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Therefore, extinction of wild species and destruction of ecosystems has been a major concern of policy makers and biotechnologists alike. One of the major efforts, has been to conduct a survey and conserve country's biodiveristy, so as to save wild plants and animals from extinction.
National parks and sanctuaries have been established in many countries to meet this objective. Under the auspices of the United Nations also, funds are being established and other efforts being made for conservation of germplasm at the global level. Biodiversity studies thus include the following: (i) (ii) a a study systematic of the examination methods by of which the diversity full can array of be maintained organisms and used on for the this benefit globe of and mankind.
A discussion on biodiversity in a book on biotechnology is relevant, because biodiversity is being utilized to provide genes from wild species for biotechnology exercises. In recent years, a discussion on biodiversity has become important also because countries in the North of the hemisphere (developed countries) have been utilizing biodiversity available in the South (developing countries) without paying any compensation.
Several Biodiversity Conventions were held in 1992 for discussions on measures required to be taken by developing and developed countries to preserve the biodiversity at the global level. In this connection the latest Biodiversity Convention was held in May, 1992 at Nairobi to formulate a treaty, that was desired to be signed at the UN Conference on Environment and Development (UNCED) later held in Brazil in June 1992. In this treaty, an agreement was sought by the developed countries to allow, as a matter of right, access of every country on the germplasm or biodiversity available anywhere in the world. Since tropical countries are far richer than temperate developed countries, such a treaty would have benefitted only the developed nations.
Current Level of Biodiversity - The life on the planet Earth still remains largely unexplored at the species and intraspecies levels. Therefore, a complete knowledge of the world fauna and flora is not available even to the systematists, who are responsible for the taxonomic description and nomenclature of all biological species.
It is estimated that the total number of species available on this planet may be close to 100 million (108), although earlier estimates give a figure of 10 million or 30 million. From such a large number of species, only about 1.4 million species of plants, animals and microorganisms have so far been given scientific names. It has been shown that the diversity of fauna and flora varies in different ecosystems, habitats, geographical regions and also among different taxonomic groups. Following are some examples: (i) (ii) In Diversity marine is water, all greater the 33 in living terrestrial animal phyla and are fresh available, water while only species 17 are than found on in land marine and fresh species. waters.
(iii) Arthropoda among phyla and Insecta among arthropods have more species diversity than other groups; similarly nematodes, mites and fungi are highly diverse, the number of species approaching hundreds of thousands or millions.
(iv)Among (v) (vi) Among
mammals, Among squirrels
rodents monocotyledons, (Sciuridae), the
species have has more
than more species
(vii) More diversity occurs in tropics (tropical rain forests and coral reefs) than elsewhere.
( ) or
Biodiversity by the
Biodiversity number of
described species in a
parameters: area and
(ii) diversity represented by the turnover of species across space. The diversity increases with the total number of individuals encompassed and thus with the increase in the area sampled and the productivity per unit area. We know that diversity is less on remote islands and increases as we move towards the equator.
However, (i) (ii)
there -diversity some taxa
exceptions along are
to gradient of
general productivity in and the
as declines north in
illustrated the than most
the productive the
following: systems; equator;
(iii) some deserts have unusually diverse plant communities. We know relatively less about areas will be surrounded by highly modified habitats.
-diversity to predict its current patterns or its future when the natural
(i) If the range is large, placed
-diversity is independent of the area sampled, so that a national park to protect diversity can be anywhere.
(ii) If diversity is low with species ranges being small (despite high total diversity) and nonoverlapping, many parks will be needed to protect diversity.
Ethical and aesthetic rewards: Since other living organisms on Earth are our living companions in the universe, an ethical or aesthetic issue concerns the moral responsibility of human beings to protect the fauna and flora, which is facing an acute danger. Hobbies like gardening, pet keeping, bird watching, etc., suggest that human beings do derive aesthetic
all of them falling within the broader concept of 'gene banks' can be broadly classified as follows: (i) In situ conservation. (ii) Maintenance of soil ecosystems having rich biota. Ex Situ Conservation -Ex situ conservation. where they natural1y occur: (ii) Ex situ conservation. CIFOR (Centre for International Forestry Research) to conduct research for in situ conservation of forest trees. Steps to Preserve Biodiversity . and diverse species occurring in these ecosystems contribute to these services. Natural Monuments. is done through establishment of 'gene banks'. This work will be done in close collaboration with IUCN (International Union for Conservation of Nature and Natural Resources). complementary ways. These services include the following: (1) Maintenance of gaseous composition of the atmosphere and thus preventing rapid changes in the mix of gases. Some of them include the following: (i) No undisturbed land be used for development or urbanization. these future possibilities will disappear. therefore. . (iv) Measures should be taken to reduce emission of greehouse gases and ozone destroying compounds. because conservation is achieved by protection of populations in nature. which may destroy fauna and flora.Gene Banks -Conservation of biodiversity can be achieved in a number of.reward from these companions. where the existing biodiversity contributes to fertility of soil thus supporting crops and forests. which includes conservation of plants and animals in their native ecosystems or even in man made ecosystems. etc. In Situ Conservation .Many ways are being suggested for preserving biodiversity. e. About 7000 plant species have been used as food. With the advent of biotechnology. CIFOR will conduct research and find more rational location of in situ reserves for the conservation of woody plants germplasm. and the national institutes in developing countries. (iii) In poor nations. industrial products. so that the threatened and endangered species may be protected against extinction. But this has been only a very small fraction of the total biodiversity which can be exploited. botanical gardens. In Situ and Ex Situ Conservation . a large number of medicines have their origin in plants or microorganisms. which includes conservation of samples of genetic diversity (particularly representing endangered species) away from their field habitats. they do include in-situ conservation methods. etc. transfer essential nutrients into the roots of plants.This type of conservation applies only to wild fauna and flora and not to the