Tuesday, April 1, 2014

Administrative Rule of the Month - 71 IAC 8-1-1.5 Medication

Disclaimer: Every April 1st there's usually a certain amount of skepticism applied to any published material on a day where hoaxes are commonplace. For the third year in a row, the Indiana Breeder & Owner Protection, Inc. (IBOP) Administrative Rule of the Month is no April Fools' Day hoax. Once again, however, the "joke" is how ineffective the Indiana Horse Racing Commission (IHRC) is in handling their responsibilities in the creation of administrative rules.

On April 1, 2013, the IBOP Administrative Rule of the Month (http://ibopindy.blogspot.com/2013/04/administrative-rule-of-month-71-iac-8-1.html) pointed out that the Indiana Horse Racing Commission had allowed the standardbred anti-ulcer medications rule expire. With this expiration, the standardbred meet, which began on April 2, 2013, had no thresholds for cimetidine (Tagamet®), omeprazole (Gastrogard®), or ranitidine (Zantac®). After notifying the Indiana Standardbred Association of this oversight, IBOP then petitioned the IHRC to have a new anti-ulcer medications administrative rule be considered as a new business item on the agenda of the IHRC's April 5, 2013 meeting. That petition was granted, a new anti-ulcer medications administrative rule was approved and filed with the Indiana Register at 3:50 PM later that day. So, a new anti-ulcer medications rule became effect before standardbred racing began that night.

This year's April Fools' Day Administrative Rule of the Month is similar in nature as the IHRC has allowed another standardbred administrative rule, '71 IAC 1-1-42.1 "Foreign substance" defined,' to expire. Here's how the rule currently looks in the Indiana Administrative Code:

71 IAC 1-1-42.1 "Foreign substance" defined (Expired)

Sec. 42.1. (Expired under IC 4-22-2.5, effective January 1, 2014.)

However, our Administrative Rule of the Month is '71 IAC 8-1-1.5 Medication' which is copied below. Pay particular attention to subsection (a) which has a direct reference to the expired '71 IAC 1-1-42.1' definition. As you'll see, the first subsection of the standardbred 'Medication' rule refers directly to "any foreign substance as defined in 71 IAC 1." 71 IAC 1 means Title 71 of the Indiana Administrative Code, Article 1 which is where all of the standardbred definitions are recorded. This line might as well read, "any foreign substance as defined in (Expired)."

71 IAC 8-1-1.5 Medication
Authority: IC 4-31-3-9
Affected: IC 4-31-12
Sec. 1.5. (a) No horse participating in a race or entered in a race shall carry in its body any foreign substance as defined in 71 IAC 1, except as provided for in this rule.
(b) No substance, foreign or otherwise, shall be administered to a horse entered to race by:
(1) injection;
(2) jugging;
(3) oral administration;
(4) tube;
(5) rectal infusion or suppository;
(6) inhalation; or
(7) any other means;
within twenty-four (24) hours prior to the scheduled post time for the first race except furosemide as provided for in this rule. The
prohibitions in this section include, but are not limited to, injection or jugging of vitamins, electrolyte solutions, and amino acid
solutions. The prohibition also includes, but is not limited to, the topical, oral, or nasal administration of compounds, such as
Traileze, Vapol, Vicks vapor-rub, wind-aid, exhale ease, or containing methylsalicylate, camphor, potassium iodide, or products
containing "caine" derivatives or dimethylsulfoxide (DMSO).
(c) Substances or metabolites thereof which are contained in equine feed or feed supplements that do not contain pharmacodynamic or chemotherapeutic agents are not considered foreign substances if consumed in the course of normal dietary intake (eating and drinking).
(d) The prohibition in subsection (b) notwithstanding, the use of nebulizers are permitted on an entered horse within twenty-four
(24) hours of the scheduled post time for the horse's race until the horse's arrival in the paddock provided their use is restricted
to water and saline solutions only.
(e) Topical dressings such as leg paints, liniments, ointments, salves, hoof dressings, and antiseptics which do not contain anesthetics or a pharmacodynamic or a chemotherapeutic agent may be administered at any time prior to a horse's arrival in the
paddock. (Indiana Horse Racing Commission; 71 IAC 8-1-1.5; emergency rule filed Apr 3, 2013, 10:37 a.m.: 20130410-IR-071130133ERA; readopted filed Nov 26, 2013, 11:25 a.m.: 20131225-IR-071130345RFA)

So, once again, this year's standardbred meet, which began on March 28th, begins without the IHRC having the ability to enforce what is arguably a very key administrative rule. Here's how the foreign substance definition read before its expiration:

71 IAC 1-1-42.1 "Foreign substance" defined
Authority: IC 4-31-3-9
Affected: IC 4-31
Sec. 42.1. "Foreign substance" means all substances except those that exist naturally in an untreated horse at normal physiological concentration, and includes all narcotics, stimulants, depressants, or other drugs or medications of any type. (Indiana Horse Racing Commission; 71 IAC 1-1-42.1; emergency rule filed Mar 9, 1994, 2:50 p.m.: 17 IR 1629; readopted filed Oct 30, 2001, 11:50 a.m.: 25 IR 899; readopted filed Mar 23, 2007, 11:31 a.m.: 20070404-IR-071070030RFA)

You may be thinking, does the IHRC know that the standardbred foreign substance definition is expired? The answer is yes they do. At their March 5th meeting, an IBOP petition to repeal the flat racing foreign substance definition was an agenda item. (You can see the petition at http://www.ibopindy.blogspot.com/2014/02/request-to-repeal-foreign-substance.html) The primary goal of our petition to repeal the flat racing foreign substance definition was a way to point out that the standardbred definition had expired. Our tongue-in-check thinking was, if the IHRC didn't think that the standardbred definition was important enough to have been readopted to their administrative rules, then the definition in the flat racing rulebook wasn't necessary either. We were shocked that the petition was given any time at the meeting at all because hearing the petition forced the IHRC to go on record regarding their view of a particular rulemaking procedure.

