Agriculture (including crops, fishery, forestry and animal husbandry) must feed an ever increasing human population forecast to reach 8000 million by 2020 AD, of which about 6700 millions will be in developing countries. With finite resources and an increasingly vulnerable environment, it is highly important that growth in efficiency rather than in number should be the dominant factor in the doubling of global output of plants and livestock products. To meet future needs and to be able to sustain agricultural production, agricultural research and its applications will have to use all available technologies, especially the rapidly developing modern biotechnologies. The convention on Biological Diversity defines biotechnology as “any technological application that uses biological systems, living organisms or derivatives thereof, to make or modify products or processes for specific uses.”

1. REPRODUCTIVE TECHNOLOGIES
   1. Artificial insemination

      Various aspects of artificial insemination technology have been fairly standardized. It has now become a practical technology in commercial dairy cattle programs in both developed and developing countries, covering a worldwide total of about 50 million first inseminations (Chupin and Schuh 1993, Chupin and Thibier 1995). In India, where well structured dairy development programmes have been established with cattle and buffalo, artificial insemination (AI) procedure has played a valuable role in facilitating appropriate genetic change in animal populations, being linked to intensive male selection. In developed countries, AI system is increasingly being developed and used in the breed development of sheep, horses and pig genetic resources. AI technology offers certain specific advantages, especially

      1. widespread use of outstanding males and dissemination of superior genetic material;
      2. progeny testing under environment and managerial conditions to improve the rate and efficiency of genetic selection;
      3. accelerated introduction of new genetic material by import of semen rather than live animals and thus, reducing the international transport costs;
      4. enabling the use of frozen semen even after the donor is dead; and
      5. reducing the risk of spreading sexually transmitted diseases.

      Long-term semen storage, without loss of viability, for use in AI, is another valuable technology for promoting conservation of endangered breeds of farm animal species, although this technology has the disadvantage of preserving only half genotypes and requiring secure cryo-preservation facilities.

   2. Embryo Transfer

      Considerable progress has been made in methods of recovery, storing and implanting cattle embryos (including drug applications to enable acceptance of implanted embryos) in several counties of the world. Approximately 460,000 bovine embryos were transferred world- wide in 1997 (Thibier 1998). Several Multiple Ovulation Embryo Transfer schemes (MOET) have been initiated and about 10% genetic gain has been achieved in cows (Nicholas and Smith 1983, Lohius 1995). In India also, techniques and protocols of ET technology are being standardized in cattle, buffalo, sheep, goat, camel, and other species of animals ( Madan et al. 1993, Misra 1993, Anon 1998-99).

      Embryo transfer and other associated reproductive technologies have been successively used for rapidly multiplying the populations of elite breeds of cattle (Willet et al., l951, Thibier 1996), buffalo (Drost et al. 1983, Madan et al.1993, Misra 1993, Misra et al 1999), sheep (Holm et al. 1996, Thibier 1996), goat (Armstrong et al. 1983, Pawshe et al. 1994, Thibier 1996), horse (Riera and McDonough 1993, Squires et al. 1999) and pig (Kvansnickii 1951, Galvin et al. 1994, Hazeleger and Kemp 1999).

      ET/MOET schemes are especially recommended for some specialized purposes, viz., (i) rapid expansion of rare and/or improved exotic/local genetic stocks of farm animals and even elite female animals (ii) reducing the cost of international transport by shipping embryos rather than living animals in which case quarantine restrictions would also apply; (iii) the rapid replacement of existing genotypes by using ET/MOET rather than grading up through repeated crossing; and (iv) the possibility of increasing the twinning rate by combining AI with the transplanted embryo (Cunningham 1999). Other advantages of ET technology are (i) pre-natal sex determination (ii) control of sexually transmitted diseases (iii) using biological diversity of embryos and (iv) environmental adaptability as compared to transport and establishment of imported animals. In combination with other animal biotechnological procedures, ET/MOET techniques can accelerate herd development and animal conservation especially of rare genetic stocks.

