TSCA Chemical Import Guidelines

The Toxic Substances Control Act (TSCA) is a federal regulation intended to prevent the commercial distribution of toxic chemical substances. It brought about the end of PCBs in commerce, and provides the framework to prevent a new molecule from causing the widespread contamination that resulted from PCBs. TSCA regulation is important, and has been beneficial to our health and the environment.

How TSCA Affects Research

The framework of the rule is simple: any novel chemical molecule must be vetted and approved through the EPA before it can be manufactured or imported. So researchers are at risk of running afoul of the EPA if:

• Novel chemicals (any that haven’t been approved and cataloged via EPA) are imported from a foreign country, or
• Novel chemicals are created in the laboratory and distributed.

Chemicals NOT Subject to TSCA Regulation

A few categories of chemical products are not subject to TSCA regulation:

• Pesticides regulated under FIFRA (the federal pesticide regulation)
• Tobacco and tobacco products regulated under the ATF
• Radioactive materials regulated by the NRC
• Foods, food additives, drugs, and cosmetics regulated by the FDA

For Boston University, the Research and Development Exemption is the mechanism through which a new chemical which is not registered with the EPA can be imported and used.

Applicability of the Research and Development Exemption

The intent of the exemption is to allow research activities, while continuing to restrict commercial uses of new chemical molecules. For the Research and Development Exemption to apply all of these must be true:

• The chemical substance must be used solely for the purposes of non-commercial scientific experimentation, analysis or research. Sale or commercial use of the material is prohibited, with a few exceptions. Contact EHS to discuss sharing or distributing these materials.
• The chemical substance must be purchased or created in a small quantity: i.e. only what you need for your research.
• The chemical substance must only be used by, or under the direct supervision of, a technically qualified individual. A technically qualified individual is a person who’s education, training, and experience prepares him or her to appreciate, and minimize, the risks of exposure to the chemical substance.
• Prudent, safe laboratory practices must be exercised at all times, and any person working with the chemical substance must be trained on the potential risks of exposure.

Operating under the Research and Development Exemption

If a research group wishes to import or use new chemical molecules under the provisions of the Research and Development Exemption, it is the responsibility of that group to document that they satisfy the requirements of the exemption.

• No sale or distribution of the material
• Training of all personnel who work with the molecule must be documented:
  • laboratory safety training,
  • molecule-specific training if that molecule poses a specific health risk
• Adherence to prudent laboratory practices, for example:
• • Compliance with the provisions of BU’s chemical hygiene plan, including storage and labeling of chemicals,
  • Compliance with BU’s chemical waste protocols, including collection, labeling and management of containers, and
  • Compliance with all other applicable laboratory safety protocols, either campus-wide or project-specific.

Importing Chemicals from Foreign Countries under the R&D Exemption

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.
• The form is available from EHS, and 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 Department.