Q&A with HISA’s Lisa Lazarus: Part One

Last week, an important piece of the Horseracing Integrity and Safety Act (HISA) puzzle was slotted into place when the Horseracing Integrity and Safety Authority's board of directors announced that Drug Free Sport International (DFSI) had been selected as the enforcement agency for the Anti-Doping and Medication Control (ADMC) arm of the program.

DFSI has helped administer drug testing programs to a slew of human sports organizations, like the National Football League, NCAA, National Basketball Association, Ladies Professional Golf Association, the PGA Tour, NASCAR and Major League Baseball.

Last week's announcement included a new wrinkle in the enforcement side of the ADMC program: DFSI will establish the Horseracing Integrity and Welfare Unit (HIWU), led by a five-member advisory council.

To discuss DFSI's newly minted role within HISA, the evolving shape of the ADMC program and implementation of the safety program on July 1, TDN spoke with HISA CEO Lisa Lazarus. The following has been edited for brevity and for clarity.

TDN: Why did you choose DFSI as the enforcement agency over some of the other possible organizations touted?

Lazarus: The first and most compelling reason is that they have a tremendous amount of experience in drug testing and test planning. As you would know by now, they handle all of the drug testing for the NFL, for the NBA, for Major League Baseball, NCAA, PGA Tour, NASCAR. They really have a wide range of experience, and they've operated in some really very challenging circumstances.

There's going to be a heavy lift, right, to get this all done by Jan. 1. [But] the amount of testing in horse racing is going to be at around the level of what [DFSI are] doing right now, if you add all their testing together. They do more human testing than any other agency in the U.S.

Sarah Andrew

The reason why I was also really impressed with them and convinced that they could make it happen is that around the time that COVID began–and a lot of these testing agencies realized that without sport they'd be really challenged, sort of economically–was [DFSI] quickly dovetailed to COVID testing. They very quickly launched a very good and effective COVID testing program that helped bring a lot of the major sports back into operation. What they were able to show us about how they made that happen in a relatively short timeframe, how successful it was, was one of the things that convinced us that they'd be up for the job.

The other thing was the value proposition. Ultimately, it's the industry that's funding HISA, and so, we want to be sure that whatever money we're spending, we're spending efficiently and wisely. That there's a good value proposition there. We felt that they did. And they also embraced the concept that we had to create this Horseracing Integrity and Welfare Unit, which I modeled after very successful international units, like the Athletics Integrity Unit, Tennis Integrity Unit. It's been the new wave in the last five or so years, and I really love the idea of trying to make that happen for horse racing. They've shared that vision and we're happy to get behind it and support it.

TDN: The Horseracing Integrity and Welfare Unit–this five-member advisory council–what is their role exactly?

Lazarus: So, the way that it's working is that HISA has entered into a contract with the Center for Drug Free Sport, and the Center for Drug Free Sport is creating this Horseracing Integrity and Welfare Unit. There are a couple reasons why we're doing it this way.

One is the horse racing testing business essentially is so big that it really requires, we believe, its own separate entity and its own sort of separate business model. Also, DFSI did not have sufficient existing expertise in some of the areas that we required to run the program effectively…

TDN: Which areas are those?

Lazarus: Those would be prosecutions, like result management–they didn't have an existing legal staff to carry those prosecutions out. Just take a step back for one second. It's very unusual for the testing agency to also do the prosecutions–[DFSI are] not doing that for other clients. That's something we have to build separately. We [also] wanted to put a lot of resources into investigations and they didn't have sufficient in-house resources for investigations.

So, by building this integrity unit, it's allowing us to hire and bring people in that have expertise in those areas.

TDN: You've said the new unit will require 32 employees to do everything from lab accreditation to results reporting, investigation and education. So, those 32 employees will fall under the remit of the Horseracing Integrity and Welfare Unit?

Lazarus: Correct. While some of those employees are existing Center for Drug Free Sport employees that will move over, it's going to be a separate unit that operates on its own. The advisory council is essentially like a smaller board that has the expertise in each of these different pillars to help guide the full-time employees.

TDN: But ultimately it's DFSI who will sign off on whatever the advisory council suggests?

Lazarus: Yes.

Sarah Andrew

TDN:  How far along are you in getting that 32-strong workforce together?

Lazarus: I would say we have about half of the key people and I expect in a couple weeks from now, we'll have all of the top people identified and agreements reached with them.

To hire the more junior workers below might take a little bit more time, but we don't expect those to be as difficult to fill–[those are] people that you need to execute the testing, some regional directors and all that. That might take us another few weeks after those two weeks, but I'm confident we're going to have everyone in place by the end of the summer.

TDN: Do you have an idea of cost?

Lazarus: If you saw the budget that was made public, you would see that there's about $5 million to $6 million in anti-doping startup costs for 2022, which also includes some tech costs, because there's various apps, things that we're going to need to build. For 2023, we don't have those costs yet because part of what we want the advisory council to help us decide is the optimum level of tests.

There are three categories of tests in horse racing. We have your out of competition, you have your TCO2 for milk shaking, and then you have regular race-day testing. We have some research and some ideas of what those numbers are optimally, but that's part of what the advisory council is going to help us decide. It'll also involve some determination around what's the right amount of money to spend on investigations. That's part of their role.

TDN: With less than two months to submit the ADMC rules to the Federal Trade Commission (FTC), specifically, what parts of the materials that U.S. Anti-Doping Agency (USADA) has put together will DFSI use?

Lazarus: Something like 90%. I mean there's only 5%, 10% where we're actually going through to make sure that we haven't missed anything, that everything is fit for purpose.

TDN: Will DFSI take a binary approach to regulating medications like USADA outlined with primary and secondary substances? Or will it look more like the Association of Racing Commissioners International (ARCI) model rules' alphanumeric system?

Lazarus: It'll be 100% only based on the [World Anti-Doping Agency (WADA)] code system, right? You saw the drafted rules and proposed rules that were based on a WADA code philosophy structure but were modified to be sensible for horses. So, that's essentially what it's going to look like. It will not be the ARCI model rules. There are some things in the ARCI model rules that are working really well, that we're going to borrow and integrate, but the system itself is going to be a WADA-based system, philosophically.

TDN: How far along are you in putting together the regulated therapeutics list?

Lazarus: That is something we hope to have together by the end of the summer. That's not something that's going to be subject to review.

TDN: Not?

Lazarus: I'm sorry, we're not going to be ready to release that list when we release the [ADMC] rules for public comment. But everything [ultimately] has to be approved by the FTC. I didn't mean to suggest that wasn't the case.

Coglianese

TDN: Some industry stakeholders have voiced concern about transparency aspects of the USADA materials. For example, “A” sample results aren't necessarily going to be made public until the “B” samples are returned. Is that something DFSI will address?

Lazarus: Yes, that's something that we're still discussing. We recognize how important transparency is. I come from the International Equestrian Federation and their system is to publish as soon as the A sample results are available. They're published unless it involves a minority, so a child, basically. That's a system I personally favor, but we're still evaluating what the right system [is] going to be for this program.

TDN: What laboratories will be used come Jan. 1? Will DFSI bring in its own set of labs?

Lazarus: No. So, the way the system is built is to allow for some fluidity so that we don't have any problem to be up and running January 1st. The law actually provides that any lab accredited by the RMTC [Racing Medication & Testing Consortium] will have a one-year provisional accreditation while we start accrediting the labs. There are nine labs that are currently accredited by the RMTC.

TDN: Does the variance in testing capability between those batch of labs pose any legal liability under this uniform banner?

Lazarus: You raise a really good question. That's something that is going to be a part of the program, which is the harmonization piece. We're going to require the labs to be harmonized, so that they [ultimately] reach agreement where screening limits are consistent from lab to lab once they're reaccredited. It would not be a success if labs had different levels of positive test assessments. If the levels or the testing had any discrepancies, that wouldn't be optimal, obviously, so that's something that we're going to work very hard at achieving.

