If you ever wanted proof that the nanotechnology research community is floundering when it comes to safe working practices, look no further than a paper just published in the journal Nature Nanotechnology.  The paper, written by researchers at the Nanoscience Institute of Aragon (NIA) in Spain, surveys nanosafety practices in labs around the world.  Sadly, the flaws in the paper make the point that more needs to be done to raise safety awareness far more eloquently than its content.

The paper “Reported nanosafety practices in research laboratories worldwide” by Balas, Arruebo and Santamaria sets out to survey safety practices used in engineered nanomaterials research.  This is a critical area – anecdotal evidence suggests that good work practices are patchy in research labs, and that dismissive attitudes to safety or lack of awareness of recommended safety measures are not uncommon.  A survey of current safety practices that replaced anecdotes with hard data would have been extremely useful in helping raise the bar here.  Unfortunately, this is not that survey.

NIA is a nanotech research lab – its expertise is in creating new stuff, rather than assessing safety.  In fact the paper’s corresponding author Jesus Santamaria is the laboratory’s Vice Director.  In other words, NIA would have been a perfect participant in a safe practices survey.  But whether they have the necessary expertise to conduct such a survey is another matter entirely.

I would love to deconstruct this paper as I did the Daily Mail nanotech story on “Grey Goo” a few weeks ago.  But due to copyright I cannot reproduce it in full here, so that’s out.  Instead, I thought it would be interesting to extract a few of the key statements and recommendations the authors make, and see how they stand up to scrutiny:

“An online survey shows that most researchers do not use suitable personal and laboratory protection equipment when handling nanomaterials that could become airborne”

This is the top-level summary of the paper.  It’s a sub-heading that wouldn’t look out of place in a Tabloid newspaper.  And its impact hinges on two words – “most” and “suitable.”  Unfortunately, neither seem justified.

The paper reports the results of survey of people selected from the authors of nanomaterial-related publications published between 2007 – 2009.  240 surveys were completed – around 10% of those solicited.  Extrapolating these data to the entirety of nanomaterials researchers with that phrase “most researchers” is a large jump.  But more significant is the term “suitable.”

Out of all those researchers surveyed who thought the materials they were using might become airborne at some stage, 21% didn’t use any form of “special protection” and 30% didn’t use respiratory protection.  Yet there is no way of telling from the survey whether “special protection” (the authors’ terminology) was needed, or indeed whether any respiratory protection was needed.  A researcher handling small amounts of fumed silica for example – used as a food additive amongst other places – might well handle it using established lab safety procedures that are entirely adequate and don’t include the use of a respirator – in this survey they would be classed in the category of “most researchers” not using “suitabe personal and laboratory protection.”

“We find that only about 10% of researchers who are working with nanomaterials reported using nano-enabled hoods, and one in four did not use any form of general laboratory protection.”

The survey question associated with this statistic was “General laboratory safety during synthesis and handling: No special protection; local extraction on lab-bench; standard fume hood; fume hood with nanosized filters (i.e. HEPA); special “nano-safe” fume hood; Other.”

The jump from “no special protection” (which I would interpret as general lab safety procedures were used) to “did not use any form of genera laboratory protection” is eye-poppingly large, to say the least.  And without information on material quantities and characteristics, who knows whether “nano-enabled” hoods were in fact needed by all of these researchers?

“Despite knowing the materials they made could become airborne, about 30% of researchers did not use any type of personal respiratory protection.”

The associated survey questions were “May the nanomaterials become airborne at any stage of the synthesis: Yes; no; I don’t know?” and “Personal protection equipment when handling nanomaterials: None; mouth mask w/o filters; respiratory mask w. standard filters; full face shield w. filter; full body protective equipment; other?”

If a material became airborne in an enclosed part of the process, but not where exposure could occur, a respondent could easily answer “yes” to the first question and “none” to the second – placing them amongst the 30% alluded to.  And yet they would not have been acting inappropriately.

Around 90% of the respondents were either not aware of or did not think there were regulations at the local or national levels for handling nanomaterials… This is not surprising because only a few regulations on nanomaterials have been enacted.

Respondents were asked questions like “Are you aware of any international legislation for handling nanomaterials?”, “Is there applicable a State/Local legislation for handling nanomaterials?” and “Is there applicable a Federal/National legislation for handling nanomaterials?” As no such “legislation” for handling nanomaterials safely in laboratories exist, it’s not surprising that most respondents weren’t aware of them, or didn’t think they had been written.  I’m not sure what useful information was expected out of this question.  But it does worry me that the responses are presented to suggest a lack of awareness amongst researchers, rather than a lack of regulations.

