Section 691-5-1 - Cannabis Testing Facility Certification Program EstablishedSection 1.1 - Statutory Authority The Department of Administrative and Financial Services (referred to heretofore as DAFS), acting through its Office of Cannabis Policy (referred to heretofore as OCP), has promulgated the following rule in accordance with the statutory authority provided in 28-B MRS §104, in order to mitigate potential threat to public health and safety following emergency legislative action, for the purpose of implementing, administering and enforcing the provisions of 28-B MRS, chapter 1. The Department of Health and Human Services (referred to heretofore as DHHS), acting through its Center for Disease Control and Prevention (referred to heretofore as the CDC) shall implement the certification program described herein in accordance with the statutory authority provided in 22 MRS §569.
Section 1.2 - Department Authority DAFS and DHHS, through the CDC, may enforce this Rule and any relevant provisions of Titles 4, 5, 22 and 28-B, and any other general statutes, laws, executive orders or subsequently passed legislation. DAFS shall set licensing fees in accordance with 28-B MRS §207, and CDC shall set certification and technology fees in accordance with 22 MRS §569. DAFS, DHHS or an agent thereof shall have the authority to inspect, during operating hours, times of apparent activity or any other reasonable time, any cannabis testing facility and its business records. DAFS shall further have the authority to inspect, during operating hours, times of apparent activity or any other reasonable time, vehicles used to transport cannabis or cannabis products to a cannabis testing facility. Approval by the CDC of the plans, standard operating procedures, financial and business arrangements or other documents and information provided for certification by the CDC during the certification process does not constitute approval by DAFS for the purposes of licensure pursuant to the Adult Use Cannabis Program Rule, 18-691 CMR, ch. 1.
Section 1.3 - Communication with DAFS and/or DHHS1.3.1Written Communications. If an applicant or licensee is required to or elects to submit anything in writing to DAFS or DHHS, unless otherwise prescribed by DAFS or DHHS, the applicant or licensee may submit the writing to DAFS or DHHS via:1.3.2Submission Deadline. If a written notification must be submitted by a deadline it must be received by DAFS or DHHS, regardless of method used to submit the writing, by 5 p.m. Eastern Time.Section 1.4 - Definitions 1.Aw means the water activity, which is the partial vapor pressure of water in a substance divided by the standard state partial vapor pressure of water. It is a measure of the quantity of water in a product that is available, and therefore capable of, supporting bacteria, yeasts and fungi. 2.Acceptance criteria means the specified limits placed on characteristics of an item, process or service that are used to determine data quality as defined in methods, rules or regulations.3.Accredited means to be recognized as conforming to a standard by an accrediting organization, such as ISO/IEC 17025.4.Accredited college or university is a college or university accredited by a regional or national accrediting agency recognized by the United States Department of Education.5.Accuracy means the degree of agreement between an observed value and an accepted reference value. Accuracy includes a combination of random error (precision) and systematic error (bias) components that are a result of sampling and analytical operations; a data quality indicator.6.Action level is the threshold value for determining whether a sample passes or fails an analytical test.7.Adult use cannabis means cannabis cultivated, manufactured, distributed or sold by a cannabis establishment.8.Adult use cannabis product means a cannabis product that is manufactured, distributed or sold by a cannabis establishment.9.Aliquot is a portion of a sample that is used in an analysis performed by a testing facility.10.Analyst means the designated individual who tests the samples by performing the "hands-on" analytical methods and associated techniques. The analyst is responsible for applying required testing facility practices and other pertinent quality controls to meet the required level of quality.11.Analyte is a chemical, compound, element, bacteria, yeast, fungus or toxin that is identified or measured.12.Analytical batch means a group of samples that is prepared and/or analyzed together with the same process and personnel, using the same lot(s) of reagents.13.Analytical method is a technique used qualitatively or quantitatively to determine the composition of a sample or a microbial contamination of a sample.14.AOAC International means Association of Official Agricultural Chemists International, a non-profit scientific association that creates, validates and publishes reliable analytical test methods.15.Apparent activity means any sight, sound, smell or other indication that persons are present at a cannabis establishment.16.Applicant means a person who submits to certification by the Maine CDC as part of an application for a license to operate a cannabis testing facility issued by OCP.17.Approved proficiency testing provider means a provider of proficiency testing samples whom the certification officer has deemed to meet the requirements of this Rule.18.Assessment means