domesticated animals and plants. Many bacteria decompose organic matter and help in producing humus. Therefore. because development of townships and shopping centres. National Parks. In situ conservation of forest trees. Essential services provided by natural ecosystems: The natural ecosystems provide essential services to human beings. Nature Reserves. Cultural Landscapes. etc. The details of these conservation methods make a separate subsdiscipline of biodiversity studies called conservation biology. can be used in future. which include national parks and sanctuaries. culture collections. Most of our crops were originally wild plants and could be developed into productive crops through selection and breeding. (v) Effective measures for conservation of biodiversity be developed and strengthened in all countries. cloth. Although the phrase 'gene banks' often refers to only ex situ conservation facilities. (ii) Catalogues of genetic resources and national biological inventories be prepared. Biosphere Reserves. It is argued that although the tropical foresters reserve forest areas against other land uses. etc.). protection of mammals or birds. Efforts are being planned by CGIAR's latest international agricultural research centre. these have been used for multiple purposes (for water catchment. medicines.g. birth rates should be lowered and sustainable. so that preservation and sustainable exploitation of biodiversity go hand in hand. particularly VAM. Quinine and penicillin arc two such examples which arc used extensively against some of the most dreadly diseases. The rich countries should provide massive assistance to meet this objective without any further delay.Other microorganisms also fix nitrogen and transfer other nutrients to the soil. which include genetic resource centres. Similarly. Economic benefits: Human beings have already obtained enormous direct economic benefits from biodiversity in the form of food. These techniques of conservation of biodiversity include in situ and ex situ conservation and are being briefly discussed in the following section. in future genes from many species will be utilized for a variety of purposes. These methods. use of forest trees for fuel and the use of swamps for paddy fields lead to loss of biodiversity. zoos. since we are already late by 50 years in starting this process. using sample populations. but several times this number has been reported to have edible parts and. It includes a system of protected areas of different categories. The fungal associations in mycorrhiza. Sanctuaries. high yielding agricultural systems be developed. But if the biodiversity is lost.
CGIAR system has also helped to ensure the conservation of more than 140 species started in the gene banks of some 450 non-CGIAR institutions in over 90 countries. it was renamed as IPGRI (International Plant Genetic Resources Institute) with headquarIC. Ex Situ Conservation Efforts at International Level. plant embryos. Most of these research centres. 'The G-15 network of gene banks will offer conservation of important germplasm in the form of seeds.5. More recently. (iv) In the fourth phase (2010-2030). and and will particularly contribute: promote to developing have nations. In view of this. genetic resources tested resources introduced. Peru. Most of these countries. However. USA allowed only 1% of a total of 37. The United Nations Environment Program (UNEP) however. (iv) to provide an international information service on plant genetic resources. Brazil. Nigeria. India will be the co ordinator of this network. there has been a competition for relative allocation of efforts directed towards in situ and ex situ conservation. being located in the tropics and the sub-tropics. (iii) In the third phase (1980-2010). an international research centre exclusively devoted to plant genetic resources (PGRs) was also established. Since 1975. the scope of activities of IBPGR has increased in recent years. there will be enhanced exploitation. It was named I8PGR (International Board for Plant Genetic Resources). Yugoslavia and Zimbabwe. advocated equality for in situ and ex situ conservation efforts. (ii) In the second phase (1950-1970). However. resources. Further. which are so important for developing economically superior crop varieties. The CGIAR is also committed to strengthening national agricultural research systems in genetic resource programmes.Major efforts in the ex situ conservation of crop genetic resources also became possible due to support provided to the crop-based research centres of CGIAR (Consultative Group on International Agriculture Research). and strengthen develop international collaboration and conservation for plant improved strategies technologies genetic resources conservation. pollen and in vitro cultured tissues. efforts and funding for ex situ conservation were enhanced in recent years. Jamaica. excluding contributions to international systems of gene banks. so that in 1992-93. approaching as many as 600. which includes the following G-15 countries: Argentina. deliberate introduction of disease causing microorganisms in carefully planned field experiments is also an accepted practice.located at Rome.The G-15 countries have also resolved to set up network of gene banks to conserve a variety of medicinal and aromatic plants in their countries. because of their utility in future crop improvement and afforestation programmes. due to their utility. long-term viability of the investment in collection is ensured. Senegal. In 1974 with the support of CGIAR.This has become particularly important for conservation of crop varieties and wild genetic resources.000 samples of crops in 120 countries. These germplasm collections are held in trust for the use of present and future generations of research workers throughout the world. . through breeding programmes.5 million dollars meant for biodiversity conservation. a wide spectrum of genetic resources were conserved. Algeria. The activity will also cover the conservation of plant species in the national parks and sanctuaries. Practical (i) In action the on first ex situ era genetic resource utility conservation of and its use can was be divided and into following genetic four major eras. Malaysia. technicians. (iii) collection of over 200. these IARCs have built up the world's largest ex-situ collection of crop gene pools. global interest in conservation has been stimulated by the 'Botanic Gardens Conservation Secretariat' and the 'Centre for Plant Conservation'. mutagenesis and selection. Venezuela. to following assess in and the meet four their needs and use for of major plant plant genetic genetic objectives: resources.000 individual accessions.Humans have been evaluating plants and microorganisms modified through conventional approaches of breeding. which have now been established in more then 100 countries." IBPGR has contributed to (i) (ii) the establishment training of of ex morc situ than conservation 1700 facilities in scientists over and 100 countries. Ex Situ Conservation Efforts by G-15 Countries . (1850-1860). This (i) (ii) (iii) to to to assist institute countries. The mandate of this institute was "to advance the conservation and use of plant genetic resources for the benefit of present and future generations. are rich in biodiversity and have gene pools. For instance in 1987 for ex situ programmes. which is a broadly based consortium supporting a world wide network of 17 (seventeen) international agricultural research centres (IARCs). Mexico. India. Egypt. Biosafety.
