in-20250910-IR-345240625RAA: _________________________

TITLE 345 INDIANA STATE BOARD OF ANIMAL HEALTH Rule Readoption Review  LSA Document #24-625 IC 4-22-2.6-4 and EO 25-17 345 IAC 1-1.1 Sale of Disease Treatment or Diagnostic Agent

II. Continued Need for the Rule

Under the Biological Products law, a person may not use or sell any substance for the prevention or treatment of a contagious or infectious disease that contains living germs in a virulent or attenuated state or may at any time cause an outbreak of a contagious or infectious disease unless the person has submitted a notice to the state veterinarian describing the substance. The state veterinarian may forbid the use of a substance that in the state veterinarian's judgment jeopardizes the health of domestic animals or causes the masking of a diagnosis of a contagious or infectious disease. A person may not manufacture or sell within Indiana a biological product for use on an animal unless it is produced at an establishment that is licensed by the United States Department of Agriculture (USDA) or located in Indiana and approved by and issued permits by the board. Only vaccines produced at establishments licensed under the federal Virus-Serum-Toxin Act (21 U.S.C. 151 through 21 U.S.C. 158) or in Indiana and approved by the board may be administered to animals. IC 15-17-12. This rule is necessary to carry out the above-described requirements. Specifically, it makes it unlawful for any person to sell any Tuberculin or Brucella antigen used as a diagnostic agent for domestic animals except to the state or federal regulatory agency which is directly responsible for the control of livestock diseases. It also makes it unlawful for any firm to receive any Tuberculin or Brucella antigen into Indiana from any other state for the purpose of sale or use in the state of Indiana, except as permitted by the rule. It makes it unlawful for any person to sell within the state any Brucella Abortus Vaccine, Rabies Vaccine or Pseudorabies Vaccine for use in domestic animals except to an accredited, licensed veterinarian, or a registered distributor. A distributor of Brucella Abortus Vaccine, Rabies Vaccine or Pseudorabies Vaccine, must be registered with the office of the state veterinarian and must have received prior written approval before receiving or selling any of the vaccines listed in this section. Sales of these vaccines by a registered distributor must be made only to a licensed, accredited veterinarian.

III.  Analysis of fees, fines and civil penalties under IC 4-22-2-19.6

A violation of 345 IAC 1-1.1 is governed by IC 15-17-18-12, which states that a person who violates this article, a rule adopted under this article, or a determination or order of the board or an agency made under this article is liable for a penalty not to exceed twenty-five thousand dollars ($25,000) for each day of the violation, plus payment to the board for the costs incurred by the board as a direct consequence of prosecution for the violation. The BOAH civil penalty schedule specifies how a penalty is calculated for a violation of animal health laws and rules. Currently, a first offense is a range of $0-$500 and a subsequent offense is $0-$1,000. BOAH recently incorporated this schedule into a civil penalty rule, which also establishes the factors that the agency will consider when determining a specific amount within this range.

IX. Other State or Federal Requirements

APHIS regulates veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin) to ensure that the veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are pure, safe, potent, and effective. For example, under the Federal Virus-Serum-Toxin Act, BOAH issues the following categories of approvals: It is important to note that the agency has occasionally had to investigate and take enforcement action to cease sales of rabies vaccines that have been shipped to animal owners in violation of state law.  BOAH has not encountered any difficulties in administering this rule. As stated above, the USDA-APHIS has a process for approval of biologics. The state law aligns with this law by requiring certain state approvals that are consistent with the federal Virus-Serum-Toxin Act and regulations. In Illinois, Idaho, Kentucky, Michigan, North Dakota, and Ohio, the requirements for distribution of Brucella abortus, rabies, and pseudorabies vaccines align with Indiana: A review of other state requirements has resulted in a finding that BOAH does not have requirements governing the distribution of vaccines and biologics that are more restrictive than other states.

XI. Integration into Indiana Code

The state biological products law prohibits the sale, offer for sale, or distribution within Indiana of a biological product for use on an animal unless the biological product is produced at an establishment that is either licensed by the USDA, or located in Indiana and approved by and issued permits by the board. Only vaccines produced at establishments licensed under the federal Virus-Serum-Toxin Act, or in Indiana and approved by the board, may be administered to animals in Indiana. The BOAH rule provides further details of how to comply with this law. For example, it clarifies that biological products must only be received by a licensed veterinarian or distributor that is registered with the BOAH. It is important to have the biological products rule to provide further detail for the distributor registration requirements and for any entities that are seeking to engage in activities that need a BOAH permit under the federal Virus-Serum Toxin Act. The rule prescribes requirements to be met under normal circumstances. In an emergency or substantial change of circumstances, such as a surge in disease detections or a need for widespread testing or vaccination, the Board may need to change how products are distributed and used. Currently the Board of Animal Health has the authority to do this by rule and could accomplish such a change quickly during an emergency meeting of the Board. If the provisions were in statue, changes could only be made during a legislative session. If it is determined that these provisions should be integrated into Indiana Code, it is still necessary to readopt 345 IAC 1-1.1 to prevent the expiration of these requirements prior to their enactment. 345 IAC 1-1.5-2 Certificates of veterinary inspection 345 IAC 1-3 Moving Animals

