Tag Archives: safety

budgloves

BudGloves Makes Handling Cannabis Safer

By Aaron G. Biros
2 Comments
budgloves

Kush Bottles, a packaging provider specific to the cannabis industry, recently launched the product BudGloves aimed at reducing the amount of human contact to cannabis products. The company is known for their child-resistant, regulatory compliant packaging.budgloves

The product BudGloves is the first glove of its kind engineered specifically for cannabis. The nitrile gloves do not contain any powder and are designed to prevent any transfer of resin, latex or powder to the cannabis. They are also slightly thicker than most other gloves to avoid getting caught or tearing, extending their life to withstand the typical shift of a trimmer or processor.

Nick Kovacevich, chief executive officer of Kush Bottles, wants to see a standard for preventing human contact with cannabis products to reduce the risk of contamination or loss in quality. Whether it is during cultivation, trimming, inspection, processing, transferring cannabis to instrumentation or even at the point of sale, it is important to minimize human contact to the cannabis.

“In California, we see bud tenders in dispensaries actually reach in a jar and grab cannabis to show the patient without gloves, which is a terrible standard operating procedure,” adds Kovacevich. “I would want all bud tenders to handle cannabis with gloves on.”rsz_budgloves2

Particularly when handling food-grade products, most health code regulations require the use of gloves like these. According to Kovacevich, oils and extracts can be at a greater risk of contamination. “It is imperative that concentrates and extracts, especially those with activated THC, are handled with gloves to prevent any outside materials or contaminants from sticking to them,” says Kovacevich. The gloves are manufactured to meet stringent quality standards. To promote safety and quality of cannabis, reducing human contact with the product should be an important part of any company’s employee manual.

Consumerguide
Soapbox

A New Tool to Make Cannabis Evaluation Easy

By Matthew Huron
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Consumerguide

All cannabis is not created equal.

Just as industry experts have developed a set of tools to assess artisan experiences with wine, craft beer and diamonds, our team of cannabis cultivators at Good Chemistry Nurseries- who hold decades of experience backed by extensive education in horticulture and botany- have developed a new consumer guide to evaluate the essential aspects of cannabis called STATS (Sight, Touch, Aroma, Taste, Sensation). We hope the newly developed guide will begin an industry-wide dialogue about consumer education and provide fundamental knowledge on how to evaluate the quality of a cannabis flower.

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A view of the materials for consumers

STATS was created in response to our customers’ growing desire to differentiate between high quality and low quality flower. Two years ago, a consumer may have walked into a dispensary, and may have been thrilled just to be able to buy legal and safe cannabis. Fast forward two years, and now they’re asking, “How do I recognize quality cannabis?” By introducing STATS as a consumer awareness campaign, we are hoping to meet the needs of consumers to understand the complexities of the cannabis flower, as well as opening up the industry to a more conservative market that might be overwhelmed and intimidated by the cannabis culture.

STATS, which is available at no cost at statsguide.org and at Good Chemistry dispensary locations, is designed as an interactive booklet that breaks down the complexities and characteristics of quality cannabis through the five main categories; sight, touch, aroma, taste and sensation. The short, easy-to-read tool also comes with a concise glossary, which includes definitions of cannabis-related words, and expressions that might not be palpable to a novice consumer. Here is an overview of the STATS tool to evaluate quality cannabis:

Consumerguide
The STATS take away guide book for consumers

Sight: Seeing the flower can sometimes be the only evaluation option before purchase. It is important to know the visual cues for remarkable cannabis. STATS help consumers evaluate qualities including: trichome content, color, structure, size and trim.

Touch: Touching the flower can help with evaluating the cure, or the controlled drying process used to achieve proper moisture content post-harvest. STATS define how the bud should feel.

Aroma: Distinctions can be made between high and poor quality cannabis aroma. Because each flower strain can have a unique scent, STATS reviews what scents should be expected, and what smells can denote poor quality.

