reglab/statecodes huggingface dataset:
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 29 - FOOD AND FOOD PRODUCTS › Section 11-29-4 - Aquatic foods

Current through June, 2024
(a) It shall be unlawful to take, sell,
				deliver for sale, hold for sale, or offer for sale, any aquatic food from
				anybody fresh, brackish, or salt water which the State department of health may
				find and declare to be polluted to the extent that such pollution constitutes a
				condition whereby the aquatic food found therein may have become contaminated
				with filth, or rendered diseased, unwholesome or injurious to health.
(b) It shall be unlawful to bring into the
				State or offer for sale, any form of toxin-bearing aquatic food, including but
				not limited to balloon fishes (also known as puffers, blow fishes, globe
				fishes, and toad fishes), for food purposes except for a generally recognized
				scientific or educational use. The department of health may fan time to time
				designate such aquatic food and the areas and periods of the year for which
				this prohibition shall apply. Such aquatic food may be brought into the State
				by a generally recognized scientific or educational user only upon the prior
				receipt of a permit signed by an authorized agent of the department of health.
				Such permit shall be immediately revoked by the department of health or its
				authorized agent upon the violation by the holder of any of the terms of the
				permit. Every physician or other authorized personnel of any medical facility
				shall report promptly to the department of health all cases or suspected cases
				of illness caused by the ingestion of toxic aquatic food which shall come to
				his attention.
(c) Any article of
				food for use as bait shall be stored separately and away from all other food
				and labeled "For Bait Use Only" in bold letters at least one inch
				high.
(d) It shall be unlawful to
				offer for sale any fish which have been bruised, torn, or otherwise rendered
				liable to spoilage; except as provided for in Section 185-25, HRS, which
				permits the sale of certain species offish taken or killed w spear.
(e) Aquatic foods taken from outside the
				boundaries of the State and labeled by its Hawaiian name shall have the general
				geographical origin of the aquatic food declared immediately and conspicuously
				preceding or following such Hawaiian name, e.g., "Imported Mahimahi" or
				"Mainland Papio."
(f) Shellfish,
				oysters, clams, and mussels shall be regulated by Chapter 35, Title 11,
				Administrative Rule entitled "Shellfish Sanitation."
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 29 - FOOD AND FOOD PRODUCTS › Section 11-29-5 - Crude salt

Current through June, 2024
(a) Crude salt which has not been
				demonstrated as being safe for human consumption shall not be sold for food
				use. This salt, if offered for sale, shall be conspicuously and durably labeled
				as follows: "Crude Salt Not For Food Use." The statement "Not For Food Use"
				shall be in bold letters not less than one-half the size of the name of the
				product, but in no case shall the letters be less than one-eighth of an inch in
				print size. This salt shall be offered for sale separately and away from other
				salts or any foods intended for human consumption.
(b) Hawaiian salt is crude salt obtained by
				the evaporation of sea water from within the boundaries of the State that has
				been demonstrated to be safe and suitable for human consumption.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 29 - FOOD AND FOOD PRODUCTS › Section 11-29-6 - Poi

Current through June, 2024
(a) Poi is the unadulterated product of the
				edible taro root (tubers) made into paste, which shall contain not less
				twenty-eight per cent of total solids.
(b) Ready-mixed poi means poi mixed with
				water and containing not less than fifteen percent of total solids. The label
				of this food shall bear, in print of uniform size and prominence, the words
				"Ready-Mixed Poi."
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 29 - FOOD AND FOOD PRODUCTS › Section 11-29-7 - Definitions and standards for other foods; exceptions

