[Pharmwaste] Industry Urges EPA To Align Pharmaceutical WasteRules With DEA

Barry Fernandez Barry at clean-fuels.net
Fri Feb 13 14:57:53 EST 2009

Hi Catherine,
While I agree that the proposed UW rule has many flaws, it is certainly
a step in the right direction.  We are lucky enough, in this country, to
be afforded an opportunity to comment on the proposal and hopefully EPA
will take note of the inconsistencies when making their first set, of
probably several, revisions.  Barring my tendency to procrastinate, I
plan to detail our concerns and be part of the process as one small
voice of a broader dialog.
One example of blatant inconsistency in the proposal is that it excludes
contaminated cleanup material and PPE from the UWR.  So we are going to
manage hazardous waste pharmaceuticals as Universal waste, but PPE
(gloves and gowns) must be managed under full RCRA?  So many comments
have been made to date supporting the proposal on it's face value
without reading the fine print.  The industry needs to get this right
the first time around because getting it changed after the fact could
take forever (or longer).
To the best of my knowledge, RCRA doesn't list ANY pharmaceuticals in
the regulation, but rather commercial chemical products that when
present -as the sole active ingredient- causes a pharmaceutical product
to be "listed" hazardous waste when discarded.  The EPA demonstrates
this in the preamble to their proposal (see footnote #26 of the FR).
They explain that warfarin (P001) is used in at least 6 drugs, and
Melphalan (U150) is used in 5 products.  That's 11 listed drugs
resulting from just two of the 31 RCRA listed wastes.  This is even more
true when addressing "characteristic" wastes:  Alcohol is a single
product with a waste code of D001.  But how many pharmaceutical
formulations are there with greater than 24% alcohol?  Not many perhaps,
but the quantity is certainly greater than one.  Then we have NIOSH,
ASHP, OSHA and a host of others who make recommendations to manage
additional drugs, yet are powerless to impose regulating them.  Too
often we encounter hospitals who post the RCRA P&U lists on the wall and
call it a program.  It's EPA's fault for not conveying it's expectations
in a clear and concise manner that the general public can understand.
Perhaps the proposed UW rule is a first step in that direction.
As to the benefits, or lack thereof, of including pharmaceuticals in the
UWR there are more than are immediately recognizable.  Allowing
"handlers" to consolidate volumes of waste from several other handlers
without full Part B RCRA permit requirements saves generators tons of
money... and make no mistake, money is among the primary obstacles to
compliance, second only to lack of education or understanding of the
regs.  Since the passage of the Universal Pharmaceutical Waste (UPW)
regulation in Florida in April '07, we have experienced a cost reduction
to the generator of over 85% with an even greater increase in
compliance.  As other states follow suit, compliance will increase along
with volumes and competition among waste handlers will drive prices down
even further.  The downside to making it too easy are the host of
unintended consequences of not properly vetting an individual or company
who intends to become an "intermediate handler", as it were.
Getting back to the subject at hand which is the article that Deborah
posted, the entire premise of the article is flawed.  But what really
caught my eye was this comment:  "Once listed as a universal waste,
substances can be more easily recycled and disposed of in landfills,
rather than in the wastewater stream ".  I nearly sprayed coffee all
over the computer when I read that.  It's this kind of misinformation
that take on lives of their own.  Perhaps a letter to the editor is
Best Regards,
Clean Fuels of Florida, Inc. 
D. Barry Fernandez, President 
2635 NE 4th Avenue 
Pompano Beach, FL 33064 
Tel:  954-791-9588 
Fax: 954-791-9366 
Cell:  305-216-4941 
Toll Free: 800-725-8711 
barry at clean-fuels.net <mailto:barry at clean-fuels.net>  
www.clean-fuels.net <http://www.clean-fuels.net/>  


From: Catherine Zimmer [mailto:zimme053 at umn.edu] 
Sent: Thursday, February 12, 2009 10:17 AM
To: DeBiasi,Deborah
Cc: pharmwaste at lists.dep.state.fl.us
Subject: Re: [Pharmwaste] Industry Urges EPA To Align Pharmaceutical
WasteRules With DEA

Hi Deborah and all,
I don't know who wrote this article, but their are errors in their
assertions and the responses from the parties cited indicate ignorance
with the proposed rule.  First, we all know pharmaceuticals are not
"recycled".  And this proposed rule will not "recycle" more
pharmaceuticals, nor does it do anything to conserve resources or reduce
waste.  The proposed pharmaceutical universal waste rule only covers
RCRA hazardous waste which is a mere 31 pharmaceuticals out of a host of
thousands.  There is no guaranty with this rule that all waste
pharmaceuticals will now be managed appropriately and not discarded to
the wastewater or landfills.  The hazardous waste pharmaceuticals still
must be managed as hazardous waste, the rule proposes some of the
management criteria are reduced.  

