333-064-0005
Purpose

(1) These rules are for the following purposes:

(a) Implementing Oregon Revised Statutes (ORS) 438.605 to 438.620, 448.280 and the Oregon Drinking Water Quality Act of 1981. ORS 438.610 states that the Oregon Health Authority shall, by adopting standards in concurrence with the accrediting body, implement an environmental laboratory accreditation program hereafter referred to as the Oregon Environmental Laboratory Accreditation Program (ORELAP).

(b) Establish requirements for the accreditation of laboratories analyzing samples under the guidance of the Clean Air Act (CAA), Clean Water Act (CWA), Safe Drinking Water Act (SDWA), the Resource, Conservation and Recovery Act (RCRA), cannabis testing under ORS 475C.540 to 475C.586, and psilocybin testing under ORS 475A.590 to 475A.622.

(2) The following must be done by an ORELAP accredited laboratory:

(a) Testing of water samples under ORS 448.150, Oregon’s Drinking Water Quality Act.

(b) Testing and sampling of cannabis under ORS 475C.540 to 475C.586, except with written permission from the Authority or Commission.

(c) Testing and sampling of psilocybin products under ORS 475A.590 to 475A.622, except with written permission from the Authority.

Statutory/Other Authority: ORS 448.150, 448.131, 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544, 475C.560, 475A.590 & 475A.606
Statutes/Other Implemented: ORS 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544, 475C.560, 475A.590 & 475A.606
History:
PH 207-2022, amend filed 12/27/2022, effective 12/27/2022
PH 34-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 30-2020, minor correction filed 05/07/2020, effective 05/07/2020
PH 17-2016, f. & cert. ef. 6-7-16
PH 31-2015(Temp), f. 12-29-15, cert. ef. 1-1-16 thru 6-28-16
PH 6-2011, f. & cert. ef. 8-9-11
PH 20-2003, f. 12-02-03, cert. ef. 12-08-03
PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04
OHD 16-2002, f. & cert. ef. 10-10-02
OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0010
Scope

(1) These rules apply to:

(a) Laboratories seeking accreditation to perform environmental or agricultural laboratory testing;

(b) Laboratories seeking accreditation to perform sampling and laboratory testing of marijuana items and industrial hemp-derived vapor items as required by ORS 475C.560;

(c) Laboratories seeking accreditation to perform sampling and laboratory testing of psilocybin products as required by ORS 475A.606; and

(d) Accredited laboratories performing:

(A) Environmental or agricultural testing;

(B) Sampling and testing of marijuana items and industrial hemp-derived vapor items; or

(C) Sampling and testing of psilocybin products.

(2) Accreditation as described in these rules is required for all laboratories reporting drinking water analysis results to the Oregon Health Authority except for Oregon Department of Agriculture Laboratory, Oregon Department of Environmental Quality Laboratory and the Oregon State Public Health Laboratory which must be certified by the United States Environmental Protection Agency for drinking water analysis.

(3) Accreditation as described in these rules is required for all Oregon laboratories sampling and testing marijuana items and industrial hemp-derived vapor items.

(4) Accreditation as described in these rules is required for all Oregon laboratories sampling and testing psilocybin products.

Statutory/Other Authority: ORS 448.150, 448.131, 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544, 475C.560, 475A.590 & 475A.606
Statutes/Other Implemented: ORS 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544, 475C.560, 475A.590 & 475A.606
History:
PH 207-2022, amend filed 12/27/2022, effective 12/27/2022
PH 35-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 31-2020, minor correction filed 05/07/2020, effective 05/07/2020
PH 17-2016, f. & cert. ef. 6-7-16
PH 31-2015(Temp), f. 12-29-15, cert. ef. 1-1-16 thru 6-28-16
PH 6-2011, f. & cert. ef. 8-9-11
PH 20-2003, f. 12-02-03, cert. ef. 12-08-03
PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04
OHD 16-2002, f. & cert. ef. 10-10-02
OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0015
Adoption by Reference

All standards, listings and publications referred to in these rules are, by those references, made a part of these rules as though fully set forth. Copies are available through Oregon Health Authority, Oregon State Public Health Laboratory.

Statutory/Other Authority: ORS 448.150, 448.131, 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544 & 475C.560
Statutes/Other Implemented: ORS 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544 & 475C.560
History:
PH 36-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 32-2020, minor correction filed 05/07/2020, effective 05/07/2020
PH 6-2011, f. & cert. ef. 8-9-11
PH 20-2003, f. 12-02-03, cert. ef. 12-08-03
PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04
OHD 16-2002, f. & cert. ef. 10-10-02
OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0020
Severability

These rules are severable. If any rule or part thereof or the application of such rule to any person or circumstance is declared invalid, that invalidity shall not affect the validity of any remaining portion of these rules.

Statutory/Other Authority: ORS 448.150 & 448.131, 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544 & 475C.560
Statutes/Other Implemented: ORS 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544 & 475C.560
History:
PH 37-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 34-2020, minor correction filed 05/07/2020, effective 05/07/2020
OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0025
Definitions

As used in these rules, unless the context indicates otherwise:

(1) "Accrediting body" means the official accrediting authority for the Oregon Environmental Laboratory Accreditation Program comprised of the Administrator of the Oregon State Public Health Laboratory or designee, the Laboratory Administrator of the Department of Environmental Quality or designee and the Laboratory Administrator of the Department of Agriculture or designee.

(2) "Adult use cannabinoid" has the meaning given that term in OAR 333-007-0310.

(3) "Air" as a matrix means air samples, which are analyzed for possible contaminants under the guidance of the Clean Air Act.

(4) "Artificially derived cannabinoid" has the meaning given that term in OAR 333-007-0310.

(5) "Authority" means the Oregon Health Authority.

(6) "Batch" means:

(a) For sample analysis, this term has the meaning assigned in the TNI Standard which is a group of samples that are prepared or analyzed together in the laboratory with the same process and personnel, using the same lot(s) of reagents.

(A) A preparation batch is composed of 1 to 20 environmental samples of the same quality systems matrix, meeting the above-mentioned criteria and with a maximum time between the start of processing the first and last sample in the batch to be 24 hours.

(B) An analytical batch is composed of prepared environmental samples (extracts, digestates, or concentrates) which are analyzed together as a group. An analytical batch can include prepared samples originating from various quality system matrices and can exceed 20 samples.

(b) For cannabis sampling:

(A) A quantity of marijuana or usable marijuana from a harvest lot; or

(B) A quantity of cannabinoid concentrate, extract, product, finished inhalable cannabinoid product, or industrial hemp-derived vapor item from a process lot.

(c) For psilocybin sampling, this term has the same meaning given that term in OAR 333-333-1010.

(7) "Biological tissue" as a matrix means samples of biological tissue, excluding those of human origin, and includes:

(a) Usable marijuana and hemp samples for compliance testing.

(b) Psilocybin-containing dried fungal tissue, such as fruiting bodies or hyphae.

(8) "Cannabis" has the meaning given that term in OAR 333-007-0310.

(9) "Cannabis sampling" means an activity related to obtaining a representative sample of a marijuana item or industrial hemp-derived vapor item for purposes of testing in accordance with these rules and OAR 333-007-0300 to 333-007-0490.

(10) "Cannabis Tracking System" or "CTS" has the meaning given that term in OAR 333-007-0310.

(11) "CBD" means cannabidiol, Chemical Abstracts Service Number 13956-29-1.

(12) "CBDA" means cannabidiolic acid, Chemical Abstracts Service Number 1244-85-2.

(13) "Clean Air Act (CAA)" means the enabling legislation, 42 U.S.C. 7401 et seq. (1974), Public Law 91-604, 84 Stat. 1676 Public Law 95-95, 91 Stat., 685 and Public Law 95-190, 91 Stat., 1399, that empowers the EPA to promulgate air quality standards, monitor and enforce them.

(14) "Clean Water Act (CWA)" means the enabling legislation under 33 U.S.C. 1251 et seq., Public Law 92-50086, Stat. 816 that empowers the EPA to set discharge limitations, write discharge permits, monitor and bring enforcement action for non-compliance.

(15) "Commission" means the Oregon Liquor and Cannabis Commission.

(16) "Delta-8-tetrahydrocannabinol" or "Delta-8 THC" means (6aR, 10aR)-6,6,9-trimethyl-3-pentyl-6a,7,10,10a-tetrahydro-6H-benzo[c]chromen-1-ol, Chemical Abstracts Service Number 5957-75-5.

(17) "Delta-9-tetrahydrocannabinol" or "Delta-9 THC" means (6aR,10aR)-6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-ol, Chemical Abstracts Service Number 1972-08-3.

