Regulators looking at revamping rule-making process
This article is more than 3 years old
Updated Feb. 19, 2015
It’s been almost two years since the association of state racing regulators, the Association of Racing Commissioners International, voted to adopt the Racing Medication and Testing Consortium’s National Uniform Medication Program. Recently, the RMTC, which is the industry’s scientific advisory organization, applauded the horse racing industry’s progress in incorporating the model rules. But not all has gone smoothly in the process, and a rising chorus of racing industry representatives are calling for a new way of doing things with regard to rule making.
More states get on board
The model rules adopted by the RMTC and ARCI involve four components: the Controlled Therapeutic Medication Schedule, which lists thresholds and recommended withdrawal times for 26 commonly used legal substances; requirements for laboratory accreditation; a multiple medication violation penalty system; and third-party administration of furosemide on race day.
By early this year, at least 16 states will have in place the medication schedule of 26 drugs, which is up from four states at the beginning of 2014, wrote RMTC executive director and chief operating officer Dr. Dionne Benson in a Dec. 9, 2014, RMTC press release. Arkansas, California, Illinois, Indiana, Kentucky, Minnesota, New Jersey, New Mexico, New York, North Dakota, Oregon, and West Virginia have joined or will soon join Delaware, Maryland, Massachusetts, and Virginia in regulating therapeutic medications under the new guidelines.
States using only RMTC-accredited laboratory testing services and an external quality assurance program for their equine drug and medication testing services—California, Kentucky, Maine, New Mexico, Ohio, and Virginia—should increase to 23 by early 2015. That’s not including laboratories in New York and Pennsylvania, which are expected to be RMTC-accredited sometime soon. A laboratory in Texas also has recently applied for RMTC accreditation.
The multiple medication violation penalty system will have gone from three adopting states in January 2014 to at least nine by early this year. The MMV penalty system, designed to work in a manner similar to the way states track an individual’s traffic violations, provides for stiffer penalties for individuals who accumulate multiple medication violations, regardless of the jurisdiction in which they occur. Arkansas, Colorado, Indiana, Maryland, New Jersey, and North Dakota have joined or will soon join Delaware, Massachusetts, and Virginia in using the system.
And finally, the number of states requiring third-party administration of furosemide on race day is anticipated to rise from 12 in January 2014 to at least 16 by early 2015. Arkansas, California, Oregon, and Pennsylvania will join Colorado, Delaware, Indiana, Kentucky, Maine, Maryland, Massachusetts, Minnesota, New Jersey, North Dakota, Virginia, and West Virginia in implementing the policy.
“We are very encouraged by the industry’s willingness to embrace reform and urge all horse racing jurisdictions in the United States to adopt the reforms in their entirety without further delay,” said Alex Waldrop, chairman of the RMTC and president and chief executive officer of the National Thoroughbred Racing Association.
Where hooves meet the track
That’s not to say that the process has gone along completely without conflict or confusion.
“In light of the changes in medicine and reform in racing, it would be good to discuss the growing pains, misconceptions, and realities,” said Dr. Jeff Blea, immediate past president of the American Association of Equine Practitioners. He co-hosted the open forum “Uniform Medication Rules in Racing” with Dr. Scott Hay, chair of the AAEP Racing Committee, Dec. 7, 2014, during the AAEP’s Annual Convention in Salt Lake City. RMTC’s Dr. Dionne Benson was also there to answer questions.
She acknowledged the common misconception that there is zero tolerance for drugs not listed on the Controlled Therapeutic Medication Schedule, for example.
“We’re not saying veterinarians have to use only these drugs, but they’re associated with withdrawal times,” Dr. Benson said. “We expect you to use drugs outside the list, they just can’t be in the horse on the day they run at detectable amounts.”
The list was developed with input from the AAEP, regulatory veterinarians—most of whom are AAEP members—and analytical chemists. Most of the substances’ thresholds are based on research, but some are historical. Currently, the RMTC is conducting research on four more medications—ranitidine, cimetidine, guaifenesin, and ceterizine—as well as omeprazole.
During the forum, one concern raised had to do with the requirement that a third-party veterinarian must administer furosemide on race day, not the horse’s regular veterinarian.
Dr. Donald Shields, a California racetrack veterinarian, questioned whether it violated the veterinarian-client-patient relationship established in some state veterinary practice acts.
“Why are we trying to rewrite state laws at the commission level that doesn’t have authority on these things?” Dr. Shields asked. “I’m seriously concerned over what’s happening here. We could be introducing an illegal act. If I’m wrong, tell me, but if it’s illegal even in one state, why is this association recommending an illegal practice?”
The AAEP supports third-party furosemide administration. Dr. Benson said the requirement, which came out of the International Summit on Race Day Medication, Exercise-Induced Pulmonary Hemorrhage and the Racehorse, held June 2011 in New York City, was created to address concerns about veterinarians being in the stall on race day.
Adrian Hochstadt, assistant director for AVMA State Legislative and Regulatory Affairs, told JAVMA that several states, including California and Kentucky, have a requirement in their statutes or regulations that the veterinarian must have a relationship with the client before administering any treatments.
“Third-party administration seems to be in conflict with the VCPR principle, but, of course, states have authority to create exceptions to that rule,” he said.
