Two of the key initiatives communicated in Indiana Breeder and Owner Protection Inc.'s (IBOP) first newsletter were the 'Protection of Owner's Rights' as well as the 'Protection of the Integrity Involved with Drug Testing' as part of our mission. February's 'Administrative Rule of the Month' is a review of a rule where the owner's rights and drug testing merge together with '71 IAC 8.5-3-3 Administrative procedures prior to split sample testing' in the flat racing rulebook. The equivalent rule in the standardbred rulebook, '71 IAC 8-4-3,' which omits one sentence that is included in the flat racing rule, will not be specifically reviewed. Yet, the standardbred rule has the exact same issues that will be pointed out in this article.
Like most other racing jurisdictions, if not all other racing jurisdictions, the Indiana Horse Racing Commission (IHRC) has adopted "trainer responsibility" rules (71 IAC 5.5-3-2) whereby the trainer is responsible for the presence of a prohibited substance or a medication in excess of an allowable level. The section of the rulebook that includes all of the IHRC's medication rules is dotted with the sentiment behind the trainer responsibility rule where the presumption is that any violation for a medication overage or prohibited substance "was administered and carried in the body of the horse while participating in a race." If there's a violation, the trainer is supposedly the sole responsible party. Yet, there are consequences to the owner as well with the potential of loss of purse money, fines, and under IHRC rules be required to stable all horses participating in a race meet at the track. Under '71 IAC 5.5-2-6 Owner - positive tests' just two positive tests for a prohibited substance in a five-year period can place an owner into this IHRC requirement. So, while the trainer is responsible, the owner can be significantly penalized as well.
Through administrative rules, the IHRC has tried to tie their penalty system for both an owner and a trainer to the Association of Racing Commissioners International's (ARCI) Uniform Classification Guidelines For Foreign Substances and Recommended Penalties. The most recent version of this document can be found at the following link: http://arci.com/druglisting.pdf. If you review this document, what you will see is that there is a penalty structure for the most serious violations (Class A) to the least serious (Class C) violations. Within each classification, the severity of the penalties to an owner is significantly ramped up for a third violation in a 365-day period in any jurisdiction within an owner's entire "stable." (The term stable is not defined which opens it's meaning to interpretation.) A question that IBOP is raising with our Administrative Rule of the Month is, are the trainer's and owner's interests always the same or always aligned given the potential ARCI penalties?
Our answer is that many times, and we stress many times, the interests of the owner and the trainer are aligned. However, there are times when they may not be, and the problem we see is that the 'administrative procedures prior to split sample testing' rules treat the owner and the trainer as one entity with interests that are the same ALL the time, and that needs to be changed. Since trainers can, and do, train horses for multiple owners, a trainer's third violation within any penalty class in a 365-day period could be an owner's first violation. Conversely, owners can, and some do, have their "stable" spread out over more than one trainer and/or have trainers at multiple locations. Therefore, an owner's third violation in 365-day period, even spread over multiple trainers, could very well be the first violation for a trainer. In both these examples, the owner and the trainer are in different penalty scenarios under the ARCI model penalties. For example, a small overage of bute is a Class C penalty. The first violation for a trainer can very well be just a warning, but if its the third for the owner in a 365-day period, there is a loss of purse money which is a much more severe penalty. The first violation in this category for an owner does not include a loss of the purse.
We can think of other scenarios where an owner's interests might be different than his or her trainer's. Here's exactly how the rule reads as of today and we've highlighted a few trouble spots in bold:
71 IAC 8.5-3-3 Administrative procedures prior to split sample testing
Authority: IC 4-31-3-9
Affected: IC 4-31-12
Sec. 3. (a) The results of all tests performed by the primary laboratory or laboratories are confidential and shall only be communicated to the commission, stewards, owner, and trainer. The trainer shall be responsible for promptly notifying the owner of a horse of a positive test as reported by the primary laboratory.
(b) The trainer or owner of a horse for which a positive result on a drug test is returned may request that the stewards submit the retained part of the specimen for testing in accordance with this section. The specimen must be tested by a laboratory that is identified on the list of approved laboratories maintained by the commission and acceptable to the following:
(1) The commission.
(2) The primary laboratory.
Laboratories providing split sample testing shall be ISO 17025 accredited unless otherwise approved by the commission. The request must be in writing and must be delivered to the stewards not later than seventy-two (72) hours after the trainer has received notice of a positive test result. Notice of a positive test result may be communicated verbally to the trainer. Failure to request testing of a split sample within seventy-two (72) hours shall constitute a waiver of the right. The split sample laboratory shall be contacted by a representative of the commission to request acceptance of a split sample. The trainer or owner may choose any laboratory on the commission maintained applicable list to test the sample. However, the commission or executive director may limit the choice of laboratory for the detection of specific drugs.
(c) The trainer or owner may elect to waive his or her right to testing of a split sample.
(d) The owner or trainer of a horse who submits a specimen for drug testing is entitled to be present or have a representative present at any time that the retained part of the specimen is prepared for storage or is tested.
(e) The owner or trainer of a horse who submits a specimen for testing to a split sample laboratory must execute a hold harmless agreement for the split sample laboratory and an agreement that the results of the split sample laboratory can be introduced as evidence in any hearing. The agreements shall remain in the hands of the stewards of the state in which the positive was reported.
(f) The trainer or owner may request that negative control samples be tested with the split sample. The identities of the negative control samples and the split sample shall be known only to the commission.
