A Public-Private Collaboration for Cannabis Testing Success Story Could This Work in Other States? Heather Krug, MS State Marijuana Laboratory Sciences Program Manager Colorado Department of Public Health and Environment Laboratory Services Division 303-691-4028 heather.krug@state.co.us
Disclaimer The view and opinions expressed in the presentation are solely those of the presenter and do not necessarily reflect those of any state agency. No legal advice or regulatory opinions or advice are being proffered and none should be intended nor inferred.
Topics Role of the CDPHE Laboratory Services Division Agency Challenges There s What in our Cannabis? We Need MRLs Yesterday A Logical Yet Uncommon Approach: PPC A Novel Approach to Setting Pesticide MRLs
Role of CDPHE Laboratory Services Division Performs audits of retail and medical marijuana testing facilities to ensure labs meet Department of Revenue (DOR) rules and are competent to carry out specific scientific tests. Provides scientific recommendations to DOR for policy and regulation development. Responsible for marijuana testing reference library and lab proficiency testing. Coming soon: Marijuana Reference Laboratory
Agency Challenges State regulatory agencies face a number of challenges in oversight of cannabis laboratories. Examples: Proficiency testing Lack of standard cannabis testing methods Inadequate sampling practices/sample adulteration Ensuring laboratories produce quality results in a highly competitive market Determining testing requirements
Colorado Testing Requirements Required testing is performed on finished products which include: Marijuana Flower (bud) Concentrates (solvent-, water-, or food-based) Oils, hash, bubble hash, wax, shatter, resin Edibles Baked goods, chocolates, hard candy, mints, gummies, drinks, tinctures, pills Personal Care Products Lotions, transdermal patches, personal lubricants, suppositories
There s What in our Cannabis?
There s What in our Cannabis?
Colorado Challenge: We Need MRLs Yesterday But! Cannabis is not a listed crop on any registered pesticide label The label is the law! EPA: Cannabis doesn t fit into any general crop category such as herbs or spices No risk assessments have been conducted Tolerance limits have not been defined November 2015: Executive order issued by the Governor
A Logical Yet Uncommon Approach PPC PPC Public-Private Collaboration A stakeholder process was initiated to determine: Pesticide analyte List The associated limits Participants in the process included: DOR/MED, CDA, CDPHE, Governor s office Cultivators, product manufacturers, other industry reps Scientists, experts from other industries
A Logical Yet Uncommon Approach PPC Through the stakeholder process it was decided: The initial list consisted only of those pesticides that are banned for use in Colorado and have not established tolerance limits The list was narrowed to 13 pesticides that had been found in marijuana in Colorado This list is intended as an initial list only. Additional compounds will be added in the future
Pesticide Analyte List Current Pesticide List CAS # Abamectin (Mixture of Avermectins 71751-41-2 B1a and B1b) Azoxystrobin 131860-33-8 Bifenazate 149877-41-8 Etoxazole 153233-91-1 Imazalil 35554-44-0 Imidacloprid 138261-41-3 Malathion 121-75-5 Myclobutanil 88671-89-0 Permethrin (Mixture of cis- and trans-) 52645-53-1 Spinosad (Mixture of A and D) 168316-95-8 (mix A/D) Spiromesifen 283594-90-1 Spirotetramat 382608-10-8 Tebuconazole 107534-96-3
A Novel Approach To Setting Pesticide MRLs MRLs Mandatory Reporting Limits Through the stakeholder process it was decided: Pesticide residue limits should be based upon laboratory method detection limits (MDLs) Most CO labs were not performing pesticide testing and could not provide this information Labs agreed to participate voluntarily in a Multi-Lab Study directed by the state
A Novel Approach To Setting Pesticide MRLs MRLs Mandatory Reporting Limits Through the stakeholder process it was decided: Studies would use protocols as designed by a stakeholder working group CDPHE partnered with Restek and two scientific consulting firms to oversee the study and its design Restek generously donated standard reference materials to the study participants
A Public-Private Collaboration for Cannabis Testing Success Story Could this Work in Other States? Joe Konschnik Business Development Manager Food & Agriculture Markets RESTEK Corporation Joe.Konschnik@restek.com
Topics Volunteer Study Design & Oversight MDL Study Design Training for Success The Results Conclusions & Acknowledgements
Volunteer Multi-Lab Study Design & Oversight Heather Krug, Eric Petty CDPHE Joe Konschnik, Julie Kowalski, Jack Cochran Shawn Kassner Jeff Lowry Lowry Consulting
Multi-Lab MDL Study Design & Documents 1. Instrument Detection Limit (IDL) 2. In Matrix Quality Check (MQC) 1 3. Method Detection Limit (MDL) 1, 2 Same Reference Standard Mixes (CRMs) Same Matrix (ground + homogenized) NOTE 1: NOTE 2: SANTE/11945/2015 30 November -1 December 2015 rev. 0 Guidance document on analytical quality control and method validation procedures for pesticides residues analysis in food and feed. 40 CFR APPENDIX B TO PART 136 - DEFINITION AND PROCEDURE FOR THE DETERMINATION OF THE METHOD DETECTION LIMIT-REVISION 1.11
Ready, Set. What about Training?
Medical Cannabis Hands-On Workshop at CDPHE August 2016 Pesticides Sample Preparation and Analysis Workflow on Cannabis Flowers Loaned Lab Space Loaned LC-MS/MS & staff Donated Flowers Donated products and Staff time Loaned Grinder/Shaker Trained 20 Chemists from CDPHE and local CO laboratories
Medical Cannabis Hands-On Workshop at CDPHE August 2016
Medical Cannabis Hands-On Workshop at CDPHE August 2016 Grinding + QuEChERS Extraction + dspe Cleanup + Filtration Spiked IS + 13 pesticides into Indica Buds 11 pesticides @ 100ppb 2 pesticides @ 1000ppb Extracts Analyzed by LC-MS/MS same day 19 participants Very Impressive Results!
Multi-Lab Pesticides MDL Study Phases Ready, Set 1. IDL Phase completed Oct-Nov 2016 1. MQC Phase completed Feb 2017 3. MDL Phase completed Jul-Aug 2017
Multi-Lab Pesticides MDL Study Results Six Labs Data Calculated MDLs (ppb) 95% and 99% Confidence Intervals Ave, Max & Min
Multi-Lab Pesticides MDL Study Results Six Labs Data Minimum, Average and Maximum MDL Values
Multi-Lab Pesticides MDL Study Results Six Labs Data Average MDL Values All are < 20 ppb
Multi-Lab Pesticides MDL Study Results Six Labs Data Average & Minimum MDL Values
Multi-Lab Pesticides MDL Study Results Six Labs Data Minimum MDL Values 4 of 6 labs values
Multi-Lab Pesticides MDL Study Results Six Labs Data MDL %RSDs Varying Instruments Varying Sample Prep Steps Varying Experience Levels
Summary & Conclusions A State agency and Private Industry Worked Together Successfully The stakeholder community responded when committed to a common goal A Well-defined Process Ensured Success Training was a necessity in such a new industry MDLs are within the range of other Botanical commodities
Acknowledgements & Special Thanks State Agencies Cannabis Testing Labs: Colorado Consultants: Lowry Consulting CO Grower Vendors/Suppliers: