What Will HISA Look Like?

We recently ran part one of our story on the challenges facing HISA. Today, we deal with lawsuits, adjudication, and more.

This time next year, the machinery of horse racing in the U.S. may be almost a month into a radical system overhaul.

But with scant few calendar pages between now and then, what do we know about how the cogs, wheels, and pulleys of the Horseracing Integrity and Safety Act (HISA) will work together?

To find out, the TDN reached out to Charles Scheeler, chair of the HISA board of directors, interim executive director Hank Zeitlin, as well as several individuals listed on HISA's two standing committees. All explained that they were unable to comment publicly at present.

U.S. Anti-Doping Agency (USADA) chief executive officer Travis Tygart was also unable to speak in person within time of the story going to print, but the agency provided answers via email.

Figures familiar with the drafting process stress the changing nature of the blueprints–cold comfort to certain state regulators and other stakeholders concerned that with so many details to thrash out, few specifics have yet been made public, especially when crucial deadlines loom large, as we detailed yesterday in part one.

In part two, we try to parse through other key aspects of the program, beginning with arguably the most salient, given recent high-profile cases in the U.S.–that of enforcement.

Lawsuits

All of these points could be moot, however, if either of the two federal lawsuits seeking to strike the law down on constitutional grounds are successful.

In March, the National Horsemen's Benevolent and Protective Association (National HBPA)–along with a variety of state affiliates–filed federal suit against the Federal Trade Commission (FTC), arguing that it affords powers to private individuals and a private organization in an area strictly limited to a government entity.

The following month, it was announced that a second lawsuit–spearheaded by the Oklahoma Attorney General in conjunction with that state's racing commission–was similarly focused on the constitutionality of the law, focusing in on the 10th amendment.

Judicial rulings are essentially pending in both cases.

Sarah Andrew

According to Frank Becker, a noted equine lawyer and former adjunct professor at the University of Kentucky College of Law, the “Oklahoma” case has a “significant chance” of prevailing.

“But what happens at the district court level will not be the final word–it's really going to be up to the court of appeals,” Becker says, speculating that either case could eventually be taken up by the Supreme Court.

If the district courts render rulings against the defendants, what might that mean for HISA's implementation on July 1 next year?

“While this case is pending, there will be this battle over whether the law will be enforceable in the interim,” says Becker, itemizing a chessboard set of scenarios made complicated by the possibility of inconsistent rulings by different courts in two different circuits.

One is that an injunction goes into immediate effect, in which case, the law would be put on the back burner until an appeals court meters out judgment–if, as would be likely, the government appeals the district court's decision.

Another is that a district court judge renders a stay on the injunction pending appeal. In this scenario, the appeal is “unlikely” to occur before the July 1 deadline, Becker says, meaning the law would theoretically go into effect.

Nevertheless, nothing is etched in stone.

Becker pointed to a potential precedent-setting scenario in a current case involving the cruise ship industry and the Centers for Disease Control and Prevention (CDC) in which the judge granted a stay on an injunction, only to subsequently withdraw it. And so, “anything could happen,” says Becker.

If the case reaches the hallowed halls of the U.S. Supreme Court, a final decision “could take years,” says Becker.

“But again, you've got the issue of, if there's an injunction in place when it goes to the Supreme Court, the Supreme Court would [likely] be asked to lift the injunction pending a decision,” says Becker. And how it might decide, he adds, “is very hard to predict.”

For the purposes of the story, however, we'll take the view the law will already be functioning a year from today.

Adjudication Process

HISA's enforcement agency serves several vital purposes, from establishing a deterrence program to implementing “anti-doping education, research, testing, compliance and adjudication,” among other duties.

Racing Post

But first, who will the Horseracing Integrity and Safety Authority–the broad non-profit umbrella established by HISA and commonly referred to as just the “Authority”–contract with to serve this purpose?

The Authority is largely expected to enter into an agreement with USADA, but the contract hasn't yet been formally inked. Indeed, according to USADA spokesperson Adam Woullard, the agency is working through the details with the Authority, “in anticipation of signing” a contract.

If, for some reason, USADA is not the contracted enforcement agency, the law instructs the Authority to enter into an agreement “with an entity that is nationally recognized as being a medication regulation agency equal in qualification” to USADA–conceivably individual state commissions.

In terms of the enforcement agency's broad remit, the processing of violations sits high on the priority list.

But which specific set of personnel will be responsible for adjudicating the first drug-related violations that arrive after July 1 next year–those belonging to the existing regulatory infrastructures within individual states or those belonging to USADA, or the contracted enforcement agency?

Specifics remain unclear. According to Woullard, USADA would “independently handle” the “investigation and results management” arm of the program.

“Independence is the cornerstone of any effective and fair anti-doping program,” he wrote. “Complementing this, education is paramount in creating a cohesive program and we look forward to working with those within the industry to help them understand and comply with the rules.”

Asked what the adjudication process might look like on a practical, everyday basis, Woullard replied that “the exact nature of how this will look is a work in progress.”

It appears, according to several individuals familiar with the process, that a tiered approach could be taken to the adjudication of medication violations, with the severity of the infraction governing which set of personnel–either the state's or USADA's–will handle the hearing.

“Extra importance could be attached to certain races and horses,” says Bill Lear, The Jockey Club (TJC) vice chairman and someone instrumental in getting the legislation passed.

Coady

Appeals

Once a violation has been adjudicated, a notice of the sanction will be filed with the FTC. The sanctioned party then has 30 days to petition for a review of the decision, which will be handled by an administrative law judge within the FTC. That judge then has 60 days to issue a ruling.

A number of stakeholders contacted for the story questioned whether the FTC has the necessary human capacity and experience to handle its expanded obligations under HISA.

“How quickly do rules and hearings move through the federal pipeline?” says Bennett Liebman, government lawyer in residence for the Albany Law School's Government Law Center.

Liebman has previously written of the FTC that it has “much bigger business to pursue than just racing,” and that it “enforces many more laws of greater consequence to the American economy than horse racing regulation.”

The FTC failed to provide a response to questions about the steps the agency has taken to prepare for HISA's implementation.

But according to Lear, the FTC has been “very engaged” with defending the two federal lawsuits challenging the constitutionality of the law.

Safety Committee

In tandem with the Anti-Doping and Medication Control Standing Committee, the Racetrack Safety Standing Committee will be responsible for establishing a uniform set of rules governing things like training and racing safety protocols that are regionally specific, crop use, racetrack surface quality standards, and a racetrack accreditation program.

What could those safety standards look like?

The safety committee is required to consider as a blueprint existing programs like the National Thoroughbred Racing Association (NTRA)'s Safety and Integrity Alliance Code of Standards, along with other comparable international programs.

“You won't see much of a sea change in most of racing,” says Alex Waldrop, president and CEO of the NTRA, pointing to tracks and jurisdictions like those in Kentucky, California, New York, and across the Mid-Atlantic region, which have in recent years implemented their own significant plans to reduce equine fatalities.

“But there are multiple states where that has not been the case,” says Waldrop.

Nevertheless, the safety measures even among the more proactive tracks and jurisdictions can vary quite significantly, and there's apprehension among respective stakeholders that the Authority's uniform safety standards won't have the same bite.

“We're pretty proud of the work we've been doing here, and we don't want to see that rolled back in any way,” says Scott Chaney, executive director of the California Horse Racing Board (CHRB), pointing to the immense political headwinds the state industry has had to withstand in recent years.

Susie Raisher

Unlike the baseline medication standards, however, the law appears to provide a certain amount of individual wriggle room in the implementation of safety and welfare protocols.

According to Lear, individual tracks–but not individual states–will have the leverage to implement stricter safety standards than that outlined by the Authority.

“That said, I think HISA is going to make every effort to work with the states to create a good working relationship, and one that doesn't back up on any safety standards,” Lear says.

State racing commissions aren't expected to be rendered redundant under the new law–indeed, the Authority will likely contract state racing commissions to enforce components of the racetrack safety program.

But whether individual tracks decide to tighten their own safety standards and protocols or not, those in charge of nailing down the specifics of the safety program have the sizeable problem of wrestling with this central question, says Liebman: Which entity, the individual state commission or the federal Authority, has exactly what responsibility?

