Conclusions - Nanomaterials for Medical Applications - page 423

Some NMs have been demonstrated to possess health and environmental
hazards . 12,24,33,44,55,118,134,144,146,185,186,188,201,202,224,242,246,247,323,330,
336,337,419,420,423,424,428,429 Hence, there is a need for NM hazard identification pro-
cess. But, the process for such identification is not yet in place therefore, a case by
case approach is still the only approach available for the risk assessment of NMs.
9.10 GOVERNMENT NANOTOXICITY REGULATIONS
In as much as NMs can bring enormous benefits to medicine, various govern-
ments have also become more aware of the possible dangers of exposure to
NMs that are found in various consumer products. 74,376 This awareness has led
to the creation or drafting of various regulatory guidelines worldwide. This has
also led to the awareness for the need to properly establish the various properties
and toxicity profiles of NMs as essential conditions for the evaluation of pos-
sible effects on health and environmental safety.
To date, knowledge on the presence of NMs in any commercial package rely
only on the information provided by the manufacturers. There is still no set-
standard in detecting or quantifying the presence of NMs that are shipped from
one place to another or from one country to another. In addition, the detection of
NMs that are added as components of consumer products suffers from the dif-
ficulty in discriminating between the background signals and added NMs. This is
also complicated by the coating proteins and other biomolecules on NMs that are
exposed to biological matrix. In addition, exposure estimation is also hampered by
lack of information on product use and use of multiple products containing NMs.
Different regulatory bodies such as the United States Environmental Pro-
tection 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. 74 The challenge
for regulation is whether a standard system of evaluating the risk to NMs can
be developed to identify NMs and the toxicity of their formulations. 229 Cur-
rently, there is no authorized body to regulate nanotech-based products and
there are also no nanotoxicity standards to follow or toxicity regulations in place
to enforce. 430 There are non-nanotechnology specific regulatory agencies that
cover some products and processes under existing regulations which are insuf-
ficient for the regulation of NMs and nano-enabled products. 431-434 An example
is titanium dioxide (TiO 2 ) that is used in sunscreen. The US FDA reviewed the
immediate health effects of exposure to this NM but did not review its impacts
for aquatic ecosystems when the sunscreen rubs off, nor did the EPA, or any
other agency. 435-438 Similarly, the Australian Therapeutic Goods Administra-
tion (TGA) approved the use of nanoparticles in sunscreens (without imposing
its inclusion in the package label). Short sighted decision of this type do not
consider prolonged use that may or may not be appropriate at this point in time
because of our lack of knowledge about the long term impacts of NMs to the
environment and to biological systems.