Well I guess I set myself up good and proper – I should have realized that in asking people for their questions on nanotechnology safety last week, they would actually want answers!

Having failed miserably to compile a catalog of websites that provide clear and concise answers to the questions asked in last week’s blog (I gave up after the 6th question),  the least I can do is provide some my own answers.  So here they are…

This being a blog and it only being an hour ’till lunchtime,  the answers are rather brief and off the cuff.  Hopefully they are of more use than not.  But if something doesn’t seem right, please check it out – and let me know.

Before I begin though, I must thank the brave souls who did attempt to provide links to answers in the previous blog – thank you!

The Questions, and some Answers:

1.  What sort of nano budget does FDA have?

If you look at the National Nanotechnology Initiative budget – a compilation of US federal agency investment in nanotechnology – FDA does not have a specific nano budget.  That said, the agency does have a number of people working on regulatory issues associated with nanotechnology in general, and engineered nanomaterials specifically.  FDA also supports the National Toxicology Program in the US, which is investigating the toxicity of a number of engineered nanomaterials, and has its own labs at the National Center for Toxicology Research, which are involved in nanomaterial toxicity studies.  So while it is tough to get a handle on the agency’s nano budget, this doesn’t mean they are not working in the area.

2. With something like nanosilver, is it possible to design out the hazard while keeping the “benefits”?

This is a tough one.  It would be nice to be able to do this, and there may be some possibilities here.  The main way silver kills microbes is to release silver ions, which are toxic to many microbes.  Silver nanoparticles are useful in that they release ions (effectively they dissolve) faster than the same quantity of larger particles, and they can be added to a wide range of products.  There is also some evidence that the nanoparticles themselves might be harmful to microbes.  The big problem here is that you have to have the ions to be effective – and if you are releasing the silver ions into the environment, they could do more than just kill the microbes you want them to.  But if there was a way to limit the rate of release and ensure only the microbes you want to get rid of come into contact with the silver ions, it might be possible to reduce possible risks while increasing benefits.  Some of the smarter uses of silver as an antimicrobial seem to be taking this approach.  The thing we really don’t want to do here is release silver nanoparticles into the environment without much thought, where they will continue to release ions and potentially cause damage.

3. What are some of the most interesting nanoparticles found in nature (not manufactured in the lab)?

I guess it depends what is meant by “interesting.”  Certainly, nanoparticles are a fact of life, and were long before humans were around.  Anything that burns and many things that get very hot release nanoparticles – think fires and volcanoes.  Liquid sprays that contain small amounts of dissolved substances can also produce nanoparticles as they evaporate – sea spray for instance is a great source of nanoparticles.  And then you have reactions between different chemicals in the atmosphere that produce nanoparticles.  Photochemical smog is a great example of man-made atmospheric “nanoparticle factories.”  But nature was there before us – terpenes released by trees can form nanoparticles in the atmosphere (the blue haze associated with the Blue Ridge Mountains is a result of naturally occurring nanoparticles).  These are all certainly interesting nanoparticles.  But they usually differ from engineered nanoparticles in that they are usually complex mixtures of nanoparticles and other stuff.

4. When will we know if it’s safe enough? I understand toxicity eg nanotubes. Do we think we can mitigate? What is safe enough?

I’m afraid that “safe enough” is a question that only policy makers, citizens and others can answer.  Science can provide information on how safe – or how risky – something is.  But then it’s up to others to work out when this is okay, and when it is not.  When it comes to nanotechnology, the first step is dividing nanotech into specific materials and products, as each will present different safety questions – including how safe is safe enough.  For example, safe enough for a cancer treatment will be very different from safe enough for a baseball bat.  We then need to work on where the plausible risks are – the materials and products that are more likely to present safety issues that we are not set up to handle well.  Then, we can start to work out where the knowledge gaps are, and how to fill them.  Governments and industry around the world are a good way along this path, although there is a long way to go still before some products of nanotechnology can be deemed “safe enough.”  For instance, we still don’t have a good handle on how to use carbon nanotubes safely, or what the safety issues around developing nanoscale food ingredients are.  On the other hand, there are nanotech-related products that, on the current balance of evidence, appear to be reasonably safe – I would consider sunscreens using well-engineered nanoparticles of titanium dioxide and zinc oxide in this category.  The bottom line though is that we still need to work on defining what is safe enough, and identifying new safety issues that emerge as nanotechnology progresses.