      Embryo splitting technique and transfer of split embryos have been standardized by National Institute of Immunology (NII), and the first bovine split embryo derived calf was born in November, 1988 (Raghupathy and Hasnain 1991; Ramachandran 1991. Such technologies enabled the production of 150 cows from an elite cow, as opposed to ten cows that she would have normally produced in her lifetime in conventional husbandry. Scientists at NII also succeeded in producing a 100% pure Holstein­Friesian calf, using a local stray cow as surrogate mother (Raghupathy and Hasnain 1991, Ramachandran 1991).

   3. Embryo cryopreservation

      Freezing of semen and embryo is an established commercial practice especially in cattle. About 800 experimental reports and papers have been published on various aspects of embryo cryobiology, especially on developing effective methods of preserving viability by freezing and quick thawing in the presence of cryoprotective additives (Leibo and Loskutoft 1993). This technique is useful as a conservation strategy for endangered breeds, and every effort should be made to select embryos representing the maximum range of current diversity. Preservation of embryonic stem cells could represent an important method of genome conservation.

   4. IVM/IVF Embryo Production

      Although Brackett et al. (1982) used in vivo matured oocytes for IVF system to produce the first calf in the world, it is now possible to adopt a fully in vitro system, whereby the immature oocytes are matured in vitro, followed by fertilization with in vitro capacitated spermatozoa and the newly formed zygotes are cultured in suitable media for development up to the transferable stage. The birth of such in vitro animals was reported in cattle (Gordon and Lu 1990), goat (Hanada 1985), pig (Cheng et al. 1986) and buffalo (Madan et at. 1994).

      Despite of several advantages of in vitro embryo production, initial application in both cattle and buffaloes has been limited by the ability to recover oocytes. However, recent development of low invasive ultra sound guided transvaginal oocyte retrieval (TVOR)/ oocyte pick up (OPU) has removed these difficulties to a large extent (Pieterse et al. 1991). This repeated recovery permits production of more embryos than might be possible by standard ET practice (Kruip 1994). TVOR also allows repeated collection of oocytes from endangered species of livestock or livestock of high economic importance in order to propagate such genetic resources in much faster way.

      Gamete intra-fallopian tube Transfer (GIFT), an assisted reproductive technology has been used to produce pregnancies in mares (Carnevale 1996, Hinrichs et al. 1998 a, b). Intra-cytoplasmic sperm injection (ICSI), another assisted reproductive technology, has been successfully used in rabbits (Hosoi et al. 1988), cattle (Goto et al. 1991), mares (Squires et al. 1996, Cochran et al. 1998), dogs (Foul ton et al. 1998), pig (Kim et al. 1998), horse/ zebra (Li et al. 1994, Meintjes et al. 1995).

      Current status of research on IVM/IVF embryo production and cryopreservation of such zygotes was reviewed by Tervit (1997) and Pieterse et al. (1988). This technique is used for bulk production of high quality embryos. Freezing of high quality oocytes and semen would provide germplasm for undertaking important future mating regimes flexibility in the conservation programmes.

   5. Sexing semen and embryos

      It is possible now to extract one cell from an early embryonic stage and with the use of a DNA probe, one can know the sex of the embryo (Thibier and Nibart 1995). Another way is the sorting of semen, one sperm at a time, into males and females, using staining procedure and detecting by laser beam with the help of standard flow cytometry equipment (Johnson et al. 1996). Thus, sperms with an X or Y chromosome could be used to produce male or female embryos /animals. Seidel et al. (1997) suggested procedures for using low sperm count, though with reduced conception rate in heifers.

      The bovine Y- chromosome specific sequences are conserved amongst buffalo, Indian zebu and Taurus cattle (Appa Rao et al. 1993). Thus, the use of bovine Y-chromosome specific primers, demonstrate the sex of buffalo or Indian zebu cattle embryos. Efficient embryo biopsy method has also been developed (Taneja et al. 1998). The high rate of survival and conception rates of biopsied embryos also clearly reflects the minimal damage of the embryos. Buffalo Y-chromosome specific probe was also developed recently (Appa Rao and Totey 1999).

