California First to Sign Voluntary Agreement, Pay HISA 2023 Fees

The Golden State is the first jurisdiction in the country to sign a voluntary agreement with the Horseracing Integrity & Welfare Unit (HIWU) to continue performing a host of vital roles when the Horseracing Integrity and Safety Act's (HISA) drug control program goes into effect Mar. 27, according to a statement Friday by the California Horse Racing Board (CHRB).

In another first among the nation's racing jurisdictions, the CHRB also agrees to pay HISA's 2023 fee assessment. The total figure for the state is more than $6.7 million. However, after HISA's credits have been applied, the final amount that California owes HISA comes out to roughly $1.5 million, according to the voluntary agreement.

“The CHRB has been enforcing and complying with safety regulations that HISA introduced July 1, 2022. Under the new agreement, the CHRB will implement rules under the Anti-Doping and Medication Control (ADMC) Program, which are scheduled to go into effect March 27, 2023,” the CHRB's Friday statement read.

Under the voluntary agreement–shared by CHRB executive director Scott Chaney with TDN–the CHRB agrees to continue performing certain tasks for the HISA Authority and for HIWU, including the collection of equine samples, and the testing of these samples at the University of California, Davis's Kenneth L. Maddy Equine Analytical Laboratory.

In turn, U.C. Davis's “Maddy Lab” also becomes the first laboratory to officially sign onto HIWU's drug testing program.

Because state racing commissions and their respective industries already pay for many of HIWU's anti-doping and medication control program components, HISA is offering credits as subsidies to its annual fees.

According to California's voluntary agreement, the commission's total “state testing credit” will be $4.7 million. This includes some $1.2 million for sample collection and $3.5 million for laboratory costs such as race-day testing, research, and the analysis of samples from other states.

California also receives an additional out-of-competition testing credit estimated to be around $450,000 annually.

“If the costs for out-of-competition testing outside of Race Day pursuant to this Paragraph exceed $450,000 at the end of 2023, the Commission will receive an additional credit for 2024 in the amount of the excess costs,” the voluntary agreement reads.

“The CHRB is proud of our work and record in safety and animal welfare, and therefore we want to have a role in shaping policy going forward,” said Chaney in the statement issued Friday. “We have partnered and supported the national effort from the beginning and appreciate the dedication of the Authority and HIWU.”

The CHRB's statement adds: “The CHRB and representatives of the Del Mar Thoroughbred Club, 1st Racing, the Thoroughbred Owners of California, and UC Davis have been advising HISA all along, promoting California's strict regulatory program, and partly for that reason the federal rules are similar to those in California, meaning participants in California horse racing will need to make fewer adjustments than some of their counterparts in other racing jurisdictions.”

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HIWU’s Scollay: New Medication Rules ‘Your New Bible’

Despite all the legal jockeying these past few weeks and months, the Horseracing Integrity and Safety Act's (HISA) anti-doping and medication control program still appears set for launch on Jan. 1 in the vast majority of states that conduct pari-mutuel wagering.

This means on the first day of 2023, thousands of trainers, veterinarians and other backstretch workers must grapple with a new set of rules guiding how and when to administer a set of everyday medications–the list of which can be found here–to avoid falling foul of a post-race and out-of-competition positive.

Is there much of a difference between the Association of Racing Commissioners International (ACRI)'s current therapeutic medication schedule and that as outlined by the Horseracing Integrity and Welfare Unit (HIWU)?

Turns out there is–one that, in short, boils down to the differences between the current world of withdrawal guidelines and thresholds, and the looming system of detection times and screening limits.

“There is a substantial difference and if the terms are used interchangeably, there is a profound risk of a medication violation,” warned Mary Scollay, chief of science at HIWU, established by Drug Free Sport International.

Some of the key points as Jan. 1 looms large:

 

  • Detection times do not necessarily provide an accurate medication withdrawal guide;

 

  • New screening limits will require different administration protocols;

 

  • There will be no enforcement “grace period” for stakeholders to adjust.

 

  • This different medication schedule will require adjustments well before Jan. 1;

 

Withdrawal Guidelines vs. Detection Times

Traditionally, withdrawal guidelines are based on administration studies with a “statistically derived margin of safety built in,” said Scollay.

