EDF Health

FDA’s latest study reaffirms short-chain PFAS biopersist. Now it must act.

By Maricel Maffini, PhD, Consultant, and Tom Neltner, JD

Female rat nursing multiple pups

FDA study found biopersistent PFAS in female rats and their pups,

What Happened

In December 2023, FDA’s scientists published a new study showing that when pregnant rats ingest a form of per- and polyfluorinated alkyl substance (PFAS) called 6:2 fluorotelomer alcohol (6:2 FTOH) their bodies break it down into other PFAS that reach the fetuses and biopersist in the mother and the pups.

The study also showed that the body of a non-pregnant animal produces different breakdown products that also biopersist. This study is the latest evidence that the assumptions made about the safety of short-chain PFAS (chemicals with fewer than 8 carbons) have been wrong. Read More »

Posted in Adverse health effects, Chemical regulation, Emerging science, FDA, Health science, Industry influence, Public health, Rules/Regulations, Vulnerable populations / Tagged , , , , , , , , | Authors: / Comments are closed

Now’s the Time—How EPA can use TSCA to turn off the PFAS tap

Faucet with the word PFAS flowing out of it

In the face of mounting evidence about the dangers posed by per- and polyfluoroalkyl substances (PFAS), one thing is clear: EPA needs to take urgent action to turn off the tap of these “forever chemicals” that have long-term consequences for our health and the environment.

As we discussed in a previous blog, it is imperative that the Environmental Protection Agency (EPA) use the Toxic Substances Control Act (TSCA) to regulate PFAS chemicals comprehensively—both those newly entering the market and those that have been in circulation for decades.

Read More »

Posted in Chemical exposure, Chemical regulation, Cumulative impact, Cumulative risk assessment, Drinking water, Emerging science, Health policy, Public health, Regulation, Risk assessment, Risk evaluation, TSCA, TSCA reform, Vulnerable populations, Worker safety / Tagged , , , | Authors: / Read 2 Responses

EPA Should Use U.S. Chemical Safety Law to Turn Off PFAS Tap

The word

PFAS is a group of synthetic chemicals used in industrial processes and consumer products, including water-repellent clothing, such as outdoor wear, and food packaging. Once these “forever chemicals” are produced and used, they often make their way into the environment and our bodies. Many pose serious threats due to their toxic effects (often at trace levels) and their ability to build up in people, animals and the environment. Studies show that they are in almost all of us.

To make matters worse, people are exposed to multiple PFAS, not individual PFAS in isolation. Yet under the nation’s primary chemical safety law, EPA evaluates the safety of PFAS chemicals one at a time and does not consider the combined risks from exposures to multiple PFAS. Combined exposures increase the risk of harmful effects, thus magnifying the risks and the need for action.

Current Situation: All Costs, No Benefits

PFAS move easily throughout the environment and are difficult to destroy. They have contaminated drinking water, food, farms, wildlife, and the environment more broadly. At the local, state and federal levels, the U.S. is spending millions of dollars to clean up PFAS contamination. Some states, such as Michigan and Maine, are trying to recoup the costs their residents have had to bear to clean-up PFAS contamination of their water and land. The federal government is also taking action to address the widespread PFAS contamination. The costs for cleaning up PFAS contamination are imposed on society by the domestic producers, importers and users of PFAS who profit from their production and use.

Yet, despite the well-documented risks and costs to society of these chemicals, companies still continue to produce, import, and use PFAS. It is time to ban all PFAS or—if there are truly essential uses for these chemicals—limit how they are produced, imported and used so that their impact on us and the environment is minimal.

Urgent Need: Revisit, Reassess, and Regulate All PFAS

While EPA has recently tightened up approvals for new PFAS entering the market, it has yet to take significant action on those that are already on the market, which includes the hundreds of PFAS the agency approved over the past few decades. It is clear these PFAS have not been produced responsibly as demonstrated by the environmental contamination associated with many of the PFAS manufacturing facilities. And yet, many of these PFAS are still on the market. They are being produced and released into the environment, are in products we use every day, and continue to contaminate us and our environment.

Many of EPA’s approvals were made 10 to 20 years ago, before we had a full picture of the pervasiveness and degree of PFAS contamination. The data on the extent of the environmental contamination of these persistent PFAS, their ability to move through the environment, and the significant difficulty in destroying them was not as robust as it is today. Furthermore, mounting evidence shows that even trace levels of PFAS can cause developmental issues in children, reduced fertility, hormonal disruptions, and certain types of cancer.

In addition, these approvals did not consider risks to vulnerable groups, such as pregnant women and children as currently required by the law. Many communities are exposed to multiple PFAS, particularly those who live, work and play near where PFAS are made and used.

Addressing the production, import and use of PFAS would limit further pollution of our water supplies, safeguard the health of our communities, and be consistent with other strong EPA actions to address PFAS, including its recent robust proposed drinking water standards.

Effective regulation of these harmful chemicals at their source would also accelerate efforts to seek out and adopt safer alternatives. Leaving chemicals with such well-documented harms on the market makes it more difficult for innovative, safer substitutes to enter it. Failing to address these risks in effect puts a thumb on the scale in support of older harmful technologies.

Our Take

EPA should re-evaluate each of the PFAS it has approved. During that re-evaluation, EPA should use the best available science and consider the full picture of PFAS exposure. Considering each PFAS in isolation rather than the multiple PFAS people, particularly those in vulnerable groups, are exposed to will underestimate their risk.

EPA should use the Toxic Substances Control Act to take action to ban these legacy PFAS, or restrict them if the uses are truly essential, rather than continuing to allow the production, import and use of these demonstrably harmful “forever chemicals.”

