SGC-49-13-00018-A Per Se Regulatory Standardbred Threshold and Restricted Time Period for DMSO

1/21/15 N.Y. St. Reg. SGC-49-13-00018-A

NEW YORK STATE REGISTER

VOLUME XXXVII, ISSUE 03

January 21, 2015

RULE MAKING ACTIVITIES

NEW YORK STATE GAMING COMMISSION

NOTICE OF ADOPTION

 

I.D No. SGC-49-13-00018-A

Filing No. 1112

Filing Date. Dec. 31, 2014

Effective Date. Apr. 01, 2015

Per Se Regulatory Standardbred Threshold and Restricted Time Period for DMSO

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

Action taken:

Amendment of section 4120.2(a)(1); and addition of sections 4120.2(e)(20) and 4120.3(a)(6) to Title 9 NYCRR.

Statutory authority:

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

Subject:

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

Purpose:

To enhance the integrity and safety of standardbred horse racing with new DMSO equine drug rules.

Text of final rule:

A new section 4120.3 would be added 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 a threshold listed below. The test result of such laboratory shall include an assessment of the measurement uncertainty and imprecision of the quantitative threshold for the substance.

(6) DMSO: 10 mcg/ml in plasma.

Paragraph 1 of subdivision (a) of section 4120.2 would be amended to read as follows:

§ 4120.2 Restricted use of drugs, medication and other substances.

Drugs and medications are permitted to be used only in accordance with the following provisions:

(a) The following substances are permitted to be used at any time up to race time:

(1) topical applications (such as antiseptics, ointments, salves, [DMSO,] leg rubs, leg paints and liniments) [which] that may contain antibiotics but do not contain benzocaine, DMSO, steroids or other drugs; and

A new paragraph 20 would be added to subdivision (e) of section 4120.2 as follows:

(e) The following substances are permitted to be administered by any means until 48 hours before the scheduled post time of the race in which the horse is to compete:

***

(20) dimethyl sulfoxide (i.e., DMSO).

Final rule as compared with last published rule:

Nonsubstantive changes were made in sections 4120.2(e)(21) and 4120.3(a).

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

Kristen Buckley, Acting Secretary, New York State Gaming Commission, 1 Broadway Center, PO Box 7500, Schenectady, NY 12305-7500, [phone], email: [e-mail]

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

The changes made to the rulemaking proposal do not require a revised RIS, RFA, RAFA or JIS as they are non-substantive in nature; therefore, the impact on small businesses, local governments, jobs, or rural areas remains the same as presented in the rule as originally proposed in the State Register on December 4, 2013.

The non-substantive changes were to renumber the proposed section 4120.2(e)(21) as 4120.2(e)(20) and the proposed section 4120.3(a)(23) as 4120.3(a)(6), and to reword the technical description of laboratory test results (e.g., changing the word “evaluation” to “assessment”) in section 4120.3(a).

Initial Review of Rule

As a rule that does not require a RFA, RAFA or JIS, this rule will be initially reviewed in the calendar year 2019, which is no later than the 5th year after the year in which this rule is being adopted.

Assessment of Public Comment

The Commission received public comments that are included in the record of its duly noticed legislative rulemaking public hearing held on January 21, 2014, in support of coordinating its restricted time period for standardbred race horses with the Commission’s proposed laboratory threshold. The executive director of the Racing Medication and Testing Consortium (“RMTC”) testified that RMTC recommended the proposed threshold for dimethyl sulfoxide (“DMSO”), and indicated that its withdrawal guidelines give sufficient warning provided RMTC’s dose and route of administration specifications are followed. Representatives of the standardbred industry were concerned about discrepancies between typical racetrack use of drugs and the regimens studied by RMTC to provide information for avoiding an inadvertent threshold violation.

The Commission’s restricted time periods complement its proposed per se thresholds and perform the essential function of providing a simple instruction for trainers to follow for when to stop the administration of various drugs before a horse’s next race. The per se threshold rule for DMSO is intended to ensure that DMSO will not be used in a manner that could endanger a horse and driver or manipulate the outcome of pari-mutuel horse races. It will simplify the administrative adjudication of equine rule violations by making it an automatic rule violation to exceed this threshold. The adoption of this threshold nationally will also make it easier for trainers to race in New York and elsewhere. Although trainers who participate in other states are explicitly not assured that the recommended withdrawal time of RMTC for DMSO will prevent the occurrence of a positive post-race test, trainers may rely on the Commission’s restricted time period, when following accepted veterinary practices (e.g., clinical doses), to ensure their compliance with the national DMSO threshold in all states.

A further assessment of the public comments is provided in the following official Fact Findings in regard to this legislative rulemaking proposal that the Commission, based on decades of institutional knowledge and close supervision of standardbred horse racing in New York, the veterinary expertise of Equine Medical Director Scott Palmer, D.V.M., and consultation with internationally-renowned equine pharmacologist, toxicologist, and equine practices scientific consultant, George A. Maylin, D.V.M., M.S., Ph.D, made on December 22, 2014.

The Commission made the following rulemaking fact findings with regard to this rulemaking:

Agency Finding H:

A horse will not incur a positive laboratory finding in excess of the following threshold, following an administration of dimethyl sulfoxide (“DMSO”) in which the drug regimen is consistent with accepted veterinary practice, e.g., the administration of a clinical dose, provided that the drug is not administered within the Commission’s restricted time periods (including as adopted on December 22, 2014):

6. DMSO [48 hours]: 10 mcg/ml in plasma

Agency Finding I:

If there is a positive laboratory finding in excess of the foregoing threshold, then the administration of DMSO had the potential to affect the race performance of such horse.

Agency Finding J:

If there is a positive laboratory finding in excess of the foregoing threshold, assuming an administration of DMSO in which the drug regimen is consistent with accepted veterinary practice, then a violation of the Commission’s restricted time period for such drug occurred.