Abstract
RCRA is a federal law that was enacted in 1976.2,3 This law gives the EPA authority to control hazardous waste from “cradle to grave” including production, transportation, treatment, storage, and disposal. 4 The goals of RCRA are to protect human health and environment from the potential hazards of waste disposal, conserve energy and natural resources, lessen the quantity of generated waste, and ensure that waste is managed in an environmentally sound manner. 5 RCRA defines hazardous waste as “chemicals or formulations so detrimental to the environment that they must be separated for special disposal and cannot be introduced into sewers or placed in landfills.” 3 Of all available pharmaceutical products, approximately 5% are classified as “RCRA hazardous”; however, many pharmaceutical agents have RCRA hazardous characteristics (ie, ignitability, toxicity, corrosivity, reactivity). The official lists of RCRA hazardous pharmaceutical agents (P and U lists) have not been updated in years despite the approval of a multitude of new chemical entities. Examples of medications on these lists currently include arsenic trioxide, epinephrine, nicotine, nitroglycerin, physo-stigmine, and warfarin over 0.3% (all P list) and chlorambucil, cyclophosphamide, melphalan, mitomycin, and streptozocin (all U list).2,3,6 If a health care institution concludes that a waste pharmaceutical is not listed under RCRA, then the facility is required to determine whether the product meets one of the previously mentioned hazardous waste characteristics. 6 The facility can determine this through the use of a standardized test method or “apply general knowledge of the waste's properties” in coming to a conclusion. More specific recommendations regarding determination of hazardous waste characteristics may be found in the August 2010 EPA Guidance Document: Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (http://water.epa.gov/scitech/wastetech/guide/upload/unuseddraftpdf).
Health care institutions that generate hazardous pharmaceutical waste are also subject to RCRA generator rules. 6 Under RCRA, these institutions may be classified into 1 of 3 generator categories: large quantity, small quantity, or conditionally exempt small quantity. Large quantity generators (ie, facilities that generate ≥1000 kg of hazardous waste per month or >1 kg of P list waste per month) are subject to the full extent of RCRA regulations such as obtaining an EPA identification number and meeting storage, manifest, reporting, and training requirements. Small quantity facilities generate >100 kg but <1000 kg of hazardous waste per month. These facilities are subject to fewer requirements under RCRA. Conditionally exempt small quantity facilities generate no more than 100 kg of hazardous waste, or no more than 1 kg of P list waste, per month. The least stringent requirements under RCRA are reserved for these facilities. Conditionally exempt small quantity facilities are not required to have an EPA identification number, manifest waste sent to an off-site disposal, or follow any time limits with regard to waste storage.
The various storage, manifest, reporting, and training requirements of RCRA can be daunting to implement for health care facilities; however, not meeting these regulations can result in high daily fines per violation and even prison sentences (when dealing with criminal cases of knowing, willful violations). 2 Also, some state requirements regarding pharmaceutical waste management may be stricter than those outlined in RCRA. If such a situation exists, the stricter regulations need to be followed.
Recognizing the significant challenges in managing pharmaceutical waste, the EPA proposed an amendment to the Universal Waste Rule in 2008 that would have essentially streamlined the pharmaceutical waste disposal process. 7 However, no action on the proposed rule change occurred after closure of the public comment period in 2009. 8 Currently, the EPA has decided to develop another proposal for hazardous waste pharmaceutical management at health care institutions due to “the substantial negative public comments on the 2008 universal waste proposal.” This new proposal, which would not replace RCRA, should be available for public comment in spring 2013.
In summary, pharmaceutical waste management for health care facilities has become a hot button issue recently, particularly due to EPA enforcement activities. Hospital pharmacists should be aware of RCRA requirements and develop a successful plan for appropriate storage, logging, and reporting of pharmaceutical waste as well as training of appropriate individuals. In the near future, there may be new federal rules put into place to aid in streamlining the process used by health care institutions to manage pharmaceutical waste appropriately.