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The Toxic Substance Control Act (TSCA) authorizes the EPA to regulate and screen all chemicals produced or imported into the United States to prevent unreasonable risks to health and the environment. As a research group, you must determine if TSCA applies to your laboratory activities.
TSCA Regulated Activities
Activities regulated by the TSCA include:
- Oversees importation of chemical(s)
- Chemical research conducted for commercial purposes
- Significant risks of chemicals and/or adverse reaction to chemicals discovered during research
Please see the Chemicals under TSCA website for more information.
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
- Solely for purposes of non-commercial scientific experimentation, analysis or research
- Under the supervision of a technically qualified individual
To maintain this exemption status, laboratories engaged in R&D must comply with the following TSCA requirements:
- Import of Chemicals
Certify the TSCA status of imports in writing. Complete the TSCA Import Certification Form and provide it to customs or the shipper at the airport.
- Shipment of Chemicals within the US
Label and mark the R&D substances properly and communicate risks by preparing shipment forms and including the SDS.
- Compliance Guidance for Lab Activities
Ensure that grant and other funding documentation indicate that funding is intended for research activities and not commercial purposes.
Substances Not Regulated by TSCA
Chemical substances not regulated or excluded by the 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 the FDA