Sampling And Testing

(1) Frequencies. (a) HDCP supplier licensees must sample and test each batch of product created from hemp or hemp products for conformance with this rule. Once full panel testing required by this RULES FOR SUPPLIERS AND WHOLESALERS OF HEMP-DERIVED CHAPTER 0100-15 CANNABINOID PRODUCTS rule is conducted on hemp or a hemp product, additional testing in downstream commerce is not required except as provided: 1. After the initial HDCP in commerce conforms to testing under subparagraph (a), if a downstream HDCP supplier uses the product as an input to make a new HDCP and during production of the new product the HDCP 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 HDCP 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 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 Commission’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, 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 HDCPs: 1. Hemp-derived cannabinoids: (i) Tetrahydrocannabiphorol (THCp) (ii) THC-O Acetates (iii) Tetrahydrocannabiphorol acetate (THCP-O) (iv) Synthetic cannabinoids 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: Mycotoxins Limit (µg/kg) Total Aflatoxin amount (sum of B1, B2, G1, G2, if determined individually) <20 Ochratoxin A <20 RULES FOR SUPPLIERS AND WHOLESALERS OF HEMP-DERIVED CHAPTER 0100-15 CANNABINOID PRODUCTS Microorganism Analyte Limit Aspergillus fumigatus, Asperigillus flavus, Aspergillus niger, Aspergillus terreus Not detected in 1 gram Salmonella Spp Not detected in 1 gram Siga toxin-producing Escherichia coli Not detected in 1 gram TYMC / TAMC Limit (cfu/g) Total Yeast and Mold Count <10,000 Total Aerobic Microbial Count <100,000 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 Acequincoyl 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 Bifenthrin 82657-04-3 0.2 ppm Bifenazate 149877-41-8 0.2 ppm Boscalid 188425-85-6 0.2 ppm Carbaryl 63-25-2 0.4 ppm Carbofuran 1563-66-2 0.2 ppm Chlorantraniliprole 500008-45-7 0.2 ppm Chlorfenapyr 122453-73-0 1.0 ppm Chlormequat chloride 999-81-5 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 Fenpyroximate 111812-58-9 0.4 ppm Fenoxycarb 72490-01-8 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 RULES FOR SUPPLIERS AND WHOLESALERS OF HEMP-DERIVED CHAPTER 0100-15 CANNABINOID PRODUCTS 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 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: Heavy Metal Limit (ppm) Arsenic <0.2 Cadmium <0.2 Lead <0.5 Mercury <0.1 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-but) 106-97-8 and 75-28-5 1,000 ppm Ethanol 64-17-5 5,000 ppm Ethyl Acetate 141-78-6 1,000 ppm RULES FOR SUPPLIERS AND WHOLESALERS OF HEMP-DERIVED CHAPTER 0100-15 CANNABINOID PRODUCTS 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, 96-14-0, 75-83-2 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 *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 HDCPs: 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 random samples for testing that are representative of each batch. For testing purposes, the sample must be in the final retail sales packaging: Flower Samples must be packaged in final packaging as it would be sold to the consumer Oral (capsules, liquids, tinctures) Samples must be packaged in final packaging as it would be sold to the consumer RULES FOR SUPPLIERS AND WHOLESALERS OF HEMP-DERIVED CHAPTER 0100-15 CANNABINOID PRODUCTS Pre-rolled flower Samples must be packaged in final packaging as it would be sold to the consumer Oils for vaporization Samples must be packaged in final packaging as it would be sold to the consumer Topical Samples must be packaged in final packaging as it would be sold to the consumer Transdermal Samples must be packaged in final packaging as it would be sold to the consumer (4) Acceptable packaging for testing purposes includes, but is not limited to, sealed vaporization cartridges, edibles in mylar bags, flower in jars, pre-rolled flowers in tubes, and bottles of tincture. Final packaging, for testing purposes, does not require complete regulatory labeling, but, at minimum, must include the product name and form, specific unique lot or batch number, and net contents. While awaiting the COA, the remainder of the batch must be stored to prevent degradation, adulteration, contamination, or mix-up until such time that the final packaging can be applied. (5) 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 Commission. 2. To register and to maintain registration with the Commission a third-party laboratory applicant must: (i) Complete in full an application for registration in a method approved by the Commission. (ii) Host and notify the Commission of one (1) landing page for retrieval of each applicable COA; (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) The ISO 17025 accrediting body must be a member of the International Laboratory Accreditation Cooperation; (vi) 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); (vii) Test and report hemp-derived cannabinoids under this chapter using a limit of quantitation <1 mg/g; (viii) Perform and report component testing as detailed under this rule; (ix) 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; RULES FOR SUPPLIERS AND WHOLESALERS OF HEMP-DERIVED CHAPTER 0100-15 CANNABINOID PRODUCTS (x) If available, produce reserve sample material to the Commission upon request; and, (xi) Provide other information as required by the Commission. (xii) Registration is valid for two years from the date of approval. 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 Commission. (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 Commission; (ii) The HDC product manufacturer’s name and address; (iii) Date the lab received the product sample for testing; (iv) The batch number and sample type represented by the sample; (v) Unique identifying information for the sample, if applicable; (vi) A photo and the state of the sample received (e.g. finished packaging). The photo must clearly indicate the batch number on the product sample; (vii) Sample history including date received and date range of each test conducted on the sample; (viii) 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; (ix) Information about the testing method (e.g. name of the method, equipment used, and date of last validation); (x) The result of the analysis for each type of analysis; 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; (xi) Attestation of the validity of the test results via a signature from an authorized representative, such as a laboratory director or quality assurance/quality control team member, and date the certificate is issued; (xii) Date the COA was generated and reported; and (xiii) Laboratory accreditation information. 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. RULES FOR SUPPLIERS AND WHOLESALERS OF HEMP-DERIVED CHAPTER 0100-15 CANNABINOID PRODUCTS 3. A result of “< LOQ” for any analyte detected below the limit of quantitation (LOQ). 4. A result of “ND” for any analyte that was tested for and not detected. 5. Retention samples must be maintained under registered conditions for two years, with access limited to laboratory personnel. (c) Failed Testing. 1. Retesting. Any sample failure may be resubmitted as follows for confirmation of testing failure. (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 retest the reserve sample following the failed test to confirm component compliance. If a reserve sample was retained, the HDC manufacturer may request a retest within seven (7) days of being notified of the failure. (ii) If the retested 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 retesting of all components listed under this rule. Retesting may not be performed at a laboratory under the same ownership as the laboratory that performed the initial or a laboratory that was subcontracted to complete the initial testing. If the second retesting 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 retests, the batch is deemed nonconforming with regulatory requirements, and the batch must be held for destruction or remediation. 2. Remedy. (i) Microbial contaminants. An HDCP 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 retested, and those test results show conformance with required tolerances; (II) The supplier submits a corrective action plan to the Commission or effective sterilization of the batch, receives written approval of the plan from the Commission 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: RULES FOR SUPPLIERS AND WHOLESALERS OF HEMP-DERIVED CHAPTER 0100-15 CANNABINOID PRODUCTS (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 to the Commission or effective dilution of the batch, receives written approval of the plan from the Commission or, (III) The batch is rendered unusable. (iii) For all other component testing failures, an HDCP manufacturer must render the batch unusable prior to disposition. 3. Testing Variance. (i) The measured cannabinoid content percentage for any product with a label claim content must be within fifteen percent of the label amount for each compound listed. If a wholesaler labels the package, the wholesaler must label the HDCP with cannabinoid content that is listed on the COA. The ±15% variance only applies when HDCPs are labeled on the package prior to the wholesaler taking possession for compliance testing.