Biotechnology & Biosafety,
Intellectual Property Right (IPR) and Protection (IPP)

Biosafety

Due to growing concerns arising from GMOs throughout the world the UNIDO/WHO/FAO/ UNEP has built up an Informal Working Group on Biosafety. In 1991, this group prepared the "Voluntary Code of Conduct for the Release of Organisms into the Environment". The ICGEB has also played an important role in issue related to biosafety and the environmentally sustainable use of biotechnology. The ICGEB organizes annual workshops on biosafety and on risk assessment for the release of GMOs. It collaborates with the management of UNIDO's BINAS (Biosafety Information Network and Advisory Service), aimed at monitoring the global development in regulatory issues in biotechnology. Since September 1998, the ICGEB has provided an on-line bibliographic data-base on biosafety and risk assessment for the environmental release of GMOs. This database which is accessible through the website of ICGEB also provides informations on biosafety to its Member States. The ICGEB is also assisting to its Member States in developing the national biosafety framework. Since February 1999, it has also adopted a legally binding biosafety protocols by the signatory countries (ICGEB, Activity Report, 1998).

Topic of Concerns on Website of ICGEB
The main "topic of concern" related to the environmental release of GMOs are given below:
(i) Risks for human health toxicity and food quality/safety allergies, pathogens' drug resistance i.e. antibiotic resistance
(ii) Risks for the environment persistence of gene or transgene or transgene products resistance of target organisms or susceptibility of non-target organisms increased use of chemicals in agriculture transgene instability unpredictable gene expression
(iii) Risks for agriculture weeds or superweeds alteration of nutritional value reduction of cultivars and loss of biodiversity
(iv) Risks of interaction with non-target organisms genetic pollution through pollen or seed dispersal horizontal gene transfer transfer of foreign gene to microorganism i.e. DNA uptake generation of new line viruses by recombination
(v) General concerns higher cost of agriculture loss of familiarity ethical issues, etc.

Hazards of Environmental Engineering

Biosafety Guidelines and Regulations
Many countries have formulated the Biosafety Guidelines for rDNA manipulation with the aims (i) to minimize the probability of occasional release of GMMs, and (ii) to ban the deliberate release of such organisms into the environment. In India, DBT has evolved "the recombinant DNA safety guidelines" to exercise powers conferred through the Environmental Protection Act 1986 for the manufacture, use, import, export and storage of hazardous microorganisms/genetically engineered organisms, cell, etc. These guidelines arebeing implemented through the following three mechanisms:

(a) the institutional biosafety committees (IBSCs) monitors the research activity at institutional level,

(b) the review committee on genetic manipulation (RCGM) functioning in the DBT which allows the risky research activities in the laboratories, and

(c) the genetic engineering approval committee (GEAC) of the Ministry of Environment and Forest has the power to permit large scale use of GMOs at commercial level, and open field trials of transgenic materials including agricultural crops, industrial products, health care products, etc. (DBT, Annual Report 1995-96).

Operation of Biosafety Guidelines and Regulations
All the institutions/industries working on genetic engineering activities have IBSCs. Moreover, with the permission of RCGM research activities are being carried out in the country using transgenic materials. Some of the examples are given below:

(a) M/S Proagro PGS India Ltd had imported the transgenic mustard seeds expressing Barstar and Barnase genes from Belgium to evaluate the performance of seeds in Indian soils. This company has also imported transgenic seeds of tomato containing B. thuringiensis (Bt) CRYIA^(b) gene to assess the resistance of cultivars containing transformed potato plants with the above gene to specific tomato fruitworms of India.

(b) M/S MAHYCO, Mumbai imported seeds of transgenic cotton containing Bt gene to conduct trials in glasshouse by back crossing with Indian cotton lines and to evaluate resistance of the transgenic plants to boll worms in India.

(c) M/S Transgene Vaccines Ltd, Hyderabad imported the recombinant strains of yeast expressing Hepatitis B surface antigen protein. The company was granted permission to carry out experiments for small scale production of vaccines at IMTECH, Chandigarh.

(d) M/S Santha Biotechnics Ltd, Hyderabad conducted experiments for the production of recombinant Hepatitis B vaccines and human a-interferon by using yeast and E.coli respectively.