Modern life is awash with chemicals. They’re in our work places, our homes, our bedrooms, the clothes we wear, the water we drink, the paint on our walls, the products we clean with. They’re all around us. Indeed, roughly 30,000 pounds of chemicals are produced per person, per year in the US. The Toxic Substances Control Act (TSCA) is a federal safety net that ensures these chemicals don’t cause harm to humans or the environment.
At least it’s supposed to.
This act is the centerpiece of the nation’s table-display of chemical regulations, which include different laws governing food, drugs, cosmetics and pesticides. For decades, however, TSCA was widely criticized by many environmental and consumer advocacy groups for being toothless—that it achieved very little in regulating the nation’s chemicals. This led to a major overhaul two years ago, and a revised TSCA signed into law near the end of the Obama administration, shepherding in a number of “important improvements.”
But as the new law, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, continues to be rolled out under the Trump administration, critics point to recent modifications made by the Environmental Protection Agency (EPA) to the way it evaluates and regulates chemicals, prioritizing industry concerns over human health and the environment. Sen. Tom Udall, ranking member of the Senate Appropriations Subcommittee overseeing EPA’s budget, has called implementation of the law a “remarkable disaster.”
Robert Sussman, a former EPA official and now a counsel for chemical reform organization Safer Chemicals Healthy Families, agrees. “I’d be hard-pressed to say that the actions of the EPA under the new law are more effective than its actions under the old law,” Sussman told Truthout. “Not much has improved, and we seem to be going backwards in a couple important areas.”
In a statement provided by the EPA on background, the agency denied the new TSCA has been diluted, and that any subsequent changes have followed the “original intent” of the Lautenberg Act.
A landmark legislation passed a little over 42 years ago, TSCA grandfathered in roughly 62,000 chemicals already in use without a proper framework for evaluating their potential risks. Over the subsequent years, thousands more chemicals were added to the inventory, which comprises all chemicals used in the US, whether they were manufactured in the US or shipped in from abroad. There are currently more than 85,000 listed on the inventory, though the EPA has identified about 37,000 in active use.
Central to the original law’s many flaws was the fundamental premise that it wasn’t up to chemical manufacturers to prove their chemicals were safe before they entered the market — it was up to regulators to prove that chemicals were unsafe. Indeed, up until 2016, the EPA had successfully restricted the use of only five chemicals during a 40-year period. One of the law’s most high-profile losses came in 1991, when the Fifth Circuit Court of Appeals overturned the EPA’s asbestos rule, which had banned its use in most products.
The Lautenberg Act was seen as a brave new world in chemical regulations—a fresh opportunity for the EPA to systematically review existing chemicals already in the marketplace, as well as all new chemicals joining them. The new law has triggered a flurry of action over the last two-plus years, with tight deadlines delineating its rollout.
Nevertheless, during the rollout, the EPA has taken a number of steps that “undermine almost everything” the Lautenberg Act was intended to achieve, said Jennifer Sass, senior scientist with the environmental not-for-profit Natural Resources Defense Council. One such action concerns the way the EPA prioritizes and then evaluates existing chemicals.
Broadly put, the Lautenberg Act requires the EPA to prioritize these chemicals by the risks they pose to human health and the environment, and then to fully evaluate the most dangerous ones. The agency is required to exclude cost considerations—as was a feature of the original law—from the process, and to factor in possible impacts on highly vulnerable populations. If the chemical is deemed to pose an “unreasonable risk,” then the EPA must regulate it, or even ban it, if necessary.
Nevertheless, the rules outlining these prioritization and risk evaluation processes have been “significantly narrowed” under the Trump administration, excluding important “pathways of exposure” that leave vulnerable populations like pregnant women and children especially susceptible to harm, according to Eve Gartner, a litigator in the Healthy Communities Program at Earthjustice, an environmental organization currently litigating the TSCA roll-backs.
Gartner calls the new risk evaluation process “a parody” of what it should be, under the Lautenberg Act. It no longer accounts for a chemical’s accumulated exposure in the real-world, for example. Nor does it consider the separate risks from each independent use of a chemical. It also excludes the use and disposal of “legacy” chemicals, like asbestos, which linger in the environment for years after use. As finalized, “the rules could result in very significant harm to the environment and to public health,” Gartner warned.
Many of the rule changes are currently tied up in litigation; and so, in an effort to handcuff TSCA through other means, the EPA is similarly narrowing the scope of the scientific data it uses to risk-evaluate chemicals, critics argue. “Now what they’re doing is chipping away at the foundations, which is frankly a much more dangerous strategy, and one that will be less visible,” said Gina McCarthy, former head of the EPA, at a recent Harvard forum.
At the heart of the EPA’s scientific approach is its Systematic Review document, which outlines the process the agency uses to select what data it includes and excludes to evaluate chemicals. The document, which didn’t undergo peer review, shuns important human health and toxicological studies in favor of industry-backed reports, which is why it has been likened to the widely derided science transparency act passed in April 2018.
According to Veena Singla, associate director of Science and Policy in the Program on Reproductive Health and the Environment at the University of California, San Francisco (UCSF), the systematic review process will toss out “many high-quality studies that should be the basis for chemical assessments.”
The systematic review document is currently used in the evaluation process for the first 10 priority chemicals, chosen for the threats they pose to human health and the environment. The Obama administration had already started the process of banning certain uses of three chemicals on this list—trichloroethylene, N-methylpyrrolidone and methylene chloride. Since 1980, 64 deaths have been linked to acute exposure to methylene chloride, a chemical used in many products such as paint stripper.
