This coming Thursday (Oct 20 2011), the US National Nanotechnology Initiative is releasing the latest version of the Initiative’s federal nanotechnology environmental, health and safety research strategy. The strategy will be available for download from 10:00 AM Eastern time, with a webinar on the release being held between 12:00 PM – 12:45 PM Eastern (registration required). Further details can be found here.
A draft of the research strategy was published in December 2010 for public comment – with the aim of using these comments where appropriate to strengthen the final strategy.
In anticipation of the final version coming out on Thursday, I’ve been revisiting the public comments received. They are still accessible on the NNI Strategy Portal, although you will need to register to read them (my comments are available separately here). I’m particularly interested in how the NNI has addressed them in the final strategy.
While going through this exercise, I thought it worth listing the key recommendations made within these public comments. These are extracted from comments posted on the NNI Strategy Portal, and i many cases just represent the key recommendations made in the comments:
Richard Harenburg
The 2011 NNI EHS Research Strategy needs to provide more focus on building a collaborative informatics infrastructure. Improved speed in disseminating risk and safety information is particularly critical. Collaboration with foreign nanotechnology research organizations should be developed in this area. Priority should also be given to the signature nanotechnology initiatives such as third generation solar energy. Collaborative informatics infrastructure examples can come from small businesses that use agility and innovation to succeed and grow. Examples can also come from some foreign countries that have demonstrated agility, innovation and growth.
Jeffrey Ellis
The strategy I recommend is for each product containing a nanomaterial and its uses to be first screened by the manufacturers for potential safety problems once it leaves the production facility. The manufacturers thereof should as a matter of course provide such data. If use requires special safety equipment (gloves, masks, etc) such instruction must be provided with the product.
Bill Kojola
An integrated and linked research effort to assess, via epidemiological studies, the impact of exposure to engineered nanomaterials on human health and any necessary resultant risk assessment/management responses seems to be missing from the strategy.
Andrew Maynard
…what would it take to craft a federal strategy that enabled agencies to work together more effectively in ensuring the safe use of nanomaterials? I’m not sure that this is entirely possible – an internal strategy will always be constrained by the system in ways that an externally-crafted strategy isn’t. But I do think that there are three areas in particular that could be built on here:
- Principles. The idea of establishing principles to which agencies sign up to is a powerful one, and could be extended further. For instance, they could include a commitment to working closely and cooperatively with other agencies, to working toward a common set of aims, and to critically reviewing progress towards these aims on a regular basis.
- Accountability. The implementation and coordination framework set out in chapter 8 of the draft strategy contains a number of items that, with a bit of work, some group within the federal government could be held accountable to. Formally, the NNCO would seem to be the most appropriate organization to be held responsible for progress here. With accountability for actions that support the implementation and coordination of the strategy, a basis could be built for an actionable strategy, rather than wishful thinking.
- Innovation. So often in documents like this, there is a sense of defeatism – “this is the system, and there’s nothing we can do to change it”. Yet there are always innovative ways to circumvent institutional barriers in order to achieve specific ends. I would strongly encourage the NEHI to start from the question “where to we want to go, and how are we going to get there”, rather than “what are we allowed to do”, and from this starting point explore innovative ways of making substantive and measurable progress towards the stated mission of the strategy. Just one possibility here is to use the model of the Signature Initiatives being developed elsewhere within the NNI – which overcome institutional barriers to encourage agencies to focus on a common challenge. Something similar to a Signature Initiative focused on predictive modeling, or personal exposure measurement, or nanomaterial characterization, could enable highly coordinated and integrated cross-agency programs that accelerate progress toward specific goals. But this is just one possibility – there are surely many more ways of getting round the system!
