Title 902 | Chapter 045 | Regulation 031E
902 KAR 45:031REG
A proposed version of this document exists.
STATEMENT OF EMERGENCY
902 KAR 45:031E
This emergency administrative regulation is being promulgated to implement the requirements of HB 544, 2023 Ky. Acts ch. 78. This emergency administrative regulation is needed pursuant to KRS 13A.190(1)(a)3. to continue the process of regulating delta-8 tetrahydrocannabinol and any other hemp-derived substances. This emergency administrative regulation is necessary to implement the requirements of HB 544, 2023 Ky. Acts ch. 78, which requires the cabinet to regulate covered products, as specified in EO 2022-799, to prohibit the sale of intoxicating products to anyone under twenty-one (21) years of age, to set the laboratory testing requirements, and to require products be labeled in accordance with the act and KRS 217.037. This emergency administrative regulation will be filed with an ordinary administrative regulation. The ordinary administrative regulation is identical to this emergency administrative regulation.
ANDY BESHEAR, Governor
ERIC C. FRIEDLANDER, Secretary
CABINET FOR HEALTH AND FAMILY SERVICES
Department for Public Health
Division of Public Health Protection and Safety
(New Emergency Administrative Regulation)
902 KAR 45:031E.Hemp-derived cannabinoid product sampling and testing requirements.
Section 1.
Product Sampling and Testing Requirements.(1)
Sampling and testing for all cannabinoid products shall be:(a)
Done for each batch or process lot; and(b)
Conducted with representative samples to ensure:1.
All batches or process lots are adequately assessed for contaminants; and2.
The cannabinoid profile is consistent throughout.(2)
Testing shall only be performed on the final product equivalent to what will be consumed.(3)
Samples shall be collected using appropriate aseptic techniques.(4)
A cannabinoid processing or manufacturing facility shall assign each batch or process lot a unique batch or lot number that shall be:(a)
Documented and maintained in the processing and manufacturing facility for at least two (2) years and available to the department upon request;(b)
Provided to the individual responsible for taking samples; and(c)
Included on the product label.(5)
Sample size, handling, storage, and disposal.(a)
Cannabinoid products samples shall consist of enough material from the batch or process lot to ensure that the required attributes in the products are homogenous and consistent with the testing facility's accredited sampling policies and procedures.(b)
A cannabinoid processing or manufacturing permittee shall prepare sampling policies and procedures that contain the information necessary for collecting and transporting samples from cannabinoid products in a manner that does not endanger the integrity of the sample for any analysis required by this administrative regulation.(6)
Reserve samples.(a)
Processors and manufacturers shall collect and hold reserve samples of each batch or process lot of packaged and labeled product.(b)
The reserve samples shall:1.
Be held using the same container-closure system that the packaged and labeled product is distributed, or if distributing to be packaged and labeled, using a container-closure system that provides the same characteristics to protect against contamination or deterioration;2.
Be identified with the batch or process number;3.
Be retained for the shelf-life date, as applicable, or for two (2) years from the date of distribution of the last batch or process lot of the product associated with the reserve sample; and4.
Consist of at least twice the quantity necessary for all tests or examinations to determine if the product meets specifications.(7)
Laboratory requirements.(a)
Testing facilities used by the cannabinoid processing or manufacturing facility shall be an independent third-party, fully accredited to the standard established by International Organization for Standardization (ISO) 17025 by an International Laboratory Accreditation Cooperation recognized accreditation body.(b)
The testing facility shall:1.
Maintain ISO 17025 accreditation; and2.
Comply with all required analytes standards for the relevant test methods of:a.
Cannabinoids;b.
Microbial impurities;c.
Mycotoxins;d.
Residual pesticides;e.
Heavy metals; andf.
Residual solvents, if applicable.(c)
Cannabinoid processing or manufacturing facilities shall maintain on file proof of a valid certificate of accreditation for the laboratory completing product testing that:1.
Is issued by an accreditation organization; and2.
Attests to the laboratory's competence to perform testing, including all the required analytes for the relevant test methods required.(8)
Testing requirements.(a)
A processing or manufacturing facility shall test every batch or process lot of cannabinoid product for sale or distribution prior to sell or transfer.(b)
Test shall be performed using cannabinoid quantification technique with a high enough specificity and sensitivity to differentiate between cannabinoids and isomers of cannabinoids.(c)
Cannabinoid products shall be tested for:1.
Cannabinoids, which shall include all cannabinoids specified in 902 KAR 45:021, Section 1(3)(a);2.
Microbial impurities;3.
Mycotoxins;4.
Residual pesticides;5.
Heavy metals; and6.
Residual solvents, if applicable.(d)
Infused cannabinoid products may not require additional testing for microbial impurities, mycotoxins, residual pesticides, heavy metals, or residual solvents, as applicable, if the cannabinoid distillate used to make an infused product was:1.
Tested for microbial impurities, mycotoxins, residual pesticides, heavy metals, or residual solvents in compliance with this administrative regulation; and2.
Test results indicate the batch or process lot was within established limits.(e)
An infused cannabinoid product shall be tested if the addition of ingredients or processing practice create a reasonable or foreseeable microbial impurity, mycotoxin, residual pesticide, heavy metals, or residual solvents hazard.(f)
All vaporizer delivery device or pressurized metered dose inhaler cartridge batches or process lots shall be tested for Acetates.(g)
In accordance with KRS 217.039, all applicable certificates of analysis shall accompany the final product.Section 2.
