The latest iteration of the US National Nanotechnology Initiative’s Environmental, Health and Safety Research Strategy was released today – downloadable from nano.gov. A draft of the document has been on the streets since last December – this version was compiled after a public comment period on that draft that closed earlier this year (the key comments received are listed here).
Given the comments received, I was interested to see how much they had influenced the final strategy. If you take the time to comment on a federal document, it’s always nice to know that someone has paid attention. Unfortunately, it isn’t usual practice for the federal government to respond directly to public comments, so I had the arduous task of carrying out a side by side comparison of the draft, and today’s document.
As it turns out, there are extremely few differences between the draft and the final strategy, and even fewer of these alter the substance of the document. Which means that, by on large, my assessment of the document at the beginning of the year still stands.
Perhaps the most significant changes were on chapter 6 – Risk Assessment and Risk Management Methods. The final strategy presents a substantially revised set of current research needs, that more accurately and appropriately (in my opinion) reflect the current state of knowledge and uncertainty (page 66). This is accompanied by an updated analysis of current projects (page 73), and additional text on page 77 stating
“Risk communication should also be appropriately tailored to the targeted audience. As a result, different approaches may be used to communicate risk(s) by Federal and state agencies, academia, and industry stakeholders with the goal of fostering the development of an effective risk management framework.”
There is also an additional bullet in the section on Implementation and Coordination of the NNI EHS Research Strategy (page 94):
“Refocus NEHI. Through consultation with agency representatives, the leadership of the NEHI Working Group adapted its meeting format to ensure better coordination of research to achieve the goals of the NNI EHS Research Strategy. Four priority areas were identified: ongoing updates on agency nanoEHS activities; new opportunities for collaboration; research strategy implementation, coordination, and evaluation; and planning and outreach.”
But these are the most significant changes I could find.
Below, I’ve listed the key changes I came across reading through the document. I’ve also looked at how some of the most specific public comments received – from Günter Oberdörster – have been addressed, as an indicator of how seriously the NNI took the comments received.
Looking at these differences – and where Günter’s comments have and have not been responded to – I can’t but help conclude that minimal attention was paid to the public comments. Even where very specific page and line comments were made, only the most trivial to respond to have been addressed.
This doesn’t worry me too much – for a federal document, the strategy isn’t bad, and certainly has the potential to help focus nanotechnology safety research efforts. But I do wonder whether the federal government needs to get its public engagement act together, and either not bother with public consultation if it is simply a box-checking exercise, or have the courtesy of responding to comments – even if they aren’t acted on – if they do take them seriously.
_________________________________________
Specific significant changes between the draft and final strategies.
I have probably missed some – but these are the ones that jumped out at me.
Vision
There was a subtle change in wording here:
Draft version: “In support of the National Nanotechnology Initiative (NNI), the vision for environmental, health, and safety research in nanotechnology is a future in which nanotechnology provides maximum benefit to human social and economic well-being and to the environment.”
Final version: “In support of the National Nanotechnology Initiative (NNI), the vision for environmental, health, and safety research in nanotechnology is a future in which nanotechnology provides maximum benefit to the environment and to human social and economic well-being.”
1. Introduction to the 2011 NNI Environmental, Health, and Safety Research Strategy
Page 1: Revised text: “… ensuring a clean water supply and remediating soil contamination.” instead of “… ensuring a clean water supply and soil remediation.”
Page 2: New text added: “Overall priority is given to the EHS research that decreases the uncertainty in assessing and managing risk and that addresses the EHS objectives in the NNI 2011 Strategic Plan.”
Page 2: New text added: “Research and development remain essential to the fundamental understanding and development of tools and materials for nanotechnology. Fundamental research, development of infrastructure, and education will continue to contribute to the knowledge needed for Federal nanoEHS research.”
Pages 3 & 4: Figs 1-2: Figures, and the accompanying text, have been clarified.
Page 5: The figure to fig. 1-3 emphasizes the importance of research management framework underpinning the strategy.