(g) The presence of a drug or drug metabolite in any quantity, excluding phenylbutazone, flunixin, ketoprofen, furosemide, or as permitted in 71 IAC 8.5-1-4.2 and 71 IAC 8.5-1-9, is sufficient for a finding of a positive test.
(Please Note: We've removed the standard History Line from the rule to save some space.)
Subsection (a) states, "The results of all tests performed by the primary laboratory or laboratories are confidential and shall only be communicated to the commission, stewards, owner, and trainer." So, the owner and the trainer are included for notification, but in reality, the next sentence places the responsibility of notifying the owner on the trainer, "The trainer shall be responsible for promptly notifying the owner of a horse of a positive test as reported by the primary laboratory." Given the IHRC's delegation of the notification to the trainer, the first sentence should read "...shall only be communicated to the commission, stewards, and trainer." While we agree that most trainers would immediately notify the owner, there is never a guarantee especially if the impact of any penalty to a trainer is minimal with an assumption that any potential penalty to the owner would be as well. Could there also be a scenario where the trainer wouldn't want the owner to know immediately? We feel that the IHRC should also notify the owner. The other concern we have is that subsection (b) states, "Notice of a positive test result may be communicated verbally to the trainer." Basically, the IHRC does not have to notify the owner of the horse of a primary positive test and has no requirement to notify anyone in writing. Providing notification in writing eliminates any potential dispute as to 'what was said to whom and when?'
IBOP is committed to petitioning the IHRC to change this rule to add a requirement that the owner of a horse and its trainer be notified in writing of a positive test for a prohibited substance or an overage of an approved medication. Given the potential consequences to both an owner and a trainer, the IHRC not being required to provide a written notification to anyone is dumbfounding. IBOP is also committed to petitioning the IHRC to require this written notification within 72 hours of the receipt of the results from their primary lab. With no specific requirement in which the IHRC is required to provide primary test results to anyone; theoretically, days, weeks and months could go by. The 72 hour notification is the same amount of time that the IHRC has given an owner or a trainer to request a split sample test when a primary test is positive. If the IHRC believes that is a reasonable time for a response, then we believe 72 hours is a reasonable timeframe for a notification. IBOP is also committed to petition the IHRC to modify subsection (c) to read "The trainer and owner may elect to waive his or her right to testing of a split sample." The sentence current reads "trainer or owner." This change would allow for both parties to be treated as having separate interests, not a combined interest.
Ironically, the IHRC through "71 IAC 8.5-3-4 Administrative procedures subsequent to split sample testing" does require that a written report from the split sample laboratory be provided to both the owner and the trainer. 71 IAC 8.5-3-4(a) reads, "The split sample laboratory shall send a confidential written report on the result of its tests to the commission which in turn shall send a confidential report to the trainer and owner forthwith." Webster's dictionary defines 'forthwith' as "immediately; without delay; directly." So, if the IHRC can send a written report on a split sample to an owner and a trainer "forthwith," why can't they do the same "forthwith" for a primary test?
The easy answer is the IHRC can, but would rather control the timing of any notification. Doing so allows the IHRC staff to determine whether a trainer is a potential serial offender with a particular medication. In this situation, the IHRC purposely does not communicate a positive test when received to allow for the possibility of having a trainer accumulate multiple violations. However, at the same time, even with the trainer being responsible, the owner is accumulating more violations through no fault of his or her own. In situations like this, which do happen in Indiana, an owner should be apprised immediately (forthwith) of the activities involved with their property. This is an owner's right that the IHRC needs to recognize. We also see this delayed notification practice by the IHRC as being contrary to state law.
The purpose of medication testing in Indiana statute, as spelled out in a chapter entitled "Medication of Race Horses," is directed at the IHRC. This section is copied below:
IC 4-31-12-1
Purpose
Sec. 1. The purpose of this chapter is to protect the integrity of horse racing, to guard the health of the horse, and to safeguard the interests of the public and the racing participants through the prohibition or control of all drugs and medications or substances foreign to the natural horse.
As added by P.L.341-1989(ss), SEC.2.
If the IHRC has a concern, based upon a positive primary test, to the degree that test results are not communicated to anyone in a timely fashion, then they have failed to meet any standard as outlined in IC 4-31-12-1. While it is in the public interest to have serial offenders penalized, this tactic employed by the IHRC does nothing to protect the integrity of wagering, nor does it protect the health of the horse or safeguard any others participating in racing. This practice also inhibits an owner's opportunity to protect themselves and compromises an owner's rights to due process.
Positive tests are considered in the IHRC administrative rules to be "prima facie evidence" meaning that unless rebutted is enough evidence to prove their position. IHRC rules also place the burden of proof on a trainer to prove otherwise. With any right to due process, timeliness of a notification of a potential violation is key. Since an owner can also be penalized, an owner should have the right to investigate any possible violation as close to when the potential violation had occurred. IHRC Executive Director Joe Gorajec seems to agree with IBOP's position.
In sworn testimony in a hearing in front of an Administrative Law Judge (ALJ), Mr. Gorajec was asked by the ALJ to clarify his testimony regarding the lack of an IHRC initiated investigation in a particular situation. He said, "It's my testimony that in a case of a serious violation, that in order to collect the kind of documentation you would likely need in order to pursue a violation or charges, you would need to begin that investigation contemporaneously or near contemporaneous with the actual violation occuring." To use his term "contemporaneously," which means happening at the same time, an owner should have the right to contemporaneously investigate any possible violation regarding his or her own horse to assist with any defense. And, an owner should have the immediate right to determine if a trainer should be retained based upon the treatment of his or her horse.
