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603.60 Amendment 603.90 Amendment 603.200 A Complete Description of the Subjects and Issues Involved: At its March 13, 2007 meeting, the Board approved the establishment of a threshold level for the drug Pyrilamine, based on a report submitted to the Board by the Medication Task Force. The Task Force recommended to the Board that threshold levels should be established for Isoxsuprine (rulemaking adopted effective April 23, 2007) and Pyrilamine. Pyrilamine, a class 3 therapeutic drug, stays in the horse’s system for long periods of time and is therefore problematic because trace levels create frequent positive tests. Under proposed rulemaking 603.60, Pyrilamine in the horse’s system cannot exceed 50 nanograms per milliliter in urine. Oklahoma and the State of Washington have established a threshold level of 50 ng/ml for Pyrilamine and Ohio and Michigan, 100 ng/ml. The use of Erythropoietin (EPO), Darbepoietin, Snake venom, and Snail venom may endanger the health and welfare of the horse, or the safety of the rider or driver. Under proposed rulemaking 603.90, possession and/or use of these substances is prohibited. The Racing Board proposes to implement a new testing program, proposed Section 603.200, that seeks to expand its present testing program by giving it discretion to take racehorse blood samples on non-race days and on race-days (pre-race), for the purpose of testing for Epogen, DarbEPO, and other blood doping agents. This “out of competition” testing would be beneficial because blood doping agents are deemed adverse to the best interest of the racehorse in that it alters its normal physiological state. Implementation of this rule will accomplish the purposes of detecting offenders, punishing offenders, and importantly deterring improper administrations at anytime. The proposed rulemaking provides that representatives of the Racing Board may, with reasonable notice, subject any racehorse to testing. This proposed rulemaking is within the statutory framework of the Horse Racing Act that permits the Racing Board to take fluid samples from any racehorse at any race meeting in the State of Illinois. Anabolic Steroids, which have gained national attention for their abuse by human athletes, are synthetic forms of the male hormone testosterone. In racehorses, anabolic steroids increase muscle mass, stimulate the production of red blood cells, and can have serious negative effects on a horse’s reproductive system. Under proposed rulemaking Section 603.210, all synthetic anabolic steroids will be banned with the exception of four commonly used steroids, with legitimate therapeutic use: Boldenone, Stanozolol, Nandrolone, and Testosterone, all of which are governed by the Racing Commissioners International model rule. Further, the RCI model rule establishes threshold levels for these four anabolic steroids. A majority of the racing jurisdictions in the U.S. either have anabolic steroid rules in place or expect to in the near future. In addition, the Thoroughbred Owners and Breeders Association has issued a directive to racing commissions for mandatory testing of Boldenone, Stanozolol, Nandrolone, and Testosterone, effective January 1, 2008, as a condition of eligibility to card graded stakes races. Foreign substances, including blood doping agents such as Erythropoietin (Epogen, EPO) and DarbEPO, may not be present in a racehorse’s system on race day (regardless of the date of administration). Further, the administration of foreign substances to a racehorse on race day is prohibited. The Racing Board presently takes fluid samples from racehorses, for the purpose of testing them for numerous prohibited foreign substances, on race day only. With regard to the blood doping agents, the Racing Board adopted a rule in January 2007, which implemented a testing methodology focused on detecting elevated titers of anti-recombinant human EPO antibodies. The Racing Board presently takes blood samples from horses post-race on race day, and tests those samples pursuant to that existing rule and other provisions of Part 603, Title 11 of the Illinois Administrative Code. The Racing Board believes that blood doping agents continue to be administered to a limited number of racehorses prior to the date such horses are scheduled to compete. The Racing Board also believes that these agents, particularly EPO and/or DarbEPO, are administered for reasons that may include attempting to impact the horse’s performance in a race, and in a manner to avoid detection by the present race day testing methodology. The Racing Board believes that any horse which is administered a blood doping agent should not participate in racing. Further, such administrations of blood doping agents may be adverse to the welfare of the animal. Published studies or reports and sources of underlying data used to compose this rulemaking: Racing Medication and Testing Consortium guidelines, Racing Commissioners International model rules, and rules from various racing jurisdictions including Ontario, Canada. Will this proposed rulemaking replace any emergency rulemaking currently in effect? No Does this rulemaking contain an automatic repeal date? No Does this rulemaking contain incorporations by reference? No Are there any other proposed rulemakings pending in this Part? No Statement of Statewide Policy Objectives: No local governmental units will be required to increase expenditures. Time, Place and Manner in which interested persons may comment on this proposed rulemaking: Written comments should be submitted, within 45 days after this notice, to: Initial Regulatory Flexibility Analysis: Types of small businesses, small municipalities and not-for-profit corporations affected: Farms used for the stabling of racehorses and training facilities. Reporting, bookkeeping or other procedures required for compliance: None Types of professional skills necessary for compliance: None Regulatory Agenda which this rulemaking was summarized: January 2008
The full text of the Proposed Amendments begins on the next page.
