Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

Following a workshop meeting among the partners, they decided to develop a "voluntary Code of Conduct for businesses engaged in nanotechnology."  That workshop resulted in this report.  As a follow-up, the Responsible Nano Code began working on the details of the Code.  On December 9. 2007, the members agreed on the the preliminary Seven Principles and accompanying Examples.  On May 13, 2008, the members met to consider the final version, who's release we are awaiting (although early returns are discussed here).

The Seven Principles, broadly speaking are:

• Principle 1 – Board Accountability: "Each Organisation should ensure that responsibility for guiding and managing its involvement with nanotechnologies resides with the Board or governing body"
• Principle 2 – Stakeholder Involvement: "Each Organisation should proactively engage with its stakeholders and be responsive to their views in its development or use of products using nanotechnologies"
• Principle 3 – Worker Health and Safety: "Each Organisation should identify and minimise sources of risk for workers handling products using nanotechnologies, at all stages in the production process or in industrial use, to ensure high standards of occupational health and safety"
• Principle 4 – Public Health, Safety and Environmental Risks: "Each Organisation should carry out thorough risk assessments and minimise any potential public health, safety and environmental risks relating to its products using nanotechnologies"
• Principle 5 – Social and Ethical Implications and Impacts: "Each Organisation should consider and respond to any social and ethical implications and impacts in the development or sale of products using nanotechnologies" 
• Principle 6 – Responsible Sales and Marketing: "Each Organisation should adopt responsible practice in the sales and marketing of products using nanotechnologies"
• Principle 7 – Engagement with Suppliers: "Each Organisation should engage with suppliers and/or business partners to encourage and stimulate their adoption of the Code and so assure its own ability to fulfil its Code commitments"

Notably, the Code is a principles based agreement, rather than a standards based agreement, and "would be developed through a process of engagement between a representative group of businesses from various stages of different supply chains and a wide range of stakeholders, including NGOs, government and consumer groups."  Also, remember that this is a voluntary set of principles, much like the Nano Risk Framework. 

Clearly more and more stakeholders are beginning to take their fate into their own hands, rather than wait for government to step in.  This kind of responsible development of industry standards will only make the transition to a regulatory framework easier when and if that occurs.  In addition, this process also helps educate stakeholders as to the important issues in order to have a voice in the regulatory debate.  The problem, though, that develops is the diverging standards that are created through independent working groups.  While a hurdle to overcome, it is not fatal to the efforts, and those efforts still result in much good.

The report distinguishes insoluble and biopersistent nanoparticles and those which are soluble and/or biodegradable.  The SCCP is primarily concerned with the uptake method of the nanomaterials, as they are applied directly to the skin in a cosmetic context. 

The report states that "At present, there is inadequate information on: i) hazard identification, ii) exposure assessment, iii) uptake (including physiologically normal and compromised human skin), iv) the role of physico-chemical parameters of nanoparticles determining absorption and
transport across membranes in the gut and lungs, v) the role of physico-chemical parameters of nanoparticles in systemic circulation determining biokinetics and accumulation in secondary target organs, vi) possible health effects (including susceptible individuals), vii) translocation of nanoparticles via the placenta to the fetus."

The SCCP concludes that the primary risk is associated with those nanoparticles that are insoluble, and that current risk assessment methodologies may not be adequate.  It does state that current risk assessments may be adequate for the soluble form of nanoparticles.

The question of risk assessment is coming more and more to the forefront, both in Europe and in the United States.  The key question to nanotechnology regulation hinges on the amount of information we have in order to set reasonable regulations, and this is the first study I've seen that attempts to draw the line between different types of nanomaterials suggesting that the type matters.  Should this be the case, it seems entirely appropriate that different risk assessment methods be used to quantify the risk posed by each.