Contemporary and Future Challenges for Australian
Nanoregulation
Thomas Faunce1,
1
Australian National University College of Law and College of Medicine, Biology and the Environment-
Canberra ACT 0200, Australia
Abstract—Nanotechnology regulation in Australia faces
challenges similar to those in other jurisdictions. These include
how to define nanoparticles, whether to establish mandatory
reporting and labeling requirements and how to implement
precautionary regulation for nanoparticles likely to be high risk
for human health or the environment. Another important
regulatory issue is how to promote nanotechnological research
and development focused on national benefit including assisting
to resolve critical problems in public health.
Keywords-Nanoregulation, Millennium Development Goals,
mandatory reporting, new chemical entity, labelling
I. INTRODUCTION-INTERNATIONAL CONTEXT
Developing models for data collection about exposure in air
and water, evaluating toxicity and predicting life cycle impact
have been presented as the major challenges for nanoregulation
internationally in the next decade.[1] In terms of internationally
harmonized regulation related goals are being worked towards
by the Organization for Economic Co-operation and
Development (OECD) Working Party on Manufactured
Nanomaterials (WPMN) particularly under Project 3 in which
various nations have agreed to take roles in providing
regulators with consistent toxicity data on common
nanomaterials (Australia is contributing on zinc oxide, cerium
oxide and nanosilver).[2] Another significant effort to
harmonise international nanoregulation involves the
International Standards Organization (“ISO”) Technical
Committee which has published work on nanotechnology
terminology and definitions [3] and international standards on
environmental, health and safety issues concerning
nanotechnology.[4] The ISO has proposed a definition of
nanoparticle as one with all three external dimensions in the
size range 1nm to 100nm.[3] Amongst self-regulation
initiatives the Responsible Nanocode has been developed to
establish consensus of good practice in the research,
production, retail and disposal of products using
nanotechnologies.[5]
Such regulatory efforts, whilst appropriate for related safety
issues, don’t emphasize the role that regulation can play in
encouraging beneficial uses of nanotechnology. In 2005, for
example, 63 nanotechnology scientists and policy makers
identified the top ten areas in which nanotechnology could
benefit developing countries in the areas of water, agriculture,
nutrition, health and energy on criteria related to: impact,
burden, appropriateness, feasibility, reducing knowledge gap,
Electronic copy available at: http://ssrn.com/abstract=1570547
capacity building and income generation.[6] United Nations
Millennium Development Goal (MDG) 7 on environmental
sustainability, targets for example, sustainable access to safe
drinking water and basic sanitation and improving the lives of
slum dwellers.[7] Regulation related to nanotechnology in
energy storage, production and conversion could promote: (i)
novel hydrogen storage systems based on carbon nanotubes
and other lightweight nanomaterials, (ii) photovoltaic cells and
organic light-emitting devices based on quantum dots, (iii)
carbon nanotubes in composite film coatings for solar cells,
(iv) nanocatalysts for hydrogen generation and (v) hybrid
protein-polymer biomimetic membranes. Regulation related to
nanotechnology in agricultural productivity enhancement could
promote: (i) nanoporous zeolites for slow-release and efficient
dosage of water and fertilizers for plants, and of nutrients and
drugs for livestock, (ii) nanocapsules for herbicide delivery,
(iii) nanosensors for soil quality and for plant health monitoring
and (iv) nanomagnets for removal of soil contaminants.
