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<chapter num="08" heading="Laboratory Registration and Operations" title_num="14" subtitle_num="17">
  <regulation prefix="Regulation" num=".01" heading="Definitions.">
    <paragraph num="A.">
      <text>In this chapter, the following terms have the meanings indicated.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Terms Defined.</text>
      <paragraph num="(1)">
        <text>“Accreditation body” means a nonprofit, impartial organization that requires conformance to 17025 ISO/IEC requirements and is a signatory to the international laboratory accreditation cooperation (ILAC) mutual recognition arrangement for testing.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>“Cannabis industry” means all cannabis registrants, licensees, and their agents in Maryland.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="Independent Testing Laboratory Registration.">
    <paragraph num="A.">
      <text>An independent testing laboratory shall register with the Administration.</text>
    </paragraph>
    <paragraph num="B.">
      <text>To register, an independent laboratory shall:</text>
      <paragraph num="(1)">
        <text>Submit a completed independent laboratory registration form;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Pay the registration fee specified in COMAR 14.17.21;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Submit a copy of the certificate of accreditation accompanied by the scope of accreditation; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Submit the name, address, date of birth, and Social Security Number or Individual Taxpayer Identification Number of each independent testing laboratory employee and a copy of the application form completed by each independent testing laboratory employee.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>The Administration may issue a provisional registration to an independent testing laboratory that has not yet been issued a certificate of accreditation in Maryland if the independent testing laboratory submits:</text>
      <paragraph num="(1)">
        <text>A copy of the contract with the accreditation body with which it is applying to become accredited and a copy of the proposed scope of the accreditation;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Evidence the independent testing laboratory has been accredited by the accreditation body in another jurisdiction; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>All other required components listed in §B of this regulation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>Once it has obtained a certificate of accreditation, a provisionally registered independent testing laboratory shall apply to be registered, subject to the following terms:</text>
      <paragraph num="(1)">
        <text>The term of the registration may not exceed the term of the provisional registration; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>No additional registration fee need be paid for that term.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Standards of Care.">
    <paragraph num="A.">
      <text>The independent testing laboratory shall:</text>
      <paragraph num="(1)">
        <text>Follow the methodologies, ranges and parameters which are contained in the scope of the accreditation for testing cannabis or cannabis products;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Establish standard operating procedures and method validation or verification, if applicable, for testing that are approved by the accrediting body and the Administration;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Establish and follow written procedures for verifying the experience and education of laboratory employees;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Before an independent testing laboratory employee works or volunteers for the independent testing laboratory, register the employee with the Administration;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Upon termination of the independent testing laboratory’s association with a registered independent testing laboratory employee:</text>
        <paragraph num="(a)">
          <text>Obtain any keys or other entry devices from the terminated independent testing laboratory employee;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Ensure the terminated independent laboratory employee can no longer gain access to the laboratory premises; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Within 1 business day of the termination of independent laboratory employee, notify the Administration of the termination;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(6)">
        <text>Notify the Administration within 1 business day after the independent testing laboratory obtains notice of any kind that its accreditation has been denied, suspended, or revoked;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Implement the testing requirements established in Regulation .05 of this chapter and identified in the Administration’s Technical Authority for cannabis testing;</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Maintain a continuous or motion-activated video surveillance recording system that:</text>
        <paragraph num="(a)">
          <text>Records all activity high quality and high resolution images capable of clearly revealing facial detail;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Operates 24 hours a day, 365 days a year without interruption;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Provides a date and time stamp for every recorded frame; and</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Captures activity at each area where cannabis is tested, disposed of, or stored;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(9)">
        <text>Store and retain all recordings of security video surveillance in a format that can be easily accessed for investigational purposes for a minimum of 90 calendar days;</text>
      </paragraph>
      <paragraph num="(10)">
        <text>Make any security video surveillance recording available to the Administration or law enforcement agency for just cause as requested within 48 hours;</text>
      </paragraph>
      <paragraph num="(11)">
        <text>Maintain a log of all visitors to the premises for 2 years; and</text>
      </paragraph>
      <paragraph num="(12)">
        <text>Conspicuously display a copy of its laboratory registration at the registered premises.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>Violation.</text>
      <paragraph num="(1)">
        <text>Failure to provide the Administration with any video surveillance recording within 48 hours of a request from the Administration is a violation of COMAR 14.17.14.04.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Each day of recording within the minimum timeframe stated in §A(9) of this regulation that a licensee fails to provide to the Administration constitutes a separate violation.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Term and Renewal.">
    <paragraph num="A.">
      <text>The registration is valid for 2 years.</text>
    </paragraph>
    <paragraph num="B.">
      <text>An independent testing laboratory may renew its registration by submitting to the Administration:</text>
      <paragraph num="(1)">
        <text>A registration renewal form completed in the manner specified by the Administration;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Payment of the registration fee specified in COMAR 14.17.21; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Submission of copies of the most recent:</text>
        <paragraph num="(a)">
          <text>Assessment from the accreditation body; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Proficiency testing results obtained by the independent testing laboratory.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".05" heading="Independent Testing Laboratory Responsibilities.">
    <paragraph num="A.">
