Richard Sieg, Regulatory Counsel, Inmar
The U.S. Environmental Protection Agency (EPA) released some much-anticipated new-rule information that could go a long way toward easing the hazardous-waste burden for retailers, who have long been forced to crudely adapt to old industrial rules.
On Monday, September 4, 2015, the EPA released pre-publication versions of two new proposed rules: The long-awaited “Management Standards for Hazardous Waste Pharmaceuticals” (“Pharmaceutical Proposal”) and the “Hazardous Waste Generator Improvements Rule.”
The first proposed rule seeks to adjust the hazardous waste regulation framework to better consider healthcare operations, including retailers (e.g., pharmacies). The latter proposal, among other things, is intended to ease the burden for episodic generators of hazardous waste, such as retailers. The bulk of this article discusses the Pharmaceutical Proposal.
You may wonder why we are taking time to discuss the new Pharmaceutical Proposal in a supply-chain newsletter. The answer lies within the proposal’s definition of “pharmaceutical”:
Pharmaceutical means any chemical or biological product that is intended for use in the diagnosis, cure, mitigation, care, treatment, or prevention of disease or injury of a human or other animal; or any chemical or biological product that is intended to affect the structure or function of the body of a human or other animal. This definition includes, but is not limited to: dietary supplements as defined by the Federal Food, Drug and Cosmetic Act, prescription drugs, over-the-counter drugs, residues of pharmaceuticals remaining in containers, personal protective equipment contaminated with pharmaceuticals, and clean-up material from spills of pharmaceuticals. – P. 233 of Pharmaceutical Proposal (emphasis added).
The Preamble to the proposal provides additional insight. As a rule of thumb, products with “drug facts” on the label should be considered a “pharmaceutical.” This proposal includes foods as well as drugs in the definition of pharmaceutical. In other words, pharmaceuticals, that when discarded are defined by federal rules to be hazardous waste, would have to be managed in accordance with the requirements of this rule.
This situation most commonly would arise when certain concentrations of selenium or chromium is present in a dietary supplement, etc., or when the retailer knows that chromium or selenium is in the product, but it does not know the concentration (EPA interpretations indicate that generators of waste, in the absence of sufficient information, must err on the side of calling such products federal hazardous waste).
Remembering the history of this rule-making effort is important to understand why EPA proposed this very broad definition. Originally, EPA considered a universal waste regulatory approach for the management of pharmaceuticals. Universal waste approaches have less rigorous management requirements and many of the stakeholders requested that EPA define pharmaceutical as broadly as possible. However, under this new proposed framework, the broad definition may significantly impact retail pharmacies, manufacturers and others.
EPA understands that legend drugs (e.g., prescription drugs), when returned through reverse logistics, are destined for disposal (e.g., incineration). According to EPA, this is a departure from the agency’s understanding of what was happening at the time it developed guidance documents stating that pharmaceuticals with potential value (e.g., potential manufacturer’s credit) were not waste until the reverse logistics provider evaluated the pharmaceutical for credit.
Because it is generally understood that these pharmaceuticals are destined for destruction, EPA has shifted the point of generation of hazardous waste pharmaceuticals to the retailer. Under that designation, the retailer must manage even potentially creditable pharmaceuticals that would be federally hazardous when discarded as hazardous waste at the store.
In light of these developments, it is important for those in the supply chain to understand what EPA is proposing and provide comments on this proposal. Dietary supplements containing chromium and/or selenium may be federally hazardous waste, when discarded.
In the retail supply chain, the presumption simply does not hold true that over-the counter-drugs, dietary supplements or “drug fact” items are destined for disposal. These may be liquidated or donated and therefore it should not be mandatory for retailers to manage them as a waste at the retail store. Importantly, if this proposal is finalized as written, the procedures are mandatory for pharmacies and others.
EPA is working on similar rule-making for consumer products at retailers, but the agency is well aware that the above assumption is not true for them. While we do not know how EPA will handle the point of generation issue for consumer products, we believe there is a very strong argument that these products should remain as non-waste at the retail store.
It would make more sense if EPA narrowed the definition of pharmaceutical for this rule and allowed over-the-counter drugs, dietary supplements or “drug fact” items to be regulated under the consumer product rule – under the presumption that these items may be liquidated or donated to the secondary market. This distinction is important because this would mean that the products would not be deemed waste at the retailer – they are still products, with useable remaining product life cycle. Also, if any of these consumer products are sent for recycling (reclamation) by the reverse distributor under the federal regulation, they would not be solid wastes even when they leave the reverse distribution facility for the recycler.
We suggest that this proposal would have unnecessary impacts to retailers and manufacturers. If you agree, we believe that you may wish to provide EPA comments on this proposed rule.
What do you think about the new proposed EPA rules? Reach out to Richard by email at Richard.Sieg@inmar.com