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THE SENATE |
S.B. NO. |
3137 |
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THIRTY-THIRD LEGISLATURE, 2026 |
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STATE OF HAWAII |
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A BILL FOR AN ACT
RELATING TO THE DEPARTMENT OF HEALTH'S AUTHORITY TO REGULATE FOOD, DRUGS, and COSMETICS.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:
To
this end, conforming amendments are made to chapter 328, Hawaii Revised
Statutes, including the addition of authority respecting the collection and
disposition of fees and penalties, and the adoption of rules related to the
issuance of permits and variances. The
consolidation of the department's regulatory authority into one chapter will
support the efficient administration of the department's retail-focused
program, the food safety branch, and the regulation by the department of higher
volume food manufacturing and wholesale distribution by its food and drug
branch, both of which will be governed by chapter 328 and the rules adopted
thereto.
SECTION
2. Chapter 328, Hawaii Revised Statutes,
is amended by adding a new part to be appropriately designated and to read as
follows:
"PART . FOOD SAFETY CONSULTATIVE AND EDUCATION
PROGRAM
§328- Food safety consultative and education
program. (a) There is established the food safety
consultative and education program within the department. The department may place this program within
any appropriate division.
(b) The program shall be managed and staffed by
persons who are trained and experienced in public health aspects of food,
including food science, foodborne disease epidemiology, food microbiology, and
food sanitation.
(c) Generic food safety information gained from
studies conducted as part of the program may be shared with foodhandlers in
certification workshops and food safety classes.
§328- Food safety control system. The department may
conduct studies using the hazard analysis critical control points system after
foodborne disease outbreak investigations are completed by the department or
when requested by food service operators.
§328- Public information monitoring system. Within the program, the department shall
investigate foodhandling practices which appear to represent poor food safety
techniques, and shall develop ways in which the public can gain information on
food safety and can report practices that appear to represent poor food safety
techniques."
SECTION
3. Chapter 328, Hawaii Revised Statutes,
is amended by adding to part I four new sections to be appropriately designated
and to read as follows:
"§328- Producers
of hand-pounded poi; exemption. A
producer of hand-pounded poi shall not be required to process poi in a
certified food-processing establishment or be required to obtain a permit from
the department, if the producer:
(1) Sells hand-pounded poi directly to
consumers;
(2) Prepares hand-pounded poi
adjacent to permanent or temporary hand-washing facilities; and
(3) Complies with rules adopted
by the department to protect the health and safety of the public.
The
department shall adopt rules pursuant to section 91 to effectuate this section.
§328-
Agricultural
processing facilities; permits; priority. (a) Any agency subject to this chapter or title 19
that issues permits shall establish and implement a procedure for the priority
processing of permit applications and renewals, at no additional cost to the
applicant, for agricultural processing facilities that process crops or
livestock from an agribusiness; provided that the majority of the lands held,
owned, or used by the agribusiness shall be land designated as important
agricultural lands pursuant to part III of chapter 205, excluding lands held,
owned, or used by the agribusiness in a conservation district.
Any
priority permit processing procedure established pursuant to this section shall
not provide or imply that any permit application filed under the priority
processing procedure shall be automatically approved.
(b) As used in this section,
"agribusiness" means a business primarily engaged in the care and
production of livestock, livestock products, poultry, poultry products, apiary,
horticultural or floricultural products, the planting, cultivating, and
harvesting of crops or trees, or the farming or ranching of any plant or animal
species in a controlled salt, brackish, or fresh water environment.
§328- Food safety and
environmental health special fund. (a) There is established within the department the
food safety and environmental health special fund into which shall be deposited
all moneys collected from fees for permits, licenses, inspections, various
certificates, variances, investigations, and reviews, pursuant to this chapter.
(b) Moneys in the fund shall be expended by the
department to partially fund the operating costs of program activities and
functions authorized pursuant to this chapter to enhance the capacity of food
safety and environmental health programs to:
(1) Improve public outreach
efforts and consultations to regulated businesses and industries;
(2) Educate the public, staff,
and regulated businesses and industries;
(3) Plan for future growth and
expansion to meet emerging needs;
(4) Provide training
opportunities to ensure the maintenance of professional competence among food
safety and environmental health staff and administrators; and
(5) Conduct program activities
and functions of the food safety, food and drug, and environmental health
programs, including permit issuance, inspections, and enforcement and the
hiring of additional inspectors; provided that for these programs, not more
than $140,000 of the fund may be used during any fiscal year for fund
administration, including the hiring of not more than two full-time equivalent
personnel, and the purchase of office and electronic equipment.