Taste: Different flowers strains will have unique flavor profiles. Similar to wine tasting, experience is necessary, STATS helps consumers learn to distinguish between different flavors among the flower strains.

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The development team of STATS

Sensation: The first sensation that comes from cannabis is the sensation of lift, or of being high. Varying experience levels may affect how people feel with each strain and the amount of time people feel lifted. We have identified the key categories of sensations that come from different strains including amplify, relax, relieve, and sleep.

Now, there is an easy and free tool to provide novice and aficionado cannabis users new insight and understanding into the purchase they’re about to make. Good Chemistry Nurseries developed STATS in conjunction with our Colorado-based master cultivators Duncan Cameron, Scott Toland, Heath Byington and Stephen Spinosa. Our development team came to this idea with a strong desire to address consumers’ interest in learning more about how to assess high quality cannabis.

good to know kit

Colorado Distributes Consumer Education ‘Good To Know’ Kits

By Aaron G. Biros
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good to know kit

The Colorado Department of Public Health and Environment (CDPHE) launched the Good to Know program in January of 2015, aimed at educating the public on consuming cannabis responsibly. The CDPHE developed a free kit for retailers that will be distributed this week, hoping to reinforce safe and responsible experiences with cannabis at the consumer level. Intended specifically for recreational cannabis retailers, the educational materials will be distributed at the point of sale.

good to know kit
The Good to Know kit for retailers

According to the CDPHE, last year between April and August, Colorado saw a 28 percent increase in retail cannabis sales. In anticipation of a period of high demand this summer, the ‘Good to Know’ retailer kits are being distributed this week. According to Ali Maffey, CDPHE policy and communication unit supervisor, the state is mailing 100 kits to additional retailers ahead of cannabis-related events, such as April 20th, which are expected to bring an influx of tourists.

The takeaway information cards in the kits display frequently asked questions regarding edibles and secondhand smoke, as well as advice for appropriate legal usage of cannabis. “The educational materials can help guide bud tenders through a conversation with a consumer to prepare them for the effects of cannabis, dosage considerations, using caution with edibles, driving impairment and the risks of second hand smoke,” says Maffey. “Voters passed the legalization of cannabis, and as the state health department our role is to educate on the safe and responsible use of cannabis, while safeguarding public health.”

The continued efforts by the state for consumer education could highlight an important push for safety. “We have been talking with other states about what works in our messaging and they are all looking at public education campaigns as well,” says Maffey. In this respect, Colorado is leading the country in educating consumers on safe, responsible and legal cannabis use.

Are You Ready For an Inspection?

By Maureen McNamara, Lezli Engelking
1 Comment

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?

AdamKohcultivation

A Case for Compartmentalization: Problems with Perpetual Harvest Models in Cultivation, Part II

By Adam Koh
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AdamKohcultivation

In the first part of this series, I presented some issues with perpetual harvest models for cultivation with respect to inefficiencies in technology and environmental monitoring. I made the case for compartmentalizing cultivation facilities to not only increase energy efficiency, but also to mitigate contamination and control risks for pest incursions. In the second part of this series, I will elaborate on how compartmentalizing your facility can help you stay compliant with pesticide use regulations and promote worker safety.

AdamKohcultivation
Photo credit: Denver Post

Problems with Pesticide Use and Worker Safety Regulations

Where there are pests there are pesticides, whether they are low-toxicity materials derived from natural sources or chemical products that are illegal to use on cannabis. Even in the case of growers that are following current pesticide guidelines and using only products approved by their state department of agriculture, perpetual harvest models present issues in ensuring that the workplace is safe for employees and compliant with pesticide use regulations.

