EDF Health

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

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: April 20, 2023

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.

Also posted in Frontline communities, Health hazards, TSCA / Authors: / Read 1 Response

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative and Maricel Maffini, PhD, Consultant / 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.

 

 

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

National Teflon Day—Seriously?!

By Lauren Ellis / Published: April 7, 2023

What’s National Teflon Day?

According to National Day Calendar, yesterday (April 6th) was “National Teflon Day”—a day to “celebrate” the accidental discovery in 1938 of a chemical called polytetrafluoroethylene (PTFE for short)—better known by the product it became associated with, Teflon™.

Two 3D emoji rolling their eyes.

Teflon™ is PFAS Wrapped in a Bow

PTFE, the main component of Teflon™, is a fluorinated polymer that belongs to the PFAS chemical class—aka “forever chemicals.” PTFE is extremely heat- and stick-resistant—properties that lend themselves to a variety of uses, ranging from nonstick pans to semiconductors.

While some argue that PTFE itself does not present a health risk when used properly, the harms of PTFE become clear when you look across the chemical’s lifecycle—particularly the ways it’s produced and how it’s disposed of.

The Harms of PTFE Production

Harmful PFAS are used to produce PTFE and are also byproducts of the production process—exposing workers and surrounding communities.

PFOA—a notoriously toxic PFAS linked to cancer and heart disease—was used to manufacture PTFE for decades. In response to public pressure to phase out PFOA due to its harms, companies created other PFAS to replace PFOA—such as GenX, which has similar health effects as its predecessor. In addition to these harmful inputs, toxic PFAS byproducts are also created and released during the manufacturing of PTFE.

Decades of manufacturing PTFE have led to widespread PFAS contamination of our environment and our bodies.

The Harms of PTFE Disposal

At the end of the chemical lifecycle, fluoropolymers like PTFE may end up in a landfill—say, when you throw away your old Teflon™ pan. Over time, particles begin to disintegrate, leading to contamination of landfill liquids with PFAS that can then make their way into soil and drinking water.

Waste containing PTFE may also be incinerated. Burning of any type of PFAS is known to generate many other harmful PFAS—including potent greenhouse gases, such as tetrafluoromethane (which has a warming potential 6,500 times that of carbon dioxide).

Next Steps

Given the public health and climate effects of PTFE throughout its lifecycle, the next steps are clear: 1) Stop producing PTFE and other fluoropolymers for uses where there are clear alternatives; and 2) Stop celebrating the discovery of Teflon™ and the explosion of PFAS products (and pollution) that followed.

Also posted in Environment / Authors: / Comments are closed

Carts Before Horses: Vinyl Institute Calls For EPA To Evaluate Risk Without Data

By Samantha Liskow / Published: March 28, 2023

Horse attached to the wrong end of the cart. Caption says "Whose bright idea was this again?"

What’s New?

Yesterday, (March 27), EDF—together with the National Wildlife Federation—filed a “friend of the court” brief in the case of Vinyl Institute v. EPA. We expressed our support for EPA’s authority to order companies to 1) Conduct health and safety studies for their chemicals and 2) Turn over those test data to EPA when the agency is evaluating risks the chemicals may pose to humans, wildlife, or the environment.

The Vinyl Institute, which lobbies for companies making vinyl chloride and other chemicals used to make PVC plastic, disagrees. It brought a case against EPA on behalf of its members, asking the U.S. Court of Appeals in Washington, DC, to overturn EPA’s order to test 1,1,2-trichloroethane—a chemical known to harm living beings.

Why It Matters

This case could affect EPA’s ability to order companies to conduct health and safety studies for their chemicals, and, by extension, the agency’s ability to regulate those chemicals. Our brief to the court examines the history that led Congress to grant EPA authority to issue test orders and explains why it is critical for EPA to retain this authority.

The Backstory

The Toxic Substances Control Act (TSCA), the nation’s primary chemical law, was first enacted in 1976. For decades afterwards, EPA managed to collect test data for only a few chemicals; in some years, EPA collected no test data from companies at all.

The original TSCA law required EPA to go through lengthy procedures and make risk determinations about a chemical before it could seek any data from companies. Members of Congress recognized this was a no-win position for EPA and tried for many years to change the law. In 2016, Congress enacted major bipartisan reforms to TSCA, giving EPA power to order companies to test their chemicals when the agency needs data to complete risk evaluations of those substances. This change was lauded by members of Congress and many others as one of the most important improvements to TSCA.

The Current Case

EPA has designated 1,1,2-trichloroethane as a “high priority” for risk evaluation and possible regulation under TSCA. The agency issued the test order because it has some data indicating that the chemical is toxic to birds—but EPA needs more information on just how toxic it is to understand the risks. The Vinyl Institute essentially argued that EPA should have shown the risk to birds before it issued a test order—a classic case of putting the cart before the horse.

On behalf of several multibillion-dollar companies, which produce vinyl chloride and are part of the case, the Vinyl Institute also complained about the cost of the test.

What’s Next?

