Congress enacted the Toxic Substances Control Act (TSCA) of 1976 giving the Environmental Protection Agency (EPA) the authority to require chemicals produced or imported into the United States to be tested for possible toxic effects before commercial manufacture or distribution. The TSCA Chemical Substance Inventory is a listing of all chemical compounds that have had their risks to human health or the environment already investigated. A new chemical is a chemical substance that is developed domestically or imported into the U.S. and is not yet listed on the TSCA Chemical Substance Inventory.
TSCA Requirements:
TSCA compliance activities are focused on specific laboratory operating practices. Most chemicals used for research and development (R&D) purposes, existing and/or newly synthesized, are exempt from most TSCA requirements except as noted here. To maintain this exemption status, laboratories engaged in R&D must maintain records of and comply with the following TSCA requirements:
- Shipping of R&D Chemicals and Samples
- Import of Chemicals
- Certify the TSCA status of imports of R&D substances, in writing for customs clearance into the U.S. by completing the TSCA Import Certification form. Additional information is located here: TSCA – Importing Guidance.
- Domestic Shipping or Export of Chemicals
- Notify recipients of R&D substances, in writing by completing the TSCA form for all shipments containing chemical substance that poses a health or environmental hazard. Further instructions can be found under Shipping and Transportation.
- Allegations of Adverse Health Reactions
- Laboratories must create and maintain records of any allegations of adverse effects to human health or the environment potentially caused by new R&D substances.
- Discovery of Substantial Risk
- Document and report any significant risks to human health or the environment potentially associated with new R&D substances.
If a new adverse health reaction or substantial risk related to a new research substance is discovered it must be reported to the EPA. Contact EHS for assistance at 401-863‐3353.
Chemical substances used for purposes other than research, are provided commercially, or laboratories do not meet these requirements of the R&D exemption they may be subject to additional TSCA requirements or enforcement action. Contact EHS with questions.