Md. Code Regs. 14.17.10.03

Current through Register Vol. 51, No. 22, November 1, 2024

Section 14.17.10.03 - Cannabis Grower Controls

A. Receipt of Material.

(1) A grower shall quarantine material that is received to produce cannabis.

(2) A grower shall inspect material for defects, contamination, and compliance with a grower's specifications.

(3) Material may not be released from quarantine by a grower until the material:

(a) Passes inspection; and

(b) Is determined to be acceptable for use as intended.

B. Growing Cannabis.

(1) Horticultural Controls.

(a) Water. The grower shall keep a record of water quality testing on-site and make it available for inspection.

(b) Fertilizer. As part of the standard operating procedure, a grower shall:

(i) Adopt a nutrient management plan prepared by a certified nutrient management consultant;

(ii) Use fertilizer or hydroponic solution of a type, formulation, and at a rate, to support healthy growth of cannabis; and

(iii) Maintain records of the type and amounts of fertilizer and any growth additives used.

(c) Unless the cannabis is field grown, a grower shall install, as part of the standard operating procedure, a system to monitor, record, and regulate:

(i) Temperature;

(ii) Humidity;

(iii) Ventilation; and

(iv) Lighting, if used.

(d) Unless the cannabis is field grown, a grower shall seal or screen the premises ventilation system with a mesh or filtering system fine enough to exclude most plant pests.

(e) Pest Monitoring. A grower shall use integrated pest management practices and techniques to identify and manage plant pathogen and pest problems, including:

(i) A door control system sufficient to prevent pest entry;

(ii) Regular visual inspection of plants and growing areas for the presence of pests;

(iii) The use of sticky cards in growing areas; and

(iv) Identification and recording of all pests or pathogens detected and the measures taken for control.

(f) Pest Control. Pesticide applicators and applications shall follow State and federal pesticide requirements for any pesticide applied.

(g) Sanitation. Sanitation shall comply with the grower's standard operating procedures.

(h) Green Waste. A grower shall weigh, document, and destroy all green waste in accordance with the standard operating procedures.

(2) Equipment. A grower shall:

(a) Maintain equipment that comes in contact with cannabis to prevent contamination;

(b) Maintain cleaning and equipment maintenance logs;

(c) Ensure all scales are National Type Evaluation Program-approved;

(d) Have any scale, balance, or other measurement device, and any automatic, mechanical, or electronic equipment:

(i) Annually calibrated by a calibration laboratory accredited to International Organization for Standardization (ISO) standard 17025 ISO/IEC by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement; and

(ii) Checked at least once per month to ensure accuracy; and

(e) Make records and certifications required under §B(2)(c) and (d) of this regulation available to the Administration available upon request.

C. Inventory Controls.

(1) A grower shall enter timely and accurate data into the Administration's designated seed-to-sale tracking system to track the grower's stock of cannabis from the time the cannabis is propagated from seed or cutting to the time it is delivered to a:

(a) Licensed processor; or

(b) Licensed dispensary.

(2) Upon receipt of raw material for cultivation, a grower shall record in the seed-to-sale tracking system:

(a) The date delivered; and

(b) The number of cuttings or seeds delivered or the weight of the seeds for each variety in the shipment.

(3) Requirements for Receipt of Material. A grower:

(a) Shall quarantine material that is received to be used to produce cannabis;

(b) Shall inspect material for defects, contamination, and compliance with a grower's specifications; and

(c) May not release material from quarantine until it:

(i) Passes inspection; and

(ii) Is determined acceptable for use as intended.

(4) Plant Tagging and Entry into Seed-to-Sale Tracking System.

(a) For each plant, as soon as practical, a grower shall:

(i) Create a unique identifier for each plant;

(ii) Assign each plant to a batch;

(iii) Enter information regarding the plant into the seed-to-sale tracking system;

(iv) Create a tag with the unique identifier and batch number; and

(v) Securely attach the tag to a plant container or plant.

