Prepared by: Dr Ilise L Feitshans JD and ScM and DIR
Fellow in international Law of Nanotechnology.
Director of SaferNano Law and Guidance for the Safernano training program
European scientific Institute
Archamps Technopole, Archamps France
whatsapp 917 239 9960 firstname.lastname@example.org
NOTE:Comments provided here are used by permission of the Author based on her new book
GLOBAL HEALTH IMPACTS OF NANOTECHNOLOGY LAW
Panstanford Publishers Singapore, available on Amazon.com
Nanotechnology’s revolution for commerce can revolutionize global public health: the scientific revolution that began at the dawn of the 21st century has taken hold, surpassing 3 trillion dollars in 2015. Every nation has a nanotechnology science strategic program under law, and most universities have big ticket programs for nano-research and training, including nuclear research and genetic research using nano-enabled products.
International treaties and national laws from countries where nanotechnology is a rapidly growing part of their economy abound. This presentation discusses the revolutionary scientific innovations that are the underpinnings for emerging rules and international laws about the research and use of nanotechnology; and outlines major policy issues presented by nanotechnology to be resolved by legislatures regulators and judges in the near future.
- Basic Principles
Nanotechnology involves manipulating known chemicals at the molecular and atomic level in order to create smaller, faster, stronger, lighter, reliable products. The nanoscale, which measures activities that apply nanotechnology is very small. A human hair has a diameter of 100 thousand nanometers (nm). A human hair is about 100,00 (one hundred thousand) nanometers in diameter.
Within a few nanometers, nanoparticles can alter the biology of life. For example, natural mechanisms with complicated names such as: “High Density Lipoproteins” range from 8-10 nm, and ribosomes, the building blocks of DNA are between 25 and 30 nm. Thus when one hears regulatory discussions about discoveries at the nanoscale under 100 nanometers this includes many proteins that are building blocks for key genetic material. Additionally, there are new elements and substances with fancy names such as one dimensional and two dimensional matter and special properties for matter at the nanoscale: gold is combustible, silver is antibacterial and highly toxic titanium dioxide at the nanoscale is commercialized for making marvelous frothy white foam to fill doughnuts, whipped cream and shaving cream!
The prefix “nano” is derived from the Greek word “dwarf”. Yet nanotechnology is quite big. As predicted, the value of nanotechnology for commerce and industry rose to trillions of dollars by 2015. Therefore, as the use of nanotechnology and nano-enabled products increases, moving from experiments in laboratories into commerce, the scope of the meaning of the term “nanotechnology” under law is elastic too, expanding with the knowledge base about its use. Touching healthcare products, cosmetics, electronics, apparel, and automobiles, nanotechnology is becoming “ubiquitous” in the global economy, impacting health and the quality of life.
Miraculous- sounding developments that sound as if they are scenes from science fiction will enable patients to use nano-enabled medical products, for new bones and organs from a patient’s own stem cells to defeat cancer or degenerative neurological diseases! For example, engineered or manufactured nanoparticles are believed to traverse such historically mysterious places as the human placenta and the blood-brain barrier, thus offering new medicines. Some of these treatments will use nanoparticle drug carriers to move between cells, others will enter cells such as those in cancer tumors, in order to alter them. Widespread application of nanotechnology in health care for drug delivery, and applications that regenerate tissue, teeth and cells may redefine “health” and “disability” under law and in daily life.
Thus, the alterations in chemical processes resulting in new products will also change the quality of life across the globe, and in time will also change many longstanding social values. This means that nanotechnology will not only be the subject of new laws but it will also create new laws using new forms of governance, such the multinational scientific partnerships that span across continetns. The Paneuropean agreements from the EU are only one example.. There is also USA EU agreements and bilateral agreements between these nations and key industrial powers in Asia such as China Singapore Korea and Japan. This is a stark change in the concept of the rule of law and the role of law as governance compared to the previous century.
