. When
scrapie is compulsorily notifiable, a slaughtered and completely destroyed. these regulations were established in
surveillance and monitoring system is The region where the semen originates 1996, Canada was included in the list of
in place, affected sheep and goats are must also enforce a ruminant-to- regions from which semen could be
slaughtered and completely destroyed, ruminant feed ban; that is, the feeding imported without additional restrictions
and the feeding of sheep and goats with of sheep and goats with meat-and-bone even though Canada is not scrapie free.
meat-and-bone meal or greaves meal or greaves derived from ruminants At that time, Canada had a scrapie
potentially contaminated with an must also be banned and the ban control program equivalent to the one in
animal transmissible spongiform effectively enforced in the whole region. the United States, and it was
encephalopathy (TSE) has been banned The certificate would have to attest that determined to be unlikely that new
and the ban effectively enforced in the the donor animals are permanently strains of scrapie would be spread into
whole region. The certificate should identified to enable traceback to their the United States from Canada. In 2001,
also attest that donor animals are premises of origin, have been kept since the United States went from a control
permanently identified to enable birth on premises in which no case of program to an eradication program,
traceback to their establishment of scrapie had been confirmed during their which is now in full implementation.
origin, have been kept since birth in residency, showed no clinical sign of However, Canada’s scrapie program has
establishments in which no case of scrapie at the time of semen collection, not advanced at the same speed as the
scrapie has been confirmed during their and did not subsequently develop one in the United States. For these
residency, and showed no clinical sign scrapie between the time of collection reasons, under the proposed rule semen
of scrapie at the time of semen and the time the semen was exported to imported from Canada would be subject
collection. the United States. The certificate would to the same restrictions as semen from
Experience and research have also have to attest that donor animals all other regions except Australia and
convinced APHIS that sheep semen were not the offspring of scrapie- New Zealand, i.e, it could be distributed
poses a minimal risk of transmitting and affected dams. only to females in a flock that is listed
disseminating scrapie in the United This certificate would be required for as a flock/herd premises in the Scrapie
States. Through the SFCP, flocks using all sheep and goat semen imported into National Database, as described above.
imported semen from scrapie-affected the United States. In addition, the
distribution of imported semen within Executive Order 12866 and Regulatory
regions have been monitored and no Flexibility Act
first generation (F1) progeny resulting the United States could be limited,
from the imported semen have been depending on the status of the region of This proposed rule has been reviewed
implicated in scrapie outbreaks. origin of the semen. Semen from regions under Executive Order 12866. The rule
Furthermore, research studies, though free of scrapie could be distributed has been determined to be not
limited in scope, have not revealed throughout the United States, but semen significant for the purposes of Executive
transmission through semen or detected from regions not scrapie free could only Order 12866 and, therefore, has not
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the infective agent in semen, testes, or be distributed to a flock that is listed as been reviewed by the Office of
seminal vesicles of affected rams.1 a flock/herd premises in the Scrapie Management and Budget.
National Database as part of either the The regulations in § 98.37 restrict the
1 See L.A. Detwiler and M. Baylis, ‘‘The regulatory or voluntary flock importation of sheep semen from
Epidemiology of Scrapie,’’ Rev. sci. tech. Off. int. certification scrapie programs described regions other than Australia, Canada,
Epiz. 2003, 22 (1), 131. in 9 CFR part 79 and 9 CFR part 54 and New Zealand due to scrapie

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45446 Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Proposed Rules