Standards for Cannabinoid Testing.(1)
A testing facility shall establish a limit of quantitation of one (1) milligram per gram (mg/g) or lower for all adult-use cannabinoids analyzed and reported.(2)
A testing facility shall report the result of the cannabinoid testing on the certificate of analysis, that includes at minimum:(a)
Total tetrahydrocannabinol concentration, calculated in accordance with subsection (3) of this section and reported in percentages;(b)
Tetrahydrocannabinol-A concentration;(c)
Milligrams per serving for total tetrahydrocannabinol and the primary cannabinoid marketed, excluding cosmetics, as applicable;(d)
Milligrams per package for total tetrahydrocannabinol and the primary cannabinoid marketed, excluding cosmetics, as applicable; and(e)
The results of all other hemp-derived cannabinoids analyzed on the COA both as a percentage and milligrams per gram (mg/g).(3)
The following calculation shall be used for calculating total tetrahydrocannabinol concentration expressed in weight: Total cannabinoid concentration (mg/g) = (cannabinoid acid form concentration (mg/g) x 0.877) + cannabinoid concentration (mg/g).(4)
For cannabinoid infused products, excluding cosmetics, potency shall be reported as milligrams of total tetrahydrocannabinol and the primary cannabinoid marketed, excluding cosmetics per gram.(5)
Cannabinoid products shall not contain a delta-9 tetrahydrocannabinol concentration of more than three-tenths of one percent (0.3) on a dry weigh basis.(6)
The serving size from a vaporizer delivery device or pressurized metered dose inhaler shall not exceed one (1) inhalation lasting two (2) seconds per serving.Section 3.
Standards for Microbial Impurities.(1)
Cannabinoid products shall be tested by a testing facility for the presence of microbial impurities.(2)
The sample of inhalable cannabinoid products shall be deemed to have passed the microbial impurities testing if the following conditions are met:(a)
Total Escherichia coli is not detected above 100 colony forming units/gram;(b)
Shiga toxin–producing Escherichia coli is not detected in one (1) gram;(c)
Salmonella spp. is not detected in one (1) gram;(d)
Pathogenic Aspergillus species A. fumigatus, A. flavus, A. niger, and A. terreus are not detected in one (1) gram;(e)
Listeria Spp. is not detected in one (1) gram; and(f)
A total combined yeast and mold do not exceed 100,000 colony forming units per gram.(3)
The sample of ingestible or cosmetic cannabinoid products shall be deemed to have passed the microbial impurities testing if the following conditions are met:(a)
Total Escherichia coli is not detected above 100 colony forming units/gram;(b)
Shiga toxin–producing Escherichia coli is not detected in one (1) gram;(c)
Salmonella spp. is not detected in one (1) gram;(d)
Listeria Spp. is not detected in one (1) gram; and(e)
A total combined yeast and mold do not exceed 100,000 colony forming units per gram.(4)
If the sample fails microbial impurities testing, the batch or process lot from which the sample was collected shall not be released for retail sale.(5)
If a sample from a batch or process lot of a cannabinoid product fails microbiological contaminant testing, the batch may be further processed if the processing method effectively sterilizes the batch.(6)
A batch or process lot that is sterilized in accordance with subsection (5) of this section shall be sampled and tested in accordance with this administrative regulation, if not otherwise required for that product, for microbiological contaminants, and residual solvents.(7)
A batch or process lot that fails microbiological contaminant testing after undergoing a sterilization process in accordance with subsection (5) of this section shall be destroyed in a manner that renders the batch or process lot denatured and unusable.Section 4.
Standards for Mycotoxin Testing.(1)
Cannabinoid products shall be tested by a testing facility for the following mycotoxins: aflatoxin B1, B2, G1, and G2 ochratoxin A.(2)
A batch or process lot shall be deemed to have passed mycotoxin testing if the following conditions are met:(a)
Total of aflatoxin B1, B2, G1, and G2 does not exceed twenty (20) microgram per kilogram (µg/kg) of substance; and(b)
Ochratoxin A does not exceed twenty (20) µg/kg of substance.(3)
A batch or process lot that fails mycotoxin testing in accordance with this subsection shall be destroyed in a manner that renders the batch or process lot denatured and unusable.Section 5.
Standards for Testing Residual Pesticides.(1)
Cannabinoid products shall be tested by a testing facility for the following residual pesticides and shall not exceed the maximum allowable concentration for each: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 |
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 |
(2)
A batch or process lot that fails residual pesticide testing in accordance with this section shall be destroyed in a manner that renders the batch or process lot denatured and unusable.Section 6.
Standards for Testing for Heavy Metals.(1)
Cannabinoid products shall be tested by a testing facility for the following metals and shall not exceed the maximum allowable concentration for each:(a)
Arsenic, maximum allowable concentration: one and five-tenths (1.5) ppm;(b)
Cadmium, maximum allowable concentration: zero and four-tenths (0.4) ppm;(c)
Lead, maximum allowable concentration: one (1) ppm; and(d)
Mercury, maximum allowable concentration: one and two-tenths (1.2) ppm.(2)
Cannabinoid distillate intended for inhalable products shall be tested by a testing facility for the following metals and shall not exceed the maximum allowable concentration for each:(a)
Arsenic, maximum allowable concentration: zero and two-tenths (0.2) ppm;(b)
Cadmium, maximum allowable concentration: zero and two-tenths (0.2) ppm;(c)
Lead, maximum allowable concentration: zero and five-tenths (0.5) ppm; and(d)
Mercury, maximum allowable concentration: zero and one-tenths (0.1) ppm.(3)
A batch or process lot that fails heavy metals testing in accordance with this section shall be destroyed in a manner that renders the batch or process lot denatured and unusable.Section 7.
