As discussed in the Winter 2016 issue of Environmental Quarterly, EPA published three proposed regulations in the fall of 2015, with each targeted for finalization in late 2016—the proposed Hazardous Waste Generator Improvements Rule and Hazardous Waste Pharmaceuticals Rule were published on September 25, 2015, followed by the proposed Hazardous Waste Export-Import Revisions Rule on October 19, 2015. EPA accepted comments on the three proposed rules through December 2015, and has been working since then to address the hundreds of comments that were submitted.
EPA is now poised to finalize the Hazardous Waste Generator Improvements Rule and the Hazardous Waste Export-Import Revisions Rule as early as October and certainly by the end of 2016. The final versions of both regulations are currently under review at the Office of Management and Budget (OMB), and final rule publication is anticipated before the change in presidential administration. The Hazardous Waste Pharmaceuticals Rule is on a different schedule and will not be finalized in 2016.
Hazardous Waste Export-Import Revisions Rule
In October 2015, EPA proposed to amend the Resource Conservation and Recovery Act (RCRA) hazardous waste export and import regulations. The proposed changes are intended to improve the consistency of the export- and import-related requirements for hazardous wastes with the requirements of the Organization for Economic Cooperation and Development (OECD) for trans-boundary shipments. The proposed revisions also incorporate electronic submittal of all export- and import-related documents (e.g., export notices, export annual reports) and electronic validation of consent prior to exit for exports of RCRA-regulated wastes. Finally, in keeping with other recent EPA rulemakings, EPA proposed to reorganize all the exporter, importer, transporter, and receiving facility requirements into one location in the regulations (40 CFR 262 Subpart H).
EPA expects OMB to complete its review and the EPA administrator to sign the final Hazardous Waste Export-Import Revisions Rule in October 2016, with publication shortly thereafter. The final rule will become effective in all states no later than December 31, 2016.
Hazardous Waste Generator Improvements Rule
The Hazardous Waste Generator Improvements Rule will affect all hazardous waste generators – Large Quantity Generators (LQGs), Small Quantity Generators (SQGs), and Conditionally Exempt Small Quantity Generators (CESQGs) – across all industry and economic sectors. The September 2015 proposal included more than 60 substantive changes and another 30 minor changes to the regulations at 40 CFR 260 through 279. EPA’s goals are to make these regulations easier to understand, clarify language that is outdated or ambiguous, and provide additional flexibility in hazardous waste management. While EPA intends for these regulations to improve generator compliance without increasing regulatory burden, there is an inherent risk and burden in any regulatory change.
EPA expects OMB to complete its review and the EPA administrator to sign the final Hazardous Waste Generator Improvements Rule by early October 2016, at which point a pre-publication copy of the final regulation will be made available. Until that time, EPA is not providing any details on what has changed in the final regulation from the September 2015 proposal.
Notably, three provisions in the 2015 proposal were identified as "less stringent" than current regulations: (1) a new waiver for storing ignitable and reactive wastes within 50 feet of the property line; (2) a contingent management approach for episodic generators of hazardous waste; and (3) an alternative management option for wastes from CESQG (being renamed in this rule to Very Small Quantity Generators, or VSQG) at companies with multiple facilities. It is not clear which, if any, of the proposed provisions will be retained in the final regulation.
Other provisions addressed in the September 2015 proposal were regulatory reorganization and revised definitions; additional recordkeeping, documentation, and notification requirements; revised marking and labeling standards; provisions related to acute and non-acute hazardous waste and to hazardous waste and non-waste determinations; and revised generator operating requirements. While few of the individual changes pose a significant burden, there are so many of them that facilities will need to be vigilant in ensuring that no single regulatory change is overlooked.
Hazardous Waste Pharmaceuticals Rule
Initially, the schedule for the Hazardous Waste Pharmaceuticals Rule was parallel to the Hazardous Waste Generator Improvements Rule; however, the two rulemaking schedules have since diverged and the final Hazardous Waste Pharmaceuticals Rule has not yet been completed. EPA has indicated that it will publish an adjusted anticipated timeline for finalization in its Fall 2016 Regulatory Agenda.
This delay will pose an additional burden on pharmacy retailers, who, in the meantime, must comply with the more stringent conditions of the Hazardous Waste Generator Improvements Rule without the regulatory relief promised by the Hazardous Waste Pharmaceuticals Rule. Until promulgation of the alternate management strategy proposed in the Hazardous Waste Pharmaceuticals Rule, many pharmacy retailers will remain classified as LQG hazardous waste generators, subject to the full regime of LQG requirements and the increased stringency of the Hazardous Waste Generator Improvements Rule.
As these regulations are finalized, facilities may benefit from reviewing their hazardous waste compliance programs, with a focus on maintaining compliance during this period of regulatory change. Additionally, third-party compliance assessments and general or site-specific training sessions, such as those offered by Trinity, may be useful to ensure continued compliance.