by Martha Hernández, Scientist, CloudLIMS.com
Hemp testing is a new and seemingly lucrative niche that several laboratories are looking to venture into. From an economic standpoint, there's every reason to venture into the industry at this point when the market is still evolving and the economic potential is huge. However, unlike typical industries, hemp is highly regulated at the federal level. There are numerous rules that touch on how hemp samples should be obtained, handled, tested, and even disposed of. This article breaks down the nine important rules that hemp testing laboratories should be familiar with.
The Demand for Hemp Testing Is Huge
The value of the global industrial hemp market was $4,452.0 million in 2021. It is projected to grow at a CAGR of 33.7% and achieve a value of $60,682.8 million by 2030.1 With such immense potential to be exploited, laboratories should consider venturing into this niche market. The nine rules mentioned below will help your laboratory remain above board as far as regulatory compliance goes.
A Brief Background on Hemp Testing Rules
Before diving into the nine cardinal rules, it's important to first understand where these rules came from. For many years, hemp was illegal in the U.S. and several other parts of the world. The Agriculture Improvement Act of 2018 legalized hemp federally by reclassifying it as any other agricultural commodity. However, that didn't mean that anyone could now cultivate, process, and distribute hemp, just like cotton, corn, barley, or wheat.
Here's Why
Hemp belongs to a plant species known as Cannabis sativa. Cannabis, which remains illegal federally, belongs to this same species. The only difference between hemp and cannabis is related to the concentration of the psychoactive cannabinoid, THC. In the U.S., hemp is Cannabis sativa that contains less than 0.3% THC on a dry weight basis. Most hemp testing laws are designed to ensure that the THC level does not exceed the 0.3% threshold (hot hemp).
USDA Issues Final Rule on Hemp Testing
The Hemp Farming Act of 2018 made provisions for hemp to be rescheduled (removed from schedule 1) and this happened on December 20, 2018, when these provisions were incorporated into the Agriculture Improvement Act of 2018. This made hemp legal under federal law. Following this, the USDA issued a set of rules known as the Interim Final Rule (IFR), which was published on October 31, 2019. On January 15, 2021, the Final Rule (FR), a revision of the IFR, was issued and adopted. The FR spells out all the rules that hemp testing laboratories must adhere to.2,3
Figure 1: A schematic representation of the nine key rules from the USDA for hemp testing laboratories. (Figure courtesy of CloudLIMS).
Rules Hemp Testing Laboratories Must Follow
The FR made some significant changes that hemp testing laboratories should follow. These changes dictate how samples should be collected, prepared, tested, and how the results should be shared.
1. Hemp Testing Laboratories Must Be Registered with the DEA
It is stipulated in the FR that “Registration is necessary because laboratories could potentially handle cannabis that tests above 0.3 percent THC on a dry weight basis, which is, by definition, marijuana and a Schedule 1 controlled substance.”
However, hemp testing laboratories have been given up to the last day of 2022 to comply with this regulation. The DEA is currently reviewing registration applications following the criteria under the Controlled Substances Act (21 U.S.C. 823(f)).
2. Measurements of Uncertainty Must Be Reported
The Measurement of Uncertainty is used in various calculations to express the limit of acceptable variance. MU is defined as “a parameter associated with the result of a measurement that characterizes the dispersion of values.”4
When calculating THC percentage, laboratories must also report the MU, which is based on standards such as the AOAC.
3. Representative Sampling
Not every part of hemp can be tested. However, the FR allowed more wiggle room on parts that can be tested, compared to the IFR. Parts of hemp that can be tested include parts of the leaves and buds that are at least 5-8 inches away from the main stem. The terminal bud and central cola are also included.
Chances of "hot hemp" would be greatly reduced if laboratories could test samples from any part of the plant since THC is usually concentrated in the floral parts, mostly the buds, of the plant.
4. Sample Preparation
The FR outlined very specific steps on how hemp samples should be prepared. This begins with ensuring that the sample is moisture free because the THC must be reported on a dry weight basis. The drying should be done within 24 hours after the sample has been received. Alternatively, the sample should be frozen at -20 degrees Celsius or lower. It is important to grind the sample into small particles so that the mixture is homogeneous before it can be tested. The sample should also be divided into two parts; test and retain. The procedure should be well stipulated in the laboratory's SOPs.5
5. Post Decarboxylation Methods Must Be Used
Raw hemp contains cannabinoids in their acidic or inactive forms. When exposed to some heat, the acidic cannabinoids (such as THCA and CBDA) convert to their active forms (such as THC and CBD).
The FR recommends that the testing method used by a laboratory should take into account the process of decarboxylation and how this can impact the THC percentage. Recommended methods include gas and liquid chromatography.
Other methods that can be used should meet the baseline requirements for post-decarboxylation and must be approved in writing prior to their use. THC percentage must always be calculated on a dry-weight basis to ensure standardization. If some laboratories report THC content in a wet sample and others in a dry sample, the variance would be significant.5
6. The Negligence Threshold
The negligence threshold gives some leeway for hot hemp. The FR increased the negligence threshold from 0.5% to 1%. Hemp testing above 0.3% THC but not exceeding 1% is not considered a negligent violation, even though it will need to be disposed of. Hemp testing above 1% THC is considered a negligent violation and the licensed producer (LP) receives a notice of violation. If an LP receives three notices within a five-year period, they will be disqualified from participating in the legal hemp program for a period of at least 5 years.5
7. Sharing Hemp Testing Results
Once a laboratory has conducted and confirmed the test results, the laboratory should share the information with the licensed producer, the USDA, and the appropriate state or tribe Department of Agriculture. The results must be reported to the USDA, whether the THC percentage exceeds the legal threshold or not. The test results must also be marked "official compliance.” The laboratory should maintain a legible copy of the results as records, which must be kept for a period of not less than three years. The laboratory must also share the results with the LP in a format that is most acceptable to them.5
8. Hemp Retesting
The licensed producer is free to ask for a retest if they are unsure about the results. In that case, the laboratory should oblige and conduct a retest but at the expense of the LP. The retest should follow the same procedure as stipulated in the SOP. The results of the retest should be shared with the LP as well as the USDA.5
9. Remediation and Testing of Hot Hemp
The FR allows for hot hemp to be remediated. This means that once a hemp sample exceeds 0.3% THC, some parts of the plant can still be used. This usually includes parts such as the seeds, stalks, leaves, and stems. The LP may also opt to shred the hemp into biomass and then submit a sample to a laboratory for retesting. The laboratory should again follow the same procedure for testing hemp.6
Those are the nine important rules that hemp testing laboratories must follow. Should hemp samples test above 0.3% THC, the FR allows licensed producers to destroy the hemp through different methods, including plowing under, mulching, burning on site, disking, and deep burial. However, hot hemp must be destroyed on-site and not transported to a different location.
A LIMS Helps Hemp Testing Laboratories Get Ahead of Compliance
A laboratory software for CBD/THC laboratories, also known as a Laboratory Information Management System (LIMS), can help hemp testing laboratories get ahead of compliance by keeping track of all regulatory requirements. A LIMS supports end-to-end tracking of samples through their life cycle, automates testing workflows, flags out-of-specification results, and enables reporting of test results to licensed producers and regulatory agencies. A cloud-hosted LIMS manages lab data in the cloud and ensures that the data is secure and accessible remotely. It also supports collaboration and data sharing with all stakeholders.7
Figure 2: A laboratory software for CBD/THC laboratories to manage multi-analyte test results and flag out-of-specification test results (Figure courtesy of CloudLIMS).
Hemp testing laboratories must follow all guidelines to assure 100% compliance with regulations. This begins with ensuring that they get the sample from the right part of the plant. They must also use a post-decarboxylation method to test hemp, report the measure of uncertainty, and share test results with the LP as well as the USDA. A retest should be conducted at the request of the licensed producer. Laboratories must also store test results for not less than three years. Laboratories should consider deploying a LIMS to avoid regulatory pitfalls and enhance operational efficiency.8
References
- P&S Intelligence: Industrial Hemp Market Size & Share Analysis by Type (Hemp Seed, Hemp Oil, Hemp Fiber, CBD Hemp Oil), Application (Food, Textiles, Beverages, Personal Care Products, Pharmaceuticals), Source (Conventional, Organic), Farm (Outdoor, Indoor) - Global Industry Revenue Forecast to 2030. Report Code: CP12296. https://www.psmarketresearch.com/market-analysis/industrial-hemp-market. Published in April 2022.
- USDA, Agricultural Marketing Service. USDA Publishes Final Rule for the Domestic Production of Hemp. https://www.ams.usda.gov/press-release/usda-publishes-final-rule-domestic-production-hemp. Issued on January 15, 2021.
- USDA, Agricultural Marketing Service. Enforcement Discretion - Interim Final Rule. https://www.ams.usda.gov/rules-regulations/hemp/enforcement. Accessed on October 18, 2022.
- Farrance I, Frenkel R. Uncertainty of Measurement: A Review of the Rules for Calculating Uncertainty Components through Functional Relationships. Clin Biochem Rev. 2012 May;33(2):49-75. PMID: 22896744; PMCID: PMC3387884. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3387884/
- USDA, Agricultural Marketing Service. Laboratory Testing Guidelines. U.S. Domestic Hemp Production Program. https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf. Issued on January 15, 2021.
- USDA, Agricultural Marketing Service. Hemp Disposal Activity. https://www.ams.usda.gov/rules-regulations/hemp/disposal-activities. Issued on Jan 15, 2021.
- CloudLIMS. USDA’s Hemp Testing Rules: What Do They Mean For You? https://cloudlims.com/hemp-lims-enabling-hemp-testing-laboratories-to-meet-usdas-testing-rules. Published on February 25, 2021.
- Analytical Cannabis. The USDA’s Hemp Testing Rules Have Changed. Are You Ready? https://cloudlims.com/resources/lims-publications/the-usdas-hemp-testing-rules-have-changed-are-you-ready/. Published on March 21, 2022
About the Author: Martha is a chemist with expertise in diverse areas of analytical chemistry. She has worked as an analyst at a licensed 3rd party analytical laboratory where she focused on developing and validating analytical methods for bioequivalence studies. Later, she served as a quality control expert in the analytical domain and as a monitor in clinical trials. Her interest in the clinical industry led her to be a part of two of the biggest hospitals in Mexico where she gained expertise in hematology, microbiology, and blood banking. Later, she became a member of a team of forensic chemical experts and started working from day one as a specialist in narcotics and drugs. This enabled her to gain rich experience in GC-MS, FTIR, HPLC-MS/MS, ICP-MS, and other analytical techniques for the separation, detection, and quantification of different molecules such as cannabinoids.
She has participated in multiple oral trials defending her legal opinions and worked as an expert consultant. She worked on the synthesis of small molecules for testing them on multi-drug resistant bacteria and mycobacteria, further developing her analytical skills in column chromatography, thin-layer chromatography, microbiology, and compound elucidation by NMR and HRMS. She carried out a research stay at the University of Barcelona with the organic synthesis team. She has also worked on natural products in France and presented her work at conferences in the USA and France. She received awards and accolades for her exceptional work. She has participated in several conferences as a moderator as well.
Martha holds a bachelor’s degree in Clinical Chemistry from the Faculty of Medicine UANL and a master’s degree in Pharmacy from the Faculty of Chemical Sciences UANL, Mexico.