1. (1) For the purposes of this rule, the terms below shall have the following meanings:

   1. (a) “Carbon Dioxide Solvent” means carbon dioxide in a liquid or supercritical state.
   2. (b) “Closed Loop System” means a commercially manufactured extraction system that is sealed during operation and designed to recover all Solvents used during the extraction process through a feedback loop.
   3. (c) “Extraction Area” means the area of an MMTC’s processing facility that is designed for Solvent-Based Extraction, which the department has inspected and approved for the area’s designated use.
   4. (d) “Hydrocarbon Solvent” means N-butane, isobutane, propane, pentane, heptane, or any isomer or combination thereof.
   5. (e) “Independent Engineer” means an engineer, licensed pursuant to Chapter 471, F.S., that is not an employee, owner, officer, board member, or manager of an MMTC.
   6. (f) “Organic Solvent” means a carbon-based substance, that is liquid at room temperature, and is identified as a class 3 Solvent by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, “Impurities: Guidelines for Residual Solvents Q3C(R6)” (10/20/2016) incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/.
   7. (g) “Plant Material” means leaves, stalks, stems, roots, and any other part of the marijuana plant.
   8. (h) “Pressure Vessel” means a component of a Closed Loop System containing marijuana Plant Material and Solvents used during Solvent-Based Extraction and designed to withstand pressure greater than 15 psi.
   9. (i) “Solvent” means a Hydrocarbon Solvent, Carbon Dioxide Solvent, or Organic Solvent, as defined in this rule, which is used to dissolve or disperse chemical compounds from marijuana Plant Material in a Closed Loop System
   10. (j) “Solvent-Based Extraction” means the process of dissolving or dispersing specific chemical compounds from the marijuana Plant Material using a Solvent in a Closed Loop System.
2. (2) MMTCs may not engage in Solvent-Based Extraction, except as specifically provided for in this rule.

3. (3) Except as provided for in subsection (13), prior to engaging in Solvent-Based Extraction, an MMTC must submit the following to the department:

   1. (a) A completed Form DH8026-OMMU-08/2021, “Request for Solvent-Based Extraction,” which is incorporated by reference and available at https://knowthefactsmmj.com/rules-and-regulations/, or the information required by the Request for Solvent-Based Extraction form through the department’s licensing portal at https://fldohommu.force.com/mmtc;
   2. (b) The certification from an Independent Engineer required by paragraphs (7)(d) and (e), and (8)(d) and (e), as applicable;
   3. (c) Evidence from a local fire code official that the MMTC has passed the inspection required by subsection (10);
   4. (d) Standard operating procedures, including employee training plans, as required by subsection (11); and
   5. (e) A floor plan identifying the location of the proposed Extraction Area.
4. (4) Except as provided for in subsection (13), an MMTC may not engage in Solvent-Based Extraction prior to receipt of written notice of approval from the department that specifies the Solvent(s) the MMTC is authorized to use.

5. (5) When engaging in Solvent-Based Extraction, an MMTC must only use Solvents that are:

   1. (a) A minimum purity of 99.5% with a certificate of analysis from the manufacturer to confirm purity;
   2. (b) Free of odorants, bitterants, or other additives; and
   3. (c) Stored, handled, and disposed of in accordance with local, state, and federal regulations.
6. (6) An MMTC approved for Solvent-Based Extraction must conduct all Solvent-Based Extraction in the designated Extraction Area of its department-approved processing facility, which has passed a Food Safety Good Manufacturing Practices inspection in accordance with s. 381.986(8)(e)9., F.S.

7. (7) An MMTC approved to conduct Hydrocarbon Solvent-Based Extraction must comply with the following provisions:

   1. (a) An MMTC must perform Hydrocarbon Solvent-Based Extraction in a Closed Loop System.
   2. (b) Every Pressure Vessel within the Closed Loop System must have a rating of at least 125% of the maximum pressure, as specified in the manufacturer’s maximum operational limits, not to exceed 10,000 psi.
   3. (c) All Pressure Vessels must contain an emergency pressure release system vented to the outside of the facility.
   4. (d) An Independent Engineer must certify that the Closed Loop System was commercially manufactured, is safe for its intended use, and is built to codes of recognized and generally accepted good engineering practices, such as American Society of Mechanical Engineers (ASME); American National Standards Institute (ANSI); Underwriters Laboratories (UL); or the American Society for Testing and Materials (ASTM).
   5. (e) The certification must include the Independent Engineer’s signature and seal, the serial number of the Closed Loop System being certified, and the name of the MMTC which will use the Closed Loop System. The MMTC must prominently display proof of the certification inside or immediately outside of the Extraction Area.
   6. (f) All Pressure Vessels must comply with section VIII, division 1 of the ASME Boiler and Pressure Vessel Code (BPVC) (2019) incorporated by reference herein. The department has determined that posting the incorporated material on the internet would constitute a violation of the federal copyright law. The incorporated materials are available for inspection at the Department of Health, 2585 Merchants Row Boulevard, Tallahassee, Florida 32399-1710, or at the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, Florida 32399-0250.
   7. (g) All MMTC processing facilities approved for Hydrocarbon Solvent-Based Extraction must comply with National Fire Protection Association (NFPA) 1, section 38.6.2 (2021) and NFPA 55 (2020), which are both incorporated by reference herein. The department has determined that posting the incorporated material on the internet would constitute a violation of the federal copyright law. The incorporated materials are available for inspection at the Department of Health, 2585 Merchants Row Boulevard, Tallahassee, Florida 32399-1710, or at the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, Florida 32399-0250.
   8. (h) The MMTC must prominently display proof of passing the inspection required by subsection (10) inside or immediately outside of the Extraction Area.
   9. (i) The storage, handling, and disposal of Hydrocarbon Solvents must comply with NFPA 55.
   10. (j) An MMTC may only use Hydrocarbon Solvents, as defined in this rule, for Hydrocarbon Solvent-Based Extraction.

