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<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>Hi Steve,<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>You have both EPA and DOT definitions
going on here. Under EPA hazardous waste regulations, if an aqueous solution
has an alcohol content of 24% or more and is being disposed, it meets the
definition of an ignitable hazardous waste and must be managed as such for
reasons of safety for both storage and transportation. It also meets the definition
of flammability for DOT. Yes, they will be incinerated and they burn really
well. It is the intervening steps that need precautions. The definition for an
empty container for these items is that all contents are removed that can be
removed and no more than 3% by weight remains. So an empty container that held
an ignitable is not hazardous waste. The “empty container rule” you
are stumbling over refers to chemicals that are on the P list of acutely
hazardous waste in the EPA regulations at 4 CFR 261.33 (e). (Think epinephrine
for example.) These are not considered empty unless they are rinsed with an
appropriate solvent and the rinsate disposed as hazardous waste, which is not
practical in healthcare. These regulations were written 30 years ago with <st1:place
w:st="on"><st1:City w:st="on">Love Canal</st1:City>, <st1:State w:st="on">NY</st1:State></st1:place>
in mind and heavy industrial applications, hence picture a 55 gallon drum or
large storage tank. So you are correct, the EPA hazardous waste regulations do
not fit pharmaceuticals in consumer or hospital usage well at all, but until
there is the political will for EPA to do an in-depth study and a carve out for
healthcare, these are the rules for pharmacies, hospitals, and other healthcare
facilities. Regarding consumer take back programs, EPA considers these
household waste and they are exempt from the federal rules. Each state has the
right to manage them more strictly, however. For example, in <st1:State w:st="on"><st1:place
w:st="on">Wisconsin</st1:place></st1:State>, they come back under regulation if
you are collecting them in a central location. It is also important to know
that only 5% of drugs on the market meet the federal definitions of hazardous
waste, although more should since the law hasn’t been updated in 30
years. Best management practices would involve at least having them incinerated
at a facility that can accept non-hazardous pharmaceutical waste, unless you
are in a state that brings them back under regulation. Only a very few
controlled substances are hazardous waste, except in some states that have
stricter rules. <o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>Having said all that, you might find it
helpful to review the H2E Blueprint on Managing Hazardous Waste which reviews
all the definitions. You can find it at <a
href="http://www.h2e-online.org/docs/h2epharmablueprint41506.pdf">http://www.h2e-online.org/docs/h2epharmablueprint41506.pdf</a>.
Of course, it is designed for hospital use, not for consumer use. <o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>Regarding the liquor industry, it is my
understanding the 24% was the result of the wine and beer lobby. The whisky and
brandy folks do need to dispose of unused alcohol as hazardous waste, in the
unlikely event that should occur. Hope this helps.<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>Best regards, <o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<div>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>Charlotte A. Smith, R. Ph., M.S., HEM</span></font><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>President</span></font><font color=navy><span
style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>PharmEcology Associates, LLC</span></font><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><st1:Street w:st="on"><st1:address w:st="on"><font size=2
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face=Arial><span style='font-size:10.0pt;font-family:Arial;color:navy'>, <st1:State
w:st="on">WI</st1:State> <st1:PostalCode w:st="on">53005</st1:PostalCode></span></font></st1:place><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>414-292-3959</span></font><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>Cell 414-915-4026</span></font><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
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<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><a href="mailto:csmith@pharmecology.com">csmith@pharmecology.com</a></span></font><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><a href="http://www.pharmecology.com">www.pharmecology.com</a></span></font><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>H2E Champion for Change Award Winner</span></font><o:p></o:p></p>
</div>
<div>
<div class=MsoNormal align=center style='text-align:center'><font size=3
face="Times New Roman"><span style='font-size:12.0pt;font-family:"Times New Roman"'>
