Scrapie in Sheep and Goats; Interstate Movement Restrictions and Indemnity Program

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 54 and 79

[Docket No. 97-093-2]

RIN 0579-AA90

Scrapie in Sheep and Goats; Interstate Movement Restrictions and

Indemnity Program

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to restrict the interstate movement of sheep

and goats from States that do not follow effective flock management

practices for scrapie. We also propose to require animal identification

for sheep and goats moving interstate and to reinstate a scrapie

indemnity program to compensate owners of certain animals destroyed due

to scrapie. These changes would help prevent the interstate spread of

scrapie, an infectious disease of sheep and goats.

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

before December 30, 1999.

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

Docket No. 97-093-2, Regulatory Analysis and Development, PPD, APHIS,

suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

[[Page 66792]]

Please state that your comments refer to Docket No. 97-093-2. 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. Diane Sutton, Senior Staff

Veterinarian, National Animal Health Programs Staff, 4700 River Road

Unit 43, Riverdale, MD 20737-1235, (301) 734-7709.

SUPPLEMENTARY INFORMATION: Scrapie is a degenerative and eventually

fatal disease affecting the central nervous systems of sheep and goats,

a member of a class of diseases called transmissible spongiform

encephalopathies (TSEs). Its control is complicated because the disease

has an extremely long incubation period without clinical signs of

disease, and because there is no live-animal test for the disease that

has been validated (demonstrated to be accurate by impartial research).

Scrapie is not a highly contagious disease; however, transmission

to uninfected and susceptible animals can sometimes occur following

exposure to small amounts of tissues from an infected animal. The exact

conditions favorable to animal-to-animal transmission are not fully

understood, though some factors that increase the risk are known (e.g.,

contact of a young animal with the afterbirth of an infected female

animal). The scrapie agent moves from infected to susceptible animals

by direct animal-to-animal contact, or indirect contact through

contaminated premises and may enter through the gastrointestinal tract,

open wounds, or other routes. Consequently, its spread appears to be

both maternal (mother to offspring) and horizontal (direct contact

between unrelated sheep).

There is no evidence that any human has ever contracted scrapie or

any similar disease by eating lamb or mutton. However, it has been

theorized that scrapie may have been spread to other animals when whole

scrapie-positive animals have been rendered and used as animal feed.

This is a prominent theory for the origin of bovine spongiform

encephalopathy (BSE) in cattle in the United Kingdom. As a

precautionary measure to prevent the possible spread of TSEs via

ruminant feed in the United States, the U.S. Food and Drug

Administration published a final rule on June 5, 1997 (62 FR 30935-

30978) that prohibited the use of animal protein derived from most

mammalian tissues in ruminant feed.

While diseases caused by TSEs do not frequently or easily cross

species lines, there is reason to be concerned that TSEs infecting one

species could at some point lead to diseases in other animal species or

humans, as has been demonstrated with BSE in cattle in the United

Kingdom. New variant Creutzfeldt Jakob Disease (vCJD) is a human

neurological disease recently identified in the United Kingdom that is

believed to have its origins in the BSE outbreak in cattle in the

United Kingdom. The agent that causes vCJD is indistinguishable from

the causative agent of BSE. As of September 21, 1999, 46 cases of vCJD

had been identified in the United Kingdom and one in France. The exact

means by which the victims were exposed to the agent is uncertain; it

may have been through eating beef products that contained high risk

materials (brain and spinal cord) from BSE-positive cattle or through

some other exposure.

Based on the above facts, it is reasonable to conclude that control

of scrapie in the United States, in addition to addressing a disease

problem in sheep, would also reduce concerns about the apparently low

but undefined risks that the scrapie agent could lead to diseases in

other species.

There are nearly 8 million sheep and lambs in the United States. It

is impossible to estimate with any accuracy how many of them are

infected with scrapie. This is because the disease may go undiagnosed.

Scrapie has a lengthy incubation period, which complicates

epidemiological studies, and there has been no live-animal test to

diagnose it. These factors have impeded surveillance programs for

scrapie, requiring it to be identified by symptoms and postmortem

examination. However, the following information can be used to develop

a rough estimate of the number of sheep in the United States that may

be infected with scrapie: (1) In a 1996 NAHMS report, 1.2 percent of

participating producers reported that they had seen scrapie in their

flock in the last 5 years; (2) The average flock size in the United

States is 105 animals; (3) The number of flocks in the United States is

68,800; (4) In a flock that has had one case, the percent of animals

that will come down with scrapie is highly variable. Based on this

data, it is likely that at least 826 flocks are affected and that at

least 86,730 sheep have been exposed to and may be infected with

scrapie. It is likely that the number of exposed and potentially

infected animals is significantly higher since owners are likely to

under report disease because it is confused with another disease.

To control the spread of scrapie within the United States, the

Animal and Plant Health Inspection Service (APHIS), U.S. Department of

Agriculture (USDA), administers regulations at 9 CFR part 79, which

restrict the interstate movement of certain sheep and goats. APHIS also

administers the Voluntary Scrapie Flock Certification Program (the

VSFCP), described in regulations at 9 CFR part 54, and produces a

program standards document entitled ``Program Standards--Voluntary

Scrapie Flock Certification Program,'' which is available at http://

www.aphis.usda.gov/vs/scrapie/umr. A hard-copy of the Program Standards

may be obtained by contacting the individual listed under FOR FURTHER

INFORMATION CONTACT. The regulations at 9 CFR parts 54 and 79 are

referred to below as the scrapie regulations.

For over 40 years USDA has had programs to eradicate or reduce the

incidence of scrapie in the United States. While comprehensive data on

the incidence of scrapie has always been hard to assemble due to the

nature of the disease and its diagnosis, these programs apparently have

not resulted in a major reduction in the incidence of scrapie. A major

reason for this result is that State programs for scrapie have varied

tremendously in their resources and effectiveness, from State to State

and over time. States where sheep are not a major agricultural

commodity may not invest sufficient resources to identify infected

flocks or reduce the incidence of scrapie within that State, and sheep

with undiagnosed cases of scrapie could then easily move to other

States, infecting new flocks. Therefore, we believe that to build an

effective national scrapie program, the current regulations must be

adjusted to recognize that sheep from States with minimal or

nonexistent scrapie programs represent a higher risk than sheep from

other States.

In an advance notice of proposed rulemaking (ANPR) published in the

Federal Register on January 26, 1998 (63 FR 3671-3673, Docket No. 97-

093-1), we solicited public comments to help us develop options for

potential changes to the scrapie regulations. The primary issues on

which we sought comment were:

Should APHIS further restrict interstate movement of

animals from States that do not consider scrapie a reportable disease

or do not quarantine infected flocks or source flocks? Should APHIS

define how a State must conduct a quarantine in order to avoid further

[[Page 66793]]

restrictions on interstate movement of animals from that State?

Should APHIS restrict interstate movement of high-risk

animals from flocks that are not infected flocks or are not source

flocks, and if so, how?

Should any of the definitions in the scrapie regulations

be revised (e.g., the definitions of source flock, trace flock, and

high-risk animal)?

Should there be additional permit or official

identification requirements for the interstate movement of any classes

of sheep and goats to allow for a more effective national program for

surveillance for scrapie and traceback of scrapie-positive animals?

Should APHIS continue to provide the following information

on the World Wide Web: The identity of scrapie infected flocks and

source flocks designated under part 79, and the identity and

certification status of flocks participating in the VSFCP?

We solicited comments concerning our ANPR for 60 days ending March

27, 1998. We received 27 comments by that date. The commenters were

sheep producers, industry associations, State agencies, and

individuals. The comments and data submitted were carefully reviewed,

and helped us develop this proposed rule.

Briefly, the three major changes we are proposing to the scrapie

regulations are:

Further restrictions on the interstate movement of sheep

and goats from States that do not consider scrapie a reportable disease

or do not quarantine infected flocks or source flocks. We are also

proposing standards describing how a State must conduct a quarantine in

order to avoid further restrictions on interstate movement of animals.

Additional official identification requirements for the

interstate movement of sheep and goats to allow for a more effective

national program for surveillance for scrapie and traceback of scrapie-

positive animals. The proposed identification requirements are similar

to current requirements for cattle and swine.

Reinstatement of a scrapie indemnification program for

sheep and goats that owners agree to destroy. The owners of destroyed

high-risk animals and animals diagnosed as scrapie positive by an

approved live-animal test would be eligible for indemnity payments.

State Quarantine Activities and Interstate Movement Restrictions

Many commenters supported the idea that States should have

intrastate quarantines and controls on the movement of sheep and goats

sufficient to prevent intrastate spread of scrapie from known sources,

and that States lacking such quarantines and controls should have the

interstate movement of their sheep and goats further restricted. These

commenters expressed the opinion that the current regulations do not do

enough to prevent the spread of scrapie from States with weak scrapie

programs into States with more effective scrapie programs. Most of

these commenters supported the idea that an adequate State program is

one that considers scrapie to be a reportable disease, that quarantines

scrapie infected and source flocks and maintains them under a flock

plan, and that imposes intrastate movement restrictions equivalent to

Federal interstate movement restrictions imposed under current part 79.

Commenters generally stated that if a State has or develops such an

intrastate program, and APHIS determines the State program to be

comparable in effectiveness to its interstate regulations in part 79,

that State should not be subject to further interstate movement

restrictions. However, a few commenters suggested that if a State

implements a program of intrastate restrictions, that should be

sufficient to avoid further interstate movement restrictions on sheep

from that State, without an APHIS determination that the State program

is comparable in effectiveness to the Federal program under part 79.

Commenters also generally stated that flocks participating in the

VSFCP should not be subject to further interstate movement

restrictions, even if they are in a State that does not have an

adequate intrastate program as described above.

We believe that programs developed and implemented by States are

essential to the control and eradication of scrapie, and we encourage

varying approaches to these programs to meet individual State needs and

to try and evaluate different control methods. However, we also believe

APHIS should have a role in determining that each State program

achieves a minimum level of effectiveness to serve national needs.

Valid complaints in the past have noted that some State programs exist

as little more than a name, and are ineffective. This introduces

unacceptable hazards when sheep and goats from such States move in

interstate commerce. Additionally, the creation of a uniform minimal

standard on the national level would be consistent with the

recommendations of international animal health organizations and the

World Trade Organization, both of which recommend that a national

authority establish minimum standards for programs affecting trade.

Therefore, we are proposing that if a State is to avoid the

requirements described below under ``Additional Interstate Movement

Restrictions for Sheep and Goats,'' the State program must be reviewed

by APHIS and determined to be comparable to the Federal program

contained in part 79. APHIS would conduct this review by evaluating the

State statutes, regulations, and directives pertaining to animal health

activities to determine whether the State has established authority to

conduct a scrapie control program comparable to the Federal one, and

would also examine reports and publications of the State animal health

agency to determine whether the existing authorities are being

exercised in the form of an effective program. The States would be

required to submit a written statement containing this information and

certifying that they are in compliance with this section.

Additional Interstate Movement Restrictions for Sheep and Goats

Most commenters supported the idea that APHIS should further

restrict interstate movement of sheep and goats from States that do not

consider scrapie a reportable disease, or that do not quarantine

infected and source flocks. Most commenters also stated APHIS should

set minimum criteria for how a State must conduct a quarantine. Four

commenters opposed APHIS setting minimum criteria in this area because

they were concerned that APHIS would dictate detailed command-and-

control requirements to State programs, rather than minimum

effectiveness criteria. This is not the intention of APHIS.

In this proposal, we describe two sets of interstate movement

restrictions: One set for ``Consistent States'' and another set for

``Inconsistent States.'' Consistent States would be States that conduct

an active State scrapie program which effectively enforces certain

requirements to identify scrapie in flocks and control its spread. We

propose to establish in the new Sec. 79.6 the requirements a State

would have to meet to be a Consistent State. These requirements include

reporting and investigating any scrapie suspect animal, affected

animal, or scrapie-positive animal; identifying and quarantining

infected and source flocks; and individually identifying certain

exposed animals and individually identifying and monitoring certain

high-risk animals in all flocks, not just source or infected flocks.

All States that are not Consistent States would be Inconsistent States.

APHIS believes almost all States currently have the State legislative

[[Page 66794]]

authority and animal health infrastructure to qualify as Consistent

States. However, this must be confirmed on a State-by-State basis

through discussions between APHIS and State animal health authorities.

Before this proposal is finalized, APHIS will develop and publish for

comment a list of States that qualify as Consistent States. After

finalizing the rule, APHIS will insert the list of ``Consistent

States'' in Sec. 79.1. From time to time, APHIS will amend the list

when it is determined that States meet or do not meet the definition of

Consistent State in Sec. 79.1.

While this proposal does not require it, it may also be desirable

to require all Consistent States to sign a compliance agreement with

APHIS describing the State scrapie program operations; we would

appreciate public comment on whether our regulations should require

such an APHIS-State compliance agreement.

Such an agreement would provide evidence of the intent of a State

to impose the requirements and provide the services necessary for it to

be considered a Consistent State. The agreement could also describe

cooperative activities between the State and APHIS to support the State

scrapie regulatory activities. This agreement would be similar to, or

could be made a part of, the cooperative agreement or memorandum of

understanding that some States have signed with APHIS to cooperate in a

number of animal disease control programs, including the VSFCP (see

Sec. 54.13). Under part 54, some States may have already signed a

cooperative agreement with APHIS that describes the respective roles of

APHIS and State personnel in implementing the VSFCP. Such agreements

also specify the financial, material, and personnel resources to be

committed by the State and APHIS and assign specific activities to

APHIS or State personnel.

APHIS considered adding one other requirement to the standard for a

State to qualify as a Consistent State. The proposed requirement states

that Consistent States must report and investigate any scrapie suspect

animal, affected animal, or scrapie-positive animal, but it does not

specify any particular level of effectiveness in these investigations,

nor does it require that States be able, in their investigation, to

trace back a scrapie-positive animal to its flock of birth, if it was

born in that State, and otherwise to its State of origin. When an

animal that has moved through several flocks is identified as scrapie-

positive, e.g., at slaughter, it greatly aids the scrapie control

program when the animal can be traced back to its flock of birth. This

is not always possible to do with the records and identification

required by current State programs. However, it might significantly

increase the burden on States to upgrade their programs to the point

where any animal sold for slaughter, breeding, or other purposes can be

traced back to its flock of birth. Therefore, we would appreciate

receiving comments on whether the standard for declaring a State to be

a Consistent State should include a requirement that the State's

scrapie control program must be able to trace any animal from a flock

in that State back to its flock of birth, if it was born in that State,

and otherwise to its State of origin, and whether provisions for

monitoring and when available live-animal testing of such flocks should

be required.

