Why Is Third Party Testing Important?
Sweeping changes in the regulation of hemp means that people will have unprecedented access to its products and the benefits they can offer. Because of this, transparency with respect to how hemp products are made and their ingredients is paramount. Third-party testing for areas such as pesticides and heavy metals has become a cornerstone of this space to ensure that consumers receive only the most reliably consistent, effective, and safe products possible. The variability of regulatory frameworks at the state, national, and international levels can certainly make things confusing when looking for a safe and consistent product. Herein lies what we have learned in our time in the CBD space and how to ensure that every person that purchases a product from us can rest easy in knowing that what they are receiving is safe and effective.
Hemp Testing: Why the Confusion?
As states continue to bring hemp programs online, they are also establishing testing programs to make certain products brought to market are safe. One of the most fascinating properties of the hemp plant is its propensity as a powerful phytoremediator, meaning it has a unique capacity to remove and contain toxins and heavy metals from the soil in which it grows.¹ While this makes hemp an excellent choice for decontaminating polluted land and has been used as such to reclaim even the radioactively-tainted lands of post-fallout Chernobyl, it also means cultivators and processors with an end goal of manufacturing hemp-based products for consumers must be very careful where they grow their crop. One must diligently test their plants and products to ensure they are safe for consumers.
Considering the different ways these products are consumed, it can be difficult to establish safe levels for potentially hazardous components such as heavy metals or pesticides. Many testing programs simply set their limits based on the assumption that the material will be heated; vaporized, smoked, or otherwise combusted for intake via the lungs. This leads to the acceptance of too-low limits as combustion of pesticides and heavy metal complexes can lead to hazardous degradation products that the end user will inhale. The difficulties are further compounded by the lack of continuity from state to state and country to country, for establishing universally accepted safe levels (or “action limits”) of heavy metals and pesticide in all natural products meant for human use, especially in regards to hemp.
As many are aware, however, inhalation is not the only way hemp products are consumed. One look at our product page, for example, shows that while our isolates may be inhaled, the vast majority of our products are meant to be consumed orally, sublingually, or topically. The act of combustion has a profound effect on the constituents of hemp products and can massively alter what is safe and not safe for internal use.
It is also critical to note that these levels are required for marijuana (high THC concentration) products, and no such requirement is currently in place for hemp products (high CBD, <0.3% THC). Therefore, the issue of contaminants in hemp-derived CBD products is doubly complicated: the testing limits set forth don’t necessarily apply to the majority of use cases for hemp-derived CBD products and companies aren’t legally compelled to test for these contaminants. This leads to confusion surrounding how hemp-derived CBD products should be tested, what standards to which they should be held, and what ultimately constitutes a safe product. To date, a good-faith effort to determine safe levels of contaminants in hemp products based on their method(s) of ingestion has not been undertaken, leaving hemp products at the mercy of inapplicable analytical standards.
Case Study: Myclobutanil
To provide more insight into this issue, let’s look at Myclobutanil as an example. Myclobutanil is a fungicide that is marketed under the trade name Eagle 20 EW and is a common fungicide used in the agricultural industry. Its chemical structure is shown below in Figure 1.
It is registered with the United States Environmental Protection Agency (US EPA), who have set Maximum Residue Limits (MRLs) for its use in a variety of agricultural applications. These limits range from as low as 0.02 PPM (asparagus) to as high as 10 ppm (raisins from grapes) and represent levels that the EPA has determined to be safe for consumption.² Figure 2 outlines the limits set by the EPA for a few crops where myclobutanil is commonly found.³
These levels are set on an individual or crop group basis, meaning that the use of a pesticide on one commodity does not confer the approval of its use on another. Due to the aforementioned propensity for hemp to act as a bioaccumulator, it is not uncommon to find this compound in hemp grown on land that was previously used for the cultivation of other crops. However, as of November 2018, there are no set acceptable limits for myclobutanil in hemp from the US EPA and thus it has been left to individual states to make the determination for themselves. Figure 3 outlines what was determined to be the MRL for myclobutanil in a number of states that have established marijuana testing programs.
