As cultivators ourselves, when we have a problem, we like to look to producers of other products for ideas and solutions. We have noticed conventional businesses, which make conventional products, rein in their testing costs and still receive predictable and consistent results. How is that?
Their solution: control
For better or worse, the testing model that assures product safety and integrity at a reasonable cost has already been invented by conventional product producers. In general, the model requires that the entire production process operate in a state of control, meaning all inputs and values are known and accounted for before the process starts. With a production system under control, the model moves routine testing in-house, which should be one of our industry’s major goals.
Food and Drug Administration (FDA)-regulated consumer packaged goods in America, including food, cosmetic and pharmaceutical products, produced by companies operating in a state of control, are tested exclusively in-house at a fraction of the cost that cultivators regularly spend on testing. A conventional American company that is regulated by the FDA would only outsource testing after determining that a particular test is so seldom required that it would not be worth buying the necessary equipment nor hiring the necessary staff. The conventional company’s control will be audited occasionally by its commercial customers and by the FDA, but it spends a fraction of what the cannabis industry spends on testing. Let’s look at the work that creates control.
The basic control model starts with the concept of product characterization. For example: What is the product’s appearance? Is it flower or a concentrate? How should it look in its final form? Once we know this information, we can establish performance specifications and technical attributes of our product.
Those technical attributes are discovered through identity testing. Hundreds of potentially active ingredients are present in cannabis, but we, the cannabis industry, are focused primarily on cannabinoids and terpenoids. Do we want to test only for THC and CBD and a few major terpenoids, or are we interested in testing for more? Our company, for example, tests for the presence of a dozen cannabinoids and 42 terpenoids. The more we know about our product, the more predictable an experience we can produce for our patients.
Product performance evaluations include stability testing. As consumers in America, we rely on product expiration dates. Daily, we gauge freshness in terms of “use by,” “packaged on,” “best by” or “expires on” dates. The same concept should apply to cannabis. We all know about the degradation of tetrahydrocannabinol (THC) to cannabinol (CBN), but many other time- and temperature-driven oxidation reactions can affect a cannabis product over time.
But before we concern ourselves with product identity testing and product stability, we should consider raw material testing, in-process testing and adherence to good manufacturing practices (GMPs). We should characterize our process input materials as well. Is our guano sourced from a reliable supplier, or might we experience lot-to-lot variation such as higher nitrogen levels from time to time? Should we concern ourselves with a salty precipitate at the bottom of a jug of liquid fertilizer? Maybe the amendment manufacturer has a reliable manufacturing process, but the regional distributor bulk stores pallets in a metal building in Arizona during summer. What might the impact be on our flower?
Basically, characterizing all products, and the inputs that go into making those products, will allow us to accurately predict quality characteristics about our products even before the testing results come back from the lab.
Sampling is the next step in proving to ourselves and others that we are operating in a state of control.
The cultivation inputs that we bring in and the products that we ship out constitute populations of material, with some differences in density, moisture content and other matters. Following characterization, sampling methodology defines how we estimate, as best we can, what we’re working with. Sampling acknowledges that every bit of guano is not identical, and that every bud is not exactly the same as every other bud, even when they come from the same 20-percent-THC strain. Different sampling methodologies might explain some of the reported differences in test results for products sent to different labs. Virtually every test that we perform requires us to sample something. Our sampling methodologies are designed to tell us that our test results accurately represent our test subjects.
Consider pulling a single, random sample as the representative sample of 100 plants in a flower room. If we test that sample, we’ll get a result, but there is no guarantee it will be a result that accurately reflects all 100 plants. If, instead, we divide those plants into clusters of 10 plants and choose a sample from each cluster, we might get a better estimate of our population. If we zoom in further and take a stratified sampling approach in which we only collect samples from the top cola of plants from each group, we’ll likely increase our characterization accuracy even further.
How and when to sample are just as important as how much to sample. If we collect a microbiological sample into a non-sterile container without using an appropriate aseptic technique, then we could receive a false positive (bad) result. Opposite to this is a false negative, which occurs when a test fails to identify a contaminant due to the presence of a masking agent (also bad). Maybe an ingredient in the formula blocked the test method’s ability to detect the target substance. Therefore, we must conduct product validation to ensure that our product doesn’t enhance or interfere with the test method.
There are many moving parts to consider. Most of this isn’t mandatory in our industry yet, but it’s coming. And before the industry can move product-quality testing to in-house laboratories, we’ll need to prove that we understand these concepts and have documented methods in place for them.
More To It
To begin testing in-house, the methodology concepts make further demands. Nevertheless, understanding these methodologies and bringing testing in-house does not mean that every one of us will become a laboratory director. As cultivators, we are comfortable knowing that our electricians and our plumbers understand things about electricity and plumbing that we do not. We know something about characterization and sampling, but our lab director knows more.
