[Federal Register Volume 60, Number 20 (Tuesday, January 31, 1995)] [Proposed Rules] [Pages 5876-5880] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-2315] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 85 [Docket No. 94-064-1] Official Pseudorabies Tests AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: We are proposing to amend the pseudorabies regulations by adding the glycoprotein I enzyme-linked immunosorbent assay approved differential test to the list of official pseudorabies tests, which would allow certain pseudorabies vaccinated swine to be moved interstate to destinations other than those currently allowed. Under the current pseudorabies regulations, pseudorabies vaccinated swine that are not from a qualified negative gene-altered vaccinated herd may be moved interstate only for slaughter or to a quarantined herd or quarantined feedlot. This proposed change would allow, under certain conditions, the glycoprotein I enzyme-linked immunosorbent assay approved differential test to be used as an official pseudorabies test to qualify certain [[Page 5877]] pseudorabies vaccinated swine for interstate movement to destinations other than slaughter or a quarantined herd or quarantined feedlot. Adding the glycoprotein I enzyme-linked immunosorbent assay approved differential test to the list of official pseudorabies tests would also allow its use for the testing of nonvaccinated swine. DATES: Consideration will be given only to comments received on or before April 3, 1995. ADDRESSES: Please send an original and three copies of your comments to Chief, Regulatory Analysis and Development, PPD, APHIS, USDA, P.O. Drawer 810, Riverdale, MD 20738. Please state that your comments refer to Docket No. 94-064-1. 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. Arnold C. Taft, Senior Staff Veterinarian, Swine Health Staff, Veterinary Services, APHIS, USDA, P.O. Drawer 810, Riverdale, MD 20738. The telephone number for the agency contact will change when agency offices in Hyattsville, MD, move to Riverdale, MD, during January 1995. Telephone: (301) 436-7767 (Hyattsville); (301) 734-7767 (Riverdale). SUPPLEMENTARY INFORMATION: Background Pseudorabies is a contagious, infectious, and communicable disease of livestock, primarily swine, and other animals. The disease, also known as Aujeszky's disease, mad itch, and infectious bulbar paralysis, is caused by a herpes virus. The Animal and Plant Health Inspection Service's (APHIS') regulations in 9 CFR part 85 (referred to below as the regulations) govern the interstate movement of swine and other livestock (cattle, sheep, and goats) in order to help prevent the spread of pseudorabies. For the purposes of interstate movement, the regulations separate swine into four basic categories: (1) Swine infected with or exposed to pseudorabies; (2) pseudorabies vaccinated swine (except swine from qualified negative gene-altered vaccinated herds) not known to be infected with or exposed to pseudorabies; (3) swine not vaccinated for pseudorabies and not known to be infected with or exposed to pseudorabies; and (4) swine from qualified negative gene-altered vaccinated herds. Provisions governing the interstate movement of swine from each category are found in Secs. 85.5, 85.6, 85.7, and 85.8, respectively. Swine that have been vaccinated for pseudorabies are further characterized as either official pseudorabies vaccinates or official gene-altered pseudorabies vaccinates. The essential difference between these two categories is the availability of tests that can differentiate between vaccinated and infected swine. Swine vaccinated with an official pseudorabies vaccine produce antibodies to the vaccine that cannot be distinguished by traditional pseudorabies tests from antibodies produced in response to the field strain of the virus that causes pseudorabies infection. However, swine vaccinated with an official gene-altered pseudorabies vaccine may be tested with an approved differential pseudorabies test that can distinguish between antibodies produced in response to the vaccine and antibodies produced in response to the field strain of the virus that causes pseudorabies infection. The two official gene-altered pseudorabies vaccines that are used most often in the United States are vaccines from which a nonessential glycoprotein--either glycoprotein X (gpX) or glycoprotein I (gpI)--has been deleted. Swine vaccinated with one of those glycoprotein-deleted vaccines would not produce antibodies to the deleted glycoprotein unless the swine were infected with the pseudorabies field virus or had been vaccinated with a vaccine containing the glycoprotein antigen. The regulations contain provisions that allow swine herds to attain qualified negative gene-altered vaccinated herd status. Simply put, such status may be attained by first subjecting a herd of swine not known to be infected with or exposed to pseudorabies to an official pseudorabies test, or, if there are already gene-altered vaccinates in the herd, to an approved differential test. A herd already designated as a qualified pseudorabies negative herd does not require another test as a first step. If all swine in the herd are negative to a test for pseudorabies, or if the herd is a qualified pseudorabies negative herd, all swine in the herd over 6 months of age are then vaccinated with an official gene-altered pseudorabies vaccine. Qualified