II. Continued Need for the Rule

The CVI and animal movement rules are necessary to implement a federal mandate. The state must ensure that its identification and documentation requirements for movement of livestock and poultry into the state align with the federal rule at 9 CFR Part 86. Indiana's livestock and poultry producers rely on the BOAH to ensure that all identification and documentation requirements align with federal standards. If the requirements are inconsistent with these standards, it may jeopardize their ability to move their animals in commerce interstate or internationally. BOAH's traceability program is subject to periodic tests by USDA-APHIS to ensure that the staff can quickly trace an animal's movements in order to demonstrate the state's ability to contain a disease of concern to animal or human health. If the appropriate intrastate identification and documentation requirements are not in place, it compromises the ability to successfully complete a trace investigation in accordance with federal standards. It is also important that these requirements are in state law so enforcement action may be taken by the state in the absence of, or in addition to, federal action if it is deemed necessary to protect animal or public health. BOAH does not impose any requirements with regard to animals moving into the state that are more stringent than 9 CFR 86. III. Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6 A violation of 345 IAC 1-1.5-2 and 345 IAC 1-3 is governed by IC 15-17-18-12, which states that a person who violates this article, a rule adopted under this article, or a determination or order of the board or an agency made under this article is liable for a penalty not to exceed twenty-five thousand dollars ($25,000) for each day of the violation, plus payment to the board for the costs incurred by the board as a direct consequence of prosecution for the violation. The BOAH civil penalty schedule specifies how a penalty is calculated for a violation of animal health laws and rules. Currently, a first offense is a range of $0-$2000 and a subsequent offense is $0-$5,000. BOAH recently incorporated this schedule into a civil penalty rule, which also establishes the factors that the agency will consider when determining a specific amount within this range. These violations are considered major violations under IC 4-21.5-2.5-2(1)(E). IV. Cost-Benefit, Economic Impact, Fiscal Impact, or Regulatory Burden Statements  The animal movement rule was amended in 2014 to align with 9 CFR 86. LSA #14-57. It was amended in 2021 to repeal the requirement for a pre-entry permit for bison, cattle, and swine moving into Indiana if an electronic CVI has been filed with the board prior to the date of movement. 21-268(F). The CVI rule was also amended to authorize the state veterinarian to only allow CVIs to be submitted that are compatible with state information management systems. However, there are a broad range of such forms available for use by veterinarians preparing the CVIs. The agency has reexamined the previous cost benefit, economic impact, and fiscal impact statements prepared for the rule under IC 4-22-2-28 and IC 4-22-2.1-5. This review resulted in a finding that there have not been any changes in circumstances that affect the analysis and necessitate a change in the analysis

II. Continued Need for the Rule

Brucellosis is a contagious disease caused by bacteria of the genus Brucella, which affects both animals and humans. The federal brucellosis regulations, contained in 9 CFR Part 78, provide a system for classifying states according to the rate of Brucella abortus (B. abortus) infection present and the general effectiveness of a brucellosis control and eradication program. The classifications are Class Free, Class A, Class B, and Class C. Restrictions on moving cattle interstate become less stringent when a state achieves Class Free status, which is the current status of all states. If BOAH’s brucellosis control rules do not align with the federal brucellosis regulations, it could jeopardize the state's Class Free status. A modification of the state's status would have negative consequences regarding economic development. Indiana's cattle farmers rely on the board to adopt and enforce standards that align with the national brucellosis program. If the Board's brucellosis rule does not align with the federal regulations, it would make these animal owners vulnerable to additional costly movement restrictions being imposed at the federal level. This rule aligns with the 2003 USDA Uniform Methods and Rules for Brucellosis Eradication, which is critical to ensuring the maintenance of Indiana’s Class Free status. All "test eligible cattle" must have a negative brucellosis test within the 30 days immediately prior to entering Indiana, unless they originate from a brucellosis-free state or herd. There are additional requirements for dairy and breeding cattle or bison.

III.  Analysis of fees, fines and civil penalties under IC 4-22-2-19.6

A violation of 345 IAC 2-6 is governed by IC 15-17-18-12, which states that a person who violates this article, a rule adopted under this article, or a determination or order of the board or an agency made under this article, is liable for a penalty not to exceed twenty-five thousand dollars ($25,000) for each day of the violation, plus payment to the board for the costs incurred by the board as a direct consequence of prosecution for the violation. The BOAH civil penalty schedule specifies how a penalty is calculated for a violation of animal health laws and rules. Currently, failure to comply with t brucellosis control laws a range of $0-$1,000 and a subsequent offense is $0-$5,000. BOAH has incorporated this schedule into a civil penalty rule, which establishes the factors that the agency will consider when determining a specific amount within this range.

II. Continued Need for the Rule

The state Chronic Wasting Disease rule (345 IAC 2-7) requires the enrollment of captive cervids in the CWD Registered Herd program that are designated by the board to be susceptible to CWD. In addition, the state administers a CWD Certified Herd program that aligns with requirements for the USDA-Animal and Plant Health Inspection Service (APHIS) National CWD Herd Certification Program (HCP). Indiana participates in this cooperative program with APHIS for Indiana cervid owners who wish to move animals interstate to be able to obtain a status authorizing such movement. The CWD programs include standards such as official identification, recordkeeping, fencing, and sampling requirements for captive cervids. Indiana’s deer and elk farming industry had a total economic impact of $49.3 million dollars in 2010. Since the study was conducted, Indiana has seen an increase in hunting preserves which are the major demand driver for the breeding industry. This study found that over 95 percent of hunting preserve clients are from out of state, bringing dollars into Indiana.1 According to the most recent survey, resident and nonresident wildlife hunters spend approximately $222 million dollars in the state and support $436 million dollars in sporting industry salaries and wages annually.2 If the BOAH does not retain its CWD rule, it would have negative consequences with regard to economic development. As discussed above, the economic impact of the deer and elk farming is significant for our state’s rural communities. Because the introduction of CWD into the state will inevitably have an adverse effect on the economic viability of both the captive and wild deer industries, it is critical that the state retain this rule to minimize the risk of transmission by animal movement.

