This is an excellent question as the cannabis industry’s strength is innovative individuals who have many skill sets. As such, we are seeing faster advances in technology than other industries could hope for, however, we also are seeing a lot of “do-it-yourself” in-house systems such as databases and client portals. Cybersecurity, while always a challenge, is often built-in to other industry software and cloud products while this functionality is sometimes overlooked in the cannabis industry. This leaves it vulnerable to data mining and loss of confidentiality at a very sensitive HIPPA-type level.
Accurate testing is essential in any industry for everything from business valuation to public health controls. Unfortunately, this industry does not have the decades of scientific development supporting difficult matrix and its testing. Therefore, testing development must start at the beginning and take as much from parallel industry as possible. Good practice begins with performing sampling and analysis according to known methods and standards in order to produce consistent data of known quality. In order to ensure that products are being tested accurately, quality assurance programs in the laboratory must capture all sampling and testing activities and these programs must have third-party oversight. These types of systems include validation of appropriate methods, review of technical data and maintenance of equipment as well as defined training programs.
How does cannabis product testing differ from food, nutritional supplements, agricultural products or pharmaceuticals?
As a follow-up then, what should an average grower and/or processor know about cGMP and ISO standards?
Consumable products in the United States that are not federally scheduled fall under FDA oversight and are subjected to audits and off-the-shelf investigations. Cannabis had vey little historical data supporting state regulations as it pertained to actual public health risk and this caused it to fall under a “Let’s try to catch everything and Let’s do it at the point of sale” Model. This has several drawbacks, including a huge risk of lost product at the final stage. In the federally supported systems, processors manage their own risk based on their operations, perform their own testing from source material through final product as well as putting in place controls to prevent human and equipment contamination. Therefore, there are no “surprises” if there are off-the-shelf investigations and control points and testing schemes vary depending on the type of risk that the product introduces. As the penalties in these systems are severe, the industries do not hesitate to pour resources into quality systems such as cGMP in order to control risk. Unfortunately, in the cannabis industry, developing these systems and evaluating risk and control points can be a large up-front cost and so it is taking large events of lost product, client complaints, or media exposes before these costs are calculated and they will always be more expensive than developing good practices from the beginning.
We have two different contamination and forensics practices between VSA and Environmental Standards (our parent company). The practice conducted by Environmental Standards is related to environmental contamination and the investigation of potential sources of contamination for soil, sediment, groundwater, surface water contaminants at a given site. For example, if arsenic contamination is known to be an issue in groundwater near common outdoor cultivation sites, our experts can map the groundwater tables and track whether a certain cultivation site might be at risk for arsenic contamination directly or adjacent to the site or if this contamination may be coming from natural sources in the area. These investigation often lead to the collection of critical information which ultimately direct and inform regulatory decisions, business location decisions and existing site remediation efforts.
With regard to product contamination, our services are much more focused on the current needs of the industry. We have scientists on our team experienced in food, nutritional supplement, and pharmaceutical industries where controlling contamination points is essential to controlling risk. We review production operations and processes and perform “HACCP” and cGMP gap assessments to identify critical control points throughout a given process in order to mitigate contamination risks. The systems developed from these evaluations include robust testing to ensure a uniform and contaminant free product from batch to batch. HACCP is the main structure that is used to assess human introduced microbial risks that can cause public health events such as salmonella and avoiding these events as well as recalls due to contaminants is a critical element of a successful industry.
Very interesting, thank you.
To start, cGMP regulatory structure has been in place for consumables (e.g, food, pharmaceuticals and dietary supplements), in order to protect public health. The main focus of the cGMP standards was to prevent public health events (e.g., recalls, outbreaks), control product and control and optimize production processes. These practices allow processors to identify and remediate known risks prior to product distribution and sale.
ISO standards are voluntary international consensus standards based on a standardized structures that an organization will commit to using in order to meet client needs. This in turn, allows for a statement of credibility across states and nations which demonstrates that a given company can operate under quality systems and standards which require procedures for training, evaluating vendors, management of documents and records, evaluating contracts, corrective action and continuous improvement.
If you would like additional information on these standards or support developing an integrated quality system, please feel free to reach out to us!
What are the state requirements for testing product? Does it vary from state to state? How would a producer in various states get ahold of your company for an evaluation?
Charlie, feel free to expand on any questions! We love to nerd out on good science!
Alright everyone it’s nearing the top of the hour here; if you have any other questions I’m sure the crew with Vitale Scientific would be more than happy to answer them here or via PM! Thank you so much to Shannon & Shane and company for joining us today and answering questions!
Our team has advised policy and legislation in multiple states and there variety of testing schemes and the rigor of those schemes varies greatly due to state regulatory limitations. Products are generally tested for two classes of analytes 1) active ingredients such as cannabinoids and terpenoids and 2) contaminants such as pesticides and metals. These testing regulations are difficult to interpret and often shock a state’s cannabis industry when introduced. We are committed to helping the industry anticipate the needs for implementation of new regulatory structures in every state and therefore would invite anyone to reach out to us through Grower’s Network or our website if they have questions relating to this. Our Top Cannabis Team emails are as follows: Evan Ogburn (Pharmaceutical Lead): [email protected], Shannon Swantek (Regulatory and Cannabis Lead) [email protected] and Ken Yeomans (Food and Cannabis Support) [email protected]
If you had to give an established cannabis testing lab one sentence of advice, what would it be?
We are new to the community and look forward to interacting with everyone. If anyone has any additional questions feel free to reach out.
Encourage industry education, client engagement, and third-party evaluations of your processes!
Hey Shane, @spenn Why is the public perception of Cannabis Product “Safety” so uncertain and how does cGMP and accurate data contribute to these perceptions moving forward?
Yes! I love this answer! These are the exact things we pride ourselves on. <3 Thanks for doing this AMA!
There is a lot of business risk involved in point of sale testing that I will touch on but there is also the risk of trying to apply “one-size-fits-all” testing structure at one point in the product cycle for hundreds or thousands of different products whom are not yet differentiated on the basis of quality, consistency, full active ingredient list, or control. These products would have an assumed minimum level of quality in a federally regulated system and the processors, producers, distributors and wholesalers would further control their risks that are unique to each product. As a result, we are not capturing all possible contaminants and we are not gathering data on public safety risk. The penalties to the license-type for failing an “off-the-shelf” test need to be severe enough for the company to fear survival as this is almost as motivating as those companies that understand a public health event may also threaten it’s viability early on. Currently, there are very few repercussions for falling outside the rules and lots of doubts as to the data that puts a product in “failing” spot so the motivation to control their own risk is low compared to their need to compete in a competitive and young market.
Business concerns start with a grey area pertaining to the responsible party to pay for good practice testing earlier in the supply chain and continue to develop through receiving “tested product” that is filed or recalled. It’s possible product prior to compliance testing is not tested properly for the matrix or for the right suite of analyses. In-house concerns contain examples such as processors unknowingly subjecting dozens of batches to contaminant carryover if their equipment cleaning or quarantine procedures are not validated.
There is also risk inherent to questionable liability and lab analysis prices have risen drastically in an industry that does not completely grasp the complete lack of reliable data they once paid $100 for in old markets without laboratory oversight.
License-holders will pay 3 times the old price and feel like their confidence in their data should be improving but, in reality, a reasonable price may be 10 times old industry costs (which were created in a fraudulent market vacuum) and they could still be running against the lab’s profit margins to produce data of high enough quality to make sound decisions. This inconsistent quality decision for supply-chain testing, along with inconsistent supply chain testing at every stage of the product, keeps liability in question and holds the license holders back from taking on too much cost in the chain in order to stay competitive.
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.