5. Given the nano-size of the particles, are there any effective respirator filters to guard against inhalation?

Yes.  There are some unanswered questions here, but in general, respirator filters are better at capturing nanometer-sized particles from the air than larger particles.  It sounds counter-intuitive, but the secret lies in Brownian motion.  Smaller particles are batted around more than larger particles by air molecules, and as a result are more likely to collide with and stick to the filter fibers or membrane.

6. What do you feel the repercussions are for extended life through utilization of nanotechnology?

Interesting question.  I think there are profound implications associated with the possibility of extending life – especially extending the span of productive/high quality life.  And nanotechnology is one of a suite of technologies that could lead to significant extensions to lifespan. Yet I’m not sure that nanotechnology per se raises questions as much as the implications of extending life – no matter what the technology used.  In thinking about the “repercussions” (I prefer “implications”) of extending life more generally, a lot has been written on this.  The possible implications are both fascinating and challenging – ranging from the possibility of severe planetary over-population, to extreme (and divisive) divides between those with and without access to life-extension technologies, to the possibility of greater environmental and social awareness as people become more aware that they have to live with the consequences of their actions.

7. How are safety tests carried out in nano tech?

There are suites of toxicity tests that are used to determine the hazard associated with chemicals.  Which ones are used depend on the regulations governing the material and how it will be used.  For instance, the toxicology tests on a new drug are substantially more comprehensive than those that would be used on a new cosmetic.  Some of these use cell cultures – in vitro tests.  Some of them are able to provide an indication of hazard without cells, by probing the chemical nature of a substance.  In other cases, computer models are used to get a handle on how toxic a new substance might be.  Most toxicologists agree though that most of these tests only go so far in predicting how a new substance might harm humans, and at some point tests with animals are needed – in vivo tests.  There are moves around the world – and rightly so – to minimize animal testing, and to find alternatives where possible.  Unfortunately, when it comes to brand new materials such as some engineered nanomaterials, it is extremely hard to predict how these materials might behave in a living organism from modeling and cell cultures.  This problem is compounded by some established toxicity tests that have been devised for chemicals not working well for some nanomaterials.  So the toxicologists face a quandary – do they rely on non-animal tests that may not be adequate, and risk allow products on the market that could cause serious harm, or do they test these materials on animals, to minimize the chances of something bad happening?  It’s a tough question.  But the bottom line is that most people involved in ensuring people are not harmed by new products will use the best possible suite of tests to provide them with the best possible information on product safety.

8. Seems that (nano)tech is moving v.fast. Is there a risk that results of safety testing will be out-of-date as soon as printed? How to keep up pace?

This is a challenge for sure.  I don’t think that sound toxicity tests will be quickly out-dated.  But I do think that there is a danger of increasingly sophisticated engineered nanomaterials being produced and used before we have a good handle on how to evaluate their risks, and develop protocols for safe use.  I would argue that in order to keep pace with the technology we need to rethink how we approach safety:  We need to work out how to reduce possible risks before we have all the safety data (by reducing exposures for instance); we need to learn how to predict possible hazards, and work out how to engineer them out of products during development; and we need better ways of tracking new developments so that we can respond quickly to safety issues.  We’re making some progress here.  But we have a heck of a long way to go still.

