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<DIV><div class=WordSection1><p class=MsoNormal>Here is<span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'> a</span> summary of key points from my initial review of the Federal Register notice of notification of proposed Safe Drug Disposal Act rulemaking (FR notice attached). Underlines identify what I considered to be the key points. Those may not coincide with your key points.<span style='color:#1F497D'> </span>At first I was disappointed that governmental entities were not permitted to run take back events but with the opportunity for pharmacy takeback and mailback allowed, I no longer think that we need an option for government run programs. I do not have any suggestions for things that should be dropped from the rule or additional things that can be added. I could accept finalization of the draft rule but would like to hear other’s comments about that and anything else in this proposed rule, especially if I have misinterpreted any parts of the draft regulation. <o:p></o:p></p><p class=MsoListParagraph><o:p> </o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>1.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]><u>Pharmacies can but governmental entities cannot</u> run events or host collection receptacles. Neither pharmacies nor governmental entities seem to be allowed to run collection programs or site collection receptacles, executive summary, p. 7. <o:p></o:p></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l1 level2 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>a.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>-However, p. 32 seems to <u>allow pharmacies to collect</u> via containers: “In particular, DEA is proposing to authorize registered retail pharmacies to become collectors because such registrants are open to the public and have theft and loss prevention measures within the pharmacy processing area as well as outside the confines of the prescription processing and pick-up area, which easily lends itself to secure collection receptacle placement.” P.32<o:p></o:p></p><p class=MsoListParagraph style='margin-left:117.0pt;text-indent:-.25in;mso-list:l1 level3 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>-<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]><u>Governmental entities are not allowed</u> to be collectors: “collection may occur only at the registered locations of manufacturers, distributors, reverse distributors, and retail pharmacies that are authorized to collect at those locations and at long term care facilities (LTCFs) at which registered retail pharmacies are authorized to maintain a collection receptacle” Apparently, the Safe Disposal Drug Act did not give DEA authority to register entities only for collection: “Finally, with the passage of the Disposal Act, <u>Congress did not provide DEA the authority to register persons specifically for the purpose of collecting and disposing of controlled substances from ultimate users</u>. DEA is therefore restricted to operating within its previously existing statutory authority with regard to registration.” P. 36<o:p></o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>2.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>“All of the proposed collection methods are <u>voluntary </u>and no person is required to establish or operate a disposal program.” executive summary, p. 7,<o:p></o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>3.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]><u>Mail-back programs</u> can be provided at no cost or for a fee - executive summary, p. 7<o:p></o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>4.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>Controlled substances can be <u>comingled</u> with non-controlled substances - executive summary, p. 7<o:p></o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>5.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]><u>Destruction standard is performance based not prescribed</u> – p. 79 , executive summary, p. 9-10, also p.61, 65<o:p></o:p></p><p class=MsoListParagraph style='margin-left:117.0pt;text-indent:-.25in;mso-list:l1 level3 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>-<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>standard is “<u>non-retrievable</u>” and intended to be “secure, convenient, and responsible, consistent with preventing the diversion of such substances”;<o:p></o:p></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l1 level2 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>b.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>–“ ‘non-retrievable’ means to permanently alter any controlled substance’s physical and/or chemical state through irreversible means in order to render that controlled substance unavailable and unusable for all practical purposes.” P. 80 <o:p></o:p></p><p class=MsoListParagraph style='margin-left:117.0pt;text-indent:-.25in;mso-list:l1 level3 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>-<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>“The ‘as soon as practicable but <u>no later than fourteen calendar day</u>’ requirement is unique to reverse distributors – other registrants that destroy must do so promptly and do not have to follow a specific time limit – because the primary business activity of reverse distributors, unlike other registrants, is to acquire controlled substances for the purpose of destruction or return.” P. 71<o:p></o:p></p><p class=MsoListParagraph style='margin-left:117.0pt;text-indent:-.25in;mso-list:l1 level3 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>-<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>“a standard of destruction – non-retrievable – for persons that destroy or cause the destruction of controlled substances. Some examples of current technology that may achieve the non-retrievable standard are incineration and chemical digestion. Flushing and mixing controlled substances with coffee grounds or kitty litter are examples of existing methods of destruction that do not meet the non-retrievable standard.” P. 79<o:p></o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>6.