2 What is agribiotech?

2.1 Results of consultations

Comments from stakeholders made it very clear to the consultants that biotechnology is much more that genetic modification (GM). They stressed that biotechnology involves a wide range of tools and technologies, not just GM.

Concern was raised by some stakeholders, that care should be taken to ensure that agribiotech’s vision and strategy was not isolated from other subsectors of biotechnology, as many innovations occur at sector interfaces.

Some considered that international thinking, for example in the European Commission, is moving away from focusing on sectoral biotechnology, including agribiotech, to the wider concept of a “Knowledge Based Bioeconomy.”⁵ The OECD’s Futures Project has taken an integrated view, where biotechnology and the economy blend into a bioeconomy, of which agriculture is but a part. These bioeconomy, rather than agribiotech, themes recognise that biotechnology is not an end in itself and is increasingly converging with other technologies to produce benefits that could potentially lead to large scale changes in the future. The OECD considers that while the bioeconomy is currently a relatively small component of the international economy, it is set to grow rapidly and permeate virtually all aspects of the economy.

One stakeholder questioned the need for an agbiotech vision and strategy, arguing that modern biotechnology was pervasive in ag-science research. It was pointed out by this stakeholder that, at one point, research in some states was undertaken in biotech centres, but now all government agricultural research laboratories are using at least one modern biotechnology tool. The question was raised whether we need an agribiotech vision and strategy or simply a strategy to deal with GM foods. However, most other stakeholders consulted saw a need for both a vision and a strategy for agriculture’s use of biotechnology, which was wider than GM. Some pointed out that while GM is currently a focus of controversy, other technologies could well take this lead in the future, as science is dynamic and some technologies are currently under the radar.

Some stakeholders stressed that agribiotech is but one of a number of tools available to improve agriculture’s competitiveness. Many issues of importance are related to the future of agriculture rather than agribiotech. For example, it was stressed that there is little value in developing new genetically modified germplasm if Australia does not have a breeding program for the particular crop in question.

It was very clear from the consultation process, that many stakeholders considered that the coverage of the agribiotech vision and strategy should be as broad as possible. It was argued by virtually all stakeholders, that they should not be limited to activity on the farm. Rather, it was strongly suggested that agribiotech should extend down the value chains to processed food, fibre and biofuels. An important rationale for this view is the role of consumers (final and intermediate) in the acceptance of products produced using this technology.

2.2 Biotechnology Definition

Most, if not all, Australians would be aware that biotechnology is not new. It has been used in agriculture, in one form or other, for many centuries. Examples of traditional biotechnology include:

• using naturally occurring yeasts in the fermentation of beer, wine, bread and cheese
• plant cloning from cuttings
• plant breeding by cross pollination
• animal breeding using selection techniques.

Modern biotechnology is distinct from traditional biotechnology because of the techniques and technologies used. The following are some examples of modern biotechnology definitions:

Biotechnology Australia
Biotechnology is a broad term generally used to describe the use of biology in industrial processes such as agriculture, brewing and drug development. The term also refers to the production of genetically modified organisms (GMOs) and the manufacture of products from them. Much of the newer activity in biotechnology involves directly modifying the genetic material of living things. This is referred to as recombinant DNA technology (or, sometimes, ‘genetic engineering’) (Biotechnology Australia website 2007).

New Zealand Ministry of Research, Science and Technology
Biotechnology is the technological use of living organisms to make or modify products, to improve plants or animals, to develop micro-organisms for specific uses or to provide goods and services.

If defined broadly, we can say that biotechnology has been around for centuries (for example, using yeast to make bread and beer, and using bacteria to make cultured dairy products such as cheese and yoghurt). Modern biotechnology came of age in the 1950s with the discovery of DNA. It includes genetic modification, but is far broader than this, including techniques for deciphering genetic codes (e.g. gene sequencing and genomics) and a wide range of cell technologies used for growing new tissue (e.g. plant cultivation and use of stem cells) (New Zealand Ministry of Research, Science and Technology, Futurewatch 2005, p16).

