Biotechnology: a modern tool for food production improvement - Patrick Heffer

ACRONYMS USED

1. INTRODUCTION

In the frame of this paper, “biotechnology” is considered in its broad sense, i.e. the use of biological processes or organisms for the improvement of the characteristics of plants, animals, micro-organisms or food derived thereof. This includes, but is not limited to, modification and enhancement of living organisms at the molecular level, frequently dubbed as “modern biotechnology.”

The paper concentrates on recent developments of biotechnology use in the seed industry. It presents biotechnology as providing powerful and useful tools, in a continuum of technical evolution that contributes or could contribute to the improvement of crop production, food quality and safety, while preserving the environment. It also addresses the complex regulatory framework surrounding modern biotechnology, as well as tools in the pipeline, and intellectual property aspects related to the technology. It analyses current and potential applications of biotechnology in developing countries and countries with economies in transition, and what should or could be the role of FAO to maximize potential benefits of biotechnology in these countries.

Finally, the paper is limited to plant biotechnology. It does not address the use of biotechnology in animal breeding or food processing.

2. USE OF BIOTECHNOLOGY IN SEED PRODUCTION AND PLANTING MATERIAL PROPAGATION

Biotechnological tools have greatly contributed to the production and supply of improved quality seed and planting material to farmers worldwide. Among other uses, biotechnology is employed to:

• speed-up the multiplication process for vegetatively propagated crops,

• detect diseases transmitted by seed or planting material,

• eradicate diseases transmitted by planting material,

• protect seed with biological control agents, and

• test varietal identity and purity.

2.1 Tissue culture

Miniaturized in vitro multiplication of plant material under aseptic and controlled artificial conditions, also known as micropropagation, has been used for decades to speed up the propagation process for several vegetatively propagated crops. This is the case for fruit trees (e.g. banana, date palm), roots and tubers (e.g. potato, cassava), vegetables (e.g. strawberry, asparagus), and ornamentals (e.g. roses, orchids). Many companies and institutions worldwide have invested or specialized in this activity, to provide farmers and growers with high quality and healthy planting material.

Somatic embryogenesis, a variation of micropropagation (where embryos are directly regenerated instead of shoots and roots), is being used widely for oil palm. In the early 1980s, several organizations investigated the possibility with some crops to use somatic embryos that could be encapsulated with different chemical and biological compounds. These “artificial seeds” would have been planted and treated as seeds. Potential benefits would have been tremendous from a plant breeding, seed production and seed treatment point of view. However, technical and economic constraints have not allowed commercial development of this technology.

2.2 Detection of diseases transmitted by seed or planting material

Two methods are being more and more used for detection of diseases transmitted by seed and planting material:

• ELISA (Enzyme Linked Immunosorbent Assay) is a widely used technique based on an antibody-antigen reaction, and used for diagnostic determination of the presence of specific molecules in a sample.

• PCR (Polymerase Chain Reaction) is a technical procedure that amplifies and makes it possible to detect a specific piece of DNA.

These two techniques are much more sensitive and reliable than conventional seed health assays on grow-out media, and will ensure a much higher seed health level. However, for the time being, they are only operational for a limited number of diseases transmitted by seed or planting material. Moreover, the high sensitivity of these techniques, in particular PCR techniques, may lead to false-positive results. As far as quarantine pests are concerned, misuse of these techniques may lead to unnecessary troubles in international seed trade. To limit these potential difficulties, and optimize potential benefits from these new technologies, ELISA and PCR techniques must be used with care and have to be associated with appropriate sample sizes and thresholds, to be set jointly by scientists and quarantine authorities.

2.3 Eradication of diseases transmitted by planting material

A major problem of vegetatively propagated crops is transmission of diseases, in particular of viruses, through planting material. Several cultivars of garlic, potato, apple tree, etc., have been known to be totally contaminated by viruses. In the absence of genetic resistance within the genepool, meristem culture has been widely used to transform these cultivars into healthy cultivars, free from diseases. The principle is that a meristem (the apical part of a stem) is normally free from diseases. If a meristem is taken from a contaminated plant and is grown in vitro under appropriate conditions, it will regenerate a plantlet that will be disease-free. This plant can then be propagated either in vitro, or in vivo under strictly controlled conditions, to ensure production of healthy planting material. This technique has been widely used for decades on many vegetatively propagated crops and is still used to regenerate some contaminated cultivars. Its association with disease detection methods such as ELISA or PCR techniques makes it a very powerful tool to ensure propagation of healthy planting material.

2.4 Seed treatment with biological control agents

Biological control agents used as seed treatments are micro-organisms that protect seeds and seedlings from various pathogens. Of the biological control agents patented by early 1999, 84% were bacteria (mainly Pseudomonas spp. and Bacillus spp.) and 16% were fungi. The mode of action of biological control agents can be categorized as antagonism, antibiosis, competition or mycoparasitism. These agents may provide a good solution for protection against specific pathogens, in particular in the case of organic farming. Cotton has been the first large-scale agronomic crop treated with biological control agents for the suppression of seedling diseases of the rhizosphere, and, today, much of the cotton planted in the USA is treated with such agents. These products have also been used and tested on several other agricultural and vegetable crops (STEC, 2000).

