[Federal Register Volume 60, Number 91 (Thursday, May 11, 1995)]
[Proposed Rules]
[Pages 25151-25162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11561]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 92 and 98
[Docket No. 94-085-2]
Importation of Sheep and Goats and Germ Plasm From Sheep and
Goats
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend the animal importation regulations
to revise who may issue health certificates for ruminants offered for
importation. This amendment would make the regulations more consistent
with regard to different animals and countries and would provide for an
alternative method of issuing health certificates. We are also
proposing to amend the animal importation regulations to revise the
conditions for importing sheep and goats. Likewise, we are proposing to
amend the animal germ plasm regulations to revise the conditions for
importing germ plasm from sheep and goats. These changes appear
necessary to prevent the importation of sheep and goats, and germ plasm
from sheep and goats, that may be affected with scrapie.
In addition, we are proposing to amend the animal importation
regulations to allow imported goats to be quarantined in privately
operated quarantine facilities that meet the requirements that now
apply to privately operated quarantine facilities for sheep. This
amendment would provide uniform rules for the quarantine of animals
which pose an identical disease risk.
Lastly, we are proposing to remove from the regulations health
certificate requirements with regard to the importation of sheep from
New Zealand. Since it appears that sheep from New Zealand pose no
greater disease risk than sheep from other countries, it is no longer
necessary to require such sheep to meet special health certificate
requirements.
COMMENTS: Consideration will be given only to comments received on or
before July 10, 1995.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 94-085-2, Animal and Plant Health Inspection Service, Policy
and Program Development, Regulatory Analysis and Development, 4700
River Road Unit 118, Riverdale, MD 20737-1228. Please state that your
comments refer to Docket No. 94-085-2. Comments received may be
inspected at USDA, room 1141, South Building, 14th Street and
Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m.,
Monday through Friday, except holidays. Persons wishing to inspect
comments are requested to call ahead on (202) 690-2817 to facilitate
entry into the comment reading room.
FOR FURTHER INFORMATION CONTACT: Dr. Joyce Bowling, Staff Veterinarian,
or Dr. Roger Perkins, Staff Veterinarian, Animal and Plant Health
Inspection Service, Veterinary Services, National Center for Import and
Export, 4700 River Road Unit 38, Riverdale, MD 20737-1228. Telephone:
(301) 734-8170. [[Page 25152]]
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 92 govern the importation into the
United States of live animals, including sheep and goats, which are
regulated in part to prevent those infected with scrapie from
transmitting the disease to livestock in the United States. The
regulations in 9 CFR part 98 govern the importation into the United
States of germ plasm (semen and embryos), including germ plasm from
sheep and goats.
Scrapie is a progressive degenerative disease of the central
nervous system of sheep and goats. Scrapie occurs more often in certain
flocks and herds and certain bloodlines, indicating that these animals
may be genetically predisposed to become infected with or develop the
disease. Scrapie may also be transmitted by breeding and other physical
contact between animals.
The disease develops slowly, with an incubation period lasting up
to 5 years. The signs which then become manifest may include
nervousness, incoordination, slight muscular tremors, visible weight
loss, lack of luster in the animals' wool, and itching. Affected
animals become debilitated and die. There is no diagnostic test for
confirming the presence of the disease in a live animal or in germ
plasm. Therefore, presence of the disease cannot be detected until an
animal becomes clinically ill. There is no known treatment for the
disease. The impact of the disease in the United States could increase
if spread of the disease is not controlled, or if incidence of the
disease increases. For these reasons, our regulations are intended to
prevent the importation of animals and germ plasm that could transmit
scrapie, while controlling spread of the disease as it exists in the
United States and eliminating foci of infection.
The regulations in 9 CFR parts 92 and 98 are designed, in part, to
prevent the importation of scrapie-infected animals and germ plasm into
the United States. Other regulations concerning scrapie are contained
in 9 CFR parts 54 and 79. The regulations in part 54 deal with
controlling scrapie in the United States, and include, among other
things, the Voluntary Scrapie Flock Certification Program. The
regulations in part 79 concern identification of sheep and goats in the
United States that are or may be affected with scrapie, and restrict
the interstate movement of sheep and goats so as to prevent the
interstate spread of scrapie.
In this document we are proposing to amend the regulations in parts
92 and 98, as they pertain to the importation of sheep and goats and of
germ plasm from sheep and goats. In our discussion, we refer to the
regulations in both these parts of the CFR as ``the regulations.''
Proposed amendments to each part are discussed separately.
Changes to Part 92
Under part 92 regulations, sheep and goats may enter the United
States only if they meet certain conditions intended to prevent the
importation of sheep and goats that may be affected with scrapie. The
regulations have varying and sometimes inconsistent requirements
concerning the source of the animals, the length of time animals must
have been in scrapie-free locations, and whether they must be
accompanied by a health certificate.
We believe the regulations should be amended to better target the
animals most likely to be infected with scrapie and not unduly restrict
the animals which do not pose a significant threat of disease. We also
believe the regulations should be amended to clarify them and make them
more uniform. We are therefore proposing various amendments, which are
discussed individually below.
Certificates--Issuance
We are proposing to amend the regulations concerning certificates.
Under our current regulations, most ruminants imported into the United
States must be accompanied by a certificate containing health
information. Our existing regulations state that most certificates must
be issued by ``a salaried veterinary officer of the national government
of the country of origin,'' unless the animal is imported from Mexico,
in which case, as an alternative, the certificate can also be issued by
a veterinarian accredited by the National Government of Mexico and
endorsed by a full-time salaried veterinary officer of the National
Government of Mexico (see existing Sec. 92.405(a)). Other sections of
the regulations, concerning specific animals from specific countries,
contain slightly different requirements. For example, existing
Sec. 92.418(a), concerning cattle from Canada, states that a
certificate ``issued or endorsed by a salaried veterinarian of the
Canadian Government'' is required. Section 92.419(a), concerning sheep
and goats from Canada, states that a ``certificate either issued by a
salaried veterinarian of the Canadian Government or issued by a
veterinarian authorized by the Canadian Government to issue such
certificates and subsequently endorsed by a salaried veterinarian of
the Canadian Government'' is required. Section 92.423(a), concerning
ruminants from Central America and the West Indies, requires a
``certificate of a salaried veterinarian of the national government of
the country of origin.''
We believe our regulations should be as consistent as possible. We
also believe an alternative method of issuing certificates, such as is
available for ruminants imported from Mexico, should be available to
importers of ruminants from all countries. Such a change would not
affect the risk of spreading animal diseases to the United States.
Therefore, we are proposing to amend the certificate requirements in
Sec. 92.405(a) to state that certificates must be either: (1) Issued by
a salaried veterinary officer of the national government of the country
of origin, or, alternatively; (2) issued by a veterinarian accredited
or designated by the national government of the country of origin and
endorsed by a full-time salaried veterinary officer of the national
government of the country of origin, thereby representing that the
veterinarian issuing the certificate was authorized to do so.
Like the United States, Mexico accredits veterinarians to act on
behalf of the national government and perform functions required under
these regulations. Other countries ``designate'' veterinarians to
perform such work. For this reason, we propose to use both terms in our
regulations. In addition, we would amend existing Secs. 92.418(a),
92.419(a), 92.423(a), 92.427, 92.428(a), and 92.429 to remove the
requirements concerning who may issue a certificate and to refer
instead to the requirements in proposed Sec. 92.405(a). As explained
above, these amendments would not have any effect on disease risk.
These amendments would, however, allow importers more flexibility, and
would make the certificate issuance requirements uniform while
consolidating them in one section of the regulations.
