Tuesday, May 1, 2012

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)


Friday, April 27, 2012

Request To Modify "Medication" Rules

On April 27, 2012, the following was sent to Indiana Horse Racing Commission (IHRC) Executive Director Joe Gorajec with a carbon copy to Assistant Executive Director Deana Pitman, and General Counsel Lea Ellingwood. The purpose of the communication was point out a conflict with newly created administrative rules regarding the use of DMSO and the IHRC's 'Medication' administrative rules.

"Executive Director Gorajec,

Pursuant to 71 IAC 2-12-1 Procedures, Indiana Breeder & Owner Protection, Inc. (IBOP) is requesting that the Indiana Horse Racing Commission (IHRC) consider an amendment to 71 IAC 8.5-1-1(e) and 71 IAC 8-1-1(e). IBOP would appreciate this request be considered as an agenda item at the next regularly scheduled IHRC meeting. Please consider this correspondence as our petition for the IHRC to amend 71 IAC 8.5-1-1(e) and 71 IAC 8-1-1(e) to conform with the intent of 71 IAC 8.5-1-4.2 Threshold levels and 71 IAC 8-1-4.2 Threshold levels. Clearly, the intent of the IHRC as expressed at their January 24, 2012, meeting was to create a specific gravity (threshold) for the topical use of DMSO via 71 IAC 8.5-1.4.2 and 71 IAC 8-1-4.2. While that intent was not established within either rule submitted to the Indiana Register on January 25, 2012, (the rules submitted at that time were regarding only clenbuterol thresholds submitted under LSA Document #12-056E), the intent was observed in an unusual, subsequent submission to the Indiana Register on February 8, 2012 under LSA Document #12-072E.

Both threshold rules, 71 IAC 8.5-1-4.2 and 71 IAC 8-1-4.2, refer to administrative rules, 71 IAC 8.5-1-1 and 71 IAC 8-1-1 respectively. Both 71 IAC 8.5-1-1(e) and 71 IAC 8-1-1(e) indicate that DMSO is a foreign substance and "prohibited" which is in conflict with any approval of a specific gravity. Essentially, the 71 IAC 8.5-1-1(e) is in conflict with the intent of 71 8.5-1-4.2 and 71 IAC 8-1-1(e) is in conflict with the intent of 71 IAC 8-1-4.2. One rule says DMSO can be used with a threshold, the other rule prohibits its use. Amending 71 IAC 8.5-1-1(e) and 71 IAC 8-1-1(e) by eliminating the term DMSO seems appropriate to avoid any confusion and establish the clear intent of the IHRC. The versions that affect the flat racing breeds are copied below for reference with emphasis added to the conflicting portions of the rules.

Thank you for your consideration,


Jim Hartman
IBOP Vice President

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)

71 IAC 8.5-1-1 Medication
Authority: IC 4-31-3-9
Affected: IC 4-31-12


Sec. 1. (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 1.5, 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 administration of breathing compounds for oral and nasal dosing, such as Traileze, Vapol, Vicks vapor-rub, wind-aid, exhale ease, or containing methylsalicylate, camphor, or potassium iodide.
(c) Substances or metabolites thereof which are contained in equine feed or feed supplements that do not containpharmacodynami c 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. 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)"

Sunday, April 1, 2012

Administrative Rule of the Month - Breeder Definition

Disclaimer: Even though IBOP is adding April's Administrative Rule of the Month to our blog on April 1st, this is not an April Fools' Day edition at all!

The Indiana horse racing industry has come to know that the Indiana Horse Racing Commission (IHRC) has two rule books; one that applies to standardbred racing and another that applies to thoroughbreds and quarter horse racing. In part, this is because standardbred races began in Indiana before the flat racing breeds. Sometimes, however, a two rule book system doesn't work quite so well.

