TOXIC SUBSTANCE CONTROL ACT (TSCA)
TSCA authorizes EPA to regulate and screen all chemicals produced or imported into the US. To prevent unreasonable risks to health and environment. TSCA, administered by EPA, requires testing and administrative control before commercial manufacturing and importing.
Research groups must determine if TSCA applies to their laboratory activities. The TSCA information source listed below are provided to assist you in determining TSCA applicability and complying with the TSCA regulations.
Activities regulated under TSCA can include:
- Importation of chemical(s) from oversea
- Chemical research conducted for commercial purposes
- Significant risks of chemicals and/or adverse reaction to chemicals discovered during research
Research and Development (R&D) exemption
Any chemical substance is exempted from many of the TSCA requirements when it is:
- Imported, manufactured or used in small quantities, and
- Sorely for purposes of non-commercial scientific experimentation, analysis or research, and
- Under the supervision of technically qualified individual
To maintain this exemption status, laboratories engaged in research and development (R&D) must comply with the following TSCA requirements:
- Import of chemical: Certify the TSCA status of imports of R&D substances, in writing - TSCA IMPORT CERTIFICATION FORM needs to be filled out by lab manager or PI to provide custom or shipper at the airport.
- Shipment of chemical to location within US - Label and mark the R&D substances properly and communicate risks by preparing shipment form and MSDS.
- Compliance guidance for laboratory activities - Ensure that grant and other funding documentation indicates that funding is intended for research activities and not commercial purpose.
Chemical substances not regulated or excluded by TSCA include:
- Pesticides regulated by FIFRA
- Tobacco and tobacco products regulated by ATF
- Radioactive materials regulated by NRC
- Foods, food additives, drugs, cosmetics or devices regulated by FDA
TSCA regulatory link:
http://www.epa.gov/opptintr/CORR/index.htm