NOTICE OF DECISION
IN THE MATTER OF THE RACING COMMISSION ACT, S.O. 2000, c.20;
AND IN THE MATTER OF THE APPEAL AND REQUEST FOR A HEARING BY
PASQUALE PARENTE
Pasquale Parente, Trainer of thoroughbred horses, appealed against the positive test result and penalties imposed on August 26, 2015, by the Stewards for the Class I drug Pemoline and the Class II drug Levamisole, for the racehorse REKHA DIAMOND, from a race at Woodbine on September 6, 2014, in TB Ruling 9425/2015.
ORC Panel: Elmer Buchanan, Chair Anthony Williams, Vice Chair
Counsel for the Appellant: Daniel J. McMahon
Counsel for the Administration of the ORC: Carlo Di Carlo
Decision: The Panel allowed the Appeal in part as to Penalty. The Reasons for Decision are attached to this Notice.
DATED at Toronto this 24th day of June, 2016.
Original signed
____________________
Jean Major
Executive Director
REASONS FOR DECISION
OVERVIEW
Pasqual Parente (“Parente”), was the trainer of record for Rekha Diamond, a thoroughbred racehorse.
On September 6, 2014, the horse competed in the sixth race at Woodbine and finished fourth.
A urine sample taken from the horse after the race resulted in a Certificate of Positive Analysis of an Official Sample for the Class I drug Pemoline and the Class II drug Levamisole.
On August 7, 2015, the Stewards held a Positive Test Hearing for Parente.
On August 27, 2015, the following penalties were imposed:
(i) $5,000 fine;
(ii) 1 year full suspension of licence;
(iii) Upon reinstatement, terms issued to licence for 2 years.
THE HEARING
On March 17, 2016, the hearing of the appeal began before a panel of the Ontario Racing Commission (“ORC”).
Counsel for the Administration called two witnesses:
(i) Fenton Platts, Steward, ORC;
(ii) Adam Chambers, Doctor of Veterinary Medicine, Manager of Veterinary Services for the Alcohol and Gaming Commission of Ontario (formerly the ORC), and Research Manager for the Canadian Pari-Mutuel Agency (“CPMA”), at Jerseyville, Ontario.
- Counsel for the Appellant called five witnesses:
(i) Pasquale Parente, Trainer;
(ii) Nicholas Gonzales, Trainer;
(iii) Richard Grant, Investigator, ORC;
(iv) Daniel Colangelo, Doctor of Veterinary Medicine
(v) Thomas Tobin, Doctor of Veterinary Medicine, Toxicologist, Pharmacologist
THE EVIDENCE
Appellant
Pasquale Parente (“Parente”) has trained thoroughbred racehorses for thirteen years.
Rekha Diamond was one of the twenty-five racehorses trained by Parente in the summer of 2014.
Parente had used Chris & Colangelo Equine Services, almost daily, for three years, for the care and treatment of the horses in his stable.
Rekha Diamond suffered from a health issue.
Parente sought the advice of Colangelo, his veterinarian.
A plan of care was implemented on the advice of Colangelo.
The plan was unsuccessful.
Parente sought further advice from his veterinarian.
Colangelo recommended the use of Levamisole, a Class II drug.
Colangelo discussed the proposal use of the drug with Parente.
Parente said that: “I did not know that Levamisole was a compounded medication.” “The ‘compound drug’ only came to light in the proceeding”.
- Parente understood that:
“Colangelo had prescribed Levamisole in the past”;
“Colangelo had never had a problem with it”;
“There was no withdrawal time on it.” (in the CPMA booklet)
- Parente agreed that “there was no set timeline (recommended by the CPMA) for certain drugs”.
Q. “That’s because certain drugs are riskier?”
A. “There’s a risk (for all drugs);
They are all difficult to deal with;
They are all dangerous drugs to use.”
Colangelo recommended a “ninety-six hour withdrawal time…with instructions as to how to give it.”
