Richard Sieg, Inmar Regulatory Counsel
All eyes should be turned toward Washington, D.C. as the U.S. Environmental Protection Agency (EPA) has submitted the second Notice of Proposed Rulemaking (NPRM) for Hazardous Waste Pharmaceuticals to the Office of Management and Budget (OMB) on March 19.
A previous NPRM, submitted in 2008, would have created a universal waste (UW) regulatory scheme to manage waste pharmaceuticals. However, that effort stalled because of stakeholder concerns that the proposal did not sufficiently address the tracking of shipments of hazardous waste pharmaceuticals (a drug-diversion issue) and the need for notification by most handlers managing hazardous waste pharmaceuticals.
The application of hazardous waste regulations created for the manufacturing environment in retail settings, including pharmacies, has created burdens on retailers that are well recognized. The NPRM submitted in March is an effort by EPA to better balance the hazardous waste regulatory requirements in the retail environment. It recognizes the actual, lesser risks at the retailer as compared to the manufacturing environment, which is the basis for the current rules being applied to retailers.
EPA has sent recent signals indicating how the proposal might look. In February, Kristin Fitzgerald from EPA Headquarters presented on the status of the future proposal at the California Unified Program Training Conference. During her presentation, Ms. Fitzgerald shared some clues as to what may lie ahead for rules regarding the return of pharmaceuticals.
First, Ms. Fitzgerald explained why this rulemaking was necessary. EPA has issued some clarifying guidance on some issues (see the “Clarifying Guidance) paragraph following the list below), but at least six regulatory issues, in the eyes of the agency officials, require rulemaking:Regulatory status of creditable pharmaceuticalsManufacturing-oriented framework of the generator regulationsLQG status due to P-listed hazardous waste (e.g., warfarin & nicotine)Intersection of EPA & DEA regulationsBetter fix for containers with P-listed pharmaceutical residuesPharmaceuticals being flushed/sewered
Clarifying Guidance: Epinephrine salts are not P-listed wastes, RCRA Online memo #14778, Oct. 15, 2007); Residues in partially-used syringes are not listed wastes, RO 14788, dated Apr. 14, 2008; Nicotine patches, gum, lozenges are P-listed when unused, RO 14817, Aug. 23, 2010; Limited fix for containers with P-listed pharmaceutical residues, RO 14287, Nov. 4, 2011; Phentermine salts are not P-listed wastes, RO 14831, Feb. 17, 2012; Household pharmaceuticals collected during take-back events should be incinerated, RO 14833, Sep. 26, 2012.
EPA has built on the prior proposal to create a sector-based proposal for the management of hazardous waste pharmaceuticals at healthcare facilities, pharmacies, and reverse distributors. Ms. Fitzgerald stated that EPA’s approach keeps aspects of the former UW proposal that were well received, addresses commenters’ concerns, promotes national consistency and addresses new areas that the old proposal did not. In prior discussions with Ms. Fitzgerald, she confirmed that reverse logistics, with checks and balances for identification and proper handling and disposition of hazardous waste, will be embraced as part of the solution.
The role that EPA intends to give reverse distributors will become clearer when the proposed rule is published. We are optimistic that EPA’s proposal will resolve issues retailers have raised and create a proposal where regulatory requirements are better balanced with the retail environment’s lesser risks to human health and the environment.
We can expect publication of the SNPR after the OMB 90-day review period is completed. The Fall EPA Regulatory Agenda projected a publishing date of June, 2015 for the proposed. After publication of the proposed rule, the next steps are:Completion of the public comment period.EPA will consider stakeholder comments as it works to finalize the rule.EPA will issue the Final Rule along with its rationale for its decisions. EPA’s. Office of Solid Waste and Emergency Response’s “Draft FY 2016-2017 National Program Manager’s Guidance” (Pub. Nr.: 530P15001 Feb. 23, 2015) estimates the rule will be finalized in FY 2016 and that significant outreach activities (webinars, etc.) will extend into FY 2017. For more information, call today at (866) 440-6917 or email email@example.com.