SGC-49-13-00009-P Per Se Regulatory Standardbred Threshold and Restricted Time Period for Clenbuterol

12/4/13 N.Y. St. Reg. SGC-49-13-00009-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-49-13-00009-P

Per Se Regulatory Standardbred Threshold and Restricted Time Period for Clenbuterol

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

Proposed Action:

Addition of sections 4120.3(a)(17), 4120.2(k); and repeal of section 4120.2(g)(5) of Title 9 NYCRR.

Statutory authority:

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

Subject:

Per Se regulatory standardbred threshold and restricted time period for clenbuterol.

Purpose:

To enhance the integrity and safety of standardbred horse racing with new clenbuterol rules.

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:

A new paragraph (17) would be added to subdivision (a) of the separately proposed new section 4120.3 to read as follows:

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.

* * *

(17) Clenbuterol:

(i) 140 pg/ml in urine; or

(ii) any clenbuterol in plasma.

A new Subdivision (k) would be added to Section 4120.2 as follows:

(k) A horse may not race for at least 14 days following an administration of clenbuterol.

Subdivision (g) of Section 4120.2 would be amended 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:

* * *

[(5) clenbuterol;]

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 standardbred 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 standardbred race horses of the drug clenbuterol close to race day, and to simplify compliance by horsepersons and the enforcement of the equine drug rules in New York by adopting a proposed national permissible regulatory laboratory threshold for such drug. This proposal would also amend the restricted time period before a horse may race after a treatment with clenbuterol to ensure that horsepersons who comply with the Commission’s restricted time periods will not incur an equine drug positive, including for exceeding the proposed clenbuterol Per Se threshold.

The proposed rule would establish for clenbuterol a 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”). The purpose of the threshold is to permit the administration of clenbuterol, but only 14 days or more before a horse’s next race. Clenbuterol is an FDA-approved drug for veterinary treatment of respiratory ailments, a common affliction of race horses routinely confined to stalls. It is widely accepted, however, that clenbuterol has become an abused drug that is regularly administered because of its anabolic steroid properties which have the potential to affect race horse health and performance. According to RMTC and other experts, standardbred horses should be able to race without routine use of clenbuterol, in part because all of the competitors would face the same restrictions on its use. Some significant concerns and opposition have been raised to the rule proposal, however, by standardbred horsepersons, their organizations at New York racetracks, and their national organization, The United States Trotting Association, Inc. (“USTA”). The Commission has established equine drug rules that are identical for both standardbreds and thoroughbreds, except where justified by substantial differences between the breeds and racing practices.

The primary focus of comments from standardbred horsepersons has been on the different impact that the proposed regulations of clenbuterol and corticosteroids could have on standardbred racing, where horses race much more often (typically every seven days), and have far fewer breakdowns, compared to thoroughbred racing. Any drug that cannot be used during the week before a horse’s next race has a disproportionate impact in standardbred racing, where horses often race weekly, in comparison to thoroughbred racing. In addition, standardbred horses break down less frequently, are a sturdier breed of horse, and race under conditions that create considerably less force on the horse’s limbs. In view of such concerns, before progressing with final rulemaking, the Commission will conduct a public hearing to gather all relevant input and fully consider the potential impacts of the proposed clenbuterol limitations given current standardbred practice.

The proposed rule would add clenbuterol to the accepted medications whose detection would be permitted in race-day samples, albeit with a restricted time period of 14 days before a horse’s next race, and establish the same threshold proposed in other states. Such threshold is meant to include clenbuterol as a recognized drug among a specific set of medications that are all that is needed for routine veterinary care close to race day of any racing horse and that can be effectively regulated by means of laboratory testing. Such drugs, which total 24, 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.

The net effect of the new rule would be to help ensure, in conjunction with New York’s restricted time period drug rule set forth in Section 4120.2, that no use of clenbuterol would be permitted that might affect race performance through such drug’s anabolic steroid properties. The proposed 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 the proposed clenbuterol regulatory laboratory threshold. The proposed rule would also amend Section 4120.2 to change the restricted time period during which a horse may not race after treatment with clenbuterol from 96 hours to 14 days.

A Per Se threshold rule would also make it easier for the Commission to establish that an improper equine drug administration has occurred. The proposed rule, unlike the restricted time period rule set forth in Section 4120.2, 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.

Adoption of an appropriate new Per Se equine clenbuterol rule would enhance the integrity of horse racing by limiting the drugs that can be used close to race day to only those that are well-accepted, necessary, and capable of control by means of laboratory testing. Such a rule would encourage the entry into New York races of horses stabled out-of-state if it makes the New York rule 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: The proposed limitation on the use of clenbuterol to 14 days before a horse’s next race would require trainers either to treat the horse with a different medication for respiratory ailments or not to race the horse for 14 days after treating it with clenbuterol. The latter option is inconsistent with the typical practice of racing a standardbred horse on a weekly basis for much of the calendar year.

5. Local government mandates: None. The New York State Gaming Commission is the only governmental entity authorized to regulate pari-mutuel harness 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 on standardbred horses close to race day of the drug clenbuterol by regulating its use by the adoption of a Per Se regulatory laboratory threshold. All trainers will be able to comply with this proposed threshold. No competitors will be able to use this restricted substances in violation of the same thresholds. The threshold will make it less expensive to prepare a horse to race in multiple jurisdictions, and inadvertent drug positives will be less common, because it is being proposed as part of a national set of thresholds in other states. The mid-Atlantic states and Massachusetts have publicly pledged to adopt this threshold by January 2014, and this threshold is favored by the other American racing jurisdictions, which all voted for this threshold 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.

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 various restrictions 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 time restriction period for clenbuterol will be raised from 96 hours to 14 days before racing.

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.