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Technology

Nanotechnology Regulation

Nanotechnology applications chart

Last week I did not post as I was preparing to chair a session at a plenary for the European Commission in Brussels. Full details are available here, but today I would like to pose a few issues that were raised during the event.

This is not the first time I have spoken at conferences about nanotechnology regulation, nor is it my first Technology bloggers post on the matter. Readers might like to take a look at these posts going back to 2012.

But as an overview my interest is in regulation. And the problems raised 3 years ago are ever more pressing. Nano products are everywhere (see the diagram above, and that is old), they do not have to be labeled, and there are still questions about health and regulation that have never been answered.

Last week’s topic was the Responsible Nano Code, a document drawn up to offer guidance to nanotechnology producers as a guide. It is voluntary, has no legal standing (I will come on to that though) and is a set of principles rather than a regulatory code.

The code can be freely downloaded here.

The principles address issues such as Director Board accountability and involvement, stakeholder involvement, worker health and safety, public health, safety and environmental risks, wider social, health, environmental and ethical implications and impacts, engaging with business partners and transparency and disclosure. And if you read the code you find nothing that anyone wouldn’t agree with.

The preparation was a serious endeavour too, it took several years to come to its final draft, and involved a lot of people. Founders included the Royal Society, Nanotechnologies Industries Association, Nanotechnology Knowledge Transfer Network and Insight Investment.

Upon completion the code was presented across the world. In the USA however several problems were seen due to the nature of the law there. One problem is the risk of being sued. If a company states that they follow a code they become liable to legal action if someone can demonstrate that they did not in fact follow some aspect of the code. So companies are reluctant to state that they follow a code unless it is mandatory.

Also if a code is followed by a group of companies, it becomes the benchmark, so all companies are then judged according to that code, even if they do not participate. So implementation carries some really serious consequences.

In the US, nanomaterials are regulated in the same way as any other materials, and not specifically as nano, which to some seems problematic. Health issues have been raised (see my first nano post through the link above) and never resolved. And we must bear in mind that we are talking about hundreds of thousands of products in all sectors. In order to follow through on the pledges in the code, producers would have to educate and look after not only their own workers, but anyone who deals with these products throughout their entire lifespan. This includes, transport workers, salespeople, shopkeepers, waste collectors and disposal workers, end users, the list goes on.

And if there is a need for regulation, who is going to write it? I can’t write it, so do we need an expert? But can we get a nanotechnology expert who is probably positive about the undoubted advantages of pursuing a technology to write the regulations? Will they be balanced? Or should we ask a member of Greenpeace, or anyone else who might hold serious doubts about the processes and politics involved?

These are open questions, and although I cannot myself offer any answers it is something that we can and should all discuss. And it makes for an interesting line of work!

Categories
Business Environment Science Series Technology

Experts, Regulation, and Food

A few weeks ago I wrote a post on the Bassetti Foundation website called The Innovation Principle.

The post was a review of a letter sent by some of Europe’s largest corporations to the European Commission. The letter claims that regulation in the EU risks damaging development and the economy, they want a series of things to be taken into account within the regulation process.

It is easy to read and short and I recommend a look, it is free to download through the link above, but I would like to take one of their suggestions and apply it to food regulation, as part of my food series.

The letter calls for the “Full inclusion of relevant expertise”, and this sounds perfectly reasonable. But what does it actually mean in practical terms?

If we take the example of GM food development that I raised last week, it means finding experts in the field and putting them on committees to determine if proposals are safe. Now this means that you have to look to industry, because most of the experts work within the industry.

Now I believe that in all likelihood an expert working for a nuclear energy company will tell you that nuclear energy production is 100% safe, a nanotechnology researcher will paint a glowing picture of how the future is bright thanks to nano developments, and a GM food expert will do the same.

In the USA, the Federal Drug Administration is responsible for regulating the safety of GM crops that are eaten by humans or animals. According to a policy established in 1992, FDA considers most GM crops as “substantially equivalent” to non-GM crops. In such cases, GM crops are designated as “Generally Recognized as Safe” under the Federal Food, Drug, and Cosmetic Act (FFDCA) and do not require pre-market approval.