Saturday, February 2, 2013
Tuesday, January 1, 2013
Administrative Rule of the Month - 71 IAC 8-1-1 Medication (Expired)
This month, IBOP's Administrative Rule of the Month takes a look at an administrative rule that the Indiana Horse Racing Commission (IHRC) has allowed to expire as of January 1, 2013. ‘71 IAC 8-1-1 Medication,’ which is a standardbred racing rule, has expired and is no longer in effect. For a little background, administrative rules in Indiana expire on January 1st following their sixth year anniversary of their approval unless they are modified or readopted. ‘71 IAC 8-1-1’ was last modified in 2006. The equivalent administrative rule in the flat racing rulebook, ‘71 IAC 8.5-1-1 Medication’ was last readopted in 2007 so its expiration date will be January 1, 2014 unless modified prior to then. Here's how the standardbred ‘Medication’ rule looked prior to its expiration:
71 IAC 8-1-1 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, 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 prohibition [sic., 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 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 twentyfour (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 8-1-1; emergency rule filed Feb 10, 1994, 9:20 a.m.: 17 IR 1168; emergency rule filed Mar 25, 1996, 10:15 a.m.: 19 IR 2078; emergency rule filed Feb 13, 1998, 10:00 a.m.: 21 IR 2410; readopted filed Oct 30, 2001, 11:50 a.m.: 25 IR 899; emergency rule filed Feb 21, 2003, 4:15 p.m.: 26 IR 2384; emergency rule filed Mar 10, 2006, 11:00 a.m.: 29 IR 2217; errata filed Apr 10, 2006, 2:00 p.m.: 29 IR 2546)
Here’s how the standardbred rulebook will look as soon as the Indiana Register is updated to note the expiration:
71 IAC 8-1-1 Medication (Expired)
Sec. 1. (Expired under IC 4-22-2.5, effective January 1, 2013.)
So, why would the IHRC allow '71 IAC 8-1-1 Medication' to expire? What does the IHRC have to gain by allowing an administrative rule to expire? The better question is what does the IHRC hope to avoid by allowing this rule to expire? The answer is that the IHRC is attempting to avoid going through the regular rulemaking process with this rule. The ‘why’ to this expiration actually began on January 24, 2012 when the IHRC added ’71 IAC 8-1-4.2 Threshold levels’ which established a specific threshold for the use of DMSO and a few other medications. You’ll notice in the text above 71 IAC 8-1-1(e) states, “Products containing "caine" derivatives or dimethylsulfoxide (DMSO) are foreign substances and are prohibited.” What the IHRC had done was create conflicting rules where one allowed for the use of DMSO while another prohibited the use of DMSO.
IBOP brought this conflict to the IHRC’s attention on April 27, 2012 with a petition under IHRC rules to have the conflicting language removed. (To view this email, please follow this link: http://ibopindy.blogspot.com/2012/04/on-april-27-2012-following-was-sent-to.html .) This conflict also became a major point within our Administrative Rule of the Month for May, 2012: http://ibopindy.blogspot.com/2012/04/administrative-rule-of-month-dimethyl.html. By not covering this conflict at their June or August meetings, the IHRC allowed racing to take place throughout 2012 knowing that there were problems with their medication rules. In advance of their October 12, 2012 meeting, on October 2, 2012, IBOP submitted a “second request” to the IHRC. (To view this email, please follow this link: http://ibopindy.blogspot.com/2012/10/second-request-to-modify-medication.html .) As part of the New Business portion of the October 12th meeting, ‘71 IAC 8-1-1 Medication’ was considered. However, since the rule was due to expire on January 1, 2013 the commissioners approved the rule’s readoption without fixing the conflict regarding DMSO use! This, of course, made no logical sense.
According to the approved minutes for that October 12, 2012 meeting, “General Counsel Ellingwood presented two rules (71 IAC 8-1-1 and 71 IAC 8-1-5.6) to the Commission that are scheduled to sunset at the end of 2012. Commission unanimously voted to begin the process for re-adoption of 71 IAC 8-1-1 and 71 IAC 8-1-5.6.” Using the emergency rulemaking process to fix the DMSO oversight actually made perfect sense. Instead, on October 17, 2012 the IHRC staff filed a ‘Notice of Intent to Readopt” both rules which can be found at this link:
http://www.in.gov/legislative/iac/20121017-IR-071120572RNA.xml.pdf. (Please note that 71 IAC 8-1-5.6 was another unrelated expiring rule that allows for use of anti-ulcer medications.)
For additional background, Indiana statue, under IC 4-22-2.5-4(a) which is copied below allows for multiple rules to be readopted at the same time with one readoption notice. If you read the notice from the link above, you will also see the following, “Requests for any part of this readoption to be separate from this action must be made in writing within 30 days of this publication.” Indiana law, under IC 4-22-2.5-4(b) copied below provides for requests to be made to have a rule or rules be considered separately from the submitted readoption notice. So, knowing that the conflicting language regarding DMSO needed to be fixed, and citing that conflict, on November 1, 2012 IBOP filed a request under IC 4-22-2.5-4(b) to have 71 IAC 8-1-1 be considered separately. Based upon the language in the statute, “....the agency must” readopt the rule separately and “follow the procedure for adoption…..under IC 4-22-2 with respect to the rule.”