Health Requirements
Section 92.405(b) contains requirements for certifying the health
status, with respect to scrapie, of sheep and goats intended for
importation into the United States. We propose to amend Sec. 92.405(b)
to require that the certificate accompanying the sheep or goats state
that:
(1) The sheep or goats have 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 immediately
prior to shipment;
(2) None of the female sheep or goats in the flock or herd from
which the [[Page 25153]] sheep or goats will be imported was
impregnated, during the 5 years immediately preceding shipment of the
sheep or goats to the United States, with embryos or semen from another
country other than the United States or from a flock or herd of unknown
scrapie status;
(3) The veterinarian issuing the certificate has inspected the
sheep or goats in the flock or herd from which the sheep or goats will
be imported and found the flock or herd to be free of clinical symptoms
of scrapie, and of any other infectious or contagious disease;
(4) None of the sheep or goats in the flock or herd from which the
sheep or goats will be imported is the progeny of a sire or dam that
has been affected with scrapie or that has produced offspring that have
been affected with scrapie; and
(5) As far as it is possible for the veterinarian who inspects the
animals to determine, none of the sheep or goats in the flock or herd
from which the sheep or goats will be imported has been exposed to
scrapie or any other infectious or contagious disease during the 60
days immediately preceding shipment to the United States.
For reasons explained below, these requirements appear necessary to
help ensure that animals to be imported into the United States are not
infected with scrapie and have not been exposed to scrapie.
Currently, our regulations require that sheep and goats come from a
scrapie-free ``district.'' This requirement was designed to ensure that
scrapie is not imported through sheep and goats originating in
districts where scrapie exists. However, because scrapie is apparently
transmitted through close physical contact, it is necessary to
determine the health status of the sheep or goats with which the
imported animal has had such contact. Therefore, we believe it is
unnecessary to require that animals come from a scrapie-free
``district,'' and our proposed regulations focus instead on the
animals' flock or herd.
Our regulations also currently require, in different sections, that
sheep and goats, to be eligible for importation into the United States,
must have been in scrapie-free locations for the preceding 3 years or
for the preceding 42 months (e.g., Secs. 92.405(b)(iii) and
92.419(a)(3)). However, an animal can be over 4 years of age before it
shows symptoms of scrapie. The age when signs first appear is variable.
We believe that 5 years, or 60 months, would be adequate to ensure that
an animal is not infected.
We are proposing to require that inspections be conducted by the
veterinarian who issues the certificate in order to ensure that the
animals are inspected by a veterinarian qualified to detect scrapie and
other diseases. The proposed requirements concerning the health of the
sire and dam, and other progeny of the sire and dam are intended to
help ensure that the animals to be imported are not infected with
scrapie. In addition, the proposed restriction on the use of embryos or
semen from other countries or from flocks or herds of unknown scrapie
status is intended to ensure that scrapie has not been introduced into
the flock or herd from which the animals are to be imported into the
United States.
We are proposing to use both ``flock'' and ``herd'', although the
terms are synonymous. This usage is standard in the livestock industry:
``flock'' is used in connection with sheep, and ``herd'' is used in
connection with goats. In connection with this proposed amendment, we
are also proposing to amend the definition of herd in Sec. 92.400. We
would make the wording identical to the definition of flock in
Sec. 54.1, which reads: ``All animals maintained on any single
premises; and all animals under common ownership or supervision on two
or more premises which are geographically separated, but among which
there is an interchange or movement of animals.'' We would also add the
same definition of flock to Sec. 92.400 and to the regulations in part
98. These changes are intended to make our regulations consistent and
avoid possible different interpretations. Later in this document, under
the heading Part 98, we discuss our proposal to add a definition of
flock to that part. Additional Requirements
To further ensure that imported sheep and goats do not transmit
scrapie to sheep and goats in the United States, we are proposing to
add a new set of requirements in proposed Sec. 92.435. Proposed
Sec. 92.435 would not apply to Australia, Canada, and New Zealand since
we do not believe sheep and goats imported from these countries pose a
risk of transmitting scrapie into the United States. Australia and New
Zealand are recognized by the United States Department of Agriculture
and the Office International des Epizooties (Office of International
Epizootics) as scrapie-free countries. Therefore, sheep and goats from
these countries pose no risk of importing scrapie into the United
States. Although Canada is not free of scrapie, Canada employs
reporting and surveillance requirements equivalent to the United
States. Such requirements include, but are not limited to: (1)
Reporting incidence of scrapie; (2) restriction of animal movement
within the country because of scrapie; (3) identification of flocks or
herds with scrapie; and (4) depopulation mechanisms for scrapie (i.e.,
removal of high-risk animals). Canadian regulations are distinctly
designed to control the spread of scrapie within that country.
Furthermore, APHIS and Canadian animal health authorities closely
coordinate scrapie control efforts. Under these circumstances, it
appears unnecessary and unproductive to impose the requirements
proposed in new Sec. 92.435 upon sheep and goats imported from
Australia, Canada or New Zealand.
With certain exceptions, we propose to allow sheep or goats to be
imported into the United States only if they meet one of the following
two conditions: (1) They are placed in a flock or herd that
participates in the Voluntary Scrapie Flock Certification Program and
qualifies at the ``Certified'' level; or (2) they are placed in a flock
or herd that participates in the Voluntary Scrapie Flock Certification
Program and the owner of the flock or herd has agreed in writing to
continue to do so until the flock or herd meets the conditions for
being ``Certified.''
The Voluntary Scrapie Flock Certification Program (see 9 CFR part
54, subpart B, Secs. 54.10-54.13 and the ``Uniform Methods and Rules--
Voluntary Scrapie Flock Certification Program'' (UM&R))1 is
designed to reduce the incidence and control the spread of scrapie. It
was established after several years of discussion and input from
industry representatives, members of the public, and other affected and
interested parties. Among other things, it establishes an official
tamper-proof identification system for sheep and goats in the Program.
It also requires that participating animals be regularly inspected and
that flock and herd owners keep records of sales and dispersals. The
long-term goal of the Program is to reduce the incidence of scrapie in
the United States.
\1\Individual copies of the UM&R may be obtained from the Animal
and Plant Health Inspection Service, Veterinary Services, National
Center for Import and Export, 4700 River Road Unit 38, Riverdale, MD
20737-1231.
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Herds and flocks participating in the Voluntary Scrapie Flock
Certification Program are classified according to the risk of their
being infected with scrapie. Each herd receives an identifying number.
From greatest to least risk (referred to also as from lowest to highest
level), the classes are: Certifiable Class C, Certifiable Class B,
Certifiable Class A, and Certified.
Under proposed Sec. 92.435, prospective importers would have to
provide the Volunteer Scrapie Flock Certification
[[Page 25154]] Program identification number of the receiving flock or
herd as part of their permit application. A permit would not be issued
unless the permit application identified a flock or herd to receive the
imported animals. Wethers, sheep and goats imported for immediate
slaughter, and wild sheep and goats imported to an approved zoological
park for exhibition purposes would be exempt from this requirement.
These animals, provided they have met all applicable permit,
certificate, and other requirements of the regulations, would not
present any significant risk of transmitting scrapie.
Under option 1, only animals from flocks or herds in the country of
origin which were participating in a program that is equivalent to our
Voluntary Scrapie Flock Certification Program, and which were at a
level equivalent to the ``Certified'' level, could qualify to be
imported. Animals imported into ``Certified'' flocks or herds could be
removed from the flocks or herds at any time, at the option of the
owner. This is in accordance with the terms of the Voluntary Scrapie
Flock Certification Program, which allows participants to leave the
program at any time. Animals in ``Certified'' flocks or herds pose
little or no risk of transmitting scrapie.
Likewise, under option 2, receiving flocks and herds would have to
participate in the Voluntary Scrapie Flock Certification Program.
However, owners of receiving flocks and herds would have to agree, in
writing, to abide by the requirements of the Program for a minimum of 5
years, or until the flock or herd reached ``Certified'' status. At that
time, animals in the flock or herd could be removed to any location.