      <text>In this regulation, “supporting data” means charts, graphs, spectra, or other information resulting from the testing of cannabis or cannabis products.</text>
    </paragraph>
    <paragraph num="B.">
      <text>An independent testing laboratory shall:</text>
      <paragraph num="(1)">
        <text>Establish and follow statistically valid sampling methods to obtain samples from licensees;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Adopt standard operating procedures that are approved by the Administration to test cannabis, cannabis concentrate, and any other product that contains more than 0.5 milligrams of THC per serving and 2.5 milligrams of THC per package;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Perform sampling, testing, and analysis of cannabis and cannabis products in accordance with the Administration’s Technical Authority;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>In the event a test result is outside action limits:</text>
        <paragraph num="(a)">
          <text>Follow standard operating procedure to confirm or refute the original result;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Notify the Administration of the failed test result via reporting in the seed-to-sale tracking system within 24 hours of the determination; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Follow testing protocols established in the MCA’s Technical Authority.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(5)">
        <text>Issue to the licensee a certificate of analysis for each batch or lot, with supporting data upon request, to report concentrations of compounds, presences of contaminants, and whether the batch or lot is within action limits for certain characteristics, as required by the Technical Authority; and</text>
      </paragraph>
      <paragraph num="(6)">
        <text>After the analysis is complete, weigh, document, and destroy all green waste in accordance with a standard operating procedure approved by the Administration.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>An independent testing laboratory may only handle, test, or analyze cannabis or cannabis products if it:</text>
      <paragraph num="(1)">
        <text>Has been registered by the Administration;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Is independent from any entity licensed under Alcoholic Beverages and Cannabis Article, §36-401, Annotated Code of Maryland, to grow, process, or dispense cannabis;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Is accredited by an accreditation body or has a provisional registration from the Administration;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Has established standard operating procedures that provide for adequate chain of custody controls for samples transferred to the independent testing laboratory for testing, which are approved by the Administration; and</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Enters timely and accurate data into the seed-to-sale tracking system that identifies and tracks samples.</text>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>Upon request, in a format determined by the Administration, independent testing laboratories shall:</text>
      <paragraph num="(1)">
        <text>Provide materials to the State Cannabis Testing Laboratory to conduct the activities under Regulation .07B of this chapter; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>As part of a licensee inspection, analyze samples and provide a written report to the Administration.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".06" heading="Transportation of Products Containing Cannabis.">
    <paragraph num="A.">
      <text>A registered independent testing laboratory may transport samples of cannabis and products containing cannabis from the premises of a licensed grower, processor, or dispensary to the independent testing laboratory.</text>
    </paragraph>
    <paragraph num="B.">
      <text>A registered independent testing laboratory shall transport samples of cannabis and products containing cannabis:</text>
      <paragraph num="(1)">
        <text>With oversight by at least one independent testing laboratory employee registered with the Administration; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Using a vehicle that meets the criteria specified in COMAR 14.17.09.03.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".07" heading="State Cannabis Testing Laboratory.">
    <paragraph num="A.">
      <text>The Administration shall operate a State Cannabis Testing Laboratory under Alcoholic Beverages and Cannabis Article, §36-204, Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The Administration shall operate a State Cannabis Testing Laboratory to:</text>
      <paragraph num="(1)">
        <text>Prepare, conduct, and analyze proficiency testing events for independent testing laboratories registered under this chapter;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Develop cannabis testing methodologies;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Conduct compliance testing on cannabis samples;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Establish and verify standard operating procedures for independent testing laboratories;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Develop and facilitate quality assurance and compliance controls for micro growers and micro processors;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Remediate problems with registered independent testing laboratories and recommend Administration sanctions; and</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Test products for adverse event reporting, research, and other purposes deemed necessary by the Administration, including:</text>
        <paragraph num="(a)">
          <text>Licensed cannabis products produced and sold in accordance with this subtitle;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Unlicensed cannabis products produced or sold in violation of this subtitle;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Hemp derived products; and</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Any other products required to be tested for the public health or public safety of Maryland.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>Pilot Programs.</text>
      <paragraph num="(1)">
        <text>The State Cannabis Testing Laboratory may establish pilot programs for the purposes of:</text>
        <paragraph num="(a)">
          <text>Improving public health and safety;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Reviewing existing regulatory standards; or</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Developing new regulatory standards.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>As part of a pilot program established under this section, the Administration may waive, reduce, or amend existing testing standards.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Participation in a pilot program will be determined by the Administration, in a manner prescribed by the Administration.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Alcoholic Beverages and Cannabis Article, §§36-202—204, and 36-408, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date:</annotation>
    <annotation type="History" subtype="Administrative History">Regulations .01—.07 adopted as an emergency provision effective July 1, 2023 (50:14 Md. R. 559); emergency status expired June 30, 2024</annotation>
    <annotation type="History" subtype="Administrative History">Regulations .01—.07 adopted as an emergency provision effective June 7, 2024 (51:14 Md. R. 676)</annotation>
    <annotation type="History" subtype="Administrative History">Regulations .01—.07 adopted effective July 22, 2024 (51:14 Md. R. 678)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03A amended effective April 14, 2025 (52:7 Md. R. 324)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .04B amended effective April 14, 2025 (52:7 Md. R. 324)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 14, 2025 (52:7 Md. R. 324)</annotation>
  </annotations>
</chapter>