But with the development of recombinant DNA techniques. competitors. (NIH) established the Recombinant Advisory Committee (RAC) in 1974.Modern biotechnology means the application of in vitro nucleic acid techniques. thereby. we briefly consider the various aspects of safety required for research on recombinant DNA and the use of GMOs (genetically modified organisms). most cloning experiments in E. A major revision of the guidelines was effected in 1982. or and ecosystems disturbed dispersal. measures. These concerns were examined by a committee of National Academy of Sciences (U. Recombinant DNA technology enables humans to combine DNA sequences from different sources to create functional DNA molecules with novel properties. complete exemption was granted for most recombinant DNA research. the external environment. in which they might be released. USA) has developed guidelines for recombinant DNA research with a view to specify the practices for constructing and handling (i) recombinant DNA molecules. undertaken within a facility. As a consequence. The first NIH guidelines were prepared in 1975. and remain a public concern even today. The recombinant DNA techniques initially raised concerns in the scientific community. (1) They may rapidly multiply and out compete the native microbes. deferred. deliberate introduction and 'field testing' are often used as synonyms of planned introduction. and experiments that were previously prohibited. Thus it was perceived that the consequences of gene transfer through recombinant DNA technology are less certain and posed a higher risk than those through conventional methods of breeding.A. Contained use means any operation. Similarly. certain strains of Bacillus subtilis and Saccharomyces cerevisiae were considered exempt from other requirements of NIH guidelines.Discussions on the possible hazards of cloning recombinant DNA molecules began in the early 1970s. populations. It was feared that genetically engineered microorganisms (GEMs) may disturb the ecosystem and its processes. persistence parasites. which involves living modified organisms that are controlled by specific measures that effectively limit their contact with and their impact on. In February 1975. and potential different (iv) such safe bacteria and plasmids that could not survive in the environment if they escaped from the laboratory should be developed. The main concerns focussed on (1) (2) laboratory possibility of practices creation of needed 'hybrid to organisms' handle with serious biological human activities of an and animal unpredictable pathogens.S. or (ii) molecules that result from replication of the molecules described in (i) above. in the following two ways. increase their virulence. California. containment levels were lowered. fears have been expressed about the consequences from accidents either in the research laboratory or in the use of recombinant DNA containing organisms in agriculture and the environment. (2) They may also transfer genes related to virulence or pathogenesis into the native bacterial populations and. new may be susceptibilities transmitted by pathogens sexually or compatible altered may weed reaction species to endanger and to the microbial symbionts ecosystem. the conclusions from the conference were as follows: (i) (ii) (iii) most of certain the risks work on were experiments recombinant assigned DNA to could should proceed with types be appropriate of safety experiments. i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to yield DNA molecules that can replicate in a living cell. nature. the National Institute of Health. or fusion of cells beyond the taxonomic family that overcomes natural physiological.) in 1974. a historic international meeting was convened at Asilomar.S. were changed to category requiring review and approval by NIH Defintions of Some Modern Biotechnology Terms. including recombinant DNA techniques and direct injection of nucleic acid into cells or organelles. they were more strict than the recommendations of the Asilomar conference. reproductive or recombination barriers and that are not the techniques of traditional breeding and selection. (i) (ii) (iii) (iv) the genetically production unexpected new characteristics may be modified plants of could toxic to to related pose biological or and ecological allergic risks follows: metabolites. These guidelines require approval and clearance of any recombinant DNA experiment that requires such . Objectives of Safety Guidelines . and were made much less restrictive. Biosafety History. U. Eventually. The terms deliberate release. In this chapter. installation or other physical structure. and (3) the escape of 'hybrid organisms' from the laboratory with unpredictable consequences. Recombinant DNA molecules are defined as either. By 1981. and (ii) organisms and viruses containing recombinant DNA molecules.A. coli K-12. The guidelines were revised after two years.The National Institute of Health (NIH.
