Here are four key reasons why your organization may ultimately find it surprisingly difficult to secure the PFAS data to comply with TSCA Section 8(a)(7).
In the last few years, concepts like ESG, sustainability, and decarbonization have transitioned from buzzy media talking points to formidable business frameworks with real valueâand real consequencesâfor a broad swath of industries.Â
While chemical regulations havenât received that same level of public attention, theyâve had a similar trajectory. As public awareness around chemical regulations has grown, so too have leading governments, powerful regulatory agencies, and some of the foremost organizations and advocacy groups in the nonprofit sector have grown progressively more focused on the tens of thousands of chemicals that now permeate nearly every aspect of our lives.Â
Nowhere is this surge in concern greater than with per- and polyfluoroalkyl substancesâor, as theyâre more commonly known, PFAS. This family of nearly 15,000 chemicals possess a number of highly desirable properties, including impressive durability, resilience, and resistance to heat, water, stains, and oil. These characteristics have made them ideal to use in everything from nonstick cookware and food packaging to cleaning supplies and waterproof clothing. But as weâve started coming to grips with the chemicalsâ more adverse traitsâwhich include a litany of health complicationsâa number of nations and governing bodies are starting to rachet up regulations around them.Â
The U.S., for its part, has started making PFAS a central focus of its environmental regulation. Under the Biden Administration, the EPA has established a âStrategic Roadmapâ to better understand and combat the pervasiveness of PFAS. As part of that roadmap, the agency has provided billions in emergency funding to address and remediate PFAS contamination; proposed a national standard for PFAS in drinking water; and introduced a significant new use rule (SNUR) severely restricting the use of 329 currently inactive PFAS. Â
This past fall, the EPA took an important step in its effort to grasp the full scope of these chemicalsâ usage within commercial industries. On October 11, the agency issued a rule under the Toxic Substances Control Act Section 8(a)(7): Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances. The new TSCA rule requires all businesses manufacturing or importing any one of around 1,400 PFAS to submit an exhaustive report to the EPA. (In addition to the new TSCA PFAS requirements, some individual states are currently in the process of drafting bills that would implement outright bans on specific PFAS. While much of this legislation is a few years away, the most prudent, anticipatory businesses are already mapping out strategies for removing PFAS from their products.)Â
TSCAâs new PFAS reporting requirements are a onetime compliance obligation. Businesses must retroactively report on their PFAS usage for the 12-year period from January 1, 2011 through December 31, 2022. Some of the information covered entities are being asked to procure include the common name, CAS, and chemical composition of the PFAS in use; the total volume of the chemical being manufactured or imported; maximum concentrations of the compound in products; and any byproducts from manufacturing and its disposal processes. (Our article from February covers the new TSCA rule in greater detail.) Businesses will have around 18 months to submit their PFAS reporting: the rule went into effect in November 2023, and the window for reporting is set to close in May 2025. Certain smaller manufacturers are being given six additional months to fulfill reporting requirements, with their window closing in November 2025.Â
The EPAâs new PFAS requirements may seem relatively straightforward, if onerous, on their face. But some companies could eventually find themselves struggling to obtain all the necessary data exclusively by searching in-house. In the final rule issued by the EPA last year, the agency stipulated that organizations may need to carry out due diligence measures to âfill gaps in the submitterâs knowledge.â These measures may entail reaching out to âupstream suppliers or downstream users or employees or other agents of the manufacturer, including persons involved in the research and development, import or production, or marketing of the PFAS.âÂ
Such ad-hoc, scattershot outreach efforts are hardly guaranteed to go off without a hitch. Many of the covered businessesâ suppliers, after all, may not be subject to the same legal PFAS reporting requirements, and thus will be far less incentivized to comply with requests from businesses. More broadly, there are a number of other reasons why your organization may ultimately find it surprisingly difficult to secure the PFAS data to comply with TSCA Section 8(a)(7)âand, in some cases, to begin preparations for state-level bans.Â
Some manufacturers in your supply chain may be smaller outfits limited by fewer personnel, finite resources, and an overall lack of available company bandwidth. If your supplier is an SME, the organization probably doesnât have a dedicated compliance team, or even an individual expert, with the time and expertise to regularly address PFAS reporting and other compliance-related requests from customers.Â
In instances like these, youâll likely find yourself chasing down your primary contact person, often a staff member in sales. That individual will then have to carry out their own reconnaissance efforts by reaching out to multiple different teams and departments at their organization. Further, the contact will almost certainly have a raft of other, more revenue-centric responsibilities within the company that they deem to be of greater urgency and importance than a retroactive data request.Â
Put simply, if the sales associate recognizes that the string of emails and phone calls theyâll have to be making at your behest will not be culminating in a sale, the request is going to be deprioritized.Â
