The "new" Toxic Substances Control Act (TSCA) refers to the Frank R. Lautenberg Chemical Safety for the 21st Century Act, signed into law on June 22, 2016. This bipartisan legislation significantly updated and modernized the original TSCA of 1976, marking the first major overhaul of federal chemical safety laws in 40 years. Its primary goal was to strengthen the U.S. Environmental Protection Agency's (EPA) authority and ability to protect human health and the environment from chemical risks.
Understanding the Frank R. Lautenberg Chemical Safety for the 21st Century Act
The Lautenberg Act was enacted to address widely acknowledged shortcomings in the original TSCA, which had been criticized for being ineffective in regulating chemicals already on the market and for placing a high burden on the EPA to prove a chemical posed an "unreasonable risk."
The new law fundamentally changed how chemicals are regulated in the United States by:
- Mandatory Safety Reviews: Requiring the EPA to conduct mandatory safety reviews of existing chemicals with clear and enforceable deadlines.
- New Risk-Based Safety Standard: Establishing a single, risk-based safety standard for evaluating chemicals that explicitly considers vulnerable populations, such as infants, children, and the elderly.
- Increased Transparency: Enhancing transparency by requiring more public access to chemical information, while also protecting legitimate confidential business information.
- Clear Deadlines: Providing the EPA with clear and enforceable deadlines for evaluating chemicals and taking action to address unreasonable risks.
- Funding Mechanism: Creating a sustainable funding source for EPA's chemical review activities through industry fees.
Core Functions of the Toxic Substances Control Act (TSCA)
Even with the updates, the foundational purpose of TSCA remains consistent. The Act continues to provide the EPA with authority to regulate chemical substances and mixtures from their entry into commerce, through their production, importation, use, and disposal.
Specifically, TSCA addresses various aspects of chemical management, including:
- Specific Chemicals: It maintains oversight for specific chemicals that have historically been of concern, such as:
- Polychlorinated biphenyls (PCBs)
- Asbestos
- Radon
- Lead-based paint
- New Chemical Substances: Under Section 5 of TSCA, a crucial provision, manufacturers are still required to submit a Pre-Manufacture Notification (PMN) for "new chemical substances" before they are manufactured or imported into the United States. This allows the EPA to review and assess potential risks before the chemicals enter the market. The Lautenberg Act further strengthened the EPA's ability to review these new chemicals, requiring an affirmative determination that a new chemical or significant new use is "not likely to present an unreasonable risk" before it can enter commerce.
Key Changes and Their Impact
The Lautenberg Act introduced significant shifts in the regulatory landscape, transforming the EPA's approach to chemical safety. Here's a comparison of some key differences:
| Feature | Original TSCA (1976) | New TSCA (2016 - Lautenberg Act) |
|---|---|---|
| Risk Standard | "Unreasonable risk" (difficult to prove) | "No unreasonable risk" based on exposure; considers susceptible populations |
| Existing Chemicals | Limited authority; EPA had to prove risk for each. | Mandatory safety reviews of existing chemicals, with clear timelines and prioritization. |
| New Chemicals | PMN required; EPA could regulate only if it found risk. | PMN required; EPA must make an affirmative finding of "no unreasonable risk" or take action. |
| EPA Authority | EPA "may" require testing/regulation. | EPA "shall" take action to address unreasonable risks identified. |
| Preemption | Federal preemption unclear; states could act. | Creates a more defined balance between federal and state chemical regulations. |
| Confidentiality (CBI) | Easy to claim and protect. | Stricter requirements for CBI claims; EPA must review and substantiate claims. |
| Funding | Primarily taxpayer-funded. | Industry fees contribute to chemical review costs, ensuring dedicated resources. |
These changes aim to provide greater certainty and public confidence in chemical safety, leading to a more efficient and effective regulatory system for chemicals in commerce.
