Korolenko V., Isayenko R.

SAFETY CONCERNS USING OF NANOTECHNOLOGY

Nanotechnologies are multidisciplinary technologies developed for matter sized less than one micron and enable research, manipulation and processing of materials in the size range of 0.1 to 100 nanometers (1 nanometer - one billionth of a meter). The theoretical basis of them was founded in 1959 by the Nobel laureate in Physics R.P.Feynman (USA), and the term itself was proposed in 1974 by Norio Taniguchi, scientist at Tokyo Science University (Japan). Nanotechnology operate such concepts as "nanoparticles" "nanorobots", "nanomaterials". The prefix "nano" means that the sizes of the particles of substance, miniature robots, materials are in the nanometer range at least in one dimension. 

In the United States, government fundings of nanotechnology development and production of new nanomaterials are more than $ 1 billion a year. In Japan, to develop in this area in 2005-2008 $ 3 billion were allocated . Under the 6th Framework Programme (2002-2006) to finance research and development work in the field of nanotechnology and fabrication of new nanomaterials for five years, €1.3 billion were spent. In the 7th Framework Programme (2007-2013) for funding this direction €3.5 billion were already provided. The total budget in the framework of the federal program of nanotechnology in Russia to 2006 was about 6 billion rubles. To facilitate the implementation of the state policy in this area the Russian Nanotechnology Corporation "Rosnanotech" was established and in 2007 it received from the federal budget of about $ 1 billion  (according to the national concept of public trust scientific and technical program "Nanotechnologies and Nanomaterials" in 2010-2014 years). 

The necessity for strategic and tactical prediction of nanobiotechnologies generates a huge number of different futuristic constructions. Among analytical materials generated by different groups of experts, the most noteworthy are Roadmap for Development of Nanotechnology, composed by Corporation RAND (Research And Development, USA, 2006), and the Roadmap of the European Commission (NanoRoadMap Medical and Health, 2006), established in preparation and implementation of the 7th Framework Programme of the European Union's research and technological development. Both docs not only analyze the situation in nanobiotechnologies at present, but also offer a forecast of various industries nanobiotechnologies for the foreseeable future (2015-2020). In addition, attention is focused on expert analysis of the situation in those areas, which in the short term should have access to production and become commercially available. 

These documents focussed on biomedical aspects of new technologies. So, American experts distinguish the following representative range application of nanotechnology: engineering living tissue and regenerative medicine, biological nanostructures, drug encapsulation and targeted drug delivery, molecular imaging, biophotonics, biocompatible implants, bioanalytical membranes, molecular biosensors, biochips and labs-on-a-chip; functional molecules: switches, pumps, vehicles. Experts of the European Commission made their list of the most important, in their view, sections of nanotechnology, which is very similar to the U.S.: drug delivery, molecular imaging, cosmetics, development of new drugs, methods of diagnosis, surgery, including transplantation of tissues and organs, genetic engineering, food technology, genomics and proteomics, and other technologies, including molecular biosensors 

In 1986 K.E. Drexler (USA) in his work "Engines of Creation: The Coming Era of Nanotechnology" first described the possibility of creating a so-called nanorobots replicators to be able to play like yourself nanomachines with material environment. This author emphasized the necessity to control their reproduction, showing a hypothetical picture of the so-called "gray goo" ("eating" of environment by unmanaged replicating nanorobots). However, in 2004, he said that such a scenario is unlikely, and nanomachines that have the ability to replicate hardly ever gain widespread. There is a view that nanorobots will be capable of replication only in limited quantities and in a certain space of nanofactory. So far, the free replicating nanorobots is hypothetical process. However, at the present time of their creation was one of the most promising modern science problems. In particular, established in 2001 in the U.S. National Nanotechnology Initiative (NNI) identified among the strategic directions of nanotechnology since 2010 - creation of nanosystems: nanorobots,  systems for control and self-organization, etc., from 2020 - the creation of molecular systems that are integrated independently evolving systems for creating molecular robots. Addressing these challenges will likely require integration achievements of all sectors of high technology that will create autonomous control technology of large-scale nanocomplex by nanocomputers, breakthrough in their development may be the most likely through the creation of relevant biological structures, built like natural viruses. 

