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

Current through June 14, 2024
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 [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:
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.