18-691-1 Me. Code R. § 7

Current through 2023-3, January 18, 2023
Section 691-1-7 - Testing

A licensee may not sell or transfer adult use cannabis or an adult use cannabis product to a cannabis store licensee for sale to a consumer under 28-B MRS, chapter 1 and this Rule unless the cannabis or cannabis product has been tested pursuant to this Rule and 18-691 CMR, Ch. 5, and mandatory testing has demonstrated that the cannabis or cannabis product does not exceed the maximum level of allowable contamination for any contaminant that is injurious to health and for which testing is required. The Department may temporarily waive mandatory testing requirements under this section for any contaminant or factor for which the Department has determined that there exists no licensed testing facility in the State capable of and certified to perform such testing.

7.1Commencement of Mandatory Testing.

The Department will not be requiring mandatory testing for pesticides (insecticides, fungicides, herbicides, acaricides, plant growth regulators, disinfectants, etc.) until December 2022. The Department may, at any time, require immediate mandatory testing for any analyte required by this Rule or any other analyte reasonably suspected to be a health hazard or safety threat, to ensure public health and safety.

7.2Mandatory Testing and Additional Analysis.
A. The following tests are mandatory for all cannabis or cannabis products, except seedlings, immature cannabis plants and seeds, in final form prior to being sold to a cannabis store for sale to a consumer in accordance with this section. A licensee may choose whether to conduct some tests, as indicated below, before the cannabis or cannabis product is in its final form, however, the licensee that transfers cannabis or cannabis products to a cannabis store for sale to a consumer shall ensure that every required test is conducted in accordance with this section prior to transfer to the cannabis store licensee. The following tests are mandatory for all cannabis and cannabis products:
(1)Filth and foreign material. Any visible contaminant, including without limitation, hair, insects, feces, mold, sand, soil, cinders, dirt, packaging contaminants and manufacturing waste and byproducts.
(2)Residual solvents, poisons and toxins. Acetone, acetonitrile, butane, ethanol, ethyl acetate, ethyl ether, heptane, hexane, isopropyl alcohol, methanol, pentane, propane, toluene, total xylenes (m, p, o-xylenes), 1,2-dichloroethane, benzene, chloroform, ethylene oxide, methylene chloride, trichloroethylene and any others used. A licensee is not required to analyze for residual solvents and processing chemicals in dried flower, kief, hashish or cannabis products manufactured without chemical solvents. A licensee is not required to analyze an orally-consumed tincture containing alcohol for residual ethanol. A licensee is not required to test a cannabis product for residual solvents, poisons and toxins if all cannabis concentrate used to make the cannabis product has previously passed mandatory testing for residual solvents.
(3)Pesticides (insecticides, fungicides, herbicides, acaricides, plant growth regulators, disinfectants, etc.) Pesticides listed in Table 6.8-A of the Rules for Certification of Cannabis Testing Facilities, 18-691 CMR, ch. 5. A licensee is not required to test a cannabis concentrate or a cannabis product for pesticides, fungicides, insecticides and growth regulators if all cannabis flower and/or trim used to make the cannabis concentrate or cannabis product has previously passed mandatory testing for pesticides, fungicides, insecticides and growth regulators.
(4)Other harmful chemicals (Metals). Cadmium (Cd), lead (Pb), arsenic (As), mercury (Hg). A licensee is not required to test a cannabis product for the other harmful chemicals listed herein if the cannabis concentrate used to make the cannabis product has previously passed mandatory testing for the other harmful chemicals listed herein.
(5)Dangerous molds and mildew. Total yeast and mold, and for any cannabis or cannabis product that fails an initial test for total yeast and mold, mycotoxins including aflatoxins (B1, B2, G1, and G2) and ochratoxin A.
(6)Harmful microbes. Total viable aerobic bacteria, total coliforms, Enterobacteriaceae, Shiga toxin-producing E. coli (STEC) and Salmonella (spp.).
(7)THC potency, homogeneity and cannabinoid profiles. THC and any other cannabinoid to be referenced in labeling or marketing materials.
(8)Water activity. Testing for water activity is mandatory for solid and semi-solid edible cannabis products that do not require preservation by other means (e.g. refrigeration) and for cannabis plant material that is dried and prepared in its final form of intended use and that is to be sold or transferred by a cultivation facility or products manufacturing facility to a cannabis store.
B. A licensed cultivation facility, licensed manufacturing facility, licensed cannabis store may submit for additional analysis samples of cannabis for research and development purposes, but such testing shall not satisfy the mandatory testing requirements of this Rule.
