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.
“Most of the pharmaceutical rule is good news,” said Elise Paeffgen, attorney in Alston & Bird’s Environment, Land Use & Natural Resources Group. “But there are particular components of the rule that healthcare facilities, manufacturers and reverse distributers should closely examine and comment on as it affects their business.”
Paeffgen also warned that without a state preemption provision in the EPA’s pharmaceutical waste rule, the regulation opens the door for states to be more stringent, potentially creating a patchwork of regulations.
“States may retain or add elements that are stricter or broader in scope than the proposed federal rules,” said Paeffgen. “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.”
The proposed rule would create a sector-specific regulatory framework, meaning that some healthcare facilities will avoid being classified as large quantity generators (LQGs) and will not be bound by all the stringencies of a Resource Conservation and Recovery Act (RCRA) permit.
“The exclusion will enable many healthcare facilities to shift to the smaller generator category with a lower regulatory burden,” said Paeffgen. “It’s tailored to how reverse distributors operate in terms of management and accumulation of waste pharmaceuticals and would reduce storage and labeling requirements onsite for a reverse distributor.”
One change it will create, Paeffgen noted, is a more stringent 90-day accumulation requirement.
“Under the current rule the 90-day accumulation clock starts after the reverse distributor makes a determination for obtaining credit from the manufacturer for returning unused items,” she said. “Under the new proposal, the clock would start as soon as the unused items comes through the door of the reverse distributor, effectively preventing most of the ‘aging’ process that reverse distributors often do, wherein they withhold a credit determination until an item has expired.”
Paeffgen also agrees with the EPA’s decision to include a sewer ban on all hazardous waste pharmaceuticals, as long as other changes in the rule are adopted.
“Depending upon how quickly states move to implement the rules, the proposed rule could create a gap of up to a year or more between when the sewer ban becomes immediately effective and when hazardous waste pharmaceutical containers will become exempt from so-called RCRA-empty requirements, which often involve rinsing containers and pouring that rinsate down the drain.”
“The most profound aspect of the changes to the hazardous waste generator rule being proposed is how wide-ranging it is,” said Jonathan Wells, partner in the firm’s Environment, Land Use & Natural Resources Group in Atlanta. “In general, it substantially increases the regulatory workload for recordkeeping, training and changes to contingency plans for LQGs.
“The proposed rule’s allowance for companies to maintain their smaller generator status if they have an episodic generation of waste that exceeds the small quantity limits should be a big relief for environmental managers of small generators,” he added. “For example, this could be helpful to a retail outlet that has an accidental spill.”
“Most of the pharmaceutical rule is good news,” said Elise Paeffgen, attorney in Alston & Bird’s Environment, Land Use & Natural Resources Group. “But there are particular components of the rule that healthcare facilities, manufacturers and reverse distributers should closely examine and comment on as it affects their business.”
Paeffgen also warned that without a state preemption provision in the EPA’s pharmaceutical waste rule, the regulation opens the door for states to be more stringent, potentially creating a patchwork of regulations.
“States may retain or add elements that are stricter or broader in scope than the proposed federal rules,” said Paeffgen. “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.”
The proposed rule would create a sector-specific regulatory framework, meaning that some healthcare facilities will avoid being classified as large quantity generators (LQGs) and will not be bound by all the stringencies of a Resource Conservation and Recovery Act (RCRA) permit.
“The exclusion will enable many healthcare facilities to shift to the smaller generator category with a lower regulatory burden,” said Paeffgen. “It’s tailored to how reverse distributors operate in terms of management and accumulation of waste pharmaceuticals and would reduce storage and labeling requirements onsite for a reverse distributor.”
One change it will create, Paeffgen noted, is a more stringent 90-day accumulation requirement.
“Under the current rule the 90-day accumulation clock starts after the reverse distributor makes a determination for obtaining credit from the manufacturer for returning unused items,” she said. “Under the new proposal, the clock would start as soon as the unused items comes through the door of the reverse distributor, effectively preventing most of the ‘aging’ process that reverse distributors often do, wherein they withhold a credit determination until an item has expired.”
Paeffgen also agrees with the EPA’s decision to include a sewer ban on all hazardous waste pharmaceuticals, as long as other changes in the rule are adopted.
“Depending upon how quickly states move to implement the rules, the proposed rule could create a gap of up to a year or more between when the sewer ban becomes immediately effective and when hazardous waste pharmaceutical containers will become exempt from so-called RCRA-empty requirements, which often involve rinsing containers and pouring that rinsate down the drain.”
“The most profound aspect of the changes to the hazardous waste generator rule being proposed is how wide-ranging it is,” said Jonathan Wells, partner in the firm’s Environment, Land Use & Natural Resources Group in Atlanta. “In general, it substantially increases the regulatory workload for recordkeeping, training and changes to contingency plans for LQGs.
“The proposed rule’s allowance for companies to maintain their smaller generator status if they have an episodic generation of waste that exceeds the small quantity limits should be a big relief for environmental managers of small generators,” he added. “For example, this could be helpful to a retail outlet that has an accidental spill.”