Limited understanding of rhizosphere ecology, formulation difficulties, storage and stability problems after application to the seed, and release of some products that sometimes did not meet performance expectations, have slowed down the growth and adoption of the technology. Moreover, regulatory issues, such as registration and discard issues, may constitute constraints to the development and use of such products. Today, they are being actively developed by a number of companies. If the investment in this technology continues at the current pace, these products will probably have a significant place in the options to protect seed and seedlings.

2.5 Control of variety identity and purity

Cultivars are described using phenotypic characteristics, i.e. using characteristics resulting from the expression of genes. These characteristics may be either morphological or physiological. They may also be electrophoretic, as in the case of isozymes. Using isozymes to check varietal identity and purity provides a great advantage to seed producers, since it is a cheap and simple technique, and it is possible to have test results without planting a posteriori control plots, contrary to the analysis of other phenotypic characteristics. Moreover, if performed under standardized conditions, isozyme electrophoresis results are unaffected by genotype environment interactions. Nevertheless, to make it possible to distinguish varieties with accuracy, this technique requires several markers, isozyme polymorphism, and cultivars that are sufficiently uniform for these characteristics (unless they were bred for). Today, this technique is used for some crops, such as maize.

3. USE OF BIOTECHNOLOGY IN PLANT BREEDING

Crop improvement is the exploitation of genetic variability, followed by several generations of selection. Breeders have always used the most modern technologies available to them. This has permitted them to make considerable progress during the last twenty years, thanks in particular to the development of biotechnology. These tools permit:

• an acceleration of the selection process,

• new genetic combinations that are not possible through conventional breeding, and

• greater precision in the desired modifications of the genome.

3.1 Doubled haploids

Using in vitro techniques, it is possible to regenerate plants from pollen or ovules. These plants, which contain only one copy of each chromosome, are called haploids. They are not viable. After appropriate chemical treatment, it is possible to restore the normal number of chromosomes and to regenerate viable plants. These plants, called double-haploids, are homozygous for all their genes. Such plants are of tremendous interest to plant breeders, since they allow development of pure line varieties or inbred parental lines much more quickly than through conventional breeding.

Androgenesis (regeneration from pollen) has been successfully used for crops such as eggplant, pepper and wheat. Gynogenesis (regeneration from ovules) is used on barley. However, the bulbosum method used with barley does not require in vitro cultivation of ovules; development of haploids is obtained in vivo through interspecific crosses between barley and Hordeum bulbosum, a wild relative.

3.2 Marker-assisted breeding

Markers may be either phenotypic or genotypic, and marker-assisted breeding developed in the 1980s with the evolution of DNA marker technologies. Today, the main DNA markers used in breeding programmes are Random Amplified Polymorphic DNA (RAPD), Amplified Fragment Length Polymorphism (AFLP), microsatellites, and Expressed Sequence Tags (ESTs). Each of these markers has a different set of advantages and limits. Cost and possible automation of the techniques are of particular importance for their adoption.

Use of molecular markers, in association with linkage maps and genomics, offers plant breeders the potential to make genetic progress much more precisely and rapidly than through phenotypic selection. It also offers the possibility of addressing previously unattainable goals.

There are many applications for the use of DNA markers in breeding programmes, which fall into four broad groups, based on the purpose of the intervention:

• enhancing knowledge of breeding material and systems, such as better understanding and more effective breeding of Quantitative Trait Loci (QTL);

• rapid introgression or backcross breeding of simple characters, as the number of back-crosses required can be reduced drastically if there are markers for the character to be introduced and for the genetic background of the recurrent parent;

• early or easy indirect character selection, which is important for genes that cannot be detected at an early development stage, such as high lysine and tryptophan genes in maize; and

• new goals not possible through traditional breeding, including pyramiding of disease resistance genes with indistinguishable phenotypes.

3.3 Embryo rescue

Breeders need access to the largest possible genetic variability. In some cases, variability available within a given species is not sufficient to answer a specific problem (e.g. resistance to some new disease). A solution available to breeders is inter-specific hybridization (crossing plants from separate but related species). However, embryos resulting from such hybridization rarely survive, due to incompatibilities between the embryo and the mother plant. Saving embryos is sometimes possible through their in vitro cultivation, which make it possible to isolate the inter-specific embryo from the hostile mother plant environment.

This technique has been used for the introduction of disease resistance into squash, lettuce, tomato, etc. This technique will be replaced by transgenesis, which will provide the same result, but much faster and with much more accuracy. Indeed, contrary to inter-specific hybridization, transgenesis leads to the introduction of solely the target gene, and eliminates the need for several generations of backcrossing.

3.4 Protoplast fusion

Fusion of protoplasts is another technique to allow inter-specific hybridization between species that cannot be crossed through conventional breeding, even using in vitro embryo rescue. Protoplasts are plant cells that have had their outer walls removed through chemical treatment. While it is difficult or impossible to fuse plant cells, it is possible through various techniques (using either chemical or physical treatments) to merge protoplasts from different crop species or genera, and then to regenerate a whole plant resulting from the fusion process.