Regulation related to nanotechnology in water treatment and
remediation could promote: (i) nanomembranes for water
purification, desalination and detoxification (ii) nanosensors for
the detection of contaminants and pathogens (iii) nanoporous
zeolites and polymers, and attapulgite clays for water
purification (iv) magnetic nanoparticles for water treatment and
remediation and (v) Tio2 nanoparticles for the catalytic
degradation of water pollutants. Regulation related to
nanotechnology in air pollution and remediation) could
promote: (i) Tio2 nanoparticle-based photocatalytic
degradation of air pollutants in self-cleaning systems (ii)
nanocatalysts for more efficient, cheaper and better controlled
catalytic converters (iii) nanosensors for detection of toxic
materials and leaks and (iv) gas separation nanodevices.[6]
Many commentators remain skeptical that nanotechnology
according to current patterns of research and development will
assist economic development, improve global public health and
reduce poverty.[8] [9]
II. NANOREGULATION IN AUSTRALIA
A. Overview
Australia has four national chemicals assessment and
registration schemes relevant to regulation of nanoparticles:
Food Standards Australia New Zealand (FSANZ) covering the
food industry;[10] National Industrial Chemicals and
Assessment Scheme (NICNAS) that covers industrial
chemicals;[11] Therapeutic Goods Administration (TGA) that
deals with pharmaceuticals;[12] and, Australian Pesticides and
Veterinary Medicines Authority (APVMA) that deals with
agricultural and veterinary chemicals.[13]
Both the APVMA and the TGA regulate products rather than
chemical substances. NICNAS administers the Australian
Inventory of Chemical Substances (AICS) just as the TGA, in
administers the Australian Register of Therapeutic Goods
(ARTG). These, in their respective fields, require applicant
manufacturers of nanoparticles to submit comprehensive
characterisation data sets which include, where appropriate,
particle size and characteristics. All food products (including
those potentially containing nanoparticles such as nanosilver)
supplied in Australia must comply with the Australia New
Zealand Food Standards Code (ANZFSC) and be safe for
human consumption. The use of industrial chemicals is also
regulated at the state and territory level by a range of agencies.
Additionally the Australian Competition and Consumer
Commission (ACCC) is responsible for product labelling in
accordance with federal Trade Practices legislation.[14]
B. Current regulatory challenges
Safe Work Australia (“SWA”) is currently revising the Code
of Practice for Safety Data Sheets (“SDS”) proposing the
addition of a number of non-mandatory specific to
nanoparticles and is implementing a nanotechnology
occupational health and safety program. There are only two
engineered nanomaterials for which Australian National
Exposure Standards have been established: fumed silica and
carbon black. SWA has established the Nanotechnology OHS
Measurement reference Group to progress the development of
nanomaterials emissions and exposure measurement capability
in Australian workplaces.[15] FSANZ is seeking to amend the
ANZFSC so that new applications contain information on
particle size, size distribution and morphology.[16]
The TGA, after a review of nanoparticles in sunscreens has
approved them for marketing in Australia on the basis that
they do not penetrate below the stratum corneum.[17]
In February 2010 the federal government announced a
National Enabling Technologies Strategy which allocated
around $38 million over four years “to guide the safe
development of new technologies such as nanotechnology and
biotechnology.” The strategy allocated $18.2 million to the
National Measurement Institute.[18]
C. NICNAS reviews
In February 2006, NICNAS issued a voluntary Call for
Information to Australian industry to provide information on
the uses and quantities of nanomaterials being manufactured
or imported for industrial purposes, or for use in cosmetics and
personal care products. Only about 20 companies responded.
