Johne's Disease in Domestic Animals; Interstate Movement

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 71 and 80

[Docket No. 98-037-1]

Johne's Disease in Domestic Animals; Interstate Movement

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing several changes to the regulations regarding

the interstate movement of domestic animals that have reacted to a test

for paratuberculosis. First, we are proposing to replace all references

to ``paratuberculosis'' with references to ``Johne's disease'' to

reflect a change in nomenclature. Second, we are proposing to identify

an official test for the detection of Johne's disease in domestic

animals. Third, we are proposing to allow sexually intact animals that

are positive to the official Johne's disease test to be moved

interstate for the collection of germ plasm. Fourth, we are proposing

to amend the requirements for moving animals interstate. These actions

would update the regulations and remove restrictions on the interstate

movement of animals that are positive to an official Johne's disease

test that do not appear necessary to prevent the interstate spread of

Johne's disease.

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

before May 21, 1999.

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

Docket No. 98-037-1, Regulatory Analysis and Development, PPD, APHIS,

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

state that your comments refer to Docket No. 98-037-1. 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. Joseph S. VanTiem, Senior Staff

Veterinarian, National Animal Health Programs, VS, APHIS, 4700 River

Road Unit 43, Riverdale, MD 20737-1231, (301) 734-7716.

SUPPLEMENTARY INFORMATION:

Background

Paratuberculosis, also known as Johne's disease, is a disease

caused by Mycobacterium paratuberculosis. This disease primarily

affects cattle, sheep, goats, and other domestic, exotic, and wild

ruminants. Paratuberculosis is a chronic and contagious enteritis that

results in progressive wasting and eventual death. Clinical signs are

rarely evident until 2 or 3 years after the initial infection, which

usually occurs soon after birth. The organism is shed in large numbers

in the feces of infected animals, and infection can be acquired by

ingestion of organisms from contaminated food and water sources. The

organism can also be present in colostrum and milk of infected cows.

The disease is nearly always introduced into a clean herd by an

infected animal that does not show symptoms of the disease. Our

regulations are intended to control the interstate spread of the

disease in the United States.

The regulations in subchapter C of chapter I, title 9, Code of

Federal Regulations, govern the interstate movement of animals to

prevent the dissemination of livestock and poultry diseases in the

United States. Parts 71 and 80 (referred to below as the regulations)

are included in subchapter C. Part 71 relates to the interstate

transportation of animals, poultry, and animal products. Part 80

pertains to the interstate movement of domestic animals that are

paratuberculosis reactors. A paratuberculosis reactor is a domestic

animal that has reacted to a test recognized by the Secretary of

Agriculture for paratuberculosis.

In this document, we are proposing several changes to the

regulations regarding the interstate movement of domestic animals

affected with paratuberculosis.

Paratuberculosis

We are proposing to amend the regulations in parts 71 and 80 by

replacing all references to ``paratuberculosis'' with references to

``Johne's disease'' to reflect a change in nomenclature. Since the

regulations were first promulgated, accepted veterinary medical

terminology has changed. Paratuberculosis is now generally referred to

as Johne's disease. In this proposed rule, we will use the term

``Johne's disease'' when referring to ``paratuberculosis,'' as

appropriate.

Definitions (Sec. 80.1)

The proposed changes to part 80 of the regulations would make it

necessary for us to add definitions in Sec. 80.1 for several terms used

in the proposed regulations. We are proposing to add definitions for

Administrator, Animal and Plant Health Inspection Service (APHIS),

APHIS representative, approved livestock facility, area veterinarian in

charge, official eartag, owner-shipper statement, permit, premises

identification number, premises of origin, recognized slaughtering

establishment, State animal health official, and State representative.

We are also proposing to add three definitions that are not

currently defined or used elsewhere in subchapter C. Germ plasm would

be defined as semen, embryos or ova. Johne's disease would be defined

as an infectious and communicable disease that primarily affects

cattle, sheep, goats, and other domestic, exotic, and wild ruminants,

also known as paratuberculosis, caused by Mycobacterium

paratuberculosis. The proposed definition for official Johne's disease

test, the third definition we would add, is discussed later in this

document.