TITLE 11: ALCOHOL, HORSE RACING, AND LOTTERY SUBCHAPTER c: RULES APPLICABLE TO ALL OCCUPATION LICENSEES Foreign Substances and Pharmaceutical Aids Banned Permitted Use of Foreign Substances and Threshold Levels 603.160 Penalties 603.170 Veterinarian's Erythropoietin and Darbepoietin Antibody Testing Program AUTHORITY: Implementing and authorized by Section 9(b) of the Illinois Horse Racing Act of 1975 [230 ILCS 5/9(b)]. SOURCE: Adopted at 21 Ill. Reg. 3232, effective March 4, 1997; amended at 22 Ill. Reg. 2217, effective January 1, 1998; amended at 22 Ill. Reg. 3594, effective February 1, 1998; amended at 25 Ill. Reg. 15611, effective December 1, 2001; amended at 26 Ill. Reg. 12360, effective August 1, 2002; amended at 27 Ill. Reg. 5027, effective March 7, 2003; amended at 27 Ill. Reg. 7331, effective April 15, 2003; amended at 28 Ill. Reg. 1374, effective January 19, 2004; amended at 28 Ill. Reg. 4751, effective March 1, 2004; emergency amendment at 28 Ill. Reg. 7565, effective May 11, 2004, for a maximum of 150 days; emergency expired October 7, 2004; amended at 28 Ill. Reg. 11250, effective August 1, 2004; amended at 28 Ill. Reg. 15790, effective December 1, 2004; emergency amendment at 29 Ill. Reg. 2779, effective February 22, 2005, for a maximum of 150 days; emergency amendment at 29 Ill. Reg. 4116, effective February 25, 2005, for a maximum of 150 days; amended at 29 Ill. Reg. 5726, effective April 8, 2005; amended at 29 Ill. Reg. 12265, effective July 24, 2005; amended at 29 Ill. Reg. 14038, effective September 1, 2005; emergency amendment at 30 Ill. Reg. 14371, effective August 21, 2006, for a maximum of 150 days; amended at 30 Ill. Reg. 18729, effective November 20, 2006; amended at 31 Ill. Reg. effective January 1, 2007; emergency amendment at 31 Ill. Reg. 6680, effective April 23, 2007, for a maximum of 150 days; amended at 31 Ill. Reg. 12982, effective September 1, 2007; amended at 32 Ill. Reg. _____, effective __________. Section 603.60 Permitted Use of Foreign Substances and Threshold Levels Anti-Inflammatories (NSAID): Threshold Levels Only one non-steroidal anti-inflammatory drug (NSAID) may be present in a horse's body while it is participating in a race. The presence of more than one NSAID, greater than the threshold level, is forbidden and will result in the purse being redistributed. Subject to the prohibition contained in Section 603.40 (24 hour ban), the only foreign substances that now meet the criteria established in Section 603.80 are phenylbutazone (or its metabolite oxyphenylbutazone), flunixin, isoxsuprine, and ketoprofen. The threshold level of phenylbutazone shall be less than 5.0 micrograms (mcg) per milliliter (ml) of serum or plasma. The threshold level for oxyphenylbutazone shall be less than 5.0 mcg/ml of serum or plasma. Within a 365 day period, in the event a post-race sample from a horse contains an amount of phenylbutazone or oxyphenylbutazone greater than or equal to 5.0 mcg/ml but less than 10.0 mcg/ml of serum or plasma, the trainer shall be subject to the following penalties absent mitigating circumstances: third or subsequent offense, minimum fine of $1,000 and a 15 day suspension. Within a 365 day period, in the event a post-race sample from a horse contains an amount of phenylbutazone or oxyphenylbutazone greater than or equal to 10.0 mcg/ml of serum or plasma, the trainer shall be subject to the following penalties absent mitigating circumstances: first offense, minimum fine of $500 and the purse shall be redistributed; second offense, minimum fine of $1,000, a 15 day suspension and the purse shall be redistributed; third or subsequent offense, minimum fine of $2,500, a 30 day suspension and the purse shall be redistributed. 