Ohio EPA initiates rulemaking process for hazardous waste pharmaceuticals



On May 6, 2019, the Ohio EPA Division of Environmental Response and Revitalization issued an early stakeholder outreach public notice, through which it seeks stakeholder input on Ohio EPA’s intent to incorporate recent federal rulemakings on hazardous waste pharmaceuticals into Ohio’s rules.    

As the first step in the rulemaking process, Ohio EPA’s public notice demonstrates to the public that Ohio EPA has identified the need for rules to be amended, rescinded or created, and will allow early feedback from interested parties before proceeding with developing rule language.

The changes that Ohio EPA is considering are being driven by the creation of counterpart provisions in federal law. Specifically, on February 22, 2019, US EPA published its final rule governing hazardous waste pharmaceuticals, which is scheduled to become effective August 21, 2019. Ohio EPA asserts that while it has yet to determine which provisions of the federal rule it will propose for adoption, some provisions will be optional for Ohio to adopt, whereas others will be required to adopt (namely, those that are more stringent than Ohio’s current rules). 

Ohio EPA represents that US EPA’s rule is intended to establish cost-savings, as well as streamlined standards for handling hazardous waste pharmaceuticals to better fit the operations of the health care sector while maintaining protection of human health and the environment. Ohio EPA references a growing body of publicly available studies documenting the presence of pharmaceuticals in drinking and surface waters and their negative impacts on aquatic and riparian ecosystems. Additionally, Ohio EPA notes that under US EPA’s final rule, FDA-approved, over-the-counter nicotine replacement therapies such as nicotine patches, gums and lozenges will no longer be considered hazardous waste when discarded, resulting in significant cost savings and a burden reduction in the management of these types of nicotine wastes.

Ohio EPA predicts that anyone currently regulated by Ohio’s hazardous waste management rules, such as a health care facility or reverse distributor managing hazardous waste pharmaceuticals, will potentially be affected by these new rules. 

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