But here the waters start to murk and merge. As I said, experts in the field working or having worked for industries working with technology are likely to be positive about their products. And the FDA seems to contain several of these experts, and some of them may have helped to make the distinction above.

According to this IVN article, over the last decade at least 7 high ranking FDA officials have also held high positions in Monsanto, the largest producer of GM seeds in the world. This is generally accepted as true, and in fact Monsanto have several employees present or past that have held high ranking positions in other capacities in the US Government. This is known as the revolving door in the USA, and it is worthy of exploration.

Monsanto and US Government Employees
Monsanto and US Government Employees (click to enlarge)

The website states that “At the forefront of this controversy is Michael R. Taylor, currently the deputy commissioner of the Office of Foods. He was also the deputy commissioner for Policy within the FDA in the mid ’90s. However, between that position and his current FDA position, Mr. Taylor was employed by Monsanto as Vice President of Public Policy.

Other Monsanto alumni include Arthur Hayes, commissioner of the FDA from 1981 to 1983, and consultant to Searle’s public relations firm, which later merged with Monsanto. Michael A. Friedman, former acting commissioner of the FDA, later went on to become senior Vice President for Clinical Affairs at Searle, which is now a pharmaceutical division of Monsanto (Oh Donald Rumsfeld ex Secretary of Defense was also on the Board of Directors).  Virginia Weldon became a member of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, after retiring as Vice President for Public Policy at Monsanto”.

Another controversy surrounded the appointment of Margaret Miller. The following is taken from Red Ice Creations website:

“In order for the FDA to determine if Monsanto’s rBGH growth hormones were safe or not, Monsanto was required to submit a scientific report on that topic. Margaret Miller, one of Monsanto’s researchers put the report together. Shortly before the report submission, Miller left Monsanto and was hired by the FDA. Her first job for the FDA was to determine whether or not to approve the report she wrote for Monsanto. In short, Monsanto approved its own report. Assisting Miller was another former Monsanto researcher, Susan Sechen”.

Obviously I am not in a position to determine whether these allegations are true, but a look at this article that appeared originally in the Observer newspaper might lead one to believe that there is a fine line being walked here.

The article states that “Monsanto received copies of the position papers of the EC Director General for Agriculture and Fisheries prior to a February 1998 meeting that approved milk from cows treated with BST.

Notes jotted down by a Canadian government researcher during a November 1997 phone call from Monsanto’s regulatory chief indicate that the company ‘received the [documents] package from Dr Nick Weber’, a researcher with the US Food and Drug Administration (FDA).
Sources noted that Weber’s supervisor at the US FDA is Dr Margaret Mitchell who, before joining the agency, directed a Monsanto laboratory working on the hormone.”

Oh and the hormone treatment made the cows sick, but you can read Robert Cohen’s reported testimony before the FDA on the subject of rBGH including the disclosure that, while at the FDA and in response to increasing sickness in cows treated with the hormones, Margaret Miller increased the amount of antibiotics that farmers can legally give cows by 100 times. Once again I cannot verify the transcription but it is widely reported on the web and was apparently shown on C-Span Congress TV live.

I am not suggesting that there is any collusion here, and as Monsanto argue people move jobs, taking jobs that suit their qualifications. A look at these people’s profiles show that they have many different positions, many of which we would say were undoubtedly working for public good. But some suggest that some of their positions might lead to conflicts of interests. But if you need experts where are you going to get them from? Here though I might simply suggest that you don’t need so many experts.

Within my life’s work of trying to promote responsible innovation I have come to the conclusion that a broader public involvement within decision-making process must be a good for society. Closed sessions full of experts deciding what is or is not safe for us may be efficient in terms of getting things done, but the public’s voice is not heard, and maybe that voice could lead to more responsible choices, or at very least some reflexivity in the decision-making process.

On a closing note, arguments are currently raging in the US about the labelling of GM foods, as currently there is no need to label it, something pushed for by many organizations. There is a counter movement that is arguing that as the FDA state that there is no fundamental difference, GM products that do not contain additives should be allowed to be labelled as “natural”, in the way organic vegetables are. This Common Dreams article presents a critical view of current practices that although strongly worded offers an insight into how a section of US society thinks about the issue.

