Cannabis Extractions, Concentrates and Infused Edibles: A Colorado Perspective Presented by Thuy Vu Director of Infused Products LivWell September 21, 2015 Western Association of Food and Drug Officials Helena, Montana
Background Denver Department of Environmental Health Public Health Inspections Division Environmental Public Health Investigator III May 2010 February 2015 Lead Investigator for Foodborne Illness & Foodborne Outbreak Investigations Marijuana Complaint & Outbreak Investigation Rocky Mountain Food Safety Conference http://archive.9news.com/rss/story.aspx?stor yid=326467 http://kdvr.com/2014/11/05/healthinspector-finds-critical-violations-in-heidihemmats-kitchen-would-your-kitchen-pass/ http://kdvr.com/2014/04/29/restaurantinspectors-go-to-pot-shops-to-make-sureedibles-meet-health-standards/
THE MILE HIGH CITY Approximately 5000 regulated food establishments, 800 marijuana operations in Denver Denver Regulatory Agencies Department of Environmental Health: Environmental Quality & Public Health Inspections Denver Public Health Denver Fire Department Department of Excise & Licenses: Denver Police Department, Vice & Drug Control Bureau Community Planning & Development: Building Department (engineering, plumbing & electrical), Developmental Services, Neighborhood Inspection Services/Zoning, Wastewater Engineering Colorado Regulatory Agencies Colorado Department of Revenue Marijuana Enforcement Division Colorado Department of Public Health and Environment Colorado Department of Agriculture
Role of DEH Public Health Inspections with Marijuana Infused Products Manufacturers Conduct plan reviews Approve business licenses for marijuana infused products manufacturers (MIPs), dispensaries, and testing facilities Apply Denver Food Establishment Regulations Investigate complaints & outbreaks Timeline: 2010: Legalization of medical marijuana in Colorado 2011: Started routine inspections of MIPs, dispensaries & testing facilities 2012 & 2013: Complaint-based investigations due to resource constraints 2014: Legalization of recreational marijuana in Colorado 2014 to present: All MIPs, dispensaries & testing facilities receive 2 full inspections annually 2015 to present: Conduct complaint-based inspections of OPCs for pesticide application
Cultivation of Cannabis
Genus: Cannabis 3 Species of Cannabis Cannabis sativa Cannabis indica Cannabis ruderalis Cannabinoids Terpenoids
Dispensaries: Medical and Recreational
Marijuana Infused Products Manufacturer
Extractions Extraction processes concentrate the cannabinoids Fire Permit and approval of extraction equipment is required 2 Main Categories of Extraction Processes Non-Hydrocarbon Extractions Cold/hot water extraction Isopropyl alcohol/isopropanol Ethyl alcohol/ethanol Acetone CO2/dry ice Dry sieve Hydrocarbon Extractions Butane, propane, heptane Alcohol extractions must be enclosed within an explosion proof fume hood Extraction rooms must be Class I Division I All equipment must have UL certification
Denver Fire Approved Extractors **This list is not all inclusive and is subject to change. An updated list can be found on www.denvergov.org/firedepartment/firedepartmenthome/permitslicensing/firesafetypermits/tabid/436031/default.aspx
Approved Extraction Equipment Vacuum Pump Bubble Bags Butane Propane Extractor Butane Propane Extractor
Approved Extraction Equipment Ethanol Extractor CO2 Extractor CO2 Extractor CO2 Extractor
Unapproved Extraction Equipment Butane Open Blasting Tubes Butane Open Blasting Tubes Isopropanol Extractor Hexane Extractor Ethanol Extractor
Unapproved Extraction Equipment Washing Machine for Cold Water Extraction
Approved or Unapproved?
Cannabinoid Extractions
Processing of Cannabis Concentrates
Cannabis Concentrates Kief Kief (mechanical or dry ice extraction) Bubble hash (ice water extraction) Hash Budder Flake Pressed Bubble Hash Shatter Butane Wax
Cannabis Concentrates Live Resin (Propane extraction) Gold Dust (Butane extraction) Hash Oil (Butane extraction) Hash oil (Hot water extraction) Hash oil (Butane extraction from open blasting) Alcohol Agave Glycerin (Tinctures from Ethanol Extraction)
Safety Concerns Associated Extractions and Infused Products Extraction processes can be dangerous if not conducted properly: Flammability of Solvents Cold Burns/Frost Bite High Pressure of Solvents Gas leaks/insufficient air change rate Solvent-based extractions can be harmful when consumed if solvent is not properly purged Residual Solvent Testing Improper dosing or potency of infused products Cannabis Concentrates/Infused Products may carry risk of foodborne illness due to the consumption of pathogenic microorganisms, toxic chemicals or other contaminants Microbial Testing Contaminant Testing
Denver Requirements for Shelf- Stability of Cannabis Concentrates Must be treated as Potentially Hazardous Food unless: Plant material is irradiated OR Extract is suspended in homogenous 190 or 200 proof alcohol mixture OR Plant material is heated to adequate temperature and pressure for an extended period OR Scientific research demonstrating safety of another critical limit/control point is provided and approved
PHF/TCS or Non-PHF/TCS? Extractions/Concentrates Must be treated as PHF/TCS unless writtenprocedures and controls submitted & approved by DEH PHI as non-phf/tcs Infused Products Assess intrinsic qualities of food product F ood A cidity T ime T emperature O xygen M oisture
Most common food safety challenges Retailers: Unapproved source Unwholesome plant material and products Refrigeration of PHFs Proper Labeling Manufacturers: Basic food safety concerns Unapproved source Unwholesome plant material Extraction Processes & Solvents Unapproved extraction equipment Proper potency and dosing of infused products Proper labeling Child-Resistant Packaging
Unwholesome Plant Material
Investigations Investigate source of raw plant material or extraction/concentrate Recalls associated with extracted hash oil being treated as non-phf Recall associated with contaminated equipment Recall due to inadequate facilities/equipment required to manufacture infused products Production of non-infused products/samples Complaints of compromised product (mold, pests) being extracted into hash oil Holds due to unapproved pesticide application
Enforcement Cease & desist orders for several operations not equipped for food handling Product disposals for vacuum packaged product, extracted hash oil and infused products being treated as non-phf/tcs without product assessment for shelf-stability and approval Summons for 3 manufacturers due to incomplete recalls Civil penalties/fines Hold Order Product recalls License revocation
Recommendations Interagency partnerships Strong interagency and industry communication Subject matter experts Create policies/regulations based on public health significance principles, scientific data and risk-based methodology Training, education and outreach Surveillance
Thuy Vu Director of Infused Products LivWell Thuy.Vu@livwell.com www.livwellco.com 303-523-3052