“The idea is that if you follow the administration protocol described in the study–dose, route of administration–and you comply with the withdrawal guidance,” said Scollay, “you should have a high degree of confidence that you will not have a medication violation.”

In other words, withdrawal guidelines provide a reliable cut-off point to administer a medication to avoid post-race positives.

This is in contrast to detection times under HISA, calculated through studies on a group of horses administered a certain medication.

These horses are then tested to determine the earliest time the drug is eliminated from all the horses' systems–a level below either the lowest concentration identified by the laboratory or below a defined screening limit.

This means that detection times “do not have any margin of safety calculated in,” warned Scollay. “It is the starting point for determining a withdrawal interval. So, the burden for establishing an appropriate withdrawal interval for medication now lies exclusively with the horses' connections.”

In any of these given studies, for example, the horses may metabolize drugs at different speeds–and potentially quicker than a racehorse given the same drug at the same dose.

Studies with a very small cohort of horses–like hydroxyzine, with a detection time of 96 hours from a study with only two horses–provide another reason why detection times can provide a very thin margin of error.

Imagine a study testing a doorframe set at six feet, explained one regulatory veterinarian. If the study participants are all under six foot, no problem. But what about all the six-foot plus individuals not studied?

For practicing veterinarians accustomed to concrete withdrawal times, therefore, this constitutes a sea-change in the way medications can be safely prescribed and administered to avoid costly post-race positives.

“There's no easy answer to this,” admitted Scollay. “I fully understand what a philosophical change this is, and yes, I understand that the vets can feel like they're flying blind right now.”

Aim of Schedule

Aside from a select few substances–like electrolytes, orally administered vitamins and anti-ulcer medications which can be administered up to 24-hours before a race–there is a mandatory 48-hour restricted administration time for all controlled medications.

For a number of these routine controlled medications, the dosage, withdrawal time and stipulated threshold in the current ARCI schedule are the same as the dosage, detection time and screening limits outlined by HIWU.

But where these differ, the differences might be subtle, easily over-looked. The ARCI's phenylbutazone threshold is 0.3 micrograms per millimeter, but is 0.2 micrograms per millimeter under HISA, for example–a small change with significant implications when it comes to its use in the days prior to a race. What's more, Scollay is unable to provide veterinarians and horsemen with specific withdrawal numbers. “HIWU and HISA are not in a position to provide withdrawal guidance,” she said. “I cannot say, 'I think you're going to be fine if you back out to 82 hours.'”

Things can get even trickier when HIWU provides zero dosage, detection time and screening limit guidance on a drug listed on the controlled medication list. But that doesn't necessarily mean veterinarians and trainers are indeed “flying blind.”

The corticosteroid betamethasone has no dosage or detection time listed, but it comes with a Restricted Administration Time (RAT) to race of 14 days (7 days for a work).

The Non-steroidal anti-inflammatory drug (NSAID) diclofenac–commonly found in a topical ointment to treat swelling and inflammation–similarly has no listed dosage and detection time.

As Scollay explains, that's because the process of calculating elimination times in an ointment–and therefore, one routinely applied in wildly different amounts to different parts of the body–is extremely difficult.

But this underscores, she said, the overarching aim of the new medication schedule–to foster a more conservative approach to veterinary medicine.

If diclofenac is used to treat a problematic joint, said Scollay, “from my perspective, once you've got that joint quieted down, I think you'd still want to assess that horse's response to treatment and assess the horse's recovery by breezing him.

“And so, you're not talking about ceasing treatment on a specific joint that has been inflamed and problematic going into a race in three days.”

In other words, if a topical diclofenac ointment is being used to treat certain musculoskeletal problems, then racing probably shouldn't be on the horse's imminent agenda, said Scollay.

Clearance Testing

More broadly, there's a very rough rule-of-thumb when it comes to calculating withdrawal times. One is that a short detection time is typically indicative of fast elimination from the system, said Scollay.

“But if something takes 96 hours to clear, I would be more conservative because I know it clears slowly,” said Scollay, speculating that “if I add just 24 hours onto that, I may not have allowed enough time for it to clear.”

