Importation of Sheep and Goat Semen, 64126-64129 [E7-22279]
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64126
Federal Register / Vol. 72, No. 220 / Thursday, November 15, 2007 / Rules and Regulations
period, and all comments timely
received will be considered prior to
finalization of this rule.
List of Subjects in 7 CFR Part 966
Marketing agreements, Reporting and
recordkeeping requirements, Tomatoes.
For the reasons set forth in the
preamble, 7 CFR part 966 is amended as
follows:
I
PART 966—TOMATOES GROWN IN
FLORIDA
1. The authority citation for 7 CFR
part 966 continues to read as follows:
I
Authority: 7 U.S.C. 601–674.
2. Section 966.234 is revised to read
as follows:
I
§ 966.234
Assessment rate.
On and after August 1 2007, an
assessment rate of $0.0325 per 25-pound
carton is established for Florida
tomatoes.
Dated: November 8, 2007.
Lloyd C. Day,
Administrator, Agricultural Marketing
Service.
[FR Doc. E7–22277 Filed 11–14–07; 8:45 am]
BILLING CODE 3410–02–P
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
Animal and Plant Health
Inspection Service, USDA.
ACTION: Final rule.
rfrederick on PROD1PC67 with RULES
AGENCY:
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.
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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:
FOR FURTHER INFORMATION CONTACT:
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
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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 scrapiefree—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
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Federal Register / Vol. 72, No. 220 / Thursday, November 15, 2007 / Rules and Regulations
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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 § 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
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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 § 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
1 Statistics of U.S. Businesses: 2001: Support
Activities for Animal Production—United States.
Washington, DC: U.S. Census Bureau.
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64127
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.
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.
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
2 Table of Size Standards based on NAICS 2002.
Washington, DC: Small Business Administration,
2004.
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).’’
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Federal Register / Vol. 72, No. 220 / Thursday, November 15, 2007 / Rules and Regulations
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
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.
I Accordingly, we are amending 9 CFR
part 98 as follows:
PART 98—IMPORTATION OF CERTAIN
ANIMAL EMBRYOS AND ANIMAL
SEMEN
1. The authority citation for part 98
continues to read as follows:
I
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 § 98.34, a new paragraph (d) is
added to read as follows:
I
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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.
https://www.sheepandgoat.com/articles/ai.html,
Maryland Sheep News, 1999.
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15:27 Nov 14, 2007
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§ 98.34 Import permits for poultry semen
and animal semen.
*
*
*
*
*
(d) Sheep and goat semen from
regions where scrapie exists.
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Importation of semen of sheep and goats
is subject to the requirements in
§ 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 § 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.
3. In § 98.35, paragraphs (e)(1), (e)(2),
and (e)(3) are revised to read as follows:
I
§ 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.
*
*
*
*
*
§ 98.37
[Removed]
4. Section 98.37 is removed and
reserved.
I
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Federal Register / Vol. 72, No. 220 / Thursday, November 15, 2007 / Rules and Regulations
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
FARM CREDIT ADMINISTRATION
12 CFR Part 630
RIN 3052–AC40
Disclosure to Investors in SystemWide and Consolidated Bank Debt
Obligations of the Farm Credit System
Farm Credit Administration.
Direct final rule.
AGENCY:
rfrederick on PROD1PC67 with RULES
ACTION:
SUMMARY: The Farm Credit
Administration (FCA or we) issues this
direct final rule amending our
regulation on the external auditor’s
assessment of internal control over
financial reporting concerning the
System-wide annual report to investors.
The effect of the amended rule is to
require the external auditor of the
Federal Farm Credit Banks Funding
Corporation (Funding Corporation) to
express an opinion on the effectiveness
of internal control over financial
reporting instead of reporting on
management’s assessment of internal
control over financial reporting. The
amended rule implements recent
changes in industry practices.
DATES: If no significant adverse
comment is received on or before
December 17, 2007, these regulations
shall be effective upon the expiration of
30 days after publication in the Federal
Register during which either or both
Houses of Congress are in session. We
will publish notice of the effective date
in the Federal Register. If we receive
significant adverse comment on an
amendment, paragraph, or section of
this rule, and that provision may be
addressed separately from the
remainder of the rule, we will withdraw
that amendment, paragraph, or section
and adopt as final those provisions of
the rule that are not the subject of a
significant comment. In such a case, we
would then tell you how we expect to
continue further rulemaking on the
provisions that were the subject of
significant adverse comment.
ADDRESSES: We offer a variety of
methods for you to submit comments.
