EPA Announces Important Updates to TSCA New Chemicals Review Program

In late March 2021, the U.S. Environmental Protection Agency (EPA) announced that it is reviewing the policies of the Toxic Substances Control Act (TSCA) new chemicals program. The goal of this review is to make sure proper coordination exists with corresponding policies and initiatives of the new presidential administration. This blog post looks at the new chemicals review process and program, including some of the key program updates.

New Chemicals Review Process

According to the EPA, there are six principal stages included in the Agency’s review process for new chemicals (for active cases under review).

  • Pre-Submission

    • When submitting a new chemical substance, companies should set up a pre-notice consultation with the EPA to discuss their submission and to ensure they have a proper understanding of the review process. The Agency offers informative tools to aid in submission preparation and estimation of environmental release, environmental fate, exposures, and more.
  • Incoming Cases

    • Prior to the start of risk assessment, a pre-screen submission review is conducted to verify inclusiveness of necessary information and to check for errors. Information that is incorrect, incomplete, or not in conformity with required regulations could result in suspension of the review by the EPA.
  • Risk Assessment

    • To determine if a chemical yields unreasonable human or environmental health risks, the EPA conducts a complete life-cycle risk assessment. During this assessment, a variety of factors (chemistry, environmental fate, etc.) are evaluated.
  • Risk Characterization

    • After an initial risk assessment has been proposed, the EPA informs submitters of its findings. Submitters have the option of providing additional information for support or clarification, which the Agency may then use to modify the original risk assessment, as needed.
  • Regulatory Decision and Action Development

    • A decision is made and documented by the EPA regarding the new chemical’s likelihood of causing unreasonable risk to health or the environment.
  • Final Determination

After the EPA’s final determination has been made, the Agency posts the decision on the new chemical substance in the status tables for TSCA Section 5 notices.

New Chemicals Review Program and Updates

The TSCA new chemicals review program is aimed at helping protect human health and the environment via managing possible risks associated with new chemical introductions. As part of the Agency’s assessment of its policies under the program, the EPA found there were several ways in which its new chemical risk management approach could be improved. Examples relate to the use of significant new use rules and assumptions about worker exposures.

  • Significant New Use Rules (SNURs)
    • According to the EPA, the Agency no longer intends to release determinations of “not likely to present an unreasonable risk” when proposed SNURs exist. If the Agency believes the use(s) of a substance yields unreasonable risks, it will release a corresponding order to address them.
  • Worker Exposures
    • The EPA will not assume that workers are fully protected under the protection standards of the Occupational Safety and Health Administration (OSHA) and by updated safety data sheets (SDS), particularly in cases where an unreasonable risk is identified that could be addressed via proper hazard communication and personal protective equipment.

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