negative gene- altered vaccinated herd status is maintained by controlling the entry of new swine to the herd, vaccinating young swine in the herd as they reach 6 months of age, and subjecting all swine in the herd over 6 months of age to an approved differential test once per year with negative results. The specific requirements for achieving and maintaining qualified negative gene-altered vaccinated herd status are contained in Sec. 85.1 in the definition of ``qualified negative gene- altered vaccinated herd.'' Under the regulations in Sec. 85.8, swine from a qualified negative gene-altered vaccinated herd are subject to relatively few restrictions on interstate movement. As set forth in Sec. 85.8, swine from a qualified negative gene-altered vaccinated herd may be moved interstate without restriction if they are moved: (1) Directly to a recognized slaughtering establishment; (2) through one or more slaughter markets to a recognized slaughtering establishment; (3) directly to a feedlot, quarantined feedlot, or approved livestock market; or (4) from an approved livestock market to a feedlot, quarantined feedlot, or other approved livestock market. For any other interstate movement, the swine must be accompanied by a certificate containing certain information regarding the interstate movement and the swine being moved. Individual official gene-altered vaccinates that are not from a qualified negative gene-altered vaccinated herd do not, however, enjoy the same relative freedom from restrictions on interstate movement. Rather, such swine must meet the conditions of Sec. 85.6, ``Interstate movement of pseudorabies vaccinate swine, except swine from qualified negative gene-altered vaccinated herds, not known to be infected with or exposed to pseudorabies.'' The provisions of Sec. 85.6 are more restrictive than those of Sec. 85.8, allowing vaccinated swine to be moved interstate only if: (1) The swine are accompanied by an owner- shipper statement and are moved directly to slaughter, or (2) the swine are accompanied by a permit and moved directly to a quarantined herd or quarantined feedlot. The differing restrictions on the interstate movement of official gene-altered pseudorabies vaccinates that are from a qualified negative gene-altered vaccinated herd and official gene-altered pseudorabies vaccinates that are not from such a herd were based on the level of confidence that APHIS had in the reliability of the approved differential tests when provisions for the use of approved differential tests and gene-altered vaccines were first added to the regulations in a final rule published in the Federal Register on May 9, 1990 (55 FR 19245-19253, [[Page 5878]] Docket No. 89-211). During the public comment period that preceded the publication of that final rule, several commenters requested that APHIS allow the use of approved differential tests to qualify individual gene-altered vaccinates for interstate movement in the same way as nonvaccinated swine may be qualified for interstate movement with an official pseudorabies serologic test under the regulations in Sec. 85.7. APHIS declined, noting that the HerdCheck anti-pseudorabies gpX enzyme-linked immunosorbent assay (ELISA) test, which was the only approved differential pseudorabies test being conducted in APHIS-approved laboratories at that time, had been recommended as a diagnostic test for herds, and not for individual swine, by the American Association of Veterinary Laboratory Diagnosticians (AAVLD), the United States Animal Health Association (USAHA), and the test's manufacturer because the test was less sensitive than standard serological procedures in detecting pseudorabies virus antibodies. Following the publication of the May 1990 final rule, APHIS approved several laboratories to conduct the gpI ELISA test, thus making two gene-altered vaccine/test combinations available to swine producers in the United States. The gpI ELISA test is more sensitive than the gpX ELISA test and has become the approved differential test used by the majority of those swine producers who have chosen to vaccinate their swine for pseudorabies. The AAVLD's Committee on Diagnostic and Interpretative Serology has recognized that the sensitivity and specificity of the gpI ELISA test is equivalent to that of official tests for the diagnosis of pseudorabies. Based on that finding, the committee recommended that APHIS designate the gpI ELISA approved differential test as an official pseudorabies test and allow its use to qualify individual swine vaccinated with the gpI-deleted pseudorabies vaccine (referred to below as gpI vaccinates) for interstate movement. Therefore, we are proposing to allow, under certain conditions, the use of the gpI ELISA test as an official pseudorabies test to qualify gpI vaccinates that are not from a qualified negative gene-altered vaccinated herd for interstate movement to destinations other than slaughter or a quarantined herd or quarantined feedlot. The AAVLD did not change its recommendation regarding other differential pseudorabies tests, so the gpI ELISA test is the only approved differential pseudorabies test included in this proposal. Additionally, we are not proposing to make any changes to the regulations pertaining to swine from qualified negative gene-altered vaccinated herds. Rather, we are proposing to designate the gpI ELISA approved differential test as an official pseudorabies