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In a major overhaul of federal chemical safety laws, a historic reform of TSCA took effect on 22 June 2016. The Frank R. Lautenberg Chemical Safety for the 21st Century Act is intended to provide the EPA with better tools to obtain testing information on chemical substances. It also eliminates certain statutory requirements that make the restriction or ban of chemicals in US commerce difficult, restructuring the way existing chemicals are evaluated and regulated by directing the agency to use scientific evaluation to guide its decisions.
Before the passage of the TSCA reform, the EPA was unable to restrict or ban a chemical’s use – or even request new toxicity data from its manufacturers – without first proving the chemical carried a certain level of risk to human health or the environment. The EPA was also required to look into the potential costs of regulating a chemical when determining whether it was safe for use and choose the “least burdensome” method of regulation. Those requirements severely limited the EPA’s ability to take action under TSCA.
The TSCA Reform Law provides the EPA with more direct tools to obtain testing information on chemical substances; eliminates certain statutory requirements that make the restriction or ban of chemicals in US commerce difficult; and restructures the way existing chemicals are evaluated and regulated by directing the EPA to use scientific evaluation to guide its decisions.
The revised law also:
- Creates a system for risk-based safety evaluation for existing chemicals based on scientific standards.
- Requires the EPA to evaluate the risk of existing chemicals under "judicially enforceable deadlines", without consideration of cost.
- Sets aggressive deadlines for the EPA to take certain actions, 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.
- Resets the TSCA Inventory by identifying active and inactive chemicals on the market.
- Requires the 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.
- Eliminates the "least burdensome" requirements for regulating chemicals.
- Initiates a review of all existing confidential business information (CBI) claims, and requires 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.
- Provides federal preemption of state law with certain waivers. After the EPA makes a final decision on whether a chemical poses an unreasonable risk, an EPA restriction would generally apply to all states and territories. States may still require reporting and monitoring of chemicals. Prior state laws (before April 22, 2016) and private rights of action under state tort or contract law are preserved.
- Requires identification and protection of the most vulnerable populations, such as children, pregnant women and chemical workers.
- Advocates non-animal testing, such as Quantitative Structure-activity Relationships (QSAR).
- Requires science-based decisions, founded on weight of evidence (WoE).
- Allows user fees to be collected and used directly for the EPA’s chemical management activity.
For more information on TSCA reform, be sure to read Julie Byrne and Barry McLaughlin's article, Chemicals in Commerce: The Impact of TSCA Safety Reform, in Risk & Compliance Magazine.
If your company requires additional data, resources and expertise, 3E stands ready to provide comprehensive TSCA support.