Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 37 - HEMP PROCESSING AND HEMP PRODUCTS › Subchapter 1 - GENERAL PROVISIONS › Section 11-37-2 - Definitions

Current through June, 2024
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.