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Legislature demands clarification of Charlotte's Web draft rule

The Joint Administrative Procedures Committee Thursday sent a 14-page letter to the Office of Compassionate Use asking for an explanation of a proposed rule for the Charlotte’s Web law.

The letter is here.

JAPC’s chief attorney Marjorie C. Holladay asked OCU director Patricia Nelson to explain how the Department of Health reached the conclusion that a statement of estimated regulatory costs would not trigger a review of the rule by the legislature.

Nelson had guided a negotiated rule making committee in crafting a rule that came in about $60,000 under the threshold in annual regulatory costs that would require lawmakers to approve the rule.

Holladay noted if any nursery would apply for a license in more than one region then costs may exceed the $1 million threshold requiring legislative ratification of the rule.  Holladay also observed that the rule did not include a biennial renewal fee.

“Depending on the amount of this fee, the statutory threshold for legislative ratification could be triggered, especially because there will be three renewal fees to be paid by the five dispensing organizations seeking renewal with five years after implementation of this rule,” wrote Holladay.

JAPC also has questions about the criteria to be used in each step of authorizing a licensee to begin cultivating, processing oil from the plant and dispensing a medicinal product.

JAPC is seeking additional information how points will be awarded to applicants when describing plans to meet OCU’s goals.

And echoing comments of grower Anthony Ardizzone, Holladay asked Nelson to explain why the department is “considering an applicant’s experience interacting with patients,” a patient education program for employees and patient counseling. The letter noted that dispensing organizations do not appear to come under the statute addressing those issues.

“Who are we to conflict with the recommending doctor patient privilege,” said Ardizzone. “I don’t see how that falls in line with our technological ability to process low-thc cannabis.”

JAPC is also seeking a list of definitions from the OCU including what is meant by terms such as “good manufacturing practices” and “supervisor.” A public hearing on the proposed rule is scheduled for Monday.

DOH defended its SERC calculation, responding to Holladay’s request Nelson wrote, “Your suggestion for potential additional costs is too speculative for the department to include in a SERC.”

And since DOH’s costs for regulating medicinal marijuana will change once the industry is up and running the department concedes future regulatory costs are unknown and at this time will not move forward with adoption of a license renewal process.

“The renewal fee will not even be set until the Department has a better idea of those recurring costs. As a result, the Department will not be moving forward with adoption of 64-4.003, F.A.C., at this time,” wrote Nelson.

With that said the department intends to implement the Compassionate Medical Cannabis Act as “swiftly and safely as possible.”

Moving forward with the rule, the department asserted in its response it, “will have done its statutory duty without placing unlawful or invalid minimum criteria on the Applicants.”

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