Toxic Substances Control Act (TSCA)
The Toxic Substances Control Act (TSCA) is a United States law passed in 1976 by Congress and administered by the EPA. TSCA seeks to regulate new and existing chemical substances to ensure the human health and environmental effects are identified and properly controlled prior to materials entering commerce. TSCA applies to Research and Development activities at the University, including synthesizing and importing new chemicals.
A “new chemical” is any chemical substance not on the TSCA Chemical Inventory List. Per TSCA, a “chemical substance” is “any organic or inorganic substance of a particular molecular identity, including any combination of these substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any element or uncombined radical.” Examples of chemical substances include:
- Chemical substances of unknown or variable composition, complex reaction products, and biological materials
Certain chemical substances are not regulated under TSCA. These include:
- Pesticides regulated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
- Tobacco, tobacco products, firearms, and ammunition regulated by the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF)
- Radioactive materials regulated by the Nuclear Regulatory Commission (NRC)
- Food, food additives, drugs, cosmetics, or devices regulated by the Food and Drug Administration (FDA)
The Toxic Substances Control Act requires that manufacturers test chemical substances for chemical health and safety information and report their findings to the EPA. Some of this testing includes specific organ toxicity, chronic toxicity, sensitization, reproductive effects, and environmental effects. These results need to be reported to the EPA and communicated to whoever the chemical substance is distributed to.
TSCA Exemption for Research and Development
Research labs are exempt from many of the burdens of TSCA if the following conditions are met:
- The chemical substance is manufactured or imported only in small quantities solely for research and development use.
- The manufacturer or importer notifies all persons in its employ or to whom it directly distributes the chemical substance of any risk to health which may be associated with this substance.
- The chemical substance is used by, or under the supervision of, a technically qualified individual.
When the research and development activity is conducted solely in a laboratory and prudent laboratory practices are followed while handling chemical substances of unknown toxicity, the health risks do not need to be reviewed or evaluated. This applies to chemicals that are synthesized in the lab.
Developing and following your Laboratory Safety Plan will ensure that prudent laboratory practices are followed.
Complying with TSCA in Research
To maintain exemption status:
- Document prudent laboratory practices through the development and implementation of a Laboratory Safety Plan.
- Document and report any substantial risks to human health and the environment. There are no research and development exemptions for substantial risk reporting. Substantial risks must be reported to the EPA within 30 days.
- A substantial risk of injury to health or the environment is a risk of considerable concern because of the seriousness of the effect, and the probability of its occurrence.
- Create and maintain records of any allegations of health effects.
- Records must be maintained for 30 years if made by an employee or 5 years for any other allegations.
- When transferring imported or synthesized chemical substances to another group for the purpose of research and development, notify the receiver in writing that the risks associated with the chemical are not fully studied, and that they are to be used for research and development only.
- Certify the TSCA status of imports in writing
- Export notifications
Keep detailed records of everything related to TSCA. This should include:
- Laboratory Safety Plan
- Import certifications
- Export notifications
- Transfer records
- Substantial risks
It is also recommended that each department assists maintaining import certifications. A coordinator for the department can help maintain these records at a central location in addition to the records the research group maintains.
Importing New Chemical Substances
When importing chemical substances from another country, researchers must comply with the TSCA Requirements for Importing Chemicals. The importer must sign a certification form and file electronically or in writing with the U.S. Customs and Border Control. Electronic certifications can be filed here. Often, the carrier (e.g. FedEx) will supply a form for this purpose. The supplier or Customs Broker may also supply the form. Maintain records of all certification forms and shipping paperwork.
The certification must include a “positive” or “negative” certification.
Positive certification: “I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order thereunder.”
This statement will be chosen even when the chemical substance is used under the research and development exemption. The exemption complies with all rules of TSCA.
Negative certification: “I certify that all chemicals in this shipment are not subject to TSCA.”
This statement will only apply to chemicals not subject to TSCA (pesticides, food, food additives, drugs, cosmetics, firearms and ammunitions, and radioactive materials). Tobacco and tobacco products do not require certification.
The certification must also include the importers information, product description (chemical name, CAS#), and the date.
Exporting Chemical Substances
If you need to export certain chemical substances, the EPA must be notified in writing. Notification is required for chemicals on the EPA’s Chemical Substances Subject to TSCA Notification list. Additionally, the Department of Transportation (DOT) and the International Air Transport Association (IATA) regulate the transport of chemicals, and they must be shipped according to their regulations. See Introduction to Shipping for more information.
Last Update: 8/2/2018