SGC-49-13-00022-A Restricted Time Period After IV Administrations of Flunixin to Thoroughbred Horses

12/31/14 N.Y. St. Reg. SGC-49-13-00022-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-49-13-00022-A

Filing No. 1053

Filing Date. Dec. 16, 2014

Effective Date. Jan. 01, 2015

Restricted Time Period After IV Administrations of Flunixin to Thoroughbred Horses

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

Action taken:

Amendment of section 4043.2(d) and (e) of Title 9 NYCRR.

Statutory authority:

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

Subject:

Restricted time period after IV administrations of flunixin to thoroughbred horses.

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-49-13-00022-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 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 thoroughbred race horses with the Commission’s separately proposed laboratory threshold for flunixin. The executive director of the Racing Medication and Testing Consortium (“RMTC”) testified that RMTC decided further research was necessary on the subject of its 24-hour withdrawal guideline, and counseled it was “very important” to administer a specific dose based on the horse’s weight in order to avoid a threshold violation. RMTC was further concerned about flunixin’s very short half-life, meaning that a horse testing just below the flunixin threshold in post-race samples will have a relatively high concentration of this drug at the time of the horse’s pre-race examination earlier in the day, causing a greater risk that the examining veterinarian might not detect lameness that should prevent a horse from being allowed to race, in comparison to a common alternative nonsteroidal anti-inflammatory drug (“NSAID”), phenylbutazone.

The Commission received several written comments following the public hearing and the public comment period. The Jockey Club (“TJC”) submitted two letters encouraging the Commission to maintain the proposed national thresholds and withdrawal times. After another organization, the New York Thoroughbred Horsemen’s Association (“NYTHA”), issued a press release urging horsepersons not to administer the specified dose any closer than 32 hours before a horse’s next race and after RMTC revised its recommended withdrawal guideline to 32 hours, TJC further commented that the Commission should move away from having restricted time periods.

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. Although trainers who participate in other states are explicitly not assured that the recommended withdrawal time of RMTC for flunixin 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 flunixin threshold in all states.

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 # 8: The Commission finds that it is necessary and proper to repeal the previous permission to inject a Thoroughbred horse with flunixin until 24 hours before its next race and to restore our historic restricted time period of administration by any means until 48 hours before a horse’s next race. For 34 years, from 1971 to 2005, the latter was the restricted time period in New York and there were no complaints and few positives. The shorter restricted time period has resulted in a large number of rule violations and is inappropriate because of a number of factors, e.g., (1) flunixin is often obtained from a compounding pharmacy which cannot be provide an accurate and reliable concentration of the drug as well as a pharmaceutical company and the Commission does not want regulated parties who comply with its restricted time periods to incur a threshold violation; (2) many regulated persons (e.g., trainers) have incurred a drug positive after having confused the limited route of administration (IV only) permitted since 2005 and given flunixin as an oral paste that has a longer clearance and detection time of the drug; (3) a 48-hour restricted time period for all permitted nonsteroidal anti-inflammatory drugs (“NSAID”) eliminates the artificial incentive for a regulated party to choose flunixin for treating a horse close to its next race when there are other permitted NSAIDs that are more efficient and predictable (a longer half-life); (4) a 48-hour restricted time period for all NSAIDs prevents administrations of multiple NSAIDs (“stacking”) for a period of 48 hours before a horse’s next race; (5) a restricted time period of 48 hours does not permit any NSAID administrations the day before a horse races and this enhances the ability of the Commission to regulate drug use in the stables; (6) the Commission expects, based on the available research data, that regulated parties would have inadvertent positives were the Commission to adopt a restricted time period for flunixin of 32 hours; (7) the Commission would introduce complexity and confusion with a 32-hour restricted time period rather than our standard multiples of 24 hours (e.g., 24, 48, 72, 96 hours) before race day; (8) a 48-hour restricted time period ensures that a person who complies with the restricted time period will not incur a drug positive with a clinical dose, the assurance described in Agency Finding # 1 [made in regard to the adoption of the rulemaking identified as SGC-49-13-00020-P, RP]; (9) a restricted time period of 48 hours minimizes how much a pre-race flunixin administration can interfere with an examining veterinarian’s detection of lameness in the hours immediately preceding a race.