Nanoscale Materials
The Federal Register’s rule states that it “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 minuscule 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 for regulated chemicals.
