in-20260826-IR-345260302FNA: BRUCELLOSIS AND PSEUDORABIES IN SWINE

TITLE 345 INDIANA STATE BOARD OF ANIMAL HEALTH Notice of First Public Comment Period LSA Document #26-302 BRUCELLOSIS AND PSEUDORABIES IN SWINE PURPOSE OF NOTICE The Indiana State Board of Animal Health (BOAH) is soliciting public comment on amending and repealing rules at 345 IAC 3-4 and 345 IAC 3-5.1 concerning brucellosis and pseudorabies in swine. ADDITIONAL DOCUMENTS Regulatory Analysis: 20260826-IR-345260302RAA Notice of Public Hearing: 20260826-IR-345260302PHA CITATIONS AFFECTED: 345 IAC 3-4-1; 345 IAC 3-4-2; 345 IAC 3-4-2.5; 345 IAC 3-4-3; 345 IAC 3-4-4; 345 IAC 3-4-5; 345 IAC 3-4-6; 345 IAC 3-4-7; 345 IAC 3-4-8; 345 IAC 3-4-9; 345 IAC 3-4-10; 345 IAC 3-4-11; 345 IAC 3-4-12; 345 IAC 3-4-13; 345 IAC 3-4-14; 345 IAC 3-4-15; 345 IAC 3-4-16; 345 IAC 3-4-17; 345 IAC 3-4-18; 345 IAC 3-4-19; 345 IAC 3-5.1-1.2; 345 IAC 3-5.1-1-1.5; 345 IAC 3-5.1-2; 345 IAC 3-5.1-2.5; 345 IAC 3-5.1-4; 345 IAC 3-5.1-6; 345 IAC 3-5.1-7; 345 IAC 3-5.1-8; 345 IAC 3-5.1-8.5; 345 IAC 3-5.1-8.7; 345 IAC 3-5.1-10; 345 IAC 3-5.1-13 AUTHORITY: IC 15-17-3-21 OVERVIEW Basic Purpose and Background The proposed rule makes technical updates to the brucellosis in swine and pseudorabies rules. The original brucellosis rule was established to implement the brucellosis eradication program. The program has advanced to a stage that requires surveillance to maintain free status. Rule provisions relevant to a wide-spread outbreak are no longer necessary, but provisions related to ongoing surveillance and incident response are still needed to maintain state status and respond to any wildlife-associated findings in swine. The proposed rule repeals unnecessary provisions and makes technical corrections to the remaining provisions. The original pseudorabies rule was established to implement the pseudorabies eradication program. The program has advanced to a stage that requires surveillance to maintain free status. Rule provisions relevant to a wide-spread outbreak are no longer necessary, but provisions related to ongoing surveillance and incident response are still needed to maintain state status and respond to any wildlife-associated findings in swine. The proposed rule repeals unnecessary provisions and makes technical corrections to the remaining provisions, including updating USDA program standards incorporated by reference. The rule maintains, with technical updates, language establishing voluntary brucellosis free and pseudorabies free status herd programs that herd owners may use to establish a herd status. These herd status programs are optional for swine producers, but are recognized nationally in the marketplace and may benefit some producers' market opportunities. Executive Order 25-17 directs state agencies to work toward a 25% reduction in regulatory requirements by January 1, 2029. The proposed rule eliminates unnecessary provisions in furtherance of this goal. The implementation costs of the proposed rule are not expected to exceed the threshold set in IC 4-22-2-22.7(c)(6). For purposes of IC 4-22-2-28.1, small businesses affected by this rulemaking may contact the Small Business Regulatory Coordinator: For purposes of IC 4-22-2-28.1, the Small Business Ombudsman designated by IC 5-28-17-6 is: Resources available to regulated entities through the small business ombudsman include the ombudsman's duties stated in IC 5-28-17-6, specifically IC 5-28-17-6(9), investigating and attempting to resolve any matter regarding compliance by a small business with a law, rule, or policy administered by a state agency, either as a party to a proceeding or as a mediator. REQUEST FOR PUBLIC COMMENT BOAH is soliciting public comment on the proposed rule. Comments may be submitted in one of the following ways: COMMENT PERIOD DEADLINE All comments must be postmarked or time-stamped not later than October 6, 2026. The rule, Regulatory Analysis, appendices referenced in the Regulatory Analysis, and materials incorporated by reference (if applicable) are on file at the Indiana State Board of Animal Health, Discovery Hall, Suite 100, 1202 East 38th Street, Indianapolis, Indiana and are available for public inspection. Copies of the rule, Regulatory Analysis, and appendices referenced in the Regulatory Analysis are available at the Indiana State Board of Animal Health office. If BOAH does not receive substantive comments during the public comment period or public hearing, the rule may be adopted with text that is the same as or does not substantially differ from the text of the proposed rule published in this notice. PROPOSED RULE Sec. 2. (a) The "Board" means the Indiana state board of animal health. (b) "Herd of swine" means all swine on the premises six (6) months of age or older maintained for breeding purposes and kept separate and apart from all other swine. (c) "Brucellosis test" means the serological test using the brucellosis test card and buffered Brucella antigen (card test), and/or and any other test approved by the board. (d) "Negative test" means any swine from an infected herd or a herd of unknown status that discloses an SPT agglutination reactor of