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EPA Announces Final Rule Reporting for Nanoscale Materials (January 2017)

The Environmental Protection Agency (EPA) issued a final rule establishing new standards regarding nanoscale materials under TSCA section 8(a). The Agency is taking this action to better assess the behavior of nanoscale materials and decide whether or not additional regulations are needed.

Nanoscale Materials

The Federal Register’s rule states that “this rule applies to chemical substances, as defined in section 3 of TSCA, that are solids at 25 °C and standard atmospheric pressure; that are manufactured or processed in a form where any particles, including aggregates and agglomerates, are in the size range of 1-100 nanometers (nm) in at least one dimension; and that are manufactured or processed to exhibit one or more unique and novel properties.”

The Agency’s interest in these substances has grown due to the increased scientific evidence demonstrating properties that are unique to these substances due to their miniscule size. This rule excludes biological materials including DNA, RNA, proteins, enzymes, etc.

Final Rule

The final rule requires one-time reporting for certain existing nanoscale materials and a standing one-time reporting requirement for certain new nanoscale materials before they are manufactured and processed. The data requested includes:

  • Specific chemical identity
  • Production volume
  • Manufacturing methods
  • Processing Information
  • Use Information
  • Exposure and Release Information
  • Available health and safety data

Submissions can be made using CDX, the Agency’s electronic reporting portal. EPA requires submitters to follow the same procedures used for other TSCA submissions.

More Information
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