Notice of Proposed Rule

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION
Division of Pari-Mutuel Wagering
Rule No.: RULE TITLE
61D-6.008: Permitted Medications for Horses
PURPOSE AND EFFECT: The purpose and effect of the proposed rule will be to implement Florida Statutes pertaining to permitted medications for horses by establishing threshold levels for certain Class IV and V medications commonly found in racehorses.
SUMMARY: The proposed rule addresses the establishment of threshold levels for certain Class IV and V medications commonly found in racehorses.
OTHER RULES INCORPORATING THIS RULE: None.
EFFECT ON THOSE OTHER RULES: None.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: The agency has determined that this rule will not have an impact on small business. A SERC has not been prepared by the agency.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 550.0251, 550.2415 FS.
LAW IMPLEMENTED: 550.0251(11), 550.2415(1), (8)(e), (9)(c), (13), (14), (16) FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE,TIME AND PLACE SHOWN BELOW(IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):
DATE AND TIME: October 7, 2010, 10:00 a.m. – 12:00 Noon
PLACE: Florida Department of Business and Professional Regulation, Northwood Centre, Board Room, 1940 N. Monroe Street, Tallahassee, Florida 32399
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 5 days before the workshop/meeting by contacting: Mary Polombo at (850)413-0750. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Mary Polombo, Clerk, Division of Pari-Mutuel Wagering, 1940 North Monroe Street, Tallahassee, Florida 32399-1035

THE FULL TEXT OF THE PROPOSED RULE IS:

61D-6.008 Permitted Medications for Horses.

(1) through (2)(a)2. No change.

(b) When the post race serum sample of such horse contains a concentration an amount of phenylbutazone or its metabolites equal to or in excess of 2 5 micrograms per milliliter of serum, but less than 8 micrograms per milliliter of serum, the trainer as the absolute insurer of the horse, shall be subject to the following penalties:

1. through 3. No change.

(c) When the post race serum sample contains a concentration an amount of phenylbutazone or its metabolites equal to or in excess of 8 micrograms per milliliter of serum, the trainer as the absolute insurer of the horse, shall be subject to the following penalties:

(2)(c)1. through (6) No change.

(7) All prescription medication, regardless of method of administration, shall be safeguarded under lock and key when not being actively administered.

(7)(8) No Androgenic-Anabolic Steroids (AAS) shall be permitted in test samples collected from racing horses, except for the major metabolites of stanozolol, nandrolone, and the naturally occurring substances boldenone and testosterone at concentrations less than the following thresholds:

(a) No change.

(b) Boldenone – 15 nanograms per milliliter in urine of male horses other than geldings. No boldenone boldennone shall be permitted in geldings or female horses.

(c) through (d) No change.

(8)(9) Urine samples of horses shall be identified as having been collected from a female, male, or gelding before being sent to the laboratory.

(9) The following permitted medications shall not be reported by the racing laboratory to the division as a violation of Section 550.2415, F.S.:

(a) The detection of cimetidine at a urinary concentration less than or equal to 10 micrograms per milliliter.

(b) The detection of dimethyl sulfoxide (DMSO) at a blood serum concentration less than or equal to 10 micrograms per milliliter.

(c) The detection of famotidine at a urinary concentration less than or equal to 10 micrograms per milliliter.

(d) The detection of flunixin at a blood serum concentration less than or equal to 20 nanograms per milliliter.

(e) The detection of guaifenesin (free) at a blood serum concentration less than or equal to 100 nanograms per milliliter.

(f) The detection of total isoxsuprine at a urinary concentration less than or equal to 100 nanograms per milliliter.

(g) The detection of ketoprofen at a blood serum concentration less than or equal to 10 nanograms per milliliter.

(h) The detection of methocarbamol (free) at a blood serum concentration less than or equal to 20 nanograms per milliliter.

(i) The detection of naproxen at a blood serum concentration less than or equal to 1 microgram per milliliter.

(j) The detection of a sulfide metabolite of omeprazole detected by LC-MS.

(k) The detection of ranitidine at a urinary concentration less than or equal to 10 micrograms per milliliter.

(10) All prescription medications, regardless of method of administration, shall be safeguarded under lock and key when not being actively administered.

Rulemaking Authority 550.0251, 550.2415 FS. Law Implemented 550.0251(11), 550.2415(1), (8)(e), (9)(c), (13), (15), (16) FS. History– New 10-20-96, Amended 1-5-98, 6-6-00, 5-14-02, 6-6-04, 7-6-06, 8-12-07, 12-30-08,_________.


NAME OF PERSON ORIGINATING PROPOSED RULE: Milton Champion, Director, Division of Pari-Mutuel Wagering
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Charlie Liem, Secretary, Department of Business and Professional Regulation
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 16, 2010
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: July 2, 2010