“…nearly three quarters of respondents reported not having internal rules to follow regarding the handling of nanomaterials; approximately half did not have rules and 27.1% were not aware of any internal regulations.”

Despite the potentially confusing use of “rules” and “regulations” this is actually a useful piece of information.  The question was “Does your organization have an internal set of rules or handling nanomaterials: Yes; no; I don’t know?” One would hope that the answer was yes in most cases – clearly this is an area where more effort is needed.

“Regarding general laboratory protection measures, 24% of respondents did not use any type of protection, and 15.2% reported only using local extraction on the lab bench… Taken together this means that nearly 40% of researchers working with nanomaterials reported using none or only weak means of general laboratory protection.”

To recap, the question here was “General laboratory safety during synthesis and handling: No special protection; local extraction on lab-bench; standard fume hood; fume hood with nanosized filters (i.e. HEPA); special “nano-safe” fume hood; Other.” Looking at this, the statement made is patently wrong. “No special protection” is not the same as “did not use any type of protection.”  And local extraction on the lab-bench is not necessarily a “weak means” of control.  As a consequence, this statement is misleading at best.

“When it comes to the use of PPE [Personal Protective Equipment], about 48.8% of researchers reported not using any type of respiratory protection and 24.4% used a mouth mask without filters, which is clearly an ineffective form of protection.”

That 48.8% of researchers not using PPE includes researchers using materials unlikely to become airborne (according to the survey) – so it’s perhaps not surprising the figure is so high.  I’m still trying to work out what a “mouth mask without filters” is – not something I have ever come across.  If, as I suspect, the authors were envisaging a N95 respirator, authoritative organizations like NIOSH do not class this as “an ineffective form of protection.”

About 85% of researchers declared disposing of nanomaterials either without a special procedure (24.3%) or with the same procedure as for other chemicals (61.0%).  This seems at odds with the fact that 81% of researchers stated that nanomaterials should be treated as hazardous waste unless they are known to be non-hazardous.”

There is considerable confusion here, and it stems from an assumption that nanomaterials need to be disposed of in some unique way.  The associated question on the survey was “Do you follow a special procedure for disposing of nanomaterials?  No special procedure; the same as for other chemicals; yes, a special procedure designed for disposing nanomaterials; others?” In answering this, anyone who routinely treated nanomaterials as a hazardous material would answer “no special procedure” or “the same as for other chemicals” – which makes perfect sense.  The interpretation of the survey returns as indicating poor practices here does not hold up well to scrutiny.

51.7% of the researchers reported using the same Materials Safety Data Sheet irrespective of whether they were handling bulk or nanosized material”

The trouble is, 60% percent of researchers were synthesizing their own material, and so wouldn’t have associated Materials Safety Data Sheets – unless they wrote their own.

“Until widely accepted exposure levels and monitoring procedures become available, the general guidelines provided by reliable organizations should be immediately implemented.”

This makes sense – although some help on what defines a “reliable” organization would be useful.

“Finally, scientists should self-regulate, because they are the ones who decide how nanomaterials are handled in the laboratory and are ultimately responsible for implementing nanosafety practices.  One effective way to speed-up the adoption of safety precautions would be for journals to require a specific description of nanosafety measures within the methods or experimental section of all papers dealing with nanomaterials”

So, a survey that appears to suggest that scientists are doing a lousy job of working safely with nanomaterials in the lab suggests that self-regulation is the way to go. And to “enforce” this self-regulation, journals should impose a burden on authors that is not necessary when publishing work on a thousand and one other extremely noxious materials.  I’m still trying to get my head round this one!.

I really don’t want to slam this paper – safe lab practices for working with engineered nanomaterials are critical, and greater efforts are urgently needed.  At the same time though, it’s hard to see how questionable research like this will support progress. The trouble is, this survey seems to have been conducted by team who understand little about crafting effective questionnaires, and who have a poor grasp of what is relevant and what is not when it comes to working safely with engineered nanomaterials.

But here’s the irony – the inadequacies of the paper illuminates more eloquently perhaps than the survey itself that researchers in nanotech laboratories are out at sea when it comes to understanding safety issues: This particular group of asked the wrong questions, didn’t ask the right ones, and interpreted what they got back within a questionable framework.

Clearly, they need help.

And this is perhaps the strongest message to come out of the paper, inadvertent as it is – that more is needed and faster from “reliable organizations” on working safely with engineered nanomaterials in the lab – before someone does themselves an injury.

