Toxic Substances Control Act Overhauled After 40 Years

By Laura A. Siclari
lsiclari@marc.law

On June 22, 2016, President Obama signed into law amendments to the Toxic Substances Control Act (TSCA), named the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” to honor the late New Jersey senator who spearheaded reform efforts. These amendments represent a sweeping overhaul of the TSCA and constitute its first major update since it was enacted in 1976.

The purpose of the TSCA is to provide regulatory guidelines to companies that manufacture or sell chemicals or products containing chemicals to reduce risks that these chemicals pose to our environment and human health. TSCA also directs how the regulations are to be enforced and which government entities are tasked with enforcing them, namely the United States Environmental Protection Agency (EPA).

These amendments are very important to the chemical industry, as well as to the environment and the public. They represent a fundamental shift in the approach to regulating chemicals in commerce by vastly expanding the EPA’s authority over chemical substances, giving the EPA new authority to review and regulate new and existing chemicals. The intent of the reforms is to provide more effective federal oversight of chemicals, which should give Americans greater confidence that chemicals in commerce are being used safely.

Some of the most critical changes in the law are as follows:

  • Mandating that the EPA update its inventory of existing chemicals;
  • Replacing TSCA’s prior cost-benefit balancing standard with a new health-based safety standard. The new risk assessment includes identifying vulnerable populations, such as children, pregnant women, the elderly, and chemical workers, and ensuring that they are protected by requiring that the EPA take into consideration only the impact on health and the environment when evaluating potential risks and determining whether to allow a chemical to be sold or manufactured;
  • Requiring the EPA to review the risks posed by chemicals already in commerce, in contrast to the prior TSCA’s grandfathering-in of chemicals already in use. In the new review process, (1) companies must identify all chemicals they are currently making or processing, and (2) the EPA will establish the priority (high or low) of active chemicals. High-priority chemicals are those the EPA determines may present an unreasonable risk. Any chemical deemed an unreasonable risk must either be banned or phased out, or restrictions on the chemical imposed. For all new chemicals, the EPA must make a specific safety finding that it is not likely to present an unreasonable risk, as a condition for market entry;
  • Chemical companies must now contribute to the cost of enforcing the regulations through the requirement that the EPA collect fees for chemicals to defray a portion of the costs of implementing the program, which will go into a “TSCA Implementation Fund;”
  • Changing how the EPA handles manufacturers’ confidential business information (CBI). The EPA must review and approve or deny all past CBI claims that allowed chemical companies to mask the identities of active chemicals on the TSCA Inventory on the grounds that they were CBI. CBI claims will also now expire after 10 years unless re-substantiated. Also, health and safety data are not eligible for CBI protection. CBI must also be shared with state governments, health and environmental professionals and first responders, subject to nondisclosure agreements; and
  • Establishing federal and state preemption standards. For example, states will not be able to impose new restrictions on the use of a chemical substance that the EPA has determined does not present an unreasonable risk nor require notifications of a significant new use of a chemical when the EPA has already required such notification.

In short, the new amendments to the TSCA pose many new restrictions on the sale and manufacture of chemicals, and impose many new compliance obligations with key implementation deadlines commencing as early as 180 days following the June 22 enactment, with more coming due in 2017. Companies and their counsel must be prepared to anticipate and meet the new challenges.


Laura A. Siclari, an associate with MARC in Florham Park, NJ, counsels and represents clients in matters from regulatory and compliance issues to remediation claims and litigation, with an emphasis on soil/groundwater contamination. She also concentrates on employment discrimination, special education/disability law and general litigation matters.

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