A Public-Private Collaboration for Cannabis Testing Success Story

Transcription

1 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

2 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.

3 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

4 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

5 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

6 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

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8 There s What in our Cannabis?

9 There s What in our Cannabis?

10 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

11 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

12 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

13 Pesticide Analyte List Current Pesticide List CAS # Abamectin (Mixture of Avermectins B1a and B1b) Azoxystrobin Bifenazate Etoxazole Imazalil Imidacloprid Malathion Myclobutanil Permethrin (Mixture of cis- and trans-) Spinosad (Mixture of A and D) (mix A/D) Spiromesifen Spirotetramat Tebuconazole

14 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

15 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

16 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

17 Topics Volunteer Study Design & Oversight MDL Study Design Training for Success The Results Conclusions & Acknowledgements

18 Volunteer Multi-Lab Study Design & Oversight Heather Krug, Eric Petty CDPHE Joe Konschnik, Julie Kowalski, Jack Cochran Shawn Kassner Jeff Lowry Lowry Consulting

19 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/ 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 DEFINITION AND PROCEDURE FOR THE DETERMINATION OF THE METHOD DETECTION LIMIT-REVISION 1.11

20 Ready, Set. What about Training?

21 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

22 Medical Cannabis Hands-On Workshop at CDPHE August 2016

23 Medical Cannabis Hands-On Workshop at CDPHE August 2016 Grinding + QuEChERS Extraction + dspe Cleanup + Filtration Spiked IS + 13 pesticides into Indica Buds ppb ppb Extracts Analyzed by LC-MS/MS same day 19 participants Very Impressive Results!

24 Multi-Lab Pesticides MDL Study Phases Ready, Set 1. IDL Phase completed Oct-Nov MQC Phase completed Feb MDL Phase completed Jul-Aug 2017

25 Multi-Lab Pesticides MDL Study Results Six Labs Data Calculated MDLs (ppb) 95% and 99% Confidence Intervals Ave, Max & Min

26 Multi-Lab Pesticides MDL Study Results Six Labs Data Minimum, Average and Maximum MDL Values

27 Multi-Lab Pesticides MDL Study Results Six Labs Data Average MDL Values All are < 20 ppb

28 Multi-Lab Pesticides MDL Study Results Six Labs Data Average & Minimum MDL Values

29 Multi-Lab Pesticides MDL Study Results Six Labs Data Minimum MDL Values 4 of 6 labs values

30 Multi-Lab Pesticides MDL Study Results Six Labs Data MDL %RSDs Varying Instruments Varying Sample Prep Steps Varying Experience Levels

31 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

32 Acknowledgements & Special Thanks State Agencies Cannabis Testing Labs: Colorado Consultants: Lowry Consulting CO Grower Vendors/Suppliers: