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Pharmaceutical drugs

Will This EPA Strategy Ease Hazardous Waste Compliance Burdens for Retailers?

Pharmaceutical drugsHazardous waste violations cost Whole Foods more than $3.5 million last month. The hazardous waste products in question? Nail polish remover, hand sanitizer, liquor and vitamins, the retailer said.

These and other every-day items are classified as hazardous waste when they can no longer be used for their intended purpose — for example, when a customer returns these products, which means retail stores can no longer resell them.

Currently retailers must comply with the same hazardous waste rules as, say, chemical manufactures. This poses compliance challenges for retailers, which aren’t managing toxic substances in an industrial setting but still must obey these laws when managing goods such as batteries and household cleaners that are hazardous wastes when disposed.

To address this disconnect between rigorous federal hazardous waste rules and their real-world use, the EPA has proposed a Retail Strategy to help companies in the retail sector better identify and manage hazardous waste and reclassify some products as non-acutely hazardous, among other actions.

In a blog about the retail strategy, EPA assistant administrator Mathy Stanislaus says that while the agency’s hazardous waste rules were primarily developed for industrial and manufacturing settings, they also apply to hospitals, schools, retail stores and other facilities that generate even small amounts of hazardous waste. The strategy takes steps to “ease the burden of managing hazardous wastes in a retail setting while maintaining important protections to human health and the environment,” Stanislaus writes.

These steps include:

Pharmaceutical reverse distributors are entities that help healthcare facilities calculate and receive credit from pharmaceutical manufacturers when healthcare facilities have unused pharmaceuticals that they no longer need.

Retailers and healthcare facilities such as pharmacies send their unused pharmaceuticals to a reverse distributor, which then works with the pharmaceutical manufacturer to facilitate providing manufacturer credit back to the healthcare facility. Then the pharmaceutical reverse distributor sends the waste pharmaceuticals for safe disposal in accordance with hazardous waste management rules.

In an advisory on the EPA’s Retail Strategy, Elise Paeffgen, an attorney in Alston & Bird’s Environment, Land Use & Natural Resources Group, explains why retailers and pharmacies should pay close attention to the policy on reverse distribution.

Historically the EPA’s policy has been that pharmaceuticals do not become waste until after a reverse distributor evaluates it for credit and makes a disposal determination. The agency’s proposed Management Standards for Hazardous Waste Pharmaceuticals Rule, however, would consider the retailer or health care facility — not the reverse distributor — to be the “point of generation” for the pharmaceuticals, meaning the retailers would be responsible for hazardous waste management of these products.

Paeffgen says the Retail Strategy “appears to recognize these concerns,” but retailers should still provide input to the agency.

“EPA will craft its Policy on Reverse Distribution and RCRA around its understanding of the flow of retail goods and the relationships between entities that manage goods and wastes, as shown in this EPA-created diagram,” Paeffgen writes. “All players in the retail system should carefully review the diagram and provide comments and points of clarification to EPA.”

In an interview, Paeffgen said she expects the EPA’s Retail Strategey will help ease the compliance burden on retailers.

“Right now all retailers have to comply with the same regulations that apply to manufacturers or heavy industry,” she said. “It really doesn’t fit well for this sector. With their Retail Strategy, the EPA has recognized that it’s almost like putting a square peg in a round hole.”

Paeffgen said the Hazardous Waste Generator Improvements Rule, in particular, has advantages to retailers. “For example, if you are a retail drug store that gets some product returned, or a Home Depot or Lowes that gets paints or some hazardous materials returned in small quantity, this rule would allow them to send their waste to anther locations that’s under the same management without triggering individual requirements for that store.”

Another advantage is for “episodic generation,” she said. “If there is, say, a spill at a retail store, that would not trigger the really stringent requirements like it would right now under outdated RCRA regulations.”


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