TDN: How quickly are you hoping that harmonization process to occur?

Lazarus: Obviously as soon as possible. That's not my area of expertise. We have Dr. Larry Bowers [former chief science officer at USADA], who's going to be our resource in that regard. I don't know off my head, but obviously we're hoping to work toward it quite quickly. And we also hope that with a smaller number of labs that are accredited, that will be something achievable [without] a whole lot of difficulty or challenge.

TDN: You had talked before, prior to DFSI coming on board, about the whereabouts program being phased in over time. Is that still the case?

Lazarus: Yes, we're looking at the optimal whereabouts program. It's something that we hope we'll be able to get off the ground fairly quickly. The question is: Given that most horses are stabled at the race tracks, what does a whereabout system really need to be?

A horse that needs to be available for testing [within] several hours notice, we need to know where the horse is. But we've realized, and as we've thought through this, that for the vast majority of horses, we already have that information. So, it's going to take us a little bit of time to figure out what the best program is, but we do expect to have one within the first couple years.

Coady

TDN: 5 Stones intelligence (5Si) is going to be bought on board as an investigative body. What layers of transparency will surround the investigative work that 5 Stones does to make sure that that work will hold up legal scrutiny?

Lazarus: The first thing I'll say is that the reason why we thought it just made a lot of sense to involve 5 Stones–and they were eager to be supportive–is that there already are entities like The Jockey Club [and] The Meadowlands that have spent considerable amount of funds to have 5 Stones investigate actors in racing. So why wouldn't we want to take the benefit of their knowledge, their research, their information base to help us?

From my standpoint, with regards to the Horseracing Integrity and Welfare Unit, our job is not to prosecute actors, or to make sure things stand up in court. The way that we'll use the investigative resource is to try to help us figure out who the cheaters are and what they're using and when to test them and for what. And that's how we'll mostly use the investigative resource.

Obviously, if they're used for prosecutions, I think they're fairly capable and also experienced at making sure that evidence is strong. But for us, it's really about getting the information that allows us to test in a way that's really efficient.

If you test humans, horses, anyone without that investigative resource, you usually have about 1% to 2% hit rate in terms of positive tests. When you use investigative resources, that goes up to 15% to 20%. So, it's a huge difference.

TDN: It's been discussed how a centralized database could be used to identify outliers, potential cheats and whatnot, as well as to help with the safety side of things. How far along is that database from being fully built and operational?

Lazarus: In one way we're far along and one way we're not far along at all.

We've already started the process of registering horses, so the database is live, it's available. If you go to our website, you could register yourself and your horses. But we don't have a huge body of data yet because the registration processes just started in the last couple of weeks.

However, come July 1, if you want to participate in the covered horse race, which is in any horse racing jurisdiction that exports their signal, then you'll have to register with us. So, we expect, in a few months, to have a very considerable database. Then we'll let the veterinary experts help us figure out how to use it in a way that's going to help horses, help keep everyone safe.

TDN: Do you have a rough date with which you'd like to see something really substantive up, a close approximation of an ideal end goal for this database?

Lazarus: I think a year from July 1 [2022]–which is our deadline [for implementation]–we'll be in a position to really have the data that we need to perform the sort of analysis that we think will make a difference. Two or three years down the line, it'll be even better.

Note: Part two of this Q&A will encompass the working relationship between the Authority and DFSI, media criticisms of the new enforcement agency and potential problems when HISA launches in less than two months. 

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Unable To Reach Final Terms: Horseracing Integrity And Safety Authority Suspends Negotiations With USADA

The Horseracing Integrity and Safety Authority (HISA) announced the suspension of negotiations pertaining to USADA's potential future role as the independent enforcement agency for HISA's Anti-Doping and Medication Control (ADMC) program. As mandated by the Horseracing Integrity and Safety Act of 2020, USADA and HISA had been engaged in good faith negotiations but were unable to reach final terms. To date, USADA has led the process of authoring draft rules for HISA's ADMC program. As set forth in the HISA statute, the Authority is evaluating options for engagement with other leading independent enforcement agencies.

