To gain public trust, nanotechnology needs a
regulatory framework – but before this can be happen we need to know one thing
– just what is a nanomaterial? Jeremy Warren tells us about a definition that
could ease the legislative deadlock
Since
first citations of the term “Nanotechnology”, scientific, industrial, public
and political stakeholders have called for a robust regulatory framework to
address the potential toxicological concerns surrounding these exciting new
materials. It is the promise of novel and useful properties from nano sizes of
familiar materials that prompts a reappraisal of our knowledge of their
potential toxicology and environmental impact. These are effectively new
materials.
The
argument goes that, without public and political confidence, this new science
risks fear and distrust, rather than being embraced as providing a multitude of
solutions to challenges in the fields green energy, world food production or pharmaceutical
advancement, to name but a few
In
October 2011 the EU Commission published a recommended definition of
Nanomaterials1. This definition is not the complete framework, but it is a
significant step towards it. Observers of embryonic nanotechnology regulation
recognised this definition as the missing jigsaw piece in planned legislation
and subsequently witnessed the French government largely adopting the
definition’s wording and getting draft legislation on compulsory labelling of
Nanomaterials out for consultation in less than three months.
Meanwhile
other stakeholders in fields including nanomaterial manufacture and workplace
exposure, handling, labelling, transportation and environmental fate now find
they have an authoritative definition to slot into nascent regulation.
The key
points of the definition are these:
1) It is a Nanomaterial if any of these three
criteria are met:
a) At least 50% of the particles by count
have one dimension external between 1 and 100nm.
b) The material has a surface area greater
than 60m2/cm3.
c) The substance appears on an “include” list
that captures materials such as graphene, which would otherwise fall outside
the definition.
2) The definition includes
naturally-occurring as well as manufactured and incidentally manufactured
particles.
3) There are no specific recommendations on
characterisation methods to meet these specifications.
4) The definition is a recommendation, not a
regulation; however its provenance bestows authority.
Despite
protracted and energetic attempts by SCENIHR (the Scientific Committee on
Emerging and Newly Identified Health Risks, part of the Directorate General for
Health and Consumers) to draw stakeholders into consultation, much of industry
and the scientific community appear taken by surprise here.
One can
sympathise with the compliance officers in, for example, tyre manufacture or
cement production, which suddenly find themselves within the nanotechnology
industry.
Sympathize
one might, but now a period of reflection is required to understand the
scientific logic that generated this definition.
Reading
back through SCENIHR’s publication, Scientific Basis for the Definition of the
Term “Nanomaterial”,they describe in depth the reasoning behind the definition.
SCENIHR exhaustively discuss the possible measures and their benefits, and make
clear the large areas of ambiguity and difficulty in these judgments. Then,
with some moral courage, they draft this definition, and in so doing take a
step forward in supplying the urgent need for regulation.
The
100nm upper limit is essentially historic, coming from original definitions in
nanotechnology. It was arbitrary then, and is so now, but it is a starting
point. Given this definition is specific
to regulation, these numbers have to be precise to be enforceable. Specifying
count rather than weight per cent recognises that chemical reactivity increases
per mass dose for smaller particles. Parameters more closely relating to potential
toxicity are missing – these are likely to follow on from this initial
size-based definition.
Regarding
the lack of recommended characterisation methodologies, one need look no
further than diesel combustion emissions or the water industry for precedents,
where regulatory need sets scientists a measurement challenge – and maybe that
is the right way to drive development of practical measurement methodologies?
Let me
clearly state my interest here – NanoSight’s NTA (Nanoparticle Tracking
Analysis) is at least a partial solution to the nanoparticle counting
requirement, and in combination with occasional electron microscopy to inform
the bottom end of the 1 – 100nm range, we have a practical,
readily-implementable solution.
As the
dust settles following the initial publication, reflect on the significant
positive drivers from industry in support of legislation. Big business surely
seeks to see nanotechnology de-risked? Potential adverse public reaction hangs
over nanotechnology, limiting investment and curbing strategic intent. More
cynically perhaps, big business deals better with regulation than SMEs; here is
a barrier to entry that will ultimately lead to profitability in this sector.
To
conclude, we welcome this definition as a starting point to deliver regulation
on potential toxicity. There is much research work to be done, and having this
definition, this building block in place, will surely enable government
investment in research to go the next steps, from simple physical parameters to
the far more complex challenges of bioavailability and biointeraction at the
heart of toxicology.
If
industry and regulators can get this right, then far from labeling “contains
nanomaterial” being in the smallest permissible font, we might see “Contains
Nano” in a bright splash of colour, implying progressiveness, advanced and
useful technology, and above all,
trustworthiness.
Reference:
1.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:275:0038:0040:EN:PDF
Kerry
Taylor Smith
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