EDF Health

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

By EDF Blogs / Published: January 25, 2024

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 »

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

FDA’s approach to systematic review of chemicals got off on the wrong foot

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 16, 2023

Scientist working on a digital tablet showing data on the chemical element Cadmium

What Happened?

Last month, FDA’s scientists published the toxicological reference value (TRV) for exposure to cadmium in the diet. This value is the amount of a chemical—in this case cadmium—a person can consume in their daily diet that would not be expected to cause adverse health effects and can be used for food safety decision-making. The TRV was based on a systematic review FDA scientists published last year. We will turn to the TRV itself in an upcoming blog but are focusing on the systematic review here.

In a May 2023 publication, experts in systematic reviews from the University of California San Francisco (UCSF) raised concerns about FDA’s “lack of compliance” from established procedures.

We discussed these concerns with FDA. They said:

  • “The systematic review and the TRV” publication “have both undergone external peer review by a third-party and experts in the field.” The agency expects to publish the reviews on its website, and
  • FDA “is working on developing a protocol for a systematic review of cardiovascular effects of cadmium exposure that will be published.”

Why It Matters

Systematic review is a method designed to collect and synthesize scientific evidence on specific questions to increase transparency and objectivity and provide conclusions that are more reliable and of higher confidence than traditional literature reviews. In particular, the National Academies of Sciences, Engineering, and Medicine have recommended the use of systematic reviews to establish values such as the TRV that may be used to inform regulatory decisions.

The National Toxicology Program (NTP) and others have developed specific methodologies to conduct systematic reviews. FDA’s authors said they followed NTP’s Office of Health Assessment and Translation (OHAT) handbook.

Unfortunately, FDA’s adherence to the methodology fell short on both transparency and objectivity grounds, undermining the credibility of its conclusions. Credibility is crucial because FDA’s authors stated that “this systematic review ultimately supports regulatory decisions and FDA initiatives, such as Closer to Zero, which identifies actions the agency will take to reduce exposures to contaminants like cadmium through foods.”

Read More »

Also posted in FDA, Public health / Tagged , , , , , | Authors: , / Comments are closed

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

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: September 18, 2023

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 »

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

New Approach Methodologies Should Adhere to TSCA Standards

By Susanne Brander, PhD, Senior Contributing Scientist / Published: August 15, 2023

What’s New?

EPA recently asked its Board of Scientific Counselors (BOSC), comprised of experts in the fields of toxicology and environmental chemistry, to make recommendations on implementing new approach methods (NAMs) for testing the safety of new chemicals.

NAMs encompass a wide array of new evaluation strategies, including testing cell lines or invertebrates (rather than mammals); using computational approaches; and estimating potential harms of new chemicals by looking at existing toxicity data on similar substances.

Why It Matters

EPA announced in 2019 that it would be redirecting resources towards developing NAMs to replace those studies. The looming concern is the possibility that NAMs may miss effects that whole animal mammalian testing accounts for and generate false negatives — potentially allowing toxic chemicals to appear in consumer products or end up in our environment.

This could happen because relying only on NAMs or using data from one chemical to predict how a new one might behave opens the door to missing negative effects. NAMs could also cause evaluators to miss opportunities to use the Toxic Substances Control Act (TSCA), the nation’s primary chemical safety law, to limit toxic chemical exposures. Read More »

Also posted in Chemical regulation, Cumulative risk assessment, Emerging science, Emerging testing methods, Frontline communities, New approach methods (NAMs), Risk assessment, Risk evaluation, TSCA / Tagged , , | Authors: / Comments are closed

Petrochemical pollution doesn’t affect communities equally. Better regulations can help.

By Michelle Allen / Published: July 3, 2023

By Michelle Allen, Manager, Community Engagement

Recent high-profile chemical disasters in East Palestine, Ohio, and Deer Park, Texas, have highlighted the risks facing communities where the petrochemical industry operates, but not every spill or toxic pollution release makes headlines. By some counts, there is a chemical fire, explosion or release every other day in this country.

As countries around the world invest in strategies to reduce carbon pollution and rely less on fossil fuels, the oil and gas industry has turned to petrochemicals as an opportunity for growth. Petrochemicals are chemical derivatives refined from petroleum, and they’re found in products we use every day: from water bottles and plastic cases on our phones to paints, fertilizers and carpets.

But images of billowing black clouds of smoke hanging over homes, schools and parks in communities from Appalachia to the Gulf Coast are a reminder that our everyday products—many of which are for the sole purpose of convenience—are not without cost. And too often, these costs are borne by someone else.

Communities are exposed to health risks from petrochemical pollution

Exposure to petrochemical pollution—from acute events like these environmental disasters, but also from prolonged exposure to these air toxics, day in and day out—puts communities at risk. But communities don’t experience these risks equally. Black and brown communities and low-income areas bear the brunt of this unequal and unjust pollution. Children, pregnant people, seniors and people with existing medical conditions are especially at risk of developing a host of health issues from exposure to this toxic pollution, including cancer, respiratory illness, asthma and more.

Communities on the frontlines of petrochemical pollution have long expressed that they have the right to know what’s in the air they’re breathing so they can take action to protect themselves and demand accountability from decisionmakers and industry. A newly proposed update to regulations in the Clean Air Act is a significant step in the right direction.

New EPA proposal would help hold polluters accountable

The Environmental Protection Agency has proposed stronger regulations for some 200 petrochemical facilities throughout the country, more than half of which are concentrated in Texas and Louisiana. These proposed rules include safeguards against petrochemical pollution that advocates have long called for: more air-quality monitoring at the fence line of facilities, stronger protections against flaring, and actions to close loopholes that allow facilities to violate regulations during periods of startup, shutdown and malfunction.

Dedicated community leaders have been leading the fight against this pollution for decades, and it’s great to see the Administration meet these efforts with long overdue protections. We need stronger regulations at the local, state and federal levels to protect the health of residents and require regulators to hold polluters accountable to the communities where they’re operating.

The additional transparency and accountability that will come from these protections are especially critical because many of these facilities have a documented history of breaking the law: our analysis shows that more than half of the facilities expected to be impacted by this proposal are currently violating at least one environmental law, and more than 80 percent have been out of compliance in the last three years.

Strong federal protections are needed to safeguard community health

We urge EPA to adopt a strong final version of this rule that is truly protective of public health. Requiring fence line monitoring to cover a greater number of chemicals and facilities, for example, would help hold polluters accountable and prevent further harm to communities.

EPA’s proposal is a critical step in the right direction—a foundational safeguard that can ground additional layers of protection for communities impacted by petrochemical pollution. Strong federal protections should be part of a comprehensive strategy to help communities achieve a healthy, thriving future for generations to come.

Also posted in Air pollution, Chemical exposure, Deep Dives, Environmental justice, Health policy / Authors: / Comments are closed

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

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: June 30, 2023

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

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