Standards for Testing Residual Solvents.(1)
Cannabinoid products shall be tested by a testing facility for residual solvents, as appropriate, and shall not exceed the maximum allowable concentration for each solvent used according to the table below:Solvent | CAS assigned number | Maximum allowable concentration stated in parts per million (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 | 5,000 ppm |
Ethyl Acetate | 141-78-6 | 1,000 ppm |
Heptane | 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 |
*Note: These solvents are not approved for use. Due to their possible presence in the solvents approved for use, limits have been listed here accordingly. | ||
(2)
A processing or manufacturing facility shall be exempt from testing for solvents if the facility:(a)
Did not use any solvent listed in subsection (1) of this section;(b)
Used a mechanical extraction process to separate cannabinoids; or(c)
Used only water, animal fat, or vegetable oil as a solvent to separate the cannabinoids.(3)
If a sample from a batch or process lot fails solvent testing, the batch or process lot may be remediated using procedures that would reduce the concentration of solvents to less than the action level.(4)
A batch or process lot that is remediated in accordance with subsection (3) of this section shall be:(a)
Sampled and tested in accordance with this administrative regulation; and(b)
Tested for solvents if not otherwise required for that product under this administrative regulation.(5)
A batch or process lot that fails solvent testing that is not remediated or that if remediated fails testing shall be destroyed in a manner that renders the batch or process lot denatured and unusable.Section 8.
Standards for Water Activity.(1)
Plant material, such as flower, shake, and plant trim, used to process and manufacture hemp-derived cannabinoid products shall have a water activity (Aw) rate of less than 0.65.(2)
If the plant material sample fails testing for water activity, the batch from which the sample was taken may:(a)
Be used to make a cannabinoid distillate; or(b)
Continue to dry or cure.(3)
Plant material that undergoes additional drying or curing as described in subsection (2)(b) of this section shall be re-sampled and tested in accordance with this section.Section 9.
Failed Testing and Remediation.(1)
A sample that fails any initial testing may be reanalyzed by the testing facility.(2)
If the reanalyzed sample passes, the processing or manufacturing facility shall resample the batch or process lot using another accredited testing facility to confirm the result in order for the batch or process lot to pass testing.(3)
A batch or process lot shall fail testing if the testing facility detects the presence of a contaminant in a sample above any limit of detection (LOD) established in this administrative regulation:(a)
During an initial test where no reanalysis is requested; or(b)
Upon reanalysis as described in this subsection.(4)
If a sample fails a test or a reanalysis, the batch or process lot:(a)
May be remediated or sterilized in accordance with this administrative regulation; or(b)
If it cannot be remediated or sterilized in accordance with this administrative regulation, it shall be destroyed in a manner that renders the batch or process lot denatured and unusable.(5)
A hemp-derived cannabinoid product batch or process lot shall only be remediated twice. If the batch or process lot fails after a second remediation attempt and the second retesting, the entire batch or process lot shall be destroyed in a manner approved by the cabinet.(6)
A hemp-derived cannabinoid product from a batch or process lot that failed testing shall not be combined with another batch or process lot. Mixed products shall be considered adulterated, regardless of the LOD or defect level of the final product.Section 10.
Certificate of Analysis.(1)
The testing facility shall:(a)
Generate a certificate of analysis (COA) for each representative sample that the testing facility analyzes; and(b)
Ensure the COA contains the results of all required analyses performed for the representative sample.(2)
The COA shall contain, at minimum:(a)
The testing facility's name, premises address, and license number, processor's or manufacturer's name, and premises address;(b)
Batch or lot number of the batch or process lot from which the sample was obtained. For products that are already packaged at the time of sampling, the labeled batch or lot number on the packaged hemp-derived cannabinoid products shall match the batch or lot number on the COA;(c)
Sample identifying information, including matrix type and unique sample identifiers;(d)
Sample history, including the date collected, the date received by the testing facility, and the date of all sample analyses and corresponding testing results;(e)
The analytical methods, analytical instrumentation used, and corresponding LOD and limits of quantitation (LOQ);(f)
Analytes detected during the analyses of the sample that are unknown, unidentified, or injurious to human health if consumed, if any; and(g)
A chromatograph of the cannabinoid test results.(3)
The testing facility shall report test results for each representative sample on the COA as an overall "pass" or "fail" for the entire batch:(a)
When reporting qualitative results for each analyte, the testing facility shall indicate "pass" or "fail";(b)
When reporting quantitative results for each analyte, the testing facility shall use the appropriate units of measurement as required in accordance with this administrative regulation;(c)
When reporting results for each test method, the testing facility shall indicate "pass" or "fail";(d)
When reporting results for any analytes that were detected below the analytical method LOQ, indicate "<LOQ", notwithstanding cannabinoid results;(e)
When reporting results for any analytes that were not detected or detected below the LOD, indicate "ND"; and(f)
Indicate "NT" for any test that the testing facility did not perform.(4)
(a)
In accordance with 2023 Ky. Acts ch. 78, a cannabinoid manufacturer or processor that ships adult-use products out of state for use or sale outside the Commonwealth of Kentucky:1.
Shall abide by the testing and labeling requirements of this administrative regulation if the receiving state or jurisdiction does not have testing and labeling requirements; or2.
May defer to the receiving state's testing requirements if that state has equivalent testing requirements.3.
