Tag Archives: processes

March 17, 2023

Audit Readiness for Plant Touching Businesses

By Angela Mays

A report issued three years ago by the Department of Treasury, Treasury Inspector General for Tax Administration (TIGTA), states that the IRS will begin to increase its audit of cannabis businesses throughout the country. The report, released on March 30, 2020, states that the IRS believes that most cannabis businesses have not accurately applied IRC 280E and as a result cannabis businesses could potentially owe hundreds of millions of dollars in outstanding taxes. This determination is based on an audit of tax filings of cannabis businesses in tax year 2016.

TIGTA conducted an audit of cannabis businesses in three different states, California, Colorado and Washington. Of the businesses audited, TIGTA determined, as a result of the incorrect application of IRC 280E, that 59% of those businesses required adjustments to their returns. These adjustments totaled over $48 million in unassessed taxes for 2016. The results of this audit caused the IRS to consider auditing cannabis businesses throughout the country where medical and/or adult use cannabis is sold. According to experts, cannabis (plant touching) businesses can expect an increase in tax returns to be audited now that the IRS has begun to increase their staffing resources and their ability to conduct most audits virtually.

Although the report calls for the IRS to develop guidance for the cannabis industry, the resources available are not very helpful nor does it provide the guidance that plant touching business owners need to make sure they are audit ready because audits have begun in Massachusetts, Michigan, Arizona, Oregon, Washington and Colorado.

As a plant touching business owner, you need to be prepared for a potential audit of your tax returns. To be prepared you should have the right tools to help you perform cannabis accounting. You will need to implement sound policies and procedures.

Preparation is Key

As a plant touching business owner, you should always be prepared for a potential audit whether by the IRS for IRC 280E compliance, or a financial state audit as a requirement by your investors. To prepare for an IRC 280E audit, you must first have an accounting and reporting system set up to perform accounting for your vertical – dispensary, cultivation or manufacturing business. This will include a chart of accounts for your business type because this is the foundation for your accounting system and help to track all transactions that are specific to your particular operation. It will simplify recordkeeping for recording revenue, inventory, cost of goods sold as well as direct and indirect labor costs. It will also help with maintaining your library of documentation that is tied to each transaction. The level of detail will enable you to perform accurate cost accounting as well as provide backup for how your accounting team arrived at their calculations. In addition to having a robust chart of accounts and a document library, you will also need to have written policies and procedures.

The 3 P’s – Policies, Procedures & Processes

The key to making sure you are always audit ready is to implement sound policies, procedures and processes. You want to make sure you have written accounting policies that provide guidance on how your business performs various accounting tasks. It should reflect requirements based on Generally Accepted Accounting Principles or could reference IRS requirements per IRC 280E and/or IRC 471-11. For example, you should have an accounting policy for how your organization values inventory which is important for plant touching businesses.

You should also have Standard Operating Procedures (SOPs) that provide step by step instructions on how specific tasks are performed. This will make sure that everyone within your organization is performing the various tasks the same. Your SOPs should be for all key tasks within the organization, especially those tasks that affect how transactions are recorded in your accounting system. It ensures accuracy and reliability of your financial statements.

Organizations should go a step further and create end-to-end business processes that go a step beyond SOPs. End-to-end processes are created from sequential steps that will allow auditors to follow each step to identify key controls, assess risks as well as potential fraud within an organization. Although having detailed end-to-end processes for your business is not a requirement, they do provide an extra layer of proof of the accuracy of your financial statements because you will have identified your key controls, mitigated potential risks associated with misstatements in your financial statements, and identified risks associated with fraud.

Although no one knows when or if their business will be audited, being prepared is the key to a less stressful and more successful audit. Being able to show an auditor items they may request but also having organized, easy to reference documentation that provides a detailed look at your accounting and reporting operations shows that you are serious about your business and you want to operate compliantly.

October 7, 2021

Solvent Remediation – The Last Step for Safe, Clean Hemp Extraction

By Tom Bisbee

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Botanical extraction is not specific to cannabis and hemp, and it is anything but new. Rudimentary forms of plant extraction have existed throughout history and evolved with high-tech equipment and scientific procedures for use in pharmaceuticals, dietary supplements and botanicals.