Here's how IHRC Executive Director Joe Gorajec explained the two rule book system to the commissioners in attendance at the IHRC's January 24, 2012 meeting:

"The way our rule book is constructed, we have certain articles. We have a standardbred rule book and we have a thoroughbred/quarter horse rule book, and there are articles or sections of that rule book that are identical for both breeds. When you talk about the duties of the Commission or responsibility of the Commission, that's identical for both breeds. When you go to the chapter on due process, identical. Pari-mutuel wagering, identical. There are a number of articles, a number of sections that are different just because there are differences within the breeds. So in those cases where a rule falls within an article, okay, in which it's a separate rule book, then we have two rules because we have two rule numbers, one for standardbred, one for thoroughbred. If the first number after the IAC is a number without a period, then it's standardbred. If it has a period, like in the second track security, 4.5, is thoroughbred and quarter horses."

There are two rules copied below. They look somewhat similar with both spelling out which definitions of terms apply to what articles of the rule books. Because of the differences between flat racing and harness racing, having two sets of definitions makes perfect sense. The first number after the '71 IAC' is the Article, so the first rule copied below is Article 1 and the second is Article 1.5. By Mr. Gorajec's explanation of the numbering system, which of the following two rules applies to thoroughbreds and quarter horses? This shouldn't be a difficult question to answer.

Rule 1. Definitions
71 IAC 1-1-1 Applicability
Authority: IC 4-31-3-9
Affected: IC 4-31
Sec. 1. The definitions in this rule apply to [sic.] throughout this title. (Indiana Horse Racing Commission; 71 IAC 1-1-1; emergency rule filed Feb 10, 1994, 9:20 a.m.: 17 IR 1113; emergency rule filed Jun 15, 1995, 5:00 p.m.: 18 IR 2814, eff Jul 1, 1995; readopted filed Oct 30, 2001, 11:50 a.m.: 25 IR 899; emergency rule filed Apr 21, 2004, 3:45 p.m.: 27 IR 2753; readopted filed Mar 23, 2007, 11:31 a.m.: 20070404-IR-071070030RFA)
(Please Note: Included in 71 IAC Article 1 are definitions that range from 71 IAC 1-1-2 which defines the "Act," the pari-mutuel wagering act through 71 IAC 1-1-115 which defines the word "Year" to mean a calendar year. 71 IAC 1-1-1 applies those defintions in the rule books.)

Rule 1. Definitions
71 IAC 1.5-1-1 Applicability
Authority: IC 4-31-3-9
Affected: IC 4-31
Sec. 1. The definitions in this rule apply to articles 1.5, 2, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5, 9, 10, 11, and 12 of this title. (Indiana Horse Racing Commission; 71 IAC 1.5-1-1; emergency rule filed Jun 15, 1995, 5:00 p.m.: 18 IR 2815, eff Jul 1, 1995; readopted filed Oct 30, 2001, 11:50 a.m.: 25 IR 899; readopted filed Mar 23, 2007, 11:31 a.m.: 20070404-IR-071070030RFA)
(Please Note: Included in 71 IAC Article 1.5 are definitions that range from 71 IAC 1.5-1-2 which defines the "Act," the pari-mutuel wagering act through 71 IAC 1.5-1-110 which defines the word "Year" to mean a calendar year. So, 71 IAC Article 1.5 is very similar to 71 IAC Article 1, and applies those definitions.)

Based upon the explanation provided, any article with the extension of .5 is a thoroughbred and quarter horse rule. So, 71 IAC 1.5-1-1 is the flat racing rule that applies to the definitions of terms to thoroughbred and quarter horse racing. Now, a tougher question, and you'll have to carefully read both rules to find the answer. Which of these two rules applies the definitions of terms to Article 13.5? Hint: The word 'title' refers to the entire Title 71 Indiana Horse Racing Commission which is shortened in administrative rules to 71 IAC.

