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<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">Hi Burke,<o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"> <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">Thanks for questioning my interpretation of the draft rules to mean that disposal via trash or flushing is banned. Reviewing the draft rules I continued to read in “ban” until I got to the section, “Environmental Considerations. I will take out the reference to a ban from my letter. See below for details.<o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><SPAN style="mso-spacerun: yes"> </SPAN><o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">With luck, the actual rule will be clear on this, and all, points! <SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">Thanks again for the feedback!</SPAN></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><SPAN style="mso-spacerun: yes"></SPAN></SPAN> </P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><SPAN style="mso-spacerun: yes">Hi Catherine, </SPAN></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><SPAN style="mso-spacerun: yes"></SPAN></SPAN> </P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><SPAN style="mso-spacerun: yes">Thanks for tweaks to the letter!</SPAN></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><SPAN style="mso-spacerun: yes"></SPAN></SPAN> </P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><SPAN style="mso-spacerun: yes">Ed</SPAN></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><o:p> </o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">This is what led me to the conclusion that disposal via trash or flushing would be banned. <SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><B style="mso-bidi-font-weight: normal">I added bold to highlight some text.<o:p></o:p></B></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal> [pg 75790 Federal Register / Vol. 77, No. 246/ Friday, Dec 21, 2012]<SPAN style="mso-spacerun: yes"> </SPAN></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><o:p> </o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">"Proposed Disposal Act Implementing Regulations" <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">"Disposal of Controlled Substances by Ultimate Users—Authorized Persons"... <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">"<B style="mso-bidi-font-weight: normal">DEA proposes three options for ultimate users to dispose of controlled substances: (1) Take-back events; (2) mail-back programs; and (3) collection receptacle locations."... <o:p></o:p></B></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><o:p> </o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">And, further down that page:<o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><o:p> </o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">"Possession for Disposal" <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">"Once a controlled substance is lawfully dispensed to an ultimate user, the ultimate user is in possession of that substance. <B style="mso-bidi-font-weight: normal">Only the ultimate user or other authorized persons</B> (i.e., persons lawfully entitled to dispose of an ultimate user decedent’s property and, in some cases, the LTCF where the ultimate user resides or has resided) <B style="mso-bidi-font-weight: normal">may dispose of such controlled substances in accordance with DEA’s proposed ultimate user disposal regulations</B>."<o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"> <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">On page 75794 the three proposed disposal options are repeated under the heading:<o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">"<B style="mso-bidi-font-weight: normal">Disposal of Controlled Substances by Ultimate Users—Authorized Methods</B>" <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"> <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">As you note, the rule discusses: <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">"Methods of Destruction <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">DEA is proposing a standard of destruction—non-retrievable—for persons that destroy or cause the destruction of controlled substances." and defines “non-retrievable”. [pg. 75803]. <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"> <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">Finally, supporting the interpretation that <B style="mso-bidi-font-weight: normal">this is not a ban</B>, from pg. 75804:<o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><o:p> </o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">"Environmental Considerations <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">In passing the Disposal Act to <B style="mso-bidi-font-weight: normal">provide</B> those individuals seeking to dispose of unwanted or unused controlled substances in their household with <B style="mso-bidi-font-weight: normal">more</B> <B style="mso-bidi-font-weight: normal">disposal options beyond discarding or flushing</B> the substances, Congress expected that there would be fewer such substances introduced into the environment, particularly into the water.<SUP>43<SPAN style="mso-spacerun: yes"> </SPAN></SUP>DEA also recognizes that the establishment of alternative, lawful means for disposing of unused or expired pharmaceutical controlled substances may alleviate some existing environmental concerns. For example, recent studies have reported on the presence of pharmaceutical chemicals in varying concentrations in water supplies. DEA is hopeful that the increased availability of methods for citizens to safely and securely dispose of unwanted prescription drugs will have a positive impact on reducing the introduction of chemical contaminants into the water supply. However, collection and destruction of unwanted and unused pharmaceuticals cannot and will not address water contamination that occurs from other means such as bodily elimination or excretion of such substances. <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><o:p> </o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">Ed</SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><o:p></o:p></SPAN> </P><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt"></SPAN></DIV>
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<P class=MsoNormal><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Thanks for all your efforts to put this letter together Ed. <o:p></o:p></SPAN></P>
<P class=MsoNormal><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Re: “Another expected key measure is a ban on the disposal of medications via trash or flushing.” <o:p></o:p></SPAN></P>
<P class=MsoNormal><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">The proposed regulations require any voluntary collection program to render controlled substances non-retrievable and trash and flushing would not meet the non-retrievable standard. However, I don’t see anything saying medications would be banned from trash or flushing. That sounds like it would be outside the DEA’s purview over the Controlled Substances Act. <o:p></o:p></SPAN></P>
<P class=MsoNormal><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Can you reference any language in the proposed regs that suggests a ban? <o:p></o:p></SPAN></P>
<P class=MsoNormal><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Burke<o:p></o:p></SPAN></P>
