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<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Thanks for sharing this one Deborah. FYI, I hear this case is currently scheduled for oral argument on April 7, 2014 in San Francisco.
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Burke<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Mr. Burke Lucy<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Integrated Waste Management Specialist<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Department of Resources Recycling and Recovery (CalRecycle)<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">1001 I Street, PO Box 4025<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Sacramento, CA 95812<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><a href="mailto:Burke.Lucy@CalRecycle.ca.gov">Burke.Lucy@CalRecycle.ca.gov</a><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">916.341.6592<o:p></o:p></span></p>
<p class="MsoNormal"><a href="http://www.calrecycle.ca.gov/"><span style="font-size:9.5pt;font-family:"Arial","sans-serif";color:#3754D4;text-decoration:none"><img border="0" width="147" height="43" id="Picture_x0020_18" src="cid:image001.jpg@01CF2E36.40515F20" alt="California Department of Resources Recycling and Recovery (CalRecycle)"></span></a><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><o:p></o:p></span></p>
<p class="MsoNormal"><b><span style="font-size:10.0pt;font-family:"Georgia","serif";color:#1F497D">Connect with us!</span></b><span style="font-size:10.0pt;font-family:"Georgia","serif";color:#1F497D">
<o:p></o:p></span></p>
<p class="MsoNormal"><a href="http://www.facebook.com/pages/Sacramento-CA/CalRecycle/232843879097"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D;text-decoration:none"><img border="0" width="36" height="36" id="Picture_x0020_17" src="cid:image002.png@01CF2E36.40515F20" alt="Visit CalRecycle on FaceBook"></span></a><span style="font-size:11.0pt;font-family:"Cambria","serif";color:#1F497D"> </span><a href="http://twitter.com/calrecycle/"><span style="font-size:9.5pt;font-family:"Arial","sans-serif";color:darkblue;text-decoration:none"><img border="0" width="36" height="36" id="Picture_x0020_16" src="cid:image003.png@01CF2E36.40515F20" alt="Follow CalRecycle on Twitter"></span></a><span style="font-size:11.0pt;font-family:"Cambria","serif";color:#1F497D"> </span><a href="http://feeds.calrecycle.ca.gov/default.aspx"><span style="font-size:9.5pt;font-family:"Arial","sans-serif";color:darkblue;text-decoration:none"><img border="0" width="36" height="36" id="Picture_x0020_15" src="cid:image004.png@01CF2E36.40515F20" alt="Subscribe to CalRecycle Feeds"></span></a><span style="font-size:11.0pt;font-family:"Cambria","serif";color:#1F497D"> </span><a href="http://www.youtube.com/user/CalRecycle?feature=creators_cornier-http%3A//s.ytimg.com/yt/img/creators_corner/YouTube/youtube_32x32.png"><span style="font-size:9.5pt;font-family:"Arial","sans-serif";color:darkblue;text-decoration:none"><img border="0" width="36" height="36" id="Picture_x0020_14" src="cid:image005.jpg@01CF2E36.40515F20" alt="Find CalRecycle videos on YouTube"></span></a><span style="font-size:11.0pt;font-family:"Cambria","serif";color:#1F497D"> </span><a href="http://m.calrecycle.ca.gov/Mobile/"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D;text-decoration:none"><img border="0" width="36" height="36" id="Picture_x0020_13" src="cid:image006.png@01CF2E36.40515F20" alt="CalRecycle Mobile App"></span></a><span style="font-size:11.0pt;font-family:"Cambria","serif";color:#1F497D"> </span><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
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<p class="MsoNormal"><b><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif";color:windowtext">From:</span></b><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif";color:windowtext"> pharmwaste-bounces@lists.dep.state.fl.us [mailto:pharmwaste-bounces@lists.dep.state.fl.us]
<b>On Behalf Of </b>DeBiasi, Deborah (DEQ)<br>
<b>Sent:</b> Thursday, February 20, 2014 8:29 AM<br>
<b>To:</b> (pharmwaste@lists.dep.state.fl.us)<br>
<b>Subject:</b> [Pharmwaste] Pharm industry challenge to Alameda County, CA Drug Take Back program<o:p></o:p></span></p>
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<p class="MsoNormal"><o:p> </o:p></p>
<p class="MsoNormal" style="line-height:13.2pt;background:white"><b><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">Advocates Cite Health Benefits In Bid To Preserve Novel Drug Take-Back Plan
<o:p></o:p></span></b></p>
<p class="MsoNormal" style="line-height:19.2pt;background:white"><b><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#949494">Posted: February 18, 2014
<o:p></o:p></span></b></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">Environmentalists, local government organizations and the California attorney general are urging an appellate court to reject an industry challenge to a California county's
novel pharmaceutical waste collection program, arguing the county has authority to establish the program and emphasizing the program's environmental and public health benefits.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">The Natural Resource Defense Council (NRDC), California State Association of Counties (CSAC), the League of California Cities (LCC) and California Attorney General (AG)
