<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.15.09.04" title_num="10" subtitle_num="15" chapter_num="09" heading="General Requirements.">
  <paragraph num="A.">
    <text>The Department shall ensure that all inspections, sampling, testing, and enforcement actions performed by the State are carried out as set forth in and in compliance with the standards, requirements, and procedures specified at:</text>
    <paragraph num="(1)">
      <text>Health-General Article, Title 21, Annotated Code of Maryland;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§321—350f;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535);</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Bulk Milk Hauler/Sampler Manual;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Maryland Laboratory Evaluation Program Manual;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Grade “A” Pasteurized Milk Ordinance, only:</text>
      <paragraph num="(a)">
        <text>Sections 5.—6.;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Standards for Grade “A” Raw Milk for Pasteurization, Ultra-Pasteurization, Aseptic Processing and Packaging or Retort Processed after Packaging, all Items except for Item 9r. Administrative Procedures 1.a.;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Standards for Grade “A” Pasteurized, Ultra-Pasteurized, Aseptically Processed and Packaged Low-Acid Milk and/or Milk Products, and Retort Processed after Packaged Low-Acid Milk and/or Milk Products, all Items except for Item 10p. Administrative Procedures 2.a., Item 11p. Administrative Procedures 2.a. and 6., Item 18p., and Item 19p.;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Section 8.;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Sections 12.—15.;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Section 18.;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Appendices A.—I.;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Appendices K.—O.; and</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Appendices R.—S.;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(7)">
      <text>Milk for Manufacturing Purposes and its Production and Processing, Recommended Requirements, only:</text>
      <paragraph num="(a)">
        <text>Subpart C, Sec. C12(a)(2)(ii) and C12(a)(3)(ii);</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Subpart E, Sec. E1, E 1.4(a)—(e);</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Subpart E, Sec. E1, E 1.15;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Subpart E, Sec. E1, E 1.16;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Subpart E, Sec. E 2, except for E 2.2.5, E 2.4.2, E 2.4.8, and E 2.4.9;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Subpart E, Sec. E 3;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Subpart E, Sec. E 4, except for E 4.3.2; and</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Subpart E, Sec. E 6; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(8)">
      <text>Beginning January 1, 2019, FDA Food Safety Modernization Act, 21 U.S.C. §§2201—2252, as amended.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>A person engaged in an occupation involving manufactured grade milk and milk products shall conduct all activities as set forth in and in compliance with the standards, requirements, and procedures specified in §A of this regulation.</text>
  </paragraph>
</regulation>