the evaluation process used to measure or establish the performance effectiveness and conformance of a testing facility and/or its systems to defined criteria and standards and requirements of testing facility certification.19.Audit means a systematic and independent examination of facilities, equipment, personnel, training, procedures, record-keeping, data validation, data management and reporting aspects of a system to determine whether quality assurance, quality control and technical activities are being conducted as planned. An audit is conducted to determine whether these activities will effectively achieve quality objectives.21.Batch number means a distinct group of numbers, letters or symbols, or any combination thereof, assigned to a specific batch of adult use cannabis by a cultivation facility, sample collector, testing facility, or a cannabis store or to a specific batch of adult use cannabis or adult use cannabis products by a products manufacturing facility, sample collector, testing facility or a cannabis store.22.Best Practices Guide means the Best Practices for the Sampling of Adult Use Cannabis, published by the Department, incorporated by reference in 18-691 CMR, ch.1. All licensees and any employee of a licensee collecting samples of cannabis, cannabis concentrate, or cannabis products for mandatory testing must collect samples in accordance with the best practices described in the guide.23.Bias means the systematic or persistent distortion of a measurement process, which causes errors in one direction, resulting in the expected sample measurement being different from the sample's true value.24.Calibration means a set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system or values represented by a material measure or a reference material, and the corresponding values realized by standards.a. In calibration of support equipment, the values realized by standards are established using reference standards that are traceable to the International System of Units (SI).b. In calibration, per methods, the values realized by standards are typically established using reference materials that are either purchased by the testing facility with a certificate of analysis or purity or prepared by the testing facility using support equipment that has been calibrated or verified to meet specifications.25.Calibration curve means the mathematical relationship between the known values, such as concentrations, of a series of calibration standards and their instrument response.26.Calibration standard means a substance or reference material used for calibration.27.Cannabinoid is a chemical compound that is unique to, and derived from, cannabis.28.Cannabis means the leaves, stems, flowers and seeds of a cannabis plant, whether growing or not. "Cannabis" includes cannabis concentrate, except where context indicates otherwise, but does not include hemp as defined in 7 MRS §2231, or a cannabis product.29.Cannabis concentrate means the resin extracted from any part of a cannabis plant and every compound, manufacture, salt, derivative, mixture or preparation from such resin, including, but not limited to hashish. In determining the weight of a cannabis concentrate in a cannabis product, the weight of any other ingredient combined with cannabis or cannabis concentrate to prepare the cannabis product may not be included.30.Cannabis flower means the pistillate reproductive organs of a mature cannabis plant, whether processed or unprocessed, including the flowers and buds of the plant. Cannabis flower does not include cannabis trim or whole mature cannabis plants.31.Cannabis plant means all species of the plant genus cannabis. Including but not limited to a mother plant, a mature cannabis plant, an immature cannabis plant or a seedling, but it does not include a cannabis product or "hemp" as defined in 7 MRS §2231.32.Cannabis product means a product composed of cannabis or cannabis concentrate and other ingredients that is intended for use or consumption. "Cannabis product" includes without limitation an edible cannabis product, a cannabis ointment and a cannabis tincture. Cannabis product does not include cannabis concentrate.33.Cannabis store means a facility licensed under Title 28-B and 18-691 CMR, ch. 1 to purchase adult use cannabis, immature cannabis plants and seedlings from a cultivation facility, to purchase adult use cannabis and adult use cannabis products from a products manufacturing facility, to collect and transport samples of cannabis, cannabis concentrate and cannabis products in that cannabis store's possession for mandatory testing, and to sell adult use cannabis, adult use cannabis products, immature cannabis plants and seedlings to consumers.34.Cannabis testing facility means an entity licensed according to 28-B MRS §503, including those also registered as cannabis testing facilities in accordance with 22 MRS §2423-A, to test cannabis, cannabis products and other substances for research and development and to analyze contaminants in and the potency and cannabinoid profile of samples in an approved location.35.Cannabis trim means any part of a cannabis plant, whether processed or unprocessed, that is not cannabis flower or a cannabis seed.36.Cannabis waste means cannabis, cannabis plants or cannabis products that are unfit for retail sale for reasons including without limitation failed mandatory testing, expired products