Rhode Island Code of Regulations
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
Section 216-RICR-60-05-6.4 - Definitions

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 [DELTA]9-tetrahydrocannnabinol ([DELTA]9-THC), delta 8 tetrahydrocannabinol ([DELTA]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:

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.