EDF Health

Carts Before Horses: Vinyl Institute Calls For EPA To Evaluate Risk Without Data

By Samantha Liskow / Published: March 28, 2023

Horse attached to the wrong end of the cart. Caption says "Whose bright idea was this again?"

What’s New?

Yesterday, (March 27), EDF—together with the National Wildlife Federation—filed a “friend of the court” brief in the case of Vinyl Institute v. EPA. We expressed our support for EPA’s authority to order companies to 1) Conduct health and safety studies for their chemicals and 2) Turn over those test data to EPA when the agency is evaluating risks the chemicals may pose to humans, wildlife, or the environment.

The Vinyl Institute, which lobbies for companies making vinyl chloride and other chemicals used to make PVC plastic, disagrees. It brought a case against EPA on behalf of its members, asking the U.S. Court of Appeals in Washington, DC, to overturn EPA’s order to test 1,1,2-trichloroethane—a chemical known to harm living beings.

Why It Matters

This case could affect EPA’s ability to order companies to conduct health and safety studies for their chemicals, and, by extension, the agency’s ability to regulate those chemicals. Our brief to the court examines the history that led Congress to grant EPA authority to issue test orders and explains why it is critical for EPA to retain this authority.

The Backstory

The Toxic Substances Control Act (TSCA), the nation’s primary chemical law, was first enacted in 1976. For decades afterwards, EPA managed to collect test data for only a few chemicals; in some years, EPA collected no test data from companies at all.

The original TSCA law required EPA to go through lengthy procedures and make risk determinations about a chemical before it could seek any data from companies. Members of Congress recognized this was a no-win position for EPA and tried for many years to change the law. In 2016, Congress enacted major bipartisan reforms to TSCA, giving EPA power to order companies to test their chemicals when the agency needs data to complete risk evaluations of those substances. This change was lauded by members of Congress and many others as one of the most important improvements to TSCA.

The Current Case

EPA has designated 1,1,2-trichloroethane as a “high priority” for risk evaluation and possible regulation under TSCA. The agency issued the test order because it has some data indicating that the chemical is toxic to birds—but EPA needs more information on just how toxic it is to understand the risks. The Vinyl Institute essentially argued that EPA should have shown the risk to birds before it issued a test order—a classic case of putting the cart before the horse.

On behalf of several multibillion-dollar companies, which produce vinyl chloride and are part of the case, the Vinyl Institute also complained about the cost of the test.

What’s Next?

The court will review the briefs and issue a decision. In the meantime, chemical companies are challenging other EPA testing orders in court, and we are keeping a close eye on those cases. We will continue supporting EPA’s ability to exercise the authority Congress gave it–along with the ability to gather the information it needs to understand how chemicals pose risks to us and the environment and it can take the actions necessary to protect us.

Go Deeper

Read the briefs for the case Vinyl Institute v. EPA:

Also posted in Public health, TSCA / Authors: / Comments are closed

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.

Also posted in Environment, Health science, 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.
Also posted in Frontline communities, PFAS, Public health, TSCA / Tagged , , , , , , | Authors: / Comments are closed

The Case of the Missing PFAS

By Lauren Ellis / Published: November 10, 2022

By Lauren Ellis, MPH, Research Analyst, Environmental Health and Samantha Liskow, Lead Counsel, Health

NOTE: In a recent blog post, EDF called for EPA to revoke PFAS approved through the agency’s “low volume exemption” (an LVE is an exemption from a full safety review for new chemicals produced in quantities less than ~10 tons) and to instead require all PFAS to undergo a full safety review under the Toxic Substances Control Act (TSCA). Last month, EDF and other groups, represented by Earthjustice, formally petitioned EPA to do just that.

What Happened: We recently discovered that EPA is withholding the names of over 100 PFAS chemicals approved as LVEs—claiming that releasing that information would reveal “confidential business information” (CBI).

Why It Matters: PFAS causes harm to both the environment and to human health—including reproductive, developmental, and cancer-related effects. Given growing concerns about the risks of PFAS, the public has the right to know if they are being exposed to PFAS, especially those approved through exemptions to EPA’s new chemical safety review process.

Our Take:

  • EPA should reveal the identities of the missing PFAS LVEs. If doing so would reveal CBI, EPA should work with PFAS manufacturers to craft a name that clearly communicates PFAS class membership.
  • EPA should require full safety review for all PFAS, including those previously approved through exemptions.

GO DEEPER… Read More »

Also posted in PFAS, Public health, Regulation, TSCA reform / Tagged | Comments are closed

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

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: May 17, 2022

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 »

Also posted in Health policy, Public health, TSCA reform / Tagged , , , | Read 3 Responses

The many ways the American Chemistry Council wants to turn back time on TSCA implementation – Part 1

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: May 17, 2022

Part 1 of a 2-part series: Minimizing or ignoring chemical risks

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. The chemical industry group looks to return to the policies of the Trump years – a time rife with scientific integrity issues and wholesale disregard of risks – particularly those risks to frontline communities, workers and other vulnerable groups: the very groups the Toxic Substances Control Act (TSCA) calls out for special consideration.

This 2-part blog series looks at the six ways ACC hopes to turn back time on chemical safety and looks at the harms that would result if trade group’s self-serving ideas were to be adopted. Part 1 looks at the types of risks ACC wants EPA to exclude from its chemical risk evaluations, the workers and other groups whose health would be affected, as well as the trade group’s goal to have itself appointed as the arbitrator of EPA science. Part 2 looks at ACC’s efforts to dictate the process for assessing new chemicals and industry’s clear goal to avoid paying its fair share of the cost to evaluate the risks posed by some of the most dangerous chemicals already in the marketplace.  Read More »

Also posted in Health policy, Health science, TSCA reform, Worker safety / Tagged , , | Comments are closed