Current through June, 2024
The definitions and standards of identity and quality for
				  foods, food products, and food by-products not specifically identified or
				  standardized by this chapter shall be identical with the following regulations
				  issued by the United States Food and Drug Administration:
21 CFR Part 103 Quality Standards for Foods With No Identity
				  Standards;
21 CFR Part 130 Food Standards: General;
21 CFR Part 133 Cheeses and Related Cheese Products;
21 CFR Part 136 Bakery Products;
21 CFR Part 137 Cereal Flours and Related Products;
21 CFR Part 139 Macaroni and Noodle Products;
21 CFR Part 145 Canned Fruits;
21 CFR Part 146 Canned Fruit Juices;
21 CFR Part 150 Fruit Butters, Jellies, Preserves, and
				  Related Products;
21 CFR Part 152 Fruit Pies;
21 CFR Part 155 Canned Vegetables;
21 CFR Part 156 Vegetable Juices;
21 CFR Part 158 Frozen Vegetables;
21 CFR Part 160 Eggs and Egg Products;
21 CFR Part 161 Fish and Shellfish;
21 CFR Part 163 Cacao Products;
21 CFR Part 164 Tree Nut and Peanut Products;
21 CFR Part 165 Nonalcoholic Beverages;
21 CFR Part 166 Margarine;
21 CFR Part 168 Sweeteners and Table Syrups;
21 CFR Part 169 Food Dressings and Flavorings;
provided, however, the exceptions to the provisions of
				  § 11-29-7 are:
(1)21 CFR Part 139
				relating to the standards of identity for macaroni and noodle products shall
				not apply to oriental type noodle products, which include, but are not limited
				to "Saimin," "Udon," "Wun tun," "Chow Funn," "Japanese noodles," "Ramen
				noodles," "Chinese noodles," etc. Although these oriental type noodles are
				sometimes made without egg solids and the shape and size may resemble the
				products described in 21 CFR Part 139, such a product will not be considered in
				violation of 21 CFR Part 139 if:
(A) Such
				product is not represented as a macaroni or noodle product described in 21 CFR
				Part 139.
(B) When such product is
				labeled as "Noodles," the word "noodles" is immediately preceded or followed by
				a qualifying term such as "Chinese," "Chow Mein," "Japanese," "Japanese Style,"
				"Ramen," "Oriental," or "Oriental Style," in print of the uniform size, style,
				color, and background contrast as the word "noodles." Furthermore, when
				coloring is added, the name of the product is immediately preceded or followed
				by the words "Artificially Colored," "Artificial Coloring Added," or "With
				Artificial Coloring Added," in print of the same style, color, and background
				contrast as the name of the product. The size of the print of such words shall
				be at least one-half the size of the name of the product, provided that in no
				case shall the size of the print be less than one-eighth of an inch
				high.
(C) Such product bears a
				complete listing of ingredients in accordance with 21 CFR Part 101.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 29 - FOOD AND FOOD PRODUCTS › Section 11-29-9 - False or misleading representation of geographical origin

Current through June, 2024
Any representation that expresses or implies that a food
				  product or any Ingredient of a food product has its geographical origin in the
				  State may render such food product misbranded except when such representation
				  is either:
(1) A truthful
				representation of geographical origin;
(2) A trademark or trade name; provided that
				as applied to the food product in question, its use is not deceptively
				misrepresented. A trademark or trade name composed in whole or in-part of
				geographical words shall not be considered deceptively misrepresentative if:
(A) Such product or trade name has been long
				and exclusively used by the manufacturer or distributor and is generally
				understood by the consumer to mean the product of a particular manufacturer or
				distributor; or
(B) Is so arbitrary
				or fanciful that it is not generally understood by the consumer to suggest
				geographic origin; or
(C) Is a part
				of the name required by applicable state or federal law or regulation;
				or
(D) Is a name whose market
				significance is generally understood by the consumer to connote a particular
				class, kind, type, or style of food rather than to indicate geographical
				origin.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 29 - FOOD AND FOOD PRODUCTS › Section 11-29-10 - Penalty; exception

Current through June, 2024
Any person who shall violate any provision of this chapter
				  shall be guilty of a misdemeanor and upon conviction thereof shall be punished
				  by a fine of not more than $500 or by imprisonment for not more than one year
				  or by both such fine and such imprisonment as provided in Section
				  321-18, HRS, as amended.
				  Each and every violation of the provisions of these rules shall constitute a
				  separate offense; except that no person shall be subject to the penalties
				  prescribed by this section if such person:
(1) Establishes a guarantee or undertaking
				with the manufacturer or distributor of a food product stating that the food
				product does not violate any provision of this chapter. Such guarantee or
				undertaking shall be made in good faith and shall be signed by and contain the
				name and address of the person residing in the United States with whom such
				guarantee was made.
(2) Furnishes
				on request of the director the name and address of the person with whom such
				guarantee was made and copies of all documents pertaining to the delivery of
				the product.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 29 - FOOD AND FOOD PRODUCTS › Section 11-29-11 - Severability

Current through June, 2024
Should any section, paragraph, sentence, clause, phrase or
				  application of this chapter be declared unconstitutional invalid for any
				  reason, the remainder or any other application of said chapter shall not be
				  affected thereby.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 29 - FOOD AND FOOD PRODUCTS › Attachment A

Current through June, 2024
The following regulations of the United States are
				  adopted:
40 CFR Part 180 Tolerances and Exemptions from Tolerances for
				  Pesticide Chemicals in or on Raw Agricultural Commodities, Subparts A, C, and
				  D;
40 CFR Part 185 Tolerances for Pesticides in Food.
The following United States Food and Drug Administration
				  Compliance Policy Guides are adopted insofar as they apply to "food" as defined
				  in this chapter:
Compliance Policy Guide 7106.10
Compliance Policy Guide 7107.02
Compliance Policy Guide 7108.07
Compliance Policy Guide 7108.20
Compliance Policy Guide 7108.24
Compliance Policy Guide 7111.03
Compliance Policy Guide 7112.02
Compliance Policy Guide 7117.05
Compliance Policy Guide 7117.06
Compliance Policy Guide 7117.07
Compliance Policy Guide 7120.26
Compliance Policy Guide 7141.01 including Attachments A
				  through B.12
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 33 - HAWAII DRUG FORMULARY OF EQUIVALENT DRUG PRODUCTS DRUG PRODUCT SELECTION BOARD › Section 11-33-2 - Definitions

