Getting Down to the Science of It All In Medina Spirit DQ Appeal

FRANKFORT, KY – After a brief private meeting between attorneys and the hearing officer to discuss “confidentiality” matters, the Kentucky Horse Racing Commission's hearing addressing trainer Bob Baffert's appeal continued, slowly but surely, on Wednesday in Frankfort, KY.

While Tuesday's session focused on the KHRC's medication rules, along with those established by the industry's Racing Medication and Testing Consortium (RMTC) and the model rules of the Association of Racing Commissioners International (ARCI), the center of interest Wednesday was the corticosteroid betamethasone itself.

The day started off with Dr. Heather Knych, a professor of clinical veterinary pharmacology and head of the pharmacology section at the K.L. Maddy Equine Analytical Pharmacology Laboratory at the School of Veterinary Medicine at the University California, Davis. She provided her testimony via Zoom (from California) as an expert witness.

Called to the stand (virtually) by KHRC general counsel Jennifer Wolsing, Knych spoke to her area of specialty in equine pharmacology, with special interests specifically in studying drug metabolism, anti-inflammatory drugs, pain management and emerging threats. Knych explained that she has studied the effects of drugs on performance horses for nearly 15 years and has had several studies focused on corticosteroids published.

Wolsing asked Knych to explain what betamethasone is, what the effects of it are, and made note of the longevity of its effects in a genomic sense. Along that line of questioning, the KHRC's Medication Classification Schedule was pulled up as an exhibit, as Knych was asked if she agreed with betamethasone being listed as a Class C medication.

“I agree with its classification as a Class C medication. Based on the description, it's an FDA approved drug, it's a therapeutic agent and it has moderate potential to affect performance. [It] could potentially mask a lameness or injury and fits nicely with the other medications in this category,” said Knych, who also serves on the RMTC's Scientific Advisory Committee.

When asked if the administration of the drug matters in terms of measuring its impact, she replied, “I don't think it matters. The drug is the drug. Once it gets in the system, that's what we're looking at, [what it does] once it gets in the body and its effect.”

Diving deeper into the specifics of betamethasone and corticosteroids in general, Knych discussed the effects of various cortisol levels, how that is measured, and the overall picture when it comes to how the concentration of a drug in the horse's system correlates directly with the effects of the drug. Wolsing presented various published studies on the topics at hand during this time, including some that Knych was involved with herself. Some of the studies focused on betamethasone, while others centered around the effects of dexamethasone, a comparable drug that is also listed as a Class C medication.

When asked if the health and safety of the horse is part of the focus in equine pharmacology work, Knych said, “The primary reason corticosteroids are so tightly regulated is to eliminate the potential to affect performance, the potential to mask [things such as] lameness.”

Knych also acknowledged that there is potential of masking underlying health issues when using higher amounts of betamethasone.

However, when it came to the findings from the studies presented, Knych did say, “We don't know the end pharmacological effect of betamethasone in the horse.” She also said there have been no studies done specifically on the effects of betamethasone in horses when administered as a topical ointment.

During this time, Wolsing cited the KHRC's case with trainer Graham Motion in 2015, involving a stewards' ruling after a horse he trained that raced was found with too much methocarbamol in its system, to show that the commission has a right to regulate in situations where there is gray scientific area with regard to medication. Craig Robertson, an attorney for Baffert, argued against its relevance when discussing the systemic effects of corticosteroids.

Motion claimed he followed the RMTC guidelines for withdrawal but was still flagged, which is a similar claim from Baffert in terms of what happened with Medina Spirit's post-race result that revealed a betamethasone overage, which ultimately resulted in the colt's disqualification from his victory in the 2021 GI Kentucky Derby.

Robertson, who was part of the KHRC case involving Motion in 2015, believed the case was being mischaracterized and stated, “The case says that you have to have a rational scientific basis for what you do.”

Wolsing also asked Knych if the route of administration of the drug has any bearing on the effect of the drug once it is in the horse's system. She replied, “No. It depends on what the concentration of the drug is regardless. I'm talking about the concentrations at the end, when we still see suppression of cortisol.”

In one of her final inquiries, Wolsing stated, “Medina Spirit was administered approximately 45 milligrams of Otomax from a bottle over a period of about Apr. 9 and going through Apr. 30, the day before the [2021] Derby.” She followed up asking Knych what the impact of that would be on the horse.

