SGC-49-13-00014-P This Proposal Would Limit the Use of the Corticosteroid Methylprednisolone Acetate (e.g., Depo Medrol) in Standardbred Racing

12/4/13 N.Y. St. Reg. SGC-49-13-00014-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-49-13-00014-P

This Proposal Would Limit the Use of the Corticosteroid Methylprednisolone Acetate (e.g., Depo Medrol) in Standardbred Racing

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

Proposed Action:

Amendment of section 4120.2(e)(9); and addition of sections 4120.2(e)(25), (l) and 4120.3(a)(22) to Title 9 NYCRR.

Statutory authority:

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

Subject:

This proposal would limit the use of the corticosteroid methylprednisolone acetate (e.g., Depo Medrol) in standardbred racing.

Purpose:

To enhance the integrity and safety of standardbred horse racing with new corticosteroid 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:

Paragraph (22) would be added to subdivision (a) of a proposed new section 4120.3 as follows:

4120.3. Equine drug thresholds; per se

(a) A horse shall have raced in violation of this rule if any of the following substances are found by the laboratory testing 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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(22) Methylprednisolone: 100 pg/ml in plasma.

Subdivision (e) of Section 4120.2 would be amended 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:

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(9) hormones and non-anabolic steroids, e.g., progesterone, estrogens, chorionic gonadotropin, glucocorticoids [(e.g., Prednisolone, Depomedrol)], except in joint injections as restricted in subdivision (i) of this section;

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(25) notwithstanding paragraph (9) of this subdivision, the corticosteroid methylprednisolone acetate (e.g., Depo Medrol) is not a substances that is permitted to be administrated by any means until 48 hours before the scheduled post time of the race in which the horse is to compete.

A new subdivision (l) would be added to Section 4120.2 as follows:

(l) A horse may not race after an administration of methylprednisolone acetate (e.g., Depo Medrol) unless such horse subsequently tests negative, i.e., below the threshold established in section 4120.3 of this Part, for such drug in a test conducted by the commission at the sole expense of the trainer of the horse, and is released to race by the Presiding Judge.

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 adjust the Commission’s restricted time period governing the systemic administration of the corticosteroids to standardbred race horses close to race day. The Commission has separately proposed to adopt a set of national regulatory laboratory thresholds for drugs, including other corticosteroids, that are necessary and sufficient to provide good veterinary care close to race day. The adoption of this proposal would limit the use of the corticosteroid methylprednisolone acetate (e.g., Depo Medrol). This corticosteroid has been identified as particularly harmful to the long term health of treated joints and tissues, and potentially affects race performance for an unusually long period of time, according to the Commission’s scientific consultant Dr. George A. Maylin. It has also been reported to persist after certain administrations at a concentration which exceeds the proposed threshold for as long as 99 days. The long period of time during which an administration of this drug might cause a violation of the proposed threshold was confirmed by the Commission when it conducted an extensive study of the veterinary records of over 75 horses whose tests results were in excess of the proposed threshold in the first half of 2013. The most reasonable restriction that could provide assurance to standardbred horsepersons that compliance would protect them from violation of the proposed thresholds is one that would require the horse to test negative before racing again. Accordingly, the new rule would require that any horse treated with this corticosteroid, methylprednisolone acetate (e.g., Depo Medrol), has to be tested at the expense of the trainer below the proposed threshold and then released by the presiding judge before the horse may race again. As a result, for those horsepersons who choose not to use the less restricted and equally available alternative corticosteroids (betamethasone, dexamethasone, prednisolone, and triamcinolone acetate), the Commission provides a means to return the horse to racing that is consistent with the proposed thresholds and with the overall purpose of reducing the use of this relatively harmful corticosteroid.

The new rule will enhance the integrity and safety of horse racing by limiting the use of the corticosteroid methylprednisolone acetate (e.g., Depo Medrol) and encouraging horsepersons to use other corticosteroids that are well-accepted, necessary, and capable of control by means of laboratory testing. The new rule will continue to ensure that corticosteroids that the Commission permits to be used will not result in a violation of the proposed laboratory thresholds.

4. Costs:

(a) Costs to regulated parties for the implementation of and continuing compliance with the rule: There are no new or additional costs imposed by this rule upon regulated persons because there are readily available alternative corticosteroids. The rule merely revises an existing rule in regard to allowable time of administration of a medication.

(b) Costs to the agency, the state and local governments for the implementation and continuation of the rule: There are no costs imposed upon the Commission, the State, or local government. The rule will be implemented using the Commission’s existing regulatory and medication testing program. There will be no costs to local governments 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 Commission has determined that no costs will be imposed because the rule does not create any new mandatory duty or obligation. The rule utilizes an existing regulatory framework and medication testing program and merely modifies a medication rule.

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 to assure horsepersons that compliance with the Commission’s restricted time periods will protect such person against an inadvertent violation of the separately proposed national regulatory laboratory thresholds for equine drugs that have been recommended by the Racing Medication and Testing Consortium and the Association of Racing Commissioners, International, Inc. The Commission considered and rejected the alternative of restricting a horse from racing for a period of 99 days after any administration of this corticosteroid.

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 proposal does not require a Regulatory Flexibility Statement, Jobs Impact Statement or Rural Area Flexibility Statement as the amendment merely limits the use of a standardbred race horse after administration of the corticosteroid methylprednisolone acetate (e.g., Depo Medrol), for which there are readily available alternatives that are relatively less harmful to a horse’s health and safety and have less potential to affect the race performance, by means of continuing efficacy, for a considerable period of time after administration of the drug. Other corticosteroids are sufficient to treat horses close to race day, are well-accepted for their intended purposes, and readily available, including betamethasone, dexamethasone, prednisolone, and triamcinolone acetonide. The rule is entirely limited to equine drug standards and testing, and merely modifies the restriction on administration of an approved drug for race horses. This rulemaking will not have a positive or negative impact on jobs. These amendments do not impact upon State Administrative Procedure Act § 102(8), nor do they affect employment. The proposal will not impose an adverse economic impact or reporting, recordkeeping or other compliance requirements on small businesses in rural or urban areas nor on employment opportunities. The rule does not impose any significant technological changes on the industry for the reasons set forth above.