Regulation of Marijuana and Hemp Products

Transcription

1

2 Regulation of Marijuana and Hemp Products IN THE MILEHIGH CITY November 15th, :20PM 2:10PM Denver s Nationally Accredited Public Health Department Richard Pruckler Cannabis Enforcement MHOA 2018 CONNECT WITH US 311 POCKETGOV DENVERGOV.ORG DENVER 8 TV

3 How did we get here? 2012: Amendment 64 petitioned onto the ballot amended the Colorado constitution legalizing the personal, private use of marijuana o Passed in Colorado by about 55% of the vote & in Denver by 66% Allows adults over 21 to: o Possess up to one ounce of marijuana o Possess and grow up to six marijuana plants, only 3 of which can be flowering o Transfer up to 1oz of MJ between adults without payment o Private consumption of MJ o Assist another adult in any of these acts

4 LOL

5 Will of the Voters!

6 Colorado Marijuana Licensing Dual Licensing System To operate a licensed marijuana business in Denver, you must have BOTHa state license AND a local license The Colorado Marijuana Enforcement Division (MED) licenses and regulates marijuana businesses for the state. TheDenver Department of Excise and Licenses (EXL) licenses and regulates for the city.

7 Colorado Marijuana Licensing Seed to Sale Tracking When a marijuana plants reach a certain size, they must all be identified with an RFID tag The RFID tag is scanned into the MED tracking system called METRC

8 Marijuana Business Licenses Denver has 10 distinct Marijuana Licenses Currently, Denver has ~1,100 licenses operating out of ~500 unique locations. Stores RETAIL Cultivation Infused Products (MIP) Testing Facility BOTH MEDICAL Centers Cultivation Infused Products (MIP) Testing Facility Social Consumption Transport

9 Main Governmental Partners City of Denver Dept. of Public Health & Environment (DDPHE) Denver Fire Dept. Denver Office of Marijuana Policy Dept. of Excise & Licenses Denver Police Dept. Community Planning & Development Risk Management City Attorney s Office State of Colorado Dept. of Revenue, Marijuana Enforcement Division Colorado Department of Agriculture Colorado Dept. of Public Health & Environment (CDPHE) Colorado Attorney s General

10 Denver Department of Public Health & Environment 7 Divisions Public Health Inspections Establishments Office of the Medical Examiner Denver Animal Protection Environmental Quality Community Health Public Health Inspections Behavioral Health Sustainability 2 Sections o Food Safety & Marijuana o Healthy Families Healthy Homes Food Service & MJ Child care facilities Residential health Noise Lead Body art establishments Pools Boarding homes

11 Home Rule Authority Denver Revised Municipal Code: Chapter 23: Food & Food Handlers o Denver is a home-rule jurisdiction- only CO locality with own food safety regulations o Regulations (Ch. 23, D.R.M.C.) are applied to marijuana food businesses since 2010 o Includes concentrates if ingested Chapter 24: Health & Sanitation o Enforcement authority for hindering an investigation o Authority to conduct recalls for contamination issues, broad authority

12 Safety Safety Concerns: o Explosion from extraction processes o Hydrocarbon toxicity from improper ventilation during extraction process o Reduced oxygen, increased CO 2 in grows o Criminal activity o Chemical exposure Tyvek o Denver safety video

13 Inspection Process Overview Role of Food Safety Section with Cannabis Food Operations Conduct plan reviews Approve business licenses Inspect food businesses & apply Denver Food Establishment Regulations Investigate complaints Timeline: o 2010: Started routine inspections of cannabis food operations o 2012 & 2013: Complaint investigations only o present: Routine inspections at least twice per year & contamination investigations as needed

14 Cannabis Products Regulated as Food All marijuana products that are consumed via non-smoking oral consumption: Infused baked goods, candies, etc. Infused pizza, ice cream, drinks, peanut butter Concentrated extractions if consumed as food Infusions such as tinctures, butters, honey, oils, etc. **contaminated smoking/vaping products regulated under Ch. 24 of DRMC

15 Anatomy of Cannabis

16 What are Cannabinoids? Cannabinoids: (kuh-nab-uh-noids) A group of compounds found in cannabis flower. When consumed cannabinoids mimic the body s naturally produced endocannabinoids, which are responsible for maintaining the body s health and homeostasis. There are over 85 cannabinoids in cannabis, classified into two categories: psychoactive and non-psychoactive. The most common cannabinoids are THC and CBD. Delta-9 Tetrahydrocannabinol (THC)is the main psychoactive component in cannabis. This compound reduces pain perception in the brain and is also neuroprotective. THC has an affinity for CB1 and CB2 receptors in your body. Cannabidiol (CBD) is not psychoactive and can actually counteract the psycho-activity of THC.

17 THC-A vs. THC THC-A: (raw form) THC-A is THC in its acidic & nonpsychoactive form Marijuana that has not been decarbed contains THC-A THC-A is in products such as: o Transdermal patches, topical products, and some tinctures THC: (activated form) Psychoactive form (euphoric effect) Activated when heated to temperature of ~219 F Reduces pain perception in the brain & is also neuroprotective o THC has an affinity for CB1 & CB2 receptors

18 Concentrates 101

19 Kief Kief is the simplest of concentrates. Kief is composed of the trichomes broken away from the dried plant material, usually via filtering screens and a little elbow grease. THC content can range from 20 percent to 60 percent.

20 Water Hash Ice water extraction, also known as bubble hash, is one of the most common processes used to create quality non-solvent concentrates. Trichome heads become brittle from the ice and break off and then are collected through different size filters.