The interstate movement restrictions proposed for Consistent States

are similar to the regulations in current part 79, except that they

include additional identification requirements and would restrict the

interstate movement of high-risk animals and prohibit the interstate

movement of scrapie positive, affected, and suspect animals (except

when they are moved for destruction or research under conditions

approved by the Administrator). The restrictions proposed for

Inconsistent States are stricter, and are designed to minimize several

areas of risk associated with the indeterminate scrapie status of sheep

and goats from these States. Sheep and goats from Inconsistent States

would be subject to stricter movement conditions to minimize their

contact with other animals, and stricter identification requirements to

aid traceback from any scrapie outbreak that may be associated with the

animals. Also, sheep and goats from Inconsistent States could not move

interstate for breeding purposes unless they are enrolled in the VSFCP

or an equivalent APHIS-recognized State flock certification program. An

equivalent APHIS-recognized State flock certification program does not

equate to a Consistent State. It is possible, though unlikely, that a

State might not institute the Statewide controls that would qualify it

as a Consistent State--investigation and identification of all suspect

and high-risk animals, quarantine of all source and infected flocks,

etc.--but would have a program providing VSFCP-like standards for

particular individual flocks within the State whose owners request it.

The following chart describes the proposed interstate movement

conditions.

Interstate Movement General Restrictions for Sheep and Goats

------------------------------------------------------------------------

Moved from Moved from

Type of interstate movement INCONSISTENT State CONSISTENT State

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Sale or other movement of

breeding animals, show

animals or any other animal

not specifically addressed

below:

High-risk animal, Prohibited*......... Prohibited*.

scrapie positive,

suspect, or affected

animal.

Non-high risk animal Prohibited*......... Prohibited*.

from an infected or

source flock.

Other animal............ Flock must be Individual animal ID

enrolled in the and certificate.

Complete Monitored

category of the

Scrapie Flock

Certification

Program or

equivalent APHIS-

recognized program

and have

certificate.

Sale or other movement

directly to slaughter or

through slaughter channels

to slaughter of animals

under 6 months of age:

Scrapie positive, Prohibited*......... Prohibited*.

suspect, or affected

animal.

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High-risk animals and Individual animal ID Individual animal ID

animals from infected and permit, or and permit, or

or source flock. sealed conveyance sealed conveyance

and permit (no and permit (no

individual ID) when individual ID) when

moving directly to moving directly to

slaughter, or a slaughter, or a

permit (no permit (no

individual ID) and individual ID) and

an indelible ``S'' an indelible ``S''

mark on the left mark on the left

jaw. jaw.

Other animal............ Premises ID** and None.

certificate.

Sale or other movement

directly to slaughter or

through slaughter channels

to slaughter of animals

over 6 months of age, or

animals of any age to

feedlots for later movement

to slaughter:

Scrapie positive, Prohibited*......... Prohibited*.

suspect, or affected

animal.

High-risk animals and Individual animal ID Individual animal ID

animals from infected and permit. and permit.

or source flock.

Other exposed animals... Individual animal ID Individual animal

and permit. ID.

Other animals over 1 Individual animal ID Individual animal

year of age. and certificate. ID.

Other animals between 6 Individual animal ID Premises ID* *.

months and 1 year of and certificate.

age, or animals under 6

months of age moving to

feedlots for later

movement to slaughter.

Movement of animals for

grazing or other management

purposes without change of

ownership

Scrapie positive, Prohibited*......... Prohibited*.

suspect, or affected

animal.

High-risk animal or Prohibited*......... Prohibited*.

animal from infected or

source flock.

Exposed animals......... Individual animal ID Premises ID.

and certificate.

Other animal............ Premises ID and None.

certificate.

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* Animals prohibited movement may be moved interstate only if they are

moving interstate for destruction or research approved by the

Administrator.

* * Premises ID is not required for slaughter animals if the animals are

kept as a group on the same premises on which they were born and are

not commingled with animals from another premises at any time,

including throughout the slaughter process, or, if they are commingled

during the slaughter process, they are officially identified on

arrival at the slaughter facility such that any animal can be traced

back to its flock of origin.

Note: A CONSISTENT STATE is one whose intrastate identification,

quarantine and movement restrictions for infected and source flocks

and high-risk animals are consistent with the APHIS standards for

State scrapie programs.

As summarized in the above chart, there are different interstate

movement conditions depending on the State's scrapie program status,

age of the animal moved, and on whether the animal is moved for

slaughter or for other purposes. The movement conditions vary with the

risk of spreading scrapie by the movement, and range from no

requirements for animals of no known risk moved to slaughter from a

State with a strong scrapie program, through severe requirements for

animals of known risk moving from Inconsistent States, to outright

prohibition of movement for the highest risk categories. The

requirements employed to control risk in the middle range include

premises identification (ID), individual animal ID, certificates,

permits, and sealed conveyances. The meanings of these terms are

discussed below under ``Changes to Definitions in Parts 54 and 79.''

The interstate movement of all scrapie-positive animals, suspect

animals, and affected animals is prohibited unless the Administrator

approves their movement for destruction or research. Uncontrolled

movement of these animals always poses a risk that they may come in

contact with other sheep and goats and spread scrapie to these other

animals. Therefore, when the Administrator approves movement for

destruction or research, the animals must be moved and maintained under

conditions to prevent the spread of scrapie.

The interstate movement of high-risk animals and animals from

infected or source flocks is subject to various restrictions that

depend on the age and source of the animal and the purpose of the

movement. High-risk animals and animals from infected or source flocks

are prohibited movement unless they are moving to slaughter or moving

in slaughter channels. Such animals of any age may be moved to a

feedlot for later slaughter if they have individual animal ID and a

permit. High-risk animals and animals from infected or source flocks

may move directly to slaughter if they are over 6 months old and have

individual animal ID and a permit. The purpose of the permit is to

trace the movement of each lot of animals, and the purpose of the

individual ID is to make it easy to ensure that individual animals are

not diverted out of slaughter channels, e.g., by becoming mixed with

other animals at feedlots prior to slaughter.

High-risk animals and animals from infected or source flocks

animals under 6 months of age may be moved directly to slaughter if

they meet one of three conditions: (1) Individual animal ID and a

permit; (2) A sealed conveyance (no animal ID) and a permit; or (3) A

permit and an indelible ``S'' mark on the jaw, in lieu of animal ID.

These additional options are provided for animals under 6 months of age

due to the large volume of lambs shipped to slaughter, and because it

is often impractical or uneconomical to individually identify younger

lambs.

Animals that are not in the categories described above (i.e., they

are not scrapie-positive animals, suspect animals, affected animals, or

high-risk animals) may move interstate to slaughter under conditions

that vary depending on their age, and whether they are moving from a

Consistent or

[[Page 66796]]

Inconsistent State. Generally, the older the animal moving to

slaughter, the more requirements apply, because older animals may have

had more opportunities to move from one flock to another and thereby

increase their exposure to scrapie. The program is more likely to need

records that allow the older animals to be traced back to earlier

premises. While it would usually be possible to trace the movement of

an animal from flock to flock in a Consistent State based on flock

records, individual animal ID makes this task easier for animals over 1

year of age, which have a longer history than lambs and may have had

several owners. Also, it is currently impossible to diagnose scrapie in

animals under 6 months of age, by either a live-animal test or

necropsy, so there is no opportunity to identify a scrapie-positive

animal under 6 months of age and trace it back to its origin.

Therefore, individual animal ID is seldom required for animals under 6

months of age; it is only required when the point of the identification

is not traceback, but to ensure individual animals are not commingled

with animals from other lots (e.g., when they are sent to a feedlot en

route to slaughter).

When animals that are not scrapie-positive animals, suspect

animals, affected animals, or high-risk animals move from a Consistent

State, the animals may move with no requirements if they are under 6

months of age and are moving to slaughter. However, if such animals

under 6 months of age are moving from an Inconsistent State to

slaughter, they require a premises ID and a certificate. When they are

over 6 months of age but less than 1 year of age, such animals may move

from a Consistent State to slaughter, or to a feedlot, with only a

premises ID; but if they are moving from an Inconsistent State, they

require individual animal ID and a certificate. In this case the

individual animal ID is required for animals from Inconsistent States

because it is sometimes possible to diagnose scrapie in an animal

between 6 months to 1 year of age, and tracing these animals back to

origin in an Inconsistent State is not possible with only a premises ID

because Inconsistent States would not require records that would allow

the animal to be traced back farther than the premises from which the

animal was shipped to slaughter. When they are over 1 year of age, such

animals may move from a Consistent State to slaughter, or to a feedlot,

only if they have individual animal ID; but if they are moving from an

Inconsistent State, they require both individual animal ID and a

certificate. The higher requirements for animals from Inconsistent

States are largely due to the fact that Consistent States impose

significant restrictions on movements between flocks within the State

but Inconsistent States do not, so our regulations must use

certificates and individual animal ID more extensively for Inconsistent

States to increase the probability of successful tracebacks.

The proposed requirements also address interstate movement for

purposes other than slaughter. Animals that are not scrapie-positive

animals, suspect animals, affected animals, high-risk animals, or

animals from infected or source flocks may move interstate from a

Consistent State for grazing or other management purposes, without

change of ownership, with no requirements (unless the animal is an

exposed animal as defined in the regulations, in which case a premises

ID is required). Such animals moving interstate from an Inconsistent

State must have a premises ID and certificate, unless they are exposed

animals, in which case individual animal ID and a certificate is

required.

Indemnification Program

We are also proposing to reinstate an indemnification program to

compensate the owners for destruction of high-risk animals, animals

diagnosed scrapie-positive by an approved live-animal test, affected

animals, suspect animals (if the postmortem indicates them to be

scrapie-positive), and other groups of animals when the Administrator

determines that their destruction will contribute to the eradication of

scrapie. We believe indemnification is necessary to contribute to

scrapie control, mainly by providing the economic incentive to remove

scrapie-positive and high-risk animals from flocks and reduce the

number of flocks under quarantine. This economic incentive, combined

with advances in diagnostic techniques that allow faster and more

accurate identification of scrapie-positive animals, should contribute

substantially to reducing the incidence of scrapie in the United

States.

The types of animals proposed as eligible for indemnity are animals

diagnosed with scrapie, or known to be closely associated with animals

diagnosed with scrapie under conditions where they could contract the

disease. These animals could potentially cause many new cases of

scrapie, and, therefore, we believe paying indemnity to destroy them is

in the interest of effective scrapie control.

The indemnity payments would be $150 for registered animals and $50

for other animals. As of January 1, 1999, the national average sale

price of a sheep was $88; as of January 1, 1998, it was $102. These

average sale prices reflect the sale of millions of slaughter sheep and

a few thousand valuable registered breeding sheep. The average price

for registered breeding sheep is in the range of $300, with some

selling for thousands of dollars. Therefore, if sale prices persist in

the range experienced in the past 2 years, the average owners of both

slaughter and registered sheep who accept indemnity for their animals

rather than selling them would recover about half the market value of

the animals.

The indemnity amounts of $150 and $50 represent an effort to

provide an indemnity that will be attractive, while also stretching

available indemnity funds to ultimately remove as large a number of

diseased animals as possible. The indemnity amounts are not so high,

compared to fair market value, as to provide a perverse incentive,

i.e., to encourage flock owners to expose animals to scrapie to obtain

a higher price. The indemnity amounts were decided based on our past

experience with industry participation in scrapie indemnity programs,

and the $150 and $50 amounts are the same indemnities used in our

previous scrapie indemnity program which expired in 1996, at which time

the national average sale price of a sheep was $87.

We considered whether it would be appropriate to pay a lower

indemnity, either for all eligible animals or for those that test

positive for scrapie on a future live-animal test, in view of the

economic fact that sheep infected with scrapie really have little or no

economic value. However, we believe that reducing the indemnities below

the proposed values would encourage owners to hide the presence of

scrapie and thus hurt the effectiveness of the scrapie control program.

This view is supported by the experience of the British Government in

controlling BSE. When the British Government increased the indemnity

for BSE-infected cattle from 50 percent of market value to 100 percent,

the number of reported BSE cases increased by 73 percent.\1\

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\1\ Food Microbiology (1990) 7:253-279.

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It should be noted that if this proposal is adopted, the total

number of animals that can be indemnified each year and the total

amount of indemnity funds expended will be limited by the amount of

program funding appropriated for that purpose. We invite comments on

the total amount of indemnity that should be needed, and on whether the

payment amounts are appropriate.

[[Page 66797]]

In deciding to propose this indemnity program, we examined

alternatives to determine whether the same funds could be expended on

other activities to control scrapie and achieve a greater reduction in

the disease. Two activities that could produce substantial reductions

in scrapie are development of a live-animal test and education of sheep

producers and veterinarians to recognize and control scrapie. However

current and planned funds for both of these initiatives appear to be at

a level that will produce optimal results, and we do not believe

diverting indemnity funds to them would accelerate their progress.

Instead, an indemnity program would complement use of a live-animal

test and education programs. The three approaches together will be

needed to successfully control scrapie.

Another alternative we considered, under the assumption that a

live-animal test for scrapie will soon be available, was to impose a

large-scale, mandatory live-animal testing requirement of all animals

moved interstate for other than slaughter purposes. For this approach

to be effective, we would need to condemn and destroy any animals that

tested positive, to ensure they do not come in contact with and infect

other animals in the future. This alternative was rejected because an

approved live-animal test is not currently available. Once a live-

animal test has been approved and fully evaluated, this option will be

reconsidered.

We also considered prohibiting the movement in interstate commerce

for any purpose of any animal that was considered to be at high risk of

being scrapie infected. This was rejected because: (1) There is no

evidence that scrapie is a threat to public health; (2) Scrapie-

infected animals moving to slaughter pose little risk of spreading the

disease; and (3) Given the past history of scrapie indemnity funding,

it is likely that we would be unable to indemnify all of these animals

causing a significant economic hardship on owners of high-risk sheep.

To mitigate the remote risk that these animals pose when moving in

slaughter channels, we have proposed to indemnify and destroy them

whenever possible. Finally, we considered restricting these animals

without compensation. This option was rejected for the reasons

discussed under indemnification.

