Licensing Analytical Laboratories for Sampling and Testing Cannabis
216-RICR-60-05-6 ACTIVE RULE
6.1Authority
These regulations are established pursuant to R.I. Gen. Laws §§ 21-28.6-12(f)(10) and 21-28.6-16(f) for the purpose of establishing the minimum standards for licensing analytical laboratories to collect, sample, and analyze cannabis products cultivated and/or manufactured by registered compassion centers and licensed cultivators. This is required to ensure the qualifications and competence of personnel and to ensure the adequacy of equipment, facilities, procedures, and quality systems required to characterize cannabinoid identity and content profiles, and test samples of finished cannabis products for biological and chemical contaminants. These regulations also establish the form and content of initial and renewal applications for licensing.
6.2Limitations
The scope of these regulations is limited to authorized activities under the Edward O. Hawkins and Thomas C. Slater Medical Marijuana Act [R.I. Gen. Laws Chapter 21-28.6] (“Medical Marijuana Act”) and does not extend to any acquisition, possession, cultivation, manufacture, delivery, transfer, transportation, or sale for other purposes. See R.I. Gen. Laws §§ 21-28.6-3(15) and 21-28.6-2(5).
6.3Incorporated Materials
A.These Regulations hereby adopt and incorporate Codex Alimentarius Commission, "General Guidelines on Sampling" CAC/GL50-2004 not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
B.These Regulations hereby adopt and incorporate Association of American Feed Control Officials (AAFCO) "Guidance on Obtaining Defensible Samples" or "GOODS" (2015) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
C.These Regulations hereby adopt and incorporate USDA Establishment of a Domestic Hemp Production Program 7 C.F.R. Part 990 Subpart B - State and Tribal Hemp Production Plans, issued January 19, 2021 by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
6.4Definitions
A.The terms in this section shall be defined as follows:
1."Acceptable Hemp THC level" or ".n%” as used throughout this Part means the level of THC in a given hemp sample reported by the laboratory conducting the testing in accordance with Licensing Analytical Laboratories for Sampling and Testing Cannabis, § 6.21 of this Part, which takes into account the measurement of uncertainty, reported in conjunction with a confidence level of at least ninety-five percent (95%) in accordance with the USDA's Establishment of a Domestic Hemp Production Program 7 C.F.R. Part 990 Subpart B - State and Tribal Hemp Production Plans incorporated in § 6.3(C) above.
2.“Accredited” means to be recognized as conforming to a standard by an accrediting organization.
3."Act" means the Laboratory Act of R.I. Gen. Laws Chapter 23-16.2, as amended, entitled, "Laboratories."
4."AHP" means the American Herbal Pharmacopoeia.
5."Analytical laboratory" means a facility for the biological, microbiological, chemical, and physical examination of cannabis and other matrices containing cannabis.
6.“Analytical reagent grade", "(AR) grade", "ACS reagent grade", and "Reagent grade" means reagents that conform to the current specifications of the Committee on Analytical Reagents of the American Chemical Society (ACS).
7."AOAC" means AOAC INTERNATIONAL.
8.“Applicant” means a laboratory applying to the Department to become a licensed analytical laboratory.
9."Cannabinoid" means any of several compounds produced by cannabis plants that have medical and/or psychotropic effects.
10."Cannabinoid profile" means the percentages of ?9-tetrahydrocannnabinol (?9-THC), delta 8 tetrahydrocannabinol (?8-THC), (cannabidiol (CBD), tetrahydrocannabinolic acid (THCa) and cannabidiolic acid (CBDa) in the total amount of THC in the cannabis products as sold. Percentage of other cannabinoids may be reported, but are not required.
11.“Cannabis” means as defined in R.I. Gen. Laws § 21-28.6-3(2).
12."Cannabis concentrate" means a cannabis product derived by using solvents or by other means to extract and concentrate cannabinoid compounds from cannabis. Concentrates are typically in the form of oils, pastes, waxes, or solids.
13."Cannabis resin", commonly known as "rosin," “hashish,” “hash,” or “bubble hash,” means a solid cannabis product produced by gathering and compressing the cannabinoid-rich trichomes (i.e., kief) of the cannabis plant.
14."Certified thermometer" means a thermometer that has documentation from the manufacturer that it has been calibrated by NIST.
15."Class ‘A’ glassware" means glassware satisfying the applicable requirements for Class “A” glassware established by NIST.
16."Change in owner" means:
a.In the case of an analytical laboratory that is a partnership, the removal, addition, or substitution of a partner which results in a new partner acquiring a controlling interest in such partnership;
b.In the case of an analytical laboratory which is an unincorporated solo proprietorship, the transfer of the title and property to another person;
c.In the case of an analytical laboratory which is a corporation:
(1)A sale, lease, exchange, or other disposition of all, or substantially all, of the property and assets of the corporation; or
(2)A merger of the corporation into another corporation; or
(3)The consolidation of two or more corporations, resulting in the creation of a new corporation; or
(4)In the case of an analytical laboratory which is a business corporation, any transfer of corporate stock which results in a new person acquiring a controlling interest in such corporation; or
(5)In the case of an analytical laboratory which is a non-business corporation, any change in membership which results in a new person acquiring a controlling vote in such corporation.
17."Compassion center" means a not-for-profit corporation subject to the provisions of R.I. Gen. Laws Chapter 7-6, and registered under R.I. Gen. Laws § 21-28.6-12 that acquires, possesses, cultivates, manufactures, delivers, transfers, transports, supplies or dispenses cannabis, and/or related supplies and educational materials, to patient cardholders and/or their registered caregiver cardholder and authorized purchaser.
18."Compliance analysis" or "Compliance testing" means the analysis of a sample that is required by law or regulation.
19."Data quality objectives" or "DQO" means performance and acceptance criteria developed to clarify study objectives, define the appropriate type of data, and specify tolerable levels of acceptable data.
20."Department of Business Regulation", or “DBR,” means the Rhode Island Department of Business Regulation or its successor agency. DBR oversees the Office of Cannabis Regulation (OCR).
21."Department" or "RIDOH" means the Rhode Island Department of Health.
22."Detection limit" means the minimum concentration of a substance that can be measured and reported with ninety-nine percent (99%) confidence that the analyte concentration is greater than zero (0) and is determined from analysis of a sample in a matrix containing the analyte.
23."Director" means the Director of the Rhode Island Department of Health.
24."Dried useable cannabis" means the dried leaves and flowers of the cannabis plant.
25."Duplicate samples" means two samples collected from and representative of the same material that are carried through all steps of the sample accessioning, preparation and analytical procedures in an identical manner.
26."Edible cannabis-infused products" or "Edibles" means a cannabis-infused product that is to be consumed by eating or drinking.
27."Emergency sampling and handling" means upon direction by the Department or DBR, samples of cannabis products must be collected, analyzed, and reported as a priority.
28."Equivalent amount" means the documented weighed and measured portion of usable cannabis components used in the manufacturing process to determine the final concentration of cannabinoids in the finished edible and infused cannabis products.
29."FDA" means the United States Food and Drug Administration.
30."Finished cannabis" means usable plant material, cannabis resin, cannabis concentrate, or cannabis-infused product (CIP). Anything not falling within this definition may be referred to as “unfinished” herein.
31."Finished plant material" means usable cannabis that has been trimmed or shaken loose and dried. Trimming includes removing the leaves subtending the buds as well as any dead leaves or stems. Flower that has fallen off of the cannabis plant due to shaking, bumping, moving, or manufacturing is referred to as "shake."
32."Flowering" means the gametophytic or reproductive state of cannabis in which the plant produces flowers, trichomes, and cannabinoids characteristic of cannabis. This stage of growth is determined by visual buds or flower or by proxy of the plant receiving less than eighteen (18) hours of light in a twenty-four (24) hour period.
33."Growing area" means the land on which a licensee cultivates, produces or plans to cultivate or produce cannabis.
34."Grower" means a person or entity who or that cultivates cannabis for commercial purposes.
35."Handler" means a person or entity who or that produces cannabis for processing into commodities, products, or agricultural hemp seed.
36."Hemp" (Industrial or Certified) means Hemp derivatives produced from hemp plants tested within thirty (30) days of harvest or after processing as applicable and found to produce industrial hemp having a delta 9 - tetrahydrocannabinol concentration that does not exceed three tenths of one percent (0.3%) on a dry weight basis or per volume basis regardless of moisture content as demonstrated through relevant documentation. All products made from hemp plants, including, but not limited to, concentrated oil, cloth, cordage, fiber, food, fuel, hemp-derived consumable CBD products, paint, paper, construction materials, plastics, seed, seed meal, seed oil, and seed certified for cultivation, which satisfy the requirements of the Hemp Growth Act as defined in R.I. Gen. Laws § 2-26-3(10).
37."Hemp derivative" means any compound or substance collected or extracted from industrial hemp including but not limited to Cannabidiol, other cannabinoids or terpenes.
38.“Hemp-derived consumable CBD product” means any product meant for ingestion by a human or animal, including, but not limited to, concentrates, extracts, and hemp-infused foods and products, which contains cannabidiol derived from a hemp plant as defined in R.I. Gen. Laws § 2-26-3.
39."Laboratory fortified blank" means a laboratory reagent blank which the target analytes from a certified source different from the source of standard target analyte standards used to establish the calibration curve for which the analytical method is designed to detect and quantify in cannabis samples.
40."Laboratory fortified sample" means a cannabis sample that includes the target analytes for which the analytical method is designed to detect and quantify.
41."Laboratory reagent blank" means a sample composed of a clean matrix and analyzed as a cannabis product sample. It contains only the reagents used in the preparation of the sample and is analyzed and treated in the manner as the cannabis samples.
42."Licensed" means the determination by the Department of Health that an analytical laboratory is capable of performing specific tests or analyses of cannabis samples in accordance with the requirements of these Regulations.
43."Licensed cultivator" means a person as identified in R.I. Gen. Laws § 21-28.6-16, who has been licensed by the Department of Business Regulation to cultivate cannabis pursuant to R.I. Gen. Laws § 21-28.6-16, and may also refer to their agents or card holders as the context may require.
44."Marijuana'' or ''Marihuana'' means all parts of the plant of any Cannabis species whether growing or not found to have a delta 9 - tetrahydrocannabinol concentration that exceeds three tenths of one percent (0.3%) on a dry weight basis or per volume basis regardless of moisture; the seeds thereof; and resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. It does not include the mature stalks of the plant, fiber produced from the stalks, oil, or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks, except the resin extracted therefrom, fiber, oil, or cake or the sterilized seed of the plant which is incapable of germination. Marijuana shall not include "industrial hemp" or "industrial hemp products" which satisfy the requirements of R.I. Gen. Laws Chapter 2-26, nor shall it include products that have been approved for marketing as a prescription medication by the U.S. Food and Drug Administration and legally prescribed.
45."Cannabis-infused product" or "CIP" means a product infused with cannabis that is intended for use or consumption, including but not limited to edible products, ointments, aerosols, oils, and tinctures. These products, when created or sold by a compassion center, shall not be considered a food.
