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Australia Addresses Nanomaterials in Third NICNAS Reforms Consultation Paper

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.

©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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