Assessment of Risk During Laboratory Researcht. The (1) (2) assessment of risk initial comprehensive during laboratory risk risk research is usually done in two steps. drying. assessment Initial Risk Assessment. and assessment. Biohazards From Processes of Manufacture in Biotechnology IndustriesOperation Raw material weighing. leakage Aersol. filtration. Cartagena Protocol on Biosafety to the Convention on Biological Diversity has been designed to cover the transboundary movement. leakage Aerosols. infectious dose. etc. spillage.derived from recombinant DNA into human subjects can not be initiated without submission of the required information to NIH and other specified agencies. on which he proposes to conduct experiments. etc. 2) Organisms included in RG2 are associated with such human diseases. Careful consideration should be given to the types of manipulations that are planned for some higher RG agents. A hazard is any imaginable adverse effect that can be identified and measured.The chief objective of risk assessment at this stage is to decide on appropriate laboratory procedures. These factors include such features of the organism used for the experiment as virulence. Risk assessment involves determination of the potential and anticipated adverse effects of the recombinant DNA research to the concerned workers. and should be in accordance with recognized risk assessment techniques. encourage these activities. spillage.approval/clearance from NIH or another Federal agency. Thus risk may be defined as the undesirable consequences of an activity in relation to the likelihood of these consequences being realized. handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity. which are rarely serious and for which preventive or therapeutic interventions are often available.The initial risk assessment is made by the investigator on the basis of the risk group (RG) to which the organism. at the. dust. Risk assessment should be carried out in a scientifically sound and transparent manner. (1) Risk group 1 (RGl) agents are not associated with disease in healthy humans. Risk Assessment-Risk is a function of the level of hazard and the probability of occurrence of the hazard. or DNA or RNA. effulent. Malt Fever . contamination. trails it. mixing etc. All experiments involving the deliberate transfer of recombinant DNA. filtration Product purification Product blending. This assessment takes into account the following. Candidiasis. taking into account risks to human health. and of the products of such research on human health and the environment consequent to their accidental or deliberate release (in case of living organisms) or as a result of their consumption. Disposal Hazard Allergic Dusts or Areosol Aresols from the reactor. a comprehensive risk assessment should be done. spillage. The ultimate objective of guidelines that regulate research and development activities using recombinant DNA technology should be to minimise risk from such activities and. (3) RG3 agents are associated with serious or lethal human diseases for which preventive or therapeutic interventions may be available. Comprehensive Risk Assessment. Dermatitis. 2. belongs. same time. Bioreactor fermentation Biomass separation by centrifugation. pathogenicity. spillage Discharge of untreated effulent Noninfectious Illnesses Associated with Production Processes Biotechnology Industries Product / Process Antibiotic Brewing Non Infective Illness Cardiovascular Disorders.Following the initial risk group based risk assessment. Experimental Organism Factors. Type of Manipulation. 1. and physical and biological containment levels for the proposed research. (4) Organisms belonging to RG4 are likely to cause serious or lethal human disease for which preventive or therapentic interventions are not usually available. spillage Aerosols. Organisms are classified into four risk groups based on their potential effects on a healthy human adult. packagin Effulent sterilization.
initiation.Many of the processes of manufacture have the potential to generate biohazards. and the risk of allergic reaction is the greatest after the product is more concentrated. use research and GMOs as well as products made from such organisms. Ant violation and nocompliance. The MOEF has an interministrial committee called the genetic engineering approval committee (GEAC). an organ of NIH) and mc before they can be initiated. 1. Experiments that require approvals by NIH/OBA (Office of Biotechnology Activities. which has a DBT nominee. and is the competent authority to decide on the large scale use of GMOs. it is not surprising that several noninfectious illnesses are associated with biotechnology industrial products/processes.Citric acid Enzymes Endotoxin Fungal Fermentation Single Cell Protein Steroids Categories of Recombinant Asthma. New Delhi. . The giodelines recognize four levels of risk in the case of experiments with microorganims. Dermatitis Feminization of males. review.N Experiments with whole animals using such organisms The DBT implements the research and development experiments utilizing GMOs and recombinant DNA products. and approval by NIH Director before their initiation. Field trials using transgenic plants began in 1995. Biosafety Levels for Introduction of Recombinant DNA into Organisms - Biosafety level Organism of risk group RG2 RG3 RG4 RG1 Introduction of recombinant DNA into the organism Approval by IBC before Initiation with Essential BL2 BL3 BL4 Notice to IBC Simultaneous with Inititation BL1 Biosafety Guidelines. In addition. the ministry of environment and forests (MOEF) promulgated in december. Department of Biotechnology (DBT). 2. 2. 1. 5. hypertension. Most reported health problems are associated with downstream processes. and a critical assessment of the biosafety performance of process equipments. 5. 3. the sailent features of these guidelines and Regulations are as follows. IBC is the nodal point for interaction of the organization wit the government.N BL4 or BL4 . in addition.In. each state has. Bronchitis Allergic. based on pathogenicity of the microorganisms. The last category consists of all such experiments that are exempt from regulation of guidelines. 1989 the rules and procedures for the manufacture. Bronchitis Asthma. initiation. a state biotechnology coordination committee. including non reporting of activities. in this area would attract the punitive actions provided under the EPA.N BL3 or BL3 . which has subject specilist as members. Experiments Experiments that mc to IBC approval before with require notice simultaneous their 6. 4. and a district level committee. During extraction of intracellular enzymes. The DBT has a review commitee for genetic manipulation (RCGM). Every organisation involved in research and development using recombinant DNA technology is required to set up an institutional biosafety committee (IBC). Dermatitis Flu Symptoms Asthma. An effective monitoring strategy should involve environmental assessment of emissions at all stages of a manufacturing process. the greatest risk is posed by the processes of handling the large quantities of cell debris. Experiments that require approval by Institutional Biosafety Committee (IBC). 