46."Mature cannabis plant" means a cannabis plant that has flowers or buds that are readily observable by an unaided visual examination.
47.“Measurement of Uncertainty” means the parameter, associated with the result of a measurement, that characterizes the dispersion of the values that could reasonably be attributed to the particular quantity subject to measurement.
48.“Medical Marijuana Act” means R.I. Gen. Laws Chapter 21-28.6 entitled “The Edward O. Hawkins and Thomas C. Slater Medical Marijuana Act,” as amended, including amendment by the 2016 Public Laws, Chapter 142 (Budget Article 14).
49.“Cannabis tracking system” means any system(s) designated by DBR and RIDOH designed and used to record and track all “seed to sale” activities and transactions with unique identifiers. The Cannabis Tracking System may also be used for registration, licensing applications, renewals, change of information, and communications, as well as to record and/or report any other additional information directed by DBR or RIDOH.
50."Medical use" means the acquisition, possession, cultivation, manufacture, use, delivery, transfer, or transportation of cannabis or paraphernalia relating to the consumption of cannabis to alleviate a patient cardholder's debilitating medical condition or symptoms associated with the medical condition.
51.“NIST” means National Institute of Standards and Technology.
52."Non-contiguous growing area" means a growing area on which a licensee grows or plans to grow industrial hemp that is separated from other growing areas by more than a mile. Partial acreage should be rounded up to the next whole acre.
53."Persons" means any individual, firm, partnership, corporation, company, association, or joint stock ownership.
54."Production batch" means a lot or a batch of finished cannabis product of plant material, cannabis resin, cannabis concentrate, or CIP produced at the same time, using the same methods, equipment, and ingredients. The cannabis producer of finished products must assign and record a unique, sequential alphanumeric identifier to each production batch for product tracking, labeling, and recalls.
55."Proficiency testing sample" or "PT sample" means a subsample of a matrix containing analytes of a concentration unknown to the laboratory that is used to evaluate the performance of its analytical systems. Proficiency testing samples must be obtained from a provider that is accredited by an accreditation body approved by the director of RIDOH.
56."Propagation" means the reproduction of cannabis plants by seeds, cuttings, or grafting.
57."Quality assurance" or "QA" means the integrated system of operations and measurements performed to assure that data meets defined standards of quality within a stated level of confidence.
58."Quality assurance plan" or "QAP" means the laboratory’s documented integrated system of operations and measurements performed to assure that data meets defined standards of quality within a stated level of confidence.
59."Quality control" or "QC" means the practice of standardized operations or measurements that determine or predict aspects of data quality.
60."Registry identification card" means a document issued by the department of business regulation that identifies a person as a testing agent for one or more registered compassion centers and/or licensed cultivators.
61."Replicate" means one of at least three portions of a sample prepared and analyzed together to determine the range of cannabinoid potency in a batch.
62."Residual solvent" means a volatile organic chemical used in the manufacture of a cannabis product and that is not completely removed by practical manufacturing techniques.
63."Sample duplicate" means two portions of collected sample prepared and analyzed in the same batch by the analytical laboratory used to determine analytical precision.
64.“Seed to sale” means all cannabis regulated activities and transactions from point of origin to the point of sale. Seed to sale activities and transactions include but are not limited to: all cultivation, harvest, processing, manufacturing, and packaging and labeling; all purchases, acquisitions or third party supply of cannabis; all sales and dispensing transactions, any other transfers of cannabis as permitted by the Medical Marijuana Act and all applicable regulations promulgated thereto; any instances of destruction of cannabis; and testing compliance tracking.
65."Standard methods" means published by the Standard Methods for the Examination of Water and Wastewater, American Public Health Association (APHA).
66."Sporophytic state of the cannabis plant" means the vegetative stage of asexual reproduction in plants during which plants do not produce resin or flowers and are bulking up to a desired production size for flowering (more than 18 hours photogenic light).
67."Testing agent" means an employee of an approved analytical laboratory who performs sampling and/or analysis of cannabis products in accordance with these regulations.
68."THC" means THC as defined in R.I. Gen. Laws § 2-26-3(13) and includes delta 9-tetrahydrocannabinol, the principal psychoactive constituent of cannabis, delta 8-tetrahydrocannabinol, tetrahydrocannabinol acid and the natural or synthetic equivalents of the substances contained in the plant, or in the resinous extractives of, Cannabis sativa L., or any synthetic substances, compounds, salts, or derivatives of the plant or chemicals and their isomers with similar chemical structure and pharmacological activity.
69."The Hemp Growth Act" means R.I. Gen. Laws § 2-26-1 et seq.
70."These regulations" means all parts of the Rules and Regulations for Licensing Analytical Laboratories for Sampling and Testing Cannabis [216-RICR-60-05-6].
71."Tincture" means an extract, typically in ethanol, of usable cannabis. Cannabis tinctures sometimes are made with glycerin or other alternatives to ethanol.
72."Trichome" means a cannabinoid-producing glandular structure that grows on the plant surface of cannabis plants, particularly on the buds of the female plant.
73."Upper limit" means the maximum allowable concentration of contaminant in the cannabis product.
74."Usable cannabis" means dried leaves and flowers of the cannabis plant, and any mixture or preparation thereof, but does not include the seeds, stalks, and roots of the plant.
75."USP" means United States Pharmacopeia.
76."Water activity" means the unbound water in plant or food products that can support the growth of bacteria, yeasts and molds (fungi). Water activity represents the ratio of the water vapor pressure of the product to the water vapor pressure of pure water under the same conditions and it is expressed as a fraction.
77."Wet cannabis" means the harvested leaves and flowers of the cannabis plant before they have reached a dry useable state, as defined by regulations promulgated by the departments of health and business regulation.
78."WHO" or the "World Health Organization" means an agency of the United Nations, established in 1948, concerned with improving the health of the world's people and preventing or controlling communicable diseases on a worldwide basis through various technical projects and programs.
6.5Cannabis Tracking System
A.Upon direction by RIDOH, each analytical laboratory licensed under the provisions of these regulations shall be required to utilize the state approved Cannabis Tracking System to document and monitor compliance with the Medical Marijuana Act, and these regulations and may be required to pay costs associated with use of the Cannabis Tracking System which may be assessed on an annual, monthly, per use, or per volume basis and payable to the state or to its approved vendor.
B.In accordance with the Uniform Electronic Transactions Act (UETA), R.I. Gen. Laws Chapter 42-127.1 RIDOH may determine whether, and the extent to which, it will accept electronic records, documents, notifications, and signatures from other persons or entities where these regulations refer to written records, documents, notifications, and signatures.
C.Wherever these regulations have recordkeeping and reporting requirements, such data and information must be recorded and reported through the Cannabis Tracking System wherever said System is configured for such recording and reporting, in addition to any other means/mechanisms of recording and reporting required by RIDOH. RIDOH will provide further guidance on use of the Cannabis Tracking System, when it is mandatory or encouraged to be used as a substitute for or supplement to any other specifically mentioned means/mechanisms in these regulations, and timing for system utilization.
6.6Application and Licensing Process Details
The analytical laboratory must fulfill the following general requirements to apply for and renew a license for sampling and testing cannabis. Unless otherwise specified, all requirements of these regulations apply to the analytical laboratory.
6.6.1General Requirements
A.Submit application for a license on forms provided by the RIDOH for initial licensing and for license renewal.
B.Include information as the RIDOH requires which may include affirmative evidence of ability to comply with the provisions of the Medical Marijuana Act and these Regulations.
C.RIDOH will evaluate applicants based upon the information provided by applicants on the application forms/submissions and otherwise obtained during the application process.
D.Only applications that RIDOH has determined to be complete shall be eligible for review. An applicant who submits an incomplete application shall receive written notification from RIDOH regarding the specific deficiencies and shall be allowed to resubmit additional material to address these deficiencies within thirty (30) days.
E.Upon notification of an approval of an application from RIDOH, the approved applicant must take reasonable and documented efforts to complete the prerequisites to the issuance of a license. If such efforts take longer than nine (9) months, the approved applicant must show good cause to RIDOH why additional time should be granted and the application approval should not be rescinded.
6.6.2Submit Application to RIDOH – Articles of Incorporation, Business Plan, Zoning Compliance, Tax Affidavit, Security Plan, and Application Fee
A.The applicant’s legal and any d/b/a name(s), certificate of incorporation under R.I. Gen. Laws § 7-6-36 or certificate of authority under R.I. Gen. Laws § 7-6-70, articles of incorporation and by-laws, and, if applicable, documentation of recognition as a tax-exempt organization by the US Internal Revenue Service.
B.A business plan, including scope of activities, budget and resource narratives, and timeline for initiating operations.
C.The proposed physical location of the analytical laboratory (by plat and lot number and mailing address), if a precise location has been determined. If a precise physical location has not been determined, a description of the general location(s) where it may be sited, if approved, and the expected schedule for purchasing or leasing said location(s). Regarding the proposed physical location(s), the applicant must submit:
1.Evidence of compliance or preliminary determination of compatibility of the location(s) with the local zoning laws;
2.A draft diagram of the proposed facilities, including where within the facility the cannabis will be received, held for processing, prepared for testing, and analyzed, and where security alarms and cameras and surveillance recording storage will be located, and showing the location of the facility relative to streets and other public areas;
3.A description of objective parameters (such as distances from streets and public areas) and/or proposed measures (such as black-out window shades) that ensure that cannabis at the premises must not be visible from the street or other public areas; and,
4.Evidence of either ownership of property or agreement by owner of property to allow the operation of an analytical laboratory on the property, if property has already been purchased or leased at the time of the application.
D.The legal name, current address, and date of birth of each principal officer, director, or owner of the analytical laboratory.
E.A list of all persons or entities (legal names and current addresses) having direct or indirect authority over the management or policies of the analytical laboratory.
F.If an analytical laboratory will have a management agreement in place, it must also include a copy of the management agreement or management agreement proposal and a list of persons who have any ownership interest or operational control over the management company.
G.A list of all persons or business entities (legal names and current addresses) having any ownership interest in the applicant entity, whether direct or indirect.
H.If the analytical laboratory premises and/or other operational assets will be owned or leased by a person or entity other than the applicant, the legal name and current address of such person or entity and a list of all persons or entities (legal names and current addresses) having any ownership interest in such entity, whether direct or indirect.
I.The legal names and current addresses of all creditors holding a security interest in the premises and/or other assets to be used in the analytical laboratory operations, if any.
J.Tax Affidavit in accordance with R.I. Gen. Laws Chapter 5-76.
K.All other information required by RIDOH as described in the application form.
L.Each application must include the non-refundable application fee as set forth in the Fee Structure for Licensing, Laboratory, and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
6.6.3RIDOH and DBR Review
RIDOH and DBR will conduct a preliminary inspection of the proposed facility design and layout.
6.6.4Preliminary Application Approval
If RIDOH receives all required information and the information meets all applicable requirements, the application will receive preliminary approval.