concerns. These restrictions include average annual payroll per and are not considered in this economic
provisions requiring the semen to be establishment of $113,106. The U.S. analysis.
transferred only to females in a United Small Business Administration’s (SBA) As this proposed rule would lift some
States flock that participates in the size standard for this particular sector is of the import restrictions on imported
SFCP, the semen originates from a $6 million or less in annual receipts.3 semen from regions that are not
donor animal participating in a program Unfortunately, the Census data do not considered scrapie-free, there would be
equivalent to the United States SFCP, include annual receipts for these a reduction in compliance requirements.
and that the semen is accompanied by establishments; however, based on the In place of current requirements,
a certificate attesting to the above average annual payroll per imported sheep or goat semen would
conditions. Additionally, the establishment, it is reasonable to have to be accompanied by an
regulations require the importer to conclude that the majority of these international veterinary certificate
provide APHIS with information businesses would be considered small consistent with OIE standards. This
regarding control programs, by SBA definitions. certificate would have to be completed
surveillance, and disease incidence in A variety of animal production by a veterinary officer prior to being
the exporting region, as well as support activities other than artificial exported to the United States, and as
information on the health status of other insemination for sheep are included in such would not pose any compliance
ruminants in the region in order to NAICS subsector 1152. APHIS does not requirements for domestic entities.
export sheep semen to the United have specific information on the
States. Benefits
number or size of businesses providing
All of these restrictions on imports of artificial insemination services. Based Importers of sheep semen, as well as
sheep and goat semen were put in place on the data for all NAICS 1152 firms engaged in agricultural support
due to scrapie concerns and with the businesses, we believe they are activities, specifically those providing
goal of preventing the spread of scrapie primarily small entities with annual artificial insemination services, could
in domestic animals. However, further receipts of not more than $6 million. possibly benefit from the proposed
scientific research, as well as APHIS welcomes public comment that changes. Imports of sheep semen are not
experience, has demonstrated to APHIS would support or contradict this tracked as a separate line item by
that sheep and goat semen pose a understanding. USDA’s Foreign Agricultural Service.
minimal risk of transmitting scrapie. However, Veterinary Services of APHIS
Therefore, this proposed rule would Additionally, it is possible the tracks raw data and estimates there were
eliminate restrictions on sheep semen proposed rule may indirectly affect 2,491 straws of sheep semen imported
being imported from regions other than domestic sheep and goat producers. The in 2004 and only 1 straw in 2003, with
Australia, Canada, and New Zealand by Census of Agriculture for 2002, the most Australia being the primary exporter.6 It
removing the provisions of § 98.37 from recent year for which we have data, is possible that the proposed changes
our regulations. In their place, we estimated that there were 43,891 farms would encourage exports of sheep and
would require that sheep or goat semen engaged in sheep and goat farming.4 The goat semen to the United States in
from scrapie-affected regions be SBA size standard for sheep and goat response to reduced import restrictions.
accompanied by an international farming (NAICS subsector 1124) is Laws of supply and demand dictate that
veterinary certificate as recommended $750,000 or less in annual receipts. The increased supply will result in lower
in OIE’s Terrestrial Animal Health Code. 2002 Census estimates the total market prices. However, if this happens, it
Consequently, this proposed rule would value of all agricultural products sold by would be over the long run because
bring the United States’ import domestic sheep and goat farmers to be currently there is not a large demand for
standards for sheep semen in harmony over $445 million, which translates into sheep semen in the United States, as is
with recognized international standards, an average of $10,147 per farm. When evidenced by the number of imports. In
while still protecting against scrapie combined with government payments, fact, domestic sheep and goat producers
introduction to the United States. the average per farm market value of rarely rely on artificial insemination as
These proposed changes in the agricultural products sold is $10,815.5 a means for breeding animals, as it is too
regulations would have a direct effect Only 114 farms are classified as having expensive. Artificial insemination
on importers of sheep semen and those $500,000 or more in market value of technology is primarily practiced by the
businesses involved in support agricultural products sold and seedstock industry. Thus, the market for
activities for animal production, which government payments. So, at least imported sheep semen is small,
includes, among other activities, 43,777, or 99 percent, of farms engaged consisting primarily of producers that
establishments providing breeding in sheep and goat farming would be raise less common breeds and desire
services. The number of establishments considered small by SBA standards. imported semen to improve and
engaged in support activities for animal Foreign exporters of sheep semen diversify their genetics.7
production is tracked by the U.S. from countries other than Australia,
Census Bureau. In 2001, the latest Canada, and New Zealand might also Costs
available year, there were 3,999 benefit from the removal of import It is possible the proposed changes
establishments in the North American restrictions on sheep semen. However, could have an indirect effect on
Industry Classification System (NAICS) as non-U.S. entities, they lie outside the domestic sheep and goat breeders over
subsector 1152, which comprises scope of the Regulatory Flexibility Act the long run. However, a variety of
establishments primarily engaged in conditions would have to be met for this
performing support activities related to 3 Table of Size Standards based on NAICS 2002.

raising livestock.2 The annual payroll Washington, DC: U.S. Small Business 6 Elizabeth McKenna, Data Manager (APHIS).
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Administration, 2004. 7 Susan Schoenian, Area Agent, Sheep & Goats

for these 3,999 establishments was 4 USDA, 2002 Census of Agriculture-United States
Western Maryland Research & Education Center,
$452.3 million, which translates into an Data, Table 50. Washington, DC: National University of Maryland Cooperative Extension; via
Agricultural Statistics Service. e-mail communication and article ‘‘An Update on
2 Statistics of U.S. Businesses: 2001: Support 5 USDA, 2002 Census of Agriculture, Table 59, Sheep A.I.’’ Maryland Small Ruminant page. http://
Activities for Animal Production—United States. under column heading ‘‘Sheep and Goat Farming, Maryland
Washington, DC: U.S. Census Bureau. (1124).’’ Sheep News, 1999.

