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.

Posted in Frontline communities, Health hazards, Public health, 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.

 

 

Posted in BPA, EFSA, Emerging science, Emerging testing methods, Environment, FDA, Health science, Public health / 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.

Posted in Environment, Public health / 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:

Posted in Industry influence, Public health, TSCA / Authors: / Comments are closed

Rhode Island expects LSL replacements to be ‘simultaneous and complete’ when funded by SRF

By Roya Alkafaji / Published: March 17, 2023

Tom Neltner, Senior Director, Safer Chemicals Initiative
and Roya Alkafaji, Manager, Healthy Communities

What Happened: The Rhode Island Department of Health (RIDOH) published notices on January 18 and January 30 indicating that Providence Water would need to stop partial replacement of lead service lines (LSLs) when the work is funded by the State Revolving Fund (SRF) program.

RIDOH specified that “only [LSL] replacement that results in simultaneous and complete replacement of both the public (water main to curb stop) and private (curb stop to water meter inside buildings) portions of the lead service lines will occur.”

Why It Matters: EPA made it clear in its FAQs that federal SRF funds should not be used to support harmful partial LSL replacements, which increases the risk of lead exposure in drinking water.[1] To our knowledge, Rhode Island is the first state that has applied its National Environmental Policy Act (NEPA)-like environmental review process to protect residents from partial LSL replacements by requiring the simultaneous and complete replacement of an LSL. All states have a similar review process pursuant to EPA requirements and should be taking similar action.

Our Take: RIDOH’s determination is an important application of the state’s environmental review requirements for its SRF program. We strongly supported RIDOH’s action in comments. We also asked that it be applied to six other SRF-funded projects that are likely to disturb LSLs, like water main replacement and asked for a public hearing if RIDOH allows partials for those other projects.

The Backstory: EDF objected to RIDOH’s March 2022 proposal to grant Providence Water a categorical exclusion that would have allowed partial LSL replacements. We reasoned that the practice would “disproportionately and adversely affect the health of low-income, Black, Latinx, and Native American residents by increasing their risk of exposure to lead in drinking water.” Accordingly, the utility was not eligible for a categorical exclusion and must either stop partial LSL replacements or conduct a full environmental review. This review would likely demonstrate the project was not eligible for funding.

Later, RIDOH withdrew the proposal based on follow-up discussions with EDF and separate discussions with Childhood Lead Action Project.

Go Deeper: Read RIDOH’s April 2022 and January 2023 public notices, a related civil rights administrative complaint filed with EPA, and EDF’s objections to RIDOH’s April 2022 proposal.

 

[1] EPA Frequent Questions about Bipartisan Infrastructure Law State Revolving Funds and LSLR:

“Question 4. If some customers (e.g., homeowners) refuse to allow the water utility access to replace the privately-owned portion of the lead service line, does this affect the project’s DWSRF funding?

State DWSRF programs may still fund the overall project but are strongly encouraged to use technical assistance and other outreach methods to achieve the fullest possible participation. If the customer continues to refuse access, then the water system should leave the publicly-owned portion of the lead service line in place (so as to not create a partial replacement) and document this action. To be clear, partial service line replacements are not eligible for DWSRF funding (from any DWSRF funding source).”

Posted in Civil rights / Tagged , , , , , | Comments are closed

Broken GRAS: FDA’s half-step to limit bias and conflicts of interest in GRAS determinations may backfire

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 15, 2023

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

What Happened? FDA finalized a long awaited guidance for industry in December to help reduce conflicts of interest and bias when a chemical manufacturer chooses to convene an expert panel to assess whether a new chemical additive is generally recognized as safe (GRAS).

Why It Matters: As written, FDA’s Best Practices for Convening a GRAS Panel guidance is excellent. If food companies convene GRAS panels consistent with the guidance, the panels’ evaluations will be more credible because they should have less of the pervasive bias and conflicts of interest that plague the current system and all too often result in unsafe chemicals being added to food. But that’s a big if.

Our Take: Unfortunately, we think the guidance is likely to backfire because of the limited scope — FDA explicitly makes GRAS panels optional – a choice the agency made when it finalized the GRAS rule in 2016. Chemical manufacturers will simply avoid convening GRAS panels, relying solely on their employees or a consulting firm they hire to conduct these safety evaluations. These employees and consultants typically have significant bias and conflicts of interest because positive opinions help their employer or client. We raised this issue in comments to FDA, calling for the best practices to apply to everyone involved in the safety evaluation process. FDA did not address our comments in their recommended best practices in the revised final guidance.

While making GRAS panels optional is a serious problem, a more fundamental concern is that FDA may not have an opportunity to review the GRAS safety evaluations made by employees or hire consultants because the company chooses not to notify the agency. FDA’s Office of Food Additive Safety fails to consider just how often companies choose not to tell the agency that a new chemical is being added to food. In our Broken GRAS series, we provided six examples of the serious risk posed by the GRAS system, the most public being hundreds of people sickened due to consumption of tara flour, an ingredient in a Daily Harvest frozen meal. Last November, using marketing materials we showed FDA that the number of new chemicals bypassing its review likely outnumber those voluntarily submitted to the agency.

We see no evidence that the agency systematically investigates or even audits the GRAS determinations that bypass their review despite promises made by the agency over the years and a scathing 2010 report by the U.S. Government Accountability Office calling for action.

Next Steps: In his effort to reform FDA’s dysfunctional food safety program, FDA Commissioner Califf told a reporter that “I want to throw in chemical safety as another really, really important area for the future – for humankind, really – and where science is evolving rapidly.”[1] If he follows through, fixing GRAS is an important step to rebuild consumer confidence and reduce the ongoing risk to public health. If he fails, the agency will continue to be hamstrung in preventing health risks posed by chemicals of unknown safety.

Go deeper: Broken GRAS series, Neltner et al (2013) Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe: Out of Balance; Toxic Free Act; Food Chemical Reassessment Act.

[1] FoodFix, January 31, 2023 edition.

Updated April 9, 2023 to add link for Broken GRAS series.

Posted in Broken GRAS, Conflict of interest, FDA, GRAS / Tagged , , , | Authors: / Read 1 Response