• Receipt of a SNUN triggers EPA review of the risks associated with the SNUN and a determination of whether such risks warrant control.
• SNUNs are reported using the standard e-PMN form and are subject to a 90-day review process similar to that for a PMN.

If the Environmental Protection Agency (EPA) promulgates a significant new use rule (SNUR) under 40 CFR 721, the Toxic Substances Control Act (TSCA) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture (including import) or process the substance for that use. Information submitted in a SNUN must include, insofar as it is known to or reasonably ascertainable by the submitter, information described in TSCA section 8(a)(2) (i.e., chemical identity, use, and exposure data), as well as test data, and descriptions of other data related to the effects on health and the environment of the manufacture, processing, use, distribution in commerce, and disposal of the chemical substance (TSCA section 5(d)).

Receipt of a SNUN triggers EPA review of the risks associated with the SNUN and a determination of whether such risks warrant control. EPA reviews specific significant new uses proposed in a SNUN on a case-by-case basis before such uses of the chemical enter commerce. The notification gives EPA the opportunity to evaluate the new use and:

• Make an affirmative determination on the safety of the significant new use; or
• Take action to prohibit or limit the activity to address any unreasonable risks identified.

EPA review of a SNUN puts the agency in the position of reviewing the risks of specific significant new uses only when introduction into commerce is imminent.

EPA recommends that submitters consult with the agency prior to submitting a SNUN to discuss what data may be useful in evaluating a significant new use. Discussions with the agency prior to submission can afford ample time to conduct any tests that might be helpful in evaluating risks posed by the substance.

Joint SNUN submissions

Potential SNUN submitters should be aware of 40 CFR 721.25(b), which authorizes joint SNUNs by two or more persons -- for example, a manufacturer and several processors. In many cases, EPA will need 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). Note that before EPA amends the SNUR, even after a manufacturer submits a SNUN and the review period expires, processors (and other manufacturers) of the substance are still legally required to submit their own SNUN before engaging in the significant new use.

Electronic submission

SNUNs are reported using the standard e-PMN form and are subject to a 90-day review process similar to that for a premanufacture notice (PMN). When submitting a SNUN, the submitter should include a cover letter that provides the Code of Federal Regulations citation of the SNUR and identifies the specific significant new use(s) for which the SNUN is being submitted.

Exemptions

Under TSCA section 5(h), EPA may exempt a chemical manufacturer or processor from submitting a SNUN when the agency determines that the use of a chemical substance would not pose an unreasonable risk, or when the agency already has information about the chemical substance. In some circumstances, EPA may not grant an exemption unless an entity applies for one. For exemptions that require an application, EPA must grant or deny the exemption within 45 days of receiving the application.