<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".03" citation="COMAR 14.17.10.03" title_num="14" subtitle_num="17" chapter_num="10" heading="Cannabis Grower Controls.">
  <paragraph num="A.">
    <text>Receipt of Material.</text>
    <paragraph num="(1)">
      <text>A grower shall quarantine material that is received to produce cannabis.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A grower shall inspect material for defects, contamination, and compliance with a grower’s specifications.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Material may not be released from quarantine by a grower until the material:</text>
      <paragraph num="(a)">
        <text>Passes inspection; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Is determined to be acceptable for use as intended.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Growing Cannabis.</text>
    <paragraph num="(1)">
      <text>Horticultural Controls.</text>
      <paragraph num="(a)">
        <text>Water. The grower shall keep a record of water quality testing on-site and make it available for inspection.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Fertilizer. As part of the standard operating procedure, a grower shall:</text>
        <paragraph num="(i)">
          <text>Adopt a nutrient management plan prepared by a certified nutrient management consultant;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Use fertilizer or hydroponic solution of a type, formulation, and at a rate, to support healthy growth of cannabis; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Maintain records of the type and amounts of fertilizer and any growth additives used.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Unless the cannabis is field grown, a grower shall install, as part of the standard operating procedure, a system to monitor, record, and regulate:</text>
        <paragraph num="(i)">
          <text>Temperature;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Humidity;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Ventilation; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Lighting, if used.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>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.</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Pest Monitoring. A grower shall use integrated pest management practices and techniques to identify and manage plant pathogen and pest problems, including:</text>
        <paragraph num="(i)">
          <text>A door control system sufficient to prevent pest entry;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Regular visual inspection of plants and growing areas for the presence of pests;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>The use of sticky cards in growing areas, when applicable; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Identification and recording of all pests or pathogens detected and the measures taken for control.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(f)">
        <text>Pest Control. Pesticide applicators and applications shall follow State and federal pesticide requirements for any pesticide applied.</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Sanitation. Sanitation shall comply with the grower’s standard operating procedures.</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Green Waste. A grower shall weigh, document, and destroy all green waste in accordance with the standard operating procedures.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Equipment. A grower shall:</text>
      <paragraph num="(a)">
        <text>Maintain equipment that comes in contact with cannabis to prevent contamination;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Maintain cleaning and equipment maintenance logs;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Ensure all scales are National Type Evaluation Program-approved;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Have any scale, balance, or other measurement device, and any automatic, mechanical, or electronic equipment:</text>
        <paragraph num="(i)">
          <text>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</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Checked at least once per month to ensure accuracy; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(e)">
        <text>Make records and certifications required under §B(2)(c) and (d) of this regulation available to the Administration available upon request.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Inventory Controls.</text>
    <paragraph num="(1)">
      <text>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:</text>
      <paragraph num="(a)">
        <text>Licensed processor; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Licensed dispensary.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Upon receipt of raw material for cultivation, a grower shall record in the seed-to-sale tracking system:</text>
      <paragraph num="(a)">
        <text>The date delivered; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The number of cuttings or seeds delivered or the weight of the seeds for each variety in the shipment.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Requirements for Receipt of Material. A grower:</text>
      <paragraph num="(a)">
        <text>Shall quarantine material that is received to be used to produce cannabis;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Shall inspect material for defects, contamination, and compliance with a grower’s specifications; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>May not release material from quarantine until it:</text>
        <paragraph num="(i)">
          <text>Passes inspection; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Is determined acceptable for use as intended.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Plant Tagging and Entry into Seed-to-Sale Tracking System.</text>
      <paragraph num="(a)">
        <text>For each plant, as soon as practical, a grower shall:</text>
        <paragraph num="(i)">
          <text>Create a unique identifier for each plant;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Assign each plant to a batch;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Enter information regarding the plant into the seed-to-sale tracking system;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Create a tag with the unique identifier and batch number; and</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Securely attach the tag to a plant container or plant.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>A tag shall be:</text>
        <paragraph num="(i)">
          <text>Indelible and tamper-evident; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Made of a material that resists variation in temperature and moisture.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Control of Harvested Cannabis. A grower shall:</text>
      <paragraph num="(a)">
        <text>Upon completion of curing or drying of each batch, weigh cannabis to update the seed-to-sale tracking system for the batch; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>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.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Quality Controls.</text>
    <paragraph num="(1)">
      <text>Production and Process Controls.</text>
      <paragraph num="(a)">
        <text>A grower shall cultivate each plant and produce each batch of cannabis in conformity with standard operating procedures.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A grower shall record the cultivation process in accordance with standard operating procedures to ensure:</text>
        <paragraph num="(i)">
          <text>Consistency of the batch with the variety; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Accuracy of the day-to-day production.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>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.</text>
      </paragraph>
      <paragraph num="(d)">
        <text>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:</text>
        <paragraph num="(i)">
          <text>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</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The determination is recorded.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>During the process of cultivation, a grower shall regularly inspect each plant to ensure proper growth and absence of pests and disease.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>A grower shall hold cannabis in secure, segregated storage until released for distribution.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>A grower shall use an Administration-registered independent testing laboratory to test each batch of cannabis and obtain a certificate of analysis.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Batch Release Controls.</text>
      <paragraph num="(a)">
        <text>If a grower, upon review of the certificate of analysis, determines that a batch meets the specification for the variety, the grower may:</text>
        <paragraph num="(i)">
          <text>Assign an expiration date to the batch;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Release the batch for distribution; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Revise the status of the batch in the seed-to-sale tracking system.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>If a grower receives test results that fall outside action limits, the grower:</text>
        <paragraph num="(i)">
          <text>May rework or reprocess the batch according to their standard operating procedure; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>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.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>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.</text>
      </paragraph>
      <paragraph num="(d)">
        <text>All cannabis products shall have a certificate of analysis, as specified in COMAR 14.17.08.05, prior to transfer to a licensed dispensary.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>A grower shall retain every certificate of analysis.</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Stability Testing and Retention Sampling.</text>
      <paragraph num="(a)">
        <text>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:</text>
        <paragraph num="(i)">
          <text>Ensure product potency and purity; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Provide support for expiration dating.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Retention samples retained from each released batch shall be:</text>
        <paragraph num="(i)">
          <text>Tested by a registered independent testing laboratory other than the original certifying laboratory following an adverse event reported to the Administration;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Properly stored by the grower; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Properly discarded 6 months after the expiration date of the batch.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Sanitation.</text>
    <paragraph num="(1)">
      <text>Scales, surfaces, and other equipment use for the purposes of creating usable cannabis products shall be cleaned and sanitized:</text>
      <paragraph num="(a)">
        <text>Between shifts;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Between packaging, repackaging, or otherwise creation of usable cannabis products with different usable cannabis batches;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Before beginning any packaging, repackaging, or other creation of usable cannabis products; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>After the completion of any packaging or creation of usable cannabis products.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A grower shall maintain an accurate log of cleaning and sanitation required under §E(1) of this regulation.</text>
    </paragraph>
  </paragraph>
</regulation>