   6. Cloning

      The first successful cloning in domesticated animals was achieved, using early embryonic source material (in sheep, Willadsen 1986, Campbell et al. 1996; cattle, Sims and First 1993, Stice et al. 1996; pig, Prather et al. 1989), nuclear transplantation (Wolfe and Kraemer 1992), embryonic cultured cell line (Wheeler et al. 1994, Campbell et al. 1996) and somatic cells of adult animals (“ Dolly” sheep Wilmut et al. 1997, cattle, Cibelli et al. 1998). Eight cloned calves were produced from cumulus and oviduct epithelial cells of an adult cow (Kato et al. 1998). Cloning using somatic cells offers opportunities to select and multiply animals of specific merits (Cunningham 1999). Cloning holds the promise of bypassing conventional breeding procedures to allow creation of thousands of precise duplicates of genetically engineered animals or other animals in a single generation. In remote areas, where sampling and storage of adequate samples of semen and embryos is not practical, one could use clonal samples from diverse animals for conservation of the available genetic diversity of such threatened genetic resources (Anon 1998, Cunningham 1999).

      Due to increasing commercial pressure, several indigenous breeds of cattle (Rathi, Tharparkar, Red Sindhi and Sahiwal etc.) are under threat from imported breeds that are being used in intensive farming systems. The local breeds may contain valuable genes that confer adaptation, especially to heart tolerance or disease resistance, and there is an urgent need to prevent their extinction. Current method of genetic conservation involves storage of frozen semen or embryos but this procedure is costly and time consuming. Cloning may eventually prove to be much simpler and effective means of conservation of breeds. Skin biopsies, hair follicles, and blood samples might be suitable sources of cells, which could be grown briefly in the laboratory, and subsequently frozen in liquid nitrogen for long- term storage.

      Many animal species are in danger of extinction. In India, one horned rhinoceros, swamp deer, Manipur bro antler deer, hispid hare, wild buffalo, Assam root turtle, pigmy hog, and Bengal florican, are classified as highly threatened animals in their present habitats. Cloning technique might be applied to increase the population sizes of endogenous species or even restore them following extinction. A broad spectrum of biodiversity can be collected and cryopreserved at modest cost (Benford 1992). San Diego zoo’s center for reproduction of endangered species has created a collection of frozen fibroblast cell cultures and tissue samples collected from various rare and threatened animal species, such as, Prezewalskis’ horse, Sumatran rhinoceros etc. China has announced the initiation of a programme to increase the giant panda populations, using nuclear transfer techniques involving even the possible use of bear as egg donors and surrogate mothers (Corley-Smith and Brandhorst 1999).

      In cross-breeding programmes involving Bos taurus dairy cattle breeds and Bos indicus local breeds in tropical countries, heterosis unto 25% has been regularly achieved in the first cross (Cunningham and Syrstad 1987). Since subsequent breeding strategies normally do not retain the achieved heterosis, embryos could be produced by IVF, using Bos indicus semen on Bos taurus oocytes collected in vivo or alternatively one could use embryos cloned from cells of high performing F1, individuals (Jarvis 1996). Principal germ cell technique is now being developed for producing germ line chimeras and transgenic poultry (Samkiss 1997, Cunningham 1999). Isolation of embryo-derived cell lines has been reported from preimplantation embryos of mouse, Syrian Golden hamster, rat, mink, pig, cattle and sheep (see review by Wheeler et al. 1994).

2. GENETIC TECHNOLOGIES
   1. Genome maps

      Recent progress in genetic linkage mapping within multiple animal species has incorporated the genomes of cattle (Bishop et al. 1994, Barendse et al. 1994), swine (Rohrer et al. 1994), sheep (Crawford et al. 1994), and poultry (Khatib et al. 1993). At present the total number of mapped loci are 2850 for cattle, 1774 for pigs and over 1000 for sheep, while the highest resolution single linkage maps in each species are 1445 for cattle, 1250 for pigs and 500 for sheep (Kappes et al. 1999).

