Growers Network is hosting an Ask Me Anything event with Shane Penn from Vitale Scientific Associates, LLC on Wednesday, April 18th, 2018 at 12 pm (noon) MST!
Vitale Scientific Associates, LLC (VSA) is a wholly owned subsidiary of Environmental Standards Holdings, Inc. VSA manages the quality and collection of data and information needed to assess and manage product safety, product purity, product stewardship, product specifications and certificates of analysis, and supply chain purity. We also provide contamination forensics and evaluation of downstream contamination events.
Our clients include a wide array of materials and goods producers and distributors.
Typically our clients are producers and distributors of foods, beverages, pharmaceuticals, personal care products, additives, fillers, and feeds. The core VSA team works in complete harmony with the parent company which handles environmental issues for many of the same clients.
Hi Shane, thanks for sharing today. I run the national cannabis risk management association (www.thencrma.org), we are addressing lots of cybersecurity issues that cannabis is likely to experience as the industry becomes a larger target for hackers, what are some of the vulnerabilities that you see retailers, processors, and cultivators facing beyond just seed2sale integration? Thanks and I’d love to connect another time. Unfortunately, I’ll be flying at 1pm.
We also provide contamination forensics and evaluation of downstream contamination events.
What exactly does this consist of? Contaminated bud is a very commonly talked about topic with cannabis, in fact there are “not so funny” memes created by trimmers of grow operations that talk about how much moldy and powdery mildew bud they trim that still gets sent off and used, or just sent to blast. What is the typical process when you get involved with this type of thing?
Early on in the cannabis industry it was a lack of standardization for both product development and testing. But as experts from other industries continue to join the cannabis industry the gap in standardization between cannabis and other industries that we work with is becoming less evident.
The most crucial element is adopting good practices which already exist in parallel industries such as Good Agricultural Practices, Good Manufacturing Practices, Good Laboratory Practices, etc. Implementation of such policies and practices will lead to the manufacturing of products of known quality and accurate laboratory data supporting that quality. These practices have been demonstrated as ways to control products and capture known risks throughout a products life-cycle. Likely, these practices, or one that is similar to, will be mandated once Cannabis becomes federally legal.
Vitale Scientific is the sister company of Environmental Standards Inc. Together, we support businesses and professionals in the environmental, pharmaceutical, nutritional supplement, chemical manufacturing, food safety, and laboratory sectors of every industry.
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.
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.
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?
