US EPA publishes significant three-year action plan: the Strategic Roadmap for PFAS 2021

Authored by Victoria Smart

On October 18, 2021, the U.S. EPA announced PFAS Strategic Roadmap to address contamination from PFAS (Perfluoroalkyl and Polyfluoroalkyl Substances, which is a class of substances). EPA has set 2023 as the target deadline for a final rule regulating PFOS and PFOA (within the class of PFAS) in drinking water, and for designation of the two compounds as hazardous substances.

The EPA’s roadmap includes pledges for research and testing on hundreds of chemicals/compounds within the set of PFAS, and could classify as hazardous substances other PFAS compounds. EPA may move toward regulation of PFAS as a class, or toward regulation of sub-groups with similar properties or impacts, or both. The American Chemical Council issued a statement that “all PFAS are not the same, and they should not all be regulated the same way. EPA’s Roadmap reinforces the differences between these chemistries…they should not all be grouped together”

The EPA’s three-year action plan sets targets for significant achievements in the control of PFAS in products, water, air and soil, including:

  • Publish national PFAS testing strategy  –  Fall 2021
  • Finalize new PFAS reporting under TSCA Section 8 –  Winter 2022
  • Establish a robust review process for new PFAS
  • Review previous decisions on PFAS
  • Enhance PFAS reporting under the Toxics Release Inventory – Spring 2022
  • Finalize new PFAS reporting under TSCA Section 8
  • Undertake nationwide monitoring for PFAS in drinking water Final Rule – Fall 2021
  • A National primary drinking water regulation for PFOA and PFOS Proposed Rule – Fall 2022, Final Rule Expected Fall 2023
  • Publish toxicity assessments for GenX (hexafluoropropylene oxide dimer acid and its ammonium salt,) and five additional PFAS – (PFBA, PFHxA, PFHxS, PFNA, and PFDA) –  Fall 2021 and Ongoing; with Health Studies to be released in 2022.
  • Restrict PFAS discharges from industrial sources through a multi-faceted Effluent Limitations Guidelines program – Expected 2022
  • Leverage NPDES permitting to reduce PFAS discharges to waterways  –  Winter 2022
  • Propose to designate certain PFAS as CERCLA hazardous substances  – Proposed rule Spring 2022; Final rule Summer 2023
  • Issue updated guidance on destruction and disposal of certain PFAS and PFAS-containing materials – by Fall 2023
  • Build technical foundation to address PFAS air emissions  –  Fall 2022
  • Develop and validate methods to detect and measure PFAS in the environment

The EPA’s PFAS program is outlined here.

EU REACH – Public access to ECHA’s chemicals database on SVHCs: improved consumer and supply chain awareness or heightened legal risks?

Authored by Sarah-Jane Dobson of Cooley LLP

Recently, the European Chemicals Agency (ECHA’s) database of Substances of Very High Concern (“SVHCs”) has been opened to allow the public to access it. The database lists details of articles containing SVHCs across a broad range of product categories, from food footwear to foodstuffs.

This development brings with it both opportunities, but also risks. The change is likely to significantly impact consumer behavior. Being more able to scrutinize their chemical composition, consumers are likely to be more selective about which products they chose to purchase. With the additional granular information provided to them at their fingertips, consumers or consumer interest groups may also be better equipped to take action, whether informal or formal (including legal action), against companies. For manufacturers and those in the supply chain, this increased accessibility to detailed information about products arguably gives greater control to manage any downstream risk, which is likely beneficial in respect of chemical laws, but also in respect of increasingly onerous corporate social responsibility requirements that rely on detailed information about component aspects of products and their supply chain and which apply to many product categories that are listed on the database.

SVHCs are substances which contain more than 0.1% weight by weight of chemicals listed on the REACH Candidate List, a list of potentially hazardous substances that are regulated by REACH. Since 5 January 2021, manufacturers and importers that supply articles containing these SVHCs, have been required to notify these to ECHA Companies. These obligations are contained within the EU Waste Framework Directive (“WFD”), which sets out basic concepts and definitions relating to waste management, including specifically addressing the historic regulatory gap which used to exist regarding the disposal of REACH- regulated products. All SVHC notifications are stored in the ECHA’s “Substances of Concern in Products (SCIP) database”, set out under the WFD. There is a particularly broad range of articles listed in the database across a wide range of product categories.

