EDF Health

“Advanced recycling” is a toxic scam — now the EPA is turning a blind eye to some of the most toxic chemicals it produces

Advanced recycling is a false solution to the plastic waste crisis

What’s new: Last month, the Environmental Protection Agency (EPA) withdrew a proposed rule covering 18 new chemicals, which would have paused industry efforts to turn toxic oils from plastic waste into fuel until the agency could review their health risks. Companies make these oils through pyrolysis, a controversial process that essentially burns plastic waste—often full of toxic additives like lead, phthalates and PFAS—at high temperatures. Industry has sought for years to re-brand this inefficient and dirty process as “advanced recycling”—a false solution to the plastic waste crisis.

Why it matters: In 2022, the EPA approved the production and use of the 18 chemicals despite significant health risks documented in the agency’s own analysis. These risks include an up-to 1-in-4 lifetime cancer risk—250,000 times greater than what the EPA typically considers acceptable. It was only after residents near the facility in Pascagoula, Mississippi that received the approval learned of these risks and filed a lawsuit that the EPA finally pulled it back.

As damning as the EPA’s 2022 analysis was, it almost certainly underestimated the true risks of the 18 chemicals by failing to consider the known health risks of toxic additives such as lead, PFAS and dioxins commonly found in waste-plastic pyrolysis oils. In response to mounting pressure, the EPA issued the proposed rule in 2023 to address these additional risks. Because it is nearly impossible to make fuels from these oils that are free from toxicants, the rule had an immediate chilling effect on industry investment in “advanced recycling” that’s thawing now that it has been withdrawn.

Our Take: The proposed rule was effective because it would have required companies to notify the EPA before producing and using the new chemicals when they contain toxic plastic additives by designating it as a significant new use. This designation also would have given the agency time to evaluate potential risks to human health and the environment—and mitigate them if necessary.

The proposed rule was also significant because it represents the first time the EPA officially acknowledged that waste plastic-derived pyrolysis oils contain toxic additives “known to cause cancer and harm the reproductive system, among other health effects.” While we believe this rule (and the list of toxic chemicals requiring review) did not go far enough—and submitted comments to the EPA in 2023 explaining why—it was a big step in the right direction.

What’s the problem with so-called “advanced recycling?” Although industry touts “advanced recycling” as a solution to the plastic waste crisis, the process has major flaws. Not only does it fail to recycle anything, but it also rarely results in new plastic products. To make matters worse, the oils it produces are so toxic that their use is highly limited. Continued investments in “advanced recycling” will lock us into burning more polluting fossil fuels that contribute to climate change. Instead of spending its resources propping up this toxic scam, industry could devote them to developing truly innovative and safe solutions.

What’s next? With the rule now out of the way, the EPA is likely to reissue its approval of the 18 chemicals and propose a new set of “rules” that would ignore both the known cancer risks and the additional risks from the highly toxic additives. This would be an unacceptable outcome for public health. The agency must consider the full picture of risk—not just part of it.

With industry actively pushing to develop new facilities across the country—and simultaneously seeking exemptions from other pollution limits for facilities like the one in Pascagoula—the EPA’s reversal opens the door to more pollution and greater harm to both people and the environment. We must hold both the EPA and industry accountable to ensure these plastic waste-derived new chemicals filled with dangerous toxins are not approved—and that any future rules protect people and the environment from unreasonable risk.

To learn more about the health risks of “advanced recycling,” check out this recent Instagram reel by Sarah Vogel, Senior Vice President of Healthy Communities.

Also posted in Adverse health effects, Chemical exposure, Chemical regulation, Contamination, Environmental justice, Frontline communities, Health policy, Industry influence, Phthalates, Risk assessment, TSCA, Vulnerable populations / Authors: , / Leave a comment

EU gets ready to ban most BPA uses. Once again: Where’s FDA?

By Maricel Maffini, PhD, Consultant, and Tom Neltner, Executive Director, Unleaded Kids

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

What’s Happening?

On February 9, 2024, the European Commission published a proposed regulation [PDF, 502KB] that would ban most uses of bisphenol A (BPA) in materials that contact food—including plastic and coatings applied to metal cans—and restrict other uses. Interested parties can comment on the draft until March 8, 2024. (You must register to comment.)

This proposed regulation is based on the 2023 European Food Safety Authority’s (EFSA) risk assessment of BPA that concluded that dietary exposures are a health concern. The proposed regulation would impact the following bisphenol-based food contact materials:

  • Plastics: Would be banned from use if made from BPA at any stage of manufacturing.1 The only exception is polysulfone resins made from a sodium salt of BPA, which are allowed for use in filtration membranes if there is no detectable migration into food.
  • Varnishes, coatings, printing inks, adhesives, ion-exchange resins, and rubbers: Use of BPA and bisphenol S (BPS)2 would be banned at any stage of manufacture. Use of BPS or other bisphenols may be authorized on a case-by-case basis. The exception to the ban is bisphenol-A diglycidyl ether (BADGE)3 made from BPA and used to make epoxy-based varnishes and coatings, which are allowed only in making materials with capacity of more than 250 liters and there is no detectable migration4 into food.
  • Recycled materials: Unintentional BPA contamination would be allowed if there is no detectable migration into food.

Why It Matters

In its 2023 reassessment, EFSA estimated that the amount of BPA that could be safely consumed daily is 20,000 times less than its 2015 estimate. Among the health problems associated with BPA exposure are harm to the immune and reproductive systems, disruption of the normal function of hormones and reduced learning and memory.