For accuracy and efficiency reasons, we
encourage commenters to submit
comments by e-mail, through the
Agency’s Web site, or the Federal
eRulemaking Portal. Regardless of the
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15:27 Nov 14, 2007
Jkt 214001
method you use, please do not submit
your comment multiple times via
different methods. You may submit
comments by any of the following
methods:
• E-mail: Send us an e-mail at regcomm@fca.gov.
• Agency Web site: https://
www.fca.gov. Once you are at the Web
site, select ‘‘Public Commenters,’’ then
‘‘Public Comments.’’
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Gary K. Van Meter, Deputy
Director, Office of Regulatory Policy,
Farm Credit Administration, 1501 Farm
Credit Drive, McLean, VA 22102–5090.
• Fax: (703) 883–4477. Posting and
processing of faxes may be delayed. As
faxes are difficult for us to process and
achieve compliance with section 508 of
the Rehabilitation Act, please consider
another means to submit your comment
if possible.
You may review copies of comments
we receive at our office in McLean,
Virginia, or from our Web site at
https://www.fca.gov. Once you are in the
Web site, select ‘‘Public Commenters,’’
then select ‘‘Public Comments,’’ then
select ‘‘Submitting a Comment’’ and
follow the instructions there. We will
show your comments as submitted, but
for technical reasons we may omit items
such as logos and special characters.
Identifying information that you
provide, such as phone numbers and
addresses, will be publicly available.
However, we will attempt to remove email addresses to help reduce Internet
spam.
FOR FURTHER INFORMATION CONTACT:
Wade Wynn, Policy Analyst, Office of
Regulatory Policy, Farm Credit
Administration, McLean, VA 22102–
5090, (703) 883–4414, TTY (703) 883–
4434, or Laura McFarland, Senior
Attorney, Office of General Counsel,
Farm Credit Administration, McLean,
VA 22102–5090, (703) 883–4020, TTY
(703) 883–4020.
SUPPLEMENTARY INFORMATION:
I. Background
The FCA adopted a final rule on
December 20, 2006, amending our
disclosure and reporting requirements
for Farm Credit System (System)
institutions.1 As part of that rulemaking,
we added a requirement in § 630.5(d) to
include a report by management
assessing the effectiveness of internal
control over financial reporting in the
System-wide annual report to investors.
We also added a requirement that the
1 71
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FR 76111 (December 20, 2006).
Frm 00011
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64129
external auditor of the Funding
Corporation review, attest, and report on
management’s assessment of internal
control over financial reporting. The
December 2006 rulemaking adding
§ 630.5(d) did not receive any objections
to requiring an external auditor to report
on management’s assessment of internal
control over financial reporting in the
System-wide annual report to investors.
Commenters did ask that the attestation
reporting requirement be similar to that
of Public Company Accounting
Oversight Board (PCAOB) auditing
standards, and we agreed. We further
explained that the external auditor’s
attestation report should conform to
other applicable industry standards,
which we identified as those regulations
of the Securities and Exchange
Commission (SEC) implementing the
Sarbanes-Oxley Act of 2002 (SarbanesOxley).2 Although the System is not
covered by the provisions of SarbanesOxley, nor regulated by the SEC, we
generally regard SEC rules as the
industry standard in this area, and we
continue to follow this same general
approach with consideration given to
the unique cooperative structure of the
System.
On June 27, 2007, the SEC revised its
requirement regarding the external
auditor’s attestation report.3 The SEC
now requires the external auditor to
express an opinion directly on the
effectiveness of internal control over
financial reporting instead of reporting
on management’s assessment of internal
control over financial reporting. The
SEC continues to require external
auditors to evaluate whether
management has included appropriate
disclosures in its assessment report.
Further, on July 25, 2007, the SEC
approved PCAOB Auditing Standard
No. 5, ‘‘An Audit of Internal Control
Over Financial Reporting That Is
Integrated With an Audit of Financial
Statements.’’ 4 Auditing Standard No. 5
is intended to increase the accuracy of
financial reports and reduce costs by
making audits more risk-based and
scalable to company size and
complexity. Auditing Standard No. 5
requires the external auditor to form an
opinion on the effectiveness of internal
control over financial reporting except
in the circumstance of a scope
limitation that would result in the
auditor disclaiming an opinion. The
2 Pub.
L. 107–204 (July 30, 2002).
FR 35310 (June 27, 2007).
4 Auditing Standard No. 5 supersedes Auditing
Standard No. 2, ‘‘An Audit of Internal Control Over
Financial Reporting Performed in Conjunction With
an Audit of Financial Statements’’ for all audits of
internal control ending on or after November 15,
2007.
3 72
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Agencies
[Federal Register Volume 72, Number 220 (Thursday, November 15, 2007)]
[Rules and Regulations]
[Pages 64126-64129]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22279]
=======================================================================
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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).''
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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 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. https://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