“The very first requirement in a hospital is that it should do the sick no harm.”
On Sept. 25, the Environmental Protection Agency (EPA) published proposed rules that will require virtually all healthcare and long-term care facilities to handle and properly dispose of “hazardous waste pharmaceuticals” in a manner consistent with the Resource Conservation and Recovery Act (RCRA).
These facilities dispose of tons of pharmaceuticals annually, including flushing much of them down the drain to treatment facilities not equipped to handle them, and most workers at these facilities lack proper training in the handling of hazardous materials. The EPA’s rule seeks to make handling, storing, reporting and disposing of these materials uniform. In other words, the EPA seeks to make sure the healthcare facilities governed by Florence Nightingale’s rule – do no harm – applies not just to the sick, but to those of us outside their four walls, too.
The proposed rule defines “pharmaceuticals” quite broadly: “any chemical or biological product that is intended for use in the diagnosis, cure, mitigation, care, treatment, or prevention of disease or injury of a human or other animal; or any chemical or biological product that is intended to affect the structure or function of the body of a human or other animal.
This definition includes, but is not limited to: dietary supplements as defined by the Federal Food, Drug and Cosmetic Act, prescription drugs, over-the-counter drugs, residues of pharmaceuticals remaining in containers, personal protective equipment contaminated with pharmaceuticals, and clean-up material from spills of pharmaceuticals.” Not only are the drugs themselves covered, but anything that may have come into contact with the drug and is potentially contaminated by it.
Not all pharmaceuticals meet the definition of “hazardous waste,” but many do. Potentially regulated entities can use the EPA’s Hazardous Waste Pharmaceuticals Wiki to determine if certain pharmaceuticals qualify as “hazardous waste” if discarded and locate other useful information.
A 2010 study titled, “Protecting the Great Lakes from Pharmaceutical Pollution,” documented the effects of widespread release of pharmaceuticals in waste water. The report identified impacts on human health and wildlife from pharmaceuticals released into surface waters by a variety of means. Healthcare facilities represent a large source for these environmental contaminants in the form of pills, patches, liquids, syringes, paper cups, etc. EPA estimates that healthcare facilities generate 36,200 tons of hazardous waste pharmaceuticals, annually.
The EPA noted that there are serious difficulties with regulating hazardous waste pharmaceuticals due to the nature of how healthcare facilities operate. The individual quantities of hazardous waste pharmaceuticals are small and scattered throughout facilities. Also, healthcare workers’ primary focus is on patient care, and they do not normally become involved in hazardous waste handling process and procedures. In addition, the items that may contain hazardous waste pharmaceuticals take a variety of forms.
In order to address these difficulties, the EPA’s proposed rule seeks to simplify the collection, reporting and disposal process. For those entities to which this rule applies, flushing hazardous waste pharmaceuticals is banned. The facility could elect to separate its hazardous and non-hazardous pharmaceuticals, as long as it uses best management practices described in “Managing Pharmaceutical Waste: A 10-Step Blueprint for Healthcare Facilities in the United States.”
Hazardous waste pharmaceuticals may also be governed by other statutes and regulatory regimes, which may or may not take precedence over the proposed rule: Controlled Substances Act and Drug Enforcement Administration regulations; medical waste regulations (primarily state-based regulations); and hazardous waste pharmaceuticals that may be radioactive (mixed waste).
The proposed rule applies to specific facilities. It broadly defines “healthcare facilities” as including facilities that treat or provide care for humans or animals or sells over-the-counter pharmaceuticals. Among the specific entities covered are long-term care facilities. Also potentially included are groceries and convenience stores that sell over-the-counter drugs.
A “pharmaceutical reverse distributor,” which “receives and accumulates potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer’s credit,” is also subject to the proposed rule. In all, the EPA estimates that the proposed rule could cover 1,634 hospitals, 142,566 healthcare facilities that are not hospitals, and 28 pharmaceutical reverse distributors.
The common practices of disposing unused or expired drugs the drains or in household-type waste will cease. Regulated facilities can accumulate regulated pharmaceuticals for 90 days or up to one year depending on the type of facility. Those transporting and disposing of regulated waste pharmaceuticals will need to comply with record-keeping requirements. Further, depending on the substance being disposed of, it will either be incinerated or disposed of at a RCRA-permitted facility.
The facilities are still required to handle their non-pharmaceutical hazardous wastes in a manner consistent with RCRA, but the amount of pharmaceutical hazardous wastes will not be counted in determining the size of the facility for the purposes of RCRA (i.e., large quantity generator, small quantity generator, or conditionally exempt small quantity generator).
As for households, the proposed rule imposes no requirements. Hazardous waste pharmaceuticals that individuals dispose of in their household waste are exempt. However, while exempt, discarded pharmaceuticals can reach surface waters if they are flushed down drains and toilets or as leachate from landfilled municipal solid wastes. Michigan urges citizens to see if their pharmacy collects unused or expired pharmaceuticals, whether there are local special collection events for such wastes or place them in the trash (if options one or two are unavailable), but NOT to flush them down the drain.
The proposed rule is now open for comment. EPA invites general comments to the proposed rule and several specific questions. Those interested in submitting comments may do so at Regulations.gov, using the Docket Number EPA-HQ-RCRA-2007-0932. The comment period is open for 60 days from the date the proposed rule was published.
- Senior Attorney
A senior attorney in Plunkett Cooney’s Bloomfield Hills office, Saulius K. Mikalonis leads the firm's Environment, Energy and Resources Law and Cannabis Law industry groups.
Mr. Mikalonis focuses his practice on all aspects of ...
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