Tellingly for these first 10 priority chemicals, the EPA decided not to evaluate the potential human health and environmental risks caused by the presence of these substances in the air, soil and water, according to agency documents reviewed by The New York Times. By calculating the risk this way, the EPA fails to account for 68 million pounds of toxic emissions a year, according to the Environmental Defense Fund.
“It all comes down to the risk assessment,” said Tracey Woodruff, director of the UCSF’s Program on Reproductive Health and the Environment. “And right now, the method the EPA has for doing it is so far away from reflecting the real risk to the public, they’re inevitably going to underestimate the risk compared to what people are truly experiencing.”
In a background statement, the EPA wrote that the Systematic Review document does not intentionally exclude any studies from the risk evaluation process. “If a study is evaluated and determined to be low quality, EPA will give it a lesser weight than any available higher quality studies. All available and relevant studies will be considered and evaluated for their quality and relevance to a risk evaluation,” the agency wrote.
It’s not just the review process for existing chemicals that concerns many experts—the current administration has also narrowed or ignored certain aspects of the Lautenberg Act’s rules concerning new chemicals entering the market.
Under the old TSCA rules, for example, the EPA couldn’t order manufacturers to conduct new tests on a chemical without pursuing a lengthy rule-making process. The revised rules give the EPA expanded muscle to demand chemical companies run additional tests, if deemed necessary. The EPA, however, has yet to flex this muscle, said Sussman. According to the EPA, 1,823 new chemical reviews have been completed since the new law’s enactment.
Indeed, the first draft risk evaluation under the Lautenberg Act was released in November for Pigment Violet 29—a chemical used in a host of commercial products like paints and carpeting. Only 24 studies were included in the evaluation. Some risk assessments can reference hundreds or thousands of studies. Even more tellingly, the EPA chose not to require additional tests to better understand the chemical’s potential to cause cancer and neurological problems, among other health issues, according to the UCSF.
What the Lautenberg Act failed to tackle in any meaningful way, however, are the loopholes that chemical manufacturers use to introduce potentially toxic chemicals into the marketplace without a standard safety review.
Journalist Sharon Lerner has chronicled the unfolding story behind potentially toxic per- and polyfluoroalkyl substances (PFAS) compounds that are ubiquitous throughout the nation’s water sources. In a recent story, Lerner explains how PFAS chemical companies have exploited these exemptions over the years, like that for chemicals manufactured in volumes lower than 10,000 kilograms per year. What’s more, of the new chemicals allowed onto the market since the Lautenberg Act was signed, “more have bypassed the safety review the law put in place than have undergone it,” Lerner wrote.
According to Eve Gartner, these exemptions that chemical manufacturers exploit, coupled with the sorts of information that industry is permitted to keep confidential from the public—such as details concerning the full composition of a chemical mixture—add an additional layer of risk. “It’s definitely an area that’s rife with abuse,” Gartner said, looking specifically at the way the EPA approaches trade secrets.
Injury to the Developing Brain
This isn’t the first time the EPA has come under fire for its data selection process. Decades ago, many companies used Industrial Bio-Test Laboratories (IBT) to conduct toxicology tests for them. These reports were then sent to EPA for registration. It later transpired that flaws in many IBT tests rendered them invalid, even after the reports had received approval from the EPA. In some instances, the decomposed bodies of test mice were left to ooze through their wire cages, for example.
In 1978, senior EPA and Canadian health officials met with chemical industry executives in secret at a Howard Johnston Motor Inn to discuss how to continue using IBT data, despite less than 10 percent of it proving scientifically valid. (A transcript of the meeting can be read here, and is part of a massive trove of agency documents called the Poison Papers.) A subsequent federal grand jury trial saw three IBT officials go to prison.
This episode illustrates the way the EPA has always been susceptible to regulatory capture by industry interests, said Evaggelos Vallianatos, an official within the EPA for 25 years, and author of the book, Poison Spring. “The agency proceeds to do what it has been doing for decades,” he told Truthout. “They’ve paid a price, of course, in terms of disease, death and pollution.”
Just recently, a former Koch Industries executive was tapped to head the scientific research arm of the EPA. Nancy Beck hopscotched from the American Chemistry Council (ACC)—an industry organization with powerful political clout—to a top deputy position in the agency’s Office of Chemical Safety and Pollution Prevention. According to The New York Times, Beck subsequently weakened rules designed to track the health consequences of legacy chemicals. The research-oriented Silent Spring Institute has noted key changes to the final risk evaluation rule that mirror industry comments made during the formal public comment period.
When asked about these ties between industry and the EPA, Jon Corley, director of communications for the ACC, wrote in an email that “not only are we fully supportive of the efficient and effective implementation of the 2016 amendments to TSCA, it’s also the top priority for ACC and our member companies.”
According to Philip Landrigan, director of the Global Public Health program at Boston College, the recent modifications to TSCA are going to have real-world implications, and especially on vulnerable populations like babies and developing children.
“We’ve now made very strong connections between a number of chemicals and disease outcomes,” said Landrigan. “One category of diseases that we’ve really nailed the connection between is pre-natal exposures and injury to the developing brain.”
This is just one important reason why the teeth given to TSCA under the Lautenberg Act must be preserved, at the very least, said Bob Sussman. “This is the critical law that protects us from hazardous chemicals,” he said. “I think we all just want peace of mind, and unless this law works effectively, we can’t have that.”
Note: This article has been amended to better clarify the working relationship between IBT Laboratories and the EPA.