The draft Racetrack Safety regulations that were submitted to the FTC earlier this month will be implemented as scheduled by the FTC on July 1, 2022, following review, public comment and education periods. There will be a temporary delay in submission of the Anti-Doping and Medication Control draft rules to the FTC until a new independent agency can be identified and an agreement finalized. This will allow HISA and another independent enforcement agency to reach an agreement and build on the progress that has been made to-date with USADA. HISA anticipates this process will permit the full implementation of the final ADMC rules in early 2023.

“We are deeply grateful for USADA's hard work, expertise and leadership in working with HISA's Anti-Doping and Medication Committee to develop comprehensive draft rules in a remarkably short period of time,” said HISA Board Chair Charles Scheeler. “HISA will continue our search for an independent enforcement agency to oversee the Medication Control protocols. The Authority will also work with the FTC to ensure the Racetrack Safety Program advances on schedule. When operational, the program will provide critical enhancements to protect the health and safety of equine and human athletes.”

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Q&A with USADA’s Dr. Tessa Muir

Last month, the United States Anti-Doping Agency (USADA) announced that in Dr. Tessa Muir, it had plucked from foreign shores a new hire to head its equine program at a time when the agency plays an integral role in implementing the Horseracing Integrity and Safety Act (HISA), overhauling the industry's governing status quo.

Before Muir joined the USADA staff roster, she had hopscotched her way up the industry ladder, from exercise rider to private veterinarian to head of the British Horseracing Authority (BHA)'s anti-doping program between 2013 and 2019. Her last position was as a regulatory veterinarian in Australia, for Racing Victoria.

Currently in the process of earning a master's degree in sports law, Muir faces an even tougher task in bringing to life the enforcement arm of racing's new regulatory framework. That's because there's much to do within a worryingly short amount of time.

Though the official implementation of HISA is set for July 1 next year, a baseline set of uniform rules–medication standards, laboratory testing accreditation rules, and racetrack safety accreditation standards–need to be squared away by the end of the year in order to meet tight administrative deadlines.

What's more, it's still unclear exactly who the enforcement agency will be when the law goes into effect. “No final agreement on USADA's involvement as the enforcement agency is currently in place,” Muir said, in a video presentation for the recent The Jockey Club Round Table Conference.

For her part, Muir tipped her hat during the Round Table to the “enormity of the task” ahead of her, saying that “USADA and myself personally are absolutely committed to our role in the inception of HISA, whether that ultimately sees USADA running the program, or contributing its expertise to the development of harmonizing rules and best practices in anti-doping.”

The Horseracing Integrity and Safety Authority–the broad non-profit umbrella established by the law and commonly referred to as just the “Authority”–is expected to unveil important program specifics at an unspecified date this fall.

To try to elicit some details before then, the TDN this week sat down with Muir. The following has been edited for brevity and clarity.

Coady

DR: What's your initial takeaway from these first few weeks on the job? 

TM: I actually started with USADA in April, so, I've been working with them for a while. The first month here [in the U.S.] has been a little bit of a whirlwind getting settled into a new country.

I've been really excited and encouraged by the engagement we've had with the people we've spoken to. Of course, we've started working with the Authority and their anti-doping and medication control committee, and then, I spent a week in Saratoga leading up to the Round Table, spending time with their state commission vets and the racetrack vets.

We've had our head down working really hard to deliver on some of the other things we need to. There are some challenges that are not unsurmountable if everyone works together and collaborates.

DR: Okay, so when it comes to HISA, given how we don't yet know who will run the enforcement arm of the law, what can you tell industry stakeholders looking at the ticking clock and worrying about the current lack of available specifics?

TM: As I've alluded to, we've got our heads down working really hard with the Authority to develop a set of rules. As you'll have heard, with what the chairman of the Authority [Charles Scheeler] said, the intention is that they'll be ready for socialization to the industry this fall.

