RWB-08-13-00003-P Prohibited Use of Anabolic Steroids in Horse Racing and Testing of Plasma Samples

2/20/13 N.Y. St. Reg. RWB-08-13-00003-P

NEW YORK STATE REGISTER

VOLUME XXXV, ISSUE 8

February 20, 2013

RULE MAKING ACTIVITIES

RACING AND WAGERING BOARD

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. RWB-08-13-00003-P

Prohibited Use of Anabolic Steroids in Horse Racing and Testing of Plasma Samples

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

Proposed Action:

Amendment of sections 4043.15, 4120.2 and 4120.12 of Title 9 NYCRR.

Statutory authority:

Racing, Pari-Mutuel Wagering and Breeding Law, sections 101(1), 301(1), (2)(a) and 902(1)

Subject:

Prohibited use of anabolic steroids in horse racing and testing of plasma samples.

Purpose:

To include plasma samples and establish plasma thresholds in anabolic steroid testing of racehorses.

Text of proposed rule:

Section 4043.15 of 9 NYCRR is amended to read as follows:

4043.15 Anabolic steroids

(a) [The use of one of four approved a]Anabolic steroids shall [be permitted] not be administered except that the following substances may be administered during permitted time frames and at concentrations that on race day are less than these thresholds [under the following conditions]:

(1) [Not to exceed the following permitted urine or plasma threshold concentrations:

(i) 16 B-hydroxystanozolol (metabolite of stanozolol [Winstrol]) - 1 ng/ml in urine;

(ii)] Boldenone (Equipoise)[ in male horses other than geldings,]: All horses may have less than 100 pg/ml (including free boldenone and boldenone liberated from its conjugates) [15 ng/ml in urine] in plasma;

(2) [(iii)] Nandrolone: [–]

(i) Female horses and geldings may have less than 100 pg/ml in plasma; and

(ii) Intact male horses may have less than [1 ng/ml in urine] 500 pg/ml in plasma.

(3) Stanozolol (Winstrol): All horses may have less than 100 pg/ml in plasma.

(4) [(iv)] Testosterone:

[(a) In geldings - 20 ng/ml in urine; and

(b) In fillies and mares - 55 ng/ml in urine.]

(i) Female horses and geldings may have less than 100 pg/ml in plasma; and

(ii) Intact male horses may have less than 2000 pg/ml in plasma.

(5) In addition, no anabolic steroid shall be administered by injection into a joint at any time.

[(2)] (b) Any other anabolic steroids are prohibited to be administered.

[(3) The presence of more than one of the above four approved anabolic steroids above the approved thresholds is not permitted.

(4)] (c) Post-race urine or plasma samples collected from intact males must be identified to the laboratory.

[(5)] (d) Any horse to which a[n] permissible anabolic steroid has been administered in order to assist in the recovery from an illness or injury may be placed on the veterinarian's list in order to monitor the concentration of the drug[ in urine]. Once the concentration is below the designated plasma threshold the horse is eligible to be removed from the list.

[(b)] (e) A violation of this section shall be considered a positive test within the meaning of this Part.

Section 4120.12 of 9 NYCRR is amended to read as follows:

4120.12 Anabolic steroids

(a) [The use of one of four approved a]Anabolic steroids shall [be permitted] not be administered except that the following substances may be administered during permitted time frames and at concentrations that on race day are less than these thresholds [under the following conditions]:

(1) [Not to exceed the following permitted urine or plasma threshold concentrations:

(i) 16 B-hydroxystanozolol (metabolite of stanozolol [Winstrol]) - 1 ng/ml in urine;

(ii)] Boldenone (Equipoise)[ in male horses other than geldings,]: All horses may have less than 100 pg/ml (including free boldenone and boldenone liberated from its conjugates) [15 ng/ml in urine] in plasma;

(2) [(iii)] Nandrolone: [–]

(i) Female horses and geldings may have less than 100 pg/ml in plasma; and

(ii) Intact male horses may have less than [1 ng/ml in urine] 500 pg/ml in plasma.

(3) Stanozolol (Winstrol): All horses may have less than 100 pg/ml in plasma.

(4) [(iv)] Testosterone:

[(a) In geldings - 20 ng/ml in urine; and

(b) In fillies and mares - 55 ng/ml in urine.]

(i) Female horses and geldings may have less than 100 pg/ml in plasma; and

(ii) Intact male horses may have less than 2000 pg/ml in plasma.

(5) In addition, no anabolic steroid shall be administered by injection into a joint at any time.

[(2)] (b) Any other anabolic steroids are prohibited to be administered.

