EDF Health

Selected tag(s): risk evaluation

Toxic Chemicals: Regulatory exemptions prioritize industry wants over safety needs

By / Bio / 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.
Posted in Industry Influence, Public Health, TSCA, Uncategorized / Also tagged , , , , , , | Comments are closed

Sperm Concerns: Sons Affected by Mom’s Exposure to Forever Chemicals

By / Published: October 19, 2022

Illustration of gray sperm swimming toward a dark purple egg on a light purple background

By Lauren Ellis, MPH, Research Analyst, Safer Chemicals

What’s New: A peer-reviewed study by Danish researchers found that a male fetus who is exposed to PFAS (per- and polyfluoroalkyl substances—also known as “forever chemicals”) during early pregnancy is more likely to have lower sperm quality in early adulthood.

It’s the first study to explore the impact of exposure to more than two PFAS compounds (as measured in maternal blood samples during early pregnancy) on adult male reproductive hormones and sperm quality.

Why It Matters: Poor sperm quality is directly related to male infertility. In addition, it has been linked to other health problems such as testicular cancer, heart disease, and all-cause mortality.

This study adds to decades of literature linking environmental chemical exposures to negative impacts on reproductive health.

Key Lessons from the Study:

  • Women who were pregnant 20+ years ago had multiple types of PFAS in their blood. The study used data on a group of Danish women who were pregnant between 1998-2003. The women gave blood samples, which were then frozen and stored; 95% of those samples were taken in the first trimester of pregnancy.
  • In 2020-2021, researchers tested those maternal samples for 15 different PFAS compounds. They found 7 of the 15 in the bloodstream of nearly 90% of mothers in the study. The seven were: PFHxS, PFHpA, PFOA, PFOS, PFNA, PFDA, and PFUnDA.
  • Exposure to PFAS during pregnancy decreases the sperm quality of adult male offspring. Researchers found that both combined and single exposure to maternal PFAS concentrations during early pregnancy had a negative effect on the sperm quality—particularly sperm count, concentration, and movement—of adult male offspring.

Our Takeaway: The new study presents a startling finding—developmental exposures to chemicals are associated with long lasting harm, including impacts that can affect future generations. It also adds to the growing evidence of PFAS health risks and demonstrates the urgent need for more health-protective PFAS policies and regulations.

Next Steps: EDF and our partners are pushing EPA to revoke existing PFAS exemptions and require those PFAS (and new PFAS coming to market) to undergo a full safety review under the Toxic Substances Control Act, our nation’s primary chemical safety law.

It is critical that these evaluations also consider the cumulative risk of exposure to PFAS mixtures in the environment.

Note: In June 2021, EDF, with a group of health, environmental, and consumer organizations, sent a formal petition to FDA asking the agency to ban all PFAS  that accumulate in the body. That petition is still under review.

Posted in Emerging Science, Regulation / Also tagged , , | Comments are closed

Workers are people too; EPA should treat them that way

By / Bio / Published: June 21, 2022

EPA’s proposed TSCA rule to limit risks from chrysotile asbestos uses a higher “acceptable” cancer risk for workers than the rest of the population

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

When it comes to drawing the line on cancer risks, should workers be treated differently than the general population? Of course not. Unfortunately, EPA’s recently proposed rule to manage risks from chrysotile asbestos does just that, using one level of acceptable risk for workers and another – more protective threshold – for everyone else.

EPA says it uses a range for determining acceptable cancer risks under the Toxic Substances Control Act (TSCA), the country’s main chemical safety law. The range spans a risk (or the chance that a person will develop cancer) of less than one in 10,000 to a risk of less than one in one million. EPA says this is consistent with the cancer benchmark used by the National Institute for Occupational Safety and Health (NIOSH).