Products intended for out-of-state sale shall be stored separately from in-state products and shall have signage indicating the products are for out-of-state sale.(b)
Batch number of the batch from which the sample was obtained shall be on the COA for all products shipped out of state.STEVEN J. STACK, MD, MBA, Commissioner
ERIC C. FRIEDLANDER, Secretary
APPROVED BY AGENCY: April 22, 2024
FILED WITH LRC: April 24, 2024 at 12:30 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on June 24, 2024, at 9:00 a.m. using the CHFS Office of Legislative and Regulatory Affairs Zoom meeting room. The Zoom invitation will be emailed to each requestor the week prior to the scheduled hearing. Individuals interested in attending this virtual hearing shall notify this agency in writing by June 17, 2024, five (5) workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who attends virtually will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on this proposed administrative regulation until June 30, 2024. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to the contact person. Pursuant to KRS 13A.280(8), copies of the statement of consideration and, if applicable, the amended after comments version of the administrative regulation shall be made available upon request.
CONTACT PERSON: Krista Quarles, Policy Analyst, Office of Legislative and Regulatory Affairs, 275 East Main Street 5 W-A, Frankfort, Kentucky 40621; phone 502-564-7476; fax 502-564-7091; email CHFSregs@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Krista Quarles or Julie Brooks
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation establishes the hemp-derived cannabinoid product sampling and testing requirements.
(b) The necessity of this administrative regulation:
Many hemp-derived cannabinoid products sold in Kentucky continue to be unregulated. This administrative regulation is necessary to ensure that all hemp-derived cannabinoid products produced and sold in the state are safe for human consumption.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
KRS 217.125(1) authorizes the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations for the efficient administration and enforcement of the Kentucky Food, Drug and Cosmetic Act, KRS 217.005 through 217.215.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation ensures all hemp-derived cannabinoid products manufactured, processed, distributed, or sold are safe for human consumption.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
This is a new administrative regulation.
(b) The necessity of the amendment to this administrative regulation:
This is a new administrative regulation.
(c) How the amendment conforms to the content of the authorizing statutes:
This is a new administrative regulation.
(d) How the amendment will assist in the effective administration of the statutes:
This is a new administrative regulation.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
There are currently thirty-eight (38) manufacturers of cannabidiol (CBD) products registered with the department.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:
Cannabinoid processor and manufacturers are currently in compliance with the requirements of 902 KAR 45:190E. This new administrative regulation does not require any additional actions for compliance with product sampling and testing requirements.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
Compliance with this new administrative regulation will not add to the cost for the regulated entities.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Producers and manufacturers will be able to ensure products offered are of the highest quality and are safe for human consumption.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
The current budget for the food manufacturing permitting and inspection program is $1,080,900. The increase in required permitting and inspection processes to implement this administrative regulation will cost the department an additional $1,551,397 in the first year.
(b) On a continuing basis:
The department will continue to need an additional $1,551,397, at a minimum, in subsequent years.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
Funding to implement and enforce this administrative regulation will be from a mix of fees paid to the department and state general fund dollars.
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
An increase in fees or funding is not needed to implement this administrative regulation.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
This administrative regulation does not contain fees.
(9) TIERING: Is tiering applied?
Tiering is applied. Testing for solvents is only required when they are used in the manufacturing or processing procedures.
FISCAL IMPACT STATEMENT
(1) Identify each state statute, federal statute, or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 217.125 and 217.155.
(2) Identify the promulgating agency and any other affected state units, parts, or divisions:
The Department for Public Health, Division of Public Health Protection and Safety is the promulgating agency.
(a) Estimate the following for the first year:
Expenditures:
Expenditures to the department to implement this administrative regulation will be approximately $1,551,397 per year.
Revenues:
This administrative regulation does not generate revenue.
Cost Savings:
This administrative regulation will not result in cost savings.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
Expenditures for the Department for Public Health may be impacted by changes in salary, fringe benefits and travel cost for state and local health department employees. These changes cannot be determined at this time.
(3) Identify affected local entities (for example: cities, counties, fire departments, school districts):
There are no affected local entities.
(a) Estimate the following for the first year:
Expenditures:
Not applicable
Revenues:
Not applicable
Cost Savings:
Not applicable
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
Not applicable
(4) Identify additional regulated entities not listed in questions (2) or (3):
Additional regulated entities are processors and manufacturers of hemp-derived cannabinoid products, and testing facilities.
(a) Estimate the following for the first year:
Expenditures:
Expenditures for the additional regulated entities will be associated with the sampling and testing requirements of this administrative regulation.
Revenues:
This administrative regulation does not generate revenue.
Cost Savings:
This administrative regulation does not result in cost savings.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
The department is not able to determine changes in expenditures in subsequent years at this time.
(5) Provide a narrative to explain the:
(a) Fiscal impact of this administrative regulation:
This administrative regulation does not have a significant fiscal impact. The department does not permit or inspect the testing facilities. Producers and manufacturers of cannabinoid products are responsible for covering the costs associated with the testing.
(b) Methodology and resources used to determine the fiscal impact:
The department does not permit or inspect the testing facilities. The increased expenditures listed in question (2) are the overall expenditures needed to increase the workforce to oversee the permitting and inspecting for processing and manufacturing facilities, and retail establishments.
(6) Explain:
(a) Whether this administrative regulation will have an overall negative or adverse major economic impact to the entities identified in questions (2) - (4). ($500,000 or more, in aggregate)
This administrative regulation will not have an overall negative or adverse major economic impact.
