[Pharmwaste] RE: Pharmwaste Digest, Vol 1, Issue 179

Stevan Gressitt gressitt at uninets.net
Wed Nov 30 20:25:26 EST 2005


It appears that at least the US Pharmaceutical companies are not engaged in
this dumping whatsoever. I can't speak for other countries of origin, but
some countries, ( again not the US nor Canada ) seem to have taken care of
some short shelf life times. 

That is not to say some "organizations" weren't heavily engaged and/or
individual households wanting to "do good."

The cost of destruction is "avoided," the donor "does good," the donor may
even get publicity or tax write offs. And the recipient country takes care
of the waste. 

The incinerator in Bandah Aceh is about the size of a double refrigerator
with a chute about the size of your average refrigerator freezer door.

Any volunteers to start shoveling the 345 tons in? Let's see..job completion
in 5 years maybe?

Stevan Gressitt 

-----Original Message-----
From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Andria
Ventura
Sent: Wednesday, November 30, 2005 5:36 PM
To: pharmwaste at lists.dep.state.fl.us
Subject: [Pharmwaste] RE: Pharmwaste Digest, Vol 1, Issue 179

The issue of dumping massive amounts of unusable drugs in other countries is
new ground for me.  I think we may find some parallel
issues/solutions/discussion to this issue, and the question about take-back
policies for drug manufacturers, in current efforts to stop the US' export
of electronic waste to developing countries.  There are quite a few
organizations doing advocacy around this issue and there is a large national
campaign to promote take-back programs for end of life products on the part
of the producers.  Calif. has a law that is a 1st step, as do other states,
though there is no national legislation yet as far as I know.  May be an
area to look at for some answers with pharmaceuticals.

-----Original Message-----
From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us]On Behalf Of
pharmwaste-request at lists.dep.state.fl.us
Sent: Wednesday, November 30, 2005 12:33 PM
To: pharmwaste at lists.dep.state.fl.us
Subject: Pharmwaste Digest, Vol 1, Issue 179


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Today's Topics:

   1. how to subscribe? (Gilliam, Allen)
   2. Hazardous Waste Exports (gressitt at uninets.net)
   3. RE: how to subscribe? (Tenace, Laurie)
   4. RE: Hazardous Waste Exports - Basel Convention,	US not a
      signator (Price, John L.)
   5. Pandemic drug/vaccine waste disposal (Bickford, Barbara J.)


----------------------------------------------------------------------

Message: 1
Date: Wed, 23 Nov 2005 10:53:58 -0600
From: "Gilliam, Allen" <GILLIAM at adeq.state.ar.us>
Subject: [Pharmwaste] how to subscribe?
To: <pharmwaste at lists.dep.state.fl.us>
Cc: Dennis Rostad <drostad at HealthyArkansas.com>
Message-ID: <6F6E732380864947BFA28E290610DE1C05C4B210 at dpex02.adpce.ad>
Content-Type: text/plain; charset="us-ascii"

would the listserve "master" please provide instruction again for
subscription to this listserve?  i've lost my directions and there's a
very knowledgable and connected state dept of health and human services
person (dennis rostad, cc'd above) who wishes to join.  dennis'
expertise is haz waste and its regs, risk assessment and overall
proactive pollution prevention expert.

thanx and have a great turkey (easy on the desserts),

allen gilliam
adeq state pretreatment coordinator
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Message: 2
Date: Wed, 23 Nov 2005 12:36:04 -0500
From: <gressitt at uninets.net>
Subject: [Pharmwaste] Hazardous Waste Exports
To: pharmwaste at lists.dep.state.fl.us
Message-ID: <web-19585799 at warpspeed.megalink.net>
Content-Type: text/plain; charset="ISO-8859-1"

A question has arisen within the historical context of the
tons of unusable medical donations that were made to
Bosnia. 3-4 million dollars were need for the incineration
through purchase of new incinerators. The incinerators were
duly purchased and the problem resolved, in part via the
development of more promotional material for the WHO Drug
Donation Guidelines.

What is the argument against the following:

1) Individual household medicines are generally not
considered hazardous in the US.

2) Consolidation of more than 1 household ( 2 or more)
moves this into the world of "consolidators" and RCRA as
well as 56 jurisdictions across the country weigh in or not
with further restrictions.

3) As a secondary and simultaneous development DEA
regulations become engaged at point 2 above regarding any
controlled substances.

4) Where classified as hazardous waste by the relevant
jurisdiction, the material now likewise falls u nder the
Berne Convention banning export of hazardous waste.

