00-8780. Johne's Disease in Domestic Animals; Interstate Movement

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Final rule.

SUMMARY:

We are amending the regulations regarding the interstate movement of domestic animals that have reacted to a test for paratuberculosis. First, we are replacing all references to “paratuberculosis” with references to “Johne's disease” to reflect a change in nomenclature. Second, we are identifying an official test for the detection of Johne's disease in domestic animals. Third, we are amending the requirements for moving animals interstate. These actions will 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.

EFFECTIVE DATE:

May 10, 2000.

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; [phone].

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 organisms 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 (CFR), 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.

On March 22, 1999, we published in the Federal Register (64 FR 13726-13732, Docket No. 98-037-1) a proposal to amend the regulations regarding the interstate movement of domestic animals affected with Johne's disease. We proposed to replace references to “paratuberculosis” with references to “Johne's disease”, to identify an official test for Johne's disease, and to allow the interstate movement of domestic animals that are positive to the official Johne's disease test for slaughter purposes or the collection of germ plasm.

We solicited comments concerning our proposal for 60 days ending May 21, 1999. We received six comments by that date. They were from a national veterinary medical association, a State veterinary association, a beef association, two dairy associations, and a State advisory committee on Johne's disease. Two commenters supported the proposed rule. One commenter stated that he could not support the proposed rule. This commenter and the remaining commenters expressed concerns that are discussed below.

Movement of Animals for the Collection of Germ Plasm

Several commenters raised concerns related to our proposed provisions to allow the interstate movement of positive animals for the collection of germ plasm (semen, embryos, and ova). We stated in our proposal that artificial insemination and embryo transfer were considered to present a low risk of transmitting Johne's disease, and that allowing interstate movement of positive animals for germ plasm collection would allow herd owners to salvage valuable genetics and continue an animal's lineage. One commenter took issue with our statement about low risk, maintaining that there is insufficient research to support our contention. One commenter mentioned that semen, embryos, and ova are not the only genetic materials that could be considered germ plasm. One commenter recommended that we allow interstate movement of positive animals only from herds that have achieved a certain status level under the United States Animal Health Association's (USAHA) Voluntary Johne's Disease Herd Status Program for Cattle, and that germ plasm be collected from other animals in a sanitized station on the premises. One commenter stated that many breeders enrolled in various voluntary Johne's disease programs are not interested in having an animal from a herd positive for Johne's disease on their property.

Based on these comments, and because germ plasm from positive animals may be collected without restriction on the premises of origin, this final rule will not allow the interstate movement of positive animals for germ plasm collection. Our proposed rule did not place any restrictions on the collection of germ plasm at the premises of origin, and we are not adding such provisions in this final rule.

In addition, because we are removing the proposed requirements for the interstate movement of positive animals for the collection of germ plasm, we have removed the definitions of accredited veterinarian, germ plasm, permit, and premises of origin from the proposed list of definitions in § 80.1. These terms were used and referenced in the aforementioned proposed requirements.

One commenter took exception to a portion of the discussion under the heading, “Executive Order 12866 and Regulatory Flexibility Act,” that stated, “However, for most producers, the impact may be insignificant.” The commenter stated that the impact of the proposed rule on a substantial number of seed stock producers will be very significant if overly vigorous administration of testing programs puts a significant number of seed stock producers out of business or reduces them to producing commercial milk products, which could have an international impact. This commenter further stated that the premature restriction of the movement of breeding animals could affect the rate of genetic gain in the United States, especially if the incidence of Johne's disease is as high as estimated. This commenter also stated that seed stock herds cannot be destroyed or locked up during the process of controlling Johne's disease.

Approximately 22 percent (25,670 herds) of U.S. dairy herds are affected with Johne's disease. In developing our proposal, we considered how breeding programs, and genetic gains, could be affected by restrictions on the interstate movement of animals that are positive to an official Johne's disease test. We proposed to limit the interstate movement of these animals, but we did not propose any quarantine or related measures, and we did not propose to require testing before interstate movement because mandatory testing programs are not currently supported by a majority of the cattle industry, partially due to the effect that testing might have on some seed stock producers. Industry sources indicated that when removing positive animals from a herd, most producers would choose to move the positive animals for slaughter purposes. Because we will allow the interstate movement of positive animals for slaughter purposes in this rule, and remove, among other things, requirements for permits and branding, seed stock producers will be able to implement more efficient and accelerated herd cleanup programs, if desired, and, thus, reduce the economic effect Johne's disease could have on their operations.