Prior to that, animals could only be removed to other flocks or herds
which have met the requirements of Sec. 92.435 for receiving sheep or
goats imported under option 2 and which have reached the same
certification level or are at a lower level (i.e., are at an equal or
greater risk). For example, sheep and goats in receiving herds at the
Certifiable Class B level could be moved to other complying herds at
the Certifiable Class B or Class C level. They could not be moved to
flocks or herds at the Certified or Certifiable Class A level.
Under current requirements of the Voluntary Scrapie Flock
Certification Program, such animals would have to remain in a
``Certifiable'' flock or herd until the flock or herd achieved
``Certified'' status, which would vary from 2 years (animals entering
Certifiable Class A herds), 4 years (animals entering Certifiable Class
B herds), and 5 years (animals entering Certifiable Class C herds). If
the classification status of the receiving herd fell after the animals
were added to the flock or herd, the animals would have to remain in
that flock or herd, or another complying flock or herd of equal or
lower status (i.e., greater risk), until the flock or herd achieved
``Certified'' status.
Animals imported under option 2 would have to be placed in
Certifiable Class C flocks or herds, unless: (1) They came from flocks
or herds that were participating in a program in the country of origin
that was equivalent to our Voluntary Scrapie Flock Certification
Program; and (2) the flock or herd was participating at a level
equivalent to ``Certifiable Class B'' or ``Certifiable Class A.'' The
animals would then be placed in either a certifiable Class B or A flock
or herd, depending upon the level in the country of origin.
In addition to meeting the requirements of Sec. 92.405, the
certificate accompanying all sheep and goats imported under proposed
Sec. 92.435, except sheep and goats placed in Certifiable Class C
flocks or herds, would have to state that: ``The animals identified on
this certificate have been monitored by a salaried veterinary officer
of [name of country of origin], for [number of months], in the same
source flock or herd which had been determined by the Administrator,
APHIS, prior to the exportation of these animals to the United States,
to be equivalent to [certification level] of the Voluntary Scrapie
Flock Certification Program authorized under 9 CFR Part 54, subpart
B.''
The Administrator of the Animal and Plant Health Inspection Service
(APHIS) would determine, in advance of the importation, whether a
country from which the animals are to be imported has a scrapie control
program equivalent to our Voluntary Scrapie Flock Certification
Program. The Administrator also would determine, in advance of the
importation, the participation status of the flock or herd. Prospective
importers who wish to import sheep and goats into flocks or herds in
the United States would have to supply certain information to APHIS, at
the time they apply for an import permit, in order for the
Administrator to make these determinations. We intend to recommend that
prospective importers apply for permits no less than 1 month prior to
the anticipated date of importation.
The information provided would have to include the name, title, and
address of a knowledgeable official in the veterinary services of the
country of origin, and details of scrapie control programs in the
country of origin, including information on disease surveillance and
border control activities and the length of time these activities have
been in effect. We would also require information concerning additions
to the herd or flock from which the sheep or goats would be imported
during the 5 years immediately preceding shipment to the United States.
Additionally, we would require any available data concerning disease
incidence, during the 5 years immediately preceding shipment, in the
flock or herd from which the sheep or goats would be imported,
including, but not limited to, the results of diagnostic tests,
especially histopathology tests, conducted on any animals in the flock
or herd. The prospective importer would also be asked to include
information concerning the health of other ruminants, flocks, and herds
with which the imported sheep and goats, and with which animals in the
sheep or goats' flock or herd, might have had physical contact over the
5 years immediately preceding shipment of the sheep or goats to the
United States, and a description of the type and frequency of the
physical contact. This information appears necessary to make a
determination of the disease status of the flock or herd from which the
sheep or goats would be imported. The Administrator could require
additional information as needed in specific cases to make a final
determination.
The Administrator would determine that a program was equivalent
only if the requirements of the program equalled or exceeded the
management practices required under our Voluntary Scrapie Flock
Certification Program. We have determined, based on experience, that if
these practices are followed, they effectively ensure that flocks and
herds remain free of scrapie. Sheep and goats imported from flocks and
herds that meet equivalent standards are unlikely to have been exposed
to scrapie.
Any violation of the import requirements set forth in proposed
Sec. 92.435 would be a basis for an enforcement action, including, but
not limited to, the removal from the United States of the animals
imported.
Miscellaneous Amendments
We also propose to remove Sec. 92.433 and to amend Sec. 92.411.
Section 92.433 concerns importation of sheep from New Zealand;
Sec. 92.411 contains cross-references to Sec. 92.433 and sheep from New
Zealand.
The provisions of current Sec. 92.433 first became effective on
June 10, 1988 (see 53 FR 21794-21809, Docket 88-057). At that time,
there appeared to be [[Page 25155]] considerable interest in importing
large numbers of sheep from New Zealand. It was anticipated that more
sheep would be imported from New Zealand than could be handled at
existing Federal quarantine facilities. The regulations were therefore
amended to provide for privately operated quarantine facilities for
sheep, including sheep from New Zealand, and to add health
certification requirements concerning sheep from New Zealand.
We propose to remove the health certification requirements. Not
only are large numbers of sheep from New Zealand not currently imported
into the United States, but our experience has shown that sheep
imported from New Zealand do not pose any disease or pest risk not also
posed by sheep from other countries. We therefore believe that
requiring sheep from New Zealand to meet special health certification
requirements is unnecessary. We are therefore proposing to remove
Sec. 92.433. In addition, we would amend Sec. 92.411(b) to remove
references to Sec. 92.433 and sheep from New Zealand.
Section 92.411(b)(1) also provides that certain ruminants imported
into the United States must be quarantined for not less than 15 days.
We propose to amend Sec. 92.411 to require quarantine of not less than
30 days for all ruminants that must be quarantined under the
regulations. A minimum of 30 days, which is already the minimum time
required for cattle, is necessary to ensure that there is adequate time
to complete required testing.
We also propose to amend Sec. 92.434. This section contains
requirements for privately operated quarantine facilities for sheep. We
would amend this section so that the same requirements would apply to
privately operated quarantine facilities for goats. Goats are normally
raised under similar conditions and are subject to the same diseases
and pests as sheep. They therefore pose the same disease risks as
sheep. Under these circumstances, we believe goats can be safely
handled in privately operated quarantine facilities that meet the same
requirements that apply to privately operated quarantine facilities for
sheep.
Changes to Part 98
The regulations in part 98 for importation of embryos from
countries free of rinderpest and foot-and-mouth disease are contained
in subpart A. These regulations require, among other things, that
embryos may be imported if the donor sire and donor dam meet all the
requirements they would have to meet under part 92 for a health
certificate for importation into the United States (Sec. 98.3 (d) and
(e)). The regulations in part 98 for importation of animal semen are
contained in subpart C. These regulations do not contain provisions for
health certification of the donor sire, except when the animal semen is
imported from a country where rinderpest or foot-and-mouth disease
exists (Sec. 98.34(c)(1)(i)). We are proposing to amend the regulations
in part 98, subparts A and C, to add specific requirements concerning
the importation of germ plasm from sheep and goats, to prevent
importations of germ plasm that could transmit scrapie.
We are proposing that sheep and goat germ plasm from any country be
accompanied by a health certificate either issued by a salaried
veterinary officer of the national government of the country of origin,
or issued by a veterinarian accredited or designated by the national
government of the country of origin and endorsed by a full-time
salaried veterinary officer of the national government of the country
of origin, thereby representing that the veterinarian issuing the
certificate was authorized to do so.
The certificate would have to state that:
(1) The semen donor, or the embryos' sire and dam, have 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 or
embryos;
(2) The semen donor, or the embryos' sire and dam, showed no
evidence of scrapie at the time of collection of the semen or embryos;
(3) Scrapie has not been suspected nor confirmed in any progeny of
the embryos' donor dam; and
(4) The parents of the semen donor, or the embryos' sire and dam,
are not, nor were not, affected with scrapie.
