With the anticipated "expiration" of medication withdrawal guidance as of April 30th, the Indiana Horse Racing Commission (IHRC) has posted two new sets of withdrawal guidelines. The first is withdrawal guidance from May 1st through May 14th with a revision date of April 30th. The second set offers guidance for May 15th and beyond which is supposed to coincide with the new regulatory thresholds for 24 therapeutic medications the IHRC established at their April 30th meeting.
http://www.in.gov/hrc/files/Medication_2014_Withdrawal_Times_1_May.pdf
http://www.in.gov/hrc/files/Medication_2014_Withdrawal_Times_15_May.pdf
One potential problem that we see is that the IHRC has a recommended withdrawal time for two therapeutic medications that were not approved for use with a regulatory threshold. Both albuterol and isoflupredone have no regulatory threshold in Indiana today, nor will they have regulatory thresholds as of May 15th. Per the IHRC, these two drugs will be considered for a threshold at their next meeting. Yet, the IHRC is advocating a withdrawal time as if there was a regulatory threshold in place already.
Albuterol and isoflupredone were added to the 'ARCI Controlled Therapeutic Medication Schedule - Version 2.1' this past month. According to that document, the suggested withdrawal guidance for albuterol is 72 hours where a regulatory threshold of 1 nanogram per milliliter of urine exists. So, why would the IHRC publish the same 72 hour withdrawal guidance when a zero tolerance level exists for albuterol under the IHRC's administrative rules? Any positive test for albuterol, even if the specific gravity is 1 nanogram per milliliter of urine or less, is a medication violation under current IHRC administrative rules. The same question can be asked of isoflupredone which has a withdrawal time of 7 days in the ARCI document, but with a regulatory testing threshold of 100 picograms per milliliter of plasma or serum. Per current IHRC administrative rules even 1 picogram, which is one-trillionth of a gram, would be considered a positive medication violation, but has the same 7 day withdrawal guidance. At this point, these two therapeutic medications would be considered a positive test at their limits of detection, which is the least amount a test can detect.
http://arcicom.businesscatalyst.com/assets/arci-controlled-therapeutic-medication-schedule---version-2.1.pdf
The IHRC's exact same withdrawal guidance as the ARCI's seems inconsistent without an established regulatory threshold. So, our plan is to ask these question to the IHRC's Medical Director and we'll post her response.
For more detail on this subject, review our article from March 28, 2014: http://www.ibopindy.blogspot.com/2014/03/ihrc-2014-medication-withdrawal-times.html
Friday, May 2, 2014
Thursday, May 1, 2014
Administrative Rule of the Month - Uniform(?) Model Rules Adopted by IHRC
Updated: May 1, 2014 at 8:24 PM EDT
According to a press release issued today by the Indiana Horse Racing Commission (IHRC), the Association of Racing Commissioners International's (ARCI) "national uniform medication rules and multiple medication violation penalties" were unanimously adopted by the IHRC at their April 30, 2014 meeting. The entirety of the press release can be found at: http://www.in.gov/hrc/files/RCI_Medication_Rules.pdf. In addition, the National Thoroughbred Racing Association is reporting that the IHRC ha adopted "all of the national uniform medication rules, penalties and testing reforms." http://www.ntra.com/en/news-media/press-releases/2014/5/1/indiana-passes-national-uniform-medication-and-penalty-reforms/#sthash.MpHuIVbr.dpuf. Given the lack of certain details being provided to horsemen, Indiana Breeder & Owner Protection, Inc. (IBOP) would like to share what's not being reported regarding yesterday's actions of the IHRC as our Administrative Rule(s) of the Month.
While only new medication thresholds are slated to go into effect on May 15, 2014 and not the entirety of the ARCI's 'Medication Restrictions' model rule, the IHRC approved the thresholds from the 'ARCI Controlled Therapeutic Medication Schedule - Version 1.0' which was adopted by the ARCI on April 1, 2013. Therefore, only the original 24 therapeutic medications will have regulatory thresholds and not the addition of thresholds for albuterol and isoflupredone added to what is now Version 2.1 adopted by the ARCI on April 9, 2014. The thresholds for albuterol and isoflupredone will be considered by the IHRC at a later date.
Contrary to current reports, the IHRC DID NOT approve the ARCI's Model Multiple Medication Violation Penalties. The IHRC's multiple medications violation rule takes a significant deviation from the model rule by making the assignment of points for a positive medication violation in Indiana an option, not a requirement as in the model rule. We see any creation of an ability for the selective application of points as weakening the concept of having a national uniform penalty system and is another step that will fuel the call for federal intervention.