This rule will allow domestic animals that are positive to an official test for Johne's disease to be moved interstate only to a recognized slaughtering establishment or to an approved livestock facility for sale to such an establishment. However, there may be circumstances, including pilot projects, where other interstate movements may be appropriate. Therefore, this final rule provides that the Administrator may, upon request in specific cases, allow animals that are positive to an official Johne's disease test to be moved interstate to other locations and for other purposes under such conditions as the Administrator may prescribe in each case to prevent the spread of Johne's disease. The Administrator must notify the State animal health officials of the States involved of any such action.

Other Comments

One commenter stated that we should require serological tests for herd screening and allow the interstate movement of an animal from a herd only if the animal is negative when tested by an organism identification test.

As noted previously in this document, mandatory testing programs are not currently supported by a majority of the cattle industry. We believe that requiring serological testing of a herd prior to the interstate movement of an individual animal would be too restrictive and put too many constraints on herd owners. Therefore, at this time, we are only restricting the interstate movement of animals that are positive to an official Johne's disease test.

One commenter had concerns regarding the identification of specific officially recognized tests. One commenter stated that our use of the term “polymerase chain reaction (PCR)” was confusing, and noted that PCR is a process. The commenter who had concerns regarding the identification of specific officially recognized tests did not elaborate further.

We continue to believe that a standard test for Johne's disease is necessary and that a test that detects the presence of the M. paratuberculosis organisms in fecal samples is the most specific and reliable index of infection in live animals. As to the comment regarding PCR, we agree that PCR is a process. In our proposal, we stated, “Organism detection tests, such as fecal culture or polymerase chain reaction (PCR), detect the presence of the M. paratuberculosis organism in fecal samples.”

Two commenters stated that there were loopholes in the proposed regulations that could contribute to the spread of Johne's disease, and one of these commenters stated that the loopholes could affect various voluntary programs. One of these commenters had concerns regarding the structure of the proposed changes for interstate movement.

The commenters who stated that there were loopholes in the proposed regulations did not identify those areas of the proposed regulations that they thought might contribute to the spread of Johne's disease or affect voluntary programs. The commenter who had concerns regarding the structure of the proposed changes did not elaborate further. We assume that these commenters were referring to the proposed requirements that would have allowed sexually intact animals that are positive to an official Johne's disease test to be moved interstate for the collection of germ plasm. As stated previously in this document, this final rule will not allow the interstate movement of positive animals for germ plasm collection. This final rule will allow domestic animals that are positive to an official Johne's disease test to be moved interstate only to a recognized slaughtering establishment or to an approved livestock facility for sale to such an establishment, or elsewhere only with specific authorization from the Administrator.

One commenter stated that new regulations should not be finalized until States have standardized control and testing programs. This commenter further stated that it may be best to eliminate the current regulations, pending the development of an appropriate proposed rule, because they cannot be enforced. This commenter also stated that he was unable to endorse any particular animal movement control systems at this time. Another commenter expressed disapproval that this rulemaking exposed the public to the existing regulations, which he maintains are “obsolete and disregarded.”

The current regulations are outdated, and this rulemaking is intended to remove language that hinders State and industry voluntary programs that are attempting to reduce the national prevalence of Johne's disease. Prior to this final rule, the regulations provided that cattle and other domestic animals that had reacted to a test for Johne's disease could be moved interstate only 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 had to be identified with an approved metal eartag that was attached to their left ear and bore a serial number and the inscription, “U.S. Reactor,” or a similar State reactor tag. Cattle also had to 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 were applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.

Based on this final rule, domestic animals that are positive to an official Johne's disease test may be moved interstate to a recognized slaughtering establishment or to an approved livestock facility for sale to such an establishment if they bear an official eartag, are shipped with an owner-shipper statement, and are moved to the destination in one continuous movement without unloading. We believe that these changes will allow herd owners to remove infected animals from their premises sooner and decrease the possibility of these animals infecting other animals on the premises. We also believe that these changes, compared to the previous requirements, will allow APHIS to better enforce restrictions on interstate movement.

One commenter stated that there needs to be an effective program to raise the level of awareness of Johne's disease among producers because only with an understanding of the disease and the mode of its transmission can broad-based support for control and eradication be gained. One commenter stated that control and eradication of Johne's disease requires producer and veterinary education, development of adequate diagnostic tests, design and implementation of herd testing and classification systems, and design of appropriate animal movement controls. One commenter stated that the regulations may need to be amended in the future to promote uniformity as States develop and implement Johne's disease control programs and to incorporate recommendations from future Johne's disease studies. Another commenter said that we should have included the voluntary herd status programs developed by USAHA's Johne's Disease Committee.

