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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 92 and 98

[Docket No. 94-085-2]

Importation of Sheep and Goats and Germ Plasm From Sheep and

Goats

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the animal importation regulations

to revise who may issue health certificates for ruminants offered for

importation. This amendment would make the regulations more consistent

with regard to different animals and countries and would provide for an

alternative method of issuing health certificates. We are also

proposing to amend the animal importation regulations to revise the

conditions for importing sheep and goats. Likewise, we are proposing to

amend the animal germ plasm regulations to revise the conditions for

importing germ plasm from sheep and goats. These changes appear

necessary to prevent the importation of sheep and goats, and germ plasm

from sheep and goats, that may be affected with scrapie.

In addition, we are proposing to amend the animal importation

regulations to allow imported goats to be quarantined in privately

operated quarantine facilities that meet the requirements that now

apply to privately operated quarantine facilities for sheep. This

amendment would provide uniform rules for the quarantine of animals

which pose an identical disease risk.

Lastly, we are proposing to remove from the regulations health

certificate requirements with regard to the importation of sheep from

New Zealand. Since it appears that sheep from New Zealand pose no

greater disease risk than sheep from other countries, it is no longer

necessary to require such sheep to meet special health certificate

requirements.

COMMENTS: Consideration will be given only to comments received on or

before July 10, 1995.

ADDRESSES: Please send an original and three copies of your comments to

Docket No. 94-085-2, Animal and Plant Health Inspection Service, Policy

and Program Development, Regulatory Analysis and Development, 4700

River Road Unit 118, Riverdale, MD 20737-1228. Please state that your

comments refer to Docket No. 94-085-2. Comments received may be

inspected at USDA, room 1141, South Building, 14th Street and

Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m.,

Monday through Friday, except holidays. Persons wishing to inspect

comments are requested to call ahead on (202) 690-2817 to facilitate

entry into the comment reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Joyce Bowling, Staff Veterinarian,

or Dr. Roger Perkins, Staff Veterinarian, Animal and Plant Health

Inspection Service, Veterinary Services, National Center for Import and

Export, 4700 River Road Unit 38, Riverdale, MD 20737-1228. Telephone:

(301) 734-8170. [[Page 25152]]

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 92 govern the importation into the

United States of live animals, including sheep and goats, which are

regulated in part to prevent those infected with scrapie from

transmitting the disease to livestock in the United States. The

regulations in 9 CFR part 98 govern the importation into the United

States of germ plasm (semen and embryos), including germ plasm from

sheep and goats.

Scrapie is a progressive degenerative disease of the central

nervous system of sheep and goats. Scrapie occurs more often in certain

flocks and herds and certain bloodlines, indicating that these animals

may be genetically predisposed to become infected with or develop the

disease. Scrapie may also be transmitted by breeding and other physical

contact between animals.

The disease develops slowly, with an incubation period lasting up

to 5 years. The signs which then become manifest may include

nervousness, incoordination, slight muscular tremors, visible weight

loss, lack of luster in the animals' wool, and itching. Affected

animals become debilitated and die. There is no diagnostic test for

confirming the presence of the disease in a live animal or in germ

plasm. Therefore, presence of the disease cannot be detected until an

animal becomes clinically ill. There is no known treatment for the

disease. The impact of the disease in the United States could increase

if spread of the disease is not controlled, or if incidence of the

disease increases. For these reasons, our regulations are intended to

prevent the importation of animals and germ plasm that could transmit

scrapie, while controlling spread of the disease as it exists in the

United States and eliminating foci of infection.

The regulations in 9 CFR parts 92 and 98 are designed, in part, to

prevent the importation of scrapie-infected animals and germ plasm into

the United States. Other regulations concerning scrapie are contained

in 9 CFR parts 54 and 79. The regulations in part 54 deal with

controlling scrapie in the United States, and include, among other

things, the Voluntary Scrapie Flock Certification Program. The

regulations in part 79 concern identification of sheep and goats in the

United States that are or may be affected with scrapie, and restrict

the interstate movement of sheep and goats so as to prevent the

interstate spread of scrapie.

In this document we are proposing to amend the regulations in parts

92 and 98, as they pertain to the importation of sheep and goats and of

germ plasm from sheep and goats. In our discussion, we refer to the

regulations in both these parts of the CFR as ``the regulations.''

Proposed amendments to each part are discussed separately.

Changes to Part 92

Under part 92 regulations, sheep and goats may enter the United

States only if they meet certain conditions intended to prevent the

importation of sheep and goats that may be affected with scrapie. The

regulations have varying and sometimes inconsistent requirements

concerning the source of the animals, the length of time animals must

have been in scrapie-free locations, and whether they must be

accompanied by a health certificate.

We believe the regulations should be amended to better target the

animals most likely to be infected with scrapie and not unduly restrict

the animals which do not pose a significant threat of disease. We also

believe the regulations should be amended to clarify them and make them

more uniform. We are therefore proposing various amendments, which are

discussed individually below.

Certificates--Issuance

We are proposing to amend the regulations concerning certificates.

Under our current regulations, most ruminants imported into the United

States must be accompanied by a certificate containing health

information. Our existing regulations state that most certificates must

be issued by ``a salaried veterinary officer of the national government

of the country of origin,'' unless the animal is imported from Mexico,

in which case, as an alternative, the certificate can also be issued by

a veterinarian accredited by the National Government of Mexico and

endorsed by a full-time salaried veterinary officer of the National

Government of Mexico (see existing Sec. 92.405(a)). Other sections of

the regulations, concerning specific animals from specific countries,

contain slightly different requirements. For example, existing

Sec. 92.418(a), concerning cattle from Canada, states that a

certificate ``issued or endorsed by a salaried veterinarian of the

Canadian Government'' is required. Section 92.419(a), concerning sheep

and goats from Canada, states that a ``certificate either issued by a

salaried veterinarian of the Canadian Government or issued by a

veterinarian authorized by the Canadian Government to issue such

certificates and subsequently endorsed by a salaried veterinarian of

the Canadian Government'' is required. Section 92.423(a), concerning

ruminants from Central America and the West Indies, requires a

``certificate of a salaried veterinarian of the national government of

the country of origin.''

We believe our regulations should be as consistent as possible. We

also believe an alternative method of issuing certificates, such as is

available for ruminants imported from Mexico, should be available to

importers of ruminants from all countries. Such a change would not

affect the risk of spreading animal diseases to the United States.

Therefore, we are proposing to amend the certificate requirements in

Sec. 92.405(a) to state that certificates must be either: (1) Issued by

a salaried veterinary officer of the national government of the country

of origin, or, alternatively; (2) issued by a veterinarian accredited

or designated by the national government of the country of origin and

endorsed by a full-time salaried veterinary officer of the national

government of the country of origin, thereby representing that the

veterinarian issuing the certificate was authorized to do so.

Like the United States, Mexico accredits veterinarians to act on

behalf of the national government and perform functions required under

these regulations. Other countries ``designate'' veterinarians to

perform such work. For this reason, we propose to use both terms in our

regulations. In addition, we would amend existing Secs. 92.418(a),

92.419(a), 92.423(a), 92.427, 92.428(a), and 92.429 to remove the

requirements concerning who may issue a certificate and to refer

instead to the requirements in proposed Sec. 92.405(a). As explained

above, these amendments would not have any effect on disease risk.

These amendments would, however, allow importers more flexibility, and

would make the certificate issuance requirements uniform while

consolidating them in one section of the regulations.