We are also proposing to update the definitions of accredited

veterinarian, moved, and State in Sec. 80.1 to make them consistent

with the definitions of these terms found in other parts of chapter I,

title 9, Code of Federal Regulations.

We are also proposing to remove several terms from Sec. 80.1 that

would no longer be used in part 80. Specifically, we would remove the

terms paratuberculosis, Federal inspector, person, specifically

approved stockyard, and State inspector. As explained earlier,

paratuberculosis would be replaced by Johne's disease. Federal

inspector would be replaced by APHIS representative; person would no

longer be used; specifically approved stockyard would be replaced with

approved

[[Page 13727]]

livestock facility; and State inspector would be replaced by State

representative.

In addition, we are proposing to amend Sec. 80.1 by removing the

paragraph designations and placing all definitions in alphabetical

order.

Official Johne's Disease Test

We are proposing to identify an official test for the detection of

domestic animals that are infected with M. paratuberculosis. Currently,

part 80 restricts the interstate movement of domestic animals that have

reacted to a test for Johne's disease. However, the regulations do not

identify a specific test. As a consequence, State and Federal

diagnostic laboratories have used various diagnostic tests to diagnose

Johne's disease in animals.

There are a number of tests currently used to diagnose Johne's

disease. Antibody detection tests, such as the enzyme-linked

immunosorbent assay, agar gel immunodiffusion, and complement fixation,

detect the presence of antibodies to M. paratuberculosis in serum

samples. Organism detection tests, such as fecal culture or polymerase

chain reaction (PCR), detect the presence of the M. paratuberculosis

organism in fecal samples. Most antibody detection tests are more rapid

or less expensive than organism detection tests. However, at this time,

we believe that an organism detection test would be the most specific

and most reliable index of infection in live animals.

We are, therefore, proposing to amend Sec. 80.1 to add a definition

for the term official Johne's disease test. An organism detection test

would be the official Johne's disease test. We would require the test

to be conducted in an approved laboratory \1\. The Administrator of the

Animal and Plant Health Inspection Service (APHIS) would approve a

laboratory to conduct the official Johne's disease test after

determining that the laboratory meets the check test proficiency

requirements prescribed by the National Veterinary Services

Laboratories. Approval would continue as long as such check test

proficiency requirements are met on an annual basis. If the laboratory

fails to pass the check test proficiency requirements, the laboratory

would be removed from the list of approved laboratories for the type of

test that it failed. For example, if a laboratory is approved for

performing fecal culture and PCR testing, but during the annual recheck

of its proficiency, the laboratory passed the fecal culture check test

proficiency requirements and failed the PCR check test proficiency

requirements, the laboratory would remain on the approved list of

laboratories for the fecal culture test but would be removed from the

approved list of laboratories for PCR.

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\1\ A list of currently approved laboratories and the

requirements for approval are available from the Diagnostic

Bacteriology Laboratory, National Veterinary Services Laboratories,

P.O. Box 844, Ames, Iowa 50010.

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We would refer to animals identified as having Johne's disease on

the basis of an organism detection test as animals ``positive to the

official Johne's disease test,'' rather than as ``reactors.'' An animal

that reacts to a test can either be infected with the organism being

detected or show a reaction due to the presence of an element in the

test sample collected from the animal that is cross reacting in the

test. For some diagnostic tests, ``reactor''is an appropriate term

because some of these tests detect the presence of antibody against an

organism. An animal may have antibodies to other organisms that cross-

react with antigens in the test, and the result may appear as a

reaction. However, the organism detection test will detect the presence

of the M. paratuberculosis organism; therefore, ``positive to'' is a

more appropriate term than ``reactor.''

Interstate Movement of Domestic Animals Positive to the Official

Johne's Disease Test

Currently, Sec. 80.4 provides that cattle and other domestic

animals that have reacted to a test for Johne's disease may only be

moved interstate to a recognized slaughtering establishment or to a

specifically approved stockyard for sale to a recognized slaughter

establishment. Prior to movement, cattle and other domestic animals

must be identified with an approved metal eartag that is attached to

their left ear and bears a serial number and the inscription, ``U.S.

Reactor,'' or a similar State reactor tag. Cattle must also be: (1)

Branded with the letter ``J'' on their left hip near the tailhead; or

(2) accompanied directly to slaughter by an APHIS or State

representative; or (3) moved in vehicles closed with official seals

that are applied and removed by an APHIS representative, State

representative, accredited veterinarian, or an individual authorized

for this purpose by an APHIS representative.

