FACT SHEET #29
Revision – Third
NORTHEASTERN UNIVERSITY GUIDELINES ON THE TOXIC SUBSTANCE CONTROL ACT
I. TSCA GENERAL INFORMATION
The Toxic Substance Control Act, TSCA, was established by the Environmental Protection Agency in 1976 to ensure that the human health and environmental effects of chemical substances are identified and properly controlled before production or transport. The chemicals regulated include:
“Any organic or inorganic substances of a particular molecular identity including any combination of such substances occurring, in whole or in part, as a result of chemical reaction or occurring in nature and any element or uncombined radical.”
Chemicals that are not regulated by TSCA are:
1. Pesticides regulated by the Federal Insecticide, Fungicide, and Rodentcide Act (FIFRA)
2. Tobacco and tobacco products regulated by the Bureau of Alcohol, Tobacco, and Firearms (ATF)
3. Radioactive materials regulated by the Nuclear Regulatory Comission (NRC)
4. Food, food additives, drugs, cosmetics or devices regulated by the Food and Drug Administration (FDA)
Laboratories here at Northeastern University are generally not subject to most requirements of the act if they meet the Research and Development (R&D) exemption. However, all appropriate forms must be filled out and sent with the shipments regardless of the exemption. Forms are required so EPA can monitor the amount of chemicals shipped between borders. The R&D exemption requires chemicals be:
1. imported, manufactured or used in small quantities; and
2. used solely for purposes of non-commercial scientific experimentation, analysis or research; and
3. under the supervision of a technically qualified individual
These guidelines will help you determine the procedures to take when handling substances regulated by TSCA:
II. IMPORTED CHEMICALS
All chemicals that are imported into the United States to be used for research must have a completed import certification along with the package’s shipping papers. There are no exceptions / exemptions from this requirement. The TSCA Import Certification Form should be completed by the principal investigator and sent along with your purchase order so the form can be available to the customs officer upon arrival and sent back along with your shipment. Upon receiving the certification form, the customs officer will attach a certification statement of validation if the shipment is not subject to the TSCA regulations (i.e, regulated under FIFRA, ATF, NRC, or FDA) and mark it as a negative import certification. If the package is regulated by TSCA, the customs officer will check to verify that the package is under exemption. If the shipment is exempted then the officer will check the EPA’s ChemView database to determine if the chemicals are subject to notification to the EPA. If no notification is required then the package will receive a positive import certification and continue in the delivery process. A copy of the certification form should be kept on file in the laboratory and the Environmental Health and Safety Office, Room 320 Renaissance Park. These procedures are for non-commercial scientific experimentation, analysis, or research chemicals only. Chemicals used for commercial purposes require additional steps.
III. EXPORTED CHEMICALS
Certain chemicals exported from the United States must be submitted to the EPA in writing using the Export Nofication Form. Use EPA’s ChemView database to see which chemicals are subject to the notification. These notifications should be sent to the following address:
Document Control Office (7407)
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency, Room G-099
401 M St., SW., Washington, DC., 20460
RE: TSCA Section 12(b) Notice
For substances the subject of TSCA Sections 5, 6, or 7 (see Chemview database) actions, the exporter must submit a notice to EPA of the first export within the calendar year per subject chemical per country of import. For substances the subject of TSCA Section 4 (see Chemview database) actions, the exporter must submit a notice to EPA of the first export after January of 1994 (not per calendar year) per subject chemical per country of import.
The notice must be postmarked within seven days after accepting a definite contractual obligation to export or an equivalent intracompany agreement to export.
Where the actual export occurs less than seven days after the export obligation or agreement has been executed, the notice must be submitted to EPA no later than the same day as the export.
IV. DOMESTIC SHIPMENTS OF CHEMICALS
Any imported or synthesized chemicals regulated by TSCA being sent to another laboratory must be labeled “Content To Be Used For Research And Development Purposes Only” and must include the environmental, health, and safety risks that the substance could cause. This is done by filling out the Domestic Shipment Form, which will be sent along with the package. A copy of this form should be recorded in the laboratory and in the Office of Environmental Health and Safety, Room 320 Renaissance Park.
Please contact the TSCA Coordinator at Environmental Health and Safety (x2769), Room 320 Renaissance Park if you have questions about importing, exporting, or any specific exemptions.