Government of Canada
Modern biotechnology refers to a number of techniques that involve the intentional manipulation of genes, cells and living tissue in a predictable and controlled manner to generate changes in the genetic make-up of an organism or produce new tissue. Examples of these techniques include: recombinant DNA techniques (rDNA or genetic engineering), tissue culture and mutagenesis (BioBasics website 2006).

OECD Biotechnology Statistics
The application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services. ….

The list-based definition of biotechnology techniques:

DNA/RNA: Genomics, pharmacogenomics, gene probes, genetic engineering, DNA/RNA sequencing/synthesis/amplification, gene expression profiling, and use of antisense technology.

Proteins and other molecules: Sequencing/synthesis/engineering of proteins and peptides (including large molecule hormones); improved delivery methods for large molecule drugs; proteomics, protein isolation and purification, signaling, identification of cell receptors.

Cell and tissue culture and engineering: Cell/tissue culture, tissue engineering (including tissue scaffolds and biomedical engineering), cellular fusion, vaccine/immunity stimulants, embryo manipulation.

Process biotechnology techniques: Fermentation using bioreactors, bioprocessing, bioleaching, biopulping, biobleaching, biodesulphurisation, bioremediation, biofiltration and phytoremediation.

Gene and RNA vectors: Gene therapy, viral vectors.

Bioinformatics: Construction of databases on genomes, protein sequences; modelling complex biological processes, including systems biology.

Nanobiotechnology: Applies the tools and processes of nano/microfabrication to build devices for studying biosystems and applications in drug delivery, diagnostics etc. (OECD 2005).

All these definitions illustrate that modern biotechnology involves the use of complex scientific technologies and techniques, which are applied to living organisms or their products to develop new products or services.

Further, the statistical definition based on the OECD list also recognises that biotechnology is increasingly being used in combination with other technologies such as nanotechnology, computing, modelling and simulation technology. The potential for biotechnology’s convergence with other technologies has similarities to the experience with information and communications technologies. In that field, we have seen the convergence of a range of technologies including phones, computers, cameras, typewriters, calculators etc.

What is also clear from these definitions is that modern biotechnology involves much more than genetic modification (GM). However, some of the stakeholders consulted suggested that GM technology is only one of a number of critical paths for biotechnology. It was argued that in the absence of frontier technologies, such as GM, benefits achieved may be incremental, whereas with GM benefits they can be further accelerated.

Many of the biotechnologies listed in the definitions above are in common use by Australian agricultural science researchers, and many already have applications in Australian agriculture either directly or indirectly. However, some applications remain at the cutting edge of science and research and are yet to be commercially introduced into the agriculture sector in Australia or elsewhere. On the other hand, in the case of GM biotechnology the take-up in Australian agriculture has been restricted, in part because of state and territory moratoria. It is these cutting edge/new horizon/next generation technologies and applications, which should be the focus of Australia’s vision and strategy for agribiotech.

2.3 Agribiotech’s coverage

The Australian Biotechnology Capabilities report has defined agricultural biotechnology – or 'agribiotech' as follows:

Agribiotech includes the application of biotechnology to improve plant and animal production and/or to create new, high-value products.

Agribiotech includes the five areas of Australian capability identified in 2005, in Australia's Biotechnology Capabilities, namely:

• animals and animal health
• aquaculture
• fibre crops
• food crops
• nutraceuticals/functional foods.

The close link between other areas of biotechnology (e.g. industrial, biomedical and environmental) is recognised in the capabilities document. However, given the direct links between food crops and food processing (and consumer perceptions), there are grounds for widening the coverage of agribiotech to cover food and fibre processing. Further, as prime agricultural land in some countries is now being used for growing biofuel inputs, there seem to be strong grounds for including biofuels within the agribiotech vision and strategy. For similar reasons, forestry should also be included.

