Restricted Time Periods for Clenbuterol Use on Standardbred Racehorses

NY-ADR

9/17/14 N.Y. St. Reg. SGC-49-13-00009-RP
NEW YORK STATE REGISTER
VOLUME XXXVI, ISSUE 37
September 17, 2014
RULE MAKING ACTIVITIES
NEW YORK STATE GAMING COMMISSION
REVISED RULE MAKING
NO HEARING(S) SCHEDULED
 
I.D No. SGC-49-13-00009-RP
Restricted Time Periods for Clenbuterol Use on Standardbred Racehorses
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following revised rule:
Proposed Action:
Amendment of sections 4120.2(g)(5) and 4120.3(a); and addition of section 4120.2(k) to Title 9 NYCRR.
Statutory authority:
Racing, Pari-Mutuel Wagering and Breeding Law, sections 103(2), 104(1), (19) and 122
Subject:
Restricted time periods for clenbuterol use on standardbred racehorses.
Purpose:
To enhance the integrity and safety of standardbred horse racing.
Text of revised rule:
The revised rule making would delete the proposed new paragraph (17) of subdivision (a) of Section 4120.3:
4120.3. 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 in excess of any one or more of the thresholds listed below. The test for each sample shall include an evaluation of the method of uncertainty and the imprecision of the analytical test.
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[(17) Clenbuterol:
(i) 140 pg/ml in urine; or
(ii) any clenbuterol in plasma.]
The rule making would revise the proposed amendment to subdivision (g) of Section 4120.2, as follows:
(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:
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[[](5) clenbuterol, except as provided in subdivision (k) of this section;[]]
The rule making would revise the proposed new subdivision (k) of Section 4120.2, as follows:
(k) If a horse has been required to qualify when not showing a current performance within 30 days or more and has not yet raced after qualifying, then such [A] horse may not race for at least 14 days following an administration of clenbuterol.
Revised rule compared with proposed rule:
Substantial revisions were made in sections 4120.2(g)(5), (k) and 4120.3(a)(17).
Text of revised proposed rule and any required statements and analyses may be obtained from
Kristen M. Buckley, New York State Gaming Commission, One Broadway Center, PO Box 7500, Schenectady, NY 12301, (518) 388-3407, email: [email protected]
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
30 days after publication of this notice.
Revised 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 standardbred horses and human participants in pari-mutuel racing, while generating reasonable revenue for the support of government.
3. Needs and benefits: This revised rule making is necessary to create reasonable restrictions for standardbred horse racing that will control and minimize the administration to the horses of the drug clenbuterol for its improper anabolic-like effects, while still permitting the common use of clenbuterol for its FDA-approved purpose of treating a horse’s bronchial disorders.
The Commission had proposed a rule that would establish a restricted time period of 14 days before a horse could race after an administration of clenbuterol and a corresponding regulatory laboratory threshold that was developed by the Racing Medication and Testing Consortium (“RMTC”) and adopted as a model rule by the Association of Racing Commissioners International, Inc. (“ARCI”). Clenbuterol is an FDA-approved drug for veterinary treatment of respiratory ailments, a common affliction of race horses confined to stalls. Clenbuterol became an abused drug, however, that was being continuously administered to thoroughbred horses in New York because of its anabolic steroid properties, which have the potential to affect race horse health and performance. This misuse of clenbuterol prompted thoroughbed industry representatives to propose a 14-day ban to reverse such effect of the drug before racing, which the Commission adopted in December 2012, and laboratory threshold that is the subject of a separate Commission rule proposal. Since this rule was proposed, however, significant concerns have arisen concerning the creation of a 14-day ban for standardbred racing in which horses are generally raced on a weekly basis. A 14-day ban would require a horseperson using clenbuterol properly on a standardbred horse for the treatment of a respiratory disorder to miss several racing opportunities, a problem that is not typical for thoroughbred racing in New York. These concerns were shared with the Commission at a public rule-making hearing held by the Commission and attended by practicing standardbred veterinarians and various horseperson organization representatives, including the standardbred horseperson’s national organization, the United States Trotting Association, Inc. In addition, the frequency of racing in standardbred racing minimizes the abuse of clenbuterol in standardbred racing, because the drug must be administered continuously for a longer period of time than one week to produce muscle growth, according to existing research. The revisions to Section 4120.2(g)(5) and the addition of a new subdivision (k) of section 4120.2 will prohibit the use of clenbuterol on standardbred horses for 14 days before racing only when the horse is returning from a lay-off from racing for 30 days or more. This criterion was selected because a standardbred horse that does not race for 30 days or more could be treated with clenbuterol to generate muscle growth but is generally required to participate in a qualifying race before the horse may race again. This gives the horseperson clear notice of when the 14-day ban will be applied to a horse, while still allowing standardbred horses that regularly race to benefit from appropriate short-term uses of clenbuterol to treat respiratory disorders. The permissible short-term use of clenbuterol is governed by the Commission’s current restriction against administering any clenbuterol for 96 hours before a horse may race. This revised rule strikes proposed Section 4120.3(a)(17) in order to eliminate the proposed Per Se threshold for clenbuterol for standardbred racing because such a threshold is too strict for a 96-hour restricted time period.
The primary purpose of this revision is to permit the appropriate use of clenbuterol to treat bronchial disorders of standardbred horses without unnecessarily forcing a treated horse to miss racing opportunities, while protecting the sport from any misuse of the drug for its anabolic-like effects. This rule making is also important to discourage any continual overuse of the drug clenbuterol, which research demonstrates causes a serious risk to the health of a horse. It should be noted that the Commission has also proposed, in a separate standardbred rule making, that a veterinarian must generally supervise every clenbuterol administration and further restricts its use to the treatment of only respiratory disorders.
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. There will be no costs to local government 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 revised proposal limits the use of clenbuterol to 14 days before a horse’s next race only when the horse is returning to racing after a lay-off of 30 days or more, thus requiring trainers to treat a horse’s respiratory ailments with a different medication only when such treatment alternatives will not interfere with the horse’s racing schedule. Based on its experience regulating standardbred racing, the Commission does not believe the rule making will result in significant costs.
5. Local government mandates: None. The New York State Gaming Commission is the only governmental entity authorized to regulate pari-mutuel standardbred 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 the comments received at the hearing. 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 this revised rule is adopted.
Revised Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement
This rulemaking proposal does not necessitate a revision to the previously published analyses and statement and does not have an adverse affect on small businesses, local governments, jobs, or rural areas.
Assessment of Public Comment
Public comments were received from numerous sources in the standardbred horseracing industry in opposition to the proposed ban against racing a horse within 14 days of any administration of clenbuterol. They commented that this ban would prevent a horse from racing on the industry-standard weekly basis when properly treated with clenbuterol for a respiratory disorder, which is the approved and widely practiced use of this drug in standardbred racing. The Commission has responded to these comments by limiting the proposed 14-day ban to horses that have to qualify following a lay-off of 30 days or more. The revisions to the rule recognize that regularly racing horses do not have sufficient time between races, particularly because the Commission already bans any use of the drug for 96 hours before a horse’s next race, to gain the muscle building effects of clenbuterol. Any respiratory disorders that arise while returning from a long lay-off can be reasonably treated by alternative methods of treatment.
End of Document