Haw. Code R. § 11-37-2
As used in this chapter:
"Actual yield" means the quantity that is actually produced at any appropriate step of manufacture or packaging of a particular hemp product.
"Adequate" means that which is needed to accomplish the intended purpose in keeping with good public health practice.
"Adulterated" means a hemp product or component:
(1) Contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use indicated in the labeling or advertisement thereof, or under such conditions of use as are customary or usual;
(2) Consists in whole or in part of any filthy, putrid, or decomposed substance;
(3) Has been manufactured, packaged, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
(4) Is in a container composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
(5) Contains any of the contaminants listed in section 11-37-23 at levels higher than the specified limit.
"Allergen cross-contact" means the unintentional incorporation of an allergen into a hemp product.
"Applicant" means the person applying to register as a hemp processor under this chapter.
"Batch" means a specific quantity of a hemp product that is intended to be uniform and that is produced during a specified time period covered by a single batch production record during the same cycle of manufacture.
"Batch number" means any distinctive group of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacturing, packaging, labeling, and/or holding of a batch of hemp products can be determined.
"Blanching" means a pre-packaging heat treatment for an adequate time and at an adequate temperature to partially or completely inactivate naturally occurring enzymes and to effect other physical or biochemical changes.
"Cannabinoids" means any of the various naturally occurring, biologically active, chemical constituents of cannabis that bind to or interact with receptors of the endogenous cannabinoid system.
"Cannabis" means the genus of the flowering plant in the family Cannabaceae. For the purpose of this chapter, cannabis refers to any form of the plant where the delta-9 tetrahydrocannabinol concentration on a dry weight basis has not yet been determined.
"Certificate of registration" means the certificate issued by the department attesting that the applicant is registered to process hemp.
"Component" means any substance intended for use in the manufacture of a hemp product, including those that may not appear in the finished batch of the hemp product.
"Consumer" means a person who is a member of the public, is not functioning in the capacity of an operator of a hemp processing facility, and does not manufacture hemp products or offer hemp products for resale.
"Contact surface" means any surface that contacts a component or hemp product, and those surfaces from which drainage onto the component or hemp product, or onto surfaces that contact the component or hemp product, occurs during the normal course of operations. Examples of contact surfaces include containers, utensils, tables, surfaces of equipment, and packaging.
"Contamination" means microbiological, chemical, radiological, or physical substances that either develop in or are added to hemp products or ingredients and are capable of causing hemp products to be:
(1) Unsafe for consumption or topical use, as intended; or
(2) In violation of a regulatory standard.
"Decarboxylated" means the completion of the chemical reaction that converts delta-9 tetrahydrocannabinol's acids (THCA) into delta-9-tetrahydrocannabinol. The decarboxylated value may be calculated using a conversion formula that sums delta-9-tetrahydrocannabinol and eighty-seven and seven tenths (87.7) per cent of THCA.
"Delta-9 tetrahydrocannabinol" or "THC" means the primary psychoactive component of cannabis.
"Department" means the department of health. "Director" means the director of health.
"Dry weight basis" refers to a method of determining the percentage of a chemical in a substance after removing the moisture from the substance.
"Enclosed indoor facility" means a permanent, stationary structure with a solid floor, rigid exterior walls that encircle the entire structure on all sides, and a roof that protects the entire interior area from the elements of weather. Nothing in this definition shall be construed to relieve the registered applicant from the applicant's duty to comply with all applicable building codes and regulations.
"FDA" means the United States Food and Drug Administration.
"Hemp" means Cannabis sativa L. and any part of that plant, whether growing or not, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, with a delta-9-tetrahydrocannabinol concentration of not more than 0.3 per cent on a dry weight basis, as measured post-decarboxylation or by other similarly reliable methods.
"Hemp processing facility" means a facility where hemp processing occurs.
"Hemp processor" means a person processing hemp to manufacture a hemp product.
"Hemp product" means a product that:
(1) Contains naturally occurring cannabinoids, compounds, concentrates, extracts, isolates, resins or derivatives from processed hemp;
(2) Does not include any living hemp plants, viable seeds, leaf materials, or floral materials;
(3) Has a delta-9-tetrahydrocannabinol concentration of not more than 0.3 per cent, as measured post-decarboxylation, or other similarly reliable methods;
(4) Is intended to be consumed orally to supplement the human or animal diet; and
(5) Is in the form of a tablet, capsule, powder, softgel, gelcap, or liquid form (e.g. hemp oil) to be used by the consumer to infuse edible items at home for personal use or for topical application to the skin or hair.
For purposes of this chapter, a hemp product shall be considered as intended for oral ingestion in liquid form only if it is formulated in a fluid carrier and it is intended for ingestion in daily quantities measured in drops or similar small units of measure per labeled directions for use.
