licensing & regulating cannabis manufacturing...security, safety and sanitation. destruction and...
TRANSCRIPT
Licensing & Regulating Cannabis
Manufacturing
CHEAC General Membership MeetingFebruary 2, 2017
Mark Starr, DVM, MPVMDeputy Director for Environmental Health
California Department of Public Health1
Released: 12 January 2017Topics 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
substancesRecommendations Address Research Gaps Improve Research Quality Improve Surveillance Capacity Address Research BarriersConclusions
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National Outlook• 28 states
& DC legalized medical use
• 8 states & DC legalized both medical and adult use
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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)
California
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“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.” (http://www.ebudget.ca.gov/FullBudgetSummary.pdf, p.130)
• 2015 – AB 243, AB 266, SB 643 created MMRSA
• 2016 – SB 837 amended the Act to MCRSA
Medical Cannabis
Regulation and Safety
Act
(MCRSA)
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- Cultivators,
- Track and Trace,
- Environmental Impact Report
- Transporters,- Distributors, - Testing Labs,- Dispensaries
- Manufacturers
CDFA / CalCannabis
DCA / BMCR -
BMC
CDPH / OMCS
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• Type 1, 1a, 1b = Cultivation; Specialty• Type 2, 2a, 2b = Cultivation; Small• Type 3, 3a, 3b = Cultivation; Medium• Type 4 = Cultivation; Nursery
CDFA
• Type 6 = Manufacturer 1• Type 7 = Manufacturer 2
CDPH
• 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*
DCA
* Prop 64 notes: Type 8 listed under CDPH – legislature can addressType 12 becomes “Microbusiness” 7
License Classifications
Category Outdoor Indoor Mixed-light
SpecialtyCultivator
Type 1Up to 5,000 sq ft,
or up to 50 mature plants
Type 1aUp to 5,000 sq ft
Type 1bUp to 5,000 sq ft
SmallCultivator
Type 25,001-10,000 sq ft
Type 2a5,001-10,000 sq ft
Type 2b5,001-10,000 sq ft
Cultivator Type 310,001 sq ft- 1 acre
Type 3a10,001- 22,000 sq ft
Type 3b10,001- 22,000 sq ft
Nursery Type 4
Prop 64 note: Type 5/5a/5b (large cultivators) added by Prop 64, effective 2023
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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
DPR’s* Roles Under The Act
* Department of Pesticide Regulations
Cannabis/cannabis infused products are
neither food nor drug
Dual licensing: local control is at the core of
the regulatory framework
State responsible for inspection, enforcement, product safety, labeling and safe packaging, etc.
State sets minimum standards, locals can be
stricter
Public Health & Safety
Over Arching Principles
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PermitLicense
Other Authorization
State License*Local Authorization
A city, county, or city and county may adopt ordinances that establish additional standards, requirements, and
regulations for local licenses and permits….(BPC 19316 (a))
* Prop 64 note: Documentation of local authorization not required by Prop 6411
Third Party Testing Lab
DispensaryCultivator
Manufacturer
Distributor
Betw
een
Lic
ense
es
= Transporter
after testing
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Manufacturing license types vary by extraction methods and solvents used
• using non-volatile solventsType 6
(Manufacturing 1)
• using volatile solventsType 7
(Manufacturing 2)
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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
Staffing
Processes and Procedures
Regulations
Lab Support
Database
Education and Outreach
Plan
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37 new positions phased in over three years: 2016 – 14 positions
Background research Regulation development
2017 – 2 additional positions Release proposed regulations for public comment Develop licensing procedures
2018 – 21 new positions (total ~$5.6M ongoing) Begin licensing, conducting inspections and
investigations Implement enforcement activities and corrective actions
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CDPH Budget – medical cannabis
Office of Manufactured
Cannabis Safety
(OMCS)
Engage stakeholders
Learn manufacturing
practices
Benefit from other states’ experience Collaborate
with sister agencies
Leverage departmental
know-how
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Conducted Pre-Regulatory Stakeholder Meetings:
1. Redding - September 19, 2016
2. Sacramento - September 20, 2016
3. Santa Rosa - September 22, 2016
4. Oakland - September 26, 2016
5. Fresno - September 27, 2016
6. Los Angeles - October 4, 2016
7. San Diego - October 5, 2016
8. Santa Ana - October 18 , 2016
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DefinitionsLicensing requirementsGood Manufacturing Practices: process control etc.Security, safety and sanitationDestruction and disposal requirementsLabeling: 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
Out
line
* Prop 64 note: Some differences in Prop 64 (label, resealable, concentration, etc)20
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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.
CDPH’s Cannabis Laboratory in Richmond
Staffing Regulations SRIA* Database Licensing
January 1, 2018
Goal: begin receiving license applications as of January 1, 2018
* Standardized Regulatory Impact Assessment
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Prop 64 note: Adult-Use regulations will be generally similar and will utilize the emergency regulation process to meet this timeline
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)
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Some Questions (CCDEH)…
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?
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CHEAC Questions…
Webpage: www.cdph.ca.gov/omcs
Email: [email protected]
List Serve: [email protected]
OMCS Chief: Asif Maan, Ph.D.
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