Health Requirements

Section 92.405(b) contains requirements for certifying the health

status, with respect to scrapie, of sheep and goats intended for

importation into the United States. We propose to amend Sec. 92.405(b)

to require that the certificate accompanying the sheep or goats state

that:

(1) The sheep or goats have not been in any flock or herd nor had

contact with sheep or goats which have been in any flock or herd where

scrapie has been diagnosed or suspected during the 5 years immediately

prior to shipment;

(2) None of the female sheep or goats in the flock or herd from

which the [[Page 25153]] sheep or goats will be imported was

impregnated, during the 5 years immediately preceding shipment of the

sheep or goats to the United States, with embryos or semen from another

country other than the United States or from a flock or herd of unknown

scrapie status;

(3) The veterinarian issuing the certificate has inspected the

sheep or goats in the flock or herd from which the sheep or goats will

be imported and found the flock or herd to be free of clinical symptoms

of scrapie, and of any other infectious or contagious disease;

(4) None of the sheep or goats in the flock or herd from which the

sheep or goats will be imported is the progeny of a sire or dam that

has been affected with scrapie or that has produced offspring that have

been affected with scrapie; and

(5) As far as it is possible for the veterinarian who inspects the

animals to determine, none of the sheep or goats in the flock or herd

from which the sheep or goats will be imported has been exposed to

scrapie or any other infectious or contagious disease during the 60

days immediately preceding shipment to the United States.

For reasons explained below, these requirements appear necessary to

help ensure that animals to be imported into the United States are not

infected with scrapie and have not been exposed to scrapie.

Currently, our regulations require that sheep and goats come from a

scrapie-free ``district.'' This requirement was designed to ensure that

scrapie is not imported through sheep and goats originating in

districts where scrapie exists. However, because scrapie is apparently

transmitted through close physical contact, it is necessary to

determine the health status of the sheep or goats with which the

imported animal has had such contact. Therefore, we believe it is

unnecessary to require that animals come from a scrapie-free

``district,'' and our proposed regulations focus instead on the

animals' flock or herd.

Our regulations also currently require, in different sections, that

sheep and goats, to be eligible for importation into the United States,

must have been in scrapie-free locations for the preceding 3 years or

for the preceding 42 months (e.g., Secs. 92.405(b)(iii) and

92.419(a)(3)). However, an animal can be over 4 years of age before it

shows symptoms of scrapie. The age when signs first appear is variable.

We believe that 5 years, or 60 months, would be adequate to ensure that

an animal is not infected.

We are proposing to require that inspections be conducted by the

veterinarian who issues the certificate in order to ensure that the

animals are inspected by a veterinarian qualified to detect scrapie and

other diseases. The proposed requirements concerning the health of the

sire and dam, and other progeny of the sire and dam are intended to

help ensure that the animals to be imported are not infected with

scrapie. In addition, the proposed restriction on the use of embryos or

semen from other countries or from flocks or herds of unknown scrapie

status is intended to ensure that scrapie has not been introduced into

the flock or herd from which the animals are to be imported into the

United States.

We are proposing to use both ``flock'' and ``herd'', although the

terms are synonymous. This usage is standard in the livestock industry:

``flock'' is used in connection with sheep, and ``herd'' is used in

connection with goats. In connection with this proposed amendment, we

are also proposing to amend the definition of herd in Sec. 92.400. We

would make the wording identical to the definition of flock in

Sec. 54.1, which reads: ``All animals maintained on any single

premises; and all animals under common ownership or supervision on two

or more premises which are geographically separated, but among which

there is an interchange or movement of animals.'' We would also add the

same definition of flock to Sec. 92.400 and to the regulations in part

98. These changes are intended to make our regulations consistent and

avoid possible different interpretations. Later in this document, under

the heading Part 98, we discuss our proposal to add a definition of

flock to that part. Additional Requirements

To further ensure that imported sheep and goats do not transmit

scrapie to sheep and goats in the United States, we are proposing to

add a new set of requirements in proposed Sec. 92.435. Proposed

Sec. 92.435 would not apply to Australia, Canada, and New Zealand since

we do not believe sheep and goats imported from these countries pose a

risk of transmitting scrapie into the United States. Australia and New

Zealand are recognized by the United States Department of Agriculture

and the Office International des Epizooties (Office of International

Epizootics) as scrapie-free countries. Therefore, sheep and goats from

these countries pose no risk of importing scrapie into the United

States. Although Canada is not free of scrapie, Canada employs

reporting and surveillance requirements equivalent to the United

States. Such requirements include, but are not limited to: (1)

Reporting incidence of scrapie; (2) restriction of animal movement

within the country because of scrapie; (3) identification of flocks or

herds with scrapie; and (4) depopulation mechanisms for scrapie (i.e.,

removal of high-risk animals). Canadian regulations are distinctly

designed to control the spread of scrapie within that country.

Furthermore, APHIS and Canadian animal health authorities closely

coordinate scrapie control efforts. Under these circumstances, it

appears unnecessary and unproductive to impose the requirements

proposed in new Sec. 92.435 upon sheep and goats imported from

Australia, Canada or New Zealand.

With certain exceptions, we propose to allow sheep or goats to be

imported into the United States only if they meet one of the following

two conditions: (1) They are placed in a flock or herd that

participates in the Voluntary Scrapie Flock Certification Program and

qualifies at the ``Certified'' level; or (2) they are placed in a flock

or herd that participates in the Voluntary Scrapie Flock Certification

Program and the owner of the flock or herd has agreed in writing to

continue to do so until the flock or herd meets the conditions for

being ``Certified.''

The Voluntary Scrapie Flock Certification Program (see 9 CFR part

54, subpart B, Secs. 54.10-54.13 and the ``Uniform Methods and Rules--

Voluntary Scrapie Flock Certification Program'' (UM&R))1 is

designed to reduce the incidence and control the spread of scrapie. It

was established after several years of discussion and input from

industry representatives, members of the public, and other affected and

interested parties. Among other things, it establishes an official

tamper-proof identification system for sheep and goats in the Program.

It also requires that participating animals be regularly inspected and

that flock and herd owners keep records of sales and dispersals. The

long-term goal of the Program is to reduce the incidence of scrapie in

the United States.

\1\Individual copies of the UM&R may be obtained from the Animal

and Plant Health Inspection Service, Veterinary Services, National

Center for Import and Export, 4700 River Road Unit 38, Riverdale, MD

20737-1231.

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Herds and flocks participating in the Voluntary Scrapie Flock

Certification Program are classified according to the risk of their

being infected with scrapie. Each herd receives an identifying number.

From greatest to least risk (referred to also as from lowest to highest

level), the classes are: Certifiable Class C, Certifiable Class B,

Certifiable Class A, and Certified.

Under proposed Sec. 92.435, prospective importers would have to

provide the Volunteer Scrapie Flock Certification

[[Page 25154]] Program identification number of the receiving flock or

herd as part of their permit application. A permit would not be issued

unless the permit application identified a flock or herd to receive the

imported animals. Wethers, sheep and goats imported for immediate

slaughter, and wild sheep and goats imported to an approved zoological

park for exhibition purposes would be exempt from this requirement.

These animals, provided they have met all applicable permit,

certificate, and other requirements of the regulations, would not

present any significant risk of transmitting scrapie.

Under option 1, only animals from flocks or herds in the country of

origin which were participating in a program that is equivalent to our

Voluntary Scrapie Flock Certification Program, and which were at a

level equivalent to the ``Certified'' level, could qualify to be

imported. Animals imported into ``Certified'' flocks or herds could be

removed from the flocks or herds at any time, at the option of the

owner. This is in accordance with the terms of the Voluntary Scrapie

Flock Certification Program, which allows participants to leave the

program at any time. Animals in ``Certified'' flocks or herds pose

little or no risk of transmitting scrapie.

Likewise, under option 2, receiving flocks and herds would have to

participate in the Voluntary Scrapie Flock Certification Program.

However, owners of receiving flocks and herds would have to agree, in

writing, to abide by the requirements of the Program for a minimum of 5

years, or until the flock or herd reached ``Certified'' status. At that

time, animals in the flock or herd could be removed to any location.

Prior to that, animals could only be removed to other flocks or herds

which have met the requirements of Sec. 92.435 for receiving sheep or

goats imported under option 2 and which have reached the same

certification level or are at a lower level (i.e., are at an equal or

greater risk). For example, sheep and goats in receiving herds at the

Certifiable Class B level could be moved to other complying herds at

the Certifiable Class B or Class C level. They could not be moved to

flocks or herds at the Certified or Certifiable Class A level.

