The Environmental Protection Agency (EPA) recently proposed changes to two hazardous waste regulations that more clearly define standards governing how companies in the health care sector – including pharmaceutical manufacturers, hospitals, retail pharmacies, veterinary clinics and reverse distributors – identify and manage waste.
Jonathan Wells, partner in Alston & Bird’s Environment, Land Use & Natural Resources Group, said the agency’s proposed rule indicates a renewed focus by the EPA on its compliance monitoring and enforcement of the Resource Conservation and Recovery Act regulations relating to pharmaceuticals.
One proposed rule gives generators of hazardous waste more flexibility in managing waste.
“The proposed rule is a welcomed relief to much of the industry,” Wells said. “[Both rules] will remove traditional manufacturing-based hazardous waste generator requirements that have been inappropriate for the health care sector, changing regulations that have been in place for decades.”
Elise Paeffgen, attorney in the firm’s Environment, Land Use & Natural Resources Group in Washington, D.C., also highlighted the potential impact at the state level.
“While the proposed rules do much to ease compliance burdens and level the playing field, the uncertainty of state-by-state regulation in this area remains,” she said. “Under the proposed rule, states have the option of adding elements to their programs that are more stringent or broader in scope than the new proposed rule. Instead, a level playing field nationwide would ease implementation through uniform application of federal law.”