The U.S. Environmental Protection Agency (EPA) recently published a much-anticipated final rule establishing standards for managing, handling, and disposing of hazardous waste pharmaceuticals. Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine (HWP Rule or Final Rule), promulgated pursuant to the Resource Conservation and Recovery Act (RCRA), will directly regulate the operations of: (1) “healthcare facilities,” which include hospitals, ambulatory surgical centers, certain long-term care facilities, providers’ offices (physicians, dentists, and veterinarians), retail establishments with pharmacies (including grocery stores, warehouse clubs, and supercenters), and other healthcare-related establishments; and (2) “reverse distributors,” i.e., logistics providers facilitating the handling of pharmaceuticals that are not used by healthcare facilities. In all but two states (Iowa and Alaska), legislatures and state environmental agencies will need to promulgate their own laws and regulations before the obligations under the Final Rule go into effect (with one key exception, discussed below).
According to EPA, the impetus behind the HWP Rule was to respond to concerns raised by stakeholders regarding the difficulty of implementing RCRA Subtitle C hazardous waste regulations – which are generally tailored to operations at industrial facilities – for the management of hazardous waste pharmaceuticals at healthcare facilities. For example, industrial facilities tend to collect hazardous waste at relatively few generation points but in large quantities and predictable waste streams. Healthcare facilities, on the other hand, generate pharmaceutical wastes in relatively small quantities, at a significant number of locations, and often containing a variety of different constituents. Accordingly, the HWP Rule creates sector-specific regulations (adding a new Subpart P to 40 C.F.R. Part 266) designed to address the day-to-day practicalities of working in the healthcare sector and requiring the management of certain pharmaceutical wastes as hazardous waste under RCRA.
Another key issue has been distinguishing between pharmaceuticals that are hazardous waste and those that are not hazardous waste. Like all hazardous determinations, this analysis begins with determining whether a pharmaceutical product is a “solid waste” as defined under RCRA; if so, it must be determined whether a solid waste is hazardous. “Solid waste” determinations under RCRA can be complex and tend to be fact-specific, with key issues revolving around intent to discard, the potential for reuse or recycling, and other factors. In the pharmaceutical context, an important issue is whether an unused (and potentially expired) pharmaceutical constitutes a “solid waste.” The HWP Rule tailors these and other determinations to the realities of how healthcare facilities and the pharmaceutical industry generally handle unused pharmaceuticals (e.g., how creditable and non-creditable products are treated in contractual arrangements, expectations for re-use, etc.). If a pharmaceutical is determined to be a “solid waste,” then it must be determined whether it exhibits one or more hazardous characteristics identified in Part 261 Subpart C (Characteristics of Hazardous Waste) or is listed in Part 261 Subpart D (Lists of Hazardous Wastes).
Several aspects of the Final Rule are notable. First, it prohibits healthcare facilities, regardless of size, and reverse distributors from disposing hazardous waste pharmaceuticals “down the drain.” This blanket prohibition highlights the importance of healthcare facilities making a determination as to what pharmaceutical products are hazardous versus non-hazardous. This “sewering” ban goes into effect nationwide on August 21, 2019, while other obligations in the Final Rule will not become effective in most states until promulgated into state law.
Second, new rules in Part 266 Subpart P are applicable to healthcare facilities that generate above the “VSQG” (very small quantity generator) threshold of hazardous waste and all reverse distributors, regardless of size. The VSQG threshold is limited to the generation of hazardous waste of no more than 100 kg per month; no more than 1 kg of acute hazardous waste per month; or no more than 100 kg of acute hazardous waste spill material per month. In determining whether a healthcare facility exceeds these thresholds, one must combine pharmaceutical hazardous waste and non-pharmaceutical hazardous waste. Exceeding these limits triggers coverage under the more stringent provisions of Subpart P, although VSQGs remain responsible for other obligations, e.g., the sewering ban and empty container standards.
Healthcare facilities exceeding the VSQG threshold are subject to a number of significant obligations. Among other things, these facilities must comply with rules related to labeling, reporting, packaging, accumulation, training, and recordkeeping. The obligations vary depending on a number of factors, including whether a product is a creditable hazardous waste pharmaceutical or a non-creditable hazardous waste pharmaceutical, and whether a product is a non-prescription hazardous waste pharmaceutical or a prescription hazardous waste pharmaceutical.
Third, the HWP Rule exempts FDA-approved, over-the-counter (OTC) nicotine replacement therapies from regulation by removing such products from the P075 hazardous waste listing. This means that OTC nicotine patches, gums, and lozenges, for example, will not be treated as hazardous waste when discarded.
Fourth, certain long-term care facilities (LTCF) will be subject to the new Subpart P regulations. The definition of LTCF includes hospice facilities, skilled nursing facilities, and nursing/skilled nursing care portions of a continuing care retirement community. It does not include group homes, independent living communities, assisted living facilities, and independent and assisted living portions of continuing care retirement communities. Notably, the HWP Rule includes a provision that LTCFs with fewer than 20 beds are VSQGs and thus subject to less stringent rules.
The HWP Rule becomes effective at the federal level on August 21, 2019. As noted above, the sewering ban will be effective nationwide on August 21, 2019. In states without EPA-authorized hazardous waste programs (i.e., Iowa and Alaska), the remaining aspects of the HWP Rule will also go into effect on August 21, 2019. However, in states with EPA-authorized hazardous waste programs (Authorized States), the HWP Rule must be adopted or otherwise incorporated into state law and/or regulation before the new rules go into effect. States must implement rules at least as stringent as the HWP Rule, but they are free to impose stricter provisions. Authorized States have until July 1, 2021 to adopt their own regulations unless a statutory amendment is required, in which case the deadline for adoption is July 1, 2022. That said, since many states simply adopt regulations through “incorporating by reference” federal rules, it is possible that some Authorized States will take steps to adopt the HWP Rule quickly so that the state rules will become effective on or shortly after August 21, 2019.
Implications for Regulated Businesses
Healthcare facilities nationwide will need to be prepared to comply with the “no sewering” obligation in August 2019. In the vast majority of states, however, state-level implementation must occur before the remaining provisions of the HWP Rule go into effect. Healthcare facilities in these states should closely monitor implementation of the HWP Rule, particularly since these states are free to implement more stringent requirements. Healthcare companies with covered facilities in multiple states should consider state-level advocacy that seeks to achieve, to the fullest extent possible, consistent regulatory obligations in the locations where they operate. Finally, healthcare companies that outsource waste services should consider reviewing contracts with waste management service providers to ensure that contract terms sufficiently address compliance with the HWP Rule.