Under current requirements of the Voluntary Scrapie Flock

Certification Program, such animals would have to remain in a

``Certifiable'' flock or herd until the flock or herd achieved

``Certified'' status, which would vary from 2 years (animals entering

Certifiable Class A herds), 4 years (animals entering Certifiable Class

B herds), and 5 years (animals entering Certifiable Class C herds). If

the classification status of the receiving herd fell after the animals

were added to the flock or herd, the animals would have to remain in

that flock or herd, or another complying flock or herd of equal or

lower status (i.e., greater risk), until the flock or herd achieved

``Certified'' status.

Animals imported under option 2 would have to be placed in

Certifiable Class C flocks or herds, unless: (1) They came from flocks

or herds that were participating in a program in the country of origin

that was equivalent to our Voluntary Scrapie Flock Certification

Program; and (2) the flock or herd was participating at a level

equivalent to ``Certifiable Class B'' or ``Certifiable Class A.'' The

animals would then be placed in either a certifiable Class B or A flock

or herd, depending upon the level in the country of origin.

In addition to meeting the requirements of Sec. 92.405, the

certificate accompanying all sheep and goats imported under proposed

Sec. 92.435, except sheep and goats placed in Certifiable Class C

flocks or herds, would have to state that: ``The animals identified on

this certificate have been monitored by a salaried veterinary officer

of [name of country of origin], for [number of months], in the same

source flock or herd which had been determined by the Administrator,

APHIS, prior to the exportation of these animals to the United States,

to be equivalent to [certification level] of the Voluntary Scrapie

Flock Certification Program authorized under 9 CFR Part 54, subpart

B.''

The Administrator of the Animal and Plant Health Inspection Service

(APHIS) would determine, in advance of the importation, whether a

country from which the animals are to be imported has a scrapie control

program equivalent to our Voluntary Scrapie Flock Certification

Program. The Administrator also would determine, in advance of the

importation, the participation status of the flock or herd. Prospective

importers who wish to import sheep and goats into flocks or herds in

the United States would have to supply certain information to APHIS, at

the time they apply for an import permit, in order for the

Administrator to make these determinations. We intend to recommend that

prospective importers apply for permits no less than 1 month prior to

the anticipated date of importation.

The information provided would have to include the name, title, and

address of a knowledgeable official in the veterinary services of the

country of origin, and details of scrapie control programs in the

country of origin, including information on disease surveillance and

border control activities and the length of time these activities have

been in effect. We would also require information concerning additions

to the herd or flock from which the sheep or goats would be imported

during the 5 years immediately preceding shipment to the United States.

Additionally, we would require any available data concerning disease

incidence, during the 5 years immediately preceding shipment, in the

flock or herd from which the sheep or goats would be imported,

including, but not limited to, the results of diagnostic tests,

especially histopathology tests, conducted on any animals in the flock

or herd. The prospective importer would also be asked to include

information concerning the health of other ruminants, flocks, and herds

with which the imported sheep and goats, and with which animals in the

sheep or goats' flock or herd, might have had physical contact over the

5 years immediately preceding shipment of the sheep or goats to the

United States, and a description of the type and frequency of the

physical contact. This information appears necessary to make a

determination of the disease status of the flock or herd from which the

sheep or goats would be imported. The Administrator could require

additional information as needed in specific cases to make a final

determination.

The Administrator would determine that a program was equivalent

only if the requirements of the program equalled or exceeded the

management practices required under our Voluntary Scrapie Flock

Certification Program. We have determined, based on experience, that if

these practices are followed, they effectively ensure that flocks and

herds remain free of scrapie. Sheep and goats imported from flocks and

herds that meet equivalent standards are unlikely to have been exposed

to scrapie.

Any violation of the import requirements set forth in proposed

Sec. 92.435 would be a basis for an enforcement action, including, but

not limited to, the removal from the United States of the animals

imported.

Miscellaneous Amendments

We also propose to remove Sec. 92.433 and to amend Sec. 92.411.

Section 92.433 concerns importation of sheep from New Zealand;

Sec. 92.411 contains cross-references to Sec. 92.433 and sheep from New

Zealand.

The provisions of current Sec. 92.433 first became effective on

June 10, 1988 (see 53 FR 21794-21809, Docket 88-057). At that time,

there appeared to be [[Page 25155]] considerable interest in importing

large numbers of sheep from New Zealand. It was anticipated that more

sheep would be imported from New Zealand than could be handled at

existing Federal quarantine facilities. The regulations were therefore

amended to provide for privately operated quarantine facilities for

sheep, including sheep from New Zealand, and to add health

certification requirements concerning sheep from New Zealand.

We propose to remove the health certification requirements. Not

only are large numbers of sheep from New Zealand not currently imported

into the United States, but our experience has shown that sheep

imported from New Zealand do not pose any disease or pest risk not also

posed by sheep from other countries. We therefore believe that

requiring sheep from New Zealand to meet special health certification

requirements is unnecessary. We are therefore proposing to remove

Sec. 92.433. In addition, we would amend Sec. 92.411(b) to remove

references to Sec. 92.433 and sheep from New Zealand.

Section 92.411(b)(1) also provides that certain ruminants imported

into the United States must be quarantined for not less than 15 days.

We propose to amend Sec. 92.411 to require quarantine of not less than

30 days for all ruminants that must be quarantined under the

regulations. A minimum of 30 days, which is already the minimum time

required for cattle, is necessary to ensure that there is adequate time

to complete required testing.

We also propose to amend Sec. 92.434. This section contains

requirements for privately operated quarantine facilities for sheep. We

would amend this section so that the same requirements would apply to

privately operated quarantine facilities for goats. Goats are normally

raised under similar conditions and are subject to the same diseases

and pests as sheep. They therefore pose the same disease risks as

sheep. Under these circumstances, we believe goats can be safely

handled in privately operated quarantine facilities that meet the same

requirements that apply to privately operated quarantine facilities for

sheep.

Changes to Part 98

The regulations in part 98 for importation of embryos from

countries free of rinderpest and foot-and-mouth disease are contained

in subpart A. These regulations require, among other things, that

embryos may be imported if the donor sire and donor dam meet all the

requirements they would have to meet under part 92 for a health

certificate for importation into the United States (Sec. 98.3 (d) and

(e)). The regulations in part 98 for importation of animal semen are

contained in subpart C. These regulations do not contain provisions for

health certification of the donor sire, except when the animal semen is

imported from a country where rinderpest or foot-and-mouth disease

exists (Sec. 98.34(c)(1)(i)). We are proposing to amend the regulations

in part 98, subparts A and C, to add specific requirements concerning

the importation of germ plasm from sheep and goats, to prevent

importations of germ plasm that could transmit scrapie.

We are proposing that sheep and goat germ plasm from any country be

accompanied by a health certificate either issued by a salaried

veterinary officer of the national government of the country of origin,

or issued by a veterinarian accredited or designated by the national

government of the country of origin and endorsed by a full-time

salaried veterinary officer of the national government of the country

of origin, thereby representing that the veterinarian issuing the

certificate was authorized to do so.

The certificate would have to state that:

(1) The semen donor, or the embryos' sire and dam, have not been in

any flock or herd nor had contact with sheep or goats which have been

in any flock or herd where scrapie has been diagnosed or suspected

during the 5 years prior to the date of collection of the semen or

embryos;

(2) The semen donor, or the embryos' sire and dam, showed no

evidence of scrapie at the time of collection of the semen or embryos;

(3) Scrapie has not been suspected nor confirmed in any progeny of

the embryos' donor dam; and

(4) The parents of the semen donor, or the embryos' sire and dam,

are not, nor were not, affected with scrapie.

These requirements appear necessary to help ensure that imported

sheep and goat germ plasm is not affected with scrapie. Although it

would be useful to confirm the absence of scrapie in the progeny of

semen donors, we are not proposing to require this information.