This begs the question: why are the limits set forth by state-specific cannabis testing programs set at a much lower level while the EPA has set limits far higher for a number of other commodities? The answer lies in the structure of the compound itself.
Myclobutanil contains a cyano functional group (circled below). This functional group appears in a variety of molecules, including those found in the pharmaceutical, clinical, and nutraceutical industries (cyanocobalamin, also known as Vitamin B12, contains one of these groups). When a cannabis product that contains myclobutanil is vaporized or combusted, myclobutanil has the propensity to degrade, and one of those potential degradation products is hydrogen cyanide. Hydrogen cyanide is well known to have toxic effects ranging from headaches and difficulty breathing to cardiac arrest and death. Thus, it is very prudent for cannabis testing labs to require a very low limit for this compound in products meant to be smoked or vaporized.
This does not, however, address the issue of toxicity of this compound in edible products. Given the higher values seen for other food commodities, it is unclear whether the level set forth by cannabis testing labs would represent an equivalent health risk for edible hemp products. In fact, given values we see for other edible commodities, one would expect that value to be substantially higher than the levels set forth by cannabis testing labs. To date, regulatory bodies have opted to utilize a blanket regulation for all cannabis products, and there is no expectation for clarity on this issue until there is a determination from the EPA or other similar regulatory body. Lazarus Naturals will continue to be at the forefront of the efforts to establish concrete regulations surrounding hemp products with robust methodology and data to support any claims or mandates.
How Does Lazarus Naturals Conduct their Third-Party Testing for Heavy Metals and Pesticides?
With respect to limits for heavy metals and pesticides and in an effort to ensure the utmost safety when using our products, we currently observe the recommendations laid out in the American Herbal Pharmacopoeia Cannabis Monograph in lieu of the lack of formal mandates from the EPA, USDA, or similarly positioned regulatory body.⁸ Testing for heavy metals and pesticide levels are tested at ISO/IEC 17025 accredited 3rd party testing laboratories. Metal Limits Recommended For Herbal Products in the US.⁸
Heavy Metal and Pesticide Limits Recommended For Herbal Products in the US
We adhere to the recommendations for heavy metal limits set forth by the AHP, as detailed in the table below:
For pesticides, the AHP recommends the following:
Where no limits are specifically established for a specific crop or class of crops, the limit is zero (0), generally considered as <0.01 ppm or <10 ppb according to the analytical methods set forth in the Pesticide Analytical Manual…
The information outlined above is the standard to which we will be holding all Lazarus Naturals products going forward. All results henceforth will be reported on a per serving basis. We also want to remind you that Lazarus Naturals CBD products should never be combusted, smoked, or diffused under any circumstance with the exception of our isolates which we hold to the standard of non-detectable levels of residual solvents, heavy metals, and pesticides before approving for sale.
It's our aim to manufacture the best CBD products so that your wellness is realized. This is also why we consider it imperative to remain transparent so that you can continue to make informed decisions and feel confident in enacting them.
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Sources:
¹https://www.researchgate.net/publication/281651509_Phytoremediation_Potential_of_Hemp_Cannabis_sativa_L_Identification_and_Characterization_of_Heavy_Metals_Responsive_Genes
²https://www.ecfr.gov/cgi-bin/text-idx?SID=2c85909360c7c5aff63ddd1447545d6a&mc=true&node=se40.24.180_1443&rgn=div8
³http://npic.orst.edu/reg/tolerance.html
⁴https://bcc.ca.gov/law_regs/mcrsa_lab_ptor.pdf
⁵https://www.colorado.gov/pacific/agplants/pesticide-use-cannabis-production-information
⁶https://www.oregon.gov/oha/ph/PreventionWellness/marijuana/Documents/oha-8964-technical-report-marijuana-contaminant-testing.pdf
⁷https://app.leg.wa.gov/WAC/default.aspx?cite=246-70-050
⁸American Herbal Pharmacopoeia (2014). Analytical. American Herbal Pharmacopoeia, Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control (pp.41-52). USA: AHP.