The additional demands for laboratory work include equipment qualification for its purpose, equipment result validation (comparable results from the same equipment across different operators), and installation qualification, operator qualification and process qualification for each piece of analytical equipment. And, of course, annual operator proficiency testing.
Getting through these methods will result in a 20-percent-THC strain testing at 20-percent-THC, no matter who uses the instrument to run that test. We won’t always know everything about the material that we are testing before we start, but we will know something (e.g., the target cannabinoid content being 20-percent THC). That something is extremely relevant. When we find a needle in a haystack, we are supposed to know that the needle is not another piece of hay. And when we find a needle in the haystack, we need to throw out the haystack.
The overall concept and methodology of control runs upstream and downstream from our grow. Looking upstream, all our inputs arrive with certificates of analysis. Our most significant inputs require three batches of full-release testing to validate. (Connecticut adopted FDA standards for its medical cannabis industry.) After three batches of full-release testing, assuming consistently compliant test results, we deem it acceptable to reduce our work and our costs. We continue with identity testing of incoming ingredients and—as appropriate—microbiological, heavy metals or other testing for contaminants, with only one lot per year subject to full-release testing on an audit basis.
Downstream, beyond good record keeping practices for everything that we do, our concern for what happens to all our products in our packaging prompts us to retain samples for each batch and to conduct stability testing. What happens in our packaging after a month? What happens at temperatures greater than 90 degrees Fahrenheit? We have the retained samples and the test results. We like controlling our risks by knowing that the products we ship to our customers are safe and consistent and that our products are exactly what their labels say they are.
The other logical result of all this work is a great reduction in testing costs. Once we can support our confidence in our control over inputs and outputs, we can move to periodical audits (as mentioned above) of samples of incoming materials and into more selective testing of finished products.
To achieve this, we must persuade our regulators that our methods and systems are just as good as the methods and systems used by conventional businesses that do their testing in-house. We should reach that goal. In general, that is how American producers of consumer-packaged goods operate.
Thomas Schultz is president of Connecticut Pharmaceutical Solutions (CPS), CTPharma.com
Rino Ferrarese is COO of Connecticut Pharmaceutical Solutions
Top photo: neznamov1984 | Adobe Stock
This is always an exciting time of year in the cannabis industry. “Croptober”—the peak harvest period for many outdoor cannabis cultivators in the U.S.—has about wrapped up, financial planning for 2019 is in full swing and the holiday season is swiftly approaching.
Our northern neighbors are also experiencing excitement this fall: Adult-use cannabis rolled out across Canada Oct. 17, and the country’s first cannabis shortage soon followed. (As has happened in several legal markets.)
USA Today reports that the province Quebec alone saw 12,500 in-store transactions and 30,000 online orders in its first day of sales. According to Global News, Nova Cannabis—which operates five stores in Alberta—made $1.3 million in sales its first day. In total, 172,000 cannabis orders were processed across five provinces, including Ontario and Quebec, Oct. 17, reports BNN Bloomberg.
Also according to BNN Bloomberg: While stocks have “fallen consistently” since adult-use legalization (at press time)—DBRS, a globally recognized credit ratings agency, has projected that the market could be worth $4 billion to $6 billion annually (starting in its first year of legalization). We’ll be watching as Canada continues to see growing mainstream interest (i.e., additional major investments and large corporate brands partnering with the country’s largest producers), as well as international growth.
There’s plenty American cultivators can be jealous or fearful of when looking north—but that shouldn’t overshadow what we can do collectively to continue advancing the cannabis industry and the understanding of this complex plant we still know so little about.
We can immerse ourselves in research and development (R&D) to continue to build on the knowledge base of cannabis’ capabilities. “We have to start to lean into this unbelievable complexity, knowing full well this is really the most phytochemically complex plant to interact with,” says the science-driven Jeremy Plumb of Pruf Cultivar in this month’s cover story.
For those inspired by Pruf’s story, Université Laval researcher James Eaves shares how to set up a proper R&D trial in your own facility in CBT’s third-annual “State of the Cannabis Lighting Market” report—one of CBT’s contributions to industry research.
And Plumb will be a keynote speaker at the third-annual Cannabis Conference, held April 1-3, 2019, in Las Vegas. He will be one of many industry pioneers to speak at this unique event, which unites the plant-touching businesses in the global cannabis industry.
At the event, science and cultivation strategies will be joined by a significant focus on cannabis cultivation and dispensary business insights and strategies. Canada’s advancement, and what it means for the future of U.S. and global cannabis economies, will also be covered in great detail.
As Tim McGraw says in “Where Are They Now”: “When you bring together some of the brightest minds in the industry, innovation happens.” So let’s make it happen.