Hochstadt added, “A state agency rule needs to be within scope of applicable statutes, or it can be challenged in court. If the same-day requirement is in a statute, however, it will have equal weight to a statute with the VCPR, and the narrower provision will generally prevail in such a conflict of laws situation.”
Up for debate
Other areas of ongoing conflict created by the model rules have centered on clenbuterol and its 14-day withdrawal period before race day, and intra-articular administration of corticosteroids not being allowed within seven days of a race.
Clenbuterol is used to treat inflammatory airway disease, but it’s also been shown to produce an anabolic steroid effect in horses. Dr. Shields questioned the 14-day withdrawal period, saying he doubts any study would show that the drug is still pharmacologically effective after that period. And breeders and trainers of Standardbreds and other breeds are anxious that the timing lessens their ability to treat inflammatory airway disease.
One session attendee said, like it or not, “We’re regulating (clenbuterol) with greater scrutiny than any other drug because it has left such a bad taste in the mouth with all that has occurred with it. It’s too bad it’s become a poster child, but it has. We can’t deal with it any other way. It’s been abused.”
Taking action on its own, the American Quarter Horse Association announced that beginning Jan. 1, 2016, it will ban clenbuterol from use in all American Quarter Horse races. The move comes after continued increases in the number of reported clenbuterol overages in racehorses across the nation. Since January 2014, there have been 64 clenbuterol overages from seven racing jurisdictions, not including additional alleged overage violations that are awaiting hearings.
The AQHA Racing Council also announced that beginning Jan. 15, 2015, the horse, owner, and trainer of any horse that is part of a medication ruling with a clenbuterol overage based on threshold levels currently allowed by the reporting jurisdiction will be penalized immediately under the AQHA Multiple Medication Violation System.
“If we are going to level the playing field, protect our horses, riders, and the betting public, taking these steps to ban clenbuterol completely and work with every racing jurisdiction is what is best for our industry,” AQHA President Johnny Trotter said.
Meanwhile, trainers and veterinarians also worry about the withdrawal time for corticosteroids because Standardbreds compete more frequently than other breeds—as often as every week.
This past year, the United States Trotting Association withdrew from the RMTC after refusing to sign on to certain model drug rules and left the organization; it believes different rules are needed for different breeds. The USTA cited its opposition to the longer withdrawal time for clenbuterol.
One veterinarian, Dr. Eric Keiser from Oregon, said he feels that harness horses, in particular, have been put at a disadvantage. Many harness horses are Standardbreds.
“The entire process is being skewed to be easier to regulate and harder for people on the backstretch. We’re getting asked every day (by trainers and owners) ‘What’s my withdrawal time on this or that?’ especially with corticosteroids on joints. That’s becoming a lightning rod between veterinarians and owners and trainers. Our livelihoods are in jeopardy. That’s where a lot of us have concern: this blanket regulation,” he said during the horse racing open forum.
Restrictions on total dose for some corticosteroids—such as 9 mg of betamethasone in a single articulation—also has elicited some backlash. Some veterinarians say that is not a realistic amount, particularly when treating multiple conditions, such as ankle and stifle problems.
Changing the rule-making process
Given the contentious atmosphere and questions about the RMTC’s integrity, the ARCI believes it has a solution: It’s requesting that the RMTC merge with an ARCI committee.
Regulators say doing so would streamline the process of rule making in the areas of medication policy and testing standards. The move would eliminate the current role of the RMTC in initially shaping rules, providing industry expertise in shaping new policies, and presenting recommendations to regulators. The ARCI called on the RMTC to merge with the ARCI Drug Testing Standards and Practices Committee, which will develop policy recommendations.
The RMTC issued a statement on Dec. 17, 2014, saying it reaffirms the decision of its board early in 2014 “to conduct strategic planning on future research needs and to reorganize the RMTC Scientific Advisory Committee and its processes to adapt and respond to new drugs, practices, and substances, which threaten the integrity of racing.” It also affirmed the importance of maintaining an “independent and apolitical” RMTC for equine drug and therapeutic medication research.
Regulators from 21 major racing jurisdictions—including California, Florida, Kentucky, and New York—directed ARCI President Edward J. Martin to send a formal letter to the RMTC proposing a partial or complete merger of the organization into a reconstituted ARCI Drug Testing Standards and Practices Committee.
In the letter, Martin wrote that while the ARCI has “always welcomed input and recommendations from racing industry participants and organizations, we reserve the right to determine how that input is assessed and what the process should be to determine recommended policy.”
Martin explained the decision thusly: “In recent years the credibility of the current RMTC process has been questioned. In some quarters, confidence has eroded, even among some of the RMTC’s strongest historical supporters. This was compounded by the departure of the USTA and some science advisors deemed essential by key regulatory jurisdictions and others. Additionally, late modifications to recent recommended policy submissions after the commencement of regulatory rule promulgations has also raised concerns.”
Functional concerns about the current scientific advisory process, transparency, and nonparticipation of key experts were also cited as factors by the ARCI.
A newly created ARCI Scientific Advisory Group would begin the policy recommendation process and be followed by the reconstituted ARCI Drug Testing Standards and Practices Committee, which would include regulatory and industry input. It also would consider input from regulatory veterinarians, regulatory attorneys, and equine welfare committees.
The letter noted that currently, before the regulatory group considers a new recommendation, the proposal goes through the RMTC Scientific Advisory Committee, the RMTC Executive Committee, and the RMTC board of directors.