(b) The methodology and resources used to reach this conclusion:
The department does not permit or inspect the testing facilities.
STATEMENT OF EMERGENCY
902 KAR 45:031E
This emergency administrative regulation is being promulgated to implement the requirements of HB 544, 2023 Ky. Acts ch. 78. This emergency administrative regulation is needed pursuant to KRS 13A.190(1)(a)3. to continue the process of regulating delta-8 tetrahydrocannabinol and any other hemp-derived substances. This emergency administrative regulation is necessary to implement the requirements of HB 544, 2023 Ky. Acts ch. 78, which requires the cabinet to regulate covered products, as specified in EO 2022-799, to prohibit the sale of intoxicating products to anyone under twenty-one (21) years of age, to set the laboratory testing requirements, and to require products be labeled in accordance with the act and KRS 217.037. This emergency administrative regulation will be filed with an ordinary administrative regulation. The ordinary administrative regulation is identical to this emergency administrative regulation.
ANDY BESHEAR, Governor
ERIC C. FRIEDLANDER, Secretary
CABINET FOR HEALTH AND FAMILY SERVICES
Department for Public Health
Division of Public Health Protection and Safety
(New Emergency Administrative Regulation)
902 KAR 45:031E.Hemp-derived cannabinoid product sampling and testing requirements.
Section 1.
Product Sampling and Testing Requirements.(1)
Sampling and testing for all cannabinoid products shall be:(a)
Done for each batch or process lot; and(b)
Conducted with representative samples to ensure:1.
All batches or process lots are adequately assessed for contaminants; and2.
The cannabinoid profile is consistent throughout.(2)
Testing shall only be performed on the final product equivalent to what will be consumed.(3)
Samples shall be collected using appropriate aseptic techniques.(4)
A cannabinoid processing or manufacturing facility shall assign each batch or process lot a unique batch or lot number that shall be:(a)
Documented and maintained in the processing and manufacturing facility for at least two (2) years and available to the department upon request;(b)
Provided to the individual responsible for taking samples; and(c)
Included on the product label.(5)
Sample size, handling, storage, and disposal.(a)
Cannabinoid products samples shall consist of enough material from the batch or process lot to ensure that the required attributes in the products are homogenous and consistent with the testing facility's accredited sampling policies and procedures.(b)
A cannabinoid processing or manufacturing permittee shall prepare sampling policies and procedures that contain the information necessary for collecting and transporting samples from cannabinoid products in a manner that does not endanger the integrity of the sample for any analysis required by this administrative regulation.(6)
Reserve samples.(a)
Processors and manufacturers shall collect and hold reserve samples of each batch or process lot of packaged and labeled product.(b)
The reserve samples shall:1.
Be held using the same container-closure system that the packaged and labeled product is distributed, or if distributing to be packaged and labeled, using a container-closure system that provides the same characteristics to protect against contamination or deterioration;2.
Be identified with the batch or process number;3.
Be retained for the shelf-life date, as applicable, or for two (2) years from the date of distribution of the last batch or process lot of the product associated with the reserve sample; and4.
Consist of at least twice the quantity necessary for all tests or examinations to determine if the product meets specifications.(7)
Laboratory requirements.(a)
Testing facilities used by the cannabinoid processing or manufacturing facility shall be an independent third-party, fully accredited to the standard established by International Organization for Standardization (ISO) 17025 by an International Laboratory Accreditation Cooperation recognized accreditation body.(b)
The testing facility shall:1.
Maintain ISO 17025 accreditation; and2.
Comply with all required analytes standards for the relevant test methods of:a.
Cannabinoids;b.
Microbial impurities;c.
Mycotoxins;d.
Residual pesticides;e.
Heavy metals; andf.
Residual solvents, if applicable.(c)
Cannabinoid processing or manufacturing facilities shall maintain on file proof of a valid certificate of accreditation for the laboratory completing product testing that:1.
Is issued by an accreditation organization; and2.
Attests to the laboratory's competence to perform testing, including all the required analytes for the relevant test methods required.(8)
Testing requirements.(a)
A processing or manufacturing facility shall test every batch or process lot of cannabinoid product for sale or distribution prior to sell or transfer.(b)
Test shall be performed using cannabinoid quantification technique with a high enough specificity and sensitivity to differentiate between cannabinoids and isomers of cannabinoids.(c)
Cannabinoid products shall be tested for:1.
Cannabinoids, which shall include all cannabinoids specified in 902 KAR 45:021, Section 1(3)(a);2.
Microbial impurities;3.
Mycotoxins;4.
Residual pesticides;5.
Heavy metals; and6.
Residual solvents, if applicable.(d)
Infused cannabinoid products may not require additional testing for microbial impurities, mycotoxins, residual pesticides, heavy metals, or residual solvents, as applicable, if the cannabinoid distillate used to make an infused product was:1.
Tested for microbial impurities, mycotoxins, residual pesticides, heavy metals, or residual solvents in compliance with this administrative regulation; and2.
Test results indicate the batch or process lot was within established limits.(e)
An infused cannabinoid product shall be tested if the addition of ingredients or processing practice create a reasonable or foreseeable microbial impurity, mycotoxin, residual pesticide, heavy metals, or residual solvents hazard.(f)
All vaporizer delivery device or pressurized metered dose inhaler cartridge batches or process lots shall be tested for Acetates.(g)
In accordance with KRS 217.039, all applicable certificates of analysis shall accompany the final product.Section 2.