As you can see, there's a list of 12 articles specifically mentioned in 71 IAC 1.5-1-1 and that list does not include Article 13.5. So, the answer is not 71 IAC 1.5-1-1. Conversely, 71 IAC 1-1-1 applies the definitions in that article "throughout this title" with, again, the title being any article under Title 71. Therefore, the ordinary and plain meaning of the language used in these two rules would indicate that the definitions in 71 IAC Article 1 would apply to Article 13.5. Here's the problem: Article 13.5 covers the Thoroughbred Breed Development Program. What this means is that the definition of 'breeder' from the standardbred rule book is technically what is in effect, as applied by the commission rules, for the Thoroughbred Breed Development Program! The definition of breeder applied to the thoroughbred breed development program from Article 1 would then be as follows:

71 IAC 1-1-18 "Breeder" defined
Authority: IC 4-31-3-9
Affected: IC 4-31
Sec. 18. "Breeder" means the owner or lessee of the horse's dam at the time of breeding. (Indiana Horse Racing Commission; 71 IAC 1-1-18; emergency rule filed Feb 10, 1994, 9:20 a.m.: 17 IR 1115; readopted filed Oct 30, 2001, 11:50 a.m.: 25 IR 899; readopted filed Mar 23, 2007, 11:31 a.m.: 20070404-IR-071070030RFA)

71 IAC 1-1-18 is the definition of breeder from the standardbred rule book. The standardbred definition of breeder, along with the quarter horse definition, is the owner of the mare (dam) at the time of breeding, not at the time of foaling. This definition of breeder in 71 IAC 1-1-18 is contrary to the recognized thoroughbred breeding industry definition and contrary to The Jockey Club definition of a thoroughbred breeder. We recognize that as a current practice the IHRC staff has been paying thoroughbred breeder awards as to the recognized thoroughbred breeding industry standards, and not to the definition in 71 IAC 1-1-18. Paying awards to the owner of the mare at foaling is the correct course of action for the thoroughbred breeding program in Indiana. However, the intent and the execution of the thoroughbred program clearly does not match the IHRC's own rules. To do so, Article 13.5 would need to be listed in 71 IAC 1.5-1-1 to apply the correct definition to the program

IBOP has petitioned the IHRC to consider an amendment to '71 IAC 1.5-1-1 Applicability' to include, at minimum, Article 13.5 Thoroughbred Development Program to the list of articles specifically mentioned in the rule. We have requested this amendment to be considered as an agenda item at the next regularly scheduled IHRC meeting. Doing so would apply the correct definition of a thoroughbred breeder (which is actually found in 71 IAC 1.5-1-19) to the thoroughbred breed development program. Without 'Article 13.5 Thoroughbred Development Program' being applied via 71 IAC 1.5-1-1, the owner of a mare at breeding, if different than the owner of the mare at foaling, would have a claim to breeder awards already paid. Any person who has sold a mare in foal, where the resulting foal has become a registered Indiana-bred thoroughbred, has a claim to any breeder awards based upon the performance of that foal. When the owner of the mare is different at foaling than at breeding, any breeder award paid to the mare owner at the time of foaling can be challenged under the IHRC's own rules. That creates a potential liability for the IHRC.

Any liability is especially difficult to quantify given the significant increases in the thoroughbred foal crops in Indiana over the last five years. Many breeders and owners grew their operations through the acquisition of in foal mares either privately or via public sale to foal in Indiana. In reviewing just one of ITOBA's 2011 champions, we found an example of a potential claim of $25,000 from just races in 2011 where the owner of the mare at her breeding was different than the owner of the mare at the foal's birth. In addition, any potential liability expands as the larger thoroughbred foal crops begin to compete and to earn breeder awards. Plus, thoroughbred mares are being bred in the 2012 breeding season that would fall under the standardbred breeder definition in 71 IAC 1-1-18.

We believe that any liability for claims against breeder awards paid and those that will be paid lies clearly with the IHRC and not those who have already received breeder award payments. A foal's Certificate of Indiana Bred has a 'Bred By' section which defines the breeder very clearly. It's just their rules don't, and that is the IHRC's problem to fix.