These requirements appear necessary to help ensure that imported
sheep and goat germ plasm is not affected with scrapie. Although it
would be useful to confirm the absence of scrapie in the progeny of
semen donors, we are not proposing to require this information.
Obtaining it would be impracticable, as semen donors may have thousands
of progeny. Consequently, as provided above in (3), we are only
requiring the certificate to state such information with regard to the
progeny of the embryos' donor dam.
To further ensure that sheep and goat germ plasm imported into the
United States does not transmit scrapie to sheep and goats in the
United States, we are proposing additional requirements for sheep and
goat germ plasm from all countries except Australia, Canada, and New
Zealand. As explained above, we do not believe sheep, goats, or germ
plasm thereof, pose a risk of transmitting scrapie into the United
States if imported from australia, Canada, or New Zealand. Australia
and New Zealand are recognized by the United States Department of
Agriculture and the Office of International Epizootics as scrapie-free
countries. Therefore, germ plasm from sheep and goats in these
countries poses no risk of importing scrapie into the United States.
Although Canada is not free of scrapie, Canada employs reporting and
surveillance requirements equivalent to the United States. Such
requirements include, but are not limited to: (1) Reporting incidence
of scrapie; (2) restriction of animal movement within the country
because of scrapie; (3) identification of flocks or herds with scrapie;
and (4) depopulation mechanisms for scrapie (i.e., removal of high-risk
animals). Canadian regulations are distinctly designed to control the
spread of scrapie within that country. Furthermore, APHIS and Canadian
animal health authorities closely coordinate scrapie control efforts.
Under these circumstances, it appears unnecessary and unproductive to
impose restrictions on the germ plasm of sheep and goats which is
imported from Australia, Canada, or New Zealand.
We are proposing to allow the germ plasm to be imported into the
United States only if it is transferred into females in a flock or herd
in the United States that meets one of the following two conditions:
(1) The flock or herd participates in the Voluntary Scrapie Flock
Certification Program and qualifies at the ``Certified'' level; or (2)
the flock or herd participates in the Voluntary Scrapie Flock
Certification Program, and the owner of the flock or herd has agreed in
writing to continue to do so until the flock or herd, including all
progeny resulting from the imported germ plasm, meets the conditions
for being ``Certified.''
Prospective importers would be required to provide the Volunteer
Scrapie Flock Certification Program identification number of the
receiving flock or herd as part of the application for an import permit
for the germ plasm.
Under option 1, only germ plasm from animals in flocks or herds in
the country of origin which were participating in a program that is
equivalent to our Voluntary Scrapie Flock Certification Program, and
which were at a level equivalent to the ``Certified'' level, could
qualify to be imported. Animals in the receiving flock or herd,
including animals born of females who received [[Page 25156]] the
imported germ plasm, could be removed from the flock or herd at any
time, at the option of the owner. This is in accordance with the terms
of the Voluntary Scrapie Flock Certification Program, which allows
participants to leave the program at any time. Animals in ``Certified''
flocks or herds pose little or no risk of transmitting scrapie.
Germ plasm imported under option 2 would have to be transferred to
females in Certifiable Class C flocks or herds, unless: (1) The germ
plasm came from animals in a flock or herd that was participating in a
program in the country of origin that was equivalent to our Voluntary
Scrapie Flock Certification Program; and (2) the flock or herd was
participating at a level equivalent to ``Certifiable Class B'' or
``Certifiable Class A.''
Animals in ``Certifiable'' flocks or herds, including all progeny
from the imported germ plasm, would have to remain in the flock or
herd, or a flock or herd of the same or lower status (i.e., greater
risk), until the flock or herd met the conditions for being
``Certified.'' (See the explanation given under ``Changes to Part 92,
Additional Requirements'')
In addition, the certificate accompanying all embryos imported
under options 1 or 2, except embryos transferred to a female in a flock
or herd at the Certifiable Class C level, would have to state that:
``The embryos identified on this certificate are the progeny of a dam
and sire that have been monitored by a salaried veterinary officer of
[name of country of origin], for [number of months], in the same source
flock or herd which had been determined by the Administrator, APHIS,
prior to the exportation of the embryos to the United States, to be
equivalent to [certification level (of dam or sire) presenting greater
risk] of the Voluntary Scrapie Flock Certification Program authorized
under 9 CFR part 54, subpart B.'' The certificate accompanying all
semen imported under options 1 or 2, except semen transferred to a
female in a flock or herd at the Certifiable Class C level, would have
to state that: ``The semen identified on this certificate has been
collected from a sire that has been monitored by a salaried veterinary
officer of [name of country of origin], for [number of months], in the
same source flock or herd which had been determined by the
Administrator, APHIS, prior to the exportation of the semen to the
United States, to be equivalent to [certification level] of the
Voluntary Scrapie Flock Certification Program authorized under 9 CFR
part 54, subpart B.''
The Administrator would determine, in advance of the importation,
whether a country from which the germ plasm is to be imported has a
scrapie control program equivalent to our Voluntary Scrapie Flock
Certification Program. The Administrator would also determine, in
advance of the importation, the participation status of the flock or
herd. Prospective importers who wish to import sheep or goat germ plasm
into flocks or herds in the United States would have to supply certain
information to APHIS at the time they apply for an import permit. We
intend to recommend that prospective importers apply for permits no
less than 1 month prior to the anticipated date of importation.
The information provided would have to include the name, title, and
address of a knowledgeable official in the veterinary services of the
country of origin, and the details of scrapie control programs in the
country of origin, including information on disease surveillance and
border control activities and the length of time that these activities
have been in effect. We would also require information concerning
additions to the herd or flock of the embryos' sire and dam, and the
flock or herd of the semen donor, during the 5 years preceding
collection of the germ plasm. Additionally, we would require any
available data concerning disease incidence during the 5 years
preceding collection of the germ plasm in the flock or herd of the
embryos' sire and dam, and the flock or herd of the semen donor,
including, but not limited to, the results of any diagnostic tests,
especially histopathology tests, conducted on any animals in the flock
or herd. The prospective importer would also be asked to include
information concerning the health of other ruminants, flocks, and herds
with which the embryos' sire and dam, the semen donor, the animals in
the flock or herd of the embryos' sire and dam, and the animals in the
flock or herd of the semen donor, might have had physical contact over
the 5 years preceding collection of the germ plasm, and a description
of the type and frequency of the physical contact. This information
appears necessary to make a determination of the disease status of the
flock or herd of the embryos' sire and dam, and the flock or herd of
the semen donor. The Administrator could require additional information
as needed in specific cases to make a final determination.
The Administrator would determine that a program was equivalent
only if the requirements of the program equalled or exceeded the
management practices required under our Voluntary Scrapie Flock
Certification Program. We have determined, based on experience, that if
these practices are followed, they effectively ensure that flocks and
herds remain free of scrapie. Germ plasm from animals in flocks or
herds that meet equivalent standards is unlikely to present a risk of
transmitting scrapie.
Any violations of the requirements set forth above for the
importation of sheep or goat germ plasm would be a basis for an
enforcement action, including, but not limited to, the removal from the
United States of the imported germ plasm and any resulting animals.
These amendments are all consistent with amendments we are
proposing to part 92, as explained above. We believe our proposed
requirements are necessary to help ensure that imported sheep and goat
germ plasm and animals resulting from the imported germ plasm, are not
affected with scrapie.
Miscellaneous
We are proposing to add a definition of ``flock'' to part 98,
subparts A and C. As explained earlier, ``flock'' is used in the
industry in connection with sheep, and ``herd'' is used in connection
with goats. The regulations in part 98 do not include a definition of
``flock.''
We are also proposing to make minor nonsubstantive, editorial
amendments to the regulations in both parts 92 and 98.