III.  Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6

A violation of 345 IAC 2-7 is governed by IC 15-17-18-12, which states that a person who violates this article, a rule adopted under this article, or a determination or order of the board or an agency made under this article is liable for a penalty not to exceed twenty-five thousand dollars ($25,000) for each day of the violation, plus payment to the board for the costs incurred by the board as a direct consequence of prosecution for the violation. The BOAH civil penalty schedule specifies how a penalty is calculated for a violation of the CWD rule. Currently, a first offense is a range of $0-$500 and a subsequent offense is $0-$1,000. BOAH has incorporated this schedule into a civil penalty rule, which also establishes the factors that the agency will consider when determining a specific amount within this range.

IV. Cost-Benefit, Economic Impact, Fiscal Impact, or Regulatory Burden Statements

The agency has reexamined the previous cost benefit, economic impact, and fiscal impact statements prepared for the rule under IC 4-22-2-28 and IC 4-22-2.1-5. This review resulted in a finding that there has not been any change in circumstances that affects the analysis and necessitates a change in the analysis.

V. Alternative methods of achieving the Purpose of the Rule 

There are requirements for CWD Registered Herds that are not required under the federal HCP. For example, the state does not allow cervids to come into Indiana from states that have had CWD in their captive or wild populations in the past 5 years. In addition, the BOAH requires the state’s hunting preserves to sample harvested CWD susceptible deer. Indiana is one of 35 states with a CWD diagnosis. In April 2024, CWD was detected in a wild Indiana deer. It is the position of the BOAH that these requirements ensure that the state is prepared to take prompt action to mitigate any possible introduction into the captive deer populations.

IX. Other State or Federal Requirements

All surrounding states have state requirements for CWD-susceptible cervids beyond the federal HCP program. In Illinois, any owner of CWD-susceptible species that will be selling these animals intra or interstate is required to be enrolled in the Certified Monitored CWD Herd Program. In Kentucky, all herds are quarterly inspected by a Kentucky Department of Agriculture inspector, as well as a yearly visit by a representative from the Kentucky Department of Fish and Wildlife. All captive whitetail deer are required to be licensed or registered with the Ohio Department of Agriculture. In Michigan, the Michigan Department of Natural Resources (DNR) and the Michigan Department of Agriculture and Rural Development (MDARD) jointly regulate farmed cervids. This includes registering facilities and performing inspections of those operations. Idaho and South Dakota also have state requirements related to CWD. The Idaho State Department of Agriculture (ISDA) regulates and enforces standards for Idaho’s domestic cervidae industry. ISDA’s role is to ensure cervid health through testing provisions, import surveillance, inventory verification and facility inspections. South Dakota has implemented regulations that are more stringent than the USDA's CWD HCP guidelines. For example, there is mandatory CWD testing in specific zones and regulations governing the transportation and disposal of cervid carcasses in CWD endemic areas. A review of these states has resulted in a finding that Indiana does not have rules that are more restrictive than the states that are required to be evaluated under EO 25-17.

XI. Integration into Indiana Code

The national status of CWD in the wild and captive populations, and the federal regulations governing the disease, is continually evolving. As noted above, the rule has been amended within the last six years. Therefore, it is the position of the BOAH that the CWD rule should not be integrated into the Indiana Code so the agency can rapidly make amendments to align with the federal HCP program standards. _________________________ 1Economic Impact of the Deer and Elk Farming Industry in Indiana, Dr. John Lee, PhD, Agricultural Economist, Alicia English, PhD candidate, Agricultural Economist, November 2011. 2National Survey of Fishing, Hunting, and Wildlife-Associated Recreation, U.S. Fish and Wildlife Service and U.S. Census Bureau; Sportsman's Economic Impact Report, Congressional Sportsmen's Foundation, 2011 data. 345 IAC 2-8 Johne’s Disease (Mycobacterium Paratuberculosis)

II. Continued Need for the Rule

Johne's is a contagious bacterial infection primarily of the lower small intestine. Also known as paratuberculosis, Johne's most often infects dairy and beef cattle, sheep and goats. Johne's spreads primarily through ingestion of feed or water contaminated by manure from infected animals. Clinical signs of Johne's include weight loss, diarrhea, and lower milk production. However, visible signs of Johne's may not appear for 10 years or more. The best detector of Johne's is a fecal culture test. Blood tests, while less accurate than culture, are faster and less expensive. Johne's disease is most accurately diagnosed by examining the lower small intestine and associated lymph nodes in a dead animal. A killed vaccine is available for use only in cattle herds under a special agreement of the State Veterinarian, producer, and herd veterinarian. The vaccine will not prevent an animal from becoming infected. It will reduce the outward signs and prolong an animal's useful life.  Because Johne's-infected animals cannot be treated, they should be sold to slaughter as soon as possible. This rule sets forth the requirements to move an animal that tests positive for Johne’s disease into or within Indiana. This rule is critical to ensuring that standards are in place to prevent further spread of this disease due to a high-risk movement of a positive animal. The rule also provides for cattle owners to participate in a voluntary Johne’s program for cattle producers to test their herds for Johne's disease at no cost.

III.  Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6

A violation of 345 IAC 2-9 is governed by IC 15-17-18-12, which states that a person who violates this article, a rule adopted under this article, or a determination or order of the board or an agency made under this article, is liable for a penalty not to exceed twenty-five thousand dollars ($25,000) for each day of the violation, plus payment to the board for the costs incurred by the board as a direct consequence of prosecution for the violation. The BOAH civil penalty schedule specifies how a penalty is calculated for a violation of animal health laws and rules. Currently, a first offense is a range of $0-$500 and a subsequent offense is $0-$1,000.

