[Federal Register Volume 61, Number 77 (Friday, April 19, 1996)]
[Rules and Regulations]
[Pages 17231-17243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9266]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 61, No. 77 / Friday, April 19, 1996 / Rules
and Regulations
[[Page 17231]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 92 and 98
[Docket No. 94-085-3]
Importation of Sheep and Goats and Germ Plasm From Sheep and
Goats
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are amending the animal importation regulations to revise
who may issue health certificates for ruminants offered for
importation. This amendment will make the regulations more consistent
with regard to different animals and countries and will provide an
alternative method of issuing health certificates.
We are also amending the animal importation regulations to revise
the conditions for importing sheep and goats. We are similarly amending
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.
We are also amending 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 will provide
uniform rules for the quarantine of animals which pose a similar
disease risk.
In addition, we are removing from the regulations health
certificate requirements that apply specifically to the importation of
sheep from New Zealand. Since sheep from New Zealand pose no greater
disease risk than sheep from other countries, there is no longer a need
to retain separate health certification requirements for sheep imported
from New Zealand.
Lastly, we are adopting as a final rule, without change, an interim
rule that amended the regulations for importing sheep and goats from
Canada and Mexico. The rule requires that, with the exception of sheep
and goats imported through land border ports for immediate slaughter,
and wethers imported through land border ports, all sheep and goats
imported into the United States from Canada and Mexico be accompanied
by an import permit. This requirement is necessary to prevent the
importation of sheep and goats that may be affected with scrapie.
EFFECTIVE DATE: May 20, 1996.
FOR FURTHER INFORMATION CONTACT: Dr. Joyce Bowling or Dr. Roger
Perkins, Staff Veterinarian, Import Animals Program, National Center
for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale,
MD 20737-1228, (301) 734-8170.
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 certain bloodlines, indicating that these animals may be
genetically predisposed to become infected with or develop the disease.
Scrapie may be transmitted through contact with the placenta or bodily
fluids of infected animals which have just given birth.
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 an interim rule effective and published in the Federal Register
on March 15, 1995 (60 FR 13898-13900, Docket No. 94-085-1), we amended
the regulations in part 92 to require that, with the exception of sheep
and goats imported through land border ports for immediate slaughter,
and wethers imported through land border ports, all sheep and goats
imported into the United States from Canada and Mexico be accompanied
by an import permit. This action was necessary to prevent the
importation of sheep and goats that may be affected with scrapie.
We solicited comments concerning the interim rule for 60 days
ending May 15, 1995. We received 4 comments by that date. They were
from one foreign government, and from industry representatives and
businesses.
On May 11, 1995, we published in the Federal Register (60 FR 25151-
25162, Docket No. 94-085-2) a proposal to amend the regulations in
parts 92 and 98 by: (1) Revising who may issue health certificates for
ruminants offered for importation; (2) revising the conditions for
importing sheep and goats; (3) revising the conditions for
[[Page 17232]]
importing germ plasm from sheep and goats; (4) allowing imported goats
to be quarantined in privately operated quarantine facilities that meet
the requirements that now apply to privately operated quarantine
facilities for sheep; and (5) removing health certificate requirements
that apply specifically to the importation of sheep from New Zealand.
We solicited comments concerning the proposed rule for 60 days
ending July 10, 1995. We received 15 comments by that date. They were
from foreign governments, Federal and State government agencies,
industry representatives, livestock producers, and private individuals.
Of the comments received in response to the interim rule, one
addressed issues which were not contained in the interim rule, but
which were contained in the proposed rule. Although we did not count
this comment as being received in response to the proposed rule, we did
consider suggestions made in the comment when we determined changes
necessary in the proposed rule.
Two comments received in response to the interim rule failed to
address any issue raised by either the interim rule or the proposed
rule. One commenter discussed the importation of washed and frozen
embryos, a topic not relevant to either the interim rule or the
proposed rule. The other comment contained the results of an industry
association member survey concerning the importation of animal
genetics. However, the survey, as described in the comment, did not
appear to have addressed the specific provisions of either the interim
or the proposed rule. For these reasons, we did not consider either of
these comments when determining changes necessary in the interim and
proposed rules.
We have carefully considered all of the relevant comments we
received in response to both the interim rule and the proposed rule.
Issues raised by the comments are discussed below by topic. In our
discussion, we refer to the regulations in both parts 92 and 98 as
``the regulations.''
Scientific Basis of Regulations
Two commenters objected to our statement, in the background of both
the interim rule and the proposed rule, that scrapie is transmitted by
breeding. The commenters are correct--breeding, itself, does not appear
to transmit scrapie. Scrapie is also not a hereditary disease. However,
it does appear that scrapie can be transmitted through contact with the
placenta or bodily fluids of infected animals which have just given
birth. In addition, there is a tendency to develop the disease which
appears to follow bloodlines. Therefore, we have amended the background
information in this document concerning scrapie transmission so that it
more accurately reflects current scientific knowledge about this
disease.
One commenter objected to proposed Sec. 92.405(b)(2), which would
have required the certificate accompanying imported sheep or goats to
state that 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.
The commenter maintained that it is scientifically unjustified to
restrict the importation of sheep and goats from flock or herds in
which females have been impregnated with germ plasm from Australia or
New Zealand. We agree with this comment, and we have made two changes
to this provision, as discussed below.
Our proposed rule and this document allow the importation of sheep
from countries other than Australia, Canada, or New Zealand, provided
such sheep enter a flock participating in the Voluntary Scrapie Flock
Certification Program (VSFCP). It was never our intention to be more
restrictive with regard to sheep from flocks in which any female has
been impregnated with germ plasm from (1) a country other than the
United States or (2) a flock of unknown scrapie status, provided such
sheep enter a flock participating in the VSFCP. Any risk of scrapie
presented by such sheep would be mitigated by placing them in a flock
participating in the VSFCP. Therefore, we are removing the requirement
that the certificate state that none of the female sheep in the flock
from which the sheep will be imported has been impregnated with germ
plasm from a country other than the United States or from a flock of
unknown scrapie status.
Additionally, sheep imported from Australia, Canada, and New
Zealand will be required to enter a flock participating in the VSFCP if
any of the females in the flock from which the sheep will be imported
has been impregnated, during the 5 years immediately preceding shipment
of the sheep to the United States, with germ plasm from a country other
than Australia, Canada, New Zealand, or the United States. Any risk of
scrapie presented by such sheep would be mitigated by placing them in a
flock participating in the VSFCP. As the commenter indicated, Australia
and New Zealand are free of scrapie. Germ plasm from sheep in Australia
and New Zealand can therefore be used to impregnate animals without
fear of transmitting scrapie. Although Canada is not free of scrapie,
Canada employs reporting and surveillance requirements equivalent to
those of the United States. Germ plasm from sheep in Canada can
likewise be utilized under the conditions set forth above without fear
of transmitting scrapie into the United States.