Kamala Harris (D) all filed </span><i><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#990000">amicus</span></i><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#990000"> briefs</span><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">
late last month in <i>Pharmaceutical Research and Manufacturers of America (PhRMA), et al., v. Alameda County, et al</i>., where pharmaceutical manufacturers are asking the U.S. Court of Appeals for the 9th Circuit to declare an Alameda County drug take-back
program unconstitutional because it places unnecessary burdens on interstate commerce.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">The
<i>amicus</i> briefs echo arguments made by Alameda County that local governments have the right to determine waste disposal requirements and that any cost to pharmaceutical manufacturers is
<i>de minimis</i> compared to the program's health and safety benefits. But they also warn that if the district court's ruling supporting the program is overturned, that could threaten numerous other extended producer responsibility (EPR) programs in California
and across the country.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">The case's importance to the future of EPR programs has also been noted by its opponents,
</span><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#990000">including free-market and industry groups</span><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black"> that have argued the
district court's endorsement of the precedent-setting approach could lead to the widespread transfer of local disposal costs to other industry sectors through an expansion of EPR programs.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">EPR is a mandatory type of product stewardship that requires producers to be responsible for the post-consumer management of their products and packaging, including shifting
financial and management responsibility away from the public sector.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">At issue is Alameda County's first-in-the-nation 2012 ordinance requiring pharmaceutical companies whose products are sold in the county to establish, run and finance a
drug take-back program for unwanted medications. Many local governments and citizen groups are concerned that a lack of such programs leads consumers to flush medications into wastewater systems, where they are eventually discharged and cause adverse developmental
effects in fish and possibly humans.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">But industry charges the ordinance violates the Constitution's Commerce Clause because it shifts the costs from a local program directly onto interstate commerce.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">Judge Richard Seeborg of the U.S. District Court for the Northern District of California rejected industry's arguments against the Alameda County regulations, ruling the
ordinance does not meet any of three criteria for proving a violation of the Commerce Clause: directly regulating interstate commerce, discriminating against interstate commerce, or favoring in-state economic interests over out-of-state interests.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<b><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">Public Health</span></b><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black"><o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#990000">NRDC warns in its
<i>amicus</i></span><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black"><a href="http://insideepa.com/iwpfile.html?file=feb2014%2Fepa2014_0277a.pdf"><span style="color:#990000;text-decoration:none"> brief</span></a> that
a ruling in favor of PhRMA would have long standing impacts on the work of health and environmental advocates, threatening their ability "to promote state and local extended producer responsibility programs that protect public health and the environment by
making product manufacturers responsible for the entire lifecycle of their products, including their take-back, recycling and final disposal."<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">Additionally, NRDC writes that since 1991 at least 70 similar EPR laws and policies for multiple products have been enacted across the United States, making the approach
commonplace despite industry's concerns.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">In California alone, NRDC says, producers already are required to fund and manage end-of-life recycling and recovery programs for cell phones, thermostats, paint, carpets,
mattresses and rechargeable batteries.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">California's AG rebukes PhRMA for insinuating that the Alameda ordinance "runs afoul of the dormant Commerce Clause," and says her office
</span><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#990000">filed the brief</span><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black"> due to a strong interest in "ensuring that the
dormant Commerce Clause continues to be interpreted in a way that preserves the abilities of state and local governments to adopt innovative programs to address threats to public health and welfare and the environment -- programs like Alameda's Ordinance."