VI. Complaints and Comments

The agency has not received complaints regarding this rule. The condemnation, depopulation, indemnity, and disposal process typically occurs in cooperation with the United States Department of Agriculture – Animal and Plant Health Inspection Service (USDA-APHIS). There is typically an agreement between the USDA-APHIS and an animal owner which sets forth the conditions under which these activities must be conducted for the owner to receive federal indemnity. BOAH is a key partner to the USDA-APHIS in this effort and assists the animal owner with performing all these activities in a manner consistent with the agreement. It is critical that the state have these provisions in place when there is a high consequence disease and the state may need to respond unilaterally.

IX. Other State or Federal Requirements

USDA-VS has stated its goal is to curtail the spread of M. avium subsp. paratuberculosis to noninfected herds and to reduce the disease prevalence in herds currently infected. To accomplish this goal, VS has developed a cooperative Federal–State–Industry program that provides producer assistance by performing risk assessments for M. avium subsp. paratuberculosis transmission and developing herd-management plans to mitigate those risks. Johne’s Certified Veterinarians must provide Johne’s risk assessments and develop herd management plans and collect and submit samples according to the program requirements. BOAH assists with this voluntary program and this rule algin with federal laws or regulations. 9 CFR 80. All surrounding states, and Idaho and South Dakota, offer the voluntary Johne’s program to cattle owners.

II. Continued Need for the Rule

Bovine tuberculosis is a disease that affects mammals, including cattle, deer, goats, dogs, and humans. Mycobacterium bovis (M. bovis) is the bacteria that causes the disease. USDA-APHIS and state animal health agencies collaborate with U.S. livestock producers to administer the National Tuberculosis Eradication Program, which has nearly eradicated tuberculosis from the US livestock population. The BOAH has a cooperative agreement with the USDA-APHIS to administer the national bovine tuberculosis (TB) eradication program, which focuses on reducing and eliminating the disease in cattle. This program includes surveillance, testing, and, if necessary, removal of infected animals to prevent the spread of M. bovis. The goal is to protect livestock, wildlife, and public health. BOAH testing requirements for TB in cattle and goats follows the federal regulations 9 CFR 77; Bovine Tuberculosis Eradication Uniform Methods and Rules, January 2005. Cattle and goats are not currently required to be tested prior to entry into Indiana because almost all of the US is accredited free states. There are some exceptions, such as the modified accredited status for Michigan and the modified accredited advanced status for Texas. However, no animal that has tested positive for tuberculosis, or originates from a herd that is quarantined for tuberculosis, may enter Indiana.

III.  Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6

A violation of 345 IAC 2.5 is governed by IC 15-17-18-12, which states that a person who violates this article, a rule adopted under this article, or a determination or order of the board or an agency made under this article, is liable for a penalty not to exceed twenty-five thousand dollars ($25,000) for each day of the violation, plus payment to the board for the costs incurred by the board as a direct consequence of prosecution for the violation. The BOAH civil penalty schedule specifies how a penalty is calculated for a violation of animal health laws and rules. Currently, a first offense is a range of $0-$1,000 and a subsequent offense is $0-$5,000. BOAH’s civil penalty rule establishes the factors that the agency will consider when determining a specific amount within this range.

IV. Revised Regulatory Analysis

The agency has reexamined the previous cost benefit, economic impact, and fiscal impact statements prepared for the rule under IC 4-22-2-28 and IC 4-22-2.1-5. This review resulted in a finding that there has not been any change in circumstances that affects the analysis and necessitate a change in the analysis.

X. Previous Amendments

This rule was last amended in 2019 (LSA 18-280) to better align with federal law. The definition of "test eligible cattle" was amended for purposes of moving animals to remove sexually intact female cattle of dairy breeds and dairy cross breeds that are six months of age or older from accredited-free and modified accredited advanced states or zones and removed the requirement that cattle under two months of age must originate from a herd that had a negative tuberculosis herd test of all animals 12 months of age and older within the past year when moving from modified accredited states or zones. It removed the requirement for a person to test sexually intact female cattle of dairy breeds, including dairy cross breeds, that are six months of age or older that originate from an accredited-free state or zone or a modified accredited advanced state or zone prior to movement into the state. It also extended the validity of the accredited herd status for both cattle and goat herds from 365 days to 730 days from the date it is earned.

XI. Integration into Indiana Code

The rule was amended six years ago. Because the status of the disease in the US is constantly changing, it is crucial that the BOAH retains the ability to quickly change import or testing requirements for tuberculosis. If Indiana experiences an outbreak, the livestock industry relies on BOAH to be able to take swift action to contain the spread and mitigate any negative economic impact to the state. BOAH will be conducting an in-depth review of all tuberculosis rules to determine if portions of the rules can be significantly modified or repealed as a part of the agency’s effort to comply with the EO 25-17 goal of reducing regulations by 25% by January 1, 2029. Integration of the rules into the Indian code prior to this review would inhibit the agency’s ability to modify or repeal rule provisions. 345 IAC 3-4 Swine Brucellosis Testing, Control, and Eradication; Validated Brucellosis-Free Herds 345 IAC 3-5.1 Swine Pseudorabies Testing, Control and Eradication; Pseudorabies–Qualified Herd

