Toxic Substances Control Act and the Regulation of Chemicals

Chemical barrels

Q&A with Trish Koman

Research Investigator in Environmental Health Sciences

As the fifth anniversary of the passage of major amendments to the Toxic Substances Control Act approaches this June, a University of Michigan researcher will address the impact the law has had on the regulation of industrial and commercial chemicals.

Trish Koman is a research investigator in Environmental Health Sciences at the U-M School of Public Health. She discusses the legislation:

What is the Toxic Substances Control Act? 

Unlike pharmaceuticals, industrial and commercial chemicals are rarely tested for safety before they reach the U.S. market. The Toxic Substances Control Act of 1976 governed chemicals in commerce in the United States, but it is widely known to be weak and ineffective and did not require manufacturers to test or provide data about the health impact of chemicals before they accessed the lucrative U.S. market. Health and safety testing was available for just 200 chemicals –less than 2% of the total manufactured chemicals– and under the 1976 TSCA law, the U.S. Environmental Protection Agency could not effectively regulate chemicals with documented adverse health effects, like asbestos and methylene chloride, for example.

The 2016 Frank Lautenberg amendments to TSCA gave the EPA new requirements and authorities. Passed with bipartisan support, the legislation provided EPA with authority to require reporting, safety testing, and restrictions relating to harmful chemical substances and/or mixtures. This reform law was designed to modernize U.S. industrial chemical policy to promote health. 

Has there been progress over the five years with the new law?

The amended TSCA law gave the U.S. Environmental Protection Agency new requirements and authorities. Whereas before "no data" meant no action, now EPA must make affirmative risk determinations. EPA has new authorities to require that companies who manufacture or distribute chemicals in the U.S. provide information about the safety of their products, especially regarding health effects among susceptible and highly exposed groups, such as children, pregnant women and workers. 

The question remains as to what extent the new administration will utilize these new authorities to protect our health. 

Importantly, the Lautenberg amendments set out judicially enforceable deadlines for the EPA risk decisions, including a review of the progress not later than the fifth anniversary of enactment, coming up June 22, 2021. The law specifically mentions a review of the adequacy of any policies, procedures and guidance for assessing and determining risk. 

After providing an opportunity for public comment, EPA must revise the policies, procedures and guidance to reflect new scientific developments or understandings.

Changes will be necessary because the previous administration has not fully utilized the science or the new powers; the nonpartisan Government Accountability Office in March 2021 criticized this program as continuing to be a high management risk in urgent need of improvement in assessing and controlling chemicals that pose risks to human health.

What are some of the challenges that remain?

The main challenges for EPA are to accelerate the pace of gathering data and making risk evaluations and risk management decisions in compliance with the new law to protect public health. The EPA implementation of the new amendments in the past administration have not used modern risk assessment principles. 

The science has advanced regarding how industrial chemicals and environmental pollutants can adversely influence people's health, but EPA methods for evaluating the evidence to use in policy decision-making has not kept pace with this science. For many chemicals, there is well-supported evidence showing there are health risks from common everyday exposures to factors that amplify the risks such as background exposures to multiple pollutants, preexisting disease, intrinsic factors like genetics, social vulnerabilities, and susceptible life stages such as when children develop or people age.

What are some of the changes you would like to see? What kind of policies are you hoping for?

Americans must demand that their environmental statutes, like the 2016 TSCA amendments, live up to their promise to protect public health. We want our children to have the opportunity to grow up without harmful exposures to industrial chemicals. We want our workplaces to be safe. We want modern risk assessment principles to be applied to robust data about chemical safety, and we want equal protection of these laws.

We must adopt environmental justice principles in chemical policymaking and implement environmental statutes as Congress intended to fundamentally transform chemical policy to address health disparities from harmful chemicals. EPA can take a first step by first expanding consideration of susceptible populations in risk assessment to include at-risk communities, such as communities in Michigan, where health problems from chemical exposures and pollutants may be worse due to legacy contamination and social factors like discrimination, poverty and lack of access to health care.

EPA must use the most scientifically up-to-date approaches to evaluate the hazards and risks of industrial chemicals and environmental pollutants that inform decision-making to protect public health. EPA should correct its definition of potentially exposed and susceptible populations, specifically similar to the definition in the 2017 TSCA proposed risk evaluation framework rule. EPA should consider classes of chemicals, such as grouping phthalates, to accelerate risk management and avoid regrettable substitutions.

Right now, EPA's methods would not consider that children in a community like Flint might have experienced higher previous exposures to lead, for example, in evaluating a different neurotoxic chemical. EPA should follow modern risk assessment techniques and add up different pathways (through the air, through drinking water, through contact with products through our skin) and all relevant conditions of use (adding up exposure to chemicals from multiple manners including as a worker, as a consumer and as a community resident).

For the 2016 Lautenberg amendments to deliver on the promise to protect Americans from adverse effects from chemical exposures, we need more information about the health impacts of chemicals. EPA must require that manufacturers provide data that shows their products are safe to continue access to U.S. markets.

With these steps, we can create U.S. policy in which the environment enhances health for all people—in the products in our homes and schools, our water resources and our workplaces.

Why is regulating these chemicals important?

In the U.S., everyone is exposed to industrial and toxic chemicals, dozens and probably hundreds—well before birth. The amount of chemicals manufactured and imported continues to grow—it is trillions of pounds—and these chemicals remain largely unregulated. Toxic chemicals can harm our health as these substances are present in everyday products (e.g., cleaning products, cookware, housing materials, bedding, toys). Some chemicals affect our immune system or cardiopulmonary health, which may result in worse health during a global pandemic.

Not everyone is equally at risk, and a higher burden of disease falls on low wealth communities and communities of color. TSCA could be an important law to reduce health disparities from environmental causes if the routine outcome of EPA's policies focus on equal protection and health-protective interpretation of the data.

The public health impact points to the need for the U.S. EPA to fully use its new powers to evaluate all risks from hazardous chemicals and set policies which protect health and are accountable to high-risk communities. Preventive actions are urgently needed.