A version of this public comment was submitted to the rules coordinator for Oregon Psilocybin Services on April 22, 2022.
Thank you for the opportunity to provide public comment on the proposed rules covering Psilocybin Products, Training Curriculum, and Testing Rules (Chapter 333) pursuant to the implementation of Measure 109 (2020)/ORS Chapter 475A.
Reason Foundation is a national 501(c)(3) public policy think tank that offers pro-bono research and technical assistance to public officials and other stakeholders to help design and implement policy solutions in a variety of areas, including public finance, public pension solvency, infrastructure, and drug policy. The emerging regulatory framework governing certain controlled substances across various states—including medical and adult-use recreational cannabis and psychedelics—is an area of particular interest. Reason Foundation has advised officials on emerging drug policy transformations in states like Michigan, New Jersey, and Nevada. We are also a founding member of the Cannabis Freedom Alliance, which seeks to advance federal cannabis legalization in a manner that respects state autonomy to self-design their own policies and ensure low barriers to market entry to maximize the opportunity for potential entrepreneurs, especially those communities that have been most severely impacted by the drug war.
Reason commends the diligence with which Oregon Psilocybin Services (OPS) and the Oregon Psilocybin Advisory Board are approaching the groundbreaking work directed by Measure 109/ORS chapter 475A. Public agency rulemaking is always a challenging process, especially so when the underlying subject of regulation is such a new and emergent policy issue. In that light, we believe that overall, you have thus far admirably set out clear goals and objectives while ensuring that the proposed regulatory framework offers licensees significant flexibility in how to achieve them.
At a more detailed level, our review of the proposed rules on psilocybin products, training curriculum, and testing yielded the following observations that we believe warrant additional consideration prior to finalizing the program rules:
- Proposed Rule 333-333-1010 (p6): We understand that for the purposes of launching a manageable regulatory framework for psilocybin services that the inclination of the advisory board centers on offering a limited scope of products (oral preparations only) derived from one authorized psilocybin species (Psilocybin Cubensis). We respect that position as sensible and appropriate for the initial stage of launch. However, we hope in the future the advisory board will consider authorizing additional strains of psilocybin species beyond Psilocybin Cubensis. We also recommend expanding the range of allowed products to include alternative, non-oral consumption modalities in the interest of encouraging product diversity and a wide range of potential product price points, which could help ensure affordable access to psilocybin services consistent with the intent of ORS chapter 475A.
- Proposed Rule 333-333-2010: The proposed rules would ban manufacturer licensees from producing psilocybin “by using genetically modified organisms such as bacteria” or “by chemical synthesis,” potentially forestalling the production of relatively low cost and high-quality psilocybin while placing upward pressure on product pricing. Market innovations have delivered synthetic, yeast-produced, and culture-grown psilocybin compounds demonstrating great promise for safe, efficient production. Accordingly, the current restrictive policy on product sourcing may drive up consumer prices and constrain low-income access to therapeutic psilocybin services, and it is unclear what purported public benefit is expected to result from such a restrictive ban, nor what societal harms the ban attempts to prevent. As current U.S. Agriculture Secretary Tom Vilsack wrote in a 2017 opinion piece, “While public skepticism around the safety of GMOs is significant, the overwhelming evidence demonstrates that these crops have not been linked to a single health risk in the more than two decades they’ve been in our marketplace.”
- Proposed Rule 333-333-2020: This proposed rule requires the prior express approval of every psilocybin product by the Oregon Health Authority. Based on the experience of several states in the medical and recreational cannabis markets, requiring agency pre-approval of every single product licensees are allowed to manufacture will be very duplicative, and it is likely to lead to an inevitable bogging down of the review process administratively, potentially creating lengthy delays in getting new and innovative or transformative products to market. While we understand launching the program with a limited scope of product species and types, we would encourage the advisory board and Oregon Health Authority (OHA) to quickly move towards outlining a set of overarching product standards and then allow any product to pass into commerce if it meets the standards without requiring prior restraint.
- Proposed Rules 333-333-3050 (p24) and 333-333-3060 (p25-27): The required training curriculum modules cover a comprehensive set of categories and subtopics overall. We are specifically encouraged to see the inclusion of the “Group Facilitation” curriculum module. We believe that ensuring regulatory flexibility for service center providers to offer group-based psilocybin services would likely create lower-cost pathways to services and expand access to a wider range of the population, particularly lower-income and historically marginalized populations.
- Proposed Rules 333-333-7090 (p39) and 333-333-7100 (p40): While the testing rules overall appear to be generally well designed, we observed that the currently proscribed sample size for testing appears to be large (2% minimum) relative to a fairly low batch maximum size (1 kilogram). As we have observed from state medical and recreational cannabis markets, beyond a certain point the required sample size relative to the volume of product can create a non-negligible cost in terms of manufacturer licensees’ inventory, not to mention direct testing costs owed by licensees. Because these factors will ultimately play a major role in the pricing of products delivered, establishing the lowest-needed sample size relative to batch size is an important aspect of meeting the stated purposes of ORS Chapter 475A to advance both the safety and affordability of access to psilocybin services. We suggest that OPS consider the potential merits of adjusting the batch size up or the sample size down.
We hope this information is useful and we welcome any related questions or dialogue from Oregon Psilocybin Services staff or members of the Oregon Psilocybin Advisory Board.