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 “pharmaceutical reverse distributors.” The rule requires that all healthcare facilities and pharmaceutical 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.
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.
On May 30th, EPA reinstated a Bush Administration RCRA exemption that allows third-party recycling of hazardous secondary materials, known as the “Transfer-Based Exclusion.” The move will make it easier for facilities to use vendors to recycle materials like spent solvents and expired pharmaceuticals without managing them as hazardous waste. As a result, it may be possible for Large Quantity Generators (“LQG”) to reduce their generator status and avoid the compliance obligations that come with being an LQG.
On Friday, May 11, California’s Department of Toxic Substances Control (DTSC) issued a notice that it is considering listing laundry detergent that includes nonylphenol ethoxylates (NPE) as a “priority product” under its Safer Consumer Products regulations. If DTSC finalizes a rule listing the product, it will kick off an alternatives assessment process, during which manufacturers, sellers, importers, and distributors of the product will have to evaluate alternatives to the use of NPE, and which may result in DTSC concluding that NPE in laundry detergent should be phased out and replaced with a “safer” alternative. Regardless, the alternatives assessment process is a time-consuming and cost-intensive process, and will be subject to a lot of scrutiny from DTSC and third parties.
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.
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.
On January 9, 2018, EPA released the pre-publication copy of its annual civil monetary penalty adjustment. The final rule is scheduled to be published in the Federal Register on January 10, 2018. The adjustments are mandated by 2015 revisions to the Federal Civil Penalties Inflation Adjustment Act, which requires federal agencies to make annual inflation adjustments to federal statutory civil penalty amounts. In the past, EPA only adjusted penalty levels for inflation once every several years. Beginning in 2017, however, EPA and other federal agencies must adjust their penalty amounts every year. Continue Reading EPA Publishes Updated Civil Penalty Amounts
Last summer, EPA finalized the TSCA Inventory Notification (Active-Inactive) Requirements, 82 FR 4255 (Active/Inactive Rule), which we previously reported on here . As a reminder, the Active/Inactive Rule requires manufacturers and processers to submit notifications to EPA for chemicals that have been manufactured or processed between June 21, 2006 and June 21, 2016. The deadline for submittal of the required reports by manufacturers – February 7, 2018, is quickly approaching.
The GeoProfessional Business Association (GBA) – formerly known as ASFE – has released a new study on the standard of care for conducting Phase I environmental site assessments. This document is the fourth in a series of studies the organization has produced since the inception of the due diligence process in the early 1990’s. The study is an evaluation of approximately 200 Phase I reports from across the country, written between 2007 and 2010. The results of the study will be a valuable tool in determining whether a Phase I conducted during that time period meets the standard of care or not.
On November 7, EPA filed a motion asking the D.C. Circuit to remand certain provisions of the CCR Rule for the Agency’s reconsideration. As background, on September 13, EPA granted USWAG’s and AES Puerto Rico’s petitions for reconsideration of the CCR Rule stating that it was “appropriate and in the public interest” for the Agency to reconsider parts of the regulation. EPA’s decision was largely based on the Water Infrastructure Improvements for the Nation (WIIN) Act, which alters the self-implementing nature of the Rule to one implemented through enforceable permit programs.