December 27, 2022
We are pleased to have the opportunity to share our views with the Environmental Protection Agency (EPA) about their draft reporting and recordkeeping requirements for perfluoroalkyl and polyfluoroalkyl substances (PFAS).
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
Recordkeeping and reporting are vital steps toward managing PFAS in consumer products, because these chemicals can be harmful to human health and the environment. Examples of risks include increasing the likelihood of children developing obesity, early puberty, and attention disorders, pregnant women developing preeclampsia, and contaminating drinking water and soil for neighborhoods and communities.1 The draft is a step forward but does not go far enough. Here are our recommendations to strengthen reporting and recordkeeping requirements.
1) EPA’s recordkeeping start date of Jan 1, 2011 will not account for all PFAS in our environment, since these chemicals have been documented in products in the U.S. since the 1950s.2 Unfortunately, failure to account for these chemicals prior to 2011 fails to provide information about decades of potential exposure. We recognize that the failure to require recordkeeping prior to 2011 and failure to enforce recordkeeping requirements since 2011 results in a greater burden on companies going forward. However, companies who failed to comply with recordkeeping requirements since 2011 should not be rewarded by creating a loophole that enables them to avoid any additional information gathering to make up for that noncompliance.
2) The draft creates a loophole that is unacceptable: EPA states that manufacturers are responsible for providing documentation on their PFAS usage unless the company does not have records and “for whom certain information is not known or reasonably ascertainable.”3 EPA widens this loophole further by recommending but not requiring companies to submit documentation on why they are missing these records. This invites the companies to fail to comply, and so this loophole is likely to be abused by many manufacturers that will disingenuously claim they lost or never recorded the PFAS information, when in fact they just choose not to look for and share those records. This loophole also clearly provides a disincentive to provide information that could potentially be used to criticize the company. To reduce reliance on this loophole, EPA should require a substantial penalty for companies that do not comply, and an additional penalty for companies that do not adequately explain why they are missing or not submitting documents.
3) We applaud EPA’s decision to encourage manufacturers to describe the PFAS if it is not already on the list of known PFAS substances; however, EPA needs to require more accountability by enforcing this regulation. The EPA states that companies have the option to register an unknown chemical with a CASRN or other identifier; this should be required and enforced, not optional. To obtain accurate records and create incentives for companies to comply rather than ignore EPA’s requirements, EPA needs to ensure that all possible PFAS chemicals are accounted for. Requiring more details about the chemical substance and creating a registration number (if one is not already present) facilitates easier identification and less administrative waste now and in the future.
4) We strongly support the EPA requiring reporting entities to assess their knowledge of PFAS. This requirement helps hold companies accountable for their actions, especially importers that may not have the same standards as companies in the United States. We urge the EPA to apply this requirement to all reporting parties, including chemical manufacturers and bulk importers, not just small entities. It is unwise to assume that large manufacturers understand these chemicals and will be more accountable.
5) Before enacting recordkeeping and reporting requirements for PFAS, there needs to be a universal standard in the U.S. Currently, there is “no single, widely accepted standard procedure to identify regulated chemicals in supply chains”3 and it seems logical that EPA should develop that standard procedure. Without such standards, the EPA cannot ensure that this process will be accurate or efficient in protecting individuals or the general public.
Thank you for considering our recommendations. The National Center for Health Research can be reached at firstname.lastname@example.org or at (202) 223-4000.
1. Seymour M. What Are PFAS Chemicals and Why Are They dangerous?. center4research.org. https://www.center4research.org/what-is-pfas-and-why-is-it-dangerous/
2. Interstate Technology and Regulatory Council. History and Use of Per- and Polyfluoroalkyl Substances (PFAS) found in the Environment. Pfas-1.itrcweb.org. https://pfas-1.itrcweb.org/wp-content/uploads/2020/10/history_and_use_508_2020Aug_Final.pdf. August, 2020.
3. Office of Pollution Prevention and Toxics. Initial Regulatory Flexibility Analysis and Updated Economic Analysis for TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances. United States: U.S. Environmental Protection Agency; November 2022 https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0549-0125