Live-Animal Testing

While no live-animal test for scrapie has yet been approved,

several varieties of live-animal tests show promise, and we anticipate

the availability of a live-animal test in the near future. Therefore,

this proposed rule includes reference to live-animal tests as a means

to identify scrapie-positive animals and affected animals, without

specifying the exact protocols of the live-animal tests. As discussed

below, the definitions for live-animal screening test (used to identify

affected animals) and scrapie-positive animal state that the tests must

use protocols approved by the Administrator and must be performed by

laboratories approved by the Administrator. Once developed, the

Administrator will initiate rulemaking in the Federal Register to

publish these protocols or incorporate them by reference.

The availability of a validated live-animal test will significantly

affect the nature of the scrapie control program. Such a test would

make it possible to identify confirmed infected live animals for

destruction, reducing the need to destroy large groups or entire flocks

of suspect animals in order to control the spread of scrapie.

Changes to Definitions in Parts 54 and 79

Three definitions would be removed because they are no longer

needed for the proposed regulations (bloodline animal, because this

category has not been used since termination of an earlier indemnity

program; department, because we refer instead in this proposal to

APHIS; and trace flock, because its definition has been absorbed by the

new definition of source flock discussed below). Nine other definitions

would be amended (affected animal, destroyed, exposed animal, flock,

flock plan, high-risk animal, infected flock, scrapie-positive animal,

and source flock). Some of these changes would be made to adapt the

regulations to the probability that a validated live-animal test for

scrapie may be available in the near future. The definition of

destroyed would be changed to remove movement to slaughter as a means

of destruction. Animals to be destroyed would have to be euthanized,

and the carcasses disposed of by means authorized by the Administrator.

Animals for which an indemnity is paid under the regulations must be

destroyed, rather than sent to slaughter, for two reasons. First, any

movement of animals eligible for indemnity represents a potential risk

of spreading scrapie, and we do not want to encourage movement of these

animals to slaughter when we have the alternative of destroying them on

their home premises and disposing of the carcasses safely. Second, if

animals eligible for indemnity are slaughtered, this may result in the

scrapie agent entering the animal food chain, and we want to avoid

this. The Food and Drug Administration has published regulations (62 FR

30935-30978, June 5, 1997) requiring that ruminant feed must not

contain animal protein derived from mammalian tissues, in order to

prevent the possible spread of transmissible spongiform

encephalopathies, such as scrapie, to ruminants. However, sheep protein

is still used for other nonruminant animal feed, such as zoo animal

foods. Research has shown that a variety of species can conceivably

contract some form of spongiform encephalopathy by oral inoculation

with protein from a scrapie-positive animal. The wide distribution of

meat byproducts from slaughter plants makes it likely that if indemnity

animals were allowed to go to slaughter, some of their protein would be

used in nonruminant animal feed. The risk that nonruminants could

contract a transmissible spongiform encephalopathy from consuming

animal feed containing protein from a scrapie-positive animal is

extremely small. However, we propose to control this small risk by

taking the opportunity presented by the indemnity program to order

indemnity animals to be destroyed, rather than sent for slaughter. The

Administrator will authorize disposal methods (often incineration or

burial) that are consistent with local laws and conditions and that

minimize the dispersal of possibly infectious material. The proposed

definition of destroyed ties into the proposed Procedures for

destruction of animals in Sec. 54.7. These procedures include a

requirement that carcasses may not be processed for animal food unless

subjected to a treatment process approved by the Administrator and

known to eliminate the agents of transmissible spongiform

encephalopathies. This requirement would address the established risk

that some species of animals conceivably could contract scrapie by

consuming animal feed generated from scrapie-positive animals.

Exposed animal would be redefined as any animal that has been in

the same flock at the same time within the previous 60 months as a

scrapie-positive animal, excluding limited contacts, and any animal

born in a flock after a scrapie-positive animal was born into that

flock, if born before that flock completes the requirements of a flock

plan. The earlier definition of this term also defined limited

contacts, which would now be defined in a separate definition. The

earlier definition also did not include animals that were born into a

flock after the removal of a scrapie-positive animal born into that

flock. We believe such animals should

[[Page 66798]]

be considered exposed because there is some risk that they may contract

scrapie from objects or animals the earlier scrapie-positive animal

came in contact with, unless this risk has been mitigated by the

completion of a flock plan.

Because the definition of flock plan currently contains a large

volume of procedures not appropriate for a definition, this definition

would be shortened by expanding and moving some of its text to new

Sec. 54.14, ``Requirements for flock plans and post-exposure management

monitoring plans.'' The definition of Uniform methods and rules--

voluntary scrapie flock certification would be updated and renamed

Scrapie Flock Certification Program standards, consistent with the

program name change discussed elsewhere in this document. For the same

reason, a definition would be added for the Scrapie Flock Certification

Program.

The following new definitions for terms used in the proposed rule

would also be added to part 54, part 79, or both:

Area veterinarian in charge would be defined as ``The veterinary

official of APHIS who is assigned by the Administrator to supervise and

perform the official animal health work of APHIS in the State

concerned.'' This definition is needed to identify those veterinarians

who perform certain duties under the regulations including processing

of indemnification applications.

Certificate would be defined as ``An official document issued in

accordance with Sec. 79.5 of this part by an APHIS representative,

State representative, or accredited veterinarian at the point of origin

of an interstate movement of animals, which includes a statement that

the animals were not exhibiting clinical signs associated with scrapie

at the time of examination.'' A certificate is required by the

regulations for interstate movement of certain animals.

Consistent State would be defined as ``A State which the

Administrator has determined conducts an active State scrapie control

program which either: (1) meets the requirements of Sec. 79.6 of this

part, or (2) effectively enforces a State designed plan that the

Administrator determines is at least as effective in controlling

scrapie as the requirements of Sec. 79.6 of this part.'' This

definition would be the basis for determining whether animals from a

particular State qualify for the less restrictive, or more restrictive,

interstate movement requirements proposed in Sec. 79.3. When the list

of Consistent States is developed, it will be added to this definition.

Any State not listed would be an Inconsistent State.

Designated scrapie epidemiologist would be defined as ``An

epidemiologist selected by the State animal health official and the

area veterinarian in charge to reclassify animals already designated as

high-risk, exposed, or affected with scrapie, based on epidemiologic

investigation or the results of a live-animal test. The regional

epidemiologist and the APHIS National Scrapie Program Coordinator must

concur in the selection and appointment of the designated scrapie

epidemiologist.'' Designated scrapie epidemiologists would operate

under proposed Sec. 79.4 to reclassify animals as necessary.

Electronic implant, one form of allowed animal identification,

would be defined as ``Any radio frequency identification device

approved for use in the scrapie program by the Administrator. The

Administrator will approve an electronic implant after determining that

it is tamper resistant, not harmful to the animal, and readable by

equipment available to APHIS and State representatives.''

The definition of flock would be amended to clarify when more than

one flock may be maintained on a single premises without being

considered a single flock. This definition considers that flocks on a

premises are separate if they never commingle, never share facilities

and equipment, and have separate flock records and identification. To

address questions raised by flock owners, this revised definition also

states that changes in ownership of a flock do not change the identity

of the flock or the regulatory requirements applicable to the flock.

Individual animal identification would be defined as ``An

electronic implant, flank tattoo, ear tattoo, or tamper-resistant ear

tag approved by APHIS. In the case of goats, the form of identification

may alternatively be a tail fold tattoo. The official identification

must provide a unique identification number that is applied by the

owner of the flock or his or her agent in accordance with instructions

by an APHIS representative or State representative.''

Inconsistent State would be defined as ``Any State other than a

Consistent State.''

Interstate commerce would be defined as ``Trade, traffic,

transportation, or other commerce between a place in a State and any

place outside of that State, or between points within a State but

through any place outside that State.''

Limited contacts would be defined as ``Incidental contacts between

animals off the flock's premises such as at fairs, shows, exhibitions

and sales; between ewes being inseminated, flushed, or implanted; or

between rams at ram test or collection stations. Embryo transfer and

artificial insemination equipment and surgical tools must be sterilized

between animals for these contacts to be considered limited contacts.

Limited contacts do not include any contact with an animal during, or

up to 60 days after, lambing or kidding. Limited contacts do not

include any activity where uninhibited contact occurs, such as sharing

an enclosure, sharing a section of a transport vehicle, or

transportation to other flocks for breeding, except as allowed by the

Scrapie Flock Certification Program standards.'' This definition is

needed to help distinguish between contacts that do not present a

pronounced risk of spreading scrapie (e.g., casual contacts between

animals at fairs or shows) and contacts that present a pronounced risk

(e.g., contacts with animals during or within 60 days following

lambing, when infectivity is high and infectious materials such as

afterbirth are present).

Post-exposure management and monitoring plan would describe an

agreement written jointly by the flock owner, an accredited

veterinarian, and an APHIS or State representative in which each

participant agrees to undertake certain actions to monitor for the

occurrence or recurrence of scrapie in the flock for at least 5 years

after the flock was exposed to a scrapie-positive animal, or contained

a high-risk animal. Experience in monitoring flocks has shown that if

scrapie recurs from a previous outbreak in a flock, its signs are

likely to become evident within 5 years. This definition, like the

definition of flock plan, would refer to new Sec. 54.14, ``Requirements

for flock plans and post-exposure management monitoring plans.''

Federally required post-exposure monitoring is necessary to guard

against recurrence of scrapie, because flocks whose owners receive

indemnity payments may or may not be subject to State quarantines, and

even if they are subject to State quarantine there is great variation

in the effectiveness of State quarantine procedures in detecting signs

of scrapie in a timely manner. As discussed in proposed Sec. 54.5, in

order to receive indemnity an owner must agree to maintain their flock

under a post-exposure monitoring management plan for 5 years after

removal of the last high-risk or scrapie-positive animal. Based on the

typical clinical progress of scrapie, we believe any renewed outbreak

of

[[Page 66799]]

scrapie in the flock would show signs within 5 years.

Premises identification, one requirement of proposed Sec. 79.3 for

moving certain animals interstate, would be defined as ``An APHIS

approved eartag, backtag, or tattoo bearing the premises identification

number assigned by a State or Federal animal health official to the

premises on which the sheep or goats originated, or a brand registered

with an official brand registry.''

The definition of scrapie-positive animal would be updated by

referring to additional laboratory techniques (western blotting,

bioassay, fibril detection by electron microscopy) that have proven

useful in confirming scrapie from tissue samples, by allowing

confirmation of scrapie-positive status by ``any other test method

approved by the Administrator,'' and by adding a footnote describing

how the Administrator will approve laboratories to conduct tests for

scrapie-positive animals.

The definition of infected flock would be changed to include any

flock in which a scrapie-positive animal had lambed within the past 18

months, counted from the time the tissues used to diagnose the scrapie-

positive animal were collected from the scrapie-positive animal. This

change would be made as a result of evidence that placenta shed 15\1/2\

months prior to death may contain infectious agent. Since the progress

of the disease and the level of infectivity can be expected to vary

somewhat among individual animals, we set the lambing limit at 18

months rather than 15\1/2\ months to allow a margin of error, and

because 18 months is an easier figure than 15\1/2\ months for planning

and compliance activities of both regulators and sheep producers. Also,

in the definitions for infected flock and source flock, we are dropping

a reference limiting their application to cases where the scrapie-

positive diagnosis was made ``after March 31, 1989.'' This date was

added to the regulations in 1992 to cover a temporary situation where

diagnoses employed one standard before 1989 and another afterwards. Due

to the lifespan of sheep and goats, there are no more flock situations

where a diagnosis prior to that date would be relevant or used, and so

the date would be deleted as superfluous and confusing.

The current definition of source flock includes flocks in which at

least two animals later diagnosed as scrapie-positive are born. Because

we agree with comments that stated that the birth of a single animal

later determined to be scrapie-positive indicates that a flock is a

significant risk as a source of scrapie, we would change this

definition to include flocks where a single animal later diagnosed as

scrapie-positive is born.

The definition of affected animal would be changed to allow the use

of a live-animal test as a screening test without affecting flock

status. The designation ``affected animal'' could be used if a live-

animal test is developed that proves to be less specific than the

current tests used to classify an animal as a scrapie-positive animal

as defined in Sec. 54.1. The type of test that may be approved to

identify affected animals is described in a new definition for live-

animal screening test, which reads ``Any test for the diagnosis of

scrapie in a live animal that is approved by the Administrator as

usually reliable but not definitive for diagnosing scrapie, and that is

conducted in a laboratory approved by the Administrator.'' This

definition also includes a footnote describing how the Administrator

will approve laboratories to conduct this test.

Genetics and DNA Testing Issues

Much current research addresses methods for identifying gene

sequences in sheep that affect the animal's resistance or

susceptibility to scrapie, or the length of the incubation period. As

answers emerge from research, we will propose further changes to our

scrapie programs to take advantage of new knowledge about the role of

genetics in the disease-host interaction. In time, it may be possible

to exempt certain breeds of sheep, or sheep that have been tested for

particular codon sequences, from some program requirements because of

their ``natural immunity.'' We are prepared to amend our regulations

when specific, relevant genetic results are confirmed, but we do not

believe any such changes to the regulations would be appropriate at the

current time.

Change of Name--Voluntary Scrapie Flock Certification Program to

Scrapie Flock Certification Program

We are proposing to change the name of the Voluntary Scrapie Flock

Certification Program, described in 9 CFR part 54, to the Scrapie Flock

Certification Program (SFCP). The purpose of the change is to increase

acceptance of the program for export purposes. There has been some

confusion and administrative delay in the acceptance by other national

governments of health certificates and other documents issued for U.S.

sheep and goats and sheep and goat products when these documents base

their determination of health status on a ``voluntary'' program; the

term is not used consistently in international commerce. In some uses

it has implied that participants adhere to some standards part of the

time, rather than meaning that participants voluntarily commit to

following all standards the entire time they participate in a program.

Removing the term ``voluntary'' will result in expedited processing of

these documents, and a clearer understanding that this program is a

valid determination of flock status that is monitored by the U.S.

Government. There is no intent to change the voluntary nature of the

program, as should be clear from the unchanged description of the

nature of the program contained in Sec. 54.10, ``Administration,'' and

Sec. 54.11, ``Participation.''

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been reviewed under Executive Order 12866.

The rule has been determined to be significant for the purposes of

Executive Order 12866 and, therefore, has been reviewed by the Office

of Management and Budget.

