Agency in Charge of Examining Novel Chemicals According to TSCA Regulations

Agency in Charge of Examining Novel Chemicals According to TSCA Regulations

In 1983, the Environmental Protection Agency (EPA) established a rule under the Toxic Substances Control Act (TSCA) Section 5, requiring companies to notify the EPA before manufacturing or importing new chemical substances or before using existing chemicals for significant new uses. This process, facilitated through Premanufacture Notices (PMNs) and Significant New Use Notices (SNUNs), is a crucial step in ensuring the safety of new and existing chemicals before they enter the market.

Under TSCA Section 5(a), any company planning to manufacture or import a new chemical, or use an existing chemical in a significant new way (as defined by EPA), must submit a notification to EPA. The EPA reviews these submissions to assess potential risks before the chemical can enter the market or before the new use begins.

The EPA can make one of five possible determinations:

1. Not likely to present an unreasonable risk – allows commercialization without restrictions.
2. Insufficient information – triggers a Section 5(e) order with restrictions pending more data.
3. May present an unreasonable risk – triggers a Section 5(e) order.
4. Substantial production/exposure – triggers a Section 5(e) order.
5. Presents an unreasonable risk – leads to a Section 5(f) order and restrictions.

EPA often accompanies orders with Significant New Use Rules (SNURs) to require notification before the new uses occur. This process aims to prevent risks from new or significantly changed chemical uses by controlling exposure, demanding testing when necessary, and allowing EPA to restrict or prohibit chemicals posing unreasonable risks.

TSCA was originally enacted by Congress in 1976, and Section 5 was designed to ensure new chemicals undergo EPA review prior to commercial use. Amendments, such as the 2016 Lautenberg Act, have strengthened EPA’s authority and clarified provisions, including the scope of reviews and risk evaluation.

The EPA has issued Section 5(e) orders and adopted SNURs particularly for complex situations such as products of advanced recycling (e.g., pyrolysis oils from waste plastics) where new chemicals might carry impurities or contamination risks. In recent years, EPA has proactively addressed chemicals like Per- and Polyfluoroalkyl Substances (PFAS), proposing SNURs for inactive PFAS to require review before resuming use.

EPA also issues test marketing exemptions under Section 5(h)(1) allowing limited manufacture for testing without full PMN requirements if no unreasonable risk is found.

The TSCA Section 5 Premanufacture and Significant New Use Notification requirements are designed to provide a framework for chemical safety evaluation. Information required to be reported includes chemical identity, production volume, byproducts, use, environmental release, disposal practices, human exposure, and existing available test data.

For more detailed information, resources such as EPA’s New Chemicals Program statistics, Federal Register notices, and guidance materials for businesses and the regulated community are available. These resources offer comprehensive regulatory information, procedural updates, and insights into handling chemicals like PFAS and advanced recycling products.

1. TSCA Section 5 requires companies to submit notifications to the Environmental Protection Agency (EPA) before manufacturing or importing new chemical substances or before using existing chemicals for significant new uses, in order to ensure the safety of these chemicals before they enter the market.
2. The EPA can make several determinations regarding new or significantly changed chemical uses, including allowing commercialization without restrictions, triggering reviews with restrictions pending more data, determining potential risks, triggering more extensive reviews, or imposing restrictions.
3. EPA's chemical safety evaluation process aims to prevent risks from new or significantly changed chemical uses by controlling exposure, demanding testing when necessary, and allowing EPA to restrict or prohibit chemicals posing unreasonable risks.
4. EPA has issued Section 5(e) orders and adopted SNURs for complex chemical situations, such as products of advanced recycling (e.g., pyrolysis oils from waste plastics), to address potential impurities or contamination risks.
5. The TSCA Section 5 Premanufacture and Significant New Use Notification requirements provide a framework for chemical safety evaluation in various domains, including science, industry, finance, lifestyle, business, technology, education and self-development, general news, and sports, making information about chemical substances accessible for the public and regulated community.

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