Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine
The USEPA published a final rule, entitled, “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine” in the Federal Register on February 22, 2019. According to the USEPA announcement, the final rule establishes cost-saving, streamlined standards for handling hazardous waste pharmaceuticals to better fit the operations of the healthcare sector while maintaining protection of human health and the environment.
This final rule will help protect drinking and surface water reducing the amount of hazardous waste pharmaceuticals entering waterways by 1,644 to 2,300 tons on an annual basis. To accomplish this the rule will prohibit disposal of pharmaceuticals in the sanitary sewer by all facilities subject to the rule. This action will help address the issue highlighted by a growing body of publicly available studies documenting the presence of pharmaceuticals in drinking and surface waters as well as their negative impacts to aquatic and riparian ecosystems.
In addition, FDA-approved, over-the-counter nicotine replacement therapies (i.e., nicotine patches, gums and lozenges) will no longer be considered hazardous waste when discarded. This will result in significant cost savings and burden reduction in the management of these types of nicotine wastes.
Finally, the final rule reaffirms EPA’s long-standing policy that non-prescription pharmaceuticals and other unsold retail items that have a reasonable expectation of being legitimately used/reused or reclaimed are not solid waste. It also provides regulatory certainty that the Resource Conservation and Recovery Act (RCRA) applies when healthcare facilities send unused, unsaleable prescription hazardous waste pharmaceuticals to reverse distributors to receive manufacturer credit. Simultaneously, the rule incorporates flexibilities to accommodate current reverse distribution business practices to facilitate its implementation.
SRM will keep you posted on this important development.
Beginning July 1, 2018, all hazardous waste shipments from
small and large quantity hazardous waste generators, and all
shipments of polychlorinated biphenyl (PCB) waste, requiring a
uniform manifest, must be submitted to the U.S. EPA for
tracking in the online e-Manifest system.
The receiving TSDF is responsible for submitting the e-Manifest information it receives to the U.S. EPA. It is also responsible for paying any e-Manifest processing fees due to the U.S. EPA following deployment. To ensure a smooth transition, generators are encouraged to review e-Manifest resources shared with them by their TSDF and to review resources on the MDEQ and USEPA websites.
Highlights for Generators
The eManifest online system is located in the USEPA CDX online system under RCRA Info and is currently available to explore. You will need to open a CDX account if you don’t already have one. There is a Youtube video from USEPA that walks you through a fictitious site and may be helpful.
To get more information, check out the MDEQ and USEPA resource pages, or contact SRM for assistance.
The next Hazardous Waste Biennial Report deadline is March 1, 2018 and covers activities during calendar year 2017. The Michigan DEQ will not be sending biennial packets to waste generators. Instead, Large Quantity Generators and TSDFs will be required to report using the federal forms and instructions.
While the MDEQ will accept paper copies, it is encouraging facilities to submit their Biennial Report data electronically through the Biennial Report component of the USEPA RCRAInfo Industry Application (RIA).
The RCRAInfo login page can be used to set up a RCRAInfo account and login. The web site provides guidance and information to be followed to prepare and submit the report. Additional information for submitting Biennial Reports to the MDEQ either electronically or on paper can be found at the MDEQ web site for Biennial Reporting.