“I don't think we can say one way or another. We don't have the science to say one way or another,” she replied.

Her response was met with audible satisfaction from Baffert's legal team, who took over from there, as they continued to argue that the KHRC's medication rules lack detail and scientific backing, specifically when it comes to administering betamethasone in the form of a topical ointment.

The cross-examination of Knych, conducted by Baffert's attorney Joe DeAngelis, delved into the inexactness of the science in the studies of and testing for betamethasone, along with how long it takes for betamethasone to leave a horse's system–intended to enforce that the 14-day withdrawal period established by the KHRC was unreliable.

The RMTC's Controlled Therapeutic Substances Monograph Series was also brought up, as DeAngelis asked if Knych recalled discussing or hearing any discussion about the ethics and safety of topical use of betamethasone. She said she hadn't. When asked if there had been any recommendation from the RMTC specifically on a stand-down period for topical use of corticosteroids, Knych replied, “No.”

DeAngelis also referenced RMTC's Position Statement on Corticosteroids, a study published in 2013, which showed that the use of topical corticosteroids was known to RMTC at the time the findings were published.

When asked if she approved of the 14-day stand-down period, Knych replied, “Yes,” and admitted she did not recall any discussion of recommending it to be longer.

Knych's time as a witness, which lasted nearly 3 1/2 hours, ended with some final questions from Wolsing and a few remaining questions for the sake of clarification from DeAngelis.

Wolsing asked, “Could a much higher concentration affect a horse's health and safety?”

“Potentially yes, but what those levels are, I don't think we necessarily know that yet,” said Knych.

After a 45-minute lunch break, members of the media were asked to leave the conference room as lawyers met behind closed doors to discuss what hearing officer Clay Patrick, a Frankfort attorney, called “proprietary information.”

The hearing addressing Baffert's appeal to get his already served 90-day suspension and a $7,500 fine removed from his record, along with reinstating Medina Spirit's victory in last year's Kentucky Derby, continues Thursday at 9 a.m. and is expected to roll over into next week, starting Monday, Aug. 29.

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Sports Betting Regulatory Association Announced, HISA Discussed at ARCI Conference

LEXINGTON, KY–The Association of Racing Commissioners International (ARCI) announced the official launch of the Sports Betting Regulators Association (SBRA) during the closing session of the group's 88th Annual Conference on Safe Horses and Honest Sport.

ARCI president and CEO Ed Martin explained that the formation of the SBRA has been in the works for several years and was organized to meet a growing need to support government agencies assigned with the responsibility of regulating sports betting within their jurisdiction. Sports betting in America continues to expand and has now been legalized in 33 states.

“With some of the sports that people are allowed to wager on, there is no transparency,” Martin explained. “The states have a responsibility to ensure that everything they allow people to wager on is on the up and up. It's a new era and it's an area that horse racing regulators have tremendous experience in. The world has changed in these past couple of years and there's a need. More and more states have gone into the business of regulating sports betting.”

The goal of the SBRA will be to ensure standards and best practices are set in place to promote integrity and transparency in the sports betting field. Martin said that the SBRA will function as an autonomous committee of the ARCI that will be open to all sports betting regulatory entities, including those that are not existing members of the ARCI. SBRA policies will emulate the rules and standards established already by the ARCI in horse and greyhound racing.

“This is an expansion of what the ARCI will work on,” Martin said. “We will not lessen what we do on the horseracing side in any way. The perception is that we're part of the racing industry, but the reality is that we serve the general public. Based on the integrity concerns that are going on in human sport, and when you look at the comparison of what is done in horse racing in regards to transparency of officials and anti-doping, it's that transparency that provides consumer protection for the public that is wagering on and supporting these sports.”

Martin said that the SBRA will conduct its first meeting on July 10 in Boston in conjunction with the National Conference of Legislatures from Gaming States.

Also during Wednesday's session of the ARCI conference, Ben Liebman, a Government Lawyer in Residence at Albany Law School, examined the pending federal court challenges to the Horseracing Integrity and Safety Act.