Obtaining it would be impracticable, as semen donors may have thousands

of progeny. Consequently, as provided above in (3), we are only

requiring the certificate to state such information with regard to the

progeny of the embryos' donor dam.

To further ensure that sheep and goat germ plasm imported into the

United States does not transmit scrapie to sheep and goats in the

United States, we are proposing additional requirements for sheep and

goat germ plasm from all countries except Australia, Canada, and New

Zealand. As explained above, we do not believe sheep, goats, or germ

plasm thereof, pose a risk of transmitting scrapie into the United

States if imported from australia, Canada, or New Zealand. Australia

and New Zealand are recognized by the United States Department of

Agriculture and the Office of International Epizootics as scrapie-free

countries. Therefore, germ plasm from sheep and goats in these

countries poses no risk of importing scrapie into the United States.

Although Canada is not free of scrapie, Canada employs reporting and

surveillance requirements equivalent to the United States. Such

requirements include, but are not limited to: (1) Reporting incidence

of scrapie; (2) restriction of animal movement within the country

because of scrapie; (3) identification of flocks or herds with scrapie;

and (4) depopulation mechanisms for scrapie (i.e., removal of high-risk

animals). Canadian regulations are distinctly designed to control the

spread of scrapie within that country. Furthermore, APHIS and Canadian

animal health authorities closely coordinate scrapie control efforts.

Under these circumstances, it appears unnecessary and unproductive to

impose restrictions on the germ plasm of sheep and goats which is

imported from Australia, Canada, or New Zealand.

We are proposing to allow the germ plasm to be imported into the

United States only if it is transferred into females in a flock or herd

in the United States that meets one of the following two conditions:

(1) The flock or herd participates in the Voluntary Scrapie Flock

Certification Program and qualifies at the ``Certified'' level; or (2)

the flock or herd participates in the Voluntary Scrapie Flock

Certification Program, and the owner of the flock or herd has agreed in

writing to continue to do so until the flock or herd, including all

progeny resulting from the imported germ plasm, meets the conditions

for being ``Certified.''

Prospective importers would be required to provide the Volunteer

Scrapie Flock Certification Program identification number of the

receiving flock or herd as part of the application for an import permit

for the germ plasm.

Under option 1, only germ plasm from animals in flocks or herds in

the country of origin which were participating in a program that is

equivalent to our Voluntary Scrapie Flock Certification Program, and

which were at a level equivalent to the ``Certified'' level, could

qualify to be imported. Animals in the receiving flock or herd,

including animals born of females who received [[Page 25156]] the

imported germ plasm, could be removed from the flock or herd at any

time, at the option of the owner. This is in accordance with the terms

of the Voluntary Scrapie Flock Certification Program, which allows

participants to leave the program at any time. Animals in ``Certified''

flocks or herds pose little or no risk of transmitting scrapie.

Germ plasm imported under option 2 would have to be transferred to

females in Certifiable Class C flocks or herds, unless: (1) The germ

plasm came from animals in a flock or herd that was participating in a

program in the country of origin that was equivalent to our Voluntary

Scrapie Flock Certification Program; and (2) the flock or herd was

participating at a level equivalent to ``Certifiable Class B'' or

``Certifiable Class A.''

Animals in ``Certifiable'' flocks or herds, including all progeny

from the imported germ plasm, would have to remain in the flock or

herd, or a flock or herd of the same or lower status (i.e., greater

risk), until the flock or herd met the conditions for being

``Certified.'' (See the explanation given under ``Changes to Part 92,

Additional Requirements'')

In addition, the certificate accompanying all embryos imported

under options 1 or 2, except embryos transferred to a female in a flock

or herd at the Certifiable Class C level, would have to state that:

``The embryos identified on this certificate are the progeny of a dam

and sire that have been monitored by a salaried veterinary officer of

[name of country of origin], for [number of months], in the same source

flock or herd which had been determined by the Administrator, APHIS,

prior to the exportation of the embryos to the United States, to be

equivalent to [certification level (of dam or sire) presenting greater

risk] of the Voluntary Scrapie Flock Certification Program authorized

under 9 CFR part 54, subpart B.'' The certificate accompanying all

semen imported under options 1 or 2, except semen transferred to a

female in a flock or herd at the Certifiable Class C level, would have

to state that: ``The semen identified on this certificate has been

collected from a sire that has been monitored by a salaried veterinary

officer of [name of country of origin], for [number of months], in the

same source flock or herd which had been determined by the

Administrator, APHIS, prior to the exportation of the semen to the

United States, to be equivalent to [certification level] of the

Voluntary Scrapie Flock Certification Program authorized under 9 CFR

part 54, subpart B.''

The Administrator would determine, in advance of the importation,

whether a country from which the germ plasm is to be imported has a

scrapie control program equivalent to our Voluntary Scrapie Flock

Certification Program. The Administrator would also determine, in

advance of the importation, the participation status of the flock or

herd. Prospective importers who wish to import sheep or goat germ plasm

into flocks or herds in the United States would have to supply certain

information to APHIS at the time they apply for an import permit. We

intend to recommend that prospective importers apply for permits no

less than 1 month prior to the anticipated date of importation.

The information provided would have to include the name, title, and

address of a knowledgeable official in the veterinary services of the

country of origin, and the details of scrapie control programs in the

country of origin, including information on disease surveillance and

border control activities and the length of time that these activities

have been in effect. We would also require information concerning

additions to the herd or flock of the embryos' sire and dam, and the

flock or herd of the semen donor, during the 5 years preceding

collection of the germ plasm. Additionally, we would require any

available data concerning disease incidence during the 5 years

preceding collection of the germ plasm in the flock or herd of the

embryos' sire and dam, and the flock or herd of the semen donor,

including, but not limited to, the results of any diagnostic tests,

especially histopathology tests, conducted on any animals in the flock

or herd. The prospective importer would also be asked to include

information concerning the health of other ruminants, flocks, and herds

with which the embryos' sire and dam, the semen donor, the animals in

the flock or herd of the embryos' sire and dam, and the animals in the

flock or herd of the semen donor, might have had physical contact over

the 5 years preceding collection of the germ plasm, and a description

of the type and frequency of the physical contact. This information

appears necessary to make a determination of the disease status of the

flock or herd of the embryos' sire and dam, and the flock or herd of

the semen donor. The Administrator could require additional information

as needed in specific cases to make a final determination.

The Administrator would determine that a program was equivalent

only if the requirements of the program equalled or exceeded the

management practices required under our Voluntary Scrapie Flock

Certification Program. We have determined, based on experience, that if

these practices are followed, they effectively ensure that flocks and

herds remain free of scrapie. Germ plasm from animals in flocks or

herds that meet equivalent standards is unlikely to present a risk of

transmitting scrapie.

Any violations of the requirements set forth above for the

importation of sheep or goat germ plasm would be a basis for an

enforcement action, including, but not limited to, the removal from the

United States of the imported germ plasm and any resulting animals.

These amendments are all consistent with amendments we are

proposing to part 92, as explained above. We believe our proposed

requirements are necessary to help ensure that imported sheep and goat

germ plasm and animals resulting from the imported germ plasm, are not

affected with scrapie.

Miscellaneous

We are proposing to add a definition of ``flock'' to part 98,

subparts A and C. As explained earlier, ``flock'' is used in the

industry in connection with sheep, and ``herd'' is used in connection

with goats. The regulations in part 98 do not include a definition of

``flock.''

We are also proposing to make minor nonsubstantive, editorial

amendments to the regulations in both parts 92 and 98.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been reviewed under Executive Order 12866.

The rule has been determined to be not significant for purposes of

Executive Order 12866, and, therefore, has not been reviewed by the

Office of Management and Budget.

Our economic analysis indicates that the proposed amendments would

have a positive economic impact on U.S. importers of sheep, goats and

their germ plasm, since importation into the United States would be

easier. The current requirements surrounding the importation of sheep,

goats, and their germ plasm are confusing and considered by many

interested parties to be too restrictive.