In the comment period prior to IHRC's meeting, we asked the IHRC to provide details "under what circumstances points will be assigned, when points won't be assigned, and who will make those decisions." At the April 30th meeting, Executive Director Joe Gorajec attempted to explain the deviation from the ARCI model rule. While we'll provide the exact language from the official transcript on this website when available, Mr. Gorajec suggested first understanding who was involved and what any points assigned from Indiana's penalty would do to that person under the multiple medication violation penalty system was being done in "deference to horsemen." We see the ability for arbitrary assignment of points as creating an open door for legal challenges should Indiana ever issue an additional penalty based upon their newly adopted points system. The arbitrary nature of the assignment of any points is the ethical equivalent of selective enforcement when compared to the overriding goal of national uniformity.
(Please note: As part of the investigation into the Indiana Horse Racing Commission by Indiana's Inspector General in 2011, the following recommendation was made, "We also recommend the elimination or modification of the “preliminary report” procedure granted by promulgation to the (I)HRC Executive Director. 71 IAC 10-3-20(b). We found this to be the most frequent complaint in our investigation, with allegations that the increases in fines were arbitrary." The noted administrative rule in the report delegates to the Executive Director the ability to issue penalties and fines. Given that the only modification made to date by the IHRC per this recommendation was to change the name of the "preliminary report" to "administrative complaint," our confidence given the subjective and arbitrary nature of Indiana's multiple medication violation penalty system is quite low when considering any potential thoughts of consistency in its application. The full report of the Indiana's Inspector General can be found at: http://www.in.gov/hrc/files/Inspector_General_Report.pdf. Our particular reference is on page 10 of the report.)
In addition, Indiana's version of the multiple medication violation rules do not include the subsection in the ARCI model rule that allows for a trainer to petition the ARCI to expunge points received for a violation. We also pointed this out in the pre-meeting comment period, yet there was no explanation provided during the meeting. Our take on this is that any points assigned for a medication violation in Indiana cannot be appealed to the ARCI for expungement which also subtracts from the concept of having any national uniformity.
IBOP also has a concern with the IHRC's approval of a new "Sample" definition that was being passed as an ARCI Model Rule which includes the following language, "Any cleared samples may be used for research and/or investigative purposes." While no such sentence appears in ARCI Model Rules, in the pre-meeting comment period we posed the question, "why would there be a need for any "investigative purposes" from a cleared sample?" We see this as an oxymoronic sentence. Our question was never answered at the meeting nor was any information offered by a commissioner or IHRC staff member as to why this "sample" definition was even necessary, especially given that "Test Sample" is already defined in Indiana's pari-mutuel racing statute.
Currently, there is no definition of exactly what a "cleared sample" even is in the IHRC's administrative rules. Also, there is no statement within the IHRC's administrative rules that no action will be taken against an owner or trainer if the results of a primary test sample are negative. We see this new "Sample" definition as the IHRC granting itself the ability to test primary samples beyond their receipt of a notice that the primary test was negative. In essence, the definition creates enough ambiguity to allow for negative tests to be investigated further. And, to do so without prescribing the conditions (time frames, ability to witness packaging of the sample, chain of custody, etc.) under which such testing would be done. With this definition, the IHRC has granted itself the ability to arbitrarily (as usual) and to continually test a sample indefinitely beyond a negative primary sample and even beyond a negative split sample. In effect, the IHRC has granted itself the ability to do their own split sample testing without the oversight of any administrative rules and, per the IHRC's use of an emergency rulemaking authority, there will be no further regulatory or legislative oversight of this definition and its implications.
Given the lack of any additional detail provided by the IHRC staff on this definition, and based upon past experience, its our view that this new definition is designed to 'legalize' what is already being done with test samples. Only time will tell us that, however, but the lack of transparency with the intent of this definition does surely have a purpose at the IHRC.
To view the IHRC's proposed rules as well as the industry comments, including those made by IBOP, please follow this link: http://www.in.gov/hrc/files/IHRC_Packet_Agenda_Item_1.pdf. The yellow highlighted lines are changes made after the close of the pre-meeting comment period. The only modification during the meeting was changing the word "All" to "Any" in the new "Sample" definitions.