4) The threshold level of flunixin shall be less than 20.0 ng/ml of serum or plasma and the threshold level of ketoprofen shall be less than 10.0 ng/ml of serum or plasma. In the event a post race sample from a horse contains an amount of : flunixin greater than or equal to 20.0 ng/ml but less than 100.0 ng/ml or ketoprofen greater than or equal to 10.0 ng/ml but less than 50.0 ng/ml, the trainer shall be subject to the following penalties, within a 365 day period, and absent mitigating circumstances: third or subsequent offense, minimum fine of $1,000 and a 15 day suspension. flunixin greater than or equal to 100.0 ng/ml or ketoprofen greater than or equal to 50.0 ng/ml, the trainer shall be subject to the following penalties, within a 365 day period, and absent mitigating circumstances: first offense, minimum fine of $500 and the purse shall be redistributed; second offense, minimum fine of $1,000, a 15 day suspension and the purse shall be redistributed; third or subsequent offense, minimum fine of $2,500, a 30 day suspension and the purse shall be redistributed. If the phenylbutazone, oxyphenylbutazone, flunixin or ketoprofen overage is due to the negligence of the veterinarian attending the horse, the veterinarian shall be subject to the same penalties as are set forth in subsections (a)(3)(A) and (B) and (a)(4)(A) and (B). To help horsemen determine the test levels of phenylbutazone, oxyphenylbutazone, flunixin, isoxsuprine, and ketoprofen, the Board laboratory will test, for the actual cost of processing the sample, all equine serum or plasma samples submitted to it which are accompanied by an affidavit indicating time, method, and route of administration. Penalties for violations of this Section shall be based on the following criteria: previous warnings and rulings for violations of this Section; whether the violator has ever been the subject of a medication ruling in this or any other racing jurisdiction; what action, if any, was taken to avoid the violation; The following foreign substances may be administered externally to a horse entered to a race: Leg paints and liniment which do not contain any "caine" derivatives, pharmacodynamic and/or chemotherapeutic agents, and which can be applied topically without penetrating the skin. Subject to the prohibition contained in Section 603.40 (24-hour ban), the following foreign substances, commonly referred to as anti-bacterial, anti-fungal, anti-protozoal or anti-ulcer drugs, may be present in the body of a horse participating in a race. Amikacin Ampicillin Ampicillin sodium Azolsulfamide Chloramphenicol Doxycycline Enrofloxacin (Baytril) Erythromycin sulfate Gentamicin sulfate Kanamycin sulfate Methnamine Levamisole (tetramisole) Metronidazole Neomycin sulfate Nitrofurantoin Oxytetracycline Penicillin G. Benzathine Penicillin G. Potassium Sulfadimethozine Sulfadimethoxine Sulfamethoxazole Sulfametranidazole Sulfapyridine Sulfathiazole Tetracycline Trimethoprim Amphotericin B Griseofulvin Neomycin Undecyclenate Nystatin This listing of anti-bacterial, anti-fungal, anti-protozoal and anti-ulcer drugs is all inclusive and shall not include any other anti-bacterial, anti-fungal, anti-protozoal or anti-ulcer drug. A foreign substance of accepted therapeutic value may be administered as prescribed by a veterinarian when threshold levels and guidelines for its use have been approved by the Board and this Part has been duly amended. The Board shall give due consideration to threshold levels and guidelines that have been established by the Quality Assurance Program Committee of the Association of Racing Commissioners International when making additions to the permitted list. Official test samples may contain the following drug substance, or its metabolites, in an amount that does not exceed the threshold level: The threshold level of Isoxsuprine shall be less than 1,000.0 ng/ml in urine. The threshold level of Pyrilamine shall be less than 50.0 ng/ml in urine. The provisions of this subsection shall be applied retroactively when substantively applicable, including all actions pending before the Board without regard to when the cause of action accrued; provided, however, that this amendment shall not operate to affect rights of individuals that have fully vested prior to April 23, 2007. (Source: Amended at 32 Ill. Reg. _____, effective __________) No veterinarian or any other person shall have in his possession or administer to any horse within any race track enclosure any chemical substance which: has not been approved for use on equines by the Food and Drug Administration, pursuant to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. Section 301 et seq., and implementing regulations, without prior written approval from the State veterinarian; or which is on any of the schedules of controlled substances as prepared by the Attorney General of the United States pursuant to 21 U.S.C. Section 811 and 812, without prior written