Promotional Factors and Trends

3.2.1 Societal and Market-Related Factors and Trends

Environmental groups and consumer organizations are increasing the pressure on retailers and growers to reduce the level of residues on fresh food. As a result, several supermarkets have even set chemical pesticide residue levels that surpass officially allowed levels, thereby limiting the number of active ingredients. GlobalGap, the global organization of food retailers and suppliers, has set standards for growers as "major musts" for crop protection measures including the use of IPM (www.globalgap.org). The role of retailers becomes the driving force from the market to reduce the use of synthetic pesticides. Biological alternatives could fill the gap.

Biopesticides are becoming a preferred option for pest control due to resistance to chemicals, restricted entry intervals for workers, and residue concerns. They are also safe for beneficial organisms, for the crop, and for the environment. Growers' awareness of these benefits is increasing and this stimulates the adoption of biopesticides.

Organic production of food has experienced worldwide growth surpassing 32 million hectares in 2007, and the area continues to expand (www.organic-world.net). It is Benuzzi's (2009) and my own experience that only about 10% of the sales of biopesticides occur in organic agriculture. The use of microbials in organic production is allowed, but not recommended by the major regulations and standards (Speiser et al. 2006). I do not expect this to change dramatically, and biopesticides will continue to be mainly used in conventional agriculture.

Genetically modified crops were cultivated on more than 125 million hectares in 2008 (Stein and Rodríguez-Cerezo 2009). Genetic engineering, however, is not a solution for all pests and diseases. A synergy between transgenic crops and biocon-trol is promising since fewer chemicals are used, and secondary pests and diseases require sustainable solutions (Kos et al. 2009; Lundgren et al. 2009). This option deserves more research and field testing with existing biocontrol products.

3.2.2 Scientific and Technological Trends

Research continually delivers new ideas and options for biocontrol. Recently new opportunities were proposed for well-known fungal insect pathogens (Vega et al.

2009). They may be used as antagonists of plant pathogens (Ownley et al. 2008; Kim et al. 2009) and for control of nematodes (Goettel et al. 2008; Shinya et al. 2008), as endophytes against insects (Vega 2008), and as plant growth promoting agents (Vega et al. 2009). Microbial disease control agents can also affect herbivorous insects through triggering the plant's defence system (Van Wees et al. 2008; Keel and Maurhofer 2009). Broader use of existing products offers companies larger markets and a better return on investment.

Strain improvement by hybridization of fungal insect pathogens may deliver strains with a broader host range and better persistence on the plant (Aiuchia et al. 2007; Yamada et al. 2009). New discoveries in production technology with Metarhizium anisopliae producing microsclerotia offer potential for improved control of soil pests (Jackson and Jaronski 2009). The discovery of a synergist, a new protein that increased the efficacy of Bt's (Abdullah et al. 2009), could widen the spectrum and the commercial use of Bt.

Genetic improvement is a promising avenue for all microbial control agents and it has led to the development of more effective, faster acting baculoviruses, bacteria, fungi, protozoa, and nematodes at lab scale (Narayanan 2002). Genetic improvement of pathogenicity has been demonstrated for bacteria (Federici 2007), for fungal entomopathogens (Lu et al. 2008; Pava-Ripoll et al. 2008) as well as for baculoviruses (Inceoglu et al. 2006; Szewczyk et al. 2006). Strain improvement by transgenic technology in nematodes has been shown for enhancements in environmental tolerances (Burnell 2002). Genetically improved MPCAs may become an option in the longer term in the EU. They could be developed today for other countries, like the United States, where they are less controversial.

3.2.3 Changes in the Regulatory Climate

Registration is still one of the greatest challenges for biopesticide companies, particularly in the EU. This is caused by the application of an inappropriate synthetic pesticides model (Chandler et al. 2008a), and by the double procedure of evaluation of the active ingredient by the EU and product registrations on national level. The new Regulation EC/1107/2009 (EC 2009a) allows for zonal authorizations and mutual recognition. A category of low risk active substances has been established, but requirements and a procedure still have to be specified. These changes are expected to facilitate registration for biopesticides.

Initiatives as the Biopesticide Scheme (UK) and the project Genoeg (NL) accomplished a substantial number of new approvals of biopesticides. The example of the regulatory innovation in the UK (Greaves 2009) should be followed up by other EU member states to facilitate procedures. Similar projects in Canada, by the Pest Management Centre (Bailey et al. 2009), and in the USA, by the IR-4 project (www.ir4.rutgers.edu), assist applicants in registering their product and boosted approvals of biopesticides.

