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<regulation prefix="Regulation" num=".14" citation="COMAR 10.15.08.14" title_num="10" subtitle_num="15" chapter_num="08" heading="Plant Construction and Plan Submission.">
  <text>Pursuant to Health-General Article, §§21-410, 21-411, and 21-413 for construction, reconstruction, or extensive alteration of a milk facility, a person shall submit to the Department:</text>
  <paragraph num="A.">
    <text>A plan and specification before:</text>
    <paragraph num="(1)">
      <text>A plant is constructed, reconstructed, or extensively altered;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>An existing building or structure is converted or remodeled for use as a plant;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>A plant process is added, replaced, relocated, or modified; or</text>
    </paragraph>
    <paragraph num="(4)">
      <text>A clean-in-place (CIP), other washing system, or part of a CIP is added, modified, or replaced;</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>A plan and drawing bearing the name of a professional engineer or a representative of the company performing the work;</text>
  </paragraph>
  <paragraph num="C.">
    <text>Contact information for the facility, including:</text>
    <paragraph num="(1)">
      <text>The full name, title, and telephone number of each applicant;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The name of the plant;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The mailing address;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The location; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Directions to the site;</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>A narrative describing the scope and purpose of the project, including a projected timeline from start to completion;</text>
  </paragraph>
  <paragraph num="E.">
    <text>An estimate of the finished product output per day;</text>
  </paragraph>
  <paragraph num="F.">
    <text>A sample product label for each product;</text>
  </paragraph>
  <paragraph num="G.">
    <text>A list of the:</text>
    <paragraph num="(1)">
      <text>Type of raw milk cheese to be processed and sold;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Each raw ingredient and the ingredient source; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Single service container source;</text>
    </paragraph>
  </paragraph>
  <paragraph num="H.">
    <text>A scale drawing showing the layout and arrangement of an area within and around the plant, including the:</text>
    <paragraph num="(1)">
      <text>Processing area;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Chemical storage;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Dry storage;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Ingredient and product storage;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Receiving area;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Load out area;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Laboratory space;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Office;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Restroom facility;</text>
    </paragraph>
    <paragraph num="(10)">
      <text>Locker or similar storage facility for the storage of personal items; and</text>
    </paragraph>
    <paragraph num="(11)">
      <text>Separate area for employees to eat and drink beverages;</text>
    </paragraph>
  </paragraph>
  <paragraph num="I.">
    <text>A scale drawing showing the location of all equipment, including the:</text>
    <paragraph num="(1)">
      <text>Milk processing equipment;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Milk tank and silo;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>CIP system;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Glycol water tank;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Recirculating cooling water tank;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Boiler; and</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Boiler makeup tank;</text>
    </paragraph>
  </paragraph>
  <paragraph num="J.">
    <text>A scale drawing showing the location of plumbing and each plumbing fixture, including the:</text>
    <paragraph num="(1)">
      <text>Water line;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Sewer line;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Hand sink;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Toilet;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Utility sink;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Utensil washing sink;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Floor drain;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Floor sink;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Hose station; and</text>
    </paragraph>
    <paragraph num="(10)">
      <text>Back flow prevention device;</text>
    </paragraph>
  </paragraph>
  <paragraph num="K.">
    <text>A legend for each drawing;</text>
  </paragraph>
  <paragraph num="L.">
    <text>Specifications for:</text>
    <paragraph num="(1)">
      <text>Ventilation, including, but not limited to, the type and location of:</text>
      <paragraph num="(a)">
        <text>An air filter;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>An air pump; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>A compressor; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Construction material for the building and interior finish;</text>
    </paragraph>
  </paragraph>
  <paragraph num="M.">
    <text>A list and description of boiler, glycol, and recirculating water additive and water treatment;</text>
  </paragraph>
  <paragraph num="N.">
    <text>A description of the:</text>
    <paragraph num="(1)">
      <text>Type of disposal for wastewater and sewage;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Source and system for the facility’s potable water supply;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Lighting fixture and placement; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Recirculating cooling system;</text>
    </paragraph>
  </paragraph>
  <paragraph num="O.">
    <text>Each specification sheet, including manufacturer and model number of the plant equipment;</text>
  </paragraph>
  <paragraph num="P.">
    <text>A document that lists the flow for a products through the plant identifying each functional piece of equipment and each process used in processing and packaging;</text>
  </paragraph>
  <paragraph num="Q.">
    <text>A CIP flow diagram from the makeup tanks through all equipment;</text>
  </paragraph>
  <paragraph num="R.">
    <text>Information and drawings on how separation from product lines will be accomplished, if applicable;</text>
  </paragraph>
  <paragraph num="S.">
    <text>Written step by step standard operating procedures for:</text>
    <paragraph num="(1)">
      <text>Receiving, processing, aging, storing, and packaging of each type of farmstead cheese product;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Drug residue testing;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Cleaning and sanitization for all equipment;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Cleaning and sanitization for the facility;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Product trace back, inclusive of production/make sheet; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Product recall;</text>
    </paragraph>
  </paragraph>
  <paragraph num="T.">
    <text>Pest and mite control program;</text>
  </paragraph>
  <paragraph num="U.">
    <text>A specification and standard operating procedure for how wood shelving used in the aging of cheese will be:</text>
    <paragraph num="(1)">
      <text>Designed;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Installed;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Used;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Cleaned;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Sanitized;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Maintained; and</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Inspected by the farmstead cheese processor; and</text>
    </paragraph>
  </paragraph>
  <paragraph num="V.">
    <text>Employee training and personal hygiene practices.</text>
  </paragraph>
</regulation>