(18) "Delta-9-tetrahydrocannabinolic acid" or "Delta-9-THCA" means (6aR,10aR)-1-hydroxy-6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromene-2-carboxylic acid, Chemical Abstracts Service Number 23978-85-0.

(19) "Drinking water" as a matrix means samples of presumed potable water and source water, which are analyzed for possible contaminants under the guidance of the Safe Drinking Water Act.

(20) "Fields of accreditation" means those matrix, technology/method, and analyte combinations for which ORELAP offers accreditation.

(21) "Finished cannabinoid concentrate or extract" has the meaning given that term in OAR 333-007-0310.

(22) "Finished cannabinoid product" has the meaning given that term in OAR 333-007-0310.

(23) "Finished inhalable cannabinoid product" has the meaning given that term in OAR 333-007-0310.

(24) "Industrial hemp-derived vapor item" has the meaning given that term in OAR 333-007-0310.

(25) "Homogenization" means physically manipulating a sample to make the sample’s material uniform in composition and properties throughout, including but not limited to reducing particle size to a fine uniform powder for solid materials or combining all layers or phases of a liquid or semi-solid sample into a uniform substance.

(26) "Laboratory" means a fixed location or mobile facility that collects or analyzes samples in a controlled and scientific manner with the appropriate equipment and instruments required by accredited sampling and testing methods.

(27) "Marijuana item" has the meaning given that term in OAR 333-007-0310.

(28) "Mobile Category 1 Laboratory" means any facility, deployed for no more than six consecutive months and no more than six months during a calendar year, that:

(a) Analyzes samples utilizing the staff and equipment from the parent fixed laboratory;

(b) Operates under the quality system of its parent fixed laboratory;

(c) Is capable of moving or being moved from site to site, such as but not limited to vans, trailers and motor coaches; and

(d) May operate under the fixed laboratory’s accreditation.

(29) "Mobile Category 2 Laboratory" means any facility that:

(a) Analyzes samples;

(b) Operates under its own quality system;

(c) Is capable of moving or being moved from site to site, such as but not limited to vans, trailers and motor coaches; and

(d) Issues the final reports or is a mobile laboratory operating with a fixed laboratory’s quality system, but is deployed for more than six consecutive months or more than six months in a calendar year.

(30) "National Environmental Laboratory Accreditation Program (NELAP)" means the program established to oversee the implementation of the TNI Standards.

(31) "NELAP approved accrediting body" means a state or federal department/agency that has been approved by NELAP as being an entity whose accreditation and assessment program meets all of the requirements of the TNI Standards.

(32) "Non-potable water" as a matrix means aqueous samples, which are analyzed under the guidance of the Clean Water Act or the Resource, Conservation and Recovery Act.

(33) "On-site assessment" means an on-site visit to the laboratory to verify items addressed in the ORELAP application and to evaluate the facility and analytical performance for conformance with the TNI Standards. During a period when the Governor has declared a state of emergency, when an on-site visit would jeopardize the health and safety of the participants, assessments may be conducted remotely by electronic means to evaluate the facility for conformance to the TNI Standards.

(34) "ORELAP approved assessor" means an assessor whose qualification has been evaluated by ORELAP and found to meet TNI Standards for laboratory on-site assessors.

(35) "Primary accreditation" means accreditation by a NELAP approved accrediting body based on a laboratory's compliance to TNI Standards after a review of the laboratory's application, quality manual, PT results and on-site assessment results as described in the TNI Standards.

(36) "Proficiency testing (PT)" means the analysis of samples obtained from providers that meet the TNI standards for PT providers. The composition of the sample is unknown to the laboratory performing the analysis, and is used in part to evaluate the ability of the laboratory to produce precise and accurate results.

(37) "Psilocin analyte" means 4-hydroxy-N,N-dimethyltryptamine, Chemical Abstracts Service Number 520-53-6.

(38) "Psilocybin analyte" means 4-phosphoryloxy-N,N-dimethyltryptamine, Chemical Abstracts Service Number 520-52-5.

(39) "Psilocybin product" has the meaning given that term in OAR 333-333-1010.

(40) "Psilocybin Tracking System" or "PTS" has the meaning given that term in OAR 333-333-1010.

(41) "Public water system" means a water system as defined in OAR 333-061-0010.

(42) "Quality manual (QM)" means a document stating the management policies, objectives, principles, organizational structure and authority, responsibilities, accountability, and implementation of a laboratory to ensure the quality of its product and the utility of its product to its users.

(43) "Replicate sample" is a sample in addition to the primary and duplicate samples that consists of the same number of increments taken in the same manner as the primary and duplicate samples.

(44) "Resource Conservation and Recovery Act (RCRA)" means the enabling legislation, 42 U.S.C. section 6901 et seq. (1976), that requires the EPA to protect human health and protecting and monitoring the environment by regulating hazardous waste disposal practices.

(45) "Safe Drinking Water Act (SDWA)" means the SDWA enacted in 1974 and the Safe Drinking Water Amendments of 1986, 42 U.S.C. 300f et seq., Public Law 93-523, that is the enabling legislation that requires the EPA to protect the quality of drinking water in the U.S. by setting maximum allowable contaminant levels, monitoring, and enforcing violations.

(46) "Scheduled proficiency testing" means a single complete sequence of circulation and scoring of proficiency testing sample for a participant in a proficiency test program with predefined opening and closing dates for any participant.

(47) "Secondary accreditation" means the recognition by reciprocity for the fields of accreditation, methods and analytes for which the laboratory holds current primary accreditation by another NELAP approved accrediting body.

(48) "Solids" as a matrix means samples of soil, sludge and other non-aqueous compounds analyzed under the guidance of the Resource, Conservation and Recovery Act, and includes:

(a) Cannabinoid products and concentrates or extracts and industrial hemp-derived vapor items as defined in OAR 333-007-0310.

(b) Psilocybin products as defined in OAR 333-333-1010 with the exception of dried fruiting bodies and hyphae.

(49) "Supplemental proficiency testing" means a PT study that may be from a lot previously released by a PT provider but that does not have a pre-determined opening date and closing date but the closing date cannot exceed 45 days from the opening date.

(50) "Total Potential Psilocin" means the sum of the psilocin analyte concentration and 0.719 times the psilocybin analyte concentration. This number is the maximum theoretical concentration of psilocin in the sample.

(51) "TNI" means the NELAC Institute. TNI is a voluntary organization of state and federal environmental officials and interest groups purposed primarily to establish mutually acceptable standards for accrediting environmental laboratories.

(52) "TNI Standards" means the adopted TNI Standards (© 2016 The NELAC Institute), which are documents describing the elements of laboratory accreditation that was developed and established by the consensus principles of TNI and meets the approval requirements of TNI procedures and policies. Available at www.nelac-institute.org

(53) "These rules" means the Oregon Administrative Rules encompassed by OAR 333-064-0005 through 333-064-0160.

(54) "Third party assessor" means an ORELAP approved assessor who has a current contract with the Oregon Health Authority to perform on-site assessments of laboratories for ORELAP and is not employed by the state agencies comprising ORELAP’s accrediting body.

(55) "United States Environmental Protection Agency (EPA)" means the federal government agency with the responsibility for protecting public health and safeguarding and improving the natural environment (that is air, water, and land) upon which human life depends.

(56) "Whole fungi" has the meaning given that term in OAR-333-333-1010.

Statutory/Other Authority: ORS 438.605, 438.610, 438.615, 438.620, 448.131, 448.150, 448.280, 475C.544, 475C.560, 475A.590 & 475A.606
Statutes/Other Implemented: ORS 438.605, 438.610, 438.615, 438.620, 448.280, 475C.544, 475C.560, 475A.590 & 475A.606
History:
PH 207-2022, amend filed 12/27/2022, effective 12/27/2022
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 89-2020, amend filed 12/30/2020, effective 01/01/2021
PH 85-2020, amend filed 12/23/2020, effective 01/01/2021
PH 54-2020, temporary amend filed 06/05/2020, effective 06/05/2020 through 12/01/2020
PH 35-2020, minor correction filed 05/07/2020, effective 05/07/2020
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 17-2016, f. & cert. ef. 6-7-16
PH 31-2015(Temp), f. 12-29-15, cert. ef. 1-1-16 thru 6-28-16
PH 6-2011, f. & cert. ef. 8-9-11
PH 8-2005, f. 6-1-05, cert. ef. 7-1-05
PH 23-2004, f. & cert. ef. 7-1-04
PH 20-2003, f. 12-02-03, cert. ef. 12-08-03
PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04
PH 5-2003, f. 5-15-03, cert. ef. 7-1-03
OHD 16-2002, f. & cert. ef. 10-10-02
OHD 1-2001, f. & cert. ef. 1-17-01
OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0030
Schedule for Requesting Accreditation, Period of Accreditation

(1) Laboratories in Oregon will be considered to be accredited by ORELAP after the laboratory has requested accreditation, been evaluated by ORELAP and has met all criteria in accordance with OAR 333-064-0035.