9. Is it possible/ necessary to regulate the use of materials which don’t yet exist?

It’s tough to regulate something that doesn’t exist!  What we can and probably should do is to use regulation, and other forms of oversight, to create frameworks within which emergent risks will naturally be identified and addressed – more a set of principles than hard command and control regulation.  The trick here is not to think of regulations as a list of “do not’s”, but as sophisticated tools for reducing uncertainty and increasing safety as businesses develop new materials and products.

10. We all want safety decisions to be informed by sound science, yet decisions must be made (indeed are being made) now, in most cases with relatively little useful data. What’s the soundest way to approach such decision making?

The million dollar question, as new materials and products come along faster than the safety science can keep up!  I would argue that we always have to come back to evidence-based decision-making as the foundation of what we do here, but that we desperately need new tools for making decisions in the absence of hard data.  There are a number of approaches to this that are emerging.  Control banding for instance is an approach to reducing risks in the workplace in the absence of good exposure data, and may be extend-able to working with new nanomaterials.  Multi-Criteria Decision-Making is another approach that is being developed to make decisions where data are lacking, or where the data are complex.  Then there are a number of approaches to filling gaps in toxicity and exposure data when trying to develop safety guidelines for new materials.  So we have some tools in the toolbox here for making decisions in the absence of data.  But the reality is that, looking to the future, we are going to be increasingly faced with situations where the data are incomplete, or the evidence is complex, and we are going to have to get increasingly sophisticated with how we make decisions in these cases.

11. Are their any lessons learned (societal/ethical issues) from GM foods that could be applied to the engineering or mechanical manipulation of foods through nanotechnology?

Enough to fill a book is the answer I think.  I’ll just touch on a couple here though.  First, issues associated with nanotechnology is very different from the issues surrounding genetically modified foods, and it is dangerous to compare them too closely.  For one thing, while GM foods are reasonably well-defined, nanotechnology is an umbrella term encompassing a huge diversity of technologies.  But looking to the GM food debate (some would say debacle), two critical issues were perceived heavy-handed tactics from big industry, and a lack of transparency – it seemed that what people really didn’t like was companies making decisions on their behalf, then not telling them about it!  Looking to nanotechnology, there are a number of important lessons to be learned here about how to engage with people when developing and introducing a new technology, to ensure that it is what people want, that they understand the pros and cons, and that they have

12. What should consumers know about nano-foods that labels won’t tell them?

“Should” is a strong word.  But I do think that many people would like to know that they could find out more about how nanotechnology was being used in the foods they were eating – and I’m sure regulators would like a better handle on this as well.  In terms of information that would be useful, I think you have to look at the ingredients list – a simple “nano-inside” sticker is a non-starter as it contains no useful information, while possibly raising speculative and in many cases unsubstantiated concerns.  On that ingredients list, I think it would be useful to identify where something has been specifically engineered at the nanometer scale and added to the food to add value to the product.  This could simply be a case of adding a “n” before the ingredient – nSiO2 for instance.  But this in itself isn’t of much use to the user – without more information, they won’t be able to tell whether that “n” is a good thing, a worrisome thing, or nothing worth fretting about at all.    What I think would be far more helpful is finding a way to link from product labels to more detailed information on the web.  Imagine for instance that you could take a snapshot of the bar code on a product using your smart phone, and be taken to a database that let you know what was in the product and why.  This would be a farm more effective way of providing people who were interested with useful information on the nano in their food – if and when it gets there (and there are remarkably few food products on the streets that clearly and unambiguously contain engineered nanomaterials).  The good news is that this is a technology which is already gaining ground.

13. Nanotech pervades all sectors and there is a huge range in riskiness between the applications. How can we develop a meaningful triage system to prioritize sectors, product classes, products and materials with respect to safety?

Short answer – stop talking about nanotechnology, start talking about specific technologies and the products that use them, and make sure we ask scientifically plausible questions about potential risks, rather than being driven by speculation.  This is a huge issue – not just for nanotechnology – and more thinking is needed on how we begin to identify and address plausible safety issues, without being side tracked by questions that, while interesting, are more speculative than scientifically sound, and run the risk of distracting attention from more important issues.

