Recommended Revisions to Proposed Rules (WAC-246-70-050) for Medical Marijuana Product Compliance Quality Assurance Testing



2(b) Certified third-party labs must screen for any pesticides that are not allowed and are designated as having the potential for misuse on a list created, maintained, and periodically updated by the department of agriculture and the WSLCB. Certified third. party labs must also screen for pyrethrins and piperonyl butoxide (PBO) in samples of finished concentrates and extracts.

Proposed Revision:

2(b) Certified tThird-party labs certified to provide pesticide analysis that must screen for any pesticides that are not allowed and are designated as having the potential for misuse on a list created, maintained, and periodically updated by the department of agriculture and the WSLCB. This list shall include limits of detection for all compounds. Certified third-party labs must also screen for pyrethrins and piperonyl butoxide (PBO) in samples of finished concentrates and extracts.

Rationale:

Although no level of a prohibited pesticide is permitted, it is necessary to establish limits of detection to define what instrumentation and methods are acceptable for detecting pesticides. Without such limits, certified labs could choose an invalid instrument or an impotent method that subverts this regulation. Detection limits also help gauge and limit the rate of false-positive and false-negative results. Without detection limits, issues enforcing pesticide regulations and testing incongruities can be expected.

Establishing specific limits of detection or maximum residue levels (MRL) for individual pesticides may not be appropriate in the regulations themselves for two reasons: 1) the toxicological data for these compounds, especially for inhalation, is uncertain and is likely to evolve over time and 2) more consideration should be given to appropriate levels than is possible with the rules expected to be finalized shortly.i Nevertheless, it is strongly recommended that the list contemplated above include detection limits and/or MRLs.  

 

 2(c)(i) A sample of any marijuana product shall be deemed to have failed if a pesticide that is not allowed is detected in any measurable and positively verified amount.

Proposed Revision:

2(c)(i) A sample of any marijuana product shall be deemed to have failed if a pesticide that is not allowed is detected in any measurable and positively verified amount. above the limit of detection for that pesticide on the list established and maintained by the department of agriculture and WSLCB.

Rationale:

Establishing limits of detection is essential for the reasons stated above.

Action Levels or Maximum Residue Levels (MRLs), i.e. tolerances, are also recommended to understand the severity of the contamination. Action Levels do not condone the use of “any” prohibited pesticide, but can be useful in understanding the degree of the potential hazard.  Since there is limited toxicological information for some of these pesticides, especially for low concentration exposure via inhalation, it is challenging to set these levels in a meaningful way from a hazard analysis perspective. Nevertheless, establishing some levels is required to inform a regulatory system that will need to triage and decide what enforcement and potentially public safety action is warranted.  

Ideally, an advisory group would be tasked with establishing detection limits that not only make sense from an analytical instrumentation perspective, but also tolerances in the context of toxicological hazard and environmental exposure from other sources. An advisory group may decide to begin with the EPA determined reference dose (mg/kg/day) for each pesticide, then use an average body weight (e.g. 50 kg) and a conservative daily consumption amount (e.g. 10 grams of cannabis flower) while addressing the potential for increased toxicity via inhalation versus ingestion (i.e. 10x safety factor) to arrive at these tolerances.

Expedient approaches for creating detection limits and tolerances for pesticides are also possible. Oregon’s medical cannabis rules [OHA 333700871190 8(c)], define a positive test for pesticides at the level of “more than 0.1 parts per million.” One more detailed approach would involve using the Action Levels specific to each compound as outlined in the Oregon Health Authority’s report of

2015.ii This approach is summarized in the attached Appendix. This does not obviate the need for an advisory group, or commissioned research, to address the matter in more depth but it does allow for the implementation of some levels immediately.  

 

2(c)(ii) A sample of finished concentrate or extract shall be deemed to have failed if more than 1.0 ppm of allowed pyrethrins or 2.0 ppm of piperonyl butoxide (PBO) is detected.

Proposed Revision:

2(c)(ii) A sample of finished concentrate or extract shall be deemed to have failed if more than 1.0 ppm of allowed pyrethrins or 2.0 ppm of piperonyl butoxide (PBO) is detected. For all other prohibited pesticides, the limit of detection will be included on the pesticide list established and maintained by the department of agriculture and WSLCB. For concentrates and extracts, pesticide analysis is not required for input material but only for the finished concentrate or extract.  