Page 7: New text added: “A draft version was posted at strategy.nano.gov for public comment (Dec. 1, 2010-Jan. 21, 2011). Where appropriate, this strategy was updated in response to comments and new information.”
2. Nanomaterial Measurement Infrastructure
Page 16 of draft report: Deleted text: “Finally, NIST has requested funding in the FY2011 NNI Supplement to the President’s Budget to develop measurement methodologies and models for dynamic physico-chemical properties (e.g., transformations) of key nanomaterials; this funding would greatly accelerate research to address research need #3.”
Page 21: There is a stronger emphasis compared to the original text on the need for more research “More effort is needed for all research in this revised category: research need #5 is a newly defined research need, so no relevant projects were reported in the FY 2009 data call. However, there is work underway at NIST and at the Consumer Product Safety Commission (CPSC) to evaluate ENM release mechanisms from NEPs due to incineration, mechanical degradation, and consumer interactions.”
3. Human Exposure Assessment
Page 24: New text: “These challenges also make international harmonization of exposure assessment methodologies and international collaboration in conducting health surveillance studies critically important.”
Page 25: Updated text: “Develop quantitative assessment methods appropriate for target population groups and conduct assessments of those population groups most likely to be exposed to engineered nanomaterials”
Page 26: New text: “Development of health surveillance projects with international partners would leverage funding and study populations, thus accelerating our understanding of human exposures and potential adverse health effects.”
Page 28: New text: “and (3) development and international harmoniza-tion of exposure assessment methodologies appropriate for epidemiological studies, studies of the effectiveness of control technologies, and other research areas.”
4. Human Health
Page 36: A new research need added: “ Evaluate the degree to which an in vitro response correlates with an in vivo response”
Page 43: Research need #3 transposed with research need #4, compared to the draft report.
5. Environment
Page 43 of the draft report: Deleted text: “and to instilling public confidence in the safety of nanomaterials and nano-enabled products that could benefit society.”
Page 58: Clarification that “An additional 9 projects include environmental transport components and are included under “Multiple Research Needs.””
Page 59: New text added “They may also bind to other contaminants in the environment.”
Page 50 of the draft report: Deleted text: “In other words, nanoscale may not be a characteristic that supports assumptions about potential toxicity for all nanomaterials.”
6. Risk Assessment and Risk Management Methods
Page 65: Clarifying text added: “The risk assessment process incorporates the best available data on the potential health effects of a nanomaterial and the exposure potential to humans and to the environment; thus, the data needs described in previous chapters and the quality of the results of studies in measurement, exposure assessment, human health, and the environment directly impact the reliability of risk estimates.”
Page 66: All research needs bullets updated.
Page 73: Significant new text added under Analysis of Current Projects
Page 77: New text: “Risk communication should also be appropriately tailored to the targeted audience. As a result, different approaches may be used to communicate risk(s) by Federal and state agencies, academia, and industry stakeholders with the goal of fostering the development of an effective risk management framework.”
7. Informatics and Modeling for NanoEHS Research
Page 80: New text: “Identifying regions in which small changes in nanomaterial structures lead to large differences in their properties (high sensitivity) and/ or large uncertainty and error in the data or models would provide a quantifiable measure of the need for greater understanding of the underlying mechanisms and help target priority areas for additional research and funding.”
8. The Path Forward
Page 95: Expanded bullet “ Name NNCO EHS Coordinator. Consistent with the PCAST recommendation, OSTP has named an NNCO Coordinator for EHS to assist agencies in integrating research across the nanoEHS continuum to achieve the objectives presented in the NNI 2011 Strategic Plan. The new NNCO EHS Coordinator serves on the NSET/NEHI leadership team; leads the NNCO and NSET Subcommittee’s efforts in identifying and leveraging research collaborations domestically and internationally; serves as the NNI point of contact for stakeholders with nanoEHS concerns; and spearheads the NNI EHS Research Strategy’s implementation, coordination, and evaluation.”
Page 95: New bullet “Refocus NEHI. Through consultation with agency representatives, the leadership of the NEHI Working Group adapted its meeting format to ensure better coordination of research to achieve the goals of the NNI EHS Research Strategy. Four priority areas were identified: ongoing updates on agency nanoEHS activities; new opportunities for collaboration; research strategy implementation, coordination, and evaluation; and planning and outreach.”
