Projects / Programmes
Procedures for ensuring safety and social acceptability of new techniques and applications of synthetic biology and modern biotechnology
| Code |
Science |
Field |
Subfield |
| 4.06.00 |
Biotechnical sciences |
Biotechnology |
|
| Code |
Science |
Field |
| T490 |
Technological sciences |
Biotechnology |
| Code |
Science |
Field |
| 2.08 |
Engineering and Technology |
Environmental biotechnology
|
synthetic biology, modern biotechnology, legislation, genetically modified organism, GMO, environmental protection, health protection, risk assessment
Researchers (8)
Organisations (4)
Abstract
The techniques of modern biotechnology, which have been applied in the seventies of the last century with the first successful cloning of bacterial genes and transfer of foreign DNA between different organisms, go beyond the possibilities offered by the conventional methods and shorten processes for modifying the genetic material. Since this is a new technology in continuous development, the precautionary principle has been established for its application and release of products. A comprehensive biosafety system has been established aiming at effective control over the use of genetically modified organisms (GMOs) in order to ensure a high level of protection of human and animal health and the environment from the potential harmful effects of new technologies. In Slovenia, this area is regulated by national law, European Union law and international agreements.
In the last decade, the existing framework of biosafety faced with new challenges. Recent scientific advances in the field of modern biotechnology have also enabled the development of new generations of plant breeding techniques. Some of these techniques are different from classical transgenic approaches in their way of introducing traits to a plant, while others are refinements of traditional techniques and insert genetic material that is derived from sexual compatible species. In addition, also new techniques that are simpler, more reliable and suitable for modifying the genetic material in all organisms, not only plants, have been developed. Another relatively new scientific discipline - synthetic biology has been introduced developed at the intersection of biology and engineering. Methodologically it is based on recombinant DNA technology; however it is not meant for a simple combining of two or more genetic elements, but for the genetic rearrangement and subsequent protein circuits in the cell. The purpose of the genetic changes is making cells perform a complex task; often we talk about cellular machines.
In addition to the issues raised by modern biotechnology on biosafety and regulation, numerous social issues are opening regarding the impact of new technologies, for example societal norms, international trade, and the possibility of consumer choice, the protection of natural resources or food security. Due to these issues the existing systems and approaches in the context of biosafety, particularly environmental and human health risk assessment (ERA) and the need for monitoring as well as anticipated potential socio-economic impacts need to be evaluated.
Within the project, we will initially introduce the new techniques of modern biotechnology and synthetic biology. We will review the existing legislation in the field of GMOs with special emphasis on the assessment of risks for the environment and human health. We will evaluate the applicability of existing approaches to risk assessment of products of modern biotechnology and synthetic biology with a view to ensuring a high level of biosafety and present a proposal for appropriate amendments. If we find it necessary, we will propose an appropriate way of monitoring. We will define a set of socio-economic factors associated with the implementation of new techniques in practice. Results of the project will be crucial in deciding on the necessary adjustment and upgrading of existing biosafety system. The scope of the research project is relevant from the scientific and technical as well as the broader social point of view; therefore, within the project we will devote a specific work package to the communication with the expert and general public.
Significance for science
New techniques in modern biotechnology together with synthetic biology represent important fields of research which gradually establish themselves in Slovenia, too. Similarly to the situation in the European Union, the status of these techniques and approaches is vague within the current legislation. It is also often unclear in the context of safety risks and work procedures, e.g. (i) in how far work has to be conducted in contained systems, (ii) how experiments should be performed in open-air trials and deliberate release, and (iii) what kind of enforcement is needed in cases where some of the new techniques are used. Such vaguely defined status could have a negative impact on the developments in the specific research fields and within biotechnology and synthetic biology in general.
Regulating the status of new techniques is thus of prime importance for science, as it will diminish doubts about the legal framework of these novel technologies, present among scientists, professionals and general public. In this context, the most striking issue is probably the risk assessment. Only with a regulated status of synthetic biology and new techniques in biotechnology it is possible to ensure further advancement of the field and to simultaneously secure an adequate level of biological safety.
Significance for the country
As observed in countries with advanced biotechnology, industry strives for simplified regulatory procedures related to new product development and placing on the market. European Union is equivocal about the positioning of synthetic biology, but especially of new techniques in biotechnology into the framework of existing legislation. An unclear legal environment represents a factor of uncertainty for the biotechnology sector. It is thus not rare that for this and related problems, enterprises are moving their development and production facilities out of Europe, where environments are more favourable for new technologies.
With a better definition of required procedures in Slovenia, we could help pharmaceutical industry and advanced biotech companies towards a smooth and statutory ascertained work. This could also have a beneficial influence on establishing new enterprises, especially if the analysis shows that risk assessments can be completed without excessive administrative workload.
State administration could profit from the project outcomes by easier positioning of its opinions about GMO-related rules, especially in the discussions about eventual modifications of existing rules and in enforcement of legally-bound procedures in the field of biotechnology. In contacts with EU partners, clear statements about new techniques can contribute to meeting straightforward decisions in questions of biological safety. In the coming years, these will certainly be on the agenda of meetings at the European level.
Most important scientific results
Most important socioeconomically and culturally relevant results
Annual report
2016,
final report
