[Pharmwaste] definition of hazardous waste pharmaceuticals

Tiferet Zimmern-Kahan tiferet@productstewardship.us
Thu, 18 Aug 2005 09:54:39 -0500


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I found this that clarifies things a bit (so it seems):  [taken from the
NIOSH Report that is referenced below, the section entitled=20
"current standards and recommendations" under the "EPA" heading.]
=20
EPA/RCRA regulations require that hazardous waste be managed by
following a strict set of regulatory requirements [40 CFR 260-279]. The
RCRA list of hazardous wastes was developed in 1976 and includes only
about 30 pharmaceuticals, 9 of which are antineoplastic drugs. Recent
evidence indicates that a number of drug formulations exhibit hazardous
waste characteristics [Smith 2002]. OSHA [1999] and ASHP [1990]
recommend that hazardous drug waste be disposed of in a manner similar
to that required for RCRA-listed hazardous waste. Hazardous drug waste
includes partially filled vials, undispensed products, unused IVs,
needles and syringes, gloves, gowns, underpads, contaminated materials
from spill cleanups, and containers such as IV bags or drug vials that
contain more than trace amounts of hazardous drugs and are not
contaminated by blood or other potentially infectious waste.=20
=20
 so basically, the OSHA standards are rather recommended additions (or
extensions) of the RCRA/EPA standards for hazardous.  this addresses the
problem of RCRA being really outdated  (1976). =20
=20
Interesting discussion.  Does anyone else know any other set of
recommendations/ammendments to RCRA Hazardous?  Are there any plans to
update RCRA at all?
=20
Tiferet Zimmern-Kahan
Product Stewardship Institute, Inc.
137 Newbury Street, 7th floor
Boston, MA 02116
tiferet@productstewardship.us
617-236-4866
=20
=20
=20
=20
 From: pharmwaste-admin@lists.dep.state.fl.us
[mailto:pharmwaste-admin@lists.dep.state.fl.us] On Behalf Of Tenace,
Laurie
Sent: Monday, August 15, 2005 3:55 PM
To: pharmwaste@lists.dep.state.fl.us
Subject: [Pharmwaste] definition of hazardous waste pharmaceuticals



I was reading the NIOSH Alert "Preventing Occupational Exposure to
Antineoplastic and Other Hazardous Drugs in Health Care Settings"
(http://www.cdc.gov/niosh/docs/2004-165/ ) today. NIOSH uses a
definition of "hazardous" that is based on an ASHP (American Society of
Health-System Pharmacists) definition originally developed in 1990.
NIOSH's definition includes carcinogenicity, teratogenicity or other
developmental toxicity, reproductive toxicity, organ toxicity at low
doses, genotoxicity, and structure and toxicity profiles of new drugs
that mimic existing drugs determined hazardous by the above criteria. It
doesn't consider ignitability or corrosivity.=20

=20

On the other hand, EPA's criteria for identifying the characteristics of
hazardous waste in 40CFR 261.11 is much different and many of the
hazardous drugs listed on the NIOSH guidance are not in 40 CFR 261
Appendix VIII. (attached)

=20

Here's some OSHA information about hazardous drugs:
http://www.osha.gov/SLTC/hazardousdrugs/index.html (scroll down to the
OSHA e-tools)

=20

If you are working with hospitals, nursing homes, extended living
facilities, etc.  it will be good to know to differentiate these two
definitions of "hazardous"- their definition of toxicity based on OSHA
will not necessarily coincide with their state environmental agency's
definitions.=20

=20

Can anyone comment more on how OSHA and EPA differ in these definitions?

=20

**

=20

I also found a web site today -
http://healthcare.monster.com/articles/hcconferencecalendar/ with this
list of pharmacy-related conferences - if it's near your home, why not
try to get on the agenda with the waste disposal issue?