test to allow individual gpI vaccinates to qualify for general interstate movements (i.e., interstate movements to destinations other than slaughter, feedlots, quarantined herds, or quarantined feedlots) under provisions similar to those of Sec. 85.7(c), which allow nonvaccinated swine not known to be infected with or exposed to pseudorabies to qualify for general interstate movements. For a gpI vaccinate that is not from a qualified negative gene- altered vaccinated herd to be moved interstate to destinations other than slaughter or a quarantined herd or quarantined feedlot, we are proposing to require that the swine be subjected to a gpI ELISA approved differential test, with negative results, within 30 days prior to the interstate movement. Given the sensitivity of the gpI ELISA test and the fact that the regulations require that the test be conducted in a laboratory approved by APHIS, we believe that any gpI vaccinates infected with pseudorabies would be detected as a result of the testing, thus ensuring that pseudorabies-infected swine would not be moved interstate without appropriate controls. To document the required testing proposed above, and to provide a record regarding the identity, health status, origin, and destination of individual gpI vaccinates (i.e., not from a qualified negative gene- altered vaccinated herd) moving interstate to destinations other than slaughter or a quarantined herd or quarantined feedlot, we are further proposing to require that such gpI vaccinates be accompanied by a certificate during the interstate movement and that the certificate be delivered to the person receiving the swine. The certificate would be issued by an APHIS representative, State representative, or accredited veterinarian prior to the interstate movement. As set forth in the definition of certificate in Sec. 85.1, a certificate must state:The number and description of the swine to be moved; That the swine to be moved are not known to be infected with or exposed to pseudorabies; The purpose for which the swine are to be moved; The points of origin and destination; and The consignor and consignee. Our proposed amendment would require that, in addition to the information described in Sec. 85.1, the certificate also state: The identification required by the regulations in 9 CFR 71.19; That each animal to be moved was vaccinated for pseudorabies with the glycoprotein I (gpI) gene-altered pseudorabies vaccine; That each animal to be moved was subjected to an approved differential pseudorabies test within 30 days prior to the interstate movement and was found negative; The date of the approved differential pseudorabies test; and The name of the laboratory that conducted the approved differential pseudorabies test. The proposed certificate requirement would ensure that there was an official record of the testing and interstate movement of individual gpI vaccinates and would enable an official pseudorabies epidemiologist to trace the movements of the gpI vaccinates forward from their farm of origin or back from their present location should an investigation become necessary. The definition of certificate currently states that a certificate is issued for ``the interstate movement of swine that * * * are not pseudorabies vaccinates, except for official gene-altered pseudorabies vaccinates from a qualified negative gene-altered vaccinated herd.'' Because this proposal contains provisions for the issuance of certificates for the interstate movement of gpI vaccinates that are not from a qualified negative gene-altered vaccinated herd, we would amend the definition of certificate to include gpI vaccinates in the scope of the definition. Adding the gpI ELISA test as an official pseudorabies test would also mean that the gpI ELISA test would be available for testing nonvaccinated swine to determine their pseudorabies status. As noted above, the AAVLD has recognized that the sensitivity and specificity of the gpI ELISA test is equivalent to that of official tests for the diagnosis of pseudorabies. The gpI ELISA test is specific for antibodies to the glycoprotein I present in the pseudorabies virus; nonvaccinated swine, as well as swine vaccinated with a gpI-deleted vaccine, would not produce positive results to the gpI ELISA test unless the swine were infected with pseudorabies. Designating the gpI ELISA test as an official pseudorabies test would enable swine producers to use a single test on both gpI vaccinates and nonvaccinated swine. [[Page 5879]] Executive Order 12866 and Regulatory Flexibility Act This proposed rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review process required by Executive Order 12866. This proposed rule would amend the pseudorabies regulations to allow, under certain conditions, swine vaccinated with a gpI-deleted gene-altered pseudorabies vaccine, but that are not from a qualified negative gene-altered vaccinated herd, to be moved interstate to destinations other than slaughter or a quarantined herd or quarantined feedlot. This proposed rule would also allow the use of the gpI ELISA test to determine the pseudorabies status of nonvaccinated swine. In December of 1993, there were 235,840 swine operations in the United States with a total inventory of about 56.8 million head. The value of the total swine inventory was estimated to be about $4.3 billion (Agricultural Statistics Board, National Agricultural