Current through Register Vol. 54, No. 44, November 2, 2024
(a) Only the
results of the following tests are in compliance with the testing requirements
of this chapter:
(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) 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.
(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.
(c) If a sample fails
any test required under §
1171a.29, the following apply to
the sample:
(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) 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.
(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:
(i) The
grower/processor to provide a root cause analysis for the initially failed
result.
(ii) Documentation from the
grower/processor and the confirming laboratory that required testing procedures
were followed and detailing chain of custody.
(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.
(iv) An
additional confirming test by an approved laboratory other than the two who
conducted the first and second tests.
(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.
(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.
(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)
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:
(i) THC.
(ii) THCA.
(iii) CBD.
(iv) CBDA.
(v) CBC.
(vi) CBN.
(vii) THCV.
(viii) CBDV.
(ix) CBG.
(x) D8.
(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:
(i) Heavy metals, mercury, lead, cadmium or
arsenic.
(ii) Foreign material such
as hair, insects, or any similar or related adulterant.
(iii) Microbiological impurity, including any
of the following:
(A) Total aerobic microbial
count.
(B) Total yeast mold
count.
(C)
P.
aeruginosa.
(D)
Aspergillus spp.
(E)
S. aureus.
(F) Aflatoxin B1, B2, G1 and G2.
(G) Ochratoxin A.
(H) Pesticide residue.
(I)
E. coli.
(J)
Salmonella.
(iv) Whether the harvest batch,
harvest lot or process lot is within the specification for the strain for the
following characteristics:
(A) Odor.
(B) Appearance.
(C) Fineness.
(D) Moisture content, when applicable for
process lot.
(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) An approved laboratory
shall establish a limit of quantification of 0.1 ug/g or lower for all
pesticides.
(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.
(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.
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).
