2.    Application of Biotechnology in Animal Husbandry and Fishery Sectors:

2.1 Farm animals in general are less amenable to transgenic development and as such the development of transgenics has not reached a significant stage. However, transgenic animals have been internationally developed for expression of human proteins for therapeutic use.

2.2  Despite an acute shortage of trained manpower, animal Science Research Centres are developing capacity in the area of embryo biotechnology, such as production and transfer of embryos in livestock.

2.3  Though the existing DBT guidelines for rDNA-based vaccines can be used for animal vaccines, the protocol for rDNA-based vaccine needs to be developed on a case-by-case basis. Additionally, the tests for the presence of tissue-specific distribution of the expressed product and its characterization need to be included.

2.4  Delivery system for plant based recombinant edible/injectable vaccines to the farmers need to be regulated taking into consideration the requirement of storage, in terms of temperature and other physical parameters of the edible plant including its transportation etc. Since no such regulatory mechanism is available at present, this aspect needs deliberation and early decision by the Agricultural wing of the proposed National Biotechnology Regulatory Authority.

2.5     The effects of recombinant vaccines administered to farm animals on human health need to be analysed, since human beings consume food and milk of animal origin. Appropriate mechanisms of safety should be developed for the plant-animal-human food chain

2.6   Effects of the GM feed/fodder on the animal as well as on milk, meat, eggs produced from such animals/birds on human health need to be studied before permitting commercialization of such feed/fodder.

2.7     For conducting clinical trials on GM feeds like genetically modified maize, soybean etc., as well as on GM edible vaccines and other recombinant vaccines for livestock and poultry, the facilities at IVRI authorized by DCGI/ICAR need to be strengthened by providing adequate infrastructure.

2.8   Quality control laboratories for GM products for livestock are very essential. In view of this, the existing quality control laboratories under D&C Act 1940 need to be strengthened to handle GMOs. This will be better than establishing new laboratories, which will be expensive, and time consuming. However, it should include the facilities being developed at Baghpat at the National Veterinary Biological Products Quality Control Centre.

2.9  Regarding the role of ICAR, DBT and GEAC, it has to be clearly spelt out that ICAR and DBT would get the feed analysis done through IVRI or other approved institutes for chemical composition, evaluation for equivalence with counterpart, small animal/ruminant/canine/poultry, safety trials and target animal production trials. Based on the results, ICAR should offer its recommendation on the use of GM crop or GM crop products in animal feed to GEAC. The GEAC should take decisions on the use of GM crop/product for animal use on the basis of the ICAR data.

2.10 Quarantine facilities for the import of aquatic live animals, biologicals, bioremediation materials and probiotics etc. are critical and must be set up speedily. Off-shore quarantine facilities may also be created for this purpose, as for example in an unmanned island in the Lakshadweep group of islands.

2.11  Extensive biosafety guidelines should be developed for undertaking rDNA work on transgenic animals including biosafety aspects for consumption.

2.12  Various biosafety issues for release of GM fish/marine animals in the environment need careful research.