less than complete agglutination in the blood titer dilution of 1:25 or that has no reaction to the card test. Any swine from a validated herd or a herd not known to be infected in a validated area or on a complete or twenty-five percent (25%) herd test that discloses an SPT agglutination reaction of less than complete agglutination in the blood titer dilution of 1:100 or that has no reaction to the card test. (e) "Suspect" means any swine positive to the card test and negative to the rivanol test. (f) "Negative herd test" means all eligible swine comprising the herd are negative under the definition of a negative test. (g) "Reactor" means any swine that discloses complete agglutination reaction to the blood titer dilution of 1:100 or higher, is positive to the card test, and is positive to the rivanol test. If a veterinary epidemiologist determines that the herd history so indicates, the animal may be classified as a suspect and quarantined until subjected to additional test(s) testing to determine the status of the animal(s). animal or animals. Swine from known infected herds having complete agglutination titer in the 1:25 dilution or higher, or positive to the card test or found infected by other means, shall be are classified as reactors. (h) "Brucellosis infected herd" means a herd of swine in which one or more reactors has been disclosed. (i) "Approved market Brucellosis test"-the card test (BBA) will be used at salebarns, auction markets, and stockyards and must be conducted by an approved veterinarian or an approved technician under his direct supervision in a Brucellosis testing laboratory in the market that has been authorized and approved by the board. (j) "Approved market veterinarian" means an accredited veterinarian licensed by the state of Indiana and authorized by the board, in writing, to conduct official tests in an approved laboratory and perform other duties in the market in a manner recommended by the board. Authorization may be revoked by the board for failure to follow recommended procedures or for violation of a regulation of the board. (k) "Immediate slaughter" means any domestic animal purchased or sold for such purpose, except animals to be slaughtered by the purchaser himself, will be consigned to a recognized slaughtering establishment or to a licensed stockyard for consignment to a recognized slaughtering establishment and must not be diverted for any other purpose. (l) "Persons" means any individual, firm, partnership, association, joint venture or corporation. (m) "Recognized slaughter establishment" means a place of business where domestic animals are slaughtered and meat products are processed for human consumption, subject to federal or state meat inspection. (n) "Cooperating agencies" means the Indiana state board of animal health and the United States Department of Agriculture, and the Animal and Plant Health Inspection Service, Veterinary Services. (o) "Auction market (salebarn) or community sale" means an established place of business and contiguous surroundings including vehicles of transportation from which animals consigned to such auction market (salebarn) or community sale are sold or exchanged at auction or otherwise and for sale or exchange of which a commission is paid to the operator of such place of business. (p) "Stockyards" means a place where livestock is assembled for sale, purchase or reassignment. (q) "Market" means auction market (salebarn), community sale or stockyards. (r) "Public sale" means any sale where the general public is invited to participate whether held at an established place of business dedicated principally to the sale or exchange of domestic animals or a place where such sales are infrequently held. (s) "Private sale" means a sale, exchange, lease or barter of domestic animals between persons. (t) (h) "Validated brucellosis-free herd" means a herd of swine that has a negative herd test or a negative test of twenty-five percent (25%) of the breeding herd every eighty (80) to one hundred five (105) days with all swine in the herd tested during a twelve (12) month period, provided the owner(s) of the herd has signed the agreement required by the cooperating agencies. Validation shall be for twelve (12) months from the date of the herd test provided the herd is maintained separate and apart from all other swine. completed the requirements to obtain brucellosis-free status under section 12 of this rule. (u) "Validated Brucellosis-free area" means a state or political subdivision that has been declared free of swine Brucellosis by the cooperating agencies and have met the requirements set forth by the Recommended Uniform Methods and Rules of the United States Department of Agriculture. Sec. 3. (a) As long as Indiana maintains a Swine moved from a state with validated brucellosis-free state status under the United States Department of Agriculture Brucellosis in Swine Control Program, including Indiana origin swine in intrastate commerce, are not required to be tested and found negative for brucellosis. before: Interstate swine must satisfy the swine brucellosis requirements of the state of destination. If Indiana (b) Except as provided in subsection (c), the following apply to movements of swine into Indiana for breeding purposes from a state that loses the validated brucellosis-free state status, the requirements in subsection (b) apply. (b) No person shall sell, offer for sale, lease, barter, or exchange any and to movements of swine for breeding purposes in Indiana unless the transaction is intrastate for breeding purposes if Indiana loses its brucellosis-free status: (c) The following are exempt from the requirements in subsection (b): Sec. 12. (a) A person may establish a validated brucellosis-free status for their swine herd by completing the following requirements: (b) A validated brucellosis-free herd status expires twelve (12) months after the testing in subsection (a)(2) is completed. Sec. 13. (a) A person may renew a brucellosis-free herd status for the herd may be revalidated if a negative herd test is conducted by completing one (1) of the following revalidation procedures: Sec. 1.2. The definitions in IC 15-17-2, the definitions in the Program Standards, and the following definitions apply throughout this rule: Sec. 1.5. (a) The board adopts and incorporates by reference the United States Department of Agriculture Pseudorabies Eradication State-Federal-Industry Program Standards in effect January 1, 2000, November 1, 2003, as rules of the board. Copies of the Pseudorabies Program Standards may be obtained from the office of the state veterinarian. by calling (317) 227-0310. Where provisions of the Program Standards conflict with this rule, the express provisions of this rule shall control. (b) Owners of qualified Pseudorabies-negative (QN) herds that maintain qualified Pseudorabies-negative herd status using the monthly testing protocol set forth in Part IV(B)(1) of the Program Standards must test every twenty-five (25) to thirty-five (35) days and must conduct twelve (12) official tests in a calendar year. (c) Part III, subpart "Stage III Mandatory Herd Cleanup", item (C) "Disposition of quarantined herds" of the Program Standards also applies to Part III, subpart "Stage II Control". Sec. 2. (a) When clinical or laboratory evidence indicates the presence of Pseudorabies in an individual animal or herd, the veterinarian shall report the diagnosis immediately to the office of the state veterinarian. (b) All animals tested must be individually identified by ear tags approved by the board or by standard ear notches. All identification must be recorded on the test form. The state veterinarian may alter the identification requirements as needed to protect animal health in Indiana. All blood samples must be drawn by a state or federal official or a licensed, accredited veterinarian, and serological tests must be conducted by a state and federally approved laboratory. (c) A veterinarian making a clinical diagnosis of Pseudorabies must confirm the diagnosis in writing and send a copy to the board within two (2) business days of the diagnosis. The final determination of herd status shall be made by the state veterinarian. Sec. 2.5. (a) Before breeding swine may be transported into the state, the swine must test negative for pseudorabies on an official serology test that is conducted within the thirty (30) days prior to transportation into the state. However, swine that meet one (1) of the following sets of criteria are exempt from the test required in this subsection: (b) All breeding swine transported into the state are quarantined to the destination premises and must be isolated from other animals and tested for pseudorabies in not less than thirty (30) nor more than forty-five (45) days from date of entry. However, the following are exemptions and alterations to exempt from the test required in this subsection: (c) Feeder pigs that originate from an area designated Stage II or Stage III by the United States Department of Agriculture under the national pseudorabies eradication program must be tested for pseudorabies utilizing an official random sample test (95/10) under the program standards defined in this rule within the thirty (30) days immediately prior to the feeder pigs entering the state. Feeder pigs originating from an area designated Stage III and from a herd that qualifies as a pseudorabies-qualified herd or a qualified negative gene-altered virus-vaccinated herd, utilizing monthly testing, in the program standards defined in this rule are exempt from the test required under this subsection. If the test required in this subsection is not completed or if any feeder pig tests positive for pseudorabies, a person is prohibited from transporting any part of that group of feeder pigs into Indiana. (d) The owner of feeder pigs that are transported into Indiana shall procure the services of a licensed and accredited veterinarian to test the imported swine for pseudorabies between thirty (30) and forty-five (45) days after entry into Indiana utilizing an official random sample test (95/10) under the program standards defined in this rule. However, the test required in this subsection is waived if one (1) of the following conditions are met: (e) A person may not transport any of