(2) The accreditation period for each laboratory is for one year with subsequent accreditation periods beginning from the first day the laboratory is granted accreditation.

(3) Laboratories must reapply for ORELAP approval annually, with the application to be received by ORELAP 120 calendar days prior to the expiration of the current accreditation period and with all appropriate fees paid no less than 60 days prior to the expiration of their current certificate of accreditation.

(4) ORELAP-accredited laboratories may apply for accreditation of additional parameters (analytes, methods, matrices) at any time during their accreditation period with accreditation for such parameters expiring with the current accreditation period.

Statutory/Other Authority: ORS 448.150, 448.131, 448.280, 438.610, 438.615, 475C.544 & 475C.560
Statutes/Other Implemented: ORS 438.605, 438.610, 438.615, 475C.544 & 475C.560
History:
PH 38-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 36-2020, minor correction filed 05/07/2020, effective 05/07/2020
PH 6-2011, f. & cert. ef. 8-9-11
PH 20-2003, f. 12-02-03, cert. ef. 12-08-03
PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04
OHD 16-2002, f. & cert. ef. 10-10-02
OHD 1-2001, f. & cert. ef. 1-17-01
OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0035
Approval Requirements

(1) This rule and the TNI Standards describe the procedure for obtaining and maintaining accreditation.

(2) Oregon Environmental Laboratory Accreditation Program (ORELAP) accreditation can be granted, denied, suspended, or revoked in total or in part as described in the TNI Standards.

(a) Reasons to deny an initial application shall include, but are not limited to:

(A) Failure to submit a completed application;

(B) Failure to pay fees;

(C) Failure of laboratory staff to meet the personnel qualifications of education, training, and experience as required by the TNI Standards;

(D) Failure to successfully analyze and report proficiency testing (PT) samples as required by the TNI Standards and these rules;

(E) Failure to respond to an assessment report from an on-site assessment with a corrective action report within 30 calendar days, or failure to respond to deficiencies identified in the first corrective action report review within 30 calendar days, as required by the TNI Standards;

(F) Failure to implement the corrective actions detailed in the corrective action report within the agreed upon time frame;

(G) Failure to implement a quality system as defined in the TNI Standards;

(H) Failure to pass required on-site assessments;

(I) Misrepresentation of any fact pertinent to receiving or maintaining accreditation; or

(J) Denial of entry during the laboratory’s normal business hours for an on-site assessment.

(b) Reasons for suspension or revocation in total or in part shall include but are not limited to:

(A) If the accreditation body finds, during the on-site assessment, that the public interest, safety or welfare imperatively requires emergency action;

(B) Failure to complete proficiency testing studies as required by the TNI Standards and these rules;

(C) Failure to notify the accreditation body of any changes in key accreditation criteria defined in the TNI Standards within 35 calendar days of the effective change, including:

(i) General features of the laboratory, including corporate entity, name, addresses, legal status, technical directors and quality managers, and technical resources;

(ii) General information concerning the laboratory such as its activities, its relationship in a larger corporate entity if any, and addresses of all its physical location(s) to be covered by the scope of accreditation;

(D) Failure to maintain a quality system as required by the TNI Standards;

(E) Failure of the laboratory to employ staff that meets qualifications for education, training, and experience as required by the TNI Standards;

(F) Misrepresentation of any fact pertinent to receiving or maintaining accreditation;

(G) Denial of entry to an accreditation body’s assessment team during the laboratory’s normal business hours for the purpose of conducting an on-site assessment;

(H) Failure to pass an on-site assessment conducted by an accreditation body;

(I) Failure to respond to an assessment report from an on-site assessment with a corrective action report within 30 calendar days, or failure to respond to deficiencies identified in the first corrective action report review within 30 calendar days, as required by the TNI Standards;

(J) Failure to implement the corrective actions detailed in the corrective action report within the agreed upon time frame;

(K) Failure to pay fees;

(L) Failure to maintain licensure by the Oregon Liquor and Cannabis Commission (Commission) under ORS 475C.548 if the laboratory is accredited under ORS 475C.560 for sampling and laboratory testing of marijuana items and industrial hemp-derived vapor items required under ORS 475C.544; or

(M) Failure to maintain licensure by Oregon Psilocybin Services under ORS 475A.594 if the laboratory is accredited under ORS 475A.606 for sampling and laboratory testing of psilocybin products required under ORS 475A.590.

(3) In no case shall a laboratory be accredited that does not comply with the TNI Standards as specified in this rule.

(4) The elements for accreditation shall include but are not restricted to:

(a) Application for accreditation:

(A) ORELAP will make online, electronic applications available to all laboratories requesting an application.

(B) The laboratory must request ORELAP accreditation by completing and submitting to ORELAP an acceptable application that includes all elements as required by the TNI Standards. For primary accreditation this includes a completed application with all required documents. For secondary accreditation this includes a completed application with all of the required documents plus proof of accreditation from a primary accrediting body.

(b) The laboratory's participation in a biennial on-site assessment(s) as required by the TNI Standards. Environmental testing laboratories seeking initial, primary ORELAP accreditation shall not be granted accreditation prior to an acceptable on-site assessment;

(c) The laboratory's participation in PT and the obtaining of acceptable PT results according to the TNI Standards and these rules;

(d) A quality manual (QM) that includes all elements as set forth in the TNI Standards;

(e) Laboratory staff members that meet the TNI Standards for training and experience for their responsibilities within the laboratory;

(f) Creation and retention of all records pertaining to samples and analyses, including chain of custody documents, log books, work sheets, raw data, calculations, quality assurance data, and reports according to TNI Standards; and

(g) The laboratory's full payment of all appropriate fees as described in OAR 333-064-0060.

(5) Laboratories accredited under ORS 475C.560 that fail to obtain licensure with the Commission under ORS 475C.548 in accordance with subsection (5)(a) below, become unlicensed pursuant to subsection (5)(b) below, or otherwise become unlicensed under ORS 475C.548, shall have their accreditation denied or revoked in accordance with ORS chapter 183.

(a) Laboratories that obtain initial accreditation under ORS 475C.560 must submit a complete application for licensure under ORS 475C.548 with the Commission within 30 days of accreditation by ORELAP and must obtain licensure within six months of accreditation. The Oregon Health Authority (Authority) may in its discretion extend the time to obtain initial licensure under ORS 475C.548 by six months upon request by an accredited laboratory due to processing delays with the Commission that are outside the control of the laboratory.

(b) The Authority shall deny accreditation renewal or revoke accreditation of a laboratory that surrenders its license, has its license revoked, is denied renewal of its license, or is otherwise no longer licensed under ORS 475C.548.

(6) Laboratories accredited under ORS 475A.606 that fail to become licensed by the Oregon Psilocybin Services program under ORS 475A.594 in accordance with subsection (6)(a) below, become unlicensed pursuant to subsection (6)(b) below, or otherwise become unlicensed under ORS 475A.594, shall have their accreditation denied or revoked in accordance with ORS chapter 183.

(a) Laboratories that obtain initial accreditation under ORS 475A.606 must submit a complete application for licensure under ORS 475A.594 with Oregon Psilocybin Services within 30 days of accreditation by ORELAP and must obtain licensure within six months of accreditation. The Authority may in its discretion extend the time to obtain initial licensure under ORS 475A.594 by six months upon request by an accredited laboratory due to processing delays with Oregon Psilocybin Services that are outside the control of the laboratory.

(b) The Authority shall deny accreditation renewal or revoke accreditation of a laboratory that surrenders its license, has its license revoked, is denied renewal of its license, or is otherwise no longer licensed under ORS 475A.594.

