ICF International is pleased to comment on the February 26th draft of the Nano Risk Framework developed by the Environmental Defense – DuPont Nano Partnership. Our comments reflect input from several senior ICF staff. We applaud your willingness to tackle this important and challenging task and believe that the Framework is built on a solid foundation, contains sound advice, and represents a major contribution to the field.
Several aspects of the framework are especially valuable; we encourage their inclusion in the final draft. In particular, we support:
Limit Flexibility to Improve Consistency of Results Given the range of nanotechnologies under development and the applications to which they will be put, we understand the need for flexibility in implementing the framework. The framework, however, gives the user very wide latitude in interpreting and applying it. This flexibility may undermine the consistency of results and in turn their credibility.
Manufacturers using the framework could take very different approaches depending on data availability and on their resource investment, risk management philosophy, and analytic rigor. What’s more, unless a manufacturer is exceedingly transparent and stakeholders have the technical capability to evaluate the results, these differences in approach may remain hidden.
As drafted, the framework is probably not prescriptive enough to serve as the basis for a public-private partnership on nanotechnology stewardship.1 Given the wide range of approaches that can be taken under the framework, stakeholders will likely argue that it does not provide sufficient assurance that a minimum level of human health and environmental protection has been achieved by all firms applying the framework.
We suggest including more prescriptive instructions and normative standards, in order to limit the range of approaches a user can take while “complying” with the guidelines. As an example, page 57 cites an ASTM standard, a NIOSH guidance document, and a nanotechnology “note” from the UK government. Are framework users meant to consult and follow the guidance in these documents? Or are they cited simply to validate the framework’s statement that risks should be managed throughout a product’s lifecycle? Clarity on this issue would be very helpful.
The guidelines seem to assume that a firm already understands and embraces proactive risk assessment and product stewardship. Instead, the benefits of using the framework and the value it can create should be made explicit. After all, application of the framework requires resources and its use could highlight the need for costly investments in risk management or might even lead to termination of product development. Accordingly, we suggest more thoroughly reviewing the business rationale for using the framework and touching on topics like:
“Compliance” – both with legal requirements and industry standards – is the minimum baseline upon which product stewardship is built. More attention should be paid to characterizing applicable requirements and incorporating them in the product development process. Failure to consider these requirements during product development can lead to higher costs later.
While the document certainly reminds users to “fully comply” with legal requirements, such compliance is not an explicit step in the framework. We did find one reference, on page 59, to compliance with packaging regulations for transportation, but otherwise all of the document’s references to regulations are made in general support of a particular risk assessment technique.
Because the framework is meant to apply to companies in jurisdictions around the world, a detailed exposition of any one standard (e.g., TSCA, REACH, Proposition 65, ISO 14000, or ISO 9000) would be inappropriate. We suggest, however, that you explain how users can identify and characterize all relevant requirements – including those under development (e.g., ISO’s pending nanotechnology standards or potential nano-specific regulations under TSCA) – which could affect the product’s production, use, or disposal.
Continuous review and adaptation is a cornerstone of quality management and good stewardship; it certainly belongs in the framework. But such iterations are substantively different for a product still in development than for one already being sold in the marketplace. In the first case, managers are deciding if and how to move forward with product development. In the second case, product is in the hands of the customer and the manufacturer is trying to exercise good stewardship based on evolving evidence about hazard and exposure. Step 6, as currently written, tries to cover both situations and is not as clear as it could be. We suggest breaking out Steps 6A and 6B to distinguish the recommended “review and adapt” practices for products in development as distinct from products already in the marketplace.
The document already addresses the first case. You should more explicitly address the later case – exercising stewardship once the product is in commerce – because in many cases, the framework may not produce results that are clearly black or white; safe or not safe. We anticipate a large gray area where the decision to release a product to commerce will be driven as much by good-faith judgments made by company managers as by definitive scientific results. In these cases, stewardship of products in the marketplace will be even more important. Accordingly, the document could be improved by giving detailed guidance on how to address several important considerations, such as:
Techniques for market surveillance and monitoring the scientific literature would help users execute Step 6B.
In addition to the more significant comments noted above, we had a few other suggestions.
Again, we applaud your efforts in developing this document. It will make an important contribution to enhancing the development of nanotechnology. If you would like to follow-up on any of our comments, please contact Peter Linquiti or John Williams.