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May 25, 2017

On the day the rule was supposed to take effect, the EPA extended the effective date of its rule requiring manufacturers and importers of certain chemicals produced at the nanoscale size (1–100 nanometers) to report particular information to the EPA. The effective date was extended to Aug. 14, 2017, over three months beyond the original date of May 12.

The rule, promulgated under section 8(a) of the Toxic Substances Control Act, applies to substances that are manufactured or processed in a form where any particles are in the nanoscale size in at least one dimension and possess “unique and novel properties” due to their size. Additionally, manufacturers of different “discrete forms” of these nanoscale particles are required to report on each discrete form. However, the EPA excluded from the rule:

  1. Certain biological materials (e.g., DNA, antibodies, microorganisms).
  2. Chemicals that dissociate completely in water to form ions with a size of less than one nanometer.
  3. Chemical substances formed at the nanoscale as part of a film on a surface.
  4. Chemicals that are comprised of less than one percent nanoparticles by weight.  

The rule requires one-time reporting of information that is known or reasonably ascertainable for subject chemicals, including:

  1. Specific chemical identity.
  2. Production volume.
  3. Methods of manufacture and processing.
  4. Use, exposure and release information.
  5. Available health and safety information. 

The rule requires manufacturers and importers who have manufactured or imported a subject chemical within the past three years to report the required information within one year of the rule’s effective date. Manufacturers and importers who intend to produce a subject chemical in the future must report the required information at least 135 days prior to manufacture or import. The rule also requires manufacturers and importers to keep records of the reported information for three years.

The EPA decided to extend the effective date of the rule without notice and comment from the public because the “complex issues” regarding the rule’s reporting requirements and the “immediate pendency” of the effective date made it impractical to provide an opportunity for public comment before extending the effective date. Additionally, the EPA determined that the public interest is best served by complete and accurate reporting under the rule, “which would be greatly facilitated by publication of the guidance” that the EPA intends to issue within the next few months.

The Federal Register for the final rule may be found here, and the notice for the extension of the effective date may be found here.

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