5) Regulations already exist therefore to ban the practice
of collecting unused medication and dumping it overseas as
in Bandah Aceh where 345 tons now await destruction. The
enforcemetn agencies would be: DEA to control export of
controlled substances, EPA to identify Berne convention
violations (?), and Homeland Security ( Customs and
Immigration) to impound Berne Convention violating
shipments.


I am vague at the point in 5 above where I am not sure
where EPA fits and have put a question mark. The string of
points above however is what I am trying to respond to from
a United States-centric position ( no I'm not defending,
just trying to work out where there may be some options for
adjustment in policy.)

And oplease I'd rather have some serious obvious criticisms
now than later. Private response is understandable as well.

Stevan Gressitt, M.D.
207-441-0291
gressitt at uninets.net


------------------------------

Message: 3
Date: Mon, 28 Nov 2005 08:37:13 -0500
From: "Tenace, Laurie" <Laurie.Tenace at dep.state.fl.us>
Subject: RE: [Pharmwaste] how to subscribe?
To: "Gilliam, Allen" <GILLIAM at adeq.state.ar.us>,
	<pharmwaste at lists.dep.state.fl.us>
Cc: Dennis Rostad <drostad at HealthyArkansas.com>
Message-ID:
	<F3B05BF073E51740B024E311F9AAC73F010D2156 at tlhexsmb4.floridadep.net>
Content-Type: text/plain; charset="us-ascii"

Anyone is welcome to join the Pharmwaste list serve. Save these directions
or
you can send any new people to me -



To join, go to this URL and follow the directions:
http://lists.dep.state.fl.us/cgi-bin/mailman/listinfo/pharmwaste
<http://lists.dep.state.fl.us/cgi-bin/mailman/listinfo/pharmwaste>

You can visit the archives to see what has already been discussed.



Also, there's lots of information about Pharmaceuticals and Personal Care
Products at EPA's PPCP web site:
http://www.epa.gov/nerlesd1/chemistry/pharma/index.htm
<http://www.epa.gov/nerlesd1/chemistry/pharma/index.htm>





I hope you all had as great a Thanksgiving as I did with my family -

Laurie



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 at dep.state.fl.us



view our mercury web pages at:

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





  _____

From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Gilliam,
Allen
Sent: Wednesday, November 23, 2005 11:54 AM
To: pharmwaste at lists.dep.state.fl.us
Cc: Dennis Rostad
Subject: [Pharmwaste] how to subscribe?



would the listserve "master" please provide instruction again for
subscription to this listserve?  i've lost my directions and there's a very
knowledgable and connected state dept of health and human services person
(dennis rostad, cc'd above) who wishes to join.  dennis' expertise is haz
waste and its regs, risk assessment and overall proactive pollution
prevention expert.



thanx and have a great turkey (easy on the desserts),



allen gilliam

adeq state pretreatment coordinator

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Message: 4
Date: Wed, 30 Nov 2005 10:07:28 -0500
From: "Price, John L." <John.L.Price at dep.state.fl.us>
Subject: RE: [Pharmwaste] Hazardous Waste Exports - Basel Convention,
	US not a signator
To: <gressitt at uninets.net>
Cc: pharmwaste at lists.dep.state.fl.us
Message-ID:
	<1CF950D45B711640999E5736460286DD4DB06E at tlhexsmb2.floridadep.net>
Content-Type: text/plain;	charset="US-ASCII"

Stevan: The international convention that restricts the export of hazardous
wastes to developing countries is, I believe, the Basel Convention (see
http://www.basel.int/).  I checked the Berne Convention and it appears that
it may have been a general precursor of the more specific Basel Convention
issued later. I am not sure about the relationship between Berne and Basel,
but I believe Basel is the applicable international convention regarding the
movement of hazardous waste between countries.

The US, to date, is not a signator to the Basel Convention so that
Convention
has no legal bearing, as far as I know, on export of hazardous waste from
the
US. The applicable regulation, enforced by the US EPA, on hazardous waste
export is the Resource and Conservation Recovery Act (RCRA), specifically 40
CFR Subpart E (40 CFR 262.50-58) and Subpart H 40 CFR 262.80-89). Generally,
there is a requirement to notify both EPA and the receiving country and to
secure the consent of the receiving country. There are record keeping and
other requirements as well. As in all hazardous waste regulations, however,
there are always complexities, conditions and sometimes exemptions, so
please
take my general statement as a gross one rather than an all inclusive one.

Your base point that there is a complex interplay of regulations governing
export of hazardous wastes is certainly on the mark and will continue to be
an issue in our discussions of proper management of pharmaceuticals.

