RWB-48-12-00006-E Implementation of Substantive Changes and Procedures Pertaining to Equine Drugs and Reporting Requirements for Thoroughbreds

11/28/12 N.Y. St. Reg. RWB-48-12-00006-E

NEW YORK STATE REGISTER

VOLUME XXXIV, ISSUE 48

November 28, 2012

RULE MAKING ACTIVITIES

RACING AND WAGERING BOARD

EMERGENCY RULE MAKING

 

I.D No. RWB-48-12-00006-E

Filing No. 1133

Filing Date. Nov. 13, 2012

Effective Date. Dec. 12, 2012

Implementation of Substantive Changes and Procedures Pertaining to Equine Drugs and Reporting Requirements for Thoroughbreds

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:

Action taken:

Amendment of sections 4038.5, 4043.2, 4043.4 and 4012.5 of Title 9 NYCRR.

Statutory authority:

Racing, Pari-Mutuel Wagering and Breeding Law, sections 101(1) and 902(1)

Finding of necessity for emergency rule:

Preservation of public safety and general welfare.

Specific reasons underlying the finding of necessity:

The Board has determined that immediate adoption of these rule amendments is necessary for the preservation of the public safety and general welfare and that compliance with the requirements of subdivision 1 of Section 202 of the State Administrative Procedure Act would be contrary to the public interest.

On September 27, 2012, the New York State Task Force on Racehorse Health and Safety released their report on the investigation of 21 equine fatalities at the 2011-12 fall and winter meet at Aqueduct Racetrack. The Task Force determined that there may have been opportunities to prevent 11 of those 21 fatalities. Among its recommendations were several amendments to the Board’s thoroughbred rules to allow an owner to void a claim if the horse is injured during the race and must be transported off the racetrack. The amendments contained in this emergency rulemaking are based upon the findings and recommendations of the Task Force.

Given the danger of a horse breaking down, and the safety threat presented to both the horse and the jockeys racing in close proximity, these rule amendments are necessary to protect the safety of human and equine athletes. Thoroughbred horses travel over the racetrack at an average speed of approximately 40 miles per hour, sometimes exceeding that average as they sprint to the finish or sprint to gain positional advantage. An unsound horse or a horse influenced by the administration of certain medications may be forced to race beyond its limits and result in a fatal breakdown, oftentimes in a sudden or uncontrollable breakdown.

This rule is also necessary to protect the general welfare of the horse racing industry and the thousands of jobs that are created through it. Public confidence in both the process of racing and in pari-mutuel wagering system is necessary for the sport to survive, and with it the jobs and revenue generated in support of government.

Subject:

Implementation of substantive changes and procedures pertaining to equine drugs and reporting requirements for thoroughbreds.

Purpose:

To protect the health and safety of thoroughbred race horses, jockeys and exercise riders.

Text of emergency rule:

Subdivision (a) of Section 4012.5 of 9E NYCRR is amended to read as follows:

(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 and/or restricted by section 4043.2(i). The board shall perform no other forensic tests on a sample.

Subdivision (c) is added to Section 4038.5 of 9 NYCRR to read as follows:

(c) The previous trainer of a claimed horse shall, within 48 hours after the race is made official, provide to the new owner an accurate record of all corticosteroid joint injections that were administered to the horse within 30 days before the race.

Amend Subdivision (g) of Section 4043.2 of 9E NYCRR by repealing paragraph (5) and renumbering paragraphs (6) through (16) as follows:

4043.2 Restricted use of drugs, medication and other substances.

(g) The following substances are permitted to be administered by any means until 96 hours before the scheduled post time of the race in which the horse is to compete:

(1) acepromazine;

(2) albuterol;

(3) atropine;

(4) butorphanol;

[(5) clenbuterol;]

[(6)](5) detomidine;

[(7)](6) glycopyrrolate;

[(8)](7) guaifenesin;

[(9)](8) hydroxyzine;

[(10)](9) isoxsuprine;

[(11)](10) lidocaine;

[(12)](11) mepivicaine;

[(13)](12) pentoxifylline;

[(14)](13) phenytoin;

[(15)](14) pyrilamine;

[(16)](15) xylazine.

They may not be administered within 96 hours of the scheduled post time of the race in which the horse is to compete. In this regard, substances ingested by a horse shall be deemed administered at the time of eating and drinking. It shall be part of the trainer's responsibility to prevent such ingestion within such 96 hours.