      Technological break through has provided an opportunity to simultaneous construct genetic linkage and physical maps for the major livestock species and merge them into comprehensive maps (Beattie and Hruska 1994). These include linkage PCR (Polymerase chain reaction) amplified highly polymorphic, repetitive elements (micro­ satellites, Weber and May 1989), and direct chromosomal assignments of these polymorphic elements either by direct amplification (Troyer et al. 1994a / 1994b) or through the use of larger pieces of DNA such as cosmids and florescence in situ hybridization (Yerle et al. 1994, Hawkin et al. 1994). Construction of livestock genome maps has also been benefited by simultaneous development of the data- bases capable of integrating genetic linkages and physical and comparative mapping data (Beattie and Hruska 1994). Furthermore, the co-ordination by FAO within the global strategy of the procedural aspects of genetic resources sampling, analytic methodologies and result reporting of the genetic distancing research activities, which are getting underway for each animal species, could help involve developing countries, and rapidly realize cost-effective country and regional conservation decision making for the large number of animal genetic resources currently identified as at risk (Cunningham 1999). The rapid multiplication of superior germplasm can be attained through the techniques of embryo transfer coupled with in vitro fertilization, twinning, and embryo splitting, sexing and cloning. Several National Institutes viz., Indian Veterinary Research Institute, National Dairy Research Institute, National Institute of Immunology and National Diary Development Board, have already initiated research and development programmes using these biotechnologies. No assessment of impact of these technologies on our cattle and buffalo populations has been made so far.

   2. Transgenesis

      Since the report of first transgenic animals (mouse, Gordon and Ruddle 1981;sheep and pig, Hammer et al., 1985; sheep, Simon et al. 1998; goat, Ebert et al. 1991;and cattle, Krimpenfort et al 1991, Cibelli et at. 1998), engineered gene constructs have also been transferred to birds and fish. Several biotechnological techniques viz., pro-nuclear micro-injection (farm animals), cytoplasmic micro-injection (fish), retrovirus based vectors (birds), are presently used to produce transgenic animals. The present technology allows survival rate of one in ten injected and transferred embryos, and about one in ten of these carries the Tran gene (Wall 1996).

      Gene transfer in animals has been aimed at (i) modifying the fat or protein synthesis in the mammary glands (Vilotte et al. 1997), (ii) transferring of growth hormone gene in pigs (Pursel and Rexroad, 1993), (iii) transferring cysteine synthesis gene into sheep for enhancing wool production (Word and Nanerrow 1991, Powell et al. 1994), (iv) transferring cold tolerance gene from flounder into salmon (Hew et al. 1995) and (v) micro-injecting gene imparting resistance to influenza virus in pig (Muller et al 1991, 1992).

      Another king of target protein could be the one, which is not a part of normal animal functioning of a specific species but for which this species could be an economic medium for production. Transgenic bacteria are now routinely producing human insulin. Similarly, although methods are now available to produce recombinant proteins in several species of micro- organisms, plants or animals, the success depends on economics of production, the maximum success so far, being in using milking animals (Bremul 1996). The human ­1 anti-trypsin is being expressed in sheep’s milk at levels high enough for commercial extraction (Wright et al. 1991). High level expression of several transgenic encoding medically important proteins have been accomplished in the transgenic goat and most notably a-1 antitrypsin at 15 -30 g / lit in sheep (carver et al.1993), a-lactalbumin at 4 -5 g / lit in cow (Colmon 1996), acid alpha-glucosidase at 1-2 g / lit in rabbit (Hersbach 1997), and tissue plasminogene activator at 6 g / lit in goat and antithrombin III at 10 g / lit in goat (Ziomek 1988).

      The potential for the synthesis of pharmaceutical products in milk has continued to be exploited, and seven such products are presently being produced with the estimated market value of US $ 3 billion (Wall 1996).

      The feasibility of developing transgenic vaccines for major diseases of farm animals, especially for diseases caused by viruses which cannot be grown in cell cultures, has also been explored, some of which seem to have potential for use in resource poor countries. (Cunningham 1999).

      Although animal biotechnology has revolutionized the generation of veterinary biologicals and has improved significantly the livestock health by providing cheaper and effective vaccines with long shelf life and not requiring elaborate cord chain, care should, however, be exercised in developing new biologicals so that they do not pose any threat to the safety of environment by safeguarding the overall health and well being of plant, animal and human life (Natrajan and Rasool 1997).

      The diagnostic uses of modern animal biotechnology are other areas of R &D efforts, especially, the use of recombinant proteins and gene deletion mutant vaccines for use in disease diagnosis (Cunningham 1990).

      Recombinant proteins and monoclonals provide means to diagnose diseases with specificity, accuracy, rapidity, uniformity, manipulatability and ease of performance, while nucleic acid hybridization detects early infection (Natrajan and Rasool 1997).