In the 20thcentury, law was about balancing diversity by maintaining cultural differences without prejudice. The 21st century has overcome many of those challenges and confronts the needs for one world with new institutions for governance and a new role for the rule of law. Nanotechnology is a key component of the social forces shaping this discourse about new approaches to governance and the regulatory state. This crossroads in science influencing social policy raises new questions about how people will survive in this world and the future we want when applying nanotechnology across a gamut of medical, security, travel, housing and nutrition venues. It is not surprising therefore, that the notion that nanotechnology is a “revolution” remains successfully echoed decades later in nanomedical literature ranging from clinical nanomedicine, to the popular press.
People who use nanotechnology every day in their homes, for personal medical needs, and in cars, buses, airplanes, trains and workplaces need basic science policy information in order to:
1 make informed choices of their own use of nano-enabled products,
- understand the information that is disclosed on labels regarding product contents;
- and 3 have their say about laws and regulations pertaining to nanosafety in order to make the best use of these amazing new technologies
This dynamic moment in history finds society at an unusual policy crossroads: the changes wrought by technology offer the opportunity to choose which old values will be kept by the new order, and which values will be thrown away. By contrast, people who ignore vital social issues raised by the implementation of nanotechnology applications in commerce, or who shy away from discourse with those with whom they disagree, risk ignoring the importance of these revolutionary developments. They will then be mystified by the results when old inequitable prejudices are accidentally embedded into the matrix for new nanotechnology laws or when old rules no longer apply.
Law and science have partnered together in the recent past to solve major public health problems, using “global health diplomacy”. Today’s global health diplomacy package embraces nanotechnology: a revolutionary approach to the long-established rules in science and nature about matter and the properties of key elements such as titanium, silver and gold; nano-enabled products manipulate these properties to improve the quality of life worldwide. Using international collaborative research and treaty-based tools of diplomacy for global commerce, nanotechnology, nano-enabled applications of new knowledge and nanomedicine will bring products from lab to market, which in turn impact food, clothing, shelter, transportation and medical care. Nanotechnology products and the local, national and international laws that may govern them therefore touch the lives of everybody. “It is expected that nanotechnology will play the role electronics played in the 20th century and metallurgy played in the 19th….Manufactured nanomaterials are expected to yield significant innovation…a new competitive edge to European industry and strong benefits… from medicine to agriculture, from biology to electronics” The greatest challenge to nanotechnology’s promised the vision may be creating flexible laws that will both: incubate new commerce while promoting health protections. Nanotechnology is here— Not only is it true that « you can’t put the toothpaste back into the tube », but the toothpaste you use already has the latest nanotechnology inside; a quiet but important example of the daily application of nanotechnology to consumer products. This arrival in commerce, however, is well planned and therefore should not surprise policymakers, consumers or stakeholders.
Global health impacts discussed in the larger book that I have prepared on this topic provide a brilliant example of how knowledgeable clear thinking people can chart a course that will guide some of the inevitable social changes caused by nanotechnology. An important additional dimension of this discussion involves interdisciplinary questions about how and why nanotechnology is bringing together law and science for the global economy. Exploring key questions about nanotechnology also offers people a unique window of opportunity to participate in shaping the laws, regulations and policies that will define the use of nanotechnology and enjoyment of life for the next generation. People can seize the opportunities brought by the nanotechnology revolution to institute meaningful, long-awaited social change to improve public health, without sacrificing economic benefits promised by nanomedicine and other nanotechnology applications.
Nanotechnology ‘s revolution for commerce and industry can bring revolutionary change in public heath
Opinion leaders in science, law and health policy have heralded nanotechnology as a “revolution”, destined to realize unprecedented economic growth by applying smart new scientific developments since the beginning of the 21st century. In 2000, Presidential Advisers in the USA proclaimed nanotechnology the ‘Next Industrial Revolution’. “ The impact of nanotechnology on the health, wealth, and lives of people could be at least as significant as the combined influences of microelectronics, medical imaging, computer-aided engineering, and man-made polymers developed in this century » according to the report to the President of the United States at the outset of the 21st Century from the National Science and Technology Council. “Compared to the physical properties and behavior of isolated molecules or bulk materials … exhibit important changes for which traditional models and theories cannot explain. Developments in these emerging fields are likely to change the way almost everything – from vaccines to computers to automobile tires to objects not yet imagined – is designed and made. … Such new forms of materials and devices herald a revolutionary age for science and technology, provided we can discover and fully utilize the underlying principles”,according to the US government’s report in 2000 .