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 purposes of
Executive Order 12866, and, therefore, has not been reviewed by the
Office of Management and Budget.
Our economic analysis indicates that the proposed amendments would
have a positive economic impact on U.S. importers of sheep, goats and
their germ plasm, since importation into the United States would be
easier. The current requirements surrounding the importation of sheep,
goats, and their germ plasm are confusing and considered by many
interested parties to be too restrictive.
In 1993, there were 98,230 operations with sheep in the United
States. Under Small Business Administration criteria, 99 percent of
them are believed to be small entities (having less than $0.5 million
in gross annual receipts for domestic producers and fewer than 100
employees for importers). No information is available on the number or
U.S. operations with goats. [[Page 25157]]
If the proposed amendments are adopted, additional certification
information would be required under the new rules for sheep, goats, and
germ plasm. However, no direct charges or user fees would be assessed
by APHIS. The cost impact would be minimal.
We anticipate that participation in the Voluntary Scrapie Flock
Certification Program will increase if these amendments are adopted, as
germ plasm and breeding stock from countries other than Australia,
Canada, and New Zealand, would be allowed to be introduced only into
Program flocks and herds. Because of the termination by the U.S.
government of the subsidy to wool and mohair growers, the expected
shift from wool and mohair production to meat production in sheep and
goats should create additional demand for breeding stock and germ plasm
imports. Wider participation in the Program would better safeguard the
U.S. sheep and goat industry against a scrapie outbreak. Participation
requires operations to maintain records on their animals, although it
is likely that potential importers of breeding animals or germ plasm
are already keeping such records. There would be no increase in costs
for sheep and goat operations if they participate in the Voluntary
Scrapie Flock Certification Program.
In addition, if the proposed rule is adopted: (1) Sheep and goat
imports from New Zealand would no longer be required to meet special
health certification requirements, and (2) regulations governing
privately operated quarantine facilities for imported sheep would apply
to privately operated quarantine facilities for imported goats as well.
These changes would not have a significant impact on importers or
producers. We believe any impact would be positive, in that the changes
would facilitate importation of sheep and goats.
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 12778
This proposed rule has been reviewed under Executive Order 12778,
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
In accordance with the Paperwork Reduction Act of 1980 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this proposed rule will be submitted for approval to the
Office of Management and Budget. Please send written comments to the
Office of Information and Regulatory Affairs, OMB, Attention: Desk
Officer for APHIS, Washington, DC 20503. Please send a copy of your
comments to: (1) Docket No. 94-085-2, Animal and Plant Health
Inspection Service, Policy and Program Development, Regulatory Analysis
and Development, 4700 River Road Unit 118, Riverdale, MD 20737-1228,
and (2) Clearance Officer, OIRM, USDA, room 404-W, 14th Street and
Independence Avenue SW., Washington, DC 20250.
List of Subjects
9 CFR Part 92
Animal diseases, Imports, Livestock, Poultry and poultry products,
Quarantine, Reporting and recordkeeping requirements.
9 CFR Part 98
Animal diseases, Imports.
Accordingly, 9 CFR parts 92 and 98 would be amended as follows:
PART 92--IMPORTATION OF CERTAIN ANIMALS AND POULTRY AND CERTAIN
ANIMAL AND POULTRY PRODUCTS; INSPECTION AND OTHER REQUIREMENTS FOR
CERTAIN MEANS OF CONVEYANCE AND SHIPPING CONTAINERS THEREON
1. The authority citation for part 92 would continue to read as
follows:
Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 102-105,
111, 114a, 134a, 134b, 134c, 134d, 134f, 135, 136, and 136a; 31
U.S.C. 9701; 7 CFR 2.17, 2.51, and 371.2(d).
2. Section 92.400 would be amended by revising the definition of
herd and by adding a definition for flock, in alphabetical order, to
read as follows:
Sec. 92.400 Definitions.
* * * * *
Flock. A herd.
Herd. All animals maintained on any single premises; and all
animals under common ownership or supervision on two or more premises
which are geographically separated, but among which there is an
interchange or movement of animals.
* * * * *
3. Section 92.405 would be amended as follows:
a. In paragraph (a), by revising the first sentence, up to and
including the words ``stating that'', to read as set forth below.
b. By revising paragraph (b) to read as set forth below.
Sec. 92.405 Certificate for ruminants.
(a) All ruminants intended for importation from any part of the
world, except as provided in Secs. 92.418(a), 92.419(a), 92.423(c), and
92.428(d) of this part, shall be accompanied by a certificate issued by
a full-time salaried veterinary officer of the national government of
the country of origin, or issued by a veterinarian designated or
accredited by the national government of the country of origin and
endorsed by a full-time salaried veterinary officer of the national
government of the country of origin, thereby representing that the
veterinarian issuing the certificate was authorized to do so. The
certificate shall state that * * *
(b) The certificate accompanying sheep and goats intended for
importation from any part of the world shall, in addition to the
statements required by paragraph (a) of this section, state that:
(1) The sheep or goats have 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 immediately
prior to shipment;
(2) None of the female sheep or goats in the flock or herd from
which the sheep or goats will be imported was impregnated, during the 5
years immediately preceding shipment of the sheep or goats to the
United States, with embryos or semen from another country other than
the United States or from a flock or herd of unknown scrapie status;
(3) The veterinarian issuing the certificate has inspected the
sheep or goats in the flock or herd from which the sheep or goats will
be imported and found the flock or herd to be free of clinical symptoms
of scrapie, and of any other infectious or contagious disease;
(4) None of the sheep or goats in the flock or herd from which the
sheep or goats will be imported is the progeny of a sire or dam that
has been affected with scrapie or that has produced offspring that have
been affected with scrapie; and
(5) As far as it is possible for the veterinarian who inspects the
animals to determine, none of the sheep or goats in the flock or herd
from which the sheep or goats will be imported has been exposed to
scrapie or any other infectious or contagious disease during the 60
days immediately preceding shipment to the United States.
* * * * * [[Page 25158]]
4. Section 92.411 would be revised to read as follows:
Sec. 92.411 Quarantine requirements.
(a) Except for cattle from Central America and the West Indies, and
except for ruminants from Canada and Mexico, all ruminants imported
into the United States shall be quarantined for not less than 30 days
counting from the date of arrival at the port of entry.
(b) Wild ruminants shall be subject, during their quarantine, to
such inspections, disinfection, blood tests, or other tests as may be
required by the Administrator to determine their freedom from disease.
5. In Sec. 92.418, paragraph (a) would be revised to read as
follows:
Sec. 92.418 Cattle from Canada.
(a) Health certificates. Except for cattle imported for immediate
slaughter in accordance with Sec. 92.420, cattle intended for
importation from Canada shall be accompanied by a certificate issued in
accordance with Sec. 92.405(a). The certificate shall state that the
cattle have been inspected and found to be free from any evidence of
communicable disease and that, as far as can be determined, they have
not been exposed to any such disease during the preceding 60 days.
Cattle found unqualified upon inspection at the port of entry will be
refused entry into the United States.
* * * * *
6. Section 92.419 would be amended by revising paragraph (a) to
read as follows:
Sec. 92.419 Sheep and goats from Canada.
(a) Except for sheep and goats imported for immediate slaughter in
accordance with Sec. 92.420, sheep and goats intended for importation
from Canada shall be accompanied by a certificate issued in accordance
with Sec. 92.405 (a) and (b).
* * * * *
7. Section 92.423 would be amended as follows:
a. In paragraph (a), by revising the first sentence, up to and
including the words ``country of origin'', to read as set forth below.
b. By revising paragraph (b) to read as set forth below.
Sec. 92.423 Ruminants from Central America and the West Indies.
