[Federal Register Volume 59, Number 77 (Thursday, April 21, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-9593] [[Page Unknown]] [Federal Register: April 21, 1994] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 78 [Docket No. 92-044-3] Brucellosis; Interstate Movement of Swine AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: We are amending the swine brucellosis regulations by standardizing and simplifying the testing requirements for States seeking validation as swine brucellosis-free, and by extending to 2 years the period during which breeding swine in States must be tested to qualify States for brucellosis-free status. We are also amending the testing requirements for validation and maintenance of brucellosis-free herd status and are restricting the interstate movement of feral swine because of swine brucellosis. These actions are necessary to achieve the goal of swine brucellosis eradication in the United States. EFFECTIVE DATE: May 23, 1994. FOR FURTHER INFORMATION CONTACT: Dr. Joseph Annelli, Epidemiologist, Swine Health Staff, Veterinary Services, APHIS, USDA, room 204, Presidential Building, 6525 Belcrest Road, Hyattsville, MD 20782, 301- 436-7781. SUPPLEMENTARY INFORMATION: Background Brucellosis is a contagious disease affecting animals and man, caused by bacteria of the genus Brucella. Brucellosis in swine is characterized by abortion, infertility, orchitis, posterior paralysis, and lameness. The brucellosis regulations in 9 CFR part 78 (referred to below as the regulations) prescribe, among other things, conditions for the interstate movement of swine. The purpose of the regulations is to control, and ultimately to eradicate, brucellosis in the United States. On July 23, 1993, we published in the Federal Register (58 FR 39458-39462, Docket No. 92-044-1) a proposed rule to amend the regulations by standardizing and simplifying the options regarding testing that are available to States seeking validation as swine brucellosis-free, and by extending to 2 years the period during which validated brucellosis-free herds must be tested to maintain brucellosis-free status. We also proposed to restrict the interstate movement of feral swine. On September 8, 1993, we published in the Federal Register (58 FR 47222, Docket No. 92-044-2) an editorial correction to the Summary and Background sections of the July 23 proposed rule. We solicited comments concerning our proposal for a 60-day comment period ending September 21, 1993. We received 3 comments by that date. They were from State and Federal governments and a professional association. All responses were in favor of our proposal. Two commenters, however, suggested modifications or clarifications. Those suggestions are discussed below. One commenter recommended that we require positive, permanent identification of all domestic and feral swine for traceback purposes. That action is outside the scope of this rulemaking and, therefore, is not discussed in this document. Any changes made as a result of that comment would be proposed as part of a separate rulemaking proceeding. Another commenter expressed confusion over the proposed rules regarding maintenance of validated brucellosis-free status for herds. This commenter supported the flexibility of the testing schedules we proposed, but was uncertain about the status of herds for which all testing had not been completed at the end of the 12-month validation period. In addition, the commenter recommended that the Administrator approve alternative testing schedules that, in exceptional circumstances, might extend to 420 days. We agree with the commenter that the testing schedule, as proposed, is unclear. It was our intention to give producers a measure of flexibility within the 365-day testing cycle for the incremental complete herd test (CHT), so we proposed to allow the 25-percent incremental tests to be conducted every 80-105 days, and the 10-percent incremental tests every 25-35 days. However, if a producer were to conduct each increment of the 25-percent incremental CHT on the 105th day, which the proposed regulations would have allowed, the testing would not be completed until 420 days had passed, thus leaving a 2- month gap between the end of the 365-day validation period and the completion of the incremental testing required to maintain validation. While the commenter agreed that there should be some measure of flexibility in the testing cycle, she was concerned about whether a herd would retain its validated brucellosis-free status during that time. In order to address the commenter's concerns and clarify the intent of the regulations, we have rewritten portions of paragraph (b) of the definition of validated brucellosis-free herd. The new text of paragraph (b)(1), ``Validation,'' makes it clear that the 25-percent incremental testing is to be conducted at 90-day intervals, thus ensuring that the testing is completed within the 365-day testing cycle. To allow some flexibility, though, we have included a provision under which the Administrator could give a producer an additional 15 days in which to conduct an incremental test when unforeseen circumstances warrant an extension. Even if an extension were granted, however, the next test would be due on the day specified on the original schedule, not 90 days after the test for which an extension was granted was actually conducted. This way, the 25-percent incremental testing would be kept on schedule and completed within the 365-day testing cycle (unless an extension were granted for the final incremental test, which would mean the testing would be completed within 375 days). The new text of paragraph (b)(2), which concerns maintenance of validated-free status, provides that, when unforeseen circumstances warrant such an extension, the Administrator may approve an alternative testing schedule under which an incremental CHT would be completed within 