That report also successfully advocated for nearly a quarter of a billion dollars for research and development in 2001, eventually becoming 23 billion dollars a decade and a half later. Anticipating the cross-cutting importance of nanotechnology in every facet of commerce and daily life, the Executive Office of the President of the USA created a network of federal agencies within its government, spanning health, homeland security, space exploration, food and drug regulation, environmental protection, household and consumer goods, the Department of Commerce, the Department of Justice and branches of the government associated with military defense. The network is called the National Nanotechnology Initiative (NNI). Similar programs exist around the world. NNI is credited, with having tagged nanotechnology as a “revolution” for industry and commerce, in 2000  Under the 21st Century Nanotechnology Research and Development Act of 2003, NNI agencies are required to develop an updated NNI Strategic Plan. OSTP describes the NNI mission as “The vision of the NNI is a future in which the ability to understand and control matter at the nanoscale leads to a revolution in technology and industry that benefits society.”. Policymakers and scientists agreed. A decade later these sentiments have been echoed by the Woodrow Wilson Center for Scholars. By 2013, this mantra had not changed: the European Union (EU) Nanosafety cluster praised nanotechnology as “one of the key technological drivers in building an innovation (sic) European Union based on smart, sustainable and inclusive growth”. Scientists in the Nanosafety Cluster use policy words, not scientific terms, describing “tremendous growth potential for a large number of industry (sic) sectors”. EU has also committed billions to baseline nanotechnology research and commericalization of nano-enabled products. The EU, in collaboration and sometimes competition with the NNI, has kept pace with every facet of the NNI strategy. The EU NanoReg2 program is tasked to chart the path for registering, licensing and certifying the nanosafety of a wide variety of substances and end products. The clear role of science policy in new laws at the national and international level demonstrates that technology and economic factors in the globalization of commerce have transformed law. I
“Nanotechnology represents the possibility of revolutionizing many aspects of our lives”, according to Dr. Varvara Karagkozaki, a leading researcher in nanomedicine. Echoing both: government voices and the boasts of scientific research academia, delegates at the World Economic Forum (WEF) in Davos, Switzerland declared “Technology is the fourth industrial revolution” embracing nanotechnology in 2016. Klaus Schwab, Founder and Executive Chairman of the WEF stated, “We feel we are not prepared sufficiently for this fourth industrial revolution which will come over us like a tsunami which will change whole systems”.
Studies of nanoparticle interactions with living systems may include:
- standard characterisation of the nanomaterials size, size distribution, surface charge as a minimum in the dispersion medium in which they will be exposed to the test species.
- * observations of agglomeration: such as Electron Microscopy imaging coupled with, differential Centrifugation Sedimentation,
- * reports regarding the distribution of particle monomers, dimmers, trimers and larger aggregates in complex biofluids.5
- Biological fate of nanoparticles requires studying the potential binding properties of proteins (and other biomolecules such as lipids and polysaccharides) if the protein corona changes as the nanoparticle moves, for example, when particles redistribute from one organ to another, esf.65 END OF TEXT BOX
Nanotechnology has already breathed new life into old industries where supply has been diminished but not depleted such as gold and diamonds, because industrial processes at the nanoscale require so much less in order to deliver their a final product. And the same attributes of nanomaterials, although in different substances, are already in industry making airplanes lighter and stronger, eyelashes longer and more alluring and constructing houses and buildings that can withstand natural disasters.
- Critical Questions
Having new materials is very exciting! New materials and new methods for using those materials offers rejuvenating promising for commerce, for stock exchanges, for startup companies, for large-scale employers who use nano-enabled products and for the future of humanity.