21 Rosin refers to an extraction process that utilizes a combination of heat and pressure to early and instantaneously squeeze resinous sap from your intimal starting material (usually kief or water hash). Commonly dabbed. Easy and affordable to make. Rosin

22 Cannabutter Basic Cannabutter recipe: Simmer cannabis plant material in water with butter, thus decarbing cannabis & melting butter Strain mixture over bowl with cheesecloth, discard plant material Refrigerate until the butter layer separates from the cooking water, discard water Use butter in edibles

23 Soak the plant material in ethanol Strain out plant material Purge off ethanol with roto-vap Used in edibles or concentrates Ethanol

24 BHO/Live Resin Butane hash oil, commonly referred to as BHO, uses butane as the solvent. Further refinement makes different textures: shatter, budder, honeycomb, and wax. Not just butane used, also using Propane and Hexane Live Resin? (Preserves Terpenes) Residual solvents concern? $20K-$40K + cost of Fire req.

25 Carbon dioxide (CO 2 ) extractions use a supercritical fluid, meaning it converts from gas to liquid when pressurized. $100K-$400K CO 2

26 Further Refinement Distillation: Uses pressure, heat, & motion to refine oil, removing waxes, chlorophyll, & water Isolate: Further refined into powder Diamonds: Similar to Isolate but in larger crystal formations, 99.9% THC-A potency, made using pentane and/or with pressure

27 Production Equipment

28 2014: Denver s First Recall

29

30 Pesticide Contamination

31 Denver s Crash Course in Pesticides Denver Fire started voicing concerns in late 2014 about sulfur burns for pest control When sulfur is burned yields sulfuric dioxide Sulfur dioxide + moisture = sulfuric acid o Harmful to eyes, lungs, nose Denver Fire concerned for first responders and cultivation employees

32 Denver s Crash Course in Pesticides Denver Fire started paying more attention -Ornamental use only -Outdoor use only

33 Which is how we made friends with the Colorado Department of Agriculture! Complex jurisdictional issues Pesticide use and application is sole authority of Colorado Dept. of Agriculture However, DDPHE has authority over contaminated consumer products DDPHE investigates off-label pesticide contamination, NOT offlabel use

34 Pesticide Contamination Denver Enforcement Initial actions in March-May, 2015 based on complaints/referrals of off-label contamination: o 11 Denver holds on grow facilities, hundreds of millions of $$ o Colorado Dept. of Ag also opened off-label pesticide use investigations (no authority over products) o Followed by a district court lawsuit alleging DDPHE pre-empted state law by addressing pesticide contamination o May 2015: judge ruled DDPHE absolutely within our authority to protect public health by placing the holds on this potentially contaminated crop

35 Pesticide Contamination Denver Enforcement 97 pesticide contamination investigations done since March pesticide contamination recalls since September 2015 affecting hundreds of thousands of units 1 recall due to unclean equipment; 2 due to shelf-stability; 1 due to mite & mold contamination 2 appeals of enforcement action to Denver s Board of Environmental Health

36

37 Mold & Pest Contamination

38 Hemp vs. Marijuana Both are species of cannabis Hemp Long history of industrial use Low in THC (Hemp defined as less than 0.3% THC by law) Legal to transport across state lines? Up for debate (and litigation?) Recent breeding for high CBD strains Marijuana Long history of psychoactive use High in THC (5-30%) Not legal to transport across state lines All derivatives must remain within state-licensed MJ system Selective breeding for high THC and CBD strains, others

39 Hemp Products in Early 2017 Growing popularity of CBD products Increasing use of hemp as CBD source Concerns voiced by some in industry about snake oil phenomenon Hemp-derived CBD products were NOT REGULATED by anybody Many products coming from California CBD concentrates sourced from Europe or China

40 Denver Action in April 2017 Administrative holds placed on consumable CBD products in Denver from unregulated sources o Products from 42 manufacturers held Based in part on info from federal agencies, DDPHE indicates no hemp or derivative allowed from outside CO Holds also affect MJ manufacturers adding hemp derived CBD to products

41 State Involvement July 2017: CDPHE accepts wholesale food facility registrations for CBD ingestible product manufacturers CDPHE allows hemp and derivatives from outside CO provided: o Hemp is grown under a regulated industrial hemp program o Standards for ingestion/consumption are applied DDPHE aligns with CDPHE allowance for hemp grown under an industrial hemp program with standards for consumption even if outside CO Still no regulation or authority over smoking/vaping hemp-derived CBD products May 2018: DDPHE begins utilizing CDPHE website link of approved sources to verify approved source for hemp derived CBD edible products

42 Added Ingredients Emerging issue hemp and MJ Concerns with ingredients added to smoking/vaping concentrates Additives commonly include GRAS flavors, propylene glycol, glycerin, essential oils Little research on smoking/vaping consumption Cannabis-derived terpenes FDA s regulation of Electronic Nicotine Delivery Systems (ENDS) November 2017: Applications for DDPHE Cannabis Health & Safety Advisory Committee January 2018: DDPHE held first Cannabis Health & Safety Advisory Committee meeting

43 Cannabis Health & Safety Advisory Committee So, we developed a Cannabis Health & Safety Advisory Committee o Subject matter experts in such areas as toxicology, chemistry, food safety, botany, patient advocacy, cannabis industry, cannabis laboratory industry, cannabis research, DDPHE officials, city attorneys o Purpose: to provide suggestions to our agency regarding public health and safety issues associated with the production and consumption of cannabis products. Topic ideas: o Random sampling/testing during our routine inspections. o Testing gaps how are consumers buying contaminated products? o Ingredients? o Potential Denver cannabis public health regulations?

44 Will of the Voters!

45 Questions?