IC 4-22-2.5-4
Request for separate readoption of rules
Sec. 4. (a) Except as provided in subsection (b) and subject to section 3.1 of this chapter, an agency may readopt all rules subject to expiration under this chapter under one (1) rule that lists all rules that are readopted by their titles and subtitles only. A rule that has expired but is readopted under this subsection may not be removed from the Indiana Administrative Code.
(b) If, not later than thirty (30) days after an agency's publication of notice of its intention to adopt a rule under IC 4-22-2-23 using the listing allowed under subsection (a), a person submits to the agency a written request and the person's basis for the request that a particular rule be readopted separately from the readoption rule described in subsection (a), the agency must:
(1) readopt that rule separately from the readoption rule described in subsection (a); and
(2) follow the procedure for adoption of administrative rules under IC 4-22-2 with respect to the rule.
(c) If the agency does not receive a written request under subsection (b) regarding a rule within thirty (30) days after the agency's publication of notice, the agency may:
(1) submit the rule for filing with the publisher under IC 4-22-2-35; or
(2) elect the procedure for readoption under IC 4-22-2.
As added by P.L.17-1996, SEC.7. Amended by P.L.188-2005, SEC.7; P.L.215-2005, SEC.10; P.L.1-2006, SEC.76; P.L.123-2006, SEC.18.
To fully grasp the impact of IBOP’s request to have 71 IAC 8-1-1 be considered separately, you have to understand that IC 4-22-2 prohibits the readoption of an administrative rule by use of the emergency rulemaking process. Therefore, the IHRC can’t simply approve the rule then file it with the Indiana Register as a final or readopted rule. According to Indiana statute, the IHRC “must” go through the regular rulemaking process which includes, among other steps, a public hearing, approval by the attorney general, and approval by the governor. In the history of the IHRC, the regular rulemaking process has never been used to establish or readopt one single rule. So, their scramble began.
On November 15, 2012, we were informed by IHRC’s General Counsel Lea Ellingwood via an email that our second request to amend ‘71 IAC 8-1-1 Medication’ and the flat racing version, 71 IAC 8.5-1-1, was tentatively scheduled to be considered at the IHRC’s next meeting on December 14, 2012. Now, all of a sudden, IBOP’s petition to amend these rules seems very important to the IHRC staff. In that email, we were asked to provide the IHRC a “redlined version” of the rule with our proposed changes. This seemed like a strange request as IBOP has submitted (and successfully had modified) four other pairs of administrative rules in 2012 without being asked to provide a redlined (edited) version. There was no mention of our request to have 71 IAC 8-1-1 considered separately through the regular rulemaking process. We immediately withdrew our petition to have 71 IAC 8-1-1 amended via emergency rulemaking stating, “We will provide appropriate comments when 71 IAC 8-1-1 is considered separately from the Notice of Intent to Readopt filed by the commission on October 17, 2012.”
To our surprise, when the agenda for the IHRCs December 14, 2012 meeting was posted one of the agenda items was “Consideration of emergency rule re: 71 IAC 8-1-1 and 71 IAC 8.5-1-1, Medication.” Upon arriving at the December 14th meeting, sure enough, one of the hand-outs was IBOP’s petition to modify both of 'Medication' rules and our redlined versions of each. Of course, there was no mention of the withdrawal of our petition to amend 71 IAC 8-1-1 or the fact that a request was made to have 71 IAC 8-1-1 considered separately through the regular rulemaking process.
Unfortunately, due to the length of the meeting, the consideration of the ‘Medication’ emergency rules was pushed back to the IHRC’s next meeting. Essentially, what the IHRC was attempting to do is readopt 71 IAC 8-1-1 via an emergency rulemaking process, which is prohibited by Indiana statute, rather than be forced to go through the regular rulemaking process. They had eight months to fix the DMSO conflict, but chose not to do so. And, only when faced with being required to go through the regular rulemaking process for the first time did fixing the rule make sense. What we fully expect is that at their first meeting in 2013 the IHRC will use their emergency rulemaking authority to replace the ‘Medication’ rules with a different version and/or take a different approach with overall medication rules as a cover. We fully expect the readoption of 71 IAC 8-1-1 through the regular rulemaking process, as required under Indiana statute, to be ignored.
The question that remains unanswered is who is making these decisions? The commissioners approved the readoption of 71 IAC 8-1-1 at their public meeting on October 12, 2012. Only a majority vote of the commissioners can change a prior IHRC action. With IBOP’s request, Indiana statute appears to compel the readoption of 71 IAC 8-1-1 via the regular rulemaking process. Yet, we don’t see that happening. In fact, with the expiration, 71 IAC 8-1-1 can never be used in the Indiana Administrative Code ever again. Nor, can ‘71 IAC 8-1-5.6 Anti-ulcer medications,’ the other administrative rule that was readopted by the IHRC on October 12, 2012, be used. As we always say, ‘we couldn’t make this stuff up even if we tried.”
71 IAC 8-1-1 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, 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 prohibition [sic., 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 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 twentyfour (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 8-1-1; emergency rule filed Feb 10, 1994, 9:20 a.m.: 17 IR 1168; emergency rule filed Mar 25, 1996, 10:15 a.m.: 19 IR 2078; emergency rule filed Feb 13, 1998, 10:00 a.m.: 21 IR 2410; readopted filed Oct 30, 2001, 11:50 a.m.: 25 IR 899; emergency rule filed Feb 21, 2003, 4:15 p.m.: 26 IR 2384; emergency rule filed Mar 10, 2006, 11:00 a.m.: 29 IR 2217; errata filed Apr 10, 2006, 2:00 p.m.: 29 IR 2546)
Here’s how the standardbred rulebook will look as soon as the Indiana Register is updated to note the expiration:
71 IAC 8-1-1 Medication (Expired)
Sec. 1. (Expired under IC 4-22-2.5, effective January 1, 2013.)
