PFAS management and supply chain resilience
What does the increasing focus on PFAS restriction mean for industrial manufacturers?
A topic that has been the subject of new focus in recent years is the use of per- and poly-fluoroalkyl substances (PFAS) in various products. These chemicals possess some unique properties that make them excellent candidates for use in several products such as stain-resistant carpets and non-stick cookware. However, these properties also make them very resistant to breaking down, and highly toxic to humans and the environment. Governments around the world are therefore encouraging companies to phase out their non-essential use. However, this is not always simple, and has serious implications for supply chain resilience.
Changing rules on PFAS
Regulatory bodies and the public around the world have been pushing for the use of these substances to be eliminated. This has created a lot of uncertainty for industrial manufacturers. How can manufacturers ensure a resilient supply chain in the face of ongoing changes in regulations and requirements about PFAS?
An interesting aspect of the use of PFAS that has gained visibility through various studies is their unintentional addition to products. For example, if a manufacturer uses equipment or machinery containing PFAS, products manufactured using that machinery could be contaminated. The manufacturer might not even be aware that the equipment contains PFAS.
These substances are widely used, and any contamination at any point in the supply chain can contaminate the final product without the manufacturers’ knowledge. How do you manage something you don’t know exists? Transparency and accountability throughout the supply chain are therefore essential to ensure compliance with current and future regulations.
Several studies have also shown that drinking water and soil have been extensively contaminated by PFAS. This could affect the health of future generations. Eliminating this contamination will require a lot of resources, time, and technology. The recent focus has therefore been removing these substances at source.
Regulatory requirements on PFAS
Many governments and regional bodies have proposed bans on PFAS. For example, the EU has proposed a ban on producing and using about 10,000 PFAS. The prohibition would apply after 18 months but manufacturers that use PFAS where alternatives are not available would have longer extensions. The EU proposal currently provides an exemption for the pharmaceutical industry for packaging materials. This is not a long-term solution, and even these exempt industries will eventually have to find alternatives to PFAS.
In the US, the Toxic Substances Control Act TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances proposes reporting and recordkeeping requirements for manufacturers and importers of PFAS. These requirements retroactively apply to PFAS manufactured or imported since January 1, 2011.
Companies will have to report information on PFAS uses, production volumes, disposal, exposure, and hazards. The main goal of the regulation is to collect detailed data on PFAS to better understand exposure, potential human and environmental impact, research, and solutions needed to inform regulatory development.
Challenges of PFAS regulation
PFAS regulations place some serious challenges on manufacturers—in addition to existing issues such as the requirement for certifications. There are very real difficulties in developing alternatives. Companies and industries must find or develop materials with the required properties within quite a short space of time. In the pharmaceutical industry, new materials will have to comply with various regulations and be safe for the environment and human health. The ban on the use and manufacture of PFAS will affect production and distribution: effectively, the entire supply chain.
In the US, industrial manufacturers will have to submit detailed data on PFAS manufacture or use from as far back as 2011. Companies have to ensure that the information submitted is known or reasonably ascertainable by them. “Known” or “reasonably ascertainable” means “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” This means that manufacturers will have to look for and collect data available within their own organizations, but also throughout the supply chain, including third parties such as suppliers, importers, and companies involved in the distribution and marketing of PFAS. Companies must report on every component of their products, which is a complex set of information to collect. It is also unclear how the authorities would enforce “known” or “reasonably ascertainable” reporting standards.
Companies will also have to provide more than 20 subject-specific requirements, including representative molecular structures, the physical form of the chemical or mixture, and workers exposed to the manufacturing site. Reporting under this regulation will be similar to reporting under the Chemical Data Reporting (CDR) rule—although stricter because there are fewer exemptions and exclusions. However, the Environmental Protection Agency has not provided additional information, which is leading to confusion among companies.
In addition to the challenges of collecting data from a complex supply chain network, there is a significant financial burden to reporting, especially with a short time frame (6 months within the effective date of the rules). The rules estimate one-time reporting costs of up to $875 million for large businesses and up to $864 million for small businesses. These reporting requirements could be particularly burdensome for smaller businesses.
The proposed changes to Reporting Requirements for Per- and Polyfluoroalkyl Substances and to Supplier Notifications for Chemicals of Special Concern; Community Right-to-Know Toxic Chemical Release Reporting (87 FR 74379) would eliminate the de minimax exemption for small quantities of PFAS that are listed as Chemicals of Special Concern. This means that industrial manufacturers that manufacture, process, or otherwise use PFAS would have to report these substances regardless of their concentration in products. This will bring more and more manufacturers within the scope of the regulations.
Delivering supply chain resilience in the face of PFAS regulations
Manufacturers also need to avoid supply chain disruptions as they prepare to comply with changing US and EU legislation on PFAS. Identification of PFAS in the supply chain can be very complex because there are over 10,000 of these chemicals, and the risks of many are still unknown. It would be prudent for manufacturers to start work now to comply with these regulations, and particularly to phase out PFAS use.
There will be massive competition for PFAS-free alternatives. Redesigning and reorienting processes, products, or operations may require a lot of time and resources. One useful option could be to establish a chemical management system across the supply chain. This could help companies to identify suppliers and switch to greener sources, and monitor and test products on an ongoing basis, especially for unintentionally added PFAS.