RWB-08-12-00001-P Out of Competition Drug Testing of Thoroughbred Race Horses
2/22/12 N.Y. St. Reg. RWB-08-12-00001-P
NEW YORK STATE REGISTER
VOLUME XXXIV, ISSUE 8
February 22, 2012
RULE MAKING ACTIVITIES
RACING AND WAGERING BOARD
PROPOSED RULE MAKING
NO HEARING(S) SCHEDULED
I.D No. RWB-08-12-00001-P
Out of Competition Drug Testing of Thoroughbred Race Horses
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Amendment of section 4043.12; and addition of section 4012.5 to Title 9 NYCRR.
Statutory authority:
Racing, Pari-Mutuel Wagering and Breeding Law, sections 101(1) and 902(1)
Subject:
Out of competition drug testing of thoroughbred race horses.
Purpose:
To amend existing equine drug testing requirements to include race horses that are not formally scheduled to race.
Text of proposed rule:
9 NYCRR § 4012.5 Out-of-Competition Testing
(a) Sampling horses
(1) The board may at a reasonable time on any date take a blood, urine, or other biologic sample, from a horse that is on a nomination list or under the care or control of a trainer or owner who is licensed by the Board, for the purpose of testing for the impermissible presence or administration of substances prohibited by section 4043.12. The board shall perform no other forensic tests on a sample.
(2) Samples shall be taken under the supervision and direction of a person who is employed or designated by the board and is qualified to safeguard the health and safety of the horse. Blood samples may be taken only by a licensed veterinarian.
(3) Horses to be tested may be selected at random, for cause, or as determined by a board executive official or steward.
(4) A selected horse that is not made available for sampling is ineligible to race for 180 days, unless the board determines that circumstances unavoidably prevented the owner and trainer from making the horse available for sampling.
(5) If a selected horse is not involved in activities related to racing in New York, then the trainer or owner may represent this to board and the board will not sample the horse. If the trainer makes this representation, then the board will notify the managing owner who may make the horse available for sampling in order to preserve its eligibility.
(b) Cooperation with taking samples
(1) The owner, trainer, and/or their designees shall cooperate with the person who takes samples by immediately assisting in the location and identification of the horse, making it available at a stall or other safe location to collect the samples, and witnessing the taking of its samples. The person who takes samples shall provide identification and disclose the purpose of the sampling. The person who collects samples on track may require that it be done at the test barn.
(i) Before arriving to sample an off-track horse the board shall notify the owner or trainer, who may instead make the horse available within 24 hours at a licensed racetrack designated by the Board.
(ii) The board may arrange for the sampling of a horse that is in another jurisdiction by its racing commission or other designated person, provided that they follow the provisions of this rule, and the test results shall also be provided to the other jurisdiction for its regulatory use. The board shall provide the owner or trainer with this as a reasonable alternative location to make the horse available within 24 hours.
(iii) An owner or trainer does not consent to a search of the premises by making a horse available for sampling at an off-track location.
(2) A licensed racetrack at which a horse may be located shall cooperate fully with a person who is authorized to take samples.
(3) No person shall knowingly interfere with or obstruct a sampling.
(c) A buyer who was not aware of the ineligibility of a horse under this rule may void the purchase, provided that it is done within 10 days after receiving notice of the horse's ineligibility.
(a) [Any horse on the grounds of a racetrack under the jurisdiction of the Board or stabled off track grounds is subject to testing without advance notice for blood doping, gene doping, protein and peptide-based drugs, including toxins and venoms, and other drugs and substances while under the care or control of a trainer or owner licensed by the Board.
(b) Horses to be tested shall be selected at the discretion of the State judges or any Board representative. Horses to be tested shall be selected from among those anticipated to compete at New York tracks within 180 days of the date of testing or demand for testing.
(c) The State steward or any board representative may require any horse of a licensed trainer or owner to be brought to a track under the jurisdiction of the board for out-of-competition testing when that horse is stabled out-of-state at a site located within a radius not greater than 100 miles from a New York State racetrack. The trainer is responsible to have the horse or horses available at the designated time and location.