II. Continued Need for the Rule

Swine brucellosis is an infectious disease of swine caused by Brucella suis (B. suis) biovars 1 or 3. Swine exposed to B. suis develop a bacteremia (bacterial infection in the blood). Infection can then localize in various tissues. The disease typically causes chronic inflammatory lesions in the reproductive organs which can cause abortions, infertility, and low milk production. It may also localize in joints, leading to lameness. It’s important to note that swine brucellosis is potentially a zoonotic disease (people can contract it). People in direct contact with potentially infected swine should take precautions as directed by public health experts. Commercial swine in all 50 states, Puerto Rico, and the U.S. Virgin Islands are free from swine brucellosis. However, feral swine remain a reservoir in the U.S. This rule provides for the Brucellosis testing of breeding swine imported into the state, with a series of exceptions such as movements from a brucellosis-free area. Currently, all US states are classified as brucellosis-free. This rule also provides for the establishment of validated Brucellosis-free herds and establishes procedures to be used in the control and eradication of swine Brucellosis. Pseudorabies (PRV) is a highly contagious infectious disease of swine caused by a herpes virus. As the only primary hosts, swine can contract the disease, recover, and remain carriers. Carrier animals with PRV do not shed the virus on a continual or daily basis. Once the acute infection is over, the virus becomes dormant within the body. The carrier animal may never again shed the virus or may shed virus when the animal is stressed. This rule contains certain disease diagnosis reporting requirements for veterinarians. It also contains testing requirements that apply in certain conditions, with exceptions such as movements from areas that maintain State IV or V in the federal eradication program. Currently, no pseudorabies testing is required for animals originating from anywhere within the US. The rule also states that no animal that has tested positive for pseudorabies may enter Indiana; no animal that originates from a herd that is quarantined for pseudorabies may enter Indiana; and no animal that has been vaccinated for pseudorabies may enter Indiana. The rule also contains procedures for handling infected herds and high-risk herds. Finally, it contains testing requirements for meeting a voluntary qualified pseudorabies-negative (QN) designation.

III.  Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6

A violation of 345 IAC 3-4 or 345 IAC 3-5.1 is governed by IC 15-17-18-12, which states that a person who violates this article, a rule adopted under this article, or a determination or order of the board or an agency made under this article, is liable for a penalty not to exceed twenty-five thousand dollars ($25,000) for each day of the violation, plus payment to the board for the costs incurred by the board as a direct consequence of prosecution for the violation. The BOAH civil penalty schedule specifies how a penalty is calculated for a violation of the swine brucellosis and pseudorabies rules. Currently, a first offense is a range of $0-$1,000 and a subsequent offense is $0-$5,000. BOAH is currently working to incorporate this schedule into a civil penalty rule, which also establishes the factors that the agency will consider when determining a specific amount within this range.

XI. Integration into Indiana Code

In light of the state’s free status, it does not seem necessary to incorporate this rule into the Indiana Code. The state swine brucellosis law provides the general authority of the BOAH to have testing requirements. IC 15-17-9. The swine brucellosis rule provides necessary detail for the BOAH to carry out this duty. It is the position of the BOAH that the state’s rules governing high consequence diseases should be as consistent as possible with federal law. Retaining the testing standard for this disease in rule aligns with the federal structure, which is to publish these standards in the CFR. 345 IAC 6-1.1 Equine Infectious Anemia (E.I.A.) Control

II. Continued Need for the Rule

Equine infectious anemia is an incurable, infectious, and often fatal disease. Horses, ponies, donkeys, asses and other equine family members are vulnerable to infection by the disease-causing virus. An estimated 30 percent to 50 percent of infected animals die within two to four weeks after the onset of clinical signs of EIA. EIA is spread through blood-to-blood contact, not close proximity. The virus can be transmitted from an infected animal to “clean” equine by unsterilized or contaminated needles, blood transfusions, medical instruments, or biting flies. EIA has no known cure or vaccine. Infected horses produce antibodies, which cannot rid the body of the disease. The virus can hide and “drift” into various forms, making complete recovery impossible and hampering efforts to create a vaccine. This rule requires that equine must be tested for EIA (sometimes called a "Coggins test") within 12 months immediately prior to an animal entering Indiana. Animals that test positive for EIA may not enter Indiana. The ELISA and AGID tests for EIA are accepted. The following equine are exempt from the EIA test requirement: The rule also contains procedures for the handling of EIA positive animals and those that have been exposed to EIA. It is critical that the BOAH have this rule in place to mitigate the risk of introduction of positive animals into Indiana’s equine population.

III.   Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6

A violation of the EIA control law is governed by IC 15-17-18-12, which states that a person who violates this article, a rule adopted under this article, or a determination or order of the board or an agency made under this article, is liable for a penalty not to exceed twenty-five thousand dollars ($25,000) for each day of the violation, plus payment to the board for the costs incurred by the board as a direct consequence of prosecution for the violation. The BOAH civil penalty schedule specifies how a penalty is calculated for a violation of the EIA control rule. Currently, a first offense is a range of $0-$1,000 and a subsequent offense is $0-$5,000. BOAH is currently working to incorporate this schedule into a civil penalty rule, which also establishes the factors that the agency will consider when determining a specific amount within this range.

XI. Integration into Indiana Code

It is the position of the BOAH that the EIA test requirement should remain in rule. This aligns with other states that were evaluated and provides the BOAH flexibility to keep the testing standards consistent with USDA-APHIS requirements for international imports. BOAH is committed to working on an in-depth review of rules for several diseases, which includes EIA. Until that review is complete, requirements for EIA control should not be placed in Indiana Code until a final determination is made regarding what requirements are no longer necessary. 345 IAC 7-3.5-2 Definitions 345 IAC 7-3.5-3 Individual and market facility dealer license and exceptions 345 IAC 7-3.5-5 Classification; fees 345 IAC 7-3.5-5.5 Annual report; license termination 345 IAC 7-3.5-6 Agents 345 IAC 7-3.5-8 Bond requirements 345 IAC 7-3.5-8.5 Claims 345 IAC 7-3.5-9 Dealer and market facility records 345 IAC 7-3.5-9.1 Dealer and market facility poultry record keeping requirements 345 IAC 7-3.5-9.5 Records and facilities inspection; falsification, retention 345 IAC 7-3.5-11 Scales 345 IAC 7-3.5-13 Sale of animals at a market facility 345 IAC 7-3.5-14 Animals not intended for slaughter; inspection and identification 345 IAC 7-3.5-15 Facilities for handling livestock; minimum construction standards 345 IAC 7-3.5-16 Care and handling; nonambulatory livestock 345 IAC 7-3.5-17 Sale of diseased animal restricted 345 IAC 7-3.5-18 Waste disposal 345 IAC 7-3.5-19 Sanitation requirements 345 IAC 7-3.5-20 Brucellosis testing service laboratories

