A legislative panel that plays a key role in overseeing state agencies has joined the chorus of critics seeking changes to a proposed soup-to-nuts rule setting up Florida's new medical-marijuana industry.
A 19-page letter from the Joint Administrative Procedures Committee to the Department of Health's general counsel questions nearly every aspect of the proposed rule, beginning with who would be allowed to apply for one of five licenses to grow, manufacture and distribute a type of cannabis approved during this year's legislative session.
The rule, proposed by health officials last month and slated for a third and final public vetting Friday, expanded eligible applicants to include businesses in which qualified nurseries have just 25 percent ownership, meaning the nurseries would not be required to have controlling shares of the entities.
But that definition is at odds with the law overwhelmingly approved this spring by the Legislature and supported by Gov. Rick Scott, according to Marjorie Holladay, chief attorney for the legislative committee.
Under the law, an applicant "must possess a valid certificate of registration" from the Department of Agriculture and Consumer Services to cultivate more than 400,000 plants, be operated by a nurseryman as defined by state law and "have been operated as a registered nursery in this state for at least 30 continuous years," Holladay wrote Friday to Department of Health General Counsel Jennifer Tschetter.
"Thus, it appears that the applicant must be a nursery that meets the criteria of this statute, not an entity with at least a 25% ownership by a nursery meeting the statutory criteria," Holladay wrote, asking Tschetter to "explain the department's statutory authority to authorize" --- a phrase used repeatedly in the letter --- the requirement.
The Legislature legalized strains of marijuana low in euphoria-inducing tetrahydrocannabinol, or THC, and high in cannabadiol, or CBD, and gave the newly-created "Office of Compassionate Use" within the Department of Health until Jan. 1 to come up with a regulatory framework for the substance. Supporters of the low-THC, high-CBD strains of cannabis believe the substance can eliminate or dramatically reduce life-threatening seizures in children with severe forms of epilepsy. Under the new law, patients with other spasm-causing diseases or cancer would also be eligible for the strains of marijuana if their doctors order it, and if their doctors say they have exhausted all other treatments.
The letter from the legislative committee also repeatedly asks the department to elaborate on how it will evaluate requirements laid out in the rule, such as documentation related to technical and technological ability.
The department also needs to explain other requirements, including why site plans need to be drawn to scale, why all employees must undergo background screenings and why all workers must be 21 years of age or older.
And the Department of Health must also come up with a reason the proposed rule would require applicants to provide photographs of public access --- including driveways and parking --- to the dispensary locations prior to getting a thumbs-up from the state to go into business.
"…It appears the department may be making construction of the facility, or at least the driveway and parking and public access, a precondition of application, which appears to be contrary to its authority," Holladay wrote.
Other questions posed by the committee's lawyer address health regulators' proposed requirement that the cannabis be organically grown and deal with "transportation plans" that would allow "dispensing organizations" to deliver their product statewide but would limit their licenses to a particular region.
The Department of Health left open the possibility that the rule could change, but that likely would not occur until after Friday's hearing.
"The department will evaluate the committee's comments, other written comments received, and testimony provided at the hearing on Friday to make decisions about whether a notice of change is appropriate for the proposed rules,'' department spokesman Nathan Dunn said in an email Wednesday. "The department will respond to JAPC's (the committee's) comments by way of a notice of change or written correspondence after that evaluation and decision-making process is complete."
The letter comes after intensive discussions between Rep. James Grant, a Tampa Republican who is vice-chairman of the legislative committee, and health department staff.
"I asked staff to make sure we get this right," Grant said.
Echoing objections expressed by many nursery owners and out-of-state operators seeking to do business in Florida, Grant initially objected to the health department's proposal to use a lottery method to select the "winner" of the five licenses. Health officials have refused to back down from that process, saying it is intended to minimize potentially drawn-out litigation over the granting of the licenses with the goal of getting the product into the hands of ailing children a quickly as possible. The letter from the committee does not challenge the lottery process.
"We're going to get sued one way or the other. We need to do our job right to mitigate our potential liability," Grant, a lawyer, said.
Grant also said the state isn't doing enough to measure the efficacy of the low-THC cannabis, which has not received approval from the Food and Drug Administration but instead has gained popularity through anecdotes shared by parents of children, some of whom suffered hundreds of seizures daily until starting on a trial-and-error regimen.
Florida's new law "may have created the first state-sanctioned clinical trials" of the low-THC cannabis, said Grant, one of the House bill's co-sponsors.
If so, Grant said, "we should be creating data sets" for the brand-new substance soon to be unleashed into "the health care eco-system." The state, the producers of the cannabis or somebody else should be coding information about the combinations of THC and CBD --- and how well the strains perform, Grant said.
Such "structured data" could provide a framework for health regulators if voters approve a proposed constitutional amendment in November authorizing "traditional" medical marijuana, which Grant called "the elephant in the room" no one wants to talk about but which goaded lawmakers into signing off on the low-THC legislation this spring.
"My fear is just to say we'll let the doctor or the nursery certify that it's low THC and that's all we need. They could write that on the back of a napkin," he said.