Update: The current version of the NTRA's online article mentioned above erroneously makes the follow statement, "Indiana’s regulations currently meet or exceed the RCI model rule requiring third-party administration of furosemide (commonly known as Lasix) - a key aspect of the reforms - through their longstanding Integrity Program instituted in 2006." Third-party administration of furosemide, which means administration by a commission veterinarian, was never part of the IHRC's 'Integrity '06' initiatives. The 'Integrity '06' document can be found at http://www.in.gov/hrc/files/integrity_06_annotated.pdf. The ARCI models rules actually require furosemide administration by a commission or track-employed veterinarian, and states, "Any veterinarian or vet techs participating in the administration process must be prohibited from working as private veterinarians or technicians on the race track or with participating licensees."
The pari-mutuel racing statute in Indiana only allows a commission veterinarian, a commission designated veterinarian or a veterinarian employed by a race track to treat a horse, which includes the administration of furosemide, unless there is an emergency. Here's the exact language in the statute:
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
Practicing veterinarians, who are licensed by the commission, but are private veterinarians that work for trainers and owners on the backsides of the Indiana tracks, administer pre-race furosemide. These practicing veterinarians would be prohibited under ARCI model rules to do so which actually means that Indiana's furosemide administration is substandard to ARCI model rules when compared. We are not sure how this type of misinformation or rationalization gets to the NTRA and beyond, but if this issue is "a key aspect of the (national) reforms" the IHRC has never petitioned the Indiana Legislature to modify the pari-mutuel racing statute to allow for third-party administration of furosemide.
According to a press release issued today by the Indiana Horse Racing Commission (IHRC), the Association of Racing Commissioners International's (ARCI) "national uniform medication rules and multiple medication violation penalties" were unanimously adopted by the IHRC at their April 30, 2014 meeting. The entirety of the press release can be found at: http://www.in.gov/hrc/files/RCI_Medication_Rules.pdf. In addition, the National Thoroughbred Racing Association is reporting that the IHRC ha adopted "all of the national uniform medication rules, penalties and testing reforms." http://www.ntra.com/en/news-media/press-releases/2014/5/1/indiana-passes-national-uniform-medication-and-penalty-reforms/#sthash.MpHuIVbr.dpuf. Given the lack of certain details being provided to horsemen, Indiana Breeder & Owner Protection, Inc. (IBOP) would like to share what's not being reported regarding yesterday's actions of the IHRC as our Administrative Rule(s) of the Month.
While only new medication thresholds are slated to go into effect on May 15, 2014 and not the entirety of the ARCI's 'Medication Restrictions' model rule, the IHRC approved the thresholds from the 'ARCI Controlled Therapeutic Medication Schedule - Version 1.0' which was adopted by the ARCI on April 1, 2013. Therefore, only the original 24 therapeutic medications will have regulatory thresholds and not the addition of thresholds for albuterol and isoflupredone added to what is now Version 2.1 adopted by the ARCI on April 9, 2014. The thresholds for albuterol and isoflupredone will be considered by the IHRC at a later date.
Contrary to current reports, the IHRC DID NOT approve the ARCI's Model Multiple Medication Violation Penalties. The IHRC's multiple medications violation rule takes a significant deviation from the model rule by making the assignment of points for a positive medication violation in Indiana an option, not a requirement as in the model rule. We see any creation of an ability for the selective application of points as weakening the concept of having a national uniform penalty system and is another step that will fuel the call for federal intervention.
In the comment period prior to IHRC's meeting, we asked the IHRC to provide details "under what circumstances points will be assigned, when points won't be assigned, and who will make those decisions." At the April 30th meeting, Executive Director Joe Gorajec attempted to explain the deviation from the ARCI model rule. While we'll provide the exact language from the official transcript on this website when available, Mr. Gorajec suggested first understanding who was involved and what any points assigned from Indiana's penalty would do to that person under the multiple medication violation penalty system was being done in "deference to horsemen." We see the ability for arbitrary assignment of points as creating an open door for legal challenges should Indiana ever issue an additional penalty based upon their newly adopted points system. The arbitrary nature of the assignment of any points is the ethical equivalent of selective enforcement when compared to the overriding goal of national uniformity.
(Please note: As part of the investigation into the Indiana Horse Racing Commission by Indiana's Inspector General in 2011, the following recommendation was made, "We also recommend the elimination or modification of the “preliminary report” procedure granted by promulgation to the (I)HRC Executive Director. 71 IAC 10-3-20(b). We found this to be the most frequent complaint in our investigation, with allegations that the increases in fines were arbitrary." The noted administrative rule in the report delegates to the Executive Director the ability to issue penalties and fines. Given that the only modification made to date by the IHRC per this recommendation was to change the name of the "preliminary report" to "administrative complaint," our confidence given the subjective and arbitrary nature of Indiana's multiple medication violation penalty system is quite low when considering any potential thoughts of consistency in its application. The full report of the Indiana's Inspector General can be found at: http://www.in.gov/hrc/files/Inspector_General_Report.pdf. Our particular reference is on page 10 of the report.)