(c) Any amount in the fund in excess of $1,500,000
on June 30 of each year shall be deposited into the general fund.
(d) The department shall submit a report to the
legislature concerning the status of the food safety and environmental health
special fund, including:
(1) The amount of moneys taken
in by and expended from the fund; and
(2) The sources of receipts and
uses of expenditures, not less than twenty days prior to the convening of each
regular session.
§328- Audit of food
safety and food and drug programs. The department shall perform annual audits of
the food safety and food and drug programs to be completed by November 30 of
each year, and shall include an audit of:
(1) Fees collected;
(2) The number and results of
inspections;
(3) The number of training
seminars held; and
(4) The cost of training
personnel in the food safety and food and drug programs."
SECTION
4. Section 321-11, Hawaii Revised
Statutes, is amended to read as follows:
"§321-11 Subjects of health rules, generally. The department of health pursuant to chapter 91 may adopt rules that it deems necessary for the public health and safety respecting:
(1) Nuisances, foul or noxious odors, gases, vapors, waters in which mosquitoes breed or may breed, sources of filth, and causes of sickness or disease, within the respective districts of the State, and on board any vessel;
[(2) Adulteration and misbranding of food or
drugs;
(3)] (2) Location, air space,
ventilation, sanitation, drainage, sewage disposal, and other health conditions
of buildings, courts, construction projects, excavations, pools, watercourses,
areas, and alleys. For purposes of this
paragraph, "pool" means a watertight artificial structure containing
a body of water that does not exchange water with any other body of water,
either naturally or mechanically, and is used for swimming, diving,
recreational bathing, or therapy by humans;
[(4)] (3) Privy vaults and
cesspools;
[(5)] (4) Fish and fishing;
[(6)] (5) Interments and dead
bodies;
[(7)] (6) Disinterments of dead
human bodies, including the exposing, disturbing, or removing of these bodies
from their place of burial, or the opening, removing, or disturbing after due
interment of any receptacle, coffin, or container holding human remains or a
dead human body or a part thereof and the issuance and terms of permits for the
aforesaid disinterments of dead human bodies;
[(8)] (7) Cemeteries and
burying grounds;
[(9)] (8) Laundries, and the
laundering, sanitation, and sterilization of articles including linen and
uniforms used by or in the following businesses and professions: barber shops, manicure shops, beauty parlors,
electrology shops, restaurants, soda fountains, hotels, rooming and boarding
houses, bakeries, butcher shops, public bathhouses, midwives, masseurs, and
others in similar calling, public or private hospitals, and canneries and
bottling works where foods or beverages are canned or bottled for public consumption
or sale; provided that nothing in this chapter shall be construed as
authorizing the prohibiting of laundering, sanitation, and sterilization by
those conducting any of these businesses or professions where the laundering or
sterilization is done in an efficient and sanitary manner;
[(10)] (9) Hospitals,
freestanding surgical outpatient facilities, skilled nursing facilities,
intermediate care facilities, adult residential care homes, adult foster homes,
assisted living facilities, special treatment facilities and programs, home
health agencies, home care agencies, hospices, freestanding birthing
facilities, adult day health centers, independent group residences, and
therapeutic living programs, but excluding youth shelter facilities unless
clinical treatment of mental, emotional, or physical disease or handicap is a
part of the routine program or constitutes the main purpose of the facility, as
defined in section 346-16 under "child caring institution". For the purpose of this paragraph, "adult
foster home" has the same meaning as provided in section 321-11.2;
[(11)] (10) Hotels, rooming
houses, lodging houses, apartment houses, tenements, and residences for persons
with developmental disabilities including those built under federal funding;
[(12)] (11) Laboratories;
[(13)] (12) Any place or building
where noisome or noxious trades or manufacturing is carried on, or intended to
be carried on;
[(14) Milk;
(15)] (13) Poisons and hazardous
substances, the latter term including any substance or mixture of substances
that:
(A) Is corrosive;
(B) Is an irritant;
(C) Is a strong sensitizer;
(D) Is inflammable; or
(E) Generates pressure through decomposition, heat, or other means,
