Richard Sieg, Inmar Regulatory Counsel
Had enough of fitting a square peg into a round regulatory hole? There may be hope on the horizon. Regulators are beginning to move toward rules that better address the true hazardous waste issues in retail and away from the force-fit of making retailers comply with rules written for industrial scenarios.
On March 19, 2015, the U.S. Environmental Protection Agency (EPA) submitted two rules to the Office of Management and Budget (OMB) for its review. These two hazardous waste regulations have the potential to ease some burdens placed on the retail industry.
First, EPA’s long-awaited Management Standards for Hazardous Waste Pharmaceuticals Rule, RIN 2050-AG39, is intended to modify the manufacturing-oriented requirements to be a better fit for retail (e.g., pharmacies) and other healthcare environments.
Under the current regulatory scheme, professionals in these environments must manage thousands of items in the formulary, making waste characterization a challenge at best, trying to fit retail waste characterization into rules written for manufacturing. Some of you will recall that EPA proposed a similar rule in 2008, but that effort lost traction when adverse comments were received. EPA representatives say that those concerns are addressed in this most recent proposal.
Did you know you’re a generator? In hazardous waste regulation, the term refers to generation of waste. The second hazardous waste rule is intended to make changes to “the hazardous waste generator regulatory program to improve its clarity and effectiveness.” The Hazardous Waste Generator Improvements Rule, RIN: 2050-AG70, may require additional information for labels; the intention is to better communicate risks associated with a waste.
Importantly, this rule is advertised as providing a generator with more flexibility, especially in those current situations when a generator triggers a more stringent generator status because of an episodic event. OMB has 90 days to review these rules but may extend its review for 30 days. Assuming OMB keeps within this timeframe and does not send it back to EPA for reconsideration, we may expect EPA to publish these proposed rules this summer.
EPA has a third initiative underway that the retail supply chain should embrace as well. EPA is following up on its “Notice of Data Availability (NODA) Hazardous Waste Management and the Retail Sector.” This effort is critically important, as EPA may comprehensively resolve the complexities retailers face in managing consumer products under a regulatory compliance scheme designed for manufacturers.
Retailers do not generate drums of hazardous waste from manufacturing processes. The risks of managing unsold or returned products in the retail sector are simply not comparable to the risks existing in the industrial sector. Instead, non-leaking consumer products in original packaging are managed for potential use, recycling and disposal.
EPA can solve the problems associated with the management of consumer products containing nicotine and products in aerosol cans. Is it really necessary for a retail store to be deemed a large quantity generator because it sells nicotine-containing consumer products? EPA should also create an equally protective regulatory scheme for the management of unsold and returned products, written to more appropriately address the actual waste realities common to retail.
Inmar continues to participate in the effort with its partners to educate the EPA and other agencies about actual supply chain challenges and the benefits of reverse distribution as a tool in more cost-effective compliance. We are walking the talk as EPA seeks to gather information it can use to better understand the retail environment.
Collaboration among manufacturers, distributors, retailers, reverse distributors and the retail associations is critical. We believe that reasonable regulation of retail will reduce costs, improve the carbon footprint, improve the environment and create a regulatory scheme that is more manageable for the federal and state regulators. But it’s up to us to demonstrate these benefits to them. Please join us in this effort.
What do you think? Questions or comments for Richard? Contact him at

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