Feedback from GE

General Electric Company

Posted on: April 07, 2007

The General Electric Company (“GE”) commends DuPont and Environmental Defense (“ED”) for taking the initiative to develop the Draft Nano Risk Framework (“Framework”). The Framework is a significant step toward enabling a model approach for the academic, government and business evaluation of potential risks posed by nanomaterials.

The Framework has a number of notable strengths:

1. It describes in one document a set of fundamental steps that could be considered to assess and manage potential risks of a nanomaterial, and the information needed to implement those steps.
2. Its use of the Life Cycle Assessment (LCA) approach supports a systematic consideration of all of the ways and points at which a nanomaterial might present a potential risk to human health or the environment.
3. It allows for continuous improvement in the assessment process.

GE’s further comments are offered in support of this important effort, and are intended to suggest potential refinements for the next version of the Framework.

The Framework should be simplified to the greatest extent possible

The length and complexity of the Framework is not a challenge for use by large organizations with dedicated Environmental, Health and Safety (EHS) and/or Product Stewardship staff, but could dissuade organizations that do not have such internal resources from using the Framework. We recommend that the Framework be simplified to the greatest extent possible to make it “user friendly” for small- and medium-sized enterprises (SME’s) and organizations.

One solution is to edit the Framework carefully to eliminate unnecessarily repetitive text. For example, there is a list of questions under the heading “Material” on p. 16 of the Framework that is intended to be used to derive the basic description of a material; there is a similar, though different, list of “physical and chemical properties data” on p. 29, and then there is another, similar, but different, list on page 1 of the Output Worksheet. Those lists could be combined and reflected on p. 1 of the Output Worksheet, and that list simply cited on pp. 16 and 20.

The scope of the Framework should be clarified

On p. 6, the Framework defines “material” as “engineered nanoscale materials that exhibit novel properties and that consist of or contain particles smaller than 100 nanometers (nm) in one or more dimensions.”

The phrase “or contain” should be removed from the definition of “material.” If, for example, a tire contains a nanomaterial, the tire should not be deemed a nanomaterial, because that would bring conventional, non-nanoscale materials into the Framework. The nanomaterial that is contained in the tire should be the focus of a risk assessment conducted under the Framework at time of manufacture, processing and characterization of potential uses.

The Life Cycle Approach Should Be Streamlined

The Framework states (e.g., pp. 19-20) that a nanomaterial will present a risk only if someone or something will be exposed to it. If there is no exposure, there is no risk. Consequently, in many cases it will make more sense to evaluate exposure potential before evaluating the hazard potential of a material at any given stage of its lifecycle. The Framework, however, calls for development of the hazard profile information described in Step 2B for every stage of a material’s life cycle before the potential for exposure is determined which increases the resource load, cost and timing of implementing the Framework.

Similarly, Step 4 could be made more efficient by starting with an assessment of the controls currently in use where materials are being made, processed, used, etc. From that baseline, a Framework user could consider and determine whether additional controls are needed/available given the hazard profile information ultimately developed in Step 2. Currently, the Framework starts Step 4 with an assessment of what is needed followed by an evaluation of current controls.

The Framework Should Provide For The Exercise of Best Professional Judgment

The Framework correctly acknowledges in a number of places that for many nanomaterials the information needed to fully identify hazards and evaluate risks is lacking, as are the tools/methods needed to collect that information. Consequently, for any given material, it might be difficult or impossible to develop all of the information called for by the Framework. It might also be unnecessary if, for example, a nano-sized material agglomerates upon exposure to air, so that there is lowered risk of inhaling a respirable nano particle per se, and such agglomerate has a different hazard profile than individual particles. The Framework should more broadly acknowledge the need to exercise best professional judgment in determining which portions of the Framework are important to use and achieve for a given nanomaterial.

The Framework should undergo a second round of comment

In these comments, we have focused on things that affect the general structure and scope of the Framework. In our review, however, we have noted specific items of varying significance that warrant further consideration. While time does not permit a full discussion, we offer the following highlights:

• On p. 4, the Framework defines “nanotechnology” as “the design and manipulation of materials at the atomic scale”. Conventional chemistry, however, involves manipulation of materials at the atomic scale. Nanotechnology, as referred to elsewhere in the Framework, is distinguished by its focus on manipulation of materials with at least one dimension of 1 to 100 nanometers.
• The Framework does not address R & D activities in its referenced Life Cycle Model and Diagram. Since R&D can involve human and environmental exposures, it would be helpful to clarify whether and how the Framework is intended to apply to this important and significant market activity.
• On p. 9, the Framework states: “[C]ompanies that manufacture nanomaterials for sale as primary products in diverse applications may have different responsibilities – relating to safe preparation, handling, use, further distribution, and disposal of these materials, and to the development of relevant data – from companies that purchase the nanomaterials for particular applications.” This could be read to mean that purchasers of nanomaterials for use in making a product can rely on the seller to evaluate risks that might arise in the purchaser’s facility/operations or downstream of the purchaser. While the purchaser should be able to rely on the information provided by the seller, The Framework should make it clear that the purchaser should evaluate its workplace and downstream risks independently.
• On p. 20, the Framework calls for projecting “reasonably anticipated activities by lifecycle stage (e.g., those upstream or downstream of the company).” There is no apparent reason why a user of the Framework should need to assess the risks of activities that occurred “upstream” of the user (i.e., before the user obtained the material).
• The Framework provides “Suggested Guidance for Exposure Measurements/Monitoring (pp. 52-3), which appropriately relies on traditional methods for such measurements. However, some of the measurements that the Guidance recommends, such as mass concentration, particle number concentration, particle size distribution and surface area, are difficult to measure outside of the laboratory setting because of current technology limitations. This section should be enhanced to discuss practical, non-laboratory approaches to exposure monitoring.

We expect that other commenters have made similar observations. Consequently, we recommend that the Framework undergo another round of review after DuPont and ED revise it to reflect their consideration of the comments received on the current draft, and the results of the pilot testing described on p. 4 of the current Framework.