Ill. Admin. Code tit. 8 § 1000.405

Current through Register Vol. 48, No. 49, December 6, 2024

Section 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.

1) No 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 food-borne illness.

2) Cannabis-infused 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.

2) Hand-washing 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 are cleaned.

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 pests.

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.

f) Permitted 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).

Ill. Admin. Code tit. 8, § 1000.405

Adopted at 38 Ill. Reg. 16731, effective 7/25/2014.