Administrative Rule of the Month - Proposed 71 IAC 1.5-1-94.1 "Sample" Defined

The Indiana Horse Racing Commission (IHRC) is proposing medication rule changes that would align Indiana's medication rules with the Association of Racing Commissioners International's (ARCI) Controlled Therapeutic Medication Schedule. This schedule is comprised of 24 therapeutic medications that 'supposedly' (the use of this term will be explained in detail at a later date) have a threshold where a post-race test would not be considered a positive test subject to penalization. The ARCI's schedule is an attempt to nationalize medication rules across all racing jurisdictions. The ARCI's Controlled Therapeutic Medication Schedule can be found at the following link: http://arcicom.businesscatalyst.com/assets/1arci-controlled-therapeutic-medication-schedule---version-1.0.pdf.

As a part of this effort, the IHRC has included the following proposed rule:

"71 IAC 1.5-1-94.1 “Sample” defined
Authority: IC 4-31-3-9
Affected: IC 4-31-12
“Sample” when used in the context of being removed from or collected from a horse, means any amount of urine, saliva, blood, or other acceptable specimen derived from a horse. All samples become property of the commission at the time they are cleared by the testing laboratory and may be used for research and/or investigative purposes."

While the industry's comment period on this proposed administrative rule has passed, we fully expect this rule, as is, to be considered at the next IHRC meeting later this month. Therefore, we are making '71 IAC 1.5-1-94.1 "Sample" defined' as proposed the Indiana Breeder & Owner Protection, Inc. (IBOP) Administrative Rule of the Month for February. (As usual there is a corresponding version for the standardbred rulebook.) Given the IHRC's adopted policy as to when proposed rules should be considered an emergency, and therefore allowing the emergency rulemaking process to be used, we also fully expect the IHRC staff to spin this proposed rule to the commissioners as being part of the ARCI efforts. The IHRC's policy is to use their emergency rulemaking authority, which has no substantive review for legality or for public policy beyond the IHRC staff, when ARCI Model Rules are being considered. Their assumption, albeit an incorrect one, is that ARCI Model Rules fit within the IHRC's statutory authorizations.

The fact is that '71 IAC 1.5-1-94.1' goes well beyond being considered an adoption of an ARCI rule. This should be reason enough for the IHRC to utilize the regular rulemaking process so there is more scrutiny of this proposed rule. Here's why. The ARCI definition of 'sample' is as follows:

ARCI-001-010 Terms - "Sample is a portion of any bodily substance or fluid, including but not limited to, tissue, hair, blood or urine obtained from a horse (or greyhound) at the direction of the commission for the purposes of determining the presence and/or concentration of regulatory analytes."

In reading both, you could easily say that the first sentence of the IHRC's proposed rule is similar to the concept behind the ARCI's model rule definition, a 'paraphrase' if you will. We agree. However, our concern lies with the second sentence which does not appear in the ARCI Model Rule, "All samples become property of the commission at the time they are cleared by the testing laboratory and may be used for research and/or investigative purposes." The IHRC staff wants to add this definition to the administrative rulebooks solely for the purpose of the second sentence. After all, Indiana Code, which should in all cases supersede any definition created by the IHRC staff, already defines 'test sample' as follows:

IC 4-31-2-23
"Test sample"
Sec. 23. "Test sample" means a body substance taken from a horse for the purpose of analysis, under the supervision of the commission
or state veterinarian and in the manner prescribed by the commission.
As added by P.L.341-1989(ss), SEC.2.

Based upon an Indiana law that states administrative rules should not duplicate what is spelled out in the law, this proposed rule should never be allowed on the books. Period. However, our confidence level for any of the five commissioners to recognize this aspect of rulemaking is quite low. And, so is our confidence in them to recognize the significance of samples becoming "property of the commission" or "for research and/or investigative purposes." Without statutory authorization, and possibly with no constitutional authority, the IHRC is claiming a property right in your horse's medication testing sample. In other words, the IHRC staff will be able to do anything they want with those samples including what is spelled out as further "investigative purposes." Basically, this means they can have 'their' sample retested at any time.

As you will see below, the Indiana legislature does grant the IHRC the authority to freeze "samples for future analysis." Yet, in an oversight, this statute doesn't provide any direction as to what may come of this "future analysis."

