Biomedical Engineering Reference
In-Depth Information
public'
228
on the implications of the CSIRO-designated 'emerging science' of
nanotechnology.
227
The second goal focused on exploring ways of integrating a
broader range of perspectives on science and technology into research planning
and assessment within CSIRO.
227
In this paper, the interested public consisted of
not only scientific 'experts' but also 'lay unrecognized experts' including gov-
ernment, non-government, industry and community-based groups, plus general
community members. This was to foster strategies and approaches that enable to
bridge knowledge divides and to find common ground across conflicting values
that may exist within a broadly-conceived 'public'. To date, these approaches
have not led to successful comprehensive regulation to oversee research and the
commercial application of nanotechnologies or to proper labeling of products that
contain NMs or are derived from nanotechnologies.
229
Various regulatory bodies such as the United States Environmental Protec-
tion Agency (US EPA), the Food and Drug Administration (US FDA) and the
Health and Consumer Protection Directorate of the European Commission have
initiated action regarding the potential risks from NMs. These regulatory bodies
have concluded that NPs form the potential for an entirely new risk and that it is
necessary to carry out an extensive analysis of the risk.
The challenge for regulation is whether a standard system of evaluating the risk
to NMs can be developed to identify NMs and their formulations' toxicological
properties or if it is more likely to test each particle or formulation separately. To
date, engineered NMs and the products or materials that contain them are not sub-
ject to any special regulation during production, handling, or labeling. Currently,
there is no authorized body to regulate nanotech-based products, there are also no
nanotoxicity standards to follow, and no toxicity regulations in place to enforce.
Most laboratories conducting nanotechnology-related studies perform their own
toxicity assessments but even the existing cytotoxicity tests that are standardized
for materials in bulk but not for NMs may fail and result in conflicting data.
52
Thus, it is urgently needed to develop standardized methods of assessing short-
and long-term effects of NMs on cells, tissues, organs, and whole organisms.
There are non-nanotechnology specific regulatory agencies that cover some
products and processes under existing regulations but there are insufficient reg-
ulations of the NMs which enable some nano-enabled products to be released
without coverage by any regulations. This is particularly the case for titanium
dioxide (TiO
2
) that are used in sunscreen. The US FDA reviewed the immedi-
ate health effects of exposure but did not review its impacts for aquatic eco-
systems when the sunscreen rubs off, nor did the EPA, or any other agency.
225
In similar context, the Australian Therapeutic Goods Administration (TGA)
230
approved the use of NPs in sunscreens (without inclusion in the package label)
on the basis that although NMs TiO
2
and zinc oxide (ZnO) produce free radi-
cals and oxidative DNA damage in vitro, these were unlikely to pass into the
stratum corneum of human skin. This decision was short sighted because it did
not consider prolonged use especially on children with cut skin, the elderly with
thin skin, people with diseased skin or use over other skin imperfections.
231
