The Toxic Substances Control Act (TSCA) was passed by the United States Congress in 1976. The act is located in the United States Code Title 15, Sections 2601-2692 (15 USC (C. 53) 2601-2692.) The main objective of the TSCA is to regulate the introduction of new or already existing chemicals. The TSCA allows the Environmental Protection Agency (EPA) to regulate new commercial chemicals before they enter the market, and regulate already existing chemicals when they pose an unreasonable risk to health or to the environment. The TSCA also regulates the distribution and use of chemicals and specifically regulates use of polychlorinated biphenyl (PCB) products, asbestos, radon and lead-based paint.
The act specifically prohibits manufacturing or importing of chemicals that are not on the TSCA inventory or not subject to one of many exemptions in the Act. Chemicals listed on the TSCA inventory are referred to as “existing chemicals” and chemicals not listed are referred to as “new chemicals”.
Chemical substances not regulated or excluded by TSCA include pesticides; tobacco and tobacco products; radioactive materials; foods, food additives, drugs, cosmetics or devices.
Section 5 of the TSCA mandates a pre-manufacture notification for “new chemical substances”. The Environmental Protection Agency established the New Chemicals Program, located in the Office of Pollution Prevention and Toxics, to manage potential risks from chemicals new to the marketplace.
The New Chemicals Program identifies conditions, up to and including a ban on production, on the use of a new chemical before it enters commerce. Section 5 mandates that anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose should provide EPA with notice before initiating the activity. This pre-manufacture notice, or PMN, must be submitted at least 90 days prior to the manufacture or import of such chemical.
Section 4 of TSCA requires testing of chemicals by manufacturers, importers, and processors when risks or exposures of concern are found. The Act gives EPA authority to issue data development regulations that require manufacturers and processors of existing chemicals to test their chemicals for health and environmental effects.
EPA is granted broad authority to issue information collection regulations that require submission of health and safety studies known or available to those who manufacture, process, or distribute in commerce specified chemicals; and EPA also issues regulations designed to gather information from manufacturers and processors about production/import volumes, chemical uses and methods of disposal, and the extent to which people and environment are exposed to it. TSCA also requires EPA to develop regulations to establish import/export requirements for the chemicals subject to certain requirements under TSCA.
Under section 5(a) of TSCA and 40 CFR part 721, if EPA promulgates a Significant New Use Rule (SNUR), a manufacturer or processor wishing to engage in a designated significant new use must submit a Significant New Use Notice (SNUN) to EPA at least 90 days before engaging in the new use. Sometimes EPA will have to respond to a SNUN by amending the SNUR to allow companies other than the SNUN submitter, such as the submitter’s processor customers, to engage in the newly approved use(s).
EPA maintains the TSCA Inventory, under Section 8 of TSCA. The inventory contains more than 83,000 chemicals. As new chemicals are commercially manufactured or imported, they are placed on the list. TSCA section 8(b) provides EPA authority to “compile, keep current, and publish a list of each chemical substance that is manufactured or processed in the United States.” TSCA section 3(2)(A) defines chemical substances as “any organic or inorganic substance of a particular molecular identity, including – (i) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and (ii) any element or uncombined radical.”
Through the addition of new chemicals in commercial TSCA applications in the US, there are more than 83,000 chemical substances, as defined in TSCA section 3(2)(A) – among them as organics, inorganics, polymers, and UVCBs (chemical substances of Unknown, or Variable composition, Complex reaction products, and Biological materials) – on the Inventory at this time.
The EPA also requires those importing or exporting chemicals, under Sections 12(b) and 13, to comply with certification reporting and/or other requirements.
Under Section 13 of TSCA and 19 CFR 12.118 through 12.127, no chemical substance, mixture or article containing a chemical substance or mixture may be imported into customs territory of the U.S. if it fails to comply with any TSCA rule or otherwise violates TSCA.
With respect to exports, Section 12(b) of TSCA and 40 CFR 707 subpart D, state that anyone intending to export a chemical that is subject to certain requirements under the TSCA must notify EPA. The EPA is responsible for notifying the importing country’s government of the chemical and of the agency’s regulatory action. Under specific and limited circumstances, TSCA Section 12(a) exempts certain chemical substances, mixtures, and articles being manufactured, processed, or distributed in commerce solely for export from the United States from some of TSCA requirements.
Section 6 of the Act (dealing with regulation of hazardous chemical substances and mixtures) prescribes rules regulating the use of PCBs, asbestos, lead, certain chemical substances that may be used in metalworking fluids and that are regulated under 40 CFR Part 747 and certain hexavalent chromium based water treatment chemicals that are regulated under 40 CFR 749.68. Section 6(e) of TSCA prohibits import or export of PCBs. The EPA may grant exemptions to allow import or export of PCBs provided statutory and regulatory requirements are met.
Under Section 8, (that deals with reporting and retention of information) TSCA requires reporting and recordkeeping by persons who manufacture, import, process, and/or distribute chemical substances in commerce. Under Section 8(e), any person who manufactures (including imports), processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment should immediately inform EPA, except in situations where EPA has been adequately informed of such information.
The EPA screens all TSCA b§8(e) submissions and voluntary “For Your Information” (FYI) submissions. The latter are not required by law, but are submitted by industry and public interest groups.
The EPA has focused efforts on protecting citizens from existing chemicals by the basic screening-level toxicity information on them made publicly available. In 2008 the EPA expanded those efforts with the Chemical Assessment and Management Program, or “ChAMP.” ChAMP is broadening EPA’s efforts to ensure the safety of existing chemicals through developing screening-level characterizations for an estimated 6,750 chemicals produced or imported in quantities of 25,000 pounds or more a year; and prioritizing the chemicals for the collection of additional data or the consideration of control measures that may be needed to address potential hazard or risk of chemicals.