The draft rule would manage the risk of BPA uses to significantly reduce dietary exposure after considering alternatives that are technically feasible at a commercial scale.

Our Take

The European Commission’s proposed rule is an excellent example of a risk management decision that considers safety and achievability. The Commission balanced protecting human health by eliminating as many sources of BPA as fast as possible with the implementation challenges. The Commission has included transition periods to eliminate all uses of food-contact articles manufactured with BPA ranging from 18 months for final food packaging (e.g., plastics, can coating) to 10 years for repeat-use, final food contact articles used in food production equipment.

In a previous blog, we stated that Americans’ exposure to BPA from food is similar to that of Europeans. Unfortunately, FDA doesn’t share the same sense of urgency as the European Commission. While Europe is on track to ban most uses of BPA in food contact materials, FDA is failing to take action to protect our families.

EDF and our allies submitted a food additive petition [PDF, 542KB] asking the agency to limit BPA exposure from food by revoking approvals for using BPA in adhesives and can coatings and to setting strict limits on using BPA in plastic that contacts food. FDA filed the petition on May 2, 2022, and has not made a final decision on it, despite a 180-day statutory deadline. It is now more than 600 days overdue.

Timeline

Once the rules are finalized, compliance would be required within 18 months for most products and within 36 months for:

  • Varnishes and coatings for processed fruit, vegetable, and processed fish products.
  • Varnishes and coatings used outside of metal packaging.
  • Manufacture of repeat-use components in professional food production equipment.

The rule would also allow repeat-use, final food contact articles used in professional food production equipment to remain in service for up to 10 years.

What’s Next?

We will submit comments to the European Commission seeking clarity on some aspects of the proposal. In addition, we will continue to press FDA to make a final decision on our petition, including potentially taking legal action for unreasonable delay in responding to it.

Go Deeper

Read our blogs on BPA.

NOTES

1 The rule is inconsistent regarding status of plastics other than polysulfone. EDF will submit comments seeking clarity.

2 The Commission may expand to more bisphenols if they are added to Annex VI, Part 3 of Regulation (EC) No 1272/2008 due to their harmonized classification as category 1A or 1B “mutagenic,” “carcinogenic,” “toxic to reproduction” or category 1 “endocrine disrupting” for human health.

3 BADGE (CAS No 1675-54-3) – is a type of epoxy resin manufactured from BPA.

4 Rule defines the limit of detection as 0.01 milligram of bisphenol per kilogram of food.

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New updates to understanding packaging scorecard spur a safer & more sustainable foodservice industry

Also posted in Food, Food contact materials, Food packaging, Markets and Retail / Tagged , , , | Authors: / Comments are closed

European Commission plans to ban food uses of BPA. We ask again: Where is FDA?

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

What Happened?

On June 2, the European Commission, the executive body of the European Union (EU) responsible for proposing legislation and implementing decisions, announced it is preparing an initiative that “will impose a ban on the use of BPA [bisphenol A] in food contact materials (FCMs), including plastic and coated packaging.” It also said it would “address the use of other bisphenols in FCMs to avoid replacing BPA with other harmful substances.” The Commission’s proposal is based on the European Food Safety Authority’s (EFSA) scientific opinion that exposure to BPA is a “concern for human health.”

Why It Matters

In April, EFSA concluded that Europeans were exposed to levels of BPA from food that were 100 to 1,000 times greater than the estimated safe amount, and that this exposure could 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. Recognizing these risks, the Commission moved quickly to protect Europeans’ public health by banning uses of BPA.

Our Take

Americans’ exposure to BPA from food is similar to that in Europe. Unfortunately, FDA doesn’t share the same sense of urgency to protect our families as the European Commission is demonstrating by its actions. While Europe is moving forward to ban the use of BPA in food contact materials, the FDA has failed to take action.

EDF and our allies submitted a food additive petition asking the agency to limit BPA exposure from food by revoking approvals for using BPA in adhesives and can coatings and to setting strict limits on using BPA in plastic that contacts food. FDA filed the petition on May 2, 2022 and has not made a final decision on it despite a 180-day statutory deadline. It is now more than 400 days overdue.

In January, FDA Commissioner Califf announced “a new and transformative vision for the FDA Human Food Programs” which includes a Deputy Commissioner for Human Foods with “decision-making authority over policy, strategy and regulatory program activities.” These are important steps, but a real measure is making timely decisions to protect American’s health by restricting the use of toxic chemicals such as BPA.

Pile of silver metal food cans with no labels

Next Steps

We will continue to press FDA to make a final decision on the petition, including potentially taking legal action for unreasonable delay in responding to our petition.

Also posted in EFSA, Endocrine disruptors, FDA, Food contact materials, Food packaging, Health hazards, Plastic, Public health, Reproductive toxicity / 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 EFSA, Emerging science, Emerging testing methods, Environment, FDA, Health science, Public health / Tagged , , , | Authors: , / Comments are closed

The new FDA Commissioner has a full plate; here are 3 steps he can take to keep focused on food safety

Tom Neltner, Senior Director, Safer Chemicals.

The U.S. Senate today voted to return Robert Califf to the role of FDA Commissioner, bringing needed leadership to an agency that plays a vital role in protecting public health. 

While Dr. Califf faces historic challenges in the form of the COVID-19 pandemic and the opioid epidemic, he also has a tremendous opportunity to elevate the agency’s important role in protecting the public from unsafe chemicals in food. 

We put together a list of three things Dr. Califf and the FDA have the authority to do right now to keep problematic chemicals out of our food:  Read More »

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