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<div>The interpretation should apply in every state because that is how Federal EPA distinguishes between HH and business waste at LTC's. I think Charlotte is right that the majority of LTC pharms are under the control of the facility, which makes it business
waste. LTC's might only generate at the CESQG level, and states do differ on how they regulate that size of generator. In MN we regulate them fully, so they have to manage all of their HW at a HW facility. This is why DEA's decision to also collect from LTC's
is very problematic here. As it stands, it puts many states in the awkward position of waiving HW rules in order to help DEA with its federal mandate. In MN, we have several years of effort into educating LTC's and DEA's mandate to collect from them has already
caused major confusion. My coworkers and I have wasted many hours trying to clarify the confusion this has caused. We still have not settled on a compliant disposal solution. There is not a perfect one that doesn't add thousands of dollars onto the cost of
the event since we have no HW incinerator in the state.</div>
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<div><font size="2" face="tahoma">A one-time event does not help the LTC situation here. It doesn't save them much money and it has caused more confusion than it is worth. I agree with W. More's message that there is no reason to favor this particular generator
by giving them "free" disposal. We need a sustainable solution for them, hopefully through the current federal rule making effort. I agree with someone else's message from way back that we shouldn't involve DEA in the collection business. I need them getting
the bad guys and we'll take care of collection and disposal in our state. We are up to 34 collection sites at law enforcement facilities. Woot!</font></div>
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<b><span style="FONT-FAMILY: 'Tahoma','sans-serif'; FONT-SIZE: 10pt">From:</span></b><span style="FONT-FAMILY: 'Tahoma','sans-serif'; FONT-SIZE: 10pt"> Gonzalez, Lillian [mailto:Lillian.Gonzalez@dphe.state.co.us]
<br>
<b>Sent:</b> Monday, April 04, 2011 4:52 PM<br>
<b>To:</b> Smith, Charlotte; DeBiasi, Deborah (DEQ); pharmwaste@lists.dep.state.fl.us<br>
<b>Subject:</b> RE: [Pharmwaste] Collection and destruction of the LTC facility patient generated pharmaceutical waste for Virginia</span></div>
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<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">All- Colorado’s view on long term care facilities matches Charlotte’s: medications under the control of the nursing home staff
do not qualify for the household hazardous waste exemption. </span></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt"></span> </p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Are there other interpretations in other states?</span></p>
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<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Lillian Gonzalez, REM</span></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Hazardous Materials and Waste Management Division</span></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Colorado Department of Public Health and Environment</span></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">4300 Cherry Creek Drive South</span></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Denver, Colorado 80246-1530</span></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">303.692.3351</span></p>
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<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><b><span style="FONT-FAMILY: 'Tahoma','sans-serif'; FONT-SIZE: 10pt">From:</span></b><span style="FONT-FAMILY: 'Tahoma','sans-serif'; FONT-SIZE: 10pt"> pharmwaste-bounces@lists.dep.state.fl.us [mailto:pharmwaste-bounces@lists.dep.state.fl.us]
<b>On Behalf Of </b>Smith, Charlotte<br>
<b>Sent:</b> Monday, April 04, 2011 12:33 PM<br>
<b>To:</b> DeBiasi, Deborah (DEQ); pharmwaste@lists.dep.state.fl.us<br>
<b>Subject:</b> RE: [Pharmwaste] Collection and destruction of the LTC facility patient generated pharmaceutical waste for Virginia</span></p>
</div>
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<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"> </p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS','sans-serif'; COLOR: #1f497d; FONT-SIZE: 10pt">Hi Deborah,</span></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS','sans-serif'; COLOR: #1f497d; FONT-SIZE: 10pt"></span> </p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS','sans-serif'; COLOR: #1f497d; FONT-SIZE: 10pt">I took a closer look at the statement included below and have some concerns:
</span></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><b><span style="COLOR: black">Those pharmaceuticals that are under the control of the patient or resident of the long-term care facility, when discarded, would be subject to RCRA’s household hazardous waste exclusion
(40 CFR 261.4(b)(1)).</span></b></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><b><span style="COLOR: black"></span></b> </p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="COLOR: black">In the majority of long term care facilities, the pharmaceuticals are NOT under the control of the patient or resident and are managed entirely by professional staff. The only instances
in which that is not the case are independent living and some assisted living facilities, depending on the competence of the resident. I am concerned that managing these as non-RCRA is not allowed under the law. Have you discussed this in Virginia with this
in mind? The Wisconsin DNR specifically does not exempt long term care facilities due to the business-like nature of the facility, as compared to an actual residence.