6.6.5Building Process
A.If an applicant is notified that its application has been preliminarily approved by RIDOH, it must provide the following before being issued a license to operate:
1.All updates to previously submitted application information;
2.A sufficient description of the final physical location of the analytical laboratory (by plat and lot number and mailing address);
3.Evidence of complete compliance of the facility with the local zoning laws, including any conditions of approval thereof, in the form of a letter from an authorized zoning official of the municipality and certification by an authorized officer of the applicant as to compliance with any other applicable local ordinances;
4.A current Certificate of Occupancy (or equivalent document) to demonstrate compliance with the relevant provisions of R.I. Gen. Laws Chapters 23-28.1 and 23-27.3 [Fire Safety Code and State Building Code, respectively] for each physical address to be utilized as an analytical laboratory;
5.Evidence of either ownership of property or agreement by owner of property to allow the operation of an analytical laboratory on the property;
6.A final diagram of the facilities, including where within the facilities the cannabis will be stored and analyzed, and where security alarms and cameras and surveillance recording storage will be located, and showing the location of the facilities relative to streets and other public areas;
7.Evidence of divestiture of prohibited material financial interest and control as follows:
a.An analytical laboratory and “key persons” thereof may not have any “material financial interest or control” in a compassion center, a cultivator, or a licensed cooperative cultivation or vice versa.
b."Material financial interest or control” means any ownership interest, regardless of the size of the holding, and including any ownership interest through a subsidiary or affiliate; trusteeship, mortgage, guarantor, endorser or surety relationship, or loan relationship, except that loan relationship for the purposes of this definition shall exclude accounts payable and accounts receivable on account of a cannabis purchase order; any other beneficial financial interest such that the holder bears the risk of loss (other than as an insurer) or has an opportunity to gain profit from the operation or sale of the regulated cannabis business; or, operational control, including but not limited to interlocking directors or officers or through a management agreement.
c.“Key persons” means directors, officers, and any persons with managing or operational control.
d.If an analytical laboratory application is approved and any prohibited material, financial interest or control has been identified by DBR or is otherwise known to the analytical laboratory applicant, such interest or control must be divested prior to issuance of the analytical laboratory license. The plan of divestiture must be filed with DBR.
e.The duty to divest prohibited material financial interests and control is a continuing obligation of licensing.
8.Evidence that all directors, managers, officers, agents and employees of the analytical laboratory have applied for a Cannabis Registry Identification Card(s) from DBR.
B.The applicant must submit the laboratory quality assurance plan and procedures manual to RIDOH as described in § 6.11 of this Part.
6.6.6Final Licensing Process
A.Submit documentation of approval of occupancy from the State Fire Marshall to RIDOH.
B.Submit a copy of all Registry Identification Card(s) from DBR to RIDOH. Each laboratory must maintain a current list of testing agent cardholders employed by the laboratory.
C.Pay the annual license fees as set forth in the Fee Structure for Licensing, Laboratory, and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
D.The Department shall issue a license no less than thirty (30) days after the applicant meets the licensing requirements of these regulations.
E.Once the license has been issued by RIDOH, the analytical laboratory must take reasonable and documented efforts to launch analytical laboratory activities, which for purposes of this paragraph shall mean actual cannabis sampling and analysis and/or other cannabis activities requiring an analytical laboratory license pursuant to these regulations. If such efforts take longer than one (1) year, the analytical laboratory must show good cause to RIDOH why the license should not be revoked for non-use.
F.The applicant must contact RIDOH to coordinate a final laboratory inspection. RIDOH, DBR and/or the Rhode Island State Police will visit the analytical laboratory to inspect the facility security and make any recommendations regarding the security of the facility and its personnel within ten (10) business days prior to the initial opening of the analytical laboratory. RIDOH may also conduct an inspection at an earlier time, if necessary, in addition to a final laboratory inspection.
6.7Licensing
6.7.1General Information
A.Licenses will not be issued to an analytical laboratory prior to an inspection and correction of any deficiencies in a manner acceptable to the RIDOH.
B.Analytical laboratories may receive samples from another laboratory in this state for examination provided the laboratory sending the samples is licensed in this state pursuant to these rules and regulations.
C.A license will be issued only for the premises and persons named in the application and will not be transferable or assignable.
D.Licenses will be issued for Industrial Hemp testing to laboratories that have obtained Drug Enforcement Agency (DEA) Controlled Substance Registration as required by the USDA and Department of Health Controlled Substance Registration for Analytical Laboratories.
E.The license issued will be the property of the state and loaned to the laboratory and must be kept posted in a conspicuous place on the premises. Said license, unless sooner suspended or revoked, shall expire by limitation on the 31st day of December, of every year following the date of licensing and shall be renewed annually.
F.The license issued to an analytical laboratory shall clearly identify the name of the laboratory, the license number, the name of the laboratory director, the issue date and expiration date. The license will include an appendix listing of the analytes and methods for each test category the laboratory is approved. Test categories approved for the analysis of cannabis will be listed separately for plant material, resins, extracts, concentrates and infused products.
G.Test categories and descriptions are as follows:
1.Cannabis finished plant material including finished resins, kief, and hashish:
a.Cannabinoid Potency – Quantitative analysis including the percentage of D 9 -tetrahydrocannnabinol (D 9 -THC), D 8 -tetrahydrocannnabinol (D 8 -THC), cannabidiol (CBD), tetrahydrocannabinolic acid (THCa) and cannabidiolic acid (CBDa) of the total amount of THC in a cannabis product. Amounts of other cannabinoids may be reported, but are not required.
b.Microbiological – total viable aerobic bacteria, total coliforms, bile-tolerant gram-negative bacteria, pathogenic E. coli, Salmonella, yeast, and mold.
c.Water Activity – total water activity.
d.Pesticides – Residues of pesticides and growth regulators listed in § 6.21(E)(1)(a) of this Part.
e.Metals – Arsenic, Cadmium, Lead, Mercury.
2.Cannabis extracts, resins, concentrates as-is or as components of Cannabis infused products:
a.Cannabinoid Potency – Quantitative analysis including the percentage of D 9 -tetrahydrocannnabinol (D 9 -THC), D 8 -tetrahydrocannnabinol (D 8 -THC), cannabidiol (CBD), tetrahydrocannabinolic acid (THCa) and cannabidiolic acid (CBDa) of the total amount of THC in a cannabis product. Amounts of other cannabinoids may be reported, but are not required.
b.Solvents – Listed in § 6.21(H)(3) of this Part.
c.Pesticides – Residues of pesticides and growth regulators listed in § 6.21(E)(1)(a) of this Part.
d.Metals – § 6.21(D)(2)(a) of this Part.
3.Industrial Hemp and Hemp Products
a.According to USDA Establishment of a Domestic Hemp Production Program 7 C.F.R. Part 990 Subpart B - State and Tribal Hemp Production Plans as incorporated in § 6.3(C) of this Part.
b.Testing for THC, CBD, and/or other material characteristics such as pesticides, heavy metals, and microbial concentration on a dry weight or per volume basis upon direction from DBR, the Rhode Island Department of Environmental Management (DEM) or RIDOH as applicable, as stated in § 230-RICR-80-10-1.9(D)(1)(a).
4.Cannabis Infused Products
a.Cannabinoid Potency – Quantitative analysis including the percentage of D 9 -tetrahydrocannnabinol (D 9 -THC), D 8 -tetrahydrocannnabinol (D 8 -THC), cannabidiol (CBD), tetrahydrocannabinolic acid (THCa) and cannabidiolic acid (CBDa) of the total amount of THC in a cannabis product. Amounts of other cannabinoids may be reported, but are not required.
b.Potency testing of infused products may be waived if the potency of manufactured cannabis infused products remains consistently uniform from manufactured batch to batch.
H.The license will be void and returned to RIDOH if the analytical laboratory discontinues its operation, unless the discontinuance is on a temporary basis approved by RIDOH.
6.7.2Post-Licensing Change Notification
A.The analytical laboratory shall provide RIDOH with a written notice of any change described below at least thirty (30) calendar days prior to the proposed effective date of the change:
1.Change in ownership, whether partial or full, of the analytical laboratory as defined in § 6.4(A)(16) of this Part;
2.Change in the laboratory director;
3.Change in the quality assurance officer;
4.Merger, dissolution, or entity conversion;
5.Entering a management agreement, changing management companies, and/or material changes to an existing management agreement;
6.Changes in the approved premises location for the laboratory analysis of cannabis;
7.Change to approved premises floor plan;
8.Proposed premises expansion; or,
9.Discontinuation of or failure to launch analytical laboratory activities.
10.The analytical laboratory experiencing any of the above changes unexpectedly must notify RIDOH within seventy-two hours (72) and request a waiver that includes an explanation of how it intends to carry on operations.
B.Unless the analytical laboratory provides timely notification of the above changes and receives prior RIDOH approval or waiver of the requirement of prior notice and approval (for example a non-material change in ownership or emergency as determined by RIDOH), the license shall be void and returned to RIDOH.
C.The analytical laboratory must follow the process for a new application, including a new application fee, for:
1.Any proposed change of ownership, whether full or partial;
2.Any change to a management agreement that will effect a change of majority control and/or decision-making authority with respect to the operation of the analytical laboratory; and
3.Any proposed change in an approved premises location for the laboratory analysis of cannabis.
D.For updates in information other than the categories requiring thirty (30) calendar days prior notice pursuant to § 6.7.2(A) of this Part, the analytical laboratory has a continuing obligation to update, amend and/or correct any information requested and/or submitted in the application process within ten (10) business days after any change in the information submitted and/or any material change in circumstances related to the application. This includes timely notification and divestiture if a prohibited interest.
E.If the analytical laboratory proposes to alter or expand the final floor plan previously submitted and approved, the analytical laboratory must first submit a renovation plan for RIDOH approval at least sixty (60) calendar days prior to commencement of construction. The renovation plan must specifically address quality control procedures for the protection of cannabis samples and cannabis product samples from any contamination during the construction process and further address any other criteria RIDOH requires.
6.7.3Annual License Renewal
A.The Department shall issue a license if the applicant meets the requirements of the Medical Marijuana Act and this Part for licensing. Said license, unless sooner suspended or revoked, shall expire by limitation on the thirty-first (31st) day of December, of every year following the date of licensing and shall be renewed annually.
B.Annual license renewal applications shall be submitted on such forms and include such information as prescribed by RIDOH.
C.No license will be renewed if, at the time of renewal, the laboratory does not meet the requirements for licensing.
6.7.4Denial, Suspension, or Revocation of License
A.The Department may deny, revoke, or suspend the license of any analytical laboratory for engaging in conduct that includes but is not limited to:
1.Failure to observe any term of licensing;
2.Failure to observe any order made under authority of the Medical Marijuana Act or under the statutory authority vested in the Department;
3.Engaging in, aiding, abetting, causing, or permitting any action prohibited under the Medical Marijuana Act;
4.Failure to comply with any regulatory requirement stated herein and any other applicable state regulation or statute;
5.Making false or deceptive representation on any application for license or renewal thereof;
6.Failure to maintain professional and competent standards of practice;
7.Making false or deceptive representation of any testing results and reports thereof; or,
8.Engaging in false or deceptive advertising of laboratory testing.