Comparing the final strategy to public comments from Günter Oberdörster on the draft document. I decided to do this as Günter provided some of the most specific public comments, and because he is one of the most respected experts in the field. The specificity of his comments also provided an indication of the extent to which they had been directly addressed in the final strategy.
Comment: Page 31, lines 7-13: Although the need for developing appropriate, reliable, etc. in vitro and in vivo assays need to be identified, this need could include and emphasize the validation of any in vitro system through in vivo studies. In addition, the choice of realistic, relevant doses/concentrations should be informed by data from exposure assessment which should be stressed.
Response: New bullet added.
Comment: Page 31, line 35: The nose is listed here as a non-traditional route of entry, it certainly is not, nasal and oral inhalation are both very traditional portals of entry.
Response: The recommended change made here, but not later on in the strategy.
Comment: Page 32, lines 3 and 4: When designing dose response and time course studies, the need for inclusion of realistic doses should be mentioned.
Response: No obvious response.
Comment: Page 32, lines 9 and 10: Likewise, with respect to alternative in vitro testing methods for rapid screening, it should be emphasized again that validation is necessary since mechanisms are dose-dependent and mechanisms associated with extraordinarily high doses in vitro are likely not to operate in vivo. So the predictability of in vitro assays for in vivo responses clearly needs to be confirmed.
Response: No obvious response.
Comment: Page 35, lines 3-14, Overview: In this well-written overview section, I would like to see more emphasis on a validation of in vitro assays by in vivo studies; just pointing to the correlation (correlation which way?) of in vitro results with in vivo outcomes is not strong enough in my view. It should be pointed out in this section that the term in vivo also requires some scrutiny with respect to methodologies: for example, inhalation as the preferred method is clearly the gold standard as far as the respiratory tract as portal of entry is concerned, yet bolus type delivery (instillation, aspiration) are continuously used, calling for a need to compare different in vivo types of exposure to assess their usefulness. (Differences in dose-rate as important determinant of acute effects).
Response: No obvious response
Comment: Page 37, lines 15-29, Overview: This section again is a good overview, however, it could be more specific with respect to what are the goals of biokinetics, which are described here as developing models that predict ENM biological exposure and fate. Important in addition is to identify from such biokinetic studies potential target tissues/organs. Specifically, sensitive tissues could be mentioned, such as bone marrow, CNS, cardio-vascular system, placenta, the latter pointing to the potential of reproductive effects.
Response: No obvious response.
Comment: Page 38, lines 38-45: This overview of ENM uptake and portal of entry tissues addresses also the issue of inhalation vs. intratracheal instillation as well as use of high exposure doses. However, it appears that for the instillation methodology (aspiration should be mentioned also, both together to be described as acute bolus type deliveries) by-passing of the upper respiratory tract is identified as the only limiting factor with respect to risk assessment. However, a major problem not mentioned here is the difference in dose rate between inhalation and bolus type delivery, in addition to differences in distributions of deposited doses in the lower respiratory tract.
Response: No obvious response.
Comment: Page 39, lines 34-46, Overview: The need for fundamental understanding of the mode of action is addressed here, and it would be helpful to remind the reader that mechanisms also are dose-dependent, and that therefore the identification of molecular mechanisms mediating biological responses also require to make certain that they are operating in vivo, particularly in case they are derived from high-dose in vitro studies.
Response: No obvious response.
Comment: Page 56, lines 9 and 10: A minor point, I suggest to reverse these two lines, to place Hazard Identification first, followed by Risk Characterization, which is dose-response assessment.
Response: This section was changed substantially.
Comment: Page 68: This last section on Informatics and Modeling identifies some problems with regard to setting up a better collaborative infrastructure considering, among others, the policies and practices of different agencies (line 5), funding mechanisms and funding evaluation schemes, etc.; but there doesn’t seem to be a solution offered to solve these problems although there is some attempt in the last section, The Path Forward (see below).