[(3) The presence of more than one of the above four approved anabolic steroids above the approved thresholds is not permitted.

(4)] (c) Post-race [urine or] plasma samples collected from intact males must be identified to the laboratory.

[(5)] (d) Any horse to which a[n] permissible anabolic steroid has been administered in order to assist in the recovery from an illness or injury may be placed on the veterinarian's list in order to monitor the concentration of the drug[ in urine]. Once the concentration is below the designated plasma threshold the horse is eligible to be removed from the list.

[(b)] (e) A violation of this section shall be considered a positive test within the meaning of this Part.

Paragraph 9 of Subdivision (e) of Section 4120.2 of 9 NYCRR is amended to read as follows:

(e) The following substances are permitted to be administered by any means until 48 hours before the scheduled post time of the race which the horse is to compete:

(9) hormones and non-anabolic steroids, [(]e.g., [testosterone,] progesterone, estrogens, chorionic gonadotropin, glucocorticoids (e.g., Prednisolone, Depormedrol), [and anabolic steroids (e.g. Equipoise), ]except in [conjunction with] joint [aspiration] injections as restricted in subdivision (i) of this section[; the use of anabolic steroids is governed by Rule 4120.12];

Subdivision (i) of Section 4120.2 of 9 NYCRR is amended to read as follows:

(i) In addition, a horse which has had a joint injected [aspirated (in conjunction] with a steroid [injection)] may not race for at least five days following such procedure, and whenever such procedure is performed, the trainer shall notify the stewards of such fact, in writing, before the horse is entered to race.

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

John Googas, New York State Racing and Wagering Board, One Broadway Center, Suite 600, Schenectady, New York 12305-2553, [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 and legislative objectives of such authority: The Board is authorized to promulgate these rules pursuant to Racing Pari-Mutuel Wagering and Breeding Law sections 101(1) and 902(1). Under section 101, the Board has general jurisdiction over all horse racing activities and all pari-mutuel betting activities in the state, both on track and off-track, and the persons engaged therein, including the authority to regulate the use of drugs that can manipulate race performance. Section 902(1) prescribes that a state college within New York with an approved equine science program shall conduct equine drug testing to assure public confidence in and to continue the high degree of integrity at pari-mutuel race meetings, and authorizes the Board to promulgate any rules and regulations necessary to implement its equine drug testing program and to impose substantial administrative penalties for anyone who races drugged horses.

2. Legislative objectives: To enable the New York State Racing and Wagering Board to preserve the integrity of pari-mutuel racing while generating reasonable revenue for the support of government.

3. Needs and benefits: These rule amendments have been identified by the New York Task Force on Racehorse Health and Safety as emergency measures required to protect the safety and health of thoroughbred race horses and jockeys in New York State. The New York State Racing and Wagering Board has reviewed these recommendations and has endorsed them for emergency adoption.

The Task Force was formed in 2012 after 21 equine deaths occurred between November 2011 and March 2012. The 21 deaths were more than double the expected frequency rate. The Task Force’s investigation revealed troubling aspects with the way horses are examined and managed in this state and found that the health and safety of racehorses and jockeys will be improved by reducing the use of legal anti-inflammatory medications in the time after the horse is entered to race.

The amendments to Board Rule 4043.2(i) are necessary to control the administration of corticosteroids to thoroughbred horses. These amendments are necessary for the health and safety of both the horse and the jockeys/riders. The withdrawal periods in the rule were prescribed explicitly by the Task Force and are necessary to provide clear guidance as to when administration should be discontinued for the purposes of testing and for the safety of the horse. The intra-articular use of corticosteroids can mask the inflammatory changes ordinarily associated with joint disease, and can frustrate the pre-race clinical examination. For these reasons, regulation of intra-articular administration of corticosteroids is appropriate. The term “intra-articular” has been revised to “joint injection” in the rule text to more accurately reflect a vernacular of the trade.

The Task Force also identified the need to tighten controls over the use of clenbuterol, which is currently permitted as a 96-hour rule under the Board’s rules. It is a potent bronchodilator that is approved by the Food and Drug Administration for treatment of lower airway inflammation and upper respiratory infections in a horse. The drug is used to prevent respiratory infections in horses experiencing exercise-induced pulmonary hemorrhage (respiratory bleeding). Some trainers have indicated that their horses look better and have increased appetites when treated with clenbuterol. The amendments will replace the existing 96-hour time restriction, prompting the change to subdivision (g) of 4043.2 of 9 NYCRR to remove any reference to clenbuterol, with a 14-day restriction to be found in a new paragraph (3) of subdivision (i) of 9E NYCRR.

The report stated that in addition to its pharmacological effect on the respiratory tract, clenbuterol mimics anabolic steroids in that it increases muscle and decreases fat in cattle, pigs, poultry and sheep. The report stated that there is a belief that illegally compounded clenbuterol has been used in thoroughbred horses as an alternative to prohibited anabolic steroids. The Task Force found: “It was abundantly clear to the Task Force that while the NYSRWB’s time limit regarding clenbuterol was being followed, the medication is in common use as a substitute for anabolic steroids and not for the legitimate therapeutic purpose for which it is intended.”

The Board also amended paragraph (9) of subdivision (e) of 4043.2 of 9 NYCRR to remove any references to steroids. This was not a recommendation by the Task Force, but in light of the Board’s existing rule limiting the administration of anabolic steroids (Rule 4043.15) and the restrictions placed on corticosteroids in this rulemaking, the Board believes that Rule 4043.2(e)(9) should contain no reference to steroids, in order to avoid confusion.

The Task Force reported: “The failure of trainers to report intra-articular injections as required prevented the NYRA veterinarians from identifying a pattern of redundant...treatments that had the potential to misrepresent the true clinical condition of a horse.” Therefore, in order to ensure proper notification, the Board amends Section 4043.4 of 9 NYCRR, which is commonly known as the “Trainer’s Responsibility Rule,” to require that a trainer maintain accurate records of all corticosteroid joint injections to a horse he or she trains. The corticosteroid reporting will require that a trainer submit a corticosteroid joint injection record to the Board within 48 hours of treatment so that examining veterinarians will have access to that information as part of the pre-race examinations. This amendment will improve the quality of pre-examinations, provide the Board with timely notice of any potential ailments and ensure that documentation is available in the event a horse’s fitness comes into question.

In response to input from the New York Thoroughbred Racing Association, the Board added a provision in the CJI reporting rule, the new 9 NYCRR 4043.4(b), authorizing trainers to delegate the reporting responsibility to the treating veterinarians.

4. Costs:

(a) Costs to regulated parties for the implementation of and continuing compliance with the rule: The costs for the New York Drug Testing and Research Program will be substantial. The cost for conducting administration trials necessary for Cortisone Testing will be $36,000. The cost of related laboratory testing of samples for corticosteroids is $18,000 per year. The cost of trial administrations of clenbuterol is $6,000. The related laboratory testing of clenbuterol samples is $5,000 per year.

(b) Costs to the agency, the state and local governments for the implementation and continuation of the rule: None. The amendments will require the New York State Racing and Wagering Board to develop a filing system for corticosteroid reporting.

There will be no costs to local government because the New York State Racing and Wagering Board is the only governmental entity authorized to regulate pari-mutuel horse racing.

(c) The information, including the source(s) of such information and the methodology upon which the cost analysis is based: The Board relied on its experience in collecting information and based upon its experience in the equine drug testing program. The costs associated with clenbuterol and corticosteroid testing was provided directly from the New York Drug Testing and Research Program.

(d) Where an agency finds that it cannot provide a statement of costs, a statement setting forth the agency’s best estimate, which shall indicate the information and methodology upon which the estimate is based and the reason(s) why a complete cost statement cannot be provided. Not applicable.

5. Local government mandates: None. The New York State Racing and Wagering Board is the only governmental entity authorized to regulate pari-mutuel horse racing activities.

6. Paperwork: There will be a need for reporting corticosteroid injections. Trainers will be required submit paperwork to the Board in a manner prescribed by the Board.

7. Duplication: None.

8. Alternatives: These rule amendments are based upon the finding and recommendations of the Task Force and no other alternatives were considered.

9. Federal standards: None.

10. Compliance schedule: This rule can be implemented upon publication in the State register. The Board expects that this will be adopted as a final rule in either May or June 2013. It is currently in effect as an emergency rule.

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

As is evident by the nature of this rulemaking, this will not have an adverse affect on jobs or rural areas. This proposal concerns the restricted administration of certain drugs to thoroughbred race horses, the testing procedures to ensure compliance with those restrictions, and reporting of the administration of certain drugs. These medications – corticosteroids and clenbuterol – are currently permitted and will continue to be permitted but under different administration schedules. These schedules will have no impact on jobs or rural areas. This amendment is intended to reduce equine deaths in thoroughbred racing, and as such will have a positive effect on horseracing and the revenue generated through pari-mutuel wagering and breeding in New York State. This will not adversely impact rural areas or jobs or local governments and does not require a Rural Area Flexibility Statement or Job Impact Statement.