Florida's Rules on Solvent-Based Cannabis Extraction & Testing
Medical cannabis extracts in Florida must undergo testing for residual solvents to ensure they are purged to safe levels before reaching patients. Initially, Medical Marijuana Treatment Centers (MMTCs) could only use carbon dioxide or organic solvents to produce these extracts. However, Florida’s Department of Health enacted an emergency rule in 2021 allowing MMTCs to use hydrocarbons like butane as well. The rule also strengthened safety requirements across the board, requiring MMTCs to comply by August 23, 2022.
This article explains Florida’s latest MMTC solvent-based extraction rules and lab testing requirements for residual solvents.
Understanding Solvents in Cannabis Extraction
Solvents play a crucial role in cannabis extraction by separating compounds, like cannabinoids and terpenes, from the plant. This process can yield highly potent products like vapes, tinctures, and edibles. However, solvents vary in chemical properties and potential toxicity, so precise regulation ensures consumer safety.
Florida allows MMTCs to use three groups of solvents:
- Hydrocarbon Solvents: These include N-butane, isobutane, propane, pentane, heptane, or any combination thereof. Hydrocarbons are prevalent because they are efficient in extracting cannabinoids and terpenes and are used to create the potent concentrate known as butane hash oil (BHO).
- Carbon Dioxide Solvent: CO2 as a solvent stands out for its non-toxic nature. Subjecting CO2 to high pressure and temperature transforms it into a supercritical state, where it acquires both liquid and gas properties, thus augmenting its solvent effectiveness. CO2 operates under similar extraction principles and hydrocarbon solvents.
- Organic Solvents: Organic solvents are carbon-based liquids at room temperature. Florida recognizes them as class 3 solvents, meaning they have a low toxic potential at the levels used in pharmaceutical manufacturing. Ethanol is a common organic solvent due to its effectiveness and relative safety.
Florida’s Latest Rules on Solvent Extractions
Florida’s 2021 Emergency Rule 64ER21-13 outlines the current framework for MMTCs to operate when producing solvent-based extracts. It mandates that MMTCs must not engage in the process unless they adhere to the rule's specific provisions.
Approval: All MMTCs must submit a comprehensive set of documents to the department for approval before engaging in solvent-based extraction. These include an engineer's certification, evidence of passing local fire code inspections, standard operating procedures, and a floor plan of the extraction area.
Purity Requirements: The emergency rule also specifies that all solvents must be of a minimum purity of 99.5%, free from additives, and handled according to local, state, and federal regulations. This ensures that the final medical cannabis products are safe and free from harmful residual solvents.
Closed Loops System: All MMTCs must utilize a closed-loop system in production. A closed-loop system is an extraction method where the solvent is recycled back into the machinery, minimizing waste and exposure. These systems and pressure vessels must adhere to rigorous engineering standards and safety codes such as those from the American Society of Mechanical Engineers (ASME) and the National Fire Protection Association (NFPA).
Hydrocarbon Solvent-Based Extraction Rules
Hydrocarbon solvents like N-butane, isobutane, propane, pentane, and heptane are now permitted for use in cannabis extraction in Florida. These solvents efficiently extract cannabinoids and terpenes from plant material but can be dangerous due to their flammability and potential toxicity if not properly purged.
Closed Loop System Requirements
Florida MMTCs must utilize closed-loop systems in hydrocarbon extracts to mitigate the risk of environmental and personnel exposure. These systems minimize waste and the risk of combustion.
Independent Engineer Certification
A licensed independent engineer must certify that hydrocarbon closed-loop systems are constructed according to high engineering standards such as those set by the ASME or ANSI. This certification acts as a guarantee that the systems are safe for use.
Compliance with Fire Safety Standards
MMTCs utilizing hydrocarbon extraction must align with the National Fire Protection Association (NFPA) fire codes, which dictate safety measures for handling flammable solvents. Regular inspections and compliance with these codes are mandatory to maintain operational approval.
Carbon Dioxide Solvent-Based Extraction Parameters
CO2 is a popular solvent choice. It offers a unique, environmentally friendly method for extracting compounds from plant material. It becomes a particularly effective solvent when used in its supercritical state. This dual nature allows CO2 to penetrate plant material efficiently like a gas while dissolving compounds effectively like a liquid.
Closed Loop
MMTCs must still utilize a closed-loop system for CO2 extracts to prevent pressure-related accidents and ensure their purity.
