[Pharmwaste] Re: Pharmwaste Digest, Vol 82, Issue 2

Ronald Ney randsney at gmail.com
Fri Aug 10 14:54:19 EDT 2012


Pharmwaste Digest, Vol 82, Issue 2

Subject: pharmaceutical incineration



For those of you that do not agree with regulations I suggest you prove
them wrong with validated peer reviewed data. I asked this once while
defending the environmental data requirements on fate and transport of
pesticides in air, water, soil, plants and animals; data requirements that
I wrote from a person who wanted certain data requirements dropped. I
agreed to consider dropping the requirement if that person had validated
data and would reveal what he had, if any. That person dropped the question
as fast as he asked the question.



By-the-way, EPA did studies on portable incinerators and incinerator ships
back in the early 1980s. I would suggest one ask EPA for that data.



Here are questions I would ask.

A.   Chemical extraction methods not determinative methods.

1.    How where extraction methods validated?

2.    Where the extraction methods peered reviewed?

3.    What where the peer review comments?

4.    What is the percent error of the extraction procedures?

5.    Has a material balance for extraction of analytes been discerned over
different time frames up to at least six months?

6.    How much of the analyte is bound to the matrix extracted?

B.   Validation of methods.

Are chemical extraction methods valid?



Are chemical extraction methods valid to extract chemicals from water with
suspended sediment, 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 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.



C.   Model(s).

1.    What are the model(s) used?

2.    How where the models validated?

3.    Where the model(s) peered reviewed?

4.    What where the peer review comments?

5.    What is the percent error of the model(s)?



Respectfully,



Ronald E. Ney, Jr.




On Fri, Aug 10, 2012 at 11:48 AM,
<pharmwaste-request at lists.dep.state.fl.us>wrote:

> Send Pharmwaste mailing list submissions to
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> Today's Topics:
>
>    1. RE: pharmaceutical incineration (Gilliam, Allen)
>    2. FW: pharmaceutical incineration (Bunnell, Ross)
>    3. RE: pharmaceutical incineration (Fredrick L. Miller)
>
>
> ---------- Forwarded message ----------
> From: "Gilliam, Allen" <GILLIAM at adeq.state.ar.us>
> To: "Volkman, Jennifer (MPCA)" <jennifer.volkman at state.mn.us>, "
> Pharmwaste at lists.dep.state.fl.us" <Pharmwaste at lists.dep.state.fl.us>
> Cc:
> Date: Fri, 10 Aug 2012 12:29:22 -0500
> Subject: [Pharmwaste] RE: pharmaceutical incineration
>
> As a preeminent scientist with EPA in Las Vegas has stated (something to
> the affect), “We’re probably doing more harm to the environment via all the
> combustion engine emissions being discharged from individual household
> vehicles to the big diesel trucks’ emissions hauling the collections to a
> distant regulated haz waste incinerator”.   ****
>
> ** **
>
> Has anyone put a pencil to that comparison to the relatively small
> emissions from the “terminator”?****
>
> ** **
>
> Just another fed reg where you cannot mention common sense in the same
> breath without creating an oxymoron, seems to me, painted road-kill
> raccoons et. al.****
>
> ** **
>
> Allen g****
>
> ** **
>
> *From:* pharmwaste-bounces at lists.dep.state.fl.us [mailto:
> pharmwaste-bounces at lists.dep.state.fl.us] *On Behalf Of *Volkman,
> Jennifer (MPCA)
> *Sent:* Friday, August 10, 2012 12:05 PM
> *To:* Pharmwaste at lists.dep.state.fl.us
> *Subject:* [Pharmwaste] RE: pharmaceutical incineration****
>
> ** **
>
> In MN, they'd have to be fully permitted according to the applicable AQ
> standards, SW or HW, I'm not sure of the specifics. Either way, the
> permitting requirements make it not feasible. Enforcement would shut them
> down. We're fortunate to have 10 WTE's available, including a medical waste
> incinerator and a few that are coal/RDF plants and half of them are
> approved to accept household generated pharm waste. All of them could be
> permitted to accept it if they choose. I should check what the longest
> travel distance would be, probably 2.5 hours one way. Some county law
> enforcement entities consolidate waste between them so that they each only
> have to make a trip every few years.****
>  ------------------------------
>
> *From:* pharmwaste-bounces at lists.dep.state.fl.us [
> pharmwaste-bounces at lists.dep.state.fl.us] on behalf of Fredrick L. Miller
> [millerfl at tricity.wsu.edu]
> *Sent:* Friday, August 10, 2012 10:56 AM
> *To:* Pharmwaste at lists.dep.state.fl.us
> *Subject:* [Pharmwaste] RE: pharmaceutical incineration****
>
> Not in Washington.  I doubt they’d ever be able to meet pollution control
> and permit requirements here.  They certainly would never pass muster with
> our actively interested and VERY vocal citizens.****
>
>  ****
>
> From a regulatory standpoint, how do they fit in non-attainment areas?
> What’s the mechanism for working with various airshed PCAs?  They’re
> combusting MSW, at best, and depending upon the source of the materials
> combusted, perhaps RCRA waste.  How are those hurdles overcome and the RCRA
> aspect controlled for?  I’m very curious as I’ve had people in states
> outside Washington propose similar operations and I’ve always advised
> against it on regulatory (pain) grounds.  If you’ve found a wrinkle in the
> CAA that allows for reasonable size burners that can meet all those
> regulatory challenges I’d be most grateful to see what you’ve got.****
>
>  ****
>
> Fred****
>
>  ****
>
>  ****
>
> *From:* pharmwaste-bounces at lists.dep.state.fl.us
> [mailto:pharmwaste-bounces at lists.dep.state.fl.us] *On Behalf Of *Hoffman,
> Deb
> *Sent:* Friday, August 10, 2012 5:39 AM
> *To:* Pharmwaste at lists.dep.state.fl.us
> *Cc:* midwestpsc at googlegroups.com
> *Subject:* [Pharmwaste] pharmaceutical incineration****
>
>  ****
>
> Greetings,****
>
>  ****
>
> Here in Ohio, we’re discussing the usage of the portable incinerators,
> from an air pollution standpoint.  I’ve been working with a colleague in
> the Ohio EPA Division of Air Pollution Control.  I’d like to know if anyone
> is aware of any recent research on the effectiveness of portable
> incinerators, or if they are being used in other states.  And if you would
> like to share incineration options in your state, I would be interested in
> hearing them.****
>
>  ****
>
> Thank you,****
>
> Deb****
>
>  ****
>
>  ****
>
> Deb Hoffman****
>
> Environmental Specialist****
>
> Division of Materials and Waste Management****
>
> Ohio EPA****
>
> 614.728.5353****
>
>  ****
>
>  ****
>
>
> ---------- Forwarded message ----------
> From: "Bunnell, Ross" <Ross.Bunnell at ct.gov>