"Ingredient" means any substance that is used in the manufacture of a hemp product and that is intended to be present in the finished batch of the hemp product.
"In-process material" means any material that is fabricated, compounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction, or processed in any other way for use in the manufacture of a hemp product.
"Manufacture" means to compound, blend, extract, infuse, or otherwise make or prepare a hemp product, but does not include planting, growing, harvesting, drying, curing, grading, or trimming a hemp plant or part of a hemp plant.
"Microorganisms" means yeasts, molds, bacteria, viruses, and other similar microscopic organisms having public health or sanitary concern. This definition includes species that:
(1) May have public health significance;
(2) May cause a component or hemp product to decompose;
(3) Indicate that the component or hemp product is contaminated with filth; or
(4) Otherwise may cause the component or hemp product to be adulterated.
"Misbranded" means a hemp product:
(1) Has labeling that is false or misleading in any particular;
(2) Fails to conform with the labeling requirements in subchapter 3; or
(3) Is in a container that is so made, formed, or filled as to be misleading.
"Pathogen" means a microorganism of public health significance.
"Person" means an individual, firm, corporation, partnership, association, or any form of business or legal entity.
"Pest" means any objectionable insect or other animal including birds, rodents, flies, mites, and larvae.
"Processing" means making a transformative change to the hemp plant following harvest by converting an agricultural commodity into a hemp product.
"Product complaint" means any communication that contains any written, electronic, or oral allegation expressing concern with the quality of a hemp product for any reason. Examples of product complaints are: Foul odor, off taste, illness or injury, disintegration time, color variation, tablet size or size variation, under-filled container, foreign material in a hemp product container, improper packaging, mislabeling, or hemp products that are superpotent, subpotent, or contain the wrong ingredient, or contain a drug or other contaminant (e.g., bacteria, pesticide, mycotoxin, glass, lead)
"Qualified individual" means a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe hemp products as appropriate to the individual's assigned duties. A qualified individual may be, but is not required to be, an employee of the hemp processor.
"Quality" means that the hemp product consistently meets established specifications for content, consistency, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration.
"Quality control operation" means a planned and systematic procedure for taking all actions necessary to prevent hemp products from being adulterated.
"Quality control personnel" means any person, persons, or group, within or outside the hemp processor's organization, designated to be responsible for its quality control operations.
"Representative sample" means a sample that consists of an adequate number of units that are drawn based on rational criteria, such as random sampling, and that are intended to ensure that the sample accurately portrays the material being sampled.
"Reprocessing" means using, in the manufacture of a hemp product, clean, uncontaminated components or hemp products that have been previously removed from manufacturing and that have been made suitable for use in the manufacture of a hemp product.
"Reserve sample" means a representative sample of product that is held for a designated period of time.
"Rework" means clean, unadulterated hemp products or ingredients that have been removed from processing or manufacture for reasons other than insanitary conditions or that have been successfully reconditioned and are suitable for use as or in hemp products.
"Safe moisture level" is a level of moisture low enough to prevent the growth of undesirable microorganisms in the hemp product under the intended conditions of manufacturing, processing, packing, and holding. The safe moisture level for a hemp product is related to its water activity (aw). An aw will be considered safe if adequate data are available that demonstrate that the hemp product or component at or below the given aw will not support the growth of undesirable microorganisms.
"Sanitize" means to adequately treat cleaned equipment, containers, utensils, or any other cleaned contact surface by a process that is effective in destroying vegetative cells of pathogens, and in substantially reducing numbers of other microorganisms, but without adversely affecting the product or its safety for the consumer.
"Standard operating procedure" or "SOP" means written instructions on how to perform tasks and descriptions of the approved or required procedures for accomplishing specific quality assurance objectives.
"Synthetic cannabinoid" means a cannabinoid that is:
(1) Produced artificially, whether from chemicals or from recombinant biological agents including but not limited to yeast and algae; and
(2) Not derived from the genus cannabis, including biosynthetic cannabinoids.
"Theoretical yield" means the quantity that would be produced at any appropriate step of manufacture or packaging of a particular hemp product, based upon the quantity of components or packaging to be used, in the absence of any loss or error in actual production.
"Total tetrahydrocannabinol" or "total THC" means the sum of the percentage by weight of:
(1) Delta-9-tetrahydrocannabinolic acid (D9-THCA) multiplied by 0.877; and
(2) Delta-9-tetrahydrocannabinol (D9-THC).
"USDA" means the United States Department of Agriculture.
"Water activity" or "aw" is a measure of the free moisture in a component or hemp product and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.
Haw. Code R. § 11-37-2