Haw. Code R. § 11-37-2 - Definitions
As used in this chapter;
''Actual yield" means the quantity that is actually produced at any appropriate step of processing, manufacture, or packaging of a particular crude extract or manufactured hemp product.
"Adequate" means that which is needed to accomplish the intended purpose in keeping with good public health practice.
"Adulterated" means a crude extract, manufactured hemp product, or component:
"Allergen cross-contact" means the unintentional incorporation of an allergen into a crude extract or manufactured hemp product.
"Applicant" means the person applying for a permit to operate as a hemp processor under chapter 328G, HRS.
"Artificially derived cannabinoid" means a chemical substance that is created by a chemical reaction that changes the molecular structure of any chemical substance derived from the plant genus cannabis (e.g., changing cannabidiol into delta-8-tetrahydrocannabinol). "Artificially derived cannabinoid" does not include:
"Batch" means a specific quantity of crude extract or manufactured 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 processing and manufacture.
"Batch number" means any distinctive group of letters, numbers, or symbols, or any combination of them, from which the complete history of the production, packaging, labeling, and holding of a batch of crude extract or manufactured 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.
"Component" means any substance intended for use in the manufacture of a crude extract or manufactured hemp product, including those that may not appear in the finished batch of the crude extract or manufactured 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 process hemp biomass, produce manufactured hemp products, or offer manufactured hemp products for resale.
"Contact surface" means any surface that contacts a component, crude extract, or manufactured hemp product, and those surfaces from which drainage onto the component, crude extract, or manufactured hemp product, or onto surfaces that contact the component, crude extract, or manufactured 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 crude extract, manufactured hemp products, or ingredients and are capable of causing manufactured hemp products to be:
"Crude extract" means an extract from hemp biomass that:
"Decarboxylated" means the completion of the chemical reaction that converts naturally occurring cannabinoid acid into a cannabinoid, including delta-9 tetrahydrocannabinol's acids (THCA) into delta-9-tetrahydrocannabinol. The decarboxylated value for delta-9-tetrahydrocannabinol 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" means one chemical in the group of cannabinoids that function as the primary psychoactive components of cannabis.
"Department" means the department of health.
"Director" means the director of the state department of health or the director's designee.
"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 permitted applicant from the applicant's duty to comply with all applicable building codes and regulations.
"FDA" means the United States Food and Drug Administration.
"Gummy" or "gummies" means a chewable soft confection made primarily from sugar with gelatin or another gelling agent such as starch or pectin.
"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 biomass" means the leaf and floral parts of hemp plant material.
"Hemp processing facility" means a facility where hemp processing occurs.
"Hemp processor" means a person who processes hemp biomass or prepares a crude extract or a manufactured hemp product.
"Ingredient" means any substance that is used in the production of a crude extract or manufactured hemp product and that is intended to be present in the finished batch of the crude extract or manufactured 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 production of a crude extract or manufactured hemp product.
"Liquid form" means a manufactured hemp product made for oral consumption that is an oil-based tincture.
"Manufactured hemp product" means a product created by processing, as defined in this chapter, that:
"Manufacturing" has the same meaning as processing.
"Microorganisms" means yeasts, molds, bacteria, viruses, and other similar microscopic organisms having public health or sanitary concern. This definition includes species that:
"Misbranded" means a crude extract or manufactured hemp product:
"Pathogen" means a microorganism of public health significance.
"Permit" means the certificate issued by the department attesting that the applicant is permitted to operate as a hemp processor.
"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:
Processing includes packaging, repackaging, labeling, and relabeling.
"Product complaint" means any communication that contains any written, electronic, or oral allegation expressing concern with the quality of a manufactured 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 manufactured hemp product container, improper packaging, mislabeling, or manufactured 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 crude extract or manufactured 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 crude extract or manufactured hemp product consistently meets established specifications for content, consistency, and limits on contaminants, and has been manufactured, processed, 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 crude extract or manufactured 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 processing or manufacture of a crude extract or manufactured hemp product, clean, uncontaminated components, crude extract, or manufactured hemp products that have been previously removed from manufacturing and that have been made suitable for use in the manufacture of a crude extract or manufactured hemp product.
"Reserve sample" means a representative sample of product that is held for a designated period of time.
"Rework" means clean, unadulterated crude extract, manufactured hemp products, or ingredients that have been removed from processing or manufacture for reasons other than insanitary conditions or that have been successfully reconditioned by reprocessing and are suitable for use as or in crude extract or manufactured hemp products.
"Safe moisture level" is a level of moisture low enough to prevent the growth of undesirable microorganisms in the crude extract or manufactured hemp product under the intended conditions of processing, packing, and holding. The safe moisture level for a crude extract or manufactured hemp product is related to its water activity (aw). An aw will be considered safe if adequate data are available that demonstrate that the crude extract, manufactured 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:
"Tetrahydrocannabinol" means the group of cannabinoids that function as the primary psychoactive components of cannabis.
"Theoretical yield" means the quantity that would be produced at any appropriate step of processing, manufacture, or packaging of a particular crude extract or manufactured hemp product, based upon the quantity of components or packaging to be used, in the absence of any loss or error in actual production.
"Time/temperature control for safety product" means a manufactured hemp product that:
"Total tetrahydrocannabinol" or "total THC" means the sum of the percentage by weight of:
"USDA" means the United States Department of Agriculture.
"Water activity" or "aw" is a measure of the free moisture in a component, crude extract, or manufactured 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.
Notes
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