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<regulation prefix="Regulation" num=".12" citation="COMAR 26.11.32.12" title_num="26" subtitle_num="11" chapter_num="32" heading="Innovative Products — Department Exemption.">
  <paragraph num="A.">
    <text>A manufacturer of a consumer product that has not been granted an exemption by the CARB may seek an innovative products exemption in accordance with this regulation.</text>
  </paragraph>
  <paragraph num="B.">
    <text>For the purposes of this regulation, “representative consumer product” means a consumer product that:</text>
    <paragraph num="(1)">
      <text>Is subject to the same VOC limit in Regulation .04B of this chapter as the innovative product;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Is of the same product form as the innovative product, unless the innovative product uses a new form which does not exist in the product category at the time the application is made; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Has at least similar efficacy as other consumer products in the same product category based on tests accepted for that product category by the consumer products industry.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Exemption Criteria.</text>
    <paragraph num="(1)">
      <text>The Department shall exempt a consumer product from the VOC limits in Regulation .04B of this chapter if the manufacturer demonstrates by clear and convincing evidence that, due to some characteristic of the product formulation, design, delivery systems, or other factors, the use of the product will result in less VOC emissions as compared to:</text>
      <paragraph num="(a)">
        <text>VOC emissions from a representative consumer product which complies with the VOC limits in Regulation .04B of this chapter; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Calculated VOC emissions from a noncomplying representative product, if the product had been reformulated to comply with the VOC limits in Regulation .04B of this chapter.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Equation.</text>
      <paragraph num="(a)">
        <text>VOC emissions shall be calculated using the following equation:</text>
        <paragraph num="(i)">
          <text>ER = VOC emissions from the noncomplying representative product, had it been reformulated;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>ENC = VOC emissions from the noncomplying representative product in its current formulation;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>VOCSTD = VOC limit specified in the table of standards in Regulation .04B of this chapter; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>VOCNC = VOC content of the noncomplying product in its current formulation.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>If a manufacturer demonstrates that this equation yields inaccurate results due to some characteristic of the product formulation or other factors, an alternative method which accurately calculates emissions may be used upon approval by the Department.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Application Information.</text>
    <paragraph num="(1)">
      <text>A manufacturer shall apply in writing to the Department for an exemption claimed under §B(1) of this regulation.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The application shall include:</text>
      <paragraph num="(a)">
        <text>Supporting documentation that verifies the emissions from the innovative product, including the actual physical test methods used to generate the data;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>If necessary, the consumer testing undertaken to document product usage; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Information necessary to enable the Department to establish enforceable conditions for granting the exemption, including the VOC content for the innovative product and test methods for determining the VOC content.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>All information submitted by a manufacturer under this section shall be maintained in accordance with the confidentiality requirements in General Provisions Article, Title 4, Annotated Code of Maryland.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>On receipt and review of the exemption application, the Department shall determine whether an application is complete.</text>
  </paragraph>
  <paragraph num="F.">
    <text>Departmental Decision on Innovative Product Exemption.</text>
    <paragraph num="(1)">
      <text>On receipt and review of a complete application, the Department shall determine whether, under what conditions, and to what extent, an exemption from the requirements of Regulation .04B of this chapter will be permitted.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The Department shall notify the applicant of a decision in writing and specify the terms and conditions necessary to ensure that emissions from the product will meet the emissions reductions specified in this regulation, and that the emissions reductions can be enforced.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>In granting an exemption for a product, the Department shall establish the following:</text>
    <paragraph num="(1)">
      <text>Enforceable conditions that include:</text>
      <paragraph num="(a)">
        <text>The VOC content of the innovative product;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Dispensing rates;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Application rates; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Other parameters the Department determines necessary; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Test methods for determining conformance to the conditions established in §G(1) of this regulation, including:</text>
      <paragraph num="(a)">
        <text>Criteria for reproducibility, accuracy, and sampling; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Laboratory procedures.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="H.">
    <text>For a product that has been granted an exemption under this regulation, the manufacturer shall notify the Department in writing within 30 days of:</text>
    <paragraph num="(1)">
      <text>A change in the product formulation or recommended product usage directions; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Information which would alter the emissions estimates submitted to the Department in support of the exemption application.</text>
    </paragraph>
  </paragraph>
  <paragraph num="I.">
    <text>Exemptions Following Modification of VOC limit.</text>
    <paragraph num="(1)">
      <text>If a VOC limit in Regulation .04B of this chapter is lowered for a product category through a subsequent rulemaking, all innovative product exemptions granted for products in that product category, except as provided in this section, have no effect as of the effective date of the modified VOC standard.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The provision of §I(1) of this regulation does not apply to those innovative products which have VOC emissions less than the applicable lowered VOC limit and for which a written notification of the product's emissions status versus the lowered VOC limit has been submitted to and approved by the Department at least 60 days before the effective date of the limits.</text>
    </paragraph>
  </paragraph>
  <paragraph num="J.">
    <text>Modification or Revocation of an Exemption.</text>
    <paragraph num="(1)">
      <text>If the Department believes that a consumer product for which an exemption has been granted no longer meets the criteria for an innovative product specified in this regulation, the Department may modify or revoke the exemption as necessary to ensure that the product will meet these criteria.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The Department shall allow the applicant an opportunity for a contested case hearing before modifying or revoking an exemption.</text>
    </paragraph>
  </paragraph>
</regulation>