> To: "'pharmwaste at lists.dep.state.fl.us'" <pharmwaste at lists.dep.state.fl.us
> >
> Cc:
> Date: Fri, 10 Aug 2012 14:05:25 -0400
> Subject: [Pharmwaste] FW: pharmaceutical incineration
>
> All humor aside, I think we need to keep in mind that there is more to
> consider here than air emissions and the effect that a small unit like this
> would have on the environment at large.  ****
>
> ** **
>
> More specifically, with a unit like this, which has a stack at or close to
> human nose level, this is also a worker exposure issue.  While a unit like
> this one could probably (I say probably) destroy most pharmaceuticals to a
> high degree of efficiency (if operated correctly), there are other
> pharmaceuticals that might be resistant to thermal destruction, that might
> form toxic combustions products (dioxins, furans, PAHs, etc.), or that
> might create inorganic emissions (e.g. arsenic fume from burning arsenic
> trioxide).  In my opinion this is actually the more relevant and germane
> issue.  I’m not sure I’d like to be the junior police officer that is
> tasked with the job of running this thing, even if I was standing upwind.*
> ***
>
> ** **
>
> Shipping the stuff to a trash-to-energy plant makes a lot more sense to me
> (no worker exposure, the combustion unit has sophisticated air pollution
> control equipment run by knowledgeable staff and has a tall stack, etc.).*
> ***
>
> ** **
>
> --Ross Bunnell, CT DEEP****
>
> ** **
>
> *From:* pharmwaste-bounces at lists.dep.state.fl.us [mailto:
> pharmwaste-bounces at lists.dep.state.fl.us] *On Behalf Of *Gilliam, Allen
> *Sent:* Friday, August 10, 2012 1:29 PM
> *To:* Volkman, Jennifer (MPCA); Pharmwaste at lists.dep.state.fl.us
> *Subject:* [Pharmwaste] RE: pharmaceutical incineration****
>
> ** **
>
> As a preeminent scientist with EPA in Las Vegas has stated (something to
> the affect), “We’re probably doing more harm to the environment via all the
> combustion engine emissions being discharged from individual household
> vehicles to the big diesel trucks’ emissions hauling the collections to a
> distant regulated haz waste incinerator”.   ****
>
> ** **
>
> Has anyone put a pencil to that comparison to the relatively small
> emissions from the “terminator”?****
>
> ** **
>
> Just another fed reg where you cannot mention common sense in the same
> breath without creating an oxymoron, seems to me, painted road-kill
> raccoons et. al.****
>
> ** **
>
> Allen g****
>
> ** **
>
> *From:* pharmwaste-bounces at lists.dep.state.fl.us [mailto:
> pharmwaste-bounces at lists.dep.state.fl.us] *On Behalf Of *Volkman,
> Jennifer (MPCA)
> *Sent:* Friday, August 10, 2012 12:05 PM
> *To:* Pharmwaste at lists.dep.state.fl.us
> *Subject:* [Pharmwaste] RE: pharmaceutical incineration****
>
> ** **
>
> In MN, they'd have to be fully permitted according to the applicable AQ
> standards, SW or HW, I'm not sure of the specifics. Either way, the
> permitting requirements make it not feasible. Enforcement would shut them
> down. We're fortunate to have 10 WTE's available, including a medical waste
> incinerator and a few that are coal/RDF plants and half of them are
> approved to accept household generated pharm waste. All of them could be
> permitted to accept it if they choose. I should check what the longest
> travel distance would be, probably 2.5 hours one way. Some county law
> enforcement entities consolidate waste between them so that they each only
> have to make a trip every few years.****
>  ------------------------------
>
> *From:* pharmwaste-bounces at lists.dep.state.fl.us [
> pharmwaste-bounces at lists.dep.state.fl.us] on behalf of Fredrick L. Miller
> [millerfl at tricity.wsu.edu]
> *Sent:* Friday, August 10, 2012 10:56 AM
> *To:* Pharmwaste at lists.dep.state.fl.us
> *Subject:* [Pharmwaste] RE: pharmaceutical incineration****
>
> Not in Washington.  I doubt they’d ever be able to meet pollution control
> and permit requirements here.  They certainly would never pass muster with
> our actively interested and VERY vocal citizens.****
>
>  ****
>
> >From a regulatory standpoint, how do they fit in non-attainment areas?
> What’s the mechanism for working with various airshed PCAs?  They’re
> combusting MSW, at best, and depending upon the source of the materials
> combusted, perhaps RCRA waste.  How are those hurdles overcome and the RCRA
> aspect controlled for?  I’m very curious as I’ve had people in states
> outside Washington propose similar operations and I’ve always advised
> against it on regulatory (pain) grounds.  If you’ve found a wrinkle in the
> CAA that allows for reasonable size burners that can meet all those
> regulatory challenges I’d be most grateful to see what you’ve got.****
>
>  ****
>
> Fred****
>
>  ****
>
>  ****
>
> *From:* pharmwaste-bounces at lists.dep.state.fl.us