The bulk of California’s sinsemilla is grown outside. The natural harvest is in autumn, and summer has traditionally been a time of shortage. In 2017, wildfires across the state’s northern counties also limited clean flower supply; much of the outdoor production was tainted with smoke and soot. And as of July 1, cannabis flowers must conform to new rules and regulations, including stringent testing protocols.
Another reason for compliant flower shortage is the ingrained reluctance amongst experienced growers to navigate the bureaucracy of license applications for the chance of conforming to unfamiliar regulations. The regulatory process is daunting, compliance costs are high, and the wholesale price of sinsemilla is at an all-time low. There are simply not as many licensed growers as expected, and nowhere near enough to feed California’s massive retail market. And, many licensed growers are unable to sell their flowers to legal distributors because they fail the required tests for biological and chemical contaminants.
Although some growers fail the tests for potentially pathogenic fungi and bacteria, many more fail because their flowers contain agricultural chemicals.
Federal and state governments set maximum residue limits (MRLs) for agricultural chemicals in food crops. These recommendations are designed for fresh, dried and concentrated fruit and vegetable products and form de facto guidelines for establishing MRLs for cannabis and other agricultural products.
The California Department of Pesticide Regulation publishes two lists of agricultural chemicals (largely pesticides) that have been detected in cannabis samples and will be controlled in commercial cannabis sales. Category I compounds are not approved for use on any food crops, and the state allows no residue levels of Category I chemicals in cannabis products. In practice, zero-tolerance levels prove to be unrealistic, as improved analysis techniques can raise detection limits from parts per million (which is the present standard) to parts per billion. Detecting traces of any chemical is largely dependent on the thoroughness of the search.
A quick survey of the Category I list shows that at least 44 agricultural chemicals are prohibited for use on cannabis crops. Several of these prohibited chemicals are monitored in a range of other crops, and MRLs have been established for each. However, Category I compounds are not allowed for cannabis use and therefore have no MRLs. Instead, they are assigned low detection thresholds of 0.01 to 0.02 ppm, which is about 10 times lower than most allowed pesticides’ MRLs. Under California guidelines, cannabis samples with any Category I chemical present cannot be legally sold.
(The most detailed listing of cannabis MRLs comes from California’s Bureau of Marijuana Control guidelines for medical cannabis testing laboratories and Department of Pesticide Regulation recommendations.)
Paclobutrazol (aka PBZ or Paclo), which has no permitted food use and a detection threshold of 0.01 ppm, is regularly detected in cannabis samples. Its use is only allowed on ornamental crops. Paclo is a plant growth regulator (PGR) that inhibits gibberellin plant growth hormone biosynthesis, thereby reducing internode growth to give stouter stems, and increasing root growth.
In cannabis, Paclo is added to a variety of nutrient products (e.g., PhosphoLoad, Gravity, Bushmaster, Flower Dragon, etc.) and is used by indoor sinsemilla growers to produce short and highly branched, dark green plants with extensive root systems and rock-hard buds. (Daminozide is another Category I PGR that is often included in nutrient products along with paclobutrazol.)
Imidacloprid is a commonly used general household insecticide sold under various brand names, and its MRLs are comparable to agricultural standards for fresh produce. Myclobutanil (sold as Eagle20 and Systhane) is a general fungicide widely used in the cannabis industry, and it is used with other crops in accordance with regulations. However, myclobutanil is considered a possible threat to groundwater supplies and is prohibited in California cannabis crops.
Several mite species present persistent problems in cannabis crops, and chemical sprays and drenches often offer the only effective and affordable control. Abamectin is a prohibited miticide commonly used on cannabis crops.
Our industry relies heavily on prohibited PGRs and pesticides that cause most regulatory compliance problems in California, and it is clear that at least with these four important agricultural chemicals, cannabis growers are subject to greater restrictions than fruit and vegetable farmers.
Several other agricultural chemicals are allowed for use on food and cannabis crops. California lists 24 Category II pesticide residues and their MRLs for inhalable and other cannabis forms.
Generally, MRLs set for inhalable cannabis are much lower than those set for other uses such as edible products, the MRLs of which are more in line with those of food products. Most of California’s residue regulations follow guidelines for other crops, though some are more stringent. As the regulatory climate surrounding cannabis production matures, we can expect to see some of these barriers lowered as policies become normalized in accordance with other industries.
Overprotective cannabis regulations, such as the Category I classification of paclobutrazol, might cause some cannabis products to fail residue screening; however, the indiscriminate use of allowable pesticides is a much greater cause for public concern and is addressed by strong regulatory controls and the establishment of MRLs. Cautious regulators are responsible for consumer health, and understandably they have set cannabis MRLs at low levels.