This technique has been used to introduce traits such as male sterility into rapeseed, or disease resistances in potato. Similarly to embryo rescue, this technique will most probably be replaced by transgenesis, which is a faster, more effective and more precise technique. Moreover, protoplast fusion is generally not effective beyond the family level due to incompatibilities between two too-distant genomes making it impossible to regenerate plants.

3.5 Transgenesis

Transgenesis (also called genetic transformation or genetic engineering) is the most recent step to increase genetic variability available within a crop. Transgenesis aims to introduce, through different techniques, a specific gene (included in a gene construct) from a donor species into the genome of a host species. Organisms resulting from transgenesis are commonly called Genetically Modified Organisms (GMOs).

Transgenesis is being used to introduce a broad range of new agronomic, processing and nutritional traits into the main agricultural and vegetable crops (see section 4, below). In comparison to embryo rescue and protoplast fusion, transgenesis is not constrained by reproduction barriers. Genes can be transferred from one realm into another. Moreover, only the specific gene construct is introduced in the host organism. This provides great precision and rapidity to the enhancement process. Transgenesis is a very promising tool for the development of new varieties with specific traits that are not present within the crop genepool.

4. GENETICALLY MODIFIED ORGANISMS

4.1 Current situation

The first GM crop approved for cultivation was the “Flavr Savr” tomato in 1994 in the USA. Since then, development of transgenic crops has been incredibly fast (see Table 1). In 1999, the area cultivated with transgenic crops reached 39.9 million ha. The total market for transgenic seed was assessed at approximately US$ 3 000 million, out of a global commercial seed market amounting to US$ 30 000 million.

Table 1. Evolution in the use of transgenic crops

SOURCE: James, 2000

In 1999, transgenic cultivars were commercially released in at least 12 countries (Table 2), with trials ongoing in several others. In 1999, of a global total of 39.9 million ha of transgenic crops planted, USA, Argentina and Canada cultivated 28.7, 6.7 and 4.0 million ha, respectively. In eastern Europe, Romania and Ukraine grew transgenic crops for the first time in 1999 (James, 2000).

Table 2. Cultivation of transgenic crops in 1999, by country

SOURCE: James, 2000

In 1999, the main GM crops were soybean, maize, cotton and rapeseed, with 21.6, 11.1, 3.7 and 3.5 million ha, respectively (Table 3). Transgenic soybean represented 30% of the global soybean acreage. This rate was 14%, 10% and 8% respectively for rapeseed, cotton and maize. Transgenic cultivars of potato, squash and papaya were also commercialized in 1999, and trials were underway on numerous other crops.

Table 3. Dominant transgenic crops in 1999

SOURCE: James, 2000

The main commercially released traits in 1999 were of agronomic interest, the so-called “input” traits. Herbicide-tolerant crops were grown on 31.1 million ha. and insect-resistant crops on 11.7 million ha, of which 2.9 million ha were both herbicide tolerant and insect resistant.

Input traits that are in the pipeline for release in the next few years include fungal, bacterial and virus resistances, delayed senescence, and hybridization genes. Other crops have been transformed and are being commercialized on limited acreages, or expected to be commercially released soon, including beet, rice, wheat, sunflower, sugar cane, tomato, pepper, sweet potato, cassava and banana.

In the short to medium term, transgenesis should be increasingly used to transform processing characteristics of crops, the so-called “output” traits. The main traits will be:

• to remedy to deficiencies, including higher vitamin content in soybean, rapeseed and rice, or higher iron content (in rice);

• improved nutritional profile, such as improved amino acid composition (maize), or improved fatty acid composition (maize, soybean, rapeseed);

• improved processing properties, including modified starch (maize, potato), higher solid content (potato), or improved fibre quality (cotton); and

• reduction of post-harvest losses, such as delayed ripening (papaya), or improved storage capacity (potato).

4.2 Benefits and risks

Benefits and risks of GMOs are assessed through comparison of the new organism with its “conventional” counterpart (variety or food) and associated techniques (e.g. pest management or food processing techniques).

Input traits, in general, allow lower use of pesticides and, as a consequence, they benefit the environment and improve farmers’ revenue. Among other specific benefits, insect-resistant varieties limit post-harvest losses (insects are the origin of up to 50% of loss of the harvested product in developing countries) and production of mycotoxins (responsible for serious health problems), and herbicide-tolerant varieties contribute to limit soil erosion. Output traits will be of considerable benefit to consumers through access to healthier food. Therefore, farmers, the environment and consumers benefit from the development of GMOs. This benefit will increase with the release of GMOs combining input and output traits.

Today, despite the fact that approximately 80 million ha have been grown with GMO crops worldwide from 1995 to 1999, and that billions of people have eaten GMO foods without any documented harmful effect on human health or the environment, we have to be aware that GMOs, as any new product, may be associated with some risks, which may be of various kinds, e.g. use of herbicide-tolerance genes could result in production of “super weeds” that would be resistant to total herbicides; introduction of a gene from a species that is known to be allergenic could result in the introduction of allergens in the novel food. Moreover, some aspects, which are not specific to GMOs, have also to be taken into account, such as the risk of insects developing resistance to Bt genes. These risks are taken seriously into consideration during the pre-release risk analysis and, where needed, specific risk management procedures may be established to minimize these risks.

