SGC-49-13-00020-P Per Se Thoroughbred Regulatory Thresholds for Equine Drugs

12/4/13 N.Y. St. Reg. SGC-49-13-00020-P

NEW YORK STATE REGISTER

VOLUME XXXV, ISSUE 49

December 04, 2013

RULE MAKING ACTIVITIES

NEW YORK STATE GAMING COMMISSION

PROPOSED RULE MAKING

HEARING(S) SCHEDULED

 

I.D No. SGC-49-13-00020-P

Per Se Thoroughbred Regulatory Thresholds for Equine Drugs

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

Proposed Action:

Renumbering of section 4043.3 to 4043.13; and addition of new section 4043.3 to Title 9 NYCRR.

Statutory authority:

Racing, Pari-Mutuel Wagering and Breeding Law, sections 103(2), 104(1), (19) and 122

Subject:

Per Se thoroughbred regulatory thresholds for equine drugs.

Purpose:

To enhance the integrity and safety of thoroughbred horse racing by adopting permissive thresholds for 24 accepted medications.

Public hearing(s) will be held at:

10:30 a.m. - 3:30 p.m., Jan. 21, 2014 at State Gaming Commission, One Broadway Center, 6th Fl. Board Rm. (overflow, 5th Fl. Multimedia Rm.), Schenectady, NY.

Interpreter Service:

Interpreter services will be made available to hearing impaired persons, at no charge, upon written request submitted within reasonable time prior to the scheduled public hearing. The written request must be addressed to the agency representative designated in the paragraph below.

Accessibility:

All public hearings have been scheduled at places reasonably accessible to persons with a mobility impairment.

Text of proposed rule:

Section 4043.3 (“Other prohibitions”) of 9 NYCRR would be renumbered Section 4043.13, and

A new Section 4043.3 would be added to Part 4043 of 9 NYCRR, to read as follows:

Section 4043.3. Equine drug thresholds; per se

(a) A horse shall have raced in violation of this section if any of the following substances is found, by the laboratory conducting tests for the commission, to be present in a race-day urine or blood sample taken from such horse at a concentration listed below. The test for each sample shall include an evaluation of the method of uncertainty and imprecision of the analytical test.

(1) Acepromazine: 10 ng/ml HEPS in urine;

(2) Betamethasone: 10 pg/ml in plasma;

(3) Butorphanol:

(i) 300 ng/ml of total butorphanol in urine; or

(ii) 2 ng/ml of free butorphanol in plasma;

(4) Clenbuterol:

(i) 140 pg/ml in urine; or

(ii) any clenbuterol in plasma;

(5) Dantrolene: 100 pg/ml of 5-hydroxydantrolene in plasma;

(6) Detomidine:

(i) 1 ng/ml of any metabolite of detomidine in urine; or

(ii) any detomidine in plasma;

(7) Dexamethasone: 5 pg/ml in plasma;

(8) Diclofenac: 5 ng/ml in plasma;

(9) DMSO: 10 mcg/ml in plasma;

(10) Firocoxib: 20 ng/ml in plasma;

(11) Flunixin: 20 ng/ml in plasma;

(12) Furosemide: 100 ng/ml in plasma and a specific gravity of urine less than 1.010;

(13) Glycopyrrolate: 3 pg/ml in plasma;

(14) Ketoprofen: 10 ng/ml in plasma;

(15) Lidocaine: 20 pg/ml of total 3-hydroxylidocaine in plasma;

(16) Mepivacaine:

(i) 10 ng/ml of total hydroxymepivacaine in urine; or

(ii) any hydroxymepivacaine in plasma;

(17) Methocarbamol: 1 ng/ml in plasma;

(18) Methylprednisolone: 100 pg/ml in plasma;

(19) Omeprazole: 1 ng/ml of omeprazole sulfide in urine;

(20) Phenylbutazone: 2 mcg/ml in plasma;

(21) Prednisolone: 1 ng/ml in plasma;

(22) Procaine penicillin: 25 ng/ml of procaine in plasma;

(23) Triamcinolone acetonide: 100 pg/ml in plasma; and

(24) Xylazine: 10 pg/ml of total xylazine and its metabolites in plasma.

(b) A horse shall have raced in violation of this section if the laboratory conducting tests by or for the commission is able to determine from such horse’s race-day urine or blood sample that a drug or other substance for which no permissible threshold is established in this Part had been administered to such horse before its race, unless such drug or other substance by its nature could not affect a horse’s organ systems.