One obvious difficulty is the impossibility of containing drift from pesticides applied as foliar sprays. At this point, due to the lack of research performed on pesticides and cannabis, there are currently no defined pre-harvest intervals (PHI), even for products allowed for use on cannabis. A pesticide’s PHI is the number of days that must pass between the time of the last application of a pesticide and when the crop is cut for harvest. While no official, research-based PHIs have been outlined for pesticide use on cannabis, most conscientious cultivators refrain from spraying their crops with anything once flowers have emerged, as the resinous, sticky buds and their many crevices would presumably retain a great amount of any material applied to them. However, flowers do not generally emerge fully until the third week of the flowering process, and many growers apply preventative applications in the first two weeks of flower. In a perpetual harvest facility, what is to stop drift from applications made early in flower from contacting plants close to harvest? One could simply not spray in flower at all, but eliminating early-flower preventative treatments could increase the chances of a pest incursion, which, as discussed above, can be seemingly intractable in this type of facility.

It is important to consider the restricted entry interval (REI) when dealing with pesticide use. The REI of a pesticide is the period of time after an area is treated during which restrictions on entry are in effect to protect people from exposure to hazardous levels of pesticide residues. Most of the products and materials approved for use on cannabis in Colorado have no REI or a relatively short one. At the time I left my former facility, the longest REI for any product in use was twelve hours (for Evergreen Pyrethrum Concentrate), though most had REIs of four hours or less. This issue could be avoided in a perpetual harvest facility by simply always scheduling pesticide applications at the end of the workday; if a product is sprayed at 6 PM, for example, then the treated area should be safe for entry by the following morning when employees arrive. However, what is to be done if a pest incursion is discovered in the middle of the day and an immediate treatment is necessary to prevent its spread? Would the management or ownership of such a facility be willing to clear out the entire perpetual harvest area for 4-12 hours, potentially leaving other tasks unperformed or incomplete, so that a few plants could be sprayed? Even if operators went to such lengths to observe REIs properly, instances such as the hypothetical described above would create massive interruptions in daily workflows and scheduled tasks that are highly undesirable in a well-managed commercial setting. Compartmentalization allows for essential tasks in a single room that might need an emergency treatment to be completed in a timely manner, and cordoned off after the pesticide application to observe the REI.

A final point concerning this topic is that perpetual harvest facility designs make it difficult to observe certain requirements of the Worker Protection Standard (WPS). WPS is administered by the EPA (but is enforced by the Colorado Department of Agriculture (CDA) in that state) and consists of training intended to reduce the risk of pesticide poisoning and injury among agricultural workers and pesticide handlers. WPS training is required for all agricultural workers and pesticide handlers, including those in the legal cannabis industry. One requirement of WPS is that employers provide decontamination supplies for their employees in case of accidental pesticide exposure or poisoning. Sandra McDonald is a pesticide safety expert and owner of Mountain West PEST, which provides WPS and other training to farmers of all crops in Colorado. She states that decontamination supplies cannot be stored in areas that are to be or have been treated by pesticides (such as perpetual harvest rooms, for the purposes of this discussion), as the applications could possibly contaminate the decontamination supplies with pesticide residues, making them useless or even dangerous.

So, in a perpetual harvest facility, where does one store decontamination materials? Again, while there are solutions to this question, they are not ideal. The materials would of course have to be located outside the perpetual harvest room, the entirety of which is a “treated area” at one time or another. But, in facilities the size of the ones under discussion, it could be difficult for an employee who has been exposed to pesticides to reach an eyewash station if he or she has to navigate the expansive perpetual harvest room, as well as a doorway or two, in order to gain access to safety supplies located somewhere that pesticide contamination is not a risk. McDonald notes that most of the products approved for use on cannabis by the CDA would not require immediate decontamination. However, as not to downplay the very real risks posed by some approved products, she also points out that first aid statements on the labels of such pesticides recommend at least 15-20 minutes of continuous rinsing in the case of a worker getting pesticides in his or her eyes, and treatment that takes place sooner rather than later is obviously preferable. Additionally, there are some approved materials with high pH levels that could be immediately damaging if a worker splashed them in his or her eyes.