The ubiquitous character of nano-enabled products may be a weakness as well as its strength. The very attractive feature of small nanoparticles that can traverse previously impermeable barriers also means that little is known about how to stop them from migrating, how to predict where they will go on their own despite human calculations, or which substances can interact as a trigger to make the nanoparticles cluster together or adhere to other substances with results that cannot be predicted at this time. It is not possible to precisely estimate risk, because so little is known about the emerging field of nanotoxicity. Therefore these questions about so called “fate” of nanoparticles loom important about controlling risk at the nanoscale. Consequently, there is a policy dilemma: whether unquantifiable but probably significant risks associated with such phenomena should block promising use of nano-enabled products in commerce.
Trying to stop nanoparticles from continuing to migrate elsewhere once the desired job is done, and then determining whether their collection in large clusters is useful presents many questions. Some of these questions are already well understood about the same substances in a larger size, but the established rules of science do not apply to the same substance in the nanoscale. For example, little is known regarding the stability, dispersion or toxicity of nanoparticles in decaying plant and animal organic matter,) Thus, mystery surrounds the behavior of nanoparticles and the subsequent impacts, a subject that will be examined in detail in the SaferNano Design and Law workshop scheduled for the Technopole in Archamps May 26 through June 4 2018.
POLICY DILEMMA:MORATORIA OR OVER EXPOSURE?
HARD CHOICES WHEN FACING UNKNOWN DANGERS
Nanotechnology is revolutionary because these discoveries challenge bedrock working assumptions in science. The ubiquitous character of their use throughout the world means that nanotechnology also has an impact on cultural values, whether people realize it or not.
Bringing new products to market, combined with the emerging social context for new rights for people with disabilities will reshape civil society; the mix between new data and new economic opportunities will pose challenges to the existing way that things are done. Bringing together a diverse group of thoughtful people to create an accurate big picture is therefore one of the great challenges brought forth by nanotechnology’s revolutionary change. According to one former staffer at OSTP, “People in grad school end up being in their own little bubble. It’s not their fault; it’s just the way the system works”25. This dilemma is called “working in silos” among the staff of the United Nations system, but the paradigm applies across many disciplines including but not limited to law, bench science, municipal bureaucracies and academia. Science policy emerges with great difficulty when people from these various narrow career paths attempt to interact.. The big picture policy problem is that none of these disciplines operate in a vacuum tube; no silo is genuinely isolated from real life. Each of these policy constructs is funded by the federal government in partnership with industry, academia and a variety off stakeholders.Any incrementalist path that would avoid making a decision in the context of this uncertainty is foggy. The trade-offs to be made are unclear. Thus uncertainty weighs heavily in the calculus, if one wishes to balance the benefits and risks in order to enjoy products and industrial processes that are already in commerce. Debating this dilemma of how to regulate unquantifiable risk in order to protect public health while also protecting a culture of innovation has been the hallmark of the first decade of juridical discussion regarding the application of nanotechnology to daily life in society. Yet debate has not stopped the infusion of revolutionary technology into products across society. Scientists and governments agree there are unknown risks and therefore, have begun drafting laws despite the absence of clear and compelling information. Examples include Swiss federation (Precautionary Matrix 2008) Royal Commission on Environmental Pollution (UK 2008), German Governmental science commission, Public testimony sought by USA National Institute for Occupational Safety and Health (NIOSH, Feb 2011), OECD working group (since 2007) WHO working group (in process of formation), ISO, WTO, several industrial groups, and various non-governmental organizations. Therefore there is consensus that nanotechnology poses risks of significant harm to presently exposed populations, the greater ecological environment and to the public health. But qualitative data to protect exposed people and the greater ecological system that surrounds the human environment lags behind industrial use, research and application of nanotechnology to consumer products.
