RWB-08-13-00006-E Implementation of Substantive Changes and Procedures Pertaining to Equine Drugs and Reporting Requirements for Thoroughbreds

5/29/13 N.Y. St. Reg. RWB-08-13-00006-E

NEW YORK STATE REGISTER

VOLUME XXXV, ISSUE 22

May 29, 2013

RULE MAKING ACTIVITIES

NEW YORK STATE GAMING COMMISSION

EMERGENCY RULE MAKING

 

I.D No. RWB-08-13-00006-E

Filing No. 506

Filing Date. May. 14, 2013

Effective Date. May. 14, 2013

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 4043.2(e)(9), (g), (i) and 4043.4(b) of Title 9 NYCRR.

Statutory authority:

Racing, Pari-Mutuel Wagering and Breeding Law, sections 103(1), 104(1), (19), 122, 128 and 902(1)

Finding of necessity for emergency rule:

Preservation of public safety and general welfare.

Specific reasons underlying the finding of necessity:

The Gaming Commission 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 its 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. The amendments contained in this emergency rulemaking are based upon the findings and recommendations of the Task Force.

The Board originally adopted emergency rules to address the administration of clenbuterol and corticosteroids. These emergency rules were requested by the industry for the purpose of protecting the horses and athletes involved in thoroughbred racing and must be implemented on an emergency basis.

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 (g) of Section 4043.2 of 9 NYCRR is amended 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] Such substances 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] 96-hour period.

Paragraph 9 of Subdivision (e) of Section 4043.2 of 9 NYCRR is amended 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 9 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 a corticosteroid; and

(3) for at least 14 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.

New Subdivision (b) is added to Section 4043.4 of 9 NYCRR to read as follows:

(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. The trainer may delegate this responsibility to the treating veterinarian, who shall make these reports when so designated. The reports 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 a notice of emergency adoption. This agency intends to adopt the provisions of this emergency rule as a permanent rule, having previously submitted to the Department of State a notice of proposed rule making, I.D. No. RWB-08-13-00006-P, Issue of February 20, 2013. The emergency rule will expire July 12, 2013.

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

John Googas, New York State Gaming Commission, One Broadway Center, Suite 600, Schenectady, New York 12305-2553, [phone], email: [e-mail]

Regulatory Impact Statement

1. Statutory authority and legislative objectives of such authority: The Gaming Commission is authorized to promulgate these rules pursuant to Racing Pari-Mutuel Wagering and Breeding Law sections 103(1), 104(1), 104(19), 122, 128, and 902(1). Under sections 103(1) and 104(1), the Gaming Commission has general jurisdiction over all horse racing and pari-mutuel wagering activities in the state and the corporations and associations and persons engaged therein, including the authority to regulate the use of drugs that can manipulate race performance, and is responsible for the supervision, regulation, and administration thereof. Section 104(19) authorizes the Gaming Commission to promulgate any rules and regulations that it deems necessary to carry out its responsibilities. Section 122 provides that all rule-making of the former New York State Racing and Wagering Board shall continue in force and effect as rule-making of the Gaming Commission until duly modified or abrogated by such commission. Section 128 authorizes the new Gaming Commission to promulgate regulations on an emergency basis by methods outside of standard administrative procedural requirements to ensure continuity through readopting current emergency rules of the Gaming Commission. 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 Gaming Commission to promulgate any rules and regulations necessary to implement its equine drug testing program and to impose substantial administrative penalties on anyone who races drugged horses.

2. Legislative objectives: To enable the New York State Gaming Commission 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 Gaming Commission 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 were more than double the expected frequency rate. The Task Force’s investigation revealed troubling aspects with 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.

The amendments to Gaming Commission 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. The withdrawal periods in the rule were prescribed explicitly 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. The intra-articular use of corticosteroids can mask the inflammatory changes ordinarily associated with joint disease, and can frustrate the pre-race clinical examination. For such reasons, regulation of joint injections of corticosteroids is appropriate. The term “intra-articular” has been revised to “joint injection” in the rule text to more accurately reflect a vernacular of the trade.