(c) A laboratory finding that a horse has not exceeded a threshold set forth in this section shall not constitute a defense to a violation of any other section of this subchapter.

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

Kristen M. Buckley, New York State Gaming Commission, One Broadway Center, Suite 600, Schenectady, NY 12305, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Same as above.

Public comment will be received until:

January 26, 2014.

Regulatory Impact Statement

1. Statutory authority and legislative objectives of such 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, 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 protect the integrity of pari-mutuel horse races and the health and safety of thoroughbred horses and human participants in pari-mutuel racing, while generating reasonable revenue for the support of government.

3. Needs and benefits: This rulemaking is necessary to limit the administration to race horses of drugs and other substances that can be administered close to race day, and to simplify compliance by horsepersons and enforcement of the equine drug rules in New York, by adopting a set of national permissible regulatory laboratory thresholds for drugs that are necessary and sufficient to provide good veterinary care close to race day.

Section 4043.3(a) of the proposed rule would establish, for 24 commonly used equine drugs, regulatory laboratory thresholds that were developed by the Racing Medication and Testing Consortium (“RMTC”), with the participation and support of the New York Thoroughbred Horsemen’s Association (“NYTHA”) that represents the thoroughbred trainers and owners who participate in racing at tracks operated by The New York Racing Association (“NYRA”), and adopted as a model rule by the Association of Racing Commissioners International, Inc. (“ARCI”). These thresholds are intended by RMTC and ARCI to apply in all horse racing jurisdictions. The selected 24 drugs are intended to encompass all of the medications that would be needed for routine veterinary care close to race day of any racing horses and that can be effectively regulated by means of laboratory testing. Such drugs were identified after lengthy consultation by the RMTC with the American Association of Equine Practitioners and many of the horse racing industry’s leading chemists and pharmacologists.

As set forth in proposed Section 4043.3(b), any detection in race-day samples of an administration of other drugs or other substances that could affect race performance would be a rule violation. The use of a drug or other substance that cannot affect race performance, a trait that is defined in veterinary terms as having no effect on the body organ systems of the horse, however, would not be affected by the new rule.

The net effect of the new rule would be to help ensure, in conjunction with New York’s restricted time period equine drug rules, that no pharmacologically significant residue of any drug or medication that could affect race performance will be present in the horse during a pari-mutuel race, while limiting the number of drugs that are used close to race day to these 24 that are well-accepted, necessary, and capable of being regulated by known threshold values. This rule would make it an automatic (“Per Se”) violation of the Commission’s equine drug rules to race a horse whose race-day blood or urine samples exceed these regulatory laboratory thresholds. This will supplement the Commission’s rule in Section 4043.2 that restricts the time periods in which certain drugs can be used. Between them, the two rules will provide clear standards governing when and how various drugs or other substances can permissibly be administered to race horses.

The new rule will provide an advantage for horsepersons because the permissible concentrations of drugs in a horse on race day will become more uniform among the racing jurisdictions. All of the racing commissions in the neighboring mid-Atlantic states and Massachusetts, for example, have publicly pledged to adopt these thresholds by January 2014. The rule will therefore simplify the veterinary treatment issues faced by trainers who are licensed to race in more than one jurisdiction, many of whom train their horses and obtain veterinary care in reference primarily to their host state’s rules. The adoption of more uniform equine drug rules will make it easier for an out-of-state trainer to decide to race a horse in New York when abiding by the equine drug rules of the other jurisdiction. Horsepersons who are confident that they will not commit an unintended violation of New York’s equine drug rules are more likely to enter their horses to race in New York, which will improve the depth and quality of the fields in New York races. The new rule will, therefore, make it easier for trainers and owners who race in multiple states to comply with the New York equine drug rules and to race in New York, while affording protection to the betting public against the manipulation of a horse’s race performance with drugs and other substances.

The Per Se rule also will make it easier for the Commission to establish that an improper equine drug administration has occurred. The new rule, unlike the restricted time period rule set forth in Section 4043.2, can be enforced without requiring either expert opinion evidence of the time of administration or direct evidence (e.g., veterinary records) to establish that an administration occurred within the restricted time period. This will simplify the enforcement of the Commission’s equine drug rules.