Standards for Cannabinoid Testing.(1)
A testing facility shall establish a limit of quantitation of one (1) milligram per gram (mg/g) or lower for all adult-use cannabinoids analyzed and reported.(2)
A testing facility shall report the result of the cannabinoid testing on the certificate of analysis, that includes at minimum:(a)
Total tetrahydrocannabinol concentration, calculated in accordance with subsection (3) of this section and reported in percentages;(b)
Tetrahydrocannabinol-A concentration;(c)
Milligrams per serving for total tetrahydrocannabinol and the primary cannabinoid marketed, excluding cosmetics, as applicable;(d)
Milligrams per package for total tetrahydrocannabinol and the primary cannabinoid marketed, excluding cosmetics, as applicable; and(e)
The results of all other hemp-derived cannabinoids analyzed on the COA both as a percentage and milligrams per gram (mg/g).(3)
The following calculation shall be used for calculating total tetrahydrocannabinol concentration expressed in weight: Total cannabinoid concentration (mg/g) = (cannabinoid acid form concentration (mg/g) x 0.877) + cannabinoid concentration (mg/g).(4)
For cannabinoid infused products, excluding cosmetics, potency shall be reported as milligrams of total tetrahydrocannabinol and the primary cannabinoid marketed, excluding cosmetics per gram.(5)
Cannabinoid products shall not contain a delta-9 tetrahydrocannabinol concentration of more than three-tenths of one percent (0.3) on a dry weigh basis.(6)
The serving size from a vaporizer delivery device or pressurized metered dose inhaler shall not exceed one (1) inhalation lasting two (2) seconds per serving.Section 3.
Standards for Microbial Impurities.(1)
Cannabinoid products shall be tested by a testing facility for the presence of microbial impurities.(2)
The sample of inhalable cannabinoid products shall be deemed to have passed the microbial impurities testing if the following conditions are met:(a)
Total Escherichia coli is not detected above 100 colony forming units/gram;(b)
Shiga toxin–producing Escherichia coli is not detected in one (1) gram;(c)
Salmonella spp. is not detected in one (1) gram;(d)
Pathogenic Aspergillus species A. fumigatus, A. flavus, A. niger, and A. terreus are not detected in one (1) gram;(e)
Listeria Spp. is not detected in one (1) gram; and(f)
A total combined yeast and mold do not exceed 100,000 colony forming units per gram.(3)
The sample of ingestible or cosmetic cannabinoid products shall be deemed to have passed the microbial impurities testing if the following conditions are met:(a)
Total Escherichia coli is not detected above 100 colony forming units/gram;(b)
Shiga toxin–producing Escherichia coli is not detected in one (1) gram;(c)
Salmonella spp. is not detected in one (1) gram;(d)
Listeria Spp. is not detected in one (1) gram; and(e)
A total combined yeast and mold do not exceed 100,000 colony forming units per gram.(4)
If the sample fails microbial impurities testing, the batch or process lot from which the sample was collected shall not be released for retail sale.(5)
If a sample from a batch or process lot of a cannabinoid product fails microbiological contaminant testing, the batch may be further processed if the processing method effectively sterilizes the batch.(6)
A batch or process lot that is sterilized in accordance with subsection (5) of this section shall be sampled and tested in accordance with this administrative regulation, if not otherwise required for that product, for microbiological contaminants, and residual solvents.(7)
A batch or process lot that fails microbiological contaminant testing after undergoing a sterilization process in accordance with subsection (5) of this section shall be destroyed in a manner that renders the batch or process lot denatured and unusable.Section 4.
Standards for Mycotoxin Testing.(1)
Cannabinoid products shall be tested by a testing facility for the following mycotoxins: aflatoxin B1, B2, G1, and G2 ochratoxin A.(2)
A batch or process lot shall be deemed to have passed mycotoxin testing if the following conditions are met:(a)
Total of aflatoxin B1, B2, G1, and G2 does not exceed twenty (20) microgram per kilogram (µg/kg) of substance; and(b)
Ochratoxin A does not exceed twenty (20) µg/kg of substance.(3)
A batch or process lot that fails mycotoxin testing in accordance with this subsection shall be destroyed in a manner that renders the batch or process lot denatured and unusable.Section 5.
Standards for Testing Residual Pesticides.(1)
Cannabinoid products shall be tested by a testing facility for the following residual pesticides and shall not exceed the maximum allowable concentration for each: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 |
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 |
(2)
A batch or process lot that fails residual pesticide testing in accordance with this section shall be destroyed in a manner that renders the batch or process lot denatured and unusable.Section 6.
Standards for Testing for Heavy Metals.(1)
Cannabinoid products shall be tested by a testing facility for the following metals and shall not exceed the maximum allowable concentration for each:(a)
Arsenic, maximum allowable concentration: one and five-tenths (1.5) ppm;(b)
Cadmium, maximum allowable concentration: zero and four-tenths (0.4) ppm;(c)
Lead, maximum allowable concentration: one (1) ppm; and(d)
Mercury, maximum allowable concentration: one and two-tenths (1.2) ppm.(2)
Cannabinoid distillate intended for inhalable products shall be tested by a testing facility for the following metals and shall not exceed the maximum allowable concentration for each:(a)
Arsenic, maximum allowable concentration: zero and two-tenths (0.2) ppm;(b)
Cadmium, maximum allowable concentration: zero and two-tenths (0.2) ppm;(c)
Lead, maximum allowable concentration: zero and five-tenths (0.5) ppm; and(d)
Mercury, maximum allowable concentration: zero and one-tenths (0.1) ppm.(3)
A batch or process lot that fails heavy metals testing in accordance with this section shall be destroyed in a manner that renders the batch or process lot denatured and unusable.Section 7.
