Section 33-44-01-52 - Failed test samples1. If a sample fails any test, the manufacturing facility may submit a written request to the department for a reanalysis. The request must be received by the department within seven calendar days from the date the laboratory sent notice of the failed test to the manufacturing facility. The department, in consultation with the laboratory, shall determine whether a reanalysis will be performed on the samples held by the laboratory or a new sample will be selected from the batch. The reanalysis must be completed by the laboratory within thirty days from the date the reanalysis request was received.2. If a sample fails a test or a reanalysis under subsection 1:a. The batch may be remediated or sterilized in accordance with this section; orb. If the batch is not or cannot be remediated or sterilized under this section, the batch must be disposed of in accordance with section 33-44-01-15.3. If a sample from a batch of dried leaves and flowers, cannabinoid concentrate, or cannabinoid product fails pesticide or degradation compound testing, the batch may not be remediated and must be disposed of as ordered by the department or the department of agriculture. An affected or contaminated batch may not be destroyed without obtaining written permission from the department or the department of agriculture.4. A manufacturing facility shall comply with the following requirements when a sample fails to meet the standards for microbiological contaminant or mycotoxin testing: a. If a sample from a batch of dried leaves and flowers fails microbiological contaminant or mycotoxin testing, the batch may be used to make a cannabinoid concentrate if the processing method effectively sterilizes the batch, such as a method using a hydrocarbon-based solvent or a carbon dioxide closed loop system, or the processing method selectively removes the mycotoxins from the batch. b. If a sample from a batch of a cannabinoid concentrate fails microbiological contaminant or mycotoxin testing, the batch may be further processed if: (1) The processing method effectively sterilizes the batch, such as a method using a hydrocarbon-based solvent or a carbon dioxide closed loop system; or(2) The processing method selectively removes the mycotoxins from the batch.c. If a sample from a batch of a medical cannabinoid product fails microbiological contaminant or mycotoxin testing, the batch may be remediated if written approval from the department is obtained prior to remediation.d. A batch that is remediated in accordance with subdivision a, b, or c of subsection 4 must be sampled and tested in accordance with these rules.e. A batch that fails microbiological contaminant or mycotoxin testing after undergoing remediation in accordance with subdivision a, b, or c of subsection 4 must be disposed of in accordance with section 33-44-01-15.5. If a sample from a batch of dried leaves and flowers, cannabinoid concentrate, or cannabinoid product fails heavy metals testing, the batch may be remediated if written approval from the department is obtained prior to remediation. A batch that is remediated must be sampled and tested in accordance with these rules. A batch that fails heavy metals testing after undergoing remediation must be disposed of in accordance with section 33-44-01-15.6. A manufacturing facility shall comply with the following requirements when a sample fails to meet the standards for solvent testing:a. If a sample from a batch fails solvent testing, the batch may be remediated using procedures that would reduce the concentration of solvents to less than the action level established in these rules.b. A batch that is remediated in accordance with subdivision a of subsection 6 must be sampled and tested in accordance with these rules.c. A batch that fails solvent testing after undergoing remediation in accordance with subdivision a must be disposed of in accordance with section 33-44-01-15.7. A manufacturing facility shall comply with the following requirements when a sample fails to meet the standards for water activity and moisture testing: a. If a sample from a batch of dried leaves and flowers fails for water activity or moisture testing, the batch from which the sample was taken may:(1) Be used to make a cannabinoid concentrate or a medical cannabinoid product and must comply with testing requirements established in these rules; or(2) Continue to dry or cure.b. A batch that undergoes additional drying or curing as described in paragraph 2 of subdivision a must be sampled and tested in accordance with these rules.8. A manufacturing facility shall comply with the following requirements when a sample fails to meet the standards for concentration testing:a. A batch that has a sample failing concentration testing under subsection 4 of section 33-44-01-51 may be remediated to meet the concentration limits permitted in North Dakota Century Code chapter 19-24.1.b. If a sample from a batch of pediatric medical marijuana fails concentration testing, the manufacturing facility may use the batch for nonpediatric usable marijuana rather than remediating the pediatric medical marijuana in accordance with subdivision a. No additional testing is required if the manufacturing facility does not label the usable marijuana for pediatric use and does no further processing with a batch of pediatric medical marijuana failing concentration testing. Any usable marijuana processed with a batch from a failed pediatric medical marijuana concentration test must be sampled and tested in accordance with these rules.c. A batch that has a sample failing concentration testing under subsection 5 of section 33-44-01-51 may be remediated or the manufacturing facility may use the concentration test results of the laboratory for labeling purposes.d. A batch that has a sample failing concentration testing under subsection 6 of section 33-44-01-51 may be remediated.e. A batch that is remediated in accordance with subdivision a, c, or d must be sampled and tested in accordance with these rules.9. A manufacturing facility shall, as applicable:a. Have detailed written procedures for remediation processes to be used pursuant to this section.b. Document all remediation processes used pursuant to this section.N.D. Admin Code 33-44-01-52
Adopted by Administrative Rules Supplement 368, April 2018, effective 4/1/2018.Amended by Administrative Rules Supplement 374, October 2019, effective 10/1/2019.Amended by Administrative Rules Supplement 2022-385, July 2022, effective 7/1/2022.General Authority: NDCC 19-24.1-36
Law Implemented: NDCC 19-24.1-36