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Statement of Need: EPA is proposing a significant new use rule (SNUR) under section 5(a)(2) of TSCA that would designate as a significant new use, any use of chemical substances as nanoscale materials after the proposed date of the rule. Persons who intend to manufacture, import, or process these chemical substances for the new use after the date of the proposed rule would be required to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs to prevent any unreasonable risks to human health or the environment.

Summary of the Legal Basis: Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a "significant new use." EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)).

Alternatives: Nanoscale materials based on chemical substances already on the TSCA Inventory are considered existing chemical substances. These nanoscale materials do not require reporting as new chemical substances because they are nanoscale forms of chemical substances already in commerce. If EPA does not use authority under 5(a)(2) of TSCA to require notification of new uses of nanoscale materials, EPA would have to use existing chemical authority under sections 4, 6, and 8 of TSCA to gather data and address any unreasonable risks.

Anticipated Costs and Benefits: EPA has evaluated the potential costs of reporting requirements for potential manufacturers, importers, and processors that would be subject to the significant new use rule. If an entity were to submit a notice to the Agency, the annual burden is estimated to average 95 hours per response. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs to prevent any unreasonable risks to human health or the environment.

Risks: There is a growing body of scientific evidence showing the differences that exist between nanoscale material(s) and their non-nanoscale counterpart(s). Nanoscale materials may have different or enhanced properties--for example, electrical, chemical, magnetic, mechanical, thermal, or optical properties--or features, such as improved hardness or strength, that are highly desirable for applications in commercial, medical, military, and environmental sectors. These properties are a direct consequence of small size, which results in a larger surface area per unit of volume and / or quantum effects that occur at the nanometer scale (i.e., 1 x 10-9 meters). Small size itself can also be a desirable property of nanoscale materials that is exploited for miniaturization of applications/processes and/or stabilization or delivery of payloads to diverse environments or incorporation into diverse products. The properties that can make nanoscale materials desirable for commercial applications also raise questions whether the small size of nanoscale materials or the unique or enhanced properties of nanoscale materials may, under specific conditions, pose new or increased hazards to humans and the environment. Government, academic, and private sector scientists in multiple countries are performing research into the environmental and human health effects of diverse nanoscale materials, resulting in a substantial and rapidly growing body of scientific evidence. These research findings point to the possibility for nanoscale materials to affect human health and the environment adversely. Research also indicates that not all materials in the nanoscale size range behave differently from larger sized materials of the same substance.