In 1993, there were 98,230 operations with sheep in the United

States. Under Small Business Administration criteria, 99 percent of

them are believed to be small entities (having less than $0.5 million

in gross annual receipts for domestic producers and fewer than 100

employees for importers). No information is available on the number or

U.S. operations with goats. [[Page 25157]]

If the proposed amendments are adopted, additional certification

information would be required under the new rules for sheep, goats, and

germ plasm. However, no direct charges or user fees would be assessed

by APHIS. The cost impact would be minimal.

We anticipate that participation in the Voluntary Scrapie Flock

Certification Program will increase if these amendments are adopted, as

germ plasm and breeding stock from countries other than Australia,

Canada, and New Zealand, would be allowed to be introduced only into

Program flocks and herds. Because of the termination by the U.S.

government of the subsidy to wool and mohair growers, the expected

shift from wool and mohair production to meat production in sheep and

goats should create additional demand for breeding stock and germ plasm

imports. Wider participation in the Program would better safeguard the

U.S. sheep and goat industry against a scrapie outbreak. Participation

requires operations to maintain records on their animals, although it

is likely that potential importers of breeding animals or germ plasm

are already keeping such records. There would be no increase in costs

for sheep and goat operations if they participate in the Voluntary

Scrapie Flock Certification Program.

In addition, if the proposed rule is adopted: (1) Sheep and goat

imports from New Zealand would no longer be required to meet special

health certification requirements, and (2) regulations governing

privately operated quarantine facilities for imported sheep would apply

to privately operated quarantine facilities for imported goats as well.

These changes would not have a significant impact on importers or

producers. We believe any impact would be positive, in that the changes

would facilitate importation of sheep and goats.

Under these circumstances, the Administrator of the Animal and

Plant Health Inspection Service has determined that this action would

not have a significant economic impact on a substantial number of small

entities.

Executive Order 12778

This proposed rule has been reviewed under Executive Order 12778,

Civil Justice Reform. If this proposed rule is adopted: (1) All State

and local laws and regulations that are inconsistent with this rule

will be preempted; (2) no retroactive effect will be given to this

rule; and (3) administrative proceedings will not be required before

parties may file suit in court challenging this rule.

Paperwork Reduction Act

In accordance with the Paperwork Reduction Act of 1980 (44 U.S.C.

3501 et seq.), the information collection or recordkeeping requirements

included in this proposed rule will be submitted for approval to the

Office of Management and Budget. Please send written comments to the

Office of Information and Regulatory Affairs, OMB, Attention: Desk

Officer for APHIS, Washington, DC 20503. Please send a copy of your

comments to: (1) Docket No. 94-085-2, Animal and Plant Health

Inspection Service, Policy and Program Development, Regulatory Analysis

and Development, 4700 River Road Unit 118, Riverdale, MD 20737-1228,

and (2) Clearance Officer, OIRM, USDA, room 404-W, 14th Street and

Independence Avenue SW., Washington, DC 20250.

List of Subjects

9 CFR Part 92

Animal diseases, Imports, Livestock, Poultry and poultry products,

Quarantine, Reporting and recordkeeping requirements.

9 CFR Part 98

Animal diseases, Imports.

Accordingly, 9 CFR parts 92 and 98 would be amended as follows:

PART 92--IMPORTATION OF CERTAIN ANIMALS AND POULTRY AND CERTAIN

ANIMAL AND POULTRY PRODUCTS; INSPECTION AND OTHER REQUIREMENTS FOR

CERTAIN MEANS OF CONVEYANCE AND SHIPPING CONTAINERS THEREON

1. The authority citation for part 92 would continue to read as

follows:

Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 102-105,

111, 114a, 134a, 134b, 134c, 134d, 134f, 135, 136, and 136a; 31

U.S.C. 9701; 7 CFR 2.17, 2.51, and 371.2(d).

2. Section 92.400 would be amended by revising the definition of

herd and by adding a definition for flock, in alphabetical order, to

read as follows:

Sec. 92.400 Definitions.

* * * * *

Flock. A herd.

Herd. All animals maintained on any single premises; and all

animals under common ownership or supervision on two or more premises

which are geographically separated, but among which there is an

interchange or movement of animals.

* * * * *

3. Section 92.405 would be amended as follows:

a. In paragraph (a), by revising the first sentence, up to and

including the words ``stating that'', to read as set forth below.

b. By revising paragraph (b) to read as set forth below.

Sec. 92.405 Certificate for ruminants.

(a) All ruminants intended for importation from any part of the

world, except as provided in Secs. 92.418(a), 92.419(a), 92.423(c), and

92.428(d) of this part, shall be accompanied by a certificate issued by

a full-time salaried veterinary officer of the national government of

the country of origin, or issued by a veterinarian designated or

accredited by the national government of the country of origin and

endorsed by a full-time salaried veterinary officer of the national

government of the country of origin, thereby representing that the

veterinarian issuing the certificate was authorized to do so. The

certificate shall state that * * *

(b) The certificate accompanying sheep and goats intended for

importation from any part of the world shall, in addition to the

statements required by paragraph (a) of this section, state that:

(1) The sheep or goats have not been in any flock or herd nor had

contact with sheep or goats which have been in any flock or herd where

scrapie has been diagnosed or suspected during the 5 years immediately

prior to shipment;

(2) None of the female sheep or goats in the flock or herd from

which the sheep or goats will be imported was impregnated, during the 5

years immediately preceding shipment of the sheep or goats to the

United States, with embryos or semen from another country other than

the United States or from a flock or herd of unknown scrapie status;

(3) The veterinarian issuing the certificate has inspected the

sheep or goats in the flock or herd from which the sheep or goats will

be imported and found the flock or herd to be free of clinical symptoms

of scrapie, and of any other infectious or contagious disease;

(4) None of the sheep or goats in the flock or herd from which the

sheep or goats will be imported is the progeny of a sire or dam that

has been affected with scrapie or that has produced offspring that have

been affected with scrapie; and

(5) As far as it is possible for the veterinarian who inspects the

animals to determine, none of the sheep or goats in the flock or herd

from which the sheep or goats will be imported has been exposed to

scrapie or any other infectious or contagious disease during the 60

days immediately preceding shipment to the United States.

* * * * * [[Page 25158]]

4. Section 92.411 would be revised to read as follows:

Sec. 92.411 Quarantine requirements.

(a) Except for cattle from Central America and the West Indies, and

except for ruminants from Canada and Mexico, all ruminants imported

into the United States shall be quarantined for not less than 30 days

counting from the date of arrival at the port of entry.

(b) Wild ruminants shall be subject, during their quarantine, to

such inspections, disinfection, blood tests, or other tests as may be

required by the Administrator to determine their freedom from disease.

5. In Sec. 92.418, paragraph (a) would be revised to read as

follows:

Sec. 92.418 Cattle from Canada.

(a) Health certificates. Except for cattle imported for immediate

slaughter in accordance with Sec. 92.420, cattle intended for

importation from Canada shall be accompanied by a certificate issued in

accordance with Sec. 92.405(a). The certificate shall state that the

cattle have been inspected and found to be free from any evidence of

communicable disease and that, as far as can be determined, they have

not been exposed to any such disease during the preceding 60 days.

Cattle found unqualified upon inspection at the port of entry will be

refused entry into the United States.

* * * * *

6. Section 92.419 would be amended by revising paragraph (a) to

read as follows:

Sec. 92.419 Sheep and goats from Canada.

(a) Except for sheep and goats imported for immediate slaughter in

accordance with Sec. 92.420, sheep and goats intended for importation

from Canada shall be accompanied by a certificate issued in accordance

with Sec. 92.405 (a) and (b).

* * * * *

7. Section 92.423 would be amended as follows:

a. In paragraph (a), by revising the first sentence, up to and

including the words ``country of origin'', to read as set forth below.

b. By revising paragraph (b) to read as set forth below.

Sec. 92.423 Ruminants from Central America and the West Indies.

