EDF Health

New Approach Methodologies Should Adhere to TSCA Standards

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, Frontline communities, Health science, New approach methods (NAMs), Risk assessment, Risk evaluation, TSCA / Tagged , , | Authors: / Comments are closed

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

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

European Food Safety Authority reaffirms that BPA uses for food are not safe. Where is FDA?

Tom Neltner, Senior Director, Safer Chemicals, and Maricel Maffini, consultant

Warning message written in bold red letters with words Bisphenol A Exposure. 3d illustration.

What Happened?

Today, the European Food Safety Authority (EFSA) finalized its Re-evaluation of the Risks to Public Health Related to the Presence of Bisphenol A (BPA) in Foodstuffs report. After considering public comments on its November 2021 draft, the agency reaffirmed its conclusion that Europeans of all ages are exposed to BPA at levels 100 to 1,000 times greater than EFSA considers to be safe.

Why It Matters

EFSA found that consumers’ dietary exposure should be less than 0.2 nanograms of BPA per kilogram of body weight per day (ng/kg-bw/day) to protect their immune systems from harm.1 Although EFSA didn’t analyze the reality for U.S. consumers, we used FDA’s 2014 estimated dietary exposure for BPA (the most recent available) to calculate that Americans’ exposure is 1,000 times greater than what EFSA deems safe.

Our Take

EFSA’s analysis is primarily based on scientific evidence that FDA had not considered in previous reviews. With the final report in place, EFSA has completed a rigorous, transparent, and comprehensive risk assessment. FDA now has no excuse for delaying action on a food additive petition submitted by EDF and our partners that the agency agreed to consider on May 2, 2022. That petition requested that FDA revoke its approvals for using BPA in adhesives and can coatings and set strict limits on using it in plastic that contacts food. FDA has not yet responded.

EFSA’s Conclusions

EFSA found that extremely low exposures to BPA can lead to an overactive immune system producing out-of-control inflammation. BPA was also associated with disrupting the endocrine system, harming reproduction, and reducing learning and memory. The immune system was most sensitive to BPA exposure.

After calculating a safe level of BPA—known as TDI (tolerable daily intake)—that would prevent anticipated harm, EFSA compared it against the estimated dietary exposure of the European population. The agency concluded that “both the mean and the 95th percentile dietary exposures in all age groups exceeded the TDI by two to three orders of magnitude.”

Putting BPA New Safe Level in Context

EFSA’s safe dose of 0.2 ng/kg-bw/day is extremely low. It may be useful to compare it to exposure from drinking water. For an adult weighing 120-pounds who drinks 2 liters of water a day, it would take only 1.2 parts per trillion of BPA to exceed the safe level.2

Next Steps

We will press FDA to act with greater urgency on our overdue petition. We are also looking at whether there is increased risk to communities near where BPA is made or processed.

NOTES

1 The limit was 0.04 ng/kg-bw/day in the draft EFSA report.

2 0.2 ng/kg-bw/day * 60 kg / 2 liters = 1.2 ng/L = 1.2 ppt. This does not account for other sources of BPA in the diet.

 

 

Also posted in BPA, EFSA, Emerging science, Environment, FDA, Health science, Public health / Tagged , , , | Authors: , / Read 1 Response

Why do we know so little about chemical exposures? Emerging technology could disrupt the status quo.

Lindsay McCormick is a Program Manager.

EDF report identifies emerging market for personal chemical exposure monitoring technologies through a first-of-its-kind analysis.

When I first started working at EDF in 2014, I learned a statistic that shocked me: We have human exposure data on less than 4% of the roughly half-million chemicals in commerce.[1] In other words, we know next to nothing about the vast majority of chemical exposures that people were experiencing on a daily basis.

Chemicals are found in nearly all commercial products and serve a foundational role in our economy. Yet this ubiquity comes with its downsides, as some chemicals are hazardous and can find their way into our environment and ultimately end up in our water, land, and air—and in our bodies. Exposure to certain chemi­cal substances have been linked to a variety of adverse health impacts, including reproductive harm, disruption of normal hormone activity, and impaired neurological development in children.

The lack of knowledge about chemical exposures poses a major problem: Without better information on exactly which chemicals individuals are exposed to every day, it is challenging to develop effective policies and interventions to reduce harmful exposures and protect health.

Disrupting the status quo

But what if anyone could use a simple home-delivered kit or wearable device to reveal the chemicals in their environment—and in their body? Such technologies could make the invisible visible—providing individuals, as well as policy makers, businesses, health professionals, and others, with critical information needed to accelerate reductions in the public’s exposure to hazardous chemicals.

In 2017, EDF pursued a Year of Innovation to better understand opportunities to advance the market for personal chemical exposure monitors (PCEMs) – with the ultimate goal of improving public health. As part of this effort, we conducted interviews and convened an expert workshop to identify bottlenecks in the development and use of such technologies.

We learned that a significant gap exists between the demand and promise of PCEM technologies and the current cost or scalability of many of the available technologies today. Experts noted that while there is significant qualitative or anecdotal evidence of demand, a quantitative understanding of the potential market for these technologies is needed to drive a robust market.

EDF took that lesson and embarked on a two-part study to fill this gap.

Read More »

Also posted in Emerging science, Health science, Public health / Tagged , | Read 1 Response

New report: Tackling lead in drinking water at child care facilities

Lindsay McCormick, Project Manager, Sam Lovell, Project Specialist and Tom Neltner, J.D.Chemicals Policy Director

Recent crises around lead in drinking water have focused national attention on the harmful effects of children’s exposure to lead. While the particular vulnerability of children to lead is well understood by most – what might be surprising is that the majority of child care facilities are not required to test their water for lead.

Only 7 states and one city have such regulations on the books. And while the Environmental Protection Agency (EPA) has provided a voluntary guidance, the “3Ts for Reducing Lead in Drinking Water,” for schools and child care, the document has significant gaps in the child care setting – including an outdated action level of 20ppb and little emphasis on identifying and replacing lead service lines.

Given the critical need for more investigation in this area, we conducted a pilot project to evaluate new approaches to testing and remediating lead in water at child care facilities. EDF collaborated with local partners to conduct lead in water testing and remediation in 11 child care facilities in Illinois, Michigan, Mississippi, and Ohio. We have previously blogged about some early takeaways from testing hot water heaters and our preliminary findings from the project. Today, we released our final report, which provides the full results of the pilot and recommendations to better protect children moving forward.

Read More »

Also posted in Drinking water, Health policy, Health science, Lead, Public health, Regulation / Tagged , , , , , | Comments are closed

Sensors and electronic health records reveal block-by-block traffic air pollution health disparities among the elderly in Oakland

Dr. Ananya Roy is a Health Scientist

Many public heath efforts, thankfully, focus on the youngest among us. We fight for a clean environment and healthy future for our kids. However, it is easy to forget that pollution affects us in every stage of life and its insidious health effects accumulate over time and can result in disease and disability.

Older people already have higher rates of disease and are highly vulnerable to air pollution, because they have been breathing for 70, 80, or 90 years. The effects of air pollution among the elderly provide insights that help us solve problems that can benefit the whole population.

Senior citizens have become the largest and fastest-growing segment of the population. By 2030 one in five Americans will be 65 and older, a demographic shift that influences everything from consumer behavior to health-care costs. Further, grandparents play a critical role in the success of families and the next generation – both emotionally and physically. It is estimated that for approximately 4.9 million families with children, the grandparent is the main breadwinner.

Read More »

Also posted in Air pollution, Emerging science, Environment, Health policy, Health science / Tagged , | Comments are closed