John Balbus, M.D., M.P.H., is Chief Health Scientist.

Some 216 delegates representing 26 countries converged on the largest city in China last week for the 7^th meeting of the International Standards Organization (ISO) Technical Committee (TC 229) on Nanotechnologies.

In China, the turtle symbolizes cosmic order, strength, endurance and wisdom.  In the US, the turtle has come to symbolize slow progress and not keeping up with the times.  Which representation better captures what's going on in ISO's TC 229?   Maybe a little of both.

ISO is an international voluntary standard-setting organization comprised of national delegations (each country has one vote) that are dominated by government and industry interests.  Most of ISO's work is devoted to harmonizing and standardizing industrial processes and products to facilitate commerce and global trade.  But a significant portion entails the development of environmental, health and safety (EHS) standards, like the ISO 14000 series.  For better or worse, these standards tend to emphasize implementing corporate management systems and procedures over achieving specific measureable results. 

There are three levels of documents that come out of ISO.  The first is a technical report, which does not carry the force of a standard or require broad consensus, making it the easiest to adopt.  Next is a technical specification, which again is short of a standard but represents a stronger consensus of the countries participating.  Getting a full standard passed is the hardest and usually takes years.

Countries are starting to put forward a number of documents addressing EHS for nanotechnology.  But given the early state of the science, most of these documents are technical reports or technical specifications.  The expectation is that it will take a few years for the science and practice to evolve to the point where developing full standards will be practical.  In the meantime, technical reports and technical specifications can provide useful guidance now, and potentially serve as the basis for standards development later. 

It's all pretty bureaucratic, but ISO is one of very few ways to influence corporate behavior on a global basis.

As I reported in my last post, the US delegation brought to ISO a proposal to use the EDF-DuPont Nano Risk Framework (NRF) as a basis for an ISO Technical Report.  The Shanghai meeting marked the first international discussion of this proposal.  Former EDF staffer (now consultant) Scott Walsh and I went to Shanghai as US experts on the project group for this document.

The Nanomaterial Risk Evaluation Framework (NMREF), as the ISO version is provisionally titled, was generally well-received by the international delegates.  While some concerns were raised about how OECD guidelines and the European Union's REACH Regulation might conflict with elements of the starting document, there was no opposition to some of the most important elements of the Framework, such as taking a lifecycle approach, information-driven decision-making, and emphasis on transparency.  And the mood for moving forward was very positive.

There are other projects underway within the EHS workgroup.  These range from detailed testing methods to general guidelines for workplace handling of nanomaterials.   In addition, the committee created a new group on nanotechnology and sustainability.  And the groups working on material specifications are including guidelines for incorporating EHS information in every specification.

Is ISO the global key to ensuring safe development of nanomaterials?  Probably not.  For starters, all ISO standards are voluntary — they don't carry the force of law.  Ensuring that all nanomaterials are carefully assessed and that all companies take the necessary precautions to limit uses and releases of potentially harmful materials will require sound regulations. 

But there are a couple of reasons to ride the turtle for now.  First, there are enormous gaps in regulatory frameworks in most if not all countries.  Until those gaps are filled, many companies will look to ISO documents for operational guidance.  And second, as countries around the world decide how to adapt or extend current regulations to the special case of nanomaterials, ISO will play a role in validating and disseminating concepts to be used in the development of regulations.

So while the turtle moves slowly, it has set out on its way, and we're doing what we can to make sure it gets steered in the right direction.

John Balbus, M.D., M.P.H., is Chief Health Scientist.

At its most recent meeting a few weeks ago, the US Technical Advisory Group (TAG) to the International Standards Organization (ISO) Technical Committee on Nanotechnologies approved a motion to have ISO develop a Technical Report based on the EDF-Dupont Nano Risk Framework (NRF). Or to put it another way in acronym-laden Washington-speak, the US TAG to the ANSI-accredited ISO TC229 approved a TR based on the EDF-DD NRF. 

The motion to submit the NRF as the basis for this ISO technical report did not come from either EDF or Dupont. Other members of the TAG took this on and helped adapt the NRF for submission to the ISO. The vote was unanimous: All 21 members were in favor of moving the NRF forward in this way.

Surprising? In some ways yes, some ways no. A technical report is not a standard, and so countries and companies will not be bound to apply the report fully to their practices as they would an ISO standard. Nonetheless, representatives of a number of US industries are supporting the information-based approach to nanotechnology risk management incorporated in the NRF. And those of us concerned about the health effects of nanomaterials can support that.

The next step will be convening the TAG in Shanghai in November to review the document and start taking comments from the other country delegations. EDF will be there to try to ensure that the principles and science-based prudent approaches of the NRF are supported and are retained in the official ISO guidance.