However, EPA’s proposed TSCA rule for asbestos does not actually use a range and it is not supported by TSCA. EPA instead applies a risk level to workers 100 times less protective than for everyone else! Read More »

Posted in Public Health, Worker Safety / Also tagged , , , , | Comments are closed

Changes for the better: EPA looks out for workers in revised risk finding for HBCD

By / Bio / Published: March 9, 2022

By Samantha Liskow, Lead Counsel, Health

EPA has started to fulfill its promise to take another look at many of the chemical risk findings made during the Trump Administration. First up was “HBCD,” a collection of flame retardants present in many goods, including building insulation, furniture, and electronics. In its revised risk determination for the chemical EPA proposed important changes that are needed to protect health and the environment and are required under TSCA, our main federal law on chemical safety.

We highlighted these positive steps in our comments to the agency and urged EPA to formalize these changes when it releases its final revised risk determination for HBCD and other chemicals undergoing reevaluation.

Here is a look at the changes EPA made: Read More »

Posted in Worker Safety / Also tagged , , , , , | Read 2 Responses

Haste makes waste: The Trump EPA’s 1,4-dioxane supplement may be its shoddiest TSCA work yet

By / Bio / Published: December 11, 2020

Richard Denison, Ph.D., is a Lead Senior Scientist.

Yesterday EDF submitted comments on a supplement to EPA’s 1,4-dioxane risk evaluation under the Toxic Substances Control Act (TSCA), which the agency issued a scant three weeks ago.

This solvent is a likely human carcinogen that contaminates drinking water nationwide and is present in millions of consumer products.

What EPA left out of its analysis swallows what it included.

The supplement expands the scope of EPA’s ongoing risk evaluation of 1,4-dioxane.  It now includes certain water exposures and certain exposures of consumers to products in which the chemical is present as a contaminant (more technically, a “byproduct”).

EPA rushed the public comment period, providing only 20 days and refusing requests from at least 14 organizations for an extension.  The agency also cut out another vital step in the process – peer review –in violation of its own rules for how risk evaluations are to be conducted.

But that wasn’t the only thing EPA rushed.  The Supplement itself was an 11th-hour affair, done mainly to appease a hypocritical demand from the formulated chemical products industry.

The haste with which it was assembled badly shows.  The additional exposures EPA examined are so narrowly constructed as to omit major, and potentially the largest, sources of exposure and risk people face from the presence of 1,4-dioxane in water and products.

And what EPA left out of its analysis swallows what it included.  Read More »

Posted in Health Policy, Health Science, Regulation, Worker Safety / Also tagged , , | Comments are closed

EPA’s final risk evaluation of trichloroethylene is scientifically flawed and understates risks to workers, the general public and those most susceptible

By / Bio / Published: November 23, 2020

Jennifer McPartland, Ph.D., is a Senior Scientist.  Richard Denison, Ph.D., is a Lead Senior Scientist.

Today the Trump Environmental Protection Agency (EPA) issued its final risk evaluation for trichloroethylene (TCE).  It largely tracks the agency’s draft document, retaining numerous flaws that severely understate the highly toxic chemical’s risks to workers, the general public and those most susceptible to its health impacts.

Among the evaluation’s most serious deficiencies is the abandonment of a bedrock principle of chemical risk assessment: that risk estimates be based on the most sensitive health effect.  Sadly, the final document retains the unprotective approach the Trump White House forced EPA to adopt, as reported in detail by Elizabeth Shogren of Reveal News.

Exposure to TCE is ubiquitous, coming from ambient and indoor air, vapor intrusion from contaminated sites, groundwater and drinking water wells, and food – yet EPA’s evaluation ignores or downplays each of these exposure sources and pathways.

Below we summarize some of the major concerns in EPA’s evaluation that we addressed in detail in our comments.

One silver lining:  Despite its glaring deficiencies, the risk evaluation did find that the great majority of TCE’s conditions of use present unreasonable risks—even as it grossly understated the extent of those risks.  As a result, EPA must now proceed to regulate those activities, providing the new Administration an opportunity to rectify the serious problems created by the Trump EPA.  Read More »

Posted in Health Policy, Health Science, Industry Influence / Also tagged , , | Comments are closed