There are numerous flaws in the proposed rule and it is but a small band
aid on the much larger issues of pharmaceutical waste and RCRA--both of
which need to be addressed in a more comprehensive and thoughtful

Catherine Zimmer
Health Care Specialist

Minnesota Technical Assistance Program
University of Minnesota
612.624.4635, 800.247.0015

Helping Minnesota businesses maximize resource efficiency, increase
energy efficiency, reduce costs, and prevent pollution

DeBiasi,Deborah wrote: 

	Daily News from InsideEPA.com - Wednesday, February 11, 2009
	Industry Urges EPA To Align Pharmaceutical Waste Rules With DEA
	EPA is giving state regulator and industry groups additional
time to
	comment on its plan to ease pharmaceutical waste regulations
	calls from some groups that the agency should work to coordinate
	proposal with another drug disposal rule being planned by the
	Enforcement Agency (DEA).   
	The agency on Nov. 20 released the proposal to add
pharmaceuticals to a
	list of wastes eligible for regulation under its Universal Waste
	which is generally less stringent than the agency's strict rules
	hazardous wastes under the Resource Conservation & Recovery Act
	EPA is developing the rule as one of several measures intended
to limit
	disposal of unused pharmaceuticals in the wastewater stream.
Once listed
	as a universal waste, substances can be more easily recycled and
	disposed of in landfills, rather than in the wastewater stream. 
	In comments submitted to EPA, industry groups said they were
	supportive of the proposal but they, along with state
regulators, said
	they would be unable to fully evaluate the proposal's impacts by
	original Feb. 2 comment deadline. 
	In a Feb. 3 Federal Register notice, EPA announced it was
extending the
	comment period for an additional month -- until March 4 -- a
move that
	appears to largely address the groups' requests, although some
had asked
	that the comment period be extended by 45 or 60 days. The move
is also
	consistent with an Obama White House memo ordering all federal
	to extend comment deadlines on rules the Bush administration
	during its final days in office. 
	The proposed rule, which applies to pharmacies, hospitals,
	offices and other medical facilities, is intended to "facilitate
	management of pharmaceutical wastes by streamlining the
	requirements and encouraging generators of hazardous
	wastes to manage them under the provisions of the Universal
Waste Rule,
	which ensures that these hazardous pharmaceutical wastes are
	disposed of and treated as hazardous wastes," according to EPA. 
	In Jan. 22 comments (see attached), the Environmental Technology
	(ETC), a trade association that represents the commercial
	waste industry, says it "strongly agree[s with EPA] that
	pharmaceutical wastes are one of the most widely mismanaged
	streams under RCRA today." ETC says that "[l]ike the Agency [it
	hopeful that health care facilities will decide to manage both
	and non-hazardous pharmaceuticals in the universal waste
program, and
	thus facilitate better management and remove substantially
	volumes of these materials from the municipal waste stream." 
	In order to determine whether the proposal will achieve this
goal, ETC
	is "reviewing waste management information on the nature,
	and/or volumes of wastes collected from health care facilities,"
	process it says it would have been unable to complete by Feb. 2.
	group is also "attempting to obtain information from members'
	pharmaceutical take-back programs and household hazardous waste
	collection programs to gauge the potential for redirecting
	pharmaceutical wastes into the [universal waste] system." 
	In addition, ETC notes that on Jan. 21 the DEA issued an
advanced notice
	of proposed rulemaking in which it is "seeking options for safe
	responsible disposal of dispense controlled substances in a
	consistent with the Controlled Substances Act and it's
	regulations," according to the notice. DEA in the advanced
notice is
	"soliciting information on the disposal of controlled substances
	dispensed to individual patients, also defined as ultimate
users, as
	well as long term care facilities" in "response to concerns
raised by
	individuals, public and private organizations, the healthcare
	and the law enforcement community." 
	ETC says that "[o]ften waste disposal companies face substantial
	to collection of pharmaceutical wastes due to the DEA
requirements" and
	that "it is critical to coordinate these two important
	initiatives by EPA and DEA, and require additional time for that
	Similarly, the Healthcare Distribution Management Association
	says in Jan. 15 comments (see attached) that it "was pleased to
see the
	publication of [the EPA] proposal" but that it needs additional
time to
	"fully consider the interplay between EPA's proposal and other
	regulations such as those of the Department of Transportation
	[DEA] and the Food and Drug Administration (FDA)." 
	The Northeast Waste Management Officials' Association (NEWMOA),
	represents state regulators, says in Jan. 15 comments (see
	that the comment period "extension would provide state
	agencies with adequate time to consider the effect that the
	would have upon currently regulated activities, exchange views
	information with other states, and prepare thoroughly considered
	The American Nurses Association (ANA) praised the proposal in
Jan. 8
	comments (see attached) and was one of few commentators not to
	an extension of the comment deadline. "ANA concurs with the
	proposal that adding certain pharmaceutical to the Universal
Waste Rule
	will indeed encourage and promote safer, more environmentally
	methods of pharmaceutical disposal for health care facilities
and other
	similar industries," the group says. "ANA agrees that this new
	will facilitate consumer take-back programs for unwanted
	Deborah L. DeBiasi 
	Email:   dldebiasi at deq.virginia.gov 
	WEB site address:  www.deq.virginia.gov 
	Virginia Department of Environmental Quality 
	Office of Water Permit Programs 
	Industrial Pretreatment/Toxics Management Program 
	PPCPs, EDCs, and Microconstituents 
	Mail:          P.O. Box 1105, Richmond, VA  23218 (NEW!) 
	Location:  629 E. Main Street, Richmond, VA  23219 
	PH:         804-698-4028 
	FAX:      804-698-4032 

	Note: As a courtesy to other listserv subscribers, please post
messages to the listserv in plain text format to avoid the garbling of
messages received by digest recipients.
e-mail to pharmwaste-unsubscribe at lists.dep.state.fl.us -- the subject
line and body of the e-mail should be blank.
	If you believe you may be subscribed with a different email
address, please visit the subscriber listing at
	FOR PROBLEMS:  Contact List Administrator
Laurie.Tenace at dep.state.fl.us 
	SEND MAIL to the list server at:
pharmwaste at lists.dep.state.fl.us

-------------- next part --------------
An HTML attachment was scrubbed...
URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20090213/49a2b4d8/attachment-0001.htm

More information about the Pharmwaste mailing list