• Under TSCA, EPA relies on scientific and technical information about a chemical to evaluate risks associated with the chemical and determine whether to regulate it.
• LCSA directs EPA to establish an SACC to provide nonbinding, independent scientific and technical advice to the agency regarding implementation of the Act.

The Environmental Protection Agency (EPA) is required to meet the scientific standards in the Toxic Substances Control Act (TSCA) for best available science, utilizing a weight-of-scientific-evidence approach when conducting risk evaluations. The application of these standards will be documented throughout the risk evaluation process and available for public comment.

EPA’s initial work on systematic review was described in the supplemental files for each TSCA scope document, which included the Strategy for Conducting Literature Searches and the Bibliography for each chemical. The agency had been using the Application of Systematic Review in TSCA Risk Evaluations when conducting TSCA chemical risk evaluations.

However, in December 2021, EPA released for public comment a Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances, that will guide the agency’s review and selection of studies and provide the public with continued transparency regarding how EPA plans to evaluate scientific information.

Lautenberg Act made specifications about use of science

Under TSCA, EPA relies on scientific and technical information about a chemical to evaluate risks associated with the chemical and determine whether to regulate it. The chemical industry and environmental and public health organizations have contested on occasion the quality of scientific and technical information that EPA has relied upon to make regulatory decisions under TSCA. To that end, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) of 2016 added various provisions specifying how EPA is to use scientific and technical information to carry out the Act.

In determining whether to require development of new information about a chemical or whether to regulate a chemical that presents unreasonable risks, EPA must consider the “best available science” and any applicable factors generally used to assess the quality of scientific information. EPA must also consider “reasonably available information” that relates to chemicals’ conditions of use and make decisions based on the “weight of the scientific evidence.”

More generally, EPA must develop policies, procedures, and guidance necessary to carry out the amendments to TSCA made by the LCSA. EPA must periodically review these policies, procedures, and guidance for their adequacy in carrying out the law and revise them if necessary to reflect new scientific developments or understandings.

Related to the requirements on the use of scientific and technical information, the LCSA directs EPA to establish a Science Advisory Committee on Chemicals (SACC) to provide nonbinding, independent scientific and technical advice to the agency regarding implementation of the Act. SACC held its first in-person meeting in June 2019 to discuss EPA’s draft risk evaluation for C.I. Pigment Violet 29. Since then, SACC has convened multiple times to provide scientific review to other EPA draft risk evaluations.