if the substance or mixture of substances may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children;
[(16)] (14) Pig and duck ranches;
[(17)] (15) Places of business,
industry, employment, and commerce, and the processes, materials, tools,
machinery, and methods of work done therein; and places of public gathering,
recreation, or entertainment;
[(18) Any restaurant, theater, market, stand,
shop, store, factory, building, wagon, vehicle, or place where any food, drug,
or cosmetic is manufactured, compounded, processed, extracted, prepared,
stored, distributed, sold, offered for sale, or offered for human consumption
or use;
(19) Foods, drugs, and cosmetics, and the
manufacture, compounding, processing, extracting, preparing, storing, selling,
and offering for sale, consumption, or use of any food, drug, or cosmetic;
(20)] (16) Device as defined in
section 328-1;
[(21)] (17) Sources of ionizing
radiation;
[(22)] (18) Medical examination,
vaccination, revaccination, and immunization of school children. No child shall be subjected to medical
examination, vaccination, revaccination, or immunization, whose parent or
guardian objects in writing thereto on grounds that the requirements are not in
accordance with the religious tenets of an established church of which the
parent or guardian is a member or adherent, but no objection shall be
recognized when, in the opinion of the department, there is danger of an
epidemic from any communicable disease;
[(23)] (19) Disinsectization of
aircraft entering or within the State as may be necessary to prevent the
introduction, transmission, or spread of disease or the introduction or spread
of any insect or other vector of significance to health;
[(24)] (20) Fumigation, including
the process by which substances emit or liberate gases, fumes, or vapors that
may be used for the destruction or control of insects, vermin, rodents, or
other pests, which, in the opinion of the department, may be lethal, poisonous,
noxious, or dangerous to human life;
[(25)] (21) Ambulances and
ambulance equipment;
[(26)] (22) Development, review,
approval, or disapproval of management plans submitted pursuant to the Asbestos
Hazard Emergency Response Act of 1986, Public Law 99-519; and
[(27)] (23) Development, review,
approval, or disapproval of an accreditation program for specially trained
persons pursuant to the Residential Lead-Based Paint Hazard Reduction Act of
1992, Public Law 102-550.
The department of health may require any certificates, permits, or licenses that it may deem necessary to adequately regulate the conditions or businesses referred to in this section."
SECTION
5. Section 328-8, Hawaii Revised
Statutes, is amended to read as follows:
"§328-8
Regulations to be prescribed. (a) Whenever in the judgment of the department
such action will promote honesty and fair dealing in the interest of consumers,
the department shall prescribe regulations fixing and establishing for any food
or class of food a reasonable definition and standard of identity, or
reasonable standard of quality or fill of container. In prescribing a definition and standard of
identity for any food or class of food in which optional ingredients are
permitted, the department shall, for the purpose of promoting honesty and fair
dealing in the interest of consumers, designate the optional ingredients which
shall be named on the label. The
definitions and standards so prescribed shall conform so far as practicable to
the definitions and standards promulgated under authority of the Federal Act.
(b) [Temporary permits now or hereafter granted
for interstate shipment of experimental packs of food varying from the
requirements of federal definitions and standards of identity are automatically
effective in this State under the conditions provided in such permits. In addition, the director may issue additional
permits where they are necessary to the completion or conclusiveness of an
otherwise adequate investigation and where the interests of consumers are
safeguarded.] No person shall
manufacture, produce, process, package, offer, distribute, or hold for sale any
food without a permit or variance issued by the department, which shall remain
valid for a period of one year unless suspended by the department, after which
they shall expire unless renewed, except that no permit or variance shall be
required for a producer of hand-pounded poi who sells directly to consumers, producers
of homemade food products, or producers of non-time/temperature control for
safety foods, as those may be defined by department rules. Such permits shall be subject to such terms
and conditions as the director may prescribe.