(d) A board veterinarian or any licensed veterinarian authorized by the State steward or any board representative may at any time take a urine or blood sample from a horse for out-of-competition testing.
(e)] Prohibited substances [are:]
(1) The presence in or administration to a horse of the following doping agents or drugs, in the absence of extraordinary mitigating circumstances that excuse the owner and trainer from their failure to fulfill their duties and responsibilities, is prohibited at any time.
(i) Blood [blood] doping agents [including, but not limited to,]: a protein or peptide based agent or drug that is capable of abnormally enhancing the oxygenation of body tissues, including but not limited to erythropoietin (EPO), darbepoetin, Oxyglobin, Hemopure, and Aranesp[, or any substance that abnormally enhances the oxygenation of body tissues;].
[(2)] (ii) Gene [gene] doping agents: [or the nontherapeutic use of] a gene[s], genetic element[s], [and/] or cell[s] that alters the expression of genes for normal physiological functions and that may [have the capacity to enhance athletic performance or] produce analgesia or enhance the performance of a horse beyond its natural ability[;].
[(3)] (iii) Any other protein and peptide[-] based agent or drug[s,] that may produce analgesia or enhance the performance of a horse beyond its natural ability, including but not limited to toxins, [and] venoms, and allosteric effectors.
(iv) These substances are prohibited regardless of any other provisions, including section 4043.2, of this Subtitle.
(2) No person shall possess or use these prohibited substances on the premises of any licensed racetrack.
(3) It shall be an affirmative defense to a violation of this rule that the person used the prohibited substance only in a time, place, and manner specifically permitted in writing by the board before its administration; for a recognized therapeutic use; and subject to such appropriate limitations as the board shall place on the return of the horse to running races.
[(f) The presence of any substance at any time described in subsections (1), (2) or (3) of subdivision (e) is a violation of this rule for which the horse may be declared ineligible to participate until the horse has tested negative for the identified substance, and for which the trainer shall be responsible pursuant to Board Rule 4043.4.
(g) The trainer, owner, and/or their designees and any licensed or franchised racing corporation shall cooperate with the board and its representatives/designees by:
(1) assisting in the immediate location and identification of the horse selected for out-of-competition testing;
(2) providing a stall or safe location to collect the samples;
(3) assisting in properly procuring the samples; and
(4) obeying any instruction necessary to accomplish the provisions of this rule. The failure or refusal to cooperate in the above by any franchisee, licensee or other person shall subject the franchisee, licensee or person to penalties, including license suspension or revocation, the imposition of a fine and exclusion from tracks or facilities subject to the jurisdiction of the board.]
(b) Penalties
[(h)] (1) A[ny] horse [which is not made available for testing as directed, including the failure to grant access on a timely basis, shall in the absence of acceptable mitigating circumstances,] in violation of this rule shall be ineligible to [participate in racing] race until it is certain that the horse is no longer affected by the prohibited substance and for not less than 180 [for one hundred twenty] days, after which the horse must qualify in a workout satisfactory to the judges and test negative for drugs. The minimum fixed period of ineligibility for a horse in violation of this rule shall be reduced from 180 to 30 days if the trainer had never violated this rule or similar rules in other jurisdictions and had, for any violations of Part 4043 or similar rules in other jurisdictions, fewer than 180 days in lifetime suspensions or revocations and fewer than two suspensions or revocations of 15 days or more in the preceding 24 months.
(2) A person who is found responsible for a violation of section (a)(1) of this rule shall incur a penalty of license revocation in addition to any other penalties authorized in this Title.
[(i) In the absence of extraordinary mitigating circumstances, a minimum penalty of a ten (10) year suspension will be assessed for any violation set forth in subdivision (f).
(j) An application to the Board for an occupational license shall be deemed to constitute consent for access to any off-track premises on which horses owned and/or trained by the individual applicant are stabled. The applicant shall take any steps necessary to authorize access by Board representatives to such off-track premises.]
(c) A buyer who was not aware of the ineligibility of a horse under this rule may void the purchase, provided that it is done within 10 days after receiving notice of the horse's ineligibility.