420 days. A herd tested under an alternative testing schedule would retain its validation until the testing has been completed. This provides the flexibility sought by the commenter by allowing a producer to maintain validated brucellosis-free status in situations where circumstances make it impossible to complete the required herd testing within the specified 365-day testing cycle. In addition to the changes discussed above, we are making one nonsubstantive editorial change to the rule. Therefore, based on the rationale set forth in the proposed rule and in this document, we are adopting the provisions of the proposal as a final rule, with the changes discussed in this document. Executive Order 12866 and Regulatory Flexibility Act This final 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. The changes in this rule should result in direct benefits for producers through testing requirements either being relaxed or removed entirely, and in indirect benefits through more standardized testing procedures. Requiring fewer tests, which cost an estimated $5 per head, will not only save herd owners money, but will also be less disruptive to normal herd operations. Similarly, savings will be realized by the removal of the requirement for routine herd testing in validated brucellosis-free States. The more stringent standard for validated brucellosis-free State status will disqualify any State with more than one confirmed brucellosis-infected herd. We expect that this new standard will provide States or producers with an incentive to depopulate the relatively few brucellosis-infected herds of domestic swine that, although sources of disease perpetuation and spread, are currently tolerated in some States. We expect, therefore, that this provision will expedite the eradication of swine brucellosis in domestic herds in all States in the United States. Once eradication has been achieved, as has been done in 40 States, fewer tests must be conducted. Producers will immediately benefit, both operationally and economically, from the reduced testing requirements. More than 90 percent of all domestic swine producers are classified as small businesses. Based on the 1991 marketing year figures, sales of fewer than 4,000 head place a producer in the ``small business'' category (gross receipts below $500,000). Of the 238,819 swine producers in the United States identified in the most recent Census of Agriculture, fewer than 24,000, or 10 percent, sell more than 1,000 head per year; precise figures above 1,000 are not available. We expect that large and small producers alike will benefit to a limited extent from relaxed testing requirements in States applying for validation and in States already validated as swine brucellosis-free. Producers in other States will be unaffected by these changes to the regulations. Feral swine have a capacity for harboring and transmitting swine brucellosis to domestic herds. Feral swine moved interstate (not intended for immediate slaughter) are presumably sold to hunting preserves or at livestock auctions. However, State records indicate minimal interstate movement of feral swine. Therefore, it is likely that few small entities will be affected by the provisions of this final rule regarding the interstate movement of feral swine. We know of no other small entities that might be affected by this rule. 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 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 rule has been reviewed under Executive Order 12778, 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 the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this final rule will be submitted for approval to the Office of Management and Budget. List of Subjects in 9 CFR Part 78 Animal diseases, Bison, Cattle, Hogs, Quarantine, Reporting and recordkeeping requirements, Transportation. Accordingly, 9 CFR part 78 is amended as follows: PART 78--BRUCELLOSIS 1. The authority citation for part 78 continues to read as follows: Authority: 21 U.S.C. 111-114a-1, 114g, 115, 117, 120, 121, 123- 126, 134b, 134f; 7 CFR 2.17, 2.51, and 371.2(d). 2. In Sec. 78.1, the term Herd blood test is amended by removing and reserving paragraph (b); the terms Validated brucellosis-free herd and Validated brucellosis-free State are revised; and the terms Complete herd test (CHT), Confirmatory test, Feral swine, Market swine test (MST) reactor, Monitored-negative feral swine population, and Swine brucellosis are added, in alphabetical order, as follows: Sec. 78.1 Definitions. * * * * * Complete herd test (CHT). An official swine brucellosis test of all swine on a premises that are 6 months of age or older and maintained for breeding purposes. Confirmatory test. A follow-up test to verify any official test results. Confirmatory tests include the standard tube test, the Rivanol test, the complement fixation test (CF), the particle concentration fluorescence immunoassay (PCFIA), the semen plasma test, and the standard plate test. * * * * * Feral swine. Free-roaming swine. Formerly free-roaming swine could qualify for reclassification as domestic swine upon testing negative to an official swine brucellosis test after a period of at least 60 days' confinement in isolation from other feral swine. * * * * * Market swine test (MST) reactor. Market swine test swine with a positive reaction to a swine brucellosis confirmatory test or other official test, if no confirmatory test is performed. * * * * * Monitored-negative feral swine population. Feral swine indicating no evidence of infection (indicators would include positive blood tests or clinical signs, such as abortion) and originating from a specified, geographically isolated area (a forest area, hunting preserve, or swamp, for example) may be classified by the designated epidemiologist as a monitored-negative feral swine population. * * * * * Swine brucellosis. The communicable