Mandated by section 5 of the 1976 Toxic Substances Control Act (TSCA), EPA's New Chemicals Program helps manage the potential risk to human health and the environment from chemicals new to the marketplace. The program functions as a "gatekeeper" that can identify conditions, up to and including a ban on production, to be placed on the use of a new chemical before it is entered into commerce. Anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose is required by section 5 of TSCA to provide EPA with notice before initiating the activity. This premanufacture notice, or PMN, must be submitted at least 90 days prior to the manufacture or import of the chemical.
A PMN includes information such as specific chemical identity, use, anticipated production volume, exposure and release information, and existing available test data.
EPA has 90 days to review a PMN. The PMN program has evolved into an efficient mechanism for identifying new chemicals that are of greatest concern during the early stages of the review process, and for focusing detailed analysis and action on these cases with the ultimate goal of identifying and controlling unreasonable risks. EPA utilizes an integrated approach that draws on knowledge and experience across scientific and organizational lines to identify and evaluate concerns regarding health and environmental effects, exposure and release, and economic impacts. Because many PMNs include little or no toxicity or fate data, the program uses several risk screening approaches to facilitate assessment in the absence of specific data. This enables rapid evaluation of potential risks and making risk-management decisions for the new chemicals within the 90-day time frame prescribed by TSCA. Some of these new chemicals program's computer models used to screen PMNs or exemption notices are available through the Sustainable Futures Initiative.
EPA may negotiate a TSCA Section 5(e) (Consent) Order to prohibit or limit activities associated with the new chemical if EPA determines that insufficient information exists to evaluate the human health and environmental effects of the substance, and that: (1) it may present an unreasonable risk ("risk-based finding") or (2) be produced in substantial quantities, and substantial or significant exposure/release ("exposure-based finding").
TSCA Section 5(e) Consent Orders are only binding on the original PMN submitter that manufactured or imported the substance. Consequently, after signing a Section 5(e) Consent Order, EPA may promulgate a Significant New Use Rule (SNUR) under TSCA Section 5(a)(2) that mimics the Consent Order to bind all other manufacturers and processors of former new chemicals to the terms and conditions contained in the Consent Order.
Also, EPA has the authority to issue SNURs without a Section 5(e) Consent Order. Under TSCA Section 5(a)(2), EPA can determine that a use of a chemical is a significant new use after considering several factors, including but not limited to the projected production and processing.
EPA provides industry with five possible exemptions under the new chemicals program. Each of these exemptions has specific reporting requirements which are unique to the exemption class. The five possible exemptions are:
- The low volume exemption (LVE) applies to those who manufacture or import 10,000 kilograms or less a year of a chemical substance and meet other criteria;
- Manufacturers that meet certain criteria may be eligible for the low release and exposure exemption (LoREX);
- The polymer exemption applies to polymers that meet specific criteria for composition, molecular weight, and degradation;
- Chemicals produced in small quantities solely for experimental or research and development purposes (R&D) also qualify for an exemption if manufactured and distributed under certain conditions; and
- Manufacturers that plan to produce a chemical solely for test marketing may qualify for an exemption.