“Forever chemical” faces increasing regulatory scrutiny

Perfluorinated and polyfluorinated alkyl substances (PFAS) are a large, complex group of synthetic chemicals. The substances have a range of chemical, physical and toxicological properties and can come in solid, liquid or gaseous forms. PFAS contain a stable fluoro-carbon segment and are sometimes referred to as the “forever chemical”. 

PFAS chemistry has been around for over 80 years and has widespread application in fluoropolymer coatings that resist heat, oil, stains, grease, and water. The chemicals are used in a myriad of sectors including transportation, aerospace, construction, renewable energy, electronics, telecommunications, lubricants, semiconductors, food contact materials and much more. They play a prominent role in designing automobiles with low emissions, improved safety, reliability, and fuel efficiency.

Despite their broad application, PFAS are facing increasing regulatory scrutiny. The chemicals are persistent – they do not break down easily in the environment. Individual PFAS have been detected in the air, soil, plants and biodata and they can move through soil and contaminate drinking water. PFAS can accumulate in humans, animals and the environment and are known to stay in the bloodstream for years. 

There are increasing concerns about the level of PFAS in the population. Scientists from the United States Center for Disease Control and Prevention (CDC) have noted widespread exposure to PFAS in the U.S. Ongoing research, that began in 1999 and measures PFAS in blood serum, has found PFAs — perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorohexane sulfonic acid (PFHxS) and perfluorononanoic acid (PFNA) in nearly all participants. Although, the CDC website notes that “finding a measurable amount of PFAS in serum does not imply that the levels of PFAS cause an adverse health effect”. 

In Europe, PFAS have been detected widely in the blood of European citizens through human biomonitoring and these chemicals have become ubiquitous in aquatic environments and organisms across the region. The presence of PFAS increases the burden of exposure to chemicals on a population. Although, there is still relatively limited research on the potential risks of individual PFAS.

A briefing by the European Environment Agency (EEA) on December 12, 2019, highlighted PFAS as an emerging chemical risk in Europe with national monitoring activities identifying the contamination of drinking water supplies in several European countries. 

The EEA is a European Union agency tasked with providing sound, independent information on the environment. Several potential adverse health impacts from exposure to PFAS were outlined in the briefing document including thyroid disease, cancer, low fertility, birth defects, obesity and suppression of the immune system. Exposure to high levels of PFAS are of particular concern to vulnerable societal groups such as children and the elderly.

A new bill is under review in the U.S. State of Minnesota. SF 834/HF 1000 proposes a sweeping ban on the sale or distribution of PFAS across a variety of categories and intends to establish a future regulatory scheme to ban additional product categories containing these chemistries. The bill is of particular significance as Minnesota is the birthplace of the “forever chemical”.

Minnesota’s proposed regulation compels companies to complete strict reporting requirements on PFAS-containing products. From 2025, manufacturers must notify the Minnesota Pollution Control Agency of any intentionally added PFAS in their products. 

The Minnesota reform follows similar regulation in Maine that was signed in 2021 and requires manufacturers to notify the Maine Department of Environmental Protection (DEP) of intentionally added PFAS from January 1, 2023. From 2030, products containing intentionally added PFAS are banned, unless the DEP determines the PFAS is unavoidable. On February 14, 2023, the DEP announced a new rule aimed at providing further guidance on the notification requirements and sales prohibitions on the state’s disclosure program for PFAS products. Comments on the proposed new rule are open until May 19, 2023.

A potential ban in Minnesota has been met with strong opposition from lobbyists with many citing the “flawed” bill in Maine they say has created “compliance nightmares”. A letter opposing SF 834/HF 1000 was received by the Minnesota House environment committee from 50 companies and trade associations representing the leading companies in the multibillion-dollar chemistry industry — including DuPont, Arkema and Chemours and the American Chemistry Council (ACC). 

The letter noted the continued performance of PFAS in “enabling lives” and warned of far-reaching negative consequences to almost every sector of the economy. A blanket ban on PFAS would cost the state countless jobs and harm economic growth in the region, says the ACC. 

