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 April 26, 2018, a North Carolina jury awarded 10 neighbors $51 million in the first North Carolina hog farming case to be heard before U.S. District Judge W. Earl Britt.  Almost a week later on May 9, 2018, Judge Britt reduced the jury’s award of $23 million in punitive damages to nearly $3 million in punitive damages because of a North Carolina state law that limits punitive damages to $250,000-per-plaintiff.  This was the first case tried of 26 lawsuits brought by 500 neighbors complaining about hog operations in eastern North Carolina against Smithfield Foods, the world’s largest pork producer.

Continue Reading Punitive Damages in North Carolina Hog Farm Cases Reduced

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.

On January 3, 2018, the Environmental Protection Agency (EPA) published the User Fees for the Electronic Hazardous Waste Manifest System and Amendments to Manifest Regulations Final Rule (“User Fee Rule” or “Rule”) in the Federal Register (83 Federal Register 420).  While the User Fee Rule does not set e-Manifest user fees, it gives EPA authority to establish user fees and establishes the methodology for EPA to do so.  The Rule becomes effective June 30, 2018.

Continue Reading e-Manifest User Fee Rule Published

On November 9, 2017, on the heels of New Jersey’s move to set a maximum contaminant level for certain perfluoroalkyl substances, California’s Office of Environmental Health Hazard Assessment (OEHHA) added perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) to the list of chemicals known to the state of California to cause reproductive toxicity (also known as the Prop 65 list).

Continue Reading California Adds PFOA and PFOS to Prop 65 Warning Requirements

On October 25, 2017, EPA Region 6 announced a settlement with Macy’s department stores for alleged violations of hazardous waste regulations.  In the press release, EPA alleged that Macy’s generated thousands of pounds of hazardous waste between 2012 – 2015 and qualified as a small-quantity generator but failed to notify EPA and state authorities.  EPA also alleged that Macy’s failed to meet the regulatory requirements for small-quantity generators and did not complete appropriate manifests.  As part of the settlement, the company is required to pay a $375,000 civil penalty and, as a supplemental environmental project, develop an internal training and audit program.  This settlement demonstrates that EPA Region 6 continues to pursue enforcement actions initiated under the former Administration using evidence from data mining of manifests and records related to hazardous waste generators, big and small.  With this EPA action, the current Administration appears to be willing to continue its focus on retail hazardous waste enforcement.  Troutman Sanders has extensive experience advising clients on retail hazardous waste management and enforcement.   Please contact Greg Blount or Angela Levin for further information.

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