8. (8) An MMTC approved to conduct Carbon Dioxide Solvent-Based Extraction must comply with the following provisions:

   1. (a) An MMTC must perform Carbon Dioxide Solvent-Based Extraction in a Closed Loop System.
   2. (b) Every Pressure Vessel within the Closed Loop System must have a rating of at least 125% of the maximum pressure, as specified in the manufacturer’s maximum operational limits, not to exceed 10,000 psi.
   3. (c) All Pressure Vessels must contain an emergency pressure release system vented to the outside of the facility.
   4. (d) An Independent Engineer must certify that the Closed Loop System was commercially manufactured, is safe for its intended use, and is built to codes of recognized and generally accepted good engineering practices, such as ASME; ANSI; UL; or ASTM.
   5. (e) The certification must include the Independent Engineer’s signature and seal, the serial number of the Closed Loop System being certified, and the name of the MMTC which will use the Closed Loop System. The MMTC must prominently display proof of the certification inside or immediately outside of the Extraction Area.
   6. (f) All Pressure Vessels must comply with section VIII, division 1 of the ASME BPVC.
   7. (g) All MMTC processing facilities approved for Carbon Dioxide Solvent-Based Extraction must comply with NFPA 1, section 38.6.4 (2021), which is incorporated by reference herein. The department has determined that posting the incorporated material on the internet would constitute a violation of the federal copyright law. The incorporated materials are available for inspection at the Department of Health, 2585 Merchants Row Boulevard, Tallahassee, Florida 32399-1710, or at the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, Florida 32399-0250.
   8. (h) The MMTC must prominently display proof of passing the inspection required by subsection (10) inside or immediately outside of the Extraction Area.
   9. (i) The storage, handling, and disposal of Carbon Dioxide Solvents must comply with NFPA 55.

9. (9) An MMTC approved to conduct Organic Solvent-Based Extraction must comply with the following provisions:

   1. (a) An MMTC must perform Organic Solvent-Based Extraction in a Closed Loop System under a maximum operational pressure of 15 psi.
   2. (b) All MMTC processing facilities approved for Organic Solvent-Based Extraction must comply with NFPA 1, section 38.6.3 (2021) and NFPA 30 (2021), which are both incorporated by reference herein. The department has determined that posting the incorporated material on the internet would constitute a violation of the federal copyright law. The incorporated materials are available for inspection at the Department of Health, 2585 Merchants Row Boulevard, Tallahassee, Florida 32399-1710, or at the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, Florida 32399-0250.
   3. (c) The MMTC must prominently display proof of passing the inspection required by subsection (10) inside or immediately outside of the Extraction Area.
   4. (d) The storage, handling, and disposal of any Organic Solvent must comply with NFPA 30.
   5. (e) An MMTC may only use Organic Solvents, as defined in this rule, for Organic Solvent-Based Extraction.
10. (10) The MMTC must ensure that the processing facilities and all Solvent-Based Extraction equipment, including the Closed Loop System, are inspected and approved for their use by a local fire code official prior to department approval, and at a minimum biennially thereafter. All MMTC processing facilities and all Solvent-Based Extraction equipment must meet any required fire, safety, and building code requirements specified in the Florida Fire Prevention Code (FFPC), NFPA 1 Fire Code, and other applicable standards, including any applicable fire, safety, and building codes in the processing, handling, and storage of Solvents.

11. (11) An MMTC must create and maintain written detailed standard operating procedures for the safety and operation of all Solvent-Based Extraction equipment, including the Closed Loop System, within the manufacturer’s equipment safety specifications.

    1. (a) All employees performing any Solvent-Based Extraction must:

       1. Obtain training on the MMTC’s standard operating procedures prior to performing Solvent-Based Extractions; and

       2. Obtain training in safety and application from the manufacturer of the Closed Loop System. The MMTC must maintain documentation of such manufacturer training for all employees performing any Solvent-Based Extraction.

    2. (b) An MMTC must prominently display a list of the names of all trained and certified employees inside or immediately outside of the Extraction Area.

12. (12) An MMTC may not alter any Closed Loop System. The equipment manufacturer must perform any alterations to the Closed Loop System.

    1. (a) An Independent Engineer must inspect any alteration and certify that the alterations are built to codes of recognized and generally accepted good engineering practices, such as ASME; ANSI; UL; or ASTM.
    2. (b) The certification must include the Independent Engineer’s signature and seal, the serial number of the Closed Loop System being certified, and the name of the MMTC which will use the Closed Loop System. The MMTC must prominently display proof of the certification inside or immediately outside of the Extraction Area.

13. (13) MMTCs that are currently approved to use Carbon Dioxide or Organic Solvents for extraction have 12 months from the effective date of this rule to comply with the applicable requirements herein. Nothing in this subsection is intended to relieve an MMTC of its obligation to comply with any applicable federal, state, or local laws and regulations.

    

    

    

    

Rulemaking Authority 381.986(8)(e)11.b., 381.986(8)(k) FS. Law Implemented 381.986(8)(e)11.b. FS. History – New 8-20-21.