John DiLoreto, The Nanotechnology Coalition
A core mission of the NNI is to foster “technological advancements that benefit society” (Draft NNI 2011 Environmental, Health, and Safety Strategy, page 1). The NNI strategy provides valuable help in identifying key research areas and, in some cases, providing the necessary funding to conduct the research itself. The Coalition believes that to fulfill its mission in this regard, the NNI could and should direct its considerable influence and resources to educating regulatory and other officials in positions of influence about nanotechnology so they can better fulfill their responsibilities to protect the safety of consumers. The EHS research strategy should also examine ways that science-based safety information can be shared with regulatory officials and others in leadership positions and provide scientific resources to assist these officials in understanding what a ‘nanomaterial’ is and help create a better understanding of properties that may impact safety.
David Berube
Section 6, p. 56, line 23/25/26/30 – 23 conflates translation with risk communication (they are different). 25 “approaches” is unclear and should reference levels of acceptable caution. 26 high uncertainty may demand whole new algorithms – your assumption whether risk communication and risk management can be integrated is incorrect. 30 is a good point to discuss the conflation of translation which occurs between parties within similar ranges of understanding and public perception (NGOs) as well as perception of public perception (legislators). Each of these subset publics have different needs and interests and standardization of terminology is hardly sufficient to the task at hand.
p. 57 line 4 – see above and consider we might need to develop algorithms appropriate to different levels of certainty. The assumption the answer to uncertainty is more certainty is not necessarily valid for all publics. The simplified version in the document seems more attuned to strategic communication involving response strategies for different risks and certainty values involving variables like plausibility, phenomenon specificity, exigence, salience, etc.
p. 63 lines 34/37 34 (see above). 37 one model does not fit all. 38 link to trust is very complex and complicated by new/digital media sources as well as new credibility (social media) and reliability.
p. 58 lines 1/5/11/27 (see above) and this demands information sharing and transparency as well as answering how data is defined, who decides what is relevant data, how it is generated, how data is compiled and concatenated. how data is vetted and debunked, and how data is revised. 5 two ways is overly simplistic, try interactional. 11 this is a model issue and we do not have a model for high uncertainty. 27 assumes risk communication is a function of data, esp. scientific data and for many publics that is not true.
p. 76 – Explanation SP objective 4.2 re: needs of the stakeholders – it might be prudent to ask them what their needs are.
Samantha Dozier, PETA
A complete, step-wise method for rigorous characterization is imperative so that measurement is not questioned and studies are not repeated. A clear requirement for nanomaterial characterization will help eliminate redundancy and imprecise data-gathering and will aid in reducing animal use for the field.
For human health effects assessment, the NNI should promote the development of a tiered, weight-of-evidence approach that is based on the most relevant methods available and encourages the NNI to support the incorporation of appropriate in vitro human-relevant cell and tissue assays for all endpoints, instead of relying on inadequately modified, non-validated animal assays. This tiered approach should start with an initial characterization of the nanomaterial, followed by in vitro basal cell and portal-of-entry toxicity assessments according to human exposure potential and a full characterization of the toxicokinetic potential.
Martin Philbert
…it is imperative that the NNI focuses on developing and implementing a plan of action that supports coordinated and responsive progress towards addressing nanomaterial safety, despite mounting barriers to achieving this. Such an approach will need to focus less on the details of what research needs to be done – there is already a plethora of information available on this – and more on cross-agency mechanisms that will support relevant and timely research.
Chapter 8 of the draft strategy begins to address this need. I would strongly encourage the NEHI working group to build on this promising start, and develop a cross-agency plan of action that enables the necessary research to progress, despite political, social, institutional and other pressures that will inevitably obstruct it.
Maria Victoria Peeler
After much discussion and reviewing comments on this web site, as well as reviewing NNI’s proposals again, I believe it’s in order to point out that while the document makes it clear that the funding is comparatively large, but limited, the critical prioritization of current US needs to achieve sustainable use of nanotechnology is missing.
The listing of the proposed projects by each requestor does not answer the question as to which projects are 1) absolutilely necessary to survive, 2) of major importance for competitive purposes (list of competitive priorities should also be defined. For example, is economic viability a higher priority than population viability..of key species or top of the chain species?) and 3) of major importance to maintain stable diversity of all Earth meeds, to avoid global to regional catastrophy. Beyond that, each project ought to require documentation that ensures the end result will not be deletirious. We do not need to foul our own nest anymore than we have already.