We do not currently have all the data necessary for a comprehensive

analysis of the effects of this rule on small entities. Therefore, in

accordance with 5 U.S.C. 603, we have performed an Initial Regulatory

Flexibility Analysis, which is summarized below. We are inviting

comments concerning potential effects. In particular, we are interested

in determining whether sheep and goat producers would be affected

positively or negatively by this rule, and whether any additional costs

may result from this rule that are not discussed in this analysis.

Below is a summary of the economic analysis for the changes to the

scrapie regulations proposed in this document. The economic analysis

provides a cost-benefit analysis as required by Executive Order 12866

and the initial analysis of impacts on small entities as required by

the Regulatory Flexibility Act. A copy of the full economic analysis is

available for review at the location listed in the ADDRESSES section at

the beginning of this document.

We are considering taking the actions described in this proposed

rule in order to strengthen scrapie control programs on the national

level, to reduce the losses that scrapie causes to the sheep and goat

industries. This action is considered necessary because not all State

scrapie control programs are effective in identifying animals that may

be infected with scrapie and controlling

[[Page 66800]]

their movement in intrastate and interstate commerce in a manner that

will prevent the further spread of scrapie. Statutory authorities

including 21 U.S.C. 111, 114, 114a, and 134a-134h authorize the

Department of Agriculture to conduct programs for the control of

communicable animal diseases and to restrict the interstate movement of

animals that may spread disease.

As alternatives to this action, APHIS considered a complete ban on

interstate movement of sheep and goats from States that do not have

effective scrapie control programs. We also considered adding stricter

certification, recordkeeping, and animal identification requirements

for all sheep and goats moving interstate, without regard to the

effectiveness of individual State scrapie programs. We also considered

setting up a system to employ a prospective live-animal test in

mandatory testing of sheep and goats before they could be sold for any

commercial purpose, with mandatory destruction and disposal of animals

that fail the test. All of these alternatives would impose more costs

and recordkeeping requirements than the proposed alternative, and we do

not believe any of these alternatives would control scrapie more

effectively than the selected alternative. A complete ban on movements

from Inconsistent States would hurt the economies of those States, and

while it would provide other States with some protection against

infection from Inconsistent States, it would not eradicate the

reservoirs of scrapie in those States. The alternative of stricter

recordkeeping and identification for all interstate movements would not

be effective as long as some of the information to be recorded is

unknown or dubious, as can frequently happen when the animal originates

in a State with a weak scrapie program. The alternative of mandatory

testing and destruction of animals that fail was discussed earlier in

this proposal, it is not a practical option because a live-animal test

has not been validated and approved and also impractical at this time

on economic grounds.

This rule would result in the expenditure of indemnity funds by

APHIS to compensate the owners of certain animals destroyed to prevent

the spread of scrapie. This would also encourage certain States to

improve the effectiveness of their State scrapie programs, to avoid

additional restrictions on the movement of sheep and goats from their

States. Finally, because this rule allows certain interstate movements

only if the flock is enrolled in the Scrapie Flock Certification

Program or an equivalent State program, this rule would encourage

producers to enroll in such programs and bear the resulting flock

management and identification costs.

The budgetary effects on APHIS of this proposal would fall into

three categories: A small increase in outlays for staff to work with

States and producers as they adapt to the new scrapie program

requirements, a new program for indemnity payments, and the cost of

providing official eartags and backtags, all within available funds.

The initial amount of indemnity payments (the first year) is estimated

to be approximately $384,250, based on an estimated 3,074 animals

eligible for indemnity in known scrapie-infected and source flocks, but

may be more than that if producer response to the availability of

indemnity results in new admissions of infection that reveal additional

cases of scrapie. The amount of indemnity paid should decline in

subsequent years, although if slaughter surveillance is initiated or if

live-animal tests are approved and widely used, this decline may not

occur for several years, depending on the number of scrapie-positive

animals that are revealed by initial use of these tests. This indemnity

program would be less costly than some previous indemnity programs

since it focuses on eliminating individual infected and high-risk

animals rather than entire flocks, a focus that should be aided in the

near future by the availability of a validated live-animal test. If a

live-animal test is accepted for official use, an increase in indemnity

costs would be expected initially as new infected flocks are

identified.

Some States would bear additional costs to improve their State

scrapie programs so that the producers in their States could avoid

additional interstate movement restrictions proposed for States without

effective intrastate programs. However, we believe that most States

already have effective intrastate programs that would qualify them as

Consistent States and that all but two or three States have the

necessary authority and infrastructure to run an effective intrastate

program.

Overview of U.S. Sheep and Goat Industry Operations, Inventory and

Trade

There were 7.822 million sheep and lambs in the United States based

on 1997 Census of Agriculture reports. In the national inventory, 5.85

million were breeding sheep and lambs and the rest were market sheep,

based on National Agricultural Statistics Service reports. Ewes, 1 year

old or older, totaled 4.57 million during the same period.

Small farms, as shown in Table 1, accounted for over 99 percent of

all the farms raising sheep and lambs, while farms considered to be

large accounted for less than 0.3 percent. About 85 percent of the

farms had an inventory of less than 100 animals and accounted for about

17 percent of the total inventory of sheep and lambs. On the other

hand, sheep operations with an inventory of 5,000 sheep or more

represented less than 0.3 percent of the farms but accounted for nearly

26 percent of the total inventory.

Table 1 Sheep and Lambs: Farms and Inventory by Size, 1997

------------------------------------------------------------------------

Number of Inventory

Farm inventory farms Farm share share

------------------------------------------------------------------------

1 to 24.......................... 35,584 0.54 0.045

25 to 99......................... 20,461 0.31 0.123

100 to 299....................... 6,010 0.09 0.123

300 to 999....................... 2,429 0.04 0.158

1,000 to 2,499................... 820 0.01 0.160

2,500 to 4,999................... 297 0.005 0.128

5,000 or more.................... 189 0.003 0.263

-------------

Total........................ 65,790

------------------------------------------------------------------------

Source: USDA, Census of Agriculture 1997.

[[Page 66801]]

Of the total number of operations, about 60 percent were full

owners, about 32 percent were part owners, and about 8 percent were

tenants.

Sheep are produced in all parts of the United States, although

stock levels vary from State to State. Ten States accounted for nearly

73 percent of the total inventory, mostly in western and central areas.

Northern and southeastern States have the smallest sheep populations,

accounting only for 5.2 percent of the total. About 3.805 million sheep

were commercially slaughtered in 1997. Additionally, about 57,000 sheep

were slaughtered on the farms, yielding a total of about 3.861 million

sheep slaughtered in 1997. About 3.62 million slaughtered sheep were

Federally inspected, of which 3.46 million were lambs and yearlings and

about 211,000 were mature sheep.

There were about 1.99 million goats in the United States in 1997,

of which 52 percent were goats other than Angora or milk goats, 41

percent were Angora goats and about 7 percent were milk goats. The

State of Texas accounted for about 64.3 percent of the goat inventory.

Other States where goats are raised include Arizona, California,

Georgia, New Mexico, North Carolina, Oklahoma, and Tennessee. These

States together represented another 14.2 percent of the U.S. goats

holdings. An average holding was about 35 goats. All goat holdings were

considered to be small.

During 1997 the United States produced about 267 million pounds of

mutton, lamb and goat meat. It exported 6.4 million pounds and imported

about 84 million pounds valued at $145 million. The United States

exported 1,474,060 sheep and goats valued at $63 million in 1997, of

which 1,457,144 went to Mexico. The United States imported 47,405 sheep

and goats valued at $6.684 million in 1997, of which 46,991 were from

Canada, 364 from New Zealand, 40 from Mexico, and 10 from Australia.

The United States imported 83,472,084 pounds of sheep and goat meat

valued at $145.174 million and exported 6,528,605 pounds of sheep and

goat meat valued at $7.362 million in 1997. Most lamb and mutton

imports came from Australia and New Zealand, countries recognized as

being free from scrapie. The United States is a net importer of lamb

and mutton.

Sheep and Goats Affected by Scrapie Interstate Movement

Restrictions

At present, of the approximately 8 million sheep and 2 million

goats in the United States,\2\ over 90 percent belong to commercial

flocks (operations rearing sheep for sale, mostly to be slaughtered).

There are 14 States altogether with 72 flocks that were on the infected

or source flock list as of June 6, 1999 (66 are scrapie infected

flocks, 6 are scrapie source flocks). Also, 31 other flocks contained a

scrapie-positive animal during FY 1998, but the implicated animals were

destroyed and the flocks are therefore not infected or source flocks.

Infected and source flocks are potential candidates for destruction and

indemnity payments. Additionally, over the last 8 years (1990-1997), an

annual average of 132 individual suspect scrapie cases have been

reported, of which approximately 48.6 percent were determined to be

scrapie-positive animals. However, it is likely that the number of

reported cases will increase as the indemnity payments become

available. There are about 1.932 million breeding sheep and lambs in

the 14 States in which positive cases have occurred in FY 1998 or in

which a source or infected flock exists. These animals represent

approximately 33 percent of all breeding sheep and lambs in the United

States and have a market value of about $185 million.

---------------------------------------------------------------------------

\2\ USDA, Sheep and Goats. Washington, DC: Agricultural

Statistics Board, Februrary 1991.

---------------------------------------------------------------------------

The average size of a flock in an operation in the 14 States was

86, with between 21 and 479 per operation. Approximately 82.5 percent

of these sheep are marketed, in most cases across State lines. However,

nearly 33 percent of the marketed sheep are lambs less than 6 months of

age, and would be exempt from individual animal identification under

the proposed rule.

Indemnity Costs for Animals Destroyed Due to Scrapie

The exact number of scrapie-positive and high-risk animals that

would qualify for indemnity payments is not known. However, an estimate

of the number of animals potentially eligible for indemnity would be

48.6 percent of the animals in an average scrapie infected or source

flock (based on past field experience). There are currently 66 scrapie

infected flocks and 6 scrapie source flocks. Additionally there were 64

other infected animals diagnosed in the past year that are no longer in

flocks on the infected flock list, because the flock owners voluntarily

destroyed the implicated animals. Thus, based on average flock size and

the average percentage of scrapie-positive animals in infected and

source flocks, the number that could be estimated to qualify for

indemnity payments during the first year would be 3,074 animals

(=(72 x 86 x .0486+64)). This estimate implies that about 0.15 percent

of the total number of breeding sheep and goats in the 14 States that

could potentially move interstate would be designated as high-risk

animals and be eligible for indemnity. The proportion of more expensive

registered animals was 74.38 percent (8,199/11,023).\3\ Assuming a 75

percent registered to 25 percent nonregistered animal composition, with

a $150 and $50 per animal indemnity payments, the estimated indemnity

expenditure would be about $384,250

(3.074 x 0.75 x 150+3,074 x 0.25 x 50). If the producer response to

indemnity payment availability is positive, resulting in an increased

number of indemnity requests, the expenditure would increase

accordingly. However, even if a much larger number of animals were to

be indemnified, the destruction of all known infected animals would

greatly advance the goal of scrapie eradication, and could only be

positive in terms of long-term reduced expenditure.

---------------------------------------------------------------------------

\3\ Based on the composition of 8,199 registered and 2,824

commercial animals as reported by APHIS personnel.

---------------------------------------------------------------------------

Costs to Producers and APHIS for Official Identification of Animals

Moving Interstate

The animal identification that would be required by this proposed

rule would result in additional costs. Of the approximately 8 million

sheep and lambs and 2 million goats in the United States, about 82.5

percent are potentially interstate movers and of these about 33 percent

are lambs less than 6 months of age, which would not require

identification tags under the new rule. Currently, the cost of metal

identification tags for cattle is about $0.15 per animal. Assuming the

total number of sheep and goats that would need identification tags is

4.633 million, the tag cost would be approximately $695,000

(4,633,000 x 0.15) for identifying interstate movers. If the time it

takes the owner to apply the tag (about 2 minutes per animal) is valued

at $7.36 per hour (the average wage for livestock workers in April,

1999), this labor cost represents another $1.137 million. In some

States, tags are provided by APHIS free to accredited veterinarians,

while in others, they are purchased by accredited veterinarians through

the State. Generally, wherever APHIS directly distributes tags they are

free; where States distribute them, there may be no charge, a small

processing fee, or a fee covering the full cost of the

[[Page 66802]]

tags, depending on State regulations. If owners elect to use backtags,

the costs would be less. Owners will incur the costs of applying

identification. The impact on goat owners would be less, since about 72

percent of goats are the angora type, which are raised for their mohair

and are less frequently moved interstate. Thus the total potential

identification cost for goat owners would be in the range of $37,000.

International Trade Effects

The United States has limited foreign trade both in live sheep and

goats and their products. Australia, a potential major importer of U.S.

sheep for breeding purposes, is scrapie-free and prohibits imports of

sheep from the United States. Australia allows imports of live goats

from the United States only if they undergo a 3-year quarantine upon

arrival. Canada and Mexico both allow the importation of U.S. sheep

only if the sheep are from flocks enrolled in the Voluntary Scrapie

Flock Certification Program or if USDA can certify the flock's scrapie

status. In 1997 the total earnings from exports of live sheep, goats,

and sheep and goat meat and meat products was approximately $65

million. The United States is a net exporter of live animals, while it

is a net importer of mutton, lamb and goat meat. Both the sources of

imports and destinations of exports are concentrated in a few

countries. Scrapie-free animals, and to some extent their products, are

likely to be highly valued in the domestic and international markets.

U.S. breeding stock that can be certified scrapie-free is expected to

be in high demand internationally. While scrapie-free status would do

little to enhance domestic or export consumption of U.S. mutton and

lamb, the lack of scrapie-free status could seriously reduce demand for

these products if public fears about transmissible spongiform

encephalopathies ever become associated with U.S. sheep products.

The U.S. competitiveness in the domestic and international markets

depends upon its reputation for producing high quality animals and

products. The actual product, as well as the purchasers' perception of

quality, both contribute to continued market acceptance. Thus, efforts

to eradicate scrapie and secure the health of U.S. sheep and goats will

continue to serve the economic interests of the industry and nation.

This proposed rule could give incentive for more rigorous efforts to

find infection and proceed rapidly to eradicate infected animals in

order to preserve a scrapie-free status.