“Do racing commissions still have the power to punish riders for improper whip use?” he says. “Who will have the power to scratch a horse for medical or welfare reasons?”

Funding Concerns

Some of the touted benefits of the new law concern improvement in racing's overall intelligence infrastructure, including greater out-of-competition testing and a more comprehensive investigatory network.

HISA also calls for the implementation of a centralized database for a variety of potential key information points, including injury and fatality data, pre- and post-training and race inspections, and inclusion on a veterinarian's list.

Coady

“We'll be able to better follow these horses wherever they are on a daily basis–we'll know what they look like a week ago, a month ago, a year ago,” says Waldrop.

But undergirding the successful implementation of any of these measures is the issue of funding–what almost everyone contacted for this story described as something of an elephant in the room.

The language of the law outlines two broad scenarios–that individual racing commissions establish a mechanism to remit fees to the Authority, or else the racing commissions permit the Authority to assess the fees for them.

How will the fees be calculated?

If a state elects to collect and remit the fees itself, it may consider “foal registration fees, sales contributions, starter fees, track fees, and other fees on covered persons,” wrote Sarah Reeves, attorney with the firm Stoll Keenon Ogden and someone who has worked extensively on building the legal architecture of the law, in an email.

If a state chooses to delegate this task, then the Authority would calculate, “on a monthly basis,” the applicable fee per racing start multiplied by the number of racing starts in the state in the preceding month, wrote Reeves.

She wrote that in the latter event, it is too early to say exactly how the Authority would decide to collect the fees, “whether on a per-start fee basis or otherwise.”

Reeves noted, however, that the law precludes a double tax. “If a state chooses not to collect fees to cover the costs of the Authority in that state, the statute precludes the state from charging members of the Thoroughbred industry any fees or taxes related to anti-doping and medication control or racetrack safety,” she wrote.

As it stands, no specific budget proposals have been publicly aired. And until more specifics are made available, states are largely hamstrung as to which fee remittance route to take, multiple stakeholders told the TDN.

What's more, like a Sword of Damocles, numerous states around the county are already embroiled in budget negotiations for the next fiscal year or two–like in Wyoming, currently in the process of thrashing out their 2022-23 biennial budget, says Charles Moore, the Wyoming Gaming Commission's executive director.

“Here we are going into a budget session and we don't know what to expect–will there be a cost, and if so, what will it be? What is the net effect?” Moore says.

Coady

The longer budget details take to concretize, the more likely are individual states to punt broader everyday responsibilities over to USADA, certain stakeholders warn.

In that scenario, does USADA have enough personnel to manage a larger-than-anticipated workload?

In answer, Woullard pointed to a recent hire in Dr. Tessa Muir, newly minted director of their Equine Testing Program.

“We will continue to recruit experts in the field and train our existing staff for the huge responsibility ahead of us,” Woullard wrote, adding that while USADA will hire additional personnel, including those with equine-specific expertise, “There is significant overlap in several areas of equine and human anti-doping, particularly in relation to doping practices, test planning and risk analysis.”

Lear, however, argues that “HISA is working hard to zero in costs,” and adds that, while “the principal driver of added costs is in out-of-competition testing,” federal consolidation and centralization will bring about efficiencies through economies of scale.

What's Next

In the meantime, some much sought-after details about the Authority could soon be available for public consumption.

On Aug. 15 at The Jockey Club's next annual Round Table Conference, Scheeler is expected to give his first public presentations on developments thus far.

According to USADA spokesperson Woullard, Tygart and Muir have also been invited to appear at the round table event.

If there's an overarching sentiment among industry stakeholders wondering how HISA will fit into their everyday operations, it's centered around caution and circumspection.

“From my own perspective, they ought to be as practical as possible getting started,” says Alan Foreman, chairman and CEO of the Thoroughbred Horsemen's Association (THA). “They're going to have to build confidence in the whole process as it's such a dramatic change.”

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Will HISA Be Ready in Time?

Part One of a Two-Part Series

If the letter of the law is any reliable prognosticator, this time next year the United States horse racing industry will already be nearly a month into what promises to be a major realignment of the planets.