We are not making any specific changes on this issue with regard to
goats. This is because, as explained elsewhere in this document, we are
amending Sec. 92.405 to exempt goats under certain circumstances from
many of the requirements of this section. Together, we believe these
amendments impose the fewest restrictions on importers while still
protecting U.S. livestock from the importation of scrapie.
We are also amending Sec. 92.405 to clarify that sheep and goats
must be accompanied by a certificate stating that none of the female
sheep or goats in the flock or herd from which the sheep or goats will
be imported has been impregnated, during the 5 years immediately
preceding shipment of the sheep or goats to the United States, with
germ plasm from a flock or herd known to be infected with scrapie. This
requirement, along with restrictions on progeny of scrapie-infected
animals, is designed to prohibit importation into the United States of
animals most likely to be infected with scrapie. This requirement was
implied in our proposed regulations. However, as we are completely
revising Sec. 92.405 in this final rule, we are taking this opportunity
to include a clear statement of this requirement.
Compliance With International Agreements
One commenter stated that requiring a permit for sheep and goats
imported from Canada is ``contrary to the domestic regulatory position
currently in effect and, therefore, not consistent with the principles
of the Treaty of the World Trade Organization [WTO].'' The commenter
did not explain how our proposal is ``inconsistent.'' The same
commenter also stated that imposing a permit requirement would be
``counterproductive to our mutual commitment under the North American
Free Trade Agreement [NAFTA] Animal Health Technical Working Group to
facilitate trade through shared risk assessments and common import
policies.'' Again, the commenter did not
[[Page 17233]]
explain how our proposal is ``counterproductive.''
We do not agree with either assertion. If the comment is
interpreted literally, no WTO signatory country would be permitted to
substantively amend its regulations, because substantive amendments
would always be ``contrary to the domestic regulatory position
currently in effect.'' This is clearly not the intention of the WTO.
The WTO clearly maintains, in Article 2, the right of countries to take
any sanitary (animal) and phytosanitary (plant) measure necessary to
protect human, animal, and plant life and health. Furthermore, the WTO
requires, in Article 5, that signatory countries base their SPS, that
is, sanitary and phytosanitary requirements, on an assessment of the
risks. If, according to this assessment, the level of risk changes, a
country may adjust its requirements. We agree with the commenter that
NAFTA obligates Canada, Mexico and the United States to work towards
common import policies. However, that commitment is secondary to each
country's biosecurity needs.
In the case of Canada, there has been an increase in the level of
risk of transmitting scrapie into the United States. Until 1994, Canada
did not generally import animals or germ plasm from countries where
scrapie exists. The few importations that did occur were rare and
easily traced. However, this is no longer true. Canada now frequently
imports germ plasm from countries where the United States believes
scrapie exists. For example, germ plasm from France and the United
Kingdom has recently been imported into Canada. This has increased the
risk that scrapie will be transmitted into the United States by animals
and germ plasm from Canada. Our proposal to require that animals and
germ plasm from Canada be accompanied by an import permit is a response
to the increase in disease risk brought about by this change in
Canadian imports.
One commenter stated that we should, to fulfill the ``rights and
obligations of the United States as a signatory to the Sanitary/Phyto-
Sanitary (SPS) Chapter of the World Trade Organization, * * * recognize
the use of [germ plasm] from sources which provide equivalent
assurances to those achieved under the Voluntary Scrapie Flock
Certification Program.'' Implementation of this SPS concept (i.e.,
equivalency), depends, to a large extent, on an official recognition of
the exporting country's procedures or systems as being equivalent. We
believe our proposed regulations recognize the use of germ plasm from
equivalent sources. Sections 92.435, 98.10a, and 98.37 of the
regulations specifically provide for importation of sheep, goats, and
sheep germ plasm in programs determined by the Administrator of the
Animal and Plant Health Inspection Service (APHIS) to be equivalent to
the VSFCP. Countries must make an official request for U.S. recognition
of equivalency in these matters. If the Administrator determines that a
country's programs are equivalent, animals from that country will then
be allowed to be imported into the United States into a flock or herd
that participates in the VSFCP, and will be required to remain in such
a flock or herd until they reach Certified status. However, the time
required for them to reach Certified status will take into account the
time spent by them in an equivalent program in the country of origin.
Classification of Countries
One commenter suggested that the Republic of South Africa be
classified as scrapie-free. We are not making any changes based on this
comment at this time. Currently, Australia and New Zealand are
recognized by the United States and the World Health Organization as
scrapie-free countries. However, we are constantly reevaluating the
disease status of countries. If we determine that the status of any
country should be changed, we will publish a proposal for public
comment in the Federal Register.
Imports From Canada
One commenter stated that the disease situation in Canada has not
changed, and there is therefore no justification to require permits for
animals imported from Canada. Two commenters stated that import permits
for sheep and goats and germ plasm from sheep and goats from Canada are
unnecessary.
We have not made any changes based on this comment. As explained
above, until 1994, Canada did not generally import animals or germ
plasm from countries where scrapie exists. The few importations that
did occur were rare and easily traced. However, this is no longer true.
Canada now frequently imports germ plasm from countries where the
United States believes scrapie exists. To ensure that there is no risk
of transmitting scrapie to livestock in the United States, we need to
be able to trace the movements of this germ plasm and animals resulting
from the germ plasm. To obtain the information needed to make tracing
possible, we are requiring that animals and germ plasm from Canada be
accompanied by an import permit.
Several commenters stated that sheep and goats imported from Canada
should be handled differently under the regulations (i.e., be subject
to more stringent requirements) than sheep and goats imported from
Australia and New Zealand. Commenters also suggested that Canada could
serve as a ``back door'' into the United States for sheep and goats
from third countries.
We had proposed to exempt sheep and goats and germ plasm of sheep
and goats from Canada, Australia and New Zealand from proposed
Secs. 92.435, 98.10a, and 98.37, which would require such animals and
germ plasm to enter a flock or herd in the United States that
participates in the VSFCP. It is true that Australia and New Zealand
are free of scrapie, while Canada is not. However, the Canadian
government has an effective system to report, trace, and destroy
infected animals. 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.
For these reasons, we consider the risk of scrapie from animals and
germ plasm from Canada to be negligible, provided that certain
requirements are met. As explained above, we are requiring that
importers obtain an import permit for sheep, goats, and germ plasm from
Canada. The permit application process is designed to provide us with
the information we need to ensure that animals and germ plasm to be
imported meet our requirements and that they are not exposed or
infected with any disease or pest of concern. This includes not only
scrapie, but other diseases and pests. The permit requirement applies
to animals and germ plasm from all countries, including Australia and
New Zealand.