This proposed rule should benefit U.S. producers in a number of

ways, especially by avoiding a number of direct costs and market

losses. Associations representing breeding sheep owners, slaughter

sheep owners, and wool-production sheep owners have all submitted

comments supporting the approach of this proposed rule and also stated

their associations' opinion that the benefits of the program would

greatly exceed the costs. Scrapie may cost the sheep industry as much

as $20.1 million per year in direct losses ($10 million in lost

breeding stock and embryo export sales, $3.95 million in disposal costs

for offal, and $6.176 to divert offal from ruminant food chains and in

loss of offal export markets. Scrapie also costs an unknown amount in

lost potential international markets and lost flock productivity.

Additionally, the sheep industry currently loses sales to drug

companies because the U.S. Food and Drug Administration requires

scrapie-free sources of sheep or goat materials for pharmaceutical or

biological products implanted or injected in humans.

Therefore, adopting this proposal could make the U.S. sheep

industry more competitive, particularly in live sheep and goat exports,

since current trade shows that the value of live animal exports is

almost four times that of the meat in the global market. This proposal

also addresses consumer concerns about the presence of a transmissible

spongiform encephalopathy in food. While there is no evidence that

scrapie is a human health risk, there is a perception of risk. This

perception might be playing a significant role in encouraging U.S.

imports of over $170 million worth of lamb and mutton, since imported

lamb sells at a higher price than domestic lamb and mutton.

In summary, this proposed rule would regulate the interstate

movement of sheep and goats from States that do not follow effective

flock management practices for scrapie. Interstate movement of sheep

and goats is beneficial, as it reduces interstate price differences

faced by consumers of livestock products, and allows producers to seek

the best available prices for their products. The proposed rule would

encourage States to carry out the necessary surveillance and quarantine

activities quickly, thereby reducing the spread of the disease. The

process outlined in the proposed rule would encourage these States to

begin stringent surveillance procedures immediately to identify any

additional infected flocks and help to realize the goal of eradicating

scrapie from the United States. The proposed rule would also encourage

flock owners to participate in State scrapie programs or the Federal

Scrapie Flock Certification Program, contributing further to the

control of scrapie. Apart from the cost of program activities by APHIS

and State agencies, and expenditure of indemnity funds by APHIS, the

cost of identifying animals for interstate movement is the primary cost

imposed by this proposed rule. This cost will impose some burden upon

owners, which will be passed along to those who are interested in

buying these animals, possibly reducing interstate commerce in sheep

and goats slightly.

The proposed changes to the regulations would result in new

information collection or recordkeeping requirements, as described

below under the heading ``Paperwork Reduction Act.'' Executive Order

12612 and Federalism

It has been determined under section 6(a) of Executive Order 12612,

Federalism, that this rule does not have sufficient federalism

implications to warrant the preparation of a federalism assessment. The

provisions contained in this proposed rule would not have a substantial

direct effect on States or their political subdivisions or on the

distribution of power and responsibilities among the various levels of

government.

The Administrator has examined the federalism implications of the

requirements in this proposal, i.e., different interstate movement

requirements for sheep and goats depending on whether they are moving

from a Consistent State or an Inconsistent State. The Administrator

believes that this action adheres to Constitutional principles for the

exercise of Federal power and is clearly authorized by statutory

authorities delegated to APHIS.

This action would not absolutely impose any new compliance costs on

State or local governments, but it is true that, if adopted, this rule

would strongly encourage some States to expend additional funds to

upgrade their State programs for disease control in sheep and goats.

Owners of sheep and goats in States that do not fund their programs to

an extent that allows them to qualify as Consistent States would face

additional restrictions on the interstate movement of their sheep and

goats.

As discussed above, this proposal was preceded by an advance notice

of proposed rulemaking which sought comments from the public, industry,

and State and local officials. That notice specifically requested

comments addressing ``the alignment of Federal interstate movement

restrictions with State standards.'' The comments that we received and

considered when drafting

[[Page 66803]]

this proposal, including comments on State issues, are addressed above.

Additionally, in drafting this proposal, APHIS had many discussions

with officials of animal health agencies in affected States.

During these consultations, most States supported the proposal's

intention to establish a system to certify that State programs for

sheep and goats meet certain minimum standards, in order to provide a

baseline of protection against the spread of disease when moving sheep

and goats in interstate commerce. A very few officials commented that

APHIS should accept any State animal health program without enforcing

minimum standards. APHIS disagrees with this position because

experience in animal health programs on a national level has shown that

the absence of effective programs for scrapie in a few States can

quickly cause animal disease problems and financial losses affecting

many States as animals move in interstate commerce.

State and local governments have the opportunity to comment on this

proposed rule, and we encourage them to submit comments on federalism

concerns or any other issues. As this rulemaking continues, APHIS

intends to continue active consultation with State animal health

agencies and the elected officials of affected State and local

governments.

Executive Order 12988

This proposed rule has been reviewed under Executive Order 12988,

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

and local laws and regulations that are in conflict 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 section 3507(d) of the Paperwork Reduction Act

of 1995 (44 U.S.C. 3501 et seq.), the information collection or

recordkeeping requirements included in this proposed rule have been

submitted for approval to the Office of Management and Budget (OMB).

Please send written comments to the Office of Information and

Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington,

DC 20503. Please state that your comments refer to Docket No. 97-093-2.

Please send a copy of your comments to: (1) Docket No. 97-093-2,

Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River

Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer,

OCIO, USDA, room 404-W, 14th Street and Independence Avenue SW.,

Washington, DC 20250. A comment to OMB is best assured of having its

full effect if OMB receives it within 30 days of publication of this

proposed rule.

This proposed rule would revise various recordkeeping and

notification requirements of APHIS scrapie regulations and the

Voluntary Scrapie Flock Certification Program. The purpose of these

requirements is primarily to prevent the uncontrolled interstate

movement of animals that could spread scrapie, and to identify and

certify flocks that are free of scrapie in order to prevent the disease

from spreading.

Collecting this information necessitates the use of a number of

information-gathering documents, including certificates and permits,

that are critical to our ability to locate flocks infected with scrapie

and to prevent the interstate spread of scrapie. The collection of this

information is therefore crucial to the success of scrapie control.

State animal health agencies would also have to submit descriptions of

their scrapie program activities to assist APHIS in determining whether

they qualify for Consistent State status.

We are soliciting comments from the public (as well as affected

agencies) concerning our proposed information collection and

recordkeeping requirements. We need this outside input to help us:

(1) Evaluate whether the proposed information collection is

necessary for the proper performance of our agency's functions,

including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the

proposed information collection, including the validity of the

methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to

be collected;

(4) Minimize the burden of the information collection on those who

are to respond (such as through the use of appropriate automated,

electronic, mechanical, or other technological collection techniques or

other forms of information technology, e.g., permitting electronic

submission responses).

Estimate of burden: The public reporting burden for this collection

of information is estimated to average 2.5049 hours per response.

Respondents: Flock owners, State animal health officials,

accredited veterinarians, State and Federal veterinary medical

officers, and State and Federal diagnostic laboratory personnel.

Estimated annual number of respondents: 1,180.

Estimated annual number of responses per respondent: 5.3610.

Estimated annual number of responses: 6,326.

Estimated total annual burden on respondents: 15,846 hours. (Due to

rounding, the total annual burden hours may not equal the product of

the annual number of responses multiplied by the average reporting

burden per response.)

Copies of this information collection can be obtained from:

Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence

Avenue, SW., Washington, DC 20250.

Unfunded Mandates Reform Act of 1995

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public

Law 104-4, establishes requirements for Federal agencies to assess the

effects of their regulatory actions on State, local, tribal

governments, and the private sector. Under section 202 of the UMRA,

APHIS generally must prepare a written statement, including a cost-

benefit analysis, for proposed and final rules with ``Federal

mandates'' that may result in expenditures by State, local, or tribal

governments, in the aggregate, or to the private sector, of $100

million or more in any one year. When such a statement is needed for a

rule, section 205 of the UMRA generally requires APHIS to identify and

consider a reasonable number of regulatory alternatives and adopt the

least costly, more cost-effective, or least burdensome alternative that

achieves the objectives of the rule.

This rule contains no Federal mandates (under the regulatory

provisions of Title II of the UMRA) that may result in expenditures by

State, local, and tribal governments, in the aggregate, or to the

private sector, of $100 million or more in any one year. A few States

may not qualify as Consistent States under this rule unless and until

they choose to increase their expenditures on scrapie control programs,

but based on knowledge of current State budgets and our experience with

the costs involved in conducting sheep and goat disease programs, we

estimate that the possible increases in expenditures by these States

will fall far below $100 million. Thus, this rule is not subject to the

requirements of sections 202 and 205 of the UMRA.

[[Page 66804]]

List of Subjects

9 CFR Part 54

Animal diseases, Goats, Indemnity payments, Scrapie, Sheep.

9 CFR Part 79

Animal diseases, Goats, Quarantine, Reporting and recordkeeping

requirements, Scrapie, Sheep, Transportation.

Accordingly, we are proposing to revise 9 CFR parts 54 and 79 as

follows:

PART 54--CONTROL OF SCRAPIE

Sec.

54.1 Definitions.

Subpart A--Scrapie Indemnification Program

54.3 Animals eligible for indemnity payments.

54.4 Application by owners for indemnity payments.

54.5 Certification by owners.

54.6 Amount of indemnity payments.

54.7 Procedures for destruction of animals.

Subpart B--Scrapie Flock Certification Program

54.10 Administration.

54.11 Participation.

54.12 State scrapie certification boards.

54.13 Cooperative agreements with States.

54.14 Requirements for flock plans and post-exposure management

monitoring plans.

Authority: 21 U.S.C. 111, 114, 114a, and 134a-134h; 7 CAR 2.22,

2.80, and 371.2(d).

Sec. 54.1 Definitions.

Accredited veterinarian. A veterinarian approved by the

Administrator in accordance with part 161 of this chapter to perform

functions specified in subchapters B, C, and D of this chapter.

Administrator. The Administrator of the Animal and Plant Health

Inspection Service, or any employee of the United States Department of

Agriculture authorized to act for the Administrator.

Affected animal. An animal for which a diagnosis of scrapie has

been made by an APHIS or State representative based on the results of a

live-animal screening test approved for this use by the Administrator.

A live-animal screening test may be approved for this use without also

being approved for the official diagnosis of a scrapie-positive animal.

Animal. A sheep or goat.

Animal and Plant Health Inspection Service (APHIS). The Animal and

Plant Health Inspection Service of the United States Department of

Agriculture.

APHIS representative. An individual employed by APHIS in animal

health activities who is authorized by the Administrator to perform the

function involved.

Area veterinarian in charge. The veterinary official of APHIS who

is assigned by the Administrator to supervise and perform the official

animal health work of APHIS in the State concerned.

Breed association and registries. Organizations that maintain the

permanent records of ancestry or pedigrees of animals (including the

animal's sire and dam), individual identification of animals, and

ownership of animals.

Commingled, commingling. Animals grouped together and having

physical contact with each other, including contact through a fence,

but not limited contacts. Commingling also includes sharing the same

section in a transportation unit where there is any physical contact.

Destroyed. Euthanized by means other than slaughter, and the

carcass disposed of, by means authorized by the Administrator.

Electronic implant. Any radio frequency identification implant

device approved for use in the scrapie program by the Administrator.

The Administrator will approve an electronic implant after determining

that it is tamper resistant, not harmful to the animal, and readable by

equipment available to APHIS and State representatives.

Exposed animal. Any animal that has been in the same flock at the

same time within the previous 60 months as a scrapie-positive animal,

excluding limited contacts. Any animal born in a flock after a scrapie-

positive animal was born into that flock, if born before that flock

completes the requirements of a flock plan.

Flock. All animals that are maintained on a single premises and all

animals under common ownership or supervision on two or more premises

with animal interchange between the premises. Changes in ownership of a

flock do not change the identity of the flock or the regulatory

requirements applicable to the flock. More than one flock may be

maintained on a single premises if:

(1) The flocks are enrolled as separate flocks in the SFCP, or an

APHIS representative determines based upon examination of flock records

that no animals have moved between the flocks;

(2) The flocks never commingle and are kept at least 30 feet apart

at all times;

(3) The flocks have separate flock records and identification;

(4) The flocks have separate lambing facilities, including

buildings and pastures, and a pasture or building used for lambing by

one flock is not used by the other flock at any time;

(5) The flocks do not share equipment without cleaning and

disinfection in accordance with the guidelines published in the Scrapie

Flock Certification Program standards; and

(6) There is no interchange of animals between the flocks.

Flock plan. A written flock management agreement designed by the

owner of a flock, an accredited veterinarian, and an APHIS

representative or State representative in which each participant agrees

to undertake actions specified in the flock plan to control the spread

of scrapie from, and eradicate scrapie in, an infected flock or source

flock or to reduce the risk of the occurrence of scrapie in a flock

that contains a high-risk or an exposed animal. As part of a flock

plan, the flock owner must provide the facilities and personnel needed

to carry out the requirements of the flock plan. The flock plan must

include the requirements in Sec. 54.14 of this part.

High-risk animal. An animal that is:

(1) The progeny of a scrapie-positive dam;

(2) Born in the same flock during the same lambing season as

progeny of a scrapie-positive dam, unless the progeny of the scrapie-

positive dam are from separate contemporary lambing groups; or

(3) Born in the same flock during the same lambing season that a

scrapie-positive animal was born, or during any subsequent lambing

season.

Infected flock. Any flock in which an APHIS representative or a

State representative has determined an animal to be a scrapie-positive

animal or in which an APHIS representative or a State representative

has determined that a scrapie-positive animal had lambed within 18

months of the time at which the tissues used for diagnosis were

collected from the scrapie-positive animal. A flock will no longer be

considered an infected flock after it has completed the requirements of

a flock plan.

Limited contacts. Incidental contacts between animals off the

flock's premises such as at fairs, shows, exhibitions and sales;

between ewes being inseminated, flushed, or implanted; or between rams

at ram test or collection stations. Embryo transfer and artificial

insemination equipment and surgical tools must be sterilized between

animals for these contacts to be considered limited contacts. Limited

contacts do not include any contact, incidental or otherwise, with an

animal during, or up to 60 days after, lambing or kidding.

[[Page 66805]]

Limited contacts do not include any activity where uninhibited contact

occurs, such as sharing an enclosure, sharing a section of a transport

vehicle, or transportation to other flocks for breeding, except as

allowed by the Scrapie Flock Certification Program standards.