Standards for Testing Residual Solvents.(1)
Cannabinoid products shall be tested by a testing facility for residual solvents, as appropriate, and shall not exceed the maximum allowable concentration for each solvent used according to the table below:Solvent | CAS assigned number | Maximum allowable concentration stated in parts per million (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 | 5,000 ppm |
Ethyl Acetate | 141-78-6 | 1,000 ppm |
Heptane | 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 |
*Note: These solvents are not approved for use. Due to their possible presence in the solvents approved for use, limits have been listed here accordingly. | ||
(2)
A processing or manufacturing facility shall be exempt from testing for solvents if the facility:(a)
Did not use any solvent listed in subsection (1) of this section;(b)
Used a mechanical extraction process to separate cannabinoids; or(c)
Used only water, animal fat, or vegetable oil as a solvent to separate the cannabinoids.(3)
If a sample from a batch or process lot fails solvent testing, the batch or process lot may be remediated using procedures that would reduce the concentration of solvents to less than the action level.(4)
A batch or process lot that is remediated in accordance with subsection (3) of this section shall be:(a)
Sampled and tested in accordance with this administrative regulation; and(b)
Tested for solvents if not otherwise required for that product under this administrative regulation.(5)
A batch or process lot that fails solvent testing that is not remediated or that if remediated fails testing shall be destroyed in a manner that renders the batch or process lot denatured and unusable.Section 8.
Standards for Water Activity.(1)
Plant material, such as flower, shake, and plant trim, used to process and manufacture hemp-derived cannabinoid products shall have a water activity (Aw) rate of less than 0.65.(2)
If the plant material sample fails testing for water activity, the batch from which the sample was taken may:(a)
Be used to make a cannabinoid distillate; or(b)
Continue to dry or cure.(3)
Plant material that undergoes additional drying or curing as described in subsection (2)(b) of this section shall be re-sampled and tested in accordance with this section.Section 9.
Failed Testing and Remediation.(1)
A sample that fails any initial testing may be reanalyzed by the testing facility.(2)
If the reanalyzed sample passes, the processing or manufacturing facility shall resample the batch or process lot using another accredited testing facility to confirm the result in order for the batch or process lot to pass testing.(3)
A batch or process lot shall fail testing if the testing facility detects the presence of a contaminant in a sample above any limit of detection (LOD) established in this administrative regulation:(a)
During an initial test where no reanalysis is requested; or(b)
Upon reanalysis as described in this subsection.(4)
If a sample fails a test or a reanalysis, the batch or process lot:(a)
May be remediated or sterilized in accordance with this administrative regulation; or(b)
If it cannot be remediated or sterilized in accordance with this administrative regulation, it shall be destroyed in a manner that renders the batch or process lot denatured and unusable.(5)
A hemp-derived cannabinoid product batch or process lot shall only be remediated twice. If the batch or process lot fails after a second remediation attempt and the second retesting, the entire batch or process lot shall be destroyed in a manner approved by the cabinet.(6)
A hemp-derived cannabinoid product from a batch or process lot that failed testing shall not be combined with another batch or process lot. Mixed products shall be considered adulterated, regardless of the LOD or defect level of the final product.Section 10.
Certificate of Analysis.(1)
The testing facility shall:(a)
Generate a certificate of analysis (COA) for each representative sample that the testing facility analyzes; and(b)
Ensure the COA contains the results of all required analyses performed for the representative sample.(2)
The COA shall contain, at minimum:(a)
The testing facility's name, premises address, and license number, processor's or manufacturer's name, and premises address;(b)
Batch or lot number of the batch or process lot from which the sample was obtained. For products that are already packaged at the time of sampling, the labeled batch or lot number on the packaged hemp-derived cannabinoid products shall match the batch or lot number on the COA;(c)
Sample identifying information, including matrix type and unique sample identifiers;(d)
Sample history, including the date collected, the date received by the testing facility, and the date of all sample analyses and corresponding testing results;(e)
The analytical methods, analytical instrumentation used, and corresponding LOD and limits of quantitation (LOQ);(f)
Analytes detected during the analyses of the sample that are unknown, unidentified, or injurious to human health if consumed, if any; and(g)
A chromatograph of the cannabinoid test results.(3)
The testing facility shall report test results for each representative sample on the COA as an overall "pass" or "fail" for the entire batch:(a)
When reporting qualitative results for each analyte, the testing facility shall indicate "pass" or "fail";(b)
When reporting quantitative results for each analyte, the testing facility shall use the appropriate units of measurement as required in accordance with this administrative regulation;(c)
When reporting results for each test method, the testing facility shall indicate "pass" or "fail";(d)
When reporting results for any analytes that were detected below the analytical method LOQ, indicate "<LOQ", notwithstanding cannabinoid results;(e)
When reporting results for any analytes that were not detected or detected below the LOD, indicate "ND"; and(f)
Indicate "NT" for any test that the testing facility did not perform.(4)
(a)
In accordance with 2023 Ky. Acts ch. 78, a cannabinoid manufacturer or processor that ships adult-use products out of state for use or sale outside the Commonwealth of Kentucky:1.
Shall abide by the testing and labeling requirements of this administrative regulation if the receiving state or jurisdiction does not have testing and labeling requirements; or2.
May defer to the receiving state's testing requirements if that state has equivalent testing requirements.3.
