Sampling And Testing

(1) Frequencies. (a) If an HDC product is created from hemp or hemp products, the HDC supplier licensee must sample and test each batch of the product for conformance with this rule. Once full panel testing required by this rule is conducted on hemp or a hemp product, additional testing in downstream commerce is not required except as provided: 1. After the initial HDC product in commerce conforms to testing under subparagraph (a), if a downstream HDC supplier uses the product as an input to make a new HDC product and during production of the new product the HDC input underwent either a chemical change (e.g. through exposure to heat or solvents) or a reconstitution through addition or removal of other components, the supplier must cause each batch of new HDC product to be sampled and tested for conformance with this rule. 2. After the initial HDC product in commerce conforms to testing under subparagraph (a), if a downstream HDC supplier uses the product as an input to make a new MANUFACTURING AND DISTRIBUTION OF HEMP-DERIVED CHAPTER 0080-10-02 CANNABINOID PRODUCTS HDC product but does not alter the chemical composition or formulation of the HDC product compared to the input used (e.g. raw flower that is only physically changed through cutting and filtering or bulk orders that are repackaged into smaller units of like product), additional sampling and testing of the resulting product batches are not required and prior test results in commerce of HDCs within the product are presumptively valid. This part shall not limit the department’s authority to test any cannabis products for compliance with the Act and this chapter. (b) Prior to transport of any HDC product in commerce, HDC suppliers must confirm conformance of the batch to all testing requirements under this rule. (2) Standards. Tolerances for each required testing analyte are listed below. Any test result exceeding allowable limits is grounds for embargo, recall, remediation, and/or destruction of the entire batch represented by the sample, regardless of whether the test result is discovered through manufacturing testing or subsequent sampling and testing of retail HDC product. (a) For all HDC products: 1. Hemp-derived cannabinoids: (i) Delta-8 tetrahydrocannabinol [Reserved]; (ii) Delta-10 tetrahydrocannabinol [Reserved]; (iii) Hexahydrocannabinol [Reserved]; (iv) Tetrahydrocannabiphorol (THCp) [Reserved]; (v) Tetrahydrocannabivarin (THCv) [Reserved]; and, (vi) Tetrahydrocannabinolic acid (THCa): (I) HDC products in commerce to an HDC supplier licensee (sample test result, less the measurement uncertainty, showing a post- decarboxylation THC value ≤ 5%); (II) HDC products in commerce to any person who is not an HDC supplier licensee (sample test result, less the measurement uncertainty, showing a post-decarboxylation THC value ≤ 0.3%); 2. Microbial contaminants: (i) Shiga toxin-producing Escherichia coli (undetectable in at least one gram); (ii) Salmonella spp. (undetectable in at least one gram); 3. Mycotoxins: (i) Aflatoxin B1 (total aflatoxin B1, B2, G1, and G2 ≤ 20 µg/kg); (ii) Aflatoxin B2 (total aflatoxin B1, B2, G1, and G2 ≤ 20 µg/kg); (iii) Aflatoxin G1 (total aflatoxin B1, B2, G1, and G2 ≤ 20 µg/kg); MANUFACTURING AND DISTRIBUTION OF HEMP-DERIVED CHAPTER 0080-10-02 CANNABINOID PRODUCTS (iv) Aflatoxin G2 (total aflatoxin B1, B2, G1, and G2 ≤ 20 µg/kg); (v) Ochratoxin A (≤ 20 µg/kg); 4. Residual pesticides: Residual pesticide Chemical Abstract Service (CAS) assigned number Maximum allowable concentration stated in parts per million (ppm) Abamectin 71751-41-2 0.5 ppm Acephate 30560-19-1 0.4 ppm Acequinocyl 57960-19-7 2.0 ppm Acetamiprid 135410-20-7 0.2 ppm Aldicarb 116-06-3 0.4 ppm Azoxystrobin 131860-33-8 0.2 ppm Bifenazate 149877-41-8 0.2 ppm Bifenthrin 82657-04-3 0.2 ppm Boscalid 188425-85-6 0.4 ppm Carbaryl 63-25-2 0.2 ppm Carbofuran 1563-66-2 0.2 ppm Chlorantraniliprole 500008-45-7 0.2 ppm Chlorfenapyr 122453-73-0 1.0 ppm Chlormequat chloride 7003-89-6 0.2 ppm Chlorpyrifos 2921-88-2 0.2 ppm Clofentezine 74115-24-5 0.2 ppm Cyfluthrin 68359-37-5 1.0 ppm Cypermethrin 52315-07-8 1.0 ppm Daminozide 1596-84-5 1.0 ppm DDVP (Dichlorvos) 62-73-7 0.1 ppm Diazinon 333-41-5 0.2 ppm Dimethoate 60-51-5 0.2 ppm Ethoprophos 13194-48-4 0.2 ppm Etofenprox 80844-07-1 0.4 ppm Etoxazole 153233-91-1 0.2 ppm Fenoxycarb 72490-01-8 0.2 ppm Fenpyroximate 134098-61-6 0.4 