SGC-49-13-00011-A Per Se Regulatory Standardbred Thresholds for Equine Drugs
1/21/15 N.Y. St. Reg. SGC-49-13-00011-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-49-13-00011-A
Filing No. 1109
Filing Date. Dec. 31, 2014
Effective Date. Apr. 01, 2015
Per Se Regulatory Standardbred Thresholds for Equine Drugs
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of section 4120.2; renumbering of section 4120.3 to 4120.18; and addition of new section 4120.3 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 thresholds for equine drugs.
Purpose:
To enhance the integrity and safety of standardbred horse racing by adopting permissive thresholds for 16 accepted medications.
Text of final rule:
Section 4120.3 (“Other prohibitions”) would be renumbered Section 4120.18.
Section 4120.2(h) would be renumbered Section 4120.2(n).
A new Section 4120.3 would be added to read as follows [note that subparagraphs (6), (8) and (15) are inserted in this new rule by other rulemaking filed today]:
§ 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.
(1) Acepromazine: 10 ng/ml HEPS in urine;
(2) Butorphanol:
(i) 300 ng/ml of total butorphanol in urine; or
(ii) 2 ng/ml of free butorphanol in plasma;
(3) Dantrolene: 100 pg/ml of 5-hydroxydantrolene in plasma;
(4) Detomidine:
(i) 1 ng/ml of any metabolite of detomidine in urine; or
(ii) any detomidine in plasma;
(5) Diclofenac: 5 ng/ml in plasma;
(7) Firocoxib: 20 ng/ml in plasma;
(9) Furosemide: 100 ng/ml in plasma and a specific gravity of urine less than 1.010;
(10) Glycopyrrolate: 3 pg/ml in plasma;
(11) Ketoprofen: 10 ng/ml in plasma;
(12) Lidocaine: 20 pg/ml of total 3-hydroxylidocaine in plasma;
(13) Mepivacaine:
(i) 10 ng/ml of total hydroxymepivacaine in urine; or
(ii) any hydroxymepivacaine in plasma;
(14) Methocarbamol: 1 ng/ml in plasma;
(16) Omeprazole: 1 ng/ml of omeprazole sulfide in urine;
(17) Phenylbutazone: 2 mcg/ml in plasma;
(18) Procaine penicillin: 25 ng/ml of procaine in plasma; and
(19) Xylazine: 10 pg/ml of total xylazine and its metabolites in plasma.
(b) A laboratory finding that a horse has not exceeded a threshold set forth in this section shall not constitute a defense to a violation of any other section of this subchapter.
Final rule as compared with last published rule:
Nonsubstantive changes were made in sections 4120.2(o), and 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, (518) 388-3407, email: gamingrules@gaming.ny.gov
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 4120.2(o) as 4120.2(n), to renumber the proposed paragraphs (6) through (16) of Section 4120.3(a) to permit the insertion in alphabetical order of paragraphs (6), (8) and (15) that have been adopted in other rulemaking, 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 regard to these proposed 16 thresholds for standardbred racing. Representatives of the standardbred industry were concerned about having sufficient information about drug regimens to avoid causing a threshold violation. One practicing veterinarian noted that the dosage or means of administration studied in research relied upon by the Racing Medication and Testing Consortium (“RMTC”) to derive these thresholds were different from typical racetrack usages of some drugs, such as methocarbomol and detomidine, respectively. RMTC representatives described the origin and assurances of their withdrawal guidelines and associated thresholds. RMTC indicated that its withdrawal guidelines give sufficient warning provided RMTC’s dose and route of administration specifications are followed, and further that these 16 thresholds excepting firocoxib are consistent with affecting race performance by being pharmacologically active. No other public comments were received.
The Commission proposed per se threshold rules for these 16 drugs to complement the Commission’s restricted time period rules, which 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 rules are intended to ensure that drugs will not be used in a manner that could endanger a horse and jockeys or manipulate the outcome of pari-mutuel horse races. They will simplify the administrative adjudication of equine rule violations by making it an automatic rule violation to exceed threshold. The adoption of the thresholds 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 using these 16 drugs at recommended withdrawal times will prevent the occurrence of a positive post-race test, trainers may rely on the Commission’s restricted time periods, when following accepted veterinary practices (e.g., clinical doses), to ensure their compliance with these thresholds 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 (with numbering in Agency Finding A based on each drug’s paragraph number in the final rule):
Agency Finding A:
A horse will not incur a positive laboratory finding in excess of the following thresholds, following an administration of the drug 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):
(1) acepromazine [96 hours]: 10 ng/ml HEPS in urine
(2) butorphanol [96 hours]: 300 ng/ml of total butorphanol in urine or 2 ng/ml of free butorphanol in plasma
(3) dantrolene [72 hours]: 100 pg/ml of 5-hydroxydantrolene in plasma
(4) detomidine [96 hours]: 1 ng/ml of any metabolite of detomidine in urine or any detomidine in plasma
(5) diclofenac [48 hours]: 5 ng/ml in plasma
(7) firocoxib [14 days]: 20 ng/ml in plasma
(9) furosemide [4 – 4.5 hours]: 100 ng/ml in plasma and a specific gravity of urine less than 1.010
(10) glycopyrrolate [96 hours]: 3 pg/ml in plasma
(11) ketoprofen [48 hours]: 10 ng/ml in plasma
(12) lidocaine [96 hours]: 20 pg/ml of total 3-hydroxylidocaine in plasma
(13) mepivacaine [96 hours]: 10 ng/ml of total hydroxymepivacaine in urine or any hydroxymepivacaine in plasma
(14) methocarbamol [72 hours]: 1 ng/ml in plasma
(16) omeprazole [24 hours]: 1 ng/ml of omeprazole sulfide in urine
(17) phenylbutazone [48 hours]: 2 mcg/ml in plasma;
(18) procaine penicillin [7 days]: 25 ng/ml of procaine in plasma
(19) xylazine [96 hours]: 10 pg/ml of total xylazine and its metabolites in plasma.
Agency Finding B:
If there is a positive laboratory finding in excess of a foregoing threshold, then the administration of such drug had the potential to affect the race performance of such horse.
Agency Finding C:
If there is a positive laboratory finding in excess of a foregoing threshold, assuming an administration of the drug 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.