</span></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS','sans-serif'; COLOR: #1f497d; FONT-SIZE: 10pt"></span> </p>
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<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Best regards,</span></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt"></span> </p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><b><span style="FONT-FAMILY: 'Trebuchet MS','sans-serif'; COLOR: #00673a; FONT-SIZE: 10pt">Charlotte A. Smith, R. Ph., M.S.</span></b></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Director, PharmEcology Services</span></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">WM Healthcare Solutions
</span></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Tel 713-725-6363
</span></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">877-247-7430</span></p>
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<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><b><span style="FONT-FAMILY: 'Trebuchet MS','sans-serif'; COLOR: #00673a; FONT-SIZE: 10pt">Waste Management
</span></b></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">1001 Fannin</span></p>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Houston, TX 77002</span></p>
</div>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS','sans-serif'; COLOR: #1f497d; FONT-SIZE: 10pt"></span> </p>
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<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"><b><span style="FONT-FAMILY: 'Tahoma','sans-serif'; FONT-SIZE: 10pt">From:</span></b><span style="FONT-FAMILY: 'Tahoma','sans-serif'; FONT-SIZE: 10pt"> 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, March 24, 2011 3:56 PM<br>
<b>To:</b> pharmwaste@lists.dep.state.fl.us<br>
<b>Subject:</b> [Pharmwaste] Collection and destruction of the LTC facility patient generated pharmaceutical waste for Virginia</span></p>
</div>
</div>
<p style="MARGIN-LEFT: 0.5in" class="MsoNormal"> </p>
<p style="MARGIN-LEFT: 0.5in"><span style="COLOR: black">There has been a great deal of discussion on the list about the feasibility of handling the pharmaceutical waste from LTC facilities in the same manner as household generated pharmaceutical waste. </span>
</p>
<p style="MARGIN-LEFT: 0.5in"><span style="COLOR: black">The Virginia DEQ</span> <span style="COLOR: black">
considers the pharmaceutical waste</span> <span style="COLOR: black">from the patients and residents to be excluded from</span>
<span style="COLOR: black">hazardous waste regulation, and it can be</span> <span style="COLOR: black">
collected and</span> <span style="COLOR: black">destroyed along with the other DEA collected residential pharmaceuticals at the Covanta WTE incinerator in Virginia.</span>
<span style="COLOR: black">The LTC facilities must still comply with the record keeping requirements of the Board of Pharmacy and maintain a list of the medications that are</span>
<span style="COLOR: black">given to the DEA for disposal. </span></p>
<p style="MARGIN-LEFT: 0.5in"><span style="COLOR: black">I am appreciative that the DEA included LTCs with their collection event, since much of the LTC residentially generated medications are disposed of through flushing. </span> <span style="COLOR: black">
My focus now is to get as many of them as possible to participate in the DEA sponsored Drug Take-Back Initiative as I can, in addition to the 80 collection sites we have registered for the April 30<sup>th</sup></span>
<span style="COLOR: black">collection</span> <span style="COLOR: black">event</span>
<span style="COLOR: black">to date. (Note that the Virginia DEA</span> <span style="COLOR: black">
agents will be collecting the pharmaceuticals from the</span> <span style="COLOR: black">
LTC</span> <span style="COLOR: black">facility in the week leading up to April 30<sup>th</sup>. LTC staff will not be transporting them.)</span></p>
<p style="MARGIN-LEFT: 0.5in"><span style="COLOR: black">Excerpts from the</span>
<span style="COLOR: black">EPA</span> <span style="COLOR: black">waste</span> <span style="COLOR: black">
preamble and</span> <span style="COLOR: black">regulation that Virginia adopted by reference are provided below: </span>
</p>
<p style="MARGIN-LEFT: 0.5in"><span style="COLOR: black">*******</span></p>
<p style="MARGIN-LEFT: 0.5in"><span style="COLOR: black">In the preamble of the UWR proposal, EPA wrote the following:</span><br>
<span style="FONT-FAMILY: 'Arial','sans-serif'; COLOR: black"> </span><span style="COLOR: black"><br>
Tuesday, December 2, 2008 Federal Register Volume 73, Number 232, page 73525 explains the following:</span>