(a) Ruminants intended for importation from Central America and the
West Indies, except as provided in paragraph (c) of this section, must
be accompanied by a certificate issued in accordance with
Sec. 92.405(a) * * *
(b) The certificate accompanying sheep and goats intended for
importation from Central America and the West Indies must, in addition
to the statements required by paragraph (a) of this section, meet all
the requirements of Sec. 92.405(b).
* * * * *
Sec. 92.427 [Amended]
8. Section 92.427 would be amended as follows:
a. In paragraph (b)(1), by revising the first sentence, up to and
including the words ``inspected the said cattle'', to read as set forth
below.
b. By revising paragraph (b)(2)(i), up to and including the words
``inspected the cattle'', to read as set forth below.
c. By revising paragraph (b)(2)(ii) to read as set forth below.
d. In paragraph (c)(1), the last sentence, by removing the words
``, issued by a salaried veterinarian of the Government of Mexico, or
issued by a veterinarian accredited by the National Government of
Mexico and endorsed by a full-time salaried veterinary officer of the
National Government of Mexico, thereby representing that the
veterinarian issuing the certificate was authorized to so do,'' and
adding in their place ``issued in accordance with Sec. 92.405(a) and''.
e. By revising paragraph (d)(1), introductory text, to read as set
forth below.
f. In paragraph (e)(2), by removing the words ``by a salaried
veterinarian of the Government of Mexico, or issued by a veterinarian
accredited by the National Government of Mexico and endorsed by a full-
time salaried veterinary officer of the National Government of Mexico,
thereby representing that the veterinarian issuing the certificate was
authorized to do so,'' and adding in their place ``in accordance with
Sec. 92.405(a) and''.
Sec. 92.427 Cattle from Mexico.
* * * * *
(b) Fever ticks. (1) Except as provided in paragraph (b)(2), all
cattle intended for importation from Mexico, for purposes other than
immediate slaughter, shall be accompanied by a certificate issued in
accordance with Sec. 92.405(a), and showing that the veterinarian
issuing the certificate inspected the cattle * * *
(2) * * *
(i) The cattle shall be accompanied by a certificate issued in
accordance with Sec. 92.405(a), and showing that the veterinarian
issuing the certificate has inspected the cattle * * *
(ii) The cattle shall be shown by a certificate issued in
accordance with Sec. 92.405(a) to have been dipped in a tickicidal dip
within 7 to 12 days before being offered for entry.
* * * * *
(d) * * *
(1) Are accompanied by a certificate issued in accordance with
Sec. 92.405(a) stating:
* * * * *
9. Section 92.428 would be amended by revising paragraph (a) to
read as follows:
Sec. 92.428 Sheep and goats and wild ruminants from Mexico.
(a) Sheep and goats intended for importation from Mexico shall be
accompanied by a certificate issued in accordance with Sec. 92.405 (a)
and (b) and stating, if such sheep or goats are shipped by rail or
truck, that such animals were loaded into cleaned and disinfected cars
or trucks for transportation direct to the port of entry.
Notwithstanding such certificate, such sheep and goats shall be
detained as provided in Sec. 92.427(a) and shall be dipped at least
once in a permitted scabies dip under supervision of an inspector.
* * * * *
Sec. 92.429 [Amended]
10. In Sec. 92.429, the first sentence would be amended by removing
the words ``issued by a salaried veterinarian of the Government of
Mexico, or issued by a veterinarian accredited by the National
Government of Mexico and endorsed by a full-time salaried veterinary
officer of the National Government of Mexico, thereby representing that
the veterinarian issuing the certificate was authorized to do so,
stating'' and adding in their place the words ``issued in accordance
with Sec. 92.405 (a) and (b) and stating that the veterinarian who
issued the certificate has inspected the animals in the herd from which
the ruminants will be imported,''.
Sec. 92.433 [Removed and Reserved]
11. Section 92.433, Sheep from New Zealand, would be removed and
reserved.
Sec. 92.434 [Amended]
12. Section 92.434 would be amended as follows:
a. By revising the heading to read ``Standards for approval of
privately operated quarantine facilities for sheep or goats, and
handling procedures for the importation of sheep or goats.''
b. In paragraph (b), introductory text, by redesignating footnote
20 and the reference to it as footnote 16. [[Page 25159]]
c. In paragraph (d)(1), by redesignating footnote 21 and the
reference to it as footnote 17.
d. By adding the words ``or goats'' after the word ``sheep'' in the
following places:
1. In paragraph (a).
2. In paragraph (b)(2)(i)(B).
3. In paragraph (b)(2)(ii)(A).
4. In paragraph (b)(2)(ii)(B).
5. In paragraph (b)(2)(ii)(D).
6. In paragraph (b)(2)(ii)(E).
7. In paragraph (b)(2)(ii)(F).
8. In paragraph (b)(2)(iii)(G), after only the third time ``sheep''
appears.
9. In paragraph (b)(2)(iii)(K).
10. In paragraph (b)(2)(iii)(L).
11. In paragraph (b)(3)(i)(A)(5).
12. In paragraph (b)(3)(ii).
13. In paragraph (b)(3)(iv), in the heading and text.
14. In paragraph (b)(3)(iv)(A), in the first sentence.
15. In paragraph (b)(3)(iv)(B).
16. In paragraph (b)(3)(v).
17. In paragraph (b)(5).
18. In paragraph (c).
19. In paragraph (d)(2).
20. In paragraph (d)(2)(iv).
21. In paragraph (d)(4).
e. by adding the words ``or goat'' after the word ``sheep'' in the
following places:
1. In paragraph (b)(2)(iii)(G), after the first and second time
``sheep'' appears.
2. In paragraph (b)(3)(iv)(A), in the second sentence.
f. By removing the word ``sheep-holding'' and adding the words
``sheep- or goat-holding'' in the following places:
1. In paragraph (b)(2)(ii)(K).
2. In paragraph (b)(2)(iii)(J).
3. In paragraph (b)(3)(i)(A).
4. In paragraph (b)(3)(i)(A)(1).
5. In paragraph (b)(3)(i)(A)(3).
6. In paragraph (b)(3)(ii).
13. A new Sec. 92.435 would be added to read as follows:
Sec. 92.435 Sheep and goats from countries other than Australia,
Canada, and New Zealand.
(a) Except for sheep and goats from Australia, Canada, or New
Zealand, sheep and goats may only be imported into the United States if
they meet all applicable provisions of this subpart and one of the
following conditions:
(1) The animals are wethers, or sheep or goats imported for
immediate slaughter, or wild sheep or goats imported for exhibition
purposes to an approved zoological park in accordance with
Sec. 92.404(c); or
(2) The animals are placed in a flock or herd in the United States
that participates in the Voluntary Scrapie Flock Certification Program
(see 9 CFR part 54, subpart B) and qualifies as a ``Certified'' flock
or herd; or
(3) The animals are placed in a flock or herd in the United States
that participates in the Voluntary Scrapie Flock Certification Program
(see 9 CFR part 54, subpart B), and the flock or herd owner must agree,
in writing, to maintain the flock or herd in compliance with all
requirements of the Voluntary Scrapie Flock Certification Program until
the flock or herd would qualify as a ``Certified'' flock or herd.
(b) Sheep or goats may be imported under paragraphs (a)(2) or
(a)(3) of this section only if the importer provides the Voluntary
Scrapie Flock Certification Program identification number of the
receiving flock or herd as part of the application for an import
permit.
(c) Sheep and goats may be imported under paragraph (a)(2) of this
section only if they come from a flock or herd in the country of origin
that participates in a program determined by the Administrator to be
equivalent to the Voluntary Scrapie Flock Certification Program, and
the flock or herd has been determined by the Administrator to be at a
level equivalent to ``Certified'' in the Voluntary Scrapie Flock
Certification Program.
