EPA delays issuance of final hazardous waste pharmaceuticals rule




By Jennifer Cave

The United States Environmental Protection Agency’s (EPA) final hazardous waste management standards for waste pharmaceuticals will not be published in 2016 as previously projected.   EPA received nearly 200 comments on its Proposed Management Standards for Hazardous Waste Pharmaceuticals Rule, 80 Federal Register 58014 (September 25, 2015).  EPA is working to address the policy implications raised in the comments before it publishes the final rule now expected in 2017.

The proposed rule making is seen by the agency, and by many stakeholders, as an attempt to streamline the management of waste pharmaceuticals generated by healthcare facilities, including hospitals, clinics, pharmacies and reverse distributors.  The proposed rule would regulate pharmaceutical wastes discarded from healthcare facilities (and incinerated, discharged into sewers, or disposed of in landfills) and sent to reverse distributors; i.e., handlers of pharmaceuticals returned to the manufacturer for credit.

The proposal would eliminate many of the Resource Conservation and Recovery Act (RCRA) hazardous waste generator requirements currently applicable to pharmaceutical wastes and would utilize a sector-based approach with unique waste management requirements tailored to specific types of healthcare facilities.

            Suitable for Healthcare Facilities

In developing the proposal, EPA recognized the RCRA hazardous waste regulations were developed for industrial and manufacturing applications and are not well-suited to healthcare facilities and reverse distributors.  Under RCRA, a material becomes a solid waste when it is “discarded.”  The entity making the decision to discard becomes a generator of solid waste and is then required to determine whether the solid waste is also a RCRA hazardous waste.  Thus, the point of waste generation is key to triggering RCRA liability.

Historically, EPA took the position that a pharmaceutical did not become a waste until after a reverse distributor evaluated the drug for credit and made a disposal determination.  Under the proposed rule, however, potentially creditable hazardous waste pharmaceuticals would be considered solid waste when the healthcare facility determined that the material would be directed to a reverse distributor.  The healthcare facility would then be considered the “point of generation” under the hazardous waste management rules.

Many comments on the rule criticized the provision that would classify all pharmaceuticals—including unopened, unused, and those that have not yet expired—as “waste” when sent to a reverse distributor.  EPA has thus far failed to explain how the current practice endangers public health and the environment warranting a change in policy.   If the rule goes into effect as proposed and the current policy is eliminated, reverse distributors will face greater burdens managing their pharmaceutical waste streams.

Other comments criticized the rule’s proposal to remove waste codes for pharmaceuticals on RCRA manifests.  Comments from the commercial hazardous waste management industry indicated that compliance with hazardous waste classification requirements should remain with the generator of the waste and not be shifted to waste management facilities.

Comments generally praised the rule’s proposals to amend the current classification of low concentration nicotine products as acutely hazardous waste; to provide a conditional exemption for hazardous waste pharmaceuticals that are also controlled substances because Drug Enforcement Administration (DEA) rules govern their disposal; to ban disposal of pharmaceuticals in sewer discharges; and to exempt pharmaceuticals managed pursuant to the rule’s waste management standards from counting toward a facility’s hazardous waste generator status.

Until the new rule is finalized, the generation, treatment, storage and disposal of hazardous waste pharmaceuticals will continue to be regulated under current RCRA regulations.   RCRA subjects generators of hazardous waste pharmaceuticals to certain accumulation limits as well as manifesting and disposal requirements.   The failure of hazardous waste generators to comply can lead to legal and administrative actions, civil and criminal liability, fines and other costs.  EPA recently raised the maximum civil penalty for certain RCRA violations to $70,117 per day, per violation.

EPA has found that generators, including healthcare facilities, often misreport their generator status and under-report the quantity of hazardous wastes generated at their facilities.  As a result, EPA is taking a series of enforcement actions against generators, claiming that their waste generator status should be re-categorized and penalizing them for improperly reporting the types and quantities of waste generated. Notably, some of the sources caught in these enforcement actions—hospitals and laboratories in particular—are not those typically involved in businesses associated with generating large volumes of hazardous waste.  As such, it is critical that healthcare facilities review the types and quantities of hazardous waste they generate, and ensure they are in compliance with the RCRA requirements—in particular, correctly identifying their RCRA generator status and reporting protocols.  In addition, facilities should continue to stay abreast of impending changes to the hazardous waste regulatory landscape affecting healthcare facilities.

-Jennifer Cave is a Member at Stites & Harbison in Louisville, Ky.