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.

Troutman Sanders partners Douglas Henderson and Lindsey Mann and associate Nicholas Howell had an Insight piece published in Bloomberg Law titled, “Contamination ‘Issue’ Class Actions—Recent Certification Realities.”

In the article, the authors review the confusing outcomes and mistaken promise of environmental “issue” class actions under Rule 23(c). Two cases from 2018—involving virtually identical facts—reach fundamentally different conclusions on whether such “issue” classes are appropriate in environmental exposure cases.

The authors note: “[i]f the Behr-Dayton approach stands, claim-wide predominance and superiority become aspirational, rather than the requirements they were intended to be, so long as the ‘issue’ class will, in the court’s estimation, advance the litigation or push the parties to settle.” Based on the these cases, Henderson, Mann and Howell conclude Rule 23(c) “issue” class actions should not be interpreted to resuscitate flawed putative classes under Rule 23(b).

To read the entire article, click here.

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

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 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.

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

Parties that are potentially responsible for residential environmental contamination in North Carolina face broad exposure and unpredictable outcomes. A recent appellate decision limiting damages commercial property owners can recover for environmental contamination to the diminution in value of the property greatly expanded the potential scope of liability for residential environmental claims. The decision recognized a personal use exception that could require responsible parties to pay well in excess of diminished value to remediate or repair residential property. When property claims are coupled with claims for non-economic injuries for diagnosed and undiagnosed conditions, the potential exposure for responsible parties in residential contamination cases can be considerable and vary greatly.  A full summary of the decision is available here.