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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Proposed Rules 45447

situation to materialize. These 2. In § 98.35, paragraphs (e)(1), (e)(2), DEPARTMENT OF TRANSPORTATION

conditions include, but are not limited and (e)(3) would be revised to read as
to, artificial insemination technology follows: Federal Aviation Administration
becoming a more cost-effective
approach to sheep and goat production § 98.35 Declaration, health certificate, and 14 CFR Part 39
other documents for animal semen.
versus using breeding animals. [Docket No. FAA–2006–25554; Directorate
Essentially, the only way sheep and goat * * * * *
Identifier 2006–NM–123–AD]
breeders would be affected over the long (e) * * *
run is if the process of artificial (1) The donor animals: RIN 2120–AA64
insemination becomes cheaper than (i) Are permanently identified, to
Airworthiness Directives; Lockheed
purchasing or maintaining replacement enable trace back to their establishment
Model L–1011 Series Airplanes
breeding animals. As of January 1, 2005, of origin; and
there were inventories of 4.53 million (ii) Have been kept since birth in AGENCY: Federal Aviation
head of breeding sheep and 2.1 million establishments in which no case of Administration (FAA), Department of
head of breeding goats in the United scrapie had been confirmed during their Transportation (DOT).
States. Thus, it is possible that, as the residency; and ACTION: Notice of proposed rulemaking
process of artificial insemination (iii) Neither showed clinical signs of (NPRM).
becomes more cost-effective and as scrapie at the time of semen collection
imported sheep semen becomes more SUMMARY: The FAA proposes to adopt a
nor developed scrapie between the time
readily available and technologies of semen collection and export of the new airworthiness directive (AD) for
improve, sheep and goat producers will semen to the United States; and certain Lockheed Model L–1011 series
substitute away from buying airplanes. This proposed AD would
(iv) The dam of the semen donor is
replacement breeding animals and use require a one-time detailed inspection of
not, nor was not, affected with scrapie.
artificial insemination instead. the C112 harness clamp assembly for
(2) In the region where the semen proper installation, a one-time detailed
However, as stated previously, this originates:
situation is long-term in nature and inspection of the C112 and C162
(i) Scrapie is a compulsorily notifiable harness assemblies for damage, and
highly conditional. disease; and corrective actions if necessary. This
Under these circumstances, the (ii) An effective surveillance and proposed AD results from a report of
Administrator of the Animal and Plant monitoring system for scrapie is in electrical arcing of the essential bus
Health Inspection Service has place; and feeder cables behind hinged circuit
determined that this action would not (iii) Affected sheep and goats are breaker panel CB3 P–K. We are
have a significant economic impact on slaughtered and completely destroyed; proposing this AD to prevent arcing of
a substantial number of small entities. and essential bus feeder cables due to
Executive Order 12988 (iv) The feeding of sheep and goats improper installation of the harness
with meat-and-bone meal or greaves C112 clamp assembly, which could
This proposed rule has been reviewed derived from ruminants has been result in loss of electrical systems and
under Executive Order 12988, Civil banned and the ban effectively enforced smoke and/or fire behind the CB3 P–K
Justice Reform. If this proposed rule is in the whole region; and hinged circuit breaker panel in the flight
adopted: (1) All State and local laws and (3) Semen originating in regions other compartment.
regulations that are inconsistent with than Australia and New Zealand is to be DATES: We must receive comments on
this rule will be preempted; (2) no transferred to females in a flock that is this proposed AD by September 25,
retroactive effect will be given to this listed as a flock/herd premises in the 2006.
rule; and (3) administrative proceedings Scrapie National Database as part of the ADDRESSES: Use one of the following
will not be required before parties may Scrapie Program in the United States, addresses to submit comments on this
file suit in court challenging this rule. and the flock owner has agreed, in proposed AD.
writing, that: • DOT Docket Web site: Go to
Paperwork Reduction Act
(i) All first generation (F1) progeny and follow the
This proposed rule contains no new resulting from imported semen will be instructions for sending your comments
information collection or recordkeeping identified with a permanent official electronically.
requirements under the Paperwork identification consistent with the • Government-wide rulemaking Web
Reduction Act of 1995 (44 U.S.C. 3501 provisions in § 79.2 of this chapter; and site: Go to
et seq.). (ii) Records of any sale of F1 progeny, and follow the instructions for sending
including the name and address of the your comments electronically.
List of Subjects in 9 CFR Part 98 buyer, will be kept for a period of 5 • Mail: Docket Management Facility,
Animal diseases, Imports. years. U.S. Department of Transportation, 400
* * * * * Seventh Street SW., Nassif Building,
Accordingly, we propose to amend 9 room PL–401, Washington, DC 20590.
CFR part 98 as follows: § 98.37 [Removed and reserved] • Fax: (202) 493–2251.
3. Section 98.37 would be removed • Hand Delivery: Room PL–401 on
PART 98—IMPORTATION OF CERTAIN the plaza level of the Nassif Building,
and reserved.
ANIMAL EMBRYOS AND ANIMAL 400 Seventh Street SW., Washington,
SEMEN Done in Washington, DC, this 3rd day of DC, between 9 a.m. and 5 p.m., Monday
August 2006.
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through Friday, except Federal holidays.

1. The authority citation for part 98 Elizabeth E. Gaston, Contact Lockheed Martin Aircraft &
would continue to read as follows: Acting Administrator, Animal and Plant Logistics Center, 120 Orion Street,
Authority: 7 U.S.C. 1622 and 8301–8317; Health Inspection Service. Greenville, South Carolina 29605, for
21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 [FR Doc. E6–12934 Filed 8–8–06; 8:45 am] the service information identified in this
CFR 2.22, 2.80, and 371.4. BILLING CODE 3410–34–P proposed AD.

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