Robert Wiacek
Responsible and cautious science-base risk analysis and risk management by the EHS community needs to be a priority in order to curtail any unsubstantiated fears of nanomaterials that might arise by the public and ultimately restrict the development of nano-based technology.
In the listing of the goals, Line 8 (Protects public health and the environment) should remain first, Line 10 (Fosters technological advancements that benefits society) should be second, and the last goal listed should be Line 9 (Employs science-based risk analysis and risk management). This would be more consistent with the overall fourfold goals of the NNI (Introduction, Page 1).
Ronald Turco
Overall, the effort is comprehensive looking at the history of the program. However, I keyed in on page 43 line 10, “Releases of engineered nanomaterials ….” as I feel the forward thinking part of the effort ignores “nanocomposites” (the word occurs one time in the document.)… I think the report needs to move forward a bit and start to think more seriously and address the real materials. Use of the term nanomaterials is too vague as it leaves it open as to what is actually being studied (pure forms or product materials). I think raw nanosilver gets a little too much attention – again in what form will it actually be entering the environment (page 54)? We need to be thinking about how the real materials are or will be transformed. The photochemistry work of Jafvert (Hou and Jafvert, 2009; Hou et al., 2010), the fungal work of Filley (Schreiner et al., 2009) and others are a great example of how readily these materials can actually be acted upon in the environment.
Karoly Meszlenyi, The Methodist Hospital Research Institute (TMHRI)
Chapter 2 Instrumentation, Metrology, and Analytical Methods
The monitoring of nano-materials in the environment is critically important for the protection of the safety of laboratory workers at all levels. Because of this, TMHRI suggests that additional research efforts be directed into and reliable methods for the rapid detection, identification and measurement of nano-materials in laboratory and other environments.Chapter 3 – Nanomaterials and Human Health
Research should also be directed toward an evaluation of the relative toxicity of each type of nano-material, as well as the methods and/or routes by which each nano-material is most likely to be taken into the body. lt is particularly important to proceed with research into the most effective equipment and methods for protection of workers from exposure to nano-materials. This research should include proper techniques for the handling and disposal of equipment once it has been used.Chapter 6 – Risk Management Methods
In addition to the activities we suggest with regard to the development of the proper equipment and methods for the handling of nano-materials, research should be conducted into the development of equipment and methods for the prevention of nano-materials spills, as well as the most effective equipment and methods for the safe, rapid and effective cleanup and remediation of any such incidents.
Gaythia Weis
I recommend that some input from industrial techniques for matrix management and virtual team building would be highly useful approaches to dealing with the inter-agency and multiple stakeholder issues… I think this document:
http://www.particlea…f/1743-8977-7-40.pdf is a great outline of how to establish protocols for working with new and unfamiliar materials, and implementation of the precautionary principle. I especially like the design tree flow chart and the figures. I believe that something very specific based on the style of this report should appear early on in the US National Nanotechnology Initiative Environmental, Health and Safety strategy document. I would place this directly after the material now in Chapter 8. Because if you want to convey concepts about health and safety you have to be clear about it. And this Particle Fiber and Technology document knows how to do that. I don’t think you can have a Environmental health and safety strategy unless you really get down to the nuts and bolts of health and safety.
The American Chemistry Council’s Nanotechnology Panel
The Panel supports the approach of integrating the risk assessment paradigm within product life cycle stages and the NNI’s overall adaptive management approach to EHS research. While we support the vision and mission in principle, we believe that the vision statement does not adequately acknowledge the potential of nanotechnology to enhance environmental quality. The panel also hopes that, contrary to the text box following the mission statement, the definition of “engineered nanomaterial” used in the EHS strategy would provide some degree of guidance (and consistency) to federal agencies developing their own definitions.
