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/
Thuy Vu, Liv Well 8-3-2015
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
Thuy Vu, Liv Well 8-3-2015
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
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Cultivation of Cannabis
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Genus: Cannabis

3 Species of Cannabis

Cannabis sativa

Cannabis indica

Cannabis ruderalis

Cannabinoids

Terpenoids
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Dispensaries: Medical and Recreational
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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
Thuy Vu, Liv Well 8-3-2015
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
Thuy Vu, Liv Well 8-3-2015
Approved Extraction Equipment
Bubble Bags
Vacuum
Pump
Butane
Propane
Extractor
Thuy Vu, Liv Well 8-3-2015
Butane
Propane
Extractor
Approved Extraction Equipment
Ethanol Extractor
CO2 Extractor
CO2 Extractor
Thuy Vu, Liv Well 8-3-2015
CO2 Extractor
Unapproved Extraction Equipment
Butane Open Blasting Tubes
Butane Open Blasting
Tubes
Isopropanol
Extractor
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Hexane
Extractor
Ethanol Extractor
Unapproved Extraction Equipment
Washing Machine for
Cold Water Extraction
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Approved or Unapproved?
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Cannabinoid Extractions
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Processing of Cannabis Concentrates
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Cannabis Concentrates

Kief
Kief (mechanical or
Bubble hash
dry ice extraction) (ice water extraction)
Flake
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Pressed Bubble Hash
Hash
Shatter
Budder
Butane Wax
Cannabis Concentrates
Hash Oil
Gold Dust
Live Resin
(Propane extraction) (Butane extraction) (Butane extraction)
Hash oil (Butane extraction
from open blasting)
Thuy Vu, Liv Well 8-3-2015
Alcohol
Hash oil
(Hot water extraction)
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
Thuy Vu, Liv Well 8-3-2015
Denver Requirements for ShelfStability 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
pressure for an extended period OR

Scientific research demonstrating safety of another
critical limit/control point is provided and approved
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temperature and
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
Thuy Vu, Liv Well 8-3-2015
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
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Unwholesome Plant Material
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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
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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
Thuy Vu, Liv Well 8-3-2015
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, Liv Well 8-3-2015
Thuy Vu
Director of Infused Products
LivWell
[email protected]
www.livwellco.com
303-523-3052