Importation of Sheep and Goats and Germ Plasm From Sheep and Goats

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

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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

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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.

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\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