Liebman looked at the two court cases that have challenged HISA–the federal lawsuit filed by the state of Oklahoma in April 2021 and another lawsuit filed by the National Horsemen's Benevolent and Protective Association (NHBPA) that was dismissed in March 2022 when U.S. District Court Judge James Wesley Hendrix said that while the Court recognized that HISA pushes boundaries of public/private collaboration, the law as constructed stays within the current constitutional limitation.

Liebman said that one of the main issues regarding the case of HISA's constitutionality is the question of to what extent the Horseracing Integrity and Safety Authority is subordinate to the Federal Trade Commission (FTC).

Liebman used an example comparing HISA and the FTC to the Financial Industry Regulatory Authority (FINRA) and the U.S. Securities and Exchange Commission (SEC). FINRA, a private, self-regulatory authority that regulates 624,000 financial brokers, is overseen by the SEC. Liebman explained that before a rule created by FINRA goes into effect, the SEC must approve that rule. The SEC's ability to control and supervise FINRA makes FINRA constitutional.

“You have a very strong belief that because of how FINRA has worked, HISA's authority should have the powers that are accorded FINRA,” Liebman said. “This issue becomes a matter of if the Authority controls racing regulation or if it is controlled by and subordinate to the Federal Trade Commission.”

Liebman added that while the FTC can review and approve rules set forth by HISA and can suggest modifications, it cannot promulgate rules itself and has no power over authority members and their terms. This prompts the question of if the FTC has sufficient authority over HISA. In the NHBPA case, Judge Hendrix said that based on how the law is currently written, HISA is subordinate to the FTC because only the FTC can approve its rules and because the adjudicative process does satisfy due process.

Another question that could come forward in the current court cases concerns anti-commandeering, meaning that Congress cannot take over a state's governing apparatus and force it to do its bid. Liebman said the court must determine if HISA would cause states to lose their ability to fund their racing integrity programs and if it would strip law enforcement agencies into federal service via mandatory cooperation. Liebman admitted that this issue alone will likely not lead to a total invalidation of HISA and its power.

Liebman listed several changes that could be made to HISA to help it defend its constitutionality including ending the mandatory cooperation clause, giving the FTC power over Authority member terms and the ability to remove members, giving the FTC greater authority over rules or even the ability to promulgate rules itself, and making all or nearly all Authority members unaffiliated with the racing industry.

“Even if the higher courts change the concepts of delegation and public control of private regulatory power, it's hard to envision that most of HISA cannot be salvaged because it is so much like FINRA,” he said. “It is unimaginable that a court ruling would take a wrecking ball to the current system of financial regulation in the country. Maybe the Authority doesn't always win and maybe it won't get what it wants, but it is likely that it will get what it needs.”

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HISA Under Discussion at ARCI Conference’s Tuesday Session

LEXINGTON, KY–The Horseracing Integrity and Safety Act (HISA) was a popular topic of discussion on Tuesday at the Association of Racing Commissioners International's (ARCI) 88th Annual Conference on Safe Horses and Honest Sport.

Early in the day's session, a panel was held on the potential legal issues that could arise with the implementation of HISA. John Roach, HISA's general counsel, joined panelists Nolan Jackson and Joel Turner of Frost, Brown, Todd, LLC.

The first issue examined concerned HISA's possible qualification as a Federal Advisory Committee Act (FACA), a federal law that places special emphasis on open meetings, public involvement and reporting. The legal implications of if HISA does qualify could mean that its authority would be required to give advanced notice of its meetings and make meetings available to the general public. Jackson said that HISA's authority appears to have taken the position that FACA does not apply.

“It's important to note that HISA has not complied with the Federal Advisory Committee Act, at least not up until this point in time,” he explained. “Perhaps that is because FACA is fairly narrow in scope. It only applies to advisory committees that are established by law or utilized by the federal government  in some way. It only applies to federal advisory committees that exist to provide advise or recommendations to the federal government, generally meaning the President or a federal agency of some kind.”

The second issue put forward during the panel focused on the six-month limbo period later this year concerning HISA's anti-doping and medication control policies.

While HISA's Racetrack Safety Program is scheduled to go into effect on July 1, 2022, yesterday HISA CEO Lisa Lazarus said they will be making an announcement about an agreement with an enforcement agency for the Anti-Doping and Medication Regulation Control (ADMC) program by next month and hope to launch the program on January 1, 2023. While she said yesterday that until then, states would continue with their own oversight, several legal questions were brought up in the panel regarding potential issues that could arise for state regulators.

