Waste

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In a recent memo issued by EPA’s Office of Enforcement & Compliance Assurance (OECA), Assistant Administrator Cynthia Giles announced that four specific “enforcement tools” should be considered “in all civil enforcement cases and incorporated in civil and administrative settlements whenever appropriate.”  OECA notes that these measures can be imposed via settlement through “injunctive relief, mitigation, or Supplemental Environmental Projects.”

As reported by Law360, Troutman Sanders LLP and members of its Environmental and Natural Resources Practice Group assisted Safeway Inc. regarding its recent settlement of retail and pharmaceutical waste issues in California.  The Alameda County District Attorney’s office, along with 43 other California jurisdictions, filed a Complaint and Stipulation of Final Judgment resolving the case for payments of penalties, investigative costs and Supplemental Environmental Projects valued at $9.87 M. Prosecutors alleged that Safeway and its approximately 500 grocery stores and pharmacies, as well as two distribution centers, had improperly disposed of hazardous and medical wastes under state laws regulating the disposal of these materials.

On December 10, 2014, EPA finalized a number of changes to the federal hazardous waste management rules. Among other things, the new rules:

  • Significantly modify the regulatory exemptions created in 2008 for reclamation of hazardous secondary materials;
  • Codify criteria for “legitimate recycling” that EPA will use to evaluate all recycling activities;
  • Establish new procedures for solid waste variances and non-waste determinations for off-site reclamation activities; and
  • Defer action on a proposal to establish container and notification requirements for pre-2008 recycling exemptions.

About the Rule

  • On September 9, 2014 the U.S. Drug Enforcement Agency (“DEA”) published new regulations that will allow retail pharmacies, hospitals, long term care facilities, and other authorized persons to collect unused medications from the public. The new DEA regulations take effect on October 9, 2014 and implement the Secure and Responsible Drug Disposal Act of 2010.
  • This Act allows ultimate end users to deliver controlled substances to authorized collectors for the purpose of disposal.
  • The regulations give ultimate end users three voluntary options for disposal: (1) take-back events, (2) mail-back programs, and (3) collection receptacles.
  • Authorized collectors may operate (1) a collection receptacle at their registered location(s), (2) collection receptacles at long-term care facilities (if the collector is a retail pharmacy or hospital/clinic with an on-site pharmacy); and/or (3) a mail-back program (if the location can destroy the drugs on-site).

Troutman Sanders is pleased to be a co-sponsor for “Healthcare Meets the Environment: A Symposium on Managing Pharmaceutical Wastes“ on Friday, September 19 from 8 a.m. to 4:15 p.m. at Georgia State University. This event was postponed from the original January 31, 2014 event date following severe snow and ice storms in Atlanta, Georgia.

In early February, EPA released a Notice of Data Availability (NODA) that gives the retail sector the opportunity to submit comments on the various challenges that they face in complying with the federal Resource Conservation and Recovery Act (RCRA).  In the NODA, EPA points out that retailers are challenged to make numerous hazardous waste determinations at thousands of sites, “generally by store employees with limited experiences with the RCRA hazardous waste regulations.”   The NODA is a continuation of EPA’s efforts, initiated in 2008, to address challenges related to hazardous waste pharmaceutical management.

Troutman Sanders is pleased to be a co-sponsor for “Healthcare Meets the Environment: A Symposium on Managing Pharmaceutical Wastes“ on Friday, January 31 from 8 a.m. to 4:15 p.m. at Georgia State University.

Population growth, an aging population, preventative medicine and improved treatment options have contributed to an increase in the use of prescription and over-the-counter medication. While the benefits of these drugs cannot be overstated, their use does impact the environment. In preparation for the spring 2014 release of the EPA’s proposed healthcare facility-specific pharmaceutical waste management standards, this one-day symposium will explore:

EPA recently released its draft “FY 2014-2018 EPA Strategic Plan” for public review and comment.  The Plan generally outlines the Agency’s regulatory, policy, and enforcement goals for next year through 2018.  As part of the Plan, EPA summarizes its specific priorities for “Enforcing Laws and Assuring Compliance” with environmental requirements (pages 42-45).  EPA notes that it will pursue “vigorous civil and criminal enforcement” that will target “the most serious water, air, and chemical hazards in communities in order to obtain compliance.”

Mitigation banking has been highlighted in a new order issued by the Secretary of the Department of Interior.  Secretary Jewell signed her first Secretarial Order on October 31, 2013, calling for the establishment of a Department of Interior mitigation strategy for developments occurring on DOI managed lands.  Order No. 3330 (“Order”) directs the previously established DOI Energy and Climate Change Task Force (“Task Force”) to develop a coordinated strategy on mitigation practices to “effectively offset impacts of large development projects of all types through the use of landscape-level planning, mitigation banking, in-lieu fee arrangements, or other possible measures.”