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.
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