With the official enactment of the Horseracing Integrity and Safety Act (HISA) on the first of July, 2022, racing jurisdictions North and South, East and West will be bound by the same medication standards, safety rules, and enforcement mechanisms–a hallelujah for many who have long championed the ouster of l'ancien regime to pave the way for national uniformity.

But with slightly more than 11 months between now and then–provided in the interim HISA successfully navigates constitutional challenges in the courts–what do we know about how this brave new world will play out on a practical level?

The TDN reached out to Charles Scheeler, chair of the HISA board of directors, and interim executive director Hank Zeitlin, as well as several individuals listed on HISA's two standing committees to discuss the practicalities of implementation. Each said that they were unable to comment publicly at present while they essentially continue to carve out the pieces of the puzzle.

U.S. Anti-Doping Agency (USADA) chief executive officer Travis Tygart was also unable to speak in person within time of the story going to print, but the agency provided answers via email.

Those familiar with some of the backroom negotiations stressed fluidity. According to USADA spokesperson Adam Woullard, the agency is “humbled and excited” to be part of racing's new governing program. “We just have to get all the details in place,” he wrote.

“This is a moving target,” says Alex Waldrop, president and CEO of the National Thoroughbred Racing Association (NTRA), who pointed out that Scheeler only officially assumed the HISA board chairmanship at the end of May. “Nothing's set in stone yet.”

Nevertheless, among many individual state regulators and other stakeholders around the country, there appears to be no small worry that in the relatively short amount of remaining time to nail down the law's working mechanics, a concerning lack of specificity has to date been made publicly available.

“You can make assumptions, you can make guesses,” says Alan Foreman, chairman and CEO of the Thoroughbred Horsemen's Association (THA). But among the industry stakeholders at large, he adds, “nobody really knows.”

Sarah Andrew

Deadlines

Wielding ultimate fiefdom over the law is the Federal Trade Commission (FTC), whose official everyday remit is to “protect consumers and promote competition.”

But practically speaking, the bulk of the work within the Horseracing Integrity and Safety Authority–the broad non-profit umbrella established by the law and commonly referred to as just the “Authority”–will be done within four main bodies.

There's the nine-member board of directors, which provides an overall governing arm to the program.

Two standing committees–the Anti-Doping and Medication Control Standing Committee and the Racetrack Safety Standing Committee–are charged with helping to establish and maintain the uniform standards within their respective arenas.

Then there's the anti-doping enforcement authority, broadly responsible for implementing and enforcing the medication control and the racetrack safety programs. It's widely believed the USADA will fill that position, though that contract hasn't yet been officially inked.

Right now, those in charge of piecing HISA together are in the rule-making process.

This necessitates the standing committees to work toward baseline rules in their respective fields, which they will then submit to the board of directors for approval. The board will then, in turn, file the proposed rules with the FTC for review, for sending out for public notice and comment, and then for promulgation.

There are some hard deadlines baked into the law. In the initial stages of implementation, for example, baseline uniform medication standards, laboratory testing accreditation rules, and racetrack safety accreditation standards will have to be put out for public comment–an as-yet undetermined amount of time.

Coady

The FTC then has 60 days from publication in the federal register to approve a proposed rule or modification.

Crucially for this initial stage, the public comment period and FTC approval needs to be completed in time for the Authority to publicly issue the new rules on or around Mar. 1 next year.

For all intents and purposes, therefore, the Authority has little more than five months to draft its initial uniform rules, says Bill Lear, vice chairman of The Jockey Club (TJC) and someone who has been instrumental in getting the legislation passed.

“I would write a big black line at the end of the year,” he says. “Most of the draft rules need to be to the FTC by the end of 2021.”

And so how far along are the committees in drafting these rules?

Current Progress

The answer is difficult to gauge, given the lack of available information.

According to several people familiar with the process, the board of directors and the racetrack safety standing committee members have conducted multiple meetings.

The committee responsible for helping to establish a baseline set of medication standards met in full for the first time only recently, on July 22.