In food production, examples of hydrocarbon extraction processes are commonplace. Nut, olive and vegetable oil production use solvents to extract the oils. Decaffeinated coffee uses hydrocarbon extraction to remediate the caffeine, and making sugar from beets, or beer from hops, also requires solvents.

As such, the FDA has set guidelines for the amount of residual solvents considered safe for consumers to ingest. Yet, without FDA guidance in cannabis and hemp, many products aren’t being tested against these standards, and consumers will ultimately pay the price.

Understanding solvent remediation technology and processes

If we use ethanol extraction as an example, the extraction process is relatively simple. First, we soak the biomass in denatured or food-grade ethanol, ending up with a final solution that is 90-95% solvent. Then, we perform a bulk removal of the solvents, which takes out most, but not all, of the solvent. The next and final step should be to strip the remaining solvents from the extract entirely.

Stripping remaining solvents in bulk requires the right equipment.

But, in order to do so effectively, you need the right equipment, and unfortunately, this is where many producers fall short. Many producers use a vacuum oven to apply heat while reducing the headspace pressure to lower the solvent’s boiling point and evaporate it off.

However, it’s a static environment in a vacuum oven, which means the material is stagnant. So, the process may effectively remove the solvents close to the surface, but solvents deep inside the material tend to get trapped without some type of agitation or mixing.

The appropriate final step to complete solvent remediation is wipe-film distillation, which feeds small volumes into a column, which is then wiped into a very thin film and heated under vacuum pressure. Although the equipment necessary is costly, this last step removes any residual solvents from the product to create a safe, effective and consumable product.

Residual solvents present huge risks

As stated, many of the same solvents used in cannabis and hemp extraction have been considered safe in food production for decades. Reviewing chemical data sheets, many of the acceptable limits on solvents were determined for ingestion, which is fine for edibles and tinctures, but many cannabis and hemp products are intended for inhalation or vaporization.

Just a few of the dozens of various products types on the market today, extracted with a variety of different solvents

Unfortunately, some solvents can have negative health impacts, especially for those using cannabis or hemp for medical purposes or with compromised immune systems. Plus, as a therapeutic and recreational substance, consumers may be consuming more than the recommended amount, as well as using the products several times a day. Unfortunately, long-term exposure or repeated inhalation of these residual solvents hasn’t been thoroughly researched.

For example, inhaling ethyl alcohol (ethanol) can irritate the nose, throat and lungs. Extended exposure can cause headaches, drowsiness, nausea, vomiting and unconsciousness. Repeated exposure can affect the liver and nervous system.

In the food industry, hexane is approved for extracting spices or hops, and this solvent is widely used in cannabis and hemp extraction. However, if used in an inhalable product, chronic exposure to hexane could be detrimental, with symptoms including numbness in the extremities, weakness, vision problems and fatigue.

Consumers deserve transparency

In the industry’s earliest days, companies were tight-lipped about their processes, the chemicals they used and how they removed them. Everyone thought they had the “secret sauce” and didn’t want to share their approach. Today, companies are more open about what they use, how they process it and providing that necessary transparency.

Lack of quality and consistent regulations in these industries creates confusion for the consumers and loopholes for producers. Some producers test for everything under the sun, and some producers know exactly which labs will pass their products, regardless of test results.

While the regulatory bodies are distracted by the amount of THC that might linger in products, getting sick is overshadowed by the risk of getting high. In the meantime, consumers are left to their own devices to determine which products are safe and which are not.

Although testing mandates and regulations will help clean up the industry, until then, consumers need to demand full-panel COAs that not only show cannabinoid potency but also accurately display the test results for residual solvents, pesticides and heavy metals.

October 6, 2021

Automated Extraction Technologies: Upping the Bar for Quality, Repeatability & Safety in Extraction

By Rob Wirtz

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Automated extraction equipment and technologies are rapidly becoming the standard in the extraction sector of the cannabis industry. Like most evolving industries, manual and operator driven processes are what starts an industry, but with explosive growth, demand for increased safety, efficiency and repeatability grows. Specifically within the cannabis industry, we’re noticing a rising demand for higher quality extracts and a safer, more repeatable environment for cannabinoid extraction. These are all reasons for the industry making a shift towards automated extraction equipment and technologies.