</p>
<p style="MARGIN-LEFT: 0.5in"><br>
<span style="COLOR: black">c. Long-Term Care Facilities</span> </p>
<p style="MARGIN-LEFT: 0.5in"><br>
<span style="COLOR: black"> Nursing homes, assisted living centers, and other long-term care facilities also may be subject to the RCRA hazardous waste generator regulations. However, many long-term care facilities may be unaware of the applicability of
the RCRA hazardous waste regulations to their hazardous pharmaceutical waste. </span></p>
<p style="MARGIN-LEFT: 0.5in"><span style="COLOR: black"> <br>
Most long-term care facilities generate two types of hazardous pharmaceutical waste. First, the facility itself may generate hazardous wastes as a result of its central management of pharmaceuticals in its pharmacy or pharmacy-like area. These hazardous
pharmaceutical wastes would be subject to the RCRA hazardous waste generator regulations since the pharmaceuticals are under the control of the facility, and, thus, the resulting wastes are generated by that facility (see 40 CFR part 262). The long-term care
facilities, like other generators, are responsible for determining whether the wastes it generates are hazardous wastes subject to regulation under RCRA subtitle C. If so, the facility must then manage the wastes accordingly. Long-term care facilities face
many of the same issues that health care facilities and pharmacies do in managing hazardous pharmaceutical waste, as discussed above.</span>
</p>
<p style="MARGIN-LEFT: 0.5in"><br>
<span style="COLOR: black"> <b>Secondly, patients and residents in long-term care facilities may generate hazardous wastes. Those pharmaceuticals that are under the control of the patient or resident of the long-term care facility, when discarded, would
be subject to RCRA’s household hazardous waste exclusion (40 CFR 261.4(b)(1)). Hazardous pharmaceutical wastes generated by the resident are excluded from regulation because they are considered to be derived from a household.</b></span></p>
<p style="MARGIN-LEFT: 0.5in"><span style="COLOR: black">********</span></p>
<p style="MARGIN-LEFT: 0.5in"><span style="COLOR: black">Regarding the facility receiving such waste, the relevant regulatory language also appears at 40 CFR 261.4(B)(1) which also states that<b> “</b>A resource recovery facility managing municipal solid waste
shall not be deemed to be treating, storing, disposing of, or otherwise managing hazardous wastes for the purposes of regulation under this subtitle, if such facility:</span><b><br>
<br>
</b><span style="COLOR: black">(i) Receives and burns only</span><b><br>
<br>
<span style="COLOR: black">(A) Household waste (from single and multiple dwellings, hotels, motels, and other residential sources)</span></b><span style="COLOR: black"> and</span><b><br>
<br>
</b><span style="COLOR: black">(B) Solid waste from commercial or industrial sources that does not contain hazardous waste; and</span><b><br>
<br>
</b><span style="COLOR: black">(ii) Such facility does not accept hazardous wastes and the owner or operator of such facility has established contractual requirements or other appropriate notification or inspection procedures to assure that hazardous wastes
are not received at or burned in such facility.”</span></p>
<p style="MARGIN-LEFT: 0.5in"><span style="COLOR: navy; FONT-SIZE: 10pt">Deborah L. DeBiasi</span><br>
<b><span style="COLOR: navy; FONT-SIZE: 10pt">Email: Deborah.DeBiasi@deq.virginia.gov</span><i>
</i></b><b><i><span style="COLOR: red; FONT-SIZE: 10pt">(NEW!)<br>
</span></i></b><span style="COLOR: navy; FONT-SIZE: 10pt">WEB site address: www.deq.virginia.gov</span><br>
<span style="COLOR: navy; FONT-SIZE: 10pt">Virginia Department of Environmental Quality</span><br>
<span style="COLOR: navy; FONT-SIZE: 10pt">Office of Water Permit and Compliance Assistance Programs</span><br>
<span style="COLOR: navy; FONT-SIZE: 10pt">Industrial Pretreatment/Whole Effluent Toxicity (WET) Program</span><br>
<span style="COLOR: navy; FONT-SIZE: 10pt">PPCPs, EDCs, and Microconstituents</span><span style="COLOR: navy"><br>
</span><span style="COLOR: navy; FONT-SIZE: 10pt">www.deq.virginia.gov/vpdes/microconstituents.html</span><br>
<span style="COLOR: navy; FONT-SIZE: 10pt">Mail: P.O. Box 1105, Richmond, VA 23218</span><br>
<span style="COLOR: navy; FONT-SIZE: 10pt">Location: 629 E. Main Street, Richmond, VA 23219</span><br>
<span style="COLOR: navy; FONT-SIZE: 10pt">PH: 804-698-4028</span><br>
<span style="COLOR: navy; FONT-SIZE: 10pt">FAX: 804-698-4032</span> </p>
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