4.3 The regulatory and political context

4.3.1 The regulatory context

Several intergovernmental organizations have adopted or are negotiating international instruments addressing the biotechnology issue, and more specifically the GMO issue. Those most relevant to the seed sector are:

• The Conference of the Parties to the Convention on Biological Diversity (CBD) adopted in 2000 the Cartagena Protocol on Biosafety, aimed at protecting biological diversity from possible adverse effects of Living Modified Organisms (LMOs) moving across borders. This Protocol is not likely to enter into force before 2002.

• Codex Alimentarius has established a Task Force on food derived from modern biotechnology, which met for the first time in March 2000, to negotiate guiding principles on food safety analysis.

• The Interim Commission on Phytosanitary Measures (ICPM), a body established under the revised International Plant Protection Convention (IPPC), convened a meeting in 2000 to discuss what should be the role of plant protection organizations vis-à-vis the implementation of the Cartagena Biosafety Protocol. It could result in specific guidelines.

• The Commission on Genetic Resources for Food and Agriculture (CGRFA) initiated in the early 1990s negotiations on a Code of Conduct for Plant Biotechnology, aimed at maximizing positive effects and minimizing possible negative effects of biotechnology. This work was interrupted, but was expected to restart in 2001.

• The Organisation for Economic Co-operation and Development (OECD), through the OECD Schemes for the Varietal Certification of Seed Moving in International Trade, initiated in 1999 discussions on an experimentation and regulatory framework regarding the issue of adventitious presence of GMOs in non-GM seeds.

4.3.2 The risk analysis framework

Before release, any new GMO has to go through a thorough environment and food safety analysis, in addition to variety registration procedures (where needed). Risk analysis has three components: risk assessment; risk management; and risk communication. Risk analysis is based on sound scientific procedures. It shall consider, among others, the recipient and donor organisms, the vector, the inserted gene, the gene construct, the resulting GMO, its intended use, the receiving environment, etc. When needed, specific management procedures may be required. In case of potential risks that cannot be prevented or mitigated to an acceptable level, through appropriate risk management procedures, the GMO shall not be released. Risk analysis is, in general, the result of a joint effort of the GMO developer (private or public) and of public regulatory agencies.

4.3.3 Issues surrounding GMOs

Despite careful scientific analysis before release of GMOs, which has proven its efficiency, several political issues surround GMO development:

• Precautionary principle vs precautionary approach

  Precaution, or the precautionary approach, is part of any research and development (R&D) activity. Before being released, any new product is subject to a scientifically sound risk analysis. Therefore, the precautionary approach is not a new concept. In contrast, the precautionary principle is a rather different concept, used by opponents to modern technologies, to argue that lack of scientific knowledge or scientific consensus should be interpreted as indicating a particular level of risk. This discussion, which may have an impact on development of modern biotechnology, although not specific to it, is a hot topic in various forums.

• Traceability

  European countries would like to trace GMOs from seed production to the consumer’s plate, so that consumers can be informed regarding the food origin, and in order to be able to quickly react in case of any possible problem. This vision is not supported by all countries, in particular due to the cost implications of traceability. Developing countries have also expressed concerns regarding implementation of this concept in their specific socio-economic environment.

• Substantial equivalence

  Substantial equivalence is a concept used to identify similarities and differences between the GM food and a comparator with a history of safe use, and which subsequently guides the safety assessment process. This concept was developed due to the complexity of food composition, which required development of a specific concept (it was not possible to adopt models used to assess safety of single chemical compounds). Despite criticism of this concept, experts recognized that there were currently no alternative concept or strategy that would provide a better assurance of safety for GM foods (FAO/WHO, 2000).

• Labelling

  This issue is the subject of a very political debate, with two opposite points of view: on one hand, those who want labelling on the process and, on the other hand, those who want food products to be labelled only for their new characteristics, if any.

• Antibiotic resistance marker genes

  Such genes were used in the early stages of genetic engineering and therefore in the first GM varieties. Researchers are working on alternatives that will soon replace these marker genes. Nevertheless, experts agree that antibiotic resistance marker genes currently used in GM crops have been previously reviewed for safety and that there is no evidence that markers currently in use pose a health risk to humans or domestic animals (FAO/WHO, 2000).

• Adventitious presence of GMOs in non-GM seeds

  Depending on the crops, the seed market is either national, regional or global. Interdependence of countries for seed supply is particularly important for maize, herbage crops, vegetable crops and some industrial crops, such as rapeseed, cotton and soybean (FIS, 2000). As regards maize, much seed is moving across oceans. However, with respect to the important acreage of transgenic maize in some maize seed exporting countries, and to the fact that maize is a cross-pollinated species, it is more and more difficult to guarantee absence of GM seed in non-GM maize varieties. This incidental and involuntary presence of GM seed is called “adventitious” presence. In 2000, Switzerland was the only country that had adopted a threshold for adventitious presence of GMOs in both seeds and food products; some countries had only adopted a threshold for food products; and some had not yet adopted any threshold. Moreover, the detection technique is not yet standardized. A joint initiative of FIS, OECD and ISTA has launched an experiment on maize, cotton and rapeseed to develop an agreed appropriate sampling and detection protocol for a 1% presence threshold.

