Tag Archives: OSHA

CannaGrow: Education on the Science of Cultivation

By Aaron G. Biros
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The CannaGrow Conference & Expo, held in San Diego on May 7th and 8th, educated attendees on the science of cannabis cultivation. The conference brought subject matter experts from around the country to discuss cannabis breeding and genetics, soil science and cultivation facility design.rsz_img_5038

Discussions at the conference delved deep into the science behind growing while providing some expert advice. Drew Plebani, chief executive officer of Commercial Cultivator, Inc., gave a comprehensive review of soil ecology and how understanding soil fertility is crucial to successfully growing consistent cannabis. “Soil fertility is measured by laboratories in terms of soil minerals, plant-available nutrients, percent of organic materials, pH levels and most importantly the balance of the soil’s chemical makeup,” says Plebani. “There is no silver bullet in soil ecology; increasing your soil fertility comes down to understanding the composition of soil with analytical testing.” Plebani went on to add that soil systems for cannabis need to be slightly fungal-dominant in developing an endomycorrhizal system, which is optimal for cannabis plant growth.

Plebani notes that growth and viability are reliant on maximum root mass.
Plebani notes that growth and viability are reliant on maximum root mass.

Tom Lauerman, colloquially known as Farmer Tom and founder of Farmer Tom Organics, kicked off the conference with an introduction to cultivation techniques. Lauerman also delved into his experience working with federal agencies in conducting the first ever health hazard evaluation (HHE) for cannabis with the National Institute for Occupational Safety and Health (NIOSH). Through the HHE program, NIOSH responds to requests for evaluations of workplace health hazards, which are then enforced by the Occupational Safety & Health Administration (OSHA). Lauerman worked with those federal agencies, allowing them to tour his cultivation facilities to perform an HHE for cannabis processing worker safety. “I was honored to introduce those federal agencies to cannabis and I think this is a great step toward normalizing cannabis by getting the federal government involved on the ground level,” says Lauerman. Through the presentation, Lauerman emphasized the importance of working with NIOSH and OSHA to show federal agencies how the cannabis production industry emerged from the black market, branding itself with a sense of legitimacy.

Attendees flocked to Jacques and his team after the presentation to meet them.
Attendees flocked to Jacques and his team after the presentation to meet them.

Adam Jacques, award-winning cultivator and owner of Grower’s Guild Gardens, discussed his success in breeding CBD-dominant strains and producing customized whole-plant extractions for specific patients’ needs. “I find higher percentages of CBD in plants harvested slightly earlier than you would for a high-THC strain,” says Jacques. “Using closed-loop carbon dioxide extraction equipment, we can use multiple strains to homogenize an oil dialed in for each patient’s specific needs.” As a huge proponent of the Entourage Effect, Jacques stressed the importance of full plant extraction using fractionation with carbon dioxide. He also stressed the importance of analytical testing at every step during processing.

Hildenbrand discussing some of the lesser-known terpenoids yet to be studied.
Hildenbrand discussing some of the lesser-known terpenoids yet to be studied.

Zacariah Hildenbrand, Ph.D., chief scientific officer at C4 Laboratories, provided the 30,000-foot view of the science behind compounds in cannabis, their interactions and his research. With the help of their DEA license, he started the C4 Cannabinomics Collaborative, where they are working with Dr. Kevin Schug at the University of Texas-Arlington to screen various cannabis strains to discover new molecules and characterize their structure. “Secondarily, we are using gene expression profiles and analysis to understand the human physiological response and the mechanism through which they elicit that response,” says Hildenbrand. “As this research evolves, we should look to epigenetics and understanding how genes are expressed.” His collaborative effort uses Shimadzu’s Vacuum Ultraviolet Spectroscopy (VUV), and they use the only VUV instrument in an academic laboratory in the United States. “Pharmaceuticals are supposed to be a targeted therapy and that is where we need to go with cannabis,” says Hildenbrand. Him and his team at C4 Laboratories want to work on the discovery of new terpenes and analyze their potential benefits, which could be significant research for cannabis medicine.

