Interstate transportation of animals and animal products (quarantine): Johne's disease in domestic animals,
[Federal Register: March 22, 1999 (Volume 64, Number 54)]
[Proposed Rules]
[Page 13726-13732]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr99-28]
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.
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
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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.
\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.
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
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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.‹SUP›2‹/SUP› 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.
\2\ See Johne's disease on U.S. Dairy Operations, National Animal Health Monitoring System, Dairy 1996, October, 1997.
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
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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
-
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).
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Section 71.3 would be amended as follows:
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In paragraph (a), by removing the word ``paratuberculosis'' and replacing it with the words ``Johne's disease''.
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By revising paragraph (c)(1) to read as set forth below.
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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. * * * * *
-
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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.‹SUP›1‹/SUP› A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this chapter to
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perform functions specified in subchapters B, C, and D of this chapter.
\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.
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.‹SUP›2‹/SUP›
\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.
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 ‹SUP›3‹/SUP› 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.
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.
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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. 99-6893Filed3-19-99; 8:45 am]
BILLING CODE 3410-34-P