The SCIP database has now reached an important milestone in its development. From 14 September 2021, public access to the database was granted and consumers have been able to search the data by article name or brand, product category, type of material or the chemical name.

The public now have access to all information contained on the database, which includes comprehensive records on chemicals issues throughout the whole lifecycle of products and materials, including the waste stage. Examples of specific, particularly relevant pieces of information that consumers and the general public can obtain from the database include technical data to identify the article, instructions on how to use it safely, the SVHC, its location, and the type of material in which it is contained.

A snapshot of the overall trends that the database has allowed insight into include:

Most commonly notified product categories in the database Most commonly SVHCs in notifications
  • Machinery and their parts
  • Measuring instruments and their parts
  • Electronic equipment and their parts
  • Vehicles and their parts
  • Articles made of rubber
  • Furniture
  • Lead (e.g. in ball bearings, batteries)
  • Lead monoxide (e.g. in lamps, vehicle parts)
  • Lead titanium trioxide (e.g. in electric cookers)
  • Silicid acid, lead salt (e.g. in lead crystalware, vehicle coatings)
  • Dechlorane PlusTM (e.g. in paints, glues)

Practical impact

There are numerous practical impacts of the database being publicly accessible now, some of which are policy drivers behind the move:

  • Ordinary consumers and/or consumer interest groups may make more informed choices by checking whether a product contains hazardous chemicals and reading its safe use instructions.
  • Waste operators may utilise the data to increase the re-use of articles and further develop recycling processes and safe instructions for disposal.
  • Increased transparency in the use of SVHCs may act as a driver for substitution i.e. to get extremely hazardous substances out of products wherever possible. This aligns with the EU’s growing focus on substituting hazardous chemicals in products wherever possible. Non-Governmental Organisations, or NGOs, therefore have a vested interest in using the data to advance goals relating to substitution, sustainability and safer chemicals.
  • It is expected that the database will act as an enabler to the EU’s circular economy action plan to put further emphasis on the tracking of SVHCs and support the policy drivers for cleaner waste streams and sustainable consumption.

Overall, this development is an important milestone in global product safety policy. If there are better informed consumers in relation to both ingredients or restrictions on certain substances, there is a growing risk for companies that more consumer claims may be brought in respect of particular products or articles. Consumers or consumer interest groups may also exercise additional rights in respect of requests for more detailed information and/or simply be better informed to ask companies more detailed questions on these topics. Producers should be alive to this growing potential risk when considering the use of SVHCs.

The development provides a rare opportunity for companies also – given the supply chain for modern-day products is complex, this database can assist producers of articles in gaining much better visibility on the ingredients they use when manufacturing. By identifying these substances upfront, safer alternatives may be sought out or pressure on downstream suppliers may be applied to better align their practices with the forward- looking policy of the EU’s chemicals and waste regime regarding safety and environmental and social concerns.

US EPA extends reporting deadline for Health and Safety Data on 20 high-priority chemicals and 30 organohalogens

The US EPA, on September 23, issued a prepublication version of a rule that would extend the reporting and submission deadline for the Health and Safety Data Reporting rule under TSCA. The deadline is extended to December 1, 2021 for High Priority Substances (twenty), and to January 25, 2022 for the thirty (30) organohalogen flame retardants.

The Health and Safety Data Reporting Rule, promulgated under TSCA section 8(d), requires manufacturers (including importers) of certain chemical substances to submit lists and copies of certain unpublished health and safety studies to the EPA.  In its draft notice and rule, EPA notes it has not issued TSCA Section 8(d) rules for several years; and because of the time lapse, manufacturers may not be familiar with certain compliance requirements.  EPA has posted an “historic” 1989 guide for this purpose.  The 22-page guide,

General Questions and Answers About Reporting Under the TSCA s 8(d) Health and Safety Study Reporting Rule  clarifies what type of monitoring reports must be submitted, how the definition of “study” as applied to monitoring data relates to operations reports, and that the rule exempts the submission of underlying data.

The Rule, in pre-publication, is posted here. This final rule will be effective as of the date of publication in the Federal Register.