December 16, 2019

EPA Reaffirms Position on Reverse Distribution Versus Reverse Logistics

When EPA promulgated its hazardous waste pharmaceuticals rule in February 2019, a significant portion of the rule and associated preamble was dedicated to discussing reverse distribution versus reverse logistics. This part of the rulemaking fulfilled the agency’s commitment to addressing RCRA applicability to unsold retail items. Amongst other things, the rule:

  1. Codified regulations for the reverse distribution of prescription hazardous waste pharmaceuticals,
  2. Codified EPA’s long-standing position on reverse logistics for nonprescription pharmaceuticals, and
  3. Established the agency’s policy on reverse logistics for other unsold retail items (i.e., nonpharmaceuticals).

EPA issued RO 14915 to reaffirm its stance on these issues.

Reverse distribution of prescription hazardous waste pharmaceuticals

The pharmaceuticals rule clearly states that prescription hazardous waste pharmaceuticals going through reverse distribution are solid waste starting at the healthcare facility. The reverse distribution process determines if manufacturer credit will be issued for the unused pharmaceuticals. However, while collecting information during the pharmaceuticals rulemaking, EPA found that pharmaceuticals undergoing reverse distribution seldom, if ever, are legitimately used/reused or reclaimed. Even when these pharmaceuticals are sent for potential manufacturer credit, they are expected to be ultimately destroyed. Thus, EPA’s new policy, codified in the 2019 final rule, is that once the decision is made to send a prescription pharmaceutical from a healthcare facility to a reverse distributor, a decision to discard has been made and the pharmaceutical is considered a solid and potentially hazardous waste.

Reverse logistics for nonprescription pharmaceuticals

In the 2019 rule’s definition of “hazardous waste pharmaceutical,” nonprescription pharmaceuticals are not solid waste if they have a reasonable expectation of being legitimately used/reused or reclaimed. Section 266.501(g)(2) clarifies that these legitimately recycled nonprescription pharmaceuticals are not subject to Parts 260273. In this scenario, the healthcare facility sends unused nonprescription pharmaceuticals to a reverse logistics center for evaluation as to their use, reuse, or reclamation. Thus, the healthcare facility is legitimately recycling the pharmaceutical, and it is the reverse logistics center which decides, after evaluation, whether the item will ultimately be recycled or disposed. Therefore, the point of solid waste generation for nonprescription pharmaceuticals that cannot be legitimately recycled is at the reverse logistics center.

Reverse logistics for nonpharmaceutical retail items

In a similar vein to the above, unsold nonpharmaceutical retail items are not solid waste at the retail store if they have a reasonable expectation of being legitimately used/reused or reclaimed. Again, the point of generation of a solid waste in this situation is at the reverse logistics center—not the retail store. While these materials sent through reverse logistics are not waste at the retail store, EPA affirms its expectation that these materials be packaged in a manner to prevent a release into the environment. Additionally, any broken or leaking items are to be managed as solid and potentially hazardous waste.

 


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This document addresses issues of a general nature related to the federal RCRA regulations. Persons evaluating specific circumstances dealing with the RCRA regulations should review state and local laws and regulations, which may be more stringent than federal requirements. In addition, the assistance of a qualified professional should be enlisted to address any site-specific circumstances.