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<p class="MsoNormal"><font size="2" face="Tahoma"><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif""><br>
<b><span style="font-weight:bold">Subject:</span></b> US, EU To Seek 'Harmonized' Endocrine Approach In New Pilot Program<o:p></o:p></span></font></p>
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<p class="MsoNormal"><font size="2" face="Calibri"><span style="font-size:11.0pt"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.2pt;background:white">
<b><font size="2" color="#ff3300" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#FF3300;font-weight:bold">US, EU To Seek 'Harmonized' Endocrine Approach In New Pilot Program<o:p></o:p></span></font></b></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">Posted: October 10, 2014
<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">Regulators from EPA and other U.S. agencies will work with the European Union
(E.U.) to initiate a new pilot program last this month with the goal of reaching a "harmonized approach" toward testing chemicals to determine whether they might be endocrine disruptors that affect human hormones, an EPA spokeswoman says.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">The kick-off meeting for the pilot program is scheduled for Oct. 15, the spokeswoman
says. "Our goal is to have a harmonized approach to prioritization and screening of chemicals based on endocrine bioactivity and environmental exposure," she says.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">The initiative on endocrine disruptors is one of three pilot programs on chemicals
launched by the U.S. and E.U. in parallel with the ongoing American-European trade negotiations known as the Transatlantic Trade and Investment Partnership (TTIP). The E.U. announced the other two pilot programs, which are focused on chemicals screening and
labeling, last summer after the sixth round of TTIP talks.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">The screening pilot program is expected to entail regulators at EPA and the
European Chemicals Agency (ECHA) figuring out how they might share the burden in testing substances that either has prioritized for further assessment. Although it is unclear how they might proceed in this area, two possible options for cooperation would be
for each agency to divide up different phases of individual risk assessments, or split up the list of chemicals that are slated to be evaluated by both agencies and share the data from the separate risk assessments at the end.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">The U.S. and E.U. industries hope that this pilot program could pave the way
for the establishment of a joint scientific committee under TTIP that would cooperate more regularly on risk assessments.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">In the labeling pilot program, the sides are planning to cooperate on how
to reduce divergences in their regimes for classification and labeling of chemicals, the commission indicated. The agreement to launch these two pilot programs appears to be the first concrete action taken by the U.S. and E.U. to test some of the proposals
for sectoral regulatory cooperation that have been explored by the TTIP talks.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">It is unclear which E.U. agencies will be involved in the endocrine disruptors
pilot program. The European Commission's directorate-generals for Health & Consumers (DG SANCO) and the Environment (DG ENV) both play a role in regulating endocrine disruptors in the EU, as does ECHA. A DG ENV spokeswoman declined to comment on the pilot
program on endocrine disruptors, and the EPA spokeswoman did not respond to subsequent requests for additional details.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><b><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black;font-weight:bold">Disruptors Criteria<o:p></o:p></span></font></b></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">The planned launch of the endocrine pilot program comes even as the E.U. seeks
to define criteria for what endocrine disruptors are, a requirement of its regulations on biocidal and plant protection products. The European Commission Sept. 29 opened a new public comment period on the issue, seeking "help [to] define criteria for endocrine
disruptors . . ." with a closing date of Jan. 16.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">However, the EPA spokeswoman's Aug. 12 statement makes clear that prioritization,
or deciding which chemicals should be tested first among the thousands on the market, will be one element of the endocrine disruptor pilot program. The U.S. and E.U. do not share a common approach to identifying which chemicals should be screened for endocrine
activity.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">But beyond that, the scope of the program is not clear. One possibility is
that the program will focus on finding a common approach toward the risk assessment of endocrine disruptors, one source said. The idea would likely be to minimize the chance that the criteria and methods used in one jurisdiction could give a different result
than in the other, the source added.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">This could be challenging -- and controversial -- for several reasons. The
first is that the European Commission is in the midst of reviewing its legislation and policies surrounding endocrine disruptors, and still has yet to agree internally on what criteria should be used to define such substances.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">One of the critical issues in that debate is whether an endocrine disruptor
should necessarily be defined as having a demonstrable adverse effect. Some environmental and health advocates argue that would set the bar too high and allow chemicals onto the market that may have latent adverse effects, or that have a disproportionate impact
on humans during critical stages of development, which may not be discernible in a risk assessment.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">Another challenge is that the E.U. law governing pesticides bars endocrine
disruptors entirely and does not allow them to be used in chemicals sprayed on crops in any quantity. This is different from the approach of the EPA, which typically aims to identify a threshold level below which usage can be considered safe in certain conditions.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><b><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black;font-weight:bold">Endocrine Program<o:p></o:p></span></font></b></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">By contrast, Congress in the 1996 Food Quality Protection Act mandated that
EPA create a program to test chemicals for their potential to interact with human estrogen hormones. As a result, EPA created a two-tiered screening and testing process, known as the Endocrine Disruptor Screening Program. The first tier, is designed to identify
chemicals that have the potential to interact with human estrogen, androgen or thyroid hormones.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">The second, still incomplete tier is aimed at gathering additional information
determining the endocrine-related effects caused by each chemical and obtaining information about effects at various doses for use in risk assessment. The program's slow pace and cost has frustrated many stakeholders, and the agency is seeking to transition
the program to more computational screening approaches to make it cheaper and more efficient.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt;font-family:"Times New Roman","serif";color:#000099"><o:p> </o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><font size="2" color="black" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">The first group of 67 chemicals identified for tier one screening in 2009
-- pesticide active ingredients and chemicals produced in high quantities used as pesticide inert ingredients -- are still undergoing EPA review to determine which should undergo tier two testing.<o:p></o:p></span></font></p>
<p class="MsoNormal"><font size="2" face="Arial"><span style="font-size:10.0pt;font-family:"Arial","sans-serif""><o:p> </o:p></span></font></p>
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