While the consortium reiterated its support for science-based regulations, the letter stressed that PFAS should not be treated as a single class. Different chemistries need to be regulated according to their specific properties or potential risk, they say. A “catch-all” ban doesn’t recognise the diversity of PFAS chemistries and has the potential to include substances with a history of safe use. Onerous reporting requirements and a potential misalignment with federal efforts on PFAS are also of concern. The governor of California, Gavin Newsom has vetoed similar legislation, in part because of pending rulemaking to require reporting of PFAS by the U.S. Environmental Protection Agency (EPA).  

Affected companies have urged policymakers to focus first on properly defining the specific subcategories of PFAS to determine those with the greatest potential risk and exposure.  Though, the EEA believes it is not possible to take a substance-by-substance risk assessment and management approach due to the diversity of PFAS chemicals and applications. 

While debate on the future of PFAS continues to rage, Minnesota-based 3M announced on December 20, 2022, it would “exit per- and polyfluoroalkyl substance manufacturing and work to discontinue the use of PFAS across its product portfolio” by the end of 2025. This is particularly significant as 3M is the original manufacturer of PFAS and one of the world’s largest producers of the products. According to a Bloomberg Intelligence report, 3M has been the recipient of 14,000 lawsuits in the U.S. over water contamination caused by PFAS.

PFAS are garnering increasing attention from the EPA. In April 2021 an EPA Council was established to develop a strategy to protect public health and the environment from PFAS impacts and the Strategic Roadmap was announced by Michael S. Regan in October 2021. In August last year, PFOA and PFOS, two of the most common types of PFAS, were designated hazardous substances under the Superfund — which provides the ability to hold polluters accountable by federal law. In June 2022, the EPA released four drinking water health advisories for PFAS and indicated that national drinking water regulations for PFAS will be introduced. Health advisories are guidance on acceptable drinking water levels, not regulations.

A series of virtual information sessions on the EPA’s Strategic Roadmap commenced on February 28, 2023, with the next session planned for April 6.  The listening sessions are designed to provide information on the EPA’s ongoing work on PFAS and to enable those affected to feedback directly on the program.

ASTM International has also announced a workshop on PFAS later in the year. The international standards organisation has highlighted a lack of PFAS test methods for vapour-phase PFAS in air—with existing methods developed for water, soils, sediments, biosolids, and biota. ASTM Committee D22 is staging the workshop on PFAS in Atmosphere – Sources, Sampling and Standards on November 1-2, 2023 in Washington DC. The event will support current efforts to develop harmonised and consensus test standards for the analysis of PFAS in air.

Canada, too, is taking aim at PFAS. The Water and Air Quality Bureau of Health Canada opened a consultation on guidelines for Canadian drinking water quality on Feb 11, 2023.  A limit of 30 nanograms per litre (ng/L) for the sum of total PFAS detected in drinking water is proposed. The 60-day consultation period closes on April 12, 2023. Canada previously established specific guidelines for PFOS and PFOA and screening values for 9 other PFAS, in 2018-2019. The proposed class-level PFAS restrictions would replace the earlier guidelines for individual PFAS.

In Europe, measures to reduce well-known PFAS and their precursors are already in force. However, on February 7, 2023, the European Chemicals Agency (ECHA) issued proposed restrictions on around 10,000 PFAS which ECHA says supports the EU’s Chemicals Strategy and the Zero Pollution action plan. Denmark, Germany, the Netherlands, Norway and Sweden are the driving force behind the proposal. 

PFAS are defined as substances that contain at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom, without any attached H/Cl/Br/I, which leaves few exceptions. A six-month consultation period starts on March 22, 2023, to determine the appropriateness of the proposed restrictions. A planned timeline indicates the Commission decision and entry into force will occur in 2025 with restrictions becoming effective in 2026/27. 

Regulated PFAS are often substituted with short-chain and polymeric PFAS. The EEA briefing indicates that several ‘novel’ PFAS and their short-chain degradation are also persistent and have been shown to contaminate ground and drinking water. While monitoring activities in Europe have observed a decrease in regulated PFAS, an increase in the levels of more ‘novel’ PFAS is evident.