What Automation Looks Like in Cannabis Extraction

Automation in the cannabis industry doesn’t necessarily mean implementing robotics and creating operator-less facilities; It typically refers to automated process control. Traditional, older technologies are manual and operator-driven. This means the equipment operator is in control of all parameters of the process, which leads to inconsistencies throughout the process caused by human error. As the extraction process has many steps: ethanol holding, chilling, extraction agitation, extraction discharge, extraction solvent removal, particle filtration, semi saturated solution storage, and so much more that involves valves, pumps and controls between each piece of the process, it becomes difficult to control such a tedious process manually. When all of these processes are controlled and monitored using proper automation technology, facilities can safely ensure that each batch is run following the same process and parameters accordingly. This is critical for product consistency, a concern for manufacturers and many end-consumers. As the cannabis industry grows, matures and makes its way closer to federal legalization, product safety and consistency become a top-priority for everyone involved.

Greater Quality Control of End-Products

Automated extraction processes ensures that the same solvent ratios are used batch-to-batch

Consistency and repeatability are just as important for cannabis processors as they are for standard food or pharmaceutical processors. Deploying a manual process of equipment operating and monitoring leaves far too much room for human error, and doesn’t provide the level of control needed for the industry as it continues to progress toward stricter product regulations and requirements. On the other hand, an automated extraction process ensures that the same solvent ratios are used batch-to-batch, the same extraction temperatures and recipe parameters are implemented, the same pump and process flow rates are deployed, and all processes are repeatable, predictable and scalable while producing a safe, consistent product.

Fewer Bottlenecks

The benefits of automated extraction are directly tied to establishing greater efficiency in processes. Efficiency can be experienced via less scrap product from unmanaged batches and/or less labor to operate and control the process. Automation means allowing a recipe-driven control system monitor and control the process, eliminating process bottlenecks that have been notorious for destroying productivity in manual extraction operations.

As Cannabis Extraction Processes Become Automated, They Become Safer.

A team is what drives any business forward. The safety of that team needs to be a top priority for any business leader. As cannabis extraction processes become automated, they become safer. With less equipment interaction, the likelihood for human error that could lead to safety hazards significantly decreases. Properly programmed automation can establish advanced system interlocks that check multiple points throughout the process for irregularities, and can halt a machine based on these irregularities it detects. That level of process monitoring and control is only available when automation and PLC logic controls equipment.

Data Collection and Validation

When we tie all the benefits of extraction automation together, it makes for a far more attractive system than traditional,manual processes that we’re used to seeing in the cannabis industry. In addition to the major benefits listed above, automation gives a superior level of data collection for process improvements and process validation which is key in cGMP or EU-GPM facilities. This is the future for every processing facility in the arena of cannabis. As the industry matures, it will continue to become more competitive. Facilities with automation will have the capacity to maximize their process efficiencies, produce a far superior and more consistent end–product and will have a competitive advantage in the extraction sector.

July 13, 2020

Moneybowl: How Data Analytics Can Improve Extraction Processes

By Dr. Markus Roggen, Sajni Shah, Stella Zhu

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When data analytics was first introduced in the sports industry, it was met with a lot of criticism. But then it began to show results; a popular example being the story of Oakland Athletics Manager Billy Beane, depicted in the movie Moneyball starring Brad Pitt. In the cannabis industry today, we face familiar hurdles. Everyone is focused on extracting as much CBD oil as they can, but not many are optimizing the process. We even hear that data analytics is too difficult, that it does not help and no one has time for it. In contrast, the sports industry nowadays widely uses statistics and analytics, because it has proved to be effective. They use data analytics to choose their players for a team so that they have the best chance to win the championship. NBA teams have entire departments focused on data analytics, so why doesn’t the cannabis industry? Focusing on basketball, what if the approach taken to pick players for an all-star team was employed in the cannabis industry? Imagine your instruments as players and their parameters as their skills. Now, all you need is data analytics to help you decide how best to optimize your team. Paying attention to the numbers, could help you win in the cannabis industry.