HISA passing is the first component of it. The development of these rules and regulations is the second part. Then [comes] the specifics for USADA, and USADA becoming the enforcement agency.

I think we're all keen to get there ASAP. Of course, the rules go into effect on the first of July next year. But as you and the industry can appreciate, there are a number of things to work through given the expanse of the program for it all to come together.

Coady

DR: How well placed is USADA to manage what would appear a significant increase in testing volume, even if it's just in an oversight role? Does it have the necessary personnel?

TM: The intent is not to totally reinvent the wheel. There are good practices in place that can be leveraged. We will look to utilize existing infrastructure–for example, in testing barns where it's possible.

I think something else that comes into the mix is how technology might play a key role in running the program. To some extent, when you look at USADA's team, they've begun to expand the team to administer the program. But certainly, there's going to be a need for people who can leverage the existing structures.

DR: When it comes to HISA's approach to the public reporting of testing, what can we expect? Will there be greater transparency concerning all horses who are tested and not just the positives, for example? How will you approach the reporting of out-of-competition testing?

TM: There's a need for transparency in competition–for race day and in the out-of-competition component. If you look at USADA's history, they've been huge advocates for transparency and for sharing testing data.

If you look on their website, you can search for an individual athlete and see how many times they've been tested in a year or in a quarter, which I think is a really positive thing.

On the equine side, we definitely want to publish testing data. I think there's a balance–you want to publish and be transparent to the point it doesn't compromise the integrity of the independent testing program you've got in place.

DR: Are you able though to talk about what you think may be made public?

TM: It's probably a little too early to delve into specifics. There are things we've discussed with the Authority. If you take USADA's example of what there is with human sports, you can search any individual athlete by name, and you can see how many times they've been tested within that breakdown.

You can also look to other racing jurisdictions where they already publish some of this data, such as in Racing Victoria. After the race day, they publish a report on what horses got tested, pre-race and post-race.

Coady

Without saying we've landed on a specific final picture of what it might look like, I think that gives you a nice example of where there are standards already set where we can look and say, 'Where can we expand on that to give the public transparency?'

Note: Click here for USADA's athlete test history database.

Click here for an example of a Racing Victoria post-race day stewards' report.

DR: You said in your Jockey Club Round Table presentation that it'll take a while before USADA's “gold standard” anti-doping infrastructure will be implemented. What kind of timetable are you envisaging?

TM: We've got the first July deadline for next year. We need a program in place that's robust and covers the essentials. One of the big bits are the rules that need to be in place to get that uniformity. Looking forward, maybe it'll take 18 to 24 months to reach that gold standard of our independent program.

You've got to look at developing laboratory standards and their capabilities, the intel and investigations of course take shape over time, and a smart testing program similar to what USADA use in their human world–you've got to develop that data to drive that forward. And again, we'll be looking at technology as one of the key components to finesse that program.

As is the case with the human program, things never stand still. We work hard every single day to continually improve and adjust and refine the program.

DR: You use that 18-month timeframe. On a very practical level, what tangible differences can industry stakeholders expect to see between implementation on July 1 next year and then 18 months from then?

TM: The real tangibles you'll see on day one is the uniformity in the rules and some of those basic interactions and processes.

The development is still to be determined in many ways–as much as we can get in on day one the better. But of course, things like the smart testing program and refining how you select horses for testing, and the things you learn as you collate and collect data, it will of course evolve over that period of time.

Getting all the laboratories to a baseline and then developing that side of it–that's probably not the front-facing side of it, it's probably the development and the refinements behind the scenes.

The labs are really good ones to look at because developing new methodologies, investigative equipment and all that kind of stuff, takes time, and so, we're looking at: What do we need on day one for the program to function as a robust program? And then, how can we look to develop that going forward?

Coady

DR: Anti-doping deterrence costs money, and I think it's fair to say the financial component is of central concern to most stakeholders. What specifics can you share about what they can expect when it comes to costs, and specifically anti-doping deterrence and prevention costs?

