[Federal Register Volume 64, Number 54 (Monday, March 22, 1999)]
[Proposed Rules]
[Pages 13726-13732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6893]


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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.
---------------------------------------------------------------------------

    \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