SGC-37-14-00006-P Limits Betamethasone, Methylprednisolone and Triamcinolone to Only Joint Injections in Thoroughbred Racehorses

9/17/14 N.Y. St. Reg. SGC-37-14-00006-P

NEW YORK STATE REGISTER

VOLUME XXXVI, ISSUE 37

September 17, 2014

RULE MAKING ACTIVITIES

NEW YORK STATE GAMING COMMISSION

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. SGC-37-14-00006-P

Limits Betamethasone, Methylprednisolone and Triamcinolone to Only Joint Injections in Thoroughbred Racehorses

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

Proposed Action:

Amendment of section 4043.2(i)(2) of Title 9 NYCRR.

Statutory authority:

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

Subject:

Limits betamethasone, methylprednisolone and triamcinolone to only joint injections in thoroughbred racehorses.

Purpose:

To enhance the integrity and safety of thoroughbred horse racing.

Text of proposed rule:

Section 4043.2 of 9 NYCRR would be amended as follows:

§ 4043.2. Restricted use of drugs, medications and other substances.

(i) In addition, a horse may not race for the following periods of time:

(2) for at least seven days following a joint injection of any corticosteroid; and the following corticosteroids may be administered only by means of a joint injection: betamethasone, any formulation of methylprednisolone and any formulation of triamcinolone;

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

Kristen Buckley, New York State Gaming Commission, 1 Broadway Center, PO Box 7500, Schenectady, New York 12301, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Same as above.

Public comment will be received until:

45 days after publication of this notice.

Regulatory Impact Statement

1. Statutory 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 thoroughbred 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 make it possible for the Commission to regulate corticosteroid joint injections effectively with laboratory thresholds that are violated only when a thoroughbred horse races too soon after receiving such a treatment.

The Commission has proposed adopting national regulatory thresholds for three corticosteroids, betamethasone and various formulations of methylprednisolone or triamcinolone, that are used to alleviate joint soreness by means of joint injection. Such thresholds are based on the concentration of these drugs at seven days after the horses are given a joint injection of such drugs, which is considered enough time to allow a treating or examining veterinarian to determine whether a thoroughbred horse has recovered from a joint ailment before it may race again. Other research has shown, however, that such thresholds are exceeded for a much longer period of time when these drugs are given to a horse by other means, such as intramuscular injection (“IM”) or orally, and it is not possible to determine from laboratory test results which route of administration has been used. Methylprednisolone acetate given by an IM administration, for example, has been found in a horse’s blood at a concentration exceeding its proposed threshold for longer than 95 days, rather than for only seven days.

This proposal would limit the use of these three corticosteroids to only joint injections. This will ensure that a threshold violation in blood samples taken from a horse on race day is the result of an improper joint injection within seven days of the horse’s race, and protect horsepersons from inadvertently incurring an equine drug positive by having given these drugs to a horse by means other than a joint injection.

There are other corticosteroids that are more commonly administered to treat a racehorse by means other than joint injection, and they do not persist in a horse’s bodily system for more than 72 hours. As a result, this proposal will not have an adverse effect on treating to a horse with corticosteroids by means other than a joint injection.

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. The rule merely revises an existing rule in regard to allowable time of administration of various medications.

(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 based upon the fact that the rule does not create any new mandatory duty or obligation, 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 the Commission’s restricted time periods are consistent with the separately proposed national regulatory laboratory thresholds for these equine drugs that have been recommended by the Racing Medication and Testing Consortium and the Association of Racing Commissioners, International, Inc. No other alternatives were considered.

9. Federal standards: None.

10. Compliance schedule: Regulated persons will be able to achieve compliance with the rule upon publication of a Notice of Adoption in the New York State Register.

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

A regulatory flexibility analysis for small business and local governments, a rural area flexibility analysis, and a job impact statement are not required for this rulemaking proposal because it will not adversely affect small businesses, local governments, rural areas, or jobs.

This proposal concerns the restricted administration of certain drugs to thoroughbred racehorses. These medications, three corticosteroids frequently used for equine corticosteroid joint injections, will be limited to such means of administration by this proposal, to protect horsepersons from inadvertent violations of proposed new regulatory thresholds for such drugs that are based on administrations solely by joint injections, and to ensure that any violations of such thresholds reliably indicate an administration of such drugs by joint injection within the applicable restricted time period before the horse races. Such regulations serve to enhance the health and safety of racehorses on race day. These medications will continue to be permitted for joint injections, and other corticosteroids that are more commonly administered by other means than by joint injection will continue to be permitted for such uses. This rule will not have an adverse economic impact on reporting, record keeping or other compliance requirements on small businesses in rural or urban areas or on employment opportunities.