Or. Admin. Code § 333-064-0140

Current through Register Vol. 63, No. 11, November 1, 2024

Section 333-064-0140 - Psilocybin Products Sampling Procedures and Testing

(1) For purposes of this rule the definitions in OAR 333-333-1010 apply unless the context indicates otherwise.

(2) Sampling.

(a) A laboratory must have and follow psilocybin products sampling policies and procedures, accredited by the Oregon Environmental Laboratory Accreditation Program (ORELAP), that:

(A) Ensure sampling will result in a sample that is representative of the batch being sampled.

(B) Require sampling and laboratory personnel to document and collect any information necessary for compliance with these rules, OAR chapter 333, division 333, and any applicable TNI Standards.

(C) Require chain of custody procedures consistent with the TNI Standards.

(D) Are appropriate to the matrix being sampled.

(E) Are consistent with OAR 333-333-7100 and the ORELAP sampling protocol, ORELAP-SOP-004 Rev 1.0, approved by the accrediting body and incorporated by reference.

(F) Ensure that only the finished psilocybin product is sampled if testing the finished product is required under OAR 333-333-7100.

(G) Contain training and education requirements for sampling personnel.

(b) Sampling policies and procedures must be accredited by ORELAP prior to any psilocybin product samples being taken.

(c) Laboratory personnel that perform sampling must:

(A) Comply with the laboratory's accredited sampling policies and procedures.

(B) After taking samples:

(i) Document the samples in accordance with subsection (2)(e) of this rule; and

(ii) If sampling for a manufacturer required to comply with Psilocybin Tracking System (PTS) tracking under ORS 475A.400, record the sampling and transfer information in the tracking system, as required by the Oregon Health Authority (Authority).

(C) Take care while sampling to avoid contamination of the non-sampled material. Sample containers must be free of analytes of interest and appropriate for the analyses requested.

(D) Take sample increments that are representative of the batch being sampled.

(d) A sufficient sample size must be taken for analysis of all requested tests and the quality control performed by the testing laboratory for these tests.

(e) A laboratory must comply with any recording requirements for samples and sample increments in the accredited policies and procedures and at a minimum:

(A) Record the location of each sample and sample increment taken.

(B) Assign a field identification number for each sample and duplicate sample that have an unequivocal link to the laboratory analysis identification.

(C) Assign a unique identification number for the test batch in accordance with OAR 333-333-7110 and TNI Standard requirements.

(D) Have a documented system for uniquely identifying the samples to be tested to ensure there can be no confusion regarding the identity of such samples at any time. This system must include identification for all samples, sample increments, preservations, sample containers, tests, and subsequent extracts or digestates.

(E) Place the laboratory identification code as a durable mark on each sample container.

(F) Enter a unique identification number into the laboratory records. This number must be the link that associates the sample with related laboratory activities such as sample preparation. In cases where the sample collector and analyst are the same individual, or the laboratory pre-assigns numbers to sample containers, the unique identification number may be the same as the field identification code.

(f) Combining sample increments.

(A) Sample increments collected from the same batch of whole fungi shall be combined into a composite sample and homogenized prior to testing.

(B) Sample increments collected from the same batch of homogenized fungi, psilocybin extract, or edibles shall be combined into a composite sample.

(i) Increments from a primary sample must be combined into a single composite sample.

(ii) Increments from a duplicate sample must be combined into a composite sample separate from the primary sample composite sample.

(C) Prior to any testing or subsampling, each composite sample must undergo the laboratory's homogenization process.

(D) 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. Testing that would be invalidated by the homogenization process includes but is not limited to, cryogenic sterilization of the sample prior to microbiological analysis.

(3) Compliance testing validity.

(a) When testing a sample for the required chemistry compliance tests as described in OAR 333-333-7040 and 333-333-7050, a laboratory shall comply with additional method validation as follows:

(A) Run a method blank in accordance with TNI Standard requirements to demonstrate the procedure is free of contaminants at or above the limit of quantitation.

(B) Run a laboratory control sample (LCS) in accordance with TNI Standard requirements to demonstrate acceptable performance of the procedure. Acceptable performance of the LCS means percent recovery for all regulated analytes are within the limits specified in Exhibit D, Table 1.

(C) Calculate a measure of precision within each analytical batch. This may be done by analyzing an analytical duplicate sample or a laboratory control sample duplicate (LCSD) and calculating the relative percent difference (RPD). An analytical duplicate sample is prepared from a second aliquot of material from the same sample to determine variability of measurements within the laboratory.

