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

Thu Feb 12 09:02:04 EST 2009

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 

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