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USEPA Proposes New Rules for Pharmaceutical Waste ManagementSeptember 28, 2015

The United States Environmental Protection Agency (“USEPA”) has released proposed new rules that will provide standards to ensure that the management of hazardous waste pharmaceuticals is safe and workable within the healthcare setting. The Management Standards for Hazardous Waste Pharmaceuticals was published today in the Federal Register and proposes a tailored, sector-specific set of regulations for the management of hazardous waste pharmaceuticals by healthcare facilities (including pharmacies) and reverse distributors.  The USEPA believes that this rule will assist the healthcare industry with the management of hazardous waste pharmaceuticals, which are historically difficult to regulate under the Resource Conservation and Recovery Act (“RCRA”).  Presently, healthcare workers are generally unaware of the RCRA hazardous waste management requirements such that pharmaceutical waste is often handled as municipal waste or medical waste.  According to EPA, this proposed rule would streamline the current regulations governing these wastes, ensuring that larger quantities of hazardous pharmaceutical wastes are managed properly. Additionally, the rule proposes a tailored set of management standards specifically designed to reduce the complexity of the RCRA hazardous waste regulations for hazardous waste pharmaceuticals. It streamlines the collection and handling requirements for widely-dispersed hazardous wastes and facilitates their inclusion in the hazardous waste management system.

Under the proposed management standards, generators of hazardous pharmaceutical wastes will manage their hazardous waste pharmaceuticals under subpart P of part 266 in Title 40 of the Code of Federal Regulations (CFR), instead of the standard RCRA generator regulations found in part 262.  According to USEPA, compared to the hazardous waste generator regulations, healthcare facilities operating under the new standards will have the following benefits:

  1. A healthcare facility will not become a Large Quantity Generator, with all the associated requirements, when it generates more than 1 kg of acute hazardous waste pharmaceuticals in a month;
  2. A healthcare facility will not have to comply with the satellite accumulation area regulations, which are a poor fit for healthcare facilities;
  3. The facility will not need to specify hazardous waste codes on manifests;
  4. The facility will be able to accumulate hazardous waste pharmaceuticals on site without a RCRA permit for 365 days, an increase of 275 days over the current generator regulations; and
  5. The facility will have basic training requirements.  

Additionally, the proposed standards are tailored to how pharmaceutical reverse distributors operate and will replace the standard generator regulations for the accumulation and management of hazardous waste pharmaceuticals at pharmaceutical reverse distributors. 

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EPA Issues New Definition of Solid Waste RuleFebruary 2, 2015

The Final Rule regarding the Definition of Solid Waste was published in the January 13, 2015 Federal Register.  On December 10, 2014, the United States Environmental Protection Agency (“EPA”) announced a final rule revising the 2008 definition of Solid Waste.  Among the changes, the rule addresses regulatory gaps in the 2008 rule by requiring off-site recycling at a facility with a RCRA permit or verified recycler variance.  This will provide both EPA and the states with the ability to verify that these facilities have the proper personnel, adequate financial assurance and proper emergency response preparedness.  The variances will also allow the public to participate and be aware of recycling facilities in their neighborhoods.  The final rule revises the definition of legitimate recycling and it includes a targeted remanufacturing exclusion for certain higher-value hazardous spent solvents, which allows manufacturers to reduce the use of virgin solvents resulting in energy conservation and reduced greenhouse gas emissions.

The final rule is effective July 13, 2015.

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Third Circuit Holds RCRA Cases Shall Be Brought in District CourtAugust 12, 2013

In the case, Litgo New Jersey Inc. v. New Jersey DEP, the Third Circuit reversed a District Court decision and held that claims made under the Resource Conservation and Recovery Act (RCRA) must be brought in federal court. The District Court held that a RCRA claim should have been brought when a previous action was filed in New Jersey Superior Court ten years prior against the same party.

The Third Circuit reversed the District Court's dismissal of the RCRA claim because it found that federal courts have exclusive jurisdiction over RCRA claims. RCRA provides that any action shall be brought in the jurisdiction in which the alleged violation occurred or the alleged endangerment may occur. The Third Circuit noted that the majority of other courts have determined that federal courts have exclusive jurisdiction over RCRA claims and that the clear language of the statute provides for same.

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NJDEP Issues Oversight Process Under SRRA For RCRA, CERCLA, and Federal Facility SitesApril 7, 2011

Pursuant to the Site Remediation Reform Act ("SRRA"), the New Jersey Department of Environmental Protection ("NJDEP") has a state to delineate which Resource Conservation and Recovery Act ("RCRA") sites, Comprehensive Environmental Response, Compensation and Liability Act ("CERCLA") sites, and Federal Facilities will be handled by the NJDEP and the United States Environmental Protection Agency ("USEPA")and which sites will require remediation under the direction of an Licensed Site Remediation Professional ("LSRP")Program in New Jersey by May 7, 2012.

For RCRA GPRA 2020 universe sites:

An LSRP will not be required for all sites that are on the USEPA's RCRA Governmental Performance and Result Act ("GPRA") 2020 universe list (which can be found at where the USEPA is the lead agency. NJDEP will continue to issue comments, but USEPA will provide the lead role. These sites will not have to follow the NJDEP's mandatory and regulatory timeframes, nor will they be required to pay the annual remediation fee. Sites listed on the RCRA GPRA 2020 universe list where NJDEP is the lead agency will be required to retain an LSRP by May 7, 2012, but there will still be a NJDEP case manager who will provide all approvals. These sites will also be required to follow the NJDEP's regulatory and mandatory timeframes, pay NJDEP's oversight fees, but not the annual remediation fee.

For RCRA non-GPRA 2020 universe sites:

At all RCRA sites that are not on the USEPA's RCRA GPRA 2020 universe list, the responsible parties must hire an LSRP by May 7, 2012, after which NJDEP will no longer provide oversight. These sites will be subject to all mandatory and regulatory timeframes, the LSRP will issue a Remedial Action Outcome ("RAO"), and they will be subject to the annual remediation fee.

For CERCLA sites and Federal Facilities:

At all CERCLA sites where USEPA is the lead agency and at Federal Facilities under Federal agreement, an LSRP is not required. At CERCLA sites where NJDEP is the lead agency, the responsible party must retain an LSRP by May 7, 2012. At CERCLA sites and Federal Facilities, NJDEP will continue to provide oversight and the annual remediation fee will not be required. If the remediation at CERCLA sites is being conducted as part of a Federal agreement or order, those sites will not be subject to the mandatory and regulatory timeframes. An RAO will not be required for these sites, but any party seeking a seeking a Final Remediation Document for use as part of a real estate transaction after May 7, 2012 must obtain an RAO from an LSRP.

This policy statement from NJDEP provides clarity for those who have a site that would fall into any of these is categories.

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