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Frequently Asked Questions About PFAS Compliance

Written by Source Intelligence | Nov 11, 2024 5:35:45 PM

The global response to PFAS  

Per- and polyfluoroalkyl substances (PFAS) have become a major regulatory focus globally due to their extensive use, persistence in the environment, and potential health risks. Many governments have imposed restrictions or outright bans on PFAS in consumer products to safeguard both human health and the environment. However, the regulatory landscape differs significantly across countries and regions, creating compliance challenges for companies with global supply chains. These variations in approach can increase risks, making it essential for businesses to stay informed and adapt to evolving regulations. Our experts answered the most frequently asked questions regarding PFAS.  

What are PFAS? 

PFAS, a group of synthetic chemicals, have been widely used in industrial and commercial applications since the 1940s due to their exceptional resistance to heat, water, and oil. The first compound, perfluorooctanoic acid (PFOA), gained popularity as the key ingredient in Teflon, a nonstick coating for cookware. Over the years, other PFAS compounds were developed for use in products like waterproof fabrics and firefighting foams. Today, the PFAS family includes over 12,000 substances, with some being extensively studied and regulated due to their environmental and health concerns

For a more in-depth look into PFAS, read our PFAS Regulatory Compliance Guide.  

What is the difference between per- and polyfluoroalkyl substances?   

The difference between these substances is found on the chemical level. In perfluoroalkyl substances, all carbons except the last one are attached to fluorines. The last carbon attaches to the functional group. In polyfluoroalkyl substances, at least one (but not all) carbon is attached to fluorine atoms. 

How are PFAS harmful to human health? 

PFAS are bioaccumulative, meaning they build up in the bodies of humans and animals faster than they can be eliminated. Studies have shown that exposure to PFAS, whether through contaminated food, water, or PFAS-containing products, can lead to adverse health effects. This exposure has been associated with various health risks, highlighting the importance of monitoring and regulating PFAS to protect human and environmental health. PFAS has been linked to:  

  • Cancer  
  • Immune system dysfunction  
  • Reproductive issues
  • Elevated blood cholesterol levels  
  • Greater risk of high blood pressure  
  • Increased risk of thyroid disease  
  • Lower infant birth weight

Given their widespread use, most people have been exposed to PFAS at some point in their lives. According to the U.S. Centers for Disease Control and Prevention (CDC), nearly all individuals in the U.S. have detectable levels of PFAS in their blood. This widespread exposure, coupled with the associated health risks, has made PFAS a global regulatory priority. Governments and health organizations around the world are focusing on reducing exposure and managing the risks posed by these persistent chemicals. 

Where are PFAS found in the environment? 

The same chemical properties that make PFAS useful in everyday products also contribute to their environmental persistence, earning them the name "forever chemicals." Due to their strong bonds, PFAS break down exceptionally slowly, leading to widespread accumulation in various environmental mediums. 

Places where PFAS contamination is prevalent include:  

Water 

PFAS frequently contaminate water sources like rivers, lakes, and groundwater through industrial discharges, landfill runoff, and the use of firefighting foams. Additionally, PFAS found in consumer products can leach into wastewater streams and be carried into water treatment plants. 

Soil 

PFAS accumulate in soil through runoff, atmospheric deposition, or direct application, eventually leaching into groundwater or being absorbed by plants. 

Air 

Water treatment plants generate effluent and biosolids which then can be contaminated with PFAS. PFAS-contaminated biosolids, often disposed of in landfills, can create further environmental hazards by generating contaminated dust, which can be dispersed by wind and inhaled by humans. Additionally, PFAS can enter the air during manufacturing or from contaminated soil and water, traveling long distances before being deposited onto land and water surfaces via precipitation.  

Food 

PFAS enter the food chain via contaminated water, soil, and air, leading to their accumulation in products like fish, meat, dairy, and crops irrigated with tainted water or grown in PFAS-contaminated soil. 

This persistence across multiple environmental pathways underscores the urgency of regulatory action to control PFAS pollution and protect ecosystems and human health. 

What products contain PFAS? 

Due to their unique qualities, PFAS are desirable in many consumer products. These products include:  

  • Nonstick cookware: Teflon coatings 
  • Waterproof clothing: outdoor apparel like jackets and boots treated with water repellents 
  • Stain-resistant fabrics: carpets and upholstery treated to resist spills 
  • Food packaging: grease-resistant materials in wrappers and pizza boxes 
  • Firefighting foams: Aqueous Film Forming Foam (AFFF) used for fire suppression 
  • Personal care products: water-resistant cosmetics and dental floss 
  • Electronics: essential for semiconductors and circuits 

What are specific regulations regarding PFAS? 

There are various regulations pertaining to PFAS substances worldwide due to the growing concern of PFAS contamination in the environment. Regulations like The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) in the European Union (EU) and laws like Maine’s consumer products PFAS law in the United States (U.S.) are aimed at reducing PFAS exposure and contamination.  