The issues raised by perpetual harvest designs in respect to pesticide use and worker safety are amplified greatly if businesses operating perpetual harvest facilities employ or have employed chemical pesticides that are illegal for use on cannabis. Unfortunately, the illegal application of restricted-use pesticides has revealed itself to be widespread, as examples from Colorado and Washington illustrate. One of the most commonly used illegal products, Eagle 20EW, carries with it a 24 hour REI. This means that to properly observe this safety measure, employees would be required to keep clear of the treated area for a full day, which I find unlikely to be enforced considering the daily requirements of a cultivation facility. Drift again poses a problem, but a much more serious one compared to the products on the CDA’s approved list.

Recommendations

It should be obvious by now that, when considering facility or site design, compartmentalization is desirable and necessary. This goes for greenhouse and outdoor production, as well as indoor. In fact, some outdoor farmers in the Emerald Triangle area of northern California work multiple, separate parcels to hedge against the threat of crop loss wiping out their entire year’s efforts. Though the discussion above focused mostly on flowering plants; propagation, vegetative, and mother areas should be separate as well, as they effectively contain all future harvests and are therefore of paramount importance.

The appropriate amount of compartmentalization will vary depending on the operation. In most agricultural businesses, some amount of loss is expected and incorporated into plans and budgets. In terms of areas for flowering plants, they should be compartmentalized to an extent that, should a severe infestation or systems failure occur, the loss of expected revenue from one or more rooms or areas will not cripple the business. Such loss should not happen often in a well-run, well-equipped facility. However, I have seen the drastic damage that russet mites can cause, in addition to experiencing the dread that permeates an entirely darkened warehouse after a transformer explosion, and would advise that cash flow projections take into account the possible loss of a harvest or two from a single room per year, just to be safe.

In cannabis farming, as in all agriculture, we must plan for the worst and hope for the best. Compartmentalization is a fundamental and effective safeguard against small pest incursions becoming widespread infestations, while allowing for grow areas to be fully sterilized and decontaminated after a harvest without completely interrupting all operations. It also allows for the observance of REIs, PHIs (even self-imposed ones), and certain WPS guidelines much more easily than perpetual harvest models. Finally, while costing more up front, ongoing operational expenses can be lessened, with a greater return on the energy that is used. While the benefits of wide-open spaces are frequently touted in a variety of contexts, cannabis cultivation is one where being boxed in is preferable to ensure that your employees, plants, and investment are protected.

keynotecannabislabs

Cannabis Labs Conference Makes History at Pittcon

By Aaron G. Biros
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keynotecannabislabs

Last week’s Pittcon, the world’s leading conference and expo for laboratory science, brought together thousands of laboratory equipment companies, scientists and laboratory professionals in Atlanta. This year’s meeting made history, as it featured Pittcon’s first cannabis conference.

Generating quite a bit of buzz at the show in Atlanta, the inaugural Cannabis Labs Conference brought Pittcon attendees, cannabis industry leaders and scientists together to discuss the changing landscape of cannabis testing, the need for standards and cannabis laboratory methods. The improvement of quality standards, outside industry expertise and noting the industry still has a long way to go were some of the themes that came out of the talks.

keynotecannabislabs
Nic Easley, CEO of Comprehensive Cannabis Consulting, delivered the keynote presentation.

Nic Easley, chief executive officer of Comprehensive Cannabis Consulting (3C), delivered the keynote, addressing concerns over consumer safety and lab testing standards in such a fast-paced market. “What we need now are outside industry experts to help guide this industry with standards and proper analytics,” he said. “With increased efficiencies and competition in the cannabis marketplace, our ethics need to be called into question as the industry reaps its profits.”

Other highlights included the sharing of new validation methods. Scott Radcliffe, technical support scientist at Romer Labs, Inc., presented his findings on the validation of immunoassays for the detection of pathogens and mycotoxins in cannabis. Amanda Rigdon, applications chemist at Restek, Inc., also led a discussion on the opportunities and challenges for method validation in the evolving cannabis industry.

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Scott Radcliffe, technical support scientist at Romer Labs, discussing the validation of immunoassays for the detection of pathogens in cannabis.