• Unapproved events

  Some transgenic events are approved in some countries, and not in others. Adventitious presence of these events not approved in an importing country, is not accepted. Tolerance for these events is zero (similarly to quarantine pests), but this requirement is impossible to implement by the industry. The problem is that events move with seeds and ignore geographical barriers. This issue is expected to create serious problems for the seed trade in the near future, and to probably lead to seed supply disruption for some crops in some countries (e.g. cotton seed in Greece, which is mainly imported).

4.4 Prospects for evolution

Today, it is very difficult to predict the evolution of GM plants acreage by 2010. It will be highly influenced by a combination of technical, regulatory, political and ethical factors. Development of output traits will probably have a positive impact on consumer acceptance in Europe. GMOs will probably develop rapidly in developing countries producing food for their domestic market (e.g. China, India), contrary to countries exporting commodities to Europe. Current negotiations to develop international binding regulatory instruments will also have an important impact, and it is difficult to predict the outcome of current and future negotiations. Indeed, the negotiators are under pressure from an active green lobby, which is anti-modern technology. Will this trend change? All these considerations make it almost impossible to make any accurate prediction in a medium-term perspective.

5. TECHNOLOGIES IN THE PIPELINE

5.1 Genomics

Genomics is the science aimed at identifying the entire set of genes of organisms. Progress in genomics is going very fast, thanks to developments in DNA sequencing techniques. As far as crop genomics are concerned, the most advanced crops are rice and maize. In April 2000, Monsanto announced that they had decoded the rice genome sequence to the level of a “working draft.” This is the first crop genome to be described in such technical detail. This information will be shared with the International Rice Genome Sequencing Project (IRGSP), a ten-member consortium of rice genome sequencing projects worldwide. Pioneer Hi-Bred has also decoded over 80% of the maize genome. For dicotyledenous plants, research is less advanced. Arabidopsis has been used as a model species, and it was expected that its genome would be entirely decoded by the end of 2000.

It is expected that these projects will lead to the establishment of gene maps for the main crops. This should provide molecular markers for agronomic traits, help understand the molecular basis of plant development, and the relationship, if any, between genome structure and gene expression.

It is expected that this detailed understanding of genome structure and functioning will lead to great developments. For instance, combining techniques permitting modifications at the nucleotide level with the outcome of genomics will probably have a tremendous impact on breeders’ activities in a medium-term perspective.

5.2 Genetic use restriction technologies

In nature, the expression of genes is regulated by several factors, which may be internal to the organism (e.g. proteins or other molecules resulting from the metabolism of the organism itself) or external (e.g. climatic factors). Modern biotechnology can also be used to regulate the expression of genes that are, for instance, not desirable at a certain stage of crop development. Methods that regulate gene expression are called Genetic Use Restriction Technologies (GURTs)^[1]. GURTs are a specific domestication of the regulation of gene expression that occurs naturally in any organism.

Plant breeders have until now focused their activity on the introduction and recombination of genes. GURTs will allow them to work on the expression (or the non-expression) of genes at any given stage of crop development or in any generation.

Some potential applications of GURTs could be:

• increased production of specific molecules;

• regulation of the expression of resistance genes, so that resistance be expressed only when necessary;

• limitation of cross-pollination with other varieties, landraces or wild relatives; and

• improved protection of intellectual property rights (see section 6.2, below).

GURTs are subject to an intense debate, in particular at the CBD level. The debate is highly emotional and focuses on impact of GURTs on biodiversity, food security and farmers’ rights. If looked at scientifically and objectively, it is obvious that GURTs could provide solutions to some specific problems, and there is no sound scientific reason to call for a general ban on these technologies. Each country should have the right to decide whether or not to use these technologies, and to define possible limits of utilization.

6. PROTECTION OF INTELLECTUAL PROPERTY

Most countries have decided to privatize their seed industry, including plant breeding activities. As a consequence, this requires incentives to research through protection of intellectual property rights.

The plant breeder community is in favour of the strong intellectual property protection necessary to ensure an acceptable return on research investment and to encourage further research efforts. This protection can be provided either through legal or technical tools.

6.1 Legal protection

What is or should be protectable?

The seed industry considers that genes sequences associated with traits, gene constructs and biotechnological processes should be patentable. In contrast, DNA sequences not associated with an expressed characteristic, such as Expressed Sequence Tags (ESTs), should not be patentable. Similarly, if protection for a patented process extents to products resulting from that process, the scope of the patent should not be too broad.

It is also unanimously agreed in the plant breeder community that alternative approaches to achieve the same product or characteristic should not be considered as infringing the pre-existing patent and should, therefore, be also patentable.

Protection of biotechnological inventions by utility patents

The seed industry considers that the most appropriate protection of biotechnological inventions is through utility patents, provided, of course, that criteria for patentability are fulfilled. These criteria are (i) novelty, (ii) inventive step (or non-obviousness, depending on the country) and (iii) utility.