*	National Association of Chain Drug Stores Pharmacy and
Technology Conference <http://www.nacds.org/wmspage.cfm?parm1=3D872> ,
August 27-31, San Diego=20
*	National Community Pharmacists Association Annual Convention &
Trade Exposition <http://www.ncpanet.org/calendar/index.shtml> , October
15-19, Fort Lauderdale=20
*	American College of Clinical Pharmacy 2005 Annual Meeting
<http://www.accp.com> , October 23-26, San Francisco=20
*	American Society of Consultant Pharmacists 36th Annual Meeting &
Exhibition <http://www.ascp.com/public/meetings/2005/am/industry/> ,
November 9-12, Boston=20
*	American Society of Health-System Pharmacists Midyear Clinical
Meeting <http://www.ashp.org/meetings/> , December 4-8, Las Vegas=20
*	American Society for Clinical Pharmacology & Therapeutics 2006
Annual Meeting <http://www.ascpt.org/annual/> , March 7-11, 2006,
Baltimore=20
*	American Pharmacists Association's APhA2006
<http://www.aphameeting.org/index.cfm?fuseaction=3DCustom.Content&MenuID=3D=
1
00> , March 17-21, 2006, San Francisco=20
*	American College of Clinical Pharmacy 2006 Spring Practice and
Research Forum <http://www.accp.com/meetings.php> , April 9-12, 2006,
Monterey, California=20

