1000.405 Production Areas − Infused or Processed Products
a) Any area within the
cultivation center where cannabis will be manufactured into an edible form
shall comply with the Illinois Food, Drug and Cosmetic Act, Sanitary Food
Preparation Act, and Food Handling Regulation Enforcement Act.
cannabis-infused products requiring refrigeration or hot-holding or
considered potentially hazardous food (Section 4 of the Food Handling
Regulation Enforcement Act) shall be manufactured at a cultivation center
for sale or distribution at a dispensing organization due to the potential for
products for sale or distribution at a dispensing organization must be prepared
by an approved staff member of a permitted cultivation center.
b) The Department of
Public Health may at all times enter every building, room, basement,
enclosure, or premises occupied or used or suspected of being occupied or used
for the production, preparation, manufacture for sale, storage, sale,
distribution or transportation of medical cannabis-infused products, to inspect
the premises and all utensils, fixtures, furniture, and machinery used for the
preparation of these products.
c) If a local
health department has a reasonable belief that a cultivation center's
cannabis-infused product poses a public health hazard, it may refer the
cultivation center to the Department of Public Health for inspection. (Section 80 of the Act)
d) General Sanitary
Requirements. All areas permitted in the cultivation center for the production
of cannabis-infused products shall take all reasonable measures and precautions
to ensure that:
1) Any person who, by
medical examination or supervisory observation, is shown to have, or appears to
have, an illness, open lesion, including boils, sores or infected wounds, or
any other abnormal source of microbial contamination for whom there is a
reasonable possibility of contact with cannabis shall be excluded from any
operations that may be expected to result in microbial contamination until the
condition is corrected.
facilities are adequate and convenient and are furnished with running water at
a suitable temperature. Hand-washing facilities shall be located in the
permitted premises and where good sanitary practices require employees to wash
and/or sanitize their hands, and provide effective hand-cleaning and sanitizing
preparations and sanitary towel service or suitable drying devices.
3) All persons working
in direct contact with cannabis shall conform to hygienic practices while on
duty, including but not limited to:
A) Maintaining adequate personal cleanliness;
B) Washing hands
thoroughly in adequate hand-washing areas before starting work and at any other
time when the hands may have become soiled or contaminated;
C) Refraining from
having direct contact with cannabis if the person has or may have an illness,
open lesion, including boils, sores or infected wounds, or any other abnormal
source of microbial contamination, until the condition is corrected.
4) Litter and waste
are properly removed and the operating systems for waste disposal are
maintained in an adequate manner so that they do not constitute a source of
contamination in areas where cannabis is exposed.
5) Floors, walls and
ceilings are constructed in such a manner that they may be adequately cleaned
and kept clean and in good repair.
6) There is adequate
lighting in all areas where cannabis is stored and where equipment or utensils
7) There is adequate
screening or other protection against the entry of pests. Rubbish shall be
disposed of so as to minimize the development of odor and minimize the
potential for the waste becoming an attractant, harborage or breeding place for
8) Any buildings,
fixtures and other facilities are maintained in a sanitary condition.
9) Toxic cleaning
compounds, sanitizing agents, and solvents used in the production of cannabis
concentrates shall be identified, held and stored in a manner that protects
against contamination of cannabis, and in a manner that is in accordance with
any applicable local, State or federal law, rule, regulation or ordinance.
10) All contact
surfaces, including utensils and equipment used for the preparation of cannabis
or cannabis-infused product, shall be cleaned and sanitized as frequently as
necessary to protect against contamination. Equipment and utensils shall be
designed and shall be of such material and workmanship as to be adequately
cleanable, and shall be properly maintained. Only sanitizing agents registered
with the Department pursuant to the Illinois Pesticide Act shall be used in
cultivation centers; they shall be used in accordance with labeled instructions.
11) The water supply
shall be sufficient for the operations intended and shall be derived from a
source that is a regulated water system. Private water supplies shall be
derived from a water source that is capable of providing a safe, potable and
adequate supply of water to meet the facility's needs.
12) Plumbing shall be
of adequate size and design, and adequately installed and maintained, to carry
sufficient quantities of water to the required locations throughout the
facility. Plumbing shall properly convey sewage and liquid disposable waste
from the facility. There shall be no cross-connections between the potable and
waste water lines.
13) All operations in
the receiving, inspecting, transporting, segregating, preparing, producing, packaging
and storing of cannabis and cannabis-infused products shall be conducted in
accordance with adequate sanitation principles.
14) Each cultivation
center shall provide its employees with adequate and readily accessible toilet
facilities that are maintained in a sanitary condition and good repair.
15) Cannabis that can
support the rapid growth of undesirable microorganisms shall be held in a
manner that prevents the growth of these microorganisms.
e) The permittee must
request DPH to conduct a pre-operational inspection at all registered
cultivation centers to determine whether the facilities, methods, practices and
controls used in the manufacture, processing or holding of cannabis-infused
products conform to or are operated or administered in conformity with good
manufacturing practices to ensure that food products for human consumption are
safe and have been prepared, packed and held under sanitary conditions.
cultivation centers shall immediately allow DPH to inspect the premises and all
utensils, fixtures, furniture, machinery and devices used for preparing
manufactured cannabis-infused products.
g) DPH will conduct
inspections of registered cultivation centers with regard to the manufacture
and preparation of cannabis-infused products under the authority of the
Illinois Food, Drug and Cosmetic Act, the Food Handling Regulation Enforcement
Act and the Food Service Sanitation Code and in accordance with DPH's
Cannabis-Infused Products rules (77 Ill. Adm. Code 946.Subpart D).
h) A cultivation
center that prepares cannabis-infused products for sale or distribution at a
dispensing organization shall be under the operational supervision of a
certified food service sanitation manager. (Section 80 of the Act) Management responsibilities and
supervision shall be in accordance with 77 Ill. Adm. Code 730.8000 and 730.8040
(Manufacturing, Processing, Packing or Holding of Food Code).