Article provided by Laura Sugano, Roux Associates, Inc.
Hazardous Waste Power Hour, the second session of the Annual Waste Conference, was moderated by Kathy Doyle, Managing Director with Relief EHS. Cara Simaga, Director of Regulatory Affairs with Stericycle, kicked off the power hour with her presentation titled “New Hazardous Waste Pharmaceuticals Rule”. She was followed by David Rieser, Of Counsel with K&L Gates, presenting “Remains of the Spray: Aerosol Cans as RCRA Universal Waste.” Tom Crosetto, RCRA Information Coordinator with the EPA, finished with “EPA’s e-Manifest System: Status Updates, and How to Create User Accounts”.
New Hazardous Waste Pharmaceuticals Rule
As Simaga described, the new hazardous waste pharmaceuticals rule (Rule), published in the Federal Register on February 22, 2019, applies to health care facilities including hospitals, dental offices, veterinary offices, and pharmaceutical retailers. The Rule will provide relief to hospitals that may otherwise be challenged with how to handle their hazardous waste, and is comprised of three main components: Subpart P, the Sewer Ban, and the Nicotine Exception.
Subpart P has an upcoming effective date of August 21, 2019. States that do not have to go through a legislative process to adopt this component have a deadline of July 1, 2021 to promulgate the Rule. However, states that need to adopt it through a legislative process will have until July 1, 2022.
Both small quantity (SQG) and large quantity (LQG) health care facility generators will be required to follow Subpart P. While it is not mandatory for very small quantity generators (VSQG) to follow Subpart P, facilities do have the option to conform to its regulations. Under the new Rule, long-term care facilities that have less than or equal to 20 beds will be presumed to be very small quantity generators.
While some states have already enacted the second part of this Rule (the Sewer Ban), generators in all states will be required to comply with it by August 21, 2019. The Sewer Ban amendment goes into effect in all states at the same time even without modification of the state regulations. The Sewer Ban prohibits discharging hazardous waste pharmaceuticals to the sewer and it applies to all levels of generators.
Since the last component of the Rule, the Nicotine Exception, is less stringent than current regulations, there is no requirement or timeline for the states to adopt it. If the state chooses to adopt the Nicotine Exception, it would apply to all generators of hazardous waste. Currently, nicotine and its empty containers are classified as P075 waste. However, the U.S. Environmental Protection Agency (EPA) has removed FDA-approved over-the-counter nicotine-containing items from the P-listing, except for prescription nicotine therapies (inhalers) and E-cigarettes.
Simaga concluded her presentation on the new hazardous waste pharmaceuticals rule by cautioning generators to monitor each state’s adoption activity to determine how it will affect them and how they should treat their pharmaceutical hazardous waste. In preparation for state Rule adoption, each generator should especially be aware of the adoption activity of the state they are a generator in and the state to which they are sending their waste, keeping in mind that the generator state regulations could differ from the disposal facility regulations.
Remains of the Spray: Aerosol Cans as RCRA Universal Waste
Rieser started his presentation with a background on how aerosol cans are handled under the Resource Conservation and Recovery Act (RCRA) today and how the EPA is proposing to handle it differently moving forward. Currently, aerosol cans that are discarded and contain hazardous waste are regulated under RCRA; however, a less stringent rule has been proposed to handle aerosol cans as a universal waste, rather than subjecting individual cans to meeting RCRA hazardous waste regulations. The proposed rule applies to aerosol cans (as defined by RCRA), that are determined to be discarded, hazardous waste-containing, not empty (as defined by RCRA), and not leaking or damaged. Management standards for the proposed rule include preventing releases by using structurally sound containers, meeting container labeling requirements, removing the actuator during the handling process, utilizing a commercially designed device to puncture and drain the can, proper training, and recordkeeping. While this proposed rule is not yet final, the final federal rule is expected in the near future. The final rule will be applicable to the Illinois Environmental Protection Agency (IEPA) when it is adopted by the Illinois Pollution Control Board. States are not required to adopt the rule, but they can be expected to if they want their program to mirror the federal RCRA program.
EPA’s E-Manifest System: Status Updates, and How to Create User Accounts
For those unfamiliar with the e-Manifest system, Crosetto described it as the EPA’s new information system that became operational in June of 2018. This system functions as a database for RCRA hazardous waste manifests created throughout the country. Additionally, it serves as a manifest routing system, allowing entities that generate, transport, and/or receive hazardous waste shipments to create, update, and transmit manifests electronically. Currently, the option to use this system for electronic manifests is just that: an option. However, the EPA plans to eventually transition away from paper manifests completely, which will make the use of the e-Manifest system mandatory. The mandatory effective date has not been determined yet, but it likely will not be for several years.
The e-Manifest module is part of the EPA’s RCRA Info Database, which includes all key RCRA data. Until recently, this database was only available to agency staff at the EPA, states, and tribes, but is now accessible to the broader industry through e-Manifest and other modules.
Moving on from the initial overview, Crosetto detailed the steps for establishing e-Manifest account access, with related navigation illustrated through PowerPoint slides containing screen shots of the system.
For more information, including access to Frequently Asked Questions (FAQs) documentation, regular EPA updates and slides from past webinar presentations, visit www.epa.gov/e-manifest.