Patent laws provide strong protection to the patent holder. Research exemption and farmer’s privilege are limited in general. The research exemption is generally limited to an experimental use exemption, allowing checking whether the patented invention performs as expected. In the European Union, it is not clear whether the Directive provides for a true research exemption. In absence of jurisprudence, its interpretation remains unclear. Farmer’s privilege exists in some patent laws (e.g. in the EU Directive), but not in others.

Protection of GMOs: a combination of plant breeder’s rights and utility patents

In most cases, GMOs are protected by a combination of Plant Breeder’s Rights (PBRs) and utility patents: PBRs protecting the genetic background in which the gene construct is introduced, and the utility patent(s) protecting the biotechnological invention(s). This system allows appropriate protection of the legitimate interests of both plant breeders and biotechnologists. Nevertheless, this may raise some potential problems, since two forms of protection with different rights and exemptions then coexist in a single product. This is particularly true regarding the breeder’s exception and the research exemption: in the Convention of the International Union for the Protection of New Varieties of Plants (UPOV), there is a provision allowing free use of protected commercialized varieties for further breeding, the so-called breeder’s exception. In utility patent laws, there is a research exemption, frequently limited to an experimental use exemption. A licence from the patent holder is necessary to use a patented invention in a breeding programme. The development of GMOs containing patented inventions may lead, therefore, to a reduction of breeder’s freedom to operate. This is the reason why the International Association of Plant Breeders (ASSINSEL) adopted a statement in 1999 on development of new plant varieties and protection of intellectual property (ASSINSEL, 1999). As far as GMOs are concerned, this statement says that:

“When a commercially available plant variety protected by PVP [plant variety protection] contains patented traits, it should remain freely available for further breeding, according to the breeder’s exception provided for in the UPOV or UPOV-like systems. ASSINSEL considers that, if a new plant variety, not an essentially derived variety, resulting from that further breeding is free of the pre-existing patented traits, it should be exploited freely. On the contrary, if the new developed variety is an essentially derived variety or if it still contains patented traits and/or patented genetic causative agents, a license from the owner of the initial variety or of the patented traits must be obtained.”

The development of GMOs may also have an impact on the so-called farmer’s privilege, allowing farmers to conserve and use on their own holding seed saved from their own harvest. The mandatory exception to the PBRs applying in case of non-commercial uses (e.g. the case of subsistence farmers), as provided for in the UPOV Convention, does not exist, or needs to be confirmed by jurisprudence, in patent laws of some countries (see above). Therefore, in these countries, in the case of transgenic varieties, the presence of patented inventions in a variety may affect the “farmer’s privilege” provision of the UPOV Convention.

Since it is more and more difficult for breeders to continue their activities without access to biotechnological inventions, and for biotechnologists to exploit their inventions without access to improved genetic backgrounds, there is a trend to develop voluntary cross-licensing agreements between holders of PBRs and patents. This is for the reciprocal benefit of both parties.

Other forms of protection

Other forms of protection may be used to protect GMOs or biotechnology inventions. One option is to maintain it as a trade secret, whereby the inventor does not publicly disclose any information about the invention; however, the invention is liable to discovery and being copied. Another option is offered by contractual agreements. Contrary to patents, protection through these two systems can last forever, and if the invention is never disclosed, the public will never have access to it.

6.2 Technical protection

Where effective legal intellectual property protection systems do not exist, breeders use, when technically feasible and economically viable, hybrid varieties. This system avoids reproduction of the variety as such through use of farm-saved seed. Hybridization is an effective protection system, available in several crops, and under development in several others.

GURTs are another alternative to stimulate plant breeding activities, in particular as regards:

• self-pollinated crops in countries where breeders do not or can hardly receive fair compensation on the use of farm-saved seed by commercial farmers; and

• cash crops (e.g. cotton, tobacco) and some food crops in countries where plant varieties or biotechnological inventions are not protected.

Depending on whether the plant breeder might be interested in protecting the whole variety genome or a specific trait, he might use either V-GURTs or T-GURTs:

• V-GURTs are systems that would prevent production of farm-saved seeds. As a consequence, the whole protected genome could not be used by farmers for production and use of farm-saved seed.

• In contrast, T-GURTs would only prevent, without paying royalties, re-use of a specific high-added-value gene, such as an insect resistance gene or an output trait. In the meantime, the rest of the genome might be used by farmers for the production and use of farm-saved seed. Only the high-added-value gene protected by T-GURT would not express in the farm-saved seed.

Moreover, it is doubtful that transfer of apomixis (a natural phenomenon occurring in some plant species, whereby plants can produce seeds without fertilization) to crop species would be fully exploited, if not associated with GURTs. Apomixis would facilitate and speed-up the plant breeding and seed production process. It would also make it easy to produce farm-saved seed and could, therefore, constitute a disincentive to breeders and researchers, if not associated with a technical protection system. GURTs are the perfect complement to allow full use of apomixis in crops. The most acceptable solution would be probably to combine apomixis with T-GURTs that would switch apomixis on for the breeding and seed production processes, and would switch apomixis off after commercialization.