Parente said:
“I had instructions from my veterinarian:
I administered it exactly the way I had been told.”
- Parente was asked:
Q. “Who has the final say?”
A. “He (the veterinarian) does.”
- Parente was asked:
Q. “Nothing you could have done better?”
A. “Other than not using it.”
Parente administered Levamisole as directed to Rekha Diamond.
The last administration was on September 1, 2014, one hundred and twenty-seven hours before the race.
On September 19, 2014, Parente was at the Racing Office at Woodbine when he received formal notice of the positive test result from the Stewards.
His reaction?
A. “I was in shock!”
Veterinarian
Daniel Colangelo (“Colangelo”) has been a Doctor of Veterinary Medicine for twenty-five years.
He has worked at the Woodbine track since 1992.
He is one of the three veterinarians who care for between eight hundred and one thousand horses at the track. Colangelo has used Levamisole in the treatment of racehorses for many years.
He said that the drug was a “good immune stimulant…to fight off infection.”
He said that Levamisole was a “zero withdrawal drug” until 2007.
It was a drug that could be “used right up to race time.”
He further said that “a scourge of Aminorex positives (a metabolite of Levamisole) in January and February 2007” led to post-race testing for the presence of Levamisole.
Colangelo said that later in 2007, Michael Weber, (Doctor of Veterinary Medicine and then Manager of Veterinary Services, ORC and Research Manager, CPMA at Jerseyville), advised the equine veterinarians that:
“Seventy-two hours is safe for you guys.” (as a guideline for elimination of Levamisole pre-race).
Colangelo said he has used a ninety-six hour elimination guideline since 2007. He has used this guideline in the administration of Levamisole for therapeutic purposes for twenty-six racehorses.
He has “used Levamisole safely for years and years.”
Colangelo has used Summit Pharmacy (Aurora) as his source for Levamisole for the past ten years.
Colangelo provided “the recipe for the compound drug” to the pharmacy.
“They prepare (Levamisole) under our guidance…to our concentrations:”
- Colangelo has been the primary veterinarian for Parente for three years.
They have almost daily contact.
Colangelo regards Parente as “a very conscientious trainer.”
Colangelo described the racehorse, Rekha Diamond, as having a “tenacious mucous problem.”
Colangelo examined the horse.
Other drug regimens were attempted, without success, to resolve this health issue.
Colangelo proposed the use of Levamisole to Parente. Colangelo told Parente of his experience with the drug.
Colangelo said he received the informed consent of Parente, for use of the compounded medication, as required by the College of Veterinarians of Ontario, before Levamisole was prescribed for Rekha Diamond.
Colangelo “decided to use (Levamisole) at ninety-six hours, knowing the guideline of the CPMA.” (72 hours).
The treatment record shows the August 30, 2014 Requisition for Levamisole powder for Rekha Diamond.
The Equine Medication Record Form shows the last administration of the drug, by Parente, on September 1”.
Rekha Diamond competed in the sixth race at Woodbine on September 6, 2014.
The Certificate of Positive Analysis for Levamisole and Pemoline was dated September 18, 2014.
Notification of the positive test result was made on September 19, 2014.
Colangelo said:
“I was astonished at the positive.”
and
“After Pat’s (Parente’s) positive, we all (the equine veterinarians) moved it (the elimination guideline for Levamisole) further, to seven days.”
- TB Rule 27.17 provides that:
“A veterinarian may be held wholly or partially responsible if any drug or medication is prescribed by him… is a cause for
(i) the issuance of a certificate of positive analysis under the Pari-Mutuel Betting Supervision Regulations…and may be fined by the Stewards.”
- On August 28, 2015 the Stewards imposed a $1000 fine upon Colangelo for the positive test result for Rekha Diamond, Ruling Number TB 9445/2015.
Trainer
Nicholas Gonzales (“Gonzales”) has been a trainer of thoroughbred racehorses for many years.
He has had more than thirteen hundred wins including victories in the Queen’s Plate in both 2010 and 2013.
He is vice-president of the Horsemen’s Benevolent and Protective Association of Ontario. He is “proudly serving (his) eighth term on the executive of the Association.”
Gonzales stated that all participants in horse racing “really rely heavily on our practicing veterinarians.”
He estimated that up to 40% of the medications prescribed by equine veterinarians at the track are compounded drugs.
Steward
Fenton Platts (“Platts”) has been a Steward with the ORC for ten years.
Platts said that on September 19, 2014:
(i) the Official Chemist notified the Stewards of the positive test report;
(ii) the Stewards received the Certificate of Positive Analysis of an Official Sample, dated September 18, 2014;
(iii) the sample analyzed was a urine sample from Rekha Diamond, following her participation in the sixth race at Woodbine on September 6, 2014;
(iv) the sample was positive for the Class II drug Levamisole and the Class I drug Pemoline;
(v) the Stewards notified Parente (as the trainer of record for Rekha Diamond) of the positive test result;
(vi) Rekha Diamond was placed on the Stewards’ List;
(vii) Rekha Diamond was declared ineligible to race for ninety days in the Province of Ontario;
(viii) The stables of the trainer were searched and the trainer interviewed;
The positive test hearing for Parente was held by the Stewards on August 7, 2015. Their Ruling was delivered on August 26, 2015. Platts was one of three Stewards on the panel.
Platts agreed that Parente, (as a thoroughbred racehorse trainer), “runs a first class operation” and that “he enjoys an excellent reputation.”
Platts said that the Stewards impose the same penalty for a positive test regardless of the concentration of the prohibited drug in the racehorse.
Platts said that the Stewards had “never imposed anything less” than the minimum penalties suggested in the Guidelines.
- Platts confirmed that Colangelo said
(i) he used Levamisole for therapeutic purposes for Rekha Diamond;
(ii) he had “used it safely for years and years;”
(iii) “Doctor Michael Weber had suggested/recommended a withdrawal time of seventy-two hours;”
Investigator
Richard Grant (“Grant”) has been an investigator with the ORC for thirteen years.
On September 19, 2014, Grant was assigned to investigate the positive test for Rekha Diamond.
Grant attended at the stables of Parente, accompanied by both Parente and a Commission Veterinarian.
Grant conducted searches of the barn, the tack and feed rooms and the office. “The barn was impeccable.”
All medications were properly secured and stored.
The medication records for the horses were provided to Grant. The last administration of Levamisole to the racehorse was by Parente on the morning of September 1, 2014, approximately 127 hours prior to the race.
The recommendation by Colangelo on the label of the Levamisole for Rekha Diamond was “96 hours out.”
- Grant interviewed three witnesses called on behalf of the Appellant:
(i) Parente (Trainer);
(ii) Colangelo (Veterinarian);
(iii) Michael Aztori (Groom).
Grant concluded his October 20, 2014, Investigation Report as follows:
“The investigator found all parties that were interviewed truthful and cooperative.”
Grant seized multiple documents which have become exhibits in this hearing
Grant was the author of the Investigation Report, dated October 20, 2014 (Ex.3, tab 16), which summarized his involvement in this matter.
Expert: Administration
Adam Chambers (“Chambers”) was qualified as an expert in veterinary medicine. Chambers was also qualified as an expert in relation to the drug Levamisole, its uses, metabolites, pharmacological effects and elimination time.
Chambers described Levamisole as a Class II drug (with a “high level of probability of affecting the outcome of a race”), and Pemoline as a Class I drug (with the “highest level of probability of affecting the outcome of a race”), under the Uniform Classification Guidelines for Foreign Substances, promulgated by the Association of Racing Commissioners International, Inc..
“Levamisole has been used as a dewormer and immune stimulant in animals.”
“The effect of Levamisole in animals may include cardiac stimulation, excitability, parasympathetic and sympathetic ganglia stimulation, and CNS depression.”
Levamisole was added to the CPMA Schedule of Drugs in 2008. The CPMA has no elimination guideline for Levamisole.
Levamisole is available as a compounded medication from pharmacies. Chambers advised that “compounded products are riskier.”
“There is no Health Canada oversight on the quality or composition of compounded products.”
“You need to be more cautious (when using compounded medication).”
- “Trainers are strongly advised to consult their own veterinarian.”
An “informed consent” is required by The College of Veterinarians of Ontario before the administration of a compounded drug.
- Chambers was asked:
Q. “Is the use of a compounded drug for therapeutic treatment of a racehorse acceptable?”
A. “Compounded medications are required from time to time."
Q. “Is the use reasonable?”
A. “Oh, yes.”
- Chambers said that
“detection after five days (following administration of Levamisole) would not be unexpected.”
The CPMA booklet (Schedule of Drugs 2011) lists one hundred and forty-three drugs. One hundred and forty drugs are subject to qualitative testing only (whether the drug is present in the sample at or above the screening level). Three drugs are subject to both qualitative and quantitative (the quantity of the drug in the sample) testing. Both Levamisole and Pemoline are subject to qualitative testing only in Canada.
Chambers further advised that Aminorex and Pemoline are metabolites of Levamisole.
“Aminorex and Pemoline are both stimulants.” Both Levamisole and Pemoline were detected by Maxxam Analytics in the urine sample of Rekha Diamond and the presence of both substances was confirmed by the referee lab.
“The detection and confirmation of Pemoline and Levamisole proves that Levamisole went through the horse.”
Chambers said that there has been “no study (conducted) about Levamisole and its effect on racehorses.”
Chambers said that the findings of the referee lab were “not close to the minimum detection levels for the analytical equipment” utilized.
Expert: Appellant
Thomas Tobin (“Tobin”) was qualified as an expert in veterinary medicine.
Tobin was also qualified as an expert in relation to Levamisole, its metabolites, its pharmacological effects and elimination time.
Tobin reviewed the October 14, 2014, Affidavit, dated October 14, 2014 of Petra G. Hartmann, Director, Drug Testing Services, Industrial Laboratories, Colorado.
Industrial Laboratories had received from Maxxam the residue of the urine sample which had been collected from Rekha Diamond on September 6, 2014, at the Woodbine racetrack.
The residue of the Official Sample was identified as “Sample No: 73 14249 345/Maxxam ID B402498-191172. The sample was described as “Secure and in good condition.” The sample was analyzed by Industrial Laboratories.
“Result of Testing:
Levamisole and Pemoline confirmed.
Concentration: approximately 1.3 ng/mL (Levamisole) and approximately 4.5 ng/mL (Pemoline)”
- Tobin in his Report of September 17, 2015 (at Part 4) stated as follows:
“…We therefore believe that the most likely interpretation for the findings reported in the post-race sample is that they are trace level residual identifications of a therapeutic administration that ceased about five days prior to the race in question, and that the very low concentration of the two substances identified, Levamisole and Pemoline, are consistent with what might be expected to be found in post-race Thoroughbred samples following the administration of Levamisole.”
- Tobin further advised in his report that:
“the traces” of both drugs were “detectable but not pharmacologically significant.”
Tobin testified that the quantity of Levamisole would have “absolute zero probability of an effect on the performance of a horse.”
Tobin further stated that the quantity of Pemoline would have “no effect on the performance of a horse.”
Tobin agreed that there was no information provided by the referee lab as to either the range of values or the margin of error in relation to the “approximate concentration of either of the drugs confirmed in the urine sample.”
Tobin was asked:
Q. “You do not know the margin of error in this report.”
A. “No.”
Q. “You have no hard evidence which tells you what the margin of error is?”
A. “No.”
ISSUE I
99.
Q. Was there a positive test?
A. Yes.
The Administration bore the burden, on a balance of probabilities, to prove the positive test.
The panel considered the cumulative effect of the Rules, the Exhibits, and the Witnesses upon this issue.
The report of the Official Chemist was received as a prima facie evidence of a positive test. TB Rule 15.04.01.