=20

=20

=20

Thanks,

Laurie

=20

Laurie J. Tenace

Environmental Specialist

Florida Department of Environmental Protection

2600 Blair Stone Road, MS 4555

Tallahassee, Florida 32399-2400

PH: (850) 245-8759

FAX: (850) 245-8811

Laurie.Tenace@dep.state.fl.us

=20

view our mercury web pages at:=20

http://www.dep.state.fl.us/waste/categories/mercury/default.htm

=20

=20

=20


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<DIV dir=3Dltr align=3Dleft><SPAN class=3D984403214-18082005><FONT =
face=3DArial><FONT=20
color=3D#0000ff><FONT size=3D2>I found this that clarifies things a bit =
(so it=20
seems):<SPAN class=3D737114714-18082005>&nbsp; [taken from the NIOSH =
Report that=20
is referenced below, the section entitled <BR>"current standards and=20
recommendations" under the "EPA"=20
heading.]</SPAN></FONT></FONT></FONT></SPAN></DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D984403214-18082005><FONT =
face=3DArial=20
color=3D#0000ff size=3D2></FONT></SPAN>&nbsp;</DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D984403214-18082005>EPA/RCRA =
regulations=20
require that hazardous waste be managed by following a strict set of =
regulatory=20
requirements [40 CFR 260&#8211;279]. The RCRA list of hazardous wastes =
was developed=20
in 1976 and includes only about 30 pharmaceuticals, 9 of which are=20
antineoplastic drugs. Recent evidence indicates that a number of drug=20
formulations exhibit hazardous waste characteristics [Smith 2002]. OSHA =
[1999]=20
and ASHP [1990] recommend that hazardous drug waste be disposed of in a =
manner=20
similar to that required for RCRA-listed hazardous waste. Hazardous drug =
waste=20
includes partially filled vials, undispensed products, unused IVs, =
needles and=20
syringes, gloves, gowns, underpads, contaminated materials from spill =
cleanups,=20
and containers such as IV bags or drug vials that contain more than =
trace=20
amounts of hazardous drugs and are not contaminated by blood or other=20
potentially infectious waste. </SPAN></DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D984403214-18082005>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D984403214-18082005><FONT =
face=3DArial><FONT=20
color=3D#0000ff><FONT size=3D2><SPAN=20
class=3D737114714-18082005>&nbsp;</SPAN></FONT></FONT></FONT></SPAN></DIV=
>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D984403214-18082005><FONT =
face=3DArial><FONT=20
color=3D#0000ff><FONT size=3D2><SPAN =
class=3D737114714-18082005>&nbsp;</SPAN>so=20
basically, the OSHA standards are rather recommended additions (or =
extensions)=20
of the RCRA/EPA standards for hazardous.&nbsp; this addresses the =
problem of=20
RCRA being really outdated&nbsp;<SPAN=20
class=3D737114714-18082005>&nbsp;(1976).&nbsp;</SPAN><SPAN=20
class=3D737114714-18082005>&nbsp;</SPAN></FONT></FONT></FONT></SPAN></DIV=
>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D984403214-18082005><FONT =
face=3DArial><FONT=20
color=3D#0000ff><FONT size=3D2><SPAN=20
class=3D737114714-18082005></SPAN></FONT></FONT></FONT></SPAN>&nbsp;</DIV=
>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D984403214-18082005><FONT =
face=3DArial><FONT=20
color=3D#0000ff><FONT size=3D2><SPAN =
class=3D737114714-18082005>Interesting=20
discussion.&nbsp; Does anyone else know any other set of=20
recommendations/ammendments to RCRA Hazardous?&nbsp; Are there any plans =
to=20
update RCRA at all?</SPAN></FONT></FONT></FONT></SPAN></DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D984403214-18082005><FONT =
face=3DArial><FONT=20
color=3D#0000ff><FONT size=3D2><SPAN=20
class=3D737114714-18082005></SPAN></FONT></FONT></FONT></SPAN>&nbsp;</DIV=
>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D984403214-18082005><FONT =
face=3DArial><FONT=20
color=3D#0000ff><FONT size=3D2><SPAN class=3D737114714-18082005>
<DIV align=3Dleft><FONT face=3D"Book Antiqua" size=3D2>Tiferet=20
Zimmern-Kahan</FONT></DIV>
<DIV align=3Dleft><FONT face=3D"Book Antiqua" size=3D2>Product =
Stewardship Institute,=20
Inc.</FONT></DIV>
<DIV align=3Dleft><FONT face=3D"Book Antiqua" size=3D2>137 Newbury =
Street, 7th=20
floor</FONT></DIV>
<DIV align=3Dleft><FONT face=3D"Book Antiqua" size=3D2>Boston, MA =
02116</FONT></DIV>
<DIV align=3Dleft><FONT face=3D"Book Antiqua" size=3D2><A=20
href=3D"mailto:tiferet@productstewardship.us">tiferet@productstewardship.=
us</A></FONT></DIV>
<DIV align=3Dleft><FONT face=3D"Book Antiqua" =
size=3D2>617-236-4866</FONT></DIV>
<DIV align=3Dleft><FONT face=3DArial=20
