The U.S. Environmental Protection Agency (EPA) has finalized a reporting and recordkeeping rule that applies to any U.S. manufacturer or importer of per- and polyfluoroalkyl substances (PFAS) and “articles” containing PFAS, which are also called “forever chemicals.”

To comply with the Toxic Substances Control Act (TCSA) under provisions of the 2020 National Defense Authorization Act, the EPA is requiring all covered entities to submit information on PFAS environmental or health effects and data on uses, production volumes, byproducts, disposal and exposures that occurred at any time since Jan. 1, 2011. Violators may be subject to penalties under the TSCA.

Large, covered entities will have 18 months and smaller companies that are mainly importers will have 24 months from the date the final rule is published in the Federal Register to submit their reports to the EPA (Refer to the pre-publication version). In addition to manufacturing, other industries expected to be affected by the rule include construction, wholesale and retail trade, and waste management and remediation services.

Unlike specific chemicals with potentially toxic health effects, OSHA does not regulate PFAS as a class of chemicals. In its guidance on PFAS exposures, testing and clinical follow-up, the National Center for Biotechnology Information reports that PFAS are comprised of more than 12,000 different compounds with various chemical properties.

PFAS are characterized as “forever chemicals” because they can persist in the human body and the environment. They are widely used in industrial applications and a broad range of products because of distinct properties such as resistance to water, oil, grease and heat, and their ability to reduce friction.

Community exposure to PFAS may occur through drinking water, air, soil, food or consumer products. (The EPA has proposed related drinking water regulations.) The National Institute for Occupational Health and Safety reports that workers might be exposed to PFAS in ways that are different from the general public, such as by touching concentrated products or breathing fumes containing PFAS. Occupations with high exposure risk include chemical manufacturing and firefighting.

How Will the Data Be Used?

In a press release, the EPA said the rule will produce actionable data that can be used to craft policies and laws that protect people from exposure to PFAS that are defined in the final rule by their chemical structure. At least 1,364 substances meet the agency’s structural definitions.

The EPA has evaluated costs and benefits and provided an economic analysis of potential impacts of the rule. The Federal Register pre-publication notice states:

“The primary benefit of this rule is providing EPA with data on PFAS which have been manufactured, including imported, for commercial purposes since 2011; the agency is not currently aware of any similar source of information for these substances of interest. Subsequently, EPA will use these data to support activities addressing PFAS under TSCA, as well as activities and programs under other environmental statutes. The additional data on the production, use, exposure, and environmental and health effects of PFAS in the United States may allow EPA to more effectively determine whether additional risk assessment and management measures are needed. This information may lead to reduced costs of risk-based decision making and improved decisions concerning PFAS.

According to the Centers for Disease Control and Prevention, research on the cause-and effect relationship between measurable levels of PFAS in blood and harmful health effects in people suggest that high levels of certain PFAS may increase risk for liver disorders, kidney or testicular cancer, and high level of cholesterol, which increases risk for hypertension and other cardiovascular conditions. It is also linked to immune system effects, high blood pressure in pregnant women and lower than average infant birth weights.

What to Do

The reporting rule will produce the largest-ever dataset of PFAS and PFAS-related materials manufactured imported into and used in the U.S. Collecting and reporting retrospective data is expected to be a daunting task for some covered entities.

Attorneys with the national business law firm Morgan Lewis recommend getting started now to understand what is required. They advise covered employers to begin collecting and organizing necessary data and planning for foreseeable next steps after their report is submitted.

“In addition to informing potential PFAS-related regulation and enforcement actions, publicly accessible reports (apart from redactions of business-sensitive information), may influence public perception of products and businesses. Responding to these challenges will require careful consideration and preparation to mitigate both legal and business risks,” Jeremy Esterkin and Stephanie Feingold, partners at Morgan Lewis, write in an Oct. 3 Lawflash post.

WorkCare’s occupational health clinicians and industry subject matter experts are monitoring these developments and are prepared to advise clients on next steps. Contact us: info@workcare.com.