One of our points was that neither the standardbred foreign substance definition nor the flat racing foreign substance definition "were necessary given the exact same definition exists in 'IC 4-31-2-7.'" In other words, these definitions were exact duplications of a definition already in existence in Indiana statute, via IC 4-31-2-7, which is copied below:

IC 4-31-2-7
"Foreign substances"
Sec. 7. "Foreign substances" means all substances except those that exist naturally in an untreated horse at normal physiological
concentration, and includes all narcotics, stimulants, depressants, or other drugs or medications of any type.
As added by P.L.341-1989(ss), SEC.2.

A sub-plot in the goals of our petition was to get the IHRC's on-record comments regarding unnecessary duplication of existing statutes in their administrative code. One of Indiana's rulemaking statutes, 'IC 4-22-2-19.5 Standards for rules,' says, in part, that administrative agencies are to "avoid duplicating standards found in state or federal laws." Yet, the IHRC administrative rule books have massive amounts of duplication of standards already in existence in their administrative rules. This petition basically became a 'test case' for future challenges to administrative rules that are no more than duplications of statute. Of course, the IHRC denied our petition, yet what we now have in the transcript will be used moving forward with other rulemaking procedural issues. But, the IHRC didn't vote to establish a new standardbred foreign substances definition either as they didn't quite understand the connection with '71 IAC 8-1-1.5 Medication.'

Had the IHRC actually considered granting our petition to repeal the flat racing foreign substance definition, we would have stopped them from doing so because that foreign substance definition has the exact same connection to the 'Medication' rule in the flat racing rulebook. Our petition even directly suggested that if the IHRC disagreed with our petition "then efforts should be made to promulgate another “Foreign substance” definition within the standardbred rulebook via 71 IAC 1. Definitions." However, we didn't further explain the connection of the expired foreign substance definition to the 'Medication' rule in the standardbred rulebook. The IHRC staff should understand their own rulebook, but they surely didn't.

The connection between the expired foreign substance definition to the standardbred 'Medication' rule was pointed out by IBOP Vice-President Jim Hartman during the discussion of the petition. The following is from page 106, Line 6 through Page 108, Line 8 of the Official Transcript from the March 5, 2014 IHRC meeting:

"MR. Hartman: What I would point to on the petition is that, in fact, the Foreign Substance definition in the standardbred rules is expired. It's been allowed to expire. That also ties into the medication rule in the standardbred rule book because it refers directly back to the definition. So in a way the point is that this rule is expired and the last paragraph here says -- should you believe otherwise, which I'm thinking that's the case -- then an effort should be made to promulgate Foreign Substance definition within the standardbred rule book, because as of today it doesn't exist.

MS. ELLINGWOOD: Mr. Hartman is right that the rule defining Foreign Substance did expire. As you may remember, Commission staff last year was in the process of attempting to renew 900 administrative rules that were scheduled to expire. Frankly, the fact that the definition of foreign substances did get renewed in thoroughbred and not in standardbred was not by design. To the extent that Commission staff can in the future make that consistent, we certainly will. To the heart of this request, which is to repeal the definition from thoroughbred, still I would recommend that the Commission not grant this request. Then if we need to move forward with defining Foreign Substance in the standardbred again, we certainly can do that.

CHAIRMAN DIENER: You would go ahead and recommend denying the petition for repeal of the rule, but you're agreeable to submitting a rule to reinstate Foreign Substance definition for standardbreds at our next Commission meeting, something like that?

MS. ELLINGWOOD: Yes, Chairman. My point is simply that I think there is a need for the definition of Foreign Substance in the rule, so this petition should be denied.

COMMISSIONER SCHAEFER: So moved.

CHAIRMAN DIENER: So moved.

MR. HARTMAN: Chairman Diener, then if the definition is not in place until the next meeting, which I think is after the standardbred meet starts, then the medication rule, 8-1-1.5, has no meaning. It starts out saying, No horse participating in a race or entered in a race shall carry in its body any Foreign Substance as defined in 71 IAC 1.

CHAIRMAN DIENER: Our governing pari-mutuel statutes will trump any rule. We'll have a basis for enforcing that, even if it's not a rule."

Ah, Chairman Diener, if that's true then the definitions in the standardbred and flat racing rulebooks ARE unnecessary duplications of statute which is specifically prohibited by Indiana law. In addition, you should have looked at '71 8-1-1.5(a)' before making that statement. The administrative rule points to an expired definition in 71 IAC 1, not to a definition in IC 4-31-2-7. The fact that a definition exists in statute may not serve to mitigate any defects in the mistake filled administrative code. On that basis, the standardbred meet is now underway without an effective 'Medication' rule and that's no April Fool.