But perhaps the most accurate guide for veterinarians and trainers concerned about a positive test, said Scollay, would be to conduct “clearance testing” well before race-day–a service provided through HIWU.

“We'll collect the sample from the horse, and then send it to the laboratory that's doing the testing. The trainer would have to provide information about the treatment, the drug, the dose, the frequency–when it was halted,” said Scollay.

It's not a free service, however.

“I don't know what that fee is yet,” Scollay added. “That would be paid for by the horse's connections.”

Importantly, the new controlled medication rules are primarily germane to post-race testing, not HISA's out-of-competition testing program, which is largely focused on banned substances.

That said, the new rules prohibit the presence of more than one NSAID or corticosteroid in both post-race and post-work samples–a prohibition designed to nix the practice of “stacking.”

HIWU's new common controlled medication list provides secondary detection times for three common NSAIDS, to help avoid a stacking offense.

Enforcement

Though the new drug rules might prove a marked change from the current status-quo, don't expect an enforcement grace period for stakeholders to acclimatize to their new regulatory expectations.

“The regulations don't provide for it,” said Scollay, categorically.

So, what are some of the implications for a positive of a controlled substance? An outline of the sanctions can be found here.

The majority of post-race positives are for everyday therapeutic medications–like phenylbutazone, a class C controlled drug, a first time positive for which would result in a fine of up to $500 and the automatic disqualification of the horse.

Which leads to another question: Who will be held responsible in the event of a positive?

The ultimate-insurer rule places the burden of responsibility on the shoulders of the trainer. But in the language of the law, there appears to be room for the veterinarian (and perhaps others) to be similarly held culpable.

As Scollay describes it, such a scenario would be case-specific. “The facts of the case would have to determine who else might be complicit,” she said. “To be fair, if it's an overage of a medication one would say, 'well, the vet didn't administer that without the trainer's knowledge and consent.'”

And so, when should veterinarians, trainers and others start applying these new controlled medication rules?

Given the 14-day stand down on all intra-articular injections–along with a 15-day detection time for the NSAID firocoxib–Scollay recommends familiarization with, and application of, the new rules as soon as possible, to avoid regulatory consequences come Jan. 1.

In other words, if trainers and veterinarians are deciding on withdrawal decisions after a horse is entered to race after Jan. 1, “they've waited too long,” said Scollay.

“I think more important is for veterinarians and trainers to review the document together and develop a shared approach to interpreting detection times,” she said. “And there is no time like the present for that.”

Education

Between now and Jan. 1, HIWU will apparently be releasing educational materials aimed towards regulatory and practicing veterinarians, and the trainers themselves.

Another intended event, said Scollay, is a webinar with a noted European veterinarian to explain how detection times and screening limits translate in Europe, where they've been in effect for much longer. Scollay was unable to provide details about then that might be, however.

The Racing Medication and Testing Consortium (RMTC) can act as an information intermediary, said Scollay, who added that industry stakeholders can contact her directly with any drug-related questions.

She also recommends printing off HIWU's controlled medication list—once again linked to here–before laminating and pinning it to the barn wall.

“I've been using the 'L' word every chance I can get. Laminate it, put it on your clipboard. Give them to your staff. That's your new bible,” Scollay said.

“There's no easy answer to this other than be more conservative and be more cautious of medication than you have been,” she said. “And ask yourself, 'does this horse really need it?'”

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No Matter Which Way HISA Goes, CHRB Confident on Rules Consistency

Despite a near-term national forecast clouded with uncertainty over last week's United States Court of Appeals order declaring the Horseracing Integrity and Safety Act (HISA) to be unconstitutional, California Horse Racing Board (CHRB) commissioners on Tuesday expressed confidence their state will be able to weather the projected turbulence over HISA's in-limbo legality better than other jurisdictions.

The reason, according to staffers and commissioners who spoke during the Nov. 22 monthly meeting, is that the CHRB has been proactively advancing safety and medication rules for the past few years, and a number of those regulations eventually got adopted as models for HISA rules.

So if or when an expected mandate for HISA to cease operations gets handed down by the Fifth Circuit on that mandate's Jan. 10 due date, the CHRB will essentially just go back to relying on a similar, in-state framework of rules that aren't too different from HISA's.

