EPA published today in the Federal Register its final rule governing hazardous waste pharmaceuticals.  This rule adopts a novel scheme under the Resource Conservation and Recovery Act (“RCRA”) for the management of hazardous waste pharmaceuticals that are discarded by healthcare facilities or managed by “reverse” distributors.  It also applies to other types of products such as e-cigarettes, liquid nicotine, and dietary supplements.

More broadly, EPA’s rule also has significant implications for companies conducting product safety recalls even outside of the pharmaceutical sector: the rule endorses an emerging EPA policy that recalled products are not waste under RCRA if they are subject to judicially or federal agency-imposed preservation obligations.  Not all recalled products contain “hazardous waste” that is subject to RCRA.  Only products that contain or are mixed with “listed” or “characteristic” waste would be considered hazardous waste under RCRA.  For that subset of products, this emerging EPA policy, which Covington attorneys helped secure, may allow companies engaged in recalls to avoid the application of RCRA through careful coordination with the agency overseeing the recall as well as EPA.

Companies have six months to come into compliance with the rule, which will become effective on August 21, 2019.  Once the rule becomes effective, EPA and states may pursue RCRA’s $37,500 per day penalty for each violation, underscoring the importance of compliance efforts before the rule becomes effective.  States may also develop and implement their own more stringent versions of this rule.  Aggrieved parties have 90 days to seek judicial review of EPA’s final rule.  42 U.S.C. § 6976(a)(1).

For a detailed assessment of the rule please see our January 8, 2019 analysis “EPA’s Final Hazardous Waste Pharmaceuticals Rule Has Significant Implications for Pharmaceuticals and Product Recalls.”