10.07.2021 EPA Significant New Use Rule: Commonly Used Chemical Substances
EPA recently issued significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for three chemical substances as a result of their premanufacture notices (PMNs). These rules require affected persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any listed chemical substances for a designated significant new use and submit a Significant New Use Notice (SNUN). The SNURs are effective October 15, 2021. The chemical substances subject to the SNURs are the following:
- Rosin adduct ester, polymer with polyols, compound with ethanolamine (generic).
- Rosin adduct ester, polymer with polyols, potassium salt (generic).
1,3-Propanediol, 2,2-Dimethyl-, 1,3-Diacetate.
All manufacturers or importers of a chemical substance must register the chemical with EPA by filing a PMN. As part of the PMN, the registering company must describe the anticipated use of the chemical substance. A person who intends to manufacture, import, or process for commercial purposes certain PMN substances and intends to engage in a significant new use of such substances must file a SNUN with the Agency.
In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considers relevant information about the toxicity of the chemical substances and potential human exposures and environmental releases that may be associated with the substances in the context of the following factors:
- 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.
New SNUR Designations
Although the new SNUR designations are for chemicals subject to confidential business information claims, the SNUR provides descriptions of those types of chemical substances covered by the new uses. Accordingly, manufacturers and importers of chemicals in the process categories listed above may be subject to the SNUR for their process chemicals and restricted in the future use and distribution of those substances.
The significant new uses for these chemicals are generally limitations on production volumes to those specified in the PMN for each. The covered facilities also must comply with existing recordkeeping requirements at 40 CFR § 721.125. EPA may at any time modify or revoke SNUN requirements for a chemical substance that has been added to the SNUR list.
To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule were undergoing PMN review at the time of signature of the proposed rule and were not on the TSCA inventory. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for the chemical substances subject to these SNURs, EPA concluded at the time of signature of the proposed rule that the designated significant new uses were not ongoing.
Conclusion and Suggested Action
Manufacturers and importers intending to process polymers and other chemical substances listed in the SNUR may wish to develop compliance plans for the recordkeeping and limitations implemented under the new regulation. A self-audit under EPA’s self-policing policies may provide the company maximum protection against enforcement for violation of the SNUR requirements.
86 Fed. Reg. 45651 (August 16, 2021)