Approximately one- third of those surveyed indicated that the
nanomaterial(s) were only being used for research purposes. A
second Voluntary Call for Information was initiated by
NICNAS in October 2008, targeted at all manufacturers or
importers of nanomaterials or products (mixtures) containing
nanomaterials for commercial or research and development
purposes in 2008 (the first call excluded the use of
Electronic copy available at: http://ssrn.com/abstract=1570547
nanomaterials for R&D purposes). This had a similarly poor
response.[19]
NICNAS, like its counterparts the European Union’s
Registration, Evaluation, Authorisation and Restriction of
Chemicals (REACH) program and the United States
Environment Protection Agency’s Toxic Substances Control
Act (TSCA), faces the challenge of how to define
nanoparticles. The standard of less than 100nm probably needs
to be supplemented by components acknowledging the
importance of novel chemical and physical properties. There is
alos the issue of whether to deem nano-formulations of
existing chemicals to be ‘new chemicals’ for regulatory and
safety purposes. To date, Australian regulators have been
reluctant to recognize that nanoparticles present new and often
greater toxicity risks than larger particles of the same chemical
composition. This was evident in National Nanotechnology
Strategy Taskforce’s report that recognized the need for a
‘whole of government approach’ to dealing with the problems
posed by nanotechnology and suggested that ‘existing
regulations may need some adjustments.’[20]
NICNAS is currently involved in a reviewing a proposal for
regulatory reform of industrial nanomaterials in Australia. One
option proposed is a staged development involving the
introduction of mandatory reporting of nanomaterials above a
100g limit as well as a permit system involving a declaration
by the notifier that chemical is a nanomaterial. More specific
information (such as particle size, shape and other specific
information on properties) may be required under specified
conditions. Nanomaterials will be administratively excluded
from non-hazardous self-assessment category on the basis of
the uncertainty concerning their hazard and NICNAS can
determine if the criterion for no unreasonable risk is met on a
case by case basis. NICNAS also can stipulate enforceable use
conditions, amend these conditions, or revoke the permit when
new information is generated.[19]
III. FUTURE CHALLENGES FOR NANOREGULATION
A. Regulatory gaps
Significant knowledge and regulatory gaps exist in all
jurisdictions with respect to managing the environmental, and
public health implications associated with widespread
industrial and consumer use of nanotechnology.
A major regulatory problem is that whilst it is clear from in
vitro test systems that nanosilver has deleterious dose and time
dependent effects on cell function and viability at unusually
low applied concentrations, such in vitro data may be of
limited assistance in in vivo risk assessment. It nevertheless
may assist in investigating possible mechanisms of toxicity,
and adding to a weight of evidence evaluation in risk
assessment.[21] A major issue here may be the difficulty of
characterizing the surface chemistry of nanoparticles in
biological systems when surrounded by a protein corona.[22]
The existing statutory threshold levels for quantity of
manufactured nanomaterials are high and unlikely to be
triggered in many cases where risks could eventuate. Hence,
regulators should look to lowering these thresholds or
modifying them to take into account unique chemical
properties and toxicities of many nanoparticles. Where
appropriate legislation should be amended to explicitly
regulate nanotechnology products. For example, introducing a
category of nanopesticides in the different jurisdictions may
assist in avoiding the circuitous route currently adopted to
regulate non-traditional pesticidal products that utilize, for
example, nanosilver such as washing machines.
Workplace exposure mitigation is a difficult exercise for
engineered nanoparticles in the absence of data suitable to
create effective occupational exposure limits. Control banding
has been proposed as a precautionary tool to mitigate
exposures when there is not enough information for
quantitative risk assessment. Problems arise however over
how to assign nanomaterials into hazard categories and
exposure scenarios and what level of exposure reduction is
afforded by specific engineering control levels.[22]
B. Pre-marketing approvals
Pre-marketing approvals are a valuable regulatory strategy
because they not only allow the government to screen any
potentially harmful materials and products, but to facilitate
products targeted at public goods. They should be extended to
nanoparticles and related products regardless of whether they
currently belong to a category of products exempt from such
approvals. REACH for all its faults (regulatory triggers based
on high levels of manufacture) in probably represents a better
model of oversight law than the TSCA because it puts the
burden on the manufacturer to prove safety rather than on the
government to prove the risk. This safety data so required
should not be limited to the physical, chemical and
toxicological properties; instead, it should (as standardised
measures for determining these parameters become
progressively available) include the shape of the nano-
formulation, particle size range and mean, aggregation
characteristics, expected lifetime in various states,
biopersistence, synthesis method, crystal structure, surface
area and charge, anti-microbial claims, concentration and
associated novel chemical characteristics and properties. Cost-
effectiveness assessment from be a robust part of any
assessment process for public expenditure on nanomedicines
and nanotechnology medical devices in Australia. It should be
emphasized in this context that innovation in nanotechnology
relates as much to the science-based concept of objectively
demonstrated therapeutic significance as it does to the more
advertising-oriented operation of competitive markets.[14]
C. Post-marketing surveillance and public engagement
It is just as important to maintain post-marketing surveillance
because new information on the life-cycle and toxicity of
engineered nanoparticles is still being gathered. Regulators
should aim to provide guidelines on safe disposing of
engineered nanoparticles over the entire life cycle of their
products.
