Today, February 22, 2019, EPA published the final “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine” rule in the Federal Register. The final rule becomes effective at the federal level on August 21, 2019. As we previously reported, EPA released a prepublication copy of the final rule on December 11, 2018.

The final rule, applicable to “healthcare facilities” and “reverse distributors,” establishes new sector-specific regulations in 40 C.F.R. Part 266 Subpart P for managing hazardous waste pharmaceuticals pursuant to the Resource Conservation and Recovery Act (RCRA). Among other provisions, the regulations include a prohibition on disposing hazardous waste pharmaceuticals in sewer systems (i.e., down the drain), a limited carve-out for hazardous waste pharmaceuticals that are also DEA controlled substances, and new management standards related to reverse distribution of prescription pharmaceuticals. The final rule also clarifies that nonprescription pharmaceuticals that are sent to reverse logistics facilities (distinguished from reverse distributors) are not yet a waste at the healthcare facility where there is a reasonable expectation of being used/reused or reclaimed. The final rule also excludes FDA-approved, over-the-counter nicotine replacement therapy products—which include gums, lozenges, and patches—from regulation as an acute hazardous waste.

For an in-depth analysis of the final rule and discussion about state adoption, please see our January 4, 2019 Law360 article, “A Closer Look at New Pharmaceutical Hazardous Waste Regs.”

For more information about this rule, please contact Gregory Blount or Karlie Webb.

Today U.S. EPA finalized new hazardous waste regulations in its final Management Standards for Hazardous Waste Pharmaceuticals rule.  In brief, the rule creates a new Subpart P to 40 Code of Federal Regulations Part 266, which is specific to hazardous waste pharmaceuticals.  The rule applies to all “healthcare facilities” (such as hospitals and retail pharmacies) and “reverse distributors.”   The rule requires that all healthcare facilities and reverse distributors manage hazardous waste pharmaceuticals in accordance with the new subpart P regulations.  We are carefully reviewing the final rule and implications to clients, as well as implications to state hazardous waste requirements.

Continue Reading EPA Finalizes Hazardous Waste Pharmaceuticals Rule

On June 27, 2018, the Environmental Protection Agency (“EPA”) submitted its final Management Standards for Hazardous Waste Pharmaceuticals rule (“Pharm Rule”) to the Office of Management and Budget (“OMB”), which is charged with reviewing every final and proposed federal agency rule before its publication in the Federal Register.  EPA published its proposed Pharm Rule in the Federal Register on September 25, 2015, nearly three years ago, but the final rule then stalled.  According to EPA’s Spring 2018 Unified Agenda, EPA anticipates publishing the final Pharm Rule in October 2018.  Sending the rule to OMB yesterday signals that EPA may well issue the final rule in October.

We continue to closely follow the progress of the Pharm Rule.  For further questions regarding the rule’s implications, please contact Karlie Webb or Greg Blount.

EPA published a proposed rule (83 Fed. Reg. 11654) today that would ease the management standards for aerosol cans.  Stakeholders, particularly the retail sector, has pushed for this addition for some time.  Currently, once a waste, aerosol cans must often be managed as hazardous waste under the Resource Conservation and Recovery Act (RCRA), generally because of their ignitability, and thus often are subject to stringent regulations related to handling, transportation, and disposal.  Today’s proposal would add aerosol cans to the existing federal list of universal wastes.

Continue Reading EPA Proposes to Classify Aerosol Cans as Universal Waste

As we previously reported, industry groups, including the American Chemistry Council, challenged the final Hazardous Waste Generator Improvements Rule (“Final Rule”) in the Court of Appeals for the D.C. Circuit on February 24, 2017.  The Final Rule was published in the Federal Register on November 28, 2016 (a discussion of the Final Rule and its potential impacts can be found here).  Since our previous post, some updates have occurred in the pending challenge.

Continue Reading Updates in Industry Challenge to Hazardous Waste Generator Improvements Rule

On February 24, 2017, industry groups challenged the final Hazardous Waste Generator Improvements Rule (“Final Rule”) in the Court of Appeals for the D.C. Circuit.  The long-anticipated Final Rule was published in the Federal Register on November 28, 2016 (81 Fed. Reg. 85732).  Pursuant to Resource Conservation and Recovery Act (“RCRA”) section 7006, petitioners have ninety days from that date to challenge the rule in the D.C. Circuit.  Because the ninety-day deadline to challenge the rule expired on Monday, February 27, 2017, no more challenges may be filed.  A previous discussion of the Final Rule and its potential impacts can be found here.

Continue Reading Industry Challenges to Hazardous Waste Generator Improvements Rule

Consistent with past changes in presidential administrations, on President Trump’s Inauguration Day, White House Chief of Staff Reince Priebus issued a “claw back” memo describing the process of reconsidering previously finalized regulations. Similar to memos issued by President Obama and President Bush, President Trump’s claw back memo speaks to three specific groups of rules:

Continue Reading New Administration Begins Reconsidering Rules with Publication of “Claw Back” Memo

You are invited to

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.

Continue Reading The Hazardous Waste Generator Improvements Final Rule is Here! A Troutman Sanders Webinar (November 18)

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.

Continue Reading EPA Finalizes the Hazardous Waste Generator Improvements Rule

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. Continue Reading U.S. EPA Announces Its Retail Strategy