Rigdon provided a glimpse into the amount of work it takes for method validation. “You can have all of the regulations in the world but that does not guarantee that you will produce good data,” Rigdon said. “We need good science, which is lacking currently in the industry.”

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Amanda Rigdon, applications chemist at Restek, leading a talk on method validation

“We need to show proficiency with a standardized method and that comes through full validation which, requires a lot of money, time and work,” Rigdon added. These components of validation include accuracy, precision, recovery, selectivity, specificity and proper instrument calibration. “The bottom line is labs need a method that is reproducible and robust,” she said. Rigdon also shared her data from recent methods validation at a cannabis laboratory in Spokane, Washington.

Next year’s Cannabis Labs Conference is scheduled to take place in Chicago during the week of March 5, 2017. To hear more about the Cannabis Labs Conference, sign up for the CannabisIndustryJournal newsletter.

OGanalytical instruments.

New Cannabis Lab Rules In Oregon Aim to Curb Fraud

By Aaron G. Biros
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OGanalytical instruments.

The Oregon Health Authority (OHA) recently implemented a set of temporary rules effective through June 28th of this year with the goal to establish a set of regulations for cannabis testing by October 1st. An investigation by The Oregonian highlighted some of the previous problems with cannabis testing in the state.

The most impactful rule changes include The NELAC Institute (TNI) mandatory standards for laboratories that the Oregon Environmental Laboratory Accreditation Program (ORELAP) will use to accredit labs. Initial rules in the Oregon medical cannabis program, HB 3460 from 2013, did not specify accreditation rules for cannabis testing.

oganalyticalworkstation
The OG Analytical laboratory in Eugene, Oregon is working to comply with new regulations, including new sample collection rules

ORELAP currently performs accreditation for lab testing under the Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act and the Safe Drinking Water Act. The new cannabis testing rules will give ORELAP the authority to accredit and regulate cannabis labs in the state of Oregon.

Rodger Voelker, Ph.D., laboratory director of OG Analytical in Eugene, OR, believes these rules are monumental in establishing legitimacy in cannabis testing. “These new rules have major repercussions mainly because they require not only getting accreditation, but maintaining it with very strict requirements,” says Voelker. “That also includes procedural guidelines that very carefully outline the quality of laboratory practices and establishes a set of criteria for method validation.”

Roger Voelker
Rodger Voelker, lab director at OG Analytical laboratory

Voelker notes that two of the biggest changes are in quality control and data management. “The documentation they require is very thorough and strict with the idea that any aspect of an analysis can be replicated,” adds Voelker. “This is a real win for us in my opinion because now we have an agency that can issue the appropriate credentials as well as have the authority to make punitive measures.”

The timeline for implementation with temporary rules allows state regulators to work with laboratories to perform accreditation and bring laboratories up to speed. According to Shannon Swantek, ORELAP compliance specialist, products that dispensaries sell in medical and recreational markets are required to be tested under the new rules and in the analyte lists by an ORELAP accredited laboratory, starting on October 1st.

Swantek’s job is to accredit cannabis labs to the TNI standards, which is essentially very similar to ISO 17025, just with more prescriptive measures and the ability to pair with state agencies to enforce rules after accreditation. “The timeline for accreditation is dependent on how ready the lab is and how compliant they are to the TNI standard already,” says Swantek. “The culture had gotten so fraudulent that the legislature felt Oregon needed some serious, more strict rules in place.”

OGanalytical instruments.
Labs need very expensive instruments to perform all of the testing required by OHA

One of the biggest changes coming to Oregon cannabis testing is the new sampling requirement. “An accredited laboratory employee must take the sample because sampling is where a lack of training or outright fraud is skewing results, which occurs when a grower brings in a sample not representative of the batch,” adds Swantek. Sample preparation methods will also be required to be more robust to meet the action limits of pesticide testing in particular, helping to identify lower levels like parts-per-billion, according to Swantek.