ppm Fipronil 120068-37-3 0.4 ppm Flonicamid 158062-67-0 1.0 ppm Fludioxonil 131341-86-1 0.4 ppm Hexythiazox 78587-05-0 1.0 ppm Imazalil 35554-44-0 0.2 ppm Imidacloprid 138261-41-3 0.4 ppm Kresoxim-methy 143390-89-0 0.4 ppm Malathion 121-75-5 0.2 ppm Metalaxyl 57837-19-1 0.2 ppm Methiocarb 2032-65-7 0.2 ppm Methomyl 16752-77-5 0.4 ppm Methyl parathion 298-00-0 0.2 ppm Myclobutanil 88671-89-0 0.2 ppm (prohibited at any concentration for inhalation) Naled 300-76-5 0.5 ppm Oxamyl 23135-22-0 1.0 ppm Paclobutrazol 76738-62-0 0.4 ppm MANUFACTURING AND DISTRIBUTION OF HEMP-DERIVED CHAPTER 0080-10-02 CANNABINOID PRODUCTS Permethrins (measured as the cumulative residue of cis- and trans-isomers) 52645-531 (54774-45-7 and 51877-74-8) 0.2 ppm Phosmet 732-11-6 0.2 ppm Piperonyl butoxide 51-03-6 2.0 ppm Prallethrin 23031-36-9 0.2 ppm Propiconazole 60207-90-1 0.4 ppm Propoxur 114-26-1 0.2 ppm Pyrethrins (measured as the cumulative residue of pyrethrin 1, cinerin 1 and jasmolin 1) 8003-34-7(121-21- 1,25402-06-6 and 4466-14-2) 1.0 ppm Pyridaben 96489-71-3 0.2 ppm Spinosad 168316-95-8 0.2 ppm Spiromesifen 283594-90-1 0.2 ppm Spirotetramat 203313-25-1 0.2 ppm Spiroxamine 118134-30-8 0.4 ppm Tebuconazole 107534-96-3 0.4 ppm Thiacloprid 111988-49-9 0.2 ppm Thiamethoxam 153719-23-4 0.2 ppm Trifloxystrobin 141517-21-7 0.2 ppm 5. Heavy metals: (i) Arsenic (≤ 0.4 ppm); (ii) Cadmium (≤ 0.4 ppm); (iii) Lead (≤ 1 ppm); (iv) Mercury (≤ 1.2 ppm); 6. Residual solvents and manufacturing chemicals: Solvent or manufacturing chemical CAS assigned number Maximum allowable concentration (ppm) Acetone 67-64-1 1,000 ppm Benzene* 71-43-2 2 ppm Butanes, (measured as the cumulative residue of n- butane and iso-butane), 106-97-8 and 75-28-5 1,000 ppm Ethanol 64-17-5 1,000 ppm Ethyl Acetate 141-78-6 1,000 ppm Heptanes 142-82-5 1,000 ppm Hexanes* (measured as the cumulative residue of n- hexane, 2-methylpentane, 3-methylpentane, 2,2- dimethylbutane, and 2,3-dimethylbutane) 110-54-3, 107-83-5 and 79-29-8 60 ppm Methanol* 67-56-1 600 ppm Pentanes (measured as the cumulative residue of n- pentane, iso-pentane, and neo-pentane) 109-66-0, 78-78-4 and 463-82-1 1,000 ppm 2-Propanol (IPA) 67-63-0 1,000 ppm Propane 74-98-6 1,000 ppm Toluene* 108-88-3 180 ppm Total Xylenes* (measured as the cumulative residue of 1,2-dimethylbenzene, 1,3-dimethylbenzene, and 1,4- dimethylbenzene, and the non-xylene, ethylbenzene) 1330-20-7 (95-47-6, 108-38-3 and 106-42- 3 and 100-41-4) 430 ppm Any other solvent not permitted for use undetected MANUFACTURING AND DISTRIBUTION OF HEMP-DERIVED CHAPTER 0080-10-02 CANNABINOID PRODUCTS *These solvents are not individually approved for use. Due to their possible presence in other solvents that are approved for use, limits have been listed here for concentrations in final products. (b) Additional testing requirements for inhalable HDC products: 1. Microbial contaminants: (i) Aspergillus A. fumigatus (undetectable in at least one gram); (ii) Aspergillus A. flavus (undetectable in at least one gram); (iii) Aspergillus A. niger (undetectable in at least one gram); (iv) Aspergillus A. terreus (undetectable in at least one gram); 2. Heavy metals: (i) Arsenic (≤ 0.2 ppm); (ii) Cadmium (≤ 0.2 ppm); (iii) Lead (≤ 0.5 ppm); (iv) Mercury (≤ 0.1 ppm). (3) Sampling. HDC product manufacturers must draw samples for testing that are representative of each batch. (4) Testing. (a) Third-party laboratories. 1. COAs required under this chapter may be supplied by a third-party laboratory provided the laboratory is registered with the department. 2. To register and to maintain registration with the department, a third-party laboratory applicant must: (i) Complete in full an application for registration on forms provided by the department; (ii) Host and notify the department of one landing page for retrieval of all COAs issued by the laboratory through use of quick reference (QR) codes; (iii) For any test method conducted pursuant to this rule, be fully accredited to standards established under International Organization for Standardization (ISO) 17025 by an International Laboratory Accreditation Cooperation recognized accreditation body; (iv) Maintain ISO 17025 accreditation; (v) Test and report analyte(s) using limits of detection and quantitation no greater than the respective tolerance(s) under this chapter for the tested analyte(s); MANUFACTURING AND DISTRIBUTION OF HEMP-DERIVED CHAPTER 0080-10-02 CANNABINOID PRODUCTS (vi) Test and report hemp-derived cannabinoids under this chapter using a limit of quantitation ≤ 1 mg/g; (vii) Perform and report component testing as detailed under this rule; (viii) Store all samples in a secure manner that reasonably protects them from degradation, contamination, and tampering; and, prior to its disposal, render all sample material unusable; (ix) If available, produce reserve sample material to the department upon request; and, (x) Provide other information as required by the department. 