Text of proposed rule and any required statements and analyses may be obtained from:
John J. Googas, New York State Racing & Wagering Board, One Broadway Center, Suite 600, Schenectady, New York 12305, (518) 395-5400, email: info@racing.ny.gov
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
45 days after publication of this notice.
Regulatory Impact Statement
1. Statutory authority and legislative objectives of such authority: The Board is authorized to promulgate these rules pursuant to Racing Pari-Mutuel Wagering and Breeding Law sections 101(1) and 902(1). Under section 101, the Board has general jurisdiction over all horse racing activities and all pari-mutuel betting activities in the state, both on track and off-track, and the persons engaged therein, including the authority to regulate the use of drugs that can manipulate race performance. Section 902(1) prescribes that a state college within New York with an approved equine science program shall conduct equine drug testing to assure public confidence in and to continue the high degree of integrity at pari-mutuel race meetings, and authorizes the Board to promulgate any rules and regulations necessary to implement such equine drug testing program and to impose substantial administrative penalties for racing a drugged horse.
2. Legislative objectives: To enable the New York State Racing and Wagering Board to preserve the integrity of pari-mutuel racing while generating reasonable revenue for the support of government.
3. Needs and benefits: This rulemaking is necessary to bring the Board's out-of-competition testing rule for thoroughbred horses in line with current enforcement needs and realities.
The amendment is necessary to provide greater protections for horse owners and trainers, by clarifying the rule and/or codifying several of the Board's internal protocols, such as that collectors will notify them before arriving at an off-track site, collectors will present their credentials when asking them to make a horse available for sampling, the owner and trainer have the option for 24 hours to bring an off-track horse to a licensed racetrack for its sample to be taken, if the owner or trainer decide to have a horse sampled at its off-track location it shall not constitute their consent to a search of the premises, the Board will not sample a horse that is not involved in New York horse racing activities on condition that the horse will not thereafter race for 180 days, the selection of horses to be sampled will be made by only supervisory employees of the Board, and the samples shall be collected at a reasonable time. If the horse is made available on track, then the new rule allows the person who takes samples to require that the horse be brought to a central area, the test barn. This minimizes the burden on racetracks, who are required to facilitate the sampling process, in the unusual situation when the Board is unable to deploy to its inspectors and veterinarians to collect out-of-competition samples on the grounds of a race track but outside of the test barn. Protections like these are commonly found in rules requiring that animals be sampled for regulatory purposes.
The amendment is necessary to establish a clear scope of inquiry for out-of-competition testing. The rule limits forensic testing of out-of-competition samples to tests for the presence of the substances prohibited by this rule. This confines the enforcement impact of this Board program to searching for the types of substances that necessitate out-of-competition testing. This will provide additional protection for owners and trainers by removing any possible overreaching governmental intrusion.
The amendment will benefit regulated parties by clarifying the definition of prohibited substances. It will expressly limit the prohibition to those protein or peptide based substances that can abnormally oxygenate bodily tissues, or anesthetize, or enhance a horse's performance beyond its natural abilities. Doping agents with these traits are posing a grave threat to racing integrity. They threaten the integrity of athletic competitions by having an affect on race performance that cannot be forecast by the betting public, and that gains an unfair advantage over other horsemen and owners. These doping agents are able to create abnormal oxygenation and gene doping or other sustained physiological changes that anesthetize or enhance athletic performance of horse beyond its natural ability. Substances with these uses have been discovered and developed to treat the sick, sore, or disabled. When used by healthy competitors, they have the capacity to create dangerous and unfair abilities to perform. These doping agents have been abused in human competitions, like cycling and track and field, and have migrated to horse racing. There are very few protein or peptide based drugs or medications that are routinely used in treating horses to begin with, and hardly any of them have the proscribed effects. The possible veterinary or therapeutic value of these doping agents for racehorses is unneeded or minimal in comparison with their potential impact on the integrity of racing and on fan wagering, the main source of revenue in pari-mutuel horse racing.