B.Lists of deficiencies noted in inspections and investigations conducted by the RIDOH shall be maintained on file in the RIDOH and shall be considered by the RIDOH in rendering determinations to deny, suspend, or revoke the license of an analytical laboratory.
C.Whenever action shall be proposed to deny, suspend, or revoke the license or take another disciplinary action, the RIDOH shall notify the facility by certified mail setting forth reasons for the proposed action, and the applicant or licensed laboratory shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws § 23-1-22 and these Regulations.
D.If the RIDOH finds that public health, safety and welfare imperatively requires emergency action and incorporates a finding to that effect in its order, the RIDOH may order summary suspension of licenses pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-20 and 42-35-14(c).
6.8Inspections
A.After the analytical laboratory license is issued, the analytical laboratory shall notify RIDOH when it commences operations. RIDOH may conduct a post-licensing inspection upon this commencement of operations, including but not limited to inspection for compliance of cannabis product sampling, chain of custody and testing requirements set forth in these regulations.
B.The Director or authorized agent(s) shall at all times have authority to enter upon all parts of the premises on which any cannabis plant or product analysis is conducted and of the premises appurtenant thereto, as well as the premises on which finished cannabis plant or products samples are collected by employees of the analytical laboratory testing. The purpose of these visits will be to observe and evaluate the sample collection and chain of custody procedures and/or for determining compliance with the provisions of the Medical Marijuana Act and these Regulations.
C.Each cannabis analytical laboratory shall be provided a written report by the Department of all deficiencies recorded because of an inspection or investigation within sixty (60) days of such inspection or investigation.
D.The cannabis analytical laboratory shall provide a plan of corrective action, including expected completion dates for all deficiencies listed on such report within thirty (30) days of receipt.
E.At the discretion of the Director, a follow-up inspection may be conducted to assure that all deficiencies have been corrected.
6.9Laboratory Governing Body, Management, and Personnel
6.9.1Governing Body
A.Each laboratory must have a governing body or equivalent legal authority ultimately responsible for:
1.The management and control of the operation;
2.The assurance of the quality of services;
3.The compliance with all state and local laws and regulations; and
4.Compliance with other relevant health and safety requirements, including these Regulations.
6.9.2Management
A.Each laboratory shall have a laboratory director who must be responsible for the day-to-day management and operation of the laboratory and to ensure the achievement and maintenance of quality standards of practice. The laboratory director must meet the following minimum qualifications:
1.Possess a doctorate in the chemical or biological sciences from a college or university accredited by a national or regional certifying authority and a minimum of two (2) years analytical laboratory experience, or possess a master's degree in the chemical or biological sciences and a minimum of four (4) years of analytical laboratory experience, or possess a bachelor’s degree in the chemical or biological sciences and a minimum of five (5) years of analytical laboratory experience.
B.The director of each laboratory or his/her designee, must be responsible for the following:
1.To be present on the premises of the laboratory during the hours of operation to ensure adequate and appropriate supervision of laboratory activities;
2.To ensure the accurate performance of all tests in the laboratory including the submission of appropriate reports on all tests;
3.To ensure the supervision of all personnel in the laboratory and for hiring adequately trained personnel commensurate with the workload;
4.To be available during the hours of operation for personal or telephone consultation with personnel;
5.To notify RIDOH within thirty (30) days of any change in laboratory services or supervisory personnel;
6.To establish and adhere to written policies and procedures for a comprehensive quality assurance program; and
7.Such other activity as may be deemed appropriate.
C.The laboratory shall notify RIDOH within seven (7) days of any change in the laboratory director position. In the event the director of the laboratory is absent for a continuous period of thirty (30) days total (including the seven (7) days), the laboratory shall cease and desist operations on the thirtieth (30th) day unless a person who meets the qualifications of § 6.9.2(A) of this Part is in attendance.
D.The laboratory director must designate a qualified quality assurance (QA) officer who is responsible for the laboratory’s quality assurance plan and its implementation. This individual may be an outside consultant or the laboratory director.
E.The quality assurance officer must have earned at least a bachelor’s degree in a chemical or biological science and two years of related laboratory experience. The quality assurance officer qualifications may be met if the person has previous laboratory quality assurance experience acceptable to the RIDOH in a licensed, certified, or accredited laboratory, or possesses other qualifications acceptable to the RIDOH.
F.The quality assurance officer must be responsible for the oversight of Quality Control (QC) data, including establishing acceptance criteria and documenting/monitoring corrective action; where staffing allows, be independent of the technical areas for which he/she has QA oversight; have general knowledge of the methodologies for which data review is performed; have oversight of the laboratory’s quality assurance system and conduct or arrange for annual internal audits of the technical operation and report findings to the laboratory director.
6.9.3Personnel
A.Each laboratory must employ enough qualified personnel commensurate with the workload to ensure that services are provided effectively and safely and in accordance with prevailing laboratory standards and practices.
B.Each laboratory must establish a job description for each classification of position, clearly delineating qualifications, duties, and responsibilities inherent in each position.
C.Each laboratory must maintain personnel records for each employee which contain no less than current background and training documentation pertaining to qualifications; orientation procedures, including an initial demonstration of capability for each method and/or instrument the analyst will be performing and/or operating; evidence of periodic evaluation of work performance; and, such other training records as may be deemed appropriate.
D.Each laboratory must train personnel initially and annually thereafter on professional conduct, ethics, and state laws regarding cannabis.
E.Each laboratory must train personnel initially and annually thereafter on the use of the Cannabis Tracking System and any other tracking systems used by the laboratory.
6.10Record Keeping
A.Each laboratory must maintain appropriate records and reports, which must be available for inspection by authorized representatives of the RIDOH. Create, control, and maintain records of raw data, chain-of-custody records, calculations, quality control data, and other essential documentation. Complete all records with signatures, units of measurement, and documentation sufficient for verification of results. Retain all records in such a manner as to permit prompt retrieval. Records must include:
1.Records of the operation and maintenance of all laboratory equipment;
2.Records of all sample collection, preparation, and analysis;
3.Records of control values, standard values, calibration curves and calculations of standard deviations; and
4.Reports of proficiency testing programs and of such other records as may be deemed necessary.
B.Each laboratory must maintain the results of all testing including correspondence related to reported results and compliance issues for no less than five (5) years. These records must be available for inspection by the RIDOH, upon request and maintained at the analytical laboratory’s expense in a form and location acceptable to the RIDOH for at least two (2) years after closure.
6.11Quality Assurance and Quality Control Programs
A.The laboratory must have a quality assurance plan that details the quality assurance system of quality control requirements in its standard operating procedures and document that all personnel review the quality assurance plan annually. The analytical laboratory must follow all applicable quality control activities described in its quality assurance plan as approved by the RIDOH. Analytical laboratories must review their quality assurance plan annually and provide a copy of the updated quality assurance plan to the RIDOH with the annual renewal application.
B.Each laboratory must have clearly established internal and external quality controls to ensure high standards of performance and reliability of test results. These quality controls must consider such factors as preventative maintenance, periodic inspection, testing for proper validation of methods, evaluation of reagents and volumetric equipment, surveillance of results, remedial action taken to correct deficiencies and quality control failures and other factors as may be deemed necessary.
C.The laboratory must perform all analyses using methods that are currently approved by the RIDOH, as described in § 6.21 of this Part.
D.The laboratory’s quality assurance plan must be accessible to all personnel in the laboratory. It must include, but not be limited to:
1.Laboratory sampling plan for collecting representative samples of finished cannabis products;
2.Laboratory sample handling procedures;
3.Emergency sampling and handling plan;
4.Laboratory glassware, plastic ware and equipment washing and sterilizing procedures;
5.Instrument calibration procedures;
6.A list of detailed analytical procedures or analytical references;
7.Data reduction, validation, and reporting procedures including non-compliance action plan;
8.Types and frequency of internal audit samples (quality control samples) and external audit samples (proficiency testing samples);
9.Internal audit procedures and frequency;
10.Preventative maintenance procedures and schedules;
11.Procedures for determining accuracy and precision and method detection limits of all analytes and specified frequency;
12.Control limits and corrective action policies;
13.Laboratory organization, staff, and responsibilities;
14.Procedures for laboratory and managerial data review;
15.Detection limits (DL) for cannabinoids, and contaminant analytes specified in these regulations must be determined by DL studies prior to placing new methods in service and annually thereafter. The resulting detection limits must be less than half of the Upper Limit concentration criteria specified in these regulations. If the laboratory cannot meet a DL that is less than half of the Upper Limit for an analyte, a request for a variance must be submitted;
16.The applicable quality control procedures required for methodologies described by the FDA, AOAC, AHP or USP.
6.12Cannabis Proficiency Testing (PT) and Demonstration of Capability
A.The quality assurance plan must include standard procedure for determining the capability of its analysts before they can begin conducting quantitative analysis of cannabis products.
B.RIDOH must be notified when significant changes are made to the standard analytical procedure such as changes to extraction technique or the instrumentation used.
C.Each analyst is required to perform initial demonstration of capability prior to implementing routine analyses.
D.Each laboratory must participate in a proficiency testing program approved by RIDOH for each analyte (or group of analytes), matrix and method for which the laboratory is certified or is requesting certification. Proficiency testing samples must be procured from a proficiency testing provider approved by RIDOH. RIDOH may require that the proficiency testing program include “round robin” proficiency testing whereby samples from the same batch are tested by more than one licensed analytical laboratory for comparison of results.
E.If proficiency test samples are not commercially available, analytical laboratories must submit a plan to define and develop in-house quality control samples it will use to demonstrate its proficiency for each analyte, matrix, and method of analysis. The plan must include:
1.The source of the sample,
2.The matrix type,
3.Preparation procedure,
4.Testing procedure,
5.Target analytes in the sample,
6.How the analyte concentration was determined,
7.Control limits and how they were determined, and
8.Shelf life and expiration testing.
F.The laboratory must participate in a PT sample annually for each analyte, matrix and method and receive an acceptable evaluation for each of the following:
1.Plants, resins, kief, hashish, shake – potency, metals, water activity, pesticides, aerobic plate count bacteria, bile-tolerant gram negative bacteria, pathogenic E. coli, Salmonella, mold, and yeast.
2.Extracts, and concentrates – potency, solvents, pesticides and metals.
3.Cannabis infused edible – potency.
G.Proficiency test results must be submitted by the accredited provider directly to the RIDOH licensing office by October thirty-first (31st) of each year. Analytical laboratories must designate RIDOH as a recipient of the provider's proficiency test results report. Analytical laboratories must not communicate or receive proficiency test results to or from other analytical laboratories before the accredited provider makes them available.
H.When a laboratory receives an unacceptable evaluation for an analyte in a study, it must determine the cause for the failure, take corrective action, and participate in another PT study for the failed analyte. Documentation of the investigation and corrective action must be maintained and a copy provided to RIDOH before the next proficiency testing study.
I.Failure to complete PT studies annually or failure to make-up an unacceptable PT result for any analyte annually will result in loss of licensing for the analyte until two (2) consecutive PT studies resulting in acceptable evaluations have been completed. There must be an interval of at least thirty (30) days between the two studies.