When thinking about players in basketball, one factor of interest is the “Players Offensive Rating”, which is the amount of points produced by a player per 100 possessions. In this scenario, you want the player to have a higher offensive rating as it means that they have a better chance of scoring points when they have the ball. Similarly, in cannabis production, you would want your instrument to yield as much product (points) per hour (possession) as possible as well. So, the cannabis extraction analogy for offensive rating is “Yield Per Hour”. By increasing the yield per hour, the instrument can extract more product in the same time frame, increasing overall output and reducing product cost per gram. In this scenario, the biggest extractor is not necessarily the fastest, and any supercritical CO₂extractor will be slower than, for example, ethanol extractors.

Another important factor that’s considered in basketball is “Shooting Efficiency,” which looks at the number of successful baskets made by a player in comparison to the number of shots taken and where the shot was taken from. Having a player with a high shooting efficiency would result in a good chance for that team scoring points over their competitors. This principle is similar in cannabis, while a high yield (number of shots) is great, you also want a high purity (baskets made) of your target compounds or “Percent Purity”. This means you will get a higher percentage of the compounds you want, such as cannabinoids, for every gram of oil extracted. Here, the supercritical CO₂ extractor shows its superiority over ethanol, as density modulation of the supercritical CO₂ allows for the separation of terpenes or cannabinoids from the rest.You can see that a team that has a better synergy has a higher winning rate. For the same reason, the cannabis extraction process can be optimized by adjusting the parameters of the instrument.

For one last example, let’s look at “Number of Steals” as well. This is the number of times a defensive player successfully tackles the ball from an opposing player before they manage to shoot a basket. If this is high, opponents have fewer opportunities to shoot and score points. Similarly, “Percent Recovery” in the cannabis industry is important to ensure that the target compounds in your flower are being extracted. The solvent should have the chance to extract the compounds (steal from the opposition), before the run ends (the opposition shoots). A high recovery gives a higher overall output for the materials that were input, generating more product overall. In theory, if you wait long enough every solvent can reach full recovery, but for supercritical CO₂ in particular there is a practical ceiling around 80% recovery.

While thinking about these variables in isolation is the first step, it is just as important to see how the variables interplay with each other. A concept is introduced here called “synergy”. A team member must establish a good cooperation with the entire team according to their own characteristics. For example, taller and stronger players whose “Offensive Rating” is higher are more suitable for guards, while those with a high “Shooting Efficiency” are more suitable for forwards. You can see that a team that has a better synergy has a higher winning rate. For the same reason, the cannabis extraction process can be optimized by adjusting the parameters of the instrument. For example, if you increase the extraction speed, which is “Yield per Hour”, you may need to compromise on “Percent Purity” as the increased speed may not allow for the optimal extraction of target compounds. Similarly, you may also need to compromise on “Percent Recovery” as a slower extraction rate will do a better job at having a higher recovery. Thus, in order to improve the overall process of extracting oil, there needs to be a focus on analyzing the synergies between different factors to guarantee optimal parameters for your benefit.

These examples highlight some of the basic data analytics that can be conducted on your instruments. However, there’s still one challenge to consider, most professional NBA teams have entire departments just for data analytics. How can you possibly accomplish conducting these analytics for your entire cannabis LP in addition to your regular job roles? That’s where we come in. Other than the “Yield per Hour”, “Percent Purity” and “Percent Recovery” listed above, CBDV can perform customized data analysis based on your company’s data. Let our team help you integrate the “boring” and “half-baked” data, and present you with a visual and clear data analysis report. Let us help you lead your team to win that championship in cannabis!

Acknowledgements

David “Davey” Jones
Dr. Tara Zepel

September 10, 2019

Soapbox

Tips to Shrink your Shrinkage

By Carl Silverberg

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I had dinner last night with a friend who is a senior executive at one of the largest automobile companies in the world. When I explained the industry-accepted rate of 25-30% shrinkage in horticulture he said, “Are you kidding me? Can you imagine the story in the Wall Street Journal if I gave a press conference and said that we were quite content to throw away three out of every ten cars we manufactured?”

