RCRA requirements would ease under pharmaceutical proposal
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September 28, 2015
RCRA requirements would ease under pharmaceutical proposal

The generation of pharmaceutical hazardous waste and pharmaceutical acute hazardous waste in healthcare facilities has presented a unique management challenge to this business sector as well as to the solid waste regulators at the EPA.  After one failed try in 2008 to include pharmaceutical hazardous waste in the federal universal waste rule (UWR), the Agency has now stepped up with an entirely different proposed approach that focuses more closely on the unique aspects of pharmaceutical waste generation in healthcare facilities and the limited abilities of those entities to understand and comply with Resource Conservation and Recovery Act (RCRA) regulations. 

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The proposal would require manifesting of pharmaceutical waste shipments.  That tracking requirement was not included in the UWR proposal, the main reason the EPA decided not to act on that proposal.

Water pollution

Pharmaceutical wastes and unused pharmaceutical products are widely disposed of “down the drain.”  Most of this disposal occurs in residences and is virtually impossible to regulate.  The practice also occurs in hospitals, pharmacies, veterinary clinics, and the very wide range of healthcare facilities in the United States.  The consequence is that various pharmaceutical active ingredients and metabolic by-products have been detected in surface waters and groundwater in the United States.  

EPA’s efforts to address the problem have been complicated because healthcare facilities differ in critical ways from industrial waste generation for which RCRA was mainly written.  EPA’s proposed solutions to several of the key differences are described below.

Determinations

Under RCRA, generators are responsible for determining if their wastes are listed hazardous wastes or if they exhibit a hazardous waste characteristic.  Determinations must be made at the point of generation.  It is not unusual for a healthcare facility to house thousands of different pharmaceutical products and, therefore, generate thousands of different wastes.  Also, generation typically occurs at the patient’s bedside; hence, doctors, nurses, and other healthcare workers are expected under the standard RCRA approach to make the hazardous waste determination.  The EPA has recognized that these individuals are not trained to make such determinations, nor should they be expected to do so when their responsibility is to care for patients.

Under the proposal, when a healthcare facility generates a solid waste pharmaceutical, the facility would still be required to determine if the pharmaceutical waste is a listed hazardous waste or if it exhibits one or more of the four characteristics of hazardous waste.  The proposal would still require that healthcare facilities make these determinations but would provide various options for doing so.  For example, the healthcare facility would not need to identify the specific waste codes applying to the pharmaceutical waste.  This would allow workers to dispose of all pharmaceutical waste into one hazardous waste container.  Manifesting will still be required for transport, but no hazardous waste codes would need to be listed on the manifest.

The EPA has also developed a Hazardous Waste Pharmaceuticals Wiki as a platform to facilitate the sharing of expertise among the healthcare industry and other stakeholders to help make accurate hazardous waste determinations for waste pharmaceuticals and increase compliance with the hazardous waste regulations.

Creditable pharmaceuticals

The proposal would establish a new hazardous waste entity called pharmaceutical reverse distributors.  These are entities that help healthcare facilities calculate and receive credit from pharmaceutical manufacturers when healthcare facilities have unused pharmaceuticals they no longer need.  Under the proposal, reverse distributors would not be considered either hazardous waste generators or treatment, storage, and disposal facilities (TSDFs), provided they only accumulate (that is, they do not treat) potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals. 

The Agency is proposing to allow healthcare facilities to continue to send potentially creditable hazardous waste pharmaceuticals to pharmaceutical reverse distributors for processing manufacturers’ credit.

Accumulation

In contrast to industrial facilities, healthcare facilities generate small amounts of pharmaceutical hazardous waste.  But some pharmaceutical wastes are acute hazardous wastes.  Under RCRA, entities that generate more than 1 kilogram (kg) of acute hazardous waste per calendar month are large quantity generators (LQGs) subject to stringent requirements, including a 90-day limit on accumulating the acute hazardous waste on-site.  Under these circumstances, healthcare facilities must arrange to transport relatively small amounts of waste for disposal or to pharmaceutical reverse distributors.

Thus, the Agency is proposing to allow healthcare facilities to accumulate hazardous waste pharmaceuticals for up to 1 year without having a RCRA TSDF permit.  This flexibility would apply only to noncreditable hazardous waste pharmaceuticals and not to any other types of hazardous waste generated on-site; it would not apply to potentially creditable hazardous waste pharmaceuticals.

Other parts of the proposal include a conditional exemption for hazardous waste pharmaceuticals that are also Drug Enforcement Administration controlled substances and management standards for hazardous waste pharmaceutical residues remaining in containers.

The proposal was published in the Federal Register on September 25, 2015.

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