TM: I think that's slightly two questions. The prevention and deterrence side is multi-factorial. It's not an isolated area. We've got education, out-of-competition no-notice testing, tip lines and investigations.

It's not an expensive cost per-se developing those rules and having those consistent results management arbitration processes–sanctions that deter those bad athletes. That covers deterrence and prevention as a whole.

On the question of the cost, that's probably the number one question that everyone asks. I think one of the challenges at the moment is that there's not any one currently accepted understanding of what the total cost and total amount currently being spent is. So, getting a handle on that is quite difficult to know: How is it going to be more expensive, and by how much?

As the chairman alluded to at the Round Table, he said publicly that they anticipate the costs are going to go up, and of course, that's to be expected for an enhanced and more effective program of the scale we're looking at here.

It's a comparatively small investment–I'm not saying it's necessarily a small amount of money, not to belittle the amount–but a comparatively small investment in protecting the fairness of clean racing for all our horsemen and obviously the health and welfare of the horses and the longevity of the sport in the future.

As far as what the actual dollar amount is, as [Scheeler] said, that's still being worked on at the moment. It's hard not having that really clear-cut number on what's currently being spent. There's money being spent in a lot of different areas currently.

DR: When it comes to the everyday adjudication of medication violations, Jockey Club vice chairman Bill Lear told me recently there'll likely be a tiered approach in the beginning, with the severity of the infraction governing which set of regulatory personnel–either the state's or USADA's–will handle the hearing. Could you elaborate on that?

TM: From a top-level look at it, the results management and adjudication process will come under the banner of the enforcement agency, so assuming that is USADA, USADA will be responsible for any of the anti-doping rule violations that occur.

As [Lear] alluded to, certainly looking at a tiered approach for that. The specifics will be made a lot clearer when the socialization process happens with the industry.

Sarah Andrew

DR: Obviously, a key issue with the current status quo is the glacial pace at which violations are adjudicated. Do you see a scenario whereby that process is expedited come July 1 next year?

TM: The intention is to have a streamlined process, but of course, there is the [matter] of due process, and that's something that is probably better answered by someone [in the] legal [department]. Obviously, we have a legal team at USADA that deals with the human side. The processes and the streamlined nature of that will become more evident when the arbitration procedures and the rules are socialized in the fall.

DR: One of USADA's big selling points is its educational programs for human sports. What will HISA's education outreach look like for racing? And how will you make sure everyone in the sport–irrespective of language barriers–gets access to the necessary information?

TM: You've made a great point that the education component of any anti-doping and medication program is a foundation to the success of the program.

There's a variety of ways to actually deliver that information in an effective way. Something we'll be looking to is a level of education in place ahead of the first of July 2022, because people will need to understand what the new requirements are. And of course, some of that will be developed beyond that.

The point about language is a really good one. That's something we're cognizant of as we look to start developing and creating education materials, ensuring that those people who need to be communicated with, and to engage with the process, can do so.

There are a lot of parties beyond just the trainers and the grooms who touch these horses on a day-to-day basis, and therefore, we want to be in the best position possible to give people the tools to comply with the rules.

DR: Have you started putting these materials together?

TM: Specific materials? No. First of all, before you can design educational materials, we need rules that we can educate people on. And so, at the moment, it's not our number one priority.

But as far as concepts and looking at good ideas–I've certainly done a few of the USADA education tools online to get an idea of some of the things that might be great to leverage.

Read part one and part two of our recent series digging down into the particulars of HISA.

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ARCI to Hold Meeting on Medication Policies

The Association of Racing Commissioners International Drug Testing Standards and Practices Committee will conduct its next meeting Monday, Apr. 12 to assess the regulation of certain medications included on the RCI Controlled Therapeutic Schedule (CTS). The meeting agenda, materials and registration link can be found on the Meetings page of the ARCI website https://www.arci.com/meetings-events/. The meeting may also be viewed later on the Horse Racing Integrity ARCI YouTube Channel.

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