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<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3>Subject: Selling and receiving
controlled substances (drugs) <?xml:namespace prefix = o ns =
"urn:schemas-microsoft-com:office:office" /><o:p></o:p></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3> <o:p></o:p></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3>I have questions on disposal of
controlled substances like pharmaceuticals waste by households, which I hope you
can provide a response. These questions concern homeowners that dispose of their
pharmaceuticals in their trash that goes to a solid waste facility and than into
landfills or to incinerators, and in the wastewater disposal system.
<o:p></o:p></FONT></SPAN></P>
<OL style="MARGIN-TOP: 0in" type=1>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list .5in; mso-list: l0 level1 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>If a county or
city is paid to have trash picked up containing controlled substances, isn’t
the county being paid to receive controlled substance or to collect controlled
substances like pharmaceuticals that have been disposed of in the
trash?<o:p></o:p></FONT></SPAN></LI>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list .5in; mso-list: l0 level1 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>Are residents
selling or dispensing controlled substances to a county or city via trash
pickup?<o:p></o:p></FONT></SPAN></LI>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list .5in; mso-list: l0 level1 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>If a county or
city pays to incinerate the waste containing pharmaceuticals is the county or
city dispensing controlled substances to the incinerating
company?<o:p></o:p></FONT></SPAN></LI>
<UL style="MARGIN-TOP: 0in" type=disc>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list 1.0in; mso-list: l0 level2 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>Will or does
the USEPA enforce emissions from an incinerator burning pharmaceuticals in
trash?<o:p></o:p></FONT></SPAN></LI></UL>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list .5in left 207.0pt; mso-list: l0 level1 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>Is an
incinerator company collecting controlled substances in trash that it is paid
to receive from a solid waste facility?<o:p></o:p></FONT></SPAN></LI>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list .5in left 207.0pt; mso-list: l0 level1 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>If a solid waste
facility receives pharmaceutical disposed of by homeowners, is the facility
responsible for what happens to the pharmaceuticals they have been paid to
receive?<o:p></o:p></FONT></SPAN></LI>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list .5in left 207.0pt; mso-list: l0 level1 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>If a county or
city is paid to take sewage and that sewage has controlled substances, are
they receiving and collecting controlled
substances?<o:p></o:p></FONT></SPAN></LI>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list .5in left 207.0pt; mso-list: l0 level1 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>If a county or
city that discharges controlled substances via wastewater into waters
disposing of controlled substances?<o:p></o:p></FONT></SPAN></LI>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list .5in left 207.0pt; mso-list: l0 level1 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>If a county or
city sales reclaimed wastewater containing controlled substances used for
irrigation dispensing controlled substances?<o:p></o:p></FONT></SPAN></LI>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list .5in left 207.0pt; mso-list: l0 level1 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>If a county or
city that uses or sales wastewater sludge containing controlled substances as
a soil conditioner or fertilizer dispensing controlled substances?
<o:p></o:p></FONT></SPAN></LI>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list .5in left 207.0pt; mso-list: l0 level1 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>Can or will the
DEA go after the sellers, dispensers and receivers of controlled substances in
trash, sewage, sewage sludge and treated wastewater?