The Panel believes that risk communication deserves increased emphasis. We do not believe that it is sufficient to simply “integrate and standardize risk communication within the risk management framework” (p. 63). As nanotechnology EHS research increases, the question of what study results mean in terms of potential health or environmental risk must be communicated effectively. The draft frequently mentions increasing the availability of EHS information, but the public needs more than the numbers from a risk assessment to interpret studies and understand what risk management measures, if needed, are in place. We recommend that risk communication be more of a priority with a focus on addressing scientific uncertainty, public perceptions, and ELSI.
The draft strategy does not prioritize the need for consistent terminology in EHS research and practice. Standardized terminology would reduce confusion (e.g., routine use of primary particle size to describe materials composed mostly or entirely of aggregates and agglomerates). The lack of common terminology can lead to erroneous conclusions about the sources of potential EHS impacts and how to perform appropriate surveillance and exposure monitoring. As noted in the draft, lack of common terminology can also undermine risk communication.
The Panel notes that the term “comparative risk assessment” is used frequently, but it is not defined. Is it a comparison of different nanomaterial risk assessments or of how different properties influence risk assessment? The Panel requests clarity on the meaning of this term and notes that assessments that compare nano and non-nano forms of materials may be useful for assessing whether nano forms of materials possess increased risk relative to non-nano forms.
Although education is a major component of the overall NNI strategic plan, there are no linkages to education in the draft EHS strategy.
Günter Oberdörster
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.
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.
Page 32, lines 3 and 4: When designing dose response and time course studies, the need for inclusion of realistic doses should be mentioned.
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.
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).
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.
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.
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.
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.
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?
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.
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.
“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.
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.
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?
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.
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….”.
Skip Rung
1. The document is not by any means a roadmap for “support(ing) responsible development of nanotechnology” (NNI goal #4), because it is almost completely focused on risk rather than on proactive activities (though these are briefly mentioned in a few places), and because there are no cost or timeline estimates for achievement of objectives that would enable such development.
2. Though the term “comparative risk” is used in places, there is almost no sense of comparison of the risks of using new nanomaterials with (a) conventional materials or (b) incumbent nanomaterials that were certified prior to recent precautionary blocking and slowdowns. This concern is somewhat personal : an ONAMI gap fund portfolio company, Dune Sciences, which has a better (performance and safety) nanosilver technology, has been severely harmed precisely because of an inability to make such beneficial tradeoffs. Unlike the world of “substances” under TSCA, at least some categories of new nanomaterials developed in the US are at this time practically blocked from commercialization here. This is causing loss of opportunity to Asia.
Two suggestions: a) Set appropriate comparative risk context in the introduction and all relevant sections. b) Fund comparative hazard/exposure/risk studies in a few key/prioritized cases
3. It is unlikely that more than a tiny fraction of the US public knows that the level of scrutiny (both because of genuine scientific interest and because of technophobic NGO influence) being applied to nanomaterials is unprecedented, and has not been applied to molecular (other than certain categories) or micron-scale materials. To cite two of many possible examples, molecular species in plastics used in many products (household items, electronics, automobiles) are known to outgas, and micron-scale particles (in the range most favored for deep lung inhalation) are emitted from paper products and office copiers.
4. It seems imperative to me, unless the NNI wants to be an enabler of even more loss of manufacturing and high-value product development activity in the US, to incorporate – or at least prominently mention in its introduction – a broader comparative sense of risks vs. benefits in the world of materials/substances, and to include/highlight more activity on proactive development of nanomaterials and nanomanufacturing processes, including not just “safe by design” efforts but also safe and low-impact fabrication and purification methods.
5. The occupational exposure research methods should use NIOSH-approved workplace and PPE protocols as the baseline, otherwise needless concern may be raised. If resources permit, comparing this baseline with less precautionary practices would provide useful sensitivity information.
6. There might be greater mention of biological assay methods that combine the best features of in vitro (e.g. small material requirement, high throughput) and in vivo (e.g. vertebrate development impact) studies. One is the use of embryonic zebrafish.
