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<section article="ghg" article_name="Health - General" number="21-336" title_number="21" title_name="Food, Drugs, and Cosmetics" subtitle_number="3" subtitle_name="Food Establishments">
  <level label="a">
    <level label="1">
      <text>In this section, “approved source” means a source of water that is:</text>
      <level label="i">
        <text>Sampled and found through laboratory analysis to comply with:</text>
        <level label="1">
          <text>The microbiological standards adopted by the Department, with testing on a monthly basis; and</text>
        </level>
        <level label="2">
          <text>The chemical and radiological standards adopted by the Department, which shall meet or exceed the standards prescribed by the federal Food and Drug Administration, with testing annually for chemical analyses and once every 4 years for radiological analyses; and</text>
        </level>
      </level>
      <level label="ii">
        <text>If applicable, constructed and inspected in accordance with regulations adopted by the Department of the Environment under §§ 9–204, 9–1305, and 9–1306 of the Environment Article.</text>
      </level>
    </level>
    <level label="2">
      <text>“Approved source” includes:</text>
      <level label="i">
        <text>An artesian well;</text>
      </level>
      <level label="ii">
        <text>A drilled well;</text>
      </level>
      <level label="iii">
        <text>A glacier;</text>
      </level>
      <level label="iv">
        <text>A public water supply;</text>
      </level>
      <level label="v">
        <text>A spring; and</text>
      </level>
      <level label="vi">
        <text>A source of mineral water that complies with the standards specified in paragraph (1) of this subsection but fails to meet the standards with respect to those properties of mineral water related to the limitations on chloride, iron, manganese, sulfate, total dissolved solids, zinc, or any other exemptions listed under 21 C.F.R. 165.110.</text>
      </level>
    </level>
    <level label="3">
      <text>The Department may approve a source that does not meet standards regulated by the United States Environmental Protection Agency as a secondary standard if the bottler shows by analysis that a particular treatment used reduces the level of contaminants in the bottled water to a level below the maximum contaminant level.</text>
    </level>
  </level>
  <level label="b">
    <text>The requirements of this section are in addition to any other provision of law.</text>
  </level>
  <level label="c">
    <text>Artesian water, mineral water, natural water, purified water, spring water, well water, and any other type of bottled water shall meet the requirements of the standard of identity for bottled water under 21 C.F.R. 165.110(a).</text>
  </level>
  <level label="d">
    <level label="1">
      <text>A person may not bottle water unless the person is licensed by the Department under § 21–305 of this subtitle.</text>
    </level>
    <level label="2">
      <text>The Department may not issue a license if the Department determines that the water is:</text>
      <level label="i">
        <text>Not from an approved source; or</text>
      </level>
      <level label="ii">
        <text>In any way injurious to the public health.</text>
      </level>
    </level>
    <level label="3">
      <text>To apply for a license to bottle water, a bottler shall:</text>
      <level label="i">
        <text>Submit an application to the Department on the form that the Department requires;</text>
      </level>
      <level label="ii">
        <text>List on the application form the types of bottled water that the applicant proposes to bottle; and</text>
      </level>
      <level label="iii">
        <text>Pay to the Department an annual fee established by the Secretary under § 2–104 of this article.</text>
      </level>
    </level>
    <level label="4">
      <text>While it is effective, a license to bottle water authorizes a bottler to bottle and sell in the State the types of bottled water identified in the license.</text>
    </level>
  </level>
  <level label="e">
    <level label="1">
      <level label="i">
        <text>A person who is licensed under this section shall submit to the Department the results of:</text>
        <level label="1">
          <text>Annual chemical and radiological analyses of a representative sample of the person’s source water and bottled water; and</text>
        </level>
        <level label="2">
          <text>A monthly microbiological analysis of a representative sample of the source water and bottled water.</text>
        </level>
      </level>
      <level label="ii">
        <text>The analyses shall demonstrate that the source water and bottled water comply with the chemical, radiological, and microbiological standards adopted by the Department, which shall meet or exceed the standards prescribed by the federal Food and Drug Administration.</text>
      </level>
      <level label="iii">
        <level label="1">
          <text>Except as otherwise required by law, mineral water is not subject to the limitations on chloride, iron, manganese, sulfate, total dissolved solids, zinc, or any other exemptions listed under 21 C.F.R. 165.110.</text>
        </level>
        <level label="2">
          <text>Bottled water may not exceed:</text>
        </level>
        <level label="A">
          <text>10 parts per billion of total trihalomethanes;</text>
        </level>
        <level label="B">
          <text>5 parts per billion of lead; or</text>
        </level>
        <level label="C">
          <text>100 parts per billion of chlorine.</text>
