Cannabis LIMS for QA and Medical Research

Regulatory Compliance – Cannabis

Federal and state regulation

Cannabis Testing Regulations.jpg

It’s still something or a wild frontier in most states with regard to standards and regulations. Indeed, in some cases pretty much anyone can set themselves up as a testing lab with nothing more than a simple—and dangerously insufficient and inaccurate—test kit. But for the most part, and increasingly, as the risks are being recognized by states for both medicinal and recreational products, regulations are beginning to be mandated.

Like the state of California has done with its various state agencies[1], other states that have legalized cannabis for medical use, adult consumption or both have also established government agencies or departments to oversee cannabis regulation or assigned those responsibilities to existing agencies. For instance, with the voters in Massachusetts having approved adult recreational use in November 2016, the state created a new agency called the Cannabis Control Commission”.[2] Washington State charged its Liquor Control Board with developing a plan for regulating cannabis testing labs.[3] There are also various validation consultants and companies who have begun to specialize in this industry.

However, despite strong state-specific efforts, regulations can still vary from state to state. Even when two states mandate testing of cannabis, how it’s done and by whom may vary significantly. To bring about more consistency, it may inevitably require the federal government “to set up policy guardrails to steer state regulatory systems” in a more unified and safe direction.[4] Additionally, the unified efforts of standards organizations and professional associations may also help to bring even more consistency to testing.

Standards

In any case, some standards apply to cannabis labs as they do to any labs, especially if they want to be competitive; baseline certifications and standards include GLP/GALP and ISO 17025/9001:2015. Additionally, while some disconnects between federal and state laws do exist, QA/QC are still subject to 21 CFR Parts 210 and 211[5] part 11, and, in New York for example, the DEA.[6] Additional standards are being developed specifically for cannabis testing labs, however. Organizations such as Americans for Safe Access Foundation (ASAF), American Herbal Pharmacopoeia (AHP), American Herbal Products Association (AHPA), Association of Official Agricultural Chemists (AOAC), and the American Oil Chemists’ Society (AOCS) have been developing standards, methods, and certifications for analysis, extraction, labeling, and laboratory operations surrounding medical (and recreational) marijuana.[7][8][9][10][11][12]

Notable among those organizations is the Foundation of Cannabis Unified Standards (FOCUS), which worked to produce internationally applicable voluntary consensus standards for various parts of the cannabis business chain, including cultivation, extraction, laboratory testing, and packaging. FOCUS completed its public review process and finalized its standards in July 2016, though at that time it wasn’t clear how to gain access to them.[13] New information came to light in March 2017, when FOCUS and ASTM International announced a collaboration between the two entities, which in April 2017 saw the formation of volunteer committee D37 at ASTM and the further adaptation of FOCUS’ standards to future ASTM releases.[14][15]

The newly formed Committee D37 agreed to pursue cannabis standardization in six key areas[16][17]:

  • indoor and outdoor horticulture and agriculture: e.g., pest management, water considerations, environmental site assessment, and sustainability
  • quality management systems: e.g., quality considerations, due dillegence
  • laboratory testing: e.g., sampling, stability testing, purity testing, analytical methods, and proficiency testing
  • processing and handling: e.g., drying and curing, exposure management, waste management, storage
  • security and transportation: e.g., packaging, shipping management, risk assessment and mitigation, occupational health and safety
  • training, assessment, and credentialing: e.g., laboratory training, clean room management, quality inspection, patient and physician education

Since its founding in April 2017, Committee D37 has made strides towards its goals. Meeting every January and June[18], D37 has made progress on developing several standards and creating a set of standardized terminology to be used across them.[19] Its first two approved standards arrived in May 2018, concerning testing methods for determining water activity in cannabis samples, as well as the range of water activity that is “safe and effective” for storing samples.[20] In August 2018, the committee announced a new standards project that would result in two guides that “will provide sampling procedures critical in generating accurate laboratory results, which in turn could lead to improved consumer safety.”[21]

Regardless, there remains at present a certain degree of inconsistency in test results from different labs, due for the most part to limited supply of good quality reference standards for QC and varying SOPs/methods. However, the trend is very much in the direction of required lab certifications to the same methods.[22] The issue is compounded in that different methods of use (smoking, vaping, edibles, capsules, sublingual, topical, drinks) yield different delivered time-release and cumulative potencies, making recommended dosages somewhat problematic. However, the increased uniformity of laws and standards is leading to a general acknowledgment that the quality and consistency in the cannabis testing industry is quickly improving.[23]

Regulation resources

There are a couple of resources that help provide guidance on where to go to see the various laws that do exist regarding cannabis generally and testing specifically:

Beyond that, accessing the specific government websites will lead to the applicable regulatory information in most cases.

