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Flunixin and Clenbuterol - changes in the CHRB rules

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Two important amendments to CHRB rule 1844 became effective on October 20, 2007. The flunixin regulatory threshold was raised to 50ng/ml in blood form the previous 20ng/ml. This should have little impact in the day-to-day operation of most stables.

 A standard 500mg (10cc) IV dose at 24 hours seldom exceeds 20ng/ml in the average horse. The 50ng/ml level was established from administration studies with flunixin administered to 28 horses; all but a handful were thoroughbreds in race training at the track. The laboratory analysis was done by Dr. Scott D. Stanley at UC Davis and Dr. Rick Sams at Ohio State University. The results were statistically analyzed, and a flunixin level above 40ng/ml can be shown to be so improbable as to be unrealistic. The regulatory level was rounded up to 50ng/ml for California for simplicity and to add an additional margin of safety.
 
The second amendment to rule 1844 involves clenbuterol. The rule change gives the CHRB the ability to regulate clenbuterol in the blood as well as urine. The new regulation adds a 25 picograms/ml in blood threshold to the 5ng/ml threshold in urine. If either exceeds the threshold limit, there is a violation. This can have an impact on any trainer administering clenbuterol within 72 hours of race time. Administration of clenbuterol up to 72 hours at 5cc twice a day to the average-sized horse will not result in a violation in blood. We estimate between one-third to one-half of horses are at risk of exceeding 25 picograms/ml in blood from an administration at 48 hours and nearly 100% within 48 hours will results in a violation.  This is very different from the current clenbuterol level of 5ng/ml in urine, where a single dose within 48 hours could pass the post-race urine. That will no longer be the case.
 
Cobra Venom
 
All trainers should be familiar with CHRB rule 1867. The rule has been on the books for over 10 years and addresses prohibited practices. The rule specifically bans the possession of snake venom at CHRB facilities. The Kentucky equivalent to our rule was the basis for Patrick Biancone’s recent suspension. Biancone was suspended even though the cobra venom was found in a container marked as belonging to Biancone’s veterinarian, Dr. Stewart. Dr. Stewart’s container with the cobra venom was stored in a refrigerator in a tack room assigned to Biancone’s Kentucky stable. Biancone denied knowledge of the cobra venom, but was held responsible as it was found in his barn. Cobra venom has been used in the past by a number of trainers and veterinarians. Regardless, and so there is no question, California will be just as aggressive as Kentucky  in prosecuting any licensee found in possession of cobra venom or any other prohibited drug under rule 1867.  In addition to snake venom, erythropoietin (EPO) and darbepoietin (darb-EPO) are specifically identified in the rule.
 
In a somewhat related matter, the same Dr. Stewart from the Biancone cobra venom situation has a case pending in California for improper labeling of medications and practicing veterinary medicine at a CHRB facility without a CHRB license. This involves medication allegedly sent to California by Dr. Stewart related to Biancone’s salmeterol positive from January. Mr. Biancone was fined $10,000 and given a 15-day, stayed suspension, even though salmeterol is a Class III violation. Neither salmeterol administration nor salmeterol dispensing had been reported to the CHRB by his California veterinarians. Dr. Stewart is currently under suspension in California; his California case will be heard after the resolution of his Kentucky problems.
 
Law Change for Hearings of Class I, II, & III Violations
 
Governor Schwarzenegger has signed AB1616, which will change the way Class I, II, & III violations are adjudicated; the law is effective in January, 2008. The new law puts the hearing process back in the hands of the CHRB. For the last 8 years, a licensee could elect to go directly to the Office of Administrative Hearing (OAH) and bypass the CHRB with Class I, II, & III violations. OAH, especially in Southern California, often has a large backlog of cases and setting hearing dates has been problematic. Several CHRB cases have taken a year to get to hearing from the date of the violation. Both the CHRB and the licensee were forced into an expensive and slow process where no one benefits but the attorneys. Under 1616, there is an option of the hearing going before the stewards or an independent hearing officer. The CHRB envisions the hearings to take place at or near our racetracks to facilitate the process.  The goal is for the hearings to be scheduled, heard, and resolved much more quickly than is currently accomplished through OAH. 
 
