Digitization: The Key to Navigate Through the Federal Hemp Testing Regulatory Challenges

Introduction

The Marihuana Act of 1937 banned hemp production in the U.S. The 2018 Farm Bill reclassified hemp and equalized it as other agricultural commodities. Although hemp is legal at the federal level, its production is still highly regulated by the United States Department of Agriculture (USDA). The USDA released a Final Rule (FR) on January 15, 2021, which includes new federal guidelines for hemp testing. All hemp testing laboratories need to comply with the new rules to avoid heavy penalties or license cancellation.

Delineating the USDA’s New Hemp Testing Rules

Hemp testing laboratories need to adopt significant changes to comply with the new federal hemp testing rules. Primarily, all hemp testing laboratories should have quality assurance protocols in place for generating valid and reliable test results. Laboratories also need to homogenize samples prior to testing to prevent inconsistencies in test results. Moreover, laboratories should also implement internal Standard Operating Procedures (SOPs) for testing and retesting hemp and enforce their staff to follow the SOPs.

Following are the few necessary changes that hemp testing laboratories should adopt to comply with the FR:

1. Register with the Drug Enforcement Administration (DEA)
   Laboratories should register with the DEA prior to the deadline of December 31, 2022. If not, they cannot continue hemp testing. Although voluntary, the USDA strongly recommends hemp testing laboratories be ISO/IEC 17025 accredited.
2. Maintain 0.3% THC
   Legal hemp is defined as Cannabis sativa having not more than 0.3% THC on a dry weight basis. The FR maintains the same. However, hemp cultivators will not be legally penalized if the THC is above 0.3% but below 1%. Hemp that contains more than 0.3% THC must be remediated.
3. Accurately Report Total THC Concentration
   Total THC is the combination of delta-9-THC with tetrahydrocannabinolic acid (THCA). Upon exposure to heat, THCA may get converted into THC. The law enforces laboratories to test and report total THC on a dry weight basis. Laboratories can determine total THC using post-decarboxylation or similar methods.
4. Measure Uncertainty
   According to the FR, laboratories should calculate and include a measurement of uncertainty (M.U.) when reporting THC test results. The M.U. is controlled by performance standards such as AOAC Standard Method Performance Requirements, not by the USDA. Hemp laboratories may refer to the guidelines provided by ISO, Eurachem, or GUM to calculate measurement uncertainty. Laboratories should report M.U. as a ± value and express it in the same unit as the THC threshold, following best practices for significant figures and rounding.
5. Dispose of Hot Hemp
   Hemp that tests more than 0.3% THC on a dry weight basis is known as hot hemp. According to the USDA, all hemp testing laboratories should include a disposal procedure for hot hemp in their testing protocols.
6. Collect Representative Samples
   Representative sampling is crucial to accurately determine the total THC concentration and generate unbiased results. Before the federal hemp testing rules came into effect, growers used to collect samples from only those plant parts that often contain lower THC compared to other parts, leading to unrepresentative sampling and fake results. As per the new rules, samples should be collected from the top 5-8 inches from the main stem. This includes leaves and flowers, terminal bud, or central cola of the flowering top of the hemp plant. The sampling method must be good enough at a confidence level of 95% so that no more than 1% of the plants in the lot exceed the threshold THC concentration.
   All hemp testing laboratories should follow the aforementioned rules to comply with the new hemp testing rules and avoid regulatory penalties. Moreover, all hemp testing laboratories need to share test results with the licensed producer, the USDA, and the appropriate state department of agriculture or tribe.

Role of a Laboratory Information Management System (LIMS) in Complying with the Final Rule

An informatics solution such as a Laboratory Information Management System (LIMS) can help hemp testing laboratories digitize operations, assure high-quality test results, and enhance productivity. A LIMS automates entire laboratory workflows, test processes, and calculation of test results. A LIMS helps laboratories manage every gram of sample from accessioning to testing to disposal. It tracks samples through the sample lifecycle. It flags samples having more than 0.3% THC and enables laboratory managers to take necessary actions. A LIMS can help laboratories adhere to the USDA’s guidelines by enforcing staff to follow SOPs and tracking deviations from standard practices. It can be integrated with the reporting system of the USDA & the state department of agriculture for sharing certificates of analysis (COAs) in the required format. A LIMS provides easy and secure access of COAs to licensed producers through the client portal. Furthermore, a LIMS helps streamline QA/QC processes, manages staff training, and schedules calibration of analytical instruments, enabling hemp testing laboratories to easily comply with the new law.

Conclusion

Although the 2018 Farm Bill legalized hemp at the federal level, it did not remove strict regulations on hemp testing. The USDA introduced new federal guidelines on sampling, test methods, measurement of uncertainty, disposal of hot hemp, and reporting of test results. Hemp testing laboratories need to follow all the requirements stated by the USDA to comply with the new rules. Any violations could lead to heavy penalties and disqualification for hemp testing. A LIMS helps laboratories follow the new rules through operational digitization.