The United States Environmental Protection Agency (EPA) has announced that it will develop a new rule to address the management and disposal of hazardous waste pharmaceuticals generated by healthcare facilities. The EPA has yet to release details about this rulemaking; however, the EPA has confirmed that it will only apply to pharmaceutical waste that meets the hazardous waste definition in the Resource Conservation and Recovery Act (RCRA) and anticipates publishing the proposed rule for public comment in August 2013. This announcement means that the EPA will not finalize its 2008 proposed rule to add hazardous pharmaceutical wastes to the universal waste program.
The EPA currently regulates healthcare facilities'
(including pharmacies) disposal of hazardous pharmaceutical waste
under RCRA's hazardous waste generator regulations. However,
these regulations are particularly unsuited for healthcare
facilities as they generate hundreds of different types of
pharmaceutical waste in numerous locations of which only a very
small portion constitutes hazardous waste under RCRA. As such,
sorting out the hazardous waste from the non-hazardous waste can be
quite burdensome and many healthcare facilities have had difficulty
maintaining compliance with RCRA.
In 2008, the EPA proposed to amend the universal waste regulations
to include hazardous pharmaceutical waste in order to relieve some
of the burden imposed on healthcare facilities under RCRA and to
encourage hospitals to treat all pharmaceutical waste, hazardous or
not, as universal waste. However, the EPA recently decided to
abandon this proposed rule, citing concerns related to the reduced
notification and tracking requirements under the universal waste
regulations.
Meantime, in the absence of a final federal rule, states have
enacted their own regulations to alleviate some of this burden on
health care facilities. For example, Florida has implemented
regulations that treat hazardous pharmaceutical waste as universal
waste pursuant to its delegated authority under RCRA. Similarly,
California recently amended the state's Medical Waste
Management Act to make it easier for health care facilities to
avoid RCRA regulations by increasing their ability to utilize
reverse distributors for disposal. However, it is uncertain how the
EPA's proposed new rule may impact these state
regulations.
Regardless, many states, including Wisconsin, have yet to
promulgate any regulations that differ from the EPA's RCRA
regulations for the handling and disposal of pharmaceutical waste.
As such, until the EPA finalizes a new rule, many healthcare
facilities are still required to comply with RCRA generator
regulations when disposing of hazardous pharmaceutical waste and
may be subject to federal or state enforcement if they fail to
comply.
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