J.All proficiency test samples must be analyzed in the same manner and frequency as real cannabis products and samples using the same staff, procedures, and equipment.
K.Laboratories must not send a PT sample, or a portion thereof, to another laboratory for any analysis for which it is certified or seeks certification.
L.A laboratory must not knowingly receive any PT sample, or a portion thereof, from another laboratory for any analysis for which the sending laboratory is licensed or seeks licensing.
M.Laboratory management or staff must not communicate with any individual at another laboratory concerning a PT sample or attempt to obtain the assigned value from their PT provider.
N.All raw data obtained in analyzing PT samples must be retained and be available for review for a minimum of five (5) years.
6.13Procedure Manual
A.Each analytical laboratory must have available, always, in the immediate working areas of personnel engaged in conducting analytical laboratory sample collection, sample accessioning and testing, a procedure manual which includes a detailed compilation of all automated and manual methods and procedures for sample collection, chain-of-custody, and analytical testing which is performed by the laboratory and for which it is licensed. Such manuals must:
1.Be written in a uniformly consistent format;
2.Specify the approved method employed;
3.Describe the quality control activities pertinent to the method;
4.Contain information concerning preparation and storage of media, reagents, control and calibration procedures and pertinent literature references;
5.Describe the laboratory's technical procedures for the collection, transporting, processing and examination of samples;
6.For tests, which are normally performed on automated test equipment, provide for alternate methods or for storage of test samples, in the event the automated equipment becomes inoperable; and,
7.Be approved, signed, and dated by the current laboratory supervisor/director and the QA Officer. Changes in procedures must be approved, signed, and dated by the current supervisor/director and QA Officer.
6.14Facility, Equipment & Supplies
6.14.1Facility
A.Each analytical laboratory must:
1.Be housed in well lighted, sanitary, vented quarters equipped with hot and cold running water, and toilet facilities and contain ample space to process and examine the samples commensurate with the total workload;
2.Be in distinct and separate locations from living quarters unless provisions exist for separate entrances, and plumbing fixtures;
3.Have ample workbench space, have sufficient water, gas, suction, electrical outlets, and sinks;
4.Have adequate and proper storage space for all chemicals including explosive, flammable, corrosive, and caustic materials;
5.Have flooring composed of non-porous material in laboratory areas where acids, caustics, and solvents are used;
6.Have adequate temperature and humidity controls as may be required for proper performance of tests and operation of instruments affected by environmental conditions;
7.Have adequate electrical supply; and
8.Have adequate refrigeration for samples, standards, and reagents used in testing.
6.14.2Equipment and Supplies
A.The laboratory must possess suitable equipment required for licensing that must meet the requirements of the methods. All instruments must be physically located on site.
B.The laboratory must have sufficient glassware and plastic labware necessary for the analyses. Glassware must be borosilicate glass or other corrosion-resistant glass. It must be free of cracks and chips. Markings and etchings must be legible. Volumetric flasks, pipettes, and other glassware used for volumetric analysis must be class “A.”
C.The laboratory must have sufficient facilities to wash and sterilize glassware, labware, and other containers used in the analysis.
D.All precision equipment and instruments (e.g., pipettors, pH meters, conductivity meters) must be calibrated and checked for accuracy at regular intervals as required by the method and the laboratory’s quality assurance policies. Documentation of calibration and accuracy checks must be maintained. Records of service by a qualified instrument service organization must be maintained.
E.Analytical balance range and sensitivity must be appropriate for the application for which it is used. Balances must be kept clean and free of corrosion and spillage and must be checked daily with weights meeting ASTM Type I, Class 1 or 2 specifications with values that bracket the laboratory’s weighing needs. Records must be maintained that include acceptance criteria for the checks. ASTM weights must be recalibrated every five (5) years or immediately if nicked or corroded. Non-reference weights may be used but must be calibrated every six (6) months against ASTM type 1, 2 or 3 weights.
F.All balances must be calibrated annually by a professional balance service. Certificates of calibration must be maintained at the laboratory.
G.Laboratories must arrange with Department of Labor and Training Office of Occupational Safety (DLTOS) to have balances or scales used in the sample collection process certified and sealed in accordance with R.I. Gen. Laws Title 47.
H.All incubators, refrigerators, ovens, autoclave or sterilizers and water baths must contain calibrated thermometers. The laboratory must maintain copies of the certificates of calibration for each thermometer. Thermometer range and graduation increments must be appropriate for the application for which it is used. Glass thermometers must be checked for accuracy annually, and other types of thermometers quarterly, by comparing with a NIST traceable thermometer at the temperatures of interest. Thermometers must be tagged with the date of accuracy check and the correction factor (may be zero (0)). There must be no separation in the liquid column of glass thermometers.
I.Use analytical reagent grade chemicals unless otherwise allowed or specified by the analytical method;
J.Date bottles of dehydrated microbiology media when received and opened. Do not use media beyond the manufacturer’s expiration date or within one (1) year from opening, whichever is sooner. Discard immediately if caked or otherwise deteriorated. Prepared, or prepackaged media are permitted.
K.Use plastic labware for microbiology that is clear and non-toxic.
L.Reagent water for chemical analyses and for general use must be distilled or deionized and have a resistivity value greater than 0.5 megaohms/cm at twenty-five degrees Celsius (25° C). Quality checks must be made according to specified analytical method requirements, but at least monthly, with a conductivity meter. All such quality checks must be recorded.
M.For microbiological analyses, reagent water must meet all the following criteria:
PARAMETER | LIMITS | FREQUENCY |
resistivity | > 0.5 megaohms/cm | monthly |
Pb, Cd, Cr, Cu, Ni, Zn | < 0.05 mg/L per contaminant and < 0.1 mg/L total | annually |
total chlorine residual | none detectable | monthly |
Heterotrophic plate count | < 500/mL | monthly |
bacteriological quality of reagent water. | ratio of growth rate: 0.8 to 3.0 (see Standard Methods, Section 9020B. This test is not required if laboratories use water that meets the criteria for Types I and II water as defined in Standard Methods Section 1080). | annually |
N.Label all reagents and solutions to indicate identity, concentration, storage requirements, expiration dates and any other pertinent information.
O.Date all reagents and solutions when received and opened. Do not use materials beyond their expiration dates.
P.All laboratory prepared reagents and solutions must be labeled with preparation and expiration dates. No laboratory prepared materials shall be used beyond their expiration dates.
6.15Safety & Security
A.The laboratory must establish and maintain adequate safety and security precautions.
B.Safety instructions must be present in a laboratory safety manual for the protection of personnel from physical, chemical, and biological hazards. The laboratory safety manual must include applicable programs for the protection of employees as outlined in the Code of Federal Regulations (29 C.F.R. Part 1910), including, but not limited to, the Occupational Safety and Health Administration standards for hazard communication, and occupational exposure to hazardous chemicals in laboratories.
C.Laboratory management and personnel must be given a safety orientation and annually review policies and procedures in the safety manual including the proper use of security measures and procedures that have been adopted specific to responding to an emergency, including robbery, violence, or accident.
D.The laboratory must keep samples, standards, reagents, solvents, acids, chemicals, and data in restricted access areas.
E.The laboratory must have visitors, repairmen, and maintenance workers sign in upon entry and supervise them in restricted areas.
F.Implementation of the minimum security requirements stated in the rules and regulations related to the Medical Marijuana Program Administered by the Department of Business Regulation (§§ 230-RICR-80-05-1.4(G)(2) through (7)) shall be deemed by RIDOH to be substantially compliant with the security requirements of these Regulations.
6.16Waste Disposal
A.Cannabis Waste and Destruction of Usable Cannabis Excluding Hemp
1.Cannabis and cannabis product waste (including all liquid, chemical, hazardous, pesticide, manufacturing solvent and chemical waste containing any traces of cannabis) must be stored, secured, and managed in accordance with all applicable state, and local statutes, regulations, ordinances, or other legal requirements.
2.Prior to disposal, cannabis and cannabis product waste must be made unusable and any cannabis plant material made indistinguishable from other plant material. This may be accomplished by grinding and incorporating the cannabis plant waste with other non-consumable solid waste or other ground materials so the resulting mixture is at least fifty percent (50%) non-cannabis waste by volume. Other methods to render cannabis waste unusable must be approved by DBR before implementing. Cannabis waste rendered unusable following an approved method may be delivered to a licensed solid waste disposal facility in Rhode Island for final disposition or disposed of in an alternative manner approved by DBR.
3.Destruction of cannabis and cannabis materials other than waste generated in the regular course of processing and/or manufacturing (such as destruction of whole plants, wet, or usable cannabis that are found to be more than statutory possession limits or destruction of a contaminated batch of cannabis product) must be in a manner acceptable to DBR, which may include consultation with law enforcement.
4.Destruction of cannabis and cannabis materials upon revocation or abandonment of the license must be specifically governed by DBR order or agreement and/or coordinated efforts with law enforcement.
B.The laboratory must manage medical waste per Medical Waste Regulations (250-RICR-140-15-1).
C.The laboratory must manage Hazardous Waste per the Department of Environmental Management Rules and Regulations for Hazardous Waste Management (250-RICR-140-10-1).
D.Wastes, which are not classified as medical waste or hazardous waste or which are not otherwise regulated by law or rule, may be disposed in dumpsters or load packers provided the following precautions are maintained:
1.Dumpsters must be tightly covered, leakproof, inaccessible to rodents and animals, and placed on concrete slabs preferably graded to a drain. Water supply must be available within easy accessibility for washing down of the area. In addition, the pickup schedule must be maintained with more frequent pickups when required. The dumping site of waste materials must be in sanitary landfills approved by the Department of Environmental Management.
2.Load packers must conform to the same restrictions required for dumpsters and must be high enough off the ground to facilitate the cleaning of the underneath areas of the stationary equipment. Also, the loading section must be constructed and maintained to prevent rubbish from blowing away.
6.17Sample Collection – General Requirements
A.Sample collection procedures must be applicable to any cannabis product that registered compassion centers or licensed cultivators may dispense, including, but not limited to, finished plant material; liquid concentrates, resins, edibles, waxes, creams, or other semi-solid or solid CIP products. The analytical laboratory sample collection must be conducted in a manner that provides representative samples so that laboratory testing of all cannabis products is accurate and product labelling requirements can be met. The analytical laboratory sample collector must document every sampling event and provide this documentation to RIDOH upon request.
B.Analytical laboratories may be directed to perform emergency sampling and testing of cannabis products by RIDOH or DBR. Additional costs must be charged to establishment where the cannabis was collected.
C.Cannabis cultivation and production facilities must provide floor plans to the analytical laboratory prior to sample collection that identifies the location and storage of all finished products in the production facility prior to distribution or dispensing.
D.The analytical laboratory sample collector must record the state cannabis tracking identification from the label on each batch of cannabis product collected. The information that accompanies samples must be sufficiently detailed and clearly printed to allow the sample collector to accurately and document the sample identification and tracking number on the chain of custody.