As to whether Canada could serve as a ``back door'' for infected
animals or germ plasm to enter the United States, we believe the permit
requirements imposed by our interim rule should close the ``back door''
that now exists. With these requirements in place, animals and germ
plasm from Canada may enter the United States only when
[[Page 17234]]
APHIS has been alerted to their health history. The application for an
import permit gives us specific information on the scrapie status of
animals and germ plasm to be imported, including the genetic history of
germ plasm donors. These requirements, along with certificate
requirements we proposed (see Secs. 92.405, 98.5, and 98.35 in this
final rule), will help ensure that animals and germ plasm are imported
into this country only under conditions designed to prevent the
importation and spread of scrapie. For example, pregnant sheep imported
from Canada will be required to enter VSFCP flocks if they have been
impregnated with germ plasm from any country other than Australia,
Canada, New Zealand or the United States.
One commenter also stated that it is ``unfair'' to treat subsequent
generations of animals differently, depending on whether they were born
in the United States or in Canada. We have carefully considered this
comment and we are not making any changes based on this comment. We
believe the commenter attempts to compare two dissimilar issues: The
treatment of animals to be imported into the United States and the
treatment of animals already in the United States. We believe these
issues require different approaches. Our intention in both the interim
rule and the proposed rule was to protect livestock in the United
States from being exposed to scrapie through imported animals and germ
plasm. The regulations in part 92 and 98 were not designed to reduce
the spread of scrapie within the United States. To accomplish that goal
we have established the VSFCP (see 9 CFR part 54). That program is
designed to encourage sheep and goats owners to eliminate scrapie
within their herds and flocks and thereby help prevent spread of the
disease within the United States. We believe the final regulations
contained in this document will encourage participation in the VSFCP.
Exemptions From Permit Requirement
Commenters suggested that certain animals or germ plasm be exempted
from the permit requirements contained in the interim rule. Suggestions
were made to exempt feeder lambs imported into the United States from
Canada and sheep and goats imported into the United States from Canada
for temporary exhibition. A suggestion was also made that sheep and
goats from flocks or herds in Canada where the only genetic material
imported into the flock or herd was semen or embryos should not be
subject to permit ``restrictions.''
We have carefully considered the suggestion that we exempt from the
permit requirement sheep and goats imported from Canada for temporary
exhibition in the United States. We need to know where these animals
are located and when and where they are moved after they enter the
United States. This information is necessary to help ensure that these
animals do not come into contact with livestock in the United States
under circumstances where they could transmit scrapie. We obtain this
information through the import permit process and therefore cannot
exempt these animals from this requirement.
We have also carefully considered the suggestion that we exempt
feeder lambs from Canada from the permit requirement. We agree that
feeder lambs are generally kept in confinement. However, we do not
agree that they pose no greater risk of transmitting scrapie than do
slaughter animals simply because they are normally kept in confinement.
On the contrary, we believe feeder lambs pose considerable risk. Feeder
lambs are usually shipped in mixed loads of ewe lambs and wether lambs.
At the time they cross into the United States, they have entered U.S.
commerce. Unlike wethers, which have no value other than slaughter, and
which in any case are unlikely to transmit scrapie, feeder ewes are
bought and sold for other purposes. Many are sold directly from
feedlots for use as breeding ewes. It is not illegal to sell and buy
feeder lambs for this purpose. Under these circumstances, we do not
believe that exempting feeder lambs from Canada from the permit
requirement is appropriate. We are therefore making no changes based on
this comment.
The comment requesting that permit ``restrictions'' not be placed
on animals from flocks or herds in Canada where the only genetic
material imported into the flock or herd was semen or embryos was also
carefully considered. It has been theorized that scrapie is not
transmitted through germ plasm. However, at this time there is
insufficient data or research to support this theory. While the topic
is under study, we believe the most prudent course is to monitor
through the VSFCP importation of animals from Canada that are from
flocks where semen or embryos have been imported into the flock from a
country other than Australia, Canada, New Zealand, or the United
States. Therefore, we are making no changes based on this comment.
Who May Issue Health Certificates
One commenter suggested that we simplify the proposed regulations
to allow licensed veterinarians to certify source flocks as free of
scrapie. We are not making any changes based on this comment. We
require government certification to ensure that the information on
certificates is reliable. If we allowed any licensed veterinarian to
certify animals, we would have no means of ensuring that the
information was accurate, and no recourse if it were not.
Additional Restrictions
Commenters also suggested that certain animals or germ plasm be
placed under greater restrictions than provided in the interim and
proposed requirements. The suggestions were to: (1) Prohibit
importation of live animals born in the same flock during the same
lambing or kidding season as progeny of scrapie-positive dams; (2)
require that sheep or goats remain for a minimum of 5 years in a flock
or herd participating in a disease prevention program; (3) restrict
movement of animals located in zoos in the United States; (4) require
identification of certain progeny; and (5) require necropsy of certain
imported animals that die before they have been in the United States
for 5 years.
We have determined that no changes are needed in response to the
suggestion that we prohibit importation of live animals born in the
same flock during the same lambing or kidding season as progeny of
scrapie-positive dams. These animals would be prohibited importation
under Sec. 92.405. That section requires that, with limited exceptions,
all ruminants intended for importation be accompanied by certificates.
The certificates for sheep and goats (except for those animals from
Australia, Canada, or New Zealand) must, in addition, specifically
state that the animals 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. Also under Sec. 92.405(a), ruminants, including
sheep or goats, would have to be accompanied by a certificate stating
that the animals are not in quarantine in the country of origin. This
is a new requirement in this final rule and is discussed below under
``Animals in quarantine in New Zealand.'' These requirements would have
the practical effect of prohibiting the importation of live animals
born in the same flock during the same lambing or kidding season as
progeny of scrapie-positive dams.
We have carefully considered the comment that we should require
sheep and goats to participate in a scrapie
[[Page 17235]]
control program for a minimum of 5 years. We have determined that no
changes are necessary in response to this comment. Except for limited
exemptions discussed elsewhere in this document, our requirements will
allow the unrestricted importation of sheep and goats and sheep germ
plasm only from countries which are free of scrapie or, in the case of
Canada, which employ reporting and surveillance requirements equivalent
to the United States and have regulations distinctly designed to
control the spread of scrapie within the country. All imported sheep
and goats and germ plasm of sheep and goats must be accompanied by a
certificate. With the exception of sheep and goats from Australia,
Canada, and New Zealand, the certificate accompanying animals must
specifically state that the sheep and goats have not been in contact
with other sheep and goats, during the 5 years previous to importation,
such that they could have been exposed to scrapie (see Sec. 92.405).