The court will review the briefs and issue a decision. In the meantime, chemical companies are challenging other EPA testing orders in court, and we are keeping a close eye on those cases. We will continue supporting EPA’s ability to exercise the authority Congress gave it–along with the ability to gather the information it needs to understand how chemicals pose risks to us and the environment and it can take the actions necessary to protect us.

Go Deeper

Read the briefs for the case Vinyl Institute v. EPA:

Also posted in Industry influence, TSCA / Authors: / Comments are closed

TSCA And The East Palestine Ohio Train Derailment Are Related–Here’s How

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: March 14, 2023

Derailed train, leaking toxic chemicalsBy Maria Doa, PhD, Senior Director, Chemicals Policy, and Lauren Ellis, MPH, Research Analyst

What Happened:  We recently expressed concern to EPA about its conclusion that “distribution in commerce” (including the transportation of chemicals) does not contribute to the unreasonable risk for any of the first 10 chemicals evaluated under the Toxic Substances Control Act (TSCA). 

In response, EPA stated that exposures from the distribution of chemicals in commerce would be minimal “given the fact that these chemicals are transported according to existing hazardous materials transportation rules.” 

Why It Matters: EPA does not currently quantify exposures and risks from spills, leaks, and other releases from transportation incidents. But people can be—and are—exposed to toxic chemicals at all stages of the chemical lifecycle, from these incidents to chemical facility releases.

For example, last month, a Norfolk Southern freight train hauling several railcars carrying toxic chemicals derailed in East Palestine, Ohio. This is just the latest example of how accidents involving highly toxic chemicals can have harmful impacts—both short- and long-term—on communities’ health and welfare.

The Ohio train derailment not only put several surrounding communities at risk of chemical pollution and negative health outcomes, but also highlighted the connection between TSCA and the risks of toxic chemicals from transportation accidents.

 

What’s Next: To accurately assess chemical risk under TSCA, EPA should consider data on spills, leaks, and releases from derailments, collisions, and other transportation incidents in its risk evaluations. These releases and exposures simply cannot be ignored.

By expanding evaluations to include the risks of chemicals at all stages of the chemical lifecycle, EPA can better protect communities.

Go Deeper: Visit our Deep Dives blog for a more in-depth analysis of this issue. 

Also posted in Deep Dives, TSCA / Read 2 Responses

Unleading Baby Food: FDA’s proposed limits are a positive step, but…

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 1, 2023

Tom Neltner, Senior Director, Safer Chemicals

What Happened: FDA recently released draft action levels for lead in foods intended for babies and young toddlers.1 Action levels represent the point above which FDA is likely to regard food as adulterated – essentially unsafe – and seek a recall. This is a key step in implementing FDA’s Closer to Zero Action Plan.

  • Lead limits would be 10 parts per billion (ppb) for most foods.
  • Limits would be 20 ppb for dry infant cereals and single-ingredient root vegetable products, because these products may have greater lead contamination levels. (Root vegetables are primarily carrots and sweet potatoes.)

The new action levels do not apply to juices; FDA proposed limits on those in April 2022.

Why It Matters: There is no safe level of lead in the diet.

For young children living in homes without lead pipes or lead paint, diet is the primary source of their lead exposure. FDA makes clear in the proposal that:

“Even low lead exposure can harm children’s health and development, specifically the brain and nervous system. Neurological effects of lead exposure during early childhood include learning disabilities, behavior difficulties, and lowered IQ. Lead exposures also may be associated with immunological, cardiovascular, renal, and reproductive and/or developmental effects. Because lead can accumulate in the body, even low-level chronic exposure can be hazardous over time.”

Lead can enter the food chain through multiple sources, including crops grown in contaminated soil and/or irrigated with contaminated water, atmospheric deposition from industrial activities, and old food-processing equipment that contains lead. The objective is to get exposure closer to zero.

Our Take: We applaud FDA’s proposed limits, which are more protective than the European Union’s 2021 standards. BUT…on the flip side:

  • FDA failed to set action levels for popular grain-based snacks, like teething biscuits and snack puffs. The agency needs to rectify this failure with all deliberate speed.
  • More protective action levels are achievable, especially for non-rice cereals and for foods that don’t contain rice or root vegetables.
  • Proposed action levels do not apply to multiple categories of foods, including:
  • FDA’s justification for the draft action levels lacks transparency—undermining both credibility of the levels and the likelihood industry will comply with them.

In addition, USDA and industry need to expand their support for research on the methods for growing, harvesting, and processing root vegetables, rice, and quinoa to further reduce lead contamination in these important foods. Research should include both store-bought and homemade baby foods.

Go Deeper: Visit our new Deep Dives blog to see our 3-part series, which provides a more detailed analysis of FDA’s proposal—including our recommendations for setting more protective limits and improving the transparency and credibility of the agency’s process of setting action levels.

NOTES
1 FDA’s guidance refers to babies and young children. Younger than two is a very narrow definition of young children, especially since children up to age six are particularly vulnerable to the harm that lead causes to their brains. Other federal agencies set standards for this broader age range. Toddlers are generally considered to be between 1 and 3 years of age. Therefore, we use the term “young toddlers” to avoid confusion.

Revised on March 21 to correct quote.

Also posted in Deep Dives, FDA, Health policy, Health science, Unleaded Juice / Read 1 Response