Reports were also lacking key information in the past. The new rules will require more information such as the procedure used, the analyst carrying it out, dilution factors and any other information you need to theoretically reproduce the result. This will result in more accurate labels on products.

Many are concerned that the new lab testing requirements will raise the price of testing too much. In reality, those current prices are not realistic for accurate data, which points to the rampant fraud that ORELAP is trying to eradicate. “The old rules were written in such an ambiguous way that the prices were set by laboratories without a proper quality program or even without proper instrumentation,” says Swantek.

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OG Analytical had to close its doors briefly to meet accreditation

The accreditation process will require particularly robust quality control systems in labs. “Accreditation to the TNI Standard means that lab quality systems will require a documentation system, training procedures, record keeping, personnel requirements, organization details, proof of no conflicts of interest and corrective actions if noncompliant,” adds Swantek. “We single out each method or procedure, look at their raw data and proficiency testing and determine if they are meeting the technical requirements.”

According to Voelker, other industries have learned to adjust their costs with stringent lab testing rules. “I get that no one wants to pay more for lab testing, but the reality is that joining the world of commodities comes with additional costs to ensure consumer safety,” says Voelker. These rule changes will undoubtedly bring more consistency to Oregon’s cannabis industry with accurate lab testing and help the OHA shed more light on issues surrounding consumer safety.

Ask the Expert: Straight Talk on Safety, Defense and Security, Part II

By Aaron G. Biros, Bruce E. Lesniak, Lezli Engelking
1 Comment

In this week’s Straight Talk on Safety, Defense and Security, we answer a reader’s question about traceability in quality processes and offer some practical advice for building a safety and security strategy. Travis Lodolinsky from Gleason Technology submitted this week’s question. For a response, we sit down with Lezli Engelking, founder of the Foundation of Cannabis Unified Standards (FOCUS), to help answer your questions. If you have questions about safety, defense and security in cannabis, please ask them in the comments section below and we will address them in the next edition of Straight Talk on Safety, Defense and Security.

T. Lodolinsky: How are safety processes being tracked in the industry to ensure regulations and quality assurance are being uniformly enforced throughout?

Lezli Engelking: In related industries, such as herbal products or pharmaceuticals, the FDA has created guidelines, or current good manufacturing processes (CGMP) that control for the quality, consistency and safety of the products being produced. Businesses must be certified by independent third parties to demonstrate they are following CGMP to protect public health and consumer safety. CGMP is a proactive approach to quality assurance. A basic tenant of CGMP is that quality cannot be tested into a product after it is made; quality must be built into the product during all stages of the manufacturing process. One common misconception is that CGMP only covers the process of manufacturing itself. CGMP actually covers all aspects of the production process including materials, premises, equipment, storage, staff training and hygiene, how complaints are handled and record keeping.

Because cannabis is federally illegal in the US, the FDA has not developed cannabis-specific CGMP guidelines, so lawmakers do not have the benefit of having those guidelines available to base regulations on. So to answer your question, state cannabis regulations do not track processes and procedures used by cannabis businesses to control for safety or quality because they do not have the federal guidelines. Instead, most state cannabis regulations currently take a reactive approach to safety, mandating only for testing of the final product. While testing is an extremely important and valuable part of any quality management program, just analytics is not enough.

This is precisely why FOCUS was created and how they assist business owners and regulators, while fulfilling the mission of protecting public health, consumer safety and safeguarding the environment. The FOCUS standards are a cannabis-specific system of guidelines (cannabis-specific current good manufacturing practices) to ensure products are consistently produced according to quality standards. FOCUS provides detailed guidance and independent, third party auditing services for all key aspects of the cannabis industry including cultivation, extraction, infusion, retail, laboratory, security, packaging, labeling and sustainability.

CannabisIndustryJournal: What advice can you offer to cannabis businesses for product safety, defense and security prior to standardization?