Given that the voluntary reporting programs have proven as
much a failure in the US and UK as in Australia, it is
recommended that mandatory reporting schemes be
introduced. Claims that this would compromise confidential
business information or constitute an unconscionable financial
or administrative burden seem unreasonable when balanced
against the public health and environmental risks associated
with particular nanoparticles (such as, for example, carbon
nanotubes and nanosilver).
One proposal for encouraging public participation in
nanotechnology safety issues would be to run a pilot scheme
whereby members of the public could notify NICNAS, the
TGA or APVMA and if fulfilling certain on-line criteria
(including a means test) would have an application for safety
evaluation considered by a committee to be performed by the
NMI. Such a scheme would send a signal that regulators were
serios about nanoparticle safety and about wishing to
encourage community engagement. It would alos act as an
indirect prompt to nanoparticle manufacturers to comply with
voluntary and mandatory notification schemes.
D. Encouraging research and collaborations
The Australian Academy of Science in its report on
Nanotechnology in Australia has recommended that the
Australian Government produce a National Strategic Plan for
Nanotechnology in consultation with the research community
from universities, government research organisations and the
Australian industry/business sector. This would include long-
term funding for a network fostering collaborations, funding
for infrastructure and equipment, as well as funding for
‘market-driven, problems-based” research and a
nanotechnology entrepreneurial fellowship scheme. [23]
Central to to creation of such collaborations must be the
Australian Research Council Nanotechnology Network
(ARCNN) and its capacity to host the biennial ICONN
conference. The later is a critical event in terms of fostering
research collaborations amongst emerging and established
Australian nanotechnology reserachers and emininent
international researchers invited as guest speakers and
participants.
IV. CONCLUSIONS
Australia is on track particularly through its involvement in
the OECD WPMN to assist in the creation of sound data on
which regulatory standards can be based. In the meantime
regulators are likely to be faced with an Australian public
which is increasingly pressing for precautionary regulation on
the basis that the existing regulatory approach in many
agencies (of accepting a nano-version is safe if that has been
the history of its bulk equivalent) is prone to too many Type II
errors (assuming a product is safe when it is not). This will
require a search for suitable precautionary policies that do not
stifle innovation and investment in this sector.[24]
One proposal that would send a signal to the public,
researchers and industry that the federal government is serious
about ensuring the long-term safety of the nanotechnology
industry in Australia, as well as encouraging industry
investment in nanotechnology, would be to commission a
feasibility study for the establishment of a National Testing
Laboratory for Enabling Technologies. Such a laboratory
could become a centre of toxicological and fundamental
research excellence that might attract and train some of the
best science students graduating from our universities.
[9] Missoni E and Foffani G, “Nanotechnologies and challenges for Global
Health,” Studies in Ethics, Law and Technology, vol 3(3), pp.1-16,
2009.
[10] Food Standards Australia New Zealand Act 1991 (Cth).
[11] Industrial Chemicals (Notification and Assessment) Act 1989 (Cth).
[12] Therapeutic Goods Act 1989 (Cth).

[13] Agricultural and Veterinary Chemicals (Code) Act 1994 (Cth);

TABLE I. CHALLENGES FOR AUSTRALIAN NANOREGULATION Agricultural and Veterinary Chemicals Administration Act 1992 (Cth).

Challenges for Australian Nanoregulation [14] Faunce TA, “Toxicological and public good considerations for the
Priority regulation of nanomaterial-containing medical products,” Expert Opinion in
Type of challenge Present Future Drug Safety, vol7(2), pp.103-106, 2008.
1 Definition of nanoparticles Yes
[15] Safe Work Australia. Engineered Nanomaterials: Evidence on the
2 Mandatory reporting Yes Effectiveness of Workplace Controls to Prevent Exposure, Canberra: Cth of
Australia, 209, pp1-4.