The work currently undertaken by OECD to develop appropriate guidance documents and test protocols for biopesticides are crucial for harmonization of the regulatory process on a global scale. Ideas from the REBECA project should be implemented in a timely manner in official procedures and criteria. IBMA continues to lobby for a new registration model specifically developed for biopesticides (see Position Paper at www.ibma.ch). A step forward is the registration of baculoviruses at species level instead of at isolate level.

The new Directive 2009/128/EC (EC 2009b) established a framework to achieve "sustainable use of pesticides". Member States must "encourage the development of Integrated Pest Management and of alternative approaches or techniques in order to reduce dependency on the use of pesticides". National Action Plans have to be developed in which the new crop protection aims will be laid down. Implementation is mandatory as from 2014. Both the new Regulation and Directive will impact the availability and use of synthetic pesticides. IPM will become the prevailing paradigm in pest management and this will create a momentum for increased use of biopesticides. Still, there is a need to increase awareness of biocontrol for policymakers, and the biopesticide industry can play an active role here by participating in the design of the National Actions Plans.

3.2.4 Biodiversity and Environmental Concerns

The extensive use of chemical insecticides and fungicides in agriculture has a negative effect on biodiversity. Insecticides also reduce the biological control potential (Geiger et al. 2010). Through the implementation of the Convention of Biodiversity governments are required to improve conservation and sustainable use of biological diversity and to mitigate negative impacts and to support sustainable agriculture. The Directive 2009/128/EC (EC 2009b) also states that due to the environment and biodiversity the use of pesticides should be minimized and that "biological control means shall be considered in the first place" (article 12). These regulations will further reduce the use of chemicals and promote biologically-based alternatives.

3.2.5 Trends in the Biopesticide Industry

Biopesticide manufacturers have made considerable progress in production efficiency, formulation, quality control, field efficacy, application strategies and marketing in the last decade. Products have become more reliable and cost-effective, and markets have expanded. Manufacturers realized that products must offer true economic benefit and value to the grower. Companies educated distributors and users, focussing on function and value, by which a wider adoption has been gained.

A substantial biopesticide business has been created which forms the foundation for further progress. Furthermore, every year new companies are established. Industry has reached a sufficient level of maturity and critical mass that will help to increase and accelerate future developments. For companies that have gained experience it becomes easier to develop and register new products. Successful companies will expand and cover larger markets. When more products are available and used by growers, the users will become more confident with microbials, and this will help adoption of new products.

Noteworthy is the recent renewed interest of the large agrochemical industry in biopesticides. They seem to complement their portfolio with microbial products, perhaps to be ready when the changes in society today will force them into other directions. Some striking examples are the activities of Bayer, BASF and several Japanese companies. In 2009, Bayer CropScience acquired Agrogreen's microbial product Bionem (B. firmus) for control of nematodes (CPM 2009a), and their post-harvest biofungicide Shemer (Metschnikowia fructicola) (CPM 2010). Bayer sells already XenTari (Bt subsp. aizawai) and Bio1020 (Metarhizium anisopliae) in some countries. In April 2009, Agraquest assigned world wide distribution rights to BASF for their biofungicide Serenade (Bacillus subtilis) (CPM 2009b), and to Bayer for the US home and garden market (www.agraquest.com). Three large Japanese companies, ArystaLifeSciences, Mitsui, and Sumitomo Chemical have played an active role in biopesticides for many years through their subsidiaries, respectively NPP, Valent BioSciences, and Certis.

I expect a greater involvement of large chemical companies in IPM and biocon-trol products in the near future.

3.2.6 New Invasive Pests

New invasive pests offer an opportunity for the use of microbial pesticides when no chemicals are available or registered, or because of resistance to chemicals. Recent examples in Europe are the western corn root worm Diabrotica virgifera virgifera (Pilz et al. 2009), and the South American tomato pinworm Tuta absoluta. Bt is applied in large quantities against T absoluta (J. van der Blom, Coexphal, personal communication) and nematodes may be used (Morton et al. 2009). New non-agricultural pests are the red palm weevil Rhynchophorus ferrugineus against which Bt (Manachini et al. 2009) and nematodes (Llacer et al. 2009) are used, and the South American palm borer Paysandisia archon (Nardi et al. 2009) against which nematodes are used as well as Beauveria bassiana (Besse 2008).

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