Botanacor gets asked several questions around harvest time about current industry procedures and guidelines for regulatory compliance and lab testing. So, we compiled a group of the top questions we receive, which impact our customers the most.
My product has a +/- X% variance. How is that accurate?
The process of analytical measurement delivers results that are estimates of the quantity of a monitored compound. This is different than counting apples for instance which yields an exact numerical result. The analytically measured value we report to you is not a discrete number, but rather a range of numbers that will include the true result. This range is referred to as measurement uncertainty or MU.
Every analytical measurement has this uncertainty and documented variance is common and expected in regulated industries like the pharmaceutical industry, as well as cannabis. Our goal, at Botanacor, is to reduce the measurement uncertainty as much as possible and provide you with the most accurate estimate range we can.
Analytical results are most accurately displayed as X ± MU. X is the number assigned from the measurement and MU the range of equally acceptable estimates. In reality, that analytical result could be any number within the range of measurement uncertainty surrounding the value X.
Accuracy in analytical measurement is not like counting apples. If I have 6 apples that is clear and easy to understand. Whereas for analytical measurements, you have a reported value that is only one possible numerical value among a range of values. Understanding that analytical measurements yield a range of possible values will allow you to understand the accuracy of your reported results.
Botanacor strives to bring its variance percentages to a low level to assure you the most accurate test results a lab can provide.
What are acceptable limits for contaminants in hemp industry/products?
Currently, there is nothing in place. Which is a problem. Consumer safety is driven by the consumer. In the absence of state/federal guidance on contaminants, businesses can look to the laws in place for licensed medical/retail marijuana in their state. Here are some helpful links:
Microbials – Look to organizations like the America Herbal Products Association (AHPA). They provide some guidance on microbial limits.
Pesticides – The AHPA offers some helpful information for pesticide limits: Pesticide Residues and Guidance Policy. Also, most states’ agriculture departments have pesticide applicator programs. Take a look at Colorado’s Program.
Heavy Metals – Again, the AHPA offers some guidance for heavy metals limits.
What is the status of hemp legislation and the USDA’s rules pertaining to it?
On September 30, 2020, the U.S. Senate has passed a continuing resolution (H.R. 8319) that contains a provision to extend hemp pilot programs through September of 2021. Hemp pilot programs, which were established by the Agricultural Act of 2014 (the 2014 Farm Bill), were initially set to expire Oct. 31 of this year. At that point, all states were required to switch to regulations set forth by the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), which are reiterated in the U.S. Department of Agriculture’s (USDA’s) interim final rule on hemp. (Source: HempGrower.com)
Is Botanacor registered with the DEA?
Short answer: Not yet but we are working on it as fast as we can.
Long answer: In early April 2020, the Botanacor Laboratories DEA Registration was submitted locally and forwarded to DEA Headquarters in Washington DC. We have been informed that the review process is slow, and as a result, the USDA Interim Final Rule on Hemp, Lab DEA Registration has been delayed until 2021. We will have the appropriate DEA registration when the rule takes effect.