We agree that educating the beef and dairy industry and the public about Johne's disease is essential to control and eradication efforts. Some beef and dairy associations have taken steps to provide educational material regarding Johne's disease and other diseases of livestock to their members. APHIS has distributed educational material on Johne's disease as well as conducted training courses for our field veterinary medical officers. In addition, a classification system—the “voluntary herd status program” mentioned by the commenter above—has been developed by USAHA's Johne's Disease Committee. While APHIS supports the U.S. Voluntary Johne's Disease Herd Status Program for Cattle, we do not believe it is appropriate at this time to make it a federally-regulated activity and, therefore, have not made it part of this rulemaking.

In the future, the regulations may be further amended to include new technologies (including diagnostic tests) and standards from voluntary programs and to incorporate changes that may be necessary as States develop and implement their own Johne's disease control programs.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

This 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 rule will establish an official test for Johne's disease. It also will make it easier to move domestic animals that are positive to an official Johne's disease test interstate to slaughter.

However, we do not anticipate that these changes will have a significant economic effect on small entities. Under the regulations in effect before this final rule, animals moved interstate to slaughter had to bear an eartag with a serial number and the inscription “U.S. Reactor” and be transported with a certificate. In addition, cattle also had to 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 removing these requirements and will 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 will not experience a savings from the removal of these requirements. However, this rule will expedite the movement of animals by 1 to 5 days because herd owners will 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.

In a recent study, APHIS examined the cost of Johne's disease on U.S. dairy cattle producers.^[1] 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 disease-related cost to producers of $227 for each cow in the herd per year. Therefore, the disease-related costs 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 for the reasons provided in the next paragraph.

We anticipate that this rule will 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 rule should benefit dairy cattle producers, but for most producers, the economic effect of the rule may be insignificant. This is because on a per head basis only about 10 percent of the cattle will test positive, not all positive animals are likely to be moved interstate for slaughter, and, as noted earlier, there are no direct costs associated with the requirements we are removing.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

Executive Order 12988

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are in conflict with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings 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 final rule have been approved by the Office of Management and Budget (OMB). The assigned OMB control number is 0579-0148.

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 are amending 9 CFR parts 71 and 80 as follows:

PART 71—GENERAL PROVISIONS

1. The authority citation for part 71 continues 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 is amended as follows:

a. In paragraph (a), by removing the word “paratuberculosis” and adding the words “Johne's disease” in its place.

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

d. In newly redesignated paragraph (c)(3), remove “; and” and add a period in its place.

§ 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 an 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 is revised to read as follows:

PART 80—JOHNE'S DISEASE IN DOMESTIC ANIMALS

80.1

Definitions.

80.2

General restrictions.

80.3

Movement of domestic animals that are positive to an official Johne's disease test.

80.4

Segregation of animals positive to an 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).

§ 80.1

Definitions.

The following definitions apply to this part:

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 § 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.

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.^[1]

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 an official Johne's disease test, and any additional information required by this part.

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.

Recognized slaughtering establishment. A slaughtering establishment ^[2] operating under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) or a State inspected slaughtering establishment.

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.

§ 80.2

General restrictions.

Domestic animals that are positive to an official Johne's disease test may not be moved interstate except in compliance with this part.

§ 80.3

Movement of domestic animals that are positive to an official Johne's disease test.

(a) Movement of domestic animals for slaughter. Domestic animals that are positive to an official Johne's 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 an 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) Other movements. The Administrator may, upon request in specific cases, allow domestic animals that are positive to an official Johne's disease test to be moved interstate other than as provided in paragraph (a) of this section, under such conditions as the Administrator may prescribe in each case to prevent the spread of Johne's disease. The Administrator will promptly notify the State animal health officials of the States involved of any such action.

(c) Cleaning and disinfecting. Each means of conveyance used to transport the animals must be cleaned and disinfected in accordance with § 71.6 of this chapter. The facilities in which the animals were maintained must be cleaned and disinfected in accordance with § 71.7 of this chapter.

§ 80.4

Segregation of animals positive to an official Johne's disease test during interstate movement.

Animals that are positive to an 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 an official Johne's disease test to the healthy animals in the vehicle.

Done in Washington, DC, this 5th day of April 2000.

Bobby R. Acord,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  See Johne's disease on U.S. DairyOperations, National Animal Health Monitoring System, Dairy 1996, October, 1997.

1.  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 an 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.

2.  A list of recognized slaughtering establishments in any State may be obtained from an APHIS representative, the State animal health official, or a State representative.