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<p class="MsoNormal"><font size="3" color="#000099" face="Times New Roman"><o:p> </o:p></font></p>
<p class="MsoNormal"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt"><a href="http://www.bna.com/epa-hasnt-shown-n17179890152/">http://www.bna.com/epa-hasnt-shown-n17179890152/</a></span><o:p></o:p></font></p>
<p class="MsoNormal"><font size="3" color="#000099" face="Times New Roman"><o:p> </o:p></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><b><font size="5" color="black" face="Times New Roman"><span style="font-size:18.0pt;color:windowtext;font-weight:bold">EPA Hasn’t Shown Its Tests Can Detect Endocrine Disruptor
Harm, Critique Says<o:p></o:p></span></font></b></p>
<p class="MsoNormal"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">Monday, May 5, 2014<o:p></o:p></span></font></p>
<p class="MsoNormal"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">from
<a href="http://www.bna.com/chemical-regulation-reporter-p4750/"><font color="blue"><span style="color:blue">Chemical Regulation Reporter ®</span></font></a><o:p></o:p></span></font></p>
<p class="MsoNormal"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt"><a href="javascript:void(0)"><font color="blue"><span style="color:blue;text-decoration:none"><img border="0" width="85" height="21" id="Picture_x0020_1" src="cid:image001.gif@01CF6DF4.CDD57540" alt="register for a free trial"></span></font></a></span></font><font color="black"><span style="color:windowtext"><o:p></o:p></span></font></p>
<p class="MsoNormal"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext"><a href="javascript:void(0);"><font color="blue"><span style="color:blue">inShare</span></font></a>9
<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><i><font size="2" color="black" face="Times New Roman"><span style="font-size:10.0pt;color:windowtext;font-style:italic">By
<a href="mailto:prizzuto@bna.com"><font color="blue"><span style="color:blue">Pat Rizzuto</span></font></a></span></font></i><font color="black"><span style="color:windowtext">
<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">May 2 --A draft Environmental Protection Agency report failed to prove the agency's
chemical testing strategy would detect health or ecological harms that may result from exposure to chemicals that mimic, block or alter how hormones work in animals and people, a National Academies critique said.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">EPA's draft report did not provide sufficient evidence to support its conclusion
that its chemical testing strategies are adequate, the academies' National Research Council said in the critique published May 2.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">The EPA issued a statement that the draft report the academies critiqued was
not evaluating whether the agency's chemical testing strategy would detect harm from exposure to chemicals that mimic how hormones work in the human body. The agency said the academies' critique commended the EPA for undertaking the challenge of examining
nontraditional ways some scientists say endocrine disruptors are affecting the body. The academies recommendations will help make the agency's science stronger, EPA said.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">The National Research Council report said the EPA should develop a plan to analyze
the adequacy of its testing strategies, explain what its strategies are, and clearly describe how it reaches its conclusions when it eventually does.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">The critique did not evaluate whether endocrine disrupting chemicals cause harm.
Instead, the academies focused on the procedures the EPA used and the scientific rationale it provided in its draft report.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><b><font size="1" color="black" face="Times New Roman"><span style="font-size:7.5pt;color:windowtext;font-weight:bold">Trade in Chemicals<o:p></o:p></span></font></b></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">The academies critique may play a role in the debate over regulatory strategies
for endocrine disruptors. The American Chemistry Council and other trade associations have flagged potential differences between the United States and European Union regulatory approaches as an issue the governments should tackle in the ongoing Transatlantic
Trade and Investment Partnership negotiations.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">European Union regulations on endocrine disruptors could affect up to $4.8 billion
in agricultural exports from the U.S., according to a November 2013 report funded by CropLife America, which represents pesticide makers .<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">Decisions about the doses at which alleged endocrine disruptors cause harm and
the resulting regulatory approaches the governments take to prevent such harms could affect trade worldwide, not just U.S.-European transactions, Herbert Estreicher, an attorney with Keller and Heckman LLP, has told Bloomberg BNA .<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><b><font size="1" color="black" face="Times New Roman"><span style="font-size:7.5pt;color:windowtext;font-weight:bold">Health Implications of Controls<o:p></o:p></span></font></b></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">In addition to trade concerns, the issue of regulating endocrine disruptors has
broad health implications. For example, a medical and scientific organization called the Endocrine Society issued a
<a href="http://op.bna.com/env.nsf/r?Open=prio-9jqkfc"><font color="blue"><span style="color:blue">statement</span></font></a> in 2009 that said:<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">“The evidence for adverse reproductive outcomes (infertility, cancers, malformations)
