Cannabis has finally managed to make it to the mainstream. It went from being an illegal substance to now being an accepted medical treatment (such as the FDA approved Epidiolex). It has also become a booming industry with extreme growth potential, in both the high THC and high CBD markets, along with industrial hemp products. This is evident by the number of states with adult-use markets or medical programs, not to mention the federal legalization of hemp and its derivatives, which has helped to usher in the new “green rush”. States are capitalizing on this recent federal move to access the revenue that is offered courtesy of the hemp crop. It appears that more people are realizing that there is more to this plant than its intoxicating effects and troubled history.
With increased consumption occurring, there is a serious need to ensure the health and safety of consumers is not compromised. Currently, the hemp industry and high THC cannabis markets face a patchwork of lab testing standards. This is very risky because it calls into question the quality and safety of the CBD product when there is a lack of uniform testing. This plant is a perfect host for pathogens like microbes and fungi and formulations could lack potency and ingredient consistencies. Maintaining consumer trust is essential for the market. As a result, it strengthens the need for lab testing standardization and allows people to purchase products without fearing for their health.
There are many benefits to lab testing for this industry. If we want this market to endure the economic and political ambiguity then certain measures must be taken to verify a product’s safety. This is due to the tendency for new industries to craft shortcuts and invent practices to make a profit in order to gain more traction in the market. A prime example of this took place in the latter half of 2019, a “vaping crisis” occurred due to legitimate and illicit manufacturers trying to increase production volume while reducing costs (Harris, 2019). They used vitamin E acetate as an agent to thin the vape oil instead of the safer, but costlier cannabis derived terpenes. It is therefore important for farmers, manufacturers, and consumers to recognize the need to have stringent, uniform, and safety testing measures in order to safeguard the health of consumers which stabilizes the industry against market volatility.
Regulatory and Safety Benefits
It is important to have proper testing in place in order to detect adulterants, additives, and other safety hazards that can arise in the cultivation and manufacturing of the supply chain. States participating in the hemp industry or have a medical cannabis program require some basic safety tests, but there is no uniformity to these safety standards. For instance, in Utah the testing of extracts (crude, distillate) requires testing to include cannabinoid potency, residual solvents, heavy metals, pesticides, and microbial analyses before it gets further processed into end products (Utah Office of Administrative Rules, 2019). However in Oregon, they only require testing of extracts to include potency, pesticides, and solvents before it gets further processed (Oregon Department of Agriculture, 2019). There is a serious need for protecting people’s health from these avoidable risks. There are many points throughout the lifespan of the plant that would benefit from lab testing, including, but not limited to, detection of pesticides, heavy metals, and mycotoxins. The many steps of product processing also benefit from testing for things like residual solvents, pesticides, microbial life, and more during the manufacturing steps.
For outdoor hemp cultivation, pesticide use is generally frowned upon as it inevitably appears in the manufacturing process. However, the Environmental Protection Agency (EPA) recently approved nine biopesticides and one conventional pesticide for hemp cultivation. Farmers and other growers should still exercise extreme caution utilizing them to avoid risking the quality of the final crop. Many consumers are adverse to pesticide use because they view it as a way that diminishes overall quality and it poses a health risk for human consumption. For folks growing indoors, pesticide use is not typically needed as cultivators are creating the growing environment and are not inundated with insects and pests unlike their outdoor counterparts. Unfortunately, even if a farmer hasn’t used pesticides for their crop, drift from nearby fields will pose a concern for contamination. Testing soil before the start of cultivation and testing plant material at the end are simple ways to guarantee the lack of pesticides present in the crop.
Besides pesticide use occurring in cultivation, another route of pesticides introduction into products is during the manufacturing process. It is common to add essential oils to formulations in the preparation of edible and topical products to add fragrance and reduce the viscosity of extracted hemp oil. Processors can obtain essential oils from all over the world, but they are not often regulated, so the chance for pesticide contamination can be significantly risky. Lab testing at this point of the process would ensure the product’s integrity and reassures consumers that their products are pesticide free.
Another aspect of pesticides to be aware of is risking contaminating an extractor’s system. A presence of pesticides will get concentrated in an extraction and distillation set up, therefore ruining the facility and rendering future products contaminated if not properly sterilized. Processors need to take extra precautions for any plant material that enters their facility to avoid polluting their system, which causes a shut down of the facility to deep clean instruments as pesticides linger long after the plant material is removed. The solution is to test any incoming plant material to avoid a disastrous situation down the road.
Cannabis has the inherent ability to accumulate many things from the soil, such as nutrients or heavy metals. As a result of this bioaccumulator trait, many people have utilized Cannabis sativa as a way to clean up toxic waste sites that involve heavy metals. It has been experimented with as a phytoremediator at nuclear waste sites such as Chernobyl, but not enough conclusive evidence points to industrial hemp effectively pulling in radioactive isotopes from the soil as much as heavy metals (Colbert, 2018). Although it is noted that hemp can still absorb some radioactive elements according to a study from 2012 which found that hemp absorbed strontium from contaminated soil, but it failed to take in cesium (Hoseini et al., 2012). It elucidates the potential for radioactive phytoextraction by hemp. More research needs to be conducted to prove the efficacy of hemp phytoremediation concerning nuclear waste sites because globally there are locations dealing with radioactive fallout that we still need to address (Colbert, 2018).
Bioaccumulation hinders hemp cultivation meant for human consumption when grown on soil with heavy metal deposits. If one suspects their growing site is located in a high risk area, it would be appropriate to test for heavy metals. The testing looks for common elements such as cadmium, lead, arsenic, and mercury. These heavy metals are known to be extremely dangerous to human health as they can cause long term damage and acute issues for children and immunocompromised adults.
At present, there are many challenges to testing this form of contamination. There is a lack of consensus amongst testing labs for determining the testing techniques and which microbial contaminants to test for in the first place. Also, many states do not agree which microbes pose a health risk which further complicates things. This can leave a consumer with anxiety because they don’t want to risk their health.
The issue with microbes is that they can appear at any point during the cannabis production. They have the ability to replicate that makes them unique from the other contaminants. For example, if a tincture came into contact with E. coli during the manufacturing process because the environment wasn’t sanitary, the microbes will grow and flourish to dangerous levels as the product sits. This replication can happen in the course of days. It is therefore prudent to have strict and consistent testing during the processing when an infectious organism could be introduced because microbes can impose serious health risks.
Researchers and scientists are working to bring clarity to this issue, but we are still far from accomplishing standards and best practices. Farmers and manufacturers must decide the level of testing their plant material and infused products undergo. Despite the cost factor and the absence of set testing requirements, consumers would prefer to see a product which underwent microbial tests. This promotes consumer’s trust in a brand.
The physiology of cannabis allows for an environment to host harmful fungi due to its resinous flowers and leaves, as well as having dense, humid structures. This trait enables the proliferation of mycotoxin producing fungi because microbes and fungi are present in the environment. Mycotoxin contamination can occur at any stage of the supply chain, from its time growing to harvesting, and during the production and storage of final infused products. Two categories commonly monitored in the cannabis industry are aflatoxins and ochratoxins. These are produced by the fungi within the Aspergillus family.
Both of these toxins pose serious health issues such as immune suppression, DNA mutation, and damage to organs. Aflatoxins are extremely carcinogenic to humans and it appears that no mammal is immune to the acute toxicity they produce. Concentrations in the range of micrograms can be enough to cause liver cancer in humans. This mycotoxin can be inhaled, ingested, and absorbed through the skin. As for ochratoxins, they appear to be less damaging compared to the aflatoxins, but this mycotoxin should not be dismissed. This variety of fungi can damage the kidneys as well as the brain. Ochratoxins are known to accumulate in the body which will lead to long term damage. It remains to be seen how toxic this fungi is really, but scientists are working to understand ochratoxin’s carcinogenicity when it comes to human health.
Due to the severity of potential impacts of mycotoxins, as well as the low concentration these compounds can work at, careful monitoring is imperative. There are measures that growers and processors can take to reduce the risk of fungi contamination. Growers need to be mindful of their cultivation environment and to know when to harvest their crop; this is due to the freshness of the plant and its dense structures which promote fungal growth. They need to maintain the hygiene of the storage facility, as well as the storage containers. More importantly, the drying stage needs to maintain a precise moisture content so as to reduce the water activity, which allows the fungi to proliferate. Processors need to maintain a hygienic environment in order to reduce the exposure to mycotoxins.
These practices are essential to understand and uphold because they will avoid and reduce the risk of aflatoxin and ochratoxin production. The harsh reality is that mycotoxin testing can be quite expensive owing to how sensitive the equipment needs to be able to detect such low levels of compounds, in the range of parts per billion. Best practices will help growers and processors avoid this contamination, but testing is a fail-safe way to guarantee a product is safe for consumption. Fortunately, mycotoxin testing may only be required if a high fungal count has been observed in the raw plant material, but it depends on the language of your local state regulations.
A solvent is a common and typically used method to extract cannabinoids and terpenes from the plant matter. If not purged correctly, solvents could remain in the product after the manufacturing process; these are deemed residual solvents as they continue to persist in the final product. These solvents can cause potential health issues depending on the type of solvent and the concentration within the product. There could also be other sources of residual solvents that could find its way in unintentionally or emerge from reactions happening within the product itself.
The extraction solvents are either volatile or non/semi volatile. For a solvent to be considered volatile it must evaporate at room temperature and these include options like ethanol, acetone, and pentane. The non/semi volatile solvents appear to show no affinity to evaporate at room temperature. Some good examples of non/semi volatile solvents include dimethyl sulfoxide (DMSO), sulfolane, N,N-dimethylacetamide, and N,N-dimethylformamide
Testing for solvents is primarily a safety concern, since many solvents are toxic to humans, some in extremely low doses (i.e. benzene). However, solvent testing can also reveal problems in manufacturing and highlight opportunities for improvement. For example, if there is a large amount of ethanol left over from the extraction process, this indicates you might have to run your crude oil for longer in the rotovap. A presence of ethylene glycol (antifreeze) might point toward a problem with any machinery used during processing. The presence of benzene in final products may arise from incompatible chemicals used in formulations or from improper preparation/storage of products.
Consumer demand for concentrates and other extracts exhibit an integral role they play in the market. They can be inhaled directly, but typically they are added to infuse food, drinks, and other goods. Routine testing for residual solvents would alleviate consumers’ fear of purchasing a contaminated product, moreover stakeholders and processors would benefit as a result to sustain their consumers’ trust.
Process Control Benefits
This industry is highly regulated from seed to sale. In addition to the cannabinoid testing and safety measures required of farmers and cultivators, it would prove to be beneficial for extractors and formulators to have supplemental testing during the production process. Routine testing would monitor the systems at work and look out for signs of anticipated failure. Unfortunately, there are many avenues of potential failure throughout the whole process of growing, extracting, and formulating, but lab testing allows for tracing and detecting contaminants as well as the monitoring of cannabinoids.
Testing throughout the grow process ensures the quality and validity of one’s hemp crop. Hemp growers should have verified early on that the grow region is free from pesticides and heavy metal contamination by conducting a soil test. Potency tests help to determine when it is the most optimal time to harvest before the crop exceeds the legal limit of THC. Being proactive and cautious in the beginning saves crops from destruction down the road. Tests are also becoming available to determine the sex of juvenile plants which saves hemp flower growers time and money. Moreover the drying step can make or break someone’s hard work after surviving a growing season. Drying conditions must be perfect to keep terpenes and cannabinoids intact as well as to properly dry the wet plant material. The risk for microbial contamination increases because it’s a perfect environment for hosting fungi as the plants release moisture in an environment suited to many microbes. Testing can be performed to confirm the plant matter is safe for processing and further extraction. Monitoring terpenes during this step also ensures the proper aroma and flavor profile is maintained throughout this stage.
