On March 13, 2019, a three-judge panel for the D.C. Circuit Court of Appeals granted EPA’s motion for voluntary remand without vacatur of the Agency’s recent revisions to the Coal Combustion Residuals (CCR) rule, commonly referred to as “Phase One, Part One.”  The D.C. Circuit’s Order comes in response to dueling arguments EPA and a coalition of environmental groups presented regarding Phase One, Part One’s future in light of the Court’s recent vacatur and remand of portions of the CCR rule in USWAG v. EPA, 901 F.3d 414 (D.C. Cir. 2018).

Significantly, the D.C. Circuit’s Order leaves in place Phase One, Part One’s October 2020 deadline for CCR surface impoundments to stop receiving CCR after triggering closure.  In granting EPA’s motion, the Court stated that EPA demonstrated that disruptive consequences would have resulted from  vacatur. 

EPA argued in its December 2018 motion that vacatur would have significant detrimental impacts, would require certain surface impoundments to immediately begin closing, and would require entities to immediately arrange for alternative disposal capacity for CCR and non-CCR wastestreams.  EPA further argued in its response to the environmental groups’ motion that immediate compliance would not be feasible in many instances, and that vacating Phase One, Part One would require many power plants to cease operating for at least some period of time, which may have led to grid destabilization.

The D.C. Circuit’s decision is a significant victory for electric utilities.  It allows them to continue closing surface impoundments based on the currently-in-place timeframe while EPA revisits the rule.

The D.C. Circuit expressed its confidence in EPA to “expedite its rulemaking proceedings on remand to the fullest extent possible.”  We will provide updates regarding the remand process as they become available.  For more information regarding the D.C. Circuit’s Order or other issues related to CCR, please contact Holly Hill or Buck Dixon.

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.