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<section article="ghg" article_name="Health - General" number="21-330.4" 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 the following words have the meanings indicated.</text>
    </level>
    <level label="2">
      <level label="i">
        <text>“Baby food” means food packaged in a jar, pouch, tub, or box sold specifically for babies and children under the age of 2 years.</text>
      </level>
      <level label="ii">
        <text>“Baby food” does not include infant formula, as defined in 21 U.S.C. § 321(z).</text>
      </level>
    </level>
    <level label="3">
      <text>“Manufacturer” includes a food manufacturer, food processor, and food packer.</text>
    </level>
    <level label="4">
      <text>“Production aggregate” means a quantity of product that is intended to have uniform composition, character, and quality and is produced according to a master manufacturing order.</text>
    </level>
    <level label="5">
      <text>“Proficient laboratory” means a laboratory that:</text>
      <level label="i">
        <text>Is accredited under the standards of the International Organization for Standardization/International Electrotechnical Commission 17025:2017;</text>
      </level>
      <level label="ii">
        <text>Uses an analytical method at least as sensitive as the analytical method described in Section 4.7 of the U.S. Food and Drug Administration Elemental Analysis Manual for Food and Related Products; and</text>
      </level>
      <level label="iii">
        <text>Demonstrates proficiency in quantifying each toxic element to at least 6 micrograms of the toxic element to kilogram of food through an independent proficiency test by achieving a z–score that is less than or equal to plus or minus two.</text>
      </level>
    </level>
    <level label="6">
      <text>“QR code” means a machine–readable code, consisting of an array of squares, used for storing an Internet website in order to access a webpage.</text>
    </level>
    <level label="7">
      <text>“Representative sample” means a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled.</text>
    </level>
    <level label="8">
      <text>“Toxic heavy metal” means arsenic, cadmium, lead, or mercury.</text>
    </level>
  </level>
  <level label="b">
    <level label="1">
      <text>Except as provided in paragraph (2) of this subsection, on or after January 1, 2025, a person may not sell, distribute, or offer for sale baby food in the State that contains toxic heavy metals that exceed the limits established by the U.S. Food and Drug Administration.</text>
    </level>
    <level label="2">
      <text>A person may sell, distribute, or offer for sale baby food manufactured before January 1, 2026.</text>
    </level>
  </level>
  <level label="c">
    <level label="1">
      <text>Beginning January 1, 2025, each manufacturer of baby food shall test a representative sample of each production aggregate of the manufacturer’s final baby food product for each toxic heavy metal.</text>
    </level>
    <level label="2">
      <text>The testing required under paragraph (1) of this subsection shall be conducted by a proficient laboratory at least once per month.</text>
    </level>
    <level label="3">
      <text>A manufacturer may test the final baby food product in accordance with paragraph (1) of this subsection before packaging individual units of baby food for sale or distribution.</text>
    </level>
  </level>
  <level label="d">
    <text>On the request of the Department, a manufacturer of baby food shall provide the results of the testing conducted under subsection (c) of this section to an authorized agent of the Department.</text>
  </level>
  <level label="e">
    <text>Beginning January 1, 2026, each manufacturer of baby food shall:</text>
    <level label="1">
      <text>Make publicly available on the manufacturer’s website for each baby food product sold, manufactured, delivered, held, or offered for sale in the State:</text>
      <level label="i">
        <text>The name and level of each toxic heavy metal present in the final baby food product as determined by the testing conducted under subsection (c) of this section;</text>
      </level>
      <level label="ii">
        <text>Sufficient information, such as the product name, universal product code, or lot or batch number, to enable consumers to identify the final baby food product; and</text>
      </level>
      <level label="iii">
        <text>A link to the U.S. Food and Drug Administration’s website that includes the most recent U.S. Food and Drug Administration guidance and information about the health effects of the toxic heavy metals on children; and</text>
      </level>
    </level>
    <level label="2">
      <text>If the baby food is tested for a toxic heavy metal subject to an action level, regulatory limit, or tolerance established by the U.S. Food and Drug Administration under 21 C.F.R. § 109, include on the baby food product label:</text>
      <level label="i">
        <text>The following statement: “For information about toxic element testing on this product, scan the QR code.”; and</text>
      </level>
      <level label="ii">
        <text>A QR code or other machine–readable code that allows consumers to access on the manufacturer’s website or the baby food product information page:</text>
        <level label="1">
          <text>The test results for the toxic heavy metals; and</text>
        </level>
        <level label="2">
          <text>A link to the webpage on the U.S. Food and Drug Administration website that includes the most recent guidance and information about the health effects of the toxic heavy metal on children.</text>
        </level>
      </level>
    </level>
  </level>
  <level label="f">
    <text>If a consumer believes, based on information gathered through the use of the code included on the baby food product label under subsection (e)(2) of this section, that baby food is being sold in the State with toxic heavy metals that exceed limits established by the U.S. Food and Drug Administration, the consumer shall report the baby food to the Department.</text>
  </level>
</section>