Bruce E. Lesniak: Businesses that make products infused with cannabis (I call these businesses “plus one” companies because they produce products that include one more ingredient than traditional food products), require a carefully written master plan that specifically addresses the unique qualities, sensitivities and critical areas of the business. When building a comprehensive plan I address three questions:

  • Why (identify the why, this is your preventative, overarching strategy)?
  • How (addresses the “why question” with products, services and training)?
  • What (what is your reactive strategy that addresses actions and activities to be performed in the event of a breech)?

First and foremost, consumer-facing businesses must safeguard their products to the public. One product recall or illness related incident could spell disaster. Build your plan correctly the first time. Contact an industry expert to review your facility and help build and implement your plan. This will save you money by quickly exposing vulnerabilities and providing corrective measures specific to your business needs and requirements. Even though product safety and defense are closely related to security and should share a complementary strategy, product safety and defense are unique (due to standards and regulations), and should be treated as such.

Banks not accepting industry money complicates normal business operations and security planning, causing retail operations to handle and store large sums of cash. I asked industry expert and security professional, Tony Gallo of Sapphire Protection LLC, what is the single most important piece of security equipment you are currently providing for the retail and dispensary owner? “Design an air tight policy of handling money,” says Gallo. “Remove money often from cash registers and place it into the best safe for your application!”

Spend time familiarizing yourself with all things product safety and defense (there are volumes written on food safety and food defense, thus the “plus one” reference). This a great starting point and protecting the consumer protects your business. When it comes to designing your security application, consult an expert! Take into account that the cannabis industry is unique due to its “plus one” ingredient. Therefore you need to build your security systems, applications and policies to systematically protect your employees, facility, suppliers, transportation, manufacturing, distribution, warehousing, supply chain and brand.

Ask the Expert Series: Straight Talk on Safety, Defense and Security with Bruce Lesniak

By Aaron G. Biros, Bruce E. Lesniak
3 Comments

This is the first part of a series dedicated to understanding more about defense, security and safety as they relate to the cannabis industry, the importance of having standards and some tips for cannabis business plans. Over the next few weeks, we will hear from multiple industry pioneers discussing those topics and offering practical solutions for problems that many cannabis businesses face daily.

Inconsistent laws across multiple states created a fragmented network of regulations for cannabis. Some third parties are filling the gaps between the industry standards and state regulations. The Colorado Marijuana Enforcement Division (MED) and the Washington Liquor and Cannabis Board’s i-502 rule provide guidance on regulations surrounding packaging and labeling, advertising, pesticide use, retail and other areas.

Still there are many opportunities to fill the gaps. The Foundation of Cannabis Unified Standards (FOCUS), is an independent non-profit founded to develop some consistency in standards governing public health, consumer safety and the environment. In cultivation, the third party certification, Clean Green Certified, works to provide some guidance for growing cannabis organically based on USDA organic standards. For laboratories, Washington’s regulations provide some guidance, but organizations like FOCUS, the American Association for Laboratory Accreditation (A2LA) and the Cannabis Safety Institute seek to fill the gaps in laboratory standards along with the ISO 17025 requirements.

Security and defense is one particular area of the cannabis industry that still needs a benchmark for businesses to follow. In this series, we sit down to discuss security, defense and safety with Bruce Lesniak, president of the Food Safety and Defense Institute and member of the oversight committee for the establishment of standards in the cannabis industry in conjunction with FOCUS.

Cannabis Industry Journal: What changes do you see coming to the cannabis industry related to product safety, defense and security? 