<o:p></o:p></FONT></SPAN></LI>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list .5in left 207.0pt; mso-list: l0 level1 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>Can or will FDA
go after the sellers of prescription drugs sold and dispensed by homeowners to
a county through trash or sewage collection
fees?<o:p></o:p></FONT></SPAN></LI>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list .5in left 207.0pt; mso-list: l0 level1 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>If food crops
and food animals are contaminated with controlled substances via use of sewage
sludge, reclaimed water or water from lakes and rivers, will the residues in
the crops be enforced by the FFDCA (Federal Food and Drug and Cosmetic Act),
USDA or the USEPA?<o:p></o:p></FONT></SPAN></LI>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list .5in left 207.0pt; mso-list: l0 level1 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>If food crops or
food animals containing controlled substance are sold is that dispensing
controlled substances?<o:p></o:p></FONT></SPAN></LI>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list .5in left 207.0pt; mso-list: l0 level1 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>If endangered
species or migratory birds were contaminated with discarded and discharged
controlled substances and will the Acts be
enforced?<o:p></o:p></FONT></SPAN></LI>
<LI
style="MARGIN: 0in 0in 0pt; tab-stops: list .5in left 207.0pt; mso-list: l0 level1 lfo1"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>Will children be
endangered from the disposal or discharged of controlled substances by
homeowners and receivers of such, and their discharge of the controlled
substances into the environment?<o:p></o:p></FONT></SPAN></LI></OL>
<P style="MARGIN: 0in 0in 0pt; tab-stops: 207.0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3> <o:p></o:p></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt; tab-stops: 207.0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3>Last but probably not least there may be
no validated extraction methods for parent and degradates that form in the
environment, in plants and animals.<o:p></o:p></FONT></SPAN></P>
<P style="TEXT-ALIGN: center; MARGIN: 0in 0in 0pt" class=MsoNormal
align=center><SPAN style="FONT-FAMILY: Arial"><FONT
size=3> <o:p></o:p></FONT></SPAN></P>
<P style="TEXT-ALIGN: center; MARGIN: 0in 0in 0pt" class=MsoNormal
align=center><SPAN style="FONT-FAMILY: Arial"><FONT size=3>Are chemical
extraction methods valid?<o:p></o:p></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3> <o:p></o:p></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.5in" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3>Are chemical extraction methods valid to
extract chemicals from soil, sediment, sewage sludge, plants and animals? These
methods may be solid waste (SW) methods or pesticide methods used to extract
chemicals and degradation products from soil, sediment, sewage sludge, plants
and animals. Do the methods extract residues that have a high Koc (organic
carbon partition coefficient) value in soil or a high Kow (octanol water
partition coefficient) value in fat tissue? If you want to know these values
read my book. Bottom line answer is almost all the methods have not been
validated. Fortifying a matrix and extracting does not prove that an extraction
procedure will work for chemicals aged in the matrix over time (i.e. 30, 60
& 120 days).<o:p></o:p></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.5in" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3> <o:p></o:p></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.5in" class=MsoNormal><FONT size=3><SPAN
style="FONT-FAMILY: Arial">By validation, I mean using procedures like those
that I wrote in 40 CFR § 158:290 </SPAN><SPAN
style="FONT-FAMILY: Arial; COLOR: black; mso-bidi-font-size: 14.0pt">and
</SPAN><SPAN style="FONT-FAMILY: Arial">§ 158.1300 Subpart N, which FIFRA
requires by aging of pesticides in soil to discern bound residues, extraction of
parent and degradates and analytical efficiency. These data requirements were
started in the USDA around 1967 because radiotracer studies for petition for
tolerances indicated pesticide residues were not being totally extracted and
where showing up in crops (rotational crops) when they shouldn’t have been. This
does not mean that those residues determined by other methods were incorrect.
Please remember that residues under FIFRA include parent and degradation
products.<o:p></o:p></SPAN></FONT></P>
<P
style="TEXT-INDENT: -0.25in; MARGIN: 0in 0in 0pt 1in; tab-stops: list 1.0in; mso-list: l2 level1 lfo3"
class=MsoNormal><SPAN
style="FONT-FAMILY: Symbol; mso-bidi-font-family: Arial"><FONT
size=3>·</FONT><SPAN
style="FONT: 7pt 'Times New Roman'">
</SPAN></SPAN><SPAN style="FONT-FAMILY: Arial"><FONT size=3>It means that the
total amount or residues extracted is questionable and that there may have been
a lot more not extracted. <o:p></o:p></FONT></SPAN></P>
<P
style="TEXT-INDENT: -0.25in; MARGIN: 0in 0in 0pt 1in; tab-stops: list 1.0in; mso-list: l2 level1 lfo3"
class=MsoNormal><SPAN
style="FONT-FAMILY: Symbol; mso-bidi-font-family: Arial"><FONT
size=3>·</FONT><SPAN
style="FONT: 7pt 'Times New Roman'">
</SPAN></SPAN><SPAN style="FONT-FAMILY: Arial"><FONT size=3>It means that many
other chemicals may not been have been extracted and thus not determined.