   3. Gene identification

      The increasing knowledge of mammalian genetic structure has helped in developing DNA based traceability for meat industry, especially to provide widespread consumer guarantees of traceability of products. (Meghen et al. 1998)

   4. Molecules conservation

      Genetic characterization of populations of target species, using a range of micro-satellite loci, can reveal a great deal about the evolutionary history of population and of their relationships with other populations (Mac Huge et al. 1997). Variations in maternal mitochondrial and paternal Y chromosome can provide additional criteria for analyzing patterns of gene flow between populations (Bradley et al. 1998).

   5. Germplasm conservation

      One of the prerequisites of effecting animal genetic resources conservation is the identification of populations to be conserved. Several techniques viz., Restriction fragment length polymorphism (RFLP), random amplification of polymorphic DNA (RAPD), single strand conformation polymorphism (SSCP), mini satellites and micro satellites etc., are used for such a purpose. An estimation of average heterozygocity of a population helps in deciding if it should be preferred for preservation over other populations. Populations with maximum homozygocity need to be preserved because those have the least potential survival value. The above said techniques help in determining the homozygocity / heterozygocity at several loci simultaneously, thereby assisting to provide an index of heterozygocity. Embryo banks, sperm banks, egg banks and DNA banks serve as an insurance against any eventual erosion of genetic diversity of animal species, and their conservation for posterity. Coupled with cryopreservation, in­vitro fertilization and other reproductive technologies, discussed above, permit medium to long-term storage of genetic material and restoration of eroded genetic diversity especially when in situ conservation is not possible. DNA marker and other molecular conservation techniques assist in animal breed cataloguing.

      Under the WTO era, every country is conscious about creating clear-cut identities of its own animal genetic resources. DNA techniques, using pooled DNA samples from random individuals, can generate breed specific DNA signatures, which can be developed as identification marks.

      The FAO Global Strategy for the Management of Farm Animal Genetic Resource places strong emphasis on the use of molecular methods to assist the conservation of endangered breeds and the Measurement of Domestic Animal Diversity aimed at reliably establishing the pair wise genetic distances amongst breeds of target species (Barker et al. 1993). An informal group of experts of FAO is identifying the common set of micro-satellites, which should be used globally for each farm animal species (Bradley et al. 1996).

3. RECOMBINANT HORMONES AND IMMUNO-MODULATION
   1. Bovine Somatotropin

      Bovine somatotropin (rBST), a natural growth hormone secreted by the anterior pituitary in all animals, has a major effect on the regulation of growth. It is now possible to transfer the DNA sequences responsible for somatoropin synthesis into bacteria and to produce large quantities of somatoropin commercially at economic levels. Milk production increased between 10 (5 mg BST/day) to 20% (20 mg BST/day) using genetically engineered rBST (Chilliard 1989, Bauman et al. 1994).

      In view of public concern about the safety of its use in dairy cows, exhaustive evaluation tests were conducted in USA and its use was found safe and permitted for commercial use (Juskevich and Guyer 1990). High production makes higher demands on animal physiology and if adequate feed supply is lacking, negative effects are observed on fertility besides other health problems especially mastitis and ketosis, and the increased frequency of twins (Phipps 1989).

      In India no serious attempt has been made so far to produce recombinant somatotropin, and thereby to increase milk production in commercial establishments. One of the problems associated with this approach is the high intake of feed, which lowers the input­output ratios, thereby reducing the profit margin.

   2. Immunomodulation

      Immunomodulation experiments aimed at modifying endogenous hormones function have shown to improve fertility, growth, lactation and body composition in farm animals (Meloen 1995, Terqui et al. 1995). Active immunization is preferred for long-term responses such as immuno-castration, while passive immunization is more appropriate for eliciting short term responses, viz., increased milk yield (Pell and Aston 1995).

      An animal birth control injection, called ‘Talsur’ was developed by scientists at the NII, for sterilization of male animals. The injection is usable in all mammals, but would be particularly useful for sterilization of bulls to stop the proliferation of animals of low economic value. Furthermore, as the bulls retain libido, they could be used as ‘teasers’ bulls to identify females in oestrus. Insemination with semen of high genetic stocks at appropriate time enhanced the chances of conception, as the fertile life of the egg was only 1-2 days. ‘Tulsur’ has also found application in the sterilization of stray dogs (Rajhupathy and Hasnain 1991).

