Perfluorinated chemicals, which include perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), have been widely used in manufacturing since at least the late 1940s. For many decades, regulators did not consider these chemicals to be of regulatory concern.
However, in the late 1990s and early 2000s, PFOA and PFOS were identified as "emerging chemicals" of potential regulatory concern due to findings of perfluorinated chemicals (PFCs) in the environment and human blood and a shift in regulatory science policies.
Manufacturers using PFCs should pay close attention to new regulations.
In November, PFOA and PFOS were listed by California as Proposition 65 chemicals "known to cause reproductive toxicity," based on the U.S. Environmental Protection Agency's issuance of drinking water guidance. Also, the New Jersey Water Quality Institute recommended a health-based drinking water standard of 13 parts per trillion for PFOS — many times lower than EPA's guidance level. Michigan just announced the establishment of a multiagency team to address PFC contamination.
The Interstate Technology & Regulatory Council has established a webpage and will release guidance for states to follow in PFC cases. Similarly, EPA and the U.S. Departments of Defense and Energy created a PFC website that compiles relevant toxicity. FDA has even banned the use of certain PFCs in food packaging, arguably based primarily on a precautionary science policy rather than on proof of causation.
These developments have accelerated the potential for more regulatory actions, particularly groundwater and soil remediation actions against not only manufacturers of PFOA and PFOS, but also companies that use PFCs in making products. If past is prologue, these regulatory actions are likely to trigger more personal injury and property damage lawsuits.
Companies vulnerable to these developments can take the following steps now to reduce business and legal risk:
• Companies that currently make or have historically made products containing PFCs — or even used products containing PFCs — may want to review their historical records and evaluate existing processes to assess the magnitude and likelihood of potential groundwater and soil contamination and/or the presence of PFCs in the company's products.
• For companies that sell products in California, a warning label is not required if the daily exposure to PFOA and PFOS in a product does not exceed the daily maximum acceptable intake level or "safe harbor" exposure level. However, determining daily exposures from a product requires converting a concentration of the chemical in the product into a daily amount of the chemical that enters the body of an "average" consumer. Furthermore, California has yet to issue a safe level and guidance on PFC remediation. Also, imported products may contain trace amounts, further complicating compliance. Unless one seeks a safe-use determination from the satate (an expensive and uncertain process), often the first time a company becomes aware that it may not be in compliance is on receipt of a private enforcer's notice letter.
• Those at risk should track regulatory developments and, if appropriate, comment on proposed regulations. Regulators have expanded their concerns beyond PFOA and PFOS. Advance preparation is important to an effective response, to make sure that any rule-making record is based on scientifically sound data and analysis.
• Companies should review supply chain contract and renegotiate out of compliance terms.
• Companies should consider establishing a step-by-step strategy to develop and implement defenses to liability for remediation of groundwater and soil contamination and/or defenses to potential personal injury or property damage liability claims.
William Walsh is a lawyer with Clark Hill plc in Washington specializing in environmental law compliance.
