The Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law on June 22, 2016 by President Obama, which amended the Toxic Substances Control Act (TSCA) for the first time since 1976. After years of inconsistent regulations, these new amendments change how the Environmental Protection Agency (EPA) regulates and administers TSCA while providing manufactures greater consistency to implement law.
The new TSCA requires EPA to reset and update its entire chemical inventory within one year of the bill’s passage into law. Included are all chemicals in US commerce, including any which are high priority in terms of presenting an unreasonable risk to human health. Although TSCA originally granted EPA such authorization, there was no mandate to implement procedure. The newest TSCA does provide clear structure for EPA to assess all commercial chemicals. Companies should be aware which chemicals are deemed high priority and be prepared to disclose all chemical substances along their supply chains to EPA.
In addition to EPA’s current tools requiring testing in conjunction with consent agreements, TSCA is also now able to order testing for chemical assessments unilaterally. In addition, EPA must include a justifying statement of an order instead of a consent agreement to require testing.
EPA is now required, per TSCA, to determine which chemicals pose an unreasonable health or environmental risk without consideration of costs or benefits while still considering impact on vulnerable populations.
While determining which chemicals pose unreasonable risk via risk evaluations, not all chemicals inventoried by EPA are subject. Determining which chemicals are high priority or low priority will be through a screening process to be developed within a year of passing the law. The priority ranking of a chemical will engage an evaluation deadline relative to the level of risk.
Companies may be ordered to conduct risk evaluations and TSCA amendments have few limits on frequency and scope; this may incur additional costs and administrative functions during the evaluation process.
If a chemical is identified to pose unreasonable risk, EPA must regulate it. Those regulations are limited to the scope of the risk evaluation and must account for economic impact. That impact includes effects on small business, national economy, technological innovations, and environmental and public health.
The highlight of TSCA reform is strengthening federal preemption. While EPA concludes whether a chemical presents unreasonable risk as high priority, a state is preempted from issuing a law on the substance. This “high priority pause” ends after EPA’s assessment and then states are prone to EPA’s findings. The pause prevents multiple states regulating a single chemical in conflicting ways while manufacturers wait additional regulation.