EPA TSCA Nanotechnology Reporting and Recordkeeping Requirements Rule
August 21, 2017
On August 14, 2017, the U.S. Environmental Protection Agency (EPA) issued guidance for the Toxic Substances Control Act (TSCA) Nanotechnology Reporting and Recordkeeping Requirements Rule.

The new rule establishes reporting and recordkeeping requirements for chemical substances that are manufactured or processed at the nanoscale. More details can be found in the January 12, 2017 ruling.

The August 14, 2017 guidance reflects comments received on draft guidance EPA issued in May 2017 and addresses issues put forward by industry groups, such as manufacturers, importers, and processors. EPA intends to further update the guidance based on additional questions and input received. The Working Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce can be found here.

Questions regarding recordkeeping and reporting are addressed in more detail in five main topic areas and give clarity to the rule:

1. What Chemicals are Reportable?

  • What properties are considered unique and novel?
  • Can enhanced properties or continuously scaling properties (such as thermal conductivity or surface area) be considered unique and novel properties?
  • If nanomaterials that aggregate into larger particles during manufacturing are still subject to the rule.
  • Reporting requirements if the same material is reported once but then manufactured for a different use.
  • Mixture issues.
  • Morphology and share variation of the material.
  • Coating issues.

2. Who is Required to Report?

  • Formulation issues developed internationally.
  • Transition from R&D to developing products.
  • How do manufacturers comply if no information is known about the characteristics for formulations?
  • Exporting issues.

3. What Information is to be Reported?

  • What is reasonably ascertainable information?
  • What if the manufacturer or processor does not know what downstream reactions or additional modifications are made to the material?
  • What if the manufacturer of processor does not know anything about the end product?

4. When is Reporting Required?

  • How does the commercialization timeline work with the 135-day reporting requirement?
  • How do you update information if it changes?
  • What are the exemptions?

5. Confidentiality

  • What is considered when making a confidential claim?

More information on the Control of Nanoscale Materials under the Toxic Substances Control Act can be found here, including how to access electronic reporting.

How Can Exponent Help?

Exponent provides expertise on nanomaterial characterization and regulatory guidance. Industry groups such as manufacturers, processors and importers using nanomaterials must begin internal standard operating procedures for reporting on nanomaterial characterization, toxicity, and record keeping for future state and federal regulations. More information on Exponent’s expertise in nanomaterials can be found on our nanotechnology page.

With expanding use of nanomaterials worldwide, assessing exposure pathways, potential risk, and conducting life cycle analyses will help ensure health and safety for manufacturers, consumers, and the environment. As the regulatory landscape for nanomaterials develops, Exponent can help develop best practices for these materials. Exponent has previously reported on information required from industry on recordkeeping here and the original January 12, 2017 final rule.