This rulemaking amends the current rule language for Rule 64-4.013, F.A.C., and initiates nonemergency rulemaking to replace the emergency rules (64ER19-3, 64ER20-16, 64ER20-36, and 64ER20-37) adopted by the Department to ....

DEPARTMENT OF HEALTH

RULE NOS.:RULE TITLES:

64-4.013Pesticide Use on Medical Marijuana

64-4.207MMTC Marijuana Waste Management and Disposal

64-4.212 MMTC Regulatory Compliance Testing

64-4.213 MMTC Remediation

PURPOSE AND EFFECT: This rulemaking amends the current rule language for Rule 64-4.013, F.A.C., and initiates nonemergency rulemaking to replace the emergency rules (64ER19-3, 64ER20-16, 64ER20-36, and 64ER20-37) adopted by the Department to implement section 381.986, Florida Statutes.

SUMMARY: Rule 64-4.013, F.A.C., updates the current rule language to clarify that pesticides must include a label that expressly has directions for use on crops or plants intended for human consumption and to add that the active ingredient(s) are allowed for use on tobacco by the U.S. EPA. Rule 64-4.207, F.A.C., establishes procedures for the storage, handling, transportation, management, and disposal of solid and liquid waste generated during marijuana production and processing by medical marijuana treatment centers. Rule 64-4.212, F.A.C., establishes procedures for regulatory compliance testing of Final Products, including requirements for resampling and retesting of Retail Batches that fail regulatory compliance testing. Rule 64-4.213, F.A.C., establishes procedures for an MMTC to remediate a Retail Batch that initially fails regulatory compliance testing.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: Pursuant to s. 381.986(17), F.S., rules adopted by the Department before July 1, 2022 are not subject to the requirements of ss. 120.54(3)(b) and 120.541, F.S.

RULEMAKING AUTHORITY: 381.986(8)(e)11., 381.986(8)(e)11.c., 381.986(8)(e)11.d., 381.986(8)(k), FS.

LAW IMPLEMENTED: 381.986(8)(e)6.a., 381.986(8)(e)11., 381.986(8)(e)11.c., FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Christopher Ferguson at [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64-4.013 Pesticide Use on Medical Marijuana.

(1) through (2) No change.

(3) Any pesticide registered with the Florida Department of Agriculture and Consumer Services may be used for the cultivation of cannabis for medical use in the State of Florida when applied in accordance with its label or labeling directions under the following conditions:

(a) No change.

(b) For pesticides registered with the United States Environmental Protection Agency (U.S. EPA) under section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act, the following conditions must be met:

1. The pesticide product label bears a U.S. EPA-approved logo and/or language indicating the pesticide is allowed for use in organic crop production safe for human consumption;

2. The active ingredient found in the pesticide is either exempt from the tolerance requirements set forth pursuant to 40 C.F.R. 180 subpart D (07/01/2017) or does not require an exemption from the tolerance requirement pursuant to 40 C.F.R. 180 subpart E (07/01/2017), both of which are incorporated herein by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-09526;

3. The pesticide product label does not prohibit use within an enclosed structure for the site of application; and

4. The pesticide product label expressly has directions for use on unspecified crops or unspecified plants; intended for human consumption.

5. The pesticide product label expressly has directions for use on crops or plants intended for human consumption; and

6. The active ingredient(s) of the pesticide product is (are) allowed for use on tobacco by the U.S. EPA.

(4) This rule shall be reviewed, and if necessary, repealed, modified, or renewed through the rulemaking process five years from the effective date.

Rulemaking Authority 381.986(8)(k) FS. Law Implemented 381.986(8)(e)6.a. FS. History–New 7-23-18, Amended 1-10-19,            .

