EPA's final rule published January 12, 2017 collects information on certain nanoscale chemical substances; it does not conclude that nanomaterials as a class are harmful. Its definition begins with substances solid at 25 degrees Celsius and standard atmospheric pressure, manufactured or processed with particles measuring 1–100 nanometers in at least one dimension for unique properties attributable to their size. [2017-00052]

Size alone does not finish the coverage test. The definition excludes forms with less than one percent by weight of particles in that range, and the regulation contains further exclusions. Separate reporting concerns discrete forms of a reportable substance. Different morphology or different coating chemistry can distinguish forms; an incidental difference between production batches is not automatically a separate reportable form. [2017-00052]

Reports seek information known or reasonably ascertainable, including identity, production, uses, exposure, releases and existing health information. EPA does not impose new testing through this rule. Gathering those records can inform whether more action is needed for a specific material; it does not certify that material as safe or establish that people exposed to it have been harmed. [2017-00052]

The April 6, 2015 proposal envisaged six months after effectiveness for covered prior manufacturers and processors to report. The final gives one year and originally schedules May 12, 2017 effectiveness. For covered new forms, its advance-reporting provision also contains an intent-based exception rather than an unconditional waiting period. Proposal and final are one evidence chain, useful for tracing the reporting design rather than independently proving health outcomes. [2017-00052][2015-07497]

Source documents

  1. Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirementshttps://www.govinfo.gov/content/pkg/FR-2017-01-12/html/2017-00052.htm
  2. Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirementshttps://www.govinfo.gov/content/pkg/FR-2015-04-06/html/2015-07497.htm