Around the middle of July, Scheeler, Zeitlin, and Tygart addressed members of the Association of Racing Commissioners International (ARCI), giving attendees the chance to ask questions.

According to Mike Hopkins, executive director of the Maryland Racing Commission, the meeting was a useful primer, but answered little in the way of specifics.

“We've talked, but it's been very broad,” he says, adding that he and his fellow commissioners were told that “they're working on the program, and it'll be ready in early fall.”

When it comes to lingering questions about the practical implementation of HISA, there appears this main through-line: How many of the everyday responsibilities will be left to individual states and their existing regulatory infrastructures?

In that regard, the law appears to leave a fair amount of wriggle room.

It states that the Authority can delegate to a state racing commission components of the racetrack safety and anti-doping and medication control programs, “if the Authority determines that the State racing commission has the ability to implement such component in accordance with the rules, standards, and requirements” that are already established.

Sarah Andrew

According to California Horse Racing Board (CHRB) executive director, Scott Chaney, given the logistical enormity of the proposed regime change, he expects things to look like “business as usual given the strict nature of our current regulations” in California, at least during the initial execution of HISA.

Nevertheless, “I think it's fair to say I have concerns,” he says. “The devil now is in the details. And by details, I mean implementation.”

Medication Standards

From the outside looking in, the easiest issue in terms of wrangling uniformity appears to be the establishment of baseline medication standards, with the law's target aim of largely prohibiting the administration of a substance to a horse “within 48 hours of its next racing start.”

When it comes to which laboratories will be used, the law extends “provisional or interim accreditation” to a laboratory with Racing Medication and Testing Consortium (RMTC) accreditation.

“It isn't clear at this point, but we wouldn't be surprised if the Authority uses this provisional or interim accreditation at least at the beginning,” wrote Sarah Reeves, attorney with the firm Stoll Keenon Ogden and someone who has worked extensively on building HISA's legal architecture, in an email.

Nine laboratories currently employed within the industry already have that accreditation.

That said, at the granular level during this process, those responsible for drafting the new rules will have to grapple with all manner of technical headaches.

Sarah Andrew

The Authority is encouraged to use as a template the International Federation of Horseracing Authorities' (IFHA) lists of permitted and banned substances–including drugs, medications, and naturally occurring substances and synthetically occurring substances–along the IFHA's screening limits for urine and blood.

It's also encouraged to seek guidance from the World Anti-Doping Agency (WADA)'s “International Standard” for laboratories, and the ARCI's out-of-competition testing standards.

When it comes to drug classifications, the law singles out the ARCI's model rules for penalty and multiple medication violations.

One of the primary differences between the current system and the one being drafted is that the IFHAs list of controlled therapeutic substances uses screening limits for blood and urine, whereas in the States, thresholds for blood are the primary benchmarks of choice.

What's the difference?

Screening Limits vs. Thresholds

A threshold is a specified value that regulatory authorities have decided, through rigorous scientific process, is an appropriate level of a certain substance permitted in a horse's system to compete.

Unlike a threshold, a screening limit is a trigger to proceed with further analysis of a sample–indeed, laboratories will often use screening limits when testing for drugs that have established thresholds.

As the RMTC puts it, a screening limit is “a point below which a sample is declared negative and above which a sample is declared 'suspect' or 'presumptive positive.'”

If a post-race sample contains an amount of a regulated substance below the IFHA's screening limit, therefore, that sample is clear.

The various experts TDN consulted for this story explained that there's already significant harmony between the IFHA's control list of therapeutic substances and that largely used in the U.S. “For California, I don't think it's going to be that big of a change,” says Dr. Rick Arthur, recently retired CHRB chief medical officer, adding however that “there will be differences.”

For one, some of the drugs on the IFHA's control list of therapeutic substances don't have U.S. Food and Drug Administration (FDA) approval for use in the U.S., and vice versa.

Coady

The Authority, therefore, will have to establish screening limits for the substances routinely used in the U.S. that aren't on the IFHA's control list if it doesn't want a hybrid model of screening limits and thresholds.

But experts warn that time is fast running out to establish screening limits for some of the U.S.-centric substances, especially if they're going to withstand legal challenges in the event of a disputed medication positive–a likely scenario, given the industry's litigious proclivities.