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 Gaming Commission’s rules. It is a potent bronchodilator that was introduced to race horse care and treatment to prevent respiratory infections in horses experiencing exercise-induced pulmonary hemorrhage (respiratory bleeding). Some trainers have indicated that their horses look better and have increased appetites when treated with clenbuterol. 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 prohibited anabolic steroids. The Task Force found: “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.” The amendments will replace the existing 96-hour time restriction, prompting the change to subdivision (g) of 4043.2 of 9 NYCRR to remove any reference to clenbuterol, with a 14-day restriction to be found in a new paragraph (3) of subdivision (i) of 9 NYCRR.

The Gaming Commission 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 Gaming Commission’s existing rule limiting the administration of anabolic steroids (Rule 4043.15) and the restrictions placed on corticosteroids in this rulemaking, the Gaming Commission believes that Rule 4043.2(e)(9) should contain no reference to steroids, in order to avoid confusion.

The Task Force reported: “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 Gaming Commission amends Section 4043.4 of 9 NYCRR, which is commonly known as the “Trainer’s Responsibility Rule,” to require that a trainer submit a corticosteroid joint injection record to the Gaming Commission within 48 hours of treatment so that examining veterinarians will have access to that information as part of the pre-race examinations. This amendment will improve the quality of pre-examinations, provide the Gaming Commission with timely notice of any potential ailments, notify the racing office at the racetrack when horses are ineligible to enter upcoming races because of a corticosteroid joint injection within seven days of the race, and ensure that documentation is available in the event a horse’s fitness comes into question. In response to input from the New York Thoroughbred Racing Association, the Gaming Commission previously added the new 9 NYCRR 4043.4(b), authorizing trainers to delegate the reporting responsibility to the treating veterinarians.

These emergency rules certainly have had had a positive impact on racing and should be continued. Since December 26, 2012 when the emergency rules took effect, there were only nine equine racing fatalities at Aqueduct (all surfaces) compared to 23 that occurred from December 26, 2011 through April 22, 2012 (the last day of racing at Aqueduct before moving to Belmont). Based on a rate of 1,000 starters, there were 4 equine racing fatalities for every 1,000 horses starting after December 26, 2011 at Aqueduct (before moving to Belmont) compared to 1.9 equine racing fatalities per 1,000 starters from December 26, 2012 to the time Belmont opened on April 26, 2013, which is a 53 percent decrease in equine racing fatalities since enforcement of these emergency rules at Aqueduct. This result was predicted by the Task Force, when it recommended that these emergency rules be adopted immediately and permanently. Such result was also recognized by the former New York State Racing and Wagering Board, when it authorized a first readoption of these rules and proposed them as permanent rules. More recently, Gaming Commission staff has affirmed the effectiveness of these emergency rules to reduce equine racing fatalities.

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 per year. The cost of trial administrations of clenbuterol is $6,000. The related laboratory testing of clenbuterol samples is $5,000 per year.

(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 Gaming Commission to develop a filing system for corticosteroid reporting.

There will be no costs to local government because the New York State Gaming Commission is the only governmental entity authorized to regulate pari-mutuel horse racing.

(c) The information, including the source(s) of such information and the methodology upon which the cost analysis is based: The Gaming Commission 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 Gaming Commission is the only governmental entity authorized to regulate pari-mutuel horse racing activities.

6. Paperwork: There will be a need for reporting corticosteroid injections. Trainers will be required submit paperwork to the Gaming Commission in a manner prescribed by the Gaming Commission.

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: This rule will be implemented upon submission to the Department of State as a second 60-day extension, the first having been filed with the Department of State on March 13, 2013, to an original emergency rulemaking that was published in the December 26, 2012 State Register. The Notice of Proposed Rule-Making to make these into permanent rules has been published in the February 20, 2013 State Register.

Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and 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.

Assessment of Public Comment

The agency received no public comment.