E.The analytical laboratory sample collector must collect representative samples of finished plant material products, liquid concentrates, and resins from each cannabis production batch for analysis. Each sample collected must be representative of the cannabis in its production batch. A minimum range of 0.3 – 0.5% of a batch of plant material is required.
F.Samples from each production batch must be collected in a ready-to-use condition, either for dispensing to patients, or for use as an intermediate or ingredient in making other products. Nothing in this paragraph should be interpreted to supersede any other provision or order requiring and/or authorizing testing at an earlier production stage. Samples of concentrates or oils must be collected following each production batch if they are to be sold, and before any further processing into CIPs.
G.After samples are collected, the establishment where the cannabis was collected must store the entire production batch in a quarantined, secure, cool, and dry location until analytical results are returned by the laboratory. The products must not be released for packaging or sale until the Cannabis Tracking System provides notice of clearance to do so.
H.Sampling frequency is dictated by the production schedules, which may vary among registered compassion centers and licensed cultivators due to scale, product types dispensed, and patient demand. The registered compassion centers and licensed cultivators are responsible for implementing a production batch tracking approach that meets the requirements of these regulations.
I.Analytical laboratory sample collectors must be able to determine that finished products they collect from compassion centers and licensed cultivators are representative of the production process and the finished product’s tracking information matches its label.
J.The amount of sample to be collected for cannabinoid or contaminant testing may vary by analytical method and laboratory-specific procedures, therefore the licensed analytical laboratory will specify the minimum sample size required for evaluation. In all cases, the amount of sample collected by the laboratory must be within the range of 0.3 – 0.5% of the batch, large enough and sufficiently homogenized to provide a representative sample of the production batch but not in excess to raise issues with possible diversion or waste disposal.
K.The analytical laboratory must follow its approved sampling plan for collecting finished cannabis products. The sampling plan’s procedures required for collecting samples of finished cannabis production batches must result in an accurate sample of the production batch. Production batches will vary in physical form (e.g., plant material, liquid extracts, concentrates and resins), density, and viscosity. Procedures for representative sampling of finished cannabis production batches must be based on those used for food products and herbal medicines in the manner described "General Guidelines on Sampling" CAC/GL50-2004 incorporated above at § 6.3(A) of this Part, and "Guidance on Obtaining Defensible Samples" incorporated at § 6.3(B) of this Part, and account for differences in the physical forms of the production batches as they relate to homogeneity and quantity.
6.18Sample Collection Procedures
A.The analytical laboratory sample collector must create a new entry for each sampling event in a sample collection logbook or prepare sample collection forms for documentation of sample collection. Sample collection documentation must identify the sample collection date and start time, participating personnel, a general description of the product type and batch number sampled, a description of the sampling procedures used, and a record of batches that would potentially be impacted should analysis results indicate unacceptable contamination levels.
B.Samples of Industrial Hemp flower must be collected according to procedures of the USDA’s Establishment of a Domestic Hemp Production Program 7 C.F.R. Part 990 Subpart B - State and Tribal Hemp Production Plans, incorporated in § 6.3(C) of this Part.
C.The analytical laboratory sample collector must identify or determine the tracking number of each finished production batch sampled and the number and amount of samples to be collected for each.
D.The analytical laboratory sample collector must record the number of samples taken from each cultivation and/or production batch must be recorded in the sample collection logbook or forms.
E.The analytical laboratory sample collector must record the sample cultivation and production batch identifiers (ID) for each sample. The batch IDs will be included on sample labels. In addition to the batch ID, the analytical laboratory sample collector must create a unique sample ID for each sample. Sample identifiers must be unique for a given sample event. Record the batch and sample IDs in the sample collection logbook.
F.The analytical laboratory sample collector must prepare sample labels and affix them to sample containers immediately before sampling. The sample label must include the analytical laboratory's license number, state tracking number of the sample batch, producer's sample identification, date/time of collection and by whom. The analytical laboratory license number, sample collector’s name, product type, collection method, and other details about the product, such as cannabis infused product type or production method must be recorded in the Chain-of Custody (COC) if not included on the sample label.
G.The analytical laboratory sample collector must wear disposable gloves, and not wear perfumes or creams to mitigate potential for contamination of samples.
H.Any tools that contact the samples must be made of stainless steel or other inert material to avoid potential contamination of the sample. Appropriate sample collection containers must be made of suitable materials.
I.The analytical laboratory sample collector must ensure that the sampling area is clean and decontaminated and lay out any tools and equipment needed.
J.The analytical laboratory sample collector must collect the samples from each cultivation or production batch one at a time following the approved sampling plan as described in §§ 6.11(D) and 6.17(K) of this Part.
K.The analytical laboratory sample collector must collect the sample using an appropriate tool. Do not touch the sample with your hands or allow the sample to touch anything that might cause cross contamination.
L.The analytical laboratory sample collector must record the time each sample was collected and record any difficulties, inconsistencies with the sampling plan, or other remarks (e.g., environmental conditions) that might be relevant to data analysis or quality assurance.
M.The analytical laboratory sample collector must clean any tools or equipment that come in contact with the finished plant material or other cannabis products before collecting the next sample to avoid cross contamination of samples.
N.The analytical laboratory sample collector must place all samples in clean, sealed sample collection containers that are large enough to hold the prescribed sample quantity with minimal headspace to preserve the chemical and biological composition. Sample containers must be firmly closed and appropriately labeled.
O.The analytical laboratory sample collector must maintain all samples on ice prior to and during transport to the analytical laboratory in a clean locked carrier.
P.The analytical laboratory sample collector must ensure that cannabis samples are secured and safe during transport. Transport vehicles must have a locked storage compartment within which the cannabis sample is secured. The sample collector must not stop for gasoline in-route between where the samples are collected and the analytical laboratory where the samples will be analyzed.
Q.The analytical laboratory sample collectors must have their testing agent registration cards for the licensed cultivator/compassion center in their possession while collecting and transporting samples.
R.The analytical laboratory sample collector must collect duplicate samples to provide verification of sampling and laboratory procedures. Specifically, a duplicate must be at least collected for five percent (5%) (one (1) per twenty (20)) of the samples collected for each cannabis product type. Duplicate samples are used to evaluate any variance in the sampling procedures. To ensure authenticity, QC samples must be taken on the same day, be derived from the same batch, and documented on the test results tracking sheet.
S.The analytical laboratory sample collector must complete the COC paperwork immediately prior to transporting the sample to the analytical laboratory. The sampler must record all sampling related information on the COC including:
1.Name and license number of the licensed analytical laboratory;
2.Date and time that each sample is collected;
3.Identity of the sampler;
4.Compassion center registration number or licensed cultivator license number, as applicable;
5.Address and contact number of the cannabis production facility where sampling occurs;
6.State tracking number of each sample collected;
7.Identification of each sample collected;
8.Identification of each product batch;
9.Description of each sample collected;
10.Location of each sampled finished product;
11.Matrix of each sample collected;
12.Approximate weight or quantity of each sample collected;
13.Specific tests requested;
14.Printed name and signature of production facility representative who relinquished the samples; and,
15.Printed name and signature of the sample collector.
16.DBR approved transport vehicle registration number.
17.Transport vehicle odometer reading when leaving lab and upon return.
6.19Sample Accessioning
A.Analytical laboratories receiving samples from the sample collector must complete the COC forms to record accessioning and internal tracking of samples including the following information:
1.The laboratory internal tracking number or other identification;
2.Printed name and signature of the person receiving the samples;
3.Date and time of sample receipt;
4.Condition of sample upon receipt;
5.Type of tests requested;
6.The name, address, and license number of analytical laboratory to which sample(s) are forwarded for procedures not performed on the premises each of which must be numbered or otherwise appropriately identified;
7.Sample tracking through each stage of storage, analysis, and disposal;
8.Date laboratory tests are performed;
9.The analytical laboratory test results;
10.Date of reporting; and,
11.Sample test reports.
B.The records of samples must contain the completed COC forms and original completed sample collection forms.
6.20Sample Preparation
A.Analytical laboratories must have a designated area of the facility dedicated to preparing cannabis product samples for analysis. Sample preparation areas must be equipped with the supplies and equipment to properly handle samples during preparation including:
1.Disposable gloves;
2.Decontaminated tool(s) such as disposable pipettes and plastic or stainless steel spatulas, knives, and sampling spears;
3.Decontaminated stainless steel bowls and implements to homogenize the product by stirring, chopping, or grinding;
4.Clean, decontaminated surfaces for sample processing;
5.Decontaminated sample containers appropriate for the analyses required;
6.Container labels and pens with indelible ink; and,
7.Supplies to thoroughly clean, decontaminate, and dry sample preparation equipment between samples.
B.Follow these steps to prepare each sample type:
1.Wear disposable gloves to avoid contaminating samples. Do not wear creams or perfumes.
2.Ensure that the sample preparation area is clean and decontaminated and lay out any tools and equipment needed.
3.Place the sample in the stainless-steel bowl or on a decontaminated cutting surface for homogenizing the sample using either the sample collection tool or separate clean, decontaminated implement.
4.Prepare the sample for analysis using an appropriate decontaminated tool. Do not touch the sample with your bare hands or allow the sample to touch anything that might cause cross contamination.
5.Clean any tools or equipment that come in contact with the finished plant material or other cannabis products before preparing the next sample.
6.Place all samples in clean, air tight sample containers that are large enough to hold the prescribed sample quantity with minimal headspace. Close and label sample containers.
7.Preserve the chemical and biological composition of the samples, by refrigerating samples at < six degrees Celsius (6º C).
8.Ensure samples of finished cannabis plant and edible products are homogenous with respect to distribution of cannabinoids or contaminants.
9.Thoroughly stir or mix before quantitatively measuring a portion for analysis. Grind and thoroughly mix solid and semi-solid products. Use a grinding device that minimizes loss (e.g., leaching of resins) and, thoroughly clean the grinding device after each use.
10.For finished cannabis products that are distributed in a ground form, quarter the product batch sample. Quartering involves heaping the ground product, dividing the heap into four (4) equal quarters, and selecting samples from two (2) of the quarters, which are then combined and mixed. The remaining quarters may then be combined and mixed, and used for microbiological and contaminant testing.
11.Do not melt resin and other solids as a means of homogenization. Heating the product may alter the cannabinoid profile or contamination levels thereby rendering the sample unrepresentative of the source product.
12.Homogenize laboratory samples of edibles prior to testing such that the sample is representative of the finished product batch. Mix or quarter homogenized samples in a manner like the procedure described in § 6.20(B)(10) of this Part. If individually packaged edibles are sampled from a production batch, combine multiple packaged products and prepare such that the distribution of cannabinoids or contaminants is representative of the production batch.
13.When subsamples are required, composite (combine) subsamples, if possible, and mix to obtain a quantity sufficient for evaluation. The quantity sufficient for evaluation may vary by analytical method and laboratory-specific procedures, therefore the analytical laboratory must define the minimum sample quantity required for evaluation.