C. The Department shall publish a Best Practices Guide that includes a sampling plan and preservation instructions appropriate to each matrix type. All cannabis testing facilities, all sample collectors and any self-sampling licensee collecting samples for mandatory testing must comply with the Department-required Best Practices Guide.
D. A licensee collecting and transporting samples for mandatory testing must comply with all recordkeeping requirements regarding sample collection, sample transport and sample receipt in accordance with this Rule and any instructions regarding sample collection, sample transport and sample receipt provided to the licensee by the cannabis testing facility(ies) conducting the mandatory analyses.
E. The Department shall publish standard operating procedures for sample collection which must be used by any licensee collecting samples for mandatory testing.
F. A licensee may sell or furnish to a cannabis store for sale to a consumer cannabis or a cannabis product without submitting it for testing if:
(1) The cannabis or cannabis product in its final form has previously undergone all required testing at the direction of another licensee or licensees as evidenced by a certificate of analysis, or in the case of cannabis concentrate or cannabis products that were tested for some analytes prior to final form, as evidenced by the certificates of analysis for testing done in accordance with the requirements of subsection A above;
(2) The previous testing demonstrated that the cannabis or cannabis product does not exceed the maximum level of allowable contamination for any contaminant that is injurious to health and for which testing is required;
(3) The mandatory testing process and the test results for the cannabis or cannabis product are documented in a certificate of analysis issued pursuant to a request for mandatory testing. A certificate of analysis for non-mandatory testing for research or development purposes does not satisfy this requirement; and
(4) The cannabis or cannabis product has been appropriately tracked in the inventory tracking system, and the cannabis or cannabis product has not been altered in any way, including any further processing or manufacturing, other than packaging and labeling of the cannabis or cannabis product for retail sale, following the issuance of the certificate(s) of analysis indicated in subparagraph 1 above.
7.3Reporting.
A. If a sample's result exceeds an action level as required by 18-691 CMR, Ch. 5, the cannabis testing facility must report in the inventory tracking system and the certificate of analysis that the sample failed the mandatory test for which the result exceeds the action level, and the cannabis testing facility must report that the sample failed mandatory testing in general unless otherwise provided for in this Rule or 18-691 CMR, Ch. 5.
(1) In the event a cannabis testing facility determines that a sample has failed testing, the entity that submitted the sample may remediate the batch in accordance with section 7.4 before the batch is re-tested.
(2) The results of failed mandatory tests must be reported to both the Department and the entity that submitted the sample.
(3) The cannabis testing facility is not required to report to the Department the results of any tests if the requester notifies the cannabis testing facility in advance that the testing is solely for research development purposes and agrees not to use the results to satisfy any mandatory testing requirements.
B. If a sample passes testing, the cannabis testing facility must, within one business day from issuance of final QC review, enter "pass" into the inventory tracking system for the batch from which the sample came. The batch is then released for distribution to a consumer.
7.4 Retesting and remediation of batches that fail mandatory testing. If a cannabis testing facility determines that a batch of cannabis or cannabis product fails mandatory testing, the cannabis testing facility must promptly report to the licensee and the Department that the sample failed mandatory testing. In accordance with this section, the licensee that submitted the sample may choose to have the batch retested without remediating the failed batch, or may remediate the failed batch and then submit samples for retesting.3 Batches of cannabis and cannabis products that have failed mandatory testing for pesticides and heavy metals may not be remediated but may be retested in accordance with this section. Batches of cannabis and cannabis products that passed mandatory testing may not be retested in order to enhance the results indicating that the sample passed for all tested analyte categories.
A. Batches of cannabis and cannabis products that have failed mandatory testing may be retested without remediation. A licensee seeking retesting of batch that failed mandatory testing without remediation shall submit two samples from the batch that failed mandatory testing to the same cannabis testing facility that issued the initial failed test result.
(1) Both samples submitted for retesting must pass all required testing required for any analyte that failed initial mandatory testing.
(a) Batches of cannabis or cannabis products that fail initial mandatory testing for yeast or mold must pass mandatory testing for total yeast and mold and mycotoxins upon retesting.
