EDF Health

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

By and / Published: April 19, 2023

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.

 

 

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Sperm Concerns: Sons Affected by Mom’s Exposure to Forever Chemicals

By / Published: October 19, 2022

Illustration of gray sperm swimming toward a dark purple egg on a light purple background

By Lauren Ellis, MPH, Research Analyst, Safer Chemicals

What’s New: A peer-reviewed study by Danish researchers found that a male fetus who is exposed to PFAS (per- and polyfluoroalkyl substances—also known as “forever chemicals”) during early pregnancy is more likely to have lower sperm quality in early adulthood.

It’s the first study to explore the impact of exposure to more than two PFAS compounds (as measured in maternal blood samples during early pregnancy) on adult male reproductive hormones and sperm quality.

Why It Matters: Poor sperm quality is directly related to male infertility. In addition, it has been linked to other health problems such as testicular cancer, heart disease, and all-cause mortality.

This study adds to decades of literature linking environmental chemical exposures to negative impacts on reproductive health.

Key Lessons from the Study:

  • Women who were pregnant 20+ years ago had multiple types of PFAS in their blood. The study used data on a group of Danish women who were pregnant between 1998-2003. The women gave blood samples, which were then frozen and stored; 95% of those samples were taken in the first trimester of pregnancy.
  • In 2020-2021, researchers tested those maternal samples for 15 different PFAS compounds. They found 7 of the 15 in the bloodstream of nearly 90% of mothers in the study. The seven were: PFHxS, PFHpA, PFOA, PFOS, PFNA, PFDA, and PFUnDA.
  • Exposure to PFAS during pregnancy decreases the sperm quality of adult male offspring. Researchers found that both combined and single exposure to maternal PFAS concentrations during early pregnancy had a negative effect on the sperm quality—particularly sperm count, concentration, and movement—of adult male offspring.

Our Takeaway: The new study presents a startling finding—developmental exposures to chemicals are associated with long lasting harm, including impacts that can affect future generations. It also adds to the growing evidence of PFAS health risks and demonstrates the urgent need for more health-protective PFAS policies and regulations.

Next Steps: EDF and our partners are pushing EPA to revoke existing PFAS exemptions and require those PFAS (and new PFAS coming to market) to undergo a full safety review under the Toxic Substances Control Act, our nation’s primary chemical safety law.

It is critical that these evaluations also consider the cumulative risk of exposure to PFAS mixtures in the environment.

Note: In June 2021, EDF, with a group of health, environmental, and consumer organizations, sent a formal petition to FDA asking the agency to ban all PFAS  that accumulate in the body. That petition is still under review.

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Heart disease and adult lead exposure – the evidence grows more compelling

By / Published: June 30, 2021

Tom Neltner, J.D., is Chemicals Policy Director

Two recent articles add to the already strong evidence that adult exposure to relatively low levels of lead is associated with heart disease, the leading cause of death in the United States, after COVID-19. These studies reinforce the urgent need to reduce not only children’s exposure to lead but also adult exposure through regulatory action.

A February 2021 Environmental Health Perspectives article found that blood lead levels were positively associated with prevalence of moderate to severe coronary artery stenosis (CAS), the narrowing of at least 25% of these vital arteries to the heart. The researchers studied a cohort of 2,000 Korean adults studied with no history of CAS, cardiovascular disease (CVD), or occupational exposure to lead. The vast majority of their blood lead levels were below the U.S. Center of Disease Control’s (CDC) reference level.[1] The researchers found that he severity of CAS is an important predictor for life threatening cardiovascular disease, even after adjusting for factors such as age, sex, hypertension, body mass index, regular exercise, smoking, and alcohol drinking.[2]

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New study: Lead reduction prevented up to 99,000 heart disease deaths in 2014 alone

By / Published: September 28, 2020

Tom Neltner, J.D., Chemicals Policy Director

EPA needs to estimate reduced heart disease deaths when it evaluates the merits of four upcoming rules addressing lead in water, paint, and air.

In 2018, we blogged on a study by Lanphear et al. that linked adult blood lead to a jaw-dropping 400,000 heart disease deaths annually. We called on federal regulatory agencies to give serious consideration to this and similar studies to develop a model they can use to quantify the socioeconomic benefits of potential regulatory changes designed to reduce adult exposure to lead. In June, 2019, the Environmental Protection Agency (EPA) successfully completed the necessary peer review of a model. The review was completed too late to be incorporated into the agency’s proposed revisions to its Lead and Copper Rule (released October 2019), but we applied the analysis to estimate that replacing all lead service lines in the nation over ten years would provide societal benefits of more than $205 billion – and called on EPA to consider the benefits when finalizing the rule.

Last week, Abt Associates, EPA’s contractor[1] who developed the initial peer-reviewed model, published a refined model in Environmental Health Perspectives and used it to estimate that between 34,000 and 99,000 cardiovascular disease (CVD)-related deaths were avoided in 2014 due to reduced adult blood lead levels from 1999 to 2014. The analysis reports that between 16% and 46% of the overall reduced CVD deaths during those 15 years was attributable to reduced lead in adult blood. Read More »

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EDF joins court challenge of FDA’s refusal to ban use of perchlorate in food contact materials

By / Published: October 29, 2019

Tom Neltner, J.D., is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

Today, EDF, represented by Earthjustice, joined with other public health advocates in filing a lawsuit to overturn the Food and Drug Administration’s (FDA) May 2017 decision, reaffirmed in April 2019 that allows the continued use of perchlorate[1], at concentrations up to 12,000 parts per million, in plastic packaging and processing equipment in contact with dry food. Perchlorate exposure is particularly dangerous for fetuses, infants, and young children, as it has been linked to developmental delays, reduced growth, and impaired learning capabilities. FDA relied on flawed reasoning while entirely ignoring important evidence developed by its own scientists revealing potentially serious risks resulting from ongoing use of perchlorate. We maintain that the intentional and unnecessary use of perchlorate in food contact materials should end.[2]

As with any litigation, we take this action reluctantly. We have long questioned FDA’s decisions that ignore evidence that endocrine disruptors like perchlorate can cause harm at levels the agency systematically dismisses as trivial. We have also pushed back on FDA’s decisions that allow toxic chemicals to be used in packaging and processing equipment that contact food ingredients multiple times from the farm to the grocery store shelf when the exposure estimate is based solely on the amount of the chemical that may migrate into food from the final product packaging. Agency assertions that its estimates are based on worst-case assumptions are misleading when they only consider a single contact. While FDA’s initial decision in November 2005 allowing the use of perchlorate-containing plastic raises all of these problems, the agency’s failure to address its own data and accompanying analysis by its own scientists that was published a decade later has left us with little choice but to act.

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

By / Published: July 31, 2019

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.

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