Administrative Rule of the Month - Threshold Levels

While IBOP is not a trainer organization, we do recognize that the regulatory environment that affects a trainer will surely have an effect on an owner as well. Owners (and breeders) also need to be educated on the current regulatory environment as well as those making the rules of racing. With that said……

Recently, the Indiana Horse Racing Commission (IHRC) issued the first of what are being called “Trainer’s Newsletters.” There was one newsletter targeted to standardbred trainers and another to thoroughbred/quarter horse trainers. In his introductory comments called the ‘Director’s Letter,’ IHRC Executive Director Joe Gorajec stated, “My goal in providing this newsletter is to make sure you know what is expected of you from a regulatory perspective in Indiana.”

(If you’ve not seen the newsletters, you can follow this link to read the thoroughbred/quarter horse version http://www.in.gov/hrc/files/TB_QH_Newsletter_Spring2012.pdf and this link to read the standardbred version http://www.in.gov/hrc/files/SB_Newsletter_Spring2012.pdf .)

The newsletters focused primarily on the actions of the IHRC over the winter with emphasis on new administrative rules that limit the use of certain medications. For example, the newsletter states that the IHRC voted unanimously to reduce allowable phenylbutazone (bute) levels for a post-race test and that the IHRC voted to eliminate the race day use of vitamin B1 and calcium. Evidently, vitamin B1 and calcium, which are naturally occurring substances, are now considered either medications or bleeder adjuncts. Quoting the newsletter, “The new national model rule permits furosemide (salix) as the only drug to be administrated on race day. Thus, any other medications, including bleeder adjuncts, are prohibited. Accordingly, the IHRC has decided to prohibit the administration of calcium and vitamin B1.” Mr. Gorajec also described vitamin B1 and calcium as “medications” to the commissioners during the two minutes they considered the recommendation to eliminate the “medications” vitamin B1 and calcium at their January 24, 2012 meeting.

If you consult the most recent “Uniform Classification Guidelines for Foreign Substances and Recommended Penalties and Model Rule” from the Association of Racing Commissioners International, Inc. (ARCI), you can find a non-classified substances section. Here’s the link to this document: http://arci.com/druglisting.pdf . Here’s a direct quote, “Substances that are considered to have no effect on the physiology of a racing animal except to improve nutrition or treat or prevent infections or parasite infestations, are not classified. These Substances normally include antimicrobials, anti-parasitic drugs, and nutrients such as vitamins.” When providing examples of these non-classified substances, this document lists “B vitamins” as well as A, D, E, K and C. Calcium, which is an element essential to most living creatures, is not even enough of a concern to be mentioned. While the ARCI considers B vitamins as having “no effect on the physiology of a racing animal,” the IHRC, however, seems to consider them to be “medications” that needed to be eliminated on race day.

What the trainer newsletters didn’t say is that the IHRC also approved a brand new administrative rule that creates threshold levels for use of clenbuterol, firocoxib, and DMSO. Why wouldn’t a trainer newsletter, designed to inform, provide this information as well? Hence, ‘Threshold levels’ is IBOP’s Administrative Rule of the Month. The standardbred version of this rule is 71 IAC 8-1-4.2 and the thoroughbred/quarter horse version of the rule is copied below:

71 IAC 8.5-1-4.2 Threshold levels
Authority: IC 4-31-3-9
Affected: IC 4-31-12
Sec. 4.2. The official blood (serum or plasma) sample may contain the following drug substances, their metabolites or analogs, and shall not exceed the threshold concentrations specified in this rule:
(1) The use of clenbuterol shall be permitted under the following conditions:
(A) Not to exceed the following permitted serum or plasma threshold concentrations of clenbuterol (or its metabolites):
Thoroughbred – twenty-five (25) picograms per milliliter.
(B) Not to exceed the following permitted serum or plasma threshold concentrations of clenbuterol (or its metabolites):
Quarter horse – two (2) picograms per milliliter.
(2) The use of firocoxib shall be permitted under the following conditions: Not to exceed forty (40) nanograms per milliliter of firocoxib (or its metabolites) in serum or plasma.
(3) The use of dimethylsulfoxide (DMSO) shall be permitted under the following conditions: Not to exceed ten (10) micrograms per milliliter of DMSO (or its metabolites) in serum or plasma which allows for topical administration of DMSO in accordance with 71 IAC 8.5-1-1 [section 1 of this rule].
(Indiana Horse Racing Commission; 71 IAC 8.5-1-4.2; emergency rule filed Jan 25, 2012, 12:20 p.m.: 20120201-IR-071120056ERA; emergency rule filed Feb 8, 2012, 12:01 p.m.: 20120215-IR-071120072ERA)

There is a problem, however. 71 IAC 8.5-1-4.2(3) above creates a threshold level for dimethyl sulfoxide (DMSO) and refers to topical administration “in accordance with 71 IAC 8.5-1-1.” This particular administrative rule is copied below, but you only need to read 71 IAC 8.5-1-1(e) to understand the problem. 71 IAC 8.5-1-1(e) indicates that as topical dressings “Products containing “caine” derivatives or dimethylsulfoxide (DMSO) are foreign substance and are prohibited.” Simultaneously, the IHRC has an administrative rule that provides a threshold for use of DMSO, yet has another administrative rule that prohibits DMSO as a foreign substance. IBOP has alerted the IHRC as to their conflicting administrative rules.

Another one of the articles in the trainer newsletters was an introduction of the IHRC new legal department. In it, Mr. Gorajec quotes himself by saying, “Two full-time attorneys means (sic) more energy can be expended to vigorously prosecute rule violations.” Perhaps these two full-time attorneys should first vigorously review and fix all of the administrative rule problems the prior legal team has created. (See: IBOP’s Administrative Rule of the Month for April.) Administrative rules that make sense and are accurate without conflict is what the regulated should expect of the regulators, isn’t it?

71 IAC 8.5-1-1 Medication
Authority: IC 4-31-3-9
Affected: IC 4-31-12
Sec. 1. (a) through (d) removed for brevity’s sake.
(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. Products containing "caine" derivatives or dimethylsulfoxide (DMSO) are foreign substances and are prohibited. (Indiana Horse Racing Commission; 71 IAC 8.5-1-1; emergency rule filed Jun 15, 1995, 5:00 p.m.: 18 IR 2880, eff Jul 1, 1995; emergency rule filed Aug 9, 1995, 10:30 a.m.: 18 IR 3413; errata filed Mar 5, 1998, 1:46 p.m.: 21 IR 2392; emergency rule filed Feb 13, 1998 10:00 a.m.: 21 IR 2419; readopted filed Oct 30, 2001, 11:50 a.m.: 25 IR 899; emergency rule filed Feb 21, 2003, 4:15 p.m.: 26 IR 2385; emergency rule filed Mar 10, 2006, 11:00 a.m.: 29 IR 2223; errata filed Apr 10, 2006, 2:00 p.m.: 29 IR 2546; readopted filed Mar 23, 2007, 11:31 a.m.: 20070404-IR-071070030RFA)