SGC-49-13-00015-A Per Se Regulatory Standardbred Threshold and Restricted Time Period for Flunixin

1/21/15 N.Y. St. Reg. SGC-49-13-00015-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-49-13-00015-A

Filing No. 1110

Filing Date. Dec. 31, 2014

Effective Date. Apr. 01, 2015

Per Se Regulatory Standardbred Threshold and Restricted Time Period for Flunixin

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

Action taken:

Repeal of section 4120.2(d); amendment of section 4120.2(e); and addition of section 4120.3(a)(8) 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 flunixin.

Purpose:

To enhance the integrity and safety of standardbred horse racing with new flunixin 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.

(8) Flunixin: 20 ng/ml in plasma;

Subdivision (d) of Section 4120.2 of 9 NYCRR would be repealed.

The final unnumbered paragraph of subdivision (e) of Section 4120.2 of 9 NYCRR would be amended as follows:

None of these substances may be administered within 48 hours of the scheduled post time of the race in which the horse is to compete[, except that flunixin may be used in accordance with the specific authorization set forth in subdivision (d) of this section]. In this regard, substances ingested by a horse shall be deemed administered at the time of eating and drinking. It shall be part of the trainer's responsibility to prevent such ingestion within such 48 hours.

Final rule as compared with last published rule:

Nonsubstantive changes were made in section 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 4120.3(a)(24) as 4120.3(a)(8) 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 for flunixin. One standardbred industry representative said that the 24 hour restricted time period needed to be lengthened or the proposed threshold would create a large number of inadvertent rule violations. The executive director of the Racing Medication and Testing Consortium (“RMTC”) testified that RMTC recommended the proposed flunixin threshold but 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.

After the public hearing, the New York Thoroughbred Horsemen’s Association issued a press release urging thoroughbred horsepersons not to administer the specified dose any closer than 32 hours before a horse’s next race, and RMTC revised its withdrawal guideline to 32 hours.

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 flunixin is intended to ensure that flunixin 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 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 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 D:

A horse will not incur a positive laboratory finding in excess of the following threshold, following an administration of flunixin 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):

8. Flunixin [48 hours]: 20 ng/ml in plasma

Agency Finding E:

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

Agency Finding F:

If there is a positive laboratory finding in excess of the foregoing threshold, assuming an administration of flunixin 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.

Agency Finding G:

The Commission finds that it is necessary and proper to repeal the previous permission to inject a standardbred 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 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 D; (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.