Live-animal screening test. Any test for the diagnosis of scrapie

in a live animal that is approved by the Administrator as usually

reliable but not definitive for diagnosing scrapie, and that is

conducted in a laboratory approved by the Administrator.\1\

---------------------------------------------------------------------------

\1\ The names and addresses of laboratories approved by the

Administrator to conduct live-animal screening tests will be

published in the Notices Section of the Federal Register. A list of

approved laboratories is also available upon request from the Animal

and Plant Health Inspection Service, Veterinary Services, National

Animal Health Programs Staff, 4700 River Road Unit 43, Riverdale, MD

20737-1235. State, Federal, and university laboratories will be

approved by the Administrator when he or she determines that the

laboratory: (a) Employs personnel trained by the National Veterinary

Services Laboratories assigned to supervise the testing; (b) Follows

standard test protocols; (c) Meets check test proficiency

requirements; and (d) Will report all test results to State and

Federal animal health officials. Before the Administrator may

withdraw approval of any laboratory for failure to meet any of these

conditions, the Administrator must give written notice of the

proposed withdrawal to the director of the laboratory, and must give

the director an opportunity to respond. If there are conflicts as to

any material fact, a hearing will be held to resolve the conflict.

---------------------------------------------------------------------------

Mortgage. Any mortgage, lien, or other security or beneficial

interest held by any person other than the one claiming indemnity.

Owner. A person, partnership, company, corporation, or any other

legal entity who has legal or rightful title to animals, whether or not

they are subject to a mortgage.

Post-exposure management and monitoring plan. A written agreement

designed by the owner of a flock, an accredited veterinarian, and an

APHIS representative or State representative in which each participant

agrees to undertake actions specified in the agreement to monitor for

the recurrence of scrapie in the flock for at least 5 years after the

last high-risk or scrapie-positive animal is removed from the flock or

to monitor for occurrence of scrapie for 5 years after the last

exposure of the flock to a scrapie-positive animal, unless otherwise

specified by an APHIS or state animal health official. As part of a

post-exposure management and monitoring plan, the flock owner must

provide the facilities and personnel needed to carry out the

requirements of the plan. The plan must include the requirements in

Sec. 54.14 of this part.

Scrapie Flock Certification Program (SFCP). The cooperative

Federal-State-industry voluntary program for the control of scrapie

conducted in accordance with this subpart.

Scrapie Flock Certification Program standards. Cooperative

procedures and standards adopted by APHIS and State scrapie

certification boards for reducing the incidence and controlling the

spread of scrapie through flock certification.\2\

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\2\ Individual copies of the Scrapie Flock Certification Program

standards may be obtained on the World Wide Web at URL http://

www.aphis.usda.gov/vs/scrapie, or from the Animal and Plant Health

Inspection Service, National Animal Health Programs Staff, 4700

River Road Unit 43, Riverdale, MD 20737-1235.

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Scrapie-positive animal. An animal for which a diagnosis of scrapie

has been made by the National Veterinary Services Laboratories, United

States Department of Agriculture, or another laboratory authorized by

the Administrator to conduct scrapie tests in accordance with this

part, through:

(1) Histopathological examination of central nervous system (CNS)

tissues from the animal for characteristic microscopic lesions of

scrapie;

(2) The use of protease-resistant protein analysis methods

including but not limited to immunohistochemistry and/or western

blotting on CNS and/or peripheral tissue samples from a live or a dead

animal for which a given method has been approved by the Administrator

for use on that tissue;

(3) Bioassay;

(4) Scrapie associated fibrils (SAF) detected by electron

microscopy; or

(5) Any other test method approved by the Administrator.\3\

---------------------------------------------------------------------------

\3\ The names and addresses of laboratories approved by the

Administrator to conduct tests are published in the Notices Section

of the Federal Register. A list of approved laboratories is also

available upon request from the Animal and Plant Health Inspection

Service, Veterinary Services, National Animal Health Programs Staff,

4700 River Road Unit 43, Riverdale, MD 20737-1235. State, Federal,

and university laboratories will be approved by the Administrator

when he or she determines that the laboratory: (a) Employs personnel

trained by the National Veterinary Services Laboratories assigned to

supervise the testing; (b) Follows standard test protocols; (c)

Meets check test proficiency requirements; and (d) Will report all

test results to State and Federal animal health officials. Before

the Administrator may withdraw approval of any laboratory for

failure to meet any of these conditions, the Administrator must give

written notice of the proposed withdrawal to the director of the

laboratory, and must give the director an opportunity to respond. If

there are conflicts as to any material fact, a hearing will be held

to resolve the conflict.

---------------------------------------------------------------------------

Separate contemporary lambing groups. To be a separate contemporary

lambing group, the group must be maintained separately such that the

animals cannot come into physical contact with other lambs, kids, ewes

or does or birth fluids or placenta from other ewes or does. This

separate maintenance must preclude contact through a fence, during

lambing and for 60 days following the date the last lamb or kid is born

in a lambing season, and must preclude using the same lambing facility

as other ewes or does, unless the lambing facility is cleaned and

disinfected between lambings in accordance with the guidelines

published in the Scrapie Flock Certification Program standards.

Source flock. A flock in which an APHIS representative or a State

representative has determined that at least one animal was born that

was diagnosed as a scrapie-positive animal at an age of 54 months or

less. A flock will no longer be a source flock after it has completed

the requirements of a flock plan.

State. Each of the 50 States, the District of Columbia, the

Northern Mariana Islands, Puerto Rico, and all territories or

possessions of the United States.

State representative. An individual employed in animal health

activities by a State or a political subdivision of a State, and who is

authorized by the State or political subdivision to perform the

function involved.

Suspect animal. A sheep or goat exhibiting any of the following

possible signs of scrapie and that has been determined to be suspicious

for scrapie by an accredited veterinarian, an APHIS representative, or

a State representative: Weight loss despite retention of appetite;

behavioral abnormalities; pruritus (itching); wool pulling; biting at

legs or side; lip smacking; motor abnormalities such as incoordination,

high stepping gait of forelimbs, bunny hop movement of rear legs, or

swaying of back end; increased sensitivity to noise and sudden

movement; tremor, ``star gazing,'' head pressing, recumbency, or other

signs of neurological disease or chronic wasting. A suspect animal will

no longer be a suspect animal upon determination by an APHIS

representative or a State representative that it no longer exhibits

such signs, or that the signs are not caused by scrapie.

Subpart A--Scrapie Indemnification Program

Sec. 54.3 Animals eligible for indemnity payments.

(a) Indemnity may be paid for an animal only after the owner of the

animal has applied for indemnification and been approved in accordance

with 54.4 of this part. Indemnity may be paid only for the following:

(1) Destruction of high-risk animals;

[[Page 66806]]

(2) Destruction of animals based on an epidemiologic investigation,

when the Administrator determines that the destruction of these animals

will contribute to the eradication of scrapie;

(3) Destruction of live scrapie-positive animals;

(4) Destruction of affected animals; and

(5) Destruction of suspect animals that are subsequently determined

to be scrapie-positive animals.

(b) No indemnity will be paid for an animal if the owner of the

animal fails to provide APHIS, within 30 days of request, with animal

registration certificates, sale and movement records, or other records

requested in accordance with Sec. 54.5 of this part. No indemnity will

be paid until the premises, including all structures, holding

facilities, conveyances, and materials contaminated because of

occupation or use by the depopulated animals, have been properly

cleaned and disinfected in accordance with the guidelines published in

the Scrapie Flock Certification Program standards. Premises or portions

of premises may be exempted from such cleaning and disinfecting

requirements if the APHIS or State representative determines that the

exempted buildings, holding facilities, conveyances, or other materials

on the premises do not require cleaning and disinfection to prevent the

spread of scrapie.

Sec. 54.4 Application by owners for indemnity payments.

(a) Normally, an application for indemnification will be initiated

by an APHIS or State representative who is working with the owner of a

flock that has already been determined to be an infected flock or

source flock, or that is already under a State quarantine. In such

cases, the flock owner will confirm information about the flock's

eligibility for indemnity that is contained in the application

submitted by the APHIS or State representative. However, an owner of a

flock that has or has not been determined to be an infected flock or

source flock, and is not under a State quarantine, may apply directly

to receive indemnification by submitting to the Administrator a written

request containing the following information:

(1) Name, address, and social security number of the flock owner;

(2) Number and breed(s) of animals in the flock, including a

current inventory;

(3) Location of flock premises;

(4) Reasons the owner believes animals in his or her flock may be

eligible for indemnification, including any diagnosis of scrapie made

for animals in the flock; any signs of scrapie observed in the flock by

the owner; and any movement of animals into the flock from flocks

infected with or exposed to scrapie;

(5) A copy of the registration papers issued in the name of the

owner for any registered animals in the flock. If the registration

papers are unavailable or if the animals are less than 1 year old and

are not registered at the time the claim for indemnity is submitted,

the area veterinarian in charge may grant a 60-day extension or the

Administrator may grant an extension longer than 60 days for the

presentation of registration papers; and

(6) Signed release letters addressed to any sheep or goat registry

associations that maintain records of the owner's sheep or goats,

requesting the associations to release to APHIS all records maintained

by the association on sheep or goats currently or formerly owned by the

applicant.

(b) APHIS will evaluate each application to determine whether the

owner's flock contains animals eligible for indemnity in accordance

with 54.3 of this part.

Sec. 54.5 Certification by owners.

Before any indemnity is paid to an owner, the owner must sign a

written agreement with APHIS, certifying the following:

(a) The owner will make available for review upon request by an

APHIS representative all bills of sale, pedigree registration

certificates, and other records regarding movement of animals into and

from the flock;

(b) If the owner maintains any flock after the payment of indemnity

or acquires a new flock that is housed on the same premises within 5

years after the last high-risk or scrapie-positive animal is removed,

the owner will maintain the flock in accordance with a post-exposure

management and monitoring plan;

(c) If the animal for which indemnity is paid is subject to any

mortgage, the owner consents to the payment of the indemnity, up to the

value of the mortgage, to the person(s) holding the mortgage.

Sec. 54.6 Amount of indemnity payments.

Indemnity paid in accordance with 54.3 of this part will be $150

for each registered animal destroyed and $50 for each unregistered

animal destroyed.

Sec. 54.7 Procedures for destruction of animals.

(a) Animals for which indemnification is sought must be destroyed

on the premises where held, pastured, or penned at the time indemnity

is approved, unless the APHIS representative involved approves in

advance of destruction moving the animals to another location for

destruction.

(b) The carcasses of animals destroyed in accordance with this

section are authorized by the Administrator to be buried, incinerated,

or disposed of by other methods in accordance with local, State, or

Federal law. The carcasses must not be processed for animal food,

unless subjected to a treatment process approved by the Administrator

and known to eliminate the agents of transmissible spongiform

encephalopathies. The carcasses may not be processed for human food.

(c) The destruction of animals and disposition of their carcasses

in accordance with this part must be monitored by an APHIS

representative who will prepare and transmit to the Administrator a

report identifying the animals and showing their disposition.

(d) APHIS will not be responsible for any costs or charges for the

destruction and disposal of animals in accordance with this part.

Subpart B--Scrapie Flock Certification Program

Sec. 54.10 Administration.

The Scrapie Flock Certification Program is a cooperative effort

between APHIS; members of the sheep and goat industry, including owners

of flocks, slaughtering and rendering establishments, and breed

associations and registries; accredited veterinarians; and State

governments. APHIS coordinates with State scrapie certification boards

and State animal health agencies to encourage flock owners to reduce

the incidence of scrapie by voluntarily complying with the Scrapie

Flock Certification Program standards.

Sec. 54.11 Participation.

Any owner of a sheep or goat flock may apply to enter the Scrapie

Flock Certification Program by sending a written request to a State

scrapie certification board or to the Administrator. A notice

containing a current list of flocks participating in the Scrapie Flock

Certification Program, and the certification status of each flock, may

be obtained from the APHIS website at URL http://www.aphis.usda.gov/vs/

scrapie, and may also be obtained by writing to the Animal and Plant

Health Inspection Service, National Animal Health Programs Staff, VS,

APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1235.

[[Page 66807]]

(Approved by the Office of Management and Budget under control

number 0579-0101)

Sec. 54.12 State scrapie certification boards.

An area veterinarian in charge, after consulting with a State

representative and industry representatives, may appoint a State

scrapie certification board for the purpose of coordinating activities

for the Scrapie Flock Certification Program, including making decisions

to admit flocks to the Scrapie Flock Certification Program and to

change flock status in accordance with the Scrapie Flock Certification

Program standards. No more than one State scrapie certification board

may be formed in each State. Each State scrapie certification board

shall include as members the area veterinarian in charge, one or more

State representatives, one or more accredited veterinarians, and one or

more owners of flocks, and, at the discretion of the area veterinarian

in charge, may include other members.

Sec. 54.13 Cooperative agreements with States.

APHIS may execute a cooperative agreement with the animal health

agency of any State to cooperatively administer the Scrapie Flock

Certification Program within that State. These cooperative agreements

will describe the respective roles of APHIS and State personnel in

implementing the Scrapie Flock Certification Program standards and

other scrapie control measures. The agreement may specify the

financial, material, and personnel resources to be committed to the

Scrapie Flock Certification Program and other scrapie control measures

by APHIS and the State; assign specific Scrapie Flock Certification

Program activities and other activities related to the control of

scrapie within a State to APHIS or State personnel; establish schedules

for APHIS representatives or State representatives to visit

participating flocks; establish procedures for maintaining and sharing

Scrapie Flock Certification Program records specified in the Scrapie

Flock Certification Program standards, and specify other

responsibilities of State representatives and APHIS representatives in

support of the Scrapie Flock Certification Program and the State

scrapie control program.

(Approved by the Office of Management and Budget under control

number 0579-0101)

Sec. 54.14 Requirements for flock plans and post-exposure management

and monitoring plans.

(a) The owner of the flock or his or her agent must identify all

animals 1 year of age or over within the flock. All animals less than 1

year of age must be identified when a change of ownership occurs, with

the exception of those animals under 6 months of age moving within

slaughter channels that must be identified in accordance with Sec. 79.2

of this chapter. The form of identification must be an electronic

implant, flank tattoo, ear tattoo, or tamper-resistant ear tag approved

by APHIS. In the case of goats, the form of identification may

alternatively be a tail fold tattoo. The official identification must

provide a unique identification number that is applied by the owner of

the flock or his or her agent.

(b) Upon request of an APHIS or State representative, the owner of

the flock or his or her agent must have an accredited veterinarian

collect and submit tissues from animals for scrapie diagnostic purposes

to a laboratory designated by an APHIS or State representative.

