Section 691-5-5 - Samples for Testing and ResearchA cannabis testing facility may offer a service to collect samples for mandatory testing from a licensee. A cannabis testing facility may contract with or otherwise accept samples for mandatory testing from a sample collector licensed pursuant to Title 28-B and 18-691 CMR, ch. 1. A cannabis testing facility may accept samples for mandatory testing from a self-sampling licensee authorized to collect samples pursuant to Title 28-B and 18-691 CMR, ch. 1. All samples for mandatory testing must be collected in accordance with Title 28-B, 18-691 CMR, ch. 1 and this Rule.
Section 5.1 - Samples for Mandatory Testing or Research and Development5.1.1.Authorized collection of samples. In accordance with 28-B MRS §§604 and 604-A, all samples for mandatory testing under this Rule must be collected by:A. An employee of the testing facility;B. A licensed sample collector; orC. A self-sampling licensee, collecting samples of cannabis or cannabis products cultivated, manufactured or otherwise produced by that licensee in compliance with all requirements of 18-691 CMR, ch. 1.5.1.2.Collection by cannabis testing facilities or sample collectors. An employee of a cannabis testing facility or a sample collector must collect samples of cannabis or cannabis products in compliance with: A. Sample collection recordkeeping requirements of 18-691 CMR, ch. 1;B. The Department-required sampling standard operating procedures;C. The Department-required Best Practices Guide;D. The requirements and restrictions of 28-B MRS §604; andE. The requirements and restrictions of 18-691 CMR, ch. 1.5.1.3.Collection by self-sampling licensees. A self-sampling licensee may collect samples of cannabis or cannabis products cultivated, manufactured, or otherwise produced or sold by that licensee if the licensee has submitted all required documentation to the Department and in compliance with: A. Sample collection recordkeeping requirements of 18-691 CMR, ch.1;B. The Department-required sampling standard operating procedures;C. The Department-required Best Practices Guide;D. The requirements and restrictions of 28-B MRS §604-A; andE. The requirements and restrictions of 18-691 CMR, ch. 1.5.1.4.Required documentation and record keeping. An adult use cannabis cultivation, manufacturing, or cannabis store licensee requesting testing by a cannabis testing facility must indicate in its request for testing whether the requested testing is for mandatory testing purposes as required by 18-691 CMR, ch. 1, or for research and development purposes. The licensee must indicate in writing, prior to collection of the samples for testing, whether such testing is for mandatory testing purposes or for research and development purposes. A. Pursuant to 28-B MRS §602(2), a licensee must maintain a record of all mandatory testing conducted at the request of the licensee that includes at a minimum: (1) A description of the cannabis, cannabis concentrate or cannabis product submitted for mandatory testing;(2) The identity of the testing facility conducting the mandatory testing; and(3) The results of any and all mandatory testing conducted at the request of the licensee.5.1.5.Qualifications. Employees of a cannabis testing facility or sample collectors who collect samples from licensees must have a current individual identification card issued by OCP and must:A. Be physically able to perform the duties, with or without reasonable accommodations;B. Pass initial and ongoing demonstrations of capability;C. When available, complete 8 hours of initial training on various sampling techniques; andD. When available, complete 8 hours of periodic refresher training annually.5.1.6.Transportation of Samples. A sample collector or self-sampling licensees may transport a sample from a licensee to the cannabis testing facility for testing and analysis. A. The sample collector or self-sampling licensee shall ensure the samples are not visible to the public. Samples shall be locked in a fully enclosed box, container or cage that is secured to the inside of the vehicle or trailer. For the purposes of this section, the inside of the vehicle includes the trunk.B. The sample collector or self-sampling licensees shall ensure that packages or containers holding cannabis goods samples are neither tampered with nor opened during transport.C. An employee of a cannabis testing facility who is collecting samples of cannabis, cannabis concentrate or cannabis products for mandatory testing shall only travel between licensees for whom the cannabis testing facility is conducting mandatory testing and the cannabis testing facility's premises when engaged in the transportation of samples; a sample collector not employed by a cannabis testing facility shall only travel between licensees for whom the sample collector is collecting samples and the cannabis testing facility(ies) conducting the mandatory testing. A sample collector shall not deviate from the travel requirements described in this section, except for necessary meals or rest required by law, or refueling.D. The sample collector may transport multiple samples obtained from multiple licensees at once. A self-sampling licensee may transport only those samples collected by the licensee and must deliver those samples to the cannabis testing facility directly.E. Only persons who are in possession of a valid individual identification card issued by OCP may be in a vehicle or trailer transporting samples.F. All samples being transported must have a label with the following statement: "For Testing Purposes Only."Section 5.2 - Protocos for Acceptance of Samples Collected by Licensees or Other Qualified Persons The cannabis testing facility must develop and maintain a plan for receiving samples for mandatory and other testing.