2.4 Is biotechnology different to other modern innovations?

The OECD’s International Futures Programme (2006) argues that biotechnology innovations are creating a “bioeconomy”. It is hypothesised that this bioeconomy will create new growth opportunities and welfare benefits for communities and economies around the world. It is argued that the bioeconomy will be different to other innovation cycles, because of:

• biotechnology’s affordability and general availability
• the convergence of, and linkages between, other disciplines and biotechnology
• the potential for far-reaching impacts on other sectors, including agriculture
• rapid, discontinuous change – e.g. some frontiers of biotechnology science in the 1990s have become routine. “Knowledge Churn” will ensure this continues
• the Human factor, which is associated with most biotechnology and as a result public opinion, is a crucial factor in the innovation wave. It affects security, safety, privacy and ethics
• safety issues surrounding biotechnology, which need to be addressed to fully realise the technology’s potential.
• increased knowledge intensity arising from the linkages with science and informatics, which is reducing the time taken on a discovery path
• the challenges posed by the complexity of the biological sciences information
• the high opportunity costs, including loss of markets and compromised growth, which will be incurred by those countries and industries that fail to keep pace with the change to a bioeconomy.

The OECD argues that all these factors combined mean that there is a strong role for governments to play in reaping the benefits of biotechnology, by:

• mapping possible future directions
• matching these directions to social and economic needs
• adjusting policy agendas.

Reflecting these factors, the OECD’s Bioeconomy to 2030⁶: Designing a policy agenda project’s objectives are to:

1. Assess the long-term prospects of the bioeconomy over the next thirty years, and the key factors (trends, drivers) that are likely to shape its evolution. This entails inter alia a discussion of possible paradigm shifts and the social implications of the rapid pace of knowledge in the biosciences and new bio-based applications.
   
2. Building on existing work, improve the indicators and metrics that are needed to monitor the development of the bioeconomy.
   
3. Identify the most critical issues that may affect the medium and longerterm prospects for the bioeconomy and sub-sector applications.
   
4. Explore the value chain and emerging new business models to identify the most promising approaches and highlight the conditions required for successful future models, including mapping inter-linkages between applications and emerging roadmaps. Identify areas for public-private cooperation and for promoting co-operation among the various stakeholders more generally.
   
5. Identify where policies and regulations are increasingly out of step with biotechnology development. From this, draw implications regarding best practices and the supportive measures that could be put in place to encourage innovation and promising bio-based applications. More broadly, propose options for a more dynamic policy framework – legal, regulatory and institutional – which would be more conducive to the development of the bioeconomy and its contribution to economy and society more generally.
   
6. Raise awareness of and shed light on the concept of the bioeconomy and its potential in the coming decades, and seek ways to make the concept more robust and concrete. Explore options for communicating successes in the biosciences. Promote recommendations of the Project inside and outside of OECD countries.

2.5 How is biotechnology being used now?

A recently released report on the application and value of non-GM biotechnology in Australian agriculture, reviewed agricultural biotechnology projects along the supply chain. These included 119 applications to plants, 79 to livestock and 11 relating to micro-organisms (Innovation Dynamics 2007). The study found that Australian researchers are making extensive use of non-GM biotechnology tools and techniques and are developing new applications, which could eventually be applied by industry. This finding was supported by comments received during this project.

Australia’s cattle, sheep and grains industries were found to be the most intensive users of non-GM biotechnology. However, the Innovation Dynamics study found that the Australian agricultural supply chain, as a whole, is making relatively limited use of commercially available non-GM biotechnology-based tools and techniques (see Table 1) For example, the study found that:

• DNA technologies are playing a significant role in plant growing and animal husbandry, particularly in the grains and cattle industries. Breeding, diagnosis and disease management were found to be the main applications.
• RNA technologies, in particular RNA interference (RNAi, also known as gene silencing) are only being used in research and there are currently no commercial applications.
• Protein profiling (proteomics ) is complementary to DNA and RNA technologies. Its main applications in agribiotech are currently in growing and animal husbandry (e.g. DNA marker assisted breeding), identification of disease and in purity and variety testing

− genetic and protein analysis involves very large amounts of information. These technologies were found to be increasingly relying on extensive databases. which can be quickly and efficiently interrogated (bioinformatics) to help sift through the volume of data.