One of the fastest and easiest ways for a supplier to communicate PFAS information to its customer is by providing them with a full material disclosure (also known as a full material declaration, or FMD). This comprehensive documentation breaks down all the substances and raw materials within a specific product or component. If your business is given a full material disclosure, it can quickly determine whether any PFAS are coming from the parts or products provided by that particular supplier, and complete the PFAS reporting requirements accordingly.Â
Alas, not all suppliers are overly eager to hand over their full material disclosure to just anybody submitting a request for it. In some cases, manufacturers may consider parts of the FMD highly sensitive, proprietary information that needs to be safeguarded within the company. Their FMDs, in other words, contain âtrade secretsâ that the business is loath to forfeit to external parties. Such trade secrets could include special materials, formulas, or manufacturing processes that are unique to the organization and serve as a kind of intellectual property, conferring economic value specifically by virtue of the fact that the company alone possesses the information. While FMDs may often be the surest, shortest path to PFAS data, if they contain anything the supplier might construe as trade secrets, itâs going to be exceedingly difficult to obtain them.Â
With influential bodies like the European Chemicals Agency (ECHA) and the EPA ramping up their regulations of PFAS, and the prospect of strict prohibitions on certain per- and polyfluoroalkyl substances firmly on the horizon, there would seem to be a large and obvious impetus on manufacturers to keep track of their PFAS use. Palpable progress on regulating the chemicals is not the same across all countries and regions of the world, however. For example, with the notable exception of Japanâwhich has banned the use of several PFAS and established maximum thresholds for the chemicalsâ presence in drinking waterâmuch of Asia has scant or altogether nonexistent PFAS regulations. Consequently, companies seeking to fulfill their reporting requirements by reaching out to suppliers in that region may find themselves navigating toward a dead end.Â
Manufacturers in regions with minimal PFAS oversight may not even be keeping track of their usage at all. As a result, their recordsâespecially as it pertains to a 12-year period beginning well over a decade agoâcould fall woefully short of what companies covered under the EPAâs PFAS reporting requirements are looking for. Fortunately, the TSCA rule accounts for circumstances in which data legitimately no longer exist or are seemingly impossible to procure. Covered businesses may indicate in their PFAS submissions that certain information is âNot Known or Reasonably Ascertainableâ (NKRA).Â
Z2Dataâs in-house compliance expert, Kelsey Brown, believes that carrying out due diligence measures, even those that donât bear meaningful fruit, is largely enough to achieve compliance. âAs long as the company makes the effort to contactâ their suppliers, she said, âtheir duties under the TSCA 8(a)(7) requirement will likely be fulfilled.â The agency cautions, however, that âReporting NKRA should only happen when data are truly not reasonably ascertainable or are unattainable.â
U.S. businesses seeking to learn more about the nature and extent of PFAS in their products may reach out to a direct supplier expecting the manufacturer to have the records theyâre looking for. But those companies will likely also have their own network of suppliers, making the process of procuring PFAS data more sprawling and convoluted than simply tapping a single contact. âItâs important to understand your supply chain,â Brown said. âUnderstanding where PFAS is most likely to be used will help identify high risk parts and point to strategies to fulfill duties to various PFAS regulations.
Companies determined to secure chemical dataâwhether for the TSCAâs PFAS reporting requirements or the impending state-level bansâwill need to map out their supply chains on a nuanced, even granular level to understand which direct and sub-tier suppliers to reach out to. This kind of complex due diligence legwork may feel needlessly intensive now. It will undoubtedly pay off, however, in a deceptively near-term future when these increasingly notorious chemicals are bridled with reporting requirements, maximum thresholds, outright bans, and other burdensome regulations.Â
Organizations struggling to obtain PFAS information from their suppliers for any of the above reasons do have a few contingency measures at their disposal. In order to address both the EPAâs PFAS reporting obligations over the next year and the innumerable challenges the chemicals will be snarled by in the latter half of the decade, many companies will conclude that securing detailed data is a critical priority. Those entities always have the option of paying for their own material reviews and chemical analysis via a third party chemical testing laboratory. While this course of action is often very expensive, it can be crucial to a companyâs compliance efforts. Further, it may also serve as an essential first step to potential reformulation decisions.Â
In addition to independent testing options, businesses that find themselves scrabbling to gain data from unresponsive or unaccommodating suppliers may want to consider modifications to their supply chains going forward. âEnvironmental compliance is not going away,â Brown said. For organizations looking to streamline data-gathering processes in the future, âit may be best to switch to more transparent suppliers.âÂ
Weâre still in the earliest stages of a large-scale push to identify, regulate, and eventually restrict the use of PFAS. Organizations practicing strategic foresight will see beyond the EPAâs onetime PFAS reporting requirements, to an era where regulatory compliance means embarking on multiyear phaseouts of these harmful chemicals and embracing ambitious plans for safer, more sustainable alternatives.Â
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