[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.
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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
