Background
Congress enacted the Toxic Substances Control Act of 1976 (TSCA). TSCA gives Environmental Protection Agency (EPA) the ability to track the 75,000 industrial chemicals produced or imported into the United States. EPA collects data on these chemicals and can require the manufacture or importer to determine the risks these chemicals pose to human health or the environment. The TSCA regulations are in 40 CFR 700–799.
Under TSCA, EPA can
- control production, distribution, and importation of new and existing chemicals;
- establish specific disposal rules; and
- ban the use of high-risk chemicals, such as polychlorinated biphenyls (PCBs).
TSCA also controls specific substances, such as PCBs, lead, and biotechnology. TSCA excludes tobacco, foods, food additives, drugs, and cosmetics. The TSCA program also excludes nuclear materials, munitions, and chemicals used solely as pesticides. Other exemptions include naturally occurring materials, products of incidental and end-use reactions, mixtures, byproducts, and substances made solely for export. These exclusions exist because other regulatory programs provide for safety, health, and environmental protection for these materials. Recently, EPA has applied its authority under TSCA to begin controlling, if not overtly regulating, nanomaterials.
Key Concepts
Commercial Research or Use
TSCA defines “research” as commercial research if a commercial entity directly provides partial or complete funding. It is not important who actually conducts the research.
Import/Export Rule
Certain certifications must accompany chemicals imported into or exported out of the United States. This TSCA requirement applies to all imports or exports of the chemicals. This requirement also extends to research and laboratory samples.
TSCA Chemical Substances Inventory
This is a list of chemicals approved for importation and manufacture in the United States. The EPA maintains this list. It is illegal to produce, import, sell, or distribute into commerce chemicals that do not appear on this list.
Significant New Use Rule (SNUR)
EPA can restrict the use, concentration, or production of a chemical by creating an SNUR. These restrictions can vary by chemical. SNURs currently exist for hundreds of chemicals. Some examples include aromatic amine compounds, pentachlorobenzene, trinitrobenzene, and DDT.
Premanufcture Notic (PMN)
EPA requires notice for importation or manufacture of any chemical that does not appear on the TSCA Chemical Substances Inventory. PMNs are required only for chemicals intended for commercial research or use — materials produced or imported in small quantities for research and development only are exempt from PMN requirements.
Does this apply to my campus?
The certification rules apply if your campus imports or exports chemicals for any purpose.
In most cases, research activities on campuses are either exempt from TSCA rules pertaining to SNUR and PMN or are subject to fewer demands than manufacturing. As long as the institution meets the safety and record-keeping requirements in 40 CFR 720.36 and 720.78, the chemicals created in small amounts for research are exempt from TSCA reporting. However, if your campus produces chemicals commercially, more extensive TSCA requirements apply.
What do I have to do?
If the import/export rule applies, your campus must certify any imported or exported chemicals. If the chemical is TSCA-regulated, contact EPA for import requirements or restrictions.
TSCA provisions forbid the use or purchase of any chemical or mixture that the user knows, or should have known, is not in compliance with the requirements of the act. Ensure that chemicals in your inventory are on the TSCA Chemical Substance Inventory.
Because the TSCA Chemical Substances Inventory includes most common laboratory chemicals, integrate the safety requirements of 40 CFR 720.36 and 720.78, including maintaining records of any adverse chemical reactions, into laboratory operations.