We are proposing a number of changes to Sec. 80.4 regarding the

interstate movement of animals. First, we are proposing to require the

use of an official eartag to identify animals that are positive to the

official Johne's disease test and remove the requirement for a ``U.S.

Reactor'' inscribed eartag. We believe that it is sufficient to

identify these animals with an official eartag, since an official

eartag can be used to trace the animals to their premises of origin,

even if they are separated from their accompanying documentation.

Second, we are proposing to remove the requirement that cattle be

branded, accompanied by an APHIS or State representative, or

transported in sealed vehicles. When Sec. 80.4 of the regulations was

promulgated, Johne's disease was an emerging disease in the United

States, and measures were instituted to clearly identify infected

animals. We believe that it is no longer necessary to require measures,

such as branding, that overtly identify cattle as infected with M.

paratuberculosis. Also, herd owners must often wait 1 to 5 days for

APHIS or State personnel to be available to brand the animals, seal the

trucks, or accompany the shipment of animals to their destination. By

removing these requirements, herd owners would be able to remove

infected animals from their premises sooner and decrease the

possibility of these animals infecting other animals on the premises.

Third, we are proposing to remove the requirement that cattle and

other domestic animals that are reactors to a test for Johne's disease

be accompanied by a certificate issued by a Federal or State inspector

or an accredited veterinarian in accordance with Sec. 80.9. Currently,

the certificate must show: (1) The animals have reacted to the test;

(2) the reactor tag number for each animal, the owner, and the date

tested; (3) the authorization for movement; (4) the destination; and

(5) the purpose for movement. Instead of a certificate, we propose to

require that an owner-shipper statement accompany animals that are

positive to the official Johne's disease test. Unlike a certificate, an

owner-shipper statement can be completed by the owner or shipper of the

animals. This would enable herd owners to ship animals sooner than they

could if they had to wait for government personnel to issue a

certificate. The owner-shipper statement would be required for the

interstate movement to slaughter of animals that are positive to the

official Johne's disease test. We would require the owner-shipper

statement to provide: (1) The number of animals to be moved; (2) the

official eartag number of each animal; (3) the species of the animals;

(4) the points of origin and destination; (5) the consignor and

consignee; (6) a statement that the animals are positive to the

official Johne's disease test; and (7) any additional information

required by part 80.

[[Page 13728]]

Finally, we are proposing to allow sexually intact animals that are

positive to the official Johne's disease test to be moved interstate

for the collection of germ plasm under certain conditions.

Johne's disease primarily affects the intestinal system of infected

animals. The primary mode of transmission is the shedding of the

organism in feces. Animals become infected when they ingest

contaminated food or water. The agent can also be shed in milk or

colostrum of some infected cows, and calves may become infected by

ingesting this milk and/or colostrum. Although Johne's disease is not

primarily recognized as a sexually transmitted disease, the organism

has been isolated from the genitalia and semen of infected bulls and

the uterine washings of infected cows. The role that herd bulls used in

natural service play in the spread of infection is unknown, and the

risk from infected semen used for artificial insemination is considered

minimal. Research has shown that calves born to infected cows can

become infected in utero; however, it is unknown at what stage this

occurs. The M. paratuberculosis organism can adhere to embryos in vitro

but can be removed with trypsin washing techniques following the

International Embryo Transfer Association collection and treatment

protocols. Embryo transfer from infected cows has rarely resulted in

infected calves and is not known to have caused infection in the

recipient cow. (Embryo transfer is the removal of embryos from the

uterus of their dam (the donor) and transferring them to the uterus of

other females (recipients) for development to term.)

Currently, animals that react to a test for Johne's disease may not

be moved interstate for either natural breeding or germ plasm

collection. The transmission of infection from these animals via semen

or embryos is not considered a significant risk. By allowing the

interstate movement of positive animals for the collection of germ

plasm, we would allow herd owners to salvage valuable genetics and

continue the animal's lineage.

We would provide herd owners with the option of having the animals

returned to the premises of origin after the collection of germ plasm.