3. conjunctivities. and NIH/OBA registration before their they are started. a committee of NIH). Biosafety During Industrial Production . which are involved in inspection and monitoring of experiments at the field sites. while entry by ingestion or skin contact can readily be prevented by good operating practice. Inhalation appears to be the most significant mode of entry of microbes or microbial products into the body. it should maintain adequate surveillance of worker health. local prevalence of the concerned disease and of epidemic causing strains in india. while MOEF implements the large scale commercial use of these.increased body weight DNA ResearchNIH guidelines recognise six categories of recombinant DNA experiments. asthma. Experiments that require approvals that by IBC and require Institutional Review Boards. in addition. Therefore. which has all the approvals of on going projects on GMOs and several other issues realted to recominant DNA research and development. Recombinant DNA Advisory Committee (RAC. import. the indian recombinant DNA safet guidelines and regulation have been prepared by and are available on request from recombinant advisory committee (RDAC). this was done under the proviiosn of the environment protection Act. 1986(EPA). All recombinant DNA molecules that are determined not to present a significant risk to health or the environment are exempt from the guidelines. BL2 or BL2 . 4.
the xylS activator protein remains inactive. the cells of this genetically engineered P. did not survive and spread outside the laboratory. NIH guidelines required the use of E. equipments. putida cells survive normally as long as 3MB is available to them. Gef causes collapse of the membrane potential. which is to provide biological containment shall be chosen or constructed so that the following types of 'scapes' are minimized: (i) survival of the vector in its host outside the laboratory. the xylS regulator is active.. The gef containment system consists of the following elements. as a result. gef gene (driven by Plac promoter) is expressed. lad driven which linked by to E. and gene. The guidelines provide a detailed description of the laboratory design. and it activates transcription of gene lad driven by Pm promoter. In a process based approach.GMOs . Plac. Any combination of vector and host. Gef protein is not produced. and could not transfer the introduced foreign genes readily into other organisms in the environment. Therefore. 3. Emphasis is placed on primary physical containment. respectively. the regulator gene lad is not transcribed and lad repressor is not produced. BLI (Biosafety Level 1). Biotechnology companies favour a product based regulation for obvious reasons. it has been advocated that GEMs should be construced that contain active biological containment systems that minimize their survival and dissemination and or prevent the dissemination of recombinant DNA outside the target area. viz. recombination be transmitted antibiotic to other non-mobilizable a bacteria). viz. Physical containment is grouped into four categories.Planned Introduction of Genetically Engineered Microorganisms . therefore.Physical containment consists of the use of special laboratory design. containment equipment and special laboratory design may be appropriate for containment of specific research activities. Immunoflurescence techniques have revealed a much higher survival of microbes than was previously suggested by the conventional techniques. when 3MB is not available to a cell. As the biosafety level increases. In the presence of 3MB. for the various biosafety levels. Special laboratory design provides secondary physical containment for protection against accidental release of organisms into the environment. therefore it is also called HV system (host-vector system). is the coli expressed promoter promoter constitutively. putida strain commit suicide as soon as 3MB is exhaused and becomes unavailable to them. Therefore. coli strains carrying transposon resistance Thus biological containment is based on the vector (plasmid. The The The xylS regulator structural regulator gene gene gef gene.Planned release of GMOs in the environment may be viewed in two different ways. are considered to pose potential hazards. in turn. Initially. 2. BL3 and BL4. it is used where experiments of moderate to high potential hazard are performed. or animal cell) in which the vector is propagated in the laboratory.Biological containments specifically aims at making such genetic changes in GMOs that reduce the hazard from these organisms when they are accidentally released from laboratories or accidentally transported by workers. The lacI repressor. transcription of the gef gene is repressed. the laboratory design and facilities. all GMOs.GEMs . The GEMs that are used live in the environment include bioremediation agents that degrade chemical waste. and the operational procedures become more and more rigid and stringent so as to minimise the risk of accidental release of the GMOs as well as infection of laboratory workers. These (1) (2) (3) (4) plasmid E. all GMOs are not recognized as a special category because they present no environmental hazards beyond those already identified for existing products. As a result. and the P. However. plant.. Biosafety Biological Containments . 1. etc. which is provided by laboratory practices and containment equipment. and (ii) transmission of the vector from the propagation host to other non laboratory hosts. BLI is applicable to while BL4 represents the most stringent containment levnonpathogenic organisms. In the absence of lad repressor. Therefore. function). some of which may be unforeseable. this minimizes their survival in the environment after they have degraded the alkylbenzoates present in the environment Biosafety Containments. ut in product based approach. which leads to cell death. 2. and Gef protein is produced. to the environment. be coli (they and achieved (limits by survival lack (such vectors can not or using following escape the of following: bacteria). Planned Introduction of Genetically Modified Organisms . This strain contains the E. Gene xylS is expressed constitutively. 3. it encodes an inactive regulator protein that becomes active on interaction with m-methylbenzoate (3MB). Several different combinations of laboratory practices. BL2. and the host (bacterial. coli gene gef. organelle or virus) used for the construction of recombinant DNA.Biological containments specifically aims at making such genetic changes in GMOs that reduce the hazard from these . in the presence of 3MB. Pm. coli strains and vectors that were severely debilitated. Gef protein causes a collapse of the membrane potential. 4. An example of such a biologically contained GEM is provided by Pseudomonas putida engineered to degrade alkyl benzoates.There is some data availble from field research using GEMs. binds promoter Plac and prevents transcription of the gef gene linked to it. that could not infect humans. 1.el. which leads to cell death. objectives auxotrophic recA vectors that are non mutants can of strains selftransmissible not E. containment equipments and special operational procedures to restrict the number of organisms accidentally released during normal laboratory operations and to prevent contamination or infection of laboratory workers. Biosafety Physical Containments .