      Increases in growth hormones (GH) are known to increase the efficiency of feed use for protein synthesis, but limited experiments conducted on rodents, sheep, goats and cattle have so far not produced consistent results (Flint 1995). Interactions between hormonal and immune system are very complex, nevertheless several successful products e.g. fecundin, vexstrate and others, have been marked for enhancing animal productivity, mostly under specialized production regimes (Cunningham 1999).

   3. FEED ENHANCEMENT

      Biotechnological contributions to livestock nutrition include single cell protein production, the genetic modification of nutritive value of forages, probiotic and biotic feed additives, and the use of enzymes for enhancing the nutritive value and quality of feeds (Cunningham 1999). Cellulose and hemi-cellulose enzymes, as silage additions, as well as bacterial inoculates for preservation and improvement in digestibility, are also available besides other possibilities for feed enhancement (Robinson and McEvoy 1993).

      These technologies assist in the effective utilization of low nutrient content feedstuff into animal products. The current approach is to survey the naturally available organisms and select the best ones. Productivity in ruminants can be enhanced by using other biotechnological approaches. Thus, not only genes from rumen microorganisms have been cloned mostly in E. coli, but also foreign genes (mostly imparting antibiotic resistance) have been transferred into and expressed in rumen bacteria (Wallace 1997). Gregg (1995) succeeded in transferring a detoxifying (dehalogenase) gene from the soil bacterium, Morexella species into the rumen bacterium, Butyrivibrio fibrisolvens. The modified organism was stable and functional in both the culture medium and in the sheep rumen.

      Another biotechnological innovation enhances animal productivity with the administration of ionophores, which disrupt the functioning of the bacterial membrane and selectively suppress gram-positive bacteria, resulting in shifting the volatile fatty acid production and improvement in feed conversion efficiency (Cunningham 1999).

4. CONCERNS
   1. Issues

      Animal biotechnological innovations and their beneficial effects, discussed in this presentation, fall into four main categories, viz., reproductive, genetic, recombinant hormones, immuno-modulation and feed enhancement. Of these innovations and related issues, the most important and contentious ones are (i) the regulation of the testing and utilization of transgenic animals in agricultural environments, (ii) immunology and (iii) the trans-species transmission of diseases. As compared to transgenic plants, there has been limited application of transgenics in animal production environment. Because of the “contained” nature of most present uses of transgenic animals, with the lesser risk of unwanted escapes into the environment, there has not been much concern in public mind on this issue. There has been, however, a public controversy over the approval and adoption of recombinant bovine Somatotropin (rBST). The main ethical concerns are (i) the social consequences associated with the restructuring of the dairy industry (Kalter 1985, Hallberg 1992); (ii) environmental impacts of dairy restructuring (Lanyon and Beegle 1989); (iii) impact on animal health and well being (Comstock, 1988), and (iv) integrity of the food industry, the regulatory process, and uncertainties about the safety of rBST milk expressed by different research organizations (Thompson 1992, 1994). Besides these considerations, there are differences based on religious believes related to the extent to which scientists may interfere with animals per se and animal genomes (for details on these and other issues, see Megloughlin 1994, Nilsson 1997). There has been little concern in public about the applications of transgenic animals for pharmaceutical purposes and in bio-medical research. However, the world debate has centered around several issues (Weil 1996) viz., public views on (i) humankind and its relationship with nature, especially commodification of nature by humans and antagonism between agrarian societies vs. industrialization; (ii) adverse social and economical impacts, especially benefits to corporations vs. small farmers; (iii) biosafety (viz., harmful side effects in recipient animals and humans) and environmental risks (especially unpredictable expressions in an alien environment); (iv) profit motives vs. altruism of human behaviour; (v) loss of animal genetic diversity and integrity of species; and (vi) altering of natural course of animal evolution. Raising calves in the dark and feeding them with diet, for developing high quality veal, and battery rearing of broilers have been considered as unethical.