Current through June, 2024
As used in this chapter:
"A code" means the designation given to drug products
				  considered by the United States Food and Drug Administration to be
				  therapeutically equivalent to other pharmaceutically equivalent
				  products.
"Board" means the drug product selection board established
				  by §
									328-96,
				  Hawaii Revised Statutes.
"Hawaii drug formulary" means a list of all therapeutically
				  equivalent drug products established and maintained by the
				  board.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 33 - HAWAII DRUG FORMULARY OF EQUIVALENT DRUG PRODUCTS DRUG PRODUCT SELECTION BOARD › Section 11-33-3 - Hawaii drug formulary; establishment, revision, and information

Current through June, 2024
(a) The "Hawaii Drug Formulary of Equivalent
				Drug Products" dated May, 1981, appended to this chapter is hereby established
				and made a part of this section. The Hawaii drug formulary shall be reviewed
				annually and may be revised as often as necessary to conform to changes made in
				"A" coded drugs.
(b) All comments
				and requests for specific information regarding drug products listed in the
				Hawaii drug formulary shall be directed to the following:
Chairman, Drug Product Selection Board State of
				  Hawaii
Department of Health
P.O. Box 3378
Honolulu, Hawaii 96801
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 35 - SHELLFISH SANITATION › Section 11-35-1 - Purpose

Current through June, 2024
The purpose of this chapter is to establish sanitary
				  controls for the shellfish industry. These provisions shall apply to the
				  growing area and to all aspects of harvesting, processing, packaging, storing,
				  and distributing of shellfish.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 35 - SHELLFISH SANITATION › Section 11-35-3 - Shellfish permit

Current through June, 2024
The regulations governing the requirements for shellfish
				  certification in their several forms (shucker-packer, shell stock-shipper,
				  reshipper, repacker) in the State of Hawaii shall equal or exceed the
				  requirements set forth by the Food and Drug Administration of the U.S.
				  Department of Health and Human Services, and the National Shellfish Sanitation
				  Program.
(a) No person in the State of
				Hawaii shall operate a plant or business engaged in growing, harvesting,
				shucking, packing, repacking, or reshipping fresh or fresh-frozen shellfish for
				sale to the public for human consumption without a valid permit issued by the
				department.
(b) Applications for
				permit shall be filed with the department. Each application, if necessary,
				shall be accompanied with sufficient written data, drawings and descriptions
				for the department to evaluate the operation relative to the provisions of this
				chapter.
(c) Authority of
				department to revoke or suspend a permit.
(1)
				Each permit issued pursuant to these regulations may be revoked or suspended by
				the department in accordance with Chapter
				91, HRS, if for any reason the safety
				of the shellfish as an article of food is not assured or if the standards set
				forth herein are not met, or if the permit was obtained by misrepresentation,
				or omission of relevant information.
(2) A permit which has been previously
				denied, revoked or suspended, may be issued, reissued or reinstated, if
				violations are subsequently cleared or corrected to the satisfaction of the
				director.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 35 - SHELLFISH SANITATION › Section 11-35-4 - Shellfish and shellfish growing water evaluation

Current through June, 2024
(a) All
				collection and transportation of shellfish growing water samples and shellstock
				shall be performed in accordance with the "Recommended Procedures for the
				Examination of Sea Water and Shellfish" (APHA, 4th ed., 1970).
(b) Analyses of these samples for
				bacteriological, toxicological, chemical and physical parameters shall be
				performed by a laboratory approved by the department and in accordance with
				methods recommended in the "Recommended Procedures for the Examination of
				Seawater and Shellfish" (APHA, Fourth Edition, 1970), "Official Methods of
				Analysis of the Association of Official Analytical Chemists" (AOAC, Thirteenth
				Edition, 1980), and "Standard Methods for Examination of Water and Wastewater"
				(APHA, 14th ed., 1975).
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 35 - SHELLFISH SANITATION › Section 11-35-5 - Enforcement and penalties

Current through June, 2024
(a) The taking of
				any shellfish from public waters is under the jurisdiction of the state
				department of land and natural resources, division offish and game, and is
				subject to that department's regulations, enforcement and penalties.
(b) Any person who violates any provision of
				these regulations shall be guilty of a misdemeanor and upon conviction thereof
				shall be fined not more than $500 or imprisoned not more than one year or both,
				as provided in §§
									321-18, HRS. Each and
				every violation of the provision of these regulations shall constitute a
				separate offense.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 35 - SHELLFISH SANITATION › Section 11-35-6 - Shellfish growing areas

