<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".09" citation="COMAR 14.17.11.09" title_num="14" subtitle_num="17" chapter_num="11" heading="Edible Cannabis Product Processing — Storage of Ingredients and Edible Cannabis Products.">
  <paragraph num="A.">
    <text>All ingredients and edible cannabis products shall be kept in a secure controlled environment that:</text>
    <paragraph num="(1)">
      <text>Meets the requirements set forth in this chapter; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Is a dry storage area, refrigerated storage area, or freezer storage area.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Storage standard operating procedures shall preserve freshness, prevent contamination, and maintain cannabinoid content of any ingredients or edible cannabis products.</text>
  </paragraph>
  <paragraph num="C.">
    <text>Food ingredients may not be stored in the same areas as cannabis unless as outlined in standard operating procedures and approved by the Administration.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Storage equipment shall be positioned so that:</text>
    <paragraph num="(1)">
      <text>Storage surfaces are at least 6 inches:</text>
      <paragraph num="(a)">
        <text>Above the floors; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Away from the walls; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Ingredient contact surfaces are at least 18 inches above the floor.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Dry Storage Area.</text>
    <paragraph num="(1)">
      <text>A dry storage area shall be maintained between 50°F and 70°F.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A dry storage area shall have:</text>
      <paragraph num="(a)">
        <text>Adequate ventilation to remain below 60 percent relative humidity; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A thermometer and hygrometer in plain sight that are calibrated based on the manufacturer’s recommendations to ensure accuracy.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Refrigerated Storage Area.</text>
    <paragraph num="(1)">
      <text>A refrigerated storage area shall:</text>
      <paragraph num="(a)">
        <text>Be maintained at or below 40°F; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Have thermometers that are easily readable and accurate to plus or minus 2°F.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A permittee shall:</text>
      <paragraph num="(a)">
        <text>Position a temperature sensor to register the warmest air in the temperature-controlled space; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Have several thermometers throughout the area to ensure accuracy, consistency, and adequate cooling.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>A refrigerator unit shall have doors that close tightly and seal fully.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>In the case of a power outage, if the refrigerator unit:</text>
      <paragraph num="(a)">
        <text>Remains below 40°F for the duration of the power outage, the refrigerator contents are considered safe; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Rises above 40°F for more than 2 hours, then:</text>
        <paragraph num="(i)">
          <text>Any ingredients or edible cannabis products shall be discarded; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The permittee shall notify the Administration within 24 hours.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>If any ingredients or edible cannabis products that were stored in the refrigerator do not require temperature control for safety, a permittee may conduct a risk analysis to determine whether the ingredients or edible cannabis products remain safe for human consumption.</text>
  </paragraph>
  <paragraph num="H.">
    <text>The permittee shall maintain a record of any risk analysis conducted, the agent responsible for the risk analysis, and any ingredients or edible cannabis products that the permittee determines remain safe for human consumption.</text>
  </paragraph>
  <paragraph num="I.">
    <text>Freezer Storage Area.</text>
    <paragraph num="(1)">
      <text>A freezer storage area shall:</text>
      <paragraph num="(a)">
        <text>Be maintained at or below 0°F; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Have thermometers that are easily readable and accurate to plus or minus 2°F.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A permittee shall:</text>
      <paragraph num="(a)">
        <text>Position a temperature sensor to register the warmest air in the temperature-controlled space; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Have several thermometers throughout the area to ensure accuracy, consistency, and adequate cooling.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>A freezer unit shall have doors that close tightly and seal fully.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>In the case of a power outage, if the freezer unit:</text>
      <paragraph num="(a)">
        <text>Remains at or below 0°F for the duration of the power outage, its contents are considered safe; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Rises above 0°F for more than 2 hours, then:</text>
        <paragraph num="(i)">
          <text>Any ingredients or edible cannabis products that were stored in the freezer shall be discarded; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The permittee shall notify the Administration within 24 hours.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>If any ingredients or edible cannabis products that were stored in the freezer do not require temperature control for safety, a permittee may conduct a risk analysis to determine whether the ingredients or edible cannabis products remain safe for human consumption.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>The permittee shall maintain a record of any risk analysis conducted, the agent responsible for the risk analysis, and any ingredients or edible cannabis products that the permittee determines remain safe for human consumption.</text>
    </paragraph>
  </paragraph>
  <paragraph num="J.">
    <text>Potentially Hazardous Ingredients.</text>
    <paragraph num="(1)">
      <text>The internal temperature of a potentially hazardous ingredient shall:</text>
      <paragraph num="(a)">
        <text>Be kept at 41°F or less, or 135°F or greater; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>For ingredients with a non-proteolytic Clostridium botulinum potential hazard, be kept at 38°F or less during refrigerated storage.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>When the internal temperature of a potentially hazardous ingredient is kept at temperatures other than specified in §J(1) of this regulation:</text>
      <paragraph num="(a)">
        <text>A scheduled process approved by the Administration, specifying the temperature and amount of time at that temperature, shall be used; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Documentation of any corrective action taken and the agent responsible for monitoring the corrective action plan shall be kept for a minimum of 2 years and made available to the Administration upon request.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="K.">
    <text>All ingredients and edible cannabis products shall be clearly labeled and stored in a manner that:</text>
    <paragraph num="(1)">
      <text>Facilitates first-expired, first-out (FEFO) procedures; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Is approved by the Administration.</text>
    </paragraph>
  </paragraph>
  <paragraph num="L.">
    <text>Each temperature-controlled equipment unit shall have a temperature sensor visible from outside of the temperature-controlled equipment unit.</text>
  </paragraph>
  <paragraph num="M.">
    <text>For each dry storage area, refrigerator storage area, and freezer storage area, a permittee shall:</text>
    <paragraph num="(1)">
      <text>Monitor the temperature 24 hours a day, 365 days a year without interruption;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Document the temperature at least two times a day, 365 days a year without interruption; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>If outside the specified temperature range, document the time, date, any appropriate corrective action, and the agent responsible for monitoring the corrective action plan.</text>
    </paragraph>
  </paragraph>
  <paragraph num="N.">
    <text>Poisonous or Toxic Materials.</text>
    <paragraph num="(1)">
      <text>A permittee shall ensure that any poisonous or toxic materials are:</text>
      <paragraph num="(a)">
        <text>Kept in the original bulk container before use;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Prominently and distinctively marked or labeled for easy identification;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Used in accordance with manufacturer’s guidelines; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Not used or stored in a way that is likely to contaminate cannabis, ingredients, edible cannabis products, or packaging and labeling materials.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A permittee shall make a safety data sheet that is specific to any poisonous or toxic material available to each agent in a form that the agent understands.</text>
    </paragraph>
  </paragraph>
</regulation>