[Pharmwaste] pharmaceuticals widespread in Minnesota waters

[Ronald Ney]

Hello all, I just wanted to point out that the study involving
pharmaceuticals widespread in Minnesota waters may not be valid
because the study had the following caveat “Concentrations for each
chemical will be available in June, 2010, pending completion of
quality assurance/quality control review.” If the study did not
validate the extraction procedures, quality assurance and quality
control review the study may not be valid. If they tried to prove
extraction methods by fortifying a matrix and extracting forget it as
this is no proof that a chemical can be extracted if aged in a matrix
over time. Next, where are final results?

About all research, I say let’s see the validated data, a material
balance study and the peer review comments.

Below is what I usually ask researchers and others about their
analytical chemical methods.

Have the chemical extraction methods been validated to prove the
extraction of 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
Fate and Transport of Organic Chemicals in the Environment (third
edition). 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).

By validation, I mean using procedures like those that I wrote in 40
CFR § 158:290 and § 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.
•       It means that the total amount or residues extracted is
questionable and that there may have been a lot more not extracted.
•       It means that many other chemicals may not been have been
extracted and thus not determined.
•       It means that there may be chemical residues not extracted,
which could be available for plant and animal uptake.
•       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).

Here are examples of some questions that I have asked concerning
chemical residues in sediment, plants, sewage sludge, water, etc.
1.      Do the extraction procedures/methods extract residues bound in
the organic matter of soil or sediment?
2.      Do the extraction procedures/methods extract residues bound in
fat in animals?
3.      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?
4.      Where radiotracer methods used to obtain data as question in
three above?

So what could all this mean?
1.      It could mean that all the residues (parent and degradates)
are not determined in the food we eat.
2.      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.
3.      It means that exposure may be greater than expected. 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.
While this may be true in many cases, safety cannot be judged on one
chemical or one biological alone.  Humans and other animals are a
mixture of chemicals and biologicals, and we take in hundreds of
different chemicals and biologicals a year.  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?  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.

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.




From: Catherine Zimmer <zenllc at usfamily.net>
To: "Volkman, Jennifer (MPCA)" <Jennifer.Volkman at state.mn.us>
Date: Thu, 17 Mar 2011 11:38:03 -0500 (CDT)
Subject: Re: [Pharmwaste] Re: LTC to DEA Pharm drop off
Hi Everyone,
Maybe this website can help.  It was developed in partnership by MPCA
and MnTAP last summer.  I was MnTAP's healthcare specialist at the
time.

www.mntap.umn.edu/healthcarehw/LTCF/Index.html


Wastewater Treatment Plant Endocrine Disrupting Compound Monitoring Study

April 15, 2010
Preliminary progress report to the Legislature

“Concentrations for each chemical will be available in June, 2010,
pending completion of quality assurance/quality control review.”