So, why would the IHRC allow '71 IAC 8-1-1 Medication' to expire? What does the IHRC have to gain by allowing an administrative rule to expire? The better question is what does the IHRC hope to avoid by allowing this rule to expire? The answer is that the IHRC is attempting to avoid going through the regular rulemaking process with this rule. The ‘why’ to this expiration actually began on January 24, 2012 when the IHRC added ’71 IAC 8-1-4.2 Threshold levels’ which established a specific threshold for the use of DMSO and a few other medications. You’ll notice in the text above 71 IAC 8-1-1(e) states, “Products containing "caine" derivatives or dimethylsulfoxide (DMSO) are foreign substances and are prohibited.” What the IHRC had done was create conflicting rules where one allowed for the use of DMSO while another prohibited the use of DMSO.
IBOP brought this conflict to the IHRC’s attention on April 27, 2012 with a petition under IHRC rules to have the conflicting language removed. (To view this email, please follow this link: http://ibopindy.blogspot.com/2012/04/on-april-27-2012-following-was-sent-to.html .) This conflict also became a major point within our Administrative Rule of the Month for May, 2012: http://ibopindy.blogspot.com/2012/04/administrative-rule-of-month-dimethyl.html. By not covering this conflict at their June or August meetings, the IHRC allowed racing to take place throughout 2012 knowing that there were problems with their medication rules. In advance of their October 12, 2012 meeting, on October 2, 2012, IBOP submitted a “second request” to the IHRC. (To view this email, please follow this link: http://ibopindy.blogspot.com/2012/10/second-request-to-modify-medication.html .) As part of the New Business portion of the October 12th meeting, ‘71 IAC 8-1-1 Medication’ was considered. However, since the rule was due to expire on January 1, 2013 the commissioners approved the rule’s readoption without fixing the conflict regarding DMSO use! This, of course, made no logical sense.
According to the approved minutes for that October 12, 2012 meeting, “General Counsel Ellingwood presented two rules (71 IAC 8-1-1 and 71 IAC 8-1-5.6) to the Commission that are scheduled to sunset at the end of 2012. Commission unanimously voted to begin the process for re-adoption of 71 IAC 8-1-1 and 71 IAC 8-1-5.6.” Using the emergency rulemaking process to fix the DMSO oversight actually made perfect sense. Instead, on October 17, 2012 the IHRC staff filed a ‘Notice of Intent to Readopt” both rules which can be found at this link:
http://www.in.gov/legislative/iac/20121017-IR-071120572RNA.xml.pdf. (Please note that 71 IAC 8-1-5.6 was another unrelated expiring rule that allows for use of anti-ulcer medications.)
For additional background, Indiana statue, under IC 4-22-2.5-4(a) which is copied below allows for multiple rules to be readopted at the same time with one readoption notice. If you read the notice from the link above, you will also see the following, “Requests for any part of this readoption to be separate from this action must be made in writing within 30 days of this publication.” Indiana law, under IC 4-22-2.5-4(b) copied below provides for requests to be made to have a rule or rules be considered separately from the submitted readoption notice. So, knowing that the conflicting language regarding DMSO needed to be fixed, and citing that conflict, on November 1, 2012 IBOP filed a request under IC 4-22-2.5-4(b) to have 71 IAC 8-1-1 be considered separately. Based upon the language in the statute, “....the agency must” readopt the rule separately and “follow the procedure for adoption…..under IC 4-22-2 with respect to the rule.”
IC 4-22-2.5-4
Request for separate readoption of rules
Sec. 4. (a) Except as provided in subsection (b) and subject to section 3.1 of this chapter, an agency may readopt all rules subject to expiration under this chapter under one (1) rule that lists all rules that are readopted by their titles and subtitles only. A rule that has expired but is readopted under this subsection may not be removed from the Indiana Administrative Code.
(b) If, not later than thirty (30) days after an agency's publication of notice of its intention to adopt a rule under IC 4-22-2-23 using the listing allowed under subsection (a), a person submits to the agency a written request and the person's basis for the request that a particular rule be readopted separately from the readoption rule described in subsection (a), the agency must:
(1) readopt that rule separately from the readoption rule described in subsection (a); and
(2) follow the procedure for adoption of administrative rules under IC 4-22-2 with respect to the rule.
(c) If the agency does not receive a written request under subsection (b) regarding a rule within thirty (30) days after the agency's publication of notice, the agency may:
(1) submit the rule for filing with the publisher under IC 4-22-2-35; or
(2) elect the procedure for readoption under IC 4-22-2.
As added by P.L.17-1996, SEC.7. Amended by P.L.188-2005, SEC.7; P.L.215-2005, SEC.10; P.L.1-2006, SEC.76; P.L.123-2006, SEC.18.
To fully grasp the impact of IBOP’s request to have 71 IAC 8-1-1 be considered separately, you have to understand that IC 4-22-2 prohibits the readoption of an administrative rule by use of the emergency rulemaking process. Therefore, the IHRC can’t simply approve the rule then file it with the Indiana Register as a final or readopted rule. According to Indiana statute, the IHRC “must” go through the regular rulemaking process which includes, among other steps, a public hearing, approval by the attorney general, and approval by the governor. In the history of the IHRC, the regular rulemaking process has never been used to establish or readopt one single rule. So, their scramble began.