5.2.1.SOPs. If the cannabis testing facility accepts samples from a sample collector or self-sampling licensee for mandatory or other testing, it must develop and maintain SOPs for receiving samples.A. A sample collector or self-sampling licensee must contact the cannabis testing facility(ies) and comply with the cannabis testing facility's recommendations, based upon matrices sampled and analyses required, regarding, without limitation: (1) Sample collection tools;(2) Sample collection and transport containers;(3) Whether any Field or Trip blanks are required to be collected, transported or otherwise used or delivered to the cannabis testing facility pursuant to the cannabis testing facility's quality system; and(4) Any limitations regarding sample delivery.B. The SOPs must have detailed chain of custody protocols for receiving samples.C. The SOPs must require sample collectors or self-samplers to address factors such as storage, environmental conditions, transportation of the batch or sample, tamper evident sealing and labeling samples for transport "For Testing Purposes Only."D. The SOPs must address representativeness of the samples received from the sample collector or self-sampler; the sampling increments must be selected at random by the sample collector or self-sampler, and designed so that the samples collected reflect the total composition of the product.E. The SOPs must be designed to meet specified sample quality criteria, which is dependent upon whether the samples provided are for mandatory testing in compliance with the requirements of Title 28-B, ch. 1 or additional analyses not required by law. For non-mandatory test samples, this requires a sampling plan that includes enough representative sample increments to meet the client-specified confidence intervals.F. The SOPs must address volume of sample to be collected by sample collector or self-sampler from each batch in compliance with the requirements of Section 6 of this rule for samples collected for mandatory testing, or client specifications for non-mandatory testing. This specification will ensure that adequate sample volume is collected for the analyses required, including all required quality control samples and any potential confirmation analysis.Section 5.3 - Chain of Custody and Document Control Requirements Testing facilities must develop and implement a chain of custody protocol to ensure accurate documentation of the handling, storage and destruction of cannabis samples. All samples for mandatory testing must also be accompanied by any documentation required by the testing facility.
5.3.1.Chain of custody forms. The chain of custody protocol must require the use of a chain of custody form that contains, at a minimum, the following: A. Cannabis testing facility name, physical address and certification number of the cannabis testing facility analyzing the sample;B. Requester name, physical address and license or registration number; or if a registered caregiver, the registration card identification number; or if an exempt caregiver, the caregiver's name and address; or if a qualifying patient, the patient's name and address;C. Information regarding each primary sample, as follows:(1) Unique primary sample identifier, as indicated on the sample container;(2) For sample increments from the same sampled batch that are separated for homogeneity testing, the unique sample increment identifier as indicated on the container holding the separate sample increment for homogeneity testing;(3) The sample location, number and type of containers used to collect samples, and the sample collection technique(s) used to collect the samples;(4) Date and time of the sample collection;(5) The printed names and signatures of the sample collector(s);(6) For cannabis products that need to be stored at specific temperatures: All conditions, including sample temperature at time of collection and temperature of the cooler used for transport; and(7) The printed name and signature of the person at the cannabis testing facility receiving the samples cannabis.5.3.2.Document control.A. Each time the sample changes custody, is transported, is removed from storage at the cannabis testing facility, or is destroyed, the date, time and the names and signatures of persons involved in these activities must be recorded on the chain of custody form.B. All documents must be controlled and retained in accordance with this rule.(1) A complete chain of custody is required for each batch.(2) If there is a quality assurance plan for the client, the sampling plan can be abbreviated to include the client and cannabis testing facility information and any variation or modification that occurred in the sampling event.Section 5.4 - Sample Rejection A. When samples are received by the cannabis testing facility, the cannabis testing facility must check the integrity of the samples. The cannabis testing facility must deem a sample compromised if one or more of the following has occurred:(1) Broken shipping container;(2) Evidence that the sample has been tampered with, manipulated, adulterated or contaminated;(3) Evidence that the sample was not collected in the manner required by this rule or the DAFS- required sample collection SOP;(4) Any missing or incomplete sample collection records required by testing facility in accordance with its quality system;(5) The temperature of the sample is out of the required range to prevent microbial growth;(6) The sample weight, as determined upon receipt by the cannabis testing facility, is greater than +/-10% difference than the weight recorded on the transport manifest accompanying the samples; or(7) Any other factor that may have negatively impacted the integrity of the sample since its collection.B. If the sample is rejected, the cannabis testing facility must document the sampling or handling errors, contact the requester and the sample collector (if the requester did not self-sample), schedule re-sampling and time for sample receipt, and document the conversation with all parties, including any additional specific instructions given to the sampling party to correct any sample deficiencies noted.Section 5.5 - Sample Collection5.5.1.Sample Collection by Cannabis Testing Facility Personnel.A. At minimum, the cannabis testing facility must use the Maine Adult Use Cannabis Program Sample Collection Standard Operating Procedure for Mandatory Testing included as Appendix A to the Adult Use Cannabis Program Rule, 18-691 CMR, ch.1, and must complete for every batch a sample collection record to ensure it is collecting samples that support accurate analyses of cannabinoids, residual solvents and processing chemicals, contaminants, pesticides, microbiological impurities, mycotoxins, water activity, filth and foreign material and heavy metals, in compliance with Best Practice Guide for the Sample Collection of Adult Use Cannabis for Mandatory Testing published by DAFS.B. The cannabis testing facility must collect adequate samples of the cannabis, cannabis concentrate or cannabis product in the form in which it will be conveyed to a consumer (finished or unfinished plant material; cannabis concentrate; or an unpackaged or pre-packaged cannabis product) in accordance with Table 5.5-A. The sample must comprise the number of sample increments, selected at random, indicated in Table 5.5-A. The cannabis testing facility will combine these increments to make one complete sample for testing. Table 5.5-A. Required Sample Size Based Upon Matrix Type and Batch Size
Matrix Type | Harvest Batch Weight | Production Batch Units* | Primary Sample Amount |
Plant Material | [LESS THAN OR EQUAL TO] 2.5 kg | | 6.5 g (13 increments of 0.5 grams each) |
| 2.5 kg < w [LESS THAN OR EQUAL TO] 5 kg | | 9.5 g (19 increments of 0.5 grams each) |
| 5 kg < w [LESS THAN OR EQUAL TO] 7.5 kg | | 16 g (16 increments of 1 gram each) |
| 7.5 kg < w [LESS THAN OR EQUAL TO] 10 kg | | 22 g (22 increments of 1 gram each) |
Concentrate | [LESS THAN OR EQUAL TO] 0.5 kg | | 6 g (12 increments of 0.5 grams each) |
| 0.5 kg < w [LESS THAN OR EQUAL TO] 1 kg | | 8 g (16 increments of 0.5 grams each) |
| 1 kg < w [LESS THAN OR EQUAL TO] 1.5 kg | | 10 g (20 increments of 0.5 grams each) |
| 1.5 kg < w [LESS THAN OR EQUAL TO] 2 kg | | 12 g (24 increments of 0.5 grams each) |
| 2 kg < w [LESS THAN OR EQUAL TO] 5 kg | | 14 g (28 increments of 0.5 grams each) |
Product ** | | [LESS THAN OR EQUAL TO] 50 | 2 units |
| | 51 -150 | 3 units |
| | 151 - 500 | 5 units |
| | 501-1200 | 8 units |
| | 1201 -3200 | 13 units |
| | 3201-10000 | 20 units |
*For harvest or production batches in excess of the sizes listed in this table (10 kg of plant material, 5 kg of concentrate or 10,000 production batch units), the batch must be divided and sampled in smaller batches in accordance with the batch size limits listed in this table, the requirements of this Rule, and the requirements of 18691 CMR, ch. 1.