14.Compositing subsamples may be impractical for some product types (e.g., hard “candies” or other products in discrete solid units). In these cases, individual product units must be collected by the analytical laboratory as samples for analysis. In some cases, the analytical laboratory may combine extracts or digestates prepared from the solid subsamples and analyze the volumetrically combined extract/digestate as a composite.
6.21Sample Analysis
A.General Requirements
1.All cannabis product samples described in these regulations must be analyzed by analytical laboratories licensed by the RIDOH.
2.Use only chemical standards manufactured by a provider acceptable to the Director to prepare calibration and quality control standards. Analytical laboratories must maintain standard preparation records and the certificates of analysis for all chemical standards, reference materials and reagents for at least five (5) years.
3.Licensed analytical laboratories must demonstrate the ability to perform the quantitative analytical methods approved by RIDOH, and to provide defensible documentation and quality assurance.
B.Approved Methods
1.Methods approved by RIDOH for the analysis of cannabinoids and contaminants in cannabis products are listed in Table 1. Equivalent test procedures may be followed if the laboratory has demonstrated the analysis is an acceptable alternative to normally used reference methods to the satisfaction of RIDOH.
2.Table 1: List of Approved Methods for the Analysis of Cannabinoids and Contaminants.
Analytical Component (where applicable, notes are listed in parenthesis, and described below in § 6.21(B)(3) of this Part) | Methodology (where applicable, notes are listed in parenthesis and described below in § 6.21(B)(3) of this Part) |
| Agency or Organization (see Definitions § 6.4 of this Part) Procedures (listed in parenthesis and described below in § 6.21(B)(3) of this Part) | ||||
FDA | AOAC | AHP | USP | USDA | WHO | ||
Cannabinoids |
|
|
|
|
|
|
|
?9-THC, ?8-THC THCa, CBD, CBDa (a) | LC-DAD (b) |
|
| (b) |
|
|
|
| LC – MS, LC-MS/MS (b) |
|
| (b) |
|
|
|
Metals |
|
|
|
|
|
|
|
Arsenic--Total mg/L | Digestion followed by ICP/MS (c) | (f) | (g), (h) |
| (j) |
|
|
| Digestion followed by ICP/AES or OES |
|
|
|
|
|
|
Cadmium--Total mg/L | Digestion followed by ICP/MS (c) | (f) | (g), (h) |
| (j) |
|
|
| Digestion followed by ICP/AES or OES |
| (i) |
|
|
|
|
Lead--Total, mg/L | Digestion followed by ICP/MS (c) | (f) | (g), (h) |
| (j) |
|
|
| Digestion followed by ICP/AES or OES |
| (i) |
|
|
|
|
Mercury – Total, mg/L | Digestion followed by ICP/MS (c) | (f) | (g), (h) |
| (j) |
|
|
| Cold Vapor AA (c) | (e) |
|
|
|
|
|
Pesticides and Plant Growth Regulators |
| ||||||
Pesticides and Plant Growth Regulators - mg/L | QuEChERS, GC-MS/MS | (k) | (l), (m) |
|
| (o) |
|
| QuEChERSLC-MS/MS | (k) | (l), (m) |
|
| (o) |
|
Water Activity |
|
|
|
|
|
|
|
Water Activity | Humidity Meter, Hygrodynamic Hygrometer |
| (q) |
|
|
|
|
Microbiological |
|
|
|
|
|
|
|
Total Viable Aerobic Bacteria | Culture and enumeration | (r) |
|
| (w), (x), (y) |
| (z) |
Total Yeast and Mold | Culture and enumeration | (s) |
|
| (w), (x), (y) |
| (z) |
Total Coliforms | Culture and enumeration | (t) |
|
|
|
|
|
Bile-tolerant Gram-negative Bacteria | Culture and enumeration |
|
|
| (w), (x) |
| (z) |
E. coli (pathogenic) | Culture | (u) |
|
|
|
| (z) |
Salmonella | Culture | (v) |
|
|
|
| (z) |
Residual Solvents |
|
|
|
|
|
|
|
Residual Solvents | Headspace GC/MS |
|
|
| (aa) |
|
|
a.Table 1 Key:
(1)GC = Gas chromatography
(2)MS = Mass spectrometry
(3)LC = Liquid chromatography.
3.Procedures and Notes for Table 1:
a.Quantitative analysis including the percentage of ?9-tetrahydrocannnabinol (?9-THC), ?8- tetrahydrocannnabinol (?8-THC), cannabidiol (CBD), tetrahydrocannabinolic acid (THCa) and cannabidiolic acid (CBDa) of the total amount of THC.
b.AHP. 2014. Cannabinoids by LC-Diode Array Detector, or modified to use LC-Mass Spectrometer instead of LC-DAD.
c.A digestion procedure is required to solubilize analytes in suspended material and to break down organic-metal complexes for determination of total metals (which are equivalent to total recoverable metals).
d.FDA Elemental Analysis Manual for Food and Related Products Section 4.5 “Cold Vapor Atomic Absorption Spectrometric Determination of Total Mercury in Seafood Using Microwave Assisted Digestion.”
e.FDA Elemental Analysis Manual for Food and Related Products Section 4.7 "Inductively Coupled Plasma-Mass Spectrometric Determination of Arsenic, Cadmium, Chromium, Lead, Mercury, and other Elements in Food Using Microwave Assisted Digestion.”
f.AOAC Official Method 2013.06 3- Arsenic, Cadmium, Mercury, and Lead in Foods – Pressure Digestion and Inductively Coupled Plasma-Mass Spectrometry (First Action 2013).
g.AOAC Official Method 2015.01 4 – Heavy Metals in Food – Inductively Coupled Plasma-Mass Spectrometry (First Action 2015)
h.Second Supplement to USP 35-NF 30 (Chapter 233) Elemental Impurities Procedures
i.FDA KAN-LAB-PES.053. Analysis of Pesticides and Industrial Chemicals by the QuEChERS Procedure
j.AOAC Official Method 2007.01. Pesticide residues in foods by acetonitrile extraction and partitioning with Magnesium Sulfate.
k.AOAC Official Method 2014.09. Determination and Confirmation of Residues of 653 Multiclass Pesticides and Chemical Pollutants in Tea
l.AOAC Official Method 998.01-2003 Synthetic pyrethroids in agricultural products.
m.USDA NOP 2611. Instructions for Laboratory Selection Criteria for Pesticide Residue Testing
n.EPA Index of Residue Analytical Methods (RAM)
o.Official Methods of Analysis of the AOAC. 978.18. Water Activity: 16th Edition,1995
p.FDA. 2001. Biological Analytical Manual. Chapter 3 Total Viable Aerobic Bacteria.
q.FDA. 2015. Biological Analytical Manual. Chapter 18 Total Yeast and Mold.
r.FDA. 2013. Biological Analytical Manual, Chapter 4 Enumeration of E. coli and Coliform.
s.FDA. 2016. Biological Analytical Manual, Chapter 4A Diarrheagenic Escherichia coli.
t.FDA. 2016. Biological Analytical Manual, Chapter 5 Salmonella.
u.USP. 2008. “Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests.” USP 31, Chapter 61.
v.USP. 2008. “Microbiological Examination of Nonsterile Products: Tests for specified Microorganisms.” USP 31, Chapter 62.
w.USP. Undated-b. “Articles of Botanical Origin.” USP 36, Chapter 561.
x.WHO 2007 guidelines for assessing quality of herbal medicines regarding contaminants and residues. Annex 5
y.USP. Chemical Tests. Chapter 467 Residual Solvents
C.Cannabinoid Profile Analysis- Additional Information/Requirements
1.All finished cannabis plant components, extracts and concentrates must be quantitatively analyzed following methods described in § 6.21(B)(1) of this Part, to determine the total THC and its cannabinoid profile in the product. Although many cannabinoids and related compounds are present in the cannabis plant, characterization of the cannabinoid profile of the total THC in the cannabis product must include, at a minimum, the percentage of ?9-tetrahydrocannnabinol (?9-THC), ?8-tetrahydrocannnabinol (?8-THC), cannabidiol (CBD), tetrahydrocannabinolic acid (THCa) and cannabidiolic acid (CBDa). Percentage amounts of other cannabinoids may be reported, but are not required.
D.Metals Analysis- Additional Information/Requirements
1.Finished cannabis plant products must be tested for metals including arsenic, cadmium, lead, and mercury following methods described in § 6.21(B)(1) of this Part. Quantitative analyses of arsenic, cadmium, and lead, must be performed using, inductively coupled plasma – mass spectrometry (ICP-MS), optical emission spectrometry (ICP-OES or ICP-AES). The analysis of mercury must be performed using cold vapor atomic absorption analysis (CVAA) or by ICP-MS.
2.The analytical limit for finished cannabis products including finished plant materials, resins, and concentrates is specified in § 6.21(D)(2)(a) of this Part (Table 2).
a.Table 2: Analysis Requirements for Metals in Finished Cannabis Products for All Uses. Analytical results which exceed these upper limits must be reported with a qualifier indicating the contaminant measured in the cannabis product is above the concentration allowable for the intended use.
Metal | All uses * Upper Limit (µg/kg) |
|
Arsenic (inorganic) | 200 |
|
Cadmium | 200 |
|
Lead | 500 |
|
Mercury | 100 |
|
* These limits apply to finished plant material, cannabis resin, cannabis concentrates intended for ingestion, inhalation or dermal application. These limits are based on inhalation limits described in USP<232> Elemental Impurities — Limits. | ||
E.Pesticides Residues Analysis- Additional Information/Requirements
1.Analytical laboratories must quantitatively analyze production batches of finished plant material and extracts, resins, and concentrates for residues of prohibited pesticides following methods described in § 6.21(B)(1) of this Part. At a minimum, samples of finished plant material must be tested for the pesticides, including plant growth regulators listed in § 6.21(E)(1)(a) of this Part (Table 3), which includes the appropriate analytical methods for each of the listed pesticides. These pesticides were identified by AHP (2014) as commonly used in cannabis cultivation.
a.Table 3: Maximum Allowable Limits for Residues of Pesticides and Plant Growth Regulators in Cannabis.