Pressure Vessel Standards
CO2 pressure vessels must withstand pressures of at least 125% of the system's maximum, with a cap of 10,000 psi. This capacity ensures the equipment can handle the pressure required for supercritical extraction without risking breaches or leaks.
Organic Solvent-Based Extraction Guidelines
Organic solvents recognized as Class 3 present a lower toxicity risk and include substances such as ethanol, methanol, isopropanol, acetone, and ethyl acetate. Some MMTS prefer to use these compounds in medical applications due to their efficiency, safety, and quality.
Closed Loop Systems for Organic Solvents
Even with lower toxicity, organic solvents must be used in closed-loop systems. This process maintains the integrity of the extracts and ensures that no residual solvents remain in the final product.
Comprehensive Compliance and Training Requirements
Florida's emergency rule also mandates comprehensive training and strict adherence to operational protocols for Medical Marijuana Treatment Centers.
- Biennial Inspection and Department Approval: All MMTCs' extraction equipment must undergo a biennial inspection by local fire code officials. Written approval from the department is necessary to continue operations, ensuring ongoing compliance with safety standards.
- Detailed SOPs and Employee Training: MMTCs are tasked with developing rigorous standard operating procedures (SOPs) for using extraction equipment. These SOPs must include employee training protocols for general safety and specific manufacturer instructions for the equipment.
- Certification and Display of Alteration Approvals: Should any alterations be necessary for the Closed Loop Systems, they must be conducted by the system manufacturer and certified by an independent engineer. This certification and a list of trained and certified employees must be displayed near the extraction area.
The rule's effective date was August 20, 2021, and it became enforceable immediately upon being filed with the Department of State. MMTCs already approved to use carbon dioxide or organic solvents for extraction at the time of the rule's effective date received a 12-month window to comply with the new requirements. Florida has not enacted any additional solvent-based extraction rules since that time.
Residual Solvent Testing
Before selling extracts to patients, MMTCs must send samples to licensed laboratories for residual solvent testing. Results must show that the product is 99.5% free from additives and each solvent level is below the acceptable limit.
Third-party laboratories must follow testing rules dictated by Florida’s Office of Medical Marijuana Use (OMMU).
Testing Methods & Rules
Florida mandates that cannabis laboratories use Gas Chromatography combined with Mass Spectrometry (GC/MS) for residual solvent testng. The state also provides a detailed framework for identifying and quantifying solvents that could remain after extraction.
The rules specify the acceptable limits for various solvents, ensuring that cannabis products are safe for consumption.
Acceptable Limits for Solvents
Class 1 Solvents: OMMU indicates Class 1 solvents have high toxicity and potential to cause significant harm. Examples include:
- Benzene: limit of 2 ppm due to its carcinogenicity.
- Carbon Tetrachloride: limit of 4 ppm because of severe toxicity to the liver and kidneys.
- 1,2-Dichloroethane: limit of 5 ppm, given its carcinogenic potential.
Class 2 Solvents: These solvents possess moderate toxicity, necessitating limits that ensure consumer safety. For example:
- Chloroform: limit of 60 ppm, considering its carcinogenic and organ toxicity risks.
- Cyclohexane: limit of 3880 ppm due to its less severe toxic effects compared to Class 1 solvents.
- N-Hexane: limit of 290 ppm because of its neurotoxicity concerns.
- Methylene Chloride (Dichloromethane): 600 ppm limit given its carcinogenicity and organ toxicity.
Class 3 Solvents: Considered to have low toxicity, these solvents have more lenient limits.
- Acetone: higher acceptable limit of 5000 ppm, reflecting its lower toxicity.
- Ethanol: limit of 5000 ppm, considering its widespread use and relatively low toxicity.
- Isopropyl Alcohol: limit of 5000 ppm, due to its safety at low exposure levels.
- Dimethyl Sulfoxide (DMSO): limit of 5000 ppm, reflecting its low acute toxicity.
Laboratories must maintain detailed records of all analyses, including calibration curves, sample preparation notes, and quantification results. Reports must indicate whether solvent levels are within the acceptable limits set for each solvent class.
Bottom Line
Florida’s emergency rule gave MMTCs the green light to expand their product line, allowing patients to access a broader range of derivatives. The rules also prioritize public health and ensure MMTCs produce extracts with the highest quality standards. The OMMU’s residual solvent testing rules further confirm these products are safe for medical use.
Florida MMTCs can contact our ACS Laboratory team today to learn about residual solvent testing and to schedule a pickup. We will pick up samples from your cultivation or processing site.
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