Yet, for all growers, operators and investors who complain about shrinkage, it’s an accepted part of the business. What if it wasn’t; what if you could shrink your shrinkage by 60% and get it down to 10% or less? How much more profitable would your business be and how much easier would your life be?

Let’s take the floriculture industry as our first example. You propagate chrysanthemums in February, they get repotted at the end of April and by the end of June, you might start to see some buds. In a very short time span your job changes from being a grower who manages 10,000 square feet of chrysanthemums to being an order taker. Over a period of eight weeks, you have to unload as many of those mums as possible. The sales team at Macy’s has more time to move their holiday merchandise than you do.

If you’re like most operations, your inventory tracking system consists of Excel spreadsheets and notebooks that tell you what happened in previous years so you can accurately predict what will happen this year. The notebooks give you a pretty accurate idea of where in the greenhouses your six cultivars are, how many you planted and which of the five stages they are in. You already have 30 different sets of data to manage before you add on how many you sell of each cultivar and what stage they were in.

The future of the industry is making data-driven decisions that free up a grower to focus on solving problems, not looking for problems.Then your first order comes in and out the window goes any firm control of where the mums are, what stage they’re in and how many of each cultivar you have left. A couple of hours after your first order, a second comes in and by the time you get back in touch, check your inventory, call back the buyer and she’s able to connect with you, those 2837 stage 3 orange mums are moving into stage 4. Only she doesn’t want stage 4 mums she only wants stage 3 so now you frantically call around to see who wants stage 4 orange mums very soon to be stage 5 mums.

And, the answer is often no one. What if you didn’t have your inventory count exact and now you have 242 yellow mums that you just found in a different location in your greenhouse and had you known they were there, you could have sold them along with 2463 other mums that you just located in various parts of your greenhouse.

It doesn’t have to be like that. We had a client in a similar situation, and they are on track to reduce their shrinkage to just a shade over 10%. The future of the industry is making data-driven decisions that free up a grower to focus on solving problems, not looking for problems.

And don’t think that shrinkage is an issue only in the purview of floriculture. It’s an even bigger problem for cannabis because of the high value of each crop. The numbers don’t sound as bad because unlike floriculture, you don’t have to throw out cannabis that’s not Grade A. You can always sell it for extract. But extract prices are significantly less per pound than flower in the bag.

Here’s how one grower explained it. “Because of the high value of the crop, and the only other crop I’ve worked with that high is truffles, you’re playing a much higher stakes game with shrinkage. Even if you try and salvage a bad crop by using all of the parts of the cannabis plant. Listen, the difference between Grade A and Grade C could be $1,000 for A while a pound of B/C is less than $400. If you produce a standard 180 to 200 pounds in your grow rooms, you’ve really screwed up. No operator is going to keep you if you just cost them $120,000.”

March 25, 2019

How a Cloud QMS Can Get Cannabis Startups ISO 9001-Certified

By Mike Hansen

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When it comes to compliance for cannabis startups, the ISO 9000 family of standards reigns supreme. Providing the guidelines for the concepts that make up a quality management system (QMS), the ISO family is composed of five standards: ISO 9000, 9001, 9002, 9003 and 9004. Outside of ISO 9001, ISO 9000 is the most important because it creates the foundation that guides all of the other standards.

ISO 9000 is split into two sections: fundamentals and vocabulary. Fundamentals covers the basic principles of quality management and the vocabulary section is a dictionary of quality management terminology. ISO 9000 is crucial because it provides direction on proper QMS implementation that will lead to achieving an ISO 9001 certification.

While the entire ISO 9000 family is focused on quality management systems that aim to help organizations “ensure that their products and services consistently meet customer’s requirements and that quality is consistently improved,” ISO 9001 is the only standard that lists actual requirements and requires certification.Cloud-based quality management software provides the flexibility and scalability, that cannabis startups need to comply with ISO 9001

Quality Management Systems (QMS)

When conceptualizing “quality management,” it is best to think of it as an organization’s definition of how it will meet the quality requirements of customers and other stakeholders who are affected by its work. Implementing this requires an extensive alignment of company processes and procedural governance.

