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        The ILSI Research Foundation project on CARES®
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<p>EPA Exposure Modeling Work Group<br>October 4, 2004<br>
Beth Julien, Ph.D.<br>ILSI Risk Science Institute</p>
<p><a href="#title">CARES®</a><br>
<a href="#why">Why develop CARES®?</a><br>
<a href="#new">New models: a response to FQPA </a><br>
<a href="#basic">Basic attributes of CARES®</a><br>
<a href="#meets">Meets criteria  for regulatory use </a><br>
<a href="#origin">Origin/development of CARES®</a><br>
<a href="#rf">ILSI Research Foundation (RF) acquires CARES®</a><br>
<a href="#research">ILSI Research Foundation (RF)</a><br>
<a href="#plans">ILSI’s plans for CARES®</a><br>
<a href="#more">For more info…</a>
</p>
<hr>
<p><a name="title"></a><strong>CARES®</strong></p>
<p>"Cumulative and Aggregate Risk Evaluation System"</p>
<p>A software program for assessing human exposure to pesticides via food, water and residential routes</p>
<hr>
<p><a name="why"></a><strong>Why develop CARES® ?</strong></p>
<p>FQPA (Food Quality Protection Act 1996):</p>
<p>Required consideration of:</p>
<p><ul>
<li><p>Potentially sensitive populations  (e.g., children)</p></li>
<li><p>Cumulative exposure (common mechanism)</p></li>
<li><p>Aggregate exposure (multiple routes)</p></li>
</ul></p>
<p>In short, required sophisticated methodology to conduct complex assessments. </p>
<hr>
<p><a name="new"></a><strong>New models:   a response to FQPA </strong></p>
<p><ul>
<li><p>Calendex/DEEM (Novigen, now Exponent)</p></li>
<li><p>LifeLine (HRI/LifeLine Group)</p></li>
<li><p>CARES (CLA, formerly ACPA)</p></li>
<li><p>SHEDS (EPA ORD)</p></li>
</ul></p>
<p>All models are publicly available</p>
<p>FIFRA SAP: supports continued development of each model<br>
(see <a href="http://www.epa.gov/scipoly/sap/#april">http://www.epa.gov/scipoly/sap/#april</a>)
</p>
<hr>
<p><a name="basic"></a><strong>Basic attributes of CARES®</strong></p>
<p><ul>
<li><p>Uses probabilistic methods to assess likelihood that specific events (e.g., given residue levels, activity) occur together </p></li>
<li><p>Considers dermal, inhalation, and ingestion routes </p></li>
<li><p>Single day, short-term, intermediate-term, chronic timeframes </p></li>
</ul></p>
<hr>
<p><a name="meets"></a><strong>Meets criteria  for regulatory use </strong></p>
<p>CARES® program is:</p>
<p><ul>
<li><p> publicly available -  for free</p></li>
<li><p>consistent with EPA regulatory guidance</p></li>
<li><p>peer reviewed (FIFRA SAP)</p></li>
</ul></p>
<hr>
<p><a name="origin"></a><strong>Origin/development of CARES®</strong></p>
<p><ul>
<li><p>Initiated, funded by agrochemical industry, with scientific contributions from expert consultants and EPA/USDA</p></li>
<li><p>Project initiated in 2000; infoscientific.com is continuing development</p>
	<p><ul>
	<li><p> 2001 alpha version</p></li>
	<li><p> 2002 Version 1.0</p></li>
	<li><p> 2003 Version 1.3</p></li>
	<li><p> 2004 Version 2.0, in progress</p></li>
	</ul></p>
</li>
</ul></p>
<hr>
<p><a name="rf"></a><strong>ILSI Research Foundation (RF) acquires CARES®</strong></p>
<p><ul>
<li><p>December 2003: ownership transferred to ILSI Research Foundation (RF)</p></li>
<li><p>Move to ILSI RF will:</p>
	<p><ul>
	<li><p>Allow independent, neutral management of CARES</p></li>
	<li><p>Facilitate broader stakeholder involvement</p></li>
	</ul></p>
</li>
</ul></p>
<hr>
<p><a name="research"></a><strong>ILSI Research Foundation (RF)</strong></p>
<p>RF: independent entity housing the Risk Science Institute (RSI) and Human Nutrition Institute (HNI)</p>
<p><ul>
<li><p>HNI: created to promote research related to nutrition</p></li>
<li><p>RSI: created to advance and improve scientific basis of risk assessment </p></li>
</ul></p>
<p>RSI has primary responsibility for CARES®:</p>
<hr>
<p><a name="plans"></a><strong>ILSI’s plans for CARES®</strong></p>
<p><ul>
<li><p>Immediate term: </p>
	<p><ul>
	<li><p>Finish/distribute production Version 2.0</p></li>
	</ul></p>
</li>
<li><p>Short term: </p>
	<p><ul>
	<li><p>Provide training, promote broader utilization<br>
	Virtual Meetings; Electronic user-forum </p></li>
	<li><p>Enhance stakeholder involvement <br>
	Steering Committee; Technical Committee</p></li>
	</ul></p>
</li>
<li><p>Longer term:</p> 
	<p><ul>
	<li><p>Add new features/functionalities for pesticide assessments</p></li>
	<li><p>Expand application to new areas</p>
		<p><ul>
		<li><p>Nutritional analysis</p></li>
		<li><p>Non-pesticide assessments?</p></li>
		</ul></p>
	</li>
	</ul></p>
</li>
</ul></p>
<hr>
<p><a name="more"></a><strong>For more info…</strong></p>
<p>Website: <a href="http://www.epa.gov/epahome/exitepa.htm">
<img src="http://www.epa.gov/epafiles/images/epafiles_misc_exitepadisc.gif" alt="exit EPA" ><a href="http://cares.ilsi.org">http://cares.ilsi.org</a></p>

<p>Contact:<br>
Beth Julien<br>
bjulien@ilsi.org <mailto:bjulien@ilsi.org><br>
202-659-3306 ext 158
</p>
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