Rationale:

Levels should be set according to maximum daily usage quantities to gauge hazard. Those quantities vary by product type. Double7testing of plant material and concentrate/extract for pesticides is redundant. Requiring pesticide testing at the concentrate/extract level is a logical “critical control point” because many pesticides may be concentrated 10-15x in extracts. In some cases, pesticides that are undetectable on plant matter can be detectable in extracts produced therefrom. Because of this, a “clean” test on input plant material is not sufficient to infer the same for an extract produced from that material.

In general, the final product should be the focus of mandated pesticide testing, whether that product is useable cannabis, concentrate or infused product. For concentrates and infused products, pesticide testing should be mandated per batch with the batch size logically defined according to one extraction or production batch unit. For example, if an extraction operation yields a maximum of 2 lbs. per run, that should be the batch size. If 10 lbs. is the maximum, 10 lbs. would require one pesticide QA test. The goal should be to avoid mega batches of finished product for which the testing sample(s) cannot possibly be representative or to implement statistical sampling plans to ensure representativeness.

 

2(d) A harvest or batch deemed to have failed pesticide screening must be destroyed.  Marijuana flowers, trim, leaves, or other plant matter deemed to have failed pesticide screening must not be used to create extracts or concentrates. Imported cannabinoids deemed to have failed pesticide screening must not be added to any marijuana product.

Proposed Revision:

2(d) A harvest or batch deemed to have failed pesticide screening must be destroyed unless the WSLCB grants permission for that material to be remediated. Marijuana flowers, trim, leaves, or other plant matter deemed to have failed pesticide screening must not be used to create extracts or concentrates. must be designated in the Traceability system as “failed for pesticides” but may be used to make extracts and can be further utilized if the licensee demonstrates to WSLCB that the concentrate or extract meets pesticide quality requirements. Imported cannabinoids deemed to have failed pesticide screening must not be added to any marijuana product. unless the licensee demonstrates to WSLCB that the remediated product meets pesticide quality standards.

Rationale:

If a product can be remediated, it is logical that it be permitted to do so pending verification of quality standards. Remediation may be impossible for some types of failures, or economically unfeasible for others. If the destruction provision is meant to be punitive to licensees caught in violation of pesticide requirements that should be dealt with in the violations section of the WAC [314-55-520 through -537].

 

3(b) A harvest deemed to have failed heavy metal screening must be destroyed.  Marijuana flowers, trim, leaves, or other plant matter deemed to have failed heavy metal screening must not be used to create extracts or concentrates. Imported cannabinoids deemed to have failed heavy metal screening must not be added to any marijuana product.

Proposed Revision:

3(b) A harvest deemed to have failed heavy metal screening must be destroyed. must be designated in the Traceability system as “failed for heavy metals” but may be used to make extracts and can be further utilized if the licensee demonstrates to WSLCB that the concentrate or extract meets metal quality requirements. Marijuana flowers, trim, leaves, or other plant matter deemed to have failed heavy metal screening must not be used to create extracts or concentrates. Imported cannabinoids deemed to have failed heavy metal screening must not be added to any marijuana product. unless the licensee demonstrates to WSLCB that the remediated product meets metal quality standards.

Rationale:

If a product can be remediated, it is logical that it be permitted to do so with verification of quality standards. Remediation may be impossible, or economically unfeasible, for some failures. Removing metal contamination presents less of a technical challenge than removing many pesticides so should be easier and less costly to accomplish.iii  

Some data suggests that a large percentage of current cannabis in the i502 system could fail the proposed metal quality standards. If this occurs and there is not a path to make that product fit for sale, patient access and availability could be challenged by a limited supply of compliant products.  

  

                           

 i Nicholas Sullivan, Sytze Elzinga, and Jeffrey C. Raber, “Determination of Pesticide Residues in

 ii Farrer DG. Technical report: Oregon Health Authority’s process to decide which types of contaminants to test for in cannabis. Oregon Health Authority. 2015 December. p. 8.

 iii Sullivan, et al. Extraction Efficiencies of Heavy Metals in Hydroethanolic Solvent from Herbs of Commerce. Journal of AOAC International. Vol. 93, No. 2, 2010.