A one-time report does not necessarily mean one entry for every chemical name. EPA's January 12, 2017 nanoscale rule requires information for each covered discrete form of a reportable substance. Different morphology or a coating made from a different chemical substance or mixture can distinguish forms. That makes material characterization part of the reporting task rather than a detail outside it. [2017-00052]

The underlying scope is also selective: solids at 25 degrees Celsius and standard atmospheric pressure, with particles of 1–100 nanometers in at least one dimension, manufactured or processed for unique size-dependent properties. Forms with less than one percent by weight in that range are excluded. Further exemptions apply. A supplier cannot infer the scope simply from the word nano in a product description. [2017-00052]

The final seeks information known or reasonably ascertainable, not new tests. For business analysis, this distinguishes assembling available production, use and exposure information from commissioning research the rule does not require. It also means the reporting framework alone cannot establish a firm's actual compliance cost. The regulation identifies information categories, not a measured competitive burden for every producer. [2017-00052]

The April 2015 proposal allowed six months after effectiveness for covered prior activity; the final allows one year and originally specifies May 12, 2017 effectiveness. That is a material planning difference within one agency process. New covered forms have a separate advance-reporting track with an intent-based exception. Neither the additional preparation time nor the reporting obligation demonstrates lower costs, safer products or a market advantage already delivered. [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