Richard Sieg, Regulatory Counsel, Inmar
The Environmental Protection Agency (EPA) is loading stakeholder comments into the regulatory dockets for the proposed rule for Management of Hazardous Waste Pharmaceuticals. Our review of comments posted thus far indicates some common themes that support retailers’ needs to change the rules to more appropriately fit the retail reverse logistics environment.
For starters, let’s be clear that there are some considerations on which regulatory agencies and companies/organizations agree. Perhaps the most common theme is that a sector-specific approach for managing hazardous waste pharmaceuticals is critically needed. This is reflected a number of comments, including those from CVS Health, Costco, Walmart, Oklahoma Department of Environmental Quality (DEQ), Joint Associations, Healthcare Distribution Management Association (HDMA) and Inmar. You can read all of the comments posted so far at theEPA web site.
There is some alignment among many commenters that EPA could establish one standard for all pharmaceuticals, with Oklahoma DEQ saying so directly in its comments. Several retailers and Inmar suggest creating a conditional exclusion to the definition of solid waste for pharmaceuticals being returned to reverse distributors. This would keep in place EPA’s longstanding interpretation that “potentially creditable” hazardous waste pharmaceuticals (HWPs) are not wastes until the reverse distributor deems them so. Unfortunately, the current proposed rule abandons this longstanding interpretation.
Regulations need to move away from the concept that a healthcare facility, retailer or wholesale distributor sending consumer products and drugs back through reverse logistics is held responsible for what someone does with it farther down the line.
Comments by retailers show that such a presumption is simply incorrect for consumer product – like HWPs (OTC products and dietary supplements) that would be regulated under this rule as it stands in the proposal. Both Walmart and CVS Health state well in their comments that this presumption is not appropriate for OTC meds and dietary supplements.
The process of reverse distribution developed for a reason. Walmart states it very well in their comment: “Even in the case of prescription pharmaceuticals sent through reverse distribution for auditing and credit, the point of discard is at the supplier or the reverse distributor, and occurs only after the legitimate business use of the product comes to an end and only when the supplier or reverse distributor actually discards the pharmaceuticals or stores them for the purpose of discarding them.”
Inmar’s comments raise these and many other issues. The proposal, if adopted similar to its current form, would institute burdensome security, tracking and inventory requirements without a achieving any additional substantive protection of human health and the environment. Reverse distributors of prescription drugs are already heavily regulated by state boards of pharmacy, DEA, FDA and others. For consumer product-like HWPs, products such as multivitamins and energy bars simply don’t carry the same risk of theft as prescription drugs. Additionally, the proposed additional pedigree-like and certain other regulatory requirements for managing HWPs simply are not warranted for consumer products in the healthcare and retail environments.
Inmar is encouraged by the comments submitted to the agency by supply chain stakeholders. We believe that if EPA heeds these comments, they will be a step forward for the agency in the evolution of these regulations. EPA can learn a lot about the supply chain, including reverse distribution, and apply what they’ve learned to any future rule-making effort.
The American Society of Health-System Pharmacists points out in its comments that pharmacists struggle to interpret the Resource Conservation and Recovery Act (RCRA) regulations for the situations that arise in the healthcare setting. Those rules were originally developed for industrial waste environments, and are a major challenge to interpret in non-industrial settings.
This is another universal theme – the current regulatory framework, applied in the healthcare and retail settings, is a square peg in a round hole. We hope EPA takes full advantage of this opportunity and creates a sector specific approach that fits well in these environments.
References (click a link to see each specific comment document):
OK DEQ (Oklahoma Department of Environmental Quality), Dec. 23, 2015
Costco, Dec. 18, 2015
CVS Health, Dec. 23, 2015
Wal-Mart, Dec. 24, 2015
Joint Associations (RILA, FMI, NACDS, NRF, NGA)
HDMA, Dec. 21, 2015
Inmar, Dec. 24, 2015