OAR 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) “Air” as a matrix means air samples, which are analyzed for possible contaminants under the guidance of the Clean Air Act.
(3) “Authority” means the Oregon Health Authority.
(4) “Biological tissue” as a matrix means samples of biological tissue, excluding those of human origin.
(5) “Cannabis sampling” means an activity related to obtaining a representative sample of a marijuana item for purposes of testing in accordance with these rules and OAR 333-007-0300 (Marijuana Testing: Purpose and Effective Date) to 333-007-0490.
(6) “Cannabis Tracking System” or “CTS” means the Oregon Liquor Control Commission’s system for tracking the transfer of marijuana items and other information as authorized by ORS 475B.177 (Duty to develop and maintain system for tracking transfer of marijuana items).
(7) “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.
(8) “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.
(9) “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.
(10) “Fields of accreditation” means those matrix, technology/method, and analyte combinations for which ORELAP offers accreditation.
(11) “Finished cannabinoid concentrate or extract” means a cannabinoid concentrate or extract that is in its final form ready for packaging for sale or transfer to a patient, designated primary caregiver or consumer.
(12) “Finished cannabinoid product” means a cannabinoid product that is in its final form ready for packaging for sale or transfer to a patient, designated primary caregiver or consumer, and includes all ingredients whether or not the ingredients contain cannabinoids.
(13) “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.
(14) “Marijuana item” has the meaning given that term in ORS 475B.550 (Definitions for ORS 475B.550 to 475B.590).
(15) “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.
(16) “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.
(17) “National Environmental Laboratory Accreditation Program (NELAP)” means the program established to oversee the implementation of the TNI Standards.
(18) “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.
(19) “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.
(20) “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.
(21) “ORELAP approved assessor” means an assessor whose qualification has been evaluated by ORELAP and found to meet TNI Standards for laboratory on-site assessors.
(22) “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.
(23) “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.
(24) “Public water system” means a water system as defined in OAR 333-061-0010 (Scope).
(25) “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.
(26) “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.
(27) “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.
(28) “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.
(29) “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.
(30) “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. Cannabinoid products and concentrates or extracts as defined in ORS 475B.550 (Definitions for ORS 475B.550 to 475B.590) shall be included in this matrix as solids.
(31) “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.
(32) “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.
(33) “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
(34) “These rules” means the Oregon Administrative Rules encompassed by OAR 333-064-0005 (Purpose) through 333-064-0120 (Proficiency Testing for Laboratories Accredited for Cannabis Testing).
(35) “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.
(36) “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.

Source: Rule 333-064-0025 — Definitions, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-064-0025.

Last Updated

Jun. 8, 2021

Rule 333-064-0025’s source at or​.us