Thomas Peters
Major comments
1) I disagree with the order of priorities in the Human Exposure Assessment area. The authors seem confused among what can be done and what needs to be done. Ultimately, I think that most would agree that the number one need is to “characterize exposures among [people, although the word ‘workers’ was used in 2008]”. The new need #1 is to “understand processes and factors that determine exposures to NM”. I disagree with this reprioritization and suspects that this change reflects the desire to have something more easily tactically achieved in the number one slot. I do not agree that the old needs map to the new needs as indicated by the arrows in Figure 3-1.
I also suspect that the authors have overstated the progress that has been made as stated on page 22, line 10. We still know very little about workplace exposures and there should still be a focus in this area.”\
2) There seems to be an opportunity for more clear linkage among the different chapters. Additionally, the different chapters do not seem parallel as they are presented. Consequently, I sense that there is not an overarching vision within this document that is not explicitly stated.
I believe that this problem would not be overly difficult resolve. I suspect that the figure on the cover of the document was an attempt to provide linkage. From this figure, I see that areas of “Predictive Modeling & Informatics” and “Nanomaterial Measurement Infrastructure” form an important overarching core that is used by “Human Health”, “Human Exposure”, and “Environment”. Ultimately, all of these areas feed “Risk Assessment and Management”. This figure and discussion should be a central piece of the Introduction.3) The Introduction needs to clearly state what the current strategy is apart from the old strategy. The introduction weaves back and forth between old and new. I am confused as a new reader of this document. The result of this confusion is that the entire strategy appears non-cohesive and weak.
4) The development of partnerships with industry and other stakeholders are absent in this document, or perhaps they are simply too deeply embedded for me to find.
Specific comments
…
3) Miscellaneous issues:
• Figure 1-3 appears on page 4 but is not referenced in the text until page 7. It is also not really discussed so it feels like an afterthought rather than a central piece of the document.
• P9, line 25. I find it strange that the words ‘new and improved’ are inherent to the definition of ‘instruments’. I suggest that they be dropped.
• P9, line 21. I find that “developed by national metrology institutes” is too exclusive for the definition of “standards” in a document of this scope.
Fred Klaessig
The issues surrounding safety and societal acceptance are broader than the specifics of any one technology, and for that reason, I am a proponent of Objective # 4 (EHS and ELSI) becoming the NNI’s Objective #1. Some separation should be encouraged so that the enthusiasm, the jargon and the promotional fervor do not cast a strong shadow over thoughtful EHS evaluations. The definition of nanomaterial in this document, the EHS Research Strategy, is more appropriate to the first three NNI objectives and less so to the fourth, and consideration should be given to using the ISO definition in its stead along with a qualifying statement.
1). When breathing, we inhale particles and not ‘nano-enabled’ products;
2). When these particles pass into our lungs, the smaller particles reach the deep alveoli based upon hydrodynamic flow and particle size, not ‘unique’ properties;
3). The particles that reach the deep long may lodge there, while the larger particles are coughed up and then go down the GI tract;
4). The body’s initial response to lodged particles is based on the innate immune system’s general reaction to any foreign body plus some immediate chemistry such as wetting, acid-base reactions, dissolution; and
5). The body’s long-term response is closely tied to persistent inflammation, while the localized chemical response is closely tied to biopersistence and particle migration.The above points favor the ISO definition of nanomaterial with an advisory that for EHS purposes, we emphasize particulate matter. A suggestion would be for the definition on page 1:
nanomaterial: material with any external dimension in the nanoscale or having internal structure or surface structure in the nanoscale
Note: For EHS purposes the primary interest is in respirable and ingestible particulates, where the information developed can be extended to larger nanomaterials.
Vincent Caprio, Nano Business Alliance (NbA)
First, NbA urges NNI to prioritize the development of consistent terminology to insure regulatory initiatives are properly focused. Standardized terminology reduces the potential for unwarranted and commercially stifling regulatory measures that have the potential to undermine the successful commercialization of nano enterprises.