“I think we have a couple different issues here,” Turner said. “First, HISA has not promulgated the rules yet, so you [regulators] are scratching your heads and asking what happens after July 1. Second, there's a statement [within the act] of exclusive and independent jurisdiction that would seem to raise the question about whether or not you can continue to regulate on a state-by-state basis.”

Turner emphasized HISA's burden to create a detailed anti-doping and medication regulation program in the short period since Congress passed the bill enabling HISA in December 2020.

“Under the circumstances, I think it's very understandable why we haven't gotten to the point where we have medication and anti-doping rules,” he said. “They're very complex to begin with and to get consensus on those rules can be very challenging. I'm looking at it from the perspective of an owner or trainer that is charged with a medication violation after July 1. What is the lawyer going to tell them about how he can defend that case? In this instance, we really have a gap.”

“The problem is that the authority's jurisdiction as defined in the act is really broad,” Jackson later added. “The act talks about national, exclusive, independent jurisdiction on the part of the authority. It leaves little room for states to think about what they're left to address. I think that while HISA has taken the position that states are able to continue enforcing their rules beyond July 1, there is an expressed preemption clause in the act, albeit specific, that could be an obstacle if this were to come up in litigation.”

While Jackson and Turner expressed their opinion that there was a definite gray area for regulators regarding anti-doping and medication regulation within the later half of this year, Roach said he believed the matter was much more clear cut, stating that HISA has taken the position that they will not preempt until they act.

“As it relates to the preemption issue, the text in this statute is pretty clear to me,” he said. “We do not preempt your laws until we promulgate regulations that are approved by the Federal Trade Commission. If we have not promulgated, you are free to continue to do what you are doing.”

Roach used the example of regulations regarding the riding crop to explain further. On July 1, HISA standards regarding the riding crop will go into effect because they are addressed in the Racetrack Safety Program. Other issues concerning safety on the racetrack that are not addressed in HISA's new regulation–in his example he mentioned drunkenness on the backside–will be left for the states to take on themselves.

Roach pointed out the advantages for state regulators once the ADMC program does go into effect as cases begin going through HISA's appeal system.

“When we talk about cases in the news for drug violations that have gone on for over a year, once HISA is up and running, the state courts have no more role,” he explained. “We will have a consistent approach and from a legal standpoint, you're not going to have to worry about injunctions in all different kinds of state courts. The one assurance I can give you, whether it's with lawsuits filed or any kind of legal issue, we are hiring the best that we can find to help us make sure we can implement this act in a way that can be defended at every point because we know how important it is to this industry.”

Roach later added that if an issue does arise in a state before January 1, 2023, HISA and possibly the Federal Trade Commission would be available to extend their assistance.

Later in Tuesday's session Steve Keech, HISA's Technology Director, gave a presentation on HISA's database registration process. The database is in the works now but has no set launch date. It will include data on horses and industry participants involved in 64 different racing-related occupations.

Keech gave an overview on how an owner will register within their system and he also explained that the system will link with other databases such as Equibase and InCompass Solutions. The database will include information on every horse in the system, from their current location and vaccination record to when they were last on a vet's list.

The 'Q and A' section of Keech's session led to much discussion on what this data would be used for and what would happen if an individual did not register. Attendees raised questions regarding how grooms would know to register, noting the current challenges behind getting backside workers appropriately licensed. They also asked who would be a responsible if a groom did not register.

Lazarus jumped in to explain that their authority is aware of and working through these issue. She said HISA will soon be launching a communication campaign to spread the word and that they have already asked several jockeys for help in advising on how to make the registration process user friendly. Lazarus explained that the program will also be offered in Spanish and said that no one will be responsible if an individual is not registered, instead it will become a question of whether or not they will be able to participate and be allowed onto the backside.

The ARCI convention continues April 13 with several presentations including an analysis of the pending federal court challenges to HISA.

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Opening Session of 2022 ARCI Conference

   LEXINGTON, KY – The Association of Racing Commissioners International (ARCI) hosted the first day of their 88th annual conference on Safe Horses and Honest Sport on Monday, April 11 at the Griffin Gate Marriott in Lexington. The three-day event is held in conjunction with the meetings of The National Racing Compact and The Horseracing Integrity and Safety Authority.

