Nanotechnology safety

The NIA is actively promoting nanotechnology safety across all areas of R&D, manufacture and commercialisation; the NIA's activities include:

 

Responsible evaluation of existing and new nanotechnologies

An industry-based perspective will be created to establish collective views on existing nomenclature, threats and opportunities associated with control-banding and risk-classification systems; it will be explored how existing hazard and risk assessment procedures are applicable to nanotechnologies.

 

Proposed Ideal Regulatory System

Oxonica, one of the founding NIA corporate members, has developed a document on the Proposed Ideal Regulatory System for nanoscale materials. The proposal is based on the safety and risk assessment of nanomaterials, initiated by Howard and de Jong in 2004, and later on modified and reported in Technological Analysis (VDI, Düsseldorf, August 2004; i.e. the final report of the EC-funded Project Nanosafe, Contract Number CT-2002-00020).

Central to the Proposed Ideal Regulatory System is a Proforma Scheme for a Preliminary Risk Assessment of Nanoparticulate Materials, illustrated in the figure below.

(Proforma Scheme for a Preliminary Risk Assessment of Nanoparticluate Materials; source: OXONICA Proposed Ideal Regulatory System; adapted from Howard and Jong, 2004; click here for an enlarged version of the diagram.)

 

 

Control-Banding of nanotechnology-enabled products

In collaboration with its members, the NIA has developed NanoSURE™ a novel control-banding scheme for the precautionary assessment of nanotechnology-enabled products.

NanoSURE™. is based on a risk assessment protocol, which enhances current procedures in identifying hazards and mitigation strategies.

Dr Peter Arnold, Group Director Technology at Smith & Nephew, describes the creation and basic outline of the NanoSURE™ Control-Banding scheme in a report entitled Nano - Making the benefits to mankind safe (click here to download the full PDF-version).

Introduction

Recently (25 January 2007), a thorough review by the European Group on Ethics in Science and New Technologies reached the conclusion to focus work on new measures to verify safety, but NOT to provide new regulatory structures. This approach places responsibility for safety at the door of industry, and it seems to me, that industry has most to lose by getting this wrong.

In 2005 and 2006, I was asked to ‘help on safety’ of human tissue engineered products (hTEPs), for which stem cells are considered the panacea, and subsequently to provide some input on nanotechnologies. As a result I gathered together a group of internationally acclaimed scientists who work in these fields to explore the ‘dimensions of risk’ relating to these two areas. It seemed to us that it was extremely challenging to examine the elements that could combine to produce potential risk to the public in a single dimension, but that there were many significant dimensions of risk for each technology; and on examining each technology, a unique profile of potential risks could be developed. We also concluded that each profile would command an individual profile of mitigation steps to be taken to minimise the potential for harm/impact of associated risk. Unfortunately, such an approach does not lend itself to formulaic regulation policies.  Fortunately, through our work together, we were able to prioritise and limit the number of dimensions to those that were considered most important in terms of potential risks to human health and/or the environment, and to come up with a systematic way to categorise the mitigation steps necessary to minimise the potential for harm/impact.

NANOSURE™ for Nanotechnologies

For nanotechnologies, we felt that there were six dimensions of risk that need to be incorporated into an evaluation of a new product.

1. The environmental toxicity and persistence (Material could be degraded rapidly or slowly [the products intended life cycle needs to be taken into account])
2. Human toxicity (Material could be total non-toxic  through all routes of exposure, or conversely be highly toxic, a teratogen and possibly transmissible)
3. Human exposure (Material might be used in a highly controlled treatment, or used in consumer or environmental quantities)
4. In-vivo bio persistence (Material may accumulate and not be removed from body, organism, or organelles)
5. Auto activity (Material may have no means of self recognition or environmental awareness, or may activate on response to, and in order to change, the environment)
6. Mobility (Material may be permanently immobilized, it may become free as a result of intended use, designed to be free for purpose, transmissible, uncontrollable, and possibly even self propelling)

An example of one of the dimensions for Nanotechnologies taken from the NANOSURE™ system is depicted below. Each technology can be considered against a guiding set of inclusion criteria for each of the six defined dimensions. The potential elements capable of combining to give rise to potential risks and an associated score can then be assigned (as shown with some colour coded symbols by way of example here).

(click here for an enlarged version of the graph)

Each of these ‘dimensions of risk’ can then be individually used to score the combined risk profile for individual nanotechnologies, and the final stage in the process is the identification and prioritisation of the consequential  mitigation steps required in order to minimise the potential for harm/impact of associated risk that should be performed.

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