Statutory/Other Authority: ORS 448.150, 448.131, 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544, 475C.560, 475A.590 & 475A.606
Statutes/Other Implemented: ORS 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544, 475C.560, 475A.590 & 475A.606
History:
PH 68-2024, amend filed 07/09/2024, effective 07/23/2024
PH 207-2022, amend filed 12/27/2022, effective 12/27/2022
PH 39-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 85-2020, amend filed 12/23/2020, effective 01/01/2021
PH 54-2020, temporary amend filed 06/05/2020, effective 06/05/2020 through 12/01/2020
PH 37-2020, minor correction filed 05/07/2020, effective 05/07/2020
PH 6-2011, f. & cert. ef. 8-9-11
PH 8-2005, f. 6-1-05, cert. ef. 7-1-05
PH 20-2003, f. 12-02-03, cert. ef. 12-08-03
PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04
OHD 16-2002, f. & cert. ef. 10-10-02
OHD 1-2001, f. & cert. ef. 1-17-01
OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0040
Action Response for Laboratory Drinking Water Analysis Results

(1) If an accredited laboratory is authorized by the water supplier to report results of analyses required by OAR 333-061-0036 and performed by the laboratory directly to the Oregon Health Authority (Authority), then it must do so within 10 days after the end of the month, or within 10 days after the end of the monitoring period.

(2) If a result exceeds the maximum contaminant level (MCL) specified in OAR 333-061-0030:

(a) The accredited lab that issues the final test report must:

(A) Validate the results of any sample analysis and report that analysis directly to the Authority and to the water supplier within 48 hours or two business days of completing the analytical run if the sample analysis:

(i) Exceeds the MCL for nitrate as specified in OAR 333-061-0030(1); or

(ii) Is positive for coliform bacteria.

(B) Report any sample analysis directly to the Authority and to the water supplier within 24 hours or on the next business day after validating a sample result that exceeds the MCL for any chemical analyte specified in OAR 333-061-0030 other than nitrate.

(C) Report any sample analysis directly to the Authority and to the water supplier within 24 hours or on the next business day after obtaining a sample result from a subcontracted laboratory, if the sample analysis:

(i) Exceeds the MCL for nitrate as specified in OAR 333-061-0030(1) or is positive for coliform bacteria; or

(ii) Exceeds the MCL for any chemical analyte specified in OAR 333-061-0030 other than nitrate upon validating the sample analysis.

(b) Accredited, subcontracted laboratories must:

(A) Validate the results of any sample analysis and report that analysis to their client laboratory within 48 hours or two business days of completing the analytical run if the analysis:

(i) Exceeds the MCL for nitrate as specified in OAR 333-061-0030(1); or

(ii) Is positive for coliform bacteria.

(B) Report any sample analysis to their client laboratory within 24 hours or on the next business day after validating a sample result that exceeds the MCL for any chemical analyte specified in OAR 333-061-0030 other than nitrate.

(3) The laboratory must notify the public water system and, if authorized by the water system, the Authority of all unregulated contaminants detected and their concentrations from each specific method used to measure the regulated contaminants.

(4) The laboratory must use report forms that have been approved by the Authority for reporting drinking water test results to the Authority.

Statutory/Other Authority: ORS 448.150, 448.131, 475C.544 & 475C.560
Statutes/Other Implemented: ORS 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544 & 475C.560
History:
PH 40-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 38-2020, minor correction filed 05/07/2020, effective 05/07/2020
PH 3-2011, f. & cert. ef. 4-21-11
PH 20-2003, f. 12-02-03, cert. ef. 12-08-03
PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04
OHD 16-2002, f. & cert. ef. 10-10-02
OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0045
Procedure for Contesting Actions of ORELAP

(1) The procedure for contesting the actions of ORELAP regarding denial, suspension and revocation of accreditation, or other changes in accreditation status is in accordance with the Administrative Procedures Act, ORS chapter 183.

(2) Laboratories shall be provided formal written notice of intended action and their right to request a contested case hearing.

(3) Actions based on PT failures are not eligible for a contested case hearing.

Statutory/Other Authority: ORS 448.150, 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544, 475C.560 & 448.131
Statutes/Other Implemented: ORS 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544 & 475C.560
History:
PH 41-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 85-2020, amend filed 12/23/2020, effective 01/01/2021
PH 39-2020, minor correction filed 05/07/2020, effective 05/07/2020
OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0050
Accreditation of Out-of-State and Mobile Category 2 Laboratories

(1) ORELAP shall accredit out-of-state laboratories that are eligible for reciprocal accreditation provided:

(a) The laboratory is accredited by a state recognized as a NELAP accrediting body for those fields of testing (analytes, methods, matrices) in which the laboratory is requesting accreditation pursuant to this rule.

(b) The laboratory submits to ORELAP an acceptable application as described in OAR 333-064-0035(4).

(c) The laboratory pays all appropriate fees as described in OAR 333-064-0060.

(d) The laboratory is not requesting accreditation for cannabis or psilocybin testing.

(2) ORELAP may accredit out-of-state laboratories that are located in states that do not have a NELAP approved accrediting body for the fields of testing and matrices in which the laboratory desires accreditation provided that the laboratory complies with all the requirements in OAR 333-064-0035.

(3) ORELAP may accredit mobile category 2 laboratories that do not operate as an entity of an Oregon fixed base facility as out-of-state laboratories. Such laboratories must meet all of the requirements for out-of-state laboratories pursuant to these rules.

Statutory/Other Authority: ORS 448.150, 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544, 475C.560, 448.131, 475A.590 & 475A.606
Statutes/Other Implemented: ORS 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544, 475C.560, 475A.590 & 475A.606
History:
PH 207-2022, amend filed 12/27/2022, effective 12/27/2022
PH 42-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 40-2020, minor correction filed 05/07/2020, effective 05/07/2020
PH 6-2011, f. & cert. ef. 8-9-11
OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0055
Display of Certificate

Accredited laboratories shall post or display their most recent ORELAP accreditation certificate and their ORELAP-accredited fields of testing in a prominent place in the laboratory facility.

Statutory/Other Authority: ORS 448.150, 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544, 475C.560, 448.131, 475A.590 & 475A.606
Statutes/Other Implemented: ORS 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544, 475C.560, 475A.590 & 475A.606
History:
PH 207-2022, amend filed 12/27/2022, effective 12/27/2022
PH 43-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 41-2020, minor correction filed 05/07/2020, effective 05/07/2020
OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0060
Fee Schedule

Fees will be charged to Oregon and out-of-state laboratories according to the following schedule. A mobile category 2 laboratory that operates as an entity of an Oregon fixed base facility will be considered an in-state laboratory, and one that does not operate as an entity of an Oregon fixed base facility will be considered an out-of-state laboratory. Mobile category 1 laboratories are covered under the parent fixed laboratory’s accreditation and are not required to pay an additional fee. Mobile category 2 laboratories require separate accreditation and are accredited to their vehicle identification numbers (VIN).

(1) A non-refundable application fee must be paid for each application requesting accreditation for methods.

(a) For laboratories located in Oregon, one of five levels of fees, Tier 1 at $1,200, Tier 2 at $2,200, Tier 3 at $3,400, Tier 4 at $4,600, and Tier 5 at $5,800 will be charged. The Tiers will be determined by the total number of points derived from the number of fields of accreditation requested for accreditation listed in subsections (2)(a) through (c) of this rule.

(A) Each Basic Field of Accreditation has a multiplier of 1.

(B) Each Moderate Field of Accreditation has a multiplier of 3.

(C) Each Complex Field of Accreditation has a multiplier of 5.

(D) Each Advanced Technology Field of Accreditation has a multiplier of 7.

(E) Cannabis and Psilocybin Sampling only for application has a multiplier of 11.

(F) The total number of points is determined by first summing the number of fields of accreditation within each category (Basic, Moderate, Complex or Advanced Technology) and then multiplying the sums by their appropriate multiplier as given in this rule. The sum of these results determines the total number of points for each laboratory. Laboratories with a total of 1 to 10 points are to be considered Tier 1 laboratories, 11 to 25 points are Tier 2 laboratories, 26 to 40 points are Tier 3 laboratories, 41 to 55 points are Tier 4 laboratories, and 56 or more points are Tier 5 laboratories.

(b) For each out-of-state laboratory requesting primary or secondary accreditation through ORELAP, one of five levels of fees, Tier 1 at $3,100, Tier 2 at $4,850, Tier 3 at $6,950, Tier 4 at $9,050, and Tier 5 at $11,150 will be charged with each Tier determined according to paragraphs (1)(a)(A) through (F) of this rule.

(c) If a new owner acquires the laboratory and wishes the laboratory to remain accredited, the laboratory must submit a new owner application, and may be required to pay the application fee and be subject to a new on-site assessment and payment of on-site assessment fees as described in this rule.

(2) Upon ORELAP's review of a laboratory's application, each laboratory requesting primary accreditation through ORELAP will be charged an assessment fee as follows:

(a) Laboratories will be charged $200 for each of the following Basic Fields of Accreditation requested for accreditation:

(A) Gravimetric;

(B) Physical;

(C) Probe.