(c) The director may establish rules as necessary
for the enforcement of this part[.], including but not limited to the
establishment and collection of fees for permits and variances. The rules shall be adopted pursuant to chapter
91; except that the director may, without regard to chapter 91, establish
tolerance levels and regulatory or action levels by reference to the provisions
of the regulations or guidelines of the United States established in 40 Code of
Federal Regulations Parts 180 and 185 or the United States Food and Drug
Administration Compliance Policy Guides as the regulations or guidelines become
effective at any time or from time to time."
SECTION
6. Section 328-21, Hawaii Revised
Statutes, is amended to read as follows:
"§328-21
Rules and regulations, hearings. (a) Subject to chapter 91 the director may adopt
and enforce such rules or regulations as the director may deem necessary for
the efficient enforcement of this part. The director may make the rules or regulations
prescribed under this part conform insofar as practicable with those
promulgated under the Federal Act.
(b) The subjects of the rules may include,
generally:
(1) Adulteration and misbranding of food or drugs;
(2) Foods, drugs, and cosmetics,
and the manufacture, compounding, processing, extracting, preparing, storing,
selling, and offering for sale, consumption, or use of any food, drug, or
cosmetic;
(3) Any restaurant, theater,
market, stand, shop, store, factory, building, wagon, vehicle, or place where
any food, drug, or cosmetic is manufactured, compounded, processed, extracted,
prepared, stored, distributed, sold, offered for sale, or offered for human
consumption or use;
(4) Milk; and
(5) Shellfish.
[(b)]
(c) Hearings authorized or
required by this part shall be conducted by the director or any officer, agent,
or employee designated by the director for that purpose and shall be subject to
chapter 91."
SECTION
7. Section 321-4.5, Hawaii Revised
Statutes, is repealed.
["§321-4.5
Inspection of food establishments.
Inspections of food establishments may
be performed only by a registered sanitarian or a food and drug inspector."]
SECTION
8. Section 321-4.6, Hawaii Revised
Statutes, is repealed.
["§321-4.6
Advisory council on food protection
practices; created. (a) There is created within the department for
administrative purposes only, an advisory council on food protection practices,
whose members shall be appointed by the director of health, consisting of one
representative from at least the following:
(1) An organization representing
the restaurant industry;
(2) An organization representing
the hotel industry;
(3) An organization representing
the food manufacturing industry;
(4) An organization representing
the food service industry;
(5) A registered sanitarian from
the department of health;
(6) The University of Hawaii,
food technology department;
(7) The community college food
service program;
(8) A corporate chain restaurant
doing business in Hawaii; and
(9) A member of the general
public.
(b) Each member shall
serve for a term of three years; provided that the director shall initially
appoint three members to serve for one year, three members to serve for two
years, and three members to serve for three years. No member shall serve for more than two
consecutive three-year terms.
(c) Vacancies occurring before the expiration of a
member's term shall be filled by election of the council. Individuals elected to fill a vacancy shall
serve only for the remainder of the unexpired term.
(d) The council shall appoint from its members a
chairperson, vice chairperson, secretary, treasurer, and any other officers
that the council may deem necessary or desirable to carry out its functions.
(e) Members shall serve without compensation, but
may be reimbursed for the necessary expenses, including travel expenses,
incurred in the performance of their duties.
(f) The council shall:
(1) Advise the department on
sanitation issues and food protection practices;
(2) Review and advise the department,
in consultation with the department of the attorney general, regarding the
adoption of rules relating to sanitation and food protection practices; and
(3) Advise the department on the
incorporation of salient provisions of the most recent version of the United
States Food and Drug Administration's Model Food Code into the department's
food sanitation rules."]
SECTION
9. Section 321-4.7, Hawaii Revised
Statutes, is repealed.
["§321-4.7 Producers of hand-pounded poi; exemption.
A producer of hand-pounded poi shall not
be required to process poi in a certified food-processing establishment or be
required to obtain a permit from the department of health, if the producer:
(1) Sells hand-pounded poi
directly to consumers;
(2) Prepares hand-pounded poi
adjacent to permanent or temporary hand-washing facilities; and
(3) Complies with rules adopted
by the department to protect the health and safety of the public.
The
department shall adopt rules pursuant to section 91 to effectuate this section
no later than December 31, 2011."]