These animals could then be maintained in a manner to prevent the

spread of infection via manure. However, if the animals are not

returned to their premises of origin after the collection of germ

plasm, we would require these animals to be moved directly to a

recognized slaughtering establishment or to an approved livestock

facility for sale to a recognized slaughtering establishment.

We are proposing to require that animals moved interstate for the

collection of germ plasm be transported under permit. The permit would

be an official document (Veterinary Services Form 1-27, Permit for

Movement of Restricted Animals, or a State form that contains the same

information but not a ``permit for entry'') issued at the point of

origin by an APHIS or State representative or accredited veterinarian

for the interstate movement of the animals. The permit would have to

indicate: (1) The number of animals to be moved; (2) the purpose of the

movement; (3) a statement that the animals are positive to the official

Johne's disease test; (4) the official eartag number of each animal;

(5) the animals' breed and sex; (6) the name of the owner of the

animals; (7) the points of origin and destination; (8) the consignor

and consignee; and (9) the transportation vehicle number or other

identification number. We would require a permit to ensure that APHIS

or State officials are aware of the interstate movement of the animals

for purposes other than slaughter. We would also require the movement

to be agreed upon by the area veterinarian in charge and the State

animal health official of the States of origin and destination. In

addition, for the return of animals to the premises of origin from the

site of the collection of germ plasm, we would require a new permit.

The issuance of a new permit would help ensure that the State officials

are aware of the return of the animals to the premises of origin.

However, if the animals are to be transported directly to a recognized

slaughtering establishment or to an approved livestock facility for

sale to a recognized slaughtering establishment after the collection of

germ plasm, their movement would require an owner-shipper statement as

previously described.

Related Changes

Currently, Sec. 71.3(c)(1) allows domestic animals that have

reacted to a test for brucellosis or paratuberculosis to be moved

interstate in accordance with the provisions of parts 78 and 80,

respectively. For clarity, we believe that brucellosis and Johne's

disease should be addressed in separate paragraphs. We are proposing to

remove all references to paratuberculosis in paragraph (c)(1) and add a

new paragraph to address Johne's disease. The new paragraph would

provide that domestic animals that are positive to the official Johne's

disease test, but are not affected with any other disease referred to

in Sec. 71.2 and are not tick infested, may be moved interstate in

accordance with part 80.

In addition, paragraph (c)(1) refers to domestic animals that have

reacted to a test recognized by the Secretary of Agriculture for

brucellosis. For consistency with the terminology used in part 78, we

are proposing to amend paragraph (c)(1) to refer to domestic animals

that have reacted to an official test for brucellosis.

Currently, Sec. 80.3 provides that domestic animals affected with

Johne's disease may not be moved interstate except in compliance with

the regulations in part 80. We are proposing to amend Sec. 80.3 to

replace the term ``affected'' with ``positive to the official Johne's

disease test.''

Currently, Sec. 80.8 provides that domestic animals that are

paratuberculosis reactors cannot be moved interstate in a vehicle that

contains healthy animals susceptible to Johne's disease unless all of

the animals are for immediate slaughter or the reactors are kept

separated from the other animals by a partition that is securely

affixed to the sides of the vehicle. We are proposing to require that

the partition also prevent the transfer of fecal matter from the

infected animals to the healthy animals in the vehicle.

Provisions We Propose To Remove From Part 80

Section 80.2 of the regulations states that on June 5, 1952, the

Secretary of Agriculture issued a notice that paratuberculosis exists

in Puerto Rico and all but six States of the United States. This

historical information is superfluous. Therefore, we believe that this

section is no longer necessary and propose to remove Sec. 80.2 in its

entirety.

Section 80.5 of the regulations sets forth conditions for the

interstate shipment of purebred animals that have been moved interstate

for breeding purposes and, subsequent to the movement, reacted to a

test for paratuberculosis. Section 80.5 provides that these animals may

be shipped to their point of origin, for purposes other than immediate

slaughter, in accordance with Secs. 80.5 and 80.4 (a) and (b). Section

80.5 also provides that, after their return to the point of origin,

these animals cannot be moved interstate again except for immediate

slaughter. As stated previously, we are proposing to amend Sec. 80.4 to

allow animals that are positive to the official Johne's disease test to

be moved interstate either for slaughter or for the collection of germ

plasm. If these proposed changes are finalized, Sec. 80.5 will no

longer be

[[Page 13729]]

necessary. Therefore, we are proposing to remove 80.5 from the

regulations.

