Blocked opportunities for bio-control 

Awareness of food safety and dangers of long-term toxicity have led to urgent demands for alternative plant protection systems. Biological controls provide solutions, but the present registration systems block their development. Bernard Blum of the International Biological Manufacturers Association reports. 

A market opportunity 
For more than 50 years, biological control research organisations have developed methods for crop protection and non-agricultural use. In spite of these intense technical and scientific efforts, living organisms and biological products account for only 1% of the world market, of which 80% is covered by one product: Bacillus thuringiensis. Biological control products could, however, replace at least 20% of chemicals, a market valued at US$7 billion. 
    Major national and international plant protection organisations (the Food and Agriculture Organisation, World Health Organisation, European Commission, and the Working Group on Pesticides of the Organisation for Economic Cooperation and Development [OECD]) recognise the need for reducing the use of chemical pesticides and for promoting integrated pest management (IPM) and biological control. In spite of this, the conventional chemical pesticide industry continues to grow fast, particularly in Asia. 
    The financial and technical support, training and information to develop and expand the industry have not been forthcoming. Laboratories are being closed. Reduced extension services lack guidelines to help them promote alternative crop protection strategies. IPM is not incorporated into protocols for crop quality. Growers receive no incentives, and the benefits are not made clear to consumers. 

A weak biocontrol industry
Biocontrol manufacturers are not well-equipped to develop markets. Of the 250 basic producers worldwide, 91% are small or very small enterprises. Many have a turnover below US$1 million, exploiting one or two products for niche markets. There is practically no specific distribution network, and producers must bear all the marketing costs. 
    Biocontrol manufacturers are therefore financially vulnerable and the number of failures is worrying – 72% of companies created between 1970 and 1995 have closed. A number of strategic alliances have resulted in failure. Many companies have been acquired by large chemical multinationals, only to be disinvested and closed.

Regulations favour chemicals
The present legislation on plant protection and pest control products sets obstacles to the commercial promotion of biologicals. The experts, scientists and officials responsible for the legislative environment believe that they are promoting the best solutions for food safety and public health. They have long experience with chemical pesticides, and are aware of the risks. In their view, alternative techniques must be both safer and more effective. 
    This position is strongly supported by the agrochemical industry. Their representatives, mostly from multinational corporations, are aware of the difficulties and costs associated with development of biological control solutions. It is almost impossible for biologicals to reach the same profit levels as chemicals, and the companies do not wish their sales to decrease. Their interests lie in promoting chemicals as a pest management option that is easy to use, effective and cheap, with any necessary changes to improve safety. The industry believes that biologicals should follow the same registration systems as chemical pesticides.
    The national and international regulators have dealt with the chemical industry over many years, and share an understanding of the issues. Most regulations for biologicals are the same as, or at best extrapolated from, those developed for chemicals. For example, under the Pesticides Directive 91/414, the European Commission includes natural and botanical products, beneficial micro-organisms (bacteria, viruses, fungi) along with synthetic chemicals. Like chemicals, the ‘active substance’ is required to be registered at EU level, even though the same living organism will not behave the same way in different environments, climates, regions and cropping systems. 

Separate systems urgent
Experts are now working on the registration requirements for insect pheromones. These molecules, that reflect the natural scent by which the female insect attracts males for mating, do not require registration in many countries. Pheromones do not kill insects, but are used to measure populations or trap them for killing. Nevertheless, some countries (France and Canada) consider pheromones as ‘pesticides’, and require the same registration as for chemicals.
    The OECD is undertaking a process of ‘harmonisation’, based on the Canadian and US rules, to encourage all countries to adopt similar rules for registering biologicals. The European Commission Health and Consumer Protection Directorate (SANCO) supports this position. This is a change from the position discussed with International Biocontrol Manufacturers’ Association (IBMA) representatives in 1998. A Guidance Document of more than 150 pages is being finalized, setting out unnecessarily onerous requirements. 
    The registration of insect pheromones will become too expensive to be viable. Few manufacturers will be able to provide a full registration dossier. The European Commission representative in the OECD Biopesticides Steering Group assured IBMA that ‘waivers will be given’, but has not indicated the scientific basis for a waiver. The International Organisation for Biological Control, does not support registration