This property is described as tangible. routinely licensed and marketed. More recently. is intangible and includes 'patents'. Cry proteins are rapidly degraded by the stomach juices of vertebrates. availability and use of plant and animal genetic resources (PGR and AGR). nor will the farmers be allowed to save and use the seed for cultivation. and the host (bacterial. both plants and animals. if patents on superior animal breeds are allowed. but they could have harmful effects on nontarget insect species. however. Field Trials with Genetically Modified Plants.In case of plants conventional breeding cell and tissue culture and genetic engineering share some major similarities in the method of generation the magnitude and type and the methods of detection of the genetic changes but they do differ in some important features.The characterization of these research results as intellectual properties encourages industries to allocate labour. so that the patented material can neither be used for further breeding. is the legal characterization and treatment of trade related biotechnological processes and products. Oilseed rape (B. which are protected through 'plant breeder's rights' or PBRs (PBRs are available in developed countries. therefore it is also called HV system (host-vector system). therefore.. Similarly. Chitinase did not affect learning performance. Another example of intellectual property is the development of crop varieties. chitinase and -1. coli strains and vectors that were severely debilitated.glucanase has been used for assaying the impack of these genes on honey bees. no industry would like to invest funds in this research. function). a dairy farmer will find that a calf born to his hybrid cow will belong to the company. Through PBR. In case of cross pollinated species. The risk of genetic engineering products lies in the possible unexpected effects of the exotic genes in the new cell environment and the new ecological surroundings. 'copyrights' and 'trademarks'.One of the most important issues. . such as household goods or land. This is understandable. therefore. undergoing changes.organisms when they are accidentally released from laboratories or accidentally transported by workers. using or selling the proprietary subject matter. viz.g. NIH guidelines required the use of E. Initially. because if public policies do not allow the development and commercial use of an intellectual property. objectives auxotrophic recA vectors that coli are non strains mutants can of strains selftransmissible not E. the advances in which are covered by the patent system and are. Any combination of vector and host. which sold him the animal. These intellectual property rights affect (favourably as well as unfavourably) the conservation. The term property. In case of viral coat protein genemediated virus resistance fears of another virus acquring the engineered protein coat and thereby produce hybrid viruses is a possibility. be coli (they and achieved (limits by survival lack (such vectors can not or using following escape recombination be transmitted antibiotic the of following: bacteria). which result from the development of genetic engineering techniques through the use of restriction enzymes to create recombinant DNA. non-mobilizable a to other bacteria). The rights to protect this property prohibits others from making. Transgeneic varieties of crops expressing cry genes for insect resistance are in commercial cultivation. laboratory and hosts. did not survive and spread outside the laboratory. not in India). and could not transfer the introduced foreign genes readily into other organisms in the environment. available to protect this property have been the subject of discussion in recent years. 'trade secrets'. the plant breeder who developed a variety enjoys the exclusive right for marketing the variety. and gene. isolation by distance is rarely sufficient to prevent interpollination. The type of regulation necessary during field trials should depend on the ability of modified plant to survive disperse reproduce and hybridize with crops and wild plants and on our ability to confine the plants to the test site. research and development (R&D) units and funding to facillitate the production of commercially marketable items. Under biotechnology. utility patents for genetic materials. Intellectual property. In this connection. carrying transposon resistance Thus biological containment is based on the vector (plasmid. which is to provide biological containment shall be chosen or constructed so that the following types of scapes' are minimized: (i) (ii) survival transmission of of the the vector vector from in the its propagation host host outside to other the non laboratory. that could not infect humans. although use of the variety for further breeding or for replantation of seed saved by a farmer (farmer's exemption) is permissible. without paying a fee to the patent holder. Usually products of both tissue culture and genetic engineering are subjected to few to many back crosses and selection and before that they both are subjected to tissue cukture. plant. napus) expressing CpTI (Cowpea trypsin inhibitor). many legal and public policies. which has been raised due to the emergence of modern biotechnology. copying. one of the most important examples of intellectual property is the processes and products. or animal cell) in which the vector is propagated in the laboratory. is often found associated with physical objects only. while CpTI and -1. 3-glucanase had detrimental effects. on the other hand. honeybees. These (1) (2) (3) (4) plasmid E. have also been allowed in some countries. for which ownership and associated rights are guaranted and protected by law prevalent in a country. e. organelle or virus) used for the construction of recombinant DNA. popularly described as Intellectual Property its protection (Intellectual Property Protection = IPP) and the Rights (Intellectual Property Rights = IPR).. which are impediments to biotechnological research are also being challenged and are. UNIT iv Biotechnology and Intellectual Property Rights (IPR) & Intellectual Property Protection (IPP) . 3. Due to these intellectual properties. one may like to compare biotechnology with other technologies.