        </level>
      </level>
    </level>
    <level label="2">
      <level label="i">
        <text>Analyses required under this subsection may be performed by a laboratory certified by:</text>
        <level label="1">
          <text>A state’s Laboratory Certification Program in accordance with the United States Environmental Protection Agency’s primacy conditions under the Agency’s Public Water System Supervision Program; or</text>
        </level>
        <level label="2">
          <text>The United States Environmental Protection Agency.</text>
        </level>
      </level>
      <level label="ii">
        <text>The Department shall accept analyses performed by any laboratory authorized under subparagraph (i) of this paragraph.</text>
      </level>
    </level>
    <level label="3">
      <text>A person licensed or registered under this section shall:</text>
      <level label="i">
        <text>For at least 2 years, maintain all inspection and sampling records at the person’s principal place of business; and</text>
      </level>
      <level label="ii">
        <text>Make inspection and sampling records available to the Department upon request.</text>
      </level>
    </level>
    <level label="4">
      <text>Notwithstanding the analyses required under paragraph (1) of this subsection, the Department may sample and analyze any bottled water.</text>
    </level>
    <level label="5">
      <text>The provisions of this subsection do not prevent the Department from prohibiting the use or sale of bottled water in the State, if, in the judgment of the Department:</text>
      <level label="i">
        <text>The water is shown by analysis to be unfit for drinking;</text>
      </level>
      <level label="ii">
        <text>The water has been misbranded under § 21–210 of this title; or</text>
      </level>
      <level label="iii">
        <text>Its quality is in any way injurious to the public health.</text>
      </level>
    </level>
  </level>
  <level label="f">
    <text>Bottled water in individual containers shall be marked on each container with a stencil, stamp, or label that clearly indicates:</text>
    <level label="1">
      <text>The identifying batch code for the water; and</text>
    </level>
    <level label="2">
      <text>In compliance with subsection (g) of this section, the type of water and any additional ingredients.</text>
    </level>
  </level>
  <level label="g">
    <text>Labeling of the type of bottled water and any additional ingredients, as required under subsection (f) of this section, shall conform to the labeling requirements for bottled water under 21 C.F.R. 165.110(a).</text>
  </level>
  <level label="h">
    <text>In accordance with regulations adopted by the Department, a person licensed under this section shall establish written procedures and implement those procedures to:</text>
    <level label="1">
      <text>Prevent contamination during the processing, packaging, transportation, or storage of bottled water; and</text>
    </level>
    <level label="2">
      <text>Recall bottled water when the person, the Department, or any other government agency determines that a supply is injurious in any way to the public health.</text>
    </level>
  </level>
  <level label="i">
    <text>The Department may suspend or revoke a license issued under this section if the licensee:</text>
    <level label="1">
      <text>Violates or fails to satisfy any requirement of this title or any regulation adopted under this title; or</text>
    </level>
    <level label="2">
      <text>Fraudulently or deceptively obtains a license.</text>
    </level>
  </level>
  <level label="j">
    <level label="1">
      <text>In addition to any other penalty applicable at law, a person who violates any provision of this section shall be liable for a civil penalty of:</text>
      <level label="i">
        <text>Not less than $1,000 and not more than $5,000 for a first offense; and</text>
      </level>
      <level label="ii">
        <text>Not less than $5,000 and not more than $10,000 for a second offense within 2 years of the first offense.</text>
      </level>
    </level>
    <level label="2">
      <text>Each day on which a violation occurs constitutes a separate offense.</text>
    </level>
  </level>
  <level label="k">
    <text>By October 1, 2008, the Department shall adopt regulations to implement the provisions of this section.</text>
  </level>
  <level label="l">
    <level label="1">
      <text>The Department shall establish a Bottled Water Advisory Committee to advise and assist the Department in the development and adoption of the regulations required under subsection (k) of this section.</text>
    </level>
    <level label="2">
      <text>The Advisory Committee shall consist of the following representatives:</text>
      <level label="i">
        <text>The Secretary of Health or the Secretary’s designee, who shall serve as chairman of the Advisory Committee;</text>
      </level>
      <level label="ii">
        <text>The Secretary of the Environment or the Secretary’s designee;</text>
      </level>
      <level label="iii">
        <text>A hydrogeologist;</text>
      </level>
      <level label="iv">
        <text>At least two individuals from the bottled water processing industry;</text>
      </level>
      <level label="v">
        <text>At least one individual from the bottled water distribution industry;</text>
      </level>
      <level label="vi">
        <text>At least one individual from the environmental community or consumer advocacy community; and</text>
      </level>
      <level label="vii">
        <text>At least one consumer of bottled water.</text>
      </level>
    </level>
  </level>
</section>