The question remains however, who do we want to regulate our food and the technology used in its production?

Categories
Media News Technology

Commercial Drones and Privacy

A couple of years ago I wrote an article on the Bassetti Foundation website about the use of drones and other robot devices in warfare. Times have moved on however, and now drones are much smaller and cheaper, so you do not need a multi-billion dollar budget to buy one.

a quadcopter drone
A commercial quadcopter drone

To give you an idea, $600 US will buy you this quadcopter. Perfect for the beginner, plate already mounted for the camera and can also carry a small payload.

If you want something that resembles an aeroplane why not take a look at  the CropCam (before it takes a look at you). $6999 I grant you but a fine machine. Hand launched it is guided by its GPS navigation system, automatically lands and takes pictures, flies at 60 Km an hour and can be fitted with a video. You set up the GPS and the autopilot does the rest.

As the name suggests, this vehicle is aimed at the commercial market, look at your crops, find your animals and catch your daughter in a haystack with the boy next door.

The haystack incident might sound like a joke but it is really a serious problem. There are no regulations about where you fly your new machine in the USA. The market for Unmanned Aircraft Systems (UAS) is in massive expansion as farmers, security companies, private detectives, news organizations, traffic and transport management companies and many others see the potential in such snooping power. The machines can be fitted with face recognition software, thermal imaging and license plate readers, and many see this as problematic.

A couple of months ago the Association for Unmanned Vehicle Systems International (AUVSI) launched a code of conduct for the industry, in the light of a new law in the USA that allows anyone to operate one of these systems (see the Federal Aviation Administration Modernization and Reform Act of 2012).

Privacy groups are up in arms however, claiming that the mass use of this type of technology will lead to massive infringements upon personal liberty, and they take no comfort from the code of conduct. Voluntary as it is, the code is extremely general, has no enforcement mandate, contains no discussion at all about the myriad potential privacy and safety issues raised by unrestricted drone use over U.S. airspace, and there is nothing about the intended audience or user.

One US Senator however is trying to take action. Sen. Rand Paul has introduced a bill that aims at protecting Americans against unwanted drone surveillance. Read about it here.

The present regulations state that 400 feet above your house you enter neutral territory, a bit like international waters off the coast, so anyone has the right to fly their drone 401 feet over your house. These machines are small so you probably wouldn’t notice it, but as we know cameras are good nowadays. At a few hundred dollars for a vehicle they are becoming available to almost anyone, and certainly any business or organization.

Do you think this could become a problem? Is it yet another invasion of privacy or a justified use of technology? I am all ears.

Categories
News Science

Nanotechnology, risks and benefits

Last year Hayley posted a really good article on this site entitled ‘What do we need to know about Nanotechnology?‘ She raised some important issues about the governance of such high technology including the facts that little research has been conducted into health implications, legal regulation is minimal and nobody really knows how much of this type of material is produced. It is however already everywhere, in cosmetics, car wax and sunscreen to name but a few.

She followed the post earlier this year with another, ‘Nanobots, the future in Nanotechnology‘. This is also an informative piece in which she describes how nanotech engineering is moving away from top down construction to a bottom up approach, and goes on to talk about the possibility of building autonomous and even self replicating robots on the nano-scale.

Last week I posted an article about synthetic biology, another branch of science that deals in the nano-scale. With synthetic biology one of the issues raised by Hayley, that of power source, is resolved, as the machines are in fact alive and get their power from the organism that they are implanted into. The two are very much related and entwined forms of science.

And all this leads me on to looking at regulation regarding these types of research and a recent publication entitled ‘A Research Strategy for Environmental, Health and Safety Aspects of Engineered Nanotechnologies’.

The document was prepared by the National Research Council and a pre publication copy is available from the National Academic Press for downloaded here.

This is a long and detailed document written with the help of a host of academics, and it raises some very important points about an industry that Barak Obama has placed at the forefront of his innovation policy. In this year’s budget Obama is asking for 123.5 million dollars to invest in nano-tech research, which if seen next to the relatively small investment of 34.8 million in 2005 signals the importance attached to this form of innovation.

