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<regulation prefix="Regulation" num=".01" citation="COMAR 10.51.03.01" title_num="10" subtitle_num="51" chapter_num="03" heading="License — General.">
  <paragraph num="A.">
    <text>General Requirements.</text>
    <paragraph num="(1)">
      <text>A person shall obtain a license from the Secretary before performing or offering to perform a forensic analysis in this State.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A person may not perform or offer to perform forensic analysis without first obtaining a forensic laboratory license from the Secretary.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Letter of Permit Exception.</text>
      <paragraph num="(a)">
        <text>The Secretary may grant an individual a letter of permit exception if:</text>
        <paragraph num="(i)">
          <text>The individual is not affiliated with a public or commercial laboratory that performs forensic analyses;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The application for the letter of permit exception is limited to an individual performing limited forensic analysis in a discipline or subdiscipline; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>The individual applying for the letter of permit exception has documentation that demonstrates the individual’s competency and experience in the specific forensic discipline or subdiscipline in which the forensic analysis will be performed.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>The individual who will perform the forensic analysis shall:</text>
        <paragraph num="(i)">
          <text>Submit an application for a letter of permit exception to the Department for approval;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Renew a letter of permit exception every 3 years from the date of issuance, if renewal is desired;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Be subject to oversight by the Department; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Be subject to the sanctions set forth in COMAR 10.51.07.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Waiver.</text>
      <paragraph num="(a)">
        <text>The Secretary may grant to a forensic laboratory not located in this State, a waiver from the licensing requirements of this subtitle if:</text>
        <paragraph num="(i)">
          <text>The forensic analysis or examination is not performed by a licensee;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The waiver is limited to a single case or related cases; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>The person requesting the waiver has documentation that demonstrates the forensic laboratory’s competency and quality.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>A licensee, a party to a criminal case or related cases, or the forensic laboratory that has been requested to perform a forensic analysis shall:</text>
        <paragraph num="(i)">
          <text>Submit a request for a waiver for approval by the Department; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Make requests in accordance with the process established by the Department.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>The Department may require an out-of-State laboratory that has been waived for licensure to apply for licensure based on the number of waivers issued to that laboratory by the Department.</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The Department may deny a waiver if:</text>
        <paragraph num="(i)">
          <text>The Department determines the laboratory has been the subject of frequent waiver requests and the laboratory has failed to apply for licensure; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The laboratory’s license application was denied or its license was suspended or revoked by the Department.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Prohibited Analyses. The Secretary may impose principal and alternative sanctions as set forth in this subtitle if a person performs or offers to perform a forensic analysis or part of a forensic analysis, including the use of a reagent, supply, procedure, method, technique, kit, or equipment, that:</text>
      <paragraph num="(a)">
        <text>Does not produce accurate or reliable forensic analysis results as evidenced by documented, independent scientific testing and evaluation; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Lacks proof of efficacy substantiated by independently conducted and documented scientifically based evidence.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Limitation. A person may not operate a forensic laboratory in a forensic science discipline or subdiscipline other than what is listed on the license unless it is a discipline or subdiscipline listed under COMAR 10.51.01.02C .</text>
  </paragraph>
  <paragraph num="C.">
    <text>Application Eligibility. A person meeting the requirements and standards of this subtitle and the requirements set forth in Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland, may apply for a forensic laboratory permit.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Issuance.</text>
    <paragraph num="(1)">
      <text>Permit. The Secretary may issue a permit that:</text>
      <paragraph num="(a)">
        <text>Is valid for not more than 3 years from the date of issue; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Shall be renewed before the date of expiration if a person intends to operate the forensic laboratory in the succeeding permit period.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Site License Required. A person shall obtain a separate license for each location at which the person maintains a site to perform forensic analyses.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>In order to maintain a State license issued by the Department pursuant to this subtitle, a licensee shall be in compliance with all applicable federal, State, and local requirements.</text>
  </paragraph>
</regulation>