N.H. Admin. Code § He-C 402.15

Current through Register No. 45, November 7, 2024
Section He-C 402.15 - Testing
(a) Each batch of cannabis harvested and each batch of cannabis concentrate produced shall be tested in accordance with this section.
(b) The testing required by this section shall be performed by an independent laboratory located in New Hampshire and licensed under RSA 151 and He-P 808.
(c) Each batch of cannabis harvested shall be tested for:
(1) The cannabinoid profile; and
(2) Contaminants as described in (e) below.
(d) Each batch of cannabis concentrate produced shall be tested for the cannabinoid profile.
(e) The testing required by (c) (2) above shall meet the following standards:
(1) For purposes of testing for microbiologicals and mycotoxins, a cannabis sample shall be deemed to have passed if it does not exceed the limits set forth in Table 402.1 below:

Table 402.1 - Contaminant Limits

Cannabis Material

Viable Aerobic Bacteria (CFU/g)

Yeast & Mold (CFU/g)

Viable Coliforms (CFU/g)

Bile-tolerant Gram Negative Bacteria (CFU/g)

E. Coli (pathogenic strains) & Salmonella spp.

Mycotoxins (alfatoxin B1, alfatoxin B2, alfatoxin O1, alfatoxin O2, ochratoxin A)

Harvested Cannabis

105

104

103

103

None detected in 1 gram

<20 µg /kg of material

Cannabis Concentrate

104

103

102

102

None detected in 1 gram

<20 µg /kg of material

CFU: colony forming unit

(2) For purposes of testing for heavy metals, a cannabis sample shall be deemed to have passed if it does not exceed the limits set forth in Table 402.2 below:

Table 402.2 - Contaminant Limits

Heavy Metal

Limit

Arsenic

4,206 ppb

Cadmium

2,704 ppb

Lead

8,712 ppb

Mercury

8,712 ppb

ppb: parts per billion

(f) The department shall require testing for the presence of prohibited pesticides and prohibited chemicals listed in He-C 402.34, Table 402.3, as follows:
(1) Testing shall be conducted for cannabis harvested at each cultivation location;
(2) Testing shall be conducted at least quarterly;
(3) The department shall directly notify the laboratory when such testing shall be conducted;
(4) Testing shall be conducted on samples provided to the laboratory for testing required by (c) above, or, if no samples have been provided at the time of notification in (3) above, on samples provided to the laboratory as directed by the department;
(5) Testing results shall be sent from the laboratory to the department; and
(6) A cannabis sample shall be deemed to have passed if no individual prohibited pesticide or chemical for which the laboratory tested is detected above 10 parts per billion.
(g) Each batch of solvent-based cannabis concentrate shall be tested for residual solvents, which, except for ethanol and isopropanol, shall not exceed 500 parts per million.
(h) The ATC shall segregate and withhold from use each batch of harvested cannabis and cannabis concentrate until the laboratory has completed its testing and either:
(1) The ATC receives written notice of passing results from the laboratory; or
(2) In the case of testing required in (f) above, the ATC receives written notice from the department that the batch has passed.
(i) In addition to test results described in (f) (5) above, the laboratory shall send to the department copies of each test result that fails to meet the standards in (e) and (g) above.
(j) Any cannabis batch whose test sample fails to pass the standards in (e) -(g) above shall be destroyed and discarded as waste in accordance with He-P 402.22.
(k) An ATC shall be required to have cannabis or CIP re-tested for its cannabinoid profile when the department determines that there is reason to believe that the cannabinoid profile on the label does not accurately reflect the actual cannabinoid profile. Copies of the testing results shall be sent to the department from the laboratory.
(l) Where testing indicates that the cannabinoid profile on the label does not accurately reflect its contents, the department shall:
(1) If the product is determined to be safe and of sufficient quality for continued sale or use:
a. Place conditions on the continued sale of such product, such as requiring re-labeling and the issuance of disclaimers or notifications to patients and caregivers; and
b. For product that has already been dispensed, order the issuance of notifications to patients and caregivers who have purchased the product, including the option for returning the product to the ATC for either replacement or refund; or
(2) If the product is determined not to be safe or of sufficient quality for continued sale or use:
a. For product that has not yet been dispensed, order the destruction of such product; and
b. For product that has already been dispensed, order a recall o f the product, including replacement or refund to patients, and order destruction of the product.
(m) The ATC shall maintain the results of all testing for no less than 4 years.
(n) The department shall require additional testing, copies of results for which shall be sent to the department, order recalls, or order destruction of cannabis or CIP:
(1) In the event it has evidence of tampering or product contamination;
(2) In order to determine the presence or absence of contaminants; or
(3) In order to verify the accuracy of labeling.
(o) The testing laboratory shall supply documentation to the ATC of the test sample size requirements, for all analytes tested, to determine a minimum yet adequate amount of cannabis required by the laboratory to perform the testing required by this section.
(p) The ATC shall develop and implement a policy describing the procedures used to collect and provide samples for testing, which meets the following requirements:
(1) The ATC shall utilize a statistically valid sampling methodology to ensure that each sample is a random, homogenized sample; and
(2) The ATC shall document each sample collection, to include batch information, collecting agent information, and chain of custody information.
(q) Laboratories and laboratory employees shall be permitted to possess cannabis on the premises of the laboratory for the purpose of testing in accordance with this section.
(r) ATCs shall be responsible for all costs associated with the testing of cannabis samples.
(s) No ATC agent shall have any financial or other interest in a laboratory providing testing services in accordance with this section.
(t) No individual employee of a laboratory providing testing services for ATCs may receive direct financial compensation from any ATC.
(u) All storage of cannabis at a laboratory providing cannabis-testing services shall comply with He-C 402.17.
(v) An ATC shall develop and implement a quality assurance policy regarding the testing of cannabis and CIP for cannabinoid profile and contaminants, not including pesticides, in addition to the required testing described in this section, as follows:
(1) The policy shall include provisions for regular and periodic testing of cannabis flower and finished CIP products so that a representative sample of flower and CIP types are tested throughout the registration period;
(2) The ATCs shall work with the testing laboratory for this purpose; and
(3) Any product, the results of which do not match the original testing results or the results printed on the label, within a margin of error established by the laboratory, or which is found to contain contaminants above the thresholds established in (e) above, shall be withheld from sale or use, the testing results shall be reported to the department, and shall be subject to the actions described in (j) or (l) above.

N.H. Admin. Code § He-C 402.15

Adopted byVolume XXXIV Number 50, Filed December 11, 2014, Proposed by #10731, Effective 11/25/2014.
Amended by Volume XXXV Number 45, Filed November 12, 2015, Proposed by #10961, Effective 10/23/2015, Expires 10/23/2025.
Amended by Volume XXXVIII Number 45, Filed November 8, 2018, Proposed by #12653, Effective 11/1/2018, Expires 11/1/2028.