The Toxic Substances Control Act, namely TSCA, was enacted by the US Congress in 1976 and came into effect in 1977, implemented by the US Environmental Protection Agency (EPA). The Act intends to prevent unreasonable risks of injury to human health or the environment as well as to limit, prohibit, or ban chemical substances posing imminent hazards. With several amendments, TSCA has become a prominent regulation for effective chemical substance management. Much attention shall be paid to TSCA compliance by manufacturers and importers with regulatory obligations.
Interpretation of TSCA
Chemical substances under TSCA are clarified as either “existing substances” or “new substances”. Any substance that is not on the TSCA Inventory is classified as a new substance. Several categories of substances such as munitions, food, food additives, pesticides, drugs, cosmetics, tobacco, nuclear materials etc. are managed by other US regulations and exempt from TSCA regulation obligations.
The TSCA Inventory is comprised of two databases, namely the confidential part and the public part. There are over 83,000 chemical substances listed in the inventory. Substances included in the inventory are regarded as existing substances while those not included are classified as new substances. Existing and new substances have different regulatory responsibilities.
Responsibilities of New Substances>
Manufactures and importers of new substances must complete a Pre-Manufacture Notice (PMN) if none of the exemption conditions were met. Exempted substances are subject to TSCA regulations but can be exempted under certain circumstances such as low volume, low release, low exposure, R&D, polymer, test marketing etc. The process of PMN is shown below:
Responsibilities of Existing Substances
- Substance Search
- Consulting Service Package and Training
- Pre-Manufacture Notices (PMN)
- PMN Exemptions (Test Marketing, Low Volume, Low Release etc.)
- Significant New Use Notices（SNUN）
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