Current through June, 2024
(a) No person shall
				buy sell, offer for sale, receive, keep, transport, deliver, or take any
				shellfish not declared by the department to be approved or otherwise fit for
				direct marketing.
(b) A sanitary
				survey shall be made by the department of each shellfish growing area prior to
				its classification as "approved," "restricted," or "prohibited." A sanitary
				survey shall evaluate all sources of actual and potential pollution in the area
				including but not limited to pesticides, industrial wastes and sewage effluent.
				In addition, the effect of wind action, water flow and currents in distributing
				polluting materials over a growing area shall be considered.
(c) Growing areas shall be designated as
				approved after the sanitary survey conducted by the department indicates that
				pathogenic microorganisms, paralytic shellfish poisons, heavy metals and
				pesticides are not present in dangerous concentrations as specified below. This
				classification of the growing area shall be verified by laboratory tests
				whenever the sanitary survey indicates the need. Shellfish from approved areas
				may be harvested for direct marketing.
(1)
				Water standards.
(A) Fecal coliform median
				MPN - The fecal coliform median MPN of the water samples shall not exceed
				fourteen per one hundred milliliters (ml) and not more than ten percent of the
				samples shall exceed an MPN of forty-three for a five-tube decimal dilution
				test. The fetal coliform standard shall be used as the primary bacteriological
				standard to evaluate a growing area. The sampling frequency shall be determined
				by the director, based on past history of data collected and the results of the
				sanitary survey.
(B) Total coliform
				median MPN - The total coliform median MPN should not exceed seventy per one
				hundred ml, and not more than ten per cent of the samples exceed an MPN of two
				hundred thirty per one hundred ml for a five-tube decimal dilution test. The
				total coliform median MPN of the water samples shall be used as an alert level
				indicator of possible fecal pollution.
(C) There shall be no continual or periodic
				occurrence of environmental indicators of a potential paralytic shellfish
				poisoning such as an algal bloom ("red tide"), animal mortality (e.g., fish
				kills, bird kills), intoxicated/sluggish animals, or irritating/burning
				aerosols in water.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 35 - SHELLFISH SANITATION › Section 11-35-7 - Artificial growing systems for shellfish

Current through June, 2024
(a) Artificial
				growing systems for shellfish shall meet the performance criteria of natural
				growing water systems as stated in § 11-35-6(c). The operator of an
				artificial growing system shall be issued a shellstock shipper's certificate.
				Harvesting, processing, packing, storing and shucking operations shall be the
				same as for shellfish reared in natural waters (see subsequent
				sections).
(b) Consultation with
				the department is strongly advised prior to the construction and operation of
				an artificial growing system to discuss construction details, flow diagrams,
				and sanitary requirements.
(c)
				System construction guidelines.
(1)
				Artificial growing systems shall be so constructed that they are not subject to
				storm waters and contamination from pollution surces.
(2) Wastewater from washing-culling
				operations shall not contaminate approved growing areas.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 35 - SHELLFISH SANITATION › Section 11-35-8 - Preparation of shellfish for marketing

Current through June, 2024
(a) Relaying.
(1) The relaying of market-size shellfish
				from a prohibited or restricted area to an approved area shall be conducted
				only with the written permission and under the supervision of the
				department.
(2) Shellfish from
				public waters shall only be relaid with the permission of the department of
				land and natural resources.
(3)
				Shellfish relaid from a prohibited or restricted area to an approved area shall
				be kept in such an area for at least fourteen consecutive days and shall be
				harvested only with the written consent from the department and under its
				supervision. Such an area shall be located and marked so that it may be readily
				identified to prevent accidental harvesting and to prevent shellfish in
				adjacent approved areas from contamination. Further need for holding shall be
				determined by laboratory tests and evaluation of such data by the
				department.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 35 - SHELLFISH SANITATION › Section 11-35-10 - Shucking and packing of shellfish

Current through June, 2024
(a) Facilities.
(1) Plant arrangement.
(A) Plants in which shellfish are shucked and
				packed shall be located so that they will not be subject to flooding. Any
				shellstock subjected to flooding shall be relayed, depurated or
				destroyed.
(B) Shucking and packing
				operations shall be conducted in separate rooms. A window shall be installed in
				the partition between the shucking and packing rooms. The window shall be
				equipped with a corrosion-resistant shelf draining toward the shucking room
				and, if necessary, curbed on the packing room side. Fly control screening may
				be accepted in lieu of a solid wall between the shucking and packing rooms,
				provided that the packing room is situated so that there is no likelihood of
				the shucked product or packing room equipment being contaminated by splash from
				the shucking room.
(C) Packing
				rooms shall be large enough to permit sanitary handling of shellfish and
				thorough cleaning of equipment.
(D)
				A separate room or rooms, or lockers shall be provided for storing employees'
				street clothing and personal articles.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 35 - SHELLFISH SANITATION › Section 11-35-11 - Repacking of shucked shellfish