> [mailto:pharmwaste-bounces at lists.dep.state.fl.us] *On Behalf Of *Hoffman,
> Deb
> *Sent:* Friday, August 10, 2012 5:39 AM
> *To:* Pharmwaste at lists.dep.state.fl.us
> *Cc:* midwestpsc at googlegroups.com
> *Subject:* [Pharmwaste] pharmaceutical incineration****
>
>  ****
>
> Greetings,****
>
>  ****
>
> Here in Ohio, we’re discussing the usage of the portable incinerators,
> from an air pollution standpoint.  I’ve been working with a colleague in
> the Ohio EPA Division of Air Pollution Control.  I’d like to know if anyone
> is aware of any recent research on the effectiveness of portable
> incinerators, or if they are being used in other states.  And if you would
> like to share incineration options in your state, I would be interested in
> hearing them.****
>
>  ****
>
> Thank you,****
>
> Deb****
>
>  ****
>
>  ****
>
> Deb Hoffman****
>
> Environmental Specialist****
>
> Division of Materials and Waste Management****
>
> Ohio EPA****
>
> 614.728.5353****
>
>  ****
>
>  ****
>
>
> ---------- Forwarded message ----------
> From: "Fredrick L. Miller" <millerfl at tricity.wsu.edu>
> To: "'pharmwaste at lists.dep.state.fl.us'" <pharmwaste at lists.dep.state.fl.us
> >
> Cc:
> Date: Fri, 10 Aug 2012 18:27:29 +0000
> Subject: [Pharmwaste] RE: pharmaceutical incineration
>
> I concur with Ross on this.****
>
> ** **
>
> Allen,****
>
> I got mad enough at  the “do something, anything, green and do it now”
> dunderheads a few years back when the panderers in Olympia declared all
> fluorescent lighting, regardless of type, from state owned and leased
> buildings in Washington would be “recycled” that I calculated both GHG and
> mercury emissions from said activity and contrasted them with landfill
> disposal.****
>
> ** **
>
> I accounted for****
>
> **1.       **Transportation, including roadway maintenance, fuel
> refining, distribution and consumption, vehicle construction and maintenance
> ****
>
> **2.       **Emissions from coal fired electrical generation in the
> manufacturing process of materials required for the above****
>
> **3.       **Fate of residuals****
>
> **4.       **Landfill standards (local disposal at modern Subtitle D v.
> Subtitle C where Hg recycler disposes), along with transport of residual
> from Hg recycler to Subtitle C landfill (Wisconsin to Alabama) and sham
> “recycling” of glass components which end up as MSW.****
>
> **5.       **MSW contribution from CFL (over 90% of mass)****
>
> ** **
>
> It turns out we emit over three times as much mercury to the atmosphere if
> we recycle out here in the west, Racine Wisconsin being the closest retort,
> as we would if we just threw the darned things down in the parking lot and
> broke them.  Then, nearly as much mercury ends up in the retort residuals
> in a landfill in Alabama which isn’t as secure as our local MSW landfill
> only 250 miles away from the most distant transfer station in the state.
> Our GHG emissions from recycling exceed what they would be from MSW
> disposal by two orders of magnitude.  And we don’t save one blessed cubic
> meter of landfill space!****
>
> ** **
>
> Oh, then there’s the little fact that those lamps cost us on the order of
> $30/kg (converted from average weight per linear ft. at state contract
> price) instead of $90/ton. ****
>
> ** **
>
> Gosh, I love it when activist amateurs save the planet.  I can’t imagine
> what useful things we could have done with that money instead of enriching
> a “recycling” industry that’s simply warehousing an unwanted commodity.***
> *
>
> ** **
>
> Fred****
>
> ** **
>
> *From:* pharmwaste-bounces at lists.dep.state.fl.us [mailto:
> pharmwaste-bounces at lists.dep.state.fl.us] *On Behalf Of *Bunnell, Ross
> *Sent:* Friday, August 10, 2012 11:05 AM
> *To:* 'pharmwaste at lists.dep.state.fl.us'
> *Subject:* [Pharmwaste] FW: pharmaceutical incineration****
>
> ** **
>
> All humor aside, I think we need to keep in mind that there is more to
> consider here than air emissions and the effect that a small unit like this
> would have on the environment at large.  ****
>
> ** **
>
> More specifically, with a unit like this, which has a stack at or close to
> human nose level, this is also a worker exposure issue.  While a unit like
> this one could probably (I say probably) destroy most pharmaceuticals to a
> high degree of efficiency (if operated correctly), there are other
> pharmaceuticals that might be resistant to thermal destruction, that might
> form toxic combustions products (dioxins, furans, PAHs, etc.), or that
> might create inorganic emissions (e.g. arsenic fume from burning arsenic
> trioxide).  In my opinion this is actually the more relevant and germane
> issue.  I’m not sure I’d like to be the junior police officer that is
> tasked with the job of running this thing, even if I was standing upwind.*
