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In this article we will discuss about ethical, legal, social and biosafety issues associated with biotechnology.
Ethical, Legal and Social Issues:
ELSI stands for Ethical, Legal and Social Issues. The term is associated with the various biotechnological issues.
The impact of new technologies, including nanotechnology, on individuals and society is a subject of inquiry for philosophers, sociologists, ethicists and psychologists. Today, the activities in this area include funding research in economic, ethical, legal and cultural implications, as well as implications for science and education, quality of life, and national security. The use of public resources for development of biotechnology also raises objections from stakeholders who believe that this technology will benefit society in the due course of time and those who do not believe in this technology poses socio-ethical risks.
The current topics of debate on the ethical issues are:
1. Development of genetically modified organisms (GMO) such as plants, animals and microbes that are used as biological control agents to the environment could cause ecological imbalance that could be disastrous for the whole ecosystem.
2. Introduction of genetically modified microbes (GMM) for industrial purposes can lead to the generation of new infectious organisms.
3. Development of herbicide resistance and enhanced photosynthesis could lead to originate more tolerant weeds as a result of cross pollination with related species.
4. Cloning of animals and humans is also a debatable issue.
5. In vitro fertilization (IVF) and other reproductive technologies may be harmful for the individual autonomy, equality, protection of vulnerable, accountability, respect for human life and dignity, non-commercialization of reproduction, appropriate use of resources and balancing individual and collective interests.
6. Stem cell technology i.e., use of embryonic stem cell and adult stem cell is also supposed to fight against nature and killing a yet to be born child. This technology is still considered as an illegal practice in some of the countries.
7. Assessment of education and workforce development needs.
8. Additional means of effective public engagement on technology issues.
9. Barriers to adoption of nanotechnology in commerce, healthcare, or environmental protection.
10. Nanotechnology impacts on economic growth, standard of living, and competitiveness.
11. Ethical issues in the selection of research priorities and applications.
Biosafety Issue:
It is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health.
Biosafety is related to several fields – in ecology (referring to imported life forms from beyond ecoregion borders), in agriculture (reducing the risk of alien viral or transgenic genes, or prions such as BSE or “MadCow”, reducing the risk of food bacterial contamination), in medicine (referring to organs or tissues from biological origin, or genetic therapy products, virus, levels of lab containment protocols measured as 1, 2, 3, 4 in rising order of danger), in chemistry (i.e., nitrates in water, PCB levels affecting fertility) and in exobiology (i.e., NASA’s policy for containing alien microbes that may exist on space samples – sometimes called “biosafety level 5”).
The international Biosafety Protocol deals primarily with the agricultural definition but many groups advocate expanding it to include post-genetic threats: new molecules, artificial life forms, and even robots which may compete directly in the natural food chain. Biosafety in agriculture, chemistry, medicine, and exobiology and beyond, will likely require application of the precautionary principle, and a new definition focused on the biological nature of the threatened organism rather than the nature of the threat.
Biosafety refers to the need to protect the environment including human and animal health from the possible adverse effects of the Genetically Modified Organisms (GMOs) and products thereof derived from the use of modern biotechnology. Biosafety also refers to promote the safe laboratory practices, procedures, proper use of containment equipment and facilities, risk assessment and risk management, evaluation of GMOs, etc. Biosafety regulations are to facilitate and regulate use of modern biotechnology work at different stages to achieve the objectives of biosafety.
The Government of India has notified “Rules for the Manufacture /Use/Import/Export and Storage of Hazardous Micro-organisms, Genetically Engineered Organisms or Cells” under the provisions of Environment (Protection) Act, 1986 through the Ministry of Environment & Forests (MoEF). These rules are commonly referred as ‘Rules 1989’. The two main agencies identified for implementation of the Rules 1989 are the Ministry of Environment & Forests and the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India. The Rules 1989 have also defined Competent Authorities and the composition of such Authorities for handling of various biosafety aspects.
For implementation of the Rules 1989, DBT has brought out Guidelines from time to time. In 1998, DBT has published guidelines under the title “Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts.” These Guidelines provide the information on level of approvals for conducting research in transgenic plants, category of experiments and testing procedures for toxicity and allergenicity etc. DBT in 1999 also brought out guidelines for “Generating pre-clinical and clinical data for r-DNA based Vaccines, Diagnostics and other biologicals”. From time to time, DBT is devising proformas for submission of applications to various Competent Authorities for specific approvals.