The certificate accompanying germ plasm must specifically state that,
in the case of embryos, the donor animals, and in the case of semen,
the donor sire, have not been in contact with other sheep and goats,
during the 5 years previous to collection of the germ plasm, such that
they could have been exposed to scrapie (see Secs. 98.5(b)(1) and
98.35(e)(1)). Except as explained later in this document (see the
discussion below headed ``Goats''), sheep, goats, and sheep germ plasm
from countries other than Canada, Australia, and New Zealand may enter
the United States only into a flock or herd participating in the VSFCP
(see Secs. 92.435, 98.10a and 98.37).1 These imported animals and
all first generation progeny resulting from the imported germ plasm
must remain in a participating flock or herd until the flock or herd
qualifies as ``Certified.'' If the flock or herd is a level ``C'' flock
or herd when the animals or germ plasm enter it, the process of
attaining ``Certified'' status takes a minimum of 5 years. Animals and
germ plasm may qualify to enter a flock or herd of higher status if
they have been imported from a source flock or herd participating in a
program which the Administrator has determined is equivalent to the
APHIS VSFCP. In that situation, the animals and any first generation
progeny resulting from the imported germ plasm may have to remain in a
participating flock or herd for fewer than 5 years. However, the
animals (or donor animals, in the case of imported germ plasm) would
have been in a participating flock or herd, or in an equivalent flock
or herd in the country of origin, for at least 5 years.
---------------------------------------------------------------------------
\1\ Note: Under this final rule, although it is not required
(except in one instance), sheep and goats and sheep germ plasm from
Australia, Canada, and New Zealand may be imported into the United
States into flocks and herds participating in the VSFCP. Likewise,
goat germ plasm, regardless of the country of origin, may be
imported into the United States into herds participating in the
VSFCP. These importations must, of course, meet the necessary
certification, permit, and quarantine requirements.
---------------------------------------------------------------------------
We are also not making any changes in response to the comment that
we place additional restrictions on the movement of animals from zoos
in the United States. Very few animals are imported to zoos, and those
which are imported are mainly from other zoos. Most zoo animals are
captive-bred and rarely moved from their home zoo. Under these
circumstances, we believe the disease risk presented by zoo animals to
be very slight. Under our current regulations, animals moving from a
zoo in the United States must be accompanied by a permit. The
information provided as part of the permit process--when and where and
under what conditions the animal is being moved--is sufficient to allow
us to trace the animal and ensure that it does not come into contact
with livestock under circumstances where it could transmit scrapie. We
believe these requirements are adequate to prevent the spread of
scrapie.
We have carefully considered the comment that we require progeny of
imported sheep and goats to be permanently identified, and that we
require a necropsy on animals which die less than 5 years after
importation. The ``Uniform Methods and Rules--Voluntary Scrapie Flock
Certification'' (UM&R), governs the VSFCP. The UM&R requires all
animals in the flock or herd, including animals born into the flock or
herd, to be permanently identified. The UM&R also requires that a
necropsy be performed on any animals that die under suspicious
circumstances. Sheep and goats imported into the United States under
this final rule, with certain exceptions, will be required to enter a
participating flock or herd. They would therefore be required to be
permanently identified. They would also have to be necropsied should
they die under suspicious circumstances. We believe these requirements
are adequate to prevent the spread of disease, should it occur. The
only sheep and goats imported into the United States not subject to
these requirements would be animals which are exempt from entering a
participating herd because they present no risk of disease. Each
category of exempt animals is explained elsewhere in this document, or
in the proposed rule.
Goats
Several commenters suggested that sheep and goats should be treated
differently under the regulations, as scrapie rarely occurs in goats.
We have carefully reviewed these comments and have determined that
some changes in the regulations with regard to goats are warranted. It
is true that goats are susceptible to scrapie. However, since 1947 in
the United States there have been only 5 reported cases of scrapie in
goats. All occurred in goats which had been in contact with scrapie-
infected sheep. As goats are not normally kept in contact with sheep,
and as the incubation period for scrapie can last up to 5 years, we
believe goats that have had no contact with sheep for a period of at
least 5 years would pose an insignificant risk of scrapie. Therefore,
under this final rule, goats will not be subject to Sec. 92.435 if they
are certified as having had no contact with sheep for at least the
previous 5 years. Further, goats from Australia, Canada, and New
Zealand would not be subject to Sec. 92.435 even if they have had
contact with sheep. Australia and New Zealand are free of scrapie.
Contact with sheep in New Zealand and Australia would therefore not
result in potential exposure to scrapie. Canada employs reporting and
surveillance requirements equivalent to those of the United States and
has regulations distinctly designed to control the spread of scrapie
within the country. Therefore, under the conditions set forth in this
final rule, we consider the risk of scrapie from goats in Canada to be
negligible.
Under this final rule, goats, regardless of the country of origin,
will not need to be certified as coming from a herd in which none of
the female goats has been impregnated, during the 5 years immediately
preceding shipment of the goats to the United States, with germ plasm
from a country other than Australia, Canada, New Zealand, or the United
States, or with germ plasm from a herd of unknown scrapie status. In
addition, goat germ plasm, regardless of the country of origin, will be
required to meet certification requirements, but will not be required
to be placed in a herd that participates in the VSFCP. We believe these
changes are warranted due to the low risk of transmitting scrapie posed
by goats.
Enforcing the Regulations
Several commenters expressed concern about enforcement of our
regulations. We are not making any changes based on these comments. We
believe these regulations are enforceable
[[Page 17236]]
and that we have adequate manpower to enforce them.
Animals in Quarantine in New Zealand
As pointed out by one commenter, there are sheep currently in
quarantine in New Zealand in a Scrapie Free Accreditation Program.
These sheep were imported into a New Zealand quarantine facility from a
country which the United States does not consider scrapie free. The
commenter asks what the ``status'' of these animals is under our
proposed rule.
Under this final rule, imported sheep must be accompanied by a
certificate issued under Sec. 92.405. Among other things, Sec. 92.405
requires the certificate to contain a statement that the sheep are not
in quarantine in the country of origin. Therefore, as long as the sheep
are in quarantine in New Zealand, they cannot be imported into the
United States.
As a matter of policy, we do not accept any ruminants from any
country which are in quarantine in the source country. To clarify that
this requirement applies to all ruminants from all countries, we are
amending Sec. 92.405 to include this requirement.
Clarify Regulations
Several commenters asked that different provisions of the proposed
regulations be clarified.
