|Footnotes for this article are available at the end of this page.
While health care providers, including long-term care providers, rightly have been consumed the past several months with preparing for and responding to the novel coronavirus pandemic, regulatory agencies across the United States have been engaged in taking the steps necessary to implement a final rule promulgated by the U.S. Environmental Protection Agency (EPA), entitled “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine,” under the Resource Conservation and Recovery Act (RCRA). The rule became effective at the federal level on August 21, 2019.
The rule consists of three primary regulatory schemes applicable to health care facilities—a prohibition against “sewering” hazardous waste pharmaceuticals (“HWPs”), management standards for HWPs (“Subpart P”), and changes to the regulatory status of over-the-counter (OTC) nicotine products. The sewering ban became effective in all states on August 21, 2019. Most states have EPA authorized state hazardous waste regulations. Because state regulations must be at least as stringent as the federal regulation, the Subpart P management standards must be adopted by each state’s regulatory body or legislature. EPA has set a deadline of 2021 or 2022 for state adoption depending on the extent of the rulemaking or legislation required in each state. The changes to the regulatory status of OTC nicotine products, however, are less stringent than what had previously been in effect at the federal level. As a result, states are free to adopt those changes or maintain their existing regulatory structure.
Despite the seemingly distant deadlines for state adoption, the Subpart P management standards are already in effect in 12 states,1 including Georgia, and another nine states2 anticipate adoption during calendar year 2020.3
The EPA rule applies to a wide array of facilities, including hospitals, physician offices, pharmacies, long-term care facilities, ambulance services, and veterinary clinics / hospitals. Long-term care facilities, however, face the greatest compliance hurdle. While most health care facilities have been subject to RCRA for years, nursing facilities historically were exempt from RCRA because they were classified as “household generators.” Promulgation of the final rule by EPA in February, 2019 changed that. Accordingly, nursing facilities will need to navigate not only Subpart P for their hazardous waste pharmaceuticals but other portions of the RCRA regulation for their non-pharmaceutical hazardous waste.
All health care facilities affected by the rule, but especially those in states that have adopted it or anticipate adopting it in 2020, will need to complete a thorough review of the federal rule, together with state regulations and guidance. They will also need to draft policies and procedures to govern day-to-day operations regarding such matters as identification, collection and storage of HWPs, and develop a training curriculum for staff. Above all, however, facilities should no longer be discharging hazardous waste pharmaceuticals into a sewer system.
For additional information concerning the EPA rule, please consult our Legal Insight, as well as the EPA’s resource page.
 The Subpart P management standards and regulatory changes to OTC nicotine products are in effect in Alabama, Alaska, Florida, Georgia, Iowa, Kentucky, New Jersey, Pennsylvania, South Carolina, South Dakota, Virginia, and Wisconsin. The regulatory changes to OTC nicotine products alone are effective in Hawaii, New Hampshire, and North Carolina, with the Subpart P management standards anticipated to take effect in North Carolina on July 1, 2020.
 Arizona, Indiana, Nebraska, North Carolina, Ohio, Oklahoma, Utah, Washington, and West Virginia.
 Several states either did not have information available or did not respond to inquiries. Health care facilities in these states should contact their state environmental regulatory agency to request an update.