(b) Laboratories will be charged $600 for each of the following Moderate Fields of Accreditation requested for accreditation:

(A) Inorganic Atomic absorption spectrometry;

(B) Inorganic Atomic fluorescence spectrometry;

(C) Inorganic-non-metals automated colorimetric;

(D) Inorganic-non-metals manual colorimetric;

(E) Inorganic-ion chromatography (IC);

(F) Organic-liquid chromatography (LC);

(G) General microbiology including but not limited to these three: 1) Chromofluorogenic; 2) Membrane Filter and /or Heterotrophic Plate Count (HPC); and 3) Multiple Tube Fermentation/Most Probable Number (MPN) (one fee applies for all);

(H) Asbestos (bulk).

(c) Laboratories will be charged $1,000 for each of the following Complex Fields of Accreditation requested for accreditation:

(A) Organic — gas chromatography/mass spectrometry (GC/MS) — volatiles;

(B) Organic — gas chromatography/mass spectrometry (GC/MS) — extractables;

(C) Organic — liquid chromatography/mass spectrometry (LC/MS);

(D) Organic — gas chromatography (GC) volatiles, extractables;

(E) Inorganic — metals — inductively coupled plasma/atomic emission spectrometry (ICP/AES);

(F) Inorganic — metals — inductively coupled plasma/mass spectrometry (ICP/MS);

(G) Inorganic — ion chromatography/mass spectrometry (IC/MS);

(H) X-ray;

(I) Whole Effluent Toxicity (WET);

(J) Radiochemistry;

(K) Immunoassay;

(L) Asbestos – electron microscopy.

(d) Laboratories will be charged $1,400 for each of the following Advanced Technology Fields of Accreditation requested for accreditation:

(A) Organic — gas chromatography/tandem mass spectrometry (GC/MS/MS);

(B) Organic — high resolution gas chromatography/high resolution mass spectrometry (HiResGC/HiResMS);

(C) Organic — liquid chromatography/tandem mass spectrometry (LC/MS/MS);

(D) Polymerase chain reaction (PCR);

(E) Mycology and Parasitology — Filtration/Immunomagnetic Separation/Immunoflurorescence Assay microscopy (Filtration/IMS/FA);

(F) Cannabis or Psilocybin Sampling.

(e) The following additional fees will be charged to Oregon laboratories for each additional matrix per field of accreditation for which the laboratory has requested accreditation:

(A) $10 for Basic Fields of Accreditation.

(B) $40 for Moderate Fields of Accreditation.

(C) $75 for Complex Fields of Accreditation.

(D) $150 for Advanced Technology Fields of Accreditation.

(f) The following additional fees will be charged to out-of-state laboratories for each additional matrix per field of accreditation for which the laboratory has requested accreditation:

(A) $13 for Basic Fields of Accreditation.

(B) $53 for Moderate Fields of Accreditation.

(C) $100 for Complex Fields of Accreditation.

(D) $198 for Advanced Technology Fields of Accreditation.

(3) For purposes of section (2) of this rule the matrices are:

(a) Air;

(b) Biological tissue;

(c) Drinking water;

(d) Non-potable water; and

(e) Solids.

(4) Assessment fees must be paid before a routine on-site assessment will be performed.

(5) All laboratories must pay the appropriate on-site assessment fee per on-site assessment performed due to just cause according to TNI Standards.

(6) ORELAP may use third party assessors to provide assessment services. In this event, the laboratory will still pay the assessment fee described in this fee schedule to ORELAP. Upon the laboratory’s consent to the third party assessment, ORELAP will pay the third party assessor costs.

(7) All out-of-state laboratories must pay all on-site assessment costs incurred by ORELAP approved assessors to perform the on-site assessment including but not limited to transportation, per diem and wages during travel. For a mobile category 2 laboratory, the travel costs are waived if it is moved to the Oregon State Public Health Laboratory for the on-site assessment, and reduced to the amount in excess of its fixed base facility when moved to the fixed base facility if both are to be assessed at the same time. The excess amount is to be determined by those fields of accreditation and matrices requested for accreditation by the mobile laboratory that have not been requested by its fixed based facility.

(8) Accredited laboratories requesting additions to their fields of accreditation during the accreditation period must pay:

(a) The difference in cost of the application fee with a minimum fee of $200;

(b) The difference in cost of the assessment fee.

Statutory/Other Authority: ORS 448.150, 448.131, 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544, 475C.560, 475A.590 & 475A.606
Statutes/Other Implemented: 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544, 475C.560, 475A.590 & 475A.606
History:
PH 207-2022, amend filed 12/27/2022, effective 12/27/2022
PH 162-2022, amend filed 07/15/2022, effective 07/15/2022
PH 44-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 89-2020, amend filed 12/30/2020, effective 01/01/2021
PH 85-2020, amend filed 12/23/2020, effective 01/01/2021
PH 54-2020, temporary amend filed 06/05/2020, effective 06/05/2020 through 12/01/2020
PH 42-2020, minor correction filed 05/07/2020, effective 05/07/2020
PH 17-2016, f. & cert. ef. 6-7-16
PH 31-2015(Temp), f. 12-29-15, cert. ef. 1-1-16 thru 6-28-16
PH 6-2011, f. & cert. ef. 8-9-11
PH 5-2006, f. & cert. ef. 4-6-06
PH 3-2006(Temp), f. & cert. ef. 2-8-06 thru 7-30-06
PH 20-2003, f. 12-02-03, cert. ef. 12-08-03
PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04
OHD 16-2002, f. & cert. ef. 10-10-02
OHD 1-2001, f. & cert. ef. 1-17-01
OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0065
Civil Penalties

(1) In addition to any other penalty provided by law, the Oregon Health Authority, in collaboration with the accrediting body, may impose a civil penalty not to exceed $500 per day per violation upon any and all laboratories that:

(a) Falsely purport to be ORELAP accredited;

(b) Improperly use their ORELAP accreditation status in order to mislead; or

(c) Use the TNI\NELAP logo in catalogs, advertisements, business solicitations, proposals, quotations, laboratory reports and other materials without proper authorization.

(2) The Oregon Health Authority reserves the right to pursue other remedies and may take any other disciplinary action against alleged violators.

(3) In establishing the amount of the penalty for each violation, the Oregon Health Authority will consider, but not be limited to the following factors:

(a) The gravity and magnitude of the violation;

(b) The laboratory's previous record of complying or failing to comply with this rule.

(c) The laboratory's history in taking all feasible steps or in following all procedures necessary or appropriate to correct the violation; and,

(d) Such other considerations as the Oregon Health Authority may consider appropriate.

(4) The Oregon Health Authority in collaboration with the accrediting body may deny, suspend or revoke accreditation of any laboratory that fails to pay on demand a civil penalty that has become due and payable, provided that it first gives the laboratory an opportunity for a hearing as outlined in ORS chapter 183.

Statutory/Other Authority: ORS 448.280, 438.605, 438.610, 438.615, 438.620 & 475C.578
Statutes/Other Implemented: ORS 448.280, 438.605, 438.610, 438.615, 438.620 & 475C.578
History:
PH 45-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 85-2020, amend filed 12/23/2020, effective 01/01/2021
PH 33-2020, minor correction filed 05/07/2020, effective 05/07/2020
PH 17-2016, f. & cert. ef. 6-7-16
PH 6-2011, f. & cert. ef. 8-9-11
PH 20-2003, f. 12-02-03, cert. ef. 12-08-03
PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04
OHD 16-2002, f. & cert. ef. 10-10-02
OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0100
Cannabis Sampling Procedures and Testing

(1) For purposes of this rule the definitions in OAR 333-007-0310 apply unless the context indicates otherwise.

(2) Sampling.

(a) A laboratory must have and follow marijuana item and industrial hemp-derived vapor items 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 7, and any applicable TNI Standards.

(C) Require chain of custody procedures consistent with TNI EL Standard V1M2 5.7 and 5.8.

(D) Are appropriate to the matrix being sampled.

(E) Are consistent with OAR 333-007-0360 and 333-007-0370 and the following ORELAP sampling protocols approved by the accrediting body, incorporated by reference:

(i) Usable Marijuana: ORELAP-SOP-001 Rev 4.1; and

(ii) Concentrates, Extracts, Products, and Industrial Hemp-derived Vapor Items: ORELAP-SOP-002 Rev 4.3.