In Ukraine, the industrial development of nanotechnology is infante, the available market for nanotechnology products mainly represented by imports. Issues regulated by State complex program of high technology (approved by the Law of Ukraine on April 9, 2004 № 1676-IV) and the State target scientific and technical program "Nanotechnologies and Nanomaterials" for 2010-2014 (approved by the Cabinet of Ministers of Ukraine dated October 28, 2009, № 1231), which sold far as scientific applications without mass industrial implementation. Attention paid to the development in this strategic sector is still negligible in our country. At the same time, for example, in the Russian Federation, recall, July 4, 2007 federal law created the Russian Nanotechnology Corporation, which is now reorganized into JSC "RUSNANO" led by well-known politician Anatoly Chubais and with working capital of 74.5 billion rubles ( of 2012) in Ukraine similar projects have not yet created, although the concept of the second of these programs stated the urgent need for this. 

Issues of health, safety and environmental protection are extremely important in the application of nanotechnology. Understanding the risks to health and the environment associated with nanomaterials and, in particular, nanoparticles, is a key factor for their safe use in standard manufacturing processes. The unique properties of nanoparticles make them both technologically interesting and potentially hazardous to human health. 

The special properties of nanoparticles that distinguish them from the properties of bulk materials of the same chemical composition, meaning that virtually nanoparticles represent a new state of substance, and experts agree that it is desperately necessary to explore the potential toxic and other adverse risks associated with this new state - risks that can not be reliably estimated based on the material properties of higher dimension. 

Currently, many questions arise regarding the safe use of nanomedicine advances, in particular, the agreement on the basis of complete information, risk assessment, toxicity and healthy person. Discussion of ethics and nanomedicine will bring many serious problems for society. In fact, nanomedicine raises many social issues. So, it is very difficult when using nanomedicine is the question of completely informed consent. Although to receive the patient's consent perhaps is not too difficult, but it is unknown when the patient will receive a complete and independent information (EC Group on Ethics in Science and New Technologies, EGE, 2006). "Consent based on complete information requires that the information was clear. How is it possible to give information about the impact of the research, which is developing rapidly, and make a realistic assessment of risk through many unknown factors and complexity? " According to the EGE, due to lack of knowledge and the complexity of the issue it will be difficult to provide adequate information on the diagnosis, prevention and therapy required for consent  based on complete information. 

An important problem that hinders the emergence of new nanobiotehnological  development, according to experts of the European Union - the gap between the sciences Life sciences and materials. Perhaps the most striking example of what needs to be effective cooperation between the various scientific disciplines. 

Another problem is the relationship between medical and non-medical uses of nanotechnology for diagnostic, therapeutic and preventive purposes. There remains the problem of whether to use nanotechnology to make deliberate changes in the body when changes are needed not from a medical point of view. Arguments "for" and "against" for improving the human body is more complex. Ethical boundaries, which should be considered this question - utilitarianism, rights, autonomy – are a subject to certain risk. On the one hand, the development of nanotechnology can contribute to solving the problems of health care, but on the other - there are many challenges: creating cyborg that may prevail person; homogenization of the human genome, the right of access to technology, and even a potential "victory of death." Here environmental ethics has to reckon with medical one. Artificial insemination, pacemaker and retinal implants actively influence the inheritance and natural evolutionary process. 

World Commission on the Ethics of Scientific Knowledge and Technology at UNESCO since formulated the main problems arising from the use of nanotechnology right now: 

• Invisible character - invisibility to the naked eye nanotechnology products during their use complicates monitoring and tracking their consequences (as with regard to nuclear technology). This problem brilliantly shown in the novel by famous writer, a physician by education Michael Crichton "The Prey". 

• Rapid development - the rapid development of nanotechnology hamper prediction, especially in the long term, their possible consequences and appropriate measures; 

• Use for military purposes and for security - the use of nanotechnology in these goals can conflict with human rights. Example - using nanoparticles and nanobots to penetrate the human body, with customizable to specific individuals or specific targeted groups; 

• Global impact – it is associated with almost all the countries attempt to master nanotechnology as part of high technology to seize the initiative in the global economy and, consequently, to geopolitics; 

• Danger of "nanobreach" - the possibility of increasing inequality between developed countries and developing ones. It is associated with different levels of economic development and, consequently, willingness to venture capital type of financing, as well as excessive patenting developments. 

Despite the huge potential and significant funding nanomedicine, research ethical, legal and social meanings applications of this field are still insufficient. "Science rushes forward, ethics behind" aptly say Anisa Mnyusiwalla, Abdallah Daar, Peter Singer (2003). Problem of nanomedical safety will exist until the study of ethical, legal and social aspects lag behind scientific development.

Korolenko Volodymyr , Dept. of Health in Kyiv State Regional Administration, MD, PhD, EADV member, EC expert 

Isayenko Roman , Dept. of Health in Kyiv State Regional Administration, MD, MPA