EDF Health

EPA Should Address Cumulative Risks from New Chemicals

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: January 11, 2023

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

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

ICYMI: EDF Cumulative Risk Assessment Framework Webinar

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: September 12, 2022

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

Public deserves strong safety reviews for chemicals

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: August 25, 2022

Maria Doa, PhD, Senior Director, Chemicals Policy

Innovation may involve bringing a new chemical to market, but before the new chemical can be used or sold, the Toxic Substances Control Act (TSCA), the nation’s primary chemical safety law, directs EPA to conduct a safety assessment. Specifically, EPA must affirmatively determine whether a new chemical may present—or is not likely to present—an “unreasonable risk of injury to health or the environment”.

Unfortunately, the chemical industry often provides EPA with very little toxicity data for its chemicals. At the same time, it pressures the agency to conduct assessments quickly, claiming that the chemicals under review support innovation and should therefore be approved quickly.

EPA should never be pressured to rubber stamp a safety assessment, no matter how innovative a company claims its new chemical to be. The potential consequences of this pressure for us could include being exposed to chemicals in unanticipated ways and having to spend enormous sums to clean up our air, water, and land. Instead, EPA must be allowed to use the best available information and conduct robust TSCA reviews. Read More »

Posted in Uncategorized / Tagged , | Comments are closed

EPA Takes Important Step to Ban Chrysotile Asbestos

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: July 20, 2022

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

EPA has made the important and long-awaited decision to propose banning nearly all remaining uses of chrysotile asbestos in the United States. EDF submitted comments supporting this proposed ban (with some caveats) because of the high risk of cancer and fatal respiratory diseases for individuals who import, process, distribute, and use chrysotile asbestos. The rule could be significantly improved by requiring a more immediate ban. If EPA chooses a more extended phase-in of the ban, we recommend that the Agency require companies to reduce workplace exposures in the interim to better protect workers.

Summary of Key EDF Concerns and Comments

Although asbestos is a known carcinogen, it is still used in automobile brake linings, gaskets, and brake blocks, as well as in permeable separators (diaphragms) at chlor-alkali facilities to produce chlorine and caustic soda. Currently, nearly 40,000 Americans die each year from asbestos-related illnesses. These deaths are preventable and must be stopped, and we applaud EPA for taking this step toward doing so.

  • EDF supports rapid implementation of EPA’s proposed chrysotile asbestos ban. Given the unreasonable risk posed by asbestos, we call on EPA to start the ban for all uses within 6 months after publishing the finalized rule.
  • In the event EPA chooses an extended phase-in (>6 months) of the ban on using chrysotile asbestos in chlor-alkali diaphragms and sheet gaskets, it should require companies to reduce workplace exposures during the interim in a way that poses the least risk to potentially exposed populations—particularly workers. In this case, we call on EPA to require hazard communication and the hierarchy of controls—first by reducing exposure through process, engineering, or administrative changes. Personal protective equipment (PPE) as a risk-reduction measure should be used only after applying these other controls to reduce chemical exposures. However, this approach would be less effective and more burdensome on workers than eliminating exposure completely and should be used only as a short-term, interim measure until the ban goes into effect.
  • EPA should explain how its proposed disposal requirements address the unreasonable risk presented by chrysotile asbestos. EDF is concerned that EPA has not demonstrated how compliance with OSHA’s Asbestos General Industry Standard and EPA’s National Emission Standards for Hazardous Air Pollutants would eliminate unreasonable risk, as TSCA requires.
  • EPA underestimates the benefits of preventing health impacts by banning chrysotile asbestos. In baseline exposure calculations, the Agency inappropriately assumes that workers will consistently and correctly use PPE while handling chrysotile asbestos and dramatically underestimates how many individuals will benefit from the rule. EPA should bolster its Economic Analysis in the final rule to more accurately reflect the benefits of the ban.

In addition, the proposed rule indicates EPA is continuing to include troubling policy decisions in its risk evaluations. Moving forward:

  • EPA should not consider costs or other non-risk factors in risk evaluations. EPA states it will consider use of PPE and other risk-management activities in its risk evaluations to help in making risk-management decisions—an approach that is not scientifically supportable and inappropriately conflates risk assessment with risk management.
  • EPA should not inappropriately treat workers differently from the general population by applying a less-protective cancer benchmark for workers. TSCA does not support this approach. Given that workers are particularly identified in TSCA for consideration and often face higher risks than the general population, making a less-protective standard is especially unjustified. (See our June 21, 2022 blog post on this issue.)

EDF also found many areas of agreement with EPA in the proposed risk-management rule. You can read the full set of comments here.

 

 

Posted in Regulation / Tagged , , | Comments are closed

Workers are people too; EPA should treat them that way

By Maria Doa, PhD, Senior Director, Chemicals Policy / 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, TSCA reform, Worker safety / Tagged , , , , | Comments are closed