III.  Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6

A violation of 345 IAC 7-3.5 is governed by IC 15-17-18-12, which states that a person who violates this article, a rule adopted under this article, or a determination or order of the board or an agency made under this article, is liable for a penalty not to exceed twenty-five thousand dollars ($25,000) for each day of the violation, plus payment to the board for the costs incurred by the board as a direct consequence of prosecution for the violation. The BOAH civil penalty schedule specifies how a penalty is calculated for a violation of animal health laws and rules. Currently, a first offense is a range of $0-$250 and a subsequent offense is $0-$1,000. BOAH’s civil penalty rule establishes the factors that the agency will consider when determining a specific amount within this range.

XI. Integration into Indiana Code

The BOAH is responsible for adopting rules to implement the livestock dealer law, including procedures for issuing, suspending, revoking, and updating licenses. State law also establishes that the BOAH is to have rules in place for requiring annual or other regular reports from licensees to determine the required amount of bond coverage or the current status of agents or other personnel acting under the license. IC 15-17-14-4. BOAH is allowing three sections of 345 IAC 7-3.5 to expire because it has been determined that they are no longer needed. It is the position of the BOAH that the specific requirements for livestock dealers remain in the Indiana Administrative Code. This is consistent with USDA-PSA, which contains the requirements to administer 7 USC 181-229(c) in 9 CFR 201. 345 IAC 7-4.5-1 Definitions and general provisions 345 IAC 7-4.5-3 Record keeping 345 IAC 7-5-1 Definitions 345 IAC 7-5-2.1 Exhibition limitations 345 IAC 7-5-2.3 Requirements imposed by the exhibition 345 IAC 7-5-2.5  Animal health documentation 345 IAC 7-5-7 Determination of eligibility of animal 345 IAC 7-5-9   Identification and description 345 IAC 7-5-14 Brucellosis test for swine; exceptions 345 IAC 7-5-22 Vaccinations and tests required for dogs and cats

II. Continued Need for the Rule

This rule defines “exhibition” to mean a fair, show, or competition of limited duration that congregates animals from multiple sources on a premises. It sets forth recordkeeping requirements for a person holding an exhibition of livestock or poultry. It prohibits certain animals from being exhibited in the state and grants the state veterinarian the authority to determine the eligibility of an animal under the rule. It also clarifies that a person moving animals to an exhibition must ensure that it is accompanied by animal health documentation that verifies compliance with BOAH animal movement requirements for that species. Because exhibitions inherently involve a congregation and subsequent dispersion of animals, they present a significant risk of spreading a high consequence animal disease. Therefore, it is critical that the BOAH have standards in place to mitigate the risk of disease transmission and provide traceability in case of a disease event.

III.  Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6

A violation of 345 IAC 7-4.5 and 345 IAC 7-5 is governed by IC 15-17-18-12, which states that a person who violates this article, a rule adopted under this article, or a determination or order of the board or an agency made under this article, is liable for a penalty not to exceed twenty-five thousand dollars ($25,000) for each day of the violation, plus payment to the board for the costs incurred by the board as a direct consequence of prosecution for the violation. The BOAH civil penalty schedule specifies how a penalty is calculated for a violation of animal health laws and rules. Currently, a first offense is a range of $0-$500 and a subsequent offense is $0-$1,000. BOAH’s civil penalty rule establishes the factors that the agency will consider when determining a specific amount within this range.

XI. Integration into Indiana Code

BOAH is charged with establishing rules governing the sale, exhibit or display of animals at a fair or livestock show. IC 15-17-15-9. BOAH is allowing five sections of this rule to expire because it has been determined that they are no longer necessary. When Indiana experienced an outbreak of Highly Pathogenic Avian Influenza (HPAI) in 2015, the agency took immediate action to amend the state’s exhibition rules to protect the poultry industry. First, it passed an emergency rule to temporarily prohibit the exhibition of poultry and implemented a recordkeeping requirement for the intrastate sale of poultry. Second, the intrastate recordkeeping requirement was placed in the permanent rule. It was crucial that the agency was able to put these requirements in effect immediately as a measure to contain spread of the virus. During the 2015 response, BOAH was able to lift the control area for all farms in Dubois County located within a 6.2-mile radius of the infected sites within 38 days. The USDA-BOAH cooperative agreement and other federal standards require changes to occur in a timely manner. If the exhibition standards are placed in the Indiana Code, it could take an entire year to make changes versus an emergency rule that can be voted upon by the board and put into effect within a few hours. 345 IAC 7-8 Livestock Brands

I. Subject Matter Statement 

The state livestock brand law states that a person owning livestock within Indiana may adopt a brand for the person's exclusive use in Indiana. A person may not brand any livestock with a brand that is of legal record with BOAH unless that brand has been certified by the board for that person's exclusive use. The BOAH is required to record and publish all livestock brands. The board, in cooperation with law enforcement officials in Indiana and other states, is required to develop a uniform procedure for notifying livestock markets and livestock slaughtering establishments of reported livestock thefts. IC 15-19-6-15.