It’s easiest to think of a QMS as the facilitator of outlined processes that are required to fulfill ISO 9001 requirements. For example, if an organization has defined a change request process, it could use a cloud-based QMS to put that process in place. However, the benefits of a cloud-based QMS don’t have to end at ISO 9001. It can also help organizations comply with other regulations like GxP.

ISO 9001 Requirements

ISO 9001 requirements can sound very generic because they’re meant to be applied to any organization, big or small, in any industry. The key to ISO 9001 is the concept of continuous improvement, which is why specific requirements for what “quality” is are not defined. Rather, companies must create objectives and work toward improving processes to meet those objectives. That said, a certified QMS still must do the following:

Meet the requirements of other stakeholders, for example, customer requirements and regulatory standards
Ensure that employees receive training outlining the quality requirements
Determine and document the processes, their interactions and their results
Be able to produce records to prove that system requirements have been met
Constantly monitor quality management software performance
Address any risks that could result from changes
Perform internal audits and correct any issues
Continuously improve the QMS

From creation to disposal, document protocols must be clear and properly followed.With that in mind, ISO 9001’s purpose is to evaluate whether or not a QMS does a good job of managing processes while also being able to help organizations identify areas that need improvement. In simple terms, ISO 9001 helps companies who were making an excellent product most of the time, make an excellent product every time.

How can cloud quality management software help you get your ISO 9001 certification? Once you create processes that adhere to ISO 9001 quality management standards, you have to put them into practice. Enter: quality management software. But, how exactly does it help?

Optimal Time to Value

First, cloud-based software is the most cost-efficient to implement. Secondly, since a QMS needs to be accessible to every employee regardless of whether they work at HQ or on-site, cloud QMS are built to be mobile-friendly and easily accessed from any location.

Automated Document Lifecycles & Version Control

From creation to disposal, document protocols must be clear and properly followed. As up-to-date documents are an important factor in maintaining high levels of quality, the most recent versions of approved documents should be readily available while previous editions should be hidden away.

With cloud quality management software, workflows can automate the review and approval processes by automatically sharing documents with the right reviewers. Then, after the document has been approved, the changes will automatically be applied to the master document while the obsolete version is archived, helping to remove any chance of it being accidentally used after the update.

Easy Document Location & Metadata

According to ISO 9001, searching through an organization’s documents should be as easy as searching with Google. It’s an added bonus when the quality management software enables users to add custom metadata to documents. Metadata is just extra information that helps to define a document (like file size, type, date modified). With certain cloud-based QMS’, you can add custom metadata fields to make documents easier to find. For example, you can add an “expiration date” field that allows you to look up policies based on when they are set to expire.With the growing number of data breaches happening every year, it’s important to address the security components of a QMS.

Document Traceability

In order to pass any ISO 9001 audit, there needs to be a complete audit trail for every document, including active documents and the earlier archived versions. While this might seem like a big ask, cloud quality management software helps make this simple. Every single change to a document, regardless of whether it’s the current or past version, is tracked. When combined with automated workflows, you’re able to produce a precise log of every change made by every user.

Advanced User Permissions & Central File Ownership

With the growing number of data breaches happening every year, it’s important to address the security components of a QMS. Many of these issues can be resolved with user permissions, which is generally related to managing users’ editing and sharing access. The proper view, edit, and approval rights go a long way to reducing the risk of human error.

Another feature that may seem like common sense is central file ownership. When the organization owns all of its documents, there’s no need to worry that important files will be lost or deleted. With one owner, the damage that can be inflicted by malicious third-parties is also limited.

Cloud-based quality management software provides the flexibility and scalability, that cannabis startups need to comply with ISO 9001. With the cloud as a foundation, these systems will continue to be assets for the cannabis industry as it gains momentum and expands more.

February 23, 2016

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

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

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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.