The U.S. Environmental Protection Agency (EPA) has announced a proposed rule, published on March 26, 2024, mandating manufacturers (including importers) of 16 chemical substances to submit copies and lists of certain unpublished health and safety studies to the EPA. This initiative is documented in the Federal Register at 89 Fed. Reg. 20918, aims to bolster the EPA's understanding of potential health and environmental risks associated with these substances under the Toxic Substances Control Act (TSCA).

Identification of Chemical Substances

Of the 16 chemical substances targeted, the EPA has identified 15 as potential candidates for prioritization based on hazard, exposure, persistence, and bioaccumulation characteristics. Additionally, the transformation product of N-(1,3-Dimethylbutyl)-N’-phenyl-p-phenylenediamine (6PPD), known as 6PPD-quinone, has been included in response to a citizen’s petition filed under Section 21 of the TSCA.

Purpose of the Rule

The proposed rule mandates the submission of health and safety studies to inform the EPA's responsibilities under the TSCA, including prioritization, risk evaluation, and risk management. The studies sought by this action will contribute crucial data to the EPA's decision-making processes regarding the regulation and management of these chemical substances.

Reporting Requirements

Manufacturers falling within the rule's scope must adhere to specific reporting requirements outlined in 40 C.F.R. Section 716.65. This includes submitting copies of health and safety studies conducted in the ten years preceding the listing of a chemical substance, as well as ongoing or subsequently initiated studies.

Implications and Exemptions

The proposed rule specifies that the exemption listed at 40 C.F.R. Section 716.20(a)(9), applicable to persons manufacturing a substance only as an impurity, would not be available for the substances subject to this rule. Moreover, EPA emphasizes that reporting is required even when a chemical substance is included as an impurity.

Types of Information Required

Manufacturers are required to submit various types of health and safety studies, encompassing toxicity, environmental effects, and exposure data. The proposed rule delineates specific requirements for the submission of information, including the composition and purity of test substances.

Confidentiality Considerations

While health and safety studies are not protected from disclosure, certain information may be subject to confidentiality claims. Submitters asserting confidential business information (CBI) claims must provide sanitized copies of their submissions, removing only the information claimed as CBI.
The proposed rule represents a significant regulatory effort by the EPA to enhance its understanding of the health and environmental impacts of these chemical substances. Comments on the proposed rule are due by May 28, 2024.


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