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Editor's Note: The original artcle has been updated since June 9, 2016.
On 22 June 2016, U.S. President Barack Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (H.R. 2576) which modernizes the 40- year-old Toxic Substances Control Act (TSCA). The amended TSCA will facilitate a number of reforms including: creating a system for risk-based safety evaluation of chemical substances; requiring the Environmental Protection Agency (EPA) to evaluate the risks of existing chemicals; setting deadlines for EPA to take certain actions; resetting the TSCA Inventory by identifying active and inactive chemicals on the market; and requiring EPA to designate low and high priorities of chemicals, conduct risk evaluations of high-priority substances, and restrict or ban those that present an unreasonable risk, among many other revisions.
In a unanimous consent voice vote, the U.S. Senate passed legislation to modernize the 40-year-old Toxic Substances Control Act (TSCA) in the night of 7 June 2016. This is the same conference committee version earlier passed by the House. Congress's final passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (H.R. 2576) comes after months of negotiations to reconcile bills passed by each chamber since 2015. The bill now heads to President Obama's desk to be signed into law.
This historic TSCA reform comes as a rare display of bipartisanship in an election year in the U.S. The Senate approved the measure on a voice vote after several Republican and Democrat Senators spoke enthusiastically about the legislation on the floor on 7 June 2016.
The reform provides EPA with more direct tools to obtain testing information on chemical substances; eliminates certain statutory requirements that make restriction or ban of chemicals difficult in U.S. commerce; and restructures the way existing chemicals are evaluated and regulated by directing EPA to use scientific evaluation to guide its decisions.
Other key revisions include:
- Create a system for risk-based safety evaluation based on scientific standards
- Require the agency to evaluate the risk of existing chemicals under "judicially enforceable deadlines", without consideration of cost. The amendment sets aggressive deadlines for EPA to take action, such as an affirmative safety finding within a 90-day pre-manufacture notice (PMN) review period and completion of risk assessments within three years of enactment
- Reset the TSCA Inventory by identifying active and inactive chemicals on the market
- Require EPA to designate low and high priorities of chemicals, conduct risk evaluation of high-priority substances, and restrict or ban those that present an unreasonable risk
- Eliminate "least burdensome" requirements for regulating chemicals
- Initiate a review of all existing confidential business information (CBI) claims, and require re-substantiation of approved claims after ten years. However, the legislation allows certain state, local, and tribal government officials and health care professionals to access the information.
- Provide federal preemption of state law with certain waivers. After EPA makes a final decision on whether a chemical poses an unreasonable risk, EPA restriction would generally apply to all states and territories. States may still require reporting and monitoring of chemicals. Prior state laws (before 22 April 2016) and private rights of action under state tort or contract law are preserved.
- Require identification and protection of most vulnerable populations, such as children, pregnant women, and chemical workers
- Advocate non-animal testing, such as QSAR
- Require science-based decisions, founded on weight of evidence (WoE)
- Collect user fees for EPA’s chemical management activity
According to the authors of the legislation and many groups (both industry and consumer groups) supporting it, modernization of TSCA is necessary to improve protections for public health and the environment, to provide the public greater confidence in the safety of U.S. chemicals, and to promote further innovation, economic growth, national harmonization and globalization.
After decades of efforts in revising the law, an unprecedented bipartisan bill, initially led by the late Senator Frank R. Lautenberg in 2013, became the best hope of TSCA reform. Fast forward to June of 2016, TSCA reform has become a reality. President Obama is expected to sign it into law in coming weeks.
The amended TSCA will have significant impacts on chemical manufacturers, importers, distributors, processors and other downstream users. Important issues include the restriction and ban of chemicals, reporting of chemical data, chemical testing, CBI claims and access, and federal preemption. Affected companies need to understand the revised statutory concepts in the bill in order to adapt to and comply with a new U.S. regulatory framework for chemical management. In addition, the legislation has early indicators of new regulations from EPA, which will have more practical day-to-day impacts on the industry.
Lastly, as EPA prioritizes, evaluates for risks, gathers chemical information, and possibly restricts individual chemicals in the upcoming months and years, affected businesses should consider participating at each stage of the EPA’s rulemaking process to have input in the final outcome and/or early awareness of coming changes.
Writen by James Lee, Sr. Regulatory Analyst, North America.