Today, GURTs are still at the experimental stage. These technologies have not yet been tested in the field. Therefore they are still very far from any commercialization.

It is very difficult to predict what will be the development of GURTs in the medium term. Their development will be influenced by a highly political and emotional debate, while, as for any other new technology, GURTs should be assessed further through a sound, science-based risk-benefit analysis. Then, it is up to each sovereign state to decide whether to use or not use these technologies, and for what purpose.

7. APPLICATION OF BIOTECHNOLOGY IN DEVELOPING COUNTRIES AND COUNTRIES WITH ECONOMIES IN TRANSITION

7.1 In-country research

Contrary to what is often believed, biotechnology research is not limited to a few industrialized countries. Public and private sector entities in several developing countries and countries with economies in transition have invested in biotechnology. The vitality of this sector is shown by the establishment of biotech industry associations in countries such as India, Argentina and Brazil, or at continental level, such AfricaBio for sub-Saharan Africa. China is also very actively embarked in plant biotechnology.

7.2 Technology transfer

Several companies and public institutions in Western countries are involved in technology transfer to developing countries and countries with economies in transition. They provide licences on most favourable terms, sometimes free. The most relevant organization is International Service for the Acquisition of Agri-Biotech Applications (ISAAA), an organization of seed companies and prestigious foundations, that aims to transfer agri-biotech inventions to developing countries. One can mention, among other, an ISAAA project in Kenya to transfer virus resistance to sweet potato varieties. “Golden Rice” (rice with higher vitamin A and iron content to remedy deficiencies in developing countries where rice is the basis food crop) and the International Rice Genome Sequencing Project are other relevant examples of collaborative efforts to facilitate access of developing countries to modern biotechnology.

7.3 Field trials

Field trials of transgenic crops are being carried out on all continents according to BINAS (a UNIDO database) and Bio-Track (an OECD database). In addition to industrialized countries, at least Argentina, Bolivia, Brazil, Bulgaria, the Czech Republic, Egypt, India, Kenya, Mexico, the Philippines, the Russian Federation, South Africa, Thailand and Ukraine are testing GM crops in the field.

As far as Central and Eastern Europe are concerned, the following transgenic crops are being tested:

• Bulgaria: alfalfa and tobacco.

• Czech Republic: maize, rapeseed and sugar beet.

• Russian Federation: maize, potato, soybean and sugar beet.

• Ukraine: maize, potato, rapeseed and sugar beet.

7.4 Commercial use

According to ISAAA (James, 2000), Argentina is, at the moment, the second-largest grower of transgenic crops. With 6.7 million ha of transgenic crops, Argentina represented approximately 17% of the global transgenic crop area in 1999. China ranked in fourth position with, officially, 0.3 million ha (this figure is an underestimate as it does not include the large acreage of transgenic tobacco cultivated in China). South Africa and Mexico have also initiated commercial use of transgenic crops. Brazil is in a special situation: while transgenic crops are not yet allowed for commercial use, transgenic soybean is grown on about 1 million ha in southern States. Brazilian farmers have gained access to this technology through informal exchange of farm-saved seed with farmers in northern Argentina.

As far as Central and Eastern Europe is concerned, the first transgenic varieties were released in 1999. Herbicide-tolerant maize was grown in Romania on 14 250 ha, and in Bulgaria reportedly on 12 000 ha. Bt potato was grown in Ukraine and Romania on limited areas (less than 1 000 ha).

7.5 Prospects

Developing countries and countries with economies in transition will greatly benefit from biotechnology. This is particularly true for crops that are of limited interest to the seed industry, such as roots and tubers, plantain or pulses, which are basic food crops in the least advanced countries. Tissue culture is already used in some of these countries to speed up multiplication of high quality planting material. Detection and eradication of diseases is also an important challenge for vegetatively propagated crops and pulses, which carry viruses with the propagating material. Use of marker-assisted breeding and transgenesis will also facilitate introduction of important genes that could provide resistance to pests, tolerance to salinity, improved nutritional patterns or even vaccines.

In all other countries, be they developing countries (e.g. Argentina, Brazil, South Africa, China, India) or countries with economies in transition (Eastern and Central Europe), biotechnology is already widely used in plant breeding and planting material propagation, either experimentally or commercially. The role will be rapidly increasing, in particular in countries that produce food for domestic consumption and that will, therefore, be little affected by consumer’s acceptance of GMOs in industrialized importing countries.

8. FAO’S ROLE IN ASSISTING MEMBER COUNTRIES TO BETTER BENEFIT FROM THE RESULTS OF MODERN BIOTECHNOLOGY

FAO adopted in 2000 a Statement on Biotechnology. This statement recognizes that biotechnology provides powerful tools for sustainable development, and can be of significant assistance to increase agricultural production and productivity to meet the needs of an expanding population. It also acknowledges that biotechnology could lead to higher yields on marginal lands, and could improve food quality and the health of many low-income communities.

In parallel, FAO recognizes the potential risks to human health and the environment. In that respect, the statement emphasizes that caution must be exercised in order to reduce risks. It also re-affirms support to science-based analysis, to objectively determine, on a case-by-case basis, the benefits and risks of each individual GMO.