Key global PFAS rules and regulations include:  

U.S. TSCA Section 8(a)(7)  

The Toxic Substances Control Act (TSCA) Section 8(a)(7) requires manufacturers and importers to report on their use of PFAS dating back to 2011. This rule is designed to help the U.S. Environmental Protection Agency (EPA) gather the largest-ever database of PFAS data in the country, enabling a better understanding of PFAS production, use, and exposure. The collected information will support the development of future regulations and policies aimed at reducing PFAS-related risks and contamination across industries. 

U.S. PFAS Reporting Under TRI  

Under the Toxics Release Inventory (TRI) program, certain PFAS are classified as "chemicals of special concern" and are subject to mandatory reporting. This rule helps the EPA gather detailed data on the release and waste management of PFAS across industries. The collected information provides critical insights to better assess environmental impacts and develop future strategies for managing PFAS contamination. 

EU POPs 

The EU Persistent Organic Pollutants (POPs) Regulation bans or restricts POPs, including PFAS, from being produced or used within the EU market. Manufacturers, importers, and sellers must monitor and report their use of these substances to EU Member States. The regulation aims to mitigate the environmental and health risks associated with these long-lasting chemicals, helping the EU manage and eventually eliminate harmful pollutants. 

EU REACH 

Under REACH Article 33, EU manufacturers, producers, and importers are required to declare the presence of Substances of Very High Concern (SVHCs) if they exceed 0.1% weight by weight (w/w) at the article level. To comply, companies must at least provide the name of the SVHC and any relevant safe-use information. While there’s no specific template for REACH declarations, companies can submit safety data sheets, certificates, or test reports. The SVHC list is updated biannually, so companies need to consistently collect and update data to remain compliant. This ensures transparency for both supply chain partners and consumers. A 45-day consultation process is required before a substance can be identified to belong on the SVHC list. Addition to the list makes a substance a candidate to be included in the REACH Authorization list.  

What are the 3 groups of PFAS included in the EU REACH SVHC list?    

Under REACH regulations, three key groups of PFAS are included in the SVHC list:  

  • 2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts, and its acyl halides (HFPO-DA) 
  • Perfluorobutane sulfonic acid (PFBS) and its salts 
  • Perfluoroheptanoic acid (PFHpA) and its salts 

The ammonium salt of HFPFAS STRUCT, which includes substances with defined structures based on specific substructural filters and fluorine content 

PFAS DEV, which consists of PFAS without explicit structures, such as polymers and other UVCB chemicals.  PO-DA, also known as GenX, is used as a substitute for PFOA. PFBS is an alternative to PFOS, while PFHpA is an alternative to legacy carboxylic PFAS in general. Regarding the proposed EU REACH PFAS restrictions, there may be exemptions lasting up to 12 years, with ongoing updates to the phase-out schedule available in the Annex XV proposal.      

Can you clarify the understanding behind the addition of the CompTox “PFAS STRUCT” and “PFAS DEV” lists?  

The original EPA CompTox Master list of PFAS was split into two categories:

  1. PFAS STRUCT, which includes substances with defined structures based on specific substructural filters and fluorine content
  2. PFAS DEV, which consists of PFAS without explicit structures, such as polymers and other UVCB chemicals.  

These lists differ from the TSCA 8(a)(7) rule, with only the CompTox and SRS PFAS 8a7 lists directly relevant to that regulation. The PFAS STRUCT list focuses on compounds with a combination of ≥30% fluorine and a specific substructure, while the PFAS DEV list captures broader chemical groups using key substrings. 

What actions are included in the EPA’s Strategic Roadmap for addressing and regulating PFAS?  

The EPA's Strategic Roadmap for regulating PFAS includes several key actions aimed at reducing contamination and exposure: 

  • Set primary drinking water standards for PFOA and PFOS 
  • Designate PFOA/PFOS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA
  • Tighten reporting requirements under TSCA 
  • Regulate PFAS as hazardous air pollutants under the Clean Air Act 
  • Establish effluent limits for PFAS under the Clean Water Act 
  • Designate PFAS as hazardous constituents under the Resource Conservation and Recovery Act 

    These actions are part of the EPA's efforts to address PFAS risks. 

Make compliance simple with Source Intelligence’s PFAS solution 

Keeping up with constantly evolving PFAS regulations can be challenging, especially in the ever-evolving regulatory landscape. This complexity often increases internal company burdens and exposes your company to risk. Our automated software helps you streamline PFAS compliance and mitigate risk by gathering Full Material Declarations (FMDs) and substance data, providing real-time compliance insights, and generating compliance documentation. Backed by our in-house regulatory experts, our PFAS solution stays up to date with emerging regulations, making your path to compliance seamless.