ARCI President Ed Martin opened the first session, emphasizing that racing currently sits at a crossroads in the sport's history with the impending implantation of the Horseracing Integrity and Safety Act.

“We are going through a massive change in the regulation of the sport in general,” he said. “We have a responsibility ultimately to the general public, secondly to the industry and sport that everyone in this room loves and in many cases comes from, and we have a moral responsibility to these wonderful animals that are the cornerstone of our sport.”

Martin introduced speaker Liza Lazarus, the CEO of the Horseracing Integrity and Safety Authority (HISA), who spoke on the current state of HISA and implored regulators that to “give us a chance” as they begin to put their regulations into action.

“The industry is facing pressure from the public and from owners, trainers and riders [asking] where is this industry going and what we can do to make it the best version of itself,” she said. “I know that all of you who work for state racing and gaming commissions are on the front lines regulating and doing good work. We are not coming in to say that your work isn't good work, instead we want to take it further and really focus on uniformity.”

She noted that there is much for racing to do in order for it to catch up with other sports in terms of uniformity.

“Our mission it to make the sport safer for horses and jockeys and to provide consistency and clarity around rules and consequences for racing participants,” Lazarus said. “Above all else, we must adhere to our mission of enhancing equine safety and the integrity of the sport. We believe that national uniform standards will benefit all participants who want to play by the rules and we approach the creation and implementation of the rules with a spirit of collaboration with the industry.”

The start date for HISA's Racetrack Safety Program is July 1 of this year. Lazarus said this program will have a significant impact on equine safety by establishing national standards for racetrack accreditation, expanding veterinary oversight, enhancing claiming rules, setting surface maintenance and measurement standards, collecting nationwide data and conducting research on medications, treatments, injuries and fatalities.

At the end of 2021, it was announced that HISA Authority was unable to reach an agreement with The United States Anti-Doping Agency (USADA) as an enforcement agency for the Horseracing Integrity and Safety Authority. Lazarus said to expect an announcement next month regarding an anti-doping control program, which will likely start in January of 2023. Until then, the states will continue with their own oversight.

Lazarus also discussed the economic impact that will come with the implementation of HISA.

“The cost allocation model approved by the FTC [Federal Trade Commission] accounts for the number of starts and the purse levels per start in each state to ensure that costs are distributed fairly and equitably across the board. We're going to work diligently to make sure that we use efficiencies and minimize costs. We are looking for supplemental funding to help the industry bear the cost of these rules and regulations.”

She continued, “The promise to you is that at HISA, we are going to do our very best. We really want this to work. We love this industry, we care about the horse and we recognize that many of you have spent your lifetime in this industry. We're going to do our best to get it right and our philosophy will always be to collaborate. Our one ask in return is that you would just give us a chance. We are going to do our very best to get it right, but we are going to make mistakes and we're going to have to look at things over again because this has never been done before. I ask that you give us a chance to get it right and that if you have a criticism, you tell us and give us a chance to fix it so we can work together. There's not going to be positive change unless it is done as an industry.”

Robert Lopez, Chair of the Washington State Horse Racing Commission and outgoing Chair of the ARCI, also spoke via teleconference about HISA in the opening session of the day, but pointed out that he had hoped a closer relationship could have developed already between the ARCI and HISA.

“We see many exciting possibilities to improve upon the good work that we collectively do,” he said. “But we also see how missteps and missed opportunities might make it more difficult for the industry and those in it to survive in the highly-competitive marketplace. During my tenure, we offered to help guide HISA through the maze of various state governments. We offered our best advise on how to make this all work, but [this advise] was often ignored. Perhaps it was the enormity of the challenge they face and the fact that almost all involved have never done this before. They are certainly within their rights to do so, but to ignore the wisdom of those who understand the challenges of the state government was inexcusable.

He concluded by saying that he hoped their partnership could improve in the future throughout the implementation of HISA rules.

“The HISA Racetrack Safety rules going into effect this summer are based upon the hard work that has been done by all of you [regulators] over the years as they have relied heavily on the ARCI model rules. We take that as a compliment. I trust that our new colleagues at HISA will come to the level of commitment and expertise we all share for the safety and honesty of the sport of horseracing and the welfare of both human and equine participants.”