The adoption of the proposed Per Se equine drug rule will enhance the integrity of horse racing by limiting which drugs can be used close to race day to only those that are well-accepted, necessary, and capable of control by means of laboratory testing. The new rule will also protect the health and safety of thoroughbred race horses and their exercise riders and jockeys by creating uniform equine drug practices that limit the medication of racing horses close to race day to only those medications that are known to be safe and effective for providing a sufficient degree of veterinary care. Finally, the new rule will encourage the entry into New York races of more horses that are stabled out-of-state by making the New York rules more consistent with those of other states.

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.

(b) Costs to the agency, the state and local governments for the implementation and continuation of the rule: None.

(c) The information, including the source(s) of such information and the methodology upon which the cost analysis is based: Commission staff reviewed the cost factors and determined that the rule can be implemented with little or no additional costs. To the extent that a less expensive alternative drug might not be permitted close to race day under the new rules, this was determined to be off-set by the anticipated overall reduction in the use of equine drugs by all horsepersons.

5. Local government mandates: None. The New York State Gaming Commission is the only governmental entity authorized to regulate pari-mutuel racing activities.

6. Paperwork: There will be no additional paperwork.

7. Duplication: None.

8. Alternatives: This rule amendment is based upon the finding and recommendations of the RMTC and the ARCI and no other alternatives were considered.

9. Federal standards: None.

10. Compliance schedule: It is expected that regulated parties will be able to comply as soon as the proposed rule is adopted.

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

This rulemaking proposal will not have an adverse affect on small businesses, local governments, jobs, or rural areas. The proposal limits the use of equine drugs close to race day to 24 specified medications and regulates their use by the adoption of Per Se regulatory laboratory thresholds. Although this might result in a veterinarian not using a less expensive alternative drug on occasion, more expensive drugs will not have to be used to maintain a competitive edge because none of the other participants will be able to use them either. It is also anticipated that any additional costs would be more than off-set by the reduced use generally of equine drugs in the time period before race day, greater ease in complying with racing rules, and simplification of veterinary care. These benefits will accrue due to the limitation of the number of drugs that may permissibly be used. It will also become less expensive to prepare a horse to race in multiple jurisdictions, and inadvertent drug positives will be less common. The mid-Atlantic states and Massachusetts have all publicly pledged to adopt these thresholds by January 2014, and the thresholds are favored by the other American racing jurisdictions, which all voted for these thresholds as a model rule. A trainer will be able to obtain veterinary care by reference to the rules of the host state without being concerned about whether this will prevent the horse from racing in a nearby jurisdiction. The restrictions will standardize veterinary care, make it easier to treat horses that might compete in multiple states, and reduce the overall cost of equine veterinary medical care.

This proposal will have no adverse impact on small businesses, local governments, jobs or rural areas. The rule does not impose any significant technological changes on the industry. It imposes no adverse economic impact or reporting, recordkeeping, or other compliance requirements on small businesses in rural or urban areas or on employment opportunities. No local government activity is involved. Trainers have been meeting almost all of these thresholds for many years in New York by complying with the Commission’s longstanding rules that restrict how long a horse must not race after being treated with various equine drugs and other substances. The only difference for these 24 drugs are with the long-lasting drug firocoxib, a change for the use of dimethyl sulfoxide (“DMSO”), and a limitation on corticosteroids. The threshold for firocoxib will require trainers not to use this drug for 14 days before racing. DMSO will have to not be used within 48 hours of racing, rather than topical use on race day and otherwise seven days before racing, to comply reliably with the new threshold. Corticosteroids will be limited to five: two will be unaffected, two will be impermissible for systemic use for two more days (seven days rather than five) before racing, and the damaging and long-lasting drug methylprednisolone acetate (“Depo Medrol”) may be used but the horse would be unable to race until it tests below the regulatory threshold. These restrictions on corticosteroids will improve the health and longevity of the racing careers of thoroughbred race horses by limiting all trainers. Presently, trainers have to compete against horses that are more freely administered corticosteroids, which can help a horse win its next race but that are a detriment to the horse’s health and safety when used too much.

Even though small businesses that own and train thoroughbred race horses will be effected, they will benefit from the reduced use throughout the industry of multiple and more expensive medications as race day approaches, standardized veterinary practices that favor recognized therapeutic medications that provide good veterinary care, limiting competitors to the same set of well-accepted and beneficial equine drugs close to race day, and the greater ease of regulatory compliance when racing in multiple states. This amendment is intended to improve veterinary care and 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 proposal will not adversely impact small businesses, local governments, jobs, or rural areas. It does not require a Regulatory Flexibility Analysis (for Small Businesses and Local Governments), Rural Area Flexibility Analysis, or Job Impact Statement.