<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".06" citation="COMAR 14.17.11.06" title_num="14" subtitle_num="17" chapter_num="11" heading="Edible Cannabis Product Processing — Definitions.">
  <paragraph num="A.">
    <text>In Regulations .05—.14 of this chapter, the following terms have the meaning indicated.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Terms Defined.</text>
    <paragraph num="(1)">
      <text>“Approved source” means a source of:</text>
      <paragraph num="(a)">
        <text>Cannabis approved, licensed, and regulated by the Administration; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Food ingredients regulated by an approving authority.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>“Approving authority” means the agency designated in the laws of Maryland, another state, or another country to license or permit a food processing plant.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>“Commercially sterile” means the condition achieved by the:</text>
      <paragraph num="(a)">
        <text>Application of heat, pressure, or other energy or matter that renders a food ingredient free of:</text>
        <paragraph num="(i)">
          <text>Microorganisms capable of reproducing in the food ingredient under normal non-refrigerated conditions of storage and distribution; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Viable microorganisms, including spores, that cause disease; or</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Control of water activity and the application of heat, pressure, or other energy or matter that renders the food ingredient free of microorganisms capable of reproducing in the food ingredient under normal non-refrigerated conditions of storage and distribution.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>“Cookware” means items used during the processing of ingredients or edible cannabis products, including pots, pans, utensils, and containers.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>“Critical control point” means a point in the receiving, storage, processing, or distribution of ingredients or edible cannabis products where there is a reasonable likelihood that improper control may cause, allow, or contribute to a hazard to public health.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Critical Item.</text>
      <paragraph num="(a)">
        <text>“Critical item” means a safety requirement that if violated requires:</text>
        <paragraph num="(i)">
          <text>Immediate correction;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Destruction of any ingredients or edible cannabis products which may be affected;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>The cessation of some or all processing operations; or</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Closure of the licensed premises.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>“Critical item” includes the following requirements:</text>
        <paragraph num="(i)">
          <text>Food ingredients be obtained from an approved source and approved for human consumption by an approving authority;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Cannabis ingredients be obtained from an approved source;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>All ingredients and edible cannabis products be protected from contamination;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>All processes provide safe edible cannabis products with proper control at critical control points;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Licensed processor sanitation be adequate, provide safety, and prevent illness transmissible through edible cannabis products or ingredients;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Equipment allows for proper processing and sanitation;</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>Edible cannabis products be packaged and labeled for safety;</text>
        </paragraph>
        <paragraph num="(viii)">
          <text>A sufficient volume of potable hot and cold water supply under adequate pressure be available to facilitate proper handwashing procedures outlined in this chapter; and</text>
        </paragraph>
        <paragraph num="(ix)">
          <text>Sewage be discharged in compliance with applicable laws and regulations.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(7)">
      <text>“Food” means any substance that is used as food or drink for human beings or as a component of food or drink for human beings.</text>
    </paragraph>
    <paragraph num="(8)">
      <text>“Food ingredient” means a substance that is used as a component of food, including:</text>
      <paragraph num="(a)">
        <text>Flavoring;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Food coloring; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Preservatives.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(9)">
      <text>“Ingredient” means any component of an edible cannabis product that is intended for human consumption, approved by the Administration, and composed of:</text>
      <paragraph num="(a)">
        <text>Food or food ingredients; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Cannabis.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(10)">
      <text>“Permit” means a permit issued by the Administration to a licensed processor for the purpose of manufacturing edible cannabis products.</text>
    </paragraph>
    <paragraph num="(11)">
      <text>“Permittee” means a licensed processor authorized by the Administration to manufacture edible cannabis products.</text>
    </paragraph>
    <paragraph num="(12)">
      <text>Potentially Hazardous Edible Cannabis Product.</text>
      <paragraph num="(a)">
        <text>“Potentially hazardous edible cannabis product” means an edible cannabis product that requires temperature control because the product is in a form capable of supporting:</text>
        <paragraph num="(i)">
          <text>The rapid and progressive growth of infectious or toxigenic microorganisms; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The growth and toxin production of Clostridium botulinum.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>“Potentially hazardous edible cannabis product” does not include products with a water activity (aw) value of 0.85 or less.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(13)">
      <text>Potentially Hazardous Ingredient.</text>
      <paragraph num="(a)">
        <text>“Potentially hazardous ingredient” means a natural or synthetic component of food or an edible cannabis product intended for human consumption that requires temperature control because the ingredient is in a form capable of supporting the:</text>
        <paragraph num="(i)">
          <text>Rapid and progressive growth of infectious or toxigenic microorganisms; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Growth and toxin production of Clostridium botulinum.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>“Potentially hazardous ingredient” does not include an ingredient with a:</text>
        <paragraph num="(i)">
          <text>Water activity (aw) value of 0.85 or less;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Commercially sterile ingredient in a hermetically sealed container.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(14)">
      <text>“Quarantine area” means an area within a licensed premise in which ingredients, cannabis, or cannabis finished products that may be contaminated are temporarily stored prior to disposal or collection by a public health agency.</text>
    </paragraph>
  </paragraph>
</regulation>