size=3D2></FONT>&nbsp;</DIV></SPAN></FONT></FONT></FONT></SPAN></DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D984403214-18082005><FONT =
face=3DArial><FONT=20
color=3D#0000ff><FONT size=3D2><SPAN=20
class=3D737114714-18082005></SPAN></FONT></FONT></FONT></SPAN>&nbsp;</DIV=
>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D984403214-18082005><FONT =
face=3DArial><FONT=20
color=3D#0000ff><FONT size=3D2><SPAN=20
class=3D737114714-18082005></SPAN></FONT></FONT></FONT></SPAN>&nbsp;</DIV=
>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D984403214-18082005><FONT =
face=3DArial><FONT=20
color=3D#0000ff><FONT size=3D2><SPAN=20
class=3D737114714-18082005></SPAN></FONT></FONT></FONT></SPAN>&nbsp;</DIV=
>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D984403214-18082005><FONT =
face=3DArial><FONT=20
color=3D#0000ff><FONT size=3D2><SPAN=20
class=3D737114714-18082005>&nbsp;</SPAN></FONT></FONT></FONT></SPAN></SPA=
N><FONT=20
face=3DTahoma><FONT size=3D2><B>From:</B> =
pharmwaste-admin@lists.dep.state.fl.us=20
[mailto:pharmwaste-admin@lists.dep.state.fl.us] <B>On Behalf Of =
</B>Tenace,=20
Laurie<BR><B>Sent:</B> Monday, August 15, 2005 3:55 PM<BR><B>To:</B>=20
pharmwaste@lists.dep.state.fl.us<BR><B>Subject:</B> [Pharmwaste] =
definition of=20
hazardous waste pharmaceuticals<BR></FONT></FONT><BR></DIV></DIV>
<DIV></DIV>
<DIV class=3DSection1>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt">I was=20
reading the NIOSH Alert &#8220;Preventing Occupational Exposure to =
Antineoplastic and=20
Other Hazardous Drugs in Health Care Settings&#8221; (<A=20
href=3D"http://www.cdc.gov/niosh/docs/2004-165/">http://www.cdc.gov/niosh=
/docs/2004-165/</A>=20
) today. NIOSH uses a definition of &#8220;hazardous&#8221; that is =
based on an ASHP=20
(American Society of Health-System Pharmacists) definition originally =
developed=20
in 1990. NIOSH&#8217;s definition includes carcinogenicity, =
teratogenicity or other=20
developmental toxicity, reproductive toxicity, organ toxicity at low =
doses,=20
genotoxicity, and structure and toxicity profiles of new drugs that =
mimic=20
existing drugs determined hazardous by the above criteria. It =
doesn&#8217;t consider=20
ignitability or corrosivity. </SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt"></SPAN></FONT>&nbsp;</P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt">On the=20
other hand, EPA&#8217;s criteria for identifying the characteristics of =
hazardous=20
waste in 40CFR 261.11 is much different and many of the hazardous drugs =
listed=20
on the NIOSH guidance are not in 40 CFR 261 Appendix VIII.=20
(attached)</SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt"></SPAN></FONT>&nbsp;</P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt">Here&#8217;s=20
some OSHA information about hazardous drugs: <A=20
href=3D"http://www.osha.gov/SLTC/hazardousdrugs/index.html">http://www.os=
ha.gov/SLTC/hazardousdrugs/index.html</A>=20
(scroll down to the OSHA e-tools)</SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt"></SPAN></FONT>&nbsp;</P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt">If you=20
are working with hospitals, nursing homes, extended living facilities, =
etc.=20
&nbsp;it will be good to know to differentiate these two definitions of=20
&#8220;hazardous&#8221;&#8211; their definition of toxicity based on =
OSHA will not necessarily=20
coincide with their state environmental agency&#8217;s definitions. =
</SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt"></SPAN></FONT>&nbsp;</P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt">Can=20
anyone comment more on how OSHA and EPA differ in these=20
definitions?</SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt"></SPAN></FONT>&nbsp;</P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt">**</SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt"></SPAN></FONT>&nbsp;</P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt">I also=20
found a web site today - <A=20
href=3D"http://healthcare.monster.com/articles/hcconferencecalendar/">htt=
p://healthcare.monster.com/articles/hcconferencecalendar/</A>=20
with this list of pharmacy-related conferences &#8211; if it&#8217;s =
near your home, why not=20
try to get on the agenda with the waste disposal =
issue?</SPAN></FONT></P>
<UL style=3D"MARGIN-TOP: 0in" type=3Ddisc>
  <LI class=3DMsoNormal style=3D"MARGIN-TOP: 6pt; COLOR: black"><FONT =
face=3DVerdana=20
  color=3Dblack size=3D1><SPAN style=3D"FONT-SIZE: 7.5pt; FONT-FAMILY: =
Verdana"><A=20
  href=3D"http://www.nacds.org/wmspage.cfm?parm1=3D872" =
target=3D_blank>National=20