On November 15, 2012, we were informed by IHRC’s General Counsel Lea Ellingwood via an email that our second request to amend ‘71 IAC 8-1-1 Medication’ and the flat racing version, 71 IAC 8.5-1-1, was tentatively scheduled to be considered at the IHRC’s next meeting on December 14, 2012. Now, all of a sudden, IBOP’s petition to amend these rules seems very important to the IHRC staff. In that email, we were asked to provide the IHRC a “redlined version” of the rule with our proposed changes. This seemed like a strange request as IBOP has submitted (and successfully had modified) four other pairs of administrative rules in 2012 without being asked to provide a redlined (edited) version. There was no mention of our request to have 71 IAC 8-1-1 considered separately through the regular rulemaking process. We immediately withdrew our petition to have 71 IAC 8-1-1 amended via emergency rulemaking stating, “We will provide appropriate comments when 71 IAC 8-1-1 is considered separately from the Notice of Intent to Readopt filed by the commission on October 17, 2012.”
To our surprise, when the agenda for the IHRCs December 14, 2012 meeting was posted one of the agenda items was “Consideration of emergency rule re: 71 IAC 8-1-1 and 71 IAC 8.5-1-1, Medication.” Upon arriving at the December 14th meeting, sure enough, one of the hand-outs was IBOP’s petition to modify both of 'Medication' rules and our redlined versions of each. Of course, there was no mention of the withdrawal of our petition to amend 71 IAC 8-1-1 or the fact that a request was made to have 71 IAC 8-1-1 considered separately through the regular rulemaking process.
Unfortunately, due to the length of the meeting, the consideration of the ‘Medication’ emergency rules was pushed back to the IHRC’s next meeting. Essentially, what the IHRC was attempting to do is readopt 71 IAC 8-1-1 via an emergency rulemaking process, which is prohibited by Indiana statute, rather than be forced to go through the regular rulemaking process. They had eight months to fix the DMSO conflict, but chose not to do so. And, only when faced with being required to go through the regular rulemaking process for the first time did fixing the rule make sense. What we fully expect is that at their first meeting in 2013 the IHRC will use their emergency rulemaking authority to replace the ‘Medication’ rules with a different version and/or take a different approach with overall medication rules as a cover. We fully expect the readoption of 71 IAC 8-1-1 through the regular rulemaking process, as required under Indiana statute, to be ignored.
The question that remains unanswered is who is making these decisions? The commissioners approved the readoption of 71 IAC 8-1-1 at their public meeting on October 12, 2012. Only a majority vote of the commissioners can change a prior IHRC action. With IBOP’s request, Indiana statute appears to compel the readoption of 71 IAC 8-1-1 via the regular rulemaking process. Yet, we don’t see that happening. In fact, with the expiration, 71 IAC 8-1-1 can never be used in the Indiana Administrative Code ever again. Nor, can ‘71 IAC 8-1-5.6 Anti-ulcer medications,’ the other administrative rule that was readopted by the IHRC on October 12, 2012, be used. As we always say, ‘we couldn’t make this stuff up even if we tried.”
Saturday, December 1, 2012
Administrative Rule of the Month - Furosemide As A Permitted Foreign Substance
When the Kentucky Horse Racing Commission (KHRC) enabled administrative rules that eliminated the use of adjunct bleeder medications, the KHRC also incorporated an Association of Racing Commissioners International (ARCI) Model Rule that requires furosemide (Salix) administration only by a KHRC veterinarian. The Blood-Horse characterized this regulation, which went into effect on October 5th, as a "model rule that is being gradually adopted by racing jurisdictions.” Immediately, a KHRC veterinarian administered furosemide to a horse that wasn’t scheduled to race on the medication. Since then, KHRC veterinarians have missed giving a horse furosemide and administered double doses to two different horses necessitating they be scratched. (http://www.bloodhorse.com/horse-racing/articles/74504/salix-errors-frustrate-kentucky-horsemen)
Given the struggles with regulatory administration of furosemide in Kentucky, and the expectation that this ARCI Model Rule would make its way to Indiana, Indiana Breeder and Owner Protection, Inc. (IBOP) decided to make ‘Furosemide as a permitted foreign substance’ our Administrative Rule of the Month. In reviewing these rules, 71 IAC 8.5-1-5 (flat racing) and 71 IAC 8-1-5 (standardbred), what we found was rather surprising. We’ve copied an abbreviated version of 71 IAC 8.5-1-5 below, with specific emphasis on Subsection 8:
71 IAC 8.5-1-5 Furosemide as a permitted foreign substance
Authority: IC 4-31-3-9
Affected: IC 4-31-12
Sec. 5. Furosemide may be administered intravenously to a horse, which is entered to compete in a race. Except under the instructions of the official veterinarian or the racing veterinarian for the purpose of removing a horse from the veterinarian's list or to facilitate the collection of a post-race urine sample, furosemide shall be permitted only after the official veterinarian has placed the horse on the furosemide list. In order for a horse to be placed on the furosemide list, the following process must be followed:
(Note: Subsections (1) through (7) removed for brevity.)