(F) Ensure that only the finished cannabinoid concentrate, extract, product, or industrial hemp-derived vapor item is sampled if testing on the finished cannabinoid concentrate, extract, product, or industrial hemp-derived vapor item is required under OAR 333-007-0330 and OAR 333-007-0340.

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

(b) Sampling policies and procedures must be accredited by ORELAP prior to any marijuana or industrial hemp-derived vapor item 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 licensee or a registrant required to comply with Cannabis Tracking System (CTS) tracking under ORS 475C.871, record the sampling and transfer information in the Oregon Liquor and Cannabis Commission’s (Commission’s) seed to sale system, as required by the Oregon Health Authority (Authority) and the Commission; and

(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, sample increment, duplicate sample, and replicate 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 333-007-0370 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 usable marijuana shall be combined into a single sample by a laboratory prior to testing.

(B) Prior to testing, a laboratory shall combine sample increments from a batch of a cannabinoid concentrate, extract, finished inhalable cannabinoid product, or industrial hemp-derived vapor item;

(i) Increments from a primary sample are combined into a single sample.

(ii) Increments from a duplicate sample are combined into a single sample.

(iii) Increments from each replicate sample are combined with each other but material from separate replicate samples are not combined.

(C) Prior to any testing or subsampling except as described in subparagraph (i) of this paragraph, the entire combined sample except as described in subparagraph (iii) of this paragraph must undergo the laboratory’s homogenization process.

(i) 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.

(ii) Potency analysis shall not be performed on material subsampled prior to homogenization steps.

(iii) Prior to homogenization, the filter or tip shall be removed from pre-rolled usable marijuana and finished inhalable cannabinoid products that include a filter or tip. Filters and tips are considered non-consumed packaging and are not part of the sample for the purpose of homogenization or testing. All other components of the pre-roll must be included in the laboratory’s homogenization process.

(D) Sample increments and samples collected from different batches may not be combined, except as permitted by OAR 333-007-0360 using the process described in ORELAP-SOP-001 Rev. 4.1.

(E) Portions of homogenized samples that are combined for testing as permitted by OAR 333-007-0360(1)(c) shall use the laboratory’s formal subsampling method to produce a proportionally representative sample from each batch involved.

(g) Sample replicate analysis for concentrates, extracts, finished inhalable cannabinoid products, and industrial hemp-derived vapor items.

(A) When replicate samples are required per OAR 333-007-0360 Exhibit B Table 7, each sample shall be analyzed individually for residual solvents as described in OAR 333-007-0410 and adult use cannabinoids and CBD as described in OAR 333-007-0430.

(B) Two samples shall be randomly selected according to the laboratory’s policy and procedures and analyzed individually for the remaining required analyses as described in OAR 333-007-0330, 333-007-0341, and 333-007-0342.

(C) Adult use cannabinoid and CBD results for the batch or process lot are reported as the calculated average result from all sample replicates.

(3) Compliance testing validity.

(a) When testing a sample for the required microbiological compliance tests as described in OAR 333-007-0390, a laboratory must comply with additional method validation as follows:

(A) Run a negative control in accordance with TNI Standard requirements to demonstrate the procedure is free of microbiological contaminants that prevent accurate testing.

(B) Run a positive control in accordance with TNI Standard requirements to demonstrate acceptable performance of the procedure. Acceptable performance of the positive control means accurate identification and quantitation of all organisms required in OAR 333-007-0390.

(C) 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 a required organism in a sample with an unacceptable performance of the IAC, follow the manufacturer’s instructions on interpretation of acceptability.

(b) When testing a sample for the required chemistry compliance tests as described in OAR 333-007-0400 to 333-007-0415 and 333-007-0425 to 333-007-0430, a laboratory must 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 standard (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 C, Table 1.

(C) Analyze duplicate samples with a precision limit of 10 percent relative percent difference (RPD), if duplicates are required as specified in OAR 333-007-0360 and analyze all replicate samples with a precision limit of 10 percent relative standard deviation (RSD), if replicates are required as specified in OAR 333-007-0360.

(4) Calculating total delta-9 THC and total CBD.

(a) Total delta-9 THC must be calculated as follows, where M is the mass or mass fraction of delta-9 THC or delta-9 THCA:

M total delta-9 THC = M delta-9 THC + 0.877 * M delta-9 THCA.

(b) Total CBD must be calculated as follows, where M is the mass or mass fraction of CBD and CBDA:

M total CBD = M CBD + 0.877 * M CBDA.

(c) Each test report must include the results for delta-8 THC, total delta-9 THC, and total CBD.

(5) Report delta-8 THC, total delta-9 THC, and total CBD for useable marijuana as dry weight. A laboratory must analyze the sample as received and report delta-8 THC, total delta-9 THC and total CBD content by dry weight calculated as follows:

P delta-8 THC(dry) = P delta-8 THC(wet) / [1-(P moisture/100)]

P total delta-9 THC(dry) = P total delta-9 THC(wet) / [1-(P moisture/100)]

P total CBD(dry) = P total CBD(wet) / [1-(P moisture/100)]

(6) Calculating RPD and 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= √(∑((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.

(e) 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 RPD or RSD.

(7) Tentative Identification of Unknown Compounds.

(a) If a laboratory is using a gas chromatography mass spectrometry instrument for analysis when testing cannabinoid concentrates, extracts, or industrial hemp-derived vapor items for solvents the laboratory shall have an established procedure for achieving tentative identification of unknown compounds in the sample. A tentatively identified compound (TIC) means an unknown chromatographic peak that is neither included in the list of analytes the laboratory is testing for nor expected to be naturally found in cannabis concentrates, extracts, or industrial hemp-derived vapor items such as terpenes.

(b) Tentative identification is achieved by searching NIST 2014 or an equivalent database (>250,000 compounds). Match scores for background subtracted or deconvoluted spectra should exceed 90 percent compared to the database library spectrum.

(c) Upon written request from the overseeing agency of the licensee or registrant, a laboratory shall report to the licensee or registrant and the Authority or the Commission all tentatively identified compounds (TICS) that meet the identification criteria in subsection (7)(b) of this rule.

(A) TIC quantitation is estimated by comparing analyte area to the closest internal standard area and assuming a response factor (RF) =1.

(B) If a laboratory does not use internal standards, TICs shall be reported as "detected" and apparent relative concentration shall be judged based on peak area.

(8) A laboratory must provide:

(a) Any pesticide test result to the Department of Agriculture (Department) upon that agency’s request.

(b) A sample or a portion of a sample to the Department upon that agency’s request, document the chain of custody from the laboratory to the Department, and document that the sample or portion of the sample was provided to the Department in the Commission’s seed to sale tracking system.

(9) A laboratory performing tests for a licensee or a registrant required to use CTS under ORS 475C.871 must enter any information required by the Commission or the Authority in CTS.

(10) A laboratory performing tests for a registrant must comply with the documentation requirements in OAR 333-007-0370 and must maintain the documentation required in these rules for at least three years and provide that information to the Authority upon request.

(11) The Authority may, in its discretion, permit a laboratory to deviate from the TNI Standard in order to comply with OAR 333-007-0300 to 333-007-0600 and these rules based on the state’s needs. Permission to deviate from the TNI Standard must be in writing from the Authority.

(12) A laboratory must be able to demonstrate that its limit of quantitation (LOQ) for all matrices in compliance testing is:

(a) Less than or equal to one-half of any action level established in OAR 333-007-0400, 333-007-0410, 333-007-0415, and 333-007-0425 Exhibit A, Tables 3, 4, 8, and 9 except for as outlined in 333-064-0110(6); and

(b) For total delta-9 THC concentration less than or equal to 0.15 percent; and

(c) For delta-8 THC concentration less than or equal to 0.15 percent.

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

(14) Sample material retention. A laboratory shall retain all of the unused sample material for a minimum of 30 calendar days after reporting results into the CTS.

[ED. NOTE: To view attachments referenced in rule text, click here to view rule.]

Statutory/Other Authority: ORS 438.605, 438.610, 438.615, 475C.544, 475C.560 & 438.620
Statutes/Other Implemented: ORS 438.605, 438.610, 438.615, 475C.544, 475C.560 & 438.620
History:
PH 14-2026, amend filed 01/13/2026, effective 01/20/2026
PH 18-2025, temporary amend filed 09/23/2025, effective 09/23/2025 through 03/21/2026
PH 10-2025, minor correction filed 04/21/2025, effective 04/21/2025
PH 68-2024, amend filed 07/09/2024, effective 07/23/2024
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 89-2020, amend filed 12/30/2020, effective 01/01/2021
PH 85-2020, amend filed 12/23/2020, effective 01/01/2021
PH 43-2020, minor correction filed 05/07/2020, effective 05/07/2020
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 38-2016(Temp), f. 12-13-16, cert. ef. 12-15-16 thru 5-30-17
PH 35-2016(Temp), f. & cert. ef. 12-2-16 thru 5-30-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-064-0110
Reporting Cannabis Test Results

(1) For purposes of this rule the definitions in OAR 333-007-0310 apply unless the context indicates otherwise.