<o:p></o:p></FONT></SPAN></P>
<P
style="TEXT-INDENT: -0.25in; MARGIN: 0in 0in 0pt 1in; tab-stops: list 1.0in; mso-list: l2 level1 lfo3"
class=MsoNormal><SPAN
style="FONT-FAMILY: Symbol; mso-bidi-font-family: Arial"><FONT
size=3>·</FONT><SPAN
style="FONT: 7pt 'Times New Roman'">
</SPAN></SPAN><SPAN style="FONT-FAMILY: Arial"><FONT size=3>It means that there
may be chemical residues not extracted, which could be available for plant and
animal uptake.<o:p></o:p></FONT></SPAN></P>
<P
style="TEXT-INDENT: -0.25in; MARGIN: 0in 0in 0pt 1in; tab-stops: list 1.0in; mso-list: l2 level1 lfo3"
class=MsoNormal><SPAN
style="FONT-FAMILY: Symbol; mso-bidi-font-family: Arial"><FONT
size=3>·</FONT><SPAN
style="FONT: 7pt 'Times New Roman'">
</SPAN></SPAN><SPAN style="FONT-FAMILY: Arial"><FONT size=3>It means that a
hazard assessment cannot be accurate without knowing total exposure via
inhalation, absorption and ingestion of total residues (extractable and
un-extractable).<o:p></o:p></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.5in" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3> <o:p></o:p></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.5in" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3>Here are examples of some questions that
I have asked concerning residues in sediment, plants, sewage sludge, water,
etc.<o:p></o:p></FONT></SPAN></P>
<P
style="TEXT-INDENT: -0.25in; MARGIN: 0in 0in 0pt 1in; tab-stops: list 1.0in; mso-list: l4 level1 lfo4"
class=MsoBodyText><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 12pt; mso-bidi-font-size: 16.0pt">1.<SPAN
style="FONT: 7pt 'Times New Roman'">
</SPAN></SPAN><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 12pt; mso-bidi-font-size: 16.0pt">Do the
extraction procedures/methods extract residues bound in the organic matter of
soil or sediment?<o:p></o:p></SPAN></P>
<P
style="TEXT-INDENT: -0.25in; MARGIN: 0in 0in 0pt 1in; tab-stops: list 1.0in; mso-list: l4 level1 lfo4"
class=MsoBodyText><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 12pt; mso-bidi-font-size: 16.0pt">2.<SPAN
style="FONT: 7pt 'Times New Roman'">
</SPAN></SPAN><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 12pt; mso-bidi-font-size: 16.0pt">Do the
extraction procedures/methods extract residues bound in fat in
animals?<o:p></o:p></SPAN></P>
<P
style="TEXT-INDENT: -0.25in; MARGIN: 0in 0in 0pt 1in; tab-stops: list 1.0in; mso-list: l4 level1 lfo4"
class=MsoBodyText><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 12pt; mso-bidi-font-size: 20.0pt">3.<SPAN
style="FONT: 7pt 'Times New Roman'">
</SPAN></SPAN><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 12pt; mso-bidi-font-size: 16.0pt">Do the
extraction procedures/methods provide a material balance for residues in each of
the following matrices soil, plants and animals, that is total residues of
parent, degradates, and bound (non-extractable residues) residues?</SPAN><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 12pt; mso-bidi-font-size: 20.0pt"><o:p></o:p></SPAN></P>
<P
style="TEXT-INDENT: -0.25in; MARGIN: 0in 0in 0pt 1in; tab-stops: list 1.0in; mso-list: l4 level1 lfo4"
class=MsoBodyText><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 12pt; mso-bidi-font-size: 10.0pt">4.<SPAN
style="FONT: 7pt 'Times New Roman'">
</SPAN></SPAN><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 12pt; mso-bidi-font-size: 16.0pt">Where
radiotracer methods used to obtain data as question in three above?</SPAN><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 12pt; mso-bidi-font-size: 10.0pt"><o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.5in" class=MsoBodyText><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 12pt; mso-bidi-font-size: 10.0pt"> <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.5in" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3>So what could all this mean?