INTERNATIONAL LAW OF SCIENTIFIC COLLABORATION ACROSS BORDERS
International projects that require a delicate mix of law and science in global health diplomacy are therefore on the front lines, at the beginning stages of major bilateral and multilateral partnerships between the U.S. and partners such as China, Israel, Brazil, the United Arab Emirates, and the European Union. At the highest levels, decisions can have lasting influence but, measuring the direct impacts is difficult when evaluating the long term impact of research or diplomacy. Each facet of the new synthesis of disciplines for nanotechnology law and policy requires input from people who think logically, how to solve problems, how to work in teams, how to think across disciplines and to do so with respect for parallel professions. One of the fascinating features of nanotechnology is that it is not born of any specific discipline; the science is inherently interdisciplinary and therefore the governance of social impacts must also be derived from a cluster of disciplines that have not previously worked closely together. This requires a multidimensional approach to charting and measuring social impacts.
Lawyers can contribute information to this discourse. Good legal training can inform every phase of this process. Creativity, however, is not random; cultivating innovations that save money and reduce duplication of efforts requires much forethought as well as new ideas. This means that policy documents and their regulatory content must be filled with more than compromise; it requires training outside one’s own professional career path and then applying the lessons learned from that training.
Nanotechnology is exciting because the state of the art of manipulating matter at the nanoscale is in its infancy, and the possibilities to be explored are wide and uncharted. At the same time that newness brings untold and unforseen risks, which law as a general principle does not handle very well. For example, 3D printing may make intellectual property regulation irrelevant or even a liability, as the embedded codes to protect patents will be easily reproduced along with the possibly faulty copy.
Legal definitions of health and disability for the purposes of sick leave, insurance and followup care may also change, with open questions about whether discrimination laws will be expanded and enforced or result in a huge gap of an underclass that will be unprotected by law because although they receive treatment they look healthy but will nonetheless experience stigma.
The cumulative effect of exposure to a variety of nanomaterials will also be subject to scrutiny using new legal tools to allocate responsibility, because exposures will be in combinations that cannot be quantified in places where exposure cannot be controlled and the source of potential harms may remain unknown. Inevitably, these aspects of nanotechnology will need to be harnessed into a global effort to asses, control and compensate for its impact on workers consumers and the environment.
Stay tuned! The next nanotechnology decisionmaker may be you!
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 John Howard and Vladimir Murashov “National Nanotechnology Partnership to Protect Workers” J Nanopart Res July 2009 “Nanotechnology is predicted to improve many aspects of human life. By 2015, it is estimated to represent $3.1 trillion in manufactured goods.” They also assert that “Nanotechnology is predicted to improve many aspects of human life. By 2015, it is estimated to represent $3.1 trillion in manufactured goods. Data is emerging that exposure to nanomaterials may pose a health risk to workers. If the economic promise of nanotechnology is to be achieved, ways need to be found to protect nanotechnology workers now. … adopting standards to protect workers from nanomaterials, whose risks are just emerging, seems even more remote. Rather, a national partnership between OSHA, NIOSH, nanotech manufacturers and downstream users, workers, researchers and safety and health practitioners is suggested. A National Nanotechnology Partnership would generate knowledge about the nature and extent of worker risk, utilize that knowledge to develop risk control strategies to protect nanotechnology workers now, and provide an evidence base for a possible nanotechnology program standard later.”
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 « The initiative will support long-term nanoscale research and development leading to potential breakthroughs in areas such as materials and manufacturing, nanoelectronics, medicine and healthcare, environment, energy, chemicals, biotechnology, agriculture, information technology, and national security. The effect of nanotechnology on the health, wealth, and lives of people could be at least as significant as the combined influences of microelectronics, medical imaging,
computer-aided engineering, and man-made polymers developed in this century »
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 National Science and Technology Council Committee on Technology Subcommittee on Nanoscale Science, Engineering and Technology, National Nanotechnology Initiative: The Initiative and Its Implementation Plan July 2000 Washington, D.C. Report to the President of the United States of America. The report further states: “The development of a healthy global marketplace for nanotechnology products and ideas will require the establishment of consumer confidence, common approaches to nanotechnology environmental, health, and safety issues, efficient and effective regulatory schemes, and equitable trade practices for nanotechnology worldwide.”
21st Century Nanotechnology Research and Development Act (15 U.S.C. §7501(c)(4), P.L. 108-153); www.gpo.gov/fdsys/pkg/PLAW-108publ153/html/PLAW-108publ153.htm).
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