What Happened

On Monday, October 14, 2024, the California Department of Resources Recycling and Recovery (CalRecyle) opened a public comment period on changes to the previously proposed regulations implementing the Plastic Pollution Prevention and Packaging Producer Responsibility Act (Act). The 15-day written comment period runs through Tuesday, October 29, 2024.

On April 19, the U.S. Environmental Protection Agency (EPA) released a pre-publication version of the long-awaited final rule designating two per- and polyfluoroalkyl substances (PFAS) as “hazardous substances” under the Comprehensive Environmental Response, Cleanup, and Liability Act (CERCLA). This final rule comes right on the heels of EPA’s April 8

As lithium-based batteries become more prevalent in everything from electric vehicles (EVs) to industrial-scale batteries, as well as e-scooters and personal electronics, more questions arise regarding how to properly manage and dispose or recycle them at the end of their lives. On May 24, the U.S. Environmental Protection Agency (EPA) issued a memorandum titled “Lithium Battery Recycling Regulatory Status and Frequently Asked Questions,” clarifying how the EPA’s current hazardous waste regulations, under the Resource Conservation and Recovery Act (RCRA), apply to lithium batteries, and describing the handling requirements imposed on companies generating the waste batteries and recycling facilities ultimately receiving the waste batteries.

In 2020, even the hand sanitizer is potentially suspect. Retailers, distributors and corporate purchasers are now grappling with the added problem of clearing their shelves of it and stopping employees from using the Food and Drug Administration (FDA) recalled product.

Earlier this year, to combat the novel coronavirus, the FDA issued temporary guidance to streamline regulatory processes for manufacturing alcohol-based hand sanitizer (typically ethanol or isopropyl alcohol) to get product quickly to market. Many manufacturers (generally foreign manufacturers), however, then distributed toxic or defective product to U.S.-based distributors. As such, the FDA issued a recall for certain hand sanitizer products beginning in June 2020. Over the following months, it has expanded this recall, citing risks that some products pose a risk of poisoning users with methanol and wood alcohol or leaving customers exposed to COVID-19 as a result of either adulteration or ineffective ingredients.. The FDA has advised importers, consignees, distributors, retailers and others not to distribute or sell certain hand sanitizers, even if the manufacturer of the product has not recalled it, due to the dangers of methanol contamination, including death.

The new hazardous waste pharmaceutical management standards established by EPA’s Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine (“Rule”) are already effective in some states. Other states must adopt the rule by July 1, 2021 or, if a statutory amendment is required prior to the state’s adoption, by July 1, 2022. Based on this, all “healthcare facilities”[1] and “reverse distributors,”[2] as defined by the Rule, will ultimately be required to comply with the Rule (as adopted in each state).

On November 15, EPA posted its pre-publication version of the Final Rule re-classifying aerosol cans as “universal waste” under the Resource Conservation and Recovery Act (RCRA), which finalizes EPA’s March 16, 2018 proposal (83 Fed. Reg. 11,654).  As discussed in our prior blog post regarding the proposal, many aerosol cans have historically been classified as hazardous waste because of their ignitability, and thus often are subject to stringent regulations related to handling, transportation, and disposal.

Universal waste is a sub-category of RCRA regulated hazardous waste that allows certain widely generated products, such as batteries, certain pesticides, and lamps, to qualify for less stringent regulation than the traditional hazardous waste regime.  The Final Rule is intended by EPA to ease regulatory burdens on retail stores and others that discard hazardous waste aerosol cans by providing an optional pathway for streamlined waste management treatment; promote the collection and recycling of these cans; and encourage the development of municipal and commercial programs to reduce the quantity of aerosol cans going to municipal solid waste landfills or combustors. 

On July 29, EPA Administrator Andrew Wheeler signed a long-anticipated proposal to amend EPA’s 2015 Coal Combustion Residuals (CCR) rule.

EPA’s proposal includes a number of changes, including the establishment of an alternate risk-based groundwater protection standard for boron, revisions to the annual groundwater monitoring and corrective action report requirements, and revisions to the CCR website requirements. The proposal also includes changes in response to the U.S. Court of Appeals for the D.C. Circuit’s August 21, 2018 remand of certain CCR rule provisions. These amendments address the “beneficial use” definition and CCR pile requirements.

On June 28, EPA proposed to partially approve Georgia’s coal combustion residuals (CCR) state permit program.  If finalized, Georgia’s program will become the second to receive EPA’s approval and will operate in place of the federal CCR requirements.

In its proposal, EPA determined that—with the exception of four provisions—Georgia’s program meets the standard for EPA approval.  EPA proposed to partially approve Georgia’s program since it does not incorporate certain endangered species provisions and because it includes now-vacated provisions that exclude inactive surface impoundments at inactive facilities from regulation, allow unlined surface impoundments to continue receiving CCR unless they leak, and classify clay-lined surface impoundments as lined.  Georgia’s CCR rule has not been revised to reflect the vacatur of these provisions because EPA has not yet finalized those changes at the federal level.  EPA plans to issue proposals to address these topics in 2019.  Once finalized, Georgia EPD can amend its regulations to align with EPA’s changes and then apply for approval of those amendments at a later date.

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.