(a) Ruminants intended for importation from Central America and the

West Indies, except as provided in paragraph (c) of this section, must

be accompanied by a certificate issued in accordance with

Sec. 92.405(a) * * *

(b) The certificate accompanying sheep and goats intended for

importation from Central America and the West Indies must, in addition

to the statements required by paragraph (a) of this section, meet all

the requirements of Sec. 92.405(b).

* * * * *

Sec. 92.427 [Amended]

8. Section 92.427 would be amended as follows:

a. In paragraph (b)(1), by revising the first sentence, up to and

including the words ``inspected the said cattle'', to read as set forth

below.

b. By revising paragraph (b)(2)(i), up to and including the words

``inspected the cattle'', to read as set forth below.

c. By revising paragraph (b)(2)(ii) to read as set forth below.

d. In paragraph (c)(1), the last sentence, by removing the words

``, issued by a salaried veterinarian of the Government of Mexico, or

issued by a veterinarian accredited by the National Government of

Mexico and endorsed by a full-time salaried veterinary officer of the

National Government of Mexico, thereby representing that the

veterinarian issuing the certificate was authorized to so do,'' and

adding in their place ``issued in accordance with Sec. 92.405(a) and''.

e. By revising paragraph (d)(1), introductory text, to read as set

forth below.

f. In paragraph (e)(2), by removing the words ``by a salaried

veterinarian of the Government of Mexico, or issued by a veterinarian

accredited by the National Government of Mexico and endorsed by a full-

time salaried veterinary officer of the National Government of Mexico,

thereby representing that the veterinarian issuing the certificate was

authorized to do so,'' and adding in their place ``in accordance with

Sec. 92.405(a) and''.

Sec. 92.427 Cattle from Mexico.

* * * * *

(b) Fever ticks. (1) Except as provided in paragraph (b)(2), all

cattle intended for importation from Mexico, for purposes other than

immediate slaughter, shall be accompanied by a certificate issued in

accordance with Sec. 92.405(a), and showing that the veterinarian

issuing the certificate inspected the cattle * * *

(2) * * *

(i) The cattle shall be accompanied by a certificate issued in

accordance with Sec. 92.405(a), and showing that the veterinarian

issuing the certificate has inspected the cattle * * *

(ii) The cattle shall be shown by a certificate issued in

accordance with Sec. 92.405(a) to have been dipped in a tickicidal dip

within 7 to 12 days before being offered for entry.

* * * * *

(d) * * *

(1) Are accompanied by a certificate issued in accordance with

Sec. 92.405(a) stating:

* * * * *

9. Section 92.428 would be amended by revising paragraph (a) to

read as follows:

Sec. 92.428 Sheep and goats and wild ruminants from Mexico.

(a) Sheep and goats intended for importation from Mexico shall be

accompanied by a certificate issued in accordance with Sec. 92.405 (a)

and (b) and stating, if such sheep or goats are shipped by rail or

truck, that such animals were loaded into cleaned and disinfected cars

or trucks for transportation direct to the port of entry.

Notwithstanding such certificate, such sheep and goats shall be

detained as provided in Sec. 92.427(a) and shall be dipped at least

once in a permitted scabies dip under supervision of an inspector.

* * * * *

Sec. 92.429 [Amended]

10. In Sec. 92.429, the first sentence would be amended by removing

the words ``issued by a salaried veterinarian of the Government of

Mexico, or issued by a veterinarian accredited by the National

Government of Mexico and endorsed by a full-time salaried veterinary

officer of the National Government of Mexico, thereby representing that

the veterinarian issuing the certificate was authorized to do so,

stating'' and adding in their place the words ``issued in accordance

with Sec. 92.405 (a) and (b) and stating that the veterinarian who

issued the certificate has inspected the animals in the herd from which

the ruminants will be imported,''.

Sec. 92.433 [Removed and Reserved]

11. Section 92.433, Sheep from New Zealand, would be removed and

reserved.

Sec. 92.434 [Amended]

12. Section 92.434 would be amended as follows:

a. By revising the heading to read ``Standards for approval of

privately operated quarantine facilities for sheep or goats, and

handling procedures for the importation of sheep or goats.''

b. In paragraph (b), introductory text, by redesignating footnote

20 and the reference to it as footnote 16. [[Page 25159]]

c. In paragraph (d)(1), by redesignating footnote 21 and the

reference to it as footnote 17.

d. By adding the words ``or goats'' after the word ``sheep'' in the

following places:

1. In paragraph (a).

2. In paragraph (b)(2)(i)(B).

3. In paragraph (b)(2)(ii)(A).

4. In paragraph (b)(2)(ii)(B).

5. In paragraph (b)(2)(ii)(D).

6. In paragraph (b)(2)(ii)(E).

7. In paragraph (b)(2)(ii)(F).

8. In paragraph (b)(2)(iii)(G), after only the third time ``sheep''

appears.

9. In paragraph (b)(2)(iii)(K).

10. In paragraph (b)(2)(iii)(L).

11. In paragraph (b)(3)(i)(A)(5).

12. In paragraph (b)(3)(ii).

13. In paragraph (b)(3)(iv), in the heading and text.

14. In paragraph (b)(3)(iv)(A), in the first sentence.

15. In paragraph (b)(3)(iv)(B).

16. In paragraph (b)(3)(v).

17. In paragraph (b)(5).

18. In paragraph (c).

19. In paragraph (d)(2).

20. In paragraph (d)(2)(iv).

21. In paragraph (d)(4).

e. by adding the words ``or goat'' after the word ``sheep'' in the

following places:

1. In paragraph (b)(2)(iii)(G), after the first and second time

``sheep'' appears.

2. In paragraph (b)(3)(iv)(A), in the second sentence.

f. By removing the word ``sheep-holding'' and adding the words

``sheep- or goat-holding'' in the following places:

1. In paragraph (b)(2)(ii)(K).

2. In paragraph (b)(2)(iii)(J).

3. In paragraph (b)(3)(i)(A).

4. In paragraph (b)(3)(i)(A)(1).

5. In paragraph (b)(3)(i)(A)(3).

6. In paragraph (b)(3)(ii).

13. A new Sec. 92.435 would be added to read as follows:

Sec. 92.435 Sheep and goats from countries other than Australia,

Canada, and New Zealand.

(a) Except for sheep and goats from Australia, Canada, or New

Zealand, sheep and goats may only be imported into the United States if

they meet all applicable provisions of this subpart and one of the

following conditions:

(1) The animals are wethers, or sheep or goats imported for

immediate slaughter, or wild sheep or goats imported for exhibition

purposes to an approved zoological park in accordance with

Sec. 92.404(c); or

(2) The animals are placed in a flock or herd in the United States

that participates in the Voluntary Scrapie Flock Certification Program

(see 9 CFR part 54, subpart B) and qualifies as a ``Certified'' flock

or herd; or

(3) The animals are placed in a flock or herd in the United States

that participates in the Voluntary Scrapie Flock Certification Program

(see 9 CFR part 54, subpart B), and the flock or herd owner must agree,

in writing, to maintain the flock or herd in compliance with all

requirements of the Voluntary Scrapie Flock Certification Program until

the flock or herd would qualify as a ``Certified'' flock or herd.

(b) Sheep or goats may be imported under paragraphs (a)(2) or

(a)(3) of this section only if the importer provides the Voluntary

Scrapie Flock Certification Program identification number of the

receiving flock or herd as part of the application for an import

permit.

(c) Sheep and goats may be imported under paragraph (a)(2) of this

section only if they come from a flock or herd in the country of origin

that participates in a program determined by the Administrator to be

equivalent to the Voluntary Scrapie Flock Certification Program, and

the flock or herd has been determined by the Administrator to be at a

level equivalent to ``Certified'' in the Voluntary Scrapie Flock

Certification Program.