Nanobama

But all of this investment is made in a technology that is as yet practically unregulated and severely lacking in health and safety legislation, with the problem being that exposure limits and contamination issues have yet to be formalized. All of this is despite the ever growing use of such particles in our everyday life.

The National Research Council document aims to develop such a research strategy starting from a conceptual framework for considering environmental, health and safety risks, through critical questions to understanding the problem, tools and approaches for identifying properties that may cause risk, resources needed and how to implement the strategy once it has been described.

The document is extremely thought provoking. The fact that safe (or dangerous) exposure levels to such particles have never been determined nor possible environmental release dangers quantified or analyzed seems to paint a picture of an entire industry that operates without a clear understanding of how to manage the risks involved in their work.

This week a rather alarming report was published on the Science News website in which scientists have discovered that exposure to nano-particles changes the way blood vessels in animals behave. They were not using a poisonous substance I might add, but a common compound of nano-particle size.

Now I am not a biologist but I imagine that if it affects mice in this way then it will probably do the same to me.

I would summarize the problem as this; regulation and law making always has a problem when dealing with high technology, lawmaking is a slow process, but technological advancement is not. Laws chase while science runs ahead. But here we are dealing with a serious situation, something is in mass production and use, generating large sums of money but practically unregulated and untested.

The possible up-sides of nanotechnology are enormous, but I would say that the down-sides need to be taken into account too.

For a more in depth debate see my and other’s posts on the Bassetti Foundation website.

Categories
Blogging Media

The State of the Blogosphere

Technocrati.com have recently published their State of the Bolgosphere 2011 report and it raises some interesting questions. The report is based upon a survey of 4114 bloggers around the world, and presents various statistics in easily readable graph format explaining who blogs and their stated reasons why and purposes.
A chalkboard expression of what a blog might be
I am one of the 30% over 44 year olds, with the majority being considerably younger than me and much more experienced. A small percentage treat blogging as their job, make an income from their posts or run a blog for their own business or employer. The vast majority do it as a hobby, in the main to express their expertise or interests. A major sector say that they just blog in order to speak their mind freely.
I am most interested in the professional category, and I in fact find myself somewhere within that group. I am not however paid to promote something, but to provoke discussion about the ethical implications and responsibility issues brought about by technological development, and one of my tools is blogging. My employer is also a non-profit research foundation, so the aim of making money is out of the equation.

Blogging is generally perceived as a pier to pier action, and the report cited above demonstrates that people trust blogs and bloggers, in many cases more that they trust other publishers. But what if we find people publishing reviews about services or products that they have a vested interest in? If I am paid by a company to review or promote their products can I be really honest in my views? And what about the breech of trust implied?

In the US the FTC (Federal Trade Commission) made a ruling in 2009 determining that bloggers have to state if they are paid for posts by an interested third party. If a blogger in the US does not state that they either receive the product to keep or are paid by someone to write the review they risk an 11000 dollar fine. In the UK the Office of Fair Trading also has extensive blogging disclosure rules. All well and good, but the report above states however that only 60% of people that find themselves in this position actually adhere to the rules, and the statistics are very likely to be skewed, as when a person is asked if they have respected the rules that almost always say yes.

How could this problem be addressed? The Technology Bloggers site refuses to publish anything that may be deemed promotion, the author guidelines are clear. But would it be possible for all blogs make this statement and enforce it, and if it were possible would they do it? The implications for trust and the spreading of reliable information are obvious.

Another issue I wish to raise involves advertising. The report offers various statistics about how many blogs have advertisement placings, before going on to analyze the reasons given either for not carrying or carrying advertising, the issue of control over who advertises and the possible financial rewards.

Here again we step into the issue of trust. If a blog has a reputation as offering reliable and quality information this reflects upon the company advertising. The placing is a two way endorsement. If advertising is not offered (as some may feel that it affects independent status or may not reflect the blogger’s ideals), how can a blog not only make money (if that is the aim) or even cover its expenses? Most bloggers sink their own money into setting up and running their blog, and if you add up the time spent in maintenance (and the administrators are undoubtedly experts in their field) each blog should be seen as a real investment in terms of many different forms of capital. You pay $120 an hour for such expertise in other fields!