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>Pharmacies can operate collection receptacles at <u>long term care facilities</u>, p. 32-33 and also exec summary<o:p></o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>7.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>“authorized collectors <u>may conduct the following activities</u>: (1) receive mail-back packages from ultimate users and persons lawfully entitled to dispose of an ultimate user decedent’s property if the collector has and utilizes an on-site method of destruction;(2) install, manage, and maintain collection receptacles at locations for which the registrant is authorized to collect; and (3) promptly dispose of sealed inner liners and their contents as provided for in § 1317.05(c)(2)” p. 35<o:p></o:p></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l1 level2 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>a.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>1317.05(c) Collected Controlled Substances. (2) Collection Receptacles. Upon removal from the permanent outer shell, the authorized collector shall promptly: (i) Destroy the inner liner and its contents; or (ii) Store the inner liner and its contents at the collector’s registered location in a manner consistent with the security requirements for Schedule II controlled substances until prompt destruction can occur.” P.115<o:p></o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>8.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>Collectors must <u>modify their DEA registration</u>: “To obtain authorization to be a collector, a manufacturer, distributor, reverse distributor, or retail pharmacy must apply for a modification to their registration…” p.34<o:p></o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>9.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]><u>Collectors may use reverse distributors and distributors for disposal/destruction</u> of collected medications: “… law enforcement agencies and authorized collectors may not have the resources to destroy controlled substances received from ultimate users. Such persons may use the services of a registered reverse distributor for this purpose. DEA proposes in section 1317.55(a) to authorize registered reverse distributors to acquire for purposes of destruction controlled substances that have been collected by: (1) law enforcement agencies; and (2) authorized collectors through collection receptacles. DEA also proposes in section 1317.55(b) to authorize registered distributors, in addition to registered reverse distributors, to acquire for purposes of destruction controlled substances collected by authorized collectors through collection receptacles” p.38<o:p></o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>10.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>Take back events p. 41-<o:p></o:p></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l1 level2 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>a.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>–must still have law enforcement p.41<o:p></o:p></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l1 level2 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>b.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>–have at least 1 receptacle “should have at least one receptacle for the collection of permitted substances . . . that is securely locked and substantially constructed with an outer shell and removable inner liner. “ p. 42-43<o:p></o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>11.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>Mail back programs p. 43 – <o:p></o:p></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l1 level2 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>a.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>–sites receiving the mail back must “ have and utilize an <u>on-site method of destruction</u> at their registered location” p. 43 and “authorized collector must promptly destroy the package on-site or securely store the package until prompt on-site destruction or timely notification to DEA of receipt of an unauthorized package in accordance with 1317.70(e) can occur.” P.48 <o:p></o:p></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l1 level2 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>b.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>–mail back <u>package requirements</u> “the packages are proposed to be postage paid (e.g., business reply), preaddressed to the authorizedmail-back location, nondescript, tamper-evident and tear-resistant, among other things.” P. 45<o:p></o:p></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l1 level2 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>c.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>–<u>record keeping to minimize diversion</u>: “a collector conducting a mail-back program must keep inventory of mailers created and record the unique identification number of each mail-back package received” p. 46<o:p></o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>12.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>Collection receptacles p.49 – <o:p></o:p></p><p class=MsoListParagraph style='margin-left:2.0in;text-indent:-.25in;mso-list:l1 level4 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>–<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>any law enforcement agency or “any DEA registered manufacturer, distributor, reverse distributor, or retail pharmacy authorized as a collector” . . . (and certain authorized LTCFs [long term care facilities]. . . )” may provide a receptacle p. 49<o:p></o:p></p><p class=MsoListParagraph style='margin-left:2.0in;text-indent:-.25in;mso-list:l1 level4 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>–<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>“may <u>not be placed at non-registered locations</u> such as libraries or community centers.” P. 49<o:p></o:p></p><p class=MsoListParagraph style='margin-left:2.0in;text-indent:-.25in;mso-list:l1 level4 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>–<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]><u>receptacle specifications</u> – “The collection receptacles used by authorized collectors must have a permanent outer container with a removable inner liner. The outer container must have an opening big enough