1. Statutory authority: The New York State Gaming Commission (“Commission”) is authorized to promulgate these rules pursuant to Racing Pari-Mutuel Wagering and Breeding Law sections 103(2), 104(1), 104(19) and 122. Under Section 103(2), the Commission is responsible to supervise, regulate, and administer all horse racing and pari-mutuel wagering activities in the State. Subdivision (1) of Section 104 confers upon the Commission general jurisdiction over all such gaming activities within the State and over the corporations, associations and persons engaged in such activities. Subdivision (19) of Section 104 authorizes the Commission to promulgate any rules and regulations that it deems necessary to carry out its responsibilities. Section 122 continues previous rules and regulations of the legacy New York State Racing and Wagering Board, subject to the authority of the Commission to modify or abrogate such rules and regulations.

2. Legislative objectives: To enable the Commission to enhance the integrity and safety of standardbred pari-mutuel racing while generating reasonable revenue for the support of government.

3. Needs and benefits: This rulemaking is necessary to restrict the administration of clenbuterol to the treatment of respiratory disorders in standardbred horses.

This proposal would add a new subdivision (p) to Section 4120.4 of 9 NYCRR, requiring that clenbuterol be administered only as prescribed by a veterinarian for the treatment of respiratory disorders. Clenbuterol is a bronchodilor and expectorant that is FDA-approved for treating bronchial disorders in racehorses. Treating veterinarians often dispense clenbuterol to the horse’s trainer, with instructions to administer the drug to the horse orally on a daily basis. A typical treatment regimen may be for two to 14 days, which is what the manufacturer recommends.

There have been reports of continuous daily clenbuterol administrations, however, to achieve an anabolic-like repartitioning effect, meaning that body fat is replaced by muscle mass. These reports in New York have been about thoroughbred racing, for which the Commission has undertaken and proposed remedial measures, but the drug could have a similar effect on standardbred horses. This anabolic-like effect has the potential to increase race performance, although such overuse can cause side effects that damage the health and racing ability of a race horse and continuous use of clenbuterol reduces its beneficial effects for bronchodilation and mucusiliary clearance.

Regardless of the precise effect such misuse of clenbuterol might have on a horse’s race performance, the manipulation of a horse’s racing ability with drugs is a matter of primary regulatory concern. Horse racing is sustained by pari-mutuel wagering, and the use of drugs to manipulate race performance has a negative effect on competitors, fan interest, public support, and the amount wagered by the betting public.

This proposal will require a veterinarian to supervise generally the administration of any clenbuterol that is dispensed. This means that the use of such clenbuterol, i.e., oral administrations under the direction of the horse’s trainer, may occur only as instructed by the veterinarian. In addition, the clenbuterol cannot be given for longer than is needed to treat a bronchial disorder. A veterinarian bears similar responsibilities when dispensing any prescription drug, such as clenbuterol. This rule will permit the Commission to provide further enforcement in the pari-mutuel racing industry.

There is no existing rule of the Commission that directly regulates treatment regimens for clenbuterol. The adoption of these requirements will help to prevent the overuse of clenbuterol in standardbred racing.

4. Costs:

(a) Costs to regulated parties for the implementation of and continuing compliance with the rule: This amendment would not add any new mandated costs to the existing rules.

(b) Costs to the agency, the state and local governments for the implementation and continuation of the rule: None. There will be no costs to local governments because they do not regulate pari-mutuel racing activities.

(c) The information, including the source(s) of such information and the methodology upon which the cost analysis is based: The Commission has determined that no costs will be imposed because the rule does not create any mandatory new duty or obligation.

(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 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 or their designated treating veterinarians will be required to make entries on the Commission’s free online reporting system.

7. Duplication: None.

8. Alternatives. The Commission considered and rejected an alternative requirement that a standardbred racehorse cannot race within 14 days of any clenbuterol treatment. Such a rule would deprive the horses of beneficial treatments when actively racing, and market forces (weekly racing) and the Commission’s existing 96-hour restricted time period are discouraging the overuse of clenbuterol. No other alternatives were considered.

9. Federal standards: None.

10. Compliance schedule: Regulated persons will be able to achieve compliance with the rule upon publication of a Notice of Adoption in the New York State Register.

A regulatory flexibility analysis for small business and local governments, a rural area flexibility analysis, and a job impact statement are not required for this rulemaking proposal because it will not adversely affect small businesses, local governments, rural areas, or jobs.

This proposal only authorizes the Commission to engage in its own enforcement action when there is an unsupervised or excessive administration of the prescription drug clenbuterol. Such regulation will serve to enhance the integrity of racing and the health and safety of racehorses, and the medication will continue to be permitted for its beneficial effects. This rule will not impose an adverse economic impact on reporting, record keeping, or other compliance requirements on small businesses in rural or urban areas or on employment opportunities. No local government activities are involved.