IC 4-31-12-11
Official laboratory
Sec. 11. The commission may direct the official laboratory to retain and preserve by freezing samples for future analysis.
As added by P.L.341-1989(ss), SEC.2.

The IHRC has, beyond its statutory authority (what else is new there), modified IC 4-31-12-11 by adding '71 IAC 8.5-2-4(b)' to their rulebooks which states, "The commission has the authority to direct the approved laboratory to retain and preserve samples for future analysis." A minor aspect of '71 IAC 8.5-2-4(b),' which further illustrates why the IHRC should have more outside scrutiny of its rulemaking, is that it expands the IHRC's authority from simply "freezing" per Indiana law to now any means possible of preserving a test sample. This could entail freeze drying, stains on microscope slide, or being placed in an hermetically sealed mayonnaise jar on Funk and Wagnall's back porch. The overriding point is that there is no direction from statute and, given the IHRC proposed definition, there are no administrative rules that place limits on the IHRC's uses of any preserved test samples.

Assuming for a moment that there aren't constitutional issues, the IHRC staff first needs to spell out WHOSE "research" and why the research is necessary. If the goal is to allow for laboratories to fine tune their testing for designer drugs or venoms that can't be detected today, we're all for that. At minimum then, get the permission of the owner of the horse from which the sample was taken before doing so. In addition, the IHRC staff should spell out what can and can't be done with any "researched" sample. Because that is the bigger issue. As written there are significant due process questions, especially when considering the specific reference to "investigative purposes" in the proposed administrative rule. The IHRC staff will be able to cite this rule to justify any of their actions pertaining to 'their' samples.

If this proposed administrative rule is approved, can the results of any samples used for "research" be evidence to prosecute a trainer or an owner for an on-track medication violation? Can the "investigative purposes" be used to prosecute a breeder whose horse was subject to an out-of-competition test? You might say 'no', but think what the IHRC's position would be given no other direction from state law or administrative rules. We can see it happening, especially as testing improves to beyond a billionth and a trillionth of a particle per specimen.

Imagine being the owner of a winning horse where the primary test has cleared, but the balance of the test sample including the split sample, which is now the property of the IHRC, is not destroyed but held for further "investigative purposes." Theoretically, advancements in testing could be used against you two or three years down the road. As of January 1, 2014, Indiana law requires that the stewards and judges penalize offenders of medication violations within a year from the violation date, which would be the date of the race. The IHRC has never adhered to any statute of limitations for penalties issued by the Executive Director. In fact, the IHRC has created administrative rules to guarantee the Executive Director an open-ended length of time to issue a penalty. (See our October, 2013 Administrative Rule of the Month: http://www.ibopindy.blogspot.com/2013/10/administrative-rule-of-month-71-iac-10_16.html).

Now, imagine being in the position of an owner or a trainer who has requested a split sample be tested due to a primary sample testing as positive for a banned substance or an overage of a therapeutic medication. Imagine YOUR split sample, not the IHRC's split sample, comes back negative. According to IHRC rules via "71 IAC 8.5-3-4(b) No action shall be taken against the trainer or owner if the results of split sample testing are negative." Ah, but what about a third or fourth test derived from samples that were preserved by the IHRC from what was left of the primary sample and sent to a third laboratory for "investigative purposes?" The IHRC can easily define "future," which is a time yet to come, as the day after they receive the notification of the split sample results being negative. A third test could be ordered immediately. Or, they could wait six months, a year, or any other length of time as this proposed administrative rule creates an open-ended opportunity.

This proposed administrative rule has significant issues with constitutionality, with statutory authority, with due process rights, and you better believe chain of custody issues as the IHRC will be enabled to use 'their' samples for "research" or for 'their' very ominous "investigative purposes." Imagine being a trainer whose split sample came back inconclusive for the drug being tested due to a laboratory mistake in standard testing protocols. You could spend years and hundreds of thousands of dollars unnecessarily fighting the impacts of this administrative rule which can include the results of a third or a fourth test. IBOP challenges the IHRC to move this proposed administrative rule through the regular rulemaking process so these issues can be raised to the Indiana Attorney General and Governor Mike Pence. We'd love to have them read our brief on this proposed administrative rule so they can see, once again, how the IHRC operates without any meaningful oversight via their emergency rulemaking.