  Association of Chain Drug Stores Pharmacy and Technology =
Conference</A>,=20
  August 27-31, San Diego</SPAN></FONT>=20
  <LI class=3DMsoNormal style=3D"MARGIN-TOP: 6pt; COLOR: black"><FONT =
face=3DVerdana=20
  color=3Dblack size=3D1><SPAN style=3D"FONT-SIZE: 7.5pt; FONT-FAMILY: =
Verdana"><A=20
  href=3D"http://www.ncpanet.org/calendar/index.shtml" =
target=3D_blank>National=20
  Community Pharmacists Association Annual Convention &amp; Trade=20
  Exposition</A>, October 15-19, Fort Lauderdale</SPAN></FONT>=20
  <LI class=3DMsoNormal style=3D"MARGIN-TOP: 6pt; COLOR: black"><FONT =
face=3DVerdana=20
  color=3Dblack size=3D1><SPAN style=3D"FONT-SIZE: 7.5pt; FONT-FAMILY: =
Verdana"><A=20
  href=3D"http://www.accp.com" target=3D_blank>American College of =
Clinical Pharmacy=20
  2005 Annual Meeting</A>, October 23-26, San Francisco</SPAN></FONT>=20
  <LI class=3DMsoNormal style=3D"MARGIN-TOP: 6pt; COLOR: black"><FONT =
face=3DVerdana=20
  color=3Dblack size=3D1><SPAN style=3D"FONT-SIZE: 7.5pt; FONT-FAMILY: =
Verdana"><A=20
  href=3D"http://www.ascp.com/public/meetings/2005/am/industry/"=20
  target=3D_blank>American Society of Consultant Pharmacists 36th Annual =
Meeting=20
  &amp; Exhibition</A>, November 9-12, Boston</SPAN></FONT>=20
  <LI class=3DMsoNormal style=3D"MARGIN-TOP: 6pt; COLOR: black"><FONT =
face=3DVerdana=20
  color=3Dblack size=3D1><SPAN style=3D"FONT-SIZE: 7.5pt; FONT-FAMILY: =
Verdana"><A=20
  href=3D"http://www.ashp.org/meetings/" target=3D_blank>American =
Society of=20
  Health-System Pharmacists Midyear Clinical Meeting</A>, December 4-8, =
Las=20
  Vegas</SPAN></FONT>=20
  <LI class=3DMsoNormal style=3D"MARGIN-TOP: 6pt; COLOR: black"><FONT =
face=3DVerdana=20
  color=3Dblack size=3D1><SPAN style=3D"FONT-SIZE: 7.5pt; FONT-FAMILY: =
Verdana"><A=20
  href=3D"http://www.ascpt.org/annual/" target=3D_blank>American Society =
for=20
  Clinical Pharmacology &amp; Therapeutics 2006 Annual Meeting</A>, =
March 7-11,=20
  2006, Baltimore</SPAN></FONT>=20
  <LI class=3DMsoNormal style=3D"MARGIN-TOP: 6pt; COLOR: black"><FONT =
face=3DVerdana=20
  color=3Dblack size=3D1><SPAN style=3D"FONT-SIZE: 7.5pt; FONT-FAMILY: =
Verdana"><A=20
  =
href=3D"http://www.aphameeting.org/index.cfm?fuseaction=3DCustom.Content&=
amp;MenuID=3D100"=20
  target=3D_blank>American Pharmacists Association's APhA2006</A>, March =
17-21,=20
  2006, San Francisco</SPAN></FONT>=20
  <LI class=3DMsoNormal style=3D"MARGIN-TOP: 6pt; COLOR: black"><FONT =
face=3DVerdana=20
  color=3Dblack size=3D1><SPAN style=3D"FONT-SIZE: 7.5pt; FONT-FAMILY: =
Verdana"><A=20
  href=3D"http://www.accp.com/meetings.php" target=3D_blank>American =
College of=20
  Clinical Pharmacy 2006 Spring Practice and Research Forum</A>, April =
9-12,=20
  2006, Monterey, California</SPAN></FONT> </LI></UL>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt"></SPAN></FONT>&nbsp;</P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt"></SPAN></FONT>&nbsp;</P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt"></SPAN></FONT>&nbsp;</P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt">Thanks,</SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt">Laurie</SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt"></SPAN></FONT>&nbsp;</P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt">Laurie=20
J. Tenace</SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt">Environmental Specialist</SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt">Florida=20
Department of Environmental Protection</SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt">2600</SPAN></FONT><FONT size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt"> Blair Stone Road, MS</SPAN></FONT><FONT =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt"> 4555</SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt">Tallahassee</SPAN></FONT><FONT size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt">, Florida 32399-2400</SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt">PH:=20
(850) 245-8759</SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt">FAX:=20
(850) 245-8811</SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt"><A=20
href=3D"mailto:Laurie.Tenace@dep.state.fl.us">Laurie.Tenace@dep.state.fl.=
us</A></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN=20
style=3D"FONT-SIZE: 11pt"></SPAN></FONT>&nbsp;</P>
<P class=3DMsoNormal><FONT face=3DArial size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt">view=20
our mercury web pages at: </SPAN></FONT></P>
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