During the second Nevada State Independent Laboratory Advisory Committee (ILAC) meeting on March 4th, committee members, Division personnel, and key stakeholders in attendance made great progress in working with the difficult language of the State's codes and statutes (NAC/NRS 453.A) concerning medical marijuana testing policy. Key items addressed at the meeting included:
What happened: The committee approved a list of pesticides (“25(b) Pesticides”) to be used by cultivators.
What it means for MMEs: The industry can move forward using the current approved list of pesticides. The list excludes commonly used items such as neem oil and pyrethrins; however, the list is considered a living document, and the committee is open to discussing the approval of other pesticides at request of the public. Laboratories are not required to test for any of the items on the 25(b) list, so the committee must still (1) identify and (2) specify testing/limits for ‘commercial’ pesticides and plant growth regulators that have the potential to harm patients. We are hoping this will be completed by the next meeting.
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.
Most of the pesticides on the 25(b) list are not amenable to accurate quantitation given the diverse chemical composition of many formulations (e.g., dried blood, putrescent whole egg solids.)
What happened: During the first ILAC meeting, the committee interpreted heavy metals limits as a function of body weight rather than an absolute value (concentration) in the product. At the second meeting, committee members discussed setting an average body weight and dosage so that the interpretation could be applied for testing.
What it means for MMEs: The original limits set by the State were unattainable by cultivators and producers, and these limits would have caused most product to fail. The updated interpretation, once body weight and dosage are defined, will be attainable while still providing a safeguard for patients.
Explained by our chemists: The metals (Cadmium, Mercury, Arsenic and Lead) limit issue has been partially resolved, with the committee and the Division deciding to interpret NAC 453A.658, Article 8 as ug/kg “body weight/day.” This implies that exposure dose is a function of body mass, instead of an expression of a product 'limit' (concentration of metals in marijuana) as ug metal per kg product, as the adopted regulations currently read. The two key issues missing for the completion of this item are:
(1) A definition of 'daily consumption'
(2) Average patient weight.
'Daily consumption' is simply a measure of the 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. Once these items are finalized, the metal limit, or tolerance, will almost certainly be in the parts per million range, as opposed to the parts per trillion range (mistakenly) specified in NAC 453A. The committee is carefully reviewing established toxicological risk assessment data on heavy metals to ensure that patients are not exposed to unhealthy levels of these contaminants.
What happened: Concern was raised that the Adopted Regulations do not comprehensively address the issue of batch failures that are allowed to be converted to extracts.
What it means for MMEs: Cultivators and Producers do not want to pay twice or “Double-Dip” for testing, but the Division and the committee need to make sure that no testing loopholes exist that could pose a health risk to patients.
Explained by our chemists: As currently written, the Adopted Regulations R004-14 stipulate in Section 127.1 that failed batches may, upon approval of the Division, be used to make a CO2 or solvent-based extract. The Regulations are unclear as to the (re)testing requirements for extracts made from these failed batches, and producers are concerned about the possibility that the Division will require 'double-dip' testing of initial harvest product AND secondary extracts for the entire suite of laboratory tests. The committee has taken these concerns under advisement and the suggestion that re-testing of batches should be limited to the specific tests that failed was favorably received. We will continue to monitor this issue, and will report on any further discussion and / or substantive action by the committee during future meetings.
Currently, meetings are scheduled once a month due to lack of Division funds and resources to arrange video conferencing. Nevada System of Higher Education (NSHE) Regent James Dean Leavitt has agreed to facilitate weekly meetings, as necessary, to allow the committee to work through urgent and unresolved issues.
Issues needing additional attention include:
- Adoption of committee bylaws
- Creation of a pesticide analyte list and methodology approval
- Finalization of the metals limit
- Finalization of testing requirements for residual solvents in extracts
highlighting committee members and attendees each session
Ed Alexander, owner of Sensible Edibles and Common Sense Botanicals in Northern Nevada was elected to chair the committee. He has proven himself adept at running meetings and keeping discourse on point and applicable to the subject at hand.
Northern Nevada committee member Dr. Glenn Miller’s analytical and chemistry expertise is much needed and helps guide the committee through crucial decisions. Together, Ed and Glenn form a strong team that works well with members of the MME community and the Division.
Representatives from the Nevada Department of Agriculture joined the meeting, expressing willingness to work with the Division and committee on establishing new precedents for pesticide use on marijuana in Nevada - a huge step in the right direction for the medical marijuana community.