approval from the State veterinarian. the possession and/or use on the premises of a facility under the jurisdiction of the Board of any drug, substance or medication specified below for which a recognized analytical method has not been developed to detect and confirm its administration; or the use of which may endanger the health and welfare of the horse, or the safety of the rider or driver. The State veterinarian shall not give such approval unless the person seeking such approval can produce evidence in recognized veterinary journals or by recognized equine experts that such chemical substance has a beneficial, therapeutic use in horses. No person except a veterinarian shall have in his possession within a race track enclosure any prescription drug, except as provided in this Section. A person may possess a prescription drug for animal use if: The person possesses, within the race track enclosure, documentary evidence that a prescription has been issued to him for such prescription drug; The prescription contains a specific dosage for the particular horse or horses to be treated by the prescription drug; and The horse or horses named in the prescription are in that person's care within the race track enclosure. (Source: Amended at 32 Ill. Reg. _____, effective __________) Any horse on the grounds of a racetrack under the jurisdiction of the Board, or stabled off-track, while under the care or control of a trainer or owner licensed by the Board, is subject to testing for blood and/or gene doping agents with reasonable notice. This section does not apply to therapeutic medications approved by the FDA for use in the horse.
Horses to be tested may be selected at random, with probable cause, or as determined by the Board for out of competition testing. The trainer is responsible to have the horse or horses available at a designated time and location (racetrack). The Board Veterinarian, or any licensed veterinarian or licensed veterinary technician authorized by the Board, may at any time, take a urine, blood or hair sample from a horse for out of competition testing. Prohibited substances, practices and procedures are defined as: blood doping agents including, but not limited to Erythropoietin (EPO), Darbepoetin, Oxyglobin, Hemopure, Aranesp, or any substance that abnormally enhances the oxygenation of body tissues. gene doping agents or the non-therapeutic use of genes, genetic elements, and/or cells that have the capacity to enhance athletic performance or produce analgesia. Cooperation with the Board Veterinarian, or any licensed veterinarian or licensed veterinary technician authorized by the Board, includes: assisting in the immediate location and identification of the horse selected for out of competition testing; providing a stall or safe location to collect the samples; assisting the veterinarian in properly procuring the samples; and obeying any instructions necessary to accomplish the provisions in this section. referee samples will be collected pursuant to Section 603.120. The Board may suspend, exclude, and/or otherwise penalize any licensee or other person who does not fully cooperate with a Board employee or representative while taking action to enforce this section. Out of competition samples will be sent to the official laboratory of the Board, or other laboratory as designated by the Board. (Source: Added at 32 Ill. Reg. _____, effective __________) The use of one of four approved anabolic steroids shall be permitted under the following conditions: Not to exceed the following permitted urine or plasma threshold concentrations: Stanozolol (Winstrol) - 1 ng/ml in urine; Boldenone (Equipoise) – in male horses other than geldings; including free boldenone and boldenone liberated from its conjugates - 15 ng/ml in urine; Testosterone – 20 ng/ml in urine in geldings and 55 ng/ml in urine in fillies and mares. Any other anabolic steroids are prohibited to be administered. The presence of more than one of the four approved anabolic steroids at Post-race urine samples collected from intact males shall be identified to Any horse to which an 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 threshold, the horse is eligible to be removed from the list. (Source: Added at 32 Ill. Reg. _____, effective __________)

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