14. How will we deal with imported nano products and how will we know they are nano?

With great difficulty I think.  Oversight of imported products – whether nano or not – is a major issue in today’s globalized market.  It’s a problem that has got regulators the world over worried.  Add nanotech in, and the problem becomes even greater – because now you have products with components that may lead to new safety issues, that do not have to be identified, and are not easy to detect!  I suspect though that part of the solution is to avoid getting too hung up on nanotechnology, and to start focusing on specific materials that raise new safety issues, and develop ways of detecting and overseeing the use of these materials.

15. What is the risk of NOT developing nanotech (in health care, environmental protection, economic development)?

I suspect that the answer to this question will differ wildly according to who answers it, but my opinion is that we cannot afford not to develop new technologies such as nanotech.  I would argue (and have done so on this blog) that the challenges facing humankind over the next 50 plus years cannot be solved using conventional technologies alone.  Access to nutritious food and clean water; disease treatment and prevention; clean, renewable energy – these are all challenges that we currently do not have the tools to address effectively.  Of course, nanotechnology is one of a number of emerging technologies that can help.  And any emerging technology-based solutions must be integrated with social, economic and conventional technology innovations if we are to ensure the focus remains on solving the problem rather than simply playing with the next new “technology toy.”  That said, I suspect that a failure to develop responsible and sustainable nanotechnologies will have a severe impact on people’s lives and the environment in the future.

16. What is the risk overall? Technology has not made us necessarily healthier and happier – although life expectancy has undeniable risen. Will the advances in 100 sectors be nullified by one “bad sector” (say nano use in weapons)?

I’m not sure you can talk about the overall risk of something as broad as nanotechnology.  Thinking as broadly as possible, there are risks associated with developing nanotechnology without appropriate checks and balances, just as there are risks associated with impeding its development at the expense of people who need food, water, medical treatment, energy…  But it’s far more useful to think about the pros and cons of specific applications of nanotechnology.  Of course, there is always that chance that, because we are working under this “brand” of “nanotechnology”  if something bad happens in one sector – say a new nano drug goes badly wrong – it will have a knock-on effect on other areas where nanotechnology is being used.  This is a possibility as so much has been lumped together under the banner of nanotech.  But I suspect that people are sophisticated enough not to stop using their nanotech baseball bat because the latest nano drug has problems.  Of course, this won’t stop equally sophisticated people from using nano-problems to push other agendas, if they see the opportunity.

17. We may need new bioassays. Can they be designed to simultaneously address animal welfare issues? Can they become models for use in non-nano contexts? Can there development be justified, financed and sped up on that argument?

As new toxicity testing challenges arise with some engineered nanomaterials, I see no reason why this cannot be used to stimulate further research towards minimizing the use of animals in tox testing.  In fact, I would argue that it is important that every opportunity is grasped to find more humane ways to evaluate material and product safety (this was something I highlighted as being important with my colleagues back in 2006 in a commentary in the journal Nature).  Nevertheless, I do feel it is important to ensure whatever assays are used, they lead to the use of products that will not end up inadvertently harming the user.

18. What is the difference between nanotech, biotech and synthetic biology?

Get ten experts in the same room, and they’ll give you at least twenty different answers to this one.  But here’s my take:  Biotechnology is a very broad technology that covers the use of biology in agriculture, food and medicine.  The term often refers to intentionally manipulating the genetic code of organisms – usually at a fairly crude level – to change them in ways that are perceived as being beneficial.  Nanotechnology is about engineering matter at a scale just a little larger than atoms and molecules, and taking advantage of the new and unusual properties that can result from such fine-level engineering.  Nanotechnology is often (but not exclusively) thought of as involving non-living materials.  Synthetic biology on the other hand is all about manipulating the genetic code of organisms at the nanometer scale, to either alter them in useful ways, or to create new organisms.  The truth of the matter is though that each of these terms is a clumsy shorthand for a continuum of science and technology innovation that is providing us with an increasingly sophisticated level of control over matter at the finest level – whether that be in living systems, dead systems, or combinations of the two.