3 Labelling Yes
[16] Food Standards Australia and New Zealand. Small Particles,
Precautionary strategies Nanotechnology and Food.Available from:
4 Yes
including control banding
http://www.foodstandards.gov.au/newsroom/factsheetsfactsheets2008/smallpa
5 OH & S standards Yes rticles nanote3923.cfm. Accessed on October 02 2009.
National Testing Laboratory [17] Faunce TA. Safety of nanoparticles in sunscreens. Medical Journal of
6 Yes
For Enabling Technologies Australia, vol 190 (8), p.463, 2009.
7 Public-initiated MNI tests Yes
[18] Australian Government. Dept. of Health and Ageing. National Enabling
) Technologies Strategy.

http://www.innovation.gov.au/Industry/Nanotechnology/Pages/NETShomepa
ACKNOWLEDGMENT ge.aspx Accessed 4 March 2010.

The author is supported by an Australian Research Council [19] National Industrial Chemical Notification and Assessment Scheme. .
(ARC) Future Fellowship. The ARC was not involved in Nanotechnology-Stakeholder Consultation. Dept, Health And Ageing
http://www.nicnas.gov.au/Current_Issues/Nanotechnology/Stakeholder_Cons
writing this paper. ultation.asp Accessed 10 March 2010.

[20] National Nanotechnology Strategy Taskforce. Options for a National

REFERENCES Nanotechnology Strategy – Report to Minister Industry, Tourism and
[1] A.D. Maynard, R.J. Aitken, T. Butz, V. Colvin, K. Donaldson, G. Resources. 32. (2006)
Oberdörster, M.A. Philbert, J.Ryan, A. Seaton, V. Stone, S.S. Tinkle, L.
Tran, N.J. Walker & D.B. Warheit, “Safe handling of nanotechnology,” [21] Dreher KL, “Health and environmental impact of nanotechnology:
Nature, vol 444, pp. 267-269, 2006. toxicological assessment of manufactured nanoparticles,” Toxicol. Sci. vol 77,
[2] OECD Environment Directorate. Joint Meeting of the Chemicals pp. 3–5, 2004.
Committee and the Working Party on Chemicals, Pesticies and [22] Faunce TA, White J, Matthaei K, “Integrated research into the
Biotechnology. No.20. Current Development/Activities on the Safety of nanoparticle-proteincCorona. Nanomedicine, vol 3 (6) pp. 859-865, 2008..
Manufactured Nanomaterials ENV/JM/MONO(2010)4.
[3] International Standards Organisation ISO/TS 27687:2008 (2008). [22] Murashov V, Engel S, Savolaninen K, Fullam B, Lee M and Kearns P,
[4] International Standards Organisation. ISO/TR 12885:2008 (2008) “Occupational safety and health in nanotechnology and Organisation for
Economic Cooperation and development,” J Nanopart. Res., vol 11, pp.1587-
[5] ResponsibleNanoCode (2008). Information on the Responsible 1591, 2009.
NanoCode Initiative, available at:
http:/www.responsiblenanocode.org/documents/InformationTheRespons [23] Australian Academy of Science. Nanotechnology in Australia. Trends,
ibleNanoCode.pdf. Applications and Collaborative Opportunities, Canberra, Australian Academy
[6] Salamanca-Buentello F et al, “Nanotechnology and the Developing of Science, 2009.
World,”. PLOS Medicine, vol 2(5), pp.383-386, 2005.
[24]Fairbrother A and Fairbrother JR, “Are environmental regulations keeping
[7] United Nations, “Millennium Development Goals”
up with innovation? A case study of the nanotechnology industry,”
http://www.un.org/millenniumgoals/ accessed 8 Feb 2010.
Ecotoxicology and Env. Safety, vol 72, pp.1327-1330, 2009.
[8] Invernizzi N et al, “Nanotechnology’s controversial role for the south,”
Science, Technology and Society , vol 33,pp.123-148, 2008.