The first commenter of this group asked that we clarify whether we
are proposing to remove all import requirements for sheep from New
Zealand, or whether only some health certificate requirements would be
removed. As explained elsewhere in this document, we are removing
certain health certificate requirements that apply specifically to
sheep imported from New Zealand. In addition, depending upon the
circumstances of each individual animal, sheep from New Zealand would
not be required to enter a flock participating in the VSFCP. Import
permits would still need to be obtained for sheep from New Zealand, and
sheep from New Zealand would still need to be accompanied by a
certificate, and be quarantined upon arrival in the United States.
The second commenter asked us to clarify the meaning of
``suspect.'' By ``suspect,'' we mean any animal which displays signs
that could indicate it is infected with scrapie. There is no live
animal test for scrapie, and a positive diagnosis can be made only
after the animal dies.
Several commenters asked for clarification of ``progeny'' when the
term is used to refer to animals required to remain in a herd or flock
in the VSFCP. In this connection, we intended the term ``progeny'' to
mean only the first generation of animals resulting from natural
breeding, artificial insemination, or embryo transfer. To eliminate any
confusion as to the meaning of ``progeny,'' we are amending the
proposed regulations to read ``first generation progeny'' where
appropriate. It would be impractical to require progeny beyond the
first generation of animals to remain in a VSFCP herd or flock. All
VSFCP herds and flocks are maintained under surveillance. In addition,
except for animals moving to slaughter, all sheep and goats in
participating herds or flocks must be permanently identified, and herd
and flock owners must maintain certain records for a minimum of 5 years
after an animal dies or has otherwise been removed from the herd or
flock. These records, along with the individual animal identification,
allows us to trace animals which leave the herd or flock.
One commenter approved of the proposed requirement that progeny
resulting from germ plasm imported under the regulations remain in a
flock or herd participating in the VSFCP until that flock or herd
qualifies as ``Certified.'' The commenter asked if the proposed
requirement would apply to each importation of germ plasm. Our response
is yes, each importation of germ plasm would be subject to this
requirement.
Regulatory Flexibility Act Analysis
One commenter stated that the Regulatory Flexibility Act analysis
needed to clarify that it costs ``something'' to participate in the
VSFCP. Flock and herd owners who elect to participate in the VSFCP do
incur the costs of making and maintaining records on the animals in
their flock or herd. However, the program is completely voluntary, and
in most cases any recordkeeping costs would be inconsequential. In
addition, the increased value of animals in VSFCP herds and flocks
would offset any recordkeeping cost.
Questions
One commenter asked if Boer goats were bred especially to sell in
the United States. The term ``Boer goat'' was used in the 19th century
in South Africa to mean farm goat. The term was apparently used to
distinguish indigenous goats from imported Angora goats. The present-
day Boer goat, bred from native stock, was developed in the early 20th
century for meat production.
A couple of other commenters asked for clarification of the length
of time under our proposed rule that various animals would have to
remain in a flock or herd that is participating in the VSFCP. All
animals must remain in a flock or herd participating in the Program
until the flock or herd reaches ``Certified'' status. This usually
takes a minimum of 5 years. If a live animal is imported into the
United States, APHIS may give ``credit'' for years the animal's flock
or herd of origin participated in a program which the Administrator of
APHIS determines is equivalent to the VSFCP. If germ plasm is imported,
the first generation of animals resulting from that germ plasm must
remain in a participating flock in the United States until the flock
reaches ``Certified'' status.
Miscellaneous Comments
One commenter suggested that APHIS should certify animals for
importation only if they come from a country where scrapie exists.
According to the comment, animals from such countries would have some
immunity to the disease. Unfortunately, we are not aware of any
evidence demonstrating that animals can develop immunity to scrapie.
For this reason we are not making any changes based on this comment.
Miscellaneous
Since we published the proposed rule, the regulations in part 98,
subpart B, which concern embryos from countries where rinderpest or
foot-and-mouth disease (FMD) exists, have been amended (see 61 FR 15180
et seq., Docket No. 94-006-2). Among other things, the regulations were
amended so they apply not only to certain cattle embryos, but to all
ruminant embryos, including sheep and goat embryos. Therefore, we are
amending part 98, subpart B, at this time to add the same health
certificate requirements concerning scrapie as are included in this
final rule for sheep and goat embryos from countries free of rinderpest
and FMD. This amendment will make the requirements consistent in
subparts A and B of part 98. We are also amending the language in
Sec. 98.14(a), stating who may issue health certificates, to make it
consistent with similar language in Secs. 92.405, 98.5, and 98.35, as
we proposed.
We have also made minor, nonsubstantive changes to correct
punctuation and to maintain consistent wording. In addition, in some
parts of this final rule, we have set out current regulatory text that
did not appear in the proposed rule. This has been done in places where
less than an entire sentence appeared in the proposed rule
[[Page 17237]]
so that readers will have an easier time understanding the text.
We have also updated our Regulatory Flexibility Act analysis to
include the latest available data.
Therefore, based on the rationale set forth in the interim rule of
March 11, 1995, and in this document, we are affirming the provisions
of the interim rule without change. In addition, based on the rationale
set forth in the proposed rule of May 11, 1995, and in this document,
we are adopting the provisions of the proposed 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 purposes of Executive
Order 12866, and, therefore, has not been reviewed by the Office of
Management and Budget.
This rule requires an import permit for certain sheep and goats
imported into the United States from Canada and Mexico through a land
border port. In 1994, 28,357 sheep and 527 goats were imported from
Canada through a land border port; none were imported from Mexico
through a land border port. Over 97 percent of these sheep and goats
were wethers or were imported for immediate slaughter. Wethers and
sheep and goats imported through land border ports for immediate
slaughter continue to be exempt from the requirement for an import
permit. Based on these numbers, we expect that only 3 percent of sheep
and goats imported from Canada or Mexico through land border ports will
be required to be accompanied by an import permit under this rule.
APHIS does not charge a user fee specifically for the import permit.
However, APHIS does charge a user fee for import or entry services
provided at all ports of entry, including land border ports along the
United States-Mexico border. These user fees may need to be adjusted to
account for the cost of issuing import permits required under this
final rule. If this is necessary, a proposed rule will be published for
public comment in the Federal Register.
This rule also requires additional certification information for
sheep, goats, and germ plasm. However, no direct charges or user fees
will be assessed by APHIS as these certificates are issued in foreign
countries. The cost impact will be minimal.
In addition, under this rule: (1) Sheep and goat imports from New
Zealand will no longer be required to meet special health certification
requirements, and (2) regulations governing privately operated
quarantine facilities for imported sheep will apply to privately
operated quarantine facilities for imported goats as well. These
changes will not have a significant impact on importers or producers.
We believe any impact will be positive, in that the changes will
facilitate importation of sheep and goats.
