ENV-16-106 Regulatory Update on TSCA Reform

Description:

The United States (US) Congress and Senate have recently finalized the reformation of the Toxic Substances Control Act (TSCA; Act; 15 U.S.C. §2601), which originated on October 11, 1976. The Act is a major new environmental legislation in over two decades that imposes stricter reporting, record-keeping, testing, import/export, and safety evaluation of chemical substances and/or mixtures. Approximately 85,000 chemicals in US commerce are subject to legacy TSCA regulations. Although TSCA has been amended several times since 1976, the Congress felt that a major reform was necessary to modernize it by capturing the latest developments in risk assessment science and toxicology. The new TSCA (TSCA Modernization Act of 2015) has received overwhelming and uncharacteristic bi-partisan support within Congress and from non-governmental organizations. On June 23, 2015 the House version passed 398-1; the Senate version passed unanimously on December 17, 2015. The House and Senate versions have since been reconciled and the Bill had been signed by the President on June 22, 2016. The Bill became effective immediately with no phase-in period. The Act Administrator, the United States Environmental Agency (USEPA), has 2 years to develop any policies, procedures, and guidance. However, certain components will be implemented immediately. For example, the USEPA has to develop a list of chemicals that may have persistent, bioaccumulative, and toxic properties (PBT). This list will be a target for subsequent quantitative human and ecological health risk assessments and, potentially, prohibitions, restrictions, and/or risk management actions. This summary paper reviews the TSCA’s reform history, intent, and outline key changes regarding the consideration of sensitive subpopulations, human and ecological risk assessments, risk-based determination, weight-of-evidence approach, data disclosure, and scientific standards. The paper also provides an early insight into the likely impacts on the industry and what additional resources/measures will be needed to implement the new chemical regulation.