19. Is there sufficient attention to the “soft science” of safety research? Governance, ethics, public relations, process research, organizational research, etc?

I would certainly argue that more need to be done here – much more.  Think about it – we live in a world where not only do we need to make decisions in the absence of information, but the very dynamics of decision-making the world-over are changing.  “Hard” science is not enough on its own to cope in this new world.  We also need to know how it fits in to a complex and shifting social, political and economic environment.  And for this, we need expertise in areas like engagement, governance, social decision-making, and a whole host of other “soft” areas.

20. The problem I have with the whole issue is that nanotech is not a “single” field, like polymers or vaccines, drugs or pesticides, say. Instead it’s a vast area of sci-tech defined rather arbitrarily by the size of the entities/particles involved. We need some way to ensure policy makers are not forced into a corner where they throw a blanket over all nanotech. How can that be achieved?

So true.  I think I touch on this a couple of times above, but somehow we need to decouple the products of nanotechnology from the brand of nanotechnology – so we can have science-informed dialogues on issues that are well-defined.  But how to do this?  We could start making sure that people have access to good information, and that they are fully engaged on the issue for a start.

21. How do we assess long term impacts in short term safety tests & decide it is safe enough?

The unfortunate truth here is that we still struggle to do this with non-nano substances, never mind the products of nanotechnology.  There are ways in which we can get a handle on what some long term impacts might be – the various assays for potential genotoxins, carcinogens etc. are helpful here for instance. But we still have a long way to go.  Maybe we should see this as an opportunity for engineered nanomaterials to stimulate some new ideas and approaches here.

22. Who is accountable if we do miss long term impacts?

Huge question.  I guess, depending on which country you are in, the lawyers would say whoever you can sue is accountable!  But beyond the possibilities of litigation, who is accountable for the impacts of decisions made – or not made – now?  Businesses developing new products are accountable to their shareholders and, perhaps surprisingly to some, their stakeholders in many cases – including customers (a number of businesses have strong value systems and codes of conduct that place stakeholders above shareholders).  This naturally leads to some degree of short to medium term accountability.  On the other hand, looking at government, it is hard to find any true accountability for the medium to long term consequences of actions – especially in an area like nanotechnology which cuts across so many departments and agencies.  Clearly, this is something that needs to be addressed.

23. What % of gov and business budget should be spent on safety?

A few years ago, a number of groups were arguing that 10% of the US nanotechnology research and development strategy should be devoted to health, safety and environmental impact-related research.  These days, I would argue that how the money is spent is at least as important as how much money is spent.  If you don’t start out with the right questions and a reasonable idea of how to get the answers, no amount of funding is going to get you to where you need to be.  That said, once you have a sound strategy, 10% of nanotech R&D is not a bad starting place.  A couple of years ago I was on a congressional testimony panel when a colleague from BASF was asked how much industry invest in ensuring the safety of a new product.  From what I remember, the answer was around 15% of the R&D budget.

24. How do we get companies to share their safety data to add to the body of evidence on safety?

Find mechanisms by which companies can share useful safety data without compromising their business, and develop trust and partnerships between businesses and other stakeholders to make data sharing easier.  This is a tough one though.  Most people in the business think it’s important and should be possible, but no-one’s come up with a viable solution yet.

25. When will 2020 Science learn to count?  (my apologies – realized after posting that I had missed four questions!)

Come off it, I’m a physicist.  Counting’s for engineers!

My apologies for the lack of links and citations here.  Time didn’t allow for more than a quick fire response – maybe this is something that needs to be added in at a later date.