> ***
>
> ** **
>
> Shipping the stuff to a trash-to-energy plant makes a lot more sense to me
> (no worker exposure, the combustion unit has sophisticated air pollution
> control equipment run by knowledgeable staff and has a tall stack, etc.).*
> ***
>
> ** **
>
> --Ross Bunnell, CT DEEP****
>
> ** **
>
> *From:* pharmwaste-bounces at lists.dep.state.fl.us
> [mailto:pharmwaste-bounces at lists.dep.state.fl.us] *On Behalf Of *Gilliam,
> Allen
> *Sent:* Friday, August 10, 2012 1:29 PM
> *To:* Volkman, Jennifer (MPCA); Pharmwaste at lists.dep.state.fl.us
> *Subject:* [Pharmwaste] RE: pharmaceutical incineration****
>
> ** **
>
> As a preeminent scientist with EPA in Las Vegas has stated (something to
> the affect), “We’re probably doing more harm to the environment via all the
> combustion engine emissions being discharged from individual household
> vehicles to the big diesel trucks’ emissions hauling the collections to a
> distant regulated haz waste incinerator”.   ****
>
> ** **
>
> Has anyone put a pencil to that comparison to the relatively small
> emissions from the “terminator”?****
>
> ** **
>
> Just another fed reg where you cannot mention common sense in the same
> breath without creating an oxymoron, seems to me, painted road-kill
> raccoons et. al.****
>
> ** **
>
> Allen g****
>
> ** **
>
> *From:* pharmwaste-bounces at lists.dep.state.fl.us
> [mailto:pharmwaste-bounces at lists.dep.state.fl.us] *On Behalf Of *Volkman,
> Jennifer (MPCA)
> *Sent:* Friday, August 10, 2012 12:05 PM
> *To:* Pharmwaste at lists.dep.state.fl.us
> *Subject:* [Pharmwaste] RE: pharmaceutical incineration****
>
> ** **
>
> In MN, they'd have to be fully permitted according to the applicable AQ
> standards, SW or HW, I'm not sure of the specifics. Either way, the
> permitting requirements make it not feasible. Enforcement would shut them
> down. We're fortunate to have 10 WTE's available, including a medical waste
> incinerator and a few that are coal/RDF plants and half of them are
> approved to accept household generated pharm waste. All of them could be
> permitted to accept it if they choose. I should check what the longest
> travel distance would be, probably 2.5 hours one way. Some county law
> enforcement entities consolidate waste between them so that they each only
> have to make a trip every few years.****
>  ------------------------------
>
> *From:* pharmwaste-bounces at lists.dep.state.fl.us [
> pharmwaste-bounces at lists.dep.state.fl.us] on behalf of Fredrick L. Miller
> [millerfl at tricity.wsu.edu]
> *Sent:* Friday, August 10, 2012 10:56 AM
> *To:* Pharmwaste at lists.dep.state.fl.us
> *Subject:* [Pharmwaste] RE: pharmaceutical incineration****
>
> Not in Washington.  I doubt they’d ever be able to meet pollution control
> and permit requirements here.  They certainly would never pass muster with
> our actively interested and VERY vocal citizens.****
>
>  ****
>
> >From a regulatory standpoint, how do they fit in non-attainment areas?
> What’s the mechanism for working with various airshed PCAs?  They’re
> combusting MSW, at best, and depending upon the source of the materials
> combusted, perhaps RCRA waste.  How are those hurdles overcome and the RCRA
> aspect controlled for?  I’m very curious as I’ve had people in states
> outside Washington propose similar operations and I’ve always advised
> against it on regulatory (pain) grounds.  If you’ve found a wrinkle in the
> CAA that allows for reasonable size burners that can meet all those
> regulatory challenges I’d be most grateful to see what you’ve got.****
>
>  ****
>
> Fred****
>
>  ****
>
>  ****
>
> *From:* pharmwaste-bounces at lists.dep.state.fl.us
> [mailto:pharmwaste-bounces at lists.dep.state.fl.us] *On Behalf Of *Hoffman,
> Deb
> *Sent:* Friday, August 10, 2012 5:39 AM
> *To:* Pharmwaste at lists.dep.state.fl.us
> *Cc:* midwestpsc at googlegroups.com
> *Subject:* [Pharmwaste] pharmaceutical incineration****
>
>  ****
>
> Greetings,****
>
>  ****
>
> Here in Ohio, we’re discussing the usage of the portable incinerators,
> from an air pollution standpoint.  I’ve been working with a colleague in
> the Ohio EPA Division of Air Pollution Control.  I’d like to know if anyone
> is aware of any recent research on the effectiveness of portable
> incinerators, or if they are being used in other states.  And if you would
> like to share incineration options in your state, I would be interested in
> hearing them.****
>
>  ****
>
> Thank you,****
>
> Deb****
>
>  ****
>
>  ****
>
> Deb Hoffman****
>
> Environmental Specialist****
>
> Division of Materials and Waste Management****
>
> Ohio EPA****
>
> 614.728.5353****
>
>  ****
>
>  ****
>
> ---
> Note: As a courtesy to other listserv subscribers, please post messages to
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