(d) Sheep and goats may be imported under paragraph (a)(3) of this
section only if they are placed in a Certifiable Class C flock or herd
participating in the Voluntary Scrapie Flock Certification Program;
Except, that if the sheep and goats come from a flock or herd in the
country of origin that participates in a program determined by the
Administrator to be equivalent to the Voluntary Scrapie Flock
Certification Program, then the sheep and goats may be placed in a herd
or flock in the United States which would be classified at a level
equivalent to or lower (i.e., at a greater risk) than the certification
level, as determined by the Administrator, of the flock or herd from
which the sheep or goats are to be imported.
(e) Sheep and goats imported under paragraph (a)(3) of this section
must be monitored for scrapie disease until the flock or herd qualifies
as a ``Certified'' flock or herd.
(f) Except for imported sheep and goats being placed in Certifiable
Class C flocks or herds, the certificate accompanying sheep or goats
imported under paragraphs (a)(2) or (a)(3) of this section must contain
the following statement: ``The animals identified on this certificate
have been monitored by a salaried veterinary officer of [name of
country of origin], for [number of months], in the same source flock or
herd which had been determined by the Administrator, APHIS, prior to
the exportation of these animals to the United States, to be equivalent
to [certification level] of the Voluntary Scrapie Flock Certification
Program authorized under 9 CFR part 54, subpart B.''
(1) The Administrator will determine, based upon information
supplied by the importer, whether the flock or herd from which the
animals are to be imported participates in a program in the country of
origin that is equivalent to the Voluntary Scrapie Flock Certification
Program, and if so, at what level the source flock or herd should be
classified.
(2) In order for the Administrator to make a determination, the
importer must supply the following information with the application for
an import permit no less than 1 month prior to the anticipated date of
importation:
(i) The name, title, and address of a knowledgeable official in the
veterinary services of the country of origin;
(ii) The details of scrapie control programs in the country of
origin, including information on disease surveillance and border
control activities and the length of time such activities have been in
effect;
(iii) Any available information concerning additions, within the 5
years immediately preceding shipment to the United States, to the flock
or herd from which the sheep and goats will be imported;
(iv) Any available data concerning disease incidence, within the 5
years immediately preceding shipment to the United States, in the flock
or herd from which the sheep or goats are to be imported, including,
but not limited to, the results of diagnostic tests, especially
histopathology tests, conducted on any animals in the flock or herd;
(v) Information concerning the health, within the 5 years
immediately preceding shipment to the United States, of other
ruminants, flocks, and herds with which the imported sheep and goats,
and with which animals in the sheep or goats' flock or herd might have
had physical contact, and a description of the type and frequency of
such physical contact; and
(vi) Any other information requested by the Administrator in
specific cases as needed to make a determination.
PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN
14. The authority citation for part 98 would be revised to read as
follows:
Authority: 7 U.S.C. 1622; 21 U.S.C. 103, 104, 105, 111, 134a,
134b, 134c, 134d, 134f, 136, and 136a; 31 U.S.C. 9701; 7 CFR 2.17,
2.51, and 371.2(d).
[[Page 25160]] 15. Section 98.2 would be amended by adding
definitions for flock and herd, in alphabetical order, to read as
follows:
Sec. 98.2 Definitions.
* * * * *
Flock. A herd.
Herd. All animals maintained on any single premises; and all
animals under common ownership or supervision on two or more premises
which are geographically separated, but among which there is an
interchange or movement of animals.
* * * * *
16. In Sec. 98.5, paragraphs (a), (b), (c), (d), and (e) would be
redesignated as paragraphs (a)(1), (a)(2), (a)(3), (a)(4), and (a)(5);
the introductory text would be designated as paragraph (a) and revised
to read as follows; and a new paragraph (b) would be added to read as
follows:
Sec. 98.5 Health certificate.
(a) Except as provided in subpart B of this part, an animal embryo
shall not be imported into the United States unless it is accompanied
by a certificate issued by a full-time salaried veterinary officer of
the national government of the country of origin, or issued by a
veterinarian designated or accredited by the national government of the
country of origin and endorsed by a full-time salaried veterinary
officer of the national government of the country of origin, thereby
representing that the veterinarian issuing the certificate was
authorized to do so. The certificate shall state:
* * * * *
(b) The certificate accompanying sheep or goat embryos intended for
importation from any part of the world shall, in addition to the
statements required by paragraph (a) of this section, state that:
(1) The embryos' sire and dam have 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 embryos;
(2) The embryos' sire and dam showed no evidence of scrapie at the
time the embryos were collected;
(3) Scrapie has not been suspected nor confirmed in any progeny of
the embryos' donor dam; and
(4) The parents of the embryos' sire and dam are not, nor were not,
affected with scrapie.
17. In part 98, subpart A, a new Sec. 98.10a would be added to read
as follows:
Sec. 98.10a Embryos from sheep and goats in countries other than
Australia, Canada, and New Zealand.
(a) Except for embryos from sheep and goats in Australia, Canada,
or New Zealand, embryos from sheep and goats may only be imported into
the United States if they comply with all applicable provisions of this
subpart and one of the following conditions:
(1) The embryos are transferred to females in a flock or herd in
the United States that participates in the Voluntary Scrapie Flock
Certification Program (see 9 CFR part 54, subpart B) and qualifies as a
``Certified'' flock or herd; or
(2) The embryos are transferred to females in a flock or herd in
the United States that participates in the Voluntary Scrapie Flock
Certification Program (see 9 CFR part 54, subpart B) and the flock or
herd owner must agree, in writing, to maintain the flock or herd, and
all progeny resulting from embryos imported in accordance with this
section, in compliance with all requirements of the Voluntary Scrapie
Flock Certification Program until the flock or herd, including all
progeny resulting from embryos imported in accordance with this
section, would qualify as a ``Certified'' flock or herd.
(b) Sheep or goat embryos may be imported under paragraphs (a)(1)
or (a)(2) of this section only if the importer provides the Voluntary
Scrapie Flock Certification Program identification number of the
receiving flock or herd as part of the application for an import
permit.
(c) Sheep and goat embryos may be imported under paragraph (a)(1)
of this section only if they are the progeny of a dam and sire that are
part of flocks or herds in the country of origin that participates in a
program determined by the Administrator to be equivalent to the
Voluntary Scrapie Flock Certification Program, and the flocks or herds
have been determined by the Administrator to be at a level equivalent
to ``Certified'' in the Voluntary Scrapie Flock Certification Program.
(d) Sheep and goat embryos may be imported under paragraph (a)(2)
of this section only if they are transferred to animals in a
Certifiable Class C flock or herd participating in the Voluntary
Scrapie Flock Certification Program: Except, that if the embryos are
the progeny of a dam and sire whose flock or herd in the country of
origin participates in a program determined by the Administrator to be
equivalent to the Voluntary Scrapie Flock Certification Program, then
the embryos may be placed in a herd or flock in the United States which
would be classified at a level equivalent to or lower (i.e., at a
greater risk) than the certification level, as determined by the
Administrator, of either the flock or herd of the dam or the flock or
herd of the sire, whichever one presents the greater risk.
(e) The flock or herd to which the sheep and goat embryos are
transferred pursuant to paragraph (a)(2) of this section, must be
monitored for scrapie disease until the flock or herd, and all progeny
resulting from the embryos imported in accordance with this section,
qualifies as a ``Certified'' flock or herd.
(f) Except for sheep and goat embryos being placed in Certifiable
Class C flocks or herds, the certificate accompanying sheep or goat
embryos imported under paragraphs (a)(1) or (a)(2) of this section must
contain the following statement: ``The embryos identified on this
certificate are the progeny of a dam and sire that have been monitored
by a salaried veterinary officer of [name of country of origin], for
[number of months], in the same source flock or herd which had been
determined by the Administrator, APHIS, prior to the exportation of
these embryos to the United States, to be equivalent to [certification
level (of dam or sire) presenting greater risk] of the Voluntary
Scrapie Flock Certification Program authorized under 9 CFR part 54,
subpart B.''