“We've been participating with HISA. We've been supporting them. We will continue to do so until told otherwise,” said the CHRB's equine medical director, Dr. Jeff Blea.

But, Blea added, “It's nice to know [that] in all actuality, HISA's safety program and medication rules are not that far different from where California is.”

Mindful that a Pandora's box of varying legal and political scenarios could still affect the future of HISA between now and when HISA's Anti-Doping and Medication Control rules go into effect Jan. 1, the CHRB voted 4-0 on Tuesday to opt in to the 2023 voluntary implementation agreement that encompasses national oversight by both the HISA Authority and the Horseracing Integrity and Welfare Unit (HIWU), which will enforce the new drug rules.

“Just to clarify, HISA medication rules go into effect Jan. 1, and the court [mandate] is Jan. 10. So those 10 days for sure, we're operating under the medication rules of HISA,” said chairman Gregory Ferraro, DVM. “And then, depending on what [a higher-court ruling or a legal stay or Congressional action] is, we go from there.”

Blea described to commissioners how he was in attendance at the annual convention of the American Association of Equine Practitioners (AAEP) in San Antonio, Texas, on Nov. 18 when news first broke about the HISA unconstitutionality ruling.

Blea said the convention was “fully staffed” with HISA Authority executives at that time, including HISA chief executive officer Lisa Lazarus and HIWU executive director Ben Mosier.

“Thirty minutes prior to the start of the meeting the announcement came out, so it was just a little bit of everybody [being] on their heels,” Blea said. “Their approach was, 'We're moving forward, we're pressing on, we'll discuss these issues with veterinarians and the veterinary community.'

“So right now it's 'business as usual,'” Blea continued. “Everyone's seen what's in the mainstream press, and it's an attorneys' field day. As it stands now, from a medication standpoint, we'll be under HISA rules for 10 days [in 2023] depending on what the courts rule. Same thing with the safety standards.”

Blea noted that even as the AAEP convention unfolded amid the legal blow to HISA, the CHRB was repeatedly referenced during a keynote address for being ahead of the curve on equine safety and welfare initiatives.

And during the professional meet-and-greet portions of the convention, Blea said he repeatedly had his brain picked by colleagues who wanted advice on how to introduce CHRB-styled reforms in their home states.

Amanda Brown, the CHRB's staff counsel, offered a legal perspective on HISA's possible path forward–or what happens if that entity is forced to shut down. She noted that a separate Court of Appeals case over HISA's constitutionality has arguments pending Dec. 7, this time in the Sixth Circuit.

“So there is a chance that the judge there rules [that HISA is] constitutional [and] we have two competing decisions,” Brown said. “Ultimately, I expect they'll ask the Supreme Court to review it.”

But in the meantime, Brown said, “Everything from HISA says that they're still going to roll out the Anti-Doping and Medication Control program Jan. 1 [and] HISA has indicated that they are going to exhaust every avenue to either get a stay or a reconsideration before that time. So it's kind of up in the air what's going to happen.”

Prior to the unanimous vote on the issue, Ferraro asked Brown is there was any legal downside to opting into the HISA and HIWU agreements in the event that those entities do get shut down. According to the HISA budget, California's financial assessment for 2023 is $7,344,139.

“I can't speak to the [CHRB's] payment portion of that, but no, the agreement would be void and there would be nothing for us to enforce,” Brown said. “We'd go back to our California rules, pre-HISA. Which for us, is probably easier than other states.”

Cynthia Alameda, the CHRB's deputy executive director, picked up on the topic of assessments where Brown left off.

“We're collecting payments currently for the first assessment [that covered the final six months of 2022],” Alameda said. “They're coming in a little bit behind, so I don't think that it would be difficult for us to kind of regroup and ensure that all of our stakeholders didn't pay any fees that were unnecessary.

“So I don't think there is any negative in entering into the agreement,” Alameda continued. “It also gives our stakeholders an opportunity to come back in December to present how they would like to fund the assessments. They did it through market access fees on the first assessment, so I'm sure they would need to present that to us as well, just so we're ready in January if everything goes forward.