The Informatics section is very useful, in particular also since it emphasizes the importance of validating predictive capabilities of in vitro and in vivo assays (lines 17 and 25) and to incorporate necessary additional information. It would be helpful to add a short paragraph about the time line of informatics, obviously these are long-term goals, can you provide any milestones for the goals? [Not addressed, as far as I can tell]
Pages 70/71, Path Forward: With respect to targeting and accelerating HS research, six bullet-points are listed, however, an overarching issue that could be introduced here (it comes several pages later) is that there ought to be a coordinating oversight body, otherwise, it might be just a continuation of how it is now.
Response: No obvious response.
Comment: Page 71, line 22: Dosemetrics such as surface area and solubility are listed as something new which certainly is not the case. Otherwise, this listing of prioritized research is well developed and makes good sense.
Response: No obvious response.
Comment: Page 77, lines 2-7, Implementation and Coordination: The essentiality of continuous coordination among agencies through the NEHI working group and addition of an NNCO coordinator is expressed. This sounds pretty good, how well will it work though? This document lists many projects for each of the research needs, but there was not much evidence of inter-project collaboration/discussions.
Response: No obvious response.
Comment: Page 78, first bullet-point, lists the new NNCO coordinator but it is not clear what, if any, directive power this coordinator will have? Just assisting agencies may not be enough.
Response: Role clarified, but comment not addressed.
Comment: Page 78, (Lines 4-9) In addition, the NEHI working group will continue to facilitate coordination and increased collaboration among the agencies, so it is not clear really how these two coordinating groups work together and how much of a directed coordinated agenda for accelerated EHS research is now in place or how is that different from the past? The NEHI working group is continuing its coordinating efforts nationally and internationally, so what is the role of the new NNCO coordinator?
Response: Text clarified.
Comment: Page 79 discusses very nicely the dissemination of knowledge and comes up with a Conclusion Paragraph. However, in both of these the NNCO coordinator is not mentioned, so how important really is this coordinator? Role of the NNCO needs to be better clarified.
Response: No obvious response.
Comment: Page 91, Appendix C. Definitions — Nanoparticle or nanoscale particle: Text reads: “ … a nano-object with all three external dimensions …” — should be “…at least one external dimension….”.
Response: Comment addressed.
I don’t know if this is relevant in this section. I’m a member of IEEE for 5 years from my school days with a strong interest in Nanotechnology, however, I noticed that Nanotechnology does not have an established group within the IEEE Irish chapter(Republic of Ireland). I stand to be corrected if I’m wrong.
Thanks, Andrew, for your continued commitment to nanotechnology EHS concerns.
I thought I might offer a few clarifications on your comments on the process used to assess the public comments we received last winter on the December 2010 draft of the NNI EHS Research Strategy.
Firstly, all public comments were considered at a special meeting of the Nanotechnology Environmental and Health Implications (NEHI) working group, the group responsible for writing the strategy. The nanoEHS strategy is a high level guidance document that agencies use to develop their mission-specific implementation plans.
For this step in our writing process, NEHI evaluated each comment to determine if it was informational (just letting us know what the person thought) or actionable. If actionable, then we determined if the comment was appropriate to a high level strategy or to a more down-in-the-weeds implementation plan. If appropriate to a strategy, we then determined where it modified the document and made the change.
As you can see, NEHI takes its responsibility to stakeholders very seriously.
I will close by noting that the comments you cited from Dr. Oberdorster were each considered, and as Gunter himself wrote at the start of his comments, most were appropriate to an implementation plan and not a strategy document.
Thanks again. NEHI appreciates partnering with you and all of our stakeholders to protect public health and the environment.
Thanks Sally, it’s extremely helpful to know that the comments were considered seriously – suspect feedback like this in other instances would go a long way to encouraging further stakeholder input to federal initiatives.
thanks for the inspiring discussion. I’m advising the European Commission on stakeholders engagement in ICT policy, and have used this as an interesting case. I’d like to involve you in the on-going discussion we’re having in the policy-making 2.0 group on linkedin.