<o:p></o:p></FONT></SPAN></P>
<P
style="TEXT-INDENT: -0.25in; MARGIN: 0in 0in 0pt 1in; tab-stops: list 1.0in; mso-list: l1 level1 lfo5"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>1.</FONT><SPAN
style="FONT: 7pt 'Times New Roman'">
</SPAN></SPAN><SPAN style="FONT-FAMILY: Arial"><FONT size=3>It could mean that
all the residues (parent and degradates) are not determined in the food we
eat.<o:p></o:p></FONT></SPAN></P>
<P
style="TEXT-INDENT: -0.25in; MARGIN: 0in 0in 0pt 1in; tab-stops: list 1.0in; mso-list: l1 level1 lfo5"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>2.</FONT><SPAN
style="FONT: 7pt 'Times New Roman'">
</SPAN></SPAN><SPAN style="FONT-FAMILY: Arial"><FONT size=3>It could mean that
all the residues (parent and degradates) are not determined in soil, animals,
sediment, and sewage sludge and residues are much higher in environmental
matrixes than extracted and determined. <o:p></o:p></FONT></SPAN></P>
<P
style="TEXT-INDENT: -0.25in; MARGIN: 0in 0in 0pt 1in; tab-stops: list 1.0in; mso-list: l1 level1 lfo5"
class=MsoNormal><SPAN style="FONT-FAMILY: Arial"><FONT size=3>3.</FONT><SPAN
style="FONT: 7pt 'Times New Roman'">
</SPAN></SPAN><SPAN style="FONT-FAMILY: Arial"><FONT size=3>It means that
exposure may be greater than expected.<o:p></o:p></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 1.5in" class=MsoBodyTextIndent><FONT size=3
face=Arial>Many may say exposure to chemicals and/or biologicals in consumer
products, in the environment, etc. is so small there is little chance of
risk.<SPAN style="mso-spacerun: yes"> </SPAN>While this may be true in
many cases, safety cannot be judged on one chemical or one biological
alone.<SPAN style="mso-spacerun: yes"> </SPAN>Humans and other animals are
a mixture of chemicals and biologicals, and we take in hundreds of different
chemicals and biologicals a year.<SPAN style="mso-spacerun: yes">
</SPAN>How safe are these chemicals and degradates (pesticides, hormones,
metals, etc.) and biologicals when the aggregate, synergistic, antagonistic,
co-metabolism and co-biometabolism effects are never mentioned or studied to any
extent, if at all and, they are not used in risk assessments?<SPAN
style="mso-spacerun: yes"> </SPAN>In other words, the total picture is
never known or considered for hazards to adults, child endangerment and
environmental safety when it should be required.</FONT></P>
<P style="MARGIN-LEFT: 0.5in"><SPAN
style="FONT-FAMILY: Arial; mso-fareast-font-family: 'Times New Roman'"><FONT
size=3> <o:p></o:p></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.5in; tab-stops: 207.0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3>The bottom line is that USEPA, FDA and
other enforcement methods do not account for total residues of parent chemical
and their degradation products. Safety cannot be
determined.<o:p></o:p></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt; tab-stops: 207.0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3> <o:p></o:p></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3>Regards,<SPAN
style="mso-spacerun: yes"> </SPAN><o:p></o:p></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3> <o:p></o:p></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial"><FONT size=3>Dr. Ron
Ney<o:p></o:p></FONT></SPAN></P></FONT></DIV></BODY></HTML>