Not only are protein or peptide based doping agents with these defined effects extremely undesirable in legitimate horse racing, it is generally impossible to detect the use of them without collecting samples a lengthy period of time before an actual competition. These substances are capable of making a profound change to a horse's physiology that can persist long after the doping agent is excreted. Toxins produce necrosis of nerve tissues that may take weeks to recover, if at all, and create the potential for unsafe racing by horses that are unable to feel the ordinary sensation of soreness, pain, or injury. Blood doping agents, particularly if used for a sustained period of time, permit the horse to perform at a higher level by enhancing the transport and delivery of oxygen to bodily tissue despite the complete absence of the doping agent on race day and the inability to detect it for over a week before a horse may race. Gene doping agents have the capacity to fundamentally alter a horse's physiology and to enhance its performance for months after the administered agent is undetectable or even absent from the body. It is also very difficult to detect protein or peptide based substances that have these effects, moreover, because of their large molecular structure and an abundance of similar substances in a horse. These reasons all support a general prohibition of protein or peptide based doping agents that have the ability to abnormally oxygenate, anesthetize, or create a horse that competes above its natural limits. A number of these substances are prohibited in human competition by WADA or in other racing jurisdictions (where New York historically has been a leader). The amendment is supported by the Board's renowned equine drug testing and research consultant, Dr. George A. Maylin. The amendment is necessary to give a more precise definition to what the rule prohibits. It provides added guidance to horsemen and veterinarians and avoids any concern that the previous rule's specific definitions of blood and gene doping agents could be inconsistent with a general prohibition of all other protein or peptide based drugs.
The amendment also states that these negative traits will make a protein or peptide based drug prohibited notwithstanding the possible applicability of other Board rules, e.g., ones permitting a handful of protein based drugs within certain time frames, 9 NYCRR § 4043.2(e)(4, 19). There are very few of these drugs, and there are readily available substitutes for them. Rather than compromise the enforceability of this rule, such listed drugs with these dangerous traits are universally forbidden. This amendment furthers the purpose of the rule to prohibit the abuse of a specific category of substances, protein or peptide based agents that are very difficult to detect, affect a horse long after race day testing can detect them, have little or no legitimate use, are unnecessary to provide proper treatment to a horse, and present a grave risk to the integrity of racing. It does so while clearly expressing that the ban of protein and peptide based drugs, including blood and gene doping agents, is limited to those capable of causing abnormal oxygenation, anesthetizing, or bestowing racing performances beyond a horse's natural ability.
The amendment makes it clear that protein or peptide based doping agents that do not create forbidden effects are not banned by the new out-of-competition rule. Therapeutic platelet therapy, i.e., platelet enriched plasma, for example, is not prohibited because it is therapeutic and does not abnormally oxygenate the blood, work as an analgesic, or raise a horse above its natural limits. More generally, the amendment clarifies that stem cell and platelet therapies undertaken to assist a sick, lame, or injured horse to become healthy are not prohibited by this rule. They do not produce abnormal oxygenation of the blood or analgesia or make it possible for a horse to race above its natural ability.
It is a classic scenario that these forbidden substances, designed to treat the unwell person or horse, are abused when administered to a healthy person or animal. As a result, if an owner or trainer has any concern about whether a doping regimen might violate this rule, the amendment allows the owner or trainer, with advance written permission from the Board, to use an otherwise prohibited substance for a proven therapeutic purpose. This makes it possible for new drugs -- that one might speculate could be discovered -- to be used more quickly than the time required to amend this rule. There is continual research into doping agents, such as gene doping. To the extent this might result in new and valuable treatments, the new rule will permit therapeutic use in a carefully regulated manner as is appropriate given the high potential for abuse of these substances. This provision provides an additional safeguard for an owner or trainer who, at any time and for any reason, wishes to be sure a drug can be used under this rule.
