Regulatory Update Feb 9, 2017

by Nick Mosely

What follows is a brief outline of what is currently being actively pursued by the Regulatory Committee on 2 main topics: LAB QA RULES REVISIONS and PACKAGING AND LABELING....

The Regulatory Committee is looking for volunteer activists. We need folks who are willing to travel to Olympia at least once per month to voice TCA consensus opinions at public hearings, and also looking for folks who are willing to draft statements describing Alliance consensus opinions. If you are interested in contributing to the regulatory committee, please send an email to Nick Mosely nick@conflabs.com to get on the list. We will be meeting about twice per month via online chat groups and in person. 

What follows is a brief outline of what is currently being actively pursued by the Regulatory Committee: 

LAB QA RULES REVISIONS

Currently there are rule revisionist awaiting supplemental CR102 filing. The 102 is expected to be filed later this month or early next. The rules are the result of 9 months of stakeholder-led discussions. The rule revisions can be found on the LCB’s website under “Proposed Rules”. In brief, the rules accomplish the following:

  1. More accurate potency analysis on flower lots, for the first time using statistical analysis as a means of potency description.
  2. Revisions to the microbiological list and limits will lead to dramatic reduction in failed flower lots. It is estimated that these rule changes will save Washington farmers tens of millions of dollars per year in failed flower.
  3. Revisions to residual solvent list and limits will have effects on some extraction techniques more than others, depending on the solvent used and its purity. In general, the residual solvent rules are relaxed under these proposals, though some solvent impurities are screened for more extensively. The biggest change that will affect processors is the description of ethanol limits.
  4. Dramatic revisions to the “Good Laboratory Checklist”, which is used by the accreditation body when auditing labs. These new rules will aid standardization of lab practices, will make the labs more accountable, and will aid enforcement against nefarious or sloppy labs.

PACKAGING AND LABELING ADVISORY PANEL

The P&L Panel is led by the LCB’s Joanna Eide and is attended by the DOH, the Poison Control Center, MJ Enforcement, and six industry organizations. 

There is currently a survey open regarding Packaging and Labeling thoughts and concerns. Please find the time to take the survey if you haven’t already. Here’s the link: https://www.surveymonkey.com/r/9TFRCPK we need as much participation as we can get.

The Packaging and Labeling Advisory Panel aims to refactor the requirements for P&L. In a broad sense, we are looking for relief on the label requirements, standardization of requirements, and simplification of what is required. Our ultimate goal here is to reduce label crowding. It so far is looking like we will be able to achieve great relief through this panel, and the LCB has communicated that they are willing to allow some of the current label requirements to either be removed from requirement, or to be moved from the label to the “accompanying documents”.

The P&L Panel is looking for your advice. Please fill out the survey.

TRACEABILITY ADVISORY PANEL

The Traceability Advisory Panel is led by multiple department heads at the LCB and is attended by their IT team, their CTO, Enforcement, Traceability, and 5 industry associations. Biotrack’s contract is up at the end of October, and the LCB is required by statute to put forward a new request for proposals. Our primary focus through this experience is to improve upon the traceability system to make it more secure, more agile, and with a more transparent and well-documented API.

What follows are two major questions/concerns that have come up in our first two meetings.

Q: Should the LCB be tasked with providing a free software for licensees to manage required inputs to traceability?

Argument for: Many licensees are already dependent on a free system for mandatory reporting purposes. These stakeholders have established business practices that rely on a free reporting software for meeting compliance requirements. Setting up a state traceability system that does not take into consideration the needs of these stakeholders, and forcing stakeholders to use a paid system is a bad decision. It would add operating costs to many 502 businesses that are already struggling. A free version of traceability is already established as a normative practice in this industry, reversing that course would put undue economic hardship on some licensees.

Argument against: Most of the legitimate complaints, and much of the LCB overhead regarding traceability, comes from the free software they provide. By offering a free software solution to licensees, the LCB is putting itself in a customer service position that adds significant operating costs to their agency, thereby ballooning the cost of this project. The free version, no matter how well intended, is not going to satisfy the needs of any businesses. Our individual operating needs are complex and unique to each business, to the point where a free version provided by government will leave its users unsatisfied and will leave the LCB stuck with offering software support to hundreds of unhappy users. Paid versions created by third-party enterprise software developers are tailored to business needs and offer solutions that are outside the scope of the LCB. By not providing a free software solution, this project could save a significant amount of money

 

Q: Should the awardee of the contract be allowed to also provide a paid version of the software?

Argument for: An awardee will be able to make extra money by providing a paid version, thereby effectively supplementing the project budget with income from their paid version.

Argument against: The contract budget should be ample to complete the project. We should not expect the awardee to “supplement” the contract with other income. Allowing the awardee to sell a paid version creates a conflict of interest, and in the case of Biotrack has led to an unfair trade advantage. We don't want a repeat of past mistakes.

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