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<regulation prefix="Regulation" num=".08" citation="COMAR 10.15.08.08" title_num="10" subtitle_num="15" chapter_num="08" heading="Examination and Standards of Raw Milk, Farmstead Cheese Finished Products, and Water Supply.">
  <paragraph num="A.">
    <text>Raw Milk Sampling and Testing Standards.</text>
    <paragraph num="(1)">
      <text>The farmstead cheese processor is responsible for the collection and cost associated with the sampling and testing of raw milk used for the manufacture of farmstead cheese;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Sampling shall be conducted by an industry plant sampler;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The raw milk used for the manufacture of farmstead cheese shall be tested monthly for:</text>
      <paragraph num="(a)">
        <text>Bacteria;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Drug residue;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Temperature;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Odor; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Appearance.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Raw Milk Quality Standards.</text>
    <paragraph num="(1)">
      <text>A standard plate count of raw milk for farmstead cheese may not exceed 500,000 per milliliter;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Raw milk shall meet the following drug residue standards:</text>
      <paragraph num="(a)">
        <text>Raw milk for farmstead cheese shall be negative for drug residue.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Before processing, the industry plant sampler shall collect a representative sample of raw milk used in the manufacture of farmstead cheese; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>An official laboratory or officially designated laboratory shall conduct drug residue testing for the presence of drug residue in accordance with the Grade “A” Pasteurized Milk Ordinance, Appendix N.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Raw milk shall meet the following temperature standards:</text>
      <paragraph num="(a)">
        <text>Raw milk for farmstead cheese shall be cooled to 7°C (45°F) or less within two hours after initial milking;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The blend temperature after the first and subsequent milkings may not exceed 10°C (50°F).</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Raw milk for farmstead cheese shall be cooled to and maintained at a temperature not to exceed 7°C (45°F).</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>The appearance and odor of raw milk used for farmstead cheese shall be free from:</text>
      <paragraph num="(a)">
        <text>Objectionable feed;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Off odors; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Abnormalities.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>In accordance with the Department, an official laboratory or officially designated laboratory shall test a composite milk sample and shall rate it “acceptable for use” if there is no actionable residue for:</text>
      <paragraph num="(a)">
        <text>Radionuclides;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Pesticides; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Herbicides.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>Added water shall be tested on an individual producer’s milk in accordance with the Department’s official laboratory or officially designated laboratory and rated “acceptable for use” if the test result is -0.540°H or less.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Farmstead Cheese Finished Product Sampling.</text>
    <paragraph num="(1)">
      <text>The farmstead cheese processor is responsible for the collection and cost associated with the sampling and testing of a finished farmstead cheese product;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Sampling shall be conducted by an industry plant sampler;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The initial three finished products of each farmstead cheese shall be tested for:</text>
      <paragraph num="(a)">
        <text>Salmonella;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Escherichia coli (E. coli);</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Listeria monocytogenes;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Staphylococcus aureus;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Enterohemorrhagic E. coli (0157:H7); and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Percent moisture.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>The finished product of each farmstead cheese shall be tested annually and is in accordance with §C(3) of this regulation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Farmstead Cheese Finished Product Quality Standards. The farmstead cheese finished product:</text>
    <paragraph num="(1)">
      <text>Shall test negative for Salmonella, Enterohemorrhagic E. coli (0157:H7), and Listeria monocytogenes;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Shall test less than 10 cfu/gram for E. coli and Staphylococcus aureus; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>May not be greater than 39 percent moisture.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Farmstead Cheese Processing Standards. The farmstead cheese:</text>
    <paragraph num="(1)">
      <text>Finished product shall be aged at least 60 calendar days before offering for sale;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Shall be aged or cured at a temperature of not less than 35°F; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Finished product may not contain more than 39 percent moisture at the end of the aging period.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>The farmstead cheese processor shall ensure that the result of all tested farmstead cheese finished products are submitted and approved by the Department before further processing or sale of the farmstead cheese.</text>
  </paragraph>
  <paragraph num="G.">
    <text>The Department may request that the farmstead cheese processor have the farmstead cheese finished product tested, as needed, as set forth in the United States Food and Drug Administration Food Compliance Program, “Domestic and Imported Cheese and Cheese Products,” to ensure compliance with this regulation.</text>
  </paragraph>
  <paragraph num="H.">
    <text>Water Samples.</text>
    <paragraph num="(1)">
      <text>Samples for bacteriological testing of the plant water supply and, if applicable, any other water used for cooling and processing shall be collected:</text>
      <paragraph num="(a)">
        <text>Upon the initial approval of the physical structure;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Every 6 months thereafter; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>When any repair or alteration to the water supply system has been made.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Plant water for testing shall be obtained from a potable water supply system that complies with Regulation .15A of this chapter.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Samples shall be taken by the Department and examined by an official laboratory.</text>
    </paragraph>
  </paragraph>
  <paragraph num="I.">
    <text>Record Keeping Required.</text>
    <paragraph num="(1)">
      <text>Current written step by step standard operating procedures are required for:</text>
      <paragraph num="(a)">
        <text>Product trace back;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Product recalls;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Drug residue testing;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Cleaning of the equipment and facility;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Sanitizing equipment and product contact surfaces;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Receiving, processing, aging, storage, and packaging of each type of farmstead cheese produced;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Pest control and preventative maintenance; and</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Employee training including personal hygiene practices;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Processing records shall include the:</text>
      <paragraph num="(a)">
        <text>Product being manufactured;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Drug residue testing as set forth in the Grade “A” Pasteurized Milk Ordinance, Appendix N;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Date and result of the raw milk testing;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Date and result of the finished farmstead cheese product tested;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>The pH of each batch after inoculation at 5 hours, 24 hours, and the end of aging; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Raw ingredient:</text>
        <paragraph num="(i)">
          <text>Origin;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Storage;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Transportation; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Other information required by the Department; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(g)">
        <text>Temperature, as set forth in Regulation .07 of this chapter.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>For each batch of farmstead cheese produced, a make record shall be maintained and include:</text>
      <paragraph num="(a)">
        <text>The name of the product being produced;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The temperature of the milk being used;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>A unique identifier assigned at the start of the production of that batch of cheese shall be:</text>
        <paragraph num="(i)">
          <text>Used to track each batch of cheese through the production process; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Included on the product label;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>The amount of product being produced;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>The name and amount of each ingredient added;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>The cook temperature;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>The pH of the product after inoculation at 5 hours, 24 hours, and the end of aging; and</text>
      </paragraph>
      <paragraph num="(h)">
        <text>The production date for the product which is the date the batch entered the aging room to start the aging process; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Each record shall be available to the Department for review during each inspection.</text>
    </paragraph>
  </paragraph>
</regulation>