Adulterated products are present in the hemp and cannabis markets because this is an issue that is present in many industries. For hemp and cannabis products, adulterants appear in the form of dilution and impurities from formulation additives. During the sourcing for new formulations of end products, or when considering new suppliers for existing ones, it is important to test all incoming materials, such as terpenes sourced from other plants, for purity and safety. Opportunities for adulteration are still available despite strict regulations. Claims of potency and purity should always be verified either by directly testing the product, or by calling the reporting lab to verify the values. Direct testing is preferable, as it will reveal if the manufacturer has diluted their product after testing.
The other form of adulteration involves product dilution. This can be detected by comparing the stated values of potency to observed values. If the observed value is significantly lower than the stated value, tests can be run to detect common cutting agents like coconut (MCT) oil or vitamin E acetate, both of which, if placed in vape cartridges, could have disastrous consequences. These substances are not meant to be inhaled. Another avenue for adulteration could be the use of novel cannabinoids (K2 and Spice) in place of classical phytocannabinoids like CBD. In appearance, they are both white, crystalline solids, making it hard to distinguish with the naked eye, but with chemical analysis, the identity can be easily determined.
The last couple of years has seen massive growth in the supply and demand of high THC and high CBD cannabis products. Many companies and solo entrepreneurs are taking advantage of the new market to stake their claim on what has been termed “The Green Rush” because there is so much potential to get in on the success. Many consumers desire to have these products and regulations are allowing for the cultivation and sale of cannabis and hemp (depending upon the state one resides in). This is especially true for the hemp crops and CBD markets, for the 2018 federal legalization of hemp opened the door for farmers and entrepreneurs to capitalize on this opportunity.
As more cannabis products continue to flood the market, companies both new and established are trying to find ways for their products to stand out. This is a significant challenge businesses are confronted with, but it’s still possible to have a successful line of cannabis infused goods. Products need to strive for palatability as cannabis has an inherently strong flavor and fragrance that some may not enjoy; terpene rich flowers and infusions appear to be the most profitable compared to ones that lack this element. Lab testing would verify the purity of the formulations thus allowing for successful marketing because terpenes can easily be adulterated. Testing would ensure one’s product is guaranteed natural and free from synthetic essential oils thereby driving up the quality of product.
Terpenes, essential oils found within nearly all plant species, are the volatile oils which help plants to attract pollinators and repel pests. Cannabis is a plant that has a significant abundance of terpenes with many variations of different ones produced by the plant. Moreover, they produce terpenes that are found within other plants such as alpha and beta pinene. Formulators for cannabis products would want to utilize other terpenes sourced from different plants because the typical process of extraction results in a crude oil yielding an unpleasant smell, therefore requiring additional inputs to make it flavorful and fragrant. This also allows them to create unique flavor profiles. Formulators are working with essential oils to make products like topicals, sublinguals, and vape oil to be very fragrant and flavorful for ease of consumption. Lab testing allows formulators to identify key components of a flavor profile in order to enhance their product’s palatability as well as document any changes that could arise from tinkering with the formula.
There are many benefits that lab testing offers for the industry. It helps to make sure that the supply chain has followed safety measures to ensure that their products are safe for consumption. Due to the nature of the plant’s anatomy and growing conditions, as well as the risk of introducing and hosting toxins during the manufacturing process, there are many routes of potential contamination. Lab testing will certify a farmer is growing legal CBD rich hemp for the regulatory standpoint, as well as confirm that the plant material does not harbor heavy metals, pesticides, or mycotoxins. Finished products would benefit from lab testing for ensuring consistency and customization in their formulations and make certain that their product does not contain adulterants or other toxins. Lab testing ultimately helps the industry to address these dilemmas before a product even reaches the consumer.
We are far from lab testing standardizations and reducing the cost of these tests, but with time, education and pressure on regulators will result in established and uniform testing. Stakeholders and processors would do well to obtain lab testing that exceeds industry standards because consumers desire to know their products are clean and safe to consume. Lab testing supports and validates the safety of the industry as it weathers the volatility and ambiguity.
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