References

  1. “California Cannabis Portal”. State of California. 2018. https://cannabis.ca.gov/. 
  2. CannaRegs and New Frontier (2017). “State-By-State Marijuana Policies”. National Cannabis Industry Association (NCIA). http://thecannabisindustry.org/state-marijuana-policies-map. Retrieved 23 January 2017. 
  3. Anderson, W.H. (26 August 2013). “Cannabis Testing Labs: Standards and Accreditation”. Washington State Liquor Control Board. https://lcb.wa.gov/publications/Marijuana/BOTEC%20reports/2b_Accrediting_Labs_Final_10_15_13.pdf. 
  4. Cole, T.; Trumble, S.; Hatalsky, L.E. (17 February 20116). “All State Marijuana Laws Are Not Created Equal”. Third Way. http://www.thirdway.org/report/all-state-marijuana-laws-are-not-created-equal. Retrieved 02 February 2017. 
  5. Saman, A. (22 May 2016). “18 GMP Cannabis defintions you need to know”. HempHacker.com. http://hemphacker.com/cgmp-definitions-for-the-cannabis-industry-21-cfr-part-210/. 
  6. Association of Public Health Laboratories (May 2016). “Guidance for State Medical Cannabis Testing Programs” (PDF). pp. 35. https://www.aphl.org/aboutAPHL/publications/Documents/EH-Guide-State-Med-Cannabis-052016.pdf. Retrieved 01 February 2017. 
  7. “New Certification Program Brings Quality Assurance to the Medical Marijuana Industry”. Information Forecast, Inc. 2016. http://infocastinc.com/industries/new-certification-program-brings-quality-assurance-to-the-medical-marijuana-industry/. Retrieved 02 February 2017. 
  8. Cannabis Committee, AHPA (02 February 2016). “Recommendations for Regulators – Cannabis Operations” (PDF). American Herbal Products Association. http://www.ahpa.org/Portals/0/pdfs/AHPA_Recommendations_for_Regulators_Cannabis_Operations.pdf. 
  9. Upton, R.; Craker, L.; ElSohly, M. et al., ed. (2014). Cannabis Inflorescence: Cannabis spp.. American Herbal Pharmacopoeia. ISBN 1929425333. http://www.herbal-ahp.org/order_online.htm. 
  10. Project CBD; Marcu, J. (16 March 2016). “Jahan Marcu: Cannabis Lab Testing & Safety Protocols”. Project CBD. Project CBD. https://www.projectcbd.org/article/jahan-marcu-cannabis-lab-testing-safety-protocols. Retrieved 03 February 2017. 
  11. Erickson, B.E. (13 November 2017). “Cleaning up cannabis”. Chemical & Engineering News. American Chemical Society. https://cen.acs.org/articles/95/i45/Cleaning-cannabis.html. Retrieved 15 November 2018. 
  12. Cassiday, L. (October 2016). “The Highs and Lows of Cannabis Testing”. INFORM. American Oil Chemists’ Society. https://www.aocs.org/stay-informed/read-inform/featured-articles/the-highs-and-lows-of-cannabis-testing-october-2016. Retrieved 03 February 2017. 
  13. “Public Review Completes Development Process”. FOCUS. 2016. http://www.focusstandards.org/public-review-of-cannabis-standards/. Retrieved 16 February 2016. 
  14. Biros, A.G. (02 March 2017). “ASTM International Launches Cannabis Committee”. Cannabis Industry Journal. Innovative Publishing Co. LLC. https://www.cannabisindustryjournal.com/news_article/astm-international-launches-cannabis-committee/. Retrieved 10 March 2017. 
  15. “Committee D37 on Cannabis (Pending approval from the ASTM Board of Directors, April 26, 2017)”. ASTM International. 01 March 2017. https://www.astm.org/COMMITTEE/D37.htm. 
  16. Maxwell, J. (May 2017). “The Need for Cannabis Standards”. ASTM Standardization News. ASTM International. https://www.astm.org/standardization-news/?q=features/need-cannabis-standards-mj17.html. Retrieved 14 November 2018. 
  17. Morgan, R. (29 March 2018). “ASTM International Committee D37 on Cannabis: The Road to Consensus Standards”. LabRoots. https://www.labroots.com/webinar/astm-international-committee-d37-cannabis-road-consensus-standards. Retrieved 14 November 2018. ”At 20:25 of the webinar” 
  18. “Committee D37 on Cannabis”. ASTM International. 2018. https://www.astm.org/COMMITTEE/D37.htm. Retrieved 14 November 2018. 
  19. May, M. (21 February 2018). “ASTM D37 Cannabis Committee Looks to Expand its Reach in 2018”. Analytical Cannabis. Technology Networks. https://www.analyticalcannabis.com/articles/astm-d37-cannabis-committee-looks-to-expand-its-reach-in-2018-297750. Retrieved 14 November 2018. 
  20. “ASTM International Cannabis Committee Approves First Two Standards”. ASTM International. 18 May 2018. https://www.astm.org/cms/drupal-7.51/newsroom/astm-international-cannabis-committee-approves-first-two-standards. Retrieved 14 November 2018. 
  21. ASTM International (23 August 2018). “ASTM Announces New International Standard Projects to Help Reduce Hazards in Cannabis Processing and Cannabis Sampling Procedures”. Cannabis Business Executive. https://www.cannabisbusinessexecutive.com/2018/08/astm-international-standard-underway-help-reduce-hazards-cannabis-processing/. Retrieved 14 November 2018. 
  22. Dorm, D.. “Certification Becoming Standard For Cannabis Testing Facilities”. Medical Jane. https://www.medicaljane.com/2013/11/04/certification-becoming-the-standard-for-cannabis-testing-facilities. Retrieved 23 January 2017. 
  23. Despres, H.. “Cannabis testing: a review of the current landscape”. AOCS. https://www.aocs.org/stay-informed/read-inform/featured-articles/cannabis-testing-a-review-of-the-current-landscape-may-2014. Retrieved 23 January 2017.