Our economic analysis indicates that these amendments will have a
positive economic impact on U.S. importers of sheep, goats, and their
germ plasm, since importation into the United States will 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 1995, there were 82,120 agricultural 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. agricultural operations with goats.
We anticipate that participation in the VSFCP will increase, as
sheep germ plasm and breeding stock from countries other than
Australia, Canada, and New Zealand, will be allowed to be introduced
only into VSFCP 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 will 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 will be no increase in costs
for sheep and goat operations if they participate in the VSFCP.
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 12778
This rule has been reviewed under Executive Order 12778, 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
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this rule have been approved by the Office of Management
and Budget (OMB) under OMB control numbers 0579-0040 and 0579-0101.
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, we are adopting as a final rule, without change, the
interim rule that amended 9 CFR 92.400, 92.417, and 92.424, and that
was published at 60 FR 13898-13900 on March 15, 1995.
Accordingly, 9 CFR parts 92 and 98 are 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 continues 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 2.22, 2.80, and 371.2(d).
2. Section 92.400 is 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 is amended as follows:
a. By revising paragraphs (a) and (b) to read as set forth below.
b. By redesignating paragraph (c) as paragraph (d), and by adding a
new paragraph (c) to read as set forth below.
c. In newly designated paragraph (d), by removing the words
``paragraphs (a)
[[Page 17238]]
and (b)'' and adding in their place the words ``paragraphs (a), (b),
and (c)''.
d. By adding a parenthetical at the end of the section 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), 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, representing that the veterinarian issuing the
certificate was authorized to do so. The certificate shall state:
(1) That the ruminants have been kept in that country during the
last 60 days immediately preceding the date of shipment to the United
States, and that during this time the country has been entirely free
from foot-and-mouth disease, rinderpest, contagious pleuropneumonia,
and surra; provided, however, that for wild ruminants for exhibition
purposes, the certificate need specify only that the district of origin
has been free from the listed diseases; and provided further, that for
sheep and goats, with respect to contagious pleuropneumonia, the
certificate may specify only that the district of origin has been free
from this disease; and
(2) That the ruminants are not in quarantine in the country of
origin.
(b) Goats. (1) In addition to the statements required by paragraph
(a) of this section, the certificate accompanying goats intended for
importation from any part of the world must state:
(i) That none of the goats in the herd from which the 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;
(ii) That none of the female goats in the herd from which the goats
will be imported has been impregnated, during the 5 years immediately
preceding shipment of the goats to the United States, with germ plasm
from a herd known to be infected with scrapie;
(iii) That the veterinarian issuing the certificate has inspected
the goats in the herd from which the animals will be imported and found
the herd to be free of any evidence of infectious or contagious
disease; and
(iv) That as far as it is possible for the veterinarian who
inspects the animals to determine, none of the goats in the herd from
which the animals will be imported has been exposed to any infectious
or contagious disease during the 60 days immediately preceding shipment
to the United States.
(2) In addition, the certificate accompanying goats intended for
importation from any part of the world except Australia, Canada, and
New Zealand must state:
(i) That the goats have not been in any herd nor had contact with
sheep or goats that have been in any flock or herd where scrapie has
been diagnosed or suspected during the 5 years immediately prior to
shipment; and
(ii) That the goats have not had any contact with sheep during the
5 years immediately prior to shipment; provided that, this statement is
not required if the goats are imported in accordance with
Sec. 92.435(a) into a herd in the United States that participates in
the Voluntary Scrapie Flock Certification Program.
(c) Sheep. (1) In addition to the statements required by paragraph
(a) of this section, the certificate accompanying sheep intended for
importation from any part of the world must state:
(i) That none of the sheep in the flock from which the sheep 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;
(ii) That none of the female sheep in the flock from which the
sheep will be imported has been impregnated, during the 5 years
immediately preceding shipment of the sheep to the United States, with
germ plasm from a flock known to be infected with scrapie;
(iii) That the veterinarian issuing the certificate has inspected
the sheep in the flock from which the animals will be imported and
found the flock to be free of any evidence of infectious or contagious
disease; and
(iv) That as far as it is possible for the veterinarian who
inspects the animals to determine, none of the sheep in the flock from
which the animals will be imported has been exposed to any infectious
or contagious disease during the 60 days immediately preceding shipment
to the United States.
(2) In addition, the certificate accompanying sheep intended for
importation from any part of the world except Australia, Canada, and
New Zealand must state that the sheep have not been in any flock nor
had contact with sheep or goats that have been in any flock or herd
where scrapie has been diagnosed or suspected during the 5 years
immediately prior to shipment.
(3) In addition, the certificate accompanying sheep intended for
importation from Australia, Canada, and New Zealand must state that
none of the female sheep in the flock from which the sheep will be
imported has been impregnated, during the 5 years immediately preceding
shipment of the sheep to the United States, with germ plasm from a
country other than Australia, Canada, New Zealand, or the United
States, or from a flock of unknown scrapie status; provided that, this
statement is not required if the sheep are imported in accordance with
Sec. 92.435(a) into a flock in the United States that participates in
the Voluntary Scrapie Flock Certification Program.
* * * * *
(Approved by the Office of Management and Budget under control
number 0579-0040)
4. Section 92.411 is 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) is 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 is amended as follows:
a. By revising paragraph (a) to read as set forth below.
b. By adding a parenthetical at the end of the section to read as
set forth below.
[[Page 17239]]
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.
* * * * *
(Approved by the Office of Management and Budget under control
number 0579-0040)
7. Section 92.423 is amended as follows:
a. In paragraph (a), by revising the first sentence to read as set
forth below.
b. By revising paragraph (b) to read as set forth below.
c. By adding a parenthetical at the end of the section 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) stating that the animals have been in that country at
least 60 days immediately preceding the date of shipment to the United
States; that he or she has inspected the ruminants on the premises of
origin and found them free from evidence of any communicable disease;
and that, as far as it has been possible to determine, the ruminants
have not been exposed to any communicable disease during the preceding
60 days. * * *
(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
of the requirements of Sec. 92.405.
* * * * *
(Approved by the Office of Management and Budget under control
number 0579-0040)
8. Section 92.427 is amended as follows:
a. In paragraph (b)(1), by revising the first sentence to read as
set forth below.
b. By revising paragraphs (b)(2)(i) and (b)(2)(ii) to read as set
forth below.
c. In paragraph (c)(1), by revising the last sentence to read as
set forth below.
d. By revising paragraph (d)(1) introductory text, to read as set
forth below.
Sec. 92.427 Cattle from Mexico.
* * * * *
(b) Fever ticks. (1) Except as provided in paragraph (b)(2) of this
section, 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 at the time
of movement to the port of entry and found them free from any evidence
of communicable disease and that, as far as it has been possible to
determine, they have not been exposed to any such disease, including
splenetic, southern or tick fever, during the preceding 60 days and, if
shipped by rail or truck, the certificate shall further specify that
the cattle were loaded into clean and disinfected cars or trucks for
transportation direct to the port of entry. * * *
(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 and found them free
from fever ticks and any evidence of communicable disease, and that, as
far as it has been possible to determine, they have not been exposed to
any such disease, except splenetic, southern, or tick fever, during the
60 days immediately preceding their movement to the port of entry.
(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.
* * * * *
(c) * * *
(1) * * * However, cattle, including steers, that originated in
herds declared to be tuberculosis-accredited by the Government of
Mexico in accordance with that country's standards do not have to
comply with the other provisions of this paragraph if they are moved
directly to the U.S. port of entry from their herd of origin without
having commingled with cattle from any herd not so accredited enroute
to the port of entry, and they are accompanied by a health certificate,
issued in accordance with Sec. 92.405(a), stating that the cattle
originated in such a tuberculosis-accredited herd and identifying the
animals by official Mexican Ministry of Agriculture and Water Resources
(SARH) blue eartag and tattoo numbers.
* * * * *
(d) * * *
(1) Are accompanied by a certificate issued in accordance with
Sec. 92.405(a) stating:
* * * * *
9. Section 92.428 is amended as follows:
a. By revising paragraph (a) to read as set forth below.
b. By adding a parenthetical at the end of the section to read as
set forth below.
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 and
stating, if such sheep and 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.
* * * * *
(Approved by the Office of Management and Budget under control
number 0579-0040)
10. In Sec. 92.429, the first sentence is revised to read as
follows:
Sec. 92.429 Ruminants for immediate slaughter.
Ruminants, other than sheep and goats, may be imported from Mexico,
subject to the applicable provisions of Secs. 92.424, 92.425, 92.426,
and 92.427(b)(2) for immediate slaughter if accompanied by a
certificate issued in accordance with Sec. 92.405(a) and stating that
the veterinarian who issued the certificate has inspected the animals
in the herd from which the ruminants will be imported and found them
free of evidence of communicable disease, and that, so far as it has
been possible to determine, they have not been exposed to any such
disease common to animals of their kind during the preceding 60 days,
and if the ruminants are shipped by rail or truck, the certificate
shall further specify that the ruminants were loaded into cleaned and
disinfected cars or trucks for transportation directly to the port of
entry. * * *
Sec. 92.433 [Removed and Reserved]
11. Section 92.433, Sheep from New Zealand, is removed and
reserved.
Sec. 92.434 [Amended]
12. Section 92.434 is amended as follows:
a. By revising the heading to read as follows:
Sec. 92.434 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 19
and the reference to it as footnote 15.
[[Page 17240]]
c. In paragraph (d)(1), by redesignating footnote 20 and the
reference to it as footnote 16.
d. By adding the words ``or goats'' after the word ``sheep'' in the
following places:
i. In paragraph (a).
ii. In paragraph (b)(2)(i)(B).
iii. In paragraph (b)(2)(ii)(A).
iv. In paragraph (b)(2)(ii)(B).
v. In paragraph (b)(2)(ii)(D) each time it appears.
vi. In paragraph (b)(2)(ii)(E).
vii. In paragraph (b)(2)(ii)(F) each time it appears.
viii. In paragraph (b)(2)(iii)(G), after only the third time
``sheep'' appears.
ix. In paragraph (b)(2)(iii)(K).
x. In paragraph (b)(2)(iii)(L).
xi. In paragraph (b)(3)(i)(A)(5).
xii. In paragraph (b)(3)(ii).
xiii. In paragraph (b)(3)(iv), in the heading and text.
xiv. In paragraph (b)(3)(iv)(A), in the first sentence.
xv. In paragraph (b)(3)(iv)(B).
xvi. In paragraph (b)(3)(v) each time it appears.
xvii. In paragraph (b)(5) each time it appears.
xviii. In paragraph (c).
xix. In paragraph (d)(2) introductory text.
xx. In paragraph (d)(2)(iv).
xxi. In paragraph (d)(4).
e. by adding the words ``or goat'' after the word ``sheep'' in the
following places:
i. In paragraph (b)(2)(iii)(G), after the first and second time
``sheep'' appears.
ii. 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:
i. In paragraph (b)(2)(ii)(K).
ii. In paragraph (b)(2)(iii)(J).
iii. In paragraph (b)(3)(i)(A) introductory text.
iv. In paragraph (b)(3)(i)(A)(1).
v. In paragraph (b)(3)(i)(A)(3).
vi. In paragraph (b)(3)(ii).
13. A new Sec. 92.435 is added to read as follows:
Sec. 92.435 Sheep and goats.
(a) Except as provided in paragraph (b) of this section, all sheep
and goats imported into the United States must be 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:
(1) The flock or herd qualifies as a ``Certified'' flock or herd;
or
(2) The flock or herd owner has agreed, 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 qualifies
as a ``Certified'' flock or herd.
(b) The following sheep and goats are not subject to paragraph (a)
of this section:
(1) Goats intended for importation from Australia, Canada, or New
Zealand;
(2) Goats intended for importation from any country other than
Australia, Canada, or New Zealand, provided that such goats have not
had any contact with sheep during the 5 years immediately prior to
shipment, in accordance with Sec. 92.405(b)(2)(ii);
(3) Sheep intended for importation from Australia, Canada, or New
Zealand, provided that none of the female sheep in the flock from which
the sheep will be imported has been impregnated, during the 5 years
immediately preceding shipment of the sheep to the United States, with
germ plasm from a country other than Australia, Canada, New Zealand, or
the United States, in accordance with Sec. 92.405(c)(3);
(4) Wethers;
(5) Sheep or goats imported for immediate slaughter; and
(6) Wild sheep or goats imported for exhibition purposes to an
approved zoological park in accordance with Sec. 92.404(c).
(c) Sheep or goats may be imported under paragraph (a) 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.
(d) Sheep and goats may be imported under paragraph (a)(1) 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.
(e) Sheep and goats may be imported under paragraph (a)(2) 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.
(f) Sheep and goats imported under paragraph (a)(2) of this section
must be monitored for scrapie disease until the flock or herd qualifies
as a ``Certified'' flock or herd.
(g) Except for imported sheep and goats placed in Certifiable Class
C flocks or herds, the certificate accompanying sheep or goats imported
under paragraph (a) 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;
[[Page 17241]]
(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.