Section 80.6 of the regulations requires all records that accompany

paratuberculosis reactors interstate to be marked with the words,

``Paratuberculosis Reactors'' and a statement that the vehicles used to

transport the animals must be cleaned and disinfected. The applicable

records are waybills, conductor's manifests, switch orders, vehicle

interchange records, etc. As previously indicated in this document, we

are proposing to require an owner-shipper statement with each

interstate shipment of positive animals for slaughter purposes and a

permit for each interstate shipment of positive animals for the

collection of germ plasm and, if applicable, return to the premises of

origin. We would require the owner-shipper statement and the permit to

indicate that the animals are positive to the official Johne's disease

test. The owner-shipper statement would accompany the animals to

slaughter, and a permit would accompany animals to the destination for

the collection of germ plasm and on return to the premises of origin

after the collection of germ plasm. Under these circumstances, we

believe that marking other records would be unnecessary. Therefore, we

are proposing to remove 80.6 from the regulations.

Section 80.7 of the regulations requires cleaning and disinfecting

of all vehicles used to transport paratuberculosis reactors interstate.

Section 80.7 requires that cleaning and disinfecting be done in

accordance with Secs. 71.6, 71.7, 71.10, and 71.11. Section 80.7 also

provides for the movement of vehicles if APHIS officials are not

present to supervise their cleaning and disinfection. Because these

same requirements are clearly spelled out in Secs. 71.6 through 71.11,

we are proposing to remove Sec. 80.7 from the regulations. We propose

to add a provision to Sec. 80.3 that states that means of conveyance

used to transport animals positive to the official Johne's disease test

must be cleaned and disinfected in accordance with Sec. 71.6, and that

facilities in which the animals were maintained must be cleaned and

disinfected in accordance with Sec. 71.7.

Section 80.9 of the regulations tells how certificates that

accompany animals moved interstate must be handled. In short, Sec. 80.9

contains the provisions for delivery of the certificate to the

transportation agency or consignee, as the case may be. Since we are

proposing to require the use of an owner-shipper statement and permit,

under specified circumstances, with each interstate shipment of

animals, rather than a certificate, we are proposing to remove

Sec. 80.9 from the regulations.

Based on the proposed removal of current Secs. 80.2, 80.5, 80.6,

80.7, and 80.9, we would redesignate remaining sections Secs. 80.3,

80.4, and 80.8 as Secs. 80.2, 80.3, and 80.4, respectively.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been reviewed under Executive Order 12866.

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

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

Office of Management and Budget.

This proposed rule would relieve some restrictions on the

interstate movement of domestic animals that are positive to the

official Johne's disease test. Currently, animals that are reactors to

a test for Johne's disease may be moved interstate for slaughter only.

This proposed rule would, among other things, make it easier to move

positive animals interstate to slaughter and would allow the interstate

movement of sexually intact positive animals for the collection of germ

plasm under certain conditions, and where applicable, the return to the

premises of origin.

However, we do not anticipate that these changes will have a

significant economic impact on small entities. Currently, animals that

are moved interstate to slaughter under the regulations must bear an

eartag with a serial number and the inscription ``U.S. Reactor'' and be

transported with a certificate. In addition, cattle must be branded

with the letter ``J'' on their left hip, accompanied directly to

slaughter by an APHIS or State representative, or moved in vehicles

closed with official seals. We are proposing to remove these

requirements and simply require positive animals moving interstate to

slaughter to bear an official eartag and be shipped with an owner-

shipper statement. There are no direct costs related to these

requirements, so herd owners would not experience a savings from the

removal of these requirements. However, this proposed rule would

expedite the movement of animals by 1 to 5 days because herd owners

would not have to wait to obtain the services of an APHIS or State

representative prior to the interstate movement of their animals to

slaughter. This may result in some small savings to herd owners.

Our proposal to allow herd owners to move positive animals

interstate for the collection of germ plasm, prior to slaughter, would

provide the herd owners the opportunity to profit from the continued

use of their most expensive and productive animals even after they have

been slaughtered by using the germ plasm in their breeding program to

continue the animals' lineage. In addition, this proposal would allow

herd owners to have these animals returned to the premises of origin

after the collection of germ plasm, if the owner so chooses.