Current through June, 2024
When repacking (packaging of shucked shellfish in plants
				  other than those in which they were originally shucked) is practiced, it shall
				  be done in accordance with the requirements of §
									11-35-10 and the following
				  provisions of this section:
(a)
				Repacking of shucked shellfish.
(1) All
				shucked shellfish shall be received in containers which prevent
				contamination.
(2) Shellfish shall
				be received from certified sources at a temperature of 45°F (7°C) or
				less and maintained at this temperature during repacking.
(3) Frozen shellfish which have thawed shall
				not be repacked nor shall frozen shellfish be thawed during the repacking
				process.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 35 - SHELLFISH SANITATION › Section 11-35-12 - Reshipping of shellfish

Current through June, 2024
Persons who reship shellfish from certified shellstock
				  shippers, shucker-packers or repackers to other certified shippers or to final
				  consumers shall be certified as reshippers. A reshipper is not permitted to
				  shuck shellfish, nor to repack shucked shellfish. If shellstock is handled, the
				  applicable requirements for shellstock dealers in §
									11-35-9(b) shall
				  be met. If only shucked shellfish is handled, the applicable requirements of
				  "Shucking and packing of shellfish" (§
									11-35-10 ) shall be
				  met.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 35 - SHELLFISH SANITATION › Section 11-35-13 - Sale of shellfish in Hawaii

Current through June, 2024
(a) Shellfish
				shipped into Hawaii.
(1) Market shellfish
				shipped into Hawaii from outside the state shall be from approved growing areas
				and certified by the appropriate agency of the state or county of origin and
				shall be acceptable to the Hawaii state department of health.
(2) Each certified shipper shall be listed on
				the current issue of the Interstate Certified Shellfish Shippers List of the
				U.S. Public Health Service-Food and Drug Administration.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 35 - SHELLFISH SANITATION › Section 11-35-14 - Severability

Current through June, 2024
If any provision of these regulations or the application
				  thereof to any person or circumstance, is held invalid, other applications, and
				  the remainder of these regulations shall not be affected
				  hereby.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 36 - SALE OF PROPHYLACTICS THROUGH VENDING MACHINE › Section 11-36-2 - Definitions

Current through June, 2024
As used in this chapter:
"Department" means department of health of the State of
				  Hawaii.
"Director" means director of health of the department, or
				  his duly authorized representative.
"Permittee" means a person who has obtained a permit from
				  the department to sell prophylactics through vending machines.
"Prophylactics" means any device or appliance used or
				  intended to be used for the prevention of venereal disease.
"School" includes every academic and noncollege type of
				  school, whether under governmental supervision or otherwise, except Sabbath and
				  trade-type schools.
"Vending machine" includes all coin-operated mechanical
				  devices used to sell prophylactics.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 36 - SALE OF PROPHYLACTICS THROUGH VENDING MACHINE › Section 11-36-3 - Permit and permit fee

Current through June, 2024
(a) Each person who
				intends to sell prophylactics through vending machines shall first obtain a
				permit to do so from the department.
(b) A separate permit shall be required for
				each vending machine.
(c) The
				permit fee shall be $10 per vending machine; except that governmental or
				non-profit organizations shall be exempt from paying this fee if:
(1) The applicant is able to prove that the
				vending machine is owned and operated by a governmental or non-profit
				organization.
(2) The applicant
				conforms with all of the other provisions of this chapter.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 36 - SALE OF PROPHYLACTICS THROUGH VENDING MACHINE › Section 11-36-4 - Location of vending machines

Current through June, 2024
(a) Before placing
				a vending machine in an establishment, the prospective permittee shall obtain
				written permission to do so from the proprietor or director of such
				establishment. Such permission shall be made available to the department upon
				request. Vending machines shall not be located:
(1) In schools.
(2) In areas where heat, water, or other
				ambient conditions may deteriorate the vending machine or its
				contents.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 36 - SALE OF PROPHYLACTICS THROUGH VENDING MACHINE › Section 11-36-5 - Vending machines

Current through June, 2024
(a) Vending
				machines shall be suitable for dispensing prophylactics in accordance with the
				provisions of this chapter.
(b) No
				items except prophylactics and educational literature about prophylactics or
				venereal disease shall be made available through vending machines.
When a vending machine is empty:
(1) The purchaser shall be notified of this
				fact; or
(2) The machine's design
				shall prevent the acceptance of any more coins; or
(3) The purchaser's money shall be
				refunded.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 36 - SALE OF PROPHYLACTICS THROUGH VENDING MACHINE › Section 11-36-6 - Types of prophylactics which maybe sold

Current through June, 2024
(a) All brands of
				prophylactics that are sold in vending machines shall be registered with the
				department.
(b) These brands shall
				have been tested and approved by:
(1) The
				United States Food and Drug Administration; or
(2) An agency of the state where the
				prophylactic was manufactured; provided that such agency is authorized by such
				state to test and approve prophylactics.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 36 - SALE OF PROPHYLACTICS THROUGH VENDING MACHINE › Section 11-36-7 - Testing of prophylactics

