Ask Me Anything: Shane Penn with Vitale Scientific [Wednesday, April 18th, 12 pm (noon) MST]

@CannaBull420

The term “Safety” is something that is thrown around quite a bit and paired with terms such as " state regulatory testing" “organic” and “pesticides” so often that it is difficult to evaluate whether we know that much about cannabis product safety.

Generally, in other types of emerging consumable products, federal agencies would be doing the leg-work on consumer health. The EPA would evaluate tolerances for pesticide use and food safety studies would indicate which microbial organisms were at most risk to grow on the products. The FDA or USP would be conducting studies in reference facilities that are not production-based for possible process-introduced contaminants and cGMP testing would be performed at each intermediate product step in addition to other control testing to standardized SOPs which would be provided by the industry in order to fill in any gaps left by the reference labs.

We do not know how to holistically capture the efforts to define public safety in the context of cannabis yet. We do know that it is not appropriate to apply parallels to EPA food tolerances of pesticides because combustion creates completely different compounds than digestion. We know it is not appropriate to look at historical health event data to claim safety of the current industry as there is a bias in the dataset due to the federal criminal element. We also know that historical data cannot directly correlate to the industry today due to the level of scale-ups businesses are going through. There is no longer a comparison at scale with the current industry.

At the base of the issue, we absolutely know that data in both historical and scale-up scenarios is of questionable consistency and/or quality due to the lack of documentation and standardization. There is not always proportionate inputs and outputs to any scale-up and without standardized procedures and validations, the ability to compare small and large systems is even more at risk to bias.

There is knowledge being applied in the industry meant to bridge the gap, without federal support, to producing legitimate systems and data to support public safety. We can look to how other industries create controls in a manufacturing process, an agricultural process, or a pharmaceutical process. In those areas, the first step to protecting public safety would be in implementing these good practices and gathering data on non-conforming products.

Another factor to consider is that the state regulatory authorities made compliance testing lists with ONLY point-of-sale testing in mind and this does not capture all risk. In order for the industry to take that next step forward, license-holders must drive the need for more robust datasets by developing a quality system that captures any risk that makes sense in their processes, not just those on a state contaminant list.
To date, I believe the industry has been fairly lucky in that the impact has only been in lost product, recalls, media exposes, and other PR challenges. There has not been a tragic outbreak or event and we need to realize how impactful that COULD be for all of us.

A very poignant line that was uttered from an individual entering this arena with experience of the first environmental lab regulations and the resulting challenges has stuck in my mind from a few years back:
“Those of you in Cannabis that are passionate about public health have a real opportunity here to drive safe products from the beginning. We don’t want to look back at the example of the environmental industry where the uninformed public waited until rivers were on fire and babies were dying before demanding regulation that protected their health.” Ty Garber, Phenova

I think we are at an important precipice where we can truly understand the work it will take to evaluate public safety in regards to cannabis or we can continue to Band-Aid the work until it truly needs to begin. I look forward to our favorite front-runners in this industry spearheading these efforts and I am cheering them on every step of the way! I love the new efforts coming out from key industry names that show a willingness to pro-active in the arena of public health and I encourage everyone to become better educated on what product safety actually means in their sectors of the industry.

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