1. (a) Only the results of the following tests are in compliance with the testing requirements of this chapter:

   1. (1) Tests conducted on harvest batch samples or harvest lot samples requested by a grower/processor under § 1171a.29 (relating to testing requirements) and identified and collected by an employee of an approved laboratory.
   2. (2) Tests conducted on process lot samples requested by a grower/processor under § 1171a.29 and identified and collected by an employee of an approved laboratory.
2. (b) The test results for each sample collected under § 1171a.28(c)(1) and (2) (relating to selection protocols for samples) shall be entered into the electronic tracking system and shall only be accessible to the grower/processor submitting the sample and to the Department.

3. (c) If a sample fails any test required under § 1171a.29, the following apply to the sample:

   1. (1) The approved laboratory that performed the initial test may re-test the sample upon a request from the grower/processor in accordance with subsection (d).

      (1.1) If the re-tested sample fails, the lot shall be disposed of under § 1151a.40 (relating to management and disposal of medical marijuana waste) unless the lot failed only for yeast or mold and the grower/processor chooses to process the lot into a topical form under section 702(a)(3) of the act (35 P.S. § 10231.702(a)(3)).

   2. (2) If the sample passes the re-test, another approved laboratory shall sample the same harvest batch, harvest lot or process lot to confirm the passing test result.

      1. (i) The grower/processor to provide a root cause analysis for the initially failed result.
      2. (ii) Documentation from the grower/processor and the confirming laboratory that required testing procedures were followed and detailing chain of custody.
      3. (iii) An affirmation by the grower/processor that the sample was not modified in any manner and was not subjected to any form of decontamination or remediation between the initially failed and confirming passing results.
      4. (iv) An additional confirming test by an approved laboratory other than the two who conducted the first and second tests.

      (2.1) Following the confirming test, and to determine whether to accept the confirming result, the Department may require any or all of the following:

   3. (3) If the Department does not agree to accept the confirming results from the approved laboratory, the sample shall be disposed of by the approved laboratory under § 1151a.40.
4. (d) A grower/processor shall notify the Department and the approved laboratory through the electronic tracking system of its intent to re-test the sample or test another sample from the same harvest batch, harvest lot or process lot that failed a test.

5. (e) An approved laboratory shall issue to a grower/processor a certificate of analysis, including the supporting data, for each harvest batch, harvest lot or process lot sample that was tested at the request of the grower/processor. The certificate of analysis must include the following information:

   1. (1) Whether the chemical profile of the harvest batch, harvest lot or process lot conforms to the approved chemical profile of the strain for the following compounds:

      1. (i) THC.
      2. (ii) THCA.
      3. (iii) CBD.
      4. (iv) CBDA.
      5. (v) CBC.
      6. (vi) CBN.
      7. (vii) THCV.
      8. (viii) CBDV.
      9. (ix) CBG.
      10. (x) D8.

   2. (2) That the presence of the following contaminants within the harvest batch, harvest lot or process lot does not exceed the approved maximum levels for the following:

      1. (i) Heavy metals, mercury, lead, cadmium or arsenic.
      2. (ii) Foreign material such as hair, insects, or any similar or related adulterant.

      3. (iii) Microbiological impurity, including any of the following:

         1. (A) Total aerobic microbial count.
         2. (B) Total yeast mold count.
         3. (C) P. aeruginosa.
         4. (D) Aspergillus spp.
         5. (E) S. aureus.
         6. (F) Aflatoxin B1, B2, G1 and G2.
         7. (G) Ochratoxin A.
         8. (H) Pesticide residue.
         9. (I) E. coli.
         10. (J) Salmonella.

      4. (iv) Whether the harvest batch, harvest lot or process lot is within the specification for the strain for the following characteristics:

         1. (A) Odor.
         2. (B) Appearance.
         3. (C) Fineness.
         4. (D) Moisture content, when applicable for process lot.

6. (f) If an approved laboratory detects an amount of a pesticide that exceeds normal or acceptable limits, the approved laboratory shall notify the Department immediately. If an approved laboratory detects a prohibited pesticide or a pesticide within the National Institute of Standards and Technology library during the testing process, the approved laboratory shall notify the Department immediately. An approved laboratory shall report whether any residual pesticides are detected above the limit of detection and shall report the results to the Department immediately. The Department may obtain test samples from a grower/processor to conduct pesticide residue testing.

   1. (1) An approved laboratory shall establish a limit of quantification of 0.1 ug/g or lower for all pesticides.
   2. (2) An approved laboratory shall analyze at minimum 0.5 grams of the representative sample of medical marijuana to determine whether residual pesticides are present.
7. (g) The Department will maintain oversight of testing methods and sampling standards under this chapter. The Department may conduct onsite visits and review certificates of analysis submitted by an approved laboratory.

Cross References

This section cited in 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).