III.  Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6

A violation of 345 IAC 7-8 is governed by IC 15-17-18-12, which states that a person who violates this article, a rule adopted under this article, or a determination or order of the board or an agency made under this article is liable for a penalty not to exceed twenty-five thousand dollars ($25,000) for each day of the violation, plus payment to the board for the costs incurred by the board as a direct consequence of prosecution for the violation. The BOAH civil penalty schedule specifies how a penalty is calculated for a violation of the livestock brand rule. Currently, a first offense is a range of $0-$500 and a subsequent offense is $0-$1,000. BOAH’s civil penalty rule establishes the factors that the agency will consider when determining a specific amount within this range.

VII. Difficulties Encountered 

The BOAH has not encountered difficulties in administering the rule.

VIII. Changes in Technology, Economic Conditions, or Other Factors 

This rule was last reviewed in 2019. Since that time, there have not been changes in technology, federal law, or economic conditions that necessitate any changes to the rule.   

IX. Other State or Federal Requirements

USDA does have branding requirements that pertain to international movements and recognizes specific brands for purposes of official animal identification and vaccination. However, brand registration for marketing and theft deterrent purposes is primarily left to state oversight. All states that are required to be evaluated under EO 25-17 have a livestock brand law with similar requirements to Indiana that are set forth in rule.

X.  Previous Amendments

The livestock brand rule has not been amended since 1993.

XI. Integration into Indiana Code

The livestock brand law authorizes the board to adopt rules to implement its requirements. IC 15-19-6-7. It is the position of the BOAH that the details in implementing IC 15-19-6, such as restrictions and guidelines in creating new brands, are appropriate to remain in rule. This structure aligns with other states that were evaluated. If it is determined that these should be integrated into the Indiana Code, this rule should be readopted to avoid any lapse in the requirements while this occurs. 345 IAC 8-2 Production, Handling, Processing, Packaging, and Distribution of Milk and Milk Products 345 IAC 8-3 Standards for Milk and Milk Products and Grade A Standards

II. Continued Need for the Rule

These rules are necessary to comply with the BOAH’s agreement with the National Conference of Interstate Milk Shipments (NCIMS). BOAH is a voting member of the NCIMS. Each member state has agreed to enforce the sanitation standards set forth in the Pasteurized Milk Ordinance (PMO). The FDA audits state program implementation by conducting check ratings. The check rating process involves the FDA inspecting all farms and plants in Indiana every six years. If BOAH’s dairy rule does not contain Grade A milk plant and drug residue standards that are consistent with the PMO, Indiana would not be able to enforce the most current federal requirements to ship milk in interstate commerce. Therefore, Indiana would be in violation of its agreement with FDA. These rules are also necessary to comply with a state mandate. State law requires the board to adopt rules that are the same as, or at least as effective in protecting health, as the federal standards for Grade A milk adopted by the NCIMS in accordance with their Memorandum of Understanding (MOU) with the FDA. IC 15-18-1-14. The PMO is the document that is accepted by the FDA as the federal standards for the interstate shipment of milk. Therefore, to comply with this statutory mandate, the agency must have Grade A plant and drug residue standards in the state dairy products rule that align with the most recent version of the PMO.

V. Alternative Methods of Achieving the Purpose of the Rule

The state dairy products law and rule play a critical role in consumer protection by ensuring that food products are being produced in a sanitary manner. BOAH provides compliance assistance to farmstead processors to minimize the economic impact of the rules on small businesses.

VI. Complaints and Comments

The agency has not received complaints regarding this rule. BOAH has 678 permitted dairy farms, 520 tanker trucks, 15 farmstead processors, and 49 processing plants. If the BOAH does not readopt these sections, it would have negative economic consequences for the dairy industry. Indiana’s farms and plants rely on the board to enforce the PMO. If the board does not require compliance with federal standards, it could jeopardize their ability to ship their product in interstate commerce. This could occur due to a plant failing their milk rating survey, which occurs every two years. A failed survey could result in a plant being delisted from the interstate shippers list. A delisting prohibits a plant from shipping their milk across state lines. Alternatively, this could occur due to Indiana ultimately failing the FDA check rating process, which would jeopardize the ability for all plants and farms to access out-of-state markets for their products.

X. Previous Amendments

BOAH has begun a rulemaking to incorporate the most recent version of the PMO (LSA #25-151). The dairy rule is updated every two years to remain current with the PMO and other applicable FDA food safety regulations. The proposed rule amends 345 IAC 8-2-2.1 to update the incorporation by reference of parts of the Food and Drug Administration (FDA) Grade A Pasteurized Milk Ordinance (PMO) as construction, operation, and sanitation requirements for manufacturing grade milk plants. It also updates the incorporation by reference of the Food and Drug Administration (FDA) Grade A Pasteurized Milk Ordinance (PMO) and other FDA food safety regulations.

XI. Integration into Indiana Code

It is the position of the BOAH that the dairy products rules remain in state law. It is in the process of being amended and is updated every two years. It is important to keep the rule in the IAC so the BOAH has the ability to ensure consistency with the FDA standards. 345 IAC 9-8-10.5 Product protection 345 IAC 9-9.5-1 Antemortem inspection of exotic livestock 345 IAC 9-10.5 Postmortem Inspection 345 IAC 9-16-16 Custom products; marking "not for sale" 345 IAC 9-17-5 Modifications of approved label; permission of area supervisor 345 IAC 9-21.5 Inspection of Rabbits and Rabbit Products 345 IAC 9-22 Detention; Seizure and Condemnation; Criminal Offenses 345 IAC 10-2 Administration; Application of Inspection and Other Requirements 345 IAC 10-7 Facilities for Inspection; Overtime and Holiday Service, Billing Establishments 345 IAC 10-13-1 Official inspection legend 345 IAC 10-13-2 Official seal 345 IAC 10-13-3 Official tags 345 IAC 10-13-4 Official detention form 345 IAC 10-13-5 Official Indiana condemned tag 345 IAC 10-13-6 Official poultry condemnation certificates; requests 345 IAC 10-13-7 Changes to certificates; copies 345 IAC 10-14-20 Modifications of approved label; permission of officer in charge 345 IAC 10-20-1 Applicability 345 IAC 10-20-2 Tagging poultry 345 IAC 10-20-3 Notification of detention to owner 345 IAC 10-20-4 Notification of detention to federal authorities 345 IAC 10-20-5 Movement of article or poultry; termination of detention