(8) Medication administration. Bleeder medication shall be administered by a veterinarian licensed by the commission at an intravenous dose level not to exceed five hundred (500) milligrams and no less than one hundred fifty (150) milligrams. The executive director or stewards may designate certain official veterinarians, racing veterinarians, and/or practicing veterinarians to administer furosemide under this rule. Such designation may be determined daily, weekly, or for any other appropriate time period. Administration of furosemide shall take place in the test barn or a specific location otherwise designated by the commission. An association employee shall be present and observe the drawing of furosemide into a syringe. The administering veterinarian shall provide a factory sealed bottle of furosemide from which the draws shall be made. The association shall establish track rules for furosemide administrations that are consistent with these regulations.
(Note: Subsections (9) through (10) removed for brevity.)
(Indiana Horse Racing Commission; 71 IAC 8.5-1-5; 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; emergency rule filed May 20, 1996, 10:00 a.m.: 19 IR 2893; emergency rule filed Feb 13, 1998, 10:00 a.m.: 21 IR 2420; errata filed Oct 15, 1998, 12:39 p.m.: 22 IR 759; emergency rule filed Jun 8,1999, 9:30 a.m.: 22 IR 3123, eff May 26, 1999 [NOTE: IC 4-22-2-37.1 establishes the effectiveness of an emergency rule upon filing with the secretary of state. LSA Document #99-107(E) was filed with the secretary of state June 8, 1999.]; readopted filed Oct 30, 2001, 11:50 a.m.: 25 IR 899; 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; emergency rule filed Jul 28, 2006, 11:17 a.m.: 20060809-IR-071060278ERA, eff Aug 1, 2006; readopted filed Mar 23, 2007, 11:31 a.m.: 20070404-IR-071070030RFA; emergency rule filed Mar 3, 2011, 11:50 a.m.: 20110309-IR-071110100ERA; emergency rule filed Jan 25, 2012, 12:20 p.m.: 20120201-IR-071120056ERA)
According to 71 IAC 8.5-1-5(8), the IHRC has already granted themselves the authority to “designate” what veterinarians administer race-day furosemide; “The executive director or stewards may designate certain official veterinarians, racing veterinarians, and/or practicing veterinarians to administer furosemide under this rule. Such designation may be determined daily, weekly, or for any other appropriate time period.” By the IHRC’s own definitions, the ‘official veterinarian’ is their Equine Medical Director and a ‘racing veterinarian’ is their stable of Commission Veterinarians. A ‘practicing veterinarian,’ while not defined specifically by the IHRC, is a private practice veterinarian. So, there you have it, the IHRC can already “designate” ANY veterinarian to administer furosemide to your horse.
One issue we see with the IHRC being able to “designate” any veterinarian to administer furosemide is the ‘trainer responsibility’ rule. Both Indiana statute and IHRC’s administrative rules place sole responsibility for medication violations on the trainer as being “negligent in their handling or care of the horse.” If the trainer has no control over who administers furosemide, then how can they be held responsible for any mistakes in its administration? Generally, most racing jurisdictions don’t readily admit to or take responsibility for their mistakes. More specifically, there’s a bigger issue with this ability to “designate” what veterinarian administers your horse’s furosemide. The IHRC’s granting themselves this authority in 71 IAC 8.5-1-5(8) and 71 IAC 8-1-5(8) appears to violate Indiana law.
According to IC 4-31-12-7(a), which is copied below, veterinarians “appointed by the commission” are prohibited from treating any horse unless an emergency exists. We view the ability to "designate" a veterinarian as used in 71 IAC 8.5-1-5(8) and 71 IAC 8-1-5(8) as synonymous to "a veterinarian appointed" as used in IC 4-31-12-7(a). Clearly, administration of furosemide is providing a medical remedy, i.e. a treatment, for alleviating a condition and is not an emergency treatment. Simply, per IC 4-31-12-7(a), the IHRC cannot designate or appoint ANY veterinarian to administer furosemide to race horses and IBOP’s view is that the Indiana Administrative Code should reflect that prohibition.
Given our view, IBOP has petitioned the IHRC staff and each commissioner to have 71 IAC 8.5-1-5(8) and 71 IAC 8-1-5(8) brought into compliance with Indiana law. We also see this as another indictment of the IHRC's perpetual use of the emergency rulemaking process to avoid the scrutiny of their administrative rules and practices.
IC 4-31-12-7
Veterinarians appointed by commission; prohibition on treatment of horses on the grounds; compensation
Sec. 7. (a) A veterinarian appointed by the commission or employed by a permit holder may not, during the period of the veterinarian's employment, treat or issue prescriptions for a horse on the grounds of or registered to race at a track, except in case of emergency. A full and complete record of an emergency treatment or a prescription shall be filed with the stewards or judges.
(b) An owner or trainer may not directly or indirectly employ or pay compensation to a veterinarian who is employed by the commission or a permit holder.
As added by P.L.341-1989(ss), SEC.2.
You can find IBOP's Letter to the Commissioners at: http://ibopindy.blogspot.com/2012/11/request-to-modify-furosemide-as.html
Given the struggles with regulatory administration of furosemide in Kentucky, and the expectation that this ARCI Model Rule would make its way to Indiana, Indiana Breeder and Owner Protection, Inc. (IBOP) decided to make ‘Furosemide as a permitted foreign substance’ our Administrative Rule of the Month. In reviewing these rules, 71 IAC 8.5-1-5 (flat racing) and 71 IAC 8-1-5 (standardbred), what we found was rather surprising. We’ve copied an abbreviated version of 71 IAC 8.5-1-5 below, with specific emphasis on Subsection 8:
71 IAC 8.5-1-5 Furosemide as a permitted foreign substance
Authority: IC 4-31-3-9
Affected: IC 4-31-12
Sec. 5. Furosemide may be administered intravenously to a horse, which is entered to compete in a race. Except under the instructions of the official veterinarian or the racing veterinarian for the purpose of removing a horse from the veterinarian's list or to facilitate the collection of a post-race urine sample, furosemide shall be permitted only after the official veterinarian has placed the horse on the furosemide list. In order for a horse to be placed on the furosemide list, the following process must be followed:
(Note: Subsections (1) through (7) removed for brevity.)