disease of swine caused by Brucella suis (B. suis) biovar 1 or 3. * * * * * Validated brucellosis-free herd. (a) A swine herd not known to be infected with swine brucellosis, located in a validated brucellosis- free State; or (b) a swine herd in a State that has not been validated as brucellosis-free, provided the herd meets the conditions for validation, as follows: (1) Validation. A swine herd may be validated as brucellosis-free if it has been found brucellosis negative after either a complete-herd test (CHT) or an incremental CHT. The incremental CHT may be conducted by testing all breeding swine 6 months of age or older with negative results within 365 days, either in four 25-percent increments, with those tests being conducted on the 90th, 180th, 270th, and 360th days of the testing cycle, or in 10-percent increments every 25-35 days until 100 percent of those swine have been tested. In cases where unforseen circumstances warrant such action, the Administrator may approve an extension of up to 15 days of the date on which a test under the 25-percent incremental herd test is to be conducted, thus allowing a test to be conducted no later than the 105th, 195th, 285th, or 375th day of the testing cycle. No swine may be tested twice during the testing cycle to comply with either the 25 percent requirement or the 10 percent requirement. No further testing is required once 100 percent of the breeding swine have been tested. After all breeding swine have tested brucellosis negative, a herd may be validated as brucellosis- free. Unless the Administrator has approved an alternative testing schedule, which might extend the testing cycle, a herd retains validated brucellosis-free status for a maximum of 365 days. (2) Maintaining validation. Validation may be continuously maintained if a complete herd test (CHT) is performed once every 365 days, with negative results, or an incremental CHT is performed. The incremental CHT may be conducted by testing all breeding swine 6 months of age or older, with negative results, within 365 days in either four 25-percent increments, with those tests being conducted on the 90th, 180th, 270th, and 360th days of the testing cycle, or in 10-percent increments every 25-35 days until 100 percent of those swine have been tested. In cases where unforeseen circumstances warrant such action, the Administrator may approve an alternative testing schedule under which the 25 percent or 10 percent incremental CHT would be completed, with negative results, within 420 days, during which time the herd's validated brucellosis-free status would be continued. No swine may be tested twice during the testing cycle to comply with these requirements. No further testing is required once 100 percent of the breeding swine have been tested. Validated brucellosis-free State. A State may apply for validated- free status when: (a) Any herd found to have swine brucellosis during the 2-year qualification period preceding the application has been depopulated. More than one finding of a swine brucellosis-infected herd during the qualification period disqualifies the State from validation as brucellosis-free; and (b) During the 2-year qualification period, the State has completed surveillance, annually, as follows: (1) Complete herd testing. Subjecting all swine in the State that are 6 months of age or older and maintained for breeding purposes to an official swine brucellosis test; or (2) Market swine testing. Subjecting 20 percent of the State's swine 6 months of age or older and maintained for breeding purposes to an official swine brucellosis test, and demonstrating successful traceback of at least 80 percent of market swine test (MST) reactors to the herd of origin. Blood samples may be collected from MST swine if the swine can be identified to their herd of origin, in accordance with Sec. 71.19(b) of this subchapter. All MST reactor herds are subject to a CHT within 30 days of the MST laboratory report date, as determined by a designated epidemiologist; or (3) Statistical analysis. Demonstrating, by a statistical analysis of all official swine brucellosis test results (including herd validation, MST, change-of-ownership, diagnostic) during the 2-year qualification period, a surveillance level equivalent or superior to CHT and MST testing programs discussed in this paragraph. (c) To maintain validation, a State must annually survey at least 5 percent of its breeding swine, and demonstrate traceback to herd of origin of at least 80 percent of all MST reactors. A State must demonstrate its continuing ability to meet the criteria set forth in paragraph (c) of this definition within 36-40 months of receiving validated brucellosis-free State status to retain that status. * * * * * Sec. 78.30 [Amended] 3. In Sec. 78.30, paragraph (a) is amended by removing the words ``and sows'' after ``brucellosis exposed swine'' and adding, in their place, the words ``feral swine, sows,''. 4. In Sec. 78.30, a new paragraph (c) is added to read as follows: Sec. 78.30 General restrictions. * * * * * (c) (1) Feral swine may be moved interstate directly to slaughter if they do not come into physical contact with any domestic swine or other livestock. (2) Feral swine from monitored-negative populations may be moved interstate other than directly to slaughter if accompanied by a permit issued by the APHIS representative or the State animal health official in the State of origin. (3) Feral swine found negative to an official test within the 30 days prior to the interstate movement may be moved interstate other than directly to slaughter if accompanied by a permit issued by the APHIS representative or the State animal health official in the State of origin. Done in Washington, DC, this 15th day of April 1994. Patricia Jensen, Acting Assistant Secretary, Marketing and Inspection Services. [FR Doc. 94-9593 Filed 4-20-94; 8:45 am] BILLING CODE 3410-34-P