Good Cannabis Grown Right
Regulations alone are difficult to blame for flowers failing biological and chemical screening. Successful growers consider what it will take to produce a clean product and make every preparation to meet that goal.
The easiest way to comply with stringent regulations may be to practice organic agriculture, applicable to both small and large grows:
- If you don’t already have a set location, pick a site with ample sun, clean water, good soil drainage, adequate airflow and low air humidity to prevent mold and mildew problems.
- Build and maintain a living soil environment.
- Use low-impact integrated pest management strategies employing biological controls and environmentally friendly pesticides where appropriate.
- Spray biological controls, such as Bacillus thuringiensis (BT) bacteria, for bud worms.
- Trap rats.
- Fence out rabbits, deer and other mammals.
An ounce of prevention is worth a pound of cure.
When growing indoors or in greenhouses, cleanliness is of primary importance. Sterilize all work areas and tools regularly to prevent the spread of invisible fungi and bacteria. Maintain only healthy, pest-free mother plants. Be sure starter cuttings are completely pest-free before using them to grow mother plants. If you are experiencing persistent pest problems in your mother plants, consider starting again from seeds.
Some allowable pesticides are systemic and are taken up by every plant part. Many take a long time to break down, so they can exceed their MRLs even after several cutting cycles. Many growers who fail residue tests claim to have not used any chemical inputs on their crops. Apparently, some pesticides are so long-lived that plants produced in a grow room or greenhouse where pesticides were used even months earlier can be tainted, and may not pass MRL screening. (Read more about clones at risk for pesticide residues in our May 2017 issue.)
As a last resort, apply chemical controls well in advance of taking cuttings in accordance with the product label and long enough before harvest to ensure that only allowable residues remain in the dried flowers. And, consider that in agriculturally zoned areas, neighboring growers of established food crops may apply chemical controls that effect the levels of prohibited or controlled compounds in nearby cannabis crops.
Other Reasons for Failure
Regulatory enforcement is a strong determinant of which cannabis products become most readily available, and we increasingly live in a concentrates- and extracts-dominated world. During the sudden normalization of cannabis products, traditional dry-sieved hashish and even modern water-sieved hashish have largely been forgotten. Sinsemilla flowers’ decreased availability is matched by increases in vape pen flavors and market share. Solvent extracts are only the most recent manifestation of cannabis concentrates.
Traditional labor-intensive, mechanical-concentration techniques, and their benefits, have been superseded in our modern age by the manufacturing ease and huge volumes achievable with solvent extraction (e.g., alcohol, butane or carbon dioxide). Extracts may offer growers a way to profit from inferior, immature or biologically contaminated flowers, but solvent extraction also concentrates chemical contaminants such as pesticide and solvent residues along with THC, CBD and terpenes, leading to failed MRL screening. That said, forward-thinking companies are developing strategies to purify extracts and remove pesticide residues.
What’s to Come?
Neither MRLs, nor growers who fail to comply, are entirely responsible for the lack of legal, high-quality flowers at reasonable prices. And, because of regulatory compliance, many growers are upping their games to compete in the legal market, and thereby bringing long overdue, environmentally positive changes to our industry.
On small, biodynamic farms, relevant agricultural technologies and management strategies come to fruition. Successful fruit and vegetable growers benefit from well-practiced skills of producing naturally grown and pesticide-free crops for boutique markets. And, pioneering craft cannabis growers can share in the same benefits, while preserving the heritage cultivars that discerning customers pay extra to enjoy. The future for innovative, small growers is bright and sunny.
Although some regulations are presently over-protective, and in serious need of adjustment to agricultural norms, the effects of legalization generally have been healthy. As the regulatory climate matures, we expect more consumer-friendly and industry-appropriate MRLs will be established for cannabis, as they have been for more familiar crops. Formerly naïve consumers are now aware that there can be increased health risks associated with unregulated cannabis. Legal cannabis states are enforcing regulations to protect consumers, and producers are seeking cannabis cultivation solutions with fewer artificial inputs. The sinsemilla market will continue to evolve, apace with regulatory compliance and consumer preferences, so our beloved flowers should be around to serve us well into the future. Be patient. California will blossom again.
Robert C. Clarke is a freelance writer, photographer, ethnobotanist, plant breeder, textile collector and co-founder of BioAgronomics Group Consultants, specializing in smoothing the transition to a wholly legal and normalized cannabis market.
Mojave Richmond is the developer of many award-winning varieties such as S.A.G.E., which served as a springboard for creating many notable cultivars. Richmond is a founding member of the international consulting company BioAgronomics Group.
Top photo courtesy of Mojave Richmond.
Cannabis Business Times’ interactive legislative map is another tool to help cultivators quickly navigate state cannabis laws and find news relevant to their markets. View More