(Approved by the Office of Management and Budget under control
numbers 0579-0040 and 0579-0101)
PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN
14. The authority citation for part 98 continues to read as
follows:
Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 103-105,
111, 134a, 134b, 134c, 134d, 134f, 136, and 136a; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.2(d).
15. Section 98.2 is 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. Section 98.5 is amended as follows:
a. By redesignating the introductory text of the section and
paragraphs (a), (b), (c), (d), and (e) as paragraph (a) introductory
text and paragraphs (a)(1), (a)(2), (a)(3), (a)(4), and (a)(5),
respectively.
b. By revising newly designated paragraph (a) introductory text to
read as set forth below.
c. By adding a new paragraph (b) to read as set forth below.
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,
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 is added to read as
follows:
Sec. 98.10a Embryos from sheep in countries other than Australia,
Canada, and New Zealand.
(a) Except for embryos from sheep in Australia, Canada, or New
Zealand, embryos from sheep 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 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
(2) The embryos are transferred to females in a flock in the United
States that participates in the Voluntary Scrapie Flock Certification
Program (see 9 CFR part 54, subpart B) and the flock owner has agreed,
in writing, to maintain the flock, and all first generation 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, including all first generation
progeny resulting from embryos imported in accordance with this
section, qualifies as a ``Certified'' flock.
(b) Sheep embryos may be imported under paragraph (a) of this
section only if the importer provides the Voluntary Scrapie Flock
Certification Program identification number of the receiving flock as
part of the application for an import permit.
(c) Sheep 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 in the country of origin that participate in a program
determined by the Administrator to be equivalent to the Voluntary
Scrapie Flock Certification Program, and the flocks have been
determined by the Administrator to be at a level equivalent to
``Certified'' in the Voluntary Scrapie Flock Certification Program.
(d) Sheep embryos may be imported under paragraph (a)(2) of this
section only if they are transferred to animals in a Certifiable Class
C flock participating in the Voluntary Scrapie Flock Certification
Program; except, that if the embryos are the progeny of a dam and sire
whose flock 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 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 of the
dam or the flock of the sire, whichever one presents the greater risk.
(e) The flock to which the sheep embryos are transferred pursuant
to paragraph (a)(2) of this section must be monitored for scrapie
disease until the flock, and all first generation progeny resulting
from the embryos imported in accordance with this section, qualifies as
a ``Certified'' flock.
(f) Except for sheep embryos being placed in Certifiable Class C
flocks, the certificate accompanying sheep embryos imported under
paragraph (a) 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 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 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
[[Page 17242]]
what level the source flock 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 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 of
the embryos' sire and dam, including, but not limited to, the results
of diagnostic tests, especially histopathology tests, conducted on any
animals in the flock;
(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 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 first generation progeny resulting from embryos imported
under this section are subject to the requirements of 9 CFR part 54 and
all other applicable regulations.
(Approved by the Office of Management and Budget under control
numbers 0579-00040 and 0579-0101)
18. In part 98, subpart B, Sec. 98.14 is amended as follows:
a. By revising paragraph (a) to read as set forth below.
b. By redesignating paragraph (d) as paragraph (e).
c. By adding a new paragraph (d) to read as set forth below.
Sec. 98.14 Health certificate.
(a) Ruminant and swine embryos shall not be imported into the
United States unless they are 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, representing that the veterinarian issuing the
certificate was authorized to do so.
* * * * *
(d) The health certificate accompanying sheep or goat embryos
intended for importation from any part of the world shall, in addition
to the statements required by paragraph (b) 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.
* * * * *
19. In part 98, subpart B, a new Sec. 98.21 is added to read as
follows:
Sec. 98.21 Embryos from sheep in countries other than Australia,
Canada, and New Zealand.
Except for embryos from sheep in Australia, Canada, or New Zealand,
embryos from sheep may only be imported into the United States if they
comply with all applicable provisions of this subpart and with
Sec. 98.10a.
(Approved by the Office of Management and Budget under control
numbers 0579-0040 and 0579-0101)
20. In part 98, subpart C, Sec. 98.30 is 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.
* * * * *
21. Section Sec. 98.35 is amended as follows:
a. By revising paragraph (c) to read as set forth below.
b. By adding a new paragraph (e) to read as set forth below.
c. By adding a parenthetical at the end of the section to read as
set forth below.
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, 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.
(Approved by the Office of Management and Budget under control
number 0579-0040)
Sec. 98.36 [Amended]
22. In Sec. 98.36, paragraph (a), introductory text is amended by
adding the words ``is not a sheep or goat and'' immediately before the
colon.
23. A new Sec. 98.37 is added to read as follows:
Sec. 98.37 Semen from sheep in countries other than Australia, Canada,
and New Zealand.
(a) Except for semen from sheep in Australia, Canada, or New
Zealand, semen from sheep 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 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
(2) The semen is transferred to females in a flock in the United
States that participates in the Voluntary Scrapie Flock Certification
Program (see 9 CFR part 54, subpart B), and the flock
[[Page 17243]]
owner has agreed, in writing, to maintain the flock, and all first
generation 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, including all
first generation progeny resulting from semen imported in accordance
with this section, qualifies as a ``Certified'' flock.
(b) Sheep semen may be imported under paragraph (a) of this section
only if the importer provides the Voluntary Scrapie Flock Certification
Program identification number of the receiving flock as part of the
application for an import permit.
(c) Sheep semen may be imported under paragraph (a)(1) of this
section only if it comes from a donor animal in a flock 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 has been determined by the
Administrator to be at a level equivalent to ``Certified'' in the
Voluntary Scrapie Flock Certification Program.
(d) Sheep semen may be imported under paragraph (a)(2) of this
section only if it is transferred to animals in a Certifiable Class C
flock participating in the Voluntary Scrapie Flock Certification
Program; except, that if the semen comes from a donor animal whose
flock 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 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 of the donor animal.
(e) The flock to which the sheep semen is transferred pursuant to
paragraph (a)(2) of this section must be monitored for scrapie disease
until the flock, and all first generation progeny resulting from the
semen imported in accordance with this section, qualifies as a
``Certified'' flock.
(f) Except for sheep semen being placed in Certifiable Class C
flocks, the certificate accompanying the sheep semen imported under
paragraph (a) 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
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 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 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 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 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, including, but not limited to, the results of
diagnostic tests, especially histopathology tests, conducted on any
animals in the flock;
(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 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 first generation progeny resulting from semen imported
under this section are subject to the requirements of 9 CFR part 54 and
all other applicable regulations.
(Approved by the Office of Management and Budget under control
numbers 0579-0040 and 0579-0101)
Done in Washington, DC, this 9th day of April 1996.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-9266 Filed 4-18-96; 8:45 am]
BILLING CODE 3410-34-P