. if a Pseudomonas strain is prepared for remediation of oil spill. there is increased risk in maintaining trade secrets. but if a different mechanism is involved (although for same purpose). so that other competitors may try to improve the patented invention. often include private proprietary information or physical material that allows a definite advantage to the owner. video recorded or expressed in any other form). Disclosure of a trade secret and its unauthorized use can be punished by the court and the owner may be allowed compensation. Patents are granted after submission of an application. corporate plans Unlike patents. is subject to regulatory purview of Food and Drug Administration (FDA) before its clinical use is allowed. Patentable subject matter. but legally equivalent to the subject matter claimed. The Indian Patents Act of 1970 allows process patents. a patent means grant of "right to exclude others from making. chemicals. Patents for life forms are discussed in greater details. monopoly rights (only to inventors) were granted in some countries of Europe. Infringement of a patent is often found when an accused object is physically different. Intellectual Property Rights (IPR) . which were decided both for and against the patent.Patents . thus further advancing the technology. Despite this. tape recorded. This can be illustrated by the popular example of Coca-Cola brand syrup formula. If no product patent is available for a product. if a trade secret becomes public knowledge by independent discovery or other means. (ii) Under the U. who has lodged the complaint. However.S.The best example of copyright is the authored and edited books. because these patents will work as impediments in free exchange of genetic materials for improvement of crops and livestock. which sometimes may become outdated before the patent is granted after the application is tiled (it takes about 2 years in USA ).The granting of special exclusive rights (for trading new articles) has been a practice to encourage innovations. thus making it difficult to maintain secrecy. whichever is less. When granted. since other Federal or State Laws need to be followed. in USA. As an example. It is believed that although utility of a new invention (biotechnological or otherwise) can be proved. While patents and trade secrets get the protection for the basic idea. lies with the original patent holder. painted. (i) A patented pharmaceutical. In India. (iii) Use of excessively noisome genetically engineered inventions might also be curtailled under local nuisance ordinances.Copyright . or lists. the copyright is possible only on the expressed material (printed. it is no longer protectable. which can not be reproduced without the permission of the person (author. is subject to some restrictions. using or selling" an invention for a 17 year period. before they are released. expressed or not expressed in writing. The duration of the patent in India is five years from the date of grant of patent or seven years from the date of filing the application. lines. Federal Insecticide. may not be required to satisfy the more difficult conditions laid down by law for patent applications. Progress is actually made through dissemination of ideas and only market ultimately determines which patented inventions are commercially successful. patent applications are published weekly by Patent and Trademark Office = PTO). then an analogously prepared Bacillus strain will infringe the patent. Under U.S. or audeo and video cassettes. but no product patents for foods. there have been problems in proving novelty and in defining the limits of statutory subject matter as applied to biotechnological products. However.The impact of IPR on the availability of genetic diversity will also be witnessed. however. editor or publisher). For instance. There have been several court cases in this connection. genetically engineered microbial pesticides require Environment Protection Agency (EPA) permits. Intellectual Property Rights (IPR) . Intellectual Property Rights (IPR) . due to large degree of research component in biotechnology. There are also arguments against patenting life forms like transgenic animals and plants. who holds the copyright. Fungicide and . therefore. fulfilling certain statutory requirements. Patents are usually allowed for a specified period. the infringement may be avoided. In case of a dispute. the burden of proving that the product has not been manufactured by an alternative process.Trade Secrets -Trade secrets. drugs and pharmaceuticals. as an incentive to develop new articles that would be of benefit to the society.Rodenticide Act. should generally meet three requirements: utility. Following are some examples. The results are published and discussed in conferences and disclosed due to exchange of graduate students. Trade secrets in the area of biotechnology may include material like (i) (ii) (iii) (iv) hybridization cell merchandising customer conditions. novelty and statutory subject matter.A patent. the same product may be manufactured by an alternative process (which is cost effective) without any infringement of the patent granted for the process. in some cases reliance on trade secrets is more prudent than the patents. law.A. a patent is also published (in USA. trade secrets have an unlimited duration and.