Current through June, 2024
(a) The director
				may collect samples of prophylactics from vending machines for testing as
				deemed necessary.
(b) The permittee
				shall make samples available to the director without cost.
(c) Prophylactics shall be tested in a manner
				approved by the director.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 36 - SALE OF PROPHYLACTICS THROUGH VENDING MACHINE › Section 11-36-8 - Penalty

Current through June, 2024
Any person who violates any provision of this chapter shall
				  be guilty of a misdemeanor and upon conviction thereof shall be punished by a
				  fine of not more than $500 or by imprisonment for not more than one year or
				  both, as provided under §
									321-18, HRS. Each and
				  every violation of the provisions of this chapter shall constitute a separate
				  offense.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 36 - SALE OF PROPHYLACTICS THROUGH VENDING MACHINE › Section 11-36-9 - Severability

Current through June, 2024
If any provision of this chapter, or the application thereof
				  to any person circumstance is held invalid, the invalidity does not affect
				  other provisions or applications of the chapter which can be given effect
				  without the invalid provision or application, and to this end the provisions of
				  this chapter are severable.
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 11-37-1 - Purpose and applicability

Current through June, 2024
(a) The purpose of
				  this chapter is to set forth the requirements for the processing of hemp and
				  the sale of hemp products to provide for the protection of the health and
				  safety of the general public.
(b)
				  Subchapters
				  1 to
				  3 apply to all persons who package,
				  label, sell, hold for sale, offer, or distribute hemp products within the
				  State, including persons who import or offer for import hemp products into the
				  State.
(c) All subchapters apply to
				  persons processing hemp within the State.
(d) If any provision of this chapter or the
				  application thereof to any person or circumstance is held invalid, the
				  invalidity does not affect other provisions or applications of this chapter
				  which can be given effect without the invalid provision or application, and to
				  this end the provisions of this chapter are severable.
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 11-37-3 - Prohibitions

Current through June, 2024
(a) No person shall sell, hold for sale,
				  offer, or distribute any hemp product that is adulterated or
				  misbranded.
(b) No person shall
				  sell, hold for sale, offer, or distribute any hemp product that does not meet
				  the testing requirements in subchapter
				  2.
(c) No person shall sell, hold for sale,
				  offer, or distribute any food, as defined in section
				  328-1, into which a
				  cannabinoid, synthetic cannabinoid, hemp extract, hemp derivatives, or other
				  hemp product has been added as an ingredient or component. This subsection
				  shall not apply to hemp that is generally recognized as safe (GRAS) by FDA for
				  use in foods, as intended, in a public GRAS notification.
(d) No person shall sell, hold for sale,
				  offer, or distribute any cannabinoid products used to aerosolize for
				  respiratory routes of delivery, such as an inhaler, nebulizer, or other device
				  designed for such purpose.
(e) No
				  person shall sell, hold for sale, offer, or distribute any hemp leaf or hemp
				  floral material that is intended to be smoked or inhaled, including but not
				  limited to hemp cigars or hemp cigarettes.
(f) No person shall sell, hold for sale,
				  offer, or distribute any hemp product containing any living hemp plants, viable
				  seeds, leaf materials, or floral materials.
(g) Except for hemp products intended for
				  external topical application to the skin or hair, no person shall sell, hold
				  for sale, offer, or distribute any products containing hemp or hemp derivatives
				  that are intended to be introduced via non-oral routes of entry to the body,
				  including but not limited to, use in eyes, ears, and nasal cavities.
(h) No person shall sell, hold for sale,
				  offer, or distribute any hemp product containing any of the following
				  ingredients:
(1) Any color additives not
				  listed in subpart A or C of 21 C.F.R. part 73, published by the U.S. Government
				  Publishing Office, as amended as of April 1, 2020;
(2) Bithionol;
(3) Vinyl chloride;
(4) Halogenated salicylanilides listed in
				  21
				  C.F.R. section 700.15, published by the U.S.
				  Government Publishing Office, as amended as of April 1, 2020;
(5) Chloroform;
(6) Methylene chloride;
(7) Prohibited cattle material, as defined in
				  21 C.F.R.
				  section 700.27, published by the U.S.
				  Government Publishing Office, as amended as of April 1, 2020;
(8) Mercury compounds;
(9) Hexachlorophene;
(10) Ephedrine alkaloids;
(11) Synthetic cannabinoids;
(12) Cannabinoids created through
				  isomerization, including delta-8-tetrahydrocannabinol and
				  delta-10-tetrahydrocannabinol; and
(13) Any ingredient the department determines
				  would render the product injurious or hazardous to health.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 37 - HEMP PROCESSING AND HEMP PRODUCTS › Subchapter 2 - HEMP PRODUCT TESTING › Section 11-37-20 - Laboratory requirements

