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Statement of Need: EPA is proposing reporting requirements under section 8(a) of TSCA for persons who are manufacturing, importing, or processing existing nanoscale materials in commerce to collect data on these activities. The data will help EPA to take any measures to ensure that nanoscale materials are manufactured and used in a manner that protects against unreasonable risks to human health and the environment.

Summary of the Legal Basis: Section 8(a) of TSCA authorizes the Administrator to promulgate rules, which require each person (other than a small manufacturer, importer, or processor) who manufactures, imports, processes, or proposes to manufacture, import, or process a chemical substance, to maintain such records and submit such reports as the Administrator may reasonably require.

Alternatives: EPA developed a voluntary Nanoscale Materials Stewardship Program (NMSP) to complement and support its regulatory activities on nanoscale materials. EPA initiated the NMSP to quickly learn about commercially available nanoscale materials by soliciting existing data and information on a voluntary basis from manufacturers, importers, processors, and users of nanoscale materials. In addition, the program was designed to identify and encourage use of risk management practices in developing and commercializing nanoscale materials. In its NMSP interim report, EPA identified data gaps for existing nanoscale material production, uses, and exposures, based on the information EPA received prior to January 2009. For example, EPA estimated that companies provided information on only about 10 percent of the nanomaterials that may be commercially available. EPA is proposing reporting requirements under section 8(a) of TSCA for persons who are manufacturing, importing, or processing nanoscale materials in commerce to address some of the data gaps identified in the NMSP interim report. EPA has not identified any other activities, including regulatory activities under TSCA that would address data gaps for existing nanoscale materials.

Anticipated Costs and Benefits: EPA has evaluated the potential costs of 8(a) reporting requirements for potential manufacturers, importers, and processors that would be subject to the proposed rule. If an entity were to submit a notice to the Agency, the annual burden is estimated to average 157 hours per response. This information would facilitate EPA’s evaluation of the materials and consideration of appropriate action under TSCA to reduce any unreasonable risk 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.