Psychedelic Law, Science & Policy

EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to an Order issued by EPA pursuant to TSCA. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rulemaking to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the conditions of that use for that chemical substance. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination.

This document announces the Agency's receipt of new chemical submissions under the Toxic Substances Control Act (TSCA), including information about the receipt of a Premanufacture Notice (PMN), Significant New Use Notice (SNUN), Microbial Commercial Activity Notice (MCAN), and an amendment to a previously submitted notice; test information; a biotechnology exemption application; an application for a test marketing exemption (TME); and a notice of commencement of manufacture (defined by statute to include import) (NOC) for a new chemical substance. This document also provides a periodic status report on the new chemical substances that are currently under EPA review or have recently concluded review. EPA is hereby providing notice of receipt of this information, as required by TSCA, and an opportunity to comment. This document covers new chemical submissions that have passed an initial screening and, for PMNs, SNUNs and MCANs, were determined to be complete, during the period from 1/1/2026 to 1/ 31/2026 regardless of the initial submission date.

Background: Understanding the benefits of psychedelic-assisted therapy (PAT) will require scientific attention to the causal interaction between the therapeutic context and process. Measuring what actually happens during PAT in large-scale studies will be an essential component of this work. Objective: We aim to develop and preliminarily evaluate the feasibility and reliability of a direct observation coding system for narrations of awe experiences during PAT, one hypothesized therapeutic mechanism. Methods: We analyzed 32 PAT clinical trial encounter recordings involving eight participants from a Phase 2 clinical trial study of psilocybin-assisted therapy in advanced cancer. Using a conceptually grounded structured codebook, two human coders independently identified start and stop times for moments exhibiting definitional characteristics of awe narration, including expressions of vastness, need for accommodation and ineffability. We used coder agreement and degree of confidence to refine the coding system. Results: During 16,760 total minutes of video, coders collectively recorded 246 moments of awe narration. Of those moments, 42% (104/246) were identified by one coder and 58% (142/246) by two coders. Coders felt substantially more confident in their judgments about a moment of awe when vastness was present compared to when vastness was absent (OR: 4.3; 95% CI: 2.4, 7.8). Iterative refinement of the coding system led to accommodation being operationalized as two distinct components: an initial cognitive disruption followed by variable engagement in the process of accommodation. Conclusions: Awe narration is directly observable using explicit definitional criteria. This work provides the empirical foundation for scalable coding systems of awe narration during PAT.

BACKGROUND: We know little about the extent psychedelic substances are consumed therapeutically and/or discussed with medical professionals despite renewed global interest in these substances. METHODS: We examined self-reported responses from the 2023 International Cannabis Policy Study (ICPS) in repeated cross-sectional surveys in Canada, the United States, Australia, and New Zealand. The survey included questions on lifetime, past year, and past month use of psilocybin, LSD, MDMA, and ketamine. It inquired about respondents' discussions with medical professionals, their self-reported medical use, and related adverse events. We estimate the mean proportion rate for each of these using logistic regression methods that adjust for demographics, country, and sampling weights. FINDINGS: Estimated results suggest nineteen per cent of all ICPS respondents reported lifetime use of one of the four substances. Psilocybin was the most commonly estimated to be used in one's lifetime and in the past year, followed by LSD and MDMA. Estimated prevalences of ever using psilocybin were higher among respondents from Canada (16.3%, CI: 15.6-16.9%) than the USA (13.0%, CI: 12.3-13.6%) and New Zealand (12.1%, CI: 10.4-13.8%). Estimated rates of psilocybin ever use in Australia were significantly lower (7.8%, CI: 6.8-8.8%). An estimated 10-20% of respondents who report ever-use of a psychedelic asked their medical provider about medical use, and over a third who had used in the past year reported experiencing an adverse health effect. Estimated rates of past month use were low for all countries. INTERPRETATION: Consumer interest in therapeutic use of psilocybin, MDMA, LSD, and ketamine has surpassed the pace of clinical trials and therapeutic use provisions. These provisions do not necessarily equate to patient access and dual use motivations are not uncommon. Access via nonregulated pathways and self-initiated use in the absence of medical supervision may influence the proportion of individuals who experience adverse events.