Feedback from Jo Anne Shatkin

The Cadmus Group, Inc.

Posted on: March 30, 2007

Dear colleagues:

Thank you for the opportunity to review the recently released draft Nano Risk Framework (framework). The draft clearly represents an in depth effort and is gratifying to see in print after seeing it presented, and discussing it with you on several occasions.

My comments are both general, about the applicability and implementation of the framework, and specific, addressing specific steps in the draft document.

General comments

1. Overall, I applaud the effort to develop a framework for analyzing risks across the lifecycle of materials and products. As you know, I am an advocate of the life cycle/risk assessment approach, and have also developed a framework not too dissimilar from this one, the main different being the scope of analysis required to inform risk management decision making. The Cadmus Adaptive Risk Framework is intended as a screening tool, and prioritizes future analysis and assessments rather than the comprehensive analytical approach proposed in the ED Dupont Nano Framework.
2. It would be helpful to have some text addressing what is nano about the framework. Other than some of the recommendations for specific material characterization, it is unclear to me why this framework should be applied only to nanomaterials and nanotechnologies. Similar exposure and hazard concerns should perhaps be addressed universally for new chemicals and other substances, regardless of whether they are nanoscale materials. In some sectors, this approach is significantly more effort than is otherwise required, and could present a barrier to development of nanotechnology vs. other approaches if only applied to nanoscale materials. If there is a rationale for applying the framework to nano only, this should be made more explicit. The framework adopts a novel approach to decision making, and needs further rationale presented.
3. I note that the implementation of the framework requires a lot of interdisciplinary expertise in diverse fields of health and environmental science. This raises a concern for me that people without training or experience in health science, toxicology, industrial ecology, environmental science, exposure assessment and risk assessment expertise would carry out the extensive research needed to apply the framework, and would be the ones making judgments about the data gathered and their significance. I would like to see discussion of the importance of consulting with experts in these broad fields if it does not exist in-house. This comment is not meant to be self-serving, it is meant to ensure that the extensive efforts recommended in the framework document are actually carried out in a meaningful way that addresses the intended environmental, health and safety concerns.
4. The framework is proposed to be developed and implemented within an organization, but implicit in its development is that it is intended for communication with stakeholders. I believe the document would benefit from some discussion of the societal dimensions of the framework. How do you anticipate it would be used? How would the data be made public? The assessments? How to address CBI concerns? Does the “documentation” become a public document? Submitted to regulatory authorities? The document should offer some guidance on these critical aspects of implementation. Also, I foresee a need for expert communication of risks. Because clear communication about risks is so important to the success of the endeavor, this expertise may need to be obtained from outside of the organization.

Specific comments on the document

5. It would be helpful to have a Table of Contents. The document is fairly lengthy, and could use a road map.
6. I particularly like that the document identifies and spells out anticipated roles and team members. However the relationship of the product steward or leader to the product stewardship manager is unclear. Why are there two individuals responsible for managing the product stewardship? Do you envision one as a corporate manager, and the other as working specifically on a particular product and application? Where is the environmental health and safety staff in this team?
7. On page 9, there is one paragraph that addresses the importance of the supply chain. I think the issue of supply chain management of product risks is a critical element to be addressed, and one way to obtain the resources to carry out risk assessments throughout the life cycle of materials. Thus, this point should be elaborated, perhaps recommending models or alternatives for establishing relationships and communicating across entities in a product supply chain.
8. Steps 1 and 2a seem to comprise the initial steps of a risk assessment that are commonly termed hazard assessment and hazard characterization. Terminology can create confusion, especially when working across disciplines. I suggest linking the terms hazard assessment and characterization to the terms material description and “lifecycle properties profile.”
9. I am pleased to see the recommendation to include the material characterization properties from the ILSI screening framework (Oberdörster et al, 2005). I believe this document represents fairly current consensus on the key materials properties of interest, and developing data for a range of materials will help to address the current questions about key parameters important to toxicological and environmental behavior.
10. On the discussion of “base sets” of data. Clearly, there is a rationale for using default assumptions when specific data are not available for decision making. My concern is that once defaults are used, there is an enormous burden of proof for an organization to demonstrate that reality differs from them. Because the judgments are based on values as well as science, it may be hard to convince others on the science alone when new data offer lower risk estimates. It could become a barrier to commercialization to have to demonstrate a product assumed to be hazardous in early stages is found not to be hazardous with subsequent testing. By that time, public opinion and perhaps regulatory judgments may have been rendered.
11. The “base set of Health Hazard Data” includes at a minimum, 8 tests, and for complete characterization, 16, that are to be carried out “for each lifecycle stage.” This amounts to 40 or 80 toxicity tests, in my interpretation. I question the need for this much analysis of all products. You may recall in the Cadmus Adaptive Risk Screening Framework, the first step is to determine whether there is significant potential for exposure at any of the lifecycle stages.
12. The evaluation step, Step 3, steps through a process to evaluate risks. With the numerous potential scenarios, this could become a lengthy effort. Again, I stress the need for adequate expertise to conduct the evaluation. Also, have you considered the feasibility of this approach for companies that do not share the resources and commitment to stewardship that is found at Dupont? Earlier in the document, it may make sense to discuss a rationale for the level of effort and its benefits to organizations I further recommend some discussion about prioritizing some scenarios over others.
13. On the issue of “reasonable worst case,” the rationale is clear for being conservative in the absence of data. This goes to the point in my last comment about discussion of the rationale for the level of effort to obtain data. However, I reiterate my concern about the risks associated with being too conservative with assumptions. Instead of reasonable worst case, a range of possible levels is an alternative approach that can provide a better indicator of the potential significance of a pathway or scenario. In addition to “reasonable worst case” the use of “most likely” and “less conservative” assumptions allows comparisons of difference scenarios in a more balanced way that only considering the worst case can’t. One way to obtain these estimates is to consult with experts, who may reasonably differ, but are likely to be fairly consistent in their estimates across scenarios.
14. Step 4, risk management assessment. Rather than Step 4, early consideration of the management alternatives can help to shape the analysis. In fact, some upfront consideration of the risk management assessment would give the team responsible some sense of the goals and purpose of the data gathering and risk analysis. The assessment of risk management options should match the level of quantification of the data and assessments in Steps 2 and 3. If exposure levels are not quantified, then risk reduction levels also can not be quantified.
15. Step 5. The text box identifying potential review team roles is a key component. When I assemble teams for projects, technical and project reviewers are part of the initial team. Rather than waiting to step 5, the review team should be formed and engaged early in the process so they have the opportunity to weigh in on the scoping, data gathering, and assessment steps.

Again, thank you for the opportunity to review and comment on this effort. I would be happy to further discuss my comments with you. I look forward to seeing the revised framework, especially the examples.

Jo Anne Shatkin, Ph.D.
Principal
The Cadmus Group, Inc.