Current through Register Vol. 54, No. 45, November 9, 2024
Section 1171a.29 - Testing requirements(a) Prior to conducting any testing of a sample at the request of a grower/processor, an approved laboratory shall enter into a written contract with the grower/ processor for testing services. The approved laboratory shall provide a copy of the contract to the Department within 2 days following the Department's request.(b) A grower/processor shall submit through the electronic tracking system a request to the approved laboratory with which it has a written contract under subsection (a) for each test to be conducted.(c) Testing shall be performed as follows: (1) An approved laboratory shall test samples from a harvest batch or harvest lot prior to using the harvest batch or harvest lot to produce a medical marijuana product.(2) An approved laboratory other than the one that tested the harvest batch or harvest lot shall test samples from each process lot before the medical marijuana is sold or offered for sale to another medical marijuana organization.(3) An approved laboratory may test other samples and test samples at the request of a grower/processor or the Department.(d) The samples identified in subsection (c) shall be tested for the following: (3) Water activity and moisture content.(4) THC and CBD concentration.(5) Microbiological contaminants.(e) Sampling and testing under this chapter shall be conducted with a statistically significant number and size of samples and with approved methodologies to ensure that all harvest batches, harvest lots and medical marijuana products are adequately tested for contaminants and that the cannabinoid profile is consistent throughout the harvest batch, harvest lot or medical marijuana products. Testing methods must be fully validated to address the accuracy, precision, specificity, linearity, range and sensitivity of the testing method.(e.1) PCR testing is not an approved methodology.(f) An approved laboratory may not test any samples when there is evidence of improper collection, improper preservation, apparent spoilage, excessive time lapse between collection of the sample and testing, or any other obvious circumstance that compromises the sample.(g) An approved laboratory shall enter test results for samples collected under § 1171a.28(c)(1) and (2) (relating to selection protocols for samples) into the electronic tracking system and, under § 1151a.40 (relating to management and disposal of medical marijuana waste), properly dispose of all tested and untested samples and test samples.Adopted by Pennsylvania Bulletin, Vol 53, No. 09. March 4, 2023, effective 3/4/2023 This section cited in 28 Pa. Code § 1171a.22 (relating to laboratories generally); 28 Pa. Code § 1171a.31 (relating to test results and reporting); 28 Pa. Code § 1171a.35 (relating to laboratory reporting); and 28 Pa. Code § 1171a.39 (relating to clarification of the requirements of §§1171a.29(c) and 1171a.31(c)-statement of policy).