(d) Sheep and goats may be imported under paragraph (a)(3) of this

section only if they are placed in a Certifiable Class C flock or herd

participating in the Voluntary Scrapie Flock Certification Program;

Except, that if the sheep and goats come from a flock or herd in the

country of origin that participates in a program determined by the

Administrator to be equivalent to the Voluntary Scrapie Flock

Certification Program, then the sheep and goats may be placed in a herd

or flock in the United States which would be classified at a level

equivalent to or lower (i.e., at a greater risk) than the certification

level, as determined by the Administrator, of the flock or herd from

which the sheep or goats are to be imported.

(e) Sheep and goats imported under paragraph (a)(3) of this section

must be monitored for scrapie disease until the flock or herd qualifies

as a ``Certified'' flock or herd.

(f) Except for imported sheep and goats being placed in Certifiable

Class C flocks or herds, the certificate accompanying sheep or goats

imported under paragraphs (a)(2) or (a)(3) of this section must contain

the following statement: ``The animals identified on this certificate

have been monitored by a salaried veterinary officer of [name of

country of origin], for [number of months], in the same source flock or

herd which had been determined by the Administrator, APHIS, prior to

the exportation of these animals to the United States, to be equivalent

to [certification level] of the Voluntary Scrapie Flock Certification

Program authorized under 9 CFR part 54, subpart B.''

(1) The Administrator will determine, based upon information

supplied by the importer, whether the flock or herd from which the

animals are to be imported participates in a program in the country of

origin that is equivalent to the Voluntary Scrapie Flock Certification

Program, and if so, at what level the source flock or herd should be

classified.

(2) In order for the Administrator to make a determination, the

importer must supply the following information with the application for

an import permit no less than 1 month prior to the anticipated date of

importation:

(i) The name, title, and address of a knowledgeable official in the

veterinary services of the country of origin;

(ii) The details of scrapie control programs in the country of

origin, including information on disease surveillance and border

control activities and the length of time such activities have been in

effect;

(iii) Any available information concerning additions, within the 5

years immediately preceding shipment to the United States, to the flock

or herd from which the sheep and goats will be imported;

(iv) Any available data concerning disease incidence, within the 5

years immediately preceding shipment to the United States, in the flock

or herd from which the sheep or goats are to be imported, including,

but not limited to, the results of diagnostic tests, especially

histopathology tests, conducted on any animals in the flock or herd;

(v) Information concerning the health, within the 5 years

immediately preceding shipment to the United States, of other

ruminants, flocks, and herds with which the imported sheep and goats,

and with which animals in the sheep or goats' flock or herd might have

had physical contact, and a description of the type and frequency of

such physical contact; and

(vi) Any other information requested by the Administrator in

specific cases as needed to make a determination.

PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN

14. The authority citation for part 98 would be revised to read as

follows:

Authority: 7 U.S.C. 1622; 21 U.S.C. 103, 104, 105, 111, 134a,

134b, 134c, 134d, 134f, 136, and 136a; 31 U.S.C. 9701; 7 CFR 2.17,

2.51, and 371.2(d).

[[Page 25160]] 15. Section 98.2 would be amended by adding

definitions for flock and herd, in alphabetical order, to read as

follows:

Sec. 98.2 Definitions.

* * * * *

Flock. A herd.

Herd. All animals maintained on any single premises; and all

animals under common ownership or supervision on two or more premises

which are geographically separated, but among which there is an

interchange or movement of animals.

* * * * *

16. In Sec. 98.5, paragraphs (a), (b), (c), (d), and (e) would be

redesignated as paragraphs (a)(1), (a)(2), (a)(3), (a)(4), and (a)(5);

the introductory text would be designated as paragraph (a) and revised

to read as follows; and a new paragraph (b) would be added to read as

follows:

Sec. 98.5 Health certificate.

(a) Except as provided in subpart B of this part, an animal embryo

shall not be imported into the United States unless it is accompanied

by a certificate issued by a full-time salaried veterinary officer of

the national government of the country of origin, or issued by a

veterinarian designated or accredited by the national government of the

country of origin and endorsed by a full-time salaried veterinary

officer of the national government of the country of origin, thereby

representing that the veterinarian issuing the certificate was

authorized to do so. The certificate shall state:

* * * * *

(b) The certificate accompanying sheep or goat embryos intended for

importation from any part of the world shall, in addition to the

statements required by paragraph (a) of this section, state that:

(1) The embryos' sire and dam have not been in any flock or herd

nor had contact with sheep or goats which have been in any flock or

herd where scrapie has been diagnosed or suspected during the 5 years

prior to the date of collection of the embryos;

(2) The embryos' sire and dam showed no evidence of scrapie at the

time the embryos were collected;

(3) Scrapie has not been suspected nor confirmed in any progeny of

the embryos' donor dam; and

(4) The parents of the embryos' sire and dam are not, nor were not,

affected with scrapie.

17. In part 98, subpart A, a new Sec. 98.10a would be added to read

as follows:

Sec. 98.10a Embryos from sheep and goats in countries other than

Australia, Canada, and New Zealand.

(a) Except for embryos from sheep and goats in Australia, Canada,

or New Zealand, embryos from sheep and goats may only be imported into

the United States if they comply with all applicable provisions of this

subpart and one of the following conditions:

(1) The embryos are transferred to females in a flock or herd in

the United States that participates in the Voluntary Scrapie Flock

Certification Program (see 9 CFR part 54, subpart B) and qualifies as a

``Certified'' flock or herd; or

(2) The embryos are transferred to females in a flock or herd in

the United States that participates in the Voluntary Scrapie Flock

Certification Program (see 9 CFR part 54, subpart B) and the flock or

herd owner must agree, in writing, to maintain the flock or herd, and

all progeny resulting from embryos imported in accordance with this

section, in compliance with all requirements of the Voluntary Scrapie

Flock Certification Program until the flock or herd, including all

progeny resulting from embryos imported in accordance with this

section, would qualify as a ``Certified'' flock or herd.

(b) Sheep or goat embryos may be imported under paragraphs (a)(1)

or (a)(2) of this section only if the importer provides the Voluntary

Scrapie Flock Certification Program identification number of the

receiving flock or herd as part of the application for an import

permit.

(c) Sheep and goat embryos may be imported under paragraph (a)(1)

of this section only if they are the progeny of a dam and sire that are

part of flocks or herds in the country of origin that participates in a

program determined by the Administrator to be equivalent to the

Voluntary Scrapie Flock Certification Program, and the flocks or herds

have been determined by the Administrator to be at a level equivalent

to ``Certified'' in the Voluntary Scrapie Flock Certification Program.

(d) Sheep and goat embryos may be imported under paragraph (a)(2)

of this section only if they are transferred to animals in a

Certifiable Class C flock or herd participating in the Voluntary

Scrapie Flock Certification Program: Except, that if the embryos are

the progeny of a dam and sire whose flock or herd in the country of

origin participates in a program determined by the Administrator to be

equivalent to the Voluntary Scrapie Flock Certification Program, then

the embryos may be placed in a herd or flock in the United States which

would be classified at a level equivalent to or lower (i.e., at a

greater risk) than the certification level, as determined by the

Administrator, of either the flock or herd of the dam or the flock or

herd of the sire, whichever one presents the greater risk.

(e) The flock or herd to which the sheep and goat embryos are

transferred pursuant to paragraph (a)(2) of this section, must be

monitored for scrapie disease until the flock or herd, and all progeny

resulting from the embryos imported in accordance with this section,

qualifies as a ``Certified'' flock or herd.

(f) Except for sheep and goat embryos being placed in Certifiable

Class C flocks or herds, the certificate accompanying sheep or goat

embryos imported under paragraphs (a)(1) or (a)(2) of this section must

contain the following statement: ``The embryos identified on this

certificate are the progeny of a dam and sire that have been monitored

by a salaried veterinary officer of [name of country of origin], for

[number of months], in the same source flock or herd which had been

determined by the Administrator, APHIS, prior to the exportation of

these embryos to the United States, to be equivalent to [certification

level (of dam or sire) presenting greater risk] of the Voluntary

Scrapie Flock Certification Program authorized under 9 CFR part 54,

subpart B.''

