Letter to the Industry – Quality Assurance
Public Hearing: May 3rd at 10am
WSLCB Headquarters, 3000 Pacific Avenue SE, Olympia, WA 98504
2017-04-18 Letter to Industry Concerning Proposed Rulemaking WSR 16-24-094 and WSR 17-07-078
The Cannabis Alliance produces this letter to describe in detail our stance on the proposed rule changes regarding Quality Assurance (QA) testing rules submitted to the code reviewers office on December 7th, 2016 as a CR102 filed as WSR 16-24-094 and then refiled on March 17th, 2017 as supplemental CR102 WSR 17-07-078. We believe that these rule revisions constitute significant improvement upon the current, and we support their prompt implementation. Furthermore, we commend the WSLCB for their sincere and ongoing effort to include stakeholder groups in the decision-making process. The complexities of our industry run deep, and only through continued collaboration between all affected parties can we reliably foster a progressive and long-lasting marketplace for safe and accountable marijuana in Washington state in accordance with voter initiative.
Below is a brief outline of the major success this rule making process has promised to deliver. These are items for which we are in full support, and are eager to see implemented.
1. Revising the failure limits for the microbiological test. Possibly the greatest victory for our industry in these proposed rules, the limits for total Aerobic, total Fungal, and total Coliform have been removed. The limit for bile-tolerant gram-negative bacteria has been lifted by 10 x. We have communicated the point that in other industries these limits tests are not used as a pass/fail metric and they are not serious public health concerns, rather, they are indicators of crop health and product quality to be used by industry to assess process sustainability and product value. We estimate that these changes will save the Washington cannabis farmers upwards of 30 million dollars per year collectively.
2. We appreciate the need for new language in rule that will enable the LCB to more rigorously monitor the behavior of accredited labs. Without dramatically increasing the licensing fees associated with accreditation, the proposed rule revisions to the laboratory checklist which will allow the accreditation body to more thoroughly investigate lab processes and documentation, and will allow for swifter response by the LCB when labs with bad practices are identified.
3. Removed microbiological screening requirements for solvent-based extracts, ethanol extracts, and CO2 extracts. These types of materials are not commonly contaminated with living microbiological organisms, so requiring this test of these products constitutes a serious waste of resources.
4. Improved definitions regarding residual solvent analysis, especially with regard to unknown and unwanted solvent impurities and cleaning agents, rather than simply a screen for solvents intentionally used directly in the extraction process.
The following are points that the Cannabis Alliance and its partners have identified as areas of concern with the proposed rules, and we are asking the WSLCB to consider improving upon the current rule revision with a few minor edits, described below:
1. Make clear allowances for non-mandatory QA testing. Cannabis laboratories should be allowed to provide testing capabilities that are not outlined in the legal requirements for QA. Genetic tests, for example, are not outlined in law but can be very informative to a cultivator. When crops are diseased, as another example, the farmer needs to be able to investigate cause by screening for plant pathogens, preferably through their cannabis lab with reasonable traceability. Neither genetic testing nor plant pathogen testing are within the scope of WAC 314-55-102 but should be specifically allowed in rule. There is no substantive argument for limiting quality assurance in a traceable marketplace.
Labs and producers should not face undue legal liability from scientific investigation or routine quality assurance, and yet, current rule is ambiguous as to whether or not voluntary QA testing is allowed and to what extent. Our opinion, which is supported by common practice in other industries – and, indeed, common practice already in this industry – is that voluntary QA should never be limited by rule. Manufacturers are always allowed to maintain and assure a desired level of quality in a product by means of attention to every stage of the process of production. No reasonable authority would limit QA, instead, the WSLCB should focus on traceability of QA material.
Section 102 is about mandatory QA samples, for which certified labs are tasked with specific requirements regarding product safety and labeling. Other forms of non-mandatory QA should not be subject to the same constraints, as these voluntary tests are often outside the scope of WAC 314-55-102.
Revise WAC 314-55-102 (2)
(2) Quality assurance testing required. The following quality assurance tests are the minimum required tests for each of the following marijuana products, respectively. Licensees and certified labs may elect to do additional testing if desired, and must maintain traceable records concerning product transfer when doing so. Only samples designated in traceability as QA samples must meet the requirements of this section ((multiple quality assurance tests on the same lot or testing for mycotoxin, pesticides, or heavy metals pursuant to chapter 246-70 WAC)).
2. Consider mycotoxin testing a temporary measure. There is not yet evidence that mycotoxins are a serious burden to marijuana manufacturing. While there may be enough speculation concerning mycotoxin exposure to justify writing this requirement into rule, we want the LCB to acknowledge that evidence for harm has not been conclusively established.
If the cannabis industry begins screening every production lot for mycotoxin, our industry will quickly collect ample data to make informed decisions about the need for this screening tool. If the data demonstrate that marijuana products are not burdened by mycotoxins at a level that should cause alarm, then we ask the LCB to revisit this issue in 6 months or less. In that time, the industry will have amassed thousands of data points, and from that data the agency can make an informed decision as to whether or not this test is appropriate. In the event the mycotoxin test is deemed unnecessary, we request prompt removal of the test requirement or replacement with a screening regimen that is known to be meaningful to consumer protection regarding marijuana contaminants that are avoidable by the producer/processor, such as: pesticides.
3. Do not set LOQs or LODs. It is the state’s responsibility to set action levels, meaning the level above which constitutes a fail. Limits of quantification (LOQs) and limits of detection (LODs) are determined by the quality of the laboratory instrumentation and the science behind it. Labs should be required to report only values that fall within their calibration curve, and the bottom of their calibration curve should be lower than the action level.
Revise WAC 314-55-103 (27) (j)
Documentation that the methodology has the specificity for the degree of quantitation reported. Final reports ((are not quantitative to any tenths or hundredths of a percent.)) provide justifiable number of significant figures and do not list values outside the appropriate calibration curve.
4. Formation and long-term support of an LCB advisory panel regarding testing rules. The current testing rule revisions are a tremendous step in the right direction, but the work is not done. Marijuana is a very complex drug, with long existing widespread use and definite impact on matters social, legal, clinical and therapeutic. A robust QA protocol will necessarily evolve over time as the industry matures and strengthens. Many of the recommendations proposed and agreed upon by the QA Work Group have not made their way into rule, either because of traceability constraints or otherwise. Examples of such include: statistical sampling of the population, and automatic retesting.
We need the LCB to continue working with industry leaders to revise and revamp the testing procedures to keep up with the evolving science of cannabis. There is still much work to be done concerning the details about how we as an industry approach quality assurance. An advisory panel is the next logical step for the progression of our testing rules, especially once the traceability system is in revision.