Safe Work Australia Recommends Classification of Carbon Nanotubes as Hazardous Chemicals

On October 22, 2012, Safe Work Australia announced the availability of a report entitled Human Health Hazard Assessment and Classification of Carbon Nanotubes, as well as an information sheet on the report. The report recommends that multi-walled carbon nanotubes should be classified as hazardous unless toxicological or other data for specific types imply otherwise. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) prepared the report in support of Safe Work Australia’s Nanotechnology Work Health and Safety Program. NICNAS extensively reviewed the published literature on the toxicity of carbon nanotubes, and concluded that multi-walled carbon nanotubes may cause damage to lungs through prolonged or repeated inhalation exposure. The report recommends classification as hazardous for repeated or prolonged inhalation exposure and for carcinogenicity. For all other endpoints, NICNAS found that carbon nanotubes either were not classified as hazardous, or cannot be classified as insufficient data are available. The information sheet summarizes the key findings from the report and discusses implications for manufacturers, importers, persons in control of a business or undertaking, and workers manufacturing or using products containing carbon nanotubes.

Australia Publishes Literature Review Relating to Six Nanomaterials

Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced on September 28, 2011, the availability of a review of the 2007-2009 literature on toxicological and health effects relating to six nanomaterials. NICNAS commissioned the review and analysis of literature concerning fullerenes, carbon nanotubes, and nanoforms of zinc oxide, titanium dioxide, cerium oxide, and silver. According to NICNAS, it chose these nanomaterials because it considers them “to already be in, or close to, commercial use in Australia.”  The goal of the review was to identify any available scientific evidence of important toxicological/health effects that had not been covered by the scope of previous reviews and therefore supplement currently available scientific information on these substances.

In the report, several “special features” of nanoparticle-induced toxicity are singled out for more detailed analysis:

  • The extent to which repeated-dose vs. single dose and/or in vitro studies can contribute useful information to undertake a health risk assessment;
  • How likely is it that fibrous nanomaterials can reproduce the adverse health effects of asbestos fibers;
  • Whether there is new information about the extent to which nanoparticles can be absorbed across unbroken skin;
  • Whether some nanoparticles represent a specific risk of neurotoxicity under conditions where they can actually reach the brain, or whether nanoparticle exposure can result in cardiovascular toxicity; and
  • Knowledge gaps which might help to inform health risk assessment, and in particular, whether advances in knowledge of the effects of surface modification, or other structure-activity relationships, or application of genomic techniques, might fill some of these gaps.

Australia Issues Guidance on New Chemical Requirements for Notification of Industrial Nanomaterials

Australia’s National Industrial Notification and Assessment Scheme (NICNAS) recently issued guidance on the new chemical requirements for the notification and assessment of industrial nanomaterials that are considered to be new chemicals. The new administrative arrangements will be effective from January 1, 2011, and will apply to any new chemical that falls under the following working definition of “industrial nanomaterial”:

. . . industrial materials intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 [nanometer (nm)] and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale).

Australia Announces Adjustments To NICNAS New Chemicals Processes For Industrial Nanomaterials

In an October 5, 2010, Chemical Gazette notice, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced that it is introducing new administrative processes for the notification and assessment of industrial nanomaterials that are considered to be new chemicals. The new administrative arrangements will be effective from January 1, 2011, and will apply to any new chemical that falls under the following working definition of “industrial nanomaterial”:

. . . industrial materials intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 [nanometer (nm)] and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale).

The notice includes the following notes to the working definition:

  • Intentionally produced, manufactured, or engineered materials are distinct from accidentally produced materials;
  • “Unique properties” refers to chemical and/or physical properties that are different because of its nanoscale features as compared to the same material without nanoscale features, and result in unique phenomena (e.g., increased strength, chemical reactivity or conductivity) that enable novel applications;
  • Aggregates and agglomerates are considered to be nanostructured substances; and
  • Where size distribution shows ten percent or more of a substance (based on number of particles) is at the nanoscale, NICNAS will consider this substance to be a nanomaterial for risk assessment purposes.

Currently, all regulatory requirements applicable to conventional chemicals also apply to their nano-forms.  Specific amendments to current processes and practices vary between new chemicals exemptions and new chemical certificates and permits.  NICNAS may require additional information, on a case-by-case basis, on the nano-specific characteristics of chemical.  NICNAS may also require further additional data such as surface area, impurity profile, and surface properties (such as charge and coatings), on a case-by-case basis.

 

Australia Releases Proposal Intended To Strengthen Nanomaterial Regulation

On November 9, 2009, Australia announced the availability of a public discussion paper proposing to strengthen regulation of industrial nanomaterials used in Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) developed the proposal in conjunction with its Nanotechnology Advisory Group, which includes representatives from industry, the community, and research sectors. Major regulatory reforms would include:  refinement of pre-market assessment categories for nanoforms of new chemicals, particularly where human health or environmental exposure can reasonably be anticipated; and a mandatory notification and assessment program for nanoforms of existing chemicals. The discussion paper contains a questionnaire and survey intended to encourage written submissions. Comments are due December 23, 2009.

Australian Unions Call for Regulation of Nanomaterials

On April 14, 2009, the Australian Council of Trade Unions (ACTU) issued a press release entitled “Nanotech Poses Possible Health and Safety Risk to Workers and Needs Regulation.” According to ACTU, “[t]he rapidly growing nanotechnology market in Australia requires urgent regulation to protect the health and safety of workers and consumers.” ACTU notes that, currently, there is no mandatory register in Australia of who is importing, manufacturing, supplying, or selling nanomaterials, and no requirement to label products.

ACTU recommends the following actions:

  • Classification of nanoscale chemicals as new chemicals under the National Industrial Chemicals and Notification and Assessment Scheme (NICNAS);
  • Development by government agencies of new standards for the handling of nanotechnology;
  • A mandatory requirement that all commercial products containing nanomaterials be labeled;
  • Establishment of a federal registry of all companies and organizations manufacturing, importing, and supplying products containing nanomaterials;
  • Establishment of a tripartite body to oversee the implementation of this regulatory framework;
  • Adoption of the “Precautionary Principle” when dealing with nanomaterials;
  • Development and improvement of hazard identification, assessment, and control mechanisms for nanomaterials;
  • Enforcement of new exposure standards using an active inspectorate; and
  • Monitoring of the health impacts on Australian workers involved in nanotechnology and investment in related medical research.