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TITLE 345 INDIANA STATE BOARD OF ANIMAL HEALTH

Economic Impact Statement
LSA Document #16-498


IC 4-22-2.1-5 Statement Concerning Rules Affecting Small Businesses
The Indiana State Board of Animal Health (BOAH) proposes to amend its rules governing rabies control. The primary purpose of the changes is to update the incorporation by reference of the National Association of State Public Health Veterinarians, Inc. Compendium of Animal Rabies Control (hereafter referred to as the "Compendium"). The proposed rule will update the incorporation by reference of components of the Compendium from the 2008 edition to the 2016 edition. The rule also clarifies the ongoing revaccination requirements for dogs and cats three months of age and older.
Rabies is a fatal zoonotic disease, which means it can be passed between species, and a serious public health problem. All mammals are believed to be susceptible to the disease. In the United States, multiple rabies virus variants are maintained in wild mammal reservoir populations such as raccoons, skunks, foxes, and bats. Rabies is usually transmitted through the saliva of the host animal, predominately via a bite or scratch. The rabies virus attacks the central nervous system causing severely distressing neurological symptoms before causing the victim to die. The disease is always fatal once clinical symptoms appear. However, postexposure prophylaxis (PEP) stops the virus before clinical symptoms appear, if given immediately after exposure (from a bite or scratch of a rabid animal). Most human cases are caused by exposure from an infected dog.1
The BOAH rabies rule has several different components related to control of this disease. State law requires that BOAH have rules in place that govern the documentation of rabies vaccinated animals and for the identification of animals that have been vaccinated for rabies. IC 15-17-6-1. Pursuant to this law, BOAH has a rule in place that requires all dogs, cats, and ferrets three months of age and older to be vaccinated against rabies. The rabies rule also sets forth other requirements such as accreditation standards for the veterinarian administering the vaccine and required information on the official certificate and tag. 345 IAC 1-5-1. Although all of these issues are addressed in the Compendium, there have been no changes in the 2016 edition that necessitate amendments to these components of the rabies rule.

1. Description of Affected Industry
The rabies control program applies to any person in Indiana who owns a dog, cat, or ferret. It also applies to animal care facilities engaged in taking custody of animals to provide humane treatment and adoption services. However, the changes in the proposed rule specifically pertain to procedures for the handling of a dog, cat, or ferret after they have been exposed to a confirmed or suspected rabid animal. Local health departments and animal control officials are typically the entities that are directly involved in working with animal owners to ensure these protocols are followed. According to the Indiana State Department of Health (ISDH), in the 2015 calendar year 7,112 animal bite cases were reported in Indiana. Of the 7,112 animal bites, 6,759 bites were attributed to dogs and cats.2 Although not all biting animals would be in the category of having been exposed to a rabid or suspected rabid animal, it is the best available data to estimate the number of animal owners affected by the proposed rule.
BOAH has worked to involve these entities in the development of the rule. Prior to the first reading of the rule at the Board's quarterly meeting in October, BOAH included information about the proposed changes to the rabies rule on its webpage. BOAH also sends out emails to interested parties that have requested to stay informed on matters being considered by the Board. BOAH has been in regular communication with ISDH to ensure that the changes align with its rule, which applies if an animal has bitten a human. 410 IAC 1-2.5-80. The affected industry includes small businesses under the definition at IC 4-22-2.1-4.

2. Estimated Annual Reporting, Record Keeping, and Other Administrative Costs
The proposed rule does not increase annual reporting, record keeping, or other administrative costs for regulated entities. However, the 2016 Compendium does provide more guidance for a local unit of government regarding what to do when an animal that has been exposed to a confirmed or suspected rabid animal is overdue for a booster vaccination. If the owner has records to show the animal has received a USDA-licensed vaccine at least once, the animal can receive a booster and be kept under the owner's control and observation for 45 days. If the owner does not have records of the dog/cat having been vaccinated at least once, they must either be treated as unvaccinated or undergo prospective serologic monitoring.
The above-described protocol does require the local unit of government to request records from the owner and review such records (if the owner is able to produce them) in order to make this determination. However, this process was already a required component of the 2008 Compendium, which stated that these cases should be evaluated on a "case by case basis" based upon factors such as severity of exposure, time elapsed since last vaccination, number of previous vaccinations, current health status, and local rabies epidemiology.

3. Estimated Total Annual Economic Impact on Small Businesses
The most significant change in the 2016 Compendium is in the Postexposure Management section, which reduces the strict quarantine period for unvaccinated dogs and cats from six months to four months following a review of the most recent incubation period data. This change presents an opportunity for cost savings for the animal owner because the rule reduces the length of time the animal must be quarantined at the owner's expense. As discussed above, it is important to note that an animal overdue for vaccination is treated as unvaccinated if the owner does not have a valid vaccination certificate proving that the animal has previously received a rabies vaccine. Therefore, there are more animal owners that can benefit from the costs savings beyond just those with animals that have never been vaccinated.

4. Justification of Requirements
a. Compliance with Federal and State Law
This rule is necessary for the BOAH to comply with a statutory mandate. ISDH has rules that govern the handling of an animal after it has bitten a human. However, under state law BOAH is responsible for having procedures in place for the handling of a domestic animal that has been exposed to a confirmed or suspected rabid animal. IC 15-17-6-11. If the BOAH does not proceed with this rulemaking, the agency would not be in compliance with its duty to clearly establish the process for postexposure management of these animals. The Compendium outlines quarantine, vaccination, and euthanasia standards that vary depending on the vaccination status of the exposed animal. As stated above, the most significant change to the Compendium is in the Postexposure Management section, which reduces the strict quarantine period for unvaccinated dogs and cats from six months to four months following a review of the most recent incubation period data.
b. Justification of Requirements not Mandated by Federal or State Law
The proposed rule does not impose a requirement or cost beyond what is expressly required by federal or state law. BOAH estimates that the total estimated impact (cost) will be less than $500,000.

5. Regulatory Flexibility Analysis
Because the proposed rule does not impose requirements beyond what is required by state law, BOAH did not examine alternative methods with regard to the rule changes. As described above, the exposure of a person to an animal that may be infected with rabies presents a significant risk to public health. It is critical that BOAH and local public health partners have the authority to refer to the most recent Compendium when issuing an order regarding how an animal must be managed postexposure to mitigate the risk the animal presents to public safety. It is also important to emphasize that the changes in the newest Compendium being incorporated will reduce versus increase compliance costs for Indiana pet owners.

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1 Global Alliance for Rabies Control, www.rabiesalliance.org.
2 Indiana State Department of Health, 2015 Animal Bite Report.

Posted: 03/08/2017 by Legislative Services Agency

DIN: 20170308-IR-345160498EIA
Composed: May 08,2024 1:32:43AM EDT
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