(2) A test report must clearly:

(a) Identify for the licensee or registrant:

(A) Whether a sample has exceeded an action limit for an analyte in OAR 333-007-0400, 333-007-0410, 333-007-0415, and 333-007-0425 Exhibit A, Tables 3, 4, 8, or 9, or has otherwise failed a test as described in OAR 333-007-0300 to 333-007-0500.

(B) A "detected" pesticide result as required in section (6) of this rule.

(C) The batch unique identification number required under OAR 333-007-0350 and the test batch number associated with the samples tested, as required by OAR 333-064-0100.

(D) Identification of the test as a compliance test or a quality control or research and development test. If the test is not for compliance, the report shall indicate clearly on the first page the testing was for quality control or research and development.

(E) If applicable, a statement that the test was done on a sample from a remediated marijuana item or industrial hemp-derived vapor item.

(b) Include all information required in Volume 1 Module 2 section 5.10 of the 2016 TNI Standard with the following exceptions:

(A) The address of the customer; and

(B) The location of sampling, including any diagrams, sketches, or photographs.

(3) Within 24 hours of completion of the laboratory’s data review and approval procedures a laboratory must report all failed tests for testing required under OAR 333-007-0300 to 333-007-0500 except for failed water activity, whether or not the laboratory is reanalyzing the sample under OAR 333-007-0450:

(a) Into the Cannabis Tracking System (CTS) if performing testing for a licensee or a registrant who is subject to CTS tracking under OAR chapter 333, division 8; and

(b) To the Oregon Health Authority (Authority) electronically at www.healthoregon.org/ommp if performing testing for a registrant, along with a copy of the test order information required in OAR 333-007-0315, regardless of whether the laboratory is also reporting into CTS on behalf of a registrant that is subject to CTS tracking under OAR chapter 333, division 8.

(c) If the laboratory discovers that an error has occurred after reporting, an amended report shall be generated and communicated to the licensee or registrant, the Oregon Liquor and Cannabis Commission (Commission) for licensees, and the Authority for registrants. The laboratory shall ensure that results entered into the CTS are accurate and updated if necessary to reflect the amended report. The laboratory shall ensure that the amended report, communication, and updates to CTS as described in this rule are completed within 48 hours of learning of the error.

(4) The laboratory must report all test results required under OAR 333-007-0300 to 333-007-0500 that have not been reported under section (3) of this rule into the Commission’s seed to sale tracking system if performing testing for a licensee or a registrant who is subject to CTS tracking under OAR chapter 333, division 8.

(5) A laboratory must determine and include on each test report its limit of quantitation (LOQ) and action level for each analyte listed in OAR 333-007-0400 Table 3, 333-007-0410 Table 4, 333-007-0415 Table 8, and 333-007-0425 Table 9.

(6) When reporting pesticide testing results the laboratory must include in the report any target compound that falls below the LOQ that has a signal to noise ratio of greater than 5:1 and meets identification criteria with a result of "detected." This additional reporting is not required if the laboratory’s LOQ is less than or equal to one half of the action level in OAR 333-007-0400 Table 3.

(7) A laboratory must include in a test report the results of all associated batch quality control samples, with the date of analysis of the quality control samples and the acceptance limits used to determine acceptability.

(a) Batch quality control samples are the method blank or negative control and laboratory control sample or positive control.

(b) The report must clearly show the association to the client samples in the report by listing the batch identification numbers.

(8) A laboratory that is reporting failed test results to the Commission or the Authority in accordance with section (3) of this rule must report the failed test at the same time or before reporting to the licensee or registrant.

(9) If requested by the Authority, a laboratory must report sampling and testing information to the Authority, in a manner prescribed by the Authority.

(10) If a laboratory’s calculated adult use cannabinoid or CBD result exceeds 100 percent and the difference between the result and 100 percent is within the laboratory’s calculated analytical uncertainty, the laboratory may report the result as 100 percent with a qualifying statement on the certificate of analysis or the laboratory may report the calculated result with or without a qualifying statement. If the difference between the result and 100 percent is outside the calculated analytical uncertainty, the calculated result shall be reported without correction.

(a) The qualifying statement on the certificate of analysis shall clearly state the calculated value and the laboratory’s analytical uncertainty.

(b) For the purposes of calculating relative percent difference (RPD) or relative standard deviation (RSD), a laboratory shall use the calculated result and not the adjusted result described in this rule.

(11) A primary accredited laboratory may subcontract with accredited laboratories to perform required compliance testing. The primary accredited laboratory shall issue the final report.

(a) Accredited, subcontracted laboratories shall validate the results of any sample analysis and report that analysis to their client laboratory within 24 hours of completing the analytical run if the analysis results in a failed compliance test.

(b) The accredited laboratory that issues the final test report shall validate and report the results of any failed sample analysis as described in section (3) of this rule.

Statutory/Other Authority: ORS 475C.544 & ORS 475C.560
Statutes/Other Implemented: ORS 475C.544 & ORS 475C.560
History:
PH 68-2024, amend filed 07/09/2024, effective 07/23/2024
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 89-2020, amend filed 12/30/2020, effective 01/01/2021
PH 44-2020, minor correction filed 05/07/2020, effective 05/07/2020
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 29-2017, amend filed 12/22/2017, effective 01/01/2018
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 38-2016(Temp), f. 12-13-16, cert. ef. 12-15-16 thru 5-30-17
PH 35-2016(Temp), f. & cert. ef. 12-2-16 thru 5-30-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-064-0120
Proficiency Testing for Laboratories Accredited for Cannabis Testing

The purpose of a proficiency testing (PT) study is to provide a means for the Oregon Environmental Laboratory Accreditation Program (ORELAP) to evaluate a laboratory’s performance, under specified conditions related to a given set of criteria in a specific area of accreditation, through analysis of PT samples provided by an external source.

(1) A laboratory accredited to test marijuana items and industrial hemp-derived vapor items must at all times have two successful PT studies out of the most recent three attempts for each field of accreditation for which the laboratory holds accreditation.

(a) The closing dates of consecutive PT studies for a particular field of accreditation can be no more than seven months apart.

(b) The opening date of a PT study for a particular field of accreditation must be at least seven calendar days after the closing date of the previous PT study for the same field of accreditation.

(2) For purposes of this rule:

(a) A PT study is a scheduled PT study or a supplemental PT study.

(b) The proficiency testing reporting limit (PTRL) is equal to required maximum laboratory limits of quantitation (LOQs) as established in OAR 333-064-0100(12).

(3) When a laboratory submits its PT study results to the PT provider, the laboratory must:

(a) Ensure that the information provided to the provider reflects accurate information about the laboratory that corresponds to the information in the laboratory’s accreditation or application for accreditation, including but not limited to:

(A) The laboratory’s name and address;

(B) The laboratory’s ORELAP ID number; and

(C) The method and analyte codes.

(b) Instruct the PT provider to send the PT results directly to ORELAP.

(c) Report each quantitative field of accreditation as follows:

(A) The obtained numeric analytical result when the result is greater than or equal to the PTRL.

(B) If the PTRL is less than the laboratory’s LOQ as allowed in OAR 333-064-0110(6), the laboratory shall report the analytical result without qualifying the result.

(C) One of the following when the obtained numeric analytical result is less than the PTRL:

(i) <PTRL; or

(ii) The obtained analytical result if greater than or equal to the laboratory’s LOQ; or

(iii) <LOQ if the obtained analytical result is less than the laboratory’s LOQ.

(D) For non-detect results, <PTRL.

(d) Report each qualitative field of accreditation according to the PT provider’s instructions. Presence or absence determinations in the PT shall be made following the laboratory’s normal procedure.

(4) Any of the following will be considered to be an unsuccessful PT study and if a study was done, may not be counted toward the laboratory’s PT history of the most recent three attempts:

(a) If a PT study for a particular field of accreditation is not performed within seven months, the laboratory will be charged with a failed study for each analyte.

(b) A PT study for a particular field of accreditation that has an opening date less than seven days from the closing date of the previous PT study for that same field of accreditation.

(c) Information on study results received from the provider does not match any of the items in OAR 333-064-0120(3).