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I didn’t want to make a big deal of it above, but I found it worrying that on two of the questions in the supplementary information, the questions and answers are transposed.  What you have in is:

“If dry synthesis, please specify method: Co-precipitation; thermal decomposition; sono-chemistry; polymerization; reverse micelles; other”

“If wet synthesis, please specify method: Laser pyrolysis; CVD/PECVD’ mechanical attrition; electrical discharge; laser ablation; other”

Anyone involved in nanomaterial synthesis will spot that the wrong answers have been mateched with the wrong questions.  Hopefully this was just an error in the supplementary information, and the original survey was correct.  But I guess someone should check…

The most recent estimate from the U.S. National Nanotechnology Initiative (NNI) puts nanotechnology risk research investment at $68 million for 2006 (the only year complete figures are currently available for—apparently).  Yet theProject on Emerging Nanotechnologies (PEN) has just completed its own assessment—and could only find $13 million associated with research projects primarily focused on addressing nanotechnology risk in the same year.  What gives—are the feds indulging in a bit of creative accounting; or have PEN forgotten the basic rules of arithmetic?

Let’s be honest, I’m not a great fan of bean-counting.  Evaluating research in terms of dollars invested (or Pounds or Euros) is a crude tool at the best of times.  But when it comes to assessing investments and returns, the fact is that bottom-line figures count.  

Faced with counting research dollars, organizations have two choices: use the figures to justify past performance, or employ them to inform future actions.  The former is the easy option—matching what was invested to what was done, rather than what should have been done.  But using past spending as a feel-good exercise is a disaster when it comes to future planning—because the assessment is invariably based on wishful thinking rather than reality.

Admittedly, the U.S. National Nanotechnology Initiative has taken a structured approach to evaluating investment in risk research.  As outlined in its recently-published nano-risk research strategy [PDF, 2.2 MB], nanotechnology risk research needs have been divided into five overarching areas; each consisting of five specific research priorities.  Research funded by the federal government in fiscal year 2006 (running from October 2006 to September 2007) has then been evaluated in terms of its relevance to these research priorities.  

The result: 246 projects that were identified as addressing nanotechnology risks in 2006.

From the report’s executive summary:
 

“In FY 2006, the Federal Government invested $68 million in 246 projects at seven agencies.  Although research categories were not prioritized with respect to each other, there is consensus among members of the NEHI Working Group that research in the Instrumentation, Metrology, and Analytical Methods category is cross-cutting, supporting research in every other category, and therefore is generally a high priority. Among the five research categories, the distribution of projects and spending was: 78 projects ($26.6 million) in Instrumentation, Metrology, and Analytical Methods; 100 projects ($24.1 million) in Nanomaterials and Human Health; 49 projects ($12.7 million) in Nanomaterials and the Environment; five projects ($1.1 million) in Human and Environmental Exposure Assessment; and 14 projects ($3.3 million) in Risk Management Methods. In short, the analysis demonstrated that the Federal Government is supporting more EHS research than has been previously identified, and the research is well-distributed across key priority areas.”

$68 million in one year sounds a lot.  But what does this mean—that all of these projects were dedicated to addressing critical knowledge gaps in the quest to develop safe nanotechnologies, or that 246 projects could somehow be justified as having some relationship to the five research categories?  The distinction is crucial—on the one hand you have a strategically important assessment; on the other, a justification for past actions.

Assessing the value and relevancy of research is not easy—as well as projects dedicated to addressing risk, there are those where risk research is a major component of a more general nanotechnology project; or projects supporting research that could be relevant to understanding risks—if it was applied in the right way.  

Reading through the government’s strategy document, I suspect that the NNI lumped all of these different types of research together without making clear distinctions.  For instance, when assessing research relevant to nanomaterials and human health, the NNI report states:
 

“Much of the research reported for FY 2006 focuses on medical applications. While this focus does contribute to the overall body of knowledge for human health effects, more systematic, targeted study of classes of nanomaterials and the relationship of their physical and chemical properties to biological response would provide better integrated data sets for risk assessment and risk management. These efforts should build upon the existing research whose primary focus is human health and safety.”

But how were these applications-focused projects evaluated in terms of their relevance to risk?  How well does the reported $68 million reflect research that will provide clear answers to well-defined risk questions, and to what extent (if at all) were nano-applications projects used to pad this figure?  Unfortunately, the report does not divulge this—just as it does not list project-specific funding that would enable an independent evaluation of the report’s assessment.

