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  <FDSYS>
    <CFRTITLE>40</CFRTITLE>
    <CFRTITLETEXT>Protection of Environment</CFRTITLETEXT>
    <VOL>23</VOL>
    <DATE>2007-07-01</DATE>
    <ORIGINALDATE>2007-07-01</ORIGINALDATE>
    <COVERONLY>false</COVERONLY>
    <TITLE>Physical and chemical characterization studies.</TITLE>
    <GRANULENUM>160.135</GRANULENUM>
    <HEADING>Section 160.135</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 E" SEQ="2">PESTICIDE PROGRAMS</PARENT>
      <PARENT HEADING="PART 160" SEQ="1">GOOD LABORATORY PRACTICE STANDARDS</PARENT>
      <PARENT HEADING="Subpart G" SEQ="0">Protocol for and Conduct of a Study</PARENT>
    </ANCESTORS>
  </FDSYS>
  <SECTION>
    <SECTNO>§ 160.135</SECTNO>
    <SUBJECT>Physical and chemical characterization studies.</SUBJECT>
    <P>(a) All provisions of the GLP standards shall apply to physical and chemical characterization studies designed to determine stability, solubility, octanol water partition coefficient, volatility, and persistence (such as biodegradation, photodegradation, and chemical degradation studies) of test, control, or reference substances.</P>

    <P>(b) The following GLP standards shall not apply to studies, other than those designated in paragraph (a) of this section, designed to determine physical and chemical characteristics of a test, control, or reference substance:
    </P>
    <EXTRACT>
      <FP SOURCE="FP-1">§ 160.31 (c), (d), and (g)</FP>
      <FP SOURCE="FP-1">§ 160.35 (b) and (c)</FP>
      <FP SOURCE="FP-1">§ 160.43</FP>
      <FP SOURCE="FP-1">§ 160.45</FP>
      <FP SOURCE="FP-1">§ 160.47</FP>
      <FP SOURCE="FP-1">§ 160.49</FP>
      <FP SOURCE="FP-1">§ 160.81(b) (1), (2), (6) through (9), and (12)</FP>
      <FP SOURCE="FP-1">§ 160.90</FP>
      <FP SOURCE="FP-1">§ 160.105 (a) through (d)</FP>
      <FP SOURCE="FP-1">§ 160.113</FP>
      <FP SOURCE="FP-1">§ 160.120(a) (5) through (12), and (15)</FP>
      <FP SOURCE="FP-1">§ 160.185(a) (5) through (8), (10), (12), and (14)</FP>
      <FP SOURCE="FP-1">§ 160.195 (c) and (d)</FP>
    </EXTRACT>
  </SECTION>
</CFRGRANULE>