The Certificate of Positive Analysis of an Official Sample was introduced by both parties, on consent, in the documentary evidence filed. (Ex. 3 tab 8 and Ex. 8 tab 2).
There was no challenge as to the admissibility of this document.
There were no restrictions or caveats sought, by either counsel, as to the use by the panel, of any of the documentary materials filed.
There was no evidence to the contrary.
The Appellant presented confirmatory evidence of the presence of both prohibited substances in the residue from the Official Sample, by the further analysis conducted by the referee lab.
The panel admitted the Certificate of Positive Analysis of an Official Sample as evidence, relevant to the subject matter of this proceeding.
“At a hearing a Commission may admit any evidence, including hearsay, relevant of the subject matter of the proceeding.”
Rules of Procedure, ORC, Rule 9.2
- The panel found that the Administration met the burden of proof upon it, to prove, on a balance of probabilities, the positive test.
ISSUE II
- Q. Did the Appellant establish diligence/due diligence?
A. Yes.
The panel found Parente to be a credible and reliable witness.
Parente presented as a concerned, responsible and conscientious trainer.
Parente has a single prior positive test for the Class IV drug Ketoprofen, an analgesic/anti-inflammatory drug, administered by a previous veterinarian, for therapeutic purposes in 2012. Parente received a four day suspension as a penalty.
Rekha Diamond suffered from a health issue.
Parente sought the advice of his veterinarian.
A plan of care was implemented by the veterinarian.
The original plan was unsuccessful.
Parente sought the further advice of his veterinarian. The veterinarian recommended the use of Levamisole, a Class II drug.
The drug was available from compounding pharmacies only.
Parente was not aware that while drug compounding is an accepted practice, it does increase the variability in quality, stability, efficacy and potency.
Parente knew that the drug was not in the CPMA booklet.
Parente knew there was no withdrawal time on it.
Parente knew that there was a risk in the use of all drugs.
Parente also knew that his veterinarian had prescribed the drug Levamisole for racehorses in the past and had never encountered a problem with it.
The veterinarian recommended a 96 hour withdrawal time. Parente administered the drug on the advice of his veterinarian. Parente used a 127 hour withdrawal time.
Rekha Diamond suffered a positive test result.
Parente provided full cooperation during the investigation (interviews and searches) and the hearing before both the Stewards and the panel.
Parente had no intention to gain an unfair advantage in the race.
The panel found that Parente exercised diligence to avoid violation of the rules.
The panel further found that Parente, on a balance of probabilities, exercised due diligence, (“all reasonable care”), to avoid violation of the rules.
ISSUE III
- Q. Is a waiver of the breach appropriate?
A. No.
- “The Commission may…in its absolute discretion…waive the breach of any of the rules…which breach the Commission does not consider prejudicial to the best interests of racing.” TB Rule 24.03
The panel has the discretion to waive the breach of any rule.
The waiver must not be “prejudicial to the best interests of racing.”
- Waiver has been restricted to exceptional or “extraordinary circumstances, where a licensee has been met with circumstances truly beyond their control.”
Clifford Siegel v. O.R.C. Ruling Number COM SB 012a/2003, at p. 13
The discretion of the panel must be exercised within the perspective of the Racing Commission Act, the enabling statute.
Drug use has had a negative impact on the racing industry.
Drug use prevention has proven difficult through a strict liability regime.
The absolute liability rule, although harsh, has been found to be “reasonably justified in the public interest to protect horse racing.”
Shakes v. Ontario Racing Commission,
2013 ONRC 4229
Can LII, at p.7, para. 35
A blameless trainer cannot avoid conviction by showing that he was free from fault or that he exercised due diligence.
Due diligence is to be considered on the penalty phase.
Levamisole and Pemoline are drugs with the potential to affect the performance of a racehorse.
A positive test for one or both of these drugs is an absolute liability offence.
A defence of due diligence does not entitle the trainer to a waiver of breach of the positive test rule.
