Vol. 919 | 05 Jul 2016

On June 22, 2016, U.S. President Barack Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act1 (Lautenberg Act) into law, the changes are effective immediately. The Act is the first major change to the Toxic Substances Control Act (TSCA) since its enactment in 1976.

TSCA was implemented to regulate existing and new chemicals in commerce to protect human health and the environment. It also regulates the use of any chemical(s) that present “an unreasonable risk of injury to human health or environment.” The new legislation provides the U.S. Environmental Protection Agency (EPA) with more oversight over the use of chemicals in everyday products. Key changes include:

  • The EPA will perform risk evaluation based on hazard and risk of exposure taking in to consideration potentially exposed or susceptible subpopulation under conditions of use, without any consideration of cost or non-risk factors.

  • Inventory reset: EPA will collect information from manufacturers to determine the existing chemicals that the manufacturers have used during past 10 years, which will reset “the Inventory.” Subsequent to this the EPA will be required to perform risk-based screening to prioritize these existing chemicals on “the inventory” and designate them as ‘high priority’ or ‘low priority.’ High priority designation for a chemical automatically triggers risk evaluation by the EPA.

  • The risk evaluation process has to be established by the EPA by June 22, 2017. Additionally EPA also has to meet the challenging timeline of performing:
    • 10 risk evaluations for chemicals drawn from the TSCA Work Plan2 within 6 months by December 20, 2016.
    • 20 risk evaluations being conducted on high-priority substances, at least 50% of which are from the TSCA Work Plan, and 20 chemicals are designated as low priority, within 3.5 years by December 23, 2019.
  • Confidential Business Information (CBI): As part of “the inventory” reset, EPA is required to review all the CBI claims and approve or deny them. The CBI claims must be substantiated by the manufacturer when made and will have to be renewed every 10 years. Lautenberg Act provides ability for the EPA to share health and safety related information under certain circumstances with the State and Federal agencies.

  • Preemption: State action on chemicals is preempted when the EPA through risk evaluation finds that the chemical is safe, or when the EPA takes final action to address the chemical’s risks. Preemption applies only to the state laws restricting or banning a chemical, not to laws that require reporting, monitoring or other information requirement.

    In addition, the Lautenberg Act grandfathered the state laws or actions based on those laws (e.g., regulations or enforcement) enacted prior to September 1, 2003. So the state law like California Proposition 65 will not be preempted by Lautenberg Act. Also, the state laws (framework statutes) enacted prior to April 22, 2016, which was this year’s Earth Day, will be preserved. So various state laws restricting individual chemicals like cadmium in children’s jewelry, BPA in certain childcare articles, and flame retardants in upholstered furniture and children’s products that were enacted prior to April 22, 2016, will not be preempted by the Lautenberg act.

  • Fees: Creates “TSCA Service Fee Fund” and provides authority to the EPA to collect fees to cover up to 25% of the cost, which is initially capped at $25 million per year, from the chemical manufacturer and processors.

    Manufacturer or processor to pay 100% of the cost, if they request risk evaluation for a chemical. This fee is reduced to 50%, if that chemical is on EPA’s TSCA Work Plan.

The EPA has published the “First Year Implementation Plan3” outlining the roadmap for the Lautenberg implementation during the first year.

For more information, please contact Dr. Pratik Ichhaporia (pratik.ichhaporia@intertek.com)



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