Second, the Alliance urges NNI to enhance its commitment to educate the public, including legislators and regulators, about nanotechnology to foster a thorough understanding of the benefits nanotechnology offers.
David Wagger (Institute of Scrap Recycling Industries inc.)
Figure 1-4 [8/9–13] should show recycling pathways from Product End of Life to each preceding step (e.g., refurbished used electronics, reused electronics components, and shredded hard-drives) and identify potential recycling worker exposure. Also, the text regards recycling unevenly, including it in Ch. 2 and Ch. 3 [10/35–36; 15/11–13; 18/18–20; 20/19–26] but tending to omit it in Ch. 5 and Ch. 6 [43/22–23; 48/22–25; 62/18–20; 64/32–34]. Recycling should be identified where appropriate.
…
Finally, ISRI agrees that “stakeholders have an essential role to play” [80/3–4] and would be interested in participating in the Strategy’s efforts to meet NNI Strategic Plan Objectives 4.1.2, 4.2, and 4.3.2.
Paul Sarahan
With respect to Chapters 4 and 5, the report should emphasize the need for proposed research projects to focus on and be designed to reflect real-life material usage, exposure doses, and exposure pathways, so that the results can be easily translated to real world operations in a meaningful way.
Regarding Chapter 6, I would encourage a review of existing statutory and regulatory authority that could spur nano operations to perform risk assessments as a regular course of business. See, e.g., http://www.fulbright…technologySafety.pdf , http://www.fulbright…technologySafety.pdf
Michael Ellenbecker
Page Line Comment
14 30 TEM and SEM are very valuable tools for analyzing properties of ENMs. Standardized protocols for sample collection, preparation and analysis need to be funded and developed.
15 18 Standardized methods for evaluating workplace exposures to ENMs must receive a very high priority.
20 17 We believe that the international harmonization of exposure assessment methodologies is of utmost importance. We recommend that US NNI agencies work closely with colleagues in the EU and elsewhere to ensure this occurs. It is important to recognize that different exposure assessment methodologies are appropriate for different exposure scenarios, i.e., exposure methods used for epidemiology studies will require different measurement equipment and strategies than exposure methods used for comparison to permissible exposure limits.
20 30 Again, it is very important that consistent quantitative assessment methods be used in all countries, so data can be compared and correlated.
24 4 International harmonization and consistency is extremely important here, since it is likely that in the near future the only way to establish large enough cohorts of workers exposed to a particular ENM is by combining populations from different countries.
30 6 The lack of any funded health surveillance projects is of great concern. Such projects should be designed and funded with international partners.
30 10 The safe levels of exposures should consider the effects of available controls applied to such exposure when the evaluation was taken, this is usually important for workplace exposure. Thus, the information about the control strategies used and associated with the studied exposure has to be reported.
30 30-38 The assessments for populations who are exposed to consumer products containing engineered nanomaterials will require a different evaluation/assessment strategy compared to workplace exposures.
31 3 The assessment models require further evaluation to be adopted for different scenarios. This will need large funding to develop the tools and appropriate instrumentation.
31 5 Harmonization of assessment models and data collection with international partners is important for further development on health surveillance.
60 44 We strongly agree with the statement that studies on exposure control methods are lacking. Equal emphasis must be given to controlling exposures as to evaluating them; the current NNI strategy seems to favor evaluation over control, which is a mistake in our view.
70 15 We strongly believe that another key principle should be “Develop effective strategies to effectively control exposures to ENMs.”
72 43 We agree with the importance of international coordination. All ENM research should be performed with an eye towards international coordination.
Lockheed Martin
The recommendation to create an exposure registry deserves further exploration.
For example:
- Who would establish the program to gather physician case reports and other reports of adverse events?
- What constitutes exposure and what factors determine who is entered into the registry? Exposure needs to be categorized. For example, the type of nanomaterials used in the workplace, exposure estimates, and control measures should be documented. Otherwise, data might not be collected in a format or using a method which could be used for future studies.
- There is no specific health impact identified, so would medical surveillance constitute a research study? Do the criteria and requirements for human subject research need to be applied?
