EDF Health

Selected tag(s): New chemicals

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

 

 

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 »

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

Broken GRAS: FDA’s lack of post-market oversight continues to create health risks

Brown glass vial surrounded by pepper corns

What Happened?

In April, a company called Prime Research Reports issued a press release in which it claimed FDA had approved THP (tetrahydropiperine) as a Generally Recognized As Safe (GRAS) substance “for use in food products.” There is no record that FDA has either reviewed or approved THP for use in food.

The report describes Sabinsa as a manufacturer of THP and as “a major player” in that market.[1] The substance, commercially known as Cosmoperine, is derived from a highly purified extract from black pepper; the extract, which is more than 95% piperine, is also made by Sabinsa and is marketed as BioPerine. The company describes piperine as an alkaloid present in black and long pepper.

Read More »

Posted in Adverse health effects, Broken GRAS, FDA, Food, GRAS, Health hazards, Industry influence, Risk assessment, Risk evaluation / Also tagged , , , , , | Authors: , / Read 1 Response

EPA Should Use U.S. Chemical Safety Law to Turn Off PFAS Tap

The word

PFAS is a group of synthetic chemicals used in industrial processes and consumer products, including water-repellent clothing, such as outdoor wear, and food packaging. Once these “forever chemicals” are produced and used, they often make their way into the environment and our bodies. Many pose serious threats due to their toxic effects (often at trace levels) and their ability to build up in people, animals and the environment. Studies show that they are in almost all of us.

To make matters worse, people are exposed to multiple PFAS, not individual PFAS in isolation. Yet under the nation’s primary chemical safety law, EPA evaluates the safety of PFAS chemicals one at a time and does not consider the combined risks from exposures to multiple PFAS. Combined exposures increase the risk of harmful effects, thus magnifying the risks and the need for action.

Current Situation: All Costs, No Benefits

PFAS move easily throughout the environment and are difficult to destroy. They have contaminated drinking water, food, farms, wildlife, and the environment more broadly. At the local, state and federal levels, the U.S. is spending millions of dollars to clean up PFAS contamination. Some states, such as Michigan and Maine, are trying to recoup the costs their residents have had to bear to clean-up PFAS contamination of their water and land. The federal government is also taking action to address the widespread PFAS contamination. The costs for cleaning up PFAS contamination are imposed on society by the domestic producers, importers and users of PFAS who profit from their production and use.

Yet, despite the well-documented risks and costs to society of these chemicals, companies still continue to produce, import, and use PFAS. It is time to ban all PFAS or—if there are truly essential uses for these chemicals—limit how they are produced, imported and used so that their impact on us and the environment is minimal.

Urgent Need: Revisit, Reassess, and Regulate All PFAS

While EPA has recently tightened up approvals for new PFAS entering the market, it has yet to take significant action on those that are already on the market, which includes the hundreds of PFAS the agency approved over the past few decades. It is clear these PFAS have not been produced responsibly as demonstrated by the environmental contamination associated with many of the PFAS manufacturing facilities. And yet, many of these PFAS are still on the market. They are being produced and released into the environment, are in products we use every day, and continue to contaminate us and our environment.

Many of EPA’s approvals were made 10 to 20 years ago, before we had a full picture of the pervasiveness and degree of PFAS contamination. The data on the extent of the environmental contamination of these persistent PFAS, their ability to move through the environment, and the significant difficulty in destroying them was not as robust as it is today. Furthermore, mounting evidence shows that even trace levels of PFAS can cause developmental issues in children, reduced fertility, hormonal disruptions, and certain types of cancer.

In addition, these approvals did not consider risks to vulnerable groups, such as pregnant women and children as currently required by the law. Many communities are exposed to multiple PFAS, particularly those who live, work and play near where PFAS are made and used.

Addressing the production, import and use of PFAS would limit further pollution of our water supplies, safeguard the health of our communities, and be consistent with other strong EPA actions to address PFAS, including its recent robust proposed drinking water standards.

