Tariff Surge + TSCA Crackdown: A Double Whammy! In-Depth Analysis of Regulatory Red Lines and Risk Mitigation Strategies

The Toxic Substances Control Act (TSCA) is an important regulation for the management of industrial chemicals in the United States, enacted by the United States Congress in 1976 and entered into force in 1977. The regulation, which is administered by the U.S. Environmental Protection Agency (EPA), aims to comprehensively assess the environmental, economic, and social impacts of chemical substances and prevent “unreasonable risks” to human health and the environment. On June 7, 2016, the U.S. Senate passed the Lautenberg Act (H.R. 2576), which introduced significant changes to the TSCA and strengthened the management and regulation of chemicals, especially new and existing chemicals.

The TSCA regulations mainly regulate industrial chemicals, while the eight categories of chemicals that  are regulated by specific regulations, such as food, food additives,  and cosmetics unified by the United States Food, Drug and Cosmetics Regulations (FDA).

The TSCA Directory is a dynamic list of more than 85,000 chemicals, divided into public and confidential sections. Substances listed on the TSCA list are existing chemicals, while those not listed are new chemicals.

The TSCA regulations impose four compliance obligations on the management of existing chemical substances:

First, the importer needs to make a self-declaration whether the chemical to be imported meets the regulatory requirements of TSCA;

Second, the importer makes an exemption statement for specific products;

Before production, import, processing or use, it must submit an important new use declaration to the EPA 90 days in advance.

The fourth is that the manufacturer or importer reports the annual activity volume, activity place, exposure information to the EPA every four years.

Typically, new chemical substances are required to file a full Pre-Production Declaration (PMN) with the EPA 90 days before commercial production or import, unless it is an exemption declaration. After submitting a complete pre-production declaration and passing the audit, the substance will be added to the TSCA directory and become an existing chemical substance.

The EPA issued five final rules on January 6, 2021, to reduce exposure to certain persistent (Persistent), Bioaccumulative, and Toxic Chemicals (PBT). At present, the specific control requirements for five PBT substances are as follows:

Companies need to have a comprehensive understanding of the TSCA regulatory requirements and clarify the regulatory details and restrictions and reporting requirements for new and existing chemical substances. If the product contains new chemicals, companies must submit a pre-production declaration (PMN) to the U.S. Environmental Protection Agency (EPA) 90 days in advance, and the annual export volume of existing chemicals exceeds 25,000 pounds (about 11.3 tons), and importers need to be reminded to submit chemical substance data reports (CDRs). When goods exported to the United States are imported into the country, companies must provide a TSCA compliance or exemption statement. Companies also need to pay special attention to the EPA’s regulatory rules for perfluoroalkyl sulfonic acid (PFAS) and five PBT substances. At the same time, enterprises need to cooperate with EPA's compliance monitoring, take the initiative to self-disclosure, timely correct violations, and continue to pay attention to regulatory updates, and flexibly adjust compliance strategies to ensure the smooth entry of products into the US market.

U.S. News Test Suggestions

In the United States, TSCA law enforcement inspections have been normalized. Illegal enterprises will face product recall, shelves, fines and other penalties, the circumstances are serious, the person in charge of the enterprise may face fines or imprisonment. Enterprises should promptly investigate the content of five harmful substances in the products to ensure compliance with the requirements of the five final rules. It is recommended to pay close attention to the latest developments in the EPA on TSCA and adjust production and compliance strategies in a timely manner.

With a dedicated technical team and extensive testing experience, Mercen Testing can provide you with a comprehensive TSCA test solution to help you easily meet the challenges of TSCA regulations and ensure product safety and compliance.