- What type of medical surveillance should be performed? There is a wide variety of nanomaterials, and it is not likely that one type of medical surveillance will suffice for all nanomaterials. With the exception of draft recommendations from NIOSH for carbon nanotubes/nanofibers, very little has been published on this issue. Thus, NNI should consider providing recommendations for appropriate medical surveillance.
References to the “transformation products” of nanomaterials and the potential for human exposure to these transformed materials appear in the Human Health and other sections of the NNI document. The draft creates the impression that generation of “transformation products” from nanomaterials is a foregone conclusion and that there is potential for a biological response. Although basic environmental chemistry may allow one to predict how a chemical will be transformed when released into the environment, this is not necessarily the case with nanomaterials/nanoparticles due to their unique properties. NNI should support well-designed studies regarding if/how specific nanomaterials are transformed in the environment. This would provide useful data while saving resources otherwise expended seeking biological responses to an unknown or nonexistent transformation product.
The use of toxicological data to create computational models for predicting toxicity in silico along with references to high throughput testing are mentioned in the Human Health section. These technologies hold great promise for the future. However, a substantial amount of work remains to be done in developing reliable, reproducible methods for conducting in vitro and in vivo toxicity testing. The emphasis for the near term should be placed on refining the latter methods and collecting data essential for developing and understanding the toxicity associated with different nanomaterials.
Christopher Bosso, Ronald Sandler, and Jacqueline Isaacs
Environmental Justice. The EHS strategy makes only one reference to environmental justice (p. 40), and not in its standard understanding as the disproportionate exposure of high-minority and low-income communities to environmental hazards. Nanotechnologies and nanomanufacturing processes are likely to produce both environmental benefits and burdens, so any meaningful EHS strategy must address research, planning, and policy outcomes necessary to ensure that nanotechnology reduces any unjust distribution of environmental burdens and benefits. It is crucial that any meaningful EHS strategy promote the development of nanotechnology ways that distribute the benefits justly – e.g., that remediation focus on toxins prevalent in environmental justice communities and that “environmental illnesses” on which resources are spent include those, such as asthma, that are more prevalent in environmental justice communities. Whether nanotechnologies are likely to exacerbate or alleviate environmental injustice depends on how they are implemented, disseminated, and situated (and who or what factors determine these); who controls them; what sorts of oversight and regulations pertain to them; and how effectively these are enforced. To address such components require substantial community engagement and significant policy development. The EHS strategic plan must, therefore, include a research strategy for these aspects of environmental justice.
Regulatory design. The EHS strategy makes no reference to fostering a deeper understanding of the suitability of existing regulatory structures and approaches to nanotechnology. There is real doubt about the efficacy of existing federal environmental and health statutes (e.g., TSCA, FIFRA), and the current capacity of federal regulatory agencies (e.g., EPA, FDA) to adequately address the expected deluge of nanoscale applications and products. The situation at the state level is of even greater concern since state governments are often in the front lines when addressing environmental and health concerns. The absence of a focus on the basic design or orientation of an effective 21st century regulatory regime is glaring.
Public Outreach and Education. Public outreach and education is among the core strategic goals of the NNI, yet the EHS research strategy nowhere addresses these concerns. Developing effective models and strategies for engaging the public about nanotechnology EHS concerns in general and in particular contexts (e.g. siting of a nanomanufacturing facility) should be part of any EHS research plan aimed at promoting the public good. For example, a crucial component of environmental justice – and of democracy – is the right of citizens to know about possible EHS concerns in their community. Strategies for communicating about EHS to communities that build on existing best practices need to be developed. Moreover, communities need to be engaged to determine what their EHS concerns are and what sorts of environmentally beneficial nanotechnologies would be most important for their community. A research strategy is therefore needed to develop effective methods of public engagement to teach and learn from a variety of “publics” regarding EHS concerns and goals. Such engagement is crucial to the responsible development of nanotechnology, and may also reveal research needs and goals that are not readily recognized by the EHS research community.