Licensing & Regulating Cannabis Manufacturing

Transcription

1 Licensing & Regulating Cannabis Manufacturing CHEAC General Membership Meeting February 2, 2017 Mark Starr, DVM, MPVM Deputy Director for Environmental Health California Department of Public Health 1

2 Released: 12 January 2017 Topics Therapeutic effects Cancer Cardiometabolic risk Respiratory disease Immunity Injury and death Prenatal, perinatal, and postnatal exposure Psychosocial Mental health Problem cannabis use Cannabis Use and abuse of other substances Recommendations Address Research Gaps Improve Research Quality Improve Surveillance Capacity Address Research Barriers Conclusions 2

3 National Outlook 28 states & DC legalized medical use 8 states & DC legalized both medical and adult use 3

4 California 1996 Proposition 215, Compassionate Use Act 2003 Senate Bill 420, Medical Marijuana Program 2015 Medical Marijuana Regulation & Safety Act 2016 Adult Use of Marijuana Act (Prop. 64) As the state moves forward with the regulation of both medical cannabis and recreational cannabis, one regulatory structure of cannabis activities across California is needed. ( p.130) 4

5 Medical Cannabis Regulation and Safety Act (MCRSA) 2015 AB 243, AB 266, SB 643 created MMRSA 2016 SB 837 amended the Act to MCRSA 5

6 CDFA / CalCannabis CDPH / OMCS DCA / BMCR - BMC - Cultivators, - Track and Trace, - Environmental Impact Report - Manufacturers - Transporters, - Distributors, - Testing Labs, - Dispensaries 6

7 License Classifications CDFA Type 1, 1a, 1b = Cultivation; Specialty Type 2, 2a, 2b = Cultivation; Small Type 3, 3a, 3b = Cultivation; Medium Type 4 = Cultivation; Nursery CDPH DCA Type 6 = Manufacturer 1 Type 7 = Manufacturer 2 Type 8* = Testing laboratory (CDPH assist w/regs.)* Type 10 = Dispensary; General Type 10A = Producing Dispensary; Max. 3 retail sites Type 11 = Distributor Type 12* = Transporter* * Prop 64 notes: Type 8 listed under CDPH legislature can address Type 12 becomes Microbusiness 7

8 Category Outdoor Indoor Mixed-light Specialty Cultivator Type 1 Up to 5,000 sq ft, or up to 50 mature plants Type 1a Up to 5,000 sq ft Type 1b Up to 5,000 sq ft Small Cultivator Type 2 5,001-10,000 sq ft Type 2a 5,001-10,000 sq ft Type 2b 5,001-10,000 sq ft Cultivator Type 3 10,001 sq ft- 1 acre Type 3a 10,001-22,000 sq ft Type 3b 10,001-22,000 sq ft Nursery Type 4 Prop 64 note: Type 5/5a/5b (large cultivators) added by Prop 64, effective 2023

9 DPR s* Roles Under The Act No licensing role (like SWRCB, CDFW, BOE, others) Provide guidance on the use of pesticides in cannabis cultivation Provide assistance to the Bureau (DCA) in developing pesticide testing methodologies, pesticide residue levels, and regulations DPR has existing guidance documents and enforcement letters * Department of Pesticide Regulations 9

10 Over Arching Principles Cannabis/cannabis infused products are neither food nor drug Dual licensing: local control is at the core of the regulatory framework Public Health & Safety State responsible for inspection, enforcement, product safety, labeling and safe packaging, etc. State sets minimum standards, locals can be stricter 10

11 Local Authorization License Permit State License* Other Authorization A city, county, or city and county may adopt ordinances that establish additional standards, requirements, and regulations for local licenses and permits.(bpc (a)) * Prop 64 note: Documentation of local authorization not required by Prop 64 11

12 Between Licensees Cultivator Manufacturer Distributor after testing Dispensary = Transporter Third Party Testing Lab 12

13 Manufacturing license types vary by extraction methods and solvents used Type 6 (Manufacturing 1) using non-volatile solvents Type 7 (Manufacturing 2) using volatile solvents 13

14 Example of Extraction Methods and Types of Solvents Used Food based (e.g. oil, food grade glycerin, butter) Supercritical fluid extraction (e.g., carbon dioxide) Uncompressed liquid solvents (e.g., ethanol, methanol, acetone, naptha ) Compressed liquid hydrocarbons (e.g., butane) 14

15 MC Products Example 15

16 Staffing Processes and Procedures Plan Regulations Lab Support Database Education and Outreach 16

17 CDPH Budget medical cannabis 37 new positions phased in over three years: positions Background research Regulation development additional positions Release proposed regulations for public comment Develop licensing procedures new positions (total ~$5.6M ongoing) Begin licensing, conducting inspections and investigations Implement enforcement activities and corrective actions 17

18 Learn manufacturing practices Benefit from other states experience Collaborate with sister agencies Engage stakeholders Office of Manufactured Cannabis Safety (OMCS) Leverage departmental know-how 18

19 Conducted Pre-Regulatory Stakeholder Meetings: 1. Redding - September 19, Sacramento - September 20, Santa Rosa - September 22, Oakland - September 26, Fresno - September 27, Los Angeles - October 4, San Diego - October 5, Santa Ana - October 18,

20 Outline Definitions Licensing requirements Good Manufacturing Practices: process control etc. Security, safety and sanitation Destruction and disposal requirements Labeling: primary and informational panel, warning statements and prohibitions* Packaging: not attractive to children, child resistant, and tamper proof* Product standards* Compliance and enforcement; due process * Prop 64 note: Some differences in Prop 64 (label, resealable, concentration, etc) 20

21 CDPH s Cannabis Laboratory in Richmond Key roles: Assist DCA to develop regulations for third party testing labs Standards, methods, sampling, QC, staff, training, records, etc. Compliance lab role in support of OMCS Inspections, field samples, enforcement, etc. 21

22 BMCR & CDFA Licensing Database 22

23 January 1, 2018 Staffing Regulations SRIA* Database Licensing * Standardized Regulatory Impact Assessment Goal: begin receiving license applications as of January 1, 2018 Prop 64 note: Adult-Use regulations will be generally similar and will utilize the emergency regulation process to meet this timeline 23

24 Some Questions (CCDEH) Dispensaries: locations, number, hours, medical vs. retail/recreational, etc. Alternatives (e.g., mobile, CFMs, TFFs, FS/CFP)? Edibles: types, packaging, labelling, samples, etc. Food-borne illness: investigations, traceback, recalls, etc. Inspections: Enforcement; State delegation? Age limits: (employees, medical vs. recreational) 24

25 CHEAC Questions State plans for $1M Cannabis Lab Testing Appropriation? Governor s Proposed Budget: CDPH s medical cannabis BCP requests redirection of 3 positions and $410,000 to DCA, due to transfer of licensing of testing laboratories (SB 837) $1,444,000 for IT application for manufacturer licensing and compliance Net request: $1,034,000 (FY 18-19) for IT system (not labs) Other questions? 25

26 Webpage: List Serve: OMCS Chief: Asif Maan, Ph.D. 26