In these supplements. either the hard way by making mistakes themselves or else spent time observing others doing it. However. young entrepreneurs in this area often repeat these mistakes. one would like to have knowledge of factors that influence success of a biotechnology company. as is currently being discussed at the international level. Similarly. who started using biotechnology companies for commercial gains had no background or familiarity with business world. nor were they designed to promote. The chapter is based on three supplements of the journal Nature Biotechnology. Certain vectors useful in recombinant research are also known by their trademarks. an effort is being made to familiarise the readers with various aspects of biotechnology that have a bearing on the success of biotechnology business. sold and licensed like any other property. The guidance being supplied is based on the wisdom of those who have learnt the art of bioentrepreneurship. An instruction manual can be copyrighted and also protected as a trade secret. In the past. it is significant that changes arc being proposed by some industrialized countries to the General Agreement on Tariffs and Trade (GATT) and to World Intellectual Property Organization (WIPO). which in turn will contribute to the development of greater crop diversity. which have an important bearing on biotechnology business. those who were in biotechnology business learnt by making mistakes. according Biotechnology Data Bank (BID) maintained at the University of Siena (Italy). a large number of biotechnology companies came into existence. In view of this.Trademarks . and discussed at the international level. it docs make a part of intellectual property of any industry. and may also find in this chapter other sources of knowledge and possible further training. we do not understand fully the implications of the extension of intellectual property righs (IPR) to plant genetic materials and crop varieties. so that the copyright is not infringed. the protection of diversity of whole ecosystems or unmodified plants. also in this chapter. crop varieties arc subject to intellectual property rights in the form of PBR (Plant Breeder's Rights). These include the following: (i) Pace of technological development: if it is rapid then a trade secret approach may be preferable to patenting. Similarly. whether trade secret is a better protection. At present. The protection to copyright is limited. if PBR is extended to all plants. but the ideas given in the book can be used for any purpose. The chapter is included in this book with the hope that students of biotechnology who happen to be aspiring to become future entrepreneurs may derive some benefit from the experience of others. Computer data bases and photomicrographs of DNA instruction manuals related to biotechnology can also be copyrighted. 2001. an effort has been made to provide guidance to those who are interested in starting and nurturing a biotechnology company. laboratory equipment bears trademarks that are well known to workers in this field. the impact of extending IPR to plant genetic material is being studied. since although one may not be allowed to photocopy the present book on biotechnology due to copyright. July 2002 and July. (iv) Need to show patents: patents may have to be shown to investors as a measure of success. In this connection. the present intellectual property right (IPR) systems do not promote. this might help in extending breeding work to more crops. In biotechnology. Consequently. many scientists. the evaluation. For instance. Furthermore. For instance. so that one may prefer rights other than secrecy.Copyright rules may be modified from time to time as has been done to allow copy right ability to computer software. but can not be protected as a patent. the copyright may cover DNA sequence data which may be published. However.In most industrialized countries. that are not patentable. an alternative sequence coding for same protein may be prepared using wobble in the genetic code. . Biotechnology Entrepreneurship Introduction During the last two decades of the 20th century (1980-2000). will be the informal innovations in developing countries.A trademark is a word. Although ordinarily this intellectual property may not raise any legal issue. If these changes are made. Choice of Intellectual Property Protection . These properties can be bought. these companies both in USA and Europe also attracted huge investments in the stock market. or symbol "adopted and used by a manufacturer or merchant to identify his goods and distinguish them from those manufactured or sold by others" in biotechnology research. (iii) Security considerations: it may be impossible to prevent disclosure of a trade secret. there were 2104 biotechnology companies in Europe in the same year (2001). but it may be more expensive to enforce the patent. Biotechnology Industry Organization there were 1379 biotechnology companies in USA in 2001. Intellectual Property Rights (IPR) . experts in the world of business were sometimes unfamiliar with the tools of biotechnology research. However. use and maintenance of plants may be encouraged indirectly by he patent system. (ii) Associated costs: although the cost of secrecy may exceed the cost of obtaining a patent. others met with failures and closures so that the profit making companies world-wide at the turn of the 20th century did not exceed 76 in number. however. when a constituent of the plant has a commercial value. In view of this. This is not so in case of patents and trade secrets. Intellectual Property Rights (IPR) and Plant Genome Resources (PGR) . because the current IPR systems reinforce the tendency of plant breeders to decrease genetic diversity. Selection of the most appropriate mode of protection is a business judgement based on several factors which differ from case to case. Due to an anticipated growth of biotechnology industry. This may have far reaching impact on maintenance and preservation of plant genetic resources. The choice of protection also depends on the nature of subject matter that needs to be protected. thus increasing at least marginally the chances of success and consequently also reducing the risk of losses in such a venture. but can not be patented. an instruction manual can be copyrighted or also protected as trade secret.S. According to U. . However.Biotechnologyical products can be protected by anyone of the four intellectual property rights discussed above. 2003 under the title'bioentrepreneur'. In this chapter. brought out in July. and therefore. since biotechnology business is young and the mistakes committed by others do not become quickly and widely known. so that one will have to decide. therefore. the only form of human innovation. while some of these companies achieved success.
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