Go Deeper

Learn more about EDF’s concerns about PFAS and read our follow-up blog  on how EPA can use TSCA to turn off the PFAS tap.

EPA’s information on PFAS

Posted in Chemical exposure, Chemical regulation, Contamination, Cumulative impact, Cumulative risk assessment, Emerging testing methods, Food, Food packaging, Health hazards, Health science, Public health, Risk assessment, Risk evaluation, TSCA, Vulnerable populations / Tagged , , , , , , , , , , , , | Authors: / Comments are closed

PFAS: EPA’s proposed notification requirements are a positive step, but exemptions will cause harm

Maria Doa, PhD, Senior Director, Chemicals Policy

The Good News

Using its authority under the Toxic Substances Control Act, EPA proposed a rule that would require companies to notify the agency before they produce or import a PFAS “forever chemical” that has not been used commercially since 2006.

These notifications are crucial because resuming production or import of these toxic chemicals would expose people to harm. The notification gives EPA an opportunity to evaluate these PFAS to determine if exposure during their lifecycle—production or import, distribution in commerce, industrial, commercial and/or consumer use, and disposal—is likely to pose an “unreasonable risk” to people or the environment.

The Not-So-Good News

EPA is proposing to exempt some parts of the PFAS lifecycle from the notification requirement if the PFAS are:

  • Part of certain types of products EPA designates as “articles”—such as carpets.
  • Impurities.
  • Byproducts used as fuels or disposed of as waste, including in a landfill or for enriching soil.

EPA also asked if it should go a step further by broadening the exemption and completely exempting the PFAS if they are byproducts with no commercial purpose on their own.

Why It Matters

Exempting any part of the PFAS lifecycle from EPA’s evaluation will result in PFAS exposure—no ifs, ands or buts. This is a big problem because small amounts of these chemicals can cause harm, and many PFAS remain in our bodies for months—or even years.

Our Take

In our comments on the proposed rule, Environmental Defense Fund said that because of the well-documented harms caused by PFAS, EPA should not allow exemptions.

The impurities and articles exemptions could have a significant impact. PFAS impurities can end up in both commercial and consumer goods (like cleaning products), leading to exposure when people use them, or unintentionally release them into the environment. PFAS can also leach out of articles through handling or weathering—exposing us and our environment.

The byproduct exemptions could have an even more significant impact. The broader exemption for PFAS produced “as a byproduct with no commercial purpose” is basically the same exemption that allowed the notorious Gen-X to be produced and released for years without any controls—contaminating the Cape Fear River and impacting the health and welfare of its residents. EPA should not allow this to happen with other PFAS.

In addition, EPA should not allow a narrower byproduct exemption either, as it would still exempt PFAS applied to soil for “enrichment” or burned as fuel. “Enriching” soil with PFAS-contaminated waste can pollute the land (including farmland), affecting the livelihood of farmers, the animals that graze on the land, and the food we eat. Burning it as a fuel is also likely to release PFAS into the air because the chemicals are so difficult to destroy.

These exemptions also are at odds with other EPA actions to address PFAS contamination, such as its recent strong and scientifically robust proposed drinking water standards.

What’s Next?

EPA should not allow any exemptions for these PFAS. EPA should ensure that it has the opportunity to review these PFAS and identify any unreasonable risks before they reenter the marketplace. Only by addressing PFAS early in the lifecycle can we limit the contamination and health harms they cause.

Posted in Frontline communities, Health hazards, Public health, TSCA / Authors: / Read 1 Response

The Case of the Missing PFAS

By Lauren Ellis, MPH, Research Analyst, Environmental Health and Samantha Liskow, Lead Counsel, Health

NOTE: In a recent blog post, EDF called for EPA to revoke PFAS approved through the agency’s “low volume exemption” (an LVE is an exemption from a full safety review for new chemicals produced in quantities less than ~10 tons) and to instead require all PFAS to undergo a full safety review under the Toxic Substances Control Act (TSCA). Last month, EDF and other groups, represented by Earthjustice, formally petitioned EPA to do just that.

What Happened: We recently discovered that EPA is withholding the names of over 100 PFAS chemicals approved as LVEs—claiming that releasing that information would reveal “confidential business information” (CBI).

Why It Matters: PFAS causes harm to both the environment and to human health—including reproductive, developmental, and cancer-related effects. Given growing concerns about the risks of PFAS, the public has the right to know if they are being exposed to PFAS, especially those approved through exemptions to EPA’s new chemical safety review process.

Our Take:

  • EPA should reveal the identities of the missing PFAS LVEs. If doing so would reveal CBI, EPA should work with PFAS manufacturers to craft a name that clearly communicates PFAS class membership.
  • EPA should require full safety review for all PFAS, including those previously approved through exemptions.

GO DEEPER… Read More »

Posted in Industry influence, Public health, Regulation, TSCA reform / Tagged , | Read 1 Response

Companies are not withdrawing PFAS exemptions on their own; EPA should

Samantha Liskow, Lead Counsel, Healthy Communities; and Lauren Ellis, Research Analyst, Environmental Health

EPA has committed to address the urgent issues presented by PFAS, a harmful class of human-made chemicals that are used widely in everyday products. Last July, as part of this effort, EPA called on companies to voluntarily withdraw some 600 PFAS that were previously allowed onto the market through a fast-track exemption process known as a “low volume exemption” (LVE).

Nearly a year later, however, less than 3% of these low volume per- and polyfluoroalkyl substances (PFAS) have been pulled from the market. That means manufacturers in the U.S. could still be making PFAS that never went through a full safety review – possibly millions of pounds each year. Read More »

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