Health regulators will almost certainly delay a rule that will eventually create the framework for the state's new medical marijuana industry after an outcry from a legislative panel saying the proposed regulation went too far.
At what was expected to be the Department of Health's final day-long hearing on the proposed rule Friday, Office of Compassionate Use Director Linda McMullen told a packed conference room that changes are likely.
"We've had many, many written comments, all of which have been helpful," McMullen said, mentioning the letter from the Legislature's Joint Administrative Procedures Committee, or JAPC, issued earlier this week. The missive challenged the health department's authority regarding nearly every aspect of the proposed rule.
JAPC, which oversees state regulations, will have to certify that the health department responded to its questions before a revised rule can be filed, McMullen said. The agency will file the notice of the changed rule at least 21 days prior to adopting the new regulation.
Among the changes under consideration: altering a proposed requirement that nurseries meeting certain qualifications have just 25 percent ownership in the entities that receive one of five licenses to grow, process and distribute the newly-authorized strain of cannabis that purportedly does not get users high.
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, JAPC's chief attorney. The law requires applicants to have a valid 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 operated as a registered nursery in the state for at least 30 continuous years. At least 60 nurseries meet the criteria.
The DOH rule was intended to provide some financial protection for nurseries while allowing them to participate in the pot industry. Banks are not willing to lend to pot growers because marijuana is still illegal under federal law.
"There isn't a nursery grower out there that wants to put their entire 30-year business on the line for this business, which has some level of uncertainty, certainly on the federal level," said Jeff Sharkey, a lobbyist and founder of Medical Marijuana Business Associates. "The legal liability is huge."
The Legislature this spring 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.
Health officials are also reconsidering regional restrictions. Under the last version of the proposed rule, nurseries would only be allowed to apply for one of five licenses -- one in each region of the state -- but could have "transportation plans" that would allow them to deliver products to patients anywhere in the state. It is unclear what health officials are considering as an alternative.
On another front, Anthony Ardizzone of Ed Miller and Son nursery in Palm City said that the proposed rule is unfair because it limits growers from applying for more than one license but does not restrict other types of companies from joining up with nurseries and possibly owning a piece of every license.
"So why would a nursery be punished and told they can only apply once ... but yet an entity has the allowability to apply multiple times? It seems like the entities are getting the better end of the deal," Ardizzone said.
Department of Health General Counsel Jennifer Tschetter said her agency wanted to let nurseries team up with businesses with the best technology or experience cultivating and processing the low-THC product elsewhere.
"I don’t know why we would deny them that opportunity," she said.
The department is also considering changes that could allow more works to have access to the "compassionate use registry," which McMullen said is ahead of schedule. Doctors will enter eligible patients' names and dosages into the database, and dispensing organizations will also access the database when they fill orders.
Artezzoni also objected to the rule that requires the dispensing facility be located on the same property or "very near" to where the plants are grown and the substance is processed, saying it puts his operation in jeopardy.
"To do it at my site and bring people to the site, and I'm sorry there is ignorance out there in the public, many people are not going to know that what we’re doing at this stage ... you can’t get high from,” he said, adding that the situation could become more problematic if Florida voters approve a constitutional amendment on the November ballot that would legalize "traditional" medical marijuana. "To have the general public have availability to where we’re growing this is not a good idea."
Holley Moseley, a Panhandle mother who helped convince the Legislature to approve the legislation on behalf of her adopted daughter RayAnn, and her husband have joined forces with the Colorado-based Stanley brothers, whose "Charlotte’s Web" strain of cannabis spearheaded the national push for the low-THC, high-CBD as a treatment for children with severe epilepsy.
"You've got to have a safe product. There's no way I am going to give my daughter a product that can cause her more harm. We've done many things and we think this is going to be her magical drug that changes her life and our lives completely," Moseley said.
