Per Se Regulatory Standardbred Threshold and Restricted Time Period for Flunixin

NY-ADR

12/4/13 N.Y. St. Reg. SGC-49-13-00015-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-49-13-00015-P
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 proposed rule:
Proposed Action:
Repeal of section 4120.2(d); amendment of section 4120.2(e); and addition of section 4120.3(a)(24) to Title 9 NYCRR.
Statutory authority:
Racing, Pari-Mutuel 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 equine drug 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 (24) would be added to subdivision (a) of the proposed new section 4120.3 as follows:
4120.3. Additional 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.
* * *
(24) Flunixin: 20 ng/ml in plasma.
Subdivision (d) of Section 4120.2 of 9 NYCRR would be repealed:
(d) [The following non-steroidal anti-inflammatory drug may be administered by intravenous injection until 24 hours before the scheduled post time of the race in which the horse is to compete:
(1) flunixin.] (Reserved)
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.
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, (518) 395-5400, email: [email protected]
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 assure the public’s confidence and preserve the high degree of integrity of racing at pari-mutuel betting tracks by regulating the use of drugs and medications in race horses so that the horses are fit and healthy, but not running on substances that have the potential to affect the outcome of a given race.
3. Needs and benefits: This rule is necessary to ensure that standardbred horses are not medicated to the point of adversely affecting the integrity of horseracing and the health and safety of race horses. The Commission believes that adopting its previous 48-hour flunixin administration rule is more appropriate than the rule adopted in 2005.
Flunixin, also known by the trade name Banamine, is a non-steroidal anti-inflammatory drug used to treat inflammation and soreness in racehorses. From 1971 to 2005, the administration of flunixin was not permitted less than 48 hours before races in New York. There were few post-race positives during that 30-year period.
Prompted by an effort of the Racing Medication and Testing Consortium (“RMTC”) and other states, such as New Jersey and Maryland, the former Racing and Wagering Board adopted a rule to allow intravenous use of flunixin within 24 hours of a race effective January 4, 2006. Flunixin continued to be restricted within 48 hours of racing when administered by any other means. Among the benefits sought was to create consistency throughout the racing states so veterinarians could have a certain threshold under which they could provide therapeutic treatment. This movement was supported by the Mid-Atlantic Consortium of Racing States, which also sought uniform levels.
During the past five years in New York, this 24-hour rule for flunixin has been violated more than any other Commission equine drug rule. There have been more than 80 flunixin drug violations by thoroughbred and standardbred horses. There are many suspected reasons for this. It has become routine for flunixin to be obtained from compounding pharmacies, which are less accurate and reliable at providing a drug with a specific known concentration than a pharmaceutical company. The use of flunixin paste, on a regular and even daily basis, has become more common. In several instances, trainers have been confused about the Commission’s rules allowing only IV use of flunixin during 48 to 24 hours before racing. In addition to newer drug regimens that include frequent administrations of flunixin paste, 11 trainers unwittingly admitted during agency investigations that they thought the paste was a permissible means to administer flunixin until 24 hours before a horse’s next race.
The RMTC has recently proposed a mandatory regulatory laboratory threshold for flunixin that, depending on the specific horse and other variables, might possibly result in a trainer who abides by the 24-hour restriction nevertheless violating the proposed new threshold. The Commission’s restricted time periods are designed to assure that one who complies with them will not be charged with an equine drug rule violation in New York.
Accordingly, the Commission’s proposed rule would return to the longstanding, time-tested, and familiar practice of restricting the administration of flunixin to 48 hours prior to a race. The Commission and industry have considerable experience with banning flunixin for 48 hours as a result of this being the rule in New York State from 1971 through 2005. During those 34 years, there were relatively few rule violations, or complaints about the rule from horsepersons, or veterinary complaints about the care, treatment, health, or safety of our race horses. The 48-hour restricted time period will reduce the number of equine drug positives that occur in New York by providing horsepersons with an added safety cushion to avoid equine drug positives and greater certainty that compliance with the time period will result in the Commission’s laboratory not reporting an equine drug violation.
Concerns that veterinarians will be restricted in their ability to treat a horse are mitigated by the fact the Commission’s rules will continue to permit veterinarians to administer several different non-steroidal anti-inflammatory drugs until 48 hours before a horse’s next race, and to provide veterinary care for inflamed or sore bodily tissues without restriction when the horse is not scheduled to race in the immediate future.
4. Costs:
a. Costs to regulated parties for the implementation of and continuing compliance with the rule: The rule will not impose new or additional costs on regulated persons. The rule merely revises an existing rule in regards to allowable dosage of a medication.
b. Costs to the agency, the state and local governments for the implementation and continuation of the rule: None.
c. The information, including the source(s) of such information and the methodology upon which the cost analysis is based: Commission staff determined that the rule will impose no additional costs because the rule does not create any new duty or obligation. The rule utilizes an existing regulatory framework and medication testing program and merely makes a modification to a medication rule.
5. Local government mandates: The supervision and regulation of pari-mutuel racing activities are the sole responsibility of the New York State Gaming Commission, and do not involve local governments. Therefore, this rule will not impose any local government mandates.
6. Paperwork: No new paperwork will be required. This rule will be implemented utilizing existing regulations and procedures.
7. Duplication: Since the New York State Gaming Commission is exclusively responsible for the regulation of pari-mutuel racing activities in New York State, there are no other relevant rules or other legal requirements of the State or federal governments regarding the administration of flunixin to race horses.
8. Alternative approaches: No other alternative was considered in light of the Commission’s preferred course of action to specifically revert to the previous standard.
9. Federal standards: There are no federal standards applicable to the subject area of state-regulated pari-mutuel racing activities.
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 removes the 24-hour rule allowing for the administration of the drug flunixin to standarbred race horses. Flunixin will still be allowed as a 48-hour drug. 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.
End of Document