Harmonized Labs are the Key to Licit Cannabis Commerce

As I listened to the lectures in the analytical track at the Cannabis Science Conference 2017, held August 28–30 in Portland, OR, I became concerned about how laboratories would function to provide uniform, safe, and efficacious cannabis products. In my view, the retail products need to be harmonized across the U.S.A. At the conference, it was clear that the labs and assay protocols were not harmonized. Several accrediting agencies were on the exhibition floor, but consensus had not formed. It was encouraging to see reports describing how individual states were devising intrastate programs for the labs and data quality. This verifies that the state-level regulators see the need for science-based data to support their program.

This led me to wonder: What can we learn from existing science-based programs? What can we do to assure public safety as the state-by-state roll-out programs mature to trusted businesses?

Background

The market for licit cannabis products is exploding rapidly. The illicit market is large—over $20 billion in annual sales. Recent liberalization of policy-based laws restricting the possession and use of cannabis products should make illicit businesses come out of the shadows. Cannabis products were once characterized primarily by brand or street names provided by growers or dealers. If assay results were cited, the data were suspect.

If there is to be a licit market for cannabis products, the public has a right to expect that products are safe and effective for intended use. Hopefully, America will provide science-based regulation of cannabis commerce. What should the workflow look like, and are there any examples? I think we have at least three.

At the successful extreme are clinical diagnostic laboratories working since 1988 under CLIA standards and FDA-approved assays to diagnose and guide treatment at the individual level. Mid-spectrum is the testing of neonates for a range of diseases. Neonatal testing is run by state public health agencies. Some test a few diseases, and others up to 56. The specific tests vary by state. Interstate harmonization is lacking. Prior to around 2013, American forensic labs defined the abysmal end of the spectrum. Fraud was too frequent, but worse, the science was often flawed (National Research Council, 2009. Strengthening Forensic Science in the United States: A Path Forward. The National Academies Press: Washington, DC; https://doi.org/10.17226/12589.).

The federal government is trapped by indecision and mistaken policies associated with the war on drugs. A majority of states have decriminalized cannabinoids for therapeutic use. Several are also decriminalizing recreational use of cannabinoids, including THC. Regulatory and product safety and efficacy are the responsibility of individual states.

Let’s see what works

The Center for Medicare Services (CMS) and the FDA have developed a comprehensive program, called CLIA 1998, for clinical diagnostics that delivers reliable test results quickly. About 250,000 labs are involved in the U.S.A. Working interlaboratory variance is low. One can routinely compare interlaboratory results, even over time. The CLIA model works and could be emulated, and this would require congressional action.

What can be improved?

In the 1960s, individual states developed testing programs for assay of phenylketonuria (PKU). During the last 50 years, these programs have been expanded to include the recommended uniform screening panel, which today includes 34 analytes. Some states have gone further, for a total of 58 conditions.

With 50 states and a few more territories, there is a range on test panels, methods, and decision or cut-points. False positives and negatives between states differ. Harmonization does not seem likely. The disputes about cut-points and panels seem to be turf wars, which are slow to resolve. It appears that the neonate-testing programs are part of each state’s key service and patronage system. This looks to be the most likely model for cannabis labs in the U.S.A.

Remediation in forensics

American forensic labs are struggling. The now famous 2009 report by the National Academy of Sciences (NAS) described a terrible performance deficiency, often based upon junk science. President Obama’s administration responded by tasking the NIST to organize a crash program to put science back into forensic science. The Organization of Scientific Area Committees (OSAC) has been operating for three years.

Why is the OSAC program working? The shocking NAS report decreased public confidence in evidence-based law enforcement. Something had to be done, rapidly. Fortunately, the U.S. already has favorable experience with standard methods with ASTM, EPA, and USP, and NIST has a very good reputation. So, the idea was to recruit a large cohort of over 500 subject-matter experts to staff 25 focus groups to draft specific analytical methods. The power is that stakeholders would work diligently to create a library of standard, field-proven, forensic methods. OSAC seems to be working well. The model should be directly transferrable.

Chaos in cannabis testing

The federal government clings to classifying cannabis as a Schedule I material in the Controlled Substances Act. The administration, led by the Department of Justice, precludes federal participation in drafting regulations and standards for medical cannabis, and is even more steadfast on recreational cannabis.

The federal prohibition of shipping cannabis material across state lines effectively criminalizes transport of analytical standards across state lines. This severely restricts creation and distribution of certified reference materials. Round-robin testing is also difficult, since it can only involve labs in each state. However, organizations such as ASTM and USP could devise programs to standardize methods for critical assays using surrogate plants such as hops. These could include potency, heavy metals, and pesticide residues. The surrogates could be spiked with specific analytes such as THC purified by HPLC from sources in each state. While this is not NIST technology, it could be better than nothing.

If labs continue to evolve with an intrastate focus, America will have another example of a system that works well for citizens of some states, probably the wealthy ones, and poorly for the remainder. Interstate leadership is the other missing item for interstate harmonization of cannabis analysis.

What are the options for filling the leadership void? Going back a bit, the University of California at Berkeley ran the Manhattan Project, which developed two distinctly different atomic bombs in five years.

If not UC Berkeley, then perhaps UC Davis. It is less than 100 miles from the region where most of America’s cannabis is grown, and is among the top five agricultural universities.

The American Chemical Society (ACS) is another option. With access to leading knowledge experts in chemistry and regulatory science, ACS could respond to national need to organize a countrywide program modeled after the OSAC approach that NIST developed for forensics. Seventy-five years ago, ACS managed Universal Oil Products (UOP) to help advance petroleum-refining technology across the U.S.A. Interestingly, Dr. Willie E. May, the former director of NIST, is running for president of the ACS. Should he win, he might be able to expedite the creation of an OSAC-like program for cannabis testing.

I fear that leaving harmonization to the 50+ states and territories will lead to a mess similar to neonate screening. Once individual states get control of their labs, they will fight to keep local control. The public will suffer.

Robert L. Stevenson, Ph.D., is Editor Emeritus, American Laboratory/Labcompare; e-mail: [email protected].

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