By Roger Brown
The USDA’s Final Rule (FR) on hemp is out, and a few regulations have changed. For one, FR raised the THC negligence standard from .5% to 1%, giving farmers more leeway before their crop gets deemed “hot.” Additionally, farmers now have 30 days–instead of 15 days– to test samples prior to harvest. But one of the rules that haven’t changed is the DEA requirement for hemp testing laboratories.
Starting January 1st, 2022, all hemp cultivators must send samples to DEA-registered labs within 30 days of harvest. The USDA gave growers an extra year to meet the DEA requirement because of the claim that very few laboratories currently meet the requirement. Why aren’t more companies registered? For one, it’s much easier for labs to buy testing equipment, follow instructions, and call themselves a verified laboratory. But it’s much harder to meet the stringent standards laid out by the DEA. For this reason, I firmly believe in the importance of this FR requirement. DEA-registration is vital to elevate the hemp industry to higher standards of quality and safety at a symbolic and systematic level.
Reason 1: DEA-certified laboratories must pass the regulatory test
To be licensed by the DEA, laboratories must meet a higher standard that is vital for consumer trust and the industry’s reputation. Eligible facilities must complete an exhaustive application where they identify all potential controlled substances they’ll handle and show they are compliant with state and federal testing requirements. Laboratories must also complete a liability questionnaire proving they’ve never been convicted of a crime, never had their state registration revoked or suspended, and were never involved with a federally convicted partner or stakeholder.
Reason 2: DEA certified testing labs know how to handle controlled substances
By registering with the DEA, laboratories show they know how to handle controlled substances. And according to federal law, hemp that contains more than .3% THC (with a negligence limit of 1%) is an illicit substance. Moreover, the definition is not limited to Delta-9 THC–the famous cannabinoid with an intense psychoactive effect. Delta-10 THC–also derived from hemp–while still flying under the radar of controlled substances, requires a separate new lab testing method for accurate detection. Only laboratories who are DEA-licensed can purchase the standards for Delta-10 testing.
Reason 3: DEA-registered laboratories are GMP-compliant
Good Manufacturing Practices (GMP) refers to regulations promoted by the US Food and Drug Administration (FDA) to ensure products are consistently produced to the highest standards. According to the FDA’s GMP guidance, hemp manufacturers must show they can create products with proven potency, purity, and strength. To obtain this lofty goal, GMP supports testing with DEA-registered laboratories.
Reason 4: DEA-registration will promulgate public acceptance
Unfortunately, there are many fraudulent and mislabeled products on the market driven (in-part) by shady business practices and inadequate, low standard testing facilities. As a result, the FDA and states have recalled countless hemp products for making false potency claims and containing dangerous contaminants. Every time an incident like this occurs, it makes headlines, and the public has one more reason to mistrust the hemp industry. I understand the skepticism, which is why I want every third-party laboratory to prove its ability to produce consistent, accurate, state-compliant, and USDA-compliant results. Requiring hemp manufacturers and farmers to work with DEA-certified labs is a huge step toward gaining mass acceptance and trust.
I want to be exact–DEA registration is a must for every trusted independent third party testing laboratory. But hemp manufacturers and growers must also seek laboratories that are further accredited, such as ISO17025 Accredited, PJLA Certified, AHCA licensed and CLIA Accredited. These high-level certifications show that laboratories generate valid results and meet medical-grade standards for quality and cleanliness. Moreover, cultivators should look for laboratories with compliance awards for accurate testing from third-party organizations, like Emerald Scientific. Emerald Scientific gives badges to laboratories that exceed performance requirements and establish quantitative valid results for blind inter-lab proficiency testing. As this industry grows from infancy to maturity, it’s incumbent upon all of us to keep raising the bar.