Other important topics at the conference included facility design and optimization regarding efficient technologies such as LED lighting and integrated pest management.

Are You Ready For an Inspection?

By Maureen McNamara, Lezli Engelking
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Would you be proud to have your customers and patients tour your production facility? When health inspectors or enforcement personnel arrive at your location is there sense of panic or pride?

When you have detailed systems in place, inspections should be informative, not stressful. Keep in mind that in the cannabis industry, products are often created for patients. Patients may have a compromised immune system and thus are more susceptible to food borne illnesses, pesticides and other contaminants.

Are you and your team doing everything you can to produce a wholesome and safe product?

According to the World Health Organization, Good Manufacturing Process (GMP) “is a system for ensuring that products are consistently produced according to quality standards.”

GMP is the proactive part of quality assurance. It is designed to minimize the risks involved in all steps of the manufacturing process. A basic tenant of GMP is that quality cannot be tested into a product. It must be built into each batch of product during all stages of the manufacturing process.

GMPs involve much more than most people think. A common misconception is that GMP only covers the process of manufacturing itself. GMPs actually cover all aspects of the production process:

  • Materials
  • Premises
  • Equipment
  • Storage
  • Record Keeping
  • Staff Training to Hygiene
  • How Complaints Are Handled

GMP & The Cannabis Industry

In most industries, agencies that control licensing for the manufacture and sale of a product recommend GMPs, or guidelines to business owners. These guidelines provide minimum requirements that a manufacturer must meet to assure that products are of high quality and do not pose any risk to the consumer or public. The guidelines generally become the basis of regulation for that industry.

In the United States, the Food and Drug Administration (FDA) recommends guidelines for anything food, drug or pharmaceutical related.

Because cannabis still remains illegal at the federal level, none of the federal agencies that would normally develop good manufacturing guidelines have done so. This has left state lawmakers and business owners on their own to navigate this new and rapidly developing industry.

The Foundation of Cannabis Unified Standards (FOCUS) has developed standards with a mission to protect public health, consumer safety and safeguard the environment by promoting integrity in the cannabis industry.

The comprehensive implementation of cannabis specific good manufacturing practices, like the FOCUS standards, across all aspects of the industry will assist business owners and regulators alike, addressing quality proactively at every step in the process, which is critical to protecting consumer safety and public health – and the overall success of a nascent and divisive industry like cannabis.

The FOCUS standards are completing the final phase of development, a thirty-day public review and comment period before being released for use in the marketplace in June. These voluntary consensus-based standards are built on GMPs drawn from agriculture, food production, chemical management, OTCs, pharmaceuticals, and other relevant industries. In addition, the standards draw best practices from the cannabis industry, as well as those published in OSHA, FDA, FTC, CDC, ISO, code of federal regulations and various state-level cannabis regulations.

There are many aspects of creating and implementing GMPs. Here are three to be aware of:

  1. Get the facility design right from the start: It’s much easier to be GMP compliant if the design and construction of the facilities and equipment are right from the start. It is important to embody GMP principles and use GMPs to drive every decision. 
  1. Document what you do and do what you document: Having good procedures in place to ensure a controlled and consistent performance is an essential part of GMP. Procedures should be clear, concise, logical, and available to everyone.
  1. Keep good records: Keeping accurate records is an essential part of GMP. It helps convey that you are following procedures and demonstrates that processes are known and under control. If it’s not written down, it did not happen.

Standards and quality programs in any industry are dynamic by nature. Nothing is static. Standards must constantly be updated to reflect ever-changing market conditions. This is why it is so crucial that regulations are based on them.

To be a standard, there are certain core principals that must be present. However, the goal of a standard is to guide an industry without impeding or controlling it. This is why there is so much inherent value in implementing standards. They bring enough structure to help reduce costs and increase efficiency, but not so much control that individual nuances or creativity is affected.

It is much less expensive to be proactive. Recovering from a recall or contaminated product can not only be costly, it is a massive hit to the company’s reputation. It may take years for sales to recover, and for consumers to trust the product again. Where could you and your team enhance your standards and processes?