This was not a case in which the increased sensitivity of the analytical testing equipment resulted in a positive test.
Chambers provided opinion evidence that the screening level at which a declaration of a positive test is made has remained constant.
- This was not a case in which “trace levels found are consistent with environmental contamination where the substance has not passed through the horse.”
Larry Cappuccitti and René Wilson
Ruling Number COM TB 23/2015 at para.41
Chambers provided opinion evidence that the prohibited substances passed through the horse.
- This was not a case where the “positive drug test arose from environmental, or other contamination rather than any act or omission of the trainer, groom or other person who has the charge, custody and care of the horse.”
Ibid, at para. 47
There was no evidence of “environmental, or other contamination.”
There was evidence that the likely cause of the “positive drug test arose” from the “act…of the trainer…who has the charge, custody and care of the horse.”
- Traces of prohibited substances which are at or above the screening level do not require further proof of a pharmacological impact upon the performance of a racehorse to constitute a positive test.
Absence of a pharmacological impact upon the performance of a racehorse, if proven, on a balance of probabilities, would not, standing alone, be sufficient to constitute extraordinary or exceptional circumstances sufficient to justify a waiver.
- The panel found that the exercise of its discretion to waive the breach by Parente of the absolute liability rule for a positive test, in these circumstances, was not appropriate, nor was it “in the best interests of racing.”
ISSUE IV
- Q. What is the appropriate penalty?
(a) The Authority
- “…a panel is free to impose a penalty lower than the Guideline penalty on the basis of any mitigating circumstances surrounding a positive test, and a penalty lower than a Guideline penalty is not restricted to no suspension and a non-oppressive fine.
Suspensions and fines may be short of the Guideline in any amount that a panel reasonably considers appropriate in the particular circumstances.
What this means is that a panel is free to impose a penalty lower than the Guidelines in a variety of cases, including, for example, where it finds that a trainer has established that he or she exercised diligence in order to avoid violating the rules but the degree of his or her diligence fell just short of the level required for a successful defence of due diligence.”
Ontario (Racing Commission) v. Durham, 2016
ONSC 2490, at paras. 41 and 42.
(b) Penalty Guidelines
A first offence for both Class I and Class II drugs has a suggested penalty of a fine of $5,000 and a suspension range for between 1 year and 5 years.
“On a first offence, the Commission…may…impose a penalty…below the range in appropriate circumstances…”
Penalty Guidelines for Equine Drug…Offences, Policy Directive No. 1-2008, January 23, 2008 (Book of Documents), Ex. 3, Tab 1, p.1)
(c) Mandatory Sanctions
(i) Rekha Diamond was declared unplaced for every purpose except pari-mutuel wagering;
TB Rule 15.04.03
(ii) Rekha Diamond was declared ineligible to race for a period of 90 days from the date of identification of the horse with the positive test and was placed on the Stewards’ List in accordance with Rule 16.11.01 j
TB Rule 15.04.04
(d) Mitigating Factors
Parente established diligence/due diligence in his attempts to avoid violation of the positive test rules.
The medication, prescribed by his veterinarian was for a legitimate therapeutic purpose.
Parente had no intention to gain an unfair advantage in a race.
Parente had an excellent reputation as a trainer.
Parente provided full cooperation throughout the investigation, searches and hearings.
Parente has served 24 days of the original suspension imposed upon him.
The mandatory sanctions which result from all positive test violations have already had a significant impact upon Parente.
(e) The Result
- In view of all the circumstances, the panel allowed the Appeal in part, as to penalty.
(i) $1,000 fine is imposed;
(ii) 1 year suspension is set aside;
(iii) terms issued to licence for 2 years, upon reinstatement, are set aside;
(iv) Rekha Diamond remains unplaced for every purpose except for pari-mutuel wagering.
Dated at Toronto this 24th day of June, 2016
Original Signed Original Signed
______________ _____________________
Elmer Buchanan Anthony Williams
Chair Vice Chair