**For production batches of prepackaged cannabis products, one production unit is one sample increment. For production batches of unpackaged cannabis products, one serving size of the cannabis product is one sample increment.
5.5.2.Sample Collection by Sample Collectors and Self-Samplers.A. Sample collectors and self-samplers must collect samples of cannabis, cannabis concentrate and cannabis products in accordance with OCP's Maine Adult Use Cannabis Program Sample Collection Standard Operating Procedure for Mandatory Testing and must complete for every batch a sample collection record in accordance with 18-691 CMR, ch. 1, § 3.11, in addition to any additional forms, including chain of custody forms, required by the cannabis testing facility receiving the samples.B. Sample collectors and self-samplers must collect the required number of sample increments, based upon matrix type and batch size, in accordance with Table 5.5-A. The sample collector or self-sampler will specify in its sample collection records, after contacting the cannabis testing facility, the number and type of sample containers required to transport the primary sample and any separate sample increments to the testing facility for mandatory testing.a. Sample increments for homogeneity testing must be stored in a separate sample collection container from the other combined primary sample to ensure accurate testing.b. Sample increments for some analyses, depending on the instrumentation of the cannabis testing facility conducting the mandatory analyses, may require storage and transport in particular kinds of sample collection containers to ensure the integrity of the samples collected.Section 5.6 - Sample Preparation and Testing A. The cannabis testing facility must designate an area for preparation of cannabis product samples for analysis.B. The preparation area must include:(1) Disposable gloves to be worn, to avoid sample contamination;(2) Decontaminated or single-use disposable tool(s), including stainless steel spatulas, knives and/or disposable pipettes;(3) Decontaminated stainless-steel bowls and implements for homogenizing samples appropriately;(4) Clean, decontaminated surfaces for sample processing;(5) Decontaminated or single use, disposable sample containers appropriate for processing;(6) Labels and pens with indelible ink; and(7) Necessary supplies for thoroughly cleaning, decontaminating and drying sample preparation tools and equipment between samples.C. The cannabis testing facility shall ensure that any primary samples of cannabis flower or cannabis trim, including pre-rolled cannabis cigarettes and infused pre-rolled cannabis cigarettes, are homogenized in accordance with the following requirements: (1) The cannabis testing facility shall first remove any sample increments required to conduct testing for microbials and water activity; and(2) The cannabis testing facility shall then homogenize, by grinding or other suitable method, enough of the remaining sample material to run all remaining analyses required plus any extra that may be needed for QC samples or retesting, including any stems, seeds or fan leaves submitted in the primary sample. Samples must be homogenized to attain an average particle size of less than 1 millimeter.(3) Any cannabis testing facility retesting of a portion of the original sample must be taken from the same homogeneous material of the original primary sample.(4) Retesting of the original sample material by the cannabis testing facility may only be done to investigate instrument malfunctions or sample handling problems such as dilution errors. In the case of a clearly identified cannabis testing facility error, the retest results must substitute for the original test result.