Richard Sieg, Regulatory Counsel, Inmar
As the future of pharmaceutical regulation continues to play out today in regulatory agency rule-making dockets, its evolution is also now before the United States Supreme Court. In its Spring 2015 Agenda, the United States Environmental Protection Agency (EPA) lists July 2015 as the expected publication date for the second Notice of Proposed Rulemaking (SNPRM) for the Management Standards for Hazardous Waste Pharmaceuticals. Meanwhile, with the Supreme Court declining to review the Alameda, CA case about drug-take-back programs, the entire regulatory landscape could potentially change.
Let’s look at the EPA effort first. EPA wishes to adjust the federal floor for regulating the management and disposal of hazardous waste pharmaceuticals “in order to provide a regulatory scheme that is adapted to the unique issues that hospitals, pharmacies and other health-related facilities face.” EPA is looking to clarify the role of reverse distribution for the return of pharmaceuticals (creditable, potentially creditable and non-creditable). The agency may also address how it views the intersection of EPA & DEA regulations in the management of pharmaceuticals. The Retail Industry Leaders Association (RILA) predicts that finalizing the Universal Waste Rule will make it easier for pharmacies to collect more pharmaceuticals and manage them in a safer and more streamlined manner.
The EPA’s adjustment of the federal floor is a good start. However, as you may know, the patchwork of state regulations makes it quite challenging, to say the least, to address compliance with both federal and state hazardous waste regulations. States may elect to make their regulations more stringent than the EPA rules and need not adopt an EPA rule establishing pharmaceuticals as a universal waste. If a state adopts the Universal Waste Rule, they may adopt it with modified requirements. The biggest challenges may arise within this difference between state and federal regulations. Hopefully, EPA’s selected approach of promoting “national consistency” will prove successful as each state evaluates how they will address the management of pharmaceutical hazardous wastes.
Meanwhile, the Supreme Court announced in late May it would not hear the challenge of Alameda County, California’s ordinance requiring manufacturers to pay for drug take-back programs in that county. This case could have a huge impact on drug manufacturers – with the potential for such hazardous material handling requirements cascading to other products (consumer products, etc.).
Product Stewardship Institute indicated in a May, 2015 presentation to the Environmental Law Institute, that there are 88 extended producer responsibility laws in 33 states. These laws regulate the management of electronic devices (24 laws), batteries (11 laws), paint (9 laws), certain bulbs (4 laws) and even include carpet and other products.
One cannot dismiss the possibility that this could serve as a catalyst for other laws, cascading to other products. As difficult as it is to navigate as a state-by-state patchwork of regulations, a county-by-county patchwork within the states would increase the complexities of compliance significantly for retailers operating stores in many counties in states with county-level regulatory authority.
It will remain to be seen what other regulations, at which levels, may spawn from this one.
Ask questions of Richard Sieg or share your thoughts by contacting him at Richard.Sieg@inmar.com.