to allow contents to be added to the inner liner, but small enough to prevent removal of the inner liner contents. The opening must be capable of being locked at times when an authorized employee is not present, unless the collection receptacle is located in a secured area of a long term care facility which is regularly monitored by LTCF personnel.” P. 50<o:p></o:p></p><p class=MsoListParagraph style='margin-left:2.0in;text-indent:-.25in;mso-list:l1 level4 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>–<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>“the inner liner must bear a permanent<u>, unique identification number</u> that enables the liner to be tracked” p. 50<o:p></o:p></p><p class=MsoListParagraph style='margin-left:2.0in;text-indent:-.25in;mso-list:l1 level4 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>–<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>“securely fastened to a permanent structure such as a wall, floor, or immovable countertop so that they cannot be removed.” P. 51<o:p></o:p></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l1 level2 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>b.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>–“ the <u>removal of the inner liner</u> of the collection receptacle shall be performed by or under the supervision <u>of at least two authorized employees</u> of the authorized collector.” P. 51<o:p></o:p></p><p class=MsoListParagraph style='margin-left:117.0pt;text-indent:-.25in;mso-list:l1 level3 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>-<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]><u>Prompt destruction</u> – “DEA is proposing the flexible “prompt” destruction, transfer, and storage standard for collectors rather than a specific time frame to ensure that controlled substances do not accumulate while pending destruction, transfer, or storage, while still accounting for the individual circumstances of registrants that operate and maintain collection receptacles.” P. 53<o:p></o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>13.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>Long term care facilities p. 53 – <o:p></o:p></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l1 level2 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>a.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>–“ <u>only a registered retail pharmacy</u> that receives authorization to collect at a specific long term care facility <u>may manage and maintain collection receptacles</u> at that long term care facility and remove or supervise the removal of the inner liner of the collection receptacles at that long term care facility” p. 53<o:p></o:p></p><p class=MsoListParagraph style='margin-left:2.0in;text-indent:-.25in;mso-list:l1 level4 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>–<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>“located in <u>a secured area monitored by personnel</u> of that long term care facility” p. 54<o:p></o:p></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l1 level2 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>b.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>–“ <u>access to the inner liner</u> is restricted to authorized employees of the registered retail pharmacy” p.54<o:p></o:p></p><p class=MsoListParagraph style='margin-left:117.0pt;text-indent:-.25in;mso-list:l1 level3 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>-<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]><u>no employee of the long term care facility will have access</u> to or influence over the contents of the collection receptacle, except to deposit controlled substances into it.” p. 54-55<o:p></o:p></p><p class=MsoListParagraph style='margin-left:2.0in;text-indent:-.25in;mso-list:l1 level4 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>–<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>“long term care facilities be <u>permitted to dispose</u> of controlled substances in Schedules II through V <u>on behalf of an ultimate user who resides or has resided</u> at such long term care facility. As with all other collection methods, controlled and non-controlled substances may be comingled in the collection receptacle.” P. 55<o:p></o:p></p><p class=MsoListParagraph style='margin-left:2.0in;text-indent:-.25in;mso-list:l1 level4 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>–<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>LTCF employees <u>not allowed</u> to take substances <u>to take back or send in mail back</u> due to diversion concerns, however “LTCF <u>residents</u> themselves <u>may utilize</u> any other disposal method available to ultimate users, including <u>mail-back programs and take-back events</u>” p. 56-57<o:p></o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>14.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]><u>Package and inner liner storage security</u><o:p></o:p></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l1 level2 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>a.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>–collectors must store “sealed mail-back packages and inner liners as though they are Schedule II controlled substances” p. 58<o:p></o:p></p><p class=MsoListParagraph style='margin-left:117.0pt;text-indent:-.25in;mso-list:l1 level3 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>-<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]><u>inventorying or counting collected substances </u>– DEA considered but decided <u>not to allow</u> due to increased opportunity for diversion as the collected substances are accessible by the persons doing the counting; not allowing counting removes one more person from handling and one more opportunity for diversion p. 59<o:p></o:p></p><p class=MsoListParagraph style='margin-left:117.0pt;text-indent:-.25in;mso-list:l1 level3 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>-<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]><u>unique tracking number </u>on each package or inner liner p. 60<o:p></o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>15.