Pharmaceutical Hazardous Waste Regulations Bring Compliance Challenges
Complying with the complex array of hazardous waste handling and disposal requirements under the Resource Conservation and Recovery Act (“RCRA”) and its state analogues is a substantial undertaking for retail pharmacies and other “healthcare facilities.” Increased federal and state enforcement against these facilities regarding, among other things, pharmaceutical waste disposal practices has prompted discussion between regulatory agencies and the regulated community about the appropriateness of applying these hazardous waste requirements to the healthcare and retail contexts.
Since 2007, the EPA has issued several guidance documents clarifying various regulatory issues related to the management and disposal of pharmaceuticals that are considered hazardous waste when discarded. Alongside these guidance documents, the EPA continues the formal rule-making process to more fundamentally reshape the regulatory regime for such waste pharmaceuticals when handled and/or disposed of by retail pharmacies, other healthcare facilities, and reverse distributors.
The EPA continues to divulge few details about the pending proposed rule, but it has signaled that the rule will address three broad problem areas: reverse distribution of pharmaceuticals; compliance difficulties caused by RCRA’s “manufacturing-oriented framework;” and problems caused by flushing of waste pharmaceuticals. In the meantime, however, a patchwork of pharmaceutical waste regulatory regimes exist among the states, and several states have recently undertaken additional pharmaceutical waste regulatory reform efforts, further complicating compliance efforts by the regulated community, particularly for entities with operations in multiple states.
For example, Rhode Island has recently adopted changes to its rules applicable to hazardous waste generators, exempting “household hazardous waste pharmaceuticals” when such waste is collected in the course of consumer take-back programs. As Rhode Island’s Department of Environmental Management has noted in summarizing the state’s recent changes to rules governing hazardous waste management by generators, Rhode Island has implemented the aforementioned exemption to avoid “creating confusing jurisdictional issues between DEA controlled substance requirements and hazardous waste rules for household waste.”
Not every state is taking this “jurisdictional issue” into account necessarily, however. New York recently enacted legislation endorsing pharmaceutical take-back events and is prompting further legislation that would establish a prescription drug disposal program in which pharmacies accept and dispose of unused drugs prescribed to residents of the state. Illinois and Pennsylvania both have pending legislation pertaining to pharmaceutical take-back events.
Even though it is clear that legislated take-back events are on the rise, the legislation itself varies and seemingly further complicates the management of pharmaceutical waste. For example, while Illinois’ pending legislation does not provide for compulsory take-back events, it seemingly fails at the same time to provide clear guidance to pharmacies should they decide to provide a receptacle for pharmaceutical take-backs. Pennsylvania’s pending legislation, on the other hand, requires retailers of pharmaceutical drugs (which includes over-the counter products) to have in place a system for the acceptance and collection of such drugs for proper disposal. And were a retailer to not comply with Pennsylvania’s pending legislation, that retailer “may not make a retail sale.” Thus, while retail pharmacies operating in multiple states should anticipate state-mandated and/or regulated pharmaceutical take-back programs, states are not implementing one-size-fits-all systems for these programs that could have potentially draconian impacts should compliance become a problem.
Indeed, already in place in several states are regulations covering substances in addition to those regulated by RCRA, thereby subjecting additional pharmaceuticals to heightened handling and storage requirements. Connecticut, for example, regulates many non-RCRA pharmaceutical wastes as “Connecticut Regulated Waste” (even though the state’s Department of Energy and Environmental Protection has concurrently established a stakeholder group to develop regulations to manage pharmaceutical waste in a different manner – as “universal waste”). “Connecticut Regulated Waste” is subject to the same storage requirements as RCRA hazardous waste and must be transported and disposed by state-permitted vendors.
Michigan, in contrast, regulates pharmaceutical waste as “universal waste,” which designation entails handling and disposal requirements greater than those applicable to non-hazardous solid waste but lesser than those applicable to RCRA hazardous waste. Moreover, Michigan distinguishes between various types of pharmaceutical waste (such as “bulk hazardous pharmaceutical waste” and “non-hazardous pharmaceutical waste”), each of which carries different requirements and has resulted in state regulation of more than 150 wastes in addition to RCRA-wastes. Florida, too, has a Universal Pharmaceutical Waste Rule, but the rule itself is not as straightforward as it might seem, since numerous pharmaceuticals have special exemptions and handling requirements within the state. Of course, these state-specific requirements become even more complicated when pharmaceutical waste is transported through or managed in multiple states, compounding the attention pharmacy retailers and health care facilities must pay to nuanced state regulations.
EPA has expressed that one of the goals of the current pharmaceutical waste rule-making is to promote consistency of pharmaceutical waste handling and disposal requirements. As is evident to regulators and the regulated community alike, this consistency is sorely needed. The pending proposed rule is expected to be published in December 2014 and the final rule could become effective around mid-2016. In the meantime, retail pharmacies, other healthcare facilities, and reverse distributors will have to continue working through the constantly evolving regulatory patchwork.
Ted Wolff is a partner in Manatt, Phelps & Phillips’ New York office and focuses his environmental practice on litigation and transactional work. He regularly counsels clients on compliance with environmental laws, including those that regulate the handling, storage, treatment and disposal of hazardous substances and waste. Mr. Wolff can be reached at (212) 790-4575 or email@example.com.
Matthew Dombroski is an associate with Manatt, Phelps & Phillips in New York and regularly counsels clients on environmental matters relating to corporate and regulatory compliance. Mr. Dombroski can be reached at (212) 790-4556 or firstname.lastname@example.org.
This column is part of a series of articles by law firm Manatt, Phelps & Phillips, LLP’s Energy, Environment & Natural Resources practice. Earlier columns in the fourth edition of this series discussed Measures to Address Drought Conditions, Guidance Pending from NEPA on Climate Change, California’s Proposed Overhaul of Standards for Transportation-related Environmental Impact Analysis, CPUC’s Energy Storage Rulemaking, EPA’s Proposed Rule for Reducing Carbon Emissions from Power Plants, Nanomaterial Safety Research Plans, the Obama Administration’s Plans to Reduce Methane Emissions, US Ban on Oil Exports and Environmental Risks in Buying Contaminated Properties.
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