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A Webinar: The Hazardous Waste Generator Improvements Final Rule

Friday, November 18, 2016 12:00 – 1:00 p.m.

The final Hazardous Waste Generator Improvements Rule is Here!

Are you a hazardous waste generator? How will the EPA’s updates to the Hazardous Waste Generator Improvements Rule affect your business? Could your company be at risk for noncompliance?

On October 28, 2016, the EPA signed the final Hazardous Waste Generator Improvements Rule. This Rule has been long in the making and addresses various issues applicable to all hazardous waste generators, regardless of the amount of hazardous waste generated or industry sector. Other changes significantly alter requirements applicable to Large Quantity Generators and Small Quantity Generators.

Yesterday, October 31, 2016, U.S. EPA posted the pre-publication version of its final Hazardous Waste Generator Improvements Rule (“Final Generator Rule”).  The Final Generator Rule was signed by EPA Administrator Gina McCarthy on October 28, 2016.  This rule has been long in the making and addresses various issues applicable to all hazardous waste generators, regardless of the amount of hazardous waste generated or industry sector.  Other changes significantly alter requirements applicable to Large Quantity Generators and Small Quantity Generators.

Yesterday, U.S. EPA announced a new Resource Conservation and Recovery Act (RCRA) retail strategy.  This strategy has been long-awaited, given that it has been well over two years since the retail industry commented on EPA’s February 14, 2014 Notice of Data Availability for the Retail Sector (20 Fed. Reg. 8926).  After last year’s release of the proposed Hazardous Waste Generator Improvements Rule and Management Standards for Hazardous Waste Pharmaceuticals rule, the industry was unclear whether and to what degree EPA would turn back to a potential sector-specific rulemaking.  Yesterday’s release of EPA’s retail strategy, however, confirms that EPA intends to use policy, guidance and rulemaking to fashion a remedy.

According to the Healthcare Environmental Resource Center, “EPA will not be publishing a rule finalizing the Hazardous Waste Pharmaceuticals Rule in October of 2016 along with the Hazardous Waste Generator Improvements final rule and previously projected.”

Pharmacy retailers have anxiously awaited the final Management Standards for Hazardous Waste Pharmaceuticals rule (80 Fed. Reg. 50,014), after the U.S. Environmental Protection Agency (U.S. EPA) published the proposed rule on September 25, 2015 in the Federal Register, but it appears the wait will continue.  Pharmacy retailers have hoped that the final rule would, among other things, provide a means of avoiding Large Quantity Generator (LQG) status and the onerous requirements, which are ill-suited for retailers.  However, based on discussions with U.S. EPA sources, we now understand that the Pharmaceuticals rule is not likely to be finalized before the change in presidential administration.  Given the change in administration, and depending on the election results, we may not see a final Pharmaceuticals rule for years.

EPA sent its final hazardous waste generator improvements rule to the White House Office of Management and Budget (OMB) for review.  EPA released a proposed version of the rule on August 31, 2015.  The proposal includes several changes to EPA’s current hazardous waste regulations.

California’s environmental prosecutors have scrutinized hazardous waste management for several years now, particularly at major retailers.  This focus has led to California settlements with Costco, CVS, Home Depot, Lowe’s, Wal-Mart, and Walgreens, among other retailers.  The settlements resolved alleged mismanagement of hazardous waste generated from material such as consumer products, pharmaceuticals, and general home improvement products.

In 2011, U.S. EPA issued guidance concluding that generators of p-listed pharmaceutical wastes did not need to count the weight of non-RCRA empty containers in determining their generator status. Instead, EPA determined that “it is only the residue in the non-RCRA empty container that is considered a p-listed hazardous waste; the container itself is not a hazardous waste.” Containers that Once Held P Listed Pharmaceuticals, November 4, 2011.  This EPA memo was long-awaited by retail pharmacies and other healthcare facilities, as it provided a mechanism to forego counting containers that previously held warfarin-family pharmaceuticals toward generator status.  This was particularly helpful, given that where a facility accumulates more than 1 kilogram (2.2 pounds) of acute hazardous waste at any one time, the facility is subject to stringent Large Quantity Generator of hazardous waste (LQG) regulations.  While such generators may still be subject to LQG requirements based on generation of other p-listed waste such as nicotine replacement therapy products, EPA’s November 4, 2011 memo significantly reduced the likelihood that retail pharmacies and other healthcare facilities would be subject to LQG regulation.