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June 9, 2017

Australian Consultation Paper Addresses Regulatory Treatment of Unlisted Chemicals Introduced at the Nanoscale

Lynn L. Bergeson Carla N. Hutton

The Industrial Chemicals Bill 2017 describes the legislative framework for a reformed, risk-based regulatory scheme for Australia to continue to regulate the introduction of industrial chemicals.  The Australian government has presented the bill to Parliament.  On June 1, 2017, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published Consultation Paper 5, which seeks feedback from stakeholders on the detail to be included in delegated legislation made under the framework established by the Industrial Chemicals Bill.  The Consultation Paper states that these are mostly “technical matters” and “relate in particular to the categorisation and assessment of unlisted chemical introductions.”  Part 7 of the Consultation Paper is a proposal for the categorization of industrial chemicals introduced at the nanoscale.  It presents options for the properties of nanoscale chemicals that should be used as criteria to define the chemicals that require pre-introduction assessment.  NICNAS states that it modified its proposal to address stakeholder feedback and concerns, and Consultation Paper 5 further refines the regulatory treatment of chemicals introduced at the nanoscale.  NICNAS proposes that it will not categorize introductions of unlisted chemicals consisting of particles at the nanoscale using the same hazard and exposure band criteria proposed for other chemicals.  Instead, NICNAS will set criteria using properties important for establishing which nanoscale chemicals require pre-introduction assessment.  The categorization outcomes for unlisted chemicals consisting of particles at the nanoscale that meet the specific nanoscale criteria will be:

  • Exempted if introduced at ≤10 kilograms per year (kg/annum) for the purposes of research and development, or as a contained import/export introduction;
  • Reported if introduced at >10 kg/annum and ≤100 kg/annum for the purposes of research and development; and
  • Assessed in all other circumstances.

NICNAS states that the information it will need as part of the application for an Assessed introduction will be commensurate with the Exposure Band (similar to other types of industrial chemicals).  NICNAS will consult further on these requirements later in 2017.  Categorization criteria may incorporate some or all of the below elements, and the Consultation Paper seeks comment on specific options within each element:

  • Size and distribution;
  • Intentionally manufactured;
  • Size-dependent properties;
  • Aggregates and agglomerates; and
  • Solubility/dissolution rate.

For the introduction of chemicals consisting of particles at the nanoscale that do not meet the criteria discussed in Consultation Paper 5, the categorization will be the same as other unlisted industrial chemicals and may result in it being categorized as Assessed, Reported, or Exempted.  It will therefore depend on the exposure (volume and use) and the hazard characteristics of the chemical (with information requirements for hazard depending on the Exposure Band).  NICNAS will hold the following public workshops:

  • Sydney public workshop, June 16, 2017, 9:30 a.m. to midday; and
  • Melbourne public workshop, June 28, 2017, 9:30 a.m. to midday.

Comments on Consultation Paper 5 are due July 12, 2017.