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<regulation prefix="Regulation" num=".05" citation="COMAR 26.04.14.05" title_num="26" subtitle_num="04" chapter_num="14" heading="Exempt and Excluded Materials.">
  <paragraph num="A.">
    <text>The packaging and paper products identified in §§B and C of this regulation are exempt or excluded in this chapter.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Packaging.</text>
    <paragraph num="(1)">
      <text>Statutorily-exempt Materials. The following materials are exempt from the definition of a covered material, as specified in
                    Environment Article, §9-2501, Annotated Code of Maryland:</text>
      <paragraph num="(a)">
        <text>Primary packaging for infant formula, as defined in 21 U.S.C. § 321(Z);</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Primary packaging for medical food, as defined in 21 U.S.C. § 360EE(B)(3);</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Primary packaging for a fortified oral nutritional supplement, or food which is formulated to be consumed or administered enterally for individuals who are unable to consume nutrition orally, used by individuals who require supplemental or sole source nutrition to meet nutritional or special dietary needs directly related to the following conditions as defined by the International Classification of Diseases, Tenth Revision:</text>
        <paragraph num="(i)">
          <text>Cancer;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Chronic kidney disease;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Diabetes;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Malnutrition; or</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Failure to thrive;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>Primary packaging for a product regulated as a drug or medical device by the U.S. Food and Drug Administration, including associated components and consumable medical equipment;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Primary packaging for medical equipment or a product used in medical settings that is regulated by the U.S. Food and Drug Administration, including associated components and consumable medical equipment;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Primary packaging for drugs, biological products, parasiticides, medical devices, or in vitro diagnostics that are used to treat, or that are administered to, animals and are regulated by:</text>
        <paragraph num="(i)">
          <text>The U.S. Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The U.S. Department of Agriculture under the Federal Virus–Serum–Toxin Act;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(g)">
        <text>Primary packaging for products regulated by the U.S. Environmental Protection Agency under the Federal Insecticide, Fungicide, and Rodenticide Act;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Primary packaging used to contain liquefied petroleum gas and designed to be refilled;</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Primary packaging used to contain hazardous or flammable products regulated under the 2012 Federal Occupational Safety and Health Administration Hazard Communication Standard that prevent the packaging from being waste reduced or made reusable, recyclable, or compostable, as determined by the department;</text>
      </paragraph>
      <paragraph num="(j)">
        <text>Primary packaging for products subject to the paint stewardship program under Environment Article, Title 9, Subtitle 17, Part V, Annotated Code of Maryland;</text>
      </paragraph>
      <paragraph num="(k)">
        <text>Material that a producer distributes to another producer that is:</text>
        <paragraph num="(i)">
          <text>Subsequently used to contain a product, and the product is distributed to a commercial business or entity; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Packaging material that is not introduced to a person other than the commercial or business entity that first received the product; or</text>
        </paragraph>
      </paragraph>
      <paragraph num="(l)">
        <text>Primary packaging used for the long–term protection or storage of a product that has a lifespan of not less than 5 years, as determined by the Department;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Beverage containers covered under a legislatively-mandated beverage container deposit return program in the State; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Packaging that is designed to be ingested.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Paper Products. The following paper products are exempt from the definition of a covered material:</text>
    <paragraph num="(1)">
      <text>Statutorily exempt material including:</text>
      <paragraph num="(a)">
        <text>Newsprint subject to
                      Environment Article, §9–1707, Annotated Code of Maryland; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A paper product used for a magazine’s print publication that has a circulation of less than 95,000 and that primarily includes content derived from primary sources related to news and current events;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Bound books as defined in this chapter; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Products that are not accepted by materials recycling facilities or composting facilities because of the unsafe or unsanitary nature of the products.</text>
    </paragraph>
  </paragraph>
</regulation>