 

64-4.207 MMTC Marijuana Waste Management and Disposal

(1) As used in this rule, the term “Marijuana Waste” includes the following materials:

(a) Plant material waste, which means leaves, stalks, stems, and any other part of the marijuana plant that contains tetrahydrocannabinol and is not processed with solvent or used in the processing of marijuana to generate usable product;

(b) Processing waste, which means spent solvents, laboratory wastes, and similar materials used in the processing of marijuana to generate usable product;

(c) Product waste, which means marijuana and usable product that is unfit for sale or consumption. Product waste includes unused, returned, surplus, contaminated, recalled, and expired marijuana or usable product; and

(d) Other contaminated materials ready for disposal. “Contaminated materials” mean any item, object, utensil, or tool that contained, or came in contact with, marijuana or usable product and has trace residuals of marijuana thereon. An MMTC may clean contaminated materials using any method that eliminates any trace marijuana residuals from the material. Once the material has been cleaned of all trace marijuana residuals, the material may be recycled or disposed of like any other non-marijuana waste that falls outside the scope of this rule.

(e) Notwithstanding the foregoing, Marijuana Waste does not include hazardous waste or universal waste, as those terms are defined in Rule 62-730.020, F.A.C. (10/31/2020), which is incorporated by reference herein and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX.

(2) Nothing herein is intended to relieve an MMTC of its obligation to comply with applicable federal and state laws and regulations for solid and liquid wastes, as required by s. 381.986(8)(e), F.S., and any applicable local regulations or ordinances.

(3) Marijuana Waste must be rendered unusable and unrecognizable or irretrievable at an MMTC’s department-approved facility before it is transported offsite as provided for in paragraphs (5)(a) and (b). An MMTC may transport Marijuana Waste from a department-approved facility to another of its department-approved facilities where the Marijuana Waste will be rendered unusable and unrecognizable or irretrievable. The transportation of Marijuana Waste must be documented in the MMTC’s seed-to-sale system.

(a) Marijuana Waste is unusable and unrecognizable if it is incapable of being salvaged and consumed through any means and all components are homogenous and indistinguishable.

(b) Marijuana Waste is irretrievable if it cannot be transformed to a physical or chemical condition or state as marijuana or a substance with a chemical structure or effect that is similar to marijuana.

(c) At least two employees of the MMTC, one of whom must be a manager, shall be present when rendering the Marijuana Waste unusable and unrecognizable or irretrievable. Steps taken to render Marijuana Waste unusable and unrecognizable or irretrievable shall be conducted under video surveillance.

(d) Until such time that the Marijuana Waste is rendered unusable and unrecognizable or irretrievable, the Marijuana Waste shall be stored in a waste receptacle(s) that is:

1. A securely locked, enclosed container;

2. Securely fastened to a permanent structure so that it cannot be removed; and

3. Located in a secured area of the facility.

(4) Prior to disposal, in accordance with subsection (5), Marijuana Waste shall be:

(a) Rendered unusable and unrecognizable by grinding and mixing the compostable Marijuana Waste with at least an equal amount of other compostable materials (e.g., food waste, yard waste, vegetable-based grease or oils);

(b) Rendered unusable and unrecognizable by grinding the Marijuana Waste with at least an equal amount of other compostable materials (e.g., food waste, yard waste, vegetable-based grease or oils) or non-compostable materials (e.g., paper waste, cardboard waste, plastic waste, or oil), or both; or

(c) Rendered irretrievable by permanently altering the physical or chemical condition through irreversible means.

(5) After Marijuana Waste is rendered unusable and unrecognizable or irretrievable, any remaining Marijuana Waste shall be disposed of via one of the following methods:

(a) Delivered to an appropriate solid waste management facility, as that term is defined in Rule 62.701.200(112), F.A.C. (02/15/2015), which is incorporated by reference herein and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX;

(b) Delivered to a composting facility that is registered with or permitted by the Department of Environmental Protection pursuant to chapter 62-709, F.A.C. (04/2021), which is incorporated by reference herein and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX; or

(c) Composted onsite by the MMTC in accordance with chapter 62-709, F.A.C. (04/2021).

(6) An MMTC must maintain a current and up-to-date waste management plan. An MMTC’s waste management plan must include, at a minimum:

(a) The identity of the MMTC’s managers and employees with access to the Marijuana Waste storage area(s) of its facility(ies);

(b) Procedures for weighing, tracking, and documenting Marijuana Waste out of the MMTC’s seed-to-sale tracking system;

(c) Procedures for rendering Marijuana Waste unusable and unrecognizable or irretrievable, as required by this rule;

(d) Procedures for storing Marijuana Waste before it is rendered unusable and unrecognizable or irretrievable, in compliance with subsection (4), and the transport thereof;

(e) The manner of disposing of Marijuana Waste after it is rendered unusable and unrecognizable or irretrievable;

(f) Record maintenance and retention procedures for Marijuana Waste records; and

(g) Employee training materials and exercises concerning the MMTC’s Marijuana Waste management procedures that cover, at a minimum, the information outlined in paragraphs (6)(b)-(f).