• Cell and tissue culture are currently used in animal breeding (artificial insemination and to a lesser extent cloning), plant breeding and in the development of vaccines. In animal and plant breeding this technology is also used in conjunction with genetic markers (marker assisted breeding), which allows breeders to select parents, preferred characteristics based their genes rather than appearance or bloodlines.
• Bioprocessing, or process biotechnology, which includes the more traditional fermentation technologies, is extending to functional foods. For example, processing aids are being used to manufacture certain foods: such as specialised yeasts for wine processing, starter cultures for cheese and yoghurt, and for the conversion of waste using enzymes. In some instances bioprocessing aids are derived from GM organisms, however, the aids themselves are not GM.
• Sub-cellular organism biotechnology, which involves gene therapy and viral vectors, was found to be very limited in Australia. Only 1.9 per cent of agribiotechnology projects being undertaken by Australian research institutions and companies involve this technology.

Table 1 Scale of the use of non-GM technologies along the agricultural supply chain

The analysis by Innovation Dynamics specifically excluded the analysis of GM biotechnology’s use in Australian agriculture and along the supply chain.

Of the 33 current GM licenses listed on the OGTR⁷ website on 25 January 2008, by far the majority were for the intentional release of GM cotton. The number of OGTR licenses by the parent organism’s common name are listed below, note that only three licenses are not related to GM in plants:

• 13 cotton
• 6 canola/brassica
• 2 bread wheat
• 2 tropical fruit (pineapple and papaya)
• 1 rice
• 2 sugarcane
• 2 flowers (rose and oilseed poppy)
• 2 animal vaccines
• 1 human vaccine
• 1 white clover
• 1 grapevine.

Currently, the only GM organisms licensed by the OGTR for commercial release are cotton, a cholera vaccine and canola (though moratoria applied by State governments have hindered the commercial release of GM canola).

In addition to these commercial release licenses, an Emergency Dealing Determination has permitted the importation, supply and use of a GM equine influenza vaccine, on a temporary basis, to address the 2007 equine influenza outbreak (OGTR October 2007a).

Until April 2007 four GM carnation lines (Moonlite™, Moonshade™, Moonshadow™ and Moonvista™), which altered the flower colour, were also subject to an OGTR commercial release licence. However, these lines no longer require a licence and have been moved to the Genetically Modified Organisms’ Register, as it has been assessed that they are sufficiently safe to be used by anyone without the need for a licence (OGTR 2007b). This is the first, and only, entry on the GMO Register.

The full details of the OGTR’s intentional release dealings may be found in Appendix C. For plants, the genetic modifications focus on a range of traits including:

• herbicide resistance or tolerance
• insect tolerance
• insecticide tolerance
• nitrogen efficiency
• water logging tolerance
• water use efficiency
• antibiotic resistance
• salt tolerance
• altered starch or sugar production
• delayed flowering or fruiting.

In a number of cases the licence covers a single variety, which has two or three traits. This is known as “stacked traits” and provides multiple benefits.

2.5.1 Comparison with uptake by competitors

Innovation Dynamics (2007) found that Australia’s take up of non-GM biotechnology along the agriculture supply chain was, in many cases, below that of its competitors. Australia’s agricultural competitors were found to be well ahead in many areas, including:

1. genome sequencing projects involving Australian species, e.g. Eucalyptus spp
2.  proteomics for agriculture (Australia being on par regarding proteomics for human health)
3. development of new vaccines (e.g. sub-unit vaccines) for livestock applications
4. biofuels
5. functional foods and nutraceuticals
6. the use of biotechnology in the fibre industry.