I. Subject Matter Statement 

State law requires the BOAH to enforce requirements with respect to intrastate operations that are at least equal to those imposed and enforced under the federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the federal Poultry Products Inspection Act (21 U.S.C. 451 et seq.). IC 15-17-5-1(4). To comply with this statutory mandate, BOAH must ensure that the Meat and Poultry Inspection (MPI) rules are in place that are at least equal to 9 CFR Subchapter E, which contains the requirements for federally inspected facilities.

II. Continued Need for the Rule

State law further authorizes the BOAH to cooperate with USDA-FSIS to effectuate the purpose of the Meat and Poultry Inspection Law, to accept federal assistance for that purpose, and to spend public funds appropriate for the administration of the law to pay not more than fifty percent (50%) of the total cost of the cooperative program (IC 15-17-5-5(11)). Pursuant to this power, the BOAH has entered into a state-federal cooperative agreement with USDA-FSIS to receive up to 60% of the annual operating costs of the Meat and Poultry Inspection (MPI) program. BOAH's MPI program is subject to regular audits by USDA-FSIS to ensure that the state standards are at least equal to federal requirements. If BOAH does not maintain rules consistent with the federal regulations, it would jeopardize the funding the agency receives under the state-federal agreement. If the BOAH does not remain in compliance with the state-federal agreement by keeping the inspection rules in place, it would have negative consequences for the regulated community. Indiana relies on the federal funding to support an adequate number of inspectors for the state’s 83 official plants and 55 custom exempt plants. If BOAH cannot fund an adequate number of inspectors, the official plants will not be able to operate at full capacity because an inspector must be on site continually during the slaughtering process and inspect the processing area once per day. These sections establish the inspection requirements for meat products and include critical food safety provisions in areas such as product labeling and plant recall procedures.

III. Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6

BOAH is authorized to adopt a schedule of civil penalties that may be levied for violations of the MPI Act. IC 15-17-5-17. The penalty may not exceed one thousand dollars ($1,000) per violation for each day of the violation. BOAH’s current civil penalty schedule authorized a fine up to $1,000 for a first or subsequent offense. BOAH’s civil penalty rule includes the factors that the agency will consider when determining a specific amount within this range.

IV. Cost-Benefit, Economic Impact, Fiscal Impact, or Regulatory Burden Statements 

The agency has reexamined the previous cost benefit, economic impact, and fiscal impact statements prepared for the rule under IC 4-22-2-28 and IC 4-22-2.1-5. This review resulted in a finding that there has not been any change in circumstances that affect the analysis and necessitates a change in the analysis.

V. Alternative Methods of Achieving the Purpose of the Rule 

As mentioned above, the BOAH has taken the approach of aligning the MPI article with federal law. The is the preferred approach of the meat processing industry and the agency has not encountered difficulties in administering the rule.

VI. Complaints and Comments

The agency has not received complaints regarding this rule. There had been significant growth in Indiana’s meat processing sector. In 2024, BOAH inspected 18.7 million pounds of meat and there are 25 Cooperative Interstate Shipment (CIS) facilities that can ship product interstate.

VII. Difficulties Encountered

BOAH has not encountered difficulties in administering this rule. BOAH receives support from the Officer of the Attorney General in enforcing administrative Orders and the collection of civil penalties for violations of 345 IAC 9 and 345 IAC 10.

VIII. Changes in Technology, Economic Conditions or Other Factors

This rules in this analysis were last reviewed in 2019 and 2021. Since that time, there have not been changes in technology, federal law, or economic conditions that necessitate any changes to the rule.   

IX. Other State or Federal Requirements 

Not all states have their own meat and poultry inspection programs. While 27 states have such programs, others rely on the USDA-FSIS for meat and poultry inspection. Idaho, Michigan, and Kentucky do not have a MPI program. Indiana agriculture organizations and the Indiana Meat Packers and Processors Association (IMPPA) have had longstanding support for a state program to support the economic growth of Indiana’s livestock and meat processing industry. All states that have an MPI program do not have standards less restrictive than Indiana because it would be prohibited by USDA-FSIS.

X. Previous Amendments

BOAH has initiated a rulemaking to make updates throughout 345 IAC 9 and 345 IAC 10. Regarding the rules in this analysis, it amends the section governing the inspection of rabbits to change the incorporation by reference from January 1, 2022, to January 1, 2024. 345 IAC 9-21.5-2 It adds a new section to 345 IAC 10-2 to clarify requirements for establishments to manufacture pet food or similar uninspected, inedible products. LSA# 25-165.

XI. Integration into Indiana Code

It is the position of the BOAH that the meat and poultry products rules should remain in the IAC.. This is important so the BOAH can ensure consistency with the USDA-FSIS regulations.

XII. Contact Information of Staff to Answer Substantive Questions

Gary Haynes Chief of Staff (317) 544-2400 ghaynes@boah.in.gov Notice of Public Comment Period for Rule Readoption: 20250910-IR-345240625RNA Notice of Determination Received: August 27, 2025