I appreciate your posts and they do inject important issues into the ongoing
discussions. Thanks.

Jack.

John L. (Jack) Price
Environmental Manager
Hazardous Waste Management MS 4555
Florida Department of Environmental Protection
2600 Blair Stone Road
Tallahassee, FL  32399-2400
Phone:850.245.8751
Fax: 850.245.8811
john.l.price at dep.state.fl.us
www.dep.state.fl.us/waste
 Please Note:  Florida has a very broad public records law.  Most written
communications to or from state officials regarding state business are
public
records available to the public and media upon request.  Your e-mail is
communications and may therefore be subject to public disclosure.

-----Original Message-----
From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of
gressitt at uninets.net
Sent: Wednesday, November 23, 2005 12:36 PM
To: pharmwaste at lists.dep.state.fl.us
Subject: [Pharmwaste] Hazardous Waste Exports

A question has arisen within the historical context of the
tons of unusable medical donations that were made to
Bosnia. 3-4 million dollars were need for the incineration
through purchase of new incinerators. The incinerators were
duly purchased and the problem resolved, in part via the
development of more promotional material for the WHO Drug
Donation Guidelines.

What is the argument against the following:

1) Individual household medicines are generally not
considered hazardous in the US.

2) Consolidation of more than 1 household ( 2 or more)
moves this into the world of "consolidators" and RCRA as
well as 56 jurisdictions across the country weigh in or not
with further restrictions.

3) As a secondary and simultaneous development DEA
regulations become engaged at point 2 above regarding any
controlled substances.

4) Where classified as hazardous waste by the relevant
jurisdiction, the material now likewise falls u nder the
Berne Convention banning export of hazardous waste.

5) Regulations already exist therefore to ban the practice
of collecting unused medication and dumping it overseas as
in Bandah Aceh where 345 tons now await destruction. The
enforcemetn agencies would be: DEA to control export of
controlled substances, EPA to identify Berne convention
violations (?), and Homeland Security ( Customs and
Immigration) to impound Berne Convention violating
shipments.


I am vague at the point in 5 above where I am not sure
where EPA fits and have put a question mark. The string of
points above however is what I am trying to respond to from
a United States-centric position ( no I'm not defending,
just trying to work out where there may be some options for
adjustment in policy.)

And oplease I'd rather have some serious obvious criticisms
now than later. Private response is understandable as well.

Stevan Gressitt, M.D.
207-441-0291
gressitt at uninets.net
_______________________________________________
Pharmwaste mailing list
Pharmwaste at lists.dep.state.fl.us
http://lists.dep.state.fl.us/cgi-bin/mailman/listinfo/pharmwaste


------------------------------

Message: 5
Date: Wed, 30 Nov 2005 14:32:58 -0600
From: "Bickford, Barbara J." <Barbara.Bickford at dnr.state.wi.us>
Subject: [Pharmwaste] Pandemic drug/vaccine waste disposal
To: "Pharmwaste, the list" <pharmwaste at lists.dep.state.fl.us>
Message-ID:
	<E16F6D6B1580AD4C964BE822F5384F6403B4D4D1 at prodml02.DNR.state.wi.us>
Content-Type: text/plain; charset="us-ascii"

We are hearing about federal and state efforts to plan responses in case
of an avian flu outbreak or other pandemic.  We have read about possible
stockpiles of anti-viral drugs such as Tamiflu (r) and Relenza (r)  and
the need for about 40 million 2 course doses of flu vaccine.

This raises some questions:
*	Whether the responses involve stockpiled vaccines or vaccines
made if novel virus is found ---is anyone figuring the cost of disposal
of unused vaccines?
*	If some or all of those "gazillion" doses are unused, who is
going to pay for disposal?
*	Are manufacturers going to take back their unused products for
proper disposal?
*	How likely is it that an avian flu vaccine would contain
thimerosal (mercury preservative) in amounts that might make it a RCRA
hazardous waste when discarded?
*	Similarly, would anti-viral drugs contain enough thimerosal or
something else that might make them RCRA hazardous waste when discarded?

*	Or are these vaccines going to contain live virus, which may
need to be managed as infectious waste when discarded?
*	Where can state waste regulators get more up-to-date information
about pandemic planning?


This is my personal opinion:  I think it would be wise if planners would
consider the cost of the dose AND the cost of disposal.   While vaccines
with thimerosal may cost less initially, the cost of managing excess
vaccine may be more than for non-thimerosal vaccines.
Barb Bickford
Wisconsin Department of Natural Resources
608-267-3548
barbara.bickford at dnr.state.wi.us

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