SGC-49-13-00019-A To Limit the Use of the Corticosteroid Methylprednisolone Acetate (e.g., Depo-Medrol) in Thoroughbred Racing

12/31/14 N.Y. St. Reg. SGC-49-13-00019-A

NEW YORK STATE REGISTER

VOLUME XXXVI, ISSUE 52

December 31, 2014

RULE MAKING ACTIVITIES

NEW YORK STATE GAMING COMMISSION

NOTICE OF ADOPTION

 

I.D No. SGC-49-13-00019-A

Filing No. 1048

Filing Date. Dec. 16, 2014

Effective Date. Jan. 01, 2015

To Limit the Use of the Corticosteroid Methylprednisolone Acetate (e.g., Depo-Medrol) in Thoroughbred Racing

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

Action taken:

Addition of section 4043.2(k) to Title 9 NYCRR.

Statutory authority:

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

Subject:

To limit the use of the corticosteroid methylprednisolone acetate (e.g., Depo-Medrol) in thoroughbred racing.

Purpose:

To enhance the integrity and safety of thoroughbred horse racing.

Text or summary was published

in the December 4, 2013 issue of the Register, I.D. No. SGC-49-13-00019-P.

Final rule as compared with last published rule:

No changes.

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

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

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, including as part of the record of its duly noticed legislative rulemaking public hearing held on January 21, 2014. Representatives of the Racing Medication and Testing Consortium (“RMTC”) distinguished its recommended threshold and withdrawal guideline for intra-articular (“IA”) administration of methylprednisolone acetate (e.g., Depo-Medrol), for which research was based on treating only a limited (one or two) number of joints with just one (e.g., a specific dose calculated by a horse’s weight) clinically accepted veterinary practice. RMTC indicated, including in its written materials for the public hearing, that this IA corticosteroid could not be used intramuscularly without greatly extending its withdrawal time, that its clearance time more than doubled when the research IA dose was increased from 100 to 200 mg, and a large number of threshold violations occurred during the first year the proposed threshold had been adopted in one state. RMTC further indicated that while the proposed threshold for this drug was derived for a pre-conceived minimum withdrawal period (seven days) to provide a sufficient period of time for a thoroughbred horse to be re-evaluated after joint treatment before racing, a test result in excess of this threshold does not establish an administration of the drug within such time period. Rather, a test result not in excess of the proposed threshold for this drug is consistent with the drug having not been not administered to the horse by means of a joint injection within seven days of the horse’s race. The Commission also received written comments submitted by The Jockey Club in support of the adoption of the national thresholds and withdrawal guidelines. The Jockey Club further suggested that the Commission do away with restricted time periods.

This amendment is designed only to provide a restriction on the use of methylprednisolone that performs the essential function of providing a simple instruction for trainers to follow for when to stop the administration of this drug before a horse’s next race. The Commission’s restrictions ensure that a trainer who complies will not incur a threshold violation with the drug.

A further assessment of the public comments is provided in the following official Fact Finding in regard to this legislative rulemaking proposal that the Commission, based on decades of institutional knowledge and close supervision of thoroughbred 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 November 24, 2014.

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

Agency Finding # 9: The threshold for methylprednisolone requires, in order for the use restriction for such drug to provide the assurance that is described in Agency Finding # 1 [made in regard to the adoption of the rulemaking identified as SGC-49-13-00020-P, RP] that the administration of any methylprednisolone acetate (e.g., Depo Medrol) causes the horse to be ineligible to race until the horse tests below the threshold and is released to race by the stewards. A clinical dose of this drug may result in a positive test for more than 50 days after some joint injections, yet a small clinical dose in a different joint may result in a concentration in the horse’s plasma below the threshold value within seven days. As a result, a single restricted time period may be unreasonable for this drug. The Commission also lacks sufficient scientific data to formulate a reasonably precise restricted time period that can protect regulated parties in all circumstances, as further described in Agency Findings # 4 and # 5 [made in regard to the adoption of the rulemaking identified as SGC-49-13-00020-RP]. There are too many unknown variables to adopt a specific time period for this drug. Rather than prohibit the use of any formulation of this drug, which might be the best therapeutic option in some circumstances, a use restriction that the horse must test negative and be released to race by the stewards will limit the use of this drug to such circumstances and provide the Commission and regulated parties with a use restriction that is reasonable to apply.