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  <FDSYS>
    <CFRTITLE>40</CFRTITLE>
    <CFRTITLETEXT>Protection of Environment</CFRTITLETEXT>
    <VOL>30</VOL>
    <DATE>2007-07-01</DATE>
    <ORIGINALDATE>2007-07-01</ORIGINALDATE>
    <COVERONLY>false</COVERONLY>
    <TITLE>Use of specific microorganisms in activities conducted outside a structure.</TITLE>
    <GRANULENUM>725.239</GRANULENUM>
    <HEADING>Section 725.239</HEADING>
    <ANCESTORS>
      <PARENT HEADING="Title 40" SEQ="4">Protection of Environment</PARENT>
      <PARENT HEADING="CHAPTER I" SEQ="3">ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)</PARENT>
      <PARENT HEADING="SUBCHAPTER R" SEQ="2">TOXIC SUBSTANCES CONTROL ACT</PARENT>
      <PARENT HEADING="PART 725" SEQ="1">REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS</PARENT>
      <PARENT HEADING="Subpart E" SEQ="0">Exemptions for Research and Development Activities</PARENT>
    </ANCESTORS>
  </FDSYS>
  <SECTION>
    <SECTNO>§ 725.239</SECTNO>
    <SUBJECT>Use of specific microorganisms in activities conducted outside a structure.</SUBJECT>
    <P>(a) <E T="03">Bradyrhizobium japonicum.</E> To qualify for an exemption under this section, all of the following conditions must be met for a test involving <E T="03">Bradyrhizobium japonicum:</E>
    </P>
    <P>(1) <E T="03">Characteristics of recipient microorganism.</E> The recipient microorganism is limited to strains of <E T="03">Bradyrhizobium japonicum</E>.</P>
    <P>(2) <E T="03">Modification of traits.</E> (i) The introduced genetic material must meet the criteria for poorly mobilizable listed in § 725.421(c).</P>
    <P>(ii) The introduced genetic material must consist only of the following components:</P>
    <P>(A) The structural gene(s) of interest, which have the following limitations:</P>
    <P>(<E T="03">1</E>) For structural genes encoding marker sequences, the gene is limited to the <E T="03">aadH</E> gene, which confers resistance to the antibiotics streptomycin and spectinomycin.</P>
    <P>(<E T="03">2</E>) For traits other than antibiotic resistance, the structural gene must be limited to the genera <E T="03">Bradyrhizobium</E> and <E T="03">Rhizobium</E>.</P>
    <P>(B) The regulatory sequences permitting the expression of solely the gene(s) of interest.</P>
    <P>(C) Associated nucleotide sequences needed to move genetic material, including linkers, homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites.</P>
    <P>(D) The vector nucleotide sequences needed for vector transfer.</P>
    <P>(E) The vector nucleotide sequences needed for vector maintenance.</P>
    <P>(3) <E T="03">Limitations on exposure.</E> (i) The test site area must be no more than 10 terrestrial acres.</P>

    <P>(ii) The technically qualified individual must select appropriate methods to limit the dissemination of modified <E T="03">Bradyrhizobium japonicum.</E>
      <PRTPAGE P="545"/>
    </P>
    <P>(b) <E T="03">Rhizobium meliloti.</E> To qualify for an exemption under this section, all of the following conditions must be met for a test involving <E T="03">Rhizobium meliloti:</E>
    </P>
    <P>(1) <E T="03">Characteristics of recipient microorganism.</E> The recipient microorganism is limited to strains of <E T="03">Rhizobium meliloti</E>.</P>
    <P>(2) <E T="03">Modification of traits.</E> (i) The introduced genetic material must meet the criteria for poorly mobilizable listed in § 725.421(c) of this part.</P>
    <P>(ii) The introduced genetic material must consist only of the following components:</P>
    <P>(A) The structural gene(s) of interest, which have the following limitations:</P>
    <P>(<E T="03">1</E>) For structural genes encoding marker sequences, the gene is limited to the <E T="03">aadH</E> gene, which confers resistance to the antibiotics streptomycin and spectinomycin.</P>
    <P>(<E T="03">2</E>) For traits other than antibiotic resistance, the structural gene must be limited to the genera <E T="03">Bradyrhizobium</E> and <E T="03">Rhizobium.</E>
    </P>
    <P>(B) The regulatory sequences permitting the expression of solely the gene(s) of interest.</P>
    <P>(C) Associated nucleotide sequences needed to move genetic material, including linkers, homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites.</P>
    <P>(D) The vector nucleotide sequences needed for vector transfer.</P>
    <P>(E) The vector nucleotide sequences needed for vector maintenance.</P>
    <P>(3) <E T="03">Limitations on exposure.</E> (i) The test site area must be no more than 10 terrestrial acres.</P>

    <P>(ii) The technically qualified individual must select appropriate methods to limit the dissemination of modified <E T="03">Rhizobium meliloti.</E>
    </P>
  </SECTION>
</CFRGRANULE>