or crop failure.37.CAS number is the unique numerical identifier assigned to every chemical substance by Chemical Abstracts Service (CAS).38.CBD is cannabidiol, CAS number 13956-29-1.39.CBDA is cannabidiolic acid, CAS number 1244-58-2.40.Certificate of analysis means the report prepared for the requester and OCP about the analytical testing performed and results obtained by the testing facility.41.Certification means the process by which an agency or organization evaluates and recognizes a testing facility as meeting certain predetermined qualifications or standards, thereby certifying the testing facility. The Department of Health and Human Services is responsible for certification of all testing facilities.42.Certification officer means the person designated by the Department of Health and Human Services to manage certification of testing facilities.43.Certified reference material means reference material, accompanied by a certificate, having a value, measurement of uncertainty and stated metrological traceability chain to a national metrology institute.44.Chain of custody form means a record, either paper-based or electronic, that documents the possession of the samples at the time of receipt by the cannabis testing facility, in accordance with chain of custody protocol prescribed by the cannabis testing facility. This record, at a minimum, must include the sample location, the number and types of containers, the mode of collection, the authorized individual who collected the sample, the date and time of collection, preservation and requested analyses.45.Chain of custody protocols means the procedures developed and employed by the cannabis testing facility to record the possession of samples from the time of sampling through the retention time specified by the client or program. These procedures are performed at the special request of the client and include the use of a chain of custody form that documents the collection, transport and receipt of compliance samples by the cannabis testing facility. In addition, these protocols document all handling of the samples within the cannabis testing facility and, if applicable, by the sample collector or self-sampler.46.Colony forming unit (CFU) means a unit of measurement of estimated number of bacteria or fungal cells in a sample.47.Contaminant means an unacceptable level of an unwanted or objectionable substance, toxin, pollution or foreign material that causes impurity in a product. Contaminants include, but are not limited to, pesticides, microbiology, filth, heavy metals and residual chemical solvents.48.Corrective action means an action taken by the cannabis testing facility to eliminate or correct the causes of an existing nonconformance to prevent the recurrence of the nonconformance.49.Corrective action plan means a report, including specific corrective actions and a specific date of completion, generated in response to deficiencies or findings of non-compliance.50.Cultivar means a specific variety of cannabis produced by selective breeding. Also commonly referred to as a "strain" of cannabis.51.Cultivation facility means a facility licensed under Title 28-B and 18-691 CMR, ch. 1 to purchase cannabis plants and seeds from other cultivation facilities; to cultivate, prepare and package adult use cannabis; to collect and transport samples of cannabis cultivated by that facility for mandatory testing; to sell adult use cannabis to products manufacturing facilities, to cannabis stores and to other cultivation facilities; and to sell cannabis plants and seeds to other cultivation facilities and immature cannabis plants and seedlings to cannabis stores. A cultivation facility includes a nursery cultivation facility. Licensees that cultivate cannabis in a nursery cultivation facility may sell an unlimited number of cannabis seeds and a sum total of 12 seedlings and immature plants to a consumer 21 years of age or older.52.Cultivator means a cultivation facility licensed under 28-B MRS, Chapter 1, subchapters 2 and 3 or a person, qualifying patient, exempt caregiver, registered caregiver or registered dispensary that is authorized under 22 MRS, chapter 558-C to cultivate cannabis.53.Deficiency means a failure of the testing facility to meet any one of the requirements in this rule.54.Demonstration of capability means a procedure to establish the ability of the analyst to generate acceptably accurate and precise analytical results.55.Department of Administrative and Financial Services (DAFS) means the Maine Department of Administrative and Financial Services. DAFS includes the Office of Cannabis Policy (OCP), which licenses adult use cannabis establishments, including cannabis testing facilities, and registers medical cannabis program participants including patients, registered caregivers, registered dispensaries, registered manufacturing facilities and registered inherently hazardous extraction facilities.56.Department of Health and Human Services (DHHS) means the Maine Department of Health and Human Services. DHHS includes the Maine Center for Disease Control and Prevention (CDC), which certifies, through its Maine Cannabis Certification Program, the technology and testing methods used by cannabis testing facilities under this Rule.57.Disciplinary action means any action taken by the CDC to limit, suspend, revoke, or deny the certification of a cannabis testing facility as a result of the cannabis testing facility's violation or other nonconformance with this rule, 28-B MRS, chapter 1, or other rules promulgated by DHHS or DAFS.58.Edible cannabis product means a cannabis product intended to be consumed orally, including, but not limited to, any type of food, drink or pill containing cannabis.59.Exempt caregiver means a medical cannabis caregiver who is exempt from the registration requirements of 22 MRS §2425-A.60.Facility director means the individual who is legally authorized to direct the activities of a testing facility and who commits the appropriate resources to comply with this rule.61.Field of testing means those programs, matrices, methods or analyte combinations, for which certification is offered.62.Final form means for the purpose of mandatory testing, adult use cannabis or an adult use cannabis product that is in the form that will be sold to an adult use cannabis consumer; except that the adult use cannabis or adult use cannabis product need not be prepackaged into individual retail units to be considered in its "final form".63.Finished plant material means cannabis that has been trimmed and dried. Trimming includes removing the leaves immediately subtending the buds and any dead leaves or stems.64.Foreign material means any physical contaminant or filth, including without limitation hair, insects, feces, packaging contaminants and manufacturing waste and by-products.65.Full active license means a license issued by the Department of Administrative and Financial Services, Office of Cannabis Policy to a cannabis testing facility that has received CDC full certification and ISO/IEC 17025:2017 or most recent version accreditation for at least one technology and analyte that authorizes testing of cannabis or cannabis products in accordance with 28-B MRS, Chapter 1, subchapters 2 and 6 and this rule.66.Full certification means certification granted by the CDC to a cannabis testing facility that has received ISO/IEC 17025:2017 or most recent version accreditation and meets all other requirements of this Rule and authorizing it to seek an active license from DAFS.67.Harvest batch means a specific quantity of adult use cannabis harvested from adult use cannabis plants of the same cultivar, grown under the same conditions, and harvested during a specified period of time from a specified cultivation area within a cultivation facility.68.Homogeneity means the amount of cannabis or cannabis concentrate and cannabinoids within the product being consistent and reasonably equally dispersed throughout the product or each portion of the product or concentrate, or a representative sample.69.Homogenization means the process by which the components of a sample are broken apart into particles that are equal in size and evenly distributed.70.Increment or sample increment means a smaller sample that, together with other increments, makes up the primary sample.71.ISO/IEC 17025:2017 or most recent version means the general requirements for the competence of testing and calibration laboratories issued in 2017 (or more recent) joint technical committee of the International Organization for Standardization and the International Electrotechnical Commission.72.Licensee means a natural person or business entity licensed pursuant to 28-B MRS, Chapter 1, subchapters 2 and 5 to operate an adult use cannabis establishment.73.Limit of detection (LOD) means an estimate of the minimum amount of an analyte in a given matrix that an analytical process can reliably detect.74.Limit of quantitation means the minimum level, concentration or quantity of a target variable (e.g., target analyte) that can be reported with a specified degree of confidence.75.Manufacturer means a manufacturing facility licensed under 28-B MRS, Chapter 1, subchapter 2 or a person, qualifying patient, registered caregiver or registered dispensary that is legally allowed to manufacture under 22 MRS, chapter 558-C.76.Marijuana has the same meaning as "cannabis" as defined in this rule. In accordance with P.L. 2021, ch. 669, An Act To Promote Equity and Increase Opportunities in the Cannabis Industry by Reducing Restrictions Related to Convictions for Drug Offenses and To Replace the Term "Marijuana" with the Term "Cannabis" in the Maine Revised Statute, this rule reflects the replacement of the term "marijuana" with the term "cannabis" throughout. Where the term "marijuana" appears in other written documents maintained or used by the Office of Cannabis Policy and regarding the Adult Use Cannabis Program, that term should be interpreted to have the same meaning as "cannabis" as defined herein.77.Matrix means the component or substrate that contains the analyte of interest.78.Matrix spike means a sample prepared by adding a known quantity of analyte and subjecting the sample to the entire analytical procedure to determine the ability to recover the known analyte or compound. The spiked concentration must be at a low to mid-range concentration of the calibration curve for the target analyte.79.Method means a body of procedures and techniques for performing an activity (e.g., sampling, chemical analysis or quantification), systematically presented in the order in which they are to be executed.80.Method blank means an analyte-free matrix, to which all reagents are added in the same volumes or proportions as are used in sample preparation and is processed in exactly the same manner as the samples.81.Method detection limit means the minimum measured concentration of a substance that can be reported with 99-percent confidence that the measured analyte is distinguishable from method blank results.82.Mycotoxin means any toxic substance produced by a fungus and especially a mold.83.National Institute of Standards and Technology (NIST) means a federal agency of the United States Department of Commerce's Technology Administration.84.Nonconformance or noncompliance means a failure of a testing facility to meet any requirement in this rule.85.Non-target organism means an organism that the test method or analytical procedure is not testing for. Non-target organisms are used in evaluating the specificity of a test method.86.Percent recovery means the percentage of a measured concentration relative to the added (i.e. spiked) concentration in a reference material, matrix spike sample or matrix spike duplicate. A testing facility shall calculate the percent recovery by dividing the sample result by the expected result then multiplying the quotient by 100.87.Pesticide means any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest; any substance or mixture of substances intended for use as a plant regulator, defoliant or desiccant; and any nitrogen stabilizer; and all substances listed in Table 6.8-A of this Rule. It does not include multicellular biological controls such as mites, nematodes, parasitic wasps, snails or other biological agents not regulated as pesticides by the U.S. Environmental Protection Agency.88.Plant growth regulator means any substance or mixture of substances intended through physiological action for accelerating or retarding the rate of growth or rate of maturation or for otherwise altering the behavior of plants or the produce thereof. "Plant growth regulator" does not include substances to the extent that they are intended as plant nutrients, trace elements, nutritional chemicals, plant inoculants or soil amendments.89.Practical experience means hands-on post-secondary-education testing facility experience, using equipment, instruments, kits and materials routinely found in a testing facility.90.Precision means the degree to which a set of observations or measurements of the same property, obtained under similar conditions, conform to themselves. Precision serves as a data quality indicator. Precision is usually expressed as standard deviation, variance or range, in either absolute or relative terms.91.Preservation means any conditions under which a sample must be kept to maintain chemical and/or biological integrity prior to analysis.92.Primary sample means a portion of cannabis or cannabis products collected from a harvest or production batch for testing. Also called a "composite" sample.93.Production batch means a specific quantity of cannabis concentrate or a cannabis product that is produced during a specified period of time using the same extraction and/or manufacturing method, formulation and/or recipe and standard operating procedure. "Production batch" also includes the combination of two or more harvest batches of cannabis trim or kief.94.Products manufacturing facility means a facility licensed under Title 28-B and 18-691 CMR, ch. 1 to purchase adult use cannabis from a cultivation facility or another products manufacturing facility; to manufacture, label and package adult use cannabis and adult use cannabis products; to collect and transport samples of cannabis, cannabis concentrate and cannabis products manufactured by that facility for mandatory testing; and to sell adult use cannabis and adult use cannabis products to cannabis stores and to other products manufacturing facilities 95. Proficiency test means an evaluation of a testing facility's performance against pre-established criteria, by means of inter-testing facility comparisons of test measurements.96.Proficiency test sample means a sample prepared by a party independent of the testing facility tasked with evaluating the sample, with a concentration and identity of an analyte that is known to the independent party but is unknown to the testing facility evaluating the sample and its personnel.97.Provisional certification means the process by which CDC evaluates and recognizes a cannabis testing facility as meeting the requirements of this Rule with the exception ISO/IEC 17025 accreditation, for which an application must be pending.98.Provisional active license means a license issued by DAFS to a cannabis testing facility that has received CDC provisional certification and has applied for, but not yet received, ISO/IEC 17025:2017 or most recent version accreditation for at least one technology and analyte that authorizes testing of cannabis or cannabis products in accordance with 28-B MRS, Chapter 1, subchapter 2 and 6 and this rule.99.Proficiency test sample means a sample, the composition of which is unknown to the testing facility, provided to test whether the testing facility can produce analytical results within the specified acceptance criteria.100.Proficiency testing means a way to evaluate a testing facility's performance under controlled conditions relative to a given set of criteria, through analysis of unknown samples provided by an external source.101.Proficiency testing program means the aggregate of providing rigorously controlled and standardized samples to a testing facility for analysis, reporting of