Bruce Lesniak: As in every industry that provides a public consumable product, the primary objective is to protect the consumer by providing products that are consistently safe. The largest change coming to the cannabis industry will be the implementation of enforceable, nationally uniform standards across all states and all product lines. I believe that the standards and regulations developed for the cannabis industry will mirror those of the food industry. Companies are already busy working to develop this uniform standard, one such group is FOCUS. Founded by Lezli Engelking, FOCUS works with diverse professionals from regulatory, quality assurance, medical, law enforcement, business, research, and the government officials, medical and research professionals along with subject matter experts from numerous business disciplines across the industry to develop impartial, comprehensive, cannabis specific standards that will be presented for adoption by state and federal governing bodies. Lezli summarizes the FOCUS Mission as “ To protect public health, consumer safety, and safeguard the environment by promoting integrity within the cannabis industry.” Look for more on this in our next Ask the Expert update, on CannabisIndustryJournal.com or you can contact Lezli Engelking at FOCUS here: 866-359-3557 x101.


This series will highlight important issues involving security, defense and safety in the cannabis industry. Next week, Bruce, along with cannabis security professional, Tony Gallo of Sapphire Protection, will provide some advice on what companies can do to improve their master business plan. Stay tuned for next week’s Part II of Ask the Expert: Straight Talk on Safety, Defense and Security with Bruce Lesniak.

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Pesticide Recalls an Ongoing Issue for Colorado

By Aaron G. Biros
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In the wake of investigations this summer in Oregon and Colorado, which found that numerous marijuana products contain levels of illegal pesticides, state regulators, laboratories, manufacturers, and cultivators alike are acting fast to minimize risks to consumers and patients. The largest recall ever to occur in the cannabis industry happened on October 30, when two companies in Denver found potential pesticide contamination in tens of thousands of packages of edible cannabis products.

As of now, it is difficult to find information available on pesticide use and flowering, its effect on the body through combustion and inhalation, and its effect on medical patients with already weakened immune systems. Research suggests up to 69.5% of pesticide residues can stay in marijuana smoke. Of course, there is a need for more research, but it is safe to accept that pesticides already banned for use on foods by the USDA or state departments should not be allowed in cannabis production.

In Colorado, “Nearly six months after the city of Denver began a crackdown on unapproved pesticides in marijuana products, a spot-check by The Denver Post found that the chemicals were still being sold to consumers.” This presents a major problem to an industry still trying to change public opinion for wider legalization efforts.

The Oregonian and OregonLive investigation found pesticides in most of the 10 marijuana concentrates that were screened. “Many of the pesticides detected aren’t regulated by Oregon’s medical marijuana rules, which means products that contain these chemicals still can be sold.”

While state regulations on pesticide use continue to get hammered out, the U.S. Department of Agriculture along with the U.S. Environmental Protection Agency is currently working on identifying pesticides that might be safe to use on cannabis. That guidance is crucial for any industry in order to establish safe levels of pesticides allowed, as well as which pesticides are more dangerous to the consumer than others.

Just last week, two of the largest recalls in the cannabis industry occurred in Colorado due to potential pesticide contamination. According to The Denver Post, as many as 30,000 packages of edibles produced by two companies were recalled by the Denver Department of Health.

Alex Garton, a cultivator in Michigan, agrees with many proponents of organic methods, citing the need for close management of the plants without pesticides. “The best way to avoid pests is to keep the grow room clean,” he says. “Mites will come and go, as will temperature and humidity issues, but without using pesticides, there are some safe, natural products that are very effective.”

“I treat my plants with natural compounds that are permitted under the federal government’s guidance for use in vegetable applications for human consumption,” Garton adds. “Never use anything remotely resembling a pesticide on flowers particularly when maturing and in the flowering process.”

Adam Jacques, master cultivator and owner of The Growers Guild in Eugene, Oregon, agrees with the sentiment of caution shared by many in the industry. “I would say, nationwide, there needs to be a more in depth look at pesticides, even organic strawberries can have [the pesticide] Eagle 20 on them,” he says. “With cannabis, we can’t scrub and wash pesticides off like fruit that you take off the vine, and there is a real lack of research on residues and combustion.”

Jacques tests all of his cannabis products for pesticides, molds, microbials and pathogens along with potency profiles, most of which is not required by the state. Growers should take lessons from Garton and Jacques by forgoing any application of pesticides until there is more confident state-level guidance on the dangers associated with pesticides on cannabis.