“If HISA [being] unconstitutional [was upheld], we would cease collecting funds,” Alameda said. “I don't know what would happen with the ones that have already been paid for the first six months, because it was kind of to handle the setup costs, so I don't think those would be recouped. That's just me guessing, though.”

Blea added at a different point in the meeting that there is one difference in the CHRB and HISA rules that he is actively trying to address before it becomes an on-track issue in 2023.

“The confusion for veterinarians is detection time versus thresholds,” Blea said. “The [HISA] detection times are based on a European model. So I'm going to recommend people push their medication administrations back further, and I'm in the process of doing some calculations and trying to figure it out to give them some information proactively to avoid any problems.”

The four CHRB commissioners voting unanimously for the HISA opt-in were Ferraro, Oscar Gonzales, Damascus Castellano and Brenda Washington Davis.

Commissioners Dennis Alfieri, Wendy Mitchell and Thomas Hudnut were absent from the meeting.

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Who Bears Compliance Responsibility if WV Can’t Hire HIWU Vets?

Facing a dire shortage of veterinarians at the state's two Thoroughbred tracks and under deadline pressure to decide whether to enter into a voluntary implementation agreement with the Horseracing Integrity and Welfare Unit (HIWU) prior to that entity's Jan. 1 start date, the West Virginia Racing Commission (WVRC) on Monday pressed a representative of HIWU for clarity on who, exactly, will bear responsibility if the minimum required number of equine drug testing employees can't be hired within the next six weeks.

It took some polite but persistent questioning by commissioner J.B. Akers to get an answer to that question. But Alex Waldrop, the recently retired National Thoroughbred Racing Association chief executive who now works as an advisor to HIWU, eventually conceded that “the burden right now is on HIWU.”

Akers had wanted assurance that West Virginia's racing wouldn't be subject to a shutdown if neither the commission nor the tracks could fill the federally required positions related to the coming of HIWU, an overarching national concern that has ramifications beyond just Mountaineer Park and Charles Town Races.

“I have a hard time believing that we're alone on this issue,” Akers said. “If it's only a few jurisdictions that's one thing. But if it's a substantial number of jurisdictions [that can't meet the staffing statute], I think that frames the issue a little differently.”

HIWU is the entity that will operate HISA's anti-doping program. HISA creates the rules HIWU will enforce.

In October, the WVRC, like racing commissions other states, was notified of the details of the combined agreements that HISA and HIWU want racing jurisdictions to either accept or decline prior to the Jan. 1 implementation date. Commissions and/or tracks have already been assessed costs for the 2023 operations of the two programs; if states opt-in to the agreements and pay some of the costs up front, their assessments will be reduced.

Joe Moore, the WVRC's executive director, said his state is already operating under a modified 2022 agreement with HISA on its racetrack safety program. He explained that he would like the proposed combined 2023 HISA and HIWU agreements split into two separate ones because the safety standards are a “much smoother agreement to extend [but] I believe the HIWU agreement is going to be a much heavier lift.”

At a time when the hiring marketplace is fierce nationwide and Mountaineer and Charles Town already find it difficult to obtain veterinary help, Moore stated it would be next to impossible for West Virginia to go out and hire at least 12 new people to work in drug testing oversight, which according to the incoming HIWU rules must consist of at least one veterinarian, a veterinary technician, a test barn supervisor, and five assistants at each track.

“I will tell you that neither of West Virginia's two test barns are anywhere close to this minimum,” Moore said.

“At Charles Town we have a vet supervisor who conducts our blood draw, two full-time assistants for urine collections, and a part-time assistant. Charles Town has one vet that does the pre-race and nightly card at the same time. We do not have a dedicated vet for the test barn, and we do not have a licensed vet tech,” Moore said.

“At Mountaineer Park, you have a licensed vet tech and three [per-diem] vet assistants for urine collection. Mountaineer Park has one vet for pre-race and nightly racing and no vet dedicated to the test barn,” Moore said.

Moore said one idea could be for the WVRC to staff the positions as best as it can, then ask HIWU to “fill in the gaps” while rebating the state for the positions West Virginia pays to cover.

