EPA Extends Effective Date of Nanotechnology Reporting and Recordkeeping Rule, Seeks Public Input on Draft Guidance
May 16, 2017
On May 8, 2017, EPA extended the effective date of the recently-published final rule on Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements to August 14, 2017.

The final rule was initially published on January 12, 2017 and was set to go into effect on May 12, 2017.

In the January 12, 2017 final rule, EPA required that companies that manufacture (including importers), intend to manufacture (includes importers), process, or intend to process certain nanoscale chemical substances, electronically report (one time) the following information “insofar as known to or reasonably ascertainable by the person making the report” the following information:

  • The specific chemical identity
  • Production volume
  • Methods of manufacture and processing, exposure and release information
  • Existing information concerning environmental and health effects.

In addition, on May 16, 2017, the EPA issued Draft Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce and is seeking comments on the draft guidance. This draft guidance is intended to provide answers to questions the Agency received from manufactures (including importers) and processors of certain chemical substances when they are manufactured or processed at the nanoscale.

How Can Exponent Help?

Exponent is a multi-disciplinary engineering and scientific consulting firm that brings together more than 90 different disciplines to solve important engineering, science, regulatory, and business issues facing our clients. We have extensive experience in all aspects of nanomaterial (NM) product design, characterization, TSCA regulations and submission, and evaluation of NM human health and environmental toxicity, exposure and risk assessments. Our combination of high-level engineering, technological expertise, and regulatory experience, with strong health sciences, food safety, and environmental practices, provides a complete team to evaluate diverse issues related to NMs.

Exponent can help you determine if your materials are subject to this Final Rule, meet EPA’s definition of a nanoscale material, advise on the data that needs to be submitted, how to comply with TSCA’s recordkeeping requirements, and assist with regulatory submissions. Our regulatory and health consultants can also prepare exposure estimates based on the use pattern and evaluate existing data on environmental and health effects and provide advice concerning acquisition of additional data.

Exponent is continually involved in NM-related initiatives, including definition, use, and potential exposures to and toxicity of NMs. Our scientists have organized and regularly participate in technical symposia and legal education seminars on NMs. We have been active participants at regulatory agency hearings (e.g., EPA, FDA) and in standards-setting committees such as the Nanotechnology Standards Panel of the American National Standards Institute.