In a recent study, APHIS examined the cost of Johne's disease on

U.S. dairy cattle producers.2 The study found that infected

herds with at least 10 percent of the culled cows showing clinical

signs of Johne's disease had an average cost to producers of $227 for

each cow in the herd per year. Therefore, the cost for a 100 cow dairy

with at least 10 percent of culled cows showing clinical disease signs

of Johne's disease would be approximately $22,700 per year. By amending

the regulations, we may be able to strengthen detection and control of

Johne's disease, which should reduce the producers' Johne's disease-

related costs. However, the reduction in disease-related costs is not

likely to be significant.

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\2\ See Johne's disease on U.S. Dairy Operations, National

Animal Health Monitoring System, Dairy 1996, October, 1997.

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We anticipate that this proposed rule would affect primarily U.S.

dairy cattle producers. In 1997, there were 116,680 dairy herds or

farms in the United States. We estimate that about 22 percent (25,670

herds) of the U.S. dairy herds are affected with Johne's disease. The

Small Business Administration (SBA) considers a dairy farm a small

entity if its annual receipts are $0.5 million or less. According to

the 1992 Census of Agriculture, 95 percent of dairy producers are

considered small entities under SBA guidelines. This proposed rule

should have a favorable economic impact on dairy cattle producers.

However, for most producers, the impact may be insignificant. This is

because on a per head basis, only about 10 percent of the cattle will

test positive and not all positive animals are likely to be moved

interstate for slaughter or the collection of germ plasm.

Under these circumstances, the Administrator of the Animal and

Plant Health Inspection Service has determined that this action would

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

entities.

Executive Order 12988

This rule has been reviewed under Executive Order 12988, Civil

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

local laws and

[[Page 13730]]

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. 98-037-1.

Please send a copy of your comments to: (1) Docket No. 98-037-1,

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

Road Unit 118, Riverdale, MD 2073-1238, 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 amend the regulations regarding the

interstate movement of domestic animals that have reacted to a test for

paratuberculosis. This proposed rule would identify an official test

for the detection of Johne's disease in domestic animals. In addition,

this proposed rule would amend the requirements for moving animals

interstate and would allow sexually intact animals that are positive to

the official Johne's disease test to be moved interstate for the

collection of germ plasm. According to this proposed rule, an owner-

shipper statement would be required for the interstate movement of

domestic animals for slaughter purposes, and a permit would be required

for the interstate movement of domestic animals for the collection of

germ plasm and, if applicable, return to the premises of origin.

The owner-shipper statement and permit are considered information

collection activities. We are asking OMB to approve these information

collection activities in connection with our efforts to ensure that

animals affected with Johne's disease are moved interstate with

negligible risk of spreading disease to other animals. We are

soliciting comments from the public (as well as affected agencies)

concerning these proposed information collection activities. We need

these comments to help us:

(1) Evaluate whether the 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

information collection, including the validity of the methodology and

assumptions used;

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

be collected; and

(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 of responses.)

Estimate of burden: Public reporting burden for this collection of

information is estimated to average 0.04 hours per response.

Respondents: Herd owners, shippers, State representatives.

Estimated annual number of respondents: 250.

Estimated annual number of responses per respondent: 1.3.

Estimated annual number of responses: 325.

Estimated total annual burden on respondents: 13 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.

Regulatory Reform

This action is part of the President's Regulatory Reform

Initiative, which, among other things, directs agencies to remove

obsolete and unnecessary regulations and to find less burdensome ways

to achieve regulatory goals.

List of Subjects

9 CFR Part 71

Animal diseases, Livestock, Poultry and poultry products,

Quarantine, Reporting and recordkeeping requirements, Transportation.

9 CFR Part 80

Animal diseases, Livestock, Transportation.

Accordingly, we propose to amend 9 CFR parts 71 and 80 as follows:

PART 71--GENERAL PROVISIONS

1. The authority citation for part 71 would continue to read as

follows:

Authority: 21 U.S.C. 111-113, 114a, 114a-1, 115-117, 120-126,

134b, and 134f; 7 CFR 2.22, 2.80, and 371.2(d).