(1) The Administrator will determine, based upon information

supplied by the importer, whether the flock or herd of the embryos' dam

and sire participates in a program in the country of origin that is

equivalent to the Voluntary Scrapie Flock Certification Program, and if

so, at what level the source flock or herd would be classified.

(2) In order for the Administrator to make a determination, the

importer must supply the following information with the application for

an import permit, no less than 1 month prior to the anticipated date of

importation:

(i) The name, title, and address of a knowledgeable official in the

veterinary services of the country of origin;

(ii) The details of scrapie control programs in the country of

origin, including information on disease surveillance and border

control activities and the length of time such activities have been in

effect;

(iii) Any available information concerning additions, within the 5

years immediately preceding collection of the embryos, to the flock or

herd of the embryos' sire and dam;

(iv) Any available data concerning disease incidence, within the 5

years immediately preceding collection of the embryos, in the flock or

herd of the [[Page 25161]] embryos' sire and dam, including, but not

limited to, the results of diagnostic tests, especially histopathology

tests, conducted on any animals in the flock(s) or herd(s);

(v) Information concerning the health, within the 5 years

immediately preceding collection of the embryos, of other ruminants,

flocks, and herds with which the embryos' sire and dam and the flock or

herd of the embryos' sire and dam might have had physical contact, and

a description of the type and frequency of the physical contact; and

(vi) Any other information requested by the Administrator in

specific cases as needed to make a determination.

(g) All progeny resulting from embryos imported under this section

are subject to the requirements of 9 CFR part 54 and all other

applicable regulations.

18. In part 98, subpart C, Sec. 98.30 would be amended by adding

definitions for flock and herd, in alphabetical order, to read as

follows:

Sec. 98.30 Definitions.

* * * * *

Flock. A herd.

Herd. All animals maintained on any single premises; and all

animals under common ownership or supervision on two or more premises

which are geographically separated, but among which there is an

interchange or movement of animals.

* * * * *

19. In Sec. 98.35, paragraph (c) would be revised and a new

paragraph (e) would be added to read as follows:

Sec. 98.35 Declaration, health certificate, and other documents for

animal semen.

* * * * *

(c) All animal semen intended for importation into the United

States shall be accompanied by a health certificate issued by a full-

time salaried veterinary officer of the national government of the

country of origin, or issued by a veterinarian designated or accredited

by the national government of the country of origin and endorsed by a

full-time salaried veterinary officer of the national government of the

country of origin, thereby representing that the veterinarian issuing

the certificate was authorized to do so.

* * * * *

(e) The certificate accompanying sheep or goat semen intended for

importation from any part of the world shall, in addition to the

statements required by paragraph (d) of this section, state that:

(1) The semen donor has not been in any flock or herd nor had

contact with sheep or goats which have been in any flock or herd where

scrapie has been diagnosed or suspected during the 5 years prior to the

date of collection of the semen;

(2) The semen donor showed no evidence of scrapie at the time the

semen was collected; and

(3) The parents of the semen donor are not, nor were not, affected

with scrapie.

Sec. 98.36 [Amended]

20. In Sec. 98.36, paragraph (a), introductory text, would be

amended by adding the words ``is not a sheep or goat and'' immediately

before the colon.

21. A new Sec. 98.37 would be added to read as follows:

Sec. 98.37 Semen from sheep and goats in countries other than

Australia, Canada, and New Zealand.

(a) Except for semen from sheep and goats in Australia, Canada, and

New Zealand, semen from sheep and goats may only be imported into the

United States if it complies with all applicable provisions of this

subpart and one of the following conditions:

(1) The semen is transferred to females in a flock or herd in the

United States that participates in the Voluntary Scrapie Flock

Certification Program (see 9 CFR part 54, subpart B) and qualifies as a

``Certified'' flock or herd; or

(2) The semen is transferred to females in a flock or herd in the

United States that participates in the Voluntary Scrapie Flock

Certification Program (see 9 CFR part 54, subpart B), and the flock or

herd owner must agree, in writing, to maintain the flock or herd, and

all progeny resulting from semen imported in accordance with this

section, in compliance with all requirements of the Voluntary Scrapie

Flock Certification Program until the flock or herd, including all

progeny resulting from semen imported in accordance with this section,

would qualify as a ``Certified'' flock or herd.

(b) Sheep or goat semen may be imported under paragraphs (a)(1) or

(a)(2) of this section only if the importer provides the Voluntary

Scrapie Flock Certification Program identification number of the

receiving flock or herd as part of the application for an import

permit.

(c) Sheep or goat semen may be imported under paragraph (a)(1) of

this section only if it comes from a donor animal in a flock or herd in

the country of origin that participates in a program determined by the

Administrator to be equivalent to the Voluntary Scrapie Flock

Certification Program, and the flock or herd has been determined by the

Administrator to be at a level equivalent to ``Certified'' in the

Voluntary Scrapie Flock Certification Program.

(d) Sheep or goat semen may be imported under paragraph (a)(2) of

this section only if it is transferred to animals in a Certifiable

Class C flock or herd participating in the Voluntary Scrapie Flock

Certification Program; Except, that if the semen comes from a donor

animal whose flock or herd in the country of origin participates in a

program determined by the Administrator to be equivalent to the

Voluntary Scrapie Flock Certification Program, then the semen may be

used in a herd or flock in the United States which would be classified

at a level equivalent to or lower (i.e., at greater risk) than the

certification level, as determined by the Administrator, of the flock

or herd of the donor animal.

(e) The flock or her to which the sheep and goat semen is

transferred pursuant to paragraph (a)(2) of this section, must be

monitored for scrapie disease until the flock or herd, and all progeny

resulting from the semen imported in accordance with this section,

qualifies as a ``Certified'' flock or herd.

(f) Except for sheep and goat semen being placed in Certifiable

Class C flocks or herds, the certificate accompanying the sheep or goat

semen imported under paragraphs (a)(1) or (a)(2) of this section must

contain the following statement: ``The semen identified on this

certificate has been collected from a sire that has been monitored by a

salaried veterinary officer of [name of country of origin], for [number

of months], in the same source flock or herd which had been determined

by the Administrator, APHIS, prior to the exportation of the semen to

the United States, to be equivalent to [certification level] of the

Voluntary Scrapie Flock Certification Program authorized under 9 CFR

part 54, subpart B.''

(1) The Administrator will determine, based upon information

supplied by the importer, whether the donor animal's flock or herd

participates in a program in the country of origin that is equivalent

to the Voluntary Scrapie Flock Certification Program, and if so, at

what level the source flock or herd would be classified.

(2) In order for the Administrator to make a determination, the

importer must supply the following information with the application for

an import permit, no less than 1 month prior to the anticipated date of

importation: [[Page 25162]]

(i) The name, title, and address of a knowledgeable official in the

veterinary services of the country of origin;

(ii) The details of scrapie control programs in the country of

origin, including information on disease surveillance and border

control activities and the length of time these activities have been in

effect;

(iii) Any available information concerning additions, within the 5

years immediately preceding collection of the semen, to the flock or

herd of the semen donor;

(iv) Any available data concerning disease incidence, within the 5

years immediately preceding collection of the semen in the donor

animal's flock or herd, including, but not limited to, the results of

diagnostic tests, especially histopathology tests, conducted on any

animals in the flock or herd;

(v) Information concerning the health, within the 5 years

immediately preceding collection of the semen, of other ruminants,

flocks, and herds with which the donor animal and the donor animal's

flock or herd might have had physical contact, and a description of the

type and frequency of the physical contact; and

(vi) Any other information requested by the Administrator in

specific cases as needed to make a determination.

(g) All progeny resulting from semen imported under this section

are subject to the requirements of 9 CFR part 54 and all other

applicable regulations.

Done in Washington, DC, this 3rd day of May 1995.

George O. Winegar,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 95-11561 Filed 5-10-95; 8:45 am]

BILLING CODE 3410-34-P