Or. Admin. R. 333-064-0025

Current through Register Vol. 63, No. 9, September 1, 2024

Section 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.

Or. Admin. R. 333-064-0025

OHD 7-1999, f. & cert. ef. 10-26-99; OHD 1-2001, f. & cert. ef. 1-17-01; OHD 16-2002, f. & cert. ef. 10-10-02; PH 5-2003, f. 5-15-03, cert. ef. 7-1-03; PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04; PH 20-2003, f. 12-02-03, cert. ef. 12-08-03; PH 23-2004, f. & cert. ef. 7-1-04; PH 8-2005, f. 6-1-05, cert. ef. 7-1-05; PH 6-2011, f. & cert. ef. 8-9-11; PH 31-2015(Temp), f. 12-29-15, cert. ef. 1-1-16 thru 6-28-16; PH 17-2016, f. & cert. ef. 6/7/2016; PH 282-2018, f. 12/20/2018, & cert. ef. 1/1/2019; PH 35-2020, minor correction filed 05/07/2020, effective 5/7/2020; PH 54-2020, temporary amend filed 06/05/2020, effective 6/5/2020 through 12/1/2020; PH 85-2020, amend filed 12/23/2020, effective 01/01/2021; PH 89-2020, amend filed 12/30/2020, effective 1/1/2021; PH 95-2021, amend filed 12/29/2021, effective 1/1/2022; PH 24-2022, amend filed 03/15/2022, effective 3/31/2022; PH 207-2022, amend filed 12/27/2022, effective 12/27/2022

Publications: Publications referenced are available from the agency.

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