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]><u>2 person integrity requirement</u> – at least 2 authorized employees of the collection entity must load/unload ( or witness it) and witness destruction to reduce chances of diversion p. 66-67<o:p></o:p></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l1 level1 lfo4'><![if !supportLists]><span style='mso-list:Ignore'>16.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]><u>Record of destruction</u> – “a registrant that destroys controlled substances or causes the destruction of controlled substances is required to maintain a record of the destruction in a form to be issued by DEA” p. 67<o:p></o:p></p><p class=MsoNormal style='margin-left:.25in'><span style='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;color:#1F497D'>John L. (Jack) Price</span><span style='color:#1F497D'><o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;color:#1F497D'>Environmental Manager<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;color:#1F497D'>Waste Reduction MS 4555<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;color:#1F497D'>Florida Department of Environmental Protection<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;color:#1F497D'>2600 Blair Stone Road<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;color:#1F497D'>Tallahassee, FL 32399-2400<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;color:#1F497D'>Phone:850.245.8751<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;color:#1F497D'>Fax: 850.245.8811<o:p></o:p></span></p><p class=MsoNormal><a href="mailto:john.l.price@dep.state.fl.us"><span style='font-size:11.0pt;color:#9D454F'>john.l.price@dep.state.fl.us</span></a><span style='font-size:11.0pt;color:#1F497D'><o:p></o:p></span></p><p class=MsoNormal><a href="http://www.dep.state.fl.us/waste"><span style='font-size:11.0pt;color:#9D454F'>www.dep.state.fl.us/waste</span></a><span style='font-size:11.0pt;color:#1F497D'><o:p></o:p></span></p><p class=MsoNormal><span style='font-size:7.5pt;font-family:"Arial","sans-serif";color:#1F497D'>Please Note: Florida has a very broad public records law. Most written communications to or from state officials regarding state business are public records available to the public and media upon request. Your e-mail is communications and may therefore be subject to public disclosure.</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></DIV>
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<DIV STYLE="FONT-FAMILY: Courier New; FONT-SIZE: 9pt"><p class=MsoNormal><b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'>From:</span></b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'> Chris Angel [<a href="mailto:info@greatlakescleanwater.org">mailto:info@greatlakescleanwater.org</a>] <br><b>Sent:</b> Thursday, December 20, 2012 12:03 PM<br><b>To:</b> Ed Gottlieb<br><b>Cc:</b> Allen Gilliam; <a href="mailto:ekrisiunas@aol.com">ekrisiunas@aol.com</a>; <a href="mailto:hodgetf@auburn.edu">hodgetf@auburn.edu</a>; <a href="mailto:burke.lucy@calrecycle.ca.gov">burke.lucy@calrecycle.ca.gov</a>; Nicolas Vaczek; 'Barry Fernandez'; <a href="mailto:amy.roering@co.hennepin.mn.us">amy.roering@co.hennepin.mn.us</a>; <a href="mailto:jcanderson27@comcast.net">jcanderson27@comcast.net</a>; Adams, Bobby; Scarborough, Jill R.; Poston, Johanna; Price, John L. "Jack"; Tenace, Laurie; Henricks, Ron; Reynolds, Shannan; Boroff, Suzanne; Partin, Tony; Deborah DeBiasi; Matthew C. Mireles; <a href="mailto:pickrel.jan@epamail.epa.gov">pickrel.jan@epamail.epa.gov</a>; <a href="mailto:stitzhal@fullcircleenvironmental.com">stitzhal@fullcircleenvironmental.com</a>; "Stevan Gressitt" <Gressitt Stevan; <a href="mailto:randsney@gmail.com">randsney@gmail.com</a>; chris angel; Tom Sinclair; Russell Mankes; Jim Mullowney; Theresa O'Keefe; 'Scott Cassel'; Jeff Hollar; <a href="mailto:jharris@sharpsinc.com">jharris@sharpsinc.com</a>; Jennifer (MPCA) Volkman; Joel Kreisberg; Fred Miller; <a href="mailto:dlotzer@uwhealth.org">dlotzer@uwhealth.org</a>; <a href="mailto:pharmwaste@lists.dep.state.fl.us">pharmwaste@lists.dep.state.fl.us</a><br><b>Subject:</b> DEA rules <o:p></o:p></span></p></div><p class=MsoNormal><o:p> </o:p></p><p>TO: List Serve Particpants<o:p></o:p></p><p>FR: Chris Angel, Great Lakes Clean Water Org. Yellow Jug Old Drugs program<o:p></o:p></p><p>The new document is available today-all 140 pages dated 12.20.12 -Link Below<o:p></o:p></p><p><a href="http://www.ofr.gov/inspection.aspx">http://www.ofr.gov/inspection.aspx</a> <o:p></o:p></p><p>Scroll down to DEA-Happy reading-Happy Holidays<o:p></o:p></p><p> <o:p></o:p></p><p> <o:p></o:p></p><p><br> <o:p></o:p></p><p>> Hi All,<br>><br>> The Pharmwaste Listserv is not posting at the moment. I grabbed your email from a recent posting so at least some of the list could get this timely news. Please pass it on to your contacts!<br>><br>> Ed<br>><br>> A congressional staffer let me know yesterday:<br>><br>> "the DEA has drafted a comprehensive Notice of Proposed Rulemaking (NPRM) to implement the Secure and Responsible Drug Disposal Act of 2010. The White House Office of Management and Budget concluded its review on December 14, 2012, and publication is anticipated on Friday this week. The draft NPRM proposes a variety of disposal options for how ultimate users may return controlled substances for the purpose of disposal. I do not know for sure, but I assume that these will be published as proposed rules with an opportunity for comment."<br>><br>> Assuming there is an opportunity to comment, I would like to suggest that we use this Listserv to share our thoughts on the proposed rules. Having others perspectives would help me craft better comments. It could turn out that the DEA did a great job and all I will need to say is, "well done". I will certainly say that about as many parts as I can, to balance the suggested changes I will likely submit.<br>><br>><br>> Ed Gottlieb<br>> Chair, Coalition for Safe Medication Disposal<br>> Industrial Pretreatment Coordinator<br>> Ithaca Area Wastewater Treatment Facility<br>> 525 3rd Street<br>> Ithaca, NY 14850<br>> (607) 273-8381<br>> fax: (607) 273-8433<br>><br><br><br>Chris Angel,President<br>Volunteer Board Of Directors<br>Great Lakes Clean Water Organization<br><a href="http://www.greatlakescleanwater.org">www.greatlakescleanwater.org</a><br>989.736.8179<o:p></o:p></p></div></DIV></DIV></DIV></BODY></HTML>