SECTION
10. Section 321-10.5, Hawaii Revised
Statutes, is repealed.
["§321-10.5
Agricultural processing facilities;
permits; priority. (a) Any agency subject to this chapter or title 19
that issues permits shall establish and implement a procedure for the priority
processing of permit applications and renewals, at no additional cost to the
applicant, for agricultural processing facilities that process crops or
livestock from an agribusiness; provided that the majority of the lands held,
owned, or used by the agribusiness shall be land designated as important
agricultural lands pursuant to part III of chapter 205, excluding lands held,
owned, or used by the agribusiness in a conservation district.
Any
priority permit processing procedure established pursuant to this section shall
not provide or imply that any permit application filed under the priority
processing procedure shall be automatically approved.
(b) As used in this section,
"agribusiness" means a business primarily engaged in the care and
production of livestock, livestock products, poultry, poultry products, apiary,
horticultural or floricultural products, the planting, cultivating, and
harvesting of crops or trees, or the farming or ranching of any plant or animal
species in a controlled salt, brackish, or fresh water environment."]
SECTION
11. Section 321-11.51, Hawaii Revised
Statutes, is repealed.
["§321-11.51
Sanitation permits; transfer.
Sanitation permits that have not expired
as of July 2, 1997, shall be transferable upon the sale of a food
establishment; provided that such transfers are subject to the new owner
agreeing to abide by the compliance schedule of the department of health."]
SECTION
12. Section 321-27, Hawaii Revised
Statutes, is repealed.
["§321-27
Sanitation and environmental health
special fund. (a) There is established within the department of
health the sanitation and environmental health special fund into which shall be
deposited all moneys collected from fees for permits, licenses, inspections,
various certificates, variances, investigations, and reviews, pursuant to
sections 321-11.5(c) and 321-15.
(b) Moneys in the fund shall be expended by the
department to partially fund the operating costs of program activities and
functions authorized pursuant to section 321-11 to enhance the capacity of
sanitation and environmental health programs to:
(1) Improve public outreach
efforts and consultations to regulated businesses and industries;
(2) Educate the public, staff,
and regulated businesses and industries;
(3) Plan for future growth and
expansion to meet emerging needs;
(4) Provide training
opportunities to ensure the maintenance of professional competence among
sanitation and environmental health staff and administrators; and
(5) Conduct program activities
and functions of the sanitation branch, including permit issuance, inspections,
and enforcement and the hiring of additional inspectors; provided that for
environmental health programs, not more than $140,000 of the fund may be used
during any fiscal year for fund administration, including the hiring of not
more than two full-time equivalent personnel, and the purchase of office and
electronic equipment.
(c) Any amount in the fund in excess of $1,500,000
on June 30 of each year shall be deposited into the general fund.
(d) The department of health shall submit a report
to the legislature concerning the status of the sanitation and environmental
health special fund, including:
(1) The amount of moneys taken
in by and expended from the fund; and
(2) The sources of receipts and
uses of expenditures, not less than twenty days prior to the convening of each
regular session."]
SECTION
13. Section 321-27.5, Hawaii Revised
Statutes, is repealed.
["§321-27.5
Audit of sanitation branch. The department shall perform annual audits of
the sanitation branch to be completed by November 30 of each year, and shall
include an audit of:
(1) Fees collected;
(2) The number and results of
sanitation inspections;
(3) The number of training
seminars held; and
(4) The cost of training
personnel in the sanitation branch."]
SECTION 14. Chapter 321, part
XXXII, Hawaii Revised Statutes, is repealed.
SECTION 15. Statutory material to be repealed is
bracketed and stricken. New statutory
material is underscored.
SECTION 16. This Act shall take effect upon its approval.
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INTRODUCED BY: |
_____________________________ |
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BY REQUEST |
Report Title:
Department of Health; Food, Drugs, and Cosmetics; Consolidation of Food Safety into Chapter 328, HRS
Description:
Removes duplicative food-related statutory material and aligns all food-related provisions under chapter 328, HRS. Ensures adequate statutory authority for permits, fees, inspections, and enforcement.
The summary description
of legislation appearing on this page is for informational purposes only and is
not legislation or evidence of legislative intent.