Rule 351-4-.05 - Production Operations(1) A production licensee shall ensure all phases of production take place in designated, restricted access areas only.(2) A production licensee shall document the formulation and size for each batch produced.(3) All ingredients, other than those naturally occurring in or otherwise derived from cannabis, shall be approved by the U.S. Food and Drug Administration.(4) Each batch shall meet the following requirements: (a) Plant tags and plant strains shall be easily identifiable and legible.(b) Each immature plant batch shall consist of no more than one hundred (100) immature plants.(c) After a tagged plant is harvested, it is part of a harvest batch.(d) A harvest batch shall be easily distinguishable from other harvest batches until the batch is manufactured into products.(e) Once the harvest batch is manufactured into products, it is part of a manufactured batch.(5) A production licensee shall submit a list of all products and their formulations, which will be manufactured on the premises, to the Commission and its employees within thirty (30) days of licensure. The list shall be maintained on the premises during the term of the license contract and provided to the Commission or its employees upon request.(6) A production licensee shall ensure that all regulated cannabis is stored in a designated, locked, and secured room or enclosure with restricted access.(7) A production licensee shall ensure that all recalled products for remediation are stored in a designated, locked, and secured room or enclosure with restricted access and are segregated from other products.(8) A production licensee shall ensure that regulated cannabis waste is: (a) Stored in a securely locked and enclosed container that is securely fastened to a permanent structure so that the receptacles cannot be moved;(b) Located in a restricted access area designated for regulated cannabis waste; and(c) Disposed, documented, and managed in accordance with all local, state, and federal regulations.(9) Regulated cannabis waste shall be disposed of by: (a) Rendering all regulated cannabis waste unusable and unrecognizable or irretrievable prior to the waste leaving the premises;(b) Transferring the regulated cannabis waste securely to a processor for recycling, reuse, or composting; or(c) A Commission approved plan for onsite composting, burial or other means of disposing of regulated cannabis waste.(10) A production licensee shall establish, maintain, and follow standard operating procedures for production operations, which shall include processes for the following: (a) Monitoring, recording, and regulating: (b) Storage and handling requirements of all fuel, chemicals, pesticides, solvents, and any other hazardous materials utilized on the premises.(c) Extraction including, but not limited to, one (1) or more of the following extraction methods:1. Using hydrocarbons N-butane, isobutane, propane, heptane, or other solvents or gasses exhibiting low to minimal potential human health related toxicity approved by the Commission. These solvents shall be of at least ninety-nine percent (99%) purity and a production licensee shall:(i) Use the solvents in a professional grade, closed-loop extraction system designed to recover the solvents;(ii) Work in a spark-free environment with proper ventilation;(iii) The hydrocarbon extraction system or room shall have sensors which detect when hydrocarbon levels reach unsafe levels and signal an alert; and(iv) Follow all applicable state and local fire, safety, and building codes in the processing, storage, and disposal of the solvents.2. A professional grade, closed-loop CO2 gas extraction system where every cylinder is rated to a minimum of nine hundred (900) pounds per square inch and it follows all applicable state and local fire, safety, and building codes in the processing and the storage of the solvents. (i) The CO2 shall be of at least ninety-nine percent (99%) purity.(ii) The CO2 gas extraction system shall have sensors which detect when CO2 levels reach unsafe levels and signal an alert.3. Ethanol extraction, provided a system to recover the ethanol to be properly disposed of exists.4. Mechanical extraction using potable water, ice, dry screening or sieving, cryonic extraction, pressure, or temperature provided a detailed description of the processes shall be on the premises. (d) Verification of compliance of any vessel, cylinder, or tank that is used in the extraction process containing pressures greater than fifteen (15) pounds per square inch with the American Society of Mechanical Engineers (ASME);(e) Refinement practices and procedures; and(f) Proper disposal of any: 3. Any other by-product resulting from the manufacturing of regulated cannabis; and4. Outdated, damaged, deteriorated, misbranded, or adulterated regulated cannabis.(11) A production licensee shall establish and implement a product waste management plan that describes, at a minimum: (a) Procedures for retrieving or receiving product waste from the dispensing licensees; and(b) Record maintenance and retention procedures for product waste records.(12) The production standard operating procedures shall be: (a) Maintained on the premises;(b) Provided to every owner and employee who performs a task, or set of tasks, that are referenced in the standard operating procedures; and(c) Made available upon request by the Commission or its employees.(13) If a production licensee makes a change to their standard operating procedures, then the licensee shall: (a) Document the change and revise the standard operating procedures accordingly;(b) Maintain records detailing the change on the premises and submit them to the Commission or its employees upon request; and(c) Record any change from the standard operating procedure: 1. The change log shall be maintained on the premises for a period of at least three (3) years.2. The change log shall be made available to the Commission or its employees upon request.Ga. Comp. R. & Regs. R. 351-4-.05
O.C.G.A. §§ 16-12-203, 16-12-210, 16-12-211, 16-12-212.
Original Rule entitled "Production Operations" adopted. F. Mar. 16, 2023; eff. Apr. 5, 2023.