Split Sample Procedures
 
A number of trainers have lost their opportunity to have their split samples tested under rule 1859.25 by not adhering to the deadlines expressly specified within the rule. Trainers need to take the deadlines in rule 1859.25 seriously if they intend to pursue a split sample analysis. There are two deadlines that must be met: The first is notifying the CHRB whether or not the owner or trainer wants a split sample analyzed. This must be done within 72 hours of the owner or trainer being notified of an adverse finding in the official sample. This is best done by notifying the Split Sample Custodian at the CHRB’s Sacramento office. That telephone number is 916-263-6050; the fax number is 916-263-6051. The notification needs to be accompanied by form CHRB-56 (Request to Release Evidence) and a check for $35 for handling and shipping expenses. The second deadline is completing arrangements with the split sample laboratory. There are nine (9) CHRB approved split sample laboratories. After the CHRB receives notification, the owner or trainer has five (5) days to finalize all arrangements with their chosen split sample laboratory. Each lab has somewhat different requirements to complete the process. This includes payment and any paperwork required by the laboratory. This is the licensee’s responsibility; it is not the CHRB’s.
 
The calculation of the deadlines gives the trainer more than adequate time to complete the process. The 72-hour (3-day) deadline to notify the CHRB of your decision to have a split sample analyzed begins the first working day after the licensee has been notified of the adverse finding and ends at the close of business on the third working day. For example, if you are notified on a Wednesday, the following Thursday, Friday, and Monday will constitute the 72 hours. If the CHRB has not been notified at the end of the workday on Monday, the licensee has missed the deadline. Similarly, with the above example and assuming the CHRB was notified on the Monday, the owner or trainer would have until the end of the following Monday to complete all arrangements with the chosen split sample laboratory. In the above example, the trainer would have 12 calendar days. This is more than enough time with any serious effort to meet the regulatory deadlines of 1859.25.
 
The Split Sample Custodian is willing to answer questions, but will not make the arrangements for you. The list of the nine (9) CHRB approved split sample laboratories is available through the Split Sample Custodian or the CHRB investigator handling the case. Keep in mind, most split sample labs are in earlier time zones than California. In addition, even though a lab is on the approved split sample laboratory list, it does not mean the laboratory can or will accept your sample. All racing laboratories experience workload constraints from time to time. This is especially true in the summer. In addition, the CHRB split sample laboratory contract requires that the lab can only accept a sample if they have the procedures and capability to confirm the target drug or medication at or below the level reported by the CHRB’s official laboratory. If they do not have that capability, they must decline the sample.
 
 
One other issue causes some confusion. The split sample is the property of the CHRB; it is not the property of the owner or trainer. In addition, the CHRB is the recipient of all reports generated by the split sample laboratory on any sample sent from the CHRB. Who pays for the analysis does not alter this. The owner or trainer requesting the split sample analysis will receive copies of all documents generated by the split sample lab. Nothing is hidden. Please be aware some labs will have additional charges for any report or documentation beyond the standard one- or two-page report confirming or not confirming the finding. The cost for any additional documentation or paperwork is the responsibility of the licensee. There may be additional charges for quantitative testing; quantitative testing provides drug levels. Depending on the drug, some quantitative testing is not important for the CHRB to proceed with a case, but may be important as a mitigating factor for the licensee during the subsequent hearing. All this needs to be finalized before the sample is shipped.
 
The CHRB does not consider an adverse finding by the official lab to constitute a positive until it is confirmed by the split sample lab. The exception is when a split sample is not requested or denied for not meeting rule 1859.25 deadlines or other requirements. Only then does the CHRB declare a positive and file a complaint.