“Or HIWU may take the stance of, 'You don't have enough [staff]. We're going to take over the whole operation,'” Moore postulated.

Another option, Moore said, would be to see if HIWU would be amenable to compromising on some of the required test barn positions by reducing or eliminating them.

Waldrop said that third option isn't likely to happen: “I don't think there is much, if any, leeway in [eliminating] the individual positions that need to be filled on a daily basis at West Virginia racetracks.”

But Waldrop did add that, “I do think that a cooperative effort between West Virginia and HIWU is the best way to go forward here. But I can't deliver that today. I can't promise that will be the case.”

Akers asked Moore if it would even be possible for the WVRC to post the jobs, interview candidates, perform background checks, and hire and train them prior to the Jan. 1, 2023, deadline.

Moore replied, “Commissioner, this couldn't be done by January of 2028. The racing commission does not have the funding to hire 12 additional personnel on a full-time basis.”

Willing and available veterinarians, Moore added, “don't exist out there right now.”

Waldrop explained that HISA and HIWU could assist with hiring by tapping into the resources of Drug Free Sport International, which has been hired to build HISA's independent Anti-Doping and Medication Control enforcement agency.

But while technicians and specimen collectors can be more easily trained to do their jobs, Waldrop admitted that, “The veterinary aspects are the most challenging. And I can tell you that HIWU is well aware of that, and they've been aware of that for some time. That's probably the biggest hurdle that they see in the near term. And they certainly intend to be prepared on Jan. 1.”

Waldrop continued: “Vets are hard to come by anywhere in the country right now, though, so I'm not going to sit here and say West Virginia is entirely unique. Equine vets [who are] familiar with the racetrack, that's a challenge. But it's one that HIWU has accepted, and they are confident that they can meet it.”

Akers then again prompted Waldrop to clarify who'd be held responsible if that didn't happen.

“Is it going to be HIWU's position, if, you know, that the state of West Virginia is out of compliance and it's our fault this didn't happen?” Akers asked. “Or is HIWU going to take responsibility and say that [the WVRC] made reasonable attempts and couldn't find the personnel to hire?  Or is our racing jurisdiction going to be allegedly out of compliance with the statutory scheme, and therefore threatened by you with regard to whether we're even allowed to race or not?”

Waldrop replied that, “At this point in time, 'Who's out of compliance?' is an issue we could debate. But I think from the industry standpoint, it's HIWU's intention to be up and running and prepared to go Jan. 1.”

Waldrop continued: “One of the challenges you have in West Virginia [is] that you don't have the budgetary resources to hire these individuals…and I respect [and] understand that. HIWU doesn't have that challenge. HIWU has the financial resources to hire these people. So it's one of those hurdles that can be overcome because HIWU has that ability…. HIWU is part of Drug Free Sport, which is an international organization which has massive resources, financial as well as personnel, that they can draw upon.”

Akers said that it was his understanding that HIWU, HISA and Drug Free Sport don't currently have any regulatory veterinarians on staff.

“You're correct,” Waldrop answered. “You're focusing on exactly the right point, which is the challenge here is reg vets. The other positions we will provide. The reg vets are the challenge.”

But Akers still hadn't received a direct answer to his compliance question, so he respectfully but emphatically asked a third time if West Virginia was at risk of having its racing shut down over not having the required HIWU hires in place.

“I don't think that last scenario is going to occur, sir,” Waldrop replied. “HIWU will work with HISA, and do their level best to keep racing going in West Virginia without interruption to provide the staff that's necessary…So I would say to you that the burden right now is on HIWU to be prepared on Jan. 1.”

Akers said he appreciated that answer, adding that while he understood that Waldrop isn't a HIWU executive, he did want the minutes of the meeting to reflect that the HIWU advisor had articulated that “the burden should be presently on HIWU to make sure that these requirements are implemented by Jan. 1 to the extent that those are their mandates.”

In light of a long list of questions that Akers said he still had about entering into a voluntary HIWU agreement for 2023, Waldrop offered to set up a conference meeting in about two weeks between HIWU's executive director and general counsel and any interested West Virginia racing stakeholders and commission members.

The commission ended up taking no action on Monday on either opting into or out of the HISA and HIWU agreements for 2023.

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