It is this lack of transparency that prompted the PEN analysis of risk-research funding for 2006.  Staring with the 246 projects listed in the NNI document (and removing those projects listed more than once), we matched the projects—where possible—to publicly available information on funding.  We then assessed the summary of each project (available on-line here), and determined whether the research being undertaken was highly relevant to addressing nanotechnology risks, substantially relevant, had some relevance, or was only marginally relevant.  We also classified the research in terms of whether it was primarily focused on engineered nanomaterials, or nanomaterials from other sources (incidental or naturally occurring).

Just to clarify; projects primarily focused on addressing nanotechnology risk (such as toxicity and exposure studies) were classed as being highly relevant.  Those focused on applications (or basic research), but with a major component addressing risk were classed as substantially relevant.  If a project was primarily focused on basic research or nano applications, but was generating information of direct use to understanding and addressing risks, it was classed as having some relevance.  And finally, research that could conceivably be useful to addressing risks—but only if there was increased investment in applying it to environmental health and safety implications—was classed as having marginal relevance.

The results of this exercise are freely available in the PEN Nanotechnology Environmental Health and Safety Research inventory – accessible here.  Although reproducing our assessment of the NNI-listed research is tough because the inventory contains a number of relevant projects that the federal government missed, the data can be searched and evaluated to give a reasonably clear idea of risk-relevant research funded in the U.S. and many other countries. 

Our classification of the NNI-listed projects is also available in testimony to the U.S. Congress House Committee on Science and Technology hearing on the National Nanotechnology Initiative Act of 2008, held 16th April 2008 [testimony available here].  This list contains estimates of annual funding for each project, and may be used to verify the PEN assessment of the NNI’s 246 risk-relevant projects.

And the assessment is revealing.  We could only find $13 million invested in research projects that were highly relevant to nanotechnology risk and received funding in 2006.  These are the projects that directly address environmental, health and safety impact. 

Including substantially relevant projects in the assessment brings this figure up to $29 million—still a little shy of the NNI-reported $68 million!

If these figures look low, take a look at the projects listed in Wednesday’s testimony and see whether the categorization looks reasonable.  To whet your appetite, here are examples of listed projects from each category:

Highly relevant: Example – Monitoring and Characterizing Airborne Carbon Nanotube Particles (NIOSH, Est. funding $400,000 over 3 years). [link to inventory record]

Substantially relevant: Example – Nanoparticles for efficient delivery to solid tumors (NIH, Est funding $333,084 over 3 years).  [link to inventory record]

Some relevance: Example – Nanoscale Science & Engineering Center for Integrated Nanopatterning and Detection Technologies (NSF, Est. funding $12,702,550 over 6 years).  [link to inventory record]

Marginal relevance: Example – National High Magnetic Field Laboratory (NSF, Est. funding $171,883,246 [not a misprint] over an estimated 6 years).  [link to inventory record]

I would be the first to agree that research in the areas of drug development and metrology—which account for many of the projects in the “substantial” and “some” categories—may be very beneficial to addressing risks.  But in the short term, this is not research that is going to answer the questions on the top of most people’s “urgent” list.  To pretend otherwise is like going to the doctor with a headache, and being told that there are millions of dollars being invested on research on cancer drugs that might also offer insight into the underlying mechanisms for head pains—when all you wanted was an aspirin!  

Fortunately, Europe seems to be a little more on the ball—in terms of honest reporting at least!  Risk research listed in the recent document “EU nanotechnology R&D in the field of health and environmental impact of nanoparticles” [PDF, 400 KB] lists projects that are almost all highly relevant to addressing risk (in my assessment at least).  And crunching the figures, you arrive at a European-wide investment in highly relevant nanotechnology risk research for 2006 of around $24 million—not far off twice the U.S. investment.  

These figures are also in the PEN inventory—for anyone to see and verify. 

The NNI’s $68 million may be a feel-good figure; it may be an attempt at international one-upmanship; or it may just reflect a naïve understanding of how to assess the true relevance and value of risk research.  Whatever the explanation, it does little to enable a true assessment of what still needs to be done to find answers to critical questions.

In terms of bean-counting to justify past performance or inform future actions, I have to conclude the NNI is guilty of the former.  The last sentence in the NNI quote above seems to confirm this: 

“In short, the analysis demonstrated that the Federal Government is supporting more EHS research than has been previously identified, and the research is well-distributed across key priority areas.”  

The PEN assessment provides in my opinion a much more honest perspective on what is and is not going on, that has the potential to inform future research strategies.  The good news is that it is also the basis for the OECD Working Party on Manufactured Nanomaterials international database on environment, health and safety research [further details here].  Hopefully the release of this database in June of this year will bring some much-needed transparency and accountability to what has so far been a less than transparent process.

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This post first appeared on the SAFENANO blog in April 2008