2. Section 71.3 would be amended as follows:

a. In paragraph (a), by removing the word ``paratuberculosis'' and

replacing it with the words ``Johne's disease''.

b. By revising paragraph (c)(1) to read as set forth below.

c. By redesignating paragraphs (c)(2), (c)(3), and (c)(4) as

paragraphs (c)(3), (c)(4), and (c)(5), respectively, and adding new

paragraph (c)(2) to read as set forth below.

Sec. 71.3 Interstate movement of diseased animals and poultry

generally prohibited.

* * * * *

(c) * * *

(1) Domestic animals that have reacted to an official test for

brucellosis, are not affected with any other disease referred to in

this section, and are not tick infested, may be moved interstate in

accordance with part 78 of this chapter.

(2) Domestic animals that are positive to the official Johne's

disease test, are not affected with any other disease referred to in

this section, and are not tick infested, may be moved interstate in

accordance with part 80 of this chapter.

* * * * *

3. Part 80, including the title of the part, would be revised to

read as follows:

PART 80--JOHNE'S DISEASE IN DOMESTIC ANIMALS

Sec.

80.1 Definitions.

80.2 General restrictions.

80.3 Movement of domestic animals that are positive to the official

Johne's disease test.

80.4 Segregation of animals positive to the official Johne's disease

test during interstate movement.

Authority: 21 U.S.C. 111-113, 114a-1, 115, 117, 120, 121, and

125; 7 CFR 2.22, 2.80, and 371.2(d).

Sec. 80.1 Definitions.

Accredited veterinarian.1 A veterinarian approved by the

Administrator in accordance with the provisions of part 161 of this

chapter to

[[Page 13731]]

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

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\1\ The provisions of subchapters B, C, and D of this chapter

authorize Federal and State veterinarians and accredited

veterinarians to perform specified functions. Full-time Federal

(including military) and State employed veterinarians are authorized

to perform such functions, pursuant to delegation of authority by

the Administrator or cooperative agreements without specific

accreditation under the provisions of subchapter J.

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Administrator. The Administrator, Animal and Plant Health

Inspection Service, or any person authorized to act for the

Administrator.

APHIS. The Animal and Plant Health Inspection Service of the United

States Department of Agriculture.

APHIS representative. An individual employed by APHIS who is

authorized to perform the function involved.

Approved livestock facility. A stockyard, livestock market, buying

station, concentration point, or any other premises that has been

approved under Sec. 71.20 of this chapter.

Area veterinarian in charge. An APHIS veterinarian authorized by

the Administrator to supervise and manage the animal health work of

APHIS in a specified area of the United States.

Germ plasm. Semen, embryos, or ova.

Interstate. From one State into or through any other State.

Johne's disease. An infectious and communicable disease that

primarily affects cattle, sheep, goats, and other domestic, exotic, and

wild ruminants, also known as paratuberculosis, caused by Mycobacterium

paratuberculosis.

Moved. Shipped, transported, delivered, or received for movement,

or otherwise aided, induced, or caused to be moved.

Official eartag. An identification eartag approved by APHIS as

being tamper-resistant and providing unique identification for each

animal. An official eartag may conform to the alpha-numeric National

Uniform Eartagging System, or it may bear a valid premises

identification number that is used in conjunction with the producer's

livestock production numbering system to provide a unique

identification number.

Official Johne's disease test. An organism detection test approved

by the Administrator and conducted in a laboratory approved by the

Administrator.2

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\2\ A list of currently approved laboratories and the

requirements for obtaining approval are available from the

Diagnostic Bacteriology Laboratory, National Veterinary Services

Laboratories, P.O. Box 844, Ames, Iowa 50010. The Administrator will

approve laboratories to conduct the official Johne's disease test

only after determining that the laboratory meets the check test

proficiency requirements prescribed by the National Veterinary

Services Laboratories. Approval will continue as long as such check

test proficiency requirements are met on an annual basis.

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Owner-shipper statement. A statement signed by the owner or shipper

of animals, which states: The number of animals to be moved, the

official eartag number of each animal, the species of the animals,

points of origin and destination, the consignor and consignee, a

statement that the animals are positive to the official Johne's disease

test, and any additional information required by this part.

