Hemp has been legal in the U.S. for years to some extent. However, the USDA is trying to determine how it should be regulated. In March 2021, they released a final rule that will end the prohibition on hemp testing laboratories and require all of them to do whatever's necessary as compliant with this new federal law.
The hemp pilot programs allowed states to cultivate industrial hemp for research purposes. This agricultural act lifted restrictions and made it possible for farmers in those areas to increase their total acreage of industrial hemp from 0 to 90 thousand.
As expected, some challenges arose with these hemp pilots programs. Those issues included inconsistent quality, varying laws between states, maintaining a consistent supply of seeds and pest control, and the knowledge and technology for hemp cultivation.
In December 2018, The Hemp Farming Act removed hemp from Schedule 1 of the Controlled Substances Act. The USDA requires that a third-party laboratory test all hemp to maintain quality and THC levels below 0.3%. Hemp is a highly regulated crop because of its close association with cannabis which still ranks under Schedule 1 controlled substances. Once hemp THC levels exceed 0.3%, it becomes classified as cannabis and must follow different regulations from those previously applied to them. This Act, however, made hemp legal at the federal level with conditions.
The FDA released the much-anticipated framework to regulate America's newest crop: hemp. The agency published an Interim Final Rule in October 2019; The final rule was published in January 2021, which contained several provisions based on public comments received during that trial period and lessons learned from the 2020 growing season. The Final Rule made significant changes to the USDA's hemp testing rules that affect how testing labs operate.
Effective March 22, 2021, here are the changes that testing labs must now adhere to.
Changes in Sampling
With the new hemp rule, growers will be able to test their plants anywhere from 5-8 inches from the main stem instead of the previous top third only. This provision offers greater flexibility and reduces the chances of "hot" hemp-which means greater than 0.3% THC levels.
Specific Lab Testing Methods
The Final Rule requires hemp testing laboratories to use reliable methods of detecting THC levels. These methods include post-decarboxylation methods that consider the conversion of THCA into THC after decarboxylation. Currently, the only acceptable practices for this are gas chromatography or liquid chromatography. USDA also expects that these facilities demonstrate consistent reliability, validity and must have high specificity for THC levels in their testing.
Negligence Limit Change
Negligence limit is the flexibility given to hemp farmers regarding the THC levels in testing. If hemp tested above 0.3% and lower than 0.5%, they would be considered negligent and not guilty of breaking federal laws. The new change increases the limit for negligence from 0.5% to 1%.
The increase is crucial. Samples testing at or above 0.3% THC must be destroyed, while those below are not a criminal offense.
Labs must be Registered with the DEA
All hemp-testing laboratories must be registered with the Drug Enforcement Agency (DEA). The USDA had extended the registration deadline to the last day of 2022, and those labs that have not complied by this deadline will be banned from testing hemp.
Measure of Uncertainty (MU)
The Final Rule requires that laboratories calculate and include the MU when reporting test results. This relates to the margin of doubt that exists for the result of any measurement, as well as how significant the doubt is.
ISO 17025 Standards
The USDA strongly recommends, but does not require, that all hemp testing laboratories be ISO 17025 compliant since they are more reliable and accurate.
Laboratory SOPs
Hemp testing labs should have SOPs in place for testing and retesting. Labs should also ensure that the technicians and all staff are following them.
Reporting
The results of all the lab tests must be shared, with the THC reported on a "dry weight" basis, with the licensed producers, appropriate State Department of Agriculture, and the USDA.
Remediating and Retesting
Any hemp sample tests over 0.3% in THC must now be flagged. Previously, the producers had to destroy the entire plant. With the new changes, parts of the tested plant can be salvaged for retesting by the lab using the same procedures.
The hemp rule took full effect on the last day of 2021; the only extended deadline is the requirement that all hemp-testing labs register with the DEA.
Fast Track Your Labs with a LIMS
If you're looking for a way to simplify the compliance process, look no further than a cloud-based Laboratory Management Information System (LIMS). With this system in place, your lab can monitor samples and analyze results while maintaining internal quality protocols. Plus, there's never any need to worry about falling behind on rules with digitization because everything is automated. This system takes the time and hard work out of being compliant.
LIMS enables hemp testing laboratories to:
- Track samples through their lifecycle
- Automatically share results
- Flag hot hemp samples
- Generate certificates of analysis (COAs) in prescribed formats
- Meet regulatory compliance
- Manage SOPs, staff training, and QA/QC protocols
Hemp that tests over 0.3% in THC is considered cannabis and is therefore illegal under federal law. Consequently, hemp testing is a process that is strictly regulated. Hemp-testing laboratories must optimize their operations to ensure regulatory compliance and the validity of their test results; a LIMS makes this all possible.