(b) A tag shall be:

(i) Indelible and tamper-evident; and

(ii) Made of a material that resists variation in temperature and moisture.

(5) Control of Harvested Cannabis. A grower shall:

(a) Upon completion of curing or drying of each batch, weigh cannabis to update the seed-to-sale tracking system for the batch; and

(b) At least monthly, conduct a physical inventory of the stock and compare the physical inventory of stock with the stock reflected in seed-to-sale tracking system.

D. Quality Controls.

(1) Production and Process Controls.

(a) A grower shall cultivate each plant and produce each batch of cannabis in conformity with standard operating procedures.

(b) A grower shall record the cultivation process in accordance with standard operating procedures to ensure:

(i) Consistency of the batch with the variety; and

(ii) Accuracy of the day-to-day production.

(c) A grower shall record any deviation defined as a material change from the standard operating procedure which would impact the quality of the batch in the log.

(d) A grower may not release any batch of cannabis if there was any deviation in production of the batch from the standard operating procedure unless:

(i) After independent testing of the batch in accordance with the criteria set forth in COMAR 14.17.08.05A, the grower determines, as a result of such testing, that the batch meets the specification for the variety; and

(ii) The determination is recorded.

(2) During the process of cultivation, a grower shall regularly inspect each plant to ensure proper growth and absence of pests and disease.

(3) A grower shall hold cannabis in secure, segregated storage until released for distribution.

(4) A grower shall use an Administration-registered independent testing laboratory to test each batch of cannabis and obtain a certificate of analysis.

(5) Batch Release Controls.

(a) If a grower, upon review of the certificate of analysis, determines that a batch meets the specification for the variety, the grower may:

(i) Assign an expiration date to the batch;

(ii) Release the batch for distribution; and

(iii) Revise the status of the batch in the seed-to-sale tracking system.

(b) If a grower receives test results that do not meet specifications, the grower:

(i) Shall notify the Administration of the determination within 24 hours of receiving the test results;

(ii) May rework or reprocess the batch according to their standard operating procedure; and

(iii) If applicable, shall ensure the reworked or reprocessed batch is resampled and retested by the independent testing laboratory to confirm that all required specifications are met.

(c) If a batch is being transferred to a licensed processor for processing, the grower may release the batch for distribution without having a certificate of analysis or being sampled or tested by an independent testing laboratory.

(d) All cannabis products shall have a certificate of analysis, as specified in COMAR 14.17.08.05, prior to transfer to a licensed dispensary.

(6) A grower shall retain every certificate of analysis.

(7) Stability Testing and Retention Sampling.

(a) A grower shall provide a sample from each released batch to an independent testing laboratory sufficient to perform stability testing at 6-month intervals to:

(i) Ensure product potency and purity; and

(ii) Provide support for expiration dating.

(b) Retention samples retained from each released batch shall be:

(i) Tested by a registered independent testing laboratory other than the original certifying laboratory following an adverse event reported to the Administration;

(ii) Properly stored by the grower; and

(iii) Properly discarded 6 months after the expiration date of the batch.

E. Sanitation.

(1) Scales, surfaces, and other equipment use for the purposes of creating usable cannabis products shall be cleaned and sanitized:

(a) Between shifts;

(b) Between packaging, repackaging, or otherwise creation of usable cannabis products with different usable cannabis batches;

(c) Before beginning any packaging, repackaging, or other creation of usable cannabis products; and

(d) After the completion of any packaging or creation of usable cannabis products.

(2) A grower shall maintain an accurate log of cleaning and sanitation required under §E(1) of this regulation.

Md. Code Regs. 14.17.10.03

Regulation .03 adopted effective 50:14 Md. R. 559, eff. 7/1/2023 (EMERGENCY); adopted effective 51:14 Md. R. 676, eff. 6/7/2024, exp. 8/31/2024 (Emergency); adopted effective 51:14 Md. R. 678, eff. 7/22/2024.