Permit. An official document (VS Form 1-27 or a State form that

contains the same information but not a ``permit for entry'') issued by

an APHIS representative, State representative, or accredited

veterinarian at the point of origin of a shipment to be moved in

accordance with this part, which states: The number of animals to be

moved, the purpose of the movement, the animals are positive to the

official Johne's disease test, the official eartag number of each

animal, the animals' breed and sex, the name of the owner of the

animals, the points of origin and destination, the consignor and

consignee, and the transportation vehicle number or other

identification number.

Premises identification number. A unique number assigned by the

State animal health official to a livestock production unit that is, in

the judgment of the State animal health official or area veterinarian

in charge, epidemiologically distinct from other livestock production

units. A premises identification number shall consist of the State's

two-letter postal abbreviation followed by the premises' assigned

number. A premises identification number may be used in conjunction

with a producer's own livestock production numbering system to provide

a unique identification number for an animal.

Premises of origin. The farm or other premises where the animals

intended for interstate movement are being raised, assembled, or both,

immediately before the interstate movement.

Recognized slaughtering establishment. A slaughtering establishment

3 operating under the Federal Meat Inspection Act (21 U.S.C.

601 et seq.) or a State inspected slaughtering establishment.

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\3\ A list or recognized slaughtering establishments in any

State may be obtained from an APHIS representative, the State animal

health official, or a State representative.

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State. Any of the 50 States, the Commonwealth of Puerto Rico, the

Commonwealth of the Northern Mariana Islands, the District of Columbia,

and any territories and possessions of the United States.

State animal health official. The State official responsible for

livestock and poultry disease control and eradication programs.

State representative. An individual employed in animal health work

by a State or political subdivision of a State, and who is authorized

by the State or political subdivision to perform tasks required by this

part.

Sec. 80.2 General restrictions.

Domestic animals that are positive to the official Johne's disease

test may not be moved interstate except in compliance with this part.

Sec. 80.3 Movement of domestic animals that are positive to the

official Johne's disease test.

(a) Movement of domestic animals for slaughter. Domestic animals

that are positive to the official Johnes disease test may be moved

interstate for slaughter if:

(1) The animals are moved directly to a recognized slaughtering

establishment or to an approved livestock facility for sale to a

recognized slaughtering establishment;

(2) An owner-shipper statement that identifies the animals as

positive to the official Johne's disease test accompanies the animals

during the movement and is delivered to the consignee;

(3) Each animal bears an official eartag; and

(4) The animals are moved to the destination in one continuous

movement without unloading.

(b) Movement of domestic animals for collection of germ plasm.

Sexually intact domestic animals that are positive to the official

Johne's disease test may be moved interstate for collection of germ

plasm if:

(1) The movement of the animals is agreed upon by the area

veterinarian in charge and the State animal health official in both the

State of origin and the State of destination;

(2) A permit that identifies the animals as positive to the

official Johne's disease test accompanies the animals during movement

and is delivered to the consignee;

(3) Each animal bears an official eartag; and

(4) The animals are returned, under permit, to the premises of

origin after the collection of germ plasm or the animals are moved

directly to a recognized slaughtering establishment or to an approved

livestock facility for sale to a recognized slaughter establishment

after the collection of germ plasm in accordance with paragraph (a) of

this section.

(c) Cleaning and disinfecting. Each means of conveyance used to

transport the animals must be cleaned and disinfected in accordance

with Sec. 71.6 of this chapter. The facilities in which the animals

were maintained must be cleaned and disinfected in accordance with

Sec. 71.7 of this chapter.

[[Page 13732]]

Sec. 80.4 Segregation of animals positive to the official Johne's

disease test during interstate movement.

Animals that are positive to the official Johne's disease test may

not be moved interstate in a railroad car, boat, truck, or other

vehicle containing healthy animals susceptible to Johne's disease

unless all of the animals are for immediate slaughter, or unless the

positive animals are kept separate from the other animals by a

partition that is securely affixed to the sides of the vehicle and

prevents the transfer of fecal matter from the animals positive to the

official Johne's disease test to the healthy animals in the vehicle.

Done in Washington, DC, this 16th day of March 1999.

Craig A. Reed,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 99-6893 Filed 3-19-99; 8:45 am]

BILLING CODE 3410-34-P