(c) The owner of the flock or his or her agent, upon request, must

make animals in the flock and the records required to be kept as a part

of these plans available for inspection by APHIS representatives and

State representatives.

(d) The owner of the flock or his or her agent must meet

requirements found necessary by the APHIS representative or State

representative to monitor for scrapie and to prevent the recurrence of

scrapie in the flock. These other requirements may include, but are not

limited to: Utilization of an approved live-animal test, segregated

lambing, cleaning and disinfection of lambing facilities, and/or

education of the owner of the flock and personnel working with the

flock in techniques to recognize clinical signs of scrapie and to

control the spread of scrapie.

(e) The owner of the flock or his or her agent must immediately

report to a State representative, APHIS representative, or an

accredited veterinarian any animals in the flock exhibiting the

following: Weight loss despite retention of appetite; behavioral

abnormalities; pruritus (itching); wool pulling; biting at legs or

side; lip smacking; motor abnormalities such as incoordination, high

stepping gait of forelimbs, bunny hop movement of rear legs, swaying of

back end; increased sensitivity to noise and sudden movement; tremor,

``star gazing'', head pressing, recumbency, or other signs of

neurological disease or chronic wasting illness. Such animals must not

be removed from the flock without written permission of an APHIS

representative or State representative.

(f) Requirements for flock plans only:

(1) An epidemiologic investigation must be conducted to identify

high-risk and exposed animals that currently reside in the flock or

that previously resided in the flock, and all high-risk animals,

scrapie-positive animals, affected animals, and suspect animals must be

removed from the flock. The animals must be removed by euthanization

and disposal of the carcasses by burial, incineration, or other methods

in accordance with State or Federal law, or, in the case of high-risk

animals, by movement to slaughter (slaughtered animals are not eligible

for indemnity) in accordance with the provisions of part 79 of this

chapter, or upon request in individual cases by another means

determined by the Administrator to be sufficient to prevent the spread

of scrapie;

(2) The premises of a flock under a flock plan must be cleaned and

disinfected in accordance with the guidelines published in the Scrapie

Flock Certification Program standards;

(3) The owner of the flock, or his or her agent, must request breed

associations and registries, livestock markets, and packers to disclose

records to APHIS representatives or State representatives, to be used

to identify source flocks and trace exposed animals, including high-

risk animals; and

(4) The flock owner must agree to conduct post-exposure management

and monitoring.

(g) Requirements for post-exposure management and monitoring plans

only: The plan will require that an APHIS representative or State

representative inspect the flock and flock records at least once every

12 months. The owner of the flock or his or her agent must maintain,

and keep for a minimum of 5 years after an animal dies or is otherwise

removed from a flock, the following records for each animal in the

flock:

(1) Any identifying marks or tags present on the animal including

the animal's individual official identification number from its

electronic implant, flank tattoo, ear tattoo tamper resistant ear tag,

or, in the case of goats, it may be a tail fold tattoo, and any

secondary form of identification the owner of the flock may choose to

maintain;

(2) Sex, breed, sire, dam, and offspring of the animal;

(3) Date of acquisition and previous flock, if the animal was not

born in the flock; and

(4) Disposition of the animal, including the date and cause of

death, if known, or date of removal from the flock and name and address

of the person to whom the animal was transferred.

[[Page 66808]]

PART 79--SCRAPIE IN SHEEP AND GOATS

Sec.

79.1 Definitions.

79.2 Identification of sheep and goats in interstate commerce.

79.3 General restrictions.

79.4 Designation of scrapie-positive animals, affected animals,

high-risk animals, exposed animals, suspect animals, source flocks,

and infected flocks; notice to owners.

79.5 Issuance of certificates.

79.6 Standards for State programs to qualify as Consistent States.

Authority: 21 U.S.C. 111-113, 115, 117, 120, 121, 123-126, 134b,

and 134f; 7 CFR 2.22, 2.80, and 371.2(d).

Sec. 79.1 Definitions.

Accredited veterinarian. A veterinarian approved by the

Administrator in accordance with part 161 of this chapter to perform

functions specified in subchapters B, C, and D of this chapter.

Administrator. The Administrator of the Animal and Plant Health

Inspection Service, or any employee of the United States Department of

Agriculture authorized to act for the Administrator.

Affected animal. An animal for which a diagnosis of scrapie has

been made by an APHIS or State representative based on the results of a

live-animal screening test approved for this use by the Administrator.

A live-animal screening test may be approved for this use without also

being approved for the diagnosis of a scrapie-positive animal.

Animal. A sheep or goat.

Animal and Plant Health Inspection Service (APHIS). The Animal and

Plant Health Inspection Service of the United States Department of

Agriculture.

APHIS representative. An individual employed by APHIS in animal

health activities who is authorized by the Administrator to perform the

function involved.

Area veterinarian in charge. The veterinary official of APHIS who

is assigned by the Administrator to supervise and perform the official

animal health work of APHIS in the State concerned.

Breed association and registries. Organizations that maintain the

permanent records of ancestry or pedigrees of animals (including the

animal's sire and dam), individual identification of animals, and

ownership of animals.

Certificate. An official document issued in accordance with

Sec. 79.5 of this part by an APHIS representative, State

representative, or accredited veterinarian at the point of origin of an

interstate movement of animals, which includes a statement that the

animals were not exhibiting clinical signs associated with scrapie at

the time of examination.

Commingled, commingling. Animals grouped together and having

physical contact with each other, including contact through a fence,

but not limited contacts. Commingling also includes sharing the same

section in a transportation unit where there is physical contact.

Consistent State. A State that the Administrator has determined

conducts an active State scrapie control program that either:

(1) Meets the requirements of Sec. 79.6 of this part; or

(2) Effectively enforces a State designed plan that the

Administrator determines is at least as effective in controlling

scrapie as the requirements of Sec. 79.6 of this part.

Designated scrapie epidemiologist. An epidemiologist selected by

the State animal health official and the area veterinarian in charge to

reclassify animals already designated as high-risk, exposed, or

affected with scrapie, based on epidemiologic investigation or the

results of a live-animal test. The regional epidemiologist and the

APHIS National Scrapie Program Coordinator must concur in the selection

and appointment of the designated scrapie epidemiologist.

Electronic implant. Any radio frequency identification implant

device approved for use in the scrapie program by the Administrator.

The Administrator will approve an electronic implant after determining

that it is tamper resistant, not harmful to the animal, and readable by

equipment available to APHIS and State representatives.

Exposed animal. Any animal that has been in the same flock at the

same time within the previous 60 months as a scrapie-positive animal,

excluding limited contacts. Any animal born in a flock after a scrapie-

positive animal was born into that flock, if born before that flock

completes the requirements of a flock plan.

Flock. All animals that are maintained on a single premises and all

animals under common ownership or supervision on two or more premises

with animal interchange between the premises. Changes in ownership of a

flock do not change the identity of the flock or the regulatory

requirements applicable to the flock. More than one flock may be

maintained on a single premises if:

(1) The flocks are enrolled as separate flocks in the SFCP, or an

APHIS representative determines based upon examination of flock records

that no animals have moved between the flocks;

(2) The flocks never commingle and are kept at least 30 feet apart

at all times;

(3) The flocks have separate flock records and identification;

(4) The flocks have separate lambing facilities, including

buildings and pastures, and a pasture or building used for lambing by

one flock is not used by the other flock at any time;

(5) The flocks do not share equipment without cleaning and

disinfection in accordance with the guidelines published in the Scrapie

Flock Certification Program standards; and

(6) There is no interchange of animals between the flocks.

Flock plan. A written flock management agreement designed by the

owner of a flock, an accredited veterinarian, and an APHIS

representative or State representative in which each participant agrees

to undertake actions specified in the flock plan to control the spread

of scrapie from, and eradicate scrapie in, an infected flock or source

flock or to reduce the risk of the occurrence of scrapie in a flock

that contains a high-risk or an exposed animal. As part of a flock

plan, the flock owner must provide the facilities and personnel needed

to carry out the requirements of the flock plan. The flock plan must

include the requirements in Sec. 54.14 of this chapter.

High-risk animal. An animal that is:

(1) The progeny of a scrapie-positive dam;

(2) Born in the same flock during the same lambing season as

progeny of a scrapie-positive dam, unless the progeny of the scrapie-

positive dam are from separate contemporary lambing groups; or

(3) Born in the same flock during the same lambing season that a

scrapie-positive animal was born, or during any subsequent lambing

season.

Inconsistent State. Any State other than a Consistent State.

Infected flock. Any flock in which an APHIS representative or a

State representative has determined an animal to be a scrapie-positive

animal or in which an APHIS representative or a State representative

has determined that a scrapie-positive animal had lambed within 18

months of the time at which the tissues used for diagnosis were

collected from the scrapie-positive animal. A flock will no longer be

considered an infected flock after it has completed the requirements of

a flock plan.

Interstate commerce. Trade, traffic, transportation, or other

commerce between a place in a State and any place

[[Page 66809]]

outside of that State, or between points within a State but through any

place outside that State.

Limited contacts. Incidental contacts between animals off the

flock's premises such as at fairs, shows, exhibitions and sales;

between ewes being inseminated, flushed, or implanted; or between rams

at ram test or collection stations. Embryo transfer and artificial

insemination equipment and surgical tools must be sterilized between

animals for these contacts to be considered limited contacts. Limited

contacts do not include any contact, incidental or otherwise, with an

animal during, or up to 60 days after, lambing or kidding. Limited

contacts do not include any activity where uninhibited contact occurs,

such as sharing an enclosure, sharing a section of a transport vehicle,

or transportation to other flocks for breeding, except as allowed by

the Scrapie Flock Certification Program standards.

Live-animal screening test. Any test for the diagnosis of scrapie

in a live animal that is approved by the Administrator as usually

reliable but not definitive for diagnosing scrapie, and that is

conducted in a laboratory approved by the Administrator.\1\

---------------------------------------------------------------------------

\1\ The names and addresses of laboratories approved by the

Administrator to conduct live-animal screening tests will be

published in the Notices Section of the Federal Register. A list of

approved laboratories is also available upon request from the Animal

and Plant Health Inspection Service, Veterinary Services, National

Animal Health Programs Staff, 4700 River Road Unit 43, Riverdale, MD

20737-1235. State, Federal, and university laboratories will be

approved by the Administrator when he or she determines that the

laboratory: (a) Employs personnel trained by the National Veterinary

Services Laboratories assigned to supervise the testing; (b) follows

standard test protocols; (c) meets check test proficiency

requirements; and (d) will report all test results to State and

Federal animal health officials. Before the Administrator may

withdraw approval of any laboratory for failure to meet any of these

conditions, the Administrator must give written notice of the

proposed withdrawal to the director of the laboratory, and must give

the director an opportunity to respond. If there are conflicts as to

any material fact, a hearing will be held to resolve the conflict.

---------------------------------------------------------------------------

Owner. A person, partnership, company, corporation, or any other

legal entity who has legal or rightful title to animals, whether or not

they are subject to a mortgage.

Permit. An official document issued in connection with the

interstate movement of animals (VS Form 1-27 or a State form that

contains the same information) that is issued by an APHIS

representative, State representative, or an accredited veterinarian

authorized to sign such permits. A new permit is required for each

change in destination for an animal. A permit lists the owner's name

and address, points of origin and destination, number of animals

covered, purpose of the movement, whether the animals are from an

infected flock or a source flock, transportation vehicle license number

or other identification number, and seal number (if a seal is

required). A permit also lists all official identification on the

animals covered, including the official eartag number, individual

animal registered breed association registration tattoo, individual

animal registered breed association registration brand, United States

Department of Agriculture backtag (when applied serially, only the

beginning and the ending numbers need be recorded), individual animal

registered breed association registration number, or any other form of

official identification present on the animal.

Premises identification. An APHIS approved eartag, backtag, or

tattoo bearing the premises identification number assigned by a State

or Federal animal health official to the premises on which the sheep or

goats originated, or a brand registered with an official brand

registry.

Scrapie Flock Certification Program (SFCP). The cooperative

Federal-State-industry voluntary program for the control of scrapie

conducted in accordance with 9 CAR part 54, subpart B.

Scrapie Flock Certification Program standards. Cooperative

procedures and standards adopted by APHIS and State Scrapie

Certification Boards for reducing the incidence and controlling the

spread of scrapie through flock certification.\2\

---------------------------------------------------------------------------

\2\ Individual copies of the Program Standards may be obtained

on the World Wide Web at URL http://www.aphis.usda.gov/vs, or from

the Animal and Plant Health Inspection service, National Animal

Health Programs Staff, 4700 River Road Unit 43, Riverdale, MD 20737-

1235.

---------------------------------------------------------------------------

Scrapie-positive animal. An animal for which a diagnosis of scrapie

has been made by the National Veterinary Services Laboratories, United

States Department of Agriculture, or another laboratory authorized by

the Administrator to conduct scrapie tests in accordance with this

part, through:

(1) Histopathological examination of central nervous system (CNS)

tissues from the animal for characteristic microscopic lesions of

scrapie;

(2) By the use of protease-resistant protein analysis methods

including but not limited to immunohistochemistry and/or western

blotting on CNS and/or peripheral tissue samples from a live or a dead

animal for which a given method has been approved by the Administrator

for use on that tissue;

(3) Bioassay;

(4) Scrapie associated fibrils (SAF) detected by electron

microscopy; or

(5) Another test method approved by the Administrator.

Separate contemporary lambing groups. To be a separate contemporary

lambing group, the group must be maintained separately such that the

animals cannot come into physical contact with other lambs, kids, ewes

or does or birth fluids or placenta from other ewes or does. This

separate maintenance must preclude contact through a fence, during

lambing and for 60 days following the date the last lamb or kid is born

in a lambing season, and must preclude using the same lambing facility

as other ewes or does, unless the lambing facility is cleaned and

disinfected between lambings in accordance with the guidelines

published in Scrapie Flock Certification Program standards.

Source flock. A flock in which an APHIS representative or a State

representative has determined that at least one animal was born that

was diagnosed as a scrapie-positive animal at an age of 54 months or

less. A flock will no longer be a source flock after it has completed

the requirements of a flock plan.

State. Each of the 50 States, the District of Columbia, the

Northern Mariana Islands, Puerto Rico, and all territories or

possessions of the United States.

State representative. An individual employed in animal health

activities by a State or a political subdivision of a State, and who is

authorized by the State or political subdivision to perform the

function involved.