Statistics Service, U.S. Department of Agriculture, ``Hogs and Pigs,'' December 29, 1993). We believe that about 99 percent of all swine operations in the United States would be considered small entities. We estimate that there are approximately 25,000 domestic swine herds that contain vaccinated animals. Of those herds, there are only about 250 qualified negative gene-altered vaccinated herds. The provisions of this proposed rule pertaining to gpI vaccinates would have an economic impact only on the owners of gpI vaccinates that are not part of a qualified negative gene-altered herd. There are currently no provisions for the interstate movement of gpI vaccinates that are not part of a qualified negative gene-altered herd to destinations other than slaughter, quarantined herds, or quarantined feedlots, so this proposed rule would have the effect of opening up new markets for the owners of such swine. Testing costs would be incurred only when an owner chose to move gpI vaccinates interstate to destinations other than slaughter or a quarantined herd or quarantined feedlot, since pseudorabies vaccinated swine do not require a test prior to interstate movement for slaughter or to a quarantined herd or quarantined feedlot. We expect that swine owners would accept the costs of testing with the gpI ELISA test if they felt the economic opportunities afforded by the new markets balanced or outweighed the costs associated with the interstate movement. The provisions of this proposed rule that would allow the use of the gpI ELISA test to determine the pseudorabies status of nonvaccinated swine are not expected to have a significant economic impact on the owners of nonvaccinated swine. Although the gpI ELISA test costs from $0.50 to $1.00 more per test than the official serologic tests currently used to determine the pseudorabies status of nonvaccinated swine, its use to test nonvaccinated swine would be optional. It is likely, therefore, that most owners of nonvaccinated swine would continue using less expensive official pseudorabies tests until the cost of the gpI ELISA test became comparable to that of other official tests. 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 12372 This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.) Executive Order 12778 This proposed rule has been reviewed under Executive Order 12778, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and 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 the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this proposed rule will be submitted for approval to the Office of Management and Budget. Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please send a copy of your comments to: (1) Chief, Regulatory Analysis and Development, PPD, APHIS, USDA, P.O. Drawer 810, Riverdale, MD 20738, and (2) Clearance Officer, OIRM, USDA, room 404-W, 14th Street and Independence Avenue SW., Washington, DC 20250. List of Subjects in 9 CFR Part 85 Animal diseases, Livestock, Quarantine, Reporting and recordkeeping requirements, Transportation. Accordingly, 9 CFR part 85 would be revised to read as follows: PART 85--PSEUDORABIES 1. The authority citation for part 85 would continue to read as follows: Authority: 21 U.S.C. 111, 112, 113, 115, 117, 120, 121, 123-126, 134b, 134f; 7 CFR 2.17, 2.51, and 371.2(d). Sec. 85.1 [Amended] 2. In Sec. 85.1, in the definition of certificate, the first sentence would be amended by adding the words ``vaccinated with a glycoprotein I (gpI) deleted gene-altered pseudorabies vaccine or'' immediately after the words ``gene-altered pseudorabies vaccinates''. 3. In Sec. 85.1, in the definition of official pseudorabies test, in the second sentence, item 4 would be amended by adding the words ``other than the glycoprotein I (gpI) ELISA test'' immediately after the word ``tests''. 4. In Sec. 85.6, a new paragraph (c) would be added to read as set forth below: Sec. 85.6 Interstate movement of pseudorabies vaccinate swine, except swine from qualified negative gene-altered herds, not known to be infected with or exposed to pseudorabies. * * * * * (c) General movements. Swine vaccinated for pseudorabies with a glycoprotein I (gpI) deleted gene-altered pseudorabies vaccine and not known to be infected with or exposed to pseudorabies, but that are not from a qualified negative gene-altered vaccinated herd, may be moved interstate to destinations other than those set forth in paragraphs (a) and (b) of this section only if: (1) The swine are accompanied by a certificate and such certificate is delivered to the consignee; and (2) The certificate, in addition to the information described in Sec. 85.1, states: (i) The identification required by Sec. 71.19 of this chapter; (ii) that each animal to be moved was vaccinated for pseudorabies with a gpI-deleted gene-altered pseudorabies vaccine; (iii) that each animal to be moved was subjected to a gpI enzyme-linked immunosorbent assay (ELISA) approved differential pseudorabies test no more than 30 days prior to the interstate movement and was found negative; (iv) the date of the gpI ELISA approved differential pseudorabies test; and (v) the name of [[Page 5880]] the laboratory that conducted the gpI ELISA approved differential pseudorabies test. Done in Washington, DC, this 25th day of January 1995. Terry L. Medley, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 95-2315 Filed 1-30-95; 8:45 am] BILLING CODE 3410-34-P