Design/construction of an arsenic biosensor and implementing a comprehensive water testing programme involves a complex mix of social, political, geographic and science/engineering issues. Therefore RR&I frameworks the development of the bacterial arsenic biosensor and requires the engagement of a variety of stakeholders to build an effective network of individuals representing biological research, engineering, social science, business, government, NGOs and affected populations. The resulting network provides support and guidance for the implementing the use, social acceptance, distribution, regulation, manufacturing and engineering of an effective arsenic biosensor.

Stakeholder Engagement for RR&I

Stakeholder engagement is an essential element for the arsenic biosensor development. This aspect of the project includes a broad range of individuals and organisations from both here in the UK/Europe as well as in the major affected regions such Nepal. As noted above, our involvement in Nepal finds its roots in a meeting organised by Dr Grimshaw in Kathmandu in 2009. Dr Grimshaw’s contacts in Nepal include Dr Suman Shakya the Director of ENPHO and we were able to arrange for Dr Shakya to come to Cambridge for initial discussions in December 2013. This meeting greatly facilitated our subsequent visit to Nepal.

Our team (except Chris French and Jim Haseloff) visited Nepal between 4 and 14 February 2013 for the purposes of meeting with stakeholders and collecting water samples from the field. The time of the visit was delayed from our original target date due to risk and uncertainty prevalent in Nepal after the failure of the Government to agree a constitution.

After talking with Dr Shakya it became clear that ENPHO not only had suitable laboratory facilities in Kathmandu but also were engaged in development projects in Nawalparasi District where JICA were funding interventions on local capacity building for arsenic mitigation. At this point, given that Dr Grimshaw no longer works for Practical Action it was decided to work with the local communities in the Terai that ENPHO were already engaged with. This would ensure on-going access to key people in the communities and lay the foundations for later testing of prototype sensors.

In Nawalparasi District we visited the ENPHO field office to talk with staff and then visited four villages: Unwach, Kunawar, Pachgaun and Kirtipur. All these villages were known to have levels of arsenic in the drinking water in excess of safe limits. The team collected water samples from tube wells in accordance with our declared milestone. We also collected samples from Kanchan filters in order to help understand the biofilm conditions. Dung samples were also collected to determine arsenic levels.

In Kathmandu we met with UNICEF, DWSS, RWSS, ENPHO, Practical Action, the National Agriculture Research Centre and scientists from Kathmandu University, including Dr Sanjay Khanal. With each of these stakeholders we explained our project and then listened for feedback. Each organization is keen to be helpful and be involved where it could make a positive contribution. Since returning to the UK we have also had preliminary conversations with Water Aid Nepal.

Stakeholder needs are diverse but there is agreement on a number of key issues. The price of the device needs to be low, so our target price is suitable. The device needs to be simple to operate, so that local community workers can administer the test with appropriate training. Concerns over colour displays in the sensor were largely overcome by our design idea to have green for OK and shades of indigo for progressively higher concentrations of arsenic set against a numeric scale. One issue that was raised when discussing the need for water testing was the need for coliform bacteria testing. ENPHO, the distributors of the coliform test thought that it might be a good idea to include a coliform test strip with our biosensor so it would provide two tests for each water sample (in Nepal there are ten times more coliform test kits than arsenic kits).

Legal and Regulatory RR&I

At this point, we cannot use the arsenic biosensor in the field within the EU because the legal and regulatory framework has not been tested for this kind of product. In the spirit of Responsible Research and Innovation, we believe that a biosensor that might be used in Nepal, Bangladesh, India or other affected region should be subject to the conditions for use in the UK and the EU. Therefore, in our discussions with the appropriate government agencies in Nepal, India and Bangladesh for approval to use the device for well-testing in affected regions, we will make our position clear by having already started the process of seeking EU approval for field use of the arsenic biosensor.

We are seeking approval for the field use of the arsenic biosensor to be considered as a contained use of a genetically modified micro-organism under EU Directive 2009/41/EC. We have been working with DEFRA and the HSE in pursuing this approach. With their guidance we have submitted a risk assessment document to the Scientific Advisory Committee on Genetic Modification. With the approval by this Advisory Committee, the risk assessment will be forwarded to the EU for consideration.