(b) When performing a speciation test as described in OAR-333-333-7030, a laboratory shall use any DNA-based approach that has been validated to show acceptable inclusivity, exclusivity, and probability of detection (POD). A laboratory shall comply with additional method validation as follows:

(A) The laboratory must perform initial method validation to include inclusivity and exclusivity testing using whole tissue or cultured organisms. This is to show the laboratory has proficiency with the DNA extraction, replication, and detection processes and can demonstrate the ability to differentiate between the target organism and other organisms that may be found in samples. Nothing in these rules prohibits testing laboratories from possessing Psilocybe cubensis for purposes of method validation and testing.

(B) Run a negative control to show laboratory reagents and equipment are not causing false positives.

(C) Run a positive control with each batch to show acceptable performance of the method. Acceptable performance means detection of target DNA sequences in the positive control that has been spiked with Psilocybe cubensis genetic material.

(D) Demonstrate acceptable performance as described in the manufacturer's instructions of an internal amplification control (IAC) in each sample analyzed by a polymerase chain reaction (PCR) method. In the case of a positive result for Psilocybe cubensis in a sample with an unacceptable performance of the IAC, follow the manufacturer's instructions on interpretation of acceptability.

(4) Compliance testing results should not be adjusted for percent moisture, or on any other basis except to account for extraction and dilution during laboratory preparation.

(5) Calculating RPD and relative standard deviation (RSD.)

(a) A laboratory must use the following calculation for determining RPD:

Relative Percent Difference

%RPD=|(sample-duplicate)|/((sample+duplicate)/2) * 100

(b) A laboratory must use the following calculation for determining RSD:

Standard Deviation

S= [SQUARE ROOT]([SIGMA]((xi-x)²)/(n-1))

Relative Standard Deviation

%RSD= (S/x)* 100

(c) For purposes of this section:

(A) S = standard deviation.

(B) n = total number of values.

(C) xi = each individual value used to calculate mean.

(D) x = mean of n values.

(d) For calculating both RPD and RSD if any results are less than the Limit of Quantitation (LOQ) the absolute value of the LOQ is used in the equation.

(6) A laboratory must provide any pesticide test result to the Authority upon its request.

(7) A laboratory performing tests for a manufacturer required to use PTS under ORS 475A.400 must enter any information required by the Authority in PTS.

(8) A laboratory performing tests for a manufacturer must comply with the documentation requirements in OAR 333-333-7100 and must maintain the documentation required in these rules for at least three years and provide that information to the Authority upon request.

(9) The Authority may, in its discretion, permit a laboratory to deviate from TNI Standards in order to comply with OAR 333-333-7020 to 333-333-7150 and these rules based on the state's needs. Permission to deviate from TNI Standards must be in writing from the Authority.

(10) A laboratory must be able to demonstrate that its limit of quantitation (LOQ) for compliance testing is less than or equal to one-half of any action level established in OAR 333-333-7050.

(11) Non-compliance testing. A laboratory that conducts a quality control or research and development test for a manufacturer may use methods not approved by the Authority, but the laboratory may not identify those test results as accredited results.

(a) Accredited laboratories may not receive psilocybin product from a source that is not licensed under ORS 475A.290.

(b) Notwithstanding subsection (11)(a), it is not a violation of these rules for an accredited laboratory to receive materials containing psilocybin for purposes of establishing instrument calibrations or validating laboratory processes necessary for testing required under ORS 475A.590 from the following entities:

(A) Providers of certified reference materials;

(B) Approved or accredited providers of proficiency tests;

(C) The Oregon State Reference Laboratory or any agent acting in an official capacity for the Authority or the Oregon Department of Agriculture; or

(D) Individuals providing material that is not tracked in PTS for the exclusive purpose of laboratory method development.

Or. Admin. Code § 333-064-0140

PH 207-2022, adopt filed 12/27/2022, effective 12/27/2022; PH 68-2024, amend filed 07/09/2024, effective 7/23/2024

To view attachments referenced in rule text, click here to view rule.

Statutory/Other Authority: ORS 438.605, 438.610, 438.615, 438.620, 475A.590 & 475A.606

Statutes/Other Implemented: ORS 438.605, 438.610, 438.615, 438.620, 475A.590 & 475A.606