(1) The Administrator will determine, based upon information
supplied by the importer, whether the flock or herd of the embryos' dam
and sire participates in a program in the country of origin that is
equivalent to the Voluntary Scrapie Flock Certification Program, and if
so, at what level the source flock or herd would be classified.
(2) In order for the Administrator to make a determination, the
importer must supply the following information with the application for
an import permit, no less than 1 month prior to the anticipated date of
importation:
(i) The name, title, and address of a knowledgeable official in the
veterinary services of the country of origin;
(ii) The details of scrapie control programs in the country of
origin, including information on disease surveillance and border
control activities and the length of time such activities have been in
effect;
(iii) Any available information concerning additions, within the 5
years immediately preceding collection of the embryos, to the flock or
herd of the embryos' sire and dam;
(iv) Any available data concerning disease incidence, within the 5
years immediately preceding collection of the embryos, in the flock or
herd of the [[Page 25161]] embryos' sire and dam, including, but not
limited to, the results of diagnostic tests, especially histopathology
tests, conducted on any animals in the flock(s) or herd(s);
(v) Information concerning the health, within the 5 years
immediately preceding collection of the embryos, of other ruminants,
flocks, and herds with which the embryos' sire and dam and the flock or
herd of the embryos' sire and dam might have had physical contact, and
a description of the type and frequency of the physical contact; and
(vi) Any other information requested by the Administrator in
specific cases as needed to make a determination.
(g) All progeny resulting from embryos imported under this section
are subject to the requirements of 9 CFR part 54 and all other
applicable regulations.
18. In part 98, subpart C, Sec. 98.30 would be amended by adding
definitions for flock and herd, in alphabetical order, to read as
follows:
Sec. 98.30 Definitions.
* * * * *
Flock. A herd.
Herd. All animals maintained on any single premises; and all
animals under common ownership or supervision on two or more premises
which are geographically separated, but among which there is an
interchange or movement of animals.
* * * * *
19. In Sec. 98.35, paragraph (c) would be revised and a new
paragraph (e) would be added to read as follows:
Sec. 98.35 Declaration, health certificate, and other documents for
animal semen.
* * * * *
(c) All animal semen intended for importation into the United
States shall be accompanied by a health certificate issued by a full-
time salaried veterinary officer of the national government of the
country of origin, or issued by a veterinarian designated or accredited
by the national government of the country of origin and endorsed by a
full-time salaried veterinary officer of the national government of the
country of origin, thereby representing that the veterinarian issuing
the certificate was authorized to do so.
* * * * *
(e) The certificate accompanying sheep or goat semen intended for
importation from any part of the world shall, in addition to the
statements required by paragraph (d) of this section, state that:
(1) 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;
(2) The semen donor showed no evidence of scrapie at the time the
semen was collected; and
(3) The parents of the semen donor are not, nor were not, affected
with scrapie.
Sec. 98.36 [Amended]
20. In Sec. 98.36, paragraph (a), introductory text, would be
amended by adding the words ``is not a sheep or goat and'' immediately
before the colon.
21. A new Sec. 98.37 would be added to read as follows:
Sec. 98.37 Semen from sheep and goats in countries other than
Australia, Canada, and New Zealand.
(a) Except for semen from sheep and goats in Australia, Canada, and
New Zealand, semen from sheep and goats may only be imported into the
United States if it complies with all applicable provisions of this
subpart and one of the following conditions:
(1) The semen is transferred to females in a flock or herd in the
United States that participates in the Voluntary Scrapie Flock
Certification Program (see 9 CFR part 54, subpart B) and qualifies as a
``Certified'' flock or herd; or
(2) The semen is transferred to females in a flock or herd in the
United States that participates in the Voluntary Scrapie Flock
Certification Program (see 9 CFR part 54, subpart B), and the flock or
herd owner must agree, in writing, to maintain the flock or herd, and
all progeny resulting from semen imported in accordance with this
section, in compliance with all requirements of the Voluntary Scrapie
Flock Certification Program until the flock or herd, including all
progeny resulting from semen imported in accordance with this section,
would qualify as a ``Certified'' flock or herd.
(b) Sheep or goat semen may be imported under paragraphs (a)(1) or
(a)(2) of this section only if the importer provides the Voluntary
Scrapie Flock Certification Program identification number of the
receiving flock or herd as part of the application for an import
permit.
(c) Sheep or goat semen may be imported under paragraph (a)(1) of
this section only if it comes from a donor animal in a flock or herd in
the country of origin that participates in a program determined by the
Administrator to be equivalent to the Voluntary Scrapie Flock
Certification Program, and the flock or herd has been determined by the
Administrator to be at a level equivalent to ``Certified'' in the
Voluntary Scrapie Flock Certification Program.
(d) Sheep or goat semen may be imported under paragraph (a)(2) of
this section only if it is transferred to animals in a Certifiable
Class C flock or herd participating in the Voluntary Scrapie Flock
Certification Program; Except, that if the semen comes from a donor
animal whose flock or herd in the country of origin participates in a
program determined by the Administrator to be equivalent to the
Voluntary Scrapie Flock Certification Program, then the semen may be
used in a herd or flock in the United States which would be classified
at a level equivalent to or lower (i.e., at greater risk) than the
certification level, as determined by the Administrator, of the flock
or herd of the donor animal.
(e) The flock or her to which the sheep and goat semen is
transferred pursuant to paragraph (a)(2) of this section, must be
monitored for scrapie disease until the flock or herd, and all progeny
resulting from the semen imported in accordance with this section,
qualifies as a ``Certified'' flock or herd.
(f) Except for sheep and goat semen being placed in Certifiable
Class C flocks or herds, the certificate accompanying the sheep or goat
semen imported under paragraphs (a)(1) or (a)(2) of this section must
contain the following statement: ``The semen identified on this
certificate has been collected from a sire that has been monitored by a
salaried veterinary officer of [name of country of origin], for [number
of months], in the same source flock or herd which had been determined
by the Administrator, APHIS, prior to the exportation of the semen to
the United States, to be equivalent to [certification level] of the
Voluntary Scrapie Flock Certification Program authorized under 9 CFR
part 54, subpart B.''
(1) The Administrator will determine, based upon information
supplied by the importer, whether the donor animal's flock or herd
participates in a program in the country of origin that is equivalent
to the Voluntary Scrapie Flock Certification Program, and if so, at
what level the source flock or herd would be classified.
(2) In order for the Administrator to make a determination, the
importer must supply the following information with the application for
an import permit, no less than 1 month prior to the anticipated date of
importation: [[Page 25162]]
(i) The name, title, and address of a knowledgeable official in the
veterinary services of the country of origin;
(ii) The details of scrapie control programs in the country of
origin, including information on disease surveillance and border
control activities and the length of time these activities have been in
effect;
(iii) Any available information concerning additions, within the 5
years immediately preceding collection of the semen, to the flock or
herd of the semen donor;
(iv) Any available data concerning disease incidence, within the 5
years immediately preceding collection of the semen in the donor
animal's flock or herd, including, but not limited to, the results of
diagnostic tests, especially histopathology tests, conducted on any
animals in the flock or herd;
(v) Information concerning the health, within the 5 years
immediately preceding collection of the semen, of other ruminants,
flocks, and herds with which the donor animal and the donor animal's
flock or herd might have had physical contact, and a description of the
type and frequency of the physical contact; and
(vi) Any other information requested by the Administrator in
specific cases as needed to make a determination.
(g) All progeny resulting from semen imported under this section
are subject to the requirements of 9 CFR part 54 and all other
applicable regulations.
Done in Washington, DC, this 3rd day of May 1995.
George O. Winegar,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-11561 Filed 5-10-95; 8:45 am]
BILLING CODE 3410-34-P
