Document ID: EPA-HQ-OPP-2007-0438-0010
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-12-10T05:00Z

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<title>Dana Vogel/DC/USEPA/US </title>
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<p class=MsoPlainText>Dana Vogel/DC/USEPA/US </p>

<p class=MsoPlainText>11/06/2008 11:10 AM<span style='mso-tab-count:1'>     </span>To</p>

<p class=MsoPlainText><span style='mso-tab-count:1'>      </span>Barbara
Madden/DC/USEPA/US@EPA</p>

<p class=MsoPlainText><span style='mso-tab-count:1'>      </span>cc</p>

<p class=MsoPlainText><span style='mso-tab-count:1'>      </span>Robert
Mitkus/DC/USEPA/US@EPA, Susan Stanton/DC/USEPA/US@EPA</p>

<p class=MsoPlainText><span style='mso-tab-count:1'>      </span>bcc</p>

<p class=MsoPlainText><span style='mso-tab-count:1'>      </span></p>

<p class=MsoPlainText><span style='mso-tab-count:1'>      </span>Subject</p>

<p class=MsoPlainText><span style='mso-tab-count:1'>      </span>immunotox
language for novaluron</p>

<p class=MsoPlainText><span style='mso-tab-count:1'>      </span></p>

<p class=MsoPlainText><span style='mso-tab-count:1'>      </span></p>

<p class=MsoPlainText><o:p> </o:p></p>

<p class=MsoPlainText>Hi Barbara,</p>

<p class=MsoPlainText><o:p> </o:p></p>

<p class=MsoPlainText>RAB1 has reviewed the hazard database for novaluron and
determined that<span style='mso-spacerun:yes'>  </span></p>

<p class=MsoPlainText>there is no evidence of immunotoxicity.<span
style='mso-spacerun:yes'>  </span>Therefore, lack of immunotox </p>

<p class=MsoPlainText>studies (as required by the revised part 158) will not
impact the FQPA </p>

<p class=MsoPlainText>factor decision.<span style='mso-spacerun:yes'> 
</span>We recommend the language (provided below) be added to </p>

<p class=MsoPlainText>the FR notice.<span style='mso-spacerun:yes'>  
</span>Please let<span style='mso-spacerun:yes'>  </span>me know if you need
and anything else.</p>

<p class=MsoPlainText><o:p> </o:p></p>

<p class=MsoPlainText>Thanks,</p>

<p class=MsoPlainText><o:p> </o:p></p>

<p class=MsoPlainText>Dana</p>

<p class=MsoPlainText><o:p> </o:p></p>

<p class=MsoPlainText>The toxicology database is essentially complete and there
is no evidence </p>

<p class=MsoPlainText>of immunotoxicity in the hazard database for
novaluron.<span style='mso-spacerun:yes'>  </span>However, the </p>

<p class=MsoPlainText>Revised Part 158 requires immunotoxicity studies be
submitted.<span style='mso-spacerun:yes'>  </span>While the </p>

<p class=MsoPlainText>new Part 158 requirement for an immunotoxicity study<span
style='mso-spacerun:yes'>  </span>have not yet been </p>

<p class=MsoPlainText>fulfilled for novaluron, the existing data are sufficient
for endpoint </p>

<p class=MsoPlainText>selection for exposure/risk assessment scenarios and for
evaluation of the </p>

<p class=MsoPlainText>requirements under the FQPA.<span
style='mso-spacerun:yes'>  </span></p>

<p class=MsoPlainText><o:p> </o:p></p>

<p class=MsoPlainText>************</p>

<p class=MsoPlainText>Dana Vogel</p>

<p class=MsoPlainText>Chief, Registration Action Branch 1</p>

<p class=MsoPlainText>USEPA</p>

<p class=MsoPlainText>Office of Pesticide Programs</p>

<p class=MsoPlainText>Health Effects Division</p>

<p class=MsoPlainText>703-305-0874</p>

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