(7) An MMTC must maintain records of the Marijuana Waste it generates. Such records must account for all activity related to the disposal of the Marijuana Waste, including:

(a) The date, time, and manner of rendering the Marijuana Waste unusable and unrecognizable or irretrievable, along with the legible names and signatures of the persons who rendered the Marijuana Waste unusable and unrecognizable or irretrievable;

(b) The video recording of the persons rendering the Marijuana Waste unusable and unrecognizable or irretrievable;

(c) The name of the entity(ies) collecting the Marijuana Waste, if any, and documentation that evidences the MMTC’s subscription to waste collection services from that entity; and

(d) The date, time, and manner of disposing of the Marijuana Waste, including whether the Marijuana Waste was disposed of via delivery to a solid waste management facility, delivery to a registered or permitted composting facility, or composted onsite by the MMTC.

(e) Video surveillance recordings must be retained for at least 45 days. All other Marijuana Waste records must be retained for at least two years.

(8) An MMTC must provide a minimum of 72 hours notice in the MMTC’s seed-to-sale tracking system prior to rendering the Marijuana Waste unusable and unrecognizable or irretrievable and must record in the tracking system the weight of the Marijuana Waste to be rendered unusable and unrecognizable or irretrievable. At least two MMTC employees, one of whom must be a manager, shall be present when documenting Marijuana Waste out of the MMTC’s seed-to-sale tracking system.

(9) This rule shall be reviewed, and if necessary, repealed, modified, or renewed through the rulemaking process five years from the effective date.

Rulemaking Authority 381.986(8)(e)11.c., FS. Law Implemented 381.986(8)(e)11.c., FS. History—New            .

 

64-4.212 MMTC Regulatory Compliance Testing

(1) The capitalized terms used in this rule shall have the same meaning as provided in the CMTL Definitions rule.

(2) An MMTC must contact a Certified Marijuana Testing Laboratory (CMTL) and arrange for the CMTL to select and collect a random and representative sample of Final Product from every Retail Batch for regulatory compliance testing from an MMTC’s department-approved processing facility or department-approved fulfillment and storage facility.

(3) All Final Products must pass regulatory compliance testing as provided in the CMTL Sample Testing rule prior to being transported by an MMTC to a dispensing facility and prior to being dispensed to a qualified patient or caregiver.

(4) Within 14 calendar days of receipt of a failed Certificate of Analysis from a CMTL due to Contaminants Unsafe for Human Consumption, an MMTC must:

(a) Provide the department with a completed Notification of Resampling and Retesting form as provided in paragraph (5)(a);

(b) Provide the department with a completed Notification of Remediation form as provided in Rule 64-4.213, F.A.C.; or

(c) Provide notice to the department via email to [e-mail] indicating that the MMTC will dispose of the Retail Batch in accordance with Rule 64-4.207, F.A.C.

(5) An MMTC may arrange for a previously failed Retail Batch to be resampled and retested by a CMTL.

(a) Prior to the resampling and retesting of a previously failed Retail Batch, the MMTC must provide the failed Certificate of Analysis together with completed Form DH8024-OMMU-03/2021, Notification of Resampling and Retesting, which is incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX to the department via email to [e-mail]. An MMTC must arrange for resampling and retesting of the previously failed Retail Batch within 30 calendar days of submission of the Notification of Resampling and Retesting form to the department.

(b) Prior to the resampling and retesting of a previously failed Retail Batch, the MMTC must ensure the CMTL conducting resampling and retesting has a copy of the failed Certificate of Analysis.

(c) The previously failed Retail Batch must be quarantined, clearly marked “not for retail sale,” and shall not be transported by the MMTC to any dispensing facility or dispensed to a qualified patient or caregiver except as provided in subparagraph (5)(d)2.