(5) For pesticide, mycotoxin analysis on or after August 1, 2024, and potency analyses in usable marijuana, a laboratory must use PT samples made with a usable marijuana matrix. If a usable marijuana matrix is unavailable, then a PT sample made with usable hemp matrix may be used with written permission from ORELAP. If a PT sample made with a usable hemp matrix is used for accreditation of potency analysis, then the PT provider must prepare the sample in usable hemp material itself and may not provide a separate spiking solution with the sample.

(6) In accordance with ORS chapter 183, the Oregon Health Authority may:

(a) Suspend the affected field of accreditation if a laboratory fails to comply with this rule.

(b) Revoke the affected field of accreditation if a laboratory fails three consecutive PT studies or fails to participate in a PT study as is required by these rules.

(7) For purposes of this rule a successful PT study means the testing results have been reported according to these rules and evaluated by the PT provider and ORELAP as acceptable.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 68-2024, amend filed 07/09/2024, effective 07/23/2024
PH 46-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 89-2020, amend filed 12/30/2020, effective 01/01/2021
PH 65-2020, temporary amend filed 09/24/2020, effective 09/24/2020 through 03/22/2021
PH 45-2020, minor correction filed 05/07/2020, effective 05/07/2020
PH 282-2018, adopt filed 12/20/2018, effective 01/01/2019

333-064-0130
Cannabis Laboratory Violations and Enforcement

(1) In addition to any violation of these rules, it is a violation for a laboratory accredited for cannabis sampling or analysis to:

(a) Falsify any documentation that is required by these rules or the laboratory’s accredited policies and procedures.

(b) Fail to collect the information required for ordering a test under OAR 333-007-0315 or 333-007-0440.

(c) Fail to comply with any applicable TNI standard.

(d) Report false or misleading information to the Authority or the Commission.

(2) For a violation of these rules, including any violation in section (1) of this rule, ORELAP may:

(a) Impose a civil penalty not to exceed $500 per day per violation against a laboratory accredited for cannabis sampling or analysis; and

(b) Deny, suspend or revoke accreditation of a laboratory accredited for sampling or analyzing cannabis.

(3) A laboratory that has its accreditation revoked under these rules may not reapply for accreditation for one year from the date the revocation is effective.

Statutory/Other Authority: ORS 475C.544 & ORS 475C.560
Statutes/Other Implemented: ORS 475C.544 & ORS 475C.560
History:
PH 47-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 46-2020, minor correction filed 05/07/2020, effective 05/07/2020
PH 282-2018, adopt filed 12/20/2018, effective 01/01/2019

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= √(∑((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.

[ED. NOTE: 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
History:
PH 68-2024, amend filed 07/09/2024, effective 07/23/2024
PH 207-2022, adopt filed 12/27/2022, effective 12/27/2022

333-064-0150
Reporting Psilocybin Products Test Results

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

(2) A test report must clearly identify for the manufacturer:

(a) Whether a sample has exceeded an action limit for an analyte in OAR 333-333-7050, or has otherwise failed a test as described in OAR 333-333-7030 and 333-333-7040.

(b) The batch unique identification number required under OAR 333-333-7090 and the test batch number associated with the samples tested, as required by OAR 333-333-7110.

(c) Identification of the test as a compliance test or a quality control or research and development test. If the test is not for compliance, the report shall indicate clearly on the first page the testing was for quality control or research and development.

(d) If applicable, a statement that the test was done on a sample from a remediated psilocybin product.

(3) Within 24 hours of completion of the laboratory’s data review and approval procedures a laboratory must report all failed tests for testing required under OAR 333-333-7030, 333-333-7040, and 333-333-7050, whether or not the laboratory is reanalyzing the sample under OAR 333-333-7120, into PTS if performing testing for a manufacturer who is subject to PTS tracking under OAR chapter 333, division 333.

(4) If the laboratory discovers that an error has occurred after reporting a result to a manufacturer or into PTS, an amended report shall be generated and communicated to the manufacturer. The laboratory shall ensure that results entered into the PTS are accurate and updated if necessary to reflect the amended report. The laboratory shall ensure that the amended report, communication, and updates to PTS as described in this rule are completed within 48 hours of learning of the error.

(5) The laboratory must report all test results required under OAR 333-333-7030, 333-333-7040, and 333-333-7050 that have not been reported under section (3) of this rule into PTS if performing testing for a manufacturer who is subject to PTS tracking under OAR chapter 333, division 333.

(6) Each potency testing report shall include the results for psilocybin analyte and psilocin analyte expressed in mg/g as well as Total Potential Psilocin in accordance with OAR-333-333-7040.

(a) Total Potential Psilocin must be calculated as follows:

mg/g Total Potential Psilocin = mg/g psilocin analyte + 0.719 * mg/g psilocybin analyte.

(b) Potency results for whole fungi shall be reported as the calculated values for psilocybin analyte, psilocin analyte, and Total Potential Psilocin as determined in the composite sample.

(c) Potency results for homogenized fungi, psilocybin extract, or edibles shall be reported as the calculated values for psilocybin analyte, psilocin analyte, and Total Potential Psilocin as determined in the primary composite sample.

(7) Each solvent testing report shall include the results for the solvent used by the manufacturer in accordance with OAR 333-333-7050.

(8) Each speciation testing report shall indicate if the batch was positively identified as Psilocybe cubensis.

(9) A laboratory must determine and include on each test report its limit of quantitation (LOQ) and action level for each analyte listed in OAR 333-333-7040 and 333-333-7050.

(10) A laboratory must include in a test report the results of all associated batch quality control samples, with the date of analysis of the quality control samples and the acceptance limits used to determine acceptability.

(a) Batch quality control samples are the method blank and laboratory control sample and the positive and negative controls in speciation testing.

(b) The report must clearly show the association to the client samples in the report by listing the batch identification numbers.

(11) A laboratory that is reporting failed test results to the Authority in accordance with section (3) of this rule must report the failed test at the same time or before reporting to the manufacturer.

(12) If requested by the Authority, a laboratory must report sampling and testing information to the Authority, in a manner prescribed by the Authority.

(13) If a laboratory’s calculated potency result exceeds 100 percent or 1000mg/g and the difference between the result and 100 percent or 1000mg/g is within the laboratory’s calculated analytical uncertainty, the laboratory may report the result as 100 percent or 1000mg/g with a qualifying statement on the certificate of analysis or the laboratory may report the calculated result with or without a qualifying statement. If the difference between the result and 100 percent or 1000mg/g is outside the calculated analytical uncertainty, the calculated result shall be reported without correction.

(a) The qualifying statement on the certificate of analysis must clearly state the calculated value and the laboratory’s analytical uncertainty.

(b) For the purposes of calculating RPD or RSD, a laboratory must use the calculated result and not the adjusted result described in this rule.

(14) A primary accredited laboratory may subcontract with accredited laboratories to perform required compliance testing. The primary accredited laboratory must issue the final report.

(a) Accredited, subcontracted laboratories must validate the results of any sample analysis and report that analysis to their client laboratory within 24 hours of completing the analytical run if the analysis results in a failed compliance test.

(b) The accredited laboratory that issues the final test report must validate and report the results of any failed sample analysis as described in section (3) of this 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
History:
PH 207-2022, adopt filed 12/27/2022, effective 12/27/2022

333-064-0160
Psilocybin Laboratory Violations and Enforcement

(1) In addition to any violation of these rules, it is a violation for a laboratory accredited for psilocybin product sampling or analysis to:

(a) Falsify any documentation that is required by these rules or the laboratory’s accredited policies and procedures.

(b) Fail to collect the information required for ordering a test under OAR 333-333-7020 or 333-333-7110.

(c) Fail to comply with any applicable TNI standard.

(d) Report false or misleading information to the Authority or to a client.

(2) For a violation of these rules, including any violation in section (1) of this rule, ORELAP may:

(a) Impose a civil penalty not to exceed $500 per day per violation against a laboratory accredited for psilocybin product sampling or analysis; and

(b) Deny, suspend or revoke accreditation of a laboratory accredited for sampling or analyzing psilocybin products.

(3) A laboratory that has its accreditation revoked under these rules may not reapply for accreditation for one year from the date the revocation is effective.

Statutory/Other Authority: ORS 438.605, 438.610, 438.615, 438.620, 475A.590, 475A.606 & 475A.618
Statutes/Other Implemented: ORS 438.605, 438.610, 438.615, 438.620, 475A.590, 475A.606 & 475A.618
History:
PH 207-2022, adopt filed 12/27/2022, effective 12/27/2022