EDF Health

New Approach Methodologies Should Adhere to TSCA Standards

By Susanne Brander, PhD, Senior Contributing Scientist / Published: August 15, 2023

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

Fatally Flawed: EDF & partners call on EPA to revoke approval for new chemicals with shocking health risks

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: August 10, 2023

 

 

A sepia-toned image showing a factory with dark smoke billowing out of multiple smokestacks.

What Happened?

EDF and other environmental groups recently asked the Environmental Protection Agency (EPA) to withdraw the approval it issued for a group of new chemicals. This approval, also known as a consent order, allows Chevron to create fuels at its refinery in Pascagoula, Mississippi, by using oils produced through a process of superheating plastic waste to break it down (a process known as pyrolysis). The consent order also allows for the use of these fuels derived from waste plastic at more than 100 locations. ProPublica published an article on the issue on August 4, 2023.

Why It Matters

EPA is required by law to provide protections against unreasonable risks posed by new chemicals. But in the consent order EPA approved the production and use of these new chemicals despite significant health risks. One of the chemicals posed a 1 in 4 risk of developing cancer for people exposed to it. Another chemical carried risks of a 7 in 100 cancer risk from eating fish contaminated by it and a greater than 1.3 in 1 cancer risk from inhaling it.

When asked about the shockingly high cancer risks it estimated, EPA claimed its cancer risk assumptions were overly conservative but failed to provide any information about what it believes are the actual risks and pointed to undefined controls under other laws as controlling the risks.

Until now, the acceptable risk standard for cancer in the general population has been 1 in 1,000,000. The risk levels EPA identified are up to 1,000,000 times greater than that. Read More »

Also posted in Adverse health effects, Chemical exposure, Chemical regulation, Health hazards, Health policy, Industry influence, Risk assessment, Risk evaluation, TSCA, Vulnerable populations / Tagged , , , , | Authors: / Comments are closed

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 Health hazards, Public health, TSCA / Authors: / Read 1 Response

Toxic Chemicals: Regulatory exemptions prioritize industry wants over safety needs

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: December 2, 2022

A rubber stamp lies on its side to the right of the photo. To the left, you see the stamped image of a skull and crossbones and the words Toxic Substances

By Maria Doa, PhD, Senior Director, Chemicals Policy

What’s the Issue?

EPA grants exemptions from full safety reviews for approximately half the new chemicals submitted by the chemical industry. Once those exemptions are granted, EPA very rarely revises or revokes them—even in the face of new information.

The Toxic Substances Control Act allows EPA to grant an exemption from a full safety review only if it determines that the chemical will not present an unreasonable risk. That’s a high standard—and one that many exemptions do not meet.

Why it Matters:

  • The chemical industry takes maximum advantage of exemptions given the abbreviated safety review and the industry’s ability to keep their use of new chemicals under the radar. For example, the chemicals that get exemptions don’t go on the national inventory of chemicals that are in use.
  • For years, EPA has granted exemptions for chemicals that can have long-term negative impacts on human health and the environment. They include hundreds of exemptions for PFAS, “forever chemicals” known to contaminate our water supplies and farmland. And it’s not just PFAS. EPA has granted exemptions for other types of persistent, bio-accumulative, toxic (PBT) chemicals that can have lasting impacts on people and the environment.
  • These exemptions often contradict TSCA’s requirement that EPA consider the risks from a chemical throughout its lifecycle. That includes the risks for vulnerable groups who may be more susceptible to the chemical or who are more highly exposed, such as frontline communities.
  • EPA does not typically consider the cumulative impacts of multiple exempted chemicals on frontline communities, consumers, or the environment.

Our Take: EPA has an important opportunity to address overuse of TSCA exemptions.

Next Steps:

  • EPA should revisit the exemptions it has already granted. The agency should determine that chemicals truly do not present an unreasonable risk—particularly to vulnerable populations—throughout their lifecycles. EPA should focus first on chemicals that can have long-lasting impacts on health and the environment, like PFAS and other PBTs.
  • Before granting any new exemptions, EPA should consider the combined impacts throughout the lifecycle of these chemicals on all stakeholders, especially frontline communities. EPA Administrator Regan recently said EPA would be embedding environmental justice into the DNA of EPA. This is another opportunity for EPA to do just that.
Also posted in Industry influence, Public health, TSCA / Tagged , , , , , , , | Authors: / Comments are closed