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<regulation prefix="Regulation" num=".02" citation="COMAR 10.15.01.02" title_num="10" subtitle_num="15" chapter_num="01" heading="Definitions.">
  <paragraph num="A.">
    <text>In this chapter, the following terms have the meanings indicated.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Terms Defined.</text>
    <paragraph num="(1)">
      <text>“Acid foods” means foods that have a natural pH of 4.6 or below.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Acidified Foods.</text>
      <paragraph num="(a)">
        <text>“Acidified foods” means low-acid foods to which acid or acids or acid food or acid foods are added and that have a:</text>
        <paragraph num="(i)">
          <text>Water activity (aw) greater than 0.85; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Finished equilibrium pH of 4.6 or below.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>“Acidified foods” includes, but is not limited to:</text>
        <paragraph num="(i)">
          <text>Beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish, singly or in combination; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Foods that are called, or may purport to be, “pickles” or “pickled”.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>“Acidified foods” does not include:</text>
        <paragraph num="(i)">
          <text>Carbonated beverages, jams, jellies, or preserves;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Acid foods that contain small amounts of low-acid food or foods and have a resultant finished equilibrium pH that does not significantly differ from that of the predominate acid or acid food, including such foods as standardized and nonstandardized food dressings and condiment sauces; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Foods that are stored, distributed, and retailed under refrigeration.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>“Canned foods” means foods that are heat treated and hermetically sealed in a container for preservation.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>“Commercially sterile” means the condition achieved by the:</text>
      <paragraph num="(a)">
        <text>Application of heat that renders the food free of:</text>
        <paragraph num="(i)">
          <text>Microorganisms capable of reproducing in the food under normal nonrefrigerated 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 that renders the food free of microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>“Culinary grade steam” means steam that is free of deleterious or harmful matter that might adulterate food.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>“Department” means the Maryland Department of Health or the Department's designee.</text>
    </paragraph>
    <paragraph num="(7)">
      <text>“Lot” means the product produced during a time period indicated by a specific code.</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Low-Acid Foods.</text>
      <paragraph num="(a)">
        <text>“Low-acid foods” means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>“Low-acid foods” does not include tomatoes and tomato products having a finished equilibrium pH less than 4.7.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(9)">
      <text>“Person-in-charge” means the licensee or other individual responsible for the overall conditions and operation of a cannery or acidified food processing plant.</text>
    </paragraph>
    <paragraph num="(10)">
      <text>“Process authority” means an individual having knowledge acquired through training about and experience with thermal processing requirements or the acidification and processing of acidified foods.</text>
    </paragraph>
    <paragraph num="(11)">
      <text>“Scheduled process” means the process selected by the processor as adequate under the conditions of manufacture that:</text>
      <paragraph num="(a)">
        <text>Is at a minimum equivalent to the process established by a process authority;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>For thermally processed low-acid foods packaged in hermetically sealed containers:</text>
        <paragraph num="(i)">
          <text>Achieves a commercially sterile product; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>May be in excess of that necessary to ensure destruction of microorganisms that cause disease;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>For acidified foods:</text>
        <paragraph num="(i)">
          <text>Achieves and maintains a food that will not permit the growth of microorganisms that cause disease; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Includes the control of pH and other critical factors; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>For thermally processed acid foods packaged in hermetically sealed containers:</text>
        <paragraph num="(i)">
          <text>Achieves a commercially sterile product; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Ensures the destruction of microorganisms that cause disease and prevents spoilage during the product's shelf life.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(12)">
      <text>“Thermal process validation study” means a scientific study conducted by a process authority to determine critical factors and establish and validate a food process.</text>
    </paragraph>
    <paragraph num="(13)">
      <text>“Water activity (aw)” means the measure of the free moisture in a product and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.</text>
    </paragraph>
  </paragraph>
</regulation>