from exposure to endocrine disrupting chemicals is strong, and there is mounting evidence for effects on other endocrine systems, including thyroid, neuroendocrine, obesity and metabolism, and insulin and glucose homeostasis.”<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">The EPA asked the National Academies to convene a panel to critique the agency's
draft 2013 report, State of the Science Evaluation: Nonmonotonic Dose Responses as They Apply to Estrogen, Androgen, and Thyroid Pathways and EPA Testing and Assessment Procedures.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">In that draft report, the EPA concluded its testing strategy for endocrine disruptors
is highly unlikely to miss problems people or wildlife would experience following their exposure to such chemicals .<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">EPA's report did not define a specific testing strategy, but referred generally
to the testing and risk assessment approaches used, for example, in its Endocrine Disruptor Screening Program.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">Among its recommendations, the academies said the EPA should specify the toxicity-testing
strategies it considered and evaluate them clearly to determine whether they would pick up the doses at which endocrine disruptors may cause their effects.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><b><font size="1" color="black" face="Times New Roman"><span style="font-size:7.5pt;color:windowtext;font-weight:bold">Missed Harm?<o:p></o:p></span></font></b></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">The concept of nonmonotonic dose responses (NMDR) is that some chemicals, such
as endocrine disruptors, may cause harm at doses that traditional toxicity tests and risk assessment approaches would fail to detect.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">The reason is that toxicologists using the internationally approved toxicity
tests that regulators require typically use only a few doses to ascertain whether a chemical is causing harm. Based on the data from those tests, risk assessors draw straight lines, which presume there is no safe dose, or they conclude that high doses might
cause harm, but that there is a dose at which point the line flattens, because below that point an organism would not be harmed (threshold assumption).<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">The implication of a curved, V-shaped, U-shaped or other nontraditional nonmonotonic
dose response curve is that the traditional testing and risk assessment approaches could conclude a chemical is safe when it is not.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">“If current testing strategies are inadequate to account for nonmonotonic dose
response relationships, changes in risk-assessment practices might be necessary,” the academies said.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">However, “the existence of nonmonotonic dose responses has been controversial
for decades,” the academies report said.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><b><font size="1" color="black" face="Times New Roman"><span style="font-size:7.5pt;color:windowtext;font-weight:bold">EPA's Goal Praised<o:p></o:p></span></font></b></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">The academies commended the EPA for taking on the challenge of examining nonmonotonic
dose responses and determining whether the agency's testing strategy would detect two different issues: 1) whether nonmonotonic dose response relationships occur and, if so, 2) whether traditional tests and risk assessment approaches would miss harms that
could occur.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">“This is one of the few attempts to evaluate specifically the implications of
the evidence on NMDR curves for testing strategies and risk-assessment practices, and the agency is to be commended for undertaking such a challenging task,” the academies said.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">The academies advised the EPA to develop a clearly described plan to analyze
NMDR curves and the adequacy of detecting them with current tests.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">The agency should include evidence from human studies as it conducts its analysis,
the academies said. The EPA's draft report did not include human studies among the scientific research it examined.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><b><font size="1" color="black" face="Times New Roman"><span style="font-size:7.5pt;color:windowtext;font-weight:bold">Initial Reactions to Critique<o:p></o:p></span></font></b></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">Laura Vandenberg, an assistant environmental health professor at the University
of Massachusetts, Amherst, said the academies' critique echoed many concerns the Endocrine Society raised when it evaluated the EPA's draft report<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">The academies critique underscores a challenging issue that regulatory, academic,
industry and other scientists must address, she said.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">Internationally approved “guideline studies,” have value because they can be
replicated by laboratories all around the world, Vandenberg said.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">But the data generated through non-guideline studies also warrant consideration,
