Chemicals, Pesticides, & Plastics

On April 17, 2024, the EPA released a final rule designating two perfluorinated chemicals—Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS)—as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).  EPA also released enforcement guidance explaining how it intends to apply the new listing with respect to certain types of potentially responsible parties.Continue Reading EPA Finalizes Rule Listing PFOA and PFOS as CERCLA Hazardous Substances

Yesterday, the European Parliament approved a new (recast) Urban Wastewater Treatment Directive (“UWWTD”) that will impose new additional costs on producers marketing pharmaceutical and cosmetic products in the European Economic Area by the end of 2027.  Some studies suggest that the costs that producers would have to collectively pay could be around €1 billion per Member State.  This is well above the figures published in the Commission’s impact assessment, which estimated the annual cost of implementing the various requirements of the UWWTD in all Member States at €3.8 billion, including €1.2 billion for micro-pollutants treatment.

The upcoming UWWTD lays down rules on the collection, treatment, and discharge of urban wastewater, and puts particular emphasis on the implementation of the polluter pays principle.  The Directive aims to address the environmental and health concerns resulting from the presence of micro-pollutants, other pollutants (e.g., heavy metals, PFAS), microplastics and antimicrobial resistant (“AMR”) bacteria in European waters.  It introduces new measures for the treatment of wastewater, including quaternary treatment for micro-pollutants, and makes producers of pharmaceutical and cosmetic producers pay for such treatment.Continue Reading New EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic Products

On October 20, 2023, EPA released a final rule under the Emergency Planning and Community Right to Know Act (“EPCRA”) relating to per- and polyfluoroalkyl substances (“PFAS”).  The Rule makes important revisions to EPA’s Toxic Release Inventory (“TRI”) program relating to 189 specified PFAS. Continue Reading Key Takeaways from EPA’s EPCRA PFAS Rule

            On September 28, 2023, EPA released a final rule under the Toxic Substances Control Act (“TCSA”) mandating reporting relating to past manufacturing of per- and polyfluoroalkyl substances (“PFAS”).  Below are key takeaways companies that may be subject to these reporting requirements should keep in mind.Continue Reading Key Takeaways from EPA’s PFAS Reporting Rule

On September 6, 2023, EPA held a webinar relating to pesticidal devices, focused on air cleaning devices.  The webinar highlighted EPA’s expectations for data that manufacturers must have on file to substantiate efficacy claims for these devices.  This provides important additional guidance to manufacturers regarding the types of testing EPA expects to be conducted.Continue Reading EPA Webinar Addresses Pesticidal Device Efficacy Data

On February 14, 2023, EPA released a compliance advisory regarding pesticide devices regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”).  EPA released the advisory in response to “substantial non-compliance with FIFRA in the device and pesticide marketplace. Examples of non-compliance include unregistered pesticides claiming to be devices, devices bearing false and misleading statements, and devices being sold and distributed that were not produced in an EPA registered establishment.”  While the compliance advisory provides a helpful overview of requirements applicable to pesticide devices, it does not provide new substantive guidance, including on key questions facing many device manufacturers and distributors.  The advisory also suggests that EPA may increase its enforcement efforts in this area, so companies producing devices (or products that may arguably be devices) should consider taking proactive steps to ensure their product lines comply with FIFRA’s requirements.Continue Reading EPA Releases New Guidance on Pesticide Devices

Last week the European Commission published its long-awaited proposal for a Packaging and Packaging Waste Regulation (“Proposed Packaging Regulation” or “proposed Regulation”), and a Plastics Communication on an “EU Policy Framework on Biobased, Biodegradable and Compostable Plastics” (“Plastics Communication”).  The Proposed Packaging Regulation is intended to replace the Packaging and Packaging Waste Directive 94/62 (“Packaging Directive”) and to ensure that all packaging marketed in the EU/EEA is fully recyclable or reusable by 2030.  If adopted, the Proposed Packaging Regulation’s new requirements and restrictions will have a significant impact on industry, distributors, and consumers.  The European Parliament and Council must now consider the proposed Regulation for adoption through the so-called “ordinary legislative procedure,” which will allow for the introduction of amendments and is likely to take at least 18 months.  

This blog post highlights the main changes and new requirements that the Proposed Packaging Regulation would introduce, and outlines the principal recommendations of the Commission’s Plastics Communication.Continue Reading The Commission unveils its proposal for a Packaging and Packaging Waste Regulation, and provides recommendations on Biobased, Biodegradable and Compostable Plastics

The U.S. Environmental Protection Agency (“EPA”) recently made two announcements regarding antimicrobial pesticides.  First, EPA released guidance regarding residual efficacy claims for antimicrobials applied to surfaces.  Second, EPA announced that it has registered the first product approved to make claims to kill viruses in the air.  EPA has also sought comment on strategies for improving indoor air quality to reduce disease transmission, which could involve the use of air sanitization products or pesticidal devices.  This blog has previously highlighted these issues, including noting steps EPA could take to improve pesticide policy in the wake of the pandemic and the emerging focus on indoor air quality and its regulatory implications.

Taken together, EPA’s recent actions are significant and provide opportunities for companies to develop novel products that could have significant public health benefits.  But they also highlight that significant uncertainty remains in this area, which presents risks that companies must carefully navigate to ensure regulatory compliance.Continue Reading EPA Provides Guidance Regarding Novel Antimicrobial Pesticides and Seeks Comment on Indoor Air Quality Issues

On October 5, 2022, the U.S. Environmental Protection Agency (“EPA”) announced its plan to streamline the typical review process for Mixed Metal Oxides (“MMOs”), including certain cathode active materials, which are key components in electric vehicles’ lithium-ion batteries, as well as clean energy generation and storage technology, including wind turbines and solar cells.  MMOs can also be used in semiconductors. 

As we have written about previously, increasing the domestic supply of EVs and semiconductors, and expanding the country’s clean energy capacity are among the core policy objectives of the Biden Administration.Continue Reading EPA to Streamline the Review Process for Certain EV and Clean Energy Chemicals

The Italian Legislative Decree 196/2021 (“Italian Decree”) implementing the Single-Use Plastic Directive (“SUPD”) will enter into force on January 14, 2022.  The Italian Decree diverges from the SUPD on significant aspects: it provides a more flexible definition of plastic; delays the entry into force of the ban on prohibited SUPs; and exempts from such ban specific biodegradable and compostable materials.  The Decree also imposes specific return obligations on waste plastic bottles.

While the Italian Decree provides companies with additional flexibilities to market their SUPs in Italy, companies should carefully assess the risks that may arise if EU Courts finally hold that the Decree is not compatible with EU law.Continue Reading Italy Transposes into National Law the EU Single-Use Plastic Products Directive