results, statistical evaluation of results and the collective demographics and results summary of all participating testing facilities.102.Protocol means the detailed written procedure for field and/or testing facility operation (e.g., sampling, analysis) that must be strictly followed.103.Qualifying patient means a person who possesses a valid certification for the medical use of cannabis pursuant to 22 MRS §2423-B.104.Quality assurance (QA) means a set of operating principles that enable testing facilities to produce defensible data of known accuracy and precision. Quality assurance includes without limitation employee training, equipment preventative maintenance procedures, calibration procedures and quality control testing.105.Quality assurance manual means a document stating the management policies, objectives, principles, organizational structure and authority, responsibilities, accountability and implementation of an agency, organization or cannabis testing facility, to ensure the quality of its product and the utility of its product to its users.106.Quality control (QC) means the overall system of technical activities that measures the attributes and performance of a process, item or service against defined standards to verify that they meet the stated requirements established by the client; operational techniques and activities that are used to fulfill requirements for quality; also the system of activities and checks used to ensure that measurement systems are maintained within prescribed limits, providing protection against "out of control" conditions and ensuring that the results are of acceptable quality.107.Quality control sample means a sample used to assess the performance of all, or a portion of, the measurement system. One of any number of samples, such as certified reference materials, a matrix fortified by spiking, or actual samples fortified by spiking, intended to demonstrate that a measurement system or activity is in control.108.Quality system means a structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability and implementation plan of an organization for ensuring quality in its work processes, products (items) and services. The quality system provides the framework for planning, implementing and assessing work performed by the organization and for carrying out required QA and QC activities. A cannabis testing facility's quality system must account for anomalies arising from the collection and transport of samples for mandatory testing conducted by a self-sampler or a sample collector licensee, including provisions regarding the use of blanks.109.Quantitate means to undertake the arithmetic process of determining the amount of analyte in a sample.110.Raw data means the documentation generated during sampling and analysis. This documentation includes, but is not limited to, field notes, electronic data, magnetic tapes, un-tabulated sample results, QC sample results, chromatograms, instrument outputs and handwritten records.111.Reagent means a compound or mixture added to a system to cause a chemical reaction, or test if a reaction occurs. A reagent may be used to determine whether or not a specific chemical substance is present by causing a reaction to occur with the chemical substance.112.Reference material means a material or substance, one or more of which the property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials.113.Reference method means a method by which the performance of an alternate method is measured or evaluated.114.Registered caregiver means a caregiver who is registered by OCP pursuant to 22 MRS §2425.115.Registered dispensary or dispensary means an entity registered under 22 MRS §2425-A that acquires, possesses, cultivates, manufactures, delivers, transfers, transports, sells, supplies or dispenses cannabis or related supplies and educational materials to qualifying patients and the caregivers of those patients.116.Relative standard deviation means the standard deviation expressed as a percentage of the mean recovery. It is the coefficient of variation multiplied by 100 and is calculated using the following equation: RSD = (s / x) x 100%, where s = standard deviation and x = mean recovery. If any results are less than the limit of quantitation, the absolute value of the limit of quantitation is used.117.Reporting limit means the lowest level of an analyte that can be accurately recovered from the matrix of interest (e.g., the level of quantitation).118.Requester means a person who submits a request to a certified testing facility for state-mandated testing of cannabis or cannabis products.119.Sample means, as applicable, an amount of:a. Cannabis, cannabis concentrate or cannabis product collected from an adult use cannabis establishment for mandatory testing: i. By an employee of a testing facility in accordance with 28-B MRS §604 and Adult Use Cannabis Program Rule, 18-691 CMR, ch. 1;ii. By a sample collector, in accordance with 28-B MRS §604 and 18-691 CMR, ch. 1; or iii. By a self-sampler in accordance with 28-B MRS §604-A and 18-691 CMR, ch.1;b. Cannabis, cannabis concentrate or cannabis product provided to a testing facility by a cannabis establishment or other person for mandatory testing or testing for research and development purposes in accordance with 28-B MRS, chapter 1;c. Adult use cannabis or adult use cannabis product collected from a licensee by the Department