Paragraph 9 of Subdivision (e) of Section 4043.2 of 9 NYCRR is amended to read as follows:

(9) hormones [and steroids] (e.g., [testosterone, progesterone, estrogens,] chorionic gonadatropin[, glucocorticoids])[, except in conjunction with joint aspiration as restricted in subdivision (i) of this section; the use of anabolic steroids is governed by section 4043.15 of this Part];

Subdivision (i) of Section 4043.2 of 9E NYCRR is amended to read as follows:

(i) In addition, a horse [which has had a joint aspirated (in conjunction with a steroid injection)] may not race for [at least five days following such procedure, and whenever such procedure is performed, the trainer shall notify the stewards of such fact, in writing, before the horse is entered to race] the following periods of time:

(1) for at least five days following a systemic administration of a corticosteroid;

(2) for at least seven days following a joint injection of any corticosteroid;

(3) for at least fifteen days following a joint injection of methylprednisolone (e.g., DepoMedrol); and

(4) for at least twenty-one days following an administration of clenbuterol.

In this regard, substances ingested by a horse shall be deemed administered at the time of eating and drinking. It shall be part of the trainer's responsibility to prevent such ingestion within such time periods.

Section 4043.4 of 9E NYCRR is amended to read as follows:

4043.4. Trainer’s responsibility.

(a) A trainer shall be responsible at all times for the condition of all horses trained by him. No trainer shall start or permit a horse in his custody, care or control to be started if he knows, or he might have known or have cause to believe, that the horse has received any drug or other restricted substance that could result in a positive test. The trainer shall be held responsible for any positive test unless he can show by substantial evidence that neither he nor any employee nor agent was responsible for the administration of the drug or other restricted substance. Every trainer must guard each horse trained by him in such manner and for such period of time prior to racing the horse so as to prevent any person, whether or not employed by or connected with the owner or trainer, from administering any drug or other restricted substance to such horse contrary to this Part.

(b) Trainers shall maintain accurate records of all corticosteroid joint injections to horses trained by them. The record(s) of every corticosteroid joint injection shall be submitted, in a form and manner approved by the Board, by the trainer to the Board within 48 hours of the treatment. It shall be accessible to the examining veterinarian for the purpose of assisting with pre-race veterinary examinations.

This notice is intended

to serve only as an emergency adoption, to be valid for 90 days or less. This rule expires February 10, 2013.

Text of rule and any required statements and analyses may be obtained from:

John Googas, New York State Racing and Wagering Board, One Broadway Center, Suite 600, Schenectady, New York 12305, [phone], email:[e-mail].

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 its equine drug testing program and to impose substantial administrative penalties for anyone who races drugged horses.

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: These rule amendments have been identified by the New York Task Force on Racehorse Health and Safety as emergency measures required to protect the safety and health of thoroughbred race horses and jockeys in New York State. The New York State Racing and Wagering Board has reviewed these recommendations and has endorsed them for emergency adoption.

The Task Force was formed in 2012 after 21 equine deaths occurred between November 2011 and March 2012. The 21 deaths was more than double the expected frequency rate. The Task Force’s investigation revealed troubling aspects as to the way horses are examined and managed in this State, and found that the health and safety of racehorses and jockeys will be improved by reducing the use of legal anti-inflammatory medications in the time after the horse is entered to race.

On September 27, 2012, the Task Force published its report and included recommendations for the adoption of several emergency rules, which are contained in this Emergency Rulemaking. With the exception of Section 4012.5, the emergency rules contained herein are expressly requested by the Task Force. The amendment to Section 4012.5 of 9 NYCRR pertains to out of competition testing, and while it was not expressly included in the Task Force recommendations, it is by implication necessary to give force and effect to the equine drug program to detect the use of certain medications that the Task Force has identified as possible contributing factors to recent equine deaths.

The amendments to Board Rule 4043.2(i) are necessary to control the administration of corticosteroids to thoroughbred horses. These amendments are necessary for the health and safety of both the horse and the jockeys/riders. The withdrawal periods in the rule were prescribed directly by the Task Force and are necessary to provide clear guidance as to when administration should be discontinued for the purposes of testing and for the safety of the horse. In the case of Methylprednisolone acetate (DepoMedrol), the Task Force found that Methylprednisolone acetate has a degradative effect on articular cartilage: “The repetitive use of intra-articular corticosteroids, particularly methylprednisolone, may cause significant damage to the cartilage in the joint. Additionally, the intra-articular use of corticosteroids can mask the inflammatory changes ordinarily associated with joint disease, and can confound the pre-race clinical examination. For these reasons, regulation of intra-articular administration of corticosteroids is appropriate.” The term “intra-articular” has been revised to “joint injection” in the rule text to more accurately reflect a more common vernacular of the trade.

The Task Force recommended the amendment to Section 4038.5(c) of 9E NYCRR to require the disclosure to the successful claimant of any intra-articular corticosteroid injection performed within 30 days of the race. The Task Force found that “Currently, there is no way for a claimant to determine if the claimed horse has been recently injected with an intra-(articular) corticosteroid, putting that horse at risk for redundant medical treatment as well as preventing an accurate assessment of the horse’s soundness.” Four of the fatally injured horses injured horses in this investigation received intra-articular corticosteroid injections within seven days of racing.