<P class=MsoNormal><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt"><o:p> </o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Mr. Burke Lucy<o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Integrated Waste Management Specialist<o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Department of Resources Recycling and Recovery (CalRecycle)<o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">1001 I Street, PO Box 4025<o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">Sacramento, CA 95812<o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt"><A href="mailto:Burke.Lucy@CalRecycle.ca.gov"><SPAN style="COLOR: blue">Burke.Lucy@CalRecycle.ca.gov</SPAN></A><o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt">916.341.6592<o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><A href="http://www.calrecycle.ca.gov/"><SPAN style="FONT-FAMILY: 'Arial','sans-serif'; COLOR: #3754d4; FONT-SIZE: 9.5pt; TEXT-DECORATION: none"><IMG id=Picture_x0020_18 border=0 alt="California Department of Resources Recycling and Recovery (CalRecycle)" src="cid:VVXNVKIJHRBJ.IMAGE_4.jpeg" width=147 height=43></SPAN></A><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt"><o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><B><SPAN style="FONT-FAMILY: 'Georgia','serif'; COLOR: #1f497d; FONT-SIZE: 10pt">Connect with us!</SPAN></B><SPAN style="FONT-FAMILY: 'Georgia','serif'; COLOR: #1f497d; FONT-SIZE: 10pt"> <o:p></o:p></SPAN></P>
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<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 'Calibri','sans-serif'; COLOR: #1f497d; FONT-SIZE: 11pt"><o:p> </o:p></SPAN></P>
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<P style="MARGIN: 0in 0in 0pt" 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>Ed Gottlieb<BR><B>Sent:</B> Wednesday, February 26, 2014 11:15 AM<BR><B>To:</B> pharmwaste@lists.dep.state.fl.us<BR><B>Subject:</B> [Pharmwaste] Letter to Pharmacies<o:p></o:p></SPAN></P></DIV></DIV>
<P class=MsoNormal><o:p> </o:p></P>
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<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 'Tahoma','sans-serif'; FONT-SIZE: 10pt">Hi All,<o:p></o:p></SPAN></P></DIV>
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<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 'Tahoma','sans-serif'; FONT-SIZE: 10pt"> <o:p></o:p></SPAN></P></DIV>
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<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 'Tahoma','sans-serif'; FONT-SIZE: 10pt">Below is a draft of a letter my group wants to send (probably this Friday) to all of our local pharmacies and their corporate HQ's (one of our local pharmacies is not part of a chain.) We may offer a free drop-box to one pharmacy if we think it will get them to participate when they otherwise wouldn't have. <o:p></o:p></SPAN></P></DIV>
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<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 'Tahoma','sans-serif'; FONT-SIZE: 10pt">Please send me any corrections, or other suggestions, you have for the letter. Thanks!<o:p></o:p></SPAN></P></DIV>
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<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 'Tahoma','sans-serif'; FONT-SIZE: 10pt"> <o:p></o:p></SPAN></P></DIV>
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<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 'Tahoma','sans-serif'; FONT-SIZE: 10pt">Ed<o:p></o:p></SPAN></P></DIV>
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<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 'Tahoma','sans-serif'; FONT-SIZE: 10pt"> <o:p></o:p></SPAN></P></DIV>
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<P style="MARGIN: 0in 0in 0pt" class=MsoNormal>February 28, 2014<o:p></o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><o:p> </o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal>Dear Pharmacist,<o:p></o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><o:p> </o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal>As you are probably aware, the DEA announced that they will publish, in March, a new rule regarding the collection and disposal of unwanted medications. Creating the new rule was required by the Secure and Responsible Drug Disposal Act, signed into law in 2010. <o:p></o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><o:p> </o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal>There are several key provisions anticipated to be included in the rule, most notably allowing pharmacies to take-back all unwanted and/or unused medications, including controlled substances. It is also expected that pharmacies will be allowed to set-up collection stations in Long-term Care Facilities. Participation will be a voluntary public service; there will be no federal funding available to implement take-back programs. The rule should include requirements governing collection procedures, storage containers, and disposal requirements.<o:p></o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><o:p> </o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal>Another expected key measure is a ban on the disposal of medications via trash or flushing. Once the rule is published, our organization is planning a public education effort. We would like to publicize all of the local take-back options that are available. <o:p></o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><o:p> </o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal>We are happy that a more convenient option, compared to the drop-boxes we placed in law enforcement buildings, could soon be available. Considering the extensive publicity that CVS recently received for no longer selling tobacco, we think any pharmacy that takes advantage of this new opportunity will benefit. Clearly, the first pharmacy in the area to offer this service will get the most media attention. <o:p></o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><o:p> </o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal>Does your pharmacy have plans to host a drop-box at your location? If so, when is it expected to be open to the public? We would be happy to help promote your program. <o:p></o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal> <o:p></o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal>We are available for consultation if you have any questions regarding the new DEA rule or about how to set up a take-back program. Please don’t hesitate to contact us.<o:p></o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><o:p> </o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal>Sincerely,<o:p></o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><o:p> </o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><o:p> </o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal>Ed Gottlieb<BR>Chair, Coalition for Safe Medication Disposal *<BR>Industrial Pretreatment Coordinator <BR>Ithaca Area Wastewater Treatment Facility<BR>525 3<SUP>rd</SUP> Street<BR>Ithaca, NY 14850<BR><BR><BR><o:p></o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal>* The Coalition for Safe Medication Disposal includes representatives of: <o:p></o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal>Tompkins County (TC) Health Dept., TC Administration, TC Sheriff, Lifelong (a senior’s group), Community Coalition for Healthy Youth, Ithaca Area Wastewater Treatment Facility, and an RN “at large” member. More information can be found at: <A href="http://www.healthyyouth.org/medication-disposal.php">http://www.healthyyouth.org/medication-disposal.php</A><o:p></o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><o:p> </o:p></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal>Cc: Corporate HQ</P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><o:p></o:p> </P></DIV></DIV>
<DIV>Ed Gottlieb</DIV>
<DIV>Industrial Pretreatment Coordinator</DIV>
<DIV>Ithaca Area Wastewater Treatment Facility<BR>525 3<SUP><FONT size=3><FONT face="Times New Roman">rd<o:p></o:p></FONT></FONT></SUP> Street</DIV>
<DIV>Ithaca, NY 14850</DIV>
<DIV>(607) 273-8381</DIV>
<DIV>fax: (607) 273-8433</DIV></BODY></HTML>