   2. Public policy

      Animal biotechnology is expected to have significant impacts on food production and processing. While supporters predict several economic, social, and environmental benefits, critics raise concerns about the bio-safety and ethics of biotechnology, including concern about whether governments (National and World Trade Organization) can adequately regulate the applications of biotechnology (Kendall and Hoban 1994). In fact, animal biotechnology has become an important, but controversial public policy issue in several countries. Since consumers will make the ultimate decisions about the acceptability of animal products generated through biotechnology, efforts should be made to educate the public about several applications and issues associated with animal biotechnology so that consumers can express informed consent.

      Instead of providing justification for such incidences, we should have an ethical code of conduct using animals for bio-medical research and development.

   3. Regulatory mechanisms

      The regulatory mechanisms related to the application of animal biotechnology are highly influenced by our perceptions of the biotechnological products. Some of us believe that such products are articles of food, food additives, animal drugs, animal biologic, laboratory animals, or are manufacturing sites for human drugs, biologics, and devices. Other people may feel that animal biotechnology is a simple extension of selective animal breeding, a technology for introducing pharmacologically active substances into animals, a source of improved farm income, a potential environmental problem, an ethical conundrum, cruelty to animals and a case for animal rights, even to the extent of demanding/putting/an embargo on the use of animals for research purposes (Matheson, 1994). Recent case of freeing the animals (monkeys at NII) by NGO, Blue cross, is another extreme case of animal rights activism. Instead of providing justifications for such incidences, we should have an ethical Code of Conduct on the use of animals for bio-medical research and development or based on these positive and negative considerations (Matheson, 1994). In any event any policy decision should not lead to slowing down of R&D efforts aimed at human and animal welfare. Consequently, formulating of the national/international animal biotechnology policy cannot be taken as an extension of such issues related to plant biotechnology; of course some issues may require common answers. General public, socio-economists, animal rights activists, religious groups, scientists and government officials (national, international organizations, WTO) differ in their perceptions of the use of products generated through animal biotechnology. Animals are capable of producing drugs, milk with medical food chains, human biologics and food products. What is our attitude towards such innovations and their products?

   4. International developments

      While several countries, which use animal biotechnological products and/or have international trade in such products, have formulated regulatory mechanisms, we in India, have done so little in this direction. Cross country surveys indicate that there are several approaches to the regulatory mechanisms, each with advantages and disadvantages, but we, in India, should formulate regulatory rules and legislation appropriate to our socio-economic and religious attitudes. A consistent approach for similar products on an international basis is certainly desirable and may ultimately emerge under the banner of WTO rules and regulations. It is also desirable to work on an International Code of Conduct on the applications of animal biotechnology as they affect animal genetic resources. This should be in line with a similar International Code on applications of plant biotechnology on plant genetic resources, under the banner of FAO Commission on Genetic Resources for Food and Agriculture. The author has continued to assist the Commission in the preparation of this code since 1990 through two consultancies and correspondences. The Indian National Academy of Agricultural Sciences through this workshop may make not only a recommendation but also prepare a draft Code of Conduct on the use of animal biotechnology. This code may eventually become a negotiating draft for an International Code of Conduct on Animal Biotechnology. The author can assist the National Academy in this noble endeavor. Advantage can also be taken from the guidelines and issues covered in the FAO Code of Conduct for Responsible Fisheries (Anon, 1995). The Codex Alimentarius Commission (CAC) of the FAO & WHO has prescribed over 200 standards, 45 codes of practices and 2000 maximum limits for residues of agricultural and veterinary chemicals (Anon, 1999). The CAC is presently developing ‘Recommendations for the Labeling of foods obtained through biotechnology’. The CAC is also considering the development of general standards, which would apply basic food safety and food control disciplines to food derived from biotechnology. Elements of concern are potential allergenicity, possible gene transfer from transgenics, pathogenicity deriving from the organisms used, nutritional aspects and labeling. The process of risk analysis should also be applied to biotechnology and food safety. Under the WTO also, its SPS Agreement (Agreement on the Application of Sanitary and Phytosanitary Measures) covers measure in trade that are intended to protect human, animals and plant health or life. These international developments should be taken notice of in formulating our national policy on biosafety of animal biotechnological products.