EDF Health

New guidelines to inform EPA’s approach to cumulative risk

What’s New?

The Environmental Protection Agency (EPA) recently released and solicited public comments on its draft Cumulative Risk Assessment (CRA) Guidelines for Planning and Problem Formulation. The purpose of a CRA is to determine the combined health and/or environmental risks from multiple stressors and chemicals that can cause the same harms. These guidelines, intended to be applied to all of EPA’s programs and regions, describe how the agency will determine when to use CRAs and the steps it will take to plan them.

Why It Matters

Currently, many EPA programs assess the health and environmental risks of single chemicals, without considering the multiple chemicals that cause the same harms and non-chemical stressors we are exposed to every day. Assessing risks cumulatively, and making regulatory decisions based on this, represents real-world exposures more accurately than single-chemical stressor risk assessments. Read More »

Posted in Chemical exposure, Cumulative impact, Cumulative risk assessment, Health policy, Public health, TSCA, Vulnerable populations / Tagged , , | Authors: / Comments are closed

EPA Should Address Cumulative Risks from New Chemicals

Names of blog authors: Maria Doa, PhD, Sr. Director, Chemicals Policy, and Lariah Edwards, PhD, Associate Research Scientist, Columbia University

What’s Happening? EPA’s current safety assessments of new chemicals proposed for market entry often fall short of effectively protecting all members of the public from risk because they don’t consider that we may be exposed to closely related chemicals that cause similar harms.

Recent Example: EPA proposed rules requiring notification of significant new uses for a group of new chemicals. Two of these chemicals, known as trimellitate esters, are very closely related, and would be expected to cause very similar harms and have very similar uses—so that people exposed to one chemical would likely be exposed to the other. Despite this, EPA did not consider the chemicals together or even use the information it had on one to inform its understanding of the safety of the other.

This doesn’t make sense.

Even though EPA said that one chemical was intended to be used as a lubricant and the other as a plasticizer (a chemical that makes plastics more flexible), it is likely that both could be used as a plasticizer or a lubricant. They may be used together or turn up in similar consumer products, such as a car’s dashboard. Further, both chemicals are very closely related to yet another plasticizer used in the auto industry, but it appears that EPA considered these nearly interchangeable chemicals in isolation from one another.

Items that require plasticizers for production. They include seats in cars, rain boots, a garden hose, medical gloves, an exercise ball, and rolls of wallpaper.

In fact, under the Toxic Substances Control Act (TSCA), EPA is required to identify such “reasonably foreseen uses,” such as ending up in the same product.

Why It Matters: Evaluating chemicals in isolation likely underestimates the exposures and risks workers, consumers, and frontline communities face. Doing so also fails to make use of all the best available science, since information on each of these two chemicals (as well as the one already being used) could inform the safety determination for the other.

Considering the combined risks from similar chemicals is not new. EPA is already doing this for another group of closely related chemicals—phthalates. Phthalates have long been widely used in a range of consumer products and are detected in almost all our bodies. Phthalates are known to impact male reproductive health. EPA is joining the ranks of other federal agencies that have considered the cumulative risks they pose.

Our Take: EPA should not stop at phthalates. They can and should be incorporating cumulative approaches from the very beginning of a chemical’s regulatory life. Considering the impact of combined exposures does not need to be complicated and EPA could make such a consideration without much extra effort.

EPA can take a first step toward doing this by considering the potential for cumulative risks when finalizing its regulation on the significant new uses for these two new closely related chemicals.

Go Deeper: Read EDF’s response to EPA’s proposed new SNURs. And check out our Cumulative Risk Assessment Framework.

Posted in Environment, Health science, Industry influence, Public health, TSCA / Comments are closed

ICYMI: EDF Cumulative Risk Assessment Framework Webinar

On Wednesday, September 7, 2022, Sarah Vogel, EDF’s Senior Vice President for Health, welcomed over 150 attendees to a webinar on EDF’s new Cumulative Risk Assessment Framework (CRAF). The event featured presentations by:

  • Lariah Edwards, PhD, EDF post-doctoral fellow and Associate Research Scientist, Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University.
  • Devon Payne-Sturges, DrPh, Associate Professor, Maryland Institute for Applied Environmental Health, School of Public Health, University of Maryland.
  • Deborah Cory-Slechta, PhD, Professor of Environmental Medicine, Pediatrics, Public Health Sciences, and Neurosciences, University of Rochester Medical Center.

EDF staff developed this new tool to provide a practical pathway for applying comprehensive, cumulative chemical risk evaluations within the framework of the Toxic Substances Control Act (TSCA).

The tool is designed to support EPA’s mandate under TSCA to provide: 1) A holistic consideration of chemical risks, and 2) Special consideration of those who may be at greater risk because they are more susceptible to a chemical’s effects or more highly exposed.

The framework begins with the evaluation of a single chemical and moves toward an approach that takes into account multiple chemical exposures, as well as other, non-chemical stressors—like racism, poverty, and lack of access to health care. In combination, these factors lead to higher risks of disease and disability from cancers and heart disease to poor birth outcomes and childhood asthma.

For more information on the Framework, visit our new CRAF webpage, where you can download the in-depth report on the development of the framework and watch a recording of the webinar.

Posted in Health policy / Tagged , , , , , | Comments are closed

Cumulative assessment better estimates the real-world risks chemicals pose on our health

NOTE: This is the second of a series about EPA’s prioritization of existing chemicals. 

What Happened? 

EPA just proposed to designate five chemicals, including the widely-known toxic chemical vinyl chloride, as high-priority chemicals – meaning they are toxic to human and/or environmental health.  If finalized, these chemicals will immediately undergo the risk evaluation process under the Toxic Substances Control Act (TSCA).  