Products intended for out-of-state sale shall be stored separately from in-state products and shall have signage indicating the products are for out-of-state sale.(b)
Batch number of the batch from which the sample was obtained shall be on the COA for all products shipped out of state.STEVEN J. STACK, MD, MBA, Commissioner
ERIC C. FRIEDLANDER, Secretary
APPROVED BY AGENCY: April 22, 2024
FILED WITH LRC: April 24, 2024 at 12:30 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on June 24, 2024, at 9:00 a.m. using the CHFS Office of Legislative and Regulatory Affairs Zoom meeting room. The Zoom invitation will be emailed to each requestor the week prior to the scheduled hearing. Individuals interested in attending this virtual hearing shall notify this agency in writing by June 17, 2024, five (5) workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who attends virtually will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on this proposed administrative regulation until June 30, 2024. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to the contact person. Pursuant to KRS 13A.280(8), copies of the statement of consideration and, if applicable, the amended after comments version of the administrative regulation shall be made available upon request.
CONTACT PERSON: Krista Quarles, Policy Analyst, Office of Legislative and Regulatory Affairs, 275 East Main Street 5 W-A, Frankfort, Kentucky 40621; phone 502-564-7476; fax 502-564-7091; email CHFSregs@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Krista Quarles or Julie Brooks
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation establishes the hemp-derived cannabinoid product sampling and testing requirements.
(b) The necessity of this administrative regulation:
Many hemp-derived cannabinoid products sold in Kentucky continue to be unregulated. This administrative regulation is necessary to ensure that all hemp-derived cannabinoid products produced and sold in the state are safe for human consumption.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
KRS 217.125(1) authorizes the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations for the efficient administration and enforcement of the Kentucky Food, Drug and Cosmetic Act, KRS 217.005 through 217.215.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation ensures all hemp-derived cannabinoid products manufactured, processed, distributed, or sold are safe for human consumption.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
This is a new administrative regulation.
(b) The necessity of the amendment to this administrative regulation:
This is a new administrative regulation.
(c) How the amendment conforms to the content of the authorizing statutes:
This is a new administrative regulation.
(d) How the amendment will assist in the effective administration of the statutes:
This is a new administrative regulation.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
There are currently thirty-eight (38) manufacturers of cannabidiol (CBD) products registered with the department.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:
Cannabinoid processor and manufacturers are currently in compliance with the requirements of 902 KAR 45:190E. This new administrative regulation does not require any additional actions for compliance with product sampling and testing requirements.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
Compliance with this new administrative regulation will not add to the cost for the regulated entities.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Producers and manufacturers will be able to ensure products offered are of the highest quality and are safe for human consumption.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
The current budget for the food manufacturing permitting and inspection program is $1,080,900. The increase in required permitting and inspection processes to implement this administrative regulation will cost the department an additional $1,551,397 in the first year.
(b) On a continuing basis:
The department will continue to need an additional $1,551,397, at a minimum, in subsequent years.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
Funding to implement and enforce this administrative regulation will be from a mix of fees paid to the department and state general fund dollars.
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
An increase in fees or funding is not needed to implement this administrative regulation.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
This administrative regulation does not contain fees.
(9) TIERING: Is tiering applied?
Tiering is applied. Testing for solvents is only required when they are used in the manufacturing or processing procedures.
FISCAL IMPACT STATEMENT
(1) Identify each state statute, federal statute, or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 217.125 and 217.155.
(2) Identify the promulgating agency and any other affected state units, parts, or divisions:
The Department for Public Health, Division of Public Health Protection and Safety is the promulgating agency.
(a) Estimate the following for the first year:
Expenditures:
Expenditures to the department to implement this administrative regulation will be approximately $1,551,397 per year.
Revenues:
This administrative regulation does not generate revenue.
Cost Savings:
This administrative regulation will not result in cost savings.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
Expenditures for the Department for Public Health may be impacted by changes in salary, fringe benefits and travel cost for state and local health department employees. These changes cannot be determined at this time.
(3) Identify affected local entities (for example: cities, counties, fire departments, school districts):
There are no affected local entities.
(a) Estimate the following for the first year:
Expenditures:
Not applicable
Revenues:
Not applicable
Cost Savings:
Not applicable
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
Not applicable
(4) Identify additional regulated entities not listed in questions (2) or (3):
Additional regulated entities are processors and manufacturers of hemp-derived cannabinoid products, and testing facilities.
(a) Estimate the following for the first year:
Expenditures:
Expenditures for the additional regulated entities will be associated with the sampling and testing requirements of this administrative regulation.
Revenues:
This administrative regulation does not generate revenue.
Cost Savings:
This administrative regulation does not result in cost savings.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
The department is not able to determine changes in expenditures in subsequent years at this time.
(5) Provide a narrative to explain the:
(a) Fiscal impact of this administrative regulation:
This administrative regulation does not have a significant fiscal impact. The department does not permit or inspect the testing facilities. Producers and manufacturers of cannabinoid products are responsible for covering the costs associated with the testing.
(b) Methodology and resources used to determine the fiscal impact:
The department does not permit or inspect the testing facilities. The increased expenditures listed in question (2) are the overall expenditures needed to increase the workforce to oversee the permitting and inspecting for processing and manufacturing facilities, and retail establishments.
(6) Explain:
(a) Whether this administrative regulation will have an overall negative or adverse major economic impact to the entities identified in questions (2) - (4). ($500,000 or more, in aggregate)
This administrative regulation will not have an overall negative or adverse major economic impact.
(b) The methodology and resources used to reach this conclusion:
The department does not permit or inspect the testing facilities.