Permanent Rule Changes to OAR 333 Division 64 Effective December 27, 2022
New rules have been established for the accreditation of psilocybin testing laboratories. These new rules were adopted to fulfill ORELAP's responsibility to accredit psilocybin testing laboratories required in ORS 475A.590 to 475A.622. These rules also support the Oregon Psilocybin Services Program rules found in OAR 333-333-7010 to 333-333-7150. The rules include new sections covering sampling, testing, and reporting. Also included are rules on psilocybin laboratory enforcement. There is a new sampling protocol for psilocybin products. The rule language includes several new terms which have important definitions. In addition, many editorial changes were made to other sections of the rules. For more information, review the full rule text below.
Permanent Rule Changes to OAR 333 Division 64 Effective July 15, 2022
New rules affecting the accreditation fee schedule are now effective. These are the fees paid by participating laboratories and form the base of ORELAP's funding. Many of the accreditation fees are increasing, while the additional matrix assessment fees are staying the same, and the in-state trip fee is going away entirely. These rule changes are the conclusion of a multi-year study analyzing ORELAP's fiscal needs and exploring possible funding scenarios. Many of these fees have not been increased since the program's establishment in 1999, and laboratories may expect to see significant increases in their annual application and assessment fees. For more information, please see the links below.
Permanent Rule Changes to OAR 333 Division 7 and 64 Effective March 31, 2022
New rules are in effect for accreditation of Cannabis laboratories. Changes were made in Oregon Administrative Rules Chapter 333, Division 7 and 64 to address concerns raised during the 2019 Secretary of State audit of the Cannabis programs. ORELAP-SOP-001, Revision 4.1 will become effective July 1, 2022. ORELAP-SOP-002, Revision 4.3 will become effective March 31, 2022. There are three implementation dates for these rules, to allow a "phase in" period.
Permanent Rule Changes to OAR 333 Divisions 7 and 64 Effective January 1, 2022
New rules are in effect for accreditation of Cannabis laboratories. Changes were made in Oregon Administrative Rules Chapter 333, Division 7 and 64, to align with bills from the 2021 state legislative session. The rule changes address testing requirements for industrial hemp-derived vapor items due to the passage of Senate Bill 96. The ORELAP sampling protocol ORELAP-SOP-002 has been updated to Revision 4.2 to include industrial hemp-derived vapor items. Starting July 1, 2022, delta-8 THC will need to be included in potency testing along with delta-9 THC, delta-9 THCA, CBD, and CBDA due to the passage of House Bill 3000. A summary of actions required by laboratories performing potency testing are below:
- Have at least two acceptable proficiency testing performances out of the past three attempts for delta-8 THC in both the biological tissue and solids matrices.
- Update their SOPs and laboratory procedures as needed.
- Ensure quality control (QC) sample spiking protocols contain all five regulated cannabinoids.
- Add delta-8 THC to their accredited scope by submitting an application request.
Rule changes not associated with legislative bills were also made. The requirement on reporting tentatively identified compounds (TICs) in every sample requiring residual solvent analysis was changed to reporting TICs only when requested by OLCC or OHA. The laboratory must have a defined procedure for evaluating TICs. A clarification was made for combining sampling increments by testing laboratories to ensure that prior to any testing, the combined sample must undergo the laboratory's homogenization process. If the homogenization process would invalidate the analysis for a required test, the laboratory must utilize a subsampling procedure to withdraw a portion of the sample prior to homogenization for the required test. In addition, the laboratory shall not substitute the LOQ for individual components of a totaled result, such as total delta-9 THC or total hexanes, in the calculation of the totaled result for the purpose of calculating relative percent difference (RPD) or relative standard deviations (RSD).