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May 10, 2016

Australia Addresses Nanomaterials in Third NICNAS Reforms Consultation Paper

Lynn L. Bergeson Carla N. Hutton

On April 29, 2016, Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published the third consultation paper on its reform initiative.  Under the reforms, the requirements to establish that a new chemical can be classified as being not hazardous to human health or the environment, and therefore falls in Hazard Band A, include consideration of several factors, including whether the chemical is a nanomaterial.  The consultation paper states that the risk matrix applies to chemicals (and their nanoforms) that are not listed on the Australian Inventory of Chemical Substances (AICS).  Chemicals used in controlled environments, such as contained import/export and research and development (R&D) situations (up to 100 kilograms introduction volume) would be categorized as Exempted.  Contained import/export is where a new chemical is imported and then exported without any repackaging or processing (i.e., packaging remains intact).  Because the packaging remains unopened and there is negligible exposure to humans or the environment, the consultation paper states that the risk is very low and categorization as an Exempted chemical is appropriate.  The proposed definition of R&D excludes commercialization, and according to the consultation paper, these chemicals are used only in controlled environments by trained personnel.  R&D facilities are regulated by the Australian State/Territory Work Health and Safety (WHS) regulations.  According to the consultation paper, the WHS model adopts a precautionary approach to nanomaterials used in R&D settings, and recommends that safety data sheets (SDS) be provided to workers handling nanomaterials, even if they are not classified as hazardous substances under the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  Nanomaterials should be labeled as “caution:  hazards unknown” or “caution:  hazards not fully characterized.”  Under the reforms, new chemicals that are nanoforms and do not qualify for the contained import/export or R&D exemption would be categorized within Hazard Bands D or E.  Comments are due June 10, 2016.  Stakeholder workshops will be held May 16, 2016, and May 18, 2016.