FAO emphasizes that efforts should be made to ensure that developing countries in general, and resource-poor farmers in particular, benefit more from biotechnology. It is proposed that this be addressed through increased public funding and dialogue between the public and private sectors.

The statement also recommends that FAO promote development of networks on plant biotechnology, provide technical information and assistance, as well as analyses and, whenever the need arises, act as an “honest broker” by providing a forum for discussion.

This FAO statement defines clearly the role of the Organization in assisting its member countries to better benefit from biotechnology.

8.1 Constitute a negotiation forum

FAO constitutes an appropriate forum for negotiating international regulatory instruments on plant biotechnology. Thus, Codex Alimentarius (a joint FAO/WHO forum) has established a Task Force to develop guiding principles on safety analysis of foods obtained through modern biotechnology; the Commission on Genetic Resources for Food and Agriculture (CGRFA) is discussing a possible Code of Conduct on Biotechnology; and the Interim Commission on Phytosanitary Measures (ICPM) is investigating what should be the role of plant protection organizations as far as the implementation of the Biosafety Protocol is concerned. Additional forums may be established, as needed, to tackle new topics that are not covered by existing forums (such as CBD or OECD).

8.2 Promote cooperation networks

Development of networks is the most effective way to promote collaboration among countries and stakeholders (governmental organizations and industry) to achieve common objectives. This is of particular interest for biotechnology. Existing crop-related or regional networks could contribute to develop cooperation on R&D in biotechnology. This is probably wiser than establishing new networks dealing specifically with biotechnology. Indeed, we have to keep in mind that biotechnology is a tool and therefore networking activities on biotechnology should be considered as a component of seed or plant breeding networks.

8.3 Provide assistance

Developing countries and countries with economies in transition in general, and the less advanced countries in particular, need technical assistance and advice to develop their national programmes on biotechnology. FAO has gained extensive experience in providing technical assistance to such countries through national or regional field projects and training programmes. These activities should include a component on plant biotechnology, where relevant.

FAO plays also a key role in information dissemination. This is also a very relevant role vis-à-vis biotechnology, since technical progress goes very fast, and it is difficult for researchers in developing countries and countries with economies in transition to keep up-to-date on recent scientific developments.

Analyses of the regulatory, scientific, technical, trade and political context surrounding development of biotechnology is also very valuable for decision-makers in FAO member countries. FAO could provide, on a regular basis, neutral and objective analyses on biotechnology to help decision-makers take appropriate decisions.

8.4 Facilitate technology transfer

FAO could act as an adviser or a facilitator between parties involved in technology transfer, in order to ensure that technology reaches the less advanced countries under preferential conditions, taking into account possible legal and trade implications.

FAO should ensure that subsistence farmers benefit as well from biotechnology.

8.5 Provide policy advice

FAO could play a strategic role in advising member countries on suitable policy aimed at promoting appropriate use of biotechnology. This implies development of relevant seed policy. FAO regional networks and consultative groups on seeds could play an important role in that respect, in particular in the perspective of regional collaborative efforts.

9. CONCLUSIONS AND RECOMMENDATIONS

Plant biotechnology has the potential to be a key tool to achieve sustainable agriculture, through improvement of food production in terms of quantity, quality and safety, while preserving the environment. However, plant biotechnology is not sufficient in itself to achieve this challenge. For instance, biotechnological inventions have no value if not associated with an improved and adapted genetic background. Similarly, if seed distribution networks are not effective, seeds carrying biotechnological inventions will not reach farmers. Therefore, plant biotechnology should be considered in the framework of the agricultural sector at large, taking into account scientific, technical, regulatory, socio-economic and political evolution.

As far as plant biotechnology is concerned, FAO has a central role to play in serving as a forum to negotiate international instruments to ensure safety while facilitating international trade, promoting collaborative work and technology transfer, and providing technical assistance and policy advice. With respect to FAO’s mandate, the Organization should ensure that all parties take measures that would ensure that the less advanced countries and resource-poor farmers also benefit from plant biotechnology. This should be done in close collaboration with other international organizations tackling agri-biotech related issues, to optimize the efforts of all those who share a common objective.

SOURCES USED

ASSINSEL. 1999. Statement on Development of New Plant Varieties and Protection of Intellectual Property, ASSINSEL [www.worldseed.org]

FAO. 2000. FAO Statement on Biotechnology [www.fao.org/biotech/state.htm]

FAO/WHO. 2000. Safety Assessment of Genetically Modified Foods of Plant Origin, Report of a Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology, Geneva, 29 May - 2 June 2000. Codex Alimentarius [www.fao.org]

FIS. 2000. Statistics on World Seed Trade [www.worldseed.org]

James, C. 2000. Global Status of Commercialized Transgenic Crops: 1999. ISAAA [www.isaaa.org]

Jefferson A.R. et al. 1999. Genetic Use Restriction Technologies. Technical assessment submitted to SBSTTA, Montreal, Canada, 21-25 June 1999. CBD [www.biodiv.org]

STEC. 2000. Biological Control Agent Seed Treatments (to be published on the Internet by FIS) [www.worldseed.org]