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

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.

©2017 Bergeson & Campbell, P.C.

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Owner of Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy...

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Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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