(8) Medication administration. Bleeder medication shall be administered by a veterinarian licensed by the commission at an intravenous dose level not to exceed five hundred (500) milligrams and no less than one hundred fifty (150) milligrams. The executive director or stewards may designate certain official veterinarians, racing veterinarians, and/or practicing veterinarians to administer furosemide under this rule. Such designation may be determined daily, weekly, or for any other appropriate time period. Administration of furosemide shall take place in the test barn or a specific location otherwise designated by the commission. An association employee shall be present and observe the drawing of furosemide into a syringe. The administering veterinarian shall provide a factory sealed bottle of furosemide from which the draws shall be made. The association shall establish track rules for furosemide administrations that are consistent with these regulations.
(Note: Subsections (9) through (10) removed for brevity.)
(Indiana Horse Racing Commission; 71 IAC 8.5-1-5; 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; emergency rule filed May 20, 1996, 10:00 a.m.: 19 IR 2893; emergency rule filed Feb 13, 1998, 10:00 a.m.: 21 IR 2420; errata filed Oct 15, 1998, 12:39 p.m.: 22 IR 759; emergency rule filed Jun 8,1999, 9:30 a.m.: 22 IR 3123, eff May 26, 1999 [NOTE: IC 4-22-2-37.1 establishes the effectiveness of an emergency rule upon filing with the secretary of state. LSA Document #99-107(E) was filed with the secretary of state June 8, 1999.]; readopted filed Oct 30, 2001, 11:50 a.m.: 25 IR 899; 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; emergency rule filed Jul 28, 2006, 11:17 a.m.: 20060809-IR-071060278ERA, eff Aug 1, 2006; readopted filed Mar 23, 2007, 11:31 a.m.: 20070404-IR-071070030RFA; emergency rule filed Mar 3, 2011, 11:50 a.m.: 20110309-IR-071110100ERA; emergency rule filed Jan 25, 2012, 12:20 p.m.: 20120201-IR-071120056ERA)
According to 71 IAC 8.5-1-5(8), the IHRC has already granted themselves the authority to “designate” what veterinarians administer race-day furosemide; “The executive director or stewards may designate certain official veterinarians, racing veterinarians, and/or practicing veterinarians to administer furosemide under this rule. Such designation may be determined daily, weekly, or for any other appropriate time period.” By the IHRC’s own definitions, the ‘official veterinarian’ is their Equine Medical Director and a ‘racing veterinarian’ is their stable of Commission Veterinarians. A ‘practicing veterinarian,’ while not defined specifically by the IHRC, is a private practice veterinarian. So, there you have it, the IHRC can already “designate” ANY veterinarian to administer furosemide to your horse.
One issue we see with the IHRC being able to “designate” any veterinarian to administer furosemide is the ‘trainer responsibility’ rule. Both Indiana statute and IHRC’s administrative rules place sole responsibility for medication violations on the trainer as being “negligent in their handling or care of the horse.” If the trainer has no control over who administers furosemide, then how can they be held responsible for any mistakes in its administration? Generally, most racing jurisdictions don’t readily admit to or take responsibility for their mistakes. More specifically, there’s a bigger issue with this ability to “designate” what veterinarian administers your horse’s furosemide. The IHRC’s granting themselves this authority in 71 IAC 8.5-1-5(8) and 71 IAC 8-1-5(8) appears to violate Indiana law.
According to IC 4-31-12-7(a), which is copied below, veterinarians “appointed by the commission” are prohibited from treating any horse unless an emergency exists. We view the ability to "designate" a veterinarian as used in 71 IAC 8.5-1-5(8) and 71 IAC 8-1-5(8) as synonymous to "a veterinarian appointed" as used in IC 4-31-12-7(a). Clearly, administration of furosemide is providing a medical remedy, i.e. a treatment, for alleviating a condition and is not an emergency treatment. Simply, per IC 4-31-12-7(a), the IHRC cannot designate or appoint ANY veterinarian to administer furosemide to race horses and IBOP’s view is that the Indiana Administrative Code should reflect that prohibition.
Given our view, IBOP has petitioned the IHRC staff and each commissioner to have 71 IAC 8.5-1-5(8) and 71 IAC 8-1-5(8) brought into compliance with Indiana law. We also see this as another indictment of the IHRC's perpetual use of the emergency rulemaking process to avoid the scrutiny of their administrative rules and practices.
IC 4-31-12-7
Veterinarians appointed by commission; prohibition on treatment of horses on the grounds; compensation
Sec. 7. (a) A veterinarian appointed by the commission or employed by a permit holder may not, during the period of the veterinarian's employment, treat or issue prescriptions for a horse on the grounds of or registered to race at a track, except in case of emergency. A full and complete record of an emergency treatment or a prescription shall be filed with the stewards or judges.
(b) An owner or trainer may not directly or indirectly employ or pay compensation to a veterinarian who is employed by the commission or a permit holder.
As added by P.L.341-1989(ss), SEC.2.
You can find IBOP's Letter to the Commissioners at: http://ibopindy.blogspot.com/2012/11/request-to-modify-furosemide-as.html
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