During the third and fourth Nevada State Independent Laboratory Advisory Committee (ILAC) meetings, committee members, Division personnel, and key stakeholders slogged through the difficult task of implementing testing policies that are protective to patients, financially feasible for MMEs and technically feasible for Independent Testing Laboratories. Items addressed included:
What happened: The committee recommended a list of 49 potentially harmful chemical analytes to be screened for by Independent Testing Laboratories. The committee recommended a regulatory threshold of 0.1 parts per million (100 parts per billion) for all 49 analytes. Additionally, the committee motioned to allow laboratories to use any testing method/equipment that can accurately determine all analytes at the 0.1 part per million regulatory threshold .
What it means for MMEs: The impact of this recommendation is unclear until a final policy is issued by the Division. State personnel will take the recommendation to the Division for consideration; however, representatives of the Division noted that approval would be a challenge as the recommended limits are in conflict with NAC 453.A.666, which mandates adoption of the "the most stringent acceptable standard for an approved pesticide chemical residue in any food item as set forth in Subpart C of 40 C.F.R. Part 180". Previously, the committee had petitioned the state for the omission of milk and meat from the lowest acceptable standards as these food items do not have pesticides applied to them directly, and, because of that, the tolerances set are extremely low. The Division consulted with legal counsel and has determined that this recommendation constituted a regulation change, which the Division does not have the authority to make at this time. Until this pesticide issue is resolved and an acceptable screening list is adopted by the Division, no product can be tested and approved for sale at a Dispensary.
Additionally, both Pyrethrins and the major active ingredient in Neem oil, Azadirachtin, have been at the forefront of the pesticide debate. While a concentration is established for Pyrethrin concentrations in milk and meat at 0.05 ppm, no tolerance is set for Azadirachtin. With no clear ruling or limits in place, it is recommended that cultivators seriously reconsider applying these compounds to their plants, as doing so may cause batches to fail.
Explained by our chemists: For the time being, the committee is allowing the use of minimum risk pesticides on medical marijuana. These pesticides are known as FIFRA (Federal Insecticide, Rodenticide and Fungicide Act) “25(b) pesticides" and are not subject to federal registration as their active and inert ingredients have been demonstrated to be safe and pose minimum risk. Here is a link to the EPA website for additional info on 25(b) Pesticides. Regarding specific pesticide use, the remaining three hurdles for the committee and the Division are to:
(1) Compile a list of pesticides to test for.
(2) Decide on applicable product concentration limits for these pesticides.
(3) Specify applicable testing methods.
What happened: During the first ILAC meeting, the committee interpreted heavy metals limits as a function of daily dosage rather than an absolute value (concentration) in the product. At the second meeting, committee members discussed setting a daily representative consumption rate so that the interpretation could be applied for testing. In the third ILAC meeting, a daily consumption rate, or 'dose', was set at 5 grams per day. This consumption rate was then applied to table 11 in the Cannabis Inflorescence, the standard adopted by the Division.
What it means for MMEs: The updated interpretation, using 5 grams as a daily consumption ‘standard’, will both protect patient health and ensure that samples submitted for metals testing will not fail when grown under normal conditions (i.e., using irrigation water, soil, and nutrient amendments containing reasonably low levels of the four regulated metals). When the Division issues the policy update using the Cannabis Inflorescence reference and the 5 grams dosage, metals limits will translate to:
- Inorganic Arsenic: 2.0 ppm
- Cadmium: 0.8 ppm
- Lead: 1.2 ppm
- Methyl Mercury: 0.4 ppm
Explained by our chemists: The metals (Cadmium, Mercury, Arsenic and Lead) limit issue has now been resolved, with the committee and the Division deciding to adopt table 11 of the Cannabis Inflorescence as the de facto standard.
By setting a expected standard daily consumption rate of 5 grams, the ILAC and the Division have effectively specified a product concentration limit, enabling the analysis of metals in cannabis flower.
As mentioned previously, 'Daily consumption' is simply an estimate of the average number of grams of marijuana consumed by patients per day. This measure is only used to calculate exposure tolerances and will not legislate patient usage quotas in any way.
Laboratory Proficiency Testing
What happened: While the committee and Division have elected not to dictate testing methods to laboratories, Nevada laboratories will have to submit to proficiency testing to prove competency and ability to return precise and accurate analytical results. Several alternatives from "Round Robin Testing" to "ISO Certification" were discussed. The Division is in the process of developing the proficiency model it will implement, and will have it in place in the next few months.
What is means for MMEs: Testing will not be delayed by proficiency testing. Proficiency testing is not required prior to labs opening for business; however, the Division intends to implement the proficiency testing model within the next few months to ensure laboratories are accurately reporting results for patients.
Thank you for your support and interest. We look forward to discussing more progress in the coming weeks. As always, we are here to help you succeed. If there is anything we can help with, or if you have questions or concerns, please contact us.
The 374 Labs Team