(d) A previously failed Retail Batch must pass two complete regulatory compliance tests using two new samples in order for the Retail Batch to be eligible for dispensation by an MMTC. The previously failed Retail Batch may only be resampled and retested twice.

1. If the previously failed Retail Batch passes the first retest, an MMTC may arrange for the Retail Batch to be retested again by a CMTL.

2. If the previously failed Retail Batch passes the second retest, the Retail Batch is eligible for dispensation by the MMTC. An MMTC must provide two passing Certificates of Analysis for the previously failed Retail Batch to the department via email to [e-mail] prior to removing the Retail Batch from quarantine and transferring it to a dispensing facility or dispensing it to a qualified patient or caregiver.

3. If the previously failed Retail Batch fails either retest, the MMTC shall dispose of the Retail Batch in accordance with Rule 64-4.207, F.A.C., or remediate it if permitted by Rule 64-4.213, F.A.C. The MMTC shall provide the department with the appropriate notice required by paragraph (4)(b) or (4)(c).

(e) If a CMTL is unable to complete regulatory compliance testing after sampling as provided in the CMTL Submission of Product for Testing rule, the MMTC from which the sample was collected may have the impacted Retail Batch(es) resampled and tested as an initial Retail Batch sample.

(6) If a Retail Batch fails regulatory compliance testing due to the labeled potency of total active THC, total active CBD, or any individual cannabinoid printed on the Final Product packaging, the MMTC shall correct the labeled potency to display the accurate concentration measured by the CMTL prior to dispensing the Final Product to qualified patients or caregivers.

(7) An MMTC may request testing of marijuana at any point during cultivation or processing. However, such testing does not exempt an MMTC from regulatory compliance testing in accordance with CMTL rules prior to dispensing the Final Product to qualified patients or caregivers.

(8) An MMTC shall bear the costs associated with resampling and retesting of a previously failed Retail Batch.

(9) This rule shall be reviewed, and if necessary, repealed, modified, or renewed through the rulemaking process five years from the effective date.

Rulemaking Authority 381.986(8)(e)11.,d. 381.986(8)(k), FS. Law Implemented 381.986(8)(e)11., FS. History-New            .

 

64-4.213 MMTC Remediation

(1) The capitalized terms used in this rule shall have the same meaning as provided in the CMTL Definitions rule.

(2) An MMTC may remediate a previously failed Retail Batch as provided for herein.

(3) Prior to remediating a previously failed Retail Batch, an MMTC must provide the failed Certificate of Analysis together with completed Form DH8025-OMMU-03/2021, Notification of Remediation, which is incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX via email to [e-mail]. An MMTC must remediate a previously failed Retail Batch within 30 calendar days of submission of the Notification of Remediation form to the department.

(4) Usable Whole Flower Marijuana that fails regulatory compliance testing may be remediated through processing to create Derivative Product. Usable Whole Flower Marijuana that fails regulatory compliance testing due to Water Activity or Moisture Content may also be remediated by subjecting the Retail Batch to additional drying or curing.

(5) Derivative Product, excluding Edibles, that fails regulatory compliance testing for Heavy Metals or Agricultural Agents shall be disposed of in accordance with Rule 64-4.207, F.A.C. Derivative Product, excluding Edibles, that fails regulatory compliance testing for Residual Solvents, Microbes, or Mycotoxins may be remediated through further processing.

(6) Edibles that fail regulatory compliance testing for any reason may not be remediated and must be disposed of in accordance with Rule 64-4.207, F.A.C.

(7) All remediated products must undergo and pass regulatory compliance testing in accordance with the MMTC Regulatory Compliance Testing rule as a new Retail Batch.

(8) A remediated Retail Batch is not eligible for additional remediation.

(9) This rule shall be reviewed, and if necessary, repealed, modified, or renewed through the rulemaking process five years from the effective date.

Rulemaking Authority 381.986(8)(e)11.d., 381.986(8)(k), FS. Law Implemented 381.986(8)(e)11., FS. History-New            .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Christopher Ferguson

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Scott A. Rivkees, MD, State Surgeon General

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 19, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: January 5, 2021