A number of the state's laws have been challenged recently under the Commerce Clause--including California's greenhouse gas reducing fuels regulation and a ban on shark fin sales-- which Harris says shows why the office has a strong interest in seeing the
doctrine interpreted correctly.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">Harris also notes the county's ordinance sets an important precedent for the state's EPR laws, especially since California is in the stages of implementing a Safer Consumer
Products law, which she says will require manufacturers of certain products to establish and maintain end-of-life management programs that include comprehensive product stewardship plans.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#990000">CSAC and LCC in their joint brief</span><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black"> say a ruling in PhRMA's favor would
depart from long-established Commerce Clause jurisprudence. "PhRMA ignores controlling authority and asks this Court to adopt a rule that would invalidate a wide array of state and local laws, thereby curtailing the longstanding authority of state and local
governments to regulate waste," the local government groups say.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<b><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">Drug Collection</span></b><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black"><o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">CSAC and LCC further defend Alameda County's right to mandate pharmaceutical companies, who sell products within county lines, to fund and collect used and unwanted drugs
within its borders. Citing <i>Maine v. Taylor</i> extensively, the two associations argue that, "State and local laws imposing costs on manufactures to protect local residents from harms associated with products that arrive through a national chain of commerce
involving multiple intermediaries are commonplace."<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">They also take issue with PhRMA's argument that "Alameda County is not exercising its authority over waste disposal, but is instead 'transferring its traditional police
power responsibility of waste disposal to [private] interstate actors.'" The groups counter that the Commerce Clause does not control a government's decision as to whether government or the private sector should provide waste management services, and they
cite <i>Maine</i> to reiterate that "the states retain authority under their general police powers to regulate matters of legitimate local concern, even though interstate commerce may be affected."<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">PhRMA, meanwhile, in
</span><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:#990000">a Jan. 31 response brief</span><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">, acknowledges that Alameda has the authority
to defray the costs of its medicine disposal program by collecting taxes and fees on sales and operate the program through its government, a system it says is comparable to waste collection programs across the country. But the industry group says the county
violates the Commerce Clause because it mandates that pharmaceutical companies run the collection programs themselves.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">"The county requires manufacturers who are located well beyond the County's jurisdiction and have no contact with the country," it writes, "to come into the county and
develop, finance and operate a waste disposal program" which "forces these out-of-jurisdiction manufacturers to absorb all of the costs associated with this program and specifically prohibits them from recouping any or all of the costs of the program locally."<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:8.4pt;mso-line-height-alt:9.6pt;background:white">
<span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">PhRMA argues the ordinance is illogical because it expects drug companies to engage in waste disposal functions "which they are neither equipped nor competent to perform."
It alleges that Alameda and its supporters could not identify a "single precedent" that showed its novel ordinance was constitutional under the dormant Commerce Clause and that there's no precedent supporting the proposition that local governments can place
total cost burdens of a program benefiting only local residents onto citizens located beyond the jurisdiction.<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-line-height-alt:9.6pt;background:white"><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">The ordinance, it writes "leverages the presence of an interstate product in the County to compel
the product's manufacturer to enter the county and perform Alameda's public functions, regardless of whether the manufacturer has any other contract with the county."<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:windowtext"><o:p> </o:p></span></p>
<p class="MsoNormal"><o:p> </o:p></p>
<p class="MsoNormal"><o:p> </o:p></p>
<p class="MsoNormal"><span style="font-size:10.0pt;color:navy">Deborah L. DeBiasi</span><span style="font-size:11.0pt;color:navy"><br>
</span><b><span style="font-size:10.0pt;color:navy">Email: <a href="mailto:Deborah.DeBiasi@deq.virginia.gov">Deborah.DeBiasi@deq.virginia.gov</a></span></b><b><i><span style="font-size:10.0pt;color:red"><br>
</span></i></b><span style="font-size:10.0pt;color:navy">WEB site address: <a href="http://www.deq.virginia.gov/">
www.deq.virginia.gov</a></span><span style="font-size:11.0pt;color:navy"><br>
</span><span style="font-size:10.0pt;color:navy">Virginia Department of Environmental Quality</span><span style="font-size:11.0pt;color:navy"><br>
</span><span style="font-size:10.0pt;color:navy">Office of Water Permits </span><span style="font-size:11.0pt;color:navy"><br>
</span><span style="font-size:10.0pt;color:navy">Industrial Pretreatment/Whole Effluent Toxicity (WET) Program</span><span style="font-size:11.0pt;color:navy"><br>
</span><span style="font-size:10.0pt;color:navy">PPCPs, EDCs, and Microconstituents<o:p></o:p></span></p>
<p class="MsoNormal"><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><span style="font-size:10.0pt;color:navy"><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:10.0pt;color:navy">Mail: P.O. Box 1105, Richmond, VA 23218</span><span style="font-size:11.0pt;color:navy"><br>
</span><span style="font-size:10.0pt;color:navy">Location: 629 E. Main Street, Richmond, VA 23219</span><span style="font-size:11.0pt;color:navy"><br>
</span><span style="font-size:10.0pt;color:navy">PH: 804-698-4028 FAX: 804-698-4032<o:p></o:p></span></p>
<p class="MsoNormal"><o:p> </o:p></p>
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