On October 2, 2015, EPA published the final significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 30 chemical substances which were the subject of premanufacture notices (PMNs). This rule will be implemented on December 1, 2015.
This new rule aims to help manage the possible risk to human health and the environment from chemicals new to commerce by identifying conditions-including a prohibition on production, to be placed on the use of a new chemical before it is entered into the marketplace. TSCA defines as “new chemical substance” in U.S. commerce any chemical that is not on the TSCA Inventory.
From December 1, 2015 you are obliged to notify the Agency with a premanufacture notice (PMN) at least 90 days before starting your activity. The purpose of this required notification is to enable the Agency to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
- According to Section 5 of TSCA, anyone who intends to manufacture a new chemical substance for a non-exempt commercial purpose must notify EPA before starting the activity.
- According to the TSCA section 13 (15 U.S.C. 2612), chemical importers have to import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must also certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA and the SNUR requirements.
- According to the TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), any persons who export or plan to export a chemical substance that is the subject of a proposed or final rule are obliged to export notification provisions and comply with the export notification requirements in 40 CFR part 707, subpart D.
Significant New Use Determination
EPA defined what would constitute a significant new use for the 30 chemical substances by taking into consideration relevant information about the toxicity of the chemical substances, possible human exposures and environmental releases associated with probable uses, and the following four bulleted factors. According to the Toxic Substances Control Act, EPA determines a use of a chemical substance as a significant new use based on all relevant factors, including:
- The projected volume of manufacturing and processing of a chemical substance.
- The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
- The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
- The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
Substances Subject to This Rule
Significant new use and recordkeeping requirements for 30 chemical substances are established in 40 CFR part 721, subpart E. In this section of the statute, you can find the following information for each chemical substance:
- PMN number
- Chemical name (generic name, if the specific name is claimed as CBI)
- Chemical Abstracts Service (CAS) Registry number (assigned for non-confidential chemical identities)
- Basis for the TSCA section 5(e) consent order or the basis for the TSCA non-section 5(e) SNURs (i.e.,SNURs without TSCA section 5(e) consent orders)
- Tests recommended by EPA to provide sufficient information in order to evaluate the chemical substance
- CFR citation assigned in the regulatory text section of this rule
For further information consult EPA’s Toxic Substances Control Act Chemical Substance Inventory or visit the site: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2015-0388-0023