Pesticide | CAS # | Action Limits (µg/g) |
|
Abamectin | 71751-41-2 | 0.05 |
|
Acephate | 30560-19-1 | 0.1 | |
Acequinocy | 57960-19-7 | 0.1 | |
Acetamiprid | 135410-20-7 | 0.1 | |
Aldicarb | 116-06-3 | 0.1 | |
Azoxystrobin | 131860-33-8 | 0.1 | |
Acephate | 30560-19-1 | 0.1 | |
Acequinocyl | 57960-19-7 | 0.1 |
|
Acetamiprid | 135410-20-7 | 0.1 | |
Aldicarb | 116-06-3 | 0.1 | |
Azoxystrobin | 131860-33-8 | 0.1 | |
Bifenazate | 149877-41-8 | 0.1 |
|
Bifenthrin | 82657-04-3 | 0.2 |
|
Boscalid | 188425-85-6 | 0.1 | |
Carbaryl | 63-25-2 | 0.2 | |
Carbofuran | 1563-66-2 | 0.1 | |
Chlorantraniliprole | 500008-45-7 | 0.2 | |
Chlormequat chloride | 999-81-5 | 0.1 |
|
Chlorfenpyr | 122453-73-0 | 0.1 | |
Chlorpyrifos | 2921-88-2 | 0.1 | |
Clofentezine | 74115-24-5 | 0.1 | |
Cyfluthrin | 6859-37-5 | 1 |
|
Cypermethrin | 52315-07-8 | 1 | |
Daminozide | 1596-84-5 | 0.05 |
|
Dimethomorph | 110488-70-5 | 2 | |
DDVP (Dichlorvos) | 62-73-7 | 0.05 | |
Diazinon | 333-41-5 | 0.1 | |
Dimethoate | 60-51-5 | 0.1 | |
Ethoprophos | 13194-48-4 | 0.05 | |
Etofenprox | 80844-07-1 | 0.1 | |
Etoxazole | 153233-91-1 | 0.1 |
|
Fenoxycarb | 72490-01-8 | 0.05 |
|
Fenpyroximate | 134098-61-6 | 0.1 | |
Fenhexamid | 126833-17-8 | 0.1 | |
Fipronil | 120068-37-3 | 0.05 | |
Flonicamid | 158062-67-0 | 0.1 | |
Fludioxonil | 131341-86-1 | 0.1 | |
Hexythiazox | 78587-05-0 | 0.1 | |
Imazalil | 35554-44-0 | 0.05 |
|
Imidacloprid | 138261-41-3 | 0.1 |
|
Kresoxim-methyl | 143390-89-0 | 0.1 | |
Malathion | 121-75-5 | 0.2 | |
Metalaxyl | 57837-19-1 | 0.2 | |
Methiocarb | 2032-65-7 | 0.1 | |
Methomyl | 16752-77-5 | 0.4 | |
Methyl parathion | 298-00-0 | 0.1 | |
MGK-264 | 113-48-4 | 0.2 | |
Myclobutanil | 88671-89-0 | 0.1 |
|
Naled | 300-76-5 | 0.1 | |
Oxamyl | 23135-22-0 | 0.5 | |
Paclobutrazol | 76738-62-0 | 0.1 |
|
PCNB | 82-68-8 | 0.1 | |
Permethrin | 52645-53-1 | 0.1 | |
Pendimethalin | 40487-42-1 | 0.1 | |
Phosmet | 732-11-6 | 0.1 | |
Piperonyl Butoxide | 51-03-6 | 0.5 | |
Prallethrin | 23031-36-9 | 0.2 | |
Propiconazole | 60207-90-1 | 0.4 | |
Propoxur | 114-26-1 | 0.2 | |
Pyrethrins | 8003-34-7 | 0.5 | |
Pyridaben | 96489-71-3 | 0.1 | |
Spinetoram | 187166-40-1 | 0.1 | |
Spinosad | 168316-95-8 | 0.1 |
|
Spiromesifen | 283594-90-1 | 0.1 |
|
Spirotetramat | 20313-25-1 | 0.1 |
|
Spiroxamine | 118134-30-8 | 0.1 | |
Tebuconazole | 107534-96-3 | 0.1 | |
Trifloxystrobin | 141517-21-7 | 0.1 |
|
F.Water Activity Analysis- Additional Information/Requirements
Finished cannabis plant material must be tested for water activity following methods described in § 6.21(B)(1) of this Part. See the definition of water activity in § 6.4 of this Part. The water activity upper limit for unbound water is equal to or less than 0.6 aW.
G.Microbiological Contaminants Analysis- Additional Information/Requirements
1.Finished cannabis plant products must be tested for microbiological contaminants following methods described in § 6.21(B)(1) of this Part. Methods used must be consistent with the following United States Pharmacopeia (USP) chapters:
a.USP Chapter <61>: Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. USP 36, Chapter 6, and
b.USP Chapter <62>: Microbiological Examination of Nonsterile Products: Tests for specified Microorganisms. USP 36, Chapter 62
2.Limits for microbiological contaminants are listed in § 6.21(G)(2)(a) of this Part (Table 4).
a.Table 4: Upper Limits for Microbiological Contaminants.
Cannabis Material | Total Viable Aerobic Bacteria (CFU)/g) | Total Yeast and Mold (CFU/g) | Total Coliforms (CFU/g) | Bile-tolerant Gram Negative Bacteria (CFU/g) | E. Coli (pathogenic strains) and Salmonella spp. |
Finished Plant Material | 100,000 | 10,000 | 1,000 | 1,000 | Not detected in 1 g of sample |
3.Notes for Table 4:
a.Analytical limits are based on American Herbal Pharmacopoeia (AHP) (2014).
b.CFU means colony forming unit.
H.Residual Solvents Analysis- Additional Information/Requirements
1.Finished cannabis extracts, resins and concentrates must be tested for residual solvents when solvent has been used in the production process following methods described in § 6.21(B) of this Part.
2.Analytical laboratories are required to test for the residual solvents listed in § 6.21(H)(3) of this Part (Table 5) unless it can document that no solvents were used in the cannabis oil production process.
3.Table 5: Analysis Requirements for Residual Solvents
4.The upper limits for residual solvents in Table 5 are given as milligrams of 17residual solvent per kilogram of cannabis oil. The upper limits in Table 5 are based on residual solvent standards provided by the USP Chapter <467>, the International Conference on Harmonization (ICH, 2011), and AHP (2014).
a.Class 1 solvents may not be used in the production of any cannabis product.
5.Analyses to determine residual solvent concentrations in cannabis products must be performed in accordance with the methods identified in USP Chapter <467>.
6.22Quality Control
A.Prepare and analyze samples in batches of up to twenty (20) samples that include a laboratory reagent blank, a laboratory fortified blank, a sample duplicate, and a laboratory fortified sample for chemical tests.
B.Initial Calibration
The analytical sequence must include initial and continuing instrument calibrations performed per the approved method requirements. If the approved method does not specify calibration requirements, then analytical laboratories must at a minimum perform a three-point initial calibration spanning a concentration range from below to above the maximum allowable contaminant concentration. Analytical laboratories are required to achieve a linear response for all cannabinoids, metals, pesticides and solvent analyses. The initial calibration for each analyte must have a relative standard deviation of fifteen percent (15%) or a correlation factor of 0.995.
C.Continuing Calibration
If approved analytical methods do not specify calibration requirements, the analytical sequence must include a continuing calibration standard and continuing calibration instrument blank before and after every ten samples (including quality control samples). The percent difference of the continuing calibration response for all analytes must be equal to or less than fifteen percent (15%) compared to the expected continuing calibration standard response. Analytical laboratories must document the calibration performance and quality control results for all analyses.
6.23Test Reporting
A.Analytical laboratories must report all testing results including all information necessary to determine product compliance to the Department of Business Regulation Cannabis Tracking System and the cannabis producer including registered compassion centers and licensed cultivators.
B.Include the following in the laboratory data package: case narrative, chains-of-custody, and summary of analytical results.
1.A case narrative written on laboratory letterhead, must describe any sample receipt, preparation, or analytical issues encountered as well as any method non-conformances or exceedance of QA/QC criteria used by the laboratory. The narrative must identify the preparation and analytical methods utilized by the laboratory. The narrative must include a signed statement by an authorized laboratory representative as to the accuracy, completeness, and compliance with the methods of the results presented.
2.Chains-of-custody (COC) information or other paperwork indicating requested analyses and documentation of sample collection and receipt must be reported with the laboratory’s results.
3.Laboratory reports must clearly identify the name, address, and license number of the laboratory (which may be a subcontracted laboratory) that performed the test(s), and must include the results and the date of the reporting.
4.Multipage reports must be paginated.
5.Summary of analytical results including sample identifier, methods performed, target compounds, sample result or reporting limit, proper qualifier according to laboratory standard procedures, units of measure, preparation date(s), where applicable, and analysis date(s).
6.Analytical results, which exceed the upper limit described in §§ 6.21(D)(2), 6.21(E)(3), 6.21(F)(1), 6.21(G)(2), and 6.21(H)(3) of this Part must be reported with a qualifier indicating the contaminant measured in the cannabis product is above the allowable concentration.
7.The laboratory data package must include sufficient data to evaluate the laboratory results, including a summary of laboratory QA/QC results.
8.Cannabis products, which are determined to be out of compliance may be resampled for follow-up testing. A production batch may be retested once and records of the original analysis must be retained.
6.24Variance Procedure
A.RIDOH may grant a variance either upon its own motion or upon request of the applicant from the provisions of any rule or regulation in specific instances where it is found that literal enforcement of such provisions will result in unnecessary hardship to the applicant and such variance will not be contrary to state regulations, the public interest, public health, or health and safety of individuals.
B.A request for variance must be made in writing, setting forth in detail the basis of the request.
C.RIDOH shall act within ninety (90) days of receipt of the completed request for variance. RIDOH must notify the applicant by certified mail of its approval, or in case of a denial, a hearing date, time, and place may be scheduled if the applicant appeals the decision.
6.25Violations
In addition to revocation or suspension of certificates granted under these Regulations, any person who violates the statutory or regulatory provisions herein will be subject to the sanctions of R.I. Gen. Laws § 23-16.2-13.
6.26Rules Governing Practices & Procedures
A.All hearings and reviews required under the provision of these Regulations shall be held in accordance with the rules and regulations for Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
B.Enforcement hearings shall be handled in accordance with R.I. Gen Laws § 23-1-22.
| Title | 216 | Department of Health |
| Chapter | 60 | Laboratories and Medical Examiner |
| Subchapter | 05 | State Laboratory |
| Part | 6 | Licensing Analytical Laboratories for Sampling and Testing Cannabis |
| Type of Filing | Amendment |
| Regulation Status | Active |
| Effective | 12/07/2023 |
Regulation Authority:
R.I. Gen. Laws §§ 21-28.6- 12(f)(10) and 21-28.6-16(f)
Purpose and Reason:
The Rhode Island Department of Health (RIDOH) is proposing to revise Licensing for Sampling and Testing Medical Cannabis including Marijuana and Industrial Hemp [216-RICR-60-05-6] to add several references, definitions, and sections regarding the testing of cannabis among other amendments.
The regulatory changes proposed in this filing are identical to the regulatory language currently in effect as of 09/11/2023. The effective version was originally noticed for public comment on 06/26/2023. During that public comment period, a technical error within the RICR system may have prevented comments submitted through RICR’s attachment field from being received by the agency. Any comments submitted directly through RICR’s text box option (with no attachments) or submitted directly to the agency were processed successfully. As a result of the technical error, the agency is repromulgating the regulatory changes (effective as of 09/11/2023) to ensure that the public has full access to submit public comments as originally intended. The regulatory language included in this notice redlines changes made in the most recent promulgation. The agency is noticing these changes for additional public comment.
Rulemaking Documents are organized by document type and are part of this rule’s rulemaking record (R.I. Gen. Laws § 42-35-2.3). If multiple documents of the same type are listed below, each is a unique document. If there are multiple Public Notice of Proposed Rulemaking documents, view each document to identify the most recently amended version, as it may be amended at any point during the Public Comment Period.