“Safe by design” approach: a new Eldorado?

“Safe by design” approach: a new Eldorado?

What is the “safe by design” approach?

The “safe by design” approach aims to minimize the risks of nanomaterials from their conception, by modifying:

• their size or structure (via the formation of aggregates or agglomerates that bind the nanoparticles together), for example, to prevent the passage of titanium dioxide nanoparticles into the skin for sun creams.
  
• and/or their surface – for example, by coating or encapsulating the nanoparticles – in order to minimize and stabilize their potential reactivity (and therefore their toxicity) during the entire life cycle of the nanoproduct.

Initially promoted by American scientists¹Beyond implications and Applications: the Story of ‘Safety by Design’, Nanoethics, 2009, 3(2): 79-96., it has gained the favor of European authorities (notably the Joint Research Centre²Impact of Engineered Nanomaterials on Health – Considerations for Benefit-Risk Assessment, EASAC & JRC, Sept. 2011, and the European Commission³Work program 2013, Theme 4, Nanosciences, nanotechnologies, materials and new production technologies – NMP, July 2012), and of French organizations such as the Centre d’analyse stratégique⁴See the 5th recommendation of the Note d’analyse 248 – Pour un dévelopement responsable des nanotechnologies of the Centre d’analyse stratégique, November 2011 or the Académie des Technologies⁵See Risques des nanoparticules manufacturées, Académie des Technologies, April 2012 who all played a role in the development of this approach.

Before the marketing success of this Anglo-Saxon designation, there was already an older incentive from the European Union in favor of clean processes, or from INRS in France, for example, which has long promoted “risk prevention from the design stage”⁶Medium term plan, 2003-2007, INRS..

Is the “safe by design” approach the solution to all ills?

An alternative to nano risk assessment?

The “safe by design” approach is presented as an alternative to nano risk assessment as it has been done until now: insufficiently organized, confronted with methodological difficulties, it has led to results that are difficult to use, concerning insufficiently characterized nanomaterials⁷Approximately 80% of nanotoxicology studies prior to 2007 did not sufficiently describe the different characteristics of the nanoparticles studied: Cf. “Il faut définir ce qu’est une nanoparticule” (We must define what a nanoparticle is), Interview with Eric Gaffet, Director of Research at the CNRS, Santé & Travail, n° 071 – July 2010 and without necessarily knowing whether they were present in products actually marketed.

A costly case-by-case approach

The “safe by design” approach is also presented as a more powerful solution than the “case by case” approach widely advocated by the scientific community to health and environmental agencies in recent years⁸Justified by the concern to take into account the particularities of each nanomaterial, this “case-by-case” approach proposes to better take into account:
– the different physico-chemical characteristics of nanoparticles (size, shape, structure, charge state, degree of agglomeration, composition, solubility, etc.) which play a determining role in their toxicity and eco-toxicity
– the conditions under which nanoparticles are synthesized, stored, possibly coated, and then integrated into a product and which influence their characteristics and therefore also their toxicity and eco-toxicity. However, some scientists now critizise it as being too costly, too time-consuming and potentially never-ending.

The promoters of the “safe-by-design” approach argue that by modifying the way nanoparticles are synthesized, coated and then integrated into a product, it will be possible to develop nanomaterials whose physicochemical characteristics will make them safe from a health and environmental point of view.

An approach largely supported by public funding

A reassuring argument… which explains why the application of the “safe by design” approach to nanotechnologies and nanomaterials is supported by public funding.

Many remaining scientific challenges

We should not be overly optimistic: the “safe by design” approach will not be free of scientific and technical difficulties¹⁴François Tardif of the CEA considered in November 2011 that “it will still take years to identify benign nanoparticles, See: Safety of Nanomaterials, Exposure Reduction State of the art and developmentsFrançois Tardif, presentation at the day “Regards sur les nanotechnologies: enjeux, débats, perspectives”, Institut de Maîtrise des Risques, 18 October 2011. A few months earlier, U.S. scientists insisted that the nanomaterials being developed and coming will be far more complex than today’s nanoparticles and present challenges that will keep toxicologists busy for the next fifty years, See: The new toxicology of sophisticated materials: nanotoxicology and beyond, Maynard AD, Warheit DB, Philbert MA, Toxicol Sci, 2011.

The “safe(r) by design” approach will not be able to control everything, especially because many factors are beyond the control of researchers and engineers:

• First, the conditions under which nanomaterials are used and second, their release, the transformations that they can undergo in the environment or in the body, etc.¹⁵In order to be able to design “safe” nanomaterials, the Serenade labex claims to want “to understand the mechanisms of interactions between inert matter (nanoparticles) and living matter (cells up to the level of chromosomes and DNA) “Labex SERENADE 2012, “Towards a design of innovative, sustainable and safe nanomaterials”, presentation of the Ministry of Research. This is indeed one of the aspects that has been least studied to date and about which much is currently unknown (particularly in terms of release as well as on the transformation and behavior of nanomaterials in the environment and in the organism), although this is essential to know if we want to minimize the risks. It requires the development of experimental approaches that reproduce more realistic exposure conditions than those that have been commonly used.
  
• Moreover, by “isolating” or modifying nanomaterials, it is indeed difficult not to lose the advantages of their specificities at the same time.

Yet, paradoxically, the extremely ambitious objectives pursued are presented with an assurance and fervor (candor?) that minimize the complexity of the task. The following questions arise: Can the challenges be met – both technically and financially – within a reasonable time frame? When will the projects currently being deployed bear fruit? And with what guarantees as to the real safety of the nanomaterials developed? Isn’t the idea that we can totally control risks through flawless design an illusion?

These are all important questions. In the meantime, nanoproducts continue to be marketed, with no further information on their risks or safety.

Besides technological questions, political issues and choices

These political questions, which have given rise to strong controversies in the case of GMOs, are still rarely discussed in the case of nanotechnologies. However, they are important issues: in particular, there is the question of the distribution of public funding between the different fields of research and the objectives pursued (toxicology, eco-toxicology, environmental health and occupational health on the one hand, and innovation and competitiveness on the other), and the one of the financing methods for research projects on the safety of nanomaterials.

Finally, as William Dab wrote in late 2013, “it is very difficult, if not impossible, to demonstrate the non-existence of a hazard. It is much more difficult, in fact, than proving its existence. This is a very disturbing situation that leaves room for speculation and confrontation, often underpinned by struggles between conflicting interests. (…) safety cannot, in all rigor, be demonstrated. (…) science does not have the answer to everything. Therefore, uncertainties should not be hidden, but on the contrary, put at the center of the “scientific democracy”, one might say. This means debating what is and is not a risk, what is a risk worth taking “¹⁶Can we demonstrate the nonexistence of a hazard?, William Dab, Of Risks and Men, December 9, 2013 . .