she said. Such non-guideline studies are among the sources of toxicity tests that showed nonmonotonic dose responses.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><b><font size="1" color="black" face="Times New Roman"><span style="font-size:7.5pt;color:windowtext;font-weight:bold">Testing Strategy Called Sound<o:p></o:p></span></font></b></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">Richard Becker, the American Chemistry Council's senior toxicologist for regulatory
and technical affairs, and Ellen Mihaich, scientific coordinator for the Endocrine Policy Forum, which is managed by CropLife America, said the academies report doesn't address the adequacy of EPA's approach to testing chemicals.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">The academies' critique urges the EPA to do a better job evaluating the science
on nonmonotonic dose response and to better explain what tests it uses to determine whether such nontraditional responses cause harm.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">Those recommendations back concerns previously raised by the academies about
the agency's failure to examine scientific studies consistently, and to transparently explain how it reaches its conclusions, Becker said.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">EPA's approach to identifying harm caused because a chemical affects the endocrine
system is fundamentally sound, provided the agency continues to improve its methods as additional science and better testing methodologies are developed, Becker said.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">Mihaich said the agency's risk-based strategy is essential.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">She agreed with the chemistry council's recommendation that governments, including
the U.S. and European Union, develop harmonized approaches to assessing the risks of endocrine disruptors.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><b><font size="1" color="black" face="Times New Roman"><span style="font-size:7.5pt;color:windowtext;font-weight:bold">Screening Under Way<o:p></o:p></span></font></b></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">While policy discussions continue, some companies already are providing the agency
with toxicity information in the first, or screening, phase of the EPA's Endocrine Disruptor Screening Program, which is designed to detect possible endocrine disruptors.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">Bayer Cropscience LP, Dow Agrosciences LLC, Dupont and Tide International USA
Inc. are among those companies.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">To contact the reporter on this story: Pat Rizzuto in Washington at
<a href="mailto:prizzuto@bna.com"><font color="blue"><span style="color:blue">prizzuto@bna.com</span></font></a><o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">To contact the editor responsible for this story: Larry Pearl at
<a href="mailto:lpearl@bna.com"><font color="blue"><span style="color:blue">lpearl@bna.com</span></font></a><o:p></o:p></span></font></p>
<div class="MsoNormal" align="center" style="text-align:center"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext">
<hr size="3" width="100%" align="center">
</span></font></div>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><i><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext;font-style:italic">The academies will post its critique, Review of the Environmental
Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response Relationships as They Apply to Endocrine Disruptors, at
<a href="http://www.nap.edu/catalog.php?record_id=18608"><font color="blue"><span style="color:blue">http://www.nap.edu/catalog.php?record_id=18608</span></font></a>.<o:p></o:p></span></font></i></p>
<p class="MsoNormal"><font size="3" color="#000099" face="Times New Roman"><o:p> </o:p></font></p>
<p class="MsoNormal"><font size="3" color="#000099" face="Times New Roman"><o:p> </o:p></font></p>
<p class="MsoNormal"><font size="2" color="navy" face="Times New Roman"><span style="font-size:10.0pt;color:navy">Deborah L. DeBiasi</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><b><font size="2" color="navy"><span style="font-size:10.0pt;color:navy;font-weight:bold">Email: Deborah.DeBiasi@deq.virginia.gov</span></font></b><b><i><font size="2" color="red"><span style="font-size:10.0pt;color:red;font-weight:bold;font-style:italic"><br>
</span></font></i></b><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">WEB site address:
<a href="http://www.deq.virginia.gov/">www.deq.virginia.gov</a></span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">Virginia Department of Environmental Quality</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">Office of Water Permits
</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">Industrial Pretreatment/Whole Effluent Toxicity (WET) Program</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">PPCPs, EDCs, and Microconstituents<o:p></o:p></span></font></p>
<p class="MsoNormal"><font size="2" color="navy" face="Times New Roman"><span style="font-size:11.0pt;color:navy"><a href="http://www.deq.virginia.gov/Programs/Water/PermittingCompliance/PollutionDischargeElimination/Microconstituents.aspx">http://www.deq.virginia.gov/Programs/Water/PermittingCompliance/PollutionDischargeElimination/Microconstituents.aspx</a></span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy"><o:p></o:p></span></font></p>
<p class="MsoNormal"><font size="2" color="navy" face="Times New Roman"><span style="font-size:10.0pt;color:navy">Mail: P.O. Box 1105, Richmond, VA 23218</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">Location: 629 E. Main Street, Richmond, VA 23219</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">PH: 804-698-4028 FAX: 804-698-4032<o:p></o:p></span></font></p>
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