[Pharmwaste] Industry Urges EPA To Align Pharmaceutical Waste Rules With DEA

Catherine Zimmer zimme053 at umn.edu
Thu Feb 12 10:17:26 EST 2009

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 fashion. 

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 amidst
> calls from some groups that the agency should work to coordinate its
> proposal with another drug disposal rule being planned by the Drug
> 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 Rule,
> which is generally less stringent than the agency's strict rules for
> hazardous wastes under the Resource Conservation & Recovery Act (RCRA). 
> 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 generally
> supportive of the proposal but they, along with state regulators, said
> they would be unable to fully evaluate the proposal's impacts by the
> 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 agencies
> to extend comment deadlines on rules the Bush administration proposed
> during its final days in office. 
> The proposed rule, which applies to pharmacies, hospitals, doctor's
> offices and other medical facilities, is intended to "facilitate better
> management of pharmaceutical wastes by streamlining the generator
> requirements and encouraging generators of hazardous pharmaceutical
> wastes to manage them under the provisions of the Universal Waste Rule,
> which ensures that these hazardous pharmaceutical wastes are properly
> disposed of and treated as hazardous wastes," according to EPA. 
> In Jan. 22 comments (see attached), the Environmental Technology Council
> (ETC), a trade association that represents the commercial hazardous
> waste industry, says it "strongly agree[s with EPA] that hazardous
> pharmaceutical wastes are one of the most widely mismanaged waste
> streams under RCRA today." ETC says that "[l]ike the Agency [it is]
> hopeful that health care facilities will decide to manage both hazardous
> and non-hazardous pharmaceuticals in the universal waste program, and
> thus facilitate better management and remove substantially greater
> 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, percentage
> and/or volumes of wastes collected from health care facilities," a
> process it says it would have been unable to complete by Feb. 2. The
> 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 and
> responsible disposal of dispense controlled substances in a manner
> consistent with the Controlled Substances Act and it's implementing
> 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 industry,
> and the law enforcement community." 
> ETC says that "[o]ften waste disposal companies face substantial hurdles
> to collection of pharmaceutical wastes due to the DEA requirements" and
> that "it is critical to coordinate these two important regulatory
> initiatives by EPA and DEA, and require additional time for that
> purpose." 
> Similarly, the Healthcare Distribution Management Association (HDMA)
> 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 (DOT),
> [DEA] and the Food and Drug Administration (FDA)." 
> The Northeast Waste Management Officials' Association (NEWMOA), which
> represents state regulators, says in Jan. 15 comments (see attached)
> that the comment period "extension would provide state environmental
> agencies with adequate time to consider the effect that the proposal
> would have upon currently regulated activities, exchange views and
> information with other states, and prepare thoroughly considered
> comments." 
> The American Nurses Association (ANA) praised the proposal in Jan. 8
> comments (see attached) and was one of few commentators not to request
> an extension of the comment deadline. "ANA concurs with the EPA's
> proposal that adding certain pharmaceutical to the Universal Waste Rule
> will indeed encourage and promote safer, more environmentally sound
> methods of pharmaceutical disposal for health care facilities and other
> similar industries," the group says. "ANA agrees that this new ruling
> will facilitate consumer take-back programs for unwanted
> pharmaceuticals." 
> 2112009_dea 
> 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.
> ---
> TO SUBSCRIBE, go to:   http://lists.dep.state.fl.us/cgi-bin/mailman/listinfo/pharmwaste 
> TO UNSUBSCRIBE, DO NOT REPLY TO THE LISTSERV. Please send an 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 http://lists.dep.state.fl.us/cgi-bin/mailman/roster/pharmwaste 
> 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/20090212/78ec3885/attachment.htm

More information about the Pharmwaste mailing list