“We can go to screening limits, but there's a lot of work we're going to have to do to be prepared to defend those in court,” says one expert, familiar with the process, who asked to remain anonymous.

To emphasize the legal imperative for a watertight set of screening limits, the expert pointed to the manner in which medication violations are handled by private entities in other prominent jurisdictions–like England's racing industry, governed by the British Horseracing Authority (BHA)–in contrast to HISA's federal framework.

USADA's Woullard didn't specifically address the question of whether the agency was anticipating a hybrid model of thresholds and screening limits. He did, however, point to other jurisdictions and organizations for potential plugs in the data gaps.

“For example, Racing Australia published screening limits for certain therapeutic substances, not all of which are included by the IFHA. Likewise, the EHSLC [European Horserace Scientific Liaison Committee] publish detection times,” Woullard wrote.

The creation of additional guidance on substances, “whether in the form of withdrawal or detection times,” would come through “scientific discovery” and research, Woullard wrote, adding that “we have not commenced a research program yet.”

The law strictly prohibits individual states from enacting medication standards that are less restrictive than the federal rules. But what happens if a state wants to implement a standard that's more stringent?

For example, California doesn't authorize any level of clenbuterol in a post-race sample, whereas the IFHA's screening limit for clenbuterol is 0.1 nanograms per millilitre in urine.

According to Lear, the language in the law rigidly prohibits individual states from enacting medication standards that differ from the Authority's, even if they're stricter. “It would not be allowed–it would be pre-empted by HISA under the language of the act,” he says.

Ultimately, explained USADA spokesperson Woullard, “the goal is to create a uniform set of rules across the sport that prioritized the health and safety of equine athletes, which is consistent with our human programs.”

Coming up tomorrow: All these points could be moot if the two legal challenges to HISA prevail. What are their chances? And who will pay for HISA? Read about that, along with welfare and safety, and the first public airing of the details, in part two in Monday's TDN.

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NY Aligns Clenbuterol Policy With RMTC’s

The New York State Gaming Commission (NYSGC) uninimoulsy voted to adopt two Thoroughbred-related medication rule changes at its May 17 meeting, although the exact timetable for implementation was not discussed.

Pending official adoption of the new rule, clenbuterol use in Thoroughbred racing will be regulated so it follows the model rule proposal of the Racing Medication and Testing Consortium (RMTC).

“Clenbuterol, a drug that is ordinarily used in horses as a bronchodilator to treat horses with lower airway disease, also causes a horse's body to build more muscle and reduce its fat content and has the potential to enhance performance,” NYSGC general counsel Edmund Burns wrote in a brief included in the informational packet for Monday's meeting.

Burns wrote that the newly amended NYSGC rules “would require the attending veterinarian to receive written approval [from] the Commission of a clenbuterol treatment plan for an identified horse prior to the start of such treatment. The proposal would also require that all clenbuterol administrations be reported to the Commission at the time of administration.

“The proposal would also require horses treated with clenbuterol to be placed on the veterinarian's list and not be removed until a workout for a regulatory veterinarian is performed and the horse is found to be negative for clenbuterol in blood and urine.

“In addition, horses on the veterinarian's list for clenbuterol use would be required to submit to periodic tests while on such list to ensure that no more clenbuterol is administered to the horse than necessary to complete the pre-approved treatment

regimen and to ensure that muscle-building and fat-reducing effects have dissipated before the horse is removed from the veterinarian's list,” Burns wrote.

A second rule conforms the NYSGC rules on thresholds for controlled therapeutic medications to national model rules of the Association of Racing Commissioners International, Inc. (ARCI).

“ARCI modified the model rule thresholds for three drugs (detomidine, omeprazole and xylazine) based on developing research,” Burns wrote. “ARCI also added to the list of thresholds amounts for another four routine therapeutic medications, three of which are antihistamines (cetirizine, cimetidine and ranitidine) and one of which is a muscle relaxant used in anesthetic protocols (guaifensin). The thresholds are consistent with New York's existing restricted time periods. Trainers who comply with such restricted time periods will be assured of not violating such thresholds.”

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