Table 2 Global Area of Biotech Crops in 2007: by Country

^{Note: * 14 biotech mega-countries growing 50,000 hectares, or more, of biotech crops
Data source: Clive James, 2006, reported in International Service for the Acquisition of Agri-biotech Applications (ISAAA) Brief 37-2007: Executive Summary,
http://www.isaaa.org/resources/publications/briefs/37/executivesummary/default.html.}

In GM agribiotech applications, Australia is well behind many of its competitors. For example, the International Service for the Acquisition of Agri-biotech Applications (ISAAA) in its latest global stocktake (by Clive James, 2006), found that for the 11^th year in a row the area planted to GM crops had increased. The area planted in 2007 was over 114 million hectares, up from just over 100 million hectares in 2006. The United States of America is by far the largest user of GM crops, measured by hectares planted. Eight countries (United States of America, Argentina, Brazil, Canada, India, China, Paraguay and South Africa) accounted for over 99 per cent of area planted to GM crops in 2007. Australia with only one GM crop (cotton), was ranked 11^th after the Philippines (see Table 2).

2.6 What is around the corner?

Spangenberg (2006) in considering the post Genome era suggests that advances in agricultural science and biotechnology are increasingly:

• knowledge intensive
• information intensive, e.g. bioinformatics
• technology intensive, e,g. high throughput DNA sequencing, biorobotics, microarrays
• moving from large scale biology to systems biology
• becoming an information science.

Professor Spangenberg and many of the stakeholders contacted in the course of developing this vision, argue that much innovation using agribiotech is possible without resorting to GM. But all argued that many critical developments in biotechnology will not be possible without GM technology.

2.6.1 Third generation GM

Glover et al (2005) provides a non-exhaustive list of traits contained in GM crops (see Table 3). Most commercialised GM crop technology is currently considered to be first or second generation (or wave) technologies. However, in Australia’s case the only crop in commercial production (i.e. cotton) is first generation. Similarly, GM canola, which since the removal of the Victorian and New South Wales moratoria may soon be grown in those states, is first generation technology.

Table 3 GM Crop traits

^{Note: The classification of GM plants to a generation is not clear cut. Glover et al have suggested that second generation modifications involve improvements in the quality or nutritional value of the food or feed, while third generation are essentially treating the crop as a biofactory to produce industrial or pharmaceutical products or processes
Data source: Glover J, Mewett O, Tifan M, Cunningham D, Ritman K, and Morrice B (2005)}

First generation genetic modifications were developed with the aim of changing input traits, while the second generation are being developed to change the nature of the output traits. Third generation GM crops are crops that are being modified with the specific aim of producing pharmaceutical or industrial products rather than food. The cultivation of these plants has been termed ‘plant molecular farming’ (Mewett, Johnson and Holtzapffel (2007).

Third generation GM crops are expected to offer considerable value for Australian agriculture. Mewett, Johnson and Holtzapffel (2007) suggest the following opportunities for Australia are feasible:

• diversification from traditional food and feed markets into new markets that may have higher profit margins
• the development of new industries, based on new crop plants
• greater returns on rotational break crops, which could be modified to produce higher value products
• potential to focus on animal and human disease priorities in our region.

Table 4 Some of the third generation GM applications under development in Australia

^{Data source: Mewett, Johnson and Holtzapffel (2007).}

Mewett, Johnson and Holtzapffel have reviewed progress with third generation crop research in Australia and internationally. They have found that, in Australia’s case, there are only seven applications of third generation underway and all seven are at the early stages of development (see Table 4). They indicated that these products are least 10 years from commercialisation.

Internationally, 27 third generation applications were found to be under development and more than half had reached the commercialisation or clinical trial phase. Maize, tobacco, potatoes and rice are commonly used for third generation GM modification internationally.

It has been suggested by some that second and third generation crops and products may achieve greater consumer acceptance than the first generation GM crops. This is because the second and third generation crops are expected to produce improvements in food quality and/or provide solutions to environmental and health problems and the like.

Genetic modification of animals is progressing at a slower rate than in crops. However, in the future there is potential for animals to be used for improving human health. For example:

• animal biopharming – such as the production of therapeutic proteins for human use from transgenic animals
  
• xenotransplantation – the supply of animal cells, tissues and organs to patients requiring transplants. Recent advances in genetic manipulation of animals and the mechanisms of transplant rejection have made this technology a possibility. However, in December 2004, the National Health Medical Research Council recommended that there should be no animalto-human clinical trials in Australia for a period of 5 years⁸
  
• development of new classes of naturally occurring antibiotics using antimicrobial peptides, also known as AMPs (New Zealand Ministry of Research, Science and Technology 2005).