the following swine into the state: Sec. 4. (a) A person must meet may obtain, maintain, and renew a pseudorabies status for their herd by meeting the requirements in this section and section 5 of this rule to maintain the Pseudorabies Program Standards for a qualified or qualified negative gene-altered vaccinated herd. (b) Animals purchased to add to a herd must test negative for Pseudorabies within thirty (30) days prior to movement and must be isolated upon arrival and retested negative not less than thirty (30) nor more than forty-five (45) days from the date of arrival. But, additions to a herd may be purchased directly from a PRV-qualified herd or a qualified negative gene-altered vaccinated herd without the negative thirty (30) day test previous to sale. (c) Members of a PRV-qualified herd or qualified negative gene-altered vaccinated herd that are exhibited or otherwise commingled with swine from non-Pseudorabies qualified herds shall be held in isolation on the herd premises or owner's isolation facility for a minimum of thirty (30) days after return and shall be tested negative to an official test for Pseudorabies not less than thirty (30) days nor more than forty-five (45) days from the first day of isolation before being reunited with other members of the herd. (d) All qualified or qualified negative gene-altered vaccinated herds shall be monitored as described in the Pseudorabies Program Standards or as further defined by this rule. Sec. 8. (a) All feeder pigs sold in Indiana except those exempted by the Indiana state veterinarian must originate from herds that have been tested for Pseudorabies and have been found negative by the following method: (b) All feeder pigs sold in Indiana shall be quarantined to the purchaser's premises until sold for slaughter except the following: (c) All feeder pigs sold through markets or feeder pig concentration points shall be quarantined to the purchaser's premises until sold for slaughter except the following: (d) Imported feeder pigs shall originate from a state where the reporting of Pseudorabies is mandatory and where all known-infected herds are quarantined. In addition, requirements for all imported Feeder pigs shall be as follows: (1) moved into the state are quarantined to the premises of the consignee until they are: The Swine when moved from a concentration point shall must be quarantined to the purchaser's premises until sold to an approved slaughter market. Sec. 8.5. (a) An owner of a swine herd described in subsection (c) (b) or (d) (c) must procure a licensed and accredited veterinarian to test the owner's swine herd for pseudorabies. The This pseudorabies testing required in subsections (c) and (d) shall be is conducted as follows: (b) Quarantined swine herds shall be tested under section 8.7 of this rule. (c) (b) If the United States Department of Agriculture (USDA) assigns the state, or portions of the state, a status under the Program Standards that is lower than Stage IV status, all swine herds in the lower status area must be tested for pseudorabies, as outlined in subsection (a), within thirty (30) days of the date the state veterinarian notifies the herd owner or manager of the requirement to test. Swine herds in the lower status area must be retested not less than once every three hundred sixty-five (365) days until the United States Department of Agriculture USDA assigns the area a Stage IV or Stage V status under the Program Standards. (d) (c) Circle testing shall be coordinated by the state veterinarian to identify pseudorabies infection within five (5) miles of each pseudorabies infected herd. The owner of a swine herd located, in whole or in part, within five (5) miles of a swine herd that tests positive for pseudorabies must test a percentage of the swine in the owner's herd, as outlined in subsection (a). Sec. 10. (a) Pseudorabies vaccine may be used only if the use is authorized by a licensed and accredited veterinarian. The veterinarian dispensing pseudorabies vaccine shall be responsible for reporting report all new vaccinated herds in writing to the office of the state veterinarian at least once each month. All swine sold under section 6(b)(1) of this rule shall be identified and vaccinated by a veterinarian. A certificate of vaccination must be completed to accompany the special permit. (b) All pseudorabies vaccine sold into Indiana must be reported monthly by the manufacturer and any registered distributor to the office of the state veterinarian. (c) Only those pseudorabies vaccines with an approved differential pseudorabies test may be used. (d) All serological results conducted on swine vaccinated with Pseudorabies vaccine will be evaluated by a veterinary epidemiologist to determine the herd status. Documents Incorporated by Reference: United States Department of Agriculture Pseudorabies Eradication State-Federal-Industry Program Standards in effect November 1, 2003 Small Business Regulatory Coordinator: Britney McMahan, Director of Legal Affairs, Indiana State Board of Animal Health, Discovery Hall, Suite 100, 1202 East 38th Street, Indianapolis, IN 46205, (317) 544-2400, bmcmahon@boah.in.gov