Suspect animal. A sheep or goat exhibiting any of the following

possible signs of scrapie and that has been determined to be suspicious

for scrapie by an accredited veterinarian, an APHIS representative, or

a State representative: Weight loss despite retention of appetite;

behavioral abnormalities; pruritus (itching); wool pulling; biting at

legs or side; lip smacking; motor abnormalities such as incoordination,

high stepping gait of forelimbs, bunny hop movement of rear legs, or

swaying of back end; increased sensitivity to noise and sudden

movement; tremor, ``star gazing,'' head pressing, recumbency, or other

signs of neurological disease or chronic wasting. A suspect animal will

no longer be a suspect animal upon determination by an APHIS

representative or a State representative that it no longer exhibits

such signs, or that the signs are not caused by scrapie.

(Approved by the Office of Management and Budget under control

number 0579-0101)

[[Page 66810]]

Sec. 79.2 Identification of sheep and goats in interstate commerce.

(a) No sheep or goat that is required to be individually identified

by Sec. 79.3 of this part may be sold, transported, received for

transportation, or offered for sale or transportation, in interstate

commerce, unless each sheep or goat is identified in accordance with

this section.

(1) The sheep or goat must be identified at whichever of the

following comes first:

(i) The point of first commingling of the sheep or goats in

interstate commerce with sheep or goats from any other source;

(ii) Upon unloading of the sheep or goats in interstate commerce at

any livestock market;

(iii) Upon transfer of ownership of the sheep or goats in

interstate commerce; or

(iv) Upon arrival of the sheep or goats in interstate commerce at

their final destination.

(2) The sheep or goats must be identified by one of the following

means of identification, and must remain so identified while they are

in interstate commerce:

(i) Electronic implants for animals required to be identified by

the SFCP, when used in a flock participating in the SFCP;

(ii) Official eartags, including tags approved for use in the SFCP,

when used on any sheep or goat;

(iii) United States Department of Agriculture backtags, when used

on sheep or goats moving to slaughter;

(iv) Official sheep or goat tattoos, when used on sheep or goats

participating in the SFCP; or

(v) Official registry tattoos that have been recorded in the book

of record of a sheep or goat registry association.

(3) Each person who buys or sells, for his or her own account or as

the agent of the buyer or seller, transports, receives for

transportation, offers for sale or transportation, or otherwise handles

sheep or goats in interstate commerce is responsible for the

identification of the sheep or goats as provided by this section.

(b) Serial numbers of United States Department of Agriculture

backtags and official sheep and goat tattoos will be assigned to each

person who applies to the State animal health official or the area

veterinarian in charge for the State in which that person maintains his

or her place of business. Serial numbers of official eartags will be

assigned to each accredited veterinarian or State or Federal

representative who requests official eartags from the State animal

health official or the area veterinarian in charge, whoever is

responsible for issuing official eartags in that State. Premises

identification numbers will be assigned to participants in the SFCP by

the State animal health official or the area veterinarian in charge,

whoever is responsible for assigning premises codes in that State.

Persons assigned serial numbers of United States Department of

Agriculture backtags, official sheep and goat tattoos, and official

eartags must:

(1) Record the following information on a document:

(i) All serial numbers applied to the sheep or goat;

(ii) Any other serial numbers and approved identification appearing

on the sheep or goat;

(iii) The street address, including the city and State, or the

township, county, and State, of the premises where the approved means

of identification was applied; and

(iv) The telephone number, if available, of the person who owns or

possesses the sheep or goat;

(2) Maintain these records for 5 years; and

(3) Make these records available for inspection and copying during

ordinary business hours (8 a.m. to 5:30 p.m., Monday through Friday)

upon request by any authorized employee of the United States Department

of Agriculture, and presentation of his or her official credentials.

(c) Each person who buys or sells, for his or her own account or as

the agent of the buyer or seller, transports, receives for

transportation, offers for sale or transportation, or otherwise handles

sheep or goats in interstate commerce must keep records relating to the

transfer of ownership, shipment, or handling of the sheep or goats,

such as yarding receipts, sale tickets, invoices, and waybills.

(1) The records must include:

(i) If individual animal identification is required, all serial

numbers and other approved means of identification appearing on the

sheep or goat; and

(ii) The street address, including city and State, or the township,

county, and State, and the telephone number, if available, of the

person from whom the sheep or goats were purchased or otherwise

obtained.

(2) Each person required to keep records under this paragraph must

maintain the records for at least 5 years after the person has sold or

otherwise disposed of the sheep or goat to another person, and for such

further period as the Administrator may require by written notice to

the person, for purposes of any investigation or action involving the

sheep or goat identified in the records. The person must make the

records available for inspection and copying during ordinary business

hours (8 a.m. to 5:30 p.m., Monday through Friday) by any authorized

employee of the United States Department of Agriculture, upon that

employee's request and presentation of his or her official credentials.

(d) No person may remove or tamper with any approved means of

identification required to be on sheep or goats pursuant to this

section while the animals are in interstate commerce, and at the time

of slaughter animal identification must be maintained throughout

postmortem inspection in accordance with regulations of the Food Safety

Inspection Service in chapter III of this title.

(e) Written requests for approval of sheep or goat identification

devices and markings not listed in paragraph (b) of this section should

be sent to the Animal and Plant Health Inspection Service, Veterinary

Services, National Animal Health Programs Staff, 4700 River Road Unit

43, Riverdale, MD 20737-1235. If the Administrator determines that the

devices and markings will provide a means of tracing sheep and goats in

interstate commerce, a proposal will be published in the Federal

Register to add the devices and markings to the list of approved means

of sheep and goat identification.

Sec. 79.3 General restrictions.

The following prohibitions and movement conditions apply to the

interstate movement of sheep and goats, and no sheep or goat may move

interstate except in compliance with them.

[[Page 66811]]

Interstate Movement General Restrictions for Sheep and Goats

------------------------------------------------------------------------

Moved from Moved from

Type of interstate movement INCONSISTENT State CONSISTENT State

------------------------------------------------------------------------

(a) Sale or other movement

of breeding animals, show

animals or any other animal

not specifically addressed

below:

(1) High-risk animal, Prohibited*......... Prohibited.*

scrapie positive,

suspect, or affected

animal.

(2) Non-high risk animal Prohibited*......... Prohibited.*

from an infected or

source flock.

(3) Other animal........ Flock must be Individual animal ID

enrolled in the and certificate.

Complete Monitored

category of the

Scrapie Flock

Certification

Program or

equivalent APHIS-

recognized program

and have

certificate.

(b) Sale or other movement

directly to slaughter, or

through slaughter channels

to slaughter, of animals

under 6 months of age:

(1) Scrapie positive, Prohibited*......... Prohibited.*

suspect, or affected

animal.

(2) High-risk animals Individual animal ID Individual animal ID

and animals from and permit or and permit or

infected or source sealed conveyance sealed conveyance

flock. and permit when and permit when

moving directly to moving directly to

slaughter, or a slaughter, or a

permit and an permit and an

indelible''S'' mark indelible ``S''

on the left jaw. mark on the left

jaw.

(3) Other animal........ Premises ID** and None.

certificate.

(c) Sale or other movement

directly to slaughter, or

through slaughter channels

to slaughter, of animals

over 6 months of age, or

animals of any age to

feedlots for later movement

to slaughter:

(1) Scrapie positive, Prohibited*......... Prohibited.*

suspect, or affected

animal.

(2) High-risk animals Individual animal ID Individual animal ID

and animals from and permit. and permit.

infected or source

flock.

(3) Other exposed Individual animal ID Individual animal

animals. and permit. ID.

(4) Other animals over 1 Individual animal ID Individual animal

year of age. and certificate. ID.

(5) Other animals Individual animal ID Premises ID.**

between 6 months and 1 and certificate.

year of age, or animals

under 6 months of age

moving to feedlots for

later movement to

slaughter.

(d) Movement of animals for

grazing or other management

purposes without change of

ownership:

(1) Scrapie positive, Prohibited*......... Prohibited.*

suspect, or affected

animal.

(2) High-risk animal or Prohibited*......... Prohibited.*

animal from infected or

source flock.

(3) Exposed animals..... Individual animal ID Premises ID.

and certificate.

(4) Other animal........ Premises ID and None.

certificate.

------------------------------------------------------------------------

*Animals prohibited movement may be moved interstate only if they are

moving interstate for destruction or research as approved by the

Administrator.

**Premises ID is not required for slaughter animals if the animals are

kept as a group on the same premises on which they were born and are

not commingled with animals from another premises at any time,

including throughout the slaughter process, or, if they are commingled

during the slaughter process, they are officially identified on

arrival at the slaughter facility such that any animal can be traced

back to its flock of origin.

Note: A CONSISTENT STATE is one whose intrastate identification,

quarantine and movement restrictions for infected and source flocks

and high-risk animals are consistent with the APHIS standards for

State scrapie programs.

Sec. 79.4 Designation of scrapie-positive animals, affected animals,

high-risk animals, exposed animals, suspect animals, source flocks, and

infected flocks; notice to owners.

(a) Designation. An APHIS representative or State representative

will designate an animal to be a scrapie-positive animal, affected

animal, high-risk animal, exposed animal, or suspect animal after

determining that the animal meets the criteria of the relevant

definition in Sec. 79.1 of this part. An APHIS representative or State

representative will designate a flock to be a source flock after

reviewing sale, movement, and breeding records that indicate the flock

meets the definition of a source flock in Sec. 79.1 of this part. An

APHIS representative or State representative will designate a flock to

be an infected flock after determining that the flock meets the

definition of an infected flock in Sec. 79.1 of this part.

(b) Reclassification. A designated scrapie epidemiologist may

reclassify an exposed animal by removing that designation after

completing an epidemiologic investigation and determining that the

exposure was limited to a scrapie-positive male animal that was not

born in the flock (the scrapie-positive animal must have individual

animal identification traceable to the flock of origin), and was not

housed in lambing facilities or commingled with lambs while in the

flock. A designated scrapie epidemiologist may reclassify an animal

designated a high-risk animal as an exposed animal after receiving

negative results from an approved live-animal test.

(c) Notice to owner. As soon as possible after making such a

determination, an APHIS representative or State representative will

attempt to notify the owner(s) of the flock(s) in

[[Page 66812]]

writing that their flock contained or contains a scrapie-positive

animal, an affected animal, a suspect animal, a high-risk animal or an

exposed animal, or that the flock is an infected flock, or source

flock. The notice will include a description of the interstate movement

restrictions and identification requirements contained in this part.

Sec. 79.5 Issuance of certificates.

(a) Certificates are required as specified by Sec. 79.3 of this

part for certain interstate movements of animals. A certificate must

show the official ear tag number, individual animal registered breed

association registration tattoo, individual animal registered breed

association registration brand, individual animal registered breed

association registration number, and any other official individual

identification of each animal to be moved; the number of animals

covered by the certificate; the purpose for which the animals are to be

moved; the points of origin and destination; the consignor; and the

consignee. Ownership brands or other premises identification may be

used in place of individual animal identification on certificates for

sheep and goats moved interstate when premises identification is

required under this part, provided the ownership brands are registered

with the official brand recording agency. Except as provided in

paragraphs (b) and (c) of this section, all of the information required

by this paragraph must be typed or written on the certificate.

(b) As an alternative to typing or writing individual animal

identification on a certificate, another document may be used to

provide this information, but only under the following conditions:

(1) The document must be a State form or APHIS form that requires

individual identification of animals;

(2) A legible copy of the document must be stapled to the original

and each copy of the certificate;

(3) Each copy of the document must identify each animal to be moved

with the certificate, but any information pertaining to other animals,

and any unused space on the document for recording animal

identification, must be crossed out in ink; and

(4) The following information must be typed or written in ink in

the identification column on the original and each copy of the

certificate and must be circled or boxed, also in ink, so that no

additional information can be added:

(i) The name of the document; and

(ii) Either the serial number on the document or, if the document

is not imprinted with a serial number, both the name of the person who

prepared the document and the date the document was signed.

(c) As an alternative to typing or writing ownership brands on a

certificate, an official brand inspection certificate may be used to

provide this information, but only under the following conditions:

(1) A legible copy of the official brand inspection certificate

must be stapled to the original and each copy of the certificate;

(2) Each copy of the official brand inspection certificate must

show the ownership brand of each animal to be moved with the

certificate, but any other ownership brands, and any unused space for

recording ownership brands, must be crossed out in ink; and

(3) The following information must be typed or written in ink in

the official identification column on the original and each copy of the

certificate and must be circled or boxed, also in ink, so that no

additional information can be added:

(i) The name of the attached document; and

(ii) Either the serial number on the official brand inspection

certificate or, if the official brand inspection certificate is not

imprinted with a serial number, both the name of the person who

prepared the official brand inspection certificate and the date it was

signed.

Sec. 79.6 Standards for State programs to qualify as Consistent

States.

(a) In reviewing a State for Consistent State status, the

Administrator will evaluate the State statutes, regulations and

directives pertaining to animal health activities, reports and

publications of the State animal health agency, and a written statement

from the State animal health agency describing State scrapie control

activities and certifying that these activities meet the requirements

of this section. In determining whether a State is a Consistent State,

the Administrator will consider whether the State's scrapie control

program:

(1) Requires the reporting of and investigation of any suspect

animal, affected animal, or scrapie-positive animal;

(2) Requires the official permanent individual identification of

any live scrapie-positive, affected, or suspect animal of any age, and

of any exposed animal, including high-risk animals, 1 year of age or

over and any exposed animals less than 1 year of age when a change of

ownership occurs, except those animals under 6 months of age moving

within slaughter channels in accordance with this part (whether or not

the exposed animal resides in a source or infected flock);

(3) Effectively enforces quarantines of all source and infected

flocks;

(4) Effectively enforces quarantines of all high-risk, affected,

suspect, and scrapie-positive animals throughout their lives unless

moved in accordance with this part;

(5) If an affected, suspect or scrapie-positive animal dies or is

destroyed, requires that tissues be submitted for diagnostic testing to

a laboratory authorized by the Administrator to conduct scrapie tests

in accordance with this part and that the carcass be completely

destroyed; and

(6) Releases quarantines of these flocks only upon completion of a

flock plan and agreement by the owner to participate in a post-exposure

monitoring and management plan as defined in part 54 of this chapter.

(b) [Reserved]

Done in Washington, DC, this 23rd day of November 1999.

Craig A. Reed,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 99-31087 Filed 11-29-99; 8:45 am]

BILLING CODE 3410-34-U