(2) If either sample submitted for retesting fails any required test for any analyte that failed initial mandatory testing, the batch of cannabis flower or trim may be transferred to another licensee for extraction following a failed retest and subsequently retested in accordance with Section 7.4(B)(2) below.
(3) If either sample submitted for retesting fails any required test for any analyte that failed initial mandatory testing, the batch cannabis concentrate or cannabis products may not be remediated or retested and must be destroyed.
B. Batches of cannabis or cannabis products that have failed mandatory testing may be remediated and shall be retested following remediation. A licensee may attempt to remediate any batch that fails mandatory testing, except batches that fail due to heavy metals or pesticide contamination. A licensee may attempt to remediate the batch at the licensee's cannabis establishment or the licensee may transfer the failed batch to another licensee for remediation. Batches of cannabis flower or trim that have failed mandatory testing may not be remediated in a manner that involves the combination of the batch that failed mandatory testing with a batch, or batches, of cannabis flower and/or trim that has not been tested or that has passed mandatory testing.
(1) If a failed batch is remediated using a remediation method that does not change the cannabis or cannabis product into a different matrix of cannabis or cannabis product (e.g. remediation that does not change cannabis flower or trim into cannabis concentrate, or remediation that changes cannabis concentrate into a cannabis product), then the licensee must submit two samples from the remediated batch to the same cannabis testing facility that issued the initial failed test result.
(a) Both samples submitted for retesting must pass all required testing required for any analyte category that failed initial mandatory testing.
(i) Batches of cannabis or cannabis products that fail initial mandatory testing for yeast or mold must pass mandatory testing for total yeast and mold and mycotoxins upon retesting.
(b) If either sample submitted for retesting fails any required test for any analyte category that failed initial mandatory testing, the batch of cannabis or cannabis products may be remediated in accordance with this section or destroyed.
(2) If a failed batch is remediated using a remediation method that changes the cannabis or cannabis product into a different matrix of cannabis or cannabis product, then the licensee must submit one sample from the remediated batch to the cannabis testing facility that issued the initial failed test result.
(a) The sample from the remediated batch must pass all mandatory testing required for the cannabis or cannabis product in the matrix it is in after remediation, including any tests previously passed, if applicable.
(b) If the remediated batch, that is in a new matrix, fails mandatory testing, the failed mandatory test is treated as an original failed mandatory test and the remediated batch may be retested or remediated in accordance with this section.
C. A licensee that remediates any failed batch must appropriately record all remediation steps and processes in the Department's inventory tracking system.
D. A licensee must ensure at all times while submitting samples for testing or retesting, or transferring batches for remediation, that all cannabis and cannabis products are appropriately tracked in the Department's inventory tracking system in accordance with this rule.
E. A licensee must take action to retest, remediate or destroy a batch of cannabis or cannabis products within 30 days of receiving notice from the cannabis testing facility of the initial failed test result. If the licensee does not record an action on the failed batch within 30 days, the Department may issue an Order of Destruction.
7.5Department action following issuance of a failed mandatory test result by a cannabis testing facility. The Department may issue an Order of Destruction to a licensee that has not taken action to retest, remediate or destroy a batch of cannabis or cannabis products that failed mandatory testing within 30 days of receiving notice from the cannabis testing facility of the initial failed test result. Unless otherwise indicated by the Department, an Order of Destruction under this subsection shall be considered final agency action and notice will be given to the licensee of the licensee's right to appeal, consistent with the Maine Administrative Procedures Act, 5 MRS, Chapter 375. The notice shall contain:
A. The batch number of the cannabis or cannabis products to be destroyed;
B. The method of destruction directed by the Department, if any;
C. Any proof of destruction required by the Department; and
D. The date by which destruction must occur and the Department must receive notice.

3Office of Cannabis Policy, Guidance Documents, OCP Website: Resources, https://www.maine.gov/dafs/ocp/sites/maine.gov.dafs.ocp/files/inline-files/OMP_Memorandum-AUMP_Retesting_of_Cannabis_Failed_Test.pdf (accessed April 29, 2022). On January 26, 2021, the Department issued a Memorandum on Retesting and Remediation of Cannabis Items Subject to a Failed Test which provides examples of the retesting and remediation requirements of this section.

18-691 C.M.R. ch. 1, § 7