Current through June, 2024
(a) Tests required
				  by this subchapter shall be conducted by a laboratory facility that is
				  accredited to the ISO/IEC 17025:2017 standard, "General requirements for the
				  competence of testing and calibration laboratories," by an accreditation
				  organization recognized by the International Laboratory Accreditation
				  Cooperation (ILAC) Mutual Recognition Arrangement.
(b) The laboratory shall:
(1) Identify and use an appropriate,
				  scientifically valid method for each established specification for which
				  testing is required to determine whether the specification is met;
				  and
(2) Establish and follow
				  written standard operating procedures for the test methods conducted to
				  determine whether specifications are met.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 37 - HEMP PROCESSING AND HEMP PRODUCTS › Subchapter 2 - HEMP PRODUCT TESTING › Section 11-37-21 - Reserve samples

Current through June, 2024
(a) A hemp
				  processor shall collect and hold representative reserve samples of each batch
				  of packaged and labeled hemp products that it distributes.
(b) The reserve samples shall:
(1) Be held under conditions consistent with
				  product labels or, if no storage conditions are recommended on the label, under
				  ordinary storage conditions;
(2) Be
				  held using the same container-closure system in which the packaged and labeled
				  hemp product is distributed;
(3) Be
				  identified with the batch number;
(4) Be retained for one year past the shelf
				  life date (if shelf life dating is used), or for two years from the date of
				  distribution of the last hemp products associated with the reserve sample, for
				  use in appropriate investigations; and
(5) Consist of at least twice the quantity
				  necessary for all tests required by sections
				  11-37-22
				  and
				  11-37-23.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 37 - HEMP PROCESSING AND HEMP PRODUCTS › Subchapter 2 - HEMP PRODUCT TESTING › Section 11-37-22 - Required testing for content and consistency

Current through June, 2024
A representative sample of every batch of packaged and
					 labeled hemp product shall be tested for content and consistency by a
					 laboratory meeting the requirements of section
					 11-37-20,
					 including the use of appropriate methods to quantify (in percentage content by
					 weight) the presence of:
(1) Total
				  tetrahydrocannabinol;
(2)
				  Delta-9-tetrahydrocannabinol;
(3)
				  Cannabidiol (CED); and
(4) Any
				  other cannabinoid specifically listed, described, or advertised in the label or
				  packaging of the hemp product, including but not limited to cannabigerol (CBG)
				  and cannabinol (CBN).
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 37 - HEMP PROCESSING AND HEMP PRODUCTS › Subchapter 2 - HEMP PRODUCT TESTING › Section 11-37-24 - Accessibility of test results

Current through June, 2024
The laboratory results for all tests required by sections
					 11-37-22
					 and
					 11-37-23
					 shall be made available to the purchaser of any hemp product by:
(1) Placing a scannable QR code on the label
				  or packaging that directs the electronic scanning device (typically a smart
				  phone or tablet) to a website displaying test results for the specific batch;
				  or
(2) Identifying a website on the
				  label or packaging where the batch number can be entered to view test results
				  for the specific batch.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 37 - HEMP PROCESSING AND HEMP PRODUCTS › Subchapter 2 - HEMP PRODUCT TESTING › Section 11-37-25 - Recordkeeping for testing

Current through June, 2024
(a) A hemp
				  processor shall make and keep records required under this subchapter in
				  accordance with section
				  11-37-55.
(b) A hemp processor shall make and keep the
				  following records:
(1) Sampling plan(s) for
				  obtaining representative samples;
(2) The testing laboratory's ISO/IEC
				  17025:2017 accreditation;
(3)
				  Laboratory reports for all samples tested, including reserve samples,
				  including:
(A) A certification by laboratory
				  staff, completed at the time of performance, that established laboratory
				  methodology was followed and that the samples tested met the laboratory's
				  quality assurance standards; and
(B) The results of the testing;
(4) Written procedures for holding
				  and distributing operations; and
(5) Records of product
				  distribution.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 37 - HEMP PROCESSING AND HEMP PRODUCTS › Subchapter 3 - HEMP PRODUCT PACKAGING AND LABELING › Section 11-37-30 - Labeling

Current through June, 2024
(a) Except as provided in subsection (d),
				  every hemp product shall be labeled with the following information displayed
				  prominently and conspicuously, but in no case may the letters or numbers be
				  less than one-sixteenth inch in height:
(1)
				  Product name;
(2) Product net
				  weight;
(3) The total quantity (in
				  milligrams) of the following cannabinoids contained in the packaged hemp
				  product:
(A) Total
				  tetrahydrocannabinol;
(B)
				  Delta-9-tetrahydrocannabinol;
(C)
				  Cannabidiol (CBD); and
(D) Any
				  other cannabinoid specifically listed, described, or advertised in the label or
				  packaging of the hemp product, including but not limited to cannabigerol (CBG)
				  and cannabinol (CBN);
(4)
				  An ingredient statement that meets the requirements of section
				  11-37-31;
(5) A responsibility statement that meets the
				  requirements of section
				  11-37-32;
(6) Batch number;
(7) Directions for use;
(8) The statement "Use this product under the
				  guidance of a physician if you have a medical condition or are pregnant or
				  lactating." or words of similar meaning;
(9) The statement "Keep out of the reach of
				  children. nor words of similar meaning;
(10) The statement "This product has been
				  tested pursuant to chapter
				  11-37 subchapter
				  2, Hawaii Administrative Rules.";
				  and
(11) A QR code or website that
				  displays test results as required by section
				  11-37-24.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 37 - HEMP PROCESSING AND HEMP PRODUCTS › Subchapter 3 - HEMP PRODUCT PACKAGING AND LABELING › Section 11-37-31 - Ingredient statement

