Tag: Product Compliance

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The Impact of PFAS ‘Forever Chemicals’ in Product Compliance

I recently had the opportunity to visit with Cally Edgren, a Senior Director of the Regulatory Expert team at Assent, who has nearly three decades of experience in manufacturing and has dedicated her career to helping manufacturers comply with regulations. We took a deep dive into the next serious matter for product compliance, forever chemicals. Every compliance professional needs to be aware of this upcoming issue for product manufacturers.

PFAS chemicals, commonly known as ‘forever chemicals’, have been used in manufacturing for approximately 85 years due to their durability and resistance to water and oil. However, these chemicals have been linked to various health effects and have been detected in water supplies and soil contamination. As a result, regulators and litigators are focusing on incorporating PFAS chemicals into regulatory instruments and holding manufacturers accountable for their use.

States like Maine and Minnesota have taken proactive measures by implementing laws to restrict the use of PFAS chemicals. For instance, Maine has released a law that requires all manufacturers selling products in the state to register any PFAS use in those products and pay a fee for registration. By the year 2030, the state plans to ban the use of PFAS in all products sold unless it is deemed an essential use by the Maine Department of Environmental Protection. Minnesota has followed suit, with even more aggressive regulations, including a reporting rule in 2026, a full PFAS ban in 2032, and a prohibition on certain products containing PFAS starting in 2025.

Manufacturers now face the challenge of assessing their supply chain to ensure compliance and avoid potential disruptions. The discontinuation of PFAS production by major manufacturer 3M by the end of 2025 poses a significant risk for manufacturers, as it could lead to supply chain disruptions. It is crucial for manufacturers to consider the broader risks associated with PFAS contamination and take proactive measures to assess their supply chain and find alternative solutions.

The Toxic Substance Control Act (TOSCA) is the primary chemicals management regulation in the United States. Under TOSCA, a recent requirement calls for the creation of an inventory of PFAS use in the country. This inventory will provide valuable information for regulators and manufacturers to better understand the extent of PFAS usage and its potential impact on human health and the environment.

One of the challenges in addressing PFAS regulation is the limited availability of test methodologies. With tens of thousands of different PFAS chemicals, there are only test techniques available for approximately 50 to 60 of them, mostly restricted to drinking water testing. As a result, regulators, including the Environmental Protection Agency (EPA) and the state of Maine, suggest inquiring via the supply chain to determine if PFAS chemicals have been added to products. This approach involves asking suppliers about the presence of PFAS in the materials they sell and understanding the specific PFAS chemicals and concentrations involved.

The regulation of PFAS chemicals differs from previous materials regulations due to additional factors beyond regulatory compliance. Litigation and financial implications surrounding PFAS are growing concerns for manufacturers and companies. While litigation primarily targets the manufacturers of PFAS, it is starting to extend to companies that use these chemicals in their products. This shift in litigation poses a significant risk for manufacturers, as they may face legal consequences and reputational damage.

Considering the potential supply chain disruptions and litigation risks, manufacturers cannot solely rely on assessing the impact of regulations. Waiting to see how regulations unfold may ignore the bigger risk of supply chain disruptions caused by the discontinuation of PFAS production. Manufacturers must take a broader approach to assess the impact of PFAS, considering the potential disruptions to their operations and the availability of alternative materials.

The regulation and impact of PFAS ‘forever chemicals’ in manufacturing require a careful balance of various factors. While the health concerns associated with PFAS chemicals are significant, manufacturers must also consider the potential disruptions to their supply chain and the financial implications of litigation. By proactively assessing their supply chain, exploring alternative materials, and staying informed about evolving regulations, manufacturers can navigate the challenges and make informed decisions that prioritize both human health and operational sustainability.

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Supply Chain and ESG – What You Need to Know: New World of Product Compliance and ESG

I recently had the opportunity to visit with several folks from Assent Inc. for a sponsored podcast series entitled Supply Chain and ESG – What You Need to Know. We discussed: ESG drivers with Jared Connors and James Calder; UFLPA, Supply Chain and ESG with Travis Miller and Jamie Wallisch; the New World of Product Compliance and ESG, with Cally Edgren and Devin O’Herron; Emissions Reporting Strategies with Devin O’Herron and Jared Connors; and Responsible Minerals, Supply Chain and ESG, with Jared Connors and Daniel Zamora. Today we look at the new world of product compliance and ESG.

I certainly see safety as a key component of the ‘S’ in ESG. However, I had always focused on worker safety and perhaps greater environmental safety. Yet consumer product safety is also a component of the ‘S’. This is not new but combines topics and regulatory concerns in product compliance which have been gaining in importance for the past 20 years.

Edgren began with explaining that product compliance is a discipline focused on ensuring that products meet regulatory requirements where they are sold. Further, there is an evolution of those regulatory requirements. Product regulatory compliance used to be more traditionally things like electrical safety or mechanical safety, but then back in 2002, the Regulatory of Hazardous Substances (RoHS) came along. The RoHS directive applied design criteria to electrical products. The significance of this was that for purposes of the RoHS directive, it was not just tied to the safety of the user as traditional product compliance regulations were; it was actually tied to the safety of the third world countries, where the electronic waste ends up.

This created a regulatory obligation with more of a sustainability focus behind it versus the traditional product safety. Over the last 20 years there has been a tremendous explosion of these types of regulatory obligations. These aren’t just nice to do things. Edgren pointed to an example of the European Union’s (EU) Ecodesign Directive which established a framework to set mandatory ecological requirements for energy-using and energy-related products sold in all 27 member states. She noted, “both of these regulations, the RoHS directive and the EU Ecodesign Directive require compliance, or you cannot sell in locations where they are effective.” This is where the product compliance bridge comes back into the area of greater sustainability or environmentally focused regulations.

O’Herron expanded on this by noting, “there’s a lot of connection directly to the E in ESG with product compliance, as there’s a focus on environmental regulations and making sure that your products are meeting those environmental regulations.” But it is more than simply meeting regulatory expectations. He explained it “has to do with externalities. What are these costs of doing business? Not just the financial cost, which are fairly well established. It is the social and environmental costs as well, which have not “traditionally been quantified.”” He provided the example of the “environmental social cost involved with the disposal of toxic chemicals at the end of their life in electronics is unacceptable. We are becoming increasingly aware of the importance and relevance of these externalities and the barrier that they present towards sustainability, environmental, social, and governance metrics represent another way of starting to measure and manage those externalities.”

One of the greatest benefits to ESG, has been not simply the realization of the inter-connectedness of what were seemingly disparate areas of business. It is that companies are taking a much more holistic approach to looking at these issues. Edgren said we may not be there quite yet in the area of safety, but she believes it is an evolving process and dialogue. She said, “what I am seeing and what I have experienced, is we are starting to merge the environmental into the more traditional product safety. We are starting to elevate those conversations which in reality, are just different pieces of the same whole puzzle. We are starting to have those conversations. I don’t think that industry is a hundred percent there yet of connecting product safety to ESG, but that’s certainly part of the message that we are highlighting.”

It is this realization of inter-connectedness that may be the most import consequence from an overall corporate ESG approach. In 2020, the Department of Justice (DOJ) released the Update to the Evaluation of Corporate Compliance Programs which mandated that the corporate compliance function have access to all corporate data. No more siloes for compliance. When you take that attitude and apply it to an ESG framework, you begin to see the power of integrating all these data points to make your overall business more robust, more resilient and more cohesive.

Join me tomorrow where look at a Scope 3 emissions reporting strategy.

To listen to the podcast this blog post is based upon, click here.