3. Failure to adhere to these requirements or requirements for issuance of COAs under this rule is grounds for denial or revocation of any registration or authorization issued by the department. (b) COAs. 1. Third-party laboratories must include at a minimum the following on each COA issued: (i) The laboratory’s name and address as it is registered with the department; (ii) The HDC product manufacturer’s name and address; (iii) The batch number of HDC product represented by the sample; (iv) Unique identifying information for the sample, if applicable; (v) Sample history including date received and date range of each test conducted on the sample; (vi) Analytical methods, limits of detection, limits of quantitation, and test results for each analyte evaluated for the sample, regardless of whether the testing conducted is required by this rule; and, (vii) A collective “pass”/“fail” assessment for the entire batch that accounts for either passage of all or failure of any one test conducted on the sample. 2. When reporting quantitative results, third-party laboratories must include in the COA the corresponding units of measurement as required for tolerances under this rule, as well as measurement uncertainties. 3. A result of “< LOQ” for any analyte detected below the limit of quantification (LOQ). 4. A result of “ND” for any analyte that was tested for and not detected. (c) Failed testing. 1. Retesting. Any sample failure may be re-submitted as follows for confirmation of testing failure. MANUFACTURING AND DISTRIBUTION OF HEMP-DERIVED CHAPTER 0080-10-02 CANNABINOID PRODUCTS (i) If a reserve sample was retained by the same third-party registered laboratory that produced the COA exhibiting a test failure, that laboratory may re-test the reserve sample following the failed test in order to confirm component compliance. (ii) If the re-tested sample passes for the suspect component(s), a new sample from the same batch must be drawn and submitted to a second third-party registered laboratory for complete re-testing of all components listed under this rule. If the second re-testing conforms to all required tolerances, the batch is deemed compliant with testing requirements and may be transported and distributed in commerce. (iii) If a reserve sample is not available from the initial third-party registered laboratory or if a sample fails either of the re-tests, the batch is deemed nonconforming with regulatory requirements. 2. Remedy. (i) Microbial contaminants. An HDC supplier is prohibited from transporting or allowing transport of a batch that has failed microbial contaminant testing unless: (I) The batch is further processed by a method that effectively sterilizes the batch, is re-tested, and those test results show conformance with required tolerances; (II) The supplier submits a corrective action plan for effective sterilization of the batch by another licensed HDC supplier, receives written approval of the plan from the department, and places the batch under immediate transport to the approved HDC supplier; or, (III) The batch is rendered unusable. (ii) Over-concentrated product. An HDC product manufacturer is prohibited from transporting or allowing transport of a batch that has failed THC concentration testing unless: (I) The batch is further processed by a method that effectively dilutes the batch, is retested, and those results show conformance with required tolerances; (II) The manufacturer submits a corrective action plan for effective dilution of the batch by another licensed HDC supplier, receives written approval of the plan from the department, and places the batch under immediate transport to the approved HDC supplier; or, (III) The batch is rendered unusable. (iii) For all other component testing failures, an HDC product manufacturer must render the batch unusable prior to disposition.