The Toxic Substance Control Act (TSCA), administered by the Environmental Protection Agency (EPA), was established to ensure that the human health and environmental effects of chemical substances are identified and properly controlled prior to placing these materials into commerce.  It is intended to prevent the commercial distribution of hazardous substances. Although research laboratories such as those found at UVA are exempt from many of the requirements of this act, certain provisions still apply.

Chemicals or Activities not Regulated by TSCA:

  • Tobacco and tobacco products regulated by the Bureau of Alcohol, Tobacco and Firearms (ATF)
  • Food, food additives, drugs, and cosmetics regulated by the Food and Drug Administration (FDA)
  • Radioactive materials regulated by the Nuclear Regulatory Commission (NRC)
  • Pesticides regulated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

How TSCA Affects Research:

Before a hazardous substance can be manufactured or imported, it must be on the TSCA Chemical Inventory list. Any hazardous substance that is not on the TSCA Chemical Inventory list is considered “new”.  The TSCA Research and Development Exemption is the mechanism through which a “new” hazardous substance can be manufactured imported for research use.  The exemption allows research activities, while continuing to restrict commercial uses of “new” hazardous substances. For the Research and Development Exemption, research laboratories must comply with the following requirements:

  • The hazardous substance must be used solely for the purposes of scientific experimentation, analysis, or research.
  • Distribution or commercial use of the “new” hazardous substance is prohibited for non-research activities.
  • If a “new” hazardous substance is transferred to another laboratory for further research and development activity, the new owner must also comply with Research and Development Exemption requirements.
  • The hazardous substance must be manufactured or imported in a small quantities.
  • The manufacture or importer must notify all individuals that are engaged in research on the hazardous substance of any risk to health.
  • The hazardous substance must only be used by, or directly under the supervision of, a technically qualified individual.
  • Any person working with the hazardous substance must be trained on the potential risks of exposure.
  • Prudent, safe laboratory practices must be exercised in compliance with UVA's Chemical Hygiene Plan.
  • Disposal of TSCA hazardous substances must be managed as hazardous waste through EH&S.

Research and Development (R&D) Exemption Requirements:

Imports:

Any chemicals imported from outside the US Customs Territory must be certified as TSCA compliant or not regulated by TSCA at the time of import.

Exports:

Any chemicals exported outside the US Customs Territory must be screened against certain EPA chemical lists. Some particular chemicals may require additional actions required by EPA prior to or within several days of export.

Shipments:

Certain chemicals shipped to other institutions or entities must be shipped for R&D purposes only. Containers of these chemicals and shipping documentation must be labeled. The environmental and health risks of these chemicals must also be evaluated and communicated to the receivers.

Reporting:

Laboratories must report significant adverse effects to human health or the environment alleged to have been caused by an R&D chemical. Laboratories must also report to EPA any information about an R&D substance that indicates that it may present a “substantial risk” to human health or the environment.

TSCA Certification Form

Federal law says that all chemical imports must be accompanied by a certification form that states that the chemical is being imported in compliance with TSCA regulation. The form must be included with the airway bill and/or shippers declaration for the chemical.

  • This form can only be filled out and signed by the importer; the company selling the chemical cannot complete for the form and is not responsible for providing it. The importer is the researcher – the Principle Investigator – who’s purchasing or otherwise bringing the chemical into the US.
  • Most carriers (FedEx, for example) have a version.
  • The research group must coordinate the shipment with the vendor supplying the chemical, informing the vendor that because the chemical is being imported into the US, the research group must supply a TSCA certification.

Complete the TSCA certification by checking either the ‘positive’ or ‘negative’ certification boxes:

  • Positive Certification: I certify that all chemical substances in this shipment comply with TSCA…
    • Check this box if the chemical material is already registered through TSCA (the vendor or EHS can confirm) or if the chemical material is going to be used under the R&D exemption.
    • Almost all of our imports will get the positive certification, and as long as the provisions of the R&D exemption are followed these certifications are true and accurate.
  • Negative Certification: I certify that all chemicals in this shipment are not subject to TSCA…
    • The only time to check this box is when the chemical material being imported falls into one of the four categories listed above in this document (pesticides, tobacco, radioactive materials, food). Keep in mind that other regulations apply to these imports.
    • Researchers rarely use the negative certification on the TSCA form.
  • Fill out the identification section of the TSCA form and provide it to the vendor or shipper prior to shipment of the material:
    • Use the Principle Investigator as the authorized name and signature
    • Work with the vendor or shipper to obtain an airway bill number for the shipment and include this number on the form.
  • Keep a copy of each certification you submit. Having these on file will help in the event of a regulatory audit.

Understand that US Customs will reject, and often investigate, chemical imports which do not include a valid, signed and dated TSCA compliance form.

If you have any questions about chemical imports or TSCA regulation, contact the EHS.