During the day's second session, Dr. Susan Stover, a professor at the University of California at Davis School of Veterinary Medicine, Chair of the Racetrack Safely Committee and board member of the Horseracing Integrity and Safety Authority, gave a lecture on 'Protecting Our Horses.' She discussed current data on injuries and fatalities in horse racing, noting that almost all come from pre-existing conditions. She emphasized that if such conditions can be caught early, horses are able to return to the racetrack in many cases without issue.

The day's third session featured a panel of the Equine Welfare Committee.

Scott Chaney, the Executive Director of the California Horse Racing Board, spoke on the many changes that have taken place in California since 2019. He said that the year brought forth a watershed moment for the state not necessarily because of an increased number of fatalities, but because of increased media attention. Chaney said that in implementing new regulations, which have now proven to be successful, they focused on four different categories: medication control, identifying high-risk horses, education and research, and perception and transparency.

Scott Palmer, the Equine Medical Director of the New York Gaming Commission, represented the Mid-Atlantic Program.

In regards to medication, Palmer said that there was a significant decrease in the total number of positive tests in the Mid-Atlantic region in 2016 and 2017 following the implementation of their Mid-Atlantic Strategic Plan. Since then, the total number of positive tests were constant from 2017 to 2021 except for a decrease in 2020.

Ann McGovern concluded the panel as the representative for HISA's Safety Program, which goes into effect July 1. She said that the positive results outlined by Chaney and Palmer are an example of what can be achieved under effective regulations and noted that HISA looked at various pre-existing successes in the industry as they were outlining their program.

“We want to assist racetracks as they adopt the medication and safety standards that are outlined by HISA,” she said. “We want to provide educational opportunities for all the industry members and through research, we want to identify injury-reducing best practices. Our regulations rely heavily on the industry sending us data and we are requiring members of the industry to provide data.”

McGovern explained that with the collected data, HISA will conduct research to give input to the industry and make improvements. She added that the data will not be used to monitor trainers and veterinarians, but to give everyone more information.

John Roach joined McGovern on the panel to explain the different components of HISA, specifically the differences between Rule Series 2100 and 2200.

Roach said the 2100 series revolves around the accreditation process for racetracks, noting that every racetrack under HISA authority will be granted an interim accreditation as many racetracks will have work to do in order to meet HISA standards. Rule violations will not take place during that time as long as racetracks are working in good faith as they move forward to meeting the outlined standards.

“We realize that there are going to be tracks that this is going to be a bit of a heavy lift for,” McGovern said. “Most racing jurisdictions [present today] are meeting the majority of the standards already and I don't think it will be that difficult to get to standard of HISA if you are not already there, but for the smaller tracks that might find it more difficult, we're not going to ask them to have all this in place on July 1. What we're looking for is a good-faith effort to do what is necessary to save horses and reduce injuries in jockeys.”

In contrast, Rule Series 2200 includes rules that will be enforced starting on July 1. Examples of these regulations include the limited use of the riding crop, as well as enforcement of safety vests and safety helmets. These rules will be enforced with sanctions set forth in the regulations immediately upon implementation.

“We know that things change and as research tells us and as you tell us, these rules will evolve,” McGovern said. “If there's something we didn't get right, we are open to suggestions. We are working as hard as we can to get everything up and running, but the next steps are to education everyone in the industry as to what HISA means, what the regulations are, and what will be needed in order to comply. I think we're all in this for the same reason. We want to save horses lives, reduce jockey injuries and deter and remove the bad actors in our industry who make the good guys look bad.”

Monday's session concluded with a panel on the topic of if cheaters should be given a pass for cooperating, which featured United States Trotting Association President Russell Williams and Nebraska Racing and Gaming Commission's Executive Director Tom Sage, as well as a panel on Federal-Jurisdiction Cooperation in Canada with Canadian Pari-Mutual Agency's Executive Director Lisa Foss, Alcohol and Gaming Commission of Ontario's Director of Regulatory Compliance Brent Stone and Horse Racing Alberta's Supervisor of Racing Doug Fenske.

The ARCI conference continues on Tuesday.

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