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<p class=MsoNormal><b><font size=2 face=Tahoma><span style='font-size:10.0pt;
font-family:Tahoma;font-weight:bold'>From:</span></font></b><font size=2
face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma'>
pharmwaste-bounces@lists.dep.state.fl.us
[mailto:pharmwaste-bounces@lists.dep.state.fl.us] <b><span style='font-weight:
bold'>On Behalf Of </span></b>Stevan Gressitt<br>
<b><span style='font-weight:bold'>Sent:</span></b> Thursday, October 04, 2007
4:37 PM<br>
<b><span style='font-weight:bold'>To:</span></b>
pharmwaste@lists.dep.state.fl.us<br>
<b><span style='font-weight:bold'>Subject:</span></b> [Pharmwaste]
Input/comment requested on categorical classificationof hazardous waste/PPCP's
and "combustibility."</span></font><font size=3 face="Times New Roman"><span
style='font-size:12.0pt;font-family:"Times New Roman"'><o:p></o:p></span></font></p>
</div>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'>If
one of the characteristics to be considered in the disposal of hazardous waste
is flammability<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'>And<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'>The
proposed method of “incineration” does indeed involve “burning”
explicitly<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'>Then<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'>Why
should there not be an exemption for that specific characteristic as a
determinant of hazardous status?<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'>The
situation arose in a discussion with a non-environmental governmental more law
enforcement minded type who was interested in minimizing the disposal costs
through either reverse distributors, hazardous waste licensees, or
any of the other commercial avenues.<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'>I
am stumped.<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'>Seems
there is no reason to apply that standard except in an almost obsessively narrow
minded way to that specific category.<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'>I
attempted to find an analogy, and without too much caffeine and certainly below
toxic espresso levels, I would ask the following:<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'>Some
states have liquor monopolies, as in <st1:State w:st="on"><st1:place w:st="on">New
Hampshire</st1:place></st1:State>. They sell Rum of 151 proof and absolute
ethanol at 195 proof. They collect a state tax on these bottles and a return
fee as well. These are flammable liquids. People get burned in restaurants from
flare ups of fancy meals known as flambe. <o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'>Empty
containers that held hazardous substances are to be considered as needing
hazardous waste disposal by “Federal?” regulation ( I saw the
citation once but am not familiar with it.) as well as some state regulations (
I have no reference here either except hearsay.)<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'>Hence:<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=msolistparagraph style='text-indent:-.25in;mso-list:l0 level1 lfo2'><![if !supportLists]><font
size=2 face=Calibri><span style='font-size:11.0pt'><span style='mso-list:Ignore'>1)<font
size=1 face="Times New Roman"><span style='font:7.0pt "Times New Roman"'>
</span></font></span></span></font><![endif]>All restaurants that serve “flambé”
should be required to dispose of their unused liquor bottles through hazardous
waste systems?<o:p></o:p></p>
<p class=msolistparagraph style='text-indent:-.25in;mso-list:l0 level1 lfo2'><![if !supportLists]><font
size=2 face=Calibri><span style='font-size:11.0pt'><span style='mso-list:Ignore'>2)<font
size=1 face="Times New Roman"><span style='font:7.0pt "Times New Roman"'>
</span></font></span></span></font><![endif]>All bars that serve over-proof
drinks and have empty containers should dispose of them through hazardous
waste?<o:p></o:p></p>
<p class=msolistparagraph style='text-indent:-.25in;mso-list:l0 level1 lfo2'><![if !supportLists]><font
size=2 face=Calibri><span style='font-size:11.0pt'><span style='mso-list:Ignore'>3)<font
size=1 face="Times New Roman"><span style='font:7.0pt "Times New Roman"'>
</span></font></span></span></font><![endif]>All bottle return facilities
should either a) refuse over-proof containers or b)segregate the over-proof
containers for hazardous waste disposal<o:p></o:p></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'>Besides
the lunacy of this line of reasoning, I think I must be missing something.<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'>Or
is this another case of “unintended consequences” which is my
hunch.<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'>Stevan
Gressitt, M.D.<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Calibri><span style='font-size:11.0pt'> <o:p></o:p></span></font></p>
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