In addition, Indiana's version of the multiple medication violation rules do not include the subsection in the ARCI model rule that allows for a trainer to petition the ARCI to expunge points received for a violation. We also pointed this out in the pre-meeting comment period, yet there was no explanation provided during the meeting. Our take on this is that any points assigned for a medication violation in Indiana cannot be appealed to the ARCI for expungement which also subtracts from the concept of having any national uniformity.
IBOP also has a concern with the IHRC's approval of a new "Sample" definition that was being passed as an ARCI Model Rule which includes the following language, "Any cleared samples may be used for research and/or investigative purposes." While no such sentence appears in ARCI Model Rules, in the pre-meeting comment period we posed the question, "why would there be a need for any "investigative purposes" from a cleared sample?" We see this as an oxymoronic sentence. Our question was never answered at the meeting nor was any information offered by a commissioner or IHRC staff member as to why this "sample" definition was even necessary, especially given that "Test Sample" is already defined in Indiana's pari-mutuel racing statute.
Currently, there is no definition of exactly what a "cleared sample" even is in the IHRC's administrative rules. Also, there is no statement within the IHRC's administrative rules that no action will be taken against an owner or trainer if the results of a primary test sample are negative. We see this new "Sample" definition as the IHRC granting itself the ability to test primary samples beyond their receipt of a notice that the primary test was negative. In essence, the definition creates enough ambiguity to allow for negative tests to be investigated further. And, to do so without prescribing the conditions (time frames, ability to witness packaging of the sample, chain of custody, etc.) under which such testing would be done. With this definition, the IHRC has granted itself the ability to arbitrarily (as usual) and to continually test a sample indefinitely beyond a negative primary sample and even beyond a negative split sample. In effect, the IHRC has granted itself the ability to do their own split sample testing without the oversight of any administrative rules and, per the IHRC's use of an emergency rulemaking authority, there will be no further regulatory or legislative oversight of this definition and its implications.
Given the lack of any additional detail provided by the IHRC staff on this definition, and based upon past experience, its our view that this new definition is designed to 'legalize' what is already being done with test samples. Only time will tell us that, however, but the lack of transparency with the intent of this definition does surely have a purpose at the IHRC.
To view the IHRC's proposed rules as well as the industry comments, including those made by IBOP, please follow this link: http://www.in.gov/hrc/files/IHRC_Packet_Agenda_Item_1.pdf. The yellow highlighted lines are changes made after the close of the pre-meeting comment period. The only modification during the meeting was changing the word "All" to "Any" in the new "Sample" definitions.
Update: The current version of the NTRA's online article mentioned above erroneously makes the follow statement, "Indiana’s regulations currently meet or exceed the RCI model rule requiring third-party administration of furosemide (commonly known as Lasix) - a key aspect of the reforms - through their longstanding Integrity Program instituted in 2006." Third-party administration of furosemide, which means administration by a commission veterinarian, was never part of the IHRC's 'Integrity '06' initiatives. The 'Integrity '06' document can be found at http://www.in.gov/hrc/files/integrity_06_annotated.pdf. The ARCI models rules actually require furosemide administration by a commission or track-employed veterinarian, and states, "Any veterinarian or vet techs participating in the administration process must be prohibited from working as private veterinarians or technicians on the race track or with participating licensees."
The pari-mutuel racing statute in Indiana only allows a commission veterinarian, a commission designated veterinarian or a veterinarian employed by a race track to treat a horse, which includes the administration of furosemide, unless there is an emergency. Here's the exact language in the statute:
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
Practicing veterinarians, who are licensed by the commission, but are private veterinarians that work for trainers and owners on the backsides of the Indiana tracks, administer pre-race furosemide. These practicing veterinarians would be prohibited under ARCI model rules to do so which actually means that Indiana's furosemide administration is substandard to ARCI model rules when compared. We are not sure how this type of misinformation or rationalization gets to the NTRA and beyond, but if this issue is "a key aspect of the (national) reforms" the IHRC has never petitioned the Indiana Legislature to modify the pari-mutuel racing statute to allow for third-party administration of furosemide.
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.
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.
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