Effective regulation of these harmful chemicals at their source would also accelerate efforts to seek out and adopt safer alternatives. Leaving chemicals with such well-documented harms on the market makes it more difficult for innovative, safer substitutes to enter it. Failing to address these risks in effect puts a thumb on the scale in support of older harmful technologies.

Our Take

EPA should re-evaluate each of the PFAS it has approved. During that re-evaluation, EPA should use the best available science and consider the full picture of PFAS exposure. Considering each PFAS in isolation rather than the multiple PFAS people, particularly those in vulnerable groups, are exposed to will underestimate their risk.

EPA should use the Toxic Substances Control Act to take action to ban these legacy PFAS, or restrict them if the uses are truly essential, rather than continuing to allow the production, import and use of these demonstrably harmful “forever chemicals.”

Go Deeper

Learn more about EDF’s concerns about PFAS and read our follow-up blog  on how EPA can use TSCA to turn off the PFAS tap.

EPA’s information on PFAS

Posted in Chemical exposure, Chemical regulation, Contamination, Cumulative impact, Cumulative risk assessment, Emerging testing methods, Food, Food packaging, Health hazards, Health science, PFAS, Public health, Risk assessment, Risk evaluation, TSCA, Vulnerable populations / Also tagged , , , , , , , , , , | Authors: / Comments are closed

Toxic Chemicals: Regulatory exemptions prioritize industry wants over safety needs

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.
Posted in Frontline communities, Industry influence, PFAS, Public health, TSCA / Also tagged , , , , , | Authors: / Comments are closed

The many ways the American Chemistry Council wants to turn back time on TSCA implementation – Part 2

Part 2 of a 2-part series: Unrestricted approvals of new chemicals, with low fees 

Maria Doa, Ph.D., Senior Director, Chemicals Policy

In its recently issued ‘State of TSCA’ report, the American Chemistry Council (ACC) tries to turn back the clock on how EPA assesses and mitigates the risks of toxic chemicals under the Toxic Substances Control Act (TSCA) and in the process leave workers, frontline communities and other vulnerable individuals at risk.  

In my previous blog, I looked at how ACC’s proposals would restrict the EPA’s ability to assess chemical risks and the science behind it. In this second and final part of our blog series looking at the chemical industry trade group’s report, I discuss ACC’s plan to dictate how EPA should assess the safety of new chemicals industry hopes to bring to the marketplace, as well as its effort to let industry avoid paying its fair share of the cost for EPA to evaluate chemical risks.  Read More »

Posted in Health policy, Industry influence, Public health, TSCA reform / Also tagged , , | Read 3 Responses

EPA’s new Collaborative Research Program – A step toward improving new chemical reviews under TSCA

Maria Doa, Ph.D., Senior Director, Chemicals Policy; Lauren Ellis, MPH, Research Analyst; and Lariah Edwards, Ph.D., Post-Doctoral Fellow 

The Environmental Defense Fund (EDF) recently filed comments on EPA’s Toxic Substances Control Act (TSCA) Collaborative Research Program to Support New Chemical Reviews (Collaborative Research Program). The Collaborative Research Program is a multi-year scientific partnership between the agency’s Office of Pollution Prevention and Toxics (OPPT) and Office of Research and Development (ORD) aimed at modernizing the methods, approaches, and tools used to evaluate new chemicals under TSCA.  

We strongly support OPPT’s collaboration with ORD, which has a breadth of scientific expertise across EPA’s different research programs. As such, ORD will help OPPT implement the best available science in its new chemical assessments, which should ultimately prevent risky chemicals from entering the marketplace. We urge OPPT to use this opportunity – and ORD’s expertise – to improve and expand its consideration of new chemical impacts to frontline communities, the risks new chemicals may pose throughout their entire life cycle, as well as cumulative risks from chemicals that may cause similar health effects. 

Below we outline the five proposed research areas for new chemicals under the Collaborative Research Program and our comments on each. All five can have an important impact on EPA’s new chemical assessments and consequently on EPA’s determination on whether a new chemical is expected to present an unreasonable risk.  Read More »

Posted in New approach methods (NAMs), TSCA reform / Also tagged , | Authors: / Comments are closed