for the purposes of testing the cannabis or cannabis product for quality control purposes pursuant to 28-B MRS §512(2).120.Sample collection SOP means a standard operating procedure for the collection of samples of cannabis, cannabis concentrate and cannabis products for mandatory testing published by the Department that must be used by all licensees collecting, transporting and transferring samples for mandatory testing. The current sample collection SOP is Appendix A of Adult Use Cannabis Program Rule, 18-691 CMR, ch. 1.121.Sample collector means a person licensed pursuant to 18-691 CMR, ch. 1 and 28-B MRS, ch. 1 to collect samples of cannabis and cannabis products for testing and to transport and deliver those samples to a testing facility. A sample collector must hold a valid individual identification card ("IIC").122.Sample increment means a portion of a batch that, together with other increments, makes up the sample.123.Sampling date means the date that a sample was collected in the field, in order to be reported as such, when reporting the sample results to testing facility clients or regulatory programs.124.Sanitize means to sterilize, disinfect or make hygienic.125.Self-sampler or Self-sampling licensee means a cultivation facility, products manufacturing facility or cannabis store licensee that collects samples of cannabis, cannabis concentrate and cannabis products for mandatory testing or an employee of a cultivation facility, products manufacturing facility or cannabis store licensee who collects samples of cannabis, cannabis concentrate and cannabis products for that licensee for mandatory testing. Any individual collecting samples for mandatory testing must hold a valid individual identification card ("IIC").126.Solid means a matrix that includes soils; sediments; solid waste; and sludges.127.Standard means the certified reference materials produced by NIST or other equivalent organization and characterized for absolute content, independent of analytical method or the dilutions made from these certified reference materials for the purposes of calibration or determining accuracy of a test method.128.Standard operating procedure (SOP) means a written document that details the method for an operation, analysis or action, with thoroughly prescribed techniques and steps. SOPs are officially approved by the testing facility's senior management as the methods for performing certain routine or repetitive tasks.129.Target or target analyte means an analyte or list of analytes within a test method that may be analyzed and for which the testing facility has obtained certification from the certification officer to test as part of a field of testing.130.Target organism is an organism that is being tested for in an analytical procedure or test method.131.Technology means a specific arrangement of analytical instruments, detection systems and/or preparation techniques.132.Technology Analyte Table (TAT) means the table used to identify methods, analytes, programs and matrices available for certification.133.Testing or test means the research and analysis of cannabis, cannabis products or other substances for contaminants, safety or potency. "Testing" or "test" includes the collection of samples of cannabis and cannabis products for testing purposes but does not include cultivation or manufacturing. Nothing in this definition shall be construed to permit any licensee except a cannabis testing facility to perform analyses of cannabis, cannabis concentrate or cannabis products for mandatory testing without a separate cannabis testing facility license issued by DAFS.134.THC is tetrahydrocannabinol (delta-9 THC), CAS number 1972-08-3.135.THCA is tetrahydrocannabinolic acid, CAS number 23978-85-0.136.Tincture means a liquid edible cannabis product with a concentration of greater than 1 mg of THC per ounce of liquid.137.Total CBD means the sum of CBD and CBDA. Total CBD is calculated using the following equation: Total CBD = CBD + (CBDA*0.877).138.Total THC means the sum of THC and THCA. Total THC is calculated using the following equation: Total THC = delta-9 THC + (THCA*0.877).139.Total Yeast and Mold Count (TYMC) means the total combined yeast and mold count in standardized plating methodologies and is usually expressed in number of colony forming units (CFU).140.Traceability means the ability to trace the history, application or location of an entity by means of recorded identifications. In a calibration sense, traceability relates measuring equipment to national or international standards, primary standards, basic physical constants or properties or reference materials. In a data collection sense, it relates calculations and data generated throughout the project back to the requirements for the quality of the project.141.Unusable means that the cannabis can no longer be smoked, eaten, ingested, topically applied or otherwise ingested. Nor can the cannabis be further manipulated in a manner to extract more than a trace amount of cannabinoid.142.Validation means the confirmation by examination and objective evidence that the requirements for a specific intended use are fulfilled.143.Verification means the confirmation by examination of, and provision of, objective evidence that specified requirements have been fulfilled. Verification refers to the process of examining a result of a given activity to determine conformance with this rule.