As nano aficionados know, last October the Australian Chemical Gazette included a notice that the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced that it was introducing new administrative processes for the notification and assessment of industrial nanomaterials that are considered to be 'new' chemicals. The new administrative provisions were effective on January 1, 2011, and apply to any new chemical that falls under the working definition of 'industrial nanomaterial.' NICNAS also issued guidance on the notification program. Recently, the NICNAS provided an update on its track record to date on the new system. Before providing the update, noted below is a brief background with the new notification program.
The new notification program applies to industrial nanomaterials, defined as follows: '... 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).'
Several additional terms are defined in the rule as follows:
- 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 their 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 chemical exemptions and new chemical certificates and permits. NICNAS may require additional information, on a case-by-case basis, on the nano-specific characteristics of a 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. NICNAS also notes that it may stipulate permit conditions for conventional chemical notifications where 'it can be reasonably assumed that a nano-form may be introduced in the future.' The guidance neglects to note what factors it would assess in determining what additional permit conditions may be needed as a result of these anticipatory nano-forms of conventional substances.
Recently, NICNAS noted that it has been providing advice to interested stakeholders on nanoscale materials, predominantly clarifying to industry that the new arrangements do not apply to nanoforms of existing chemicals. NICNAS also confirmed that it has received no new notifications under the new arrangements as of the end of March 2011.
Further, NICNAS is aware of no concerns that have been raised regarding the impact of these arrangements for nanomaterials that are new chemicals. This is either good news, or stakeholders have been less than diligent to bringing any such concerns to NICNAS' attention.
NICNAS reports that general outreach sessions have been conducted in Perth, Adelaide, and Sydney, and have included a nanotechnology regulatory update component. Additional sessions are planned for Melbourne, Brisbane, and Darwin.
Compliance activities began in April 2011 to assess the extent to which business is complying with the new arrangements. The results of this assessment will inform the ongoing outreach sessions that will assist industry in understanding these changes.
Businesses are encouraged to contact NICNAS to clarify whether the nanomaterials they are introducing are new or existing chemicals, and thus determine whether they must address new obligations under these changes.
Finally, NICNAS reports that it is further developing options for notification and assessment of nanoforms of existing chemicals, including the concept of an integrated notification and assessment program for new and existing industrial nanomaterials. This option will be subject to future public consultation.