The recent announcement from the Environmental Protection Agency (EPA) that it is delaying implementation of a new PFAS reporting rule has some breathing a sigh of relief. Although those concerned about the presence and impact of these “forever chemicals” would likely rather see the much more stringent reporting requirements enacted sooner rather than later — the EPA says it doesn’t currently have the budget to build the software needed for implementation.
Here, we’ll take a look at:
- What PFAS refers to
- Potential health impacts
- Recent related research
- The new PFAS reporting rule and timeline
What are PFAS?
Also referred to as per- and polyfluoroalkyl substances, the EPA says PFAS are “widely used, long lasting chemicals, components of which break down very slowly over time.”
The agency provides the following PFAS facts:
- Since they are widely used and persistent in the environment, many PFAS are “found in the blood of people and animals all over the world and are present at low levels in a variety of food products and in the environment.”
- PFAS are found “in water, air, fish, and soil at locations across the nation and the globe.”
- According to scientific studies, “exposure to some PFAS in the environment may be linked to harmful health effects in humans and animals.”
“There are thousands of PFAS chemicals, and they are found in many different consumer, commercial, and industrial products,” EPA says. “This makes it challenging to study and assess the potential human health and environmental risks.”
Potential health impacts of PFAS
According to the Agency for Toxic Substances and Disease Registry (ATSDR), ongoing research seeks to better understand how PFAS toxicity occurs. However, the epidemiological evidence “suggests associations between increases in exposure to (specific) PFAS and certain health effects,” ATSDR says. The agency describes them in relation to specific PFAS:
- Increases in cholesterol levels (PFOA, PFOS, PFNA, PFDA)
- Lower antibody response to some vaccines (PFOA, PFOS, PFHxS, PFDA)
- Changes in liver enzymes (PFOA, PFOS, PFHxS)
- Pregnancy-induced hypertension and preeclampsia (PFOA, PFOS)
- Small decreases in birth weight (PFOA, PFOS)
- Kidney and testicular cancer (PFOA)
ATSDR says health risks associated with PFAS are dependent on:
- Exposure factors (e.g., dose, frequency, route, and duration)
- Individual factors (e.g., sensitivity and disease burden)
- Other determinants of health (e.g., access to safe water and quality healthcare)
“At this time, scientists are still learning about the health effects of exposures to mixtures of different PFAS,” the agency says. “Additional research may change our understanding of the relationship between exposure to PFAS and human health effects.”
In its resource for clinicians, ATSDR says ingestion of contaminated food and water is a main route of PFAS exposure.
“Communities with documented PFAS contamination in drinking water supplies or food are often near facilities that have manufactured, used, or handled PFAS; these include some factories, airports, military bases, wastewater treatment plants, farms where sewage sludge was used for fertilizer, landfills, or incinerators,” the agency says. “Other PFAS exposure sources include PFAS-containing consumer products and workplaces that manufacture, use, or handle PFAS.”
USGS tap water study
In July 2023, the U.S. Geological Survey (USGS) released the results of a first-of-its-kind study revealing that at least 45% of the nation’s tap water is estimated to contain one or more types of PFAS. Of the more than 12,000 types — which cannot all be detected with current methods — the USGS tested for the presence of 32.
“USGS scientists tested water collected directly from people’s kitchen sinks across the nation, providing the most comprehensive study to date on PFAS in tap water from both private wells and public supplies,” said USGS research hydrologist Kelly Smalling, the study’s lead author. “The study estimates that at least one type of PFAS – of those that were monitored – could be present in nearly half of the tap water in the U.S. Furthermore, PFAS concentrations were similar between public supplies and private wells.”
On April 10, 2024, the EPA announced the “first-ever national legally enforceable drinking water standard for PFAS, which will protect 100 million people from PFAS exposure, prevent tens of thousands of serious illnesses, and save lives,” according to a White House fact sheet. “…As the first-ever Safe Drinking Water Act standard for PFAS – and the first for any new contaminants since 1996 – this rule sets health safeguards and will require public water systems to monitor and reduce the levels of PFAS in our nation’s drinking water and notify the public of any exceedances of those levels.”
SEAS research
On October 16, 2024, researchers from The Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) announced the findings of a new study which found that fish can “accumulate high levels of per- and polyfluoroalkyl substances (PFAS), even far from sources of contamination…” — which SEAS says underscores the need for more monitoring.
“This study underscores the urgent need for more comprehensive monitoring of PFAS in aquatic ecosystems, particularly in regions where freshwater fishing is an important food source for recreational and subsistence fishers,” said Elsie Sunderland, the Fred Kavli Professor of Environmental Chemistry and Professor of Earth and Planetary Sciences at SEAS and senior author of the study. “The public health risks posed by PFAS extend beyond immediate contamination sites and can affect communities living far from known sources. To protect these communities, it is crucial to measure PFAS in fish at sites that are hydrologically connected to known contamination sources and to develop consumption advisories.”
SEAS says PFAS include thousands of synthetic chemicals that are popular due to their “stain-resistant, water-resistant, and non-stick properties” and are widely used.
“They have seeped into our water, soil, and food, and can be found in more than 98-99% of Americans,” the announcement says, noting that although EPA has established federal drinking water standards for six PFAS chemicals linked to adverse health outcomes, “there are no federal guidelines for PFAS in food.”
For more details about the study, please see the announcement.
EPA’s new PFAS requirements
In a summary of the new PFAS Rule, the EPA says it has “finalized reporting and recordkeeping requirements for Per- and Polyfluoroalkyl Substances (PFAS) under the Toxic Substances Control Act (TSCA).”
According to the new requirements:
- “…any person that manufactures (including import) or has manufactured (including imported) PFAS or PFAS-containing articles in any year since January 1, 2011, to electronically report information regarding PFAS uses, production volumes, disposal, exposures, and hazards.”
- “Any entities, including small entities, that have manufactured (including imported) PFAS in any year since 2011 will need to report their data to EPA through Central Data Exchange (CDX).”
- “When the submission period begins, manufacturers will have six months to provide their data.”
- “Small manufacturers (as defined at 40 CFR 704.3) whose reporting obligations under this rule are exclusively from imported articles will have an additional six months to report PFAS to EPA.”
Reporting period update
Although the reporting period for the new PFAS rule was scheduled to begin on November 12, 2024, the EPA announced a direct final rule and a parallel proposed rule in September 2024 to delay the beginning of the reporting period until July 2025 due to “budgetary constraints.”
“EPA’s TSCA program has had resource constraints for years, which has delayed a number of important efforts, including full implementation of this rule,” the agency said. “In March 2024, the Fiscal Year (FY) 2024 program area budget that includes EPA’s TSCA program was reduced by $5 million compared to what was enacted in the FY 2023 budget …”
EPA said the budget reductions “stopped ongoing software development and negatively impacted operations and maintenance activities associated with both CDX and TSCA CBI-based applications, which are critical to the Agency’s TSCA data collections, including for this rule” — which means the software needed to collect the massive amounts of PFAS data wouldn’t be ready in time for the original November 2024 opening of the reporting period.
“This direct final rule changes the data submission period to open on July 11, 2025, when the Agency expects the software reporting application to be fully functional,” EPA said. “Most reporters would be required to complete all reporting by January 11, 2026. Small businesses reporting data solely on importing PFAS contained in articles will have until July 11, 2026, to submit reports.”
The Final Rule regarding changes to the submission periods as published in the Federal Register is available here.