When designating these chemicals as high priority and moving forward in assessing their health risks, EPA can – and should – consider exposures to multiple chemicals that can cause the same health harms. To demonstrate the importance of these cumulative exposures, we conducted analysis on co-exposures to these five chemicals and submitted this analysis to EPA for greater consideration of real-world risks faced by individuals exposed to these toxic chemicals.  

Why It Matters 

Communities near industrial facilities are often exposed to multiple chemicals that cause the same health effects. Evaluating the health risk of these chemicals individually, as currently done by EPA’s TSCA program, often underestimates the true risks communities face. Additionally, many of these fenceline communities experience a variety of non-chemical stressors that exacerbate health effects from chemical exposure, such as physiological stress from poverty and racial discrimination, limited access to healthcare, or health effects from climate stressors like flooding and heat. Failing to consider these cumulative stressors on health in chemical risk evaluations often underestimates the actual risks these chemicals can pose to human health.  

Our Take 

Our analysis of Toxics Release Inventory (TRI) data from 2016-2021 shows that many chemicals that cause the same health effects – such as cancer, central nervous system (neurological), cardiorespiratory, liver, kidney, and thyroid, and reproductive and developmental effects – are often released together from the same facilities. For example, chemicals that cause cardiorespiratory effects are released with at least one other chemical that causes these same effects 74% of the time.  

For the five chemicals that have just been proposed as high priority under TSCA, all are known or probable carcinogens with some causing other adverse health effects. Based on our analysis, there are a few notable co-releases that EPA should consider when assessing cumulative risk with other chemicals causing the same harms. For example, creosotes, which are also probable carcinogens that can cause liver, kidney, and thyroid effects, are released 11% of the time with acrylonitrile, 18% with aniline, 11% with vinyl chloride, and 11% with 4,4-methylene bis(2-chloroaniline). 

Screenshot - Heatmap of co-releases of carcinogenic chemicals that are part of the TSCA Workplan.

Heatmap of co-releases of carcinogenic chemicals that are part of the TSCA Workplan. Legend represents the percentage of facilities releasing both chemicals out of the facilities releasing at least one of the pair of chemicals. Stars represent the 15 chemicals that were considered as part of TSCA’s pre-prioritization.

To demonstrate that EPA should also consider non-chemical stressors such as climate and environmental justice in its TSCA prioritization and risk evaluations, we looked at the vulnerability of communities to climate and environmental justice factors in areas where certain chemicals are released using EDF’s Climate Vulnerability Index. On average, vinyl chloride is released into communities with higher vulnerability than other chemicals analyzed – up to 12% higher than the average for other carcinogenic chemicals.  

What’s Next? 

EPA is now accepting comments on their proposal to designate these five chemicals as high priority, and we plan to submit comments to support the high priority designation. If finalized, EPA will begin risk evaluations for these chemicals. We hope EPA will consider cumulative risk and environmental justice as it moves through this process.   

In our next post in this series, we will recommend ways EPA can improve its prioritization process by considering risks from transportation and distribution of chemicals. 

Posted in Adverse health effects, Chemical exposure, Chemical regulation, Cumulative impact, Cumulative risk assessment, Environmental justice, Health policy, Public health, Regulation, Risk assessment, Risk evaluation, Rules/Regulations, TSCA, TSCA reform, Vulnerable populations / Authors: / Comments are closed

Anti-androgenic chemicals as a class of related substances with cumulative toxicological effects

Maricel Maffini, consultant, and Tom Neltner, Chemicals Policy Director

Scientists and regulators have known for decades that certain chemicals disrupt the actions of male hormones—identified collectively as androgens—in the body. Because of their effects, these chemicals are called anti-androgens or anti-androgenic chemicals.

During gestation, fetal testes begin producing testosterone, the critical hormone required to develop reproductive organs and genitalia. Insufficient production of testosterone leads to malformation of the genital tract that may need corrective surgery in infant boys and may result in reproductive health problems later in life. Ortho-phthalates (aka phthalates), known to interfere with the production of fetal testosterone, are considered anti-androgenic chemicals.

Although phthalates are perhaps the most recognizable group of anti-androgenic chemicals in the diet, there are others, including bisphenol A (BPA), propyl paraben, and certain pesticides used in food crops. Because they cause similar harmful effects, namely adverse health outcomes for male reproductive system, their safety assessment must take into account the cumulative effects of similar substances in the diet as established by law. But what does “cumulative effect” mean? Below, we use a recent study to explain what it means, why it is important, and why FDA is failing.

Biology is not math and the concept of something from nothing Read More »

Posted in Adverse health effects, FDA, Phthalates / Tagged , , , , | Authors: / Read 1 Response

EDF outlines steps for EPA to strengthen its plan to assess risks to frontline communities

Maria Doa, Senior Director, Chemicals Policy

This week Environmental Defense Fund (EDF) filed comments on EPA’s plan to assess the risks to frontline communities from nearby releases of chemicals to the air and water. The EPA’s proposal is an improvement from the previous administration, which failed to follow the requirements of the Toxic Substances Control Act (TSCA) and consider air and water releases and other significant exposure pathways for residents in “fenceline” communities near manufacturing or disposal facilities.

As we made clear in our comments, however, the agency’s planned screening approach is too narrow in scope and would underestimate the real-world risks faced by many communities.

Residents of these frontline communities often face exposure from multiple sources or higher levels of exposure than the general population, or both combined. Failing to consider the full scope of these risks could hamper EPA’s ability to craft protective rules that reduce the risks those living near industrial facilities.

We outline several areas where EPA can strengthen its screening approach Read More »

Posted in Air pollution, Public health / Tagged , , , , , | Comments are closed