2.6.2 Non-GM applications

As highlighted in section 2.5, there are numerous non-GM biotechnology applications being used to produce and process agricultural crops. In some instances, these technologies are a substitute for GM techniques. For example, the New Zealand Futurewatch has pointed to “Smart Breeding” as an alternative to GM:

Advances in understanding of the precise genetics of plant traits may mean that traits like drought resistance or an increase in nutritional value can be achieved without genetic modification.

Over the past decade scientists have discovered that crops are full of dormant characteristics. In practice, this means that, rather than inserting a bacteria gene into a plant to ward off pests, it may be possible often to simply turn on a plant’s own innate ability. Consumer resistance to GM food crops may also mean that smart breeding will have an important future role to play in crop development (New Zealand Ministry of Research, Science and Technology, 2005, p.64).

However, in other instances, ACIL Tasman was advised that GM technology is being used to create traits that are then being used to inform other breeding technologies, such as marker assisted breeding. This work is largely being undertaken to overcome resistance to GM and, because processes are essentially being duplicated, costs of the research are clearly higher.

Over 230 genome sequencing programs are complete, or near complete, and cover a wide range of plants and animals (Spangenberg 2006). As gene sequencing of plants and animals expands, there will be increased opportunities to undertake marker assisted breeding of input and output traits, and to use other technologies such as gene silencing to improve the plant and animal traits.

For example, Innovation Dynamics (2007) pointed to potential applications of DNA technologies to support development of fibre and oil processing industries. RNA technologies are currently being used in research organisations such as CSIRO to create immunities against disease in plants.

Proteomics, which is a much newer science than DNA, is expected to continue to complement DNA/RNA. Proteomics tools are also likely to play an increasingly important role in variety and purity testing of grains and seeds (Innovation Dynamics 2007).

Vaccines (GM and non-GM) are expected play an important role in the management of disease, including bird flu, and foot and mouth disease. Further research in the United Kingdom indicates there is potential to improve human health outcomes through the development of vaccines to prevent particular strains of E. coli developing in animals. This could reduce the potential for food poisoning in humans (Innovation Dynamics 2007).

Reproductive cloning is an asexual method of reproduction, where the new life created is an exact duplicate of another individual’s genes. In this sense, reproductive cloning is not genetic modification. However, in the future it is feasible that the genes used in the cloning process could be modified, thus blurring the distinction between GM and other non-GM biotechnology applications (see for example, Strong 2005).

Cloning of animals is currently a costly process and restricted to high value animals. Cloned animals have a higher rate of stillborns, death and disease, than animals reproduced using more conventional techniques. However, separate research reports recently released by the European Food Safety Authority (EFSA)⁹ (2008) and the United States Food and Drug Authority

(2006), have found that healthy clones¹⁰ and their offspring are no different to conventionally bred animals. Hence they pose no food safety or environmental safety concerns. These recent findings, coupled with improvements in the somatic cell nucleus transfer technology used in cloning, could in the future lead to an increased market for cloned agricultural animals.

It is clear that many of these horizon technologies (GM and non-GM) are likely to be controversial and some, such as cloning, could raise ethical concerns. Public acceptance will be crucial to their uptake in agriculture.

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^{5 See for example, European Union, 2007. See http://www.oecd.org/dataoecd/7/51/37504590.pdf
6 See http://www.oecd.org/dataoecd/7/51/37504590.pdf (accessed 14/07/2008)
7 The Office of the Gene Technology Regulator (OGTR) is responsible for licensing field trials, limited and controlled release and the commercial release of GM organisms. OGTR approval is only provided if the Regulator is satisfied that the trials or commercial release will not pose any risks to human health and safety or the environment that cannot be managed. 
8 National Health Medical Research Council website
9 Interested parties were invited to submit comments and pertinent scientific information on the draft report by 25 February 2008.
10 The EFSA restricted its option to cattle and pigs cloned using somatic cell nucleus transfer technology.}

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