The Task Force also identified the need to tighten controls over the use of clenbuterol, which is currently permitted as a 96-hour rule under the Board’s rules. It is a potent bronchodilator that is Food and Drug Administration-approved for treatment of lower airway inflammation and upper respiratory infections in the horse. It is used to prevent respiratory infections in horses experiencing exercise-induced pulmonary hemorrhage (respiratory bleeding), while some trainers have indicated that their horses look better and have increased appetites when treated with clenbuterol.

Nevertheless, the report stated that in addition to its pharmacological effect on the respiratory tract, clenbuterol mimics anabolic steroids in that it increases muscle and decreases fat in cattle, pigs, poultry and sheep. The report stated that there is a belief that illegally compounded clenbuterol has been used in thoroughbred horses as an alternative to the prohibited anabolic steroids. The Task Force found that “It was abundantly clear to the Task Force that while the NYSRWB’s time limit regarding clenbuterol was being followed, the medication is in common use as a substitute for anabolic steroids and not for the legitimate therapeutic purpose for which it is intended.”

Therefore, the amendment to 4043.2(g)(5) is necessary to remove it from the permissible 96-hour drug rule and only permit its administration 21 days before a race by virtue of amendment to Board rule 4043.2(i)(4).

The Board also amended Paragraph (9) of Subdivision (e) of 4043.2 of 9 NYCRR to remove any references to steroids. This was not a recommendation by the Task Force, but in light of the Board’s existing rule limiting the administration of anabolic steroids (Rule 4043.15) and the restrictions placed on corticosteroids in this rulemaking, the Board believes that no reference to steroids should be contained in 4043.2(e)(9) in order to avoid confusion.

The Task Force reported that “The failure of trainers to report intra-articular injections as required prevented the NYRA veterinarians from identifying a pattern of redundant...treatments that had the potential to misrepresent the true clinical condition of a horse...” Therefore, in order to ensure proper notification, the Board will amend Section 4043.4 of 9 NYCRR, which is commonly known as the “Trainer’s Responsibility Rule,” to require that trainers maintain accurate records of all corticosteroid joint injections to horse trained by them. The corticosteroid reporting will require that a trainer submit a corticosteroid joint injection record to the Board within 48 hours of treatment so that examining veterinarians will have access as part of the pre-race examinations. This amendment will improve the quality of pre-examinations, provide the Board with timely notice of any potential ailments and ensure that a document trail is available in the event the horse’s fitness comes into question.

4. Costs:

(a) Costs to regulated parties for the implementation of and continuing compliance with the rule: The costs for the New York Drug Testing and Research Program will be substantial. The cost for conducting administration trials necessary for Cortisone Testing will be $36,000. The cost of related laboratory testing of samples for corticosteroids is $18,000. The cost of trial administrations of clenbuterol is $6,000. The related laboratory testing of clenbuterol samples is $5,000.

(b) Costs to the agency, the state and local governments for the implementation and continuation of the rule: None. The amendments will require the New York State Racing and Wagering Board to develop a filing system for corticosteroid reporting.

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 information and based upon its experience in the equine drug testing program. The costs associated with clenbuterol and corticosteroid testing was provided directly from the New York Drug Testing and Research Program.

(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 a need for reporting corticosteroid injections. Trainers will be required submit paperwork to the Board in a manner prescribed by the Board.

7. Duplication: None.

8. Alternatives. These rule amendments are based upon the finding and recommendations of the Task Force and no other alternatives were considered.

9. Federal standards: None.

10. Compliance schedule: The rule will be effective December 12, 2012. The Board intends to submit this rule as a Proposed Rulemaking in the future and the extension of this rule may be necessary pursuant to the provisions of the State Administrative Procedure Act.

Regulatory Flexibility Analysis, Rural Area Flexibility Analysis, Job Impact Statement

As is evident by the nature of this rulemaking, this will not have an adverse affect on jobs or rural areas. This proposal concerns the restricted administration of certain drugs to thoroughbred race horses, the testing procedures to ensure compliance with those restrictions, and reporting of the administration of certain drugs. These medications – corticosteroids and clenbuterol – are currently permitted and will continue to be permitted but under different administration schedules. These schedules will have no impact on jobs or rural areas. This amendment is intended to reduce equine deaths in thoroughbred racing, and as such will have a positive effect on horseracing and the revenue generated through pari-mutuel wagering and breeding in New York State. This will not adversely impact rural areas or jobs or local governments and does not require a Rural Area Flexibility Statement or Job Impact Statement.