The amendment is necessary to include in the Board's out-of-competition test program all horses involved in New York horse racing activities. The new rule authorizes the Board to select for sampling any horse of a Board licensed owner or trainer or that has been nominated to race in New York. The previous rule allowed the Board to sample only horses that were already in the hands of a Board licensee, and was not applicable to horses stabled out-of-state by more than 100 miles. Major stakes races often require an advance commitment from the owner and trainer, paying a fee to nominate a horse to be eligible to enter the race at a later date. These owners and trainers can nominate a horse without a Board license, which is required only when the horse is entered in the race, often a few days or weeks before the race. Horses also participate in New York races after shipping in from farms or training centers located more than 100 miles from the state line. The amendment widens the scope of the Board's out-of-competition sampling to include all horses that are preparing to participate, including the normal rest periods that occur during a racing career, in New York races. This serves the best interests of New York racing by requiring, in order to participate in New York races, all horses that have been nominated to race in New York or are owned or trained by persons with a New York license, wherever the horse is stabled, to submit to the same scrutiny that applies to the horses that are stabled in New York.
The new rule limits the horses that must submit to out-of-competition tests to only horses involved in New York horse racing activities by allowing the owner or trainer to decline a sampling of a horse that is not preparing to participate in New York racing, subject to a significant period of ineligibility that is required to deter guilty parties from using this option to evade detection of an illegal doping with its more serious sanction of license revocation, as well as to protect competitors from having to race against a horse that has been effectually drugged by a prohibited substance. Under the new rule, when a licensee refuses to produce a horse for sampling, the horse not eligible to race for a period of 180 days; the current rule excludes the horse for 120 days. The amendment also clarifies that the Board expects to be advised by the owner or trainer regarding whether a horse is anticipated to race in New York. The amendment provides more clear notification of the Board's internal protocol of planning to select any horse, nominated to race in New York or owned or trained by a Board licensee, then allowing the owner or trainer to decline the sampling of any horse that is not involved in New York horse racing activities.
In order to provide some latitude to the horse owner, the amendment requires the Board to notify a horse's owner, when its trainer has declined to have a horse sampled, to give the owner a chance to present the horse to be sampled. This protects an innocent owner from the possible interruption of a racehorse's career by a guilty trainer who, attempting to evade a doping violation, is preventing the sampling of a horse. The owner could hire a new trainer and/or order that the horse immediately be made available for sampling.
The amendment expressly authorizes the Board to make arrangements for out-of-state horses to be sampled by collaborative racing commissions, the practical means for all out-of-state horses to be sampled. The previous rule also allowed the Board to require the owners and trainers to bring to a New York racetrack an out-of-state horse, provided it was stabled within 100 miles of the state, and exempted more distant horses. The new rule reduces their potential burden by providing the owner or trainer of an out-of-state horse with the option to have the horse sampled by the state racing commission or other designee at a reasonable location in the state where the horse is stabled. This also makes it feasible for the Board to require any eligible out-of-state horse to be sampled. The Board has experience with the practice of sister states collecting samples for each other for Breeders' Cup races. The new rule incorporates this practice, including its standard requirement that laboratory test results are shared to enable the racing commissions in both states to regulate the horse and licensees.
The amendment standardizes the consequences of non-compliance. The minimum ineligibility period for a horse that is not tested, absent unavoidable circumstances, is raised from 120 to 180 days. A horse that tests positive for a prohibited substance as defined by this rule is made ineligible to resume racing until it is known that the doping effects have disappeared and for a minimum period of 180 days unless the trainer has a good record, in which case the minimum fixed period of ineligibility for a positive horse is 30 days. The lesser period of ineligibility is warranted when the owner, who bears much of the consequence of horse ineligibility, had selected a trainer who did not have readily-apparent equine drug issues. The greater period of ineligibility puts pressure on owners not to use trainers with suspect records unless the owner knows that the trainer will ensure that no substances prohibited by this rule will be administered to the horses.
An unwittingly buyer of a horse that is ineligible to race under this rule is allowed to void the purchase for 10 days after receiving notice. Horses change ownership routinely through claiming races and out-of-state sales, where the Board has little to no ability to ensure that the seller provides notice of the horse's ineligibility to the new owner. The new rule should result in owners disclosing horse ineligibility and reduce the possibility of private disputes about whether a transfer of a horse to an unwitting buyer is valid.
The amendment penalty for a trainer (or anyone directly involved) who is responsible for a positive for a prohibited substance as defined by this rule is reduced from a 10 year suspension to a license revocation. A license revocation may or may not be accompanied by a minimum period in which a person is considered ineligible to reapply. The new rule, therefore, gives the Board greater flexibility to consider mitigating or aggravating circumstances and relieves the responsible party of a mandatory 10 year suspension.
Finally, the amendment reorganizes the current rule by moving the provisions about the manner in which sample collection and testing will occur to Part 4012, where similar provisions are located in the Board's rules. It leaves the prohibition of doping agents in Part 4043, again, where similar provisions are located in the Board's rules. The prior rule combined both aspects of this thoroughbred rule into a single rule and placed it within Part 4043 which could have created confusion or difficulty in locating the rule.
4. Costs:
(a) Costs to regulated parties for the implementation of and continuing compliance with the rule: These amendments will not add any new mandated costs to the existing rules, and the cost of making a horse available for sampling will be reduced in some instances. The new rule gives the owner or trainer the option to produce the horse at a nearby racetrack, including one located in the horse's home state, and eliminates the requirement that a horse stabled no more than 100 miles out-of-state must be brought to a New York racetrack to be sampled.
(b) Costs to the agency, the state and local governments for the implementation and continuation of the rule: None. The amendments will not add any new costs. The new rule will potentially reduce administrative costs by encouraging horsemen to bring their horses to a licensed racetrack's test barn for sampling. The cost of samples taken by sister states from out-of-state horses will remain constant, as the owner or trainer will make the horse available during normal racing hours when staff is already present to collect samples and the cost of collections by one state will be offset by collections obtained for it by its sister state. Both states will be able to use a single laboratory test to enforce their own state rules, which will cost less than the normal practice of each state conducting its own laboratory tests. The samples require separate shipping whether collected in or out of state.
There will be no costs to local government because the New York State Racing and Wagering Board is the only governmental entity authorized to regulate pari-mutuel harness racing.
(c) The information, including the source(s) of such information and the methodology upon which the cost analysis is based: The Board relied on its experience in collecting samples for collaborative states and on the studies and/or advice provided by its Director of the New York State Racing and Wagering Board's Drug Testing and Research Program, Dr. George A. Maylin.
(d) Where an agency finds that it cannot provide a statement of costs, a statement setting forth the agency's best estimate, which shall indicate the information and methodology upon which the estimate is based and the reason(s) why a complete cost statement cannot be provided. Not applicable.
5. Local government mandates: None. The New York State Racing and Wagering Board is the only governmental entity authorized to regulate pari-mutuel harness racing activities.
6. Paperwork: There will be no additional paperwork. The Board will utilize the existing documents for its chain of custody protocol and memorandums of understanding with other state racing commissions, as well as administrative adjudication to determine whether a violation has occurred and what sanctions may be appropriate.
7. Duplication: None.
8. Alternatives. The Board considered a suggestion by a representative of a horseman's group that the Board require all off-track stables in New York to be licensed and subject to inspection by the Board. This alternative was rejected because the administrative costs would be prohibitive and the alternative was far more intrusive than is required to address the concerns that underlie the out-of-competition program.
9. Federal standards: None.
10. Compliance schedule: The rule can be implemented immediately upon publication as an adopted rule.
Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement
As is apparent from the nature of this rulemaking, this proposal does not require a Regulatory Flexibility Statement, Rural Area Flexibility Statement, or Job Impact Statement since the amendments serve to narrow and simplify the Board's existing out-of-competition equine drug testing rule, by codifying the protections afforded to horse owners and trainers and clarifying both the definition of prohibited substances and the right of owners and trainers to choose where a horse will be sampled. These amendments do not expand the scope of the existing regulatory framework, but merely revise ministerial aspects within the existing out-of-competition rule. In fact, these changes benefit regulated parties by allowing flexibility in compliance with Board requests for samples. This rule does not affect small business, local governments, jobs or rural areas. Further, this proposal will not impose an adverse economic impact on reporting, record keeping or other compliance requirements on small businesses in rural or urban areas nor on employment opportunities. Due to the straightforward nature of the rulemaking, there is no need for the development of a small business regulation guide to assist in compliance. These provisions are clear as to what equine drugs are impermissible, how the Board's program will be implemented, and what is necessary to comply with the rule.