Current through June, 2024
(a) All ingredients
				  shall be listed on the label in order of prominence by weight and shall be
				  preceded by the word "Ingredients".
(b) The common or usual name of ingredients
				  shall be consistent with the names standardized in:
(1) For ingredients that are botanicals
				  (including fungi and algae):
Herbs of Commerce,
second
				  edition, published by the American Herbal Products Association. The listing of
				  these names on the label shall be followed by statements of:
(A) The part of the plant (e.g., root,
				  leaves) from which the ingredient is derived (e.g., "Hemp flower" or "Hemp
				  (flower)"), except that this designation is not required for algae;
				  and
(B) The Latin binomial name of
				  the plant, in parentheses, except that this name is not required when it is
				  available in
Herbs of Commerce,
second edition, for the common
				  or usual name listed on the label, and, when required, the Latin binomial name
				  may be listed before the part of the plant. Any name in Latin form shall be in
				  accordance with internationally accepted rules on nomenclature, such as those
				  found in the
International Code of Botanical Nomenclature
(Shenzhen Code), 2018 edition, published by the International Association for
				  Plant Taxonomy, and shall include the designation of the author or authors who
				  published the Latin name, when a positive identification cannot be made in its
				  absence.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 37 - HEMP PROCESSING AND HEMP PRODUCTS › Subchapter 3 - HEMP PRODUCT PACKAGING AND LABELING › Section 11-37-32 - Responsibility statement

Current through June, 2024
(a) The
				  responsibility statement on the label shall include:
(1) The name and address of the manufacturer,
				  packer, or distributor; and
(2) A
				  statement such as "manufactured by or "distributed by that identifies which
				  party is included on the label.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 37 - HEMP PROCESSING AND HEMP PRODUCTS › Subchapter 3 - HEMP PRODUCT PACKAGING AND LABELING › Section 11-37-33 - Packaging

Current through June, 2024
The immediate container that is in contact with the hemp
					 product shall be made of material that:
(1) Protects the product from contamination
				  and does not impart any toxic or harmful substance to the hemp product;
				  and
(2) Is not reactive, additive,
				  or absorptive so as to alter the safety, identity, strength, quality, or purity
				  of the hemp product.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 37 - HEMP PROCESSING AND HEMP PRODUCTS › Subchapter 4 - HEMP PROCESSOR REGISTRY › Section 11-37-40 - Registration required

Current through June, 2024
No person shall engage in the processing of hemp without a
					 valid certificate of registration issued by the department pursuant to this
					 subchapter.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 37 - HEMP PROCESSING AND HEMP PRODUCTS › Subchapter 4 - HEMP PROCESSOR REGISTRY › Section 11-37-41 - Eligibility

Current through June, 2024
(a) To apply for a certificate of
				  registration, an applicant shall:
(1) Have a
				  Hawaii tax identification number;
(2) Be registered to do business in the State
				  of Hawaii, unless the business is a sole proprietorship; and
(3) Have a license to produce hemp issued by
				  the USDA pursuant to title
				  7 United States Code section
				  1639q.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 37 - HEMP PROCESSING AND HEMP PRODUCTS › Subchapter 4 - HEMP PROCESSOR REGISTRY › Section 11-37-42 - Application

Current through June, 2024
(a) To apply for a certificate of
				  registration, an applicant shall submit the following information to the
				  department on a form and in a manner prescribed by the department:
(1) The applicant's name, mailing address,
				  and phone number in Hawaii;
(2) A
				  copy of the applicant's license to produce hemp, issued by the USDA pursuant to
				  title
				  7 United States Code section
				  1639q;
(3) The physical address and tax map key
				  (TMK) number of the land on which each hemp processing facility is to be
				  located;
(4) A description of the
				  enclosed indoor facility where hemp processing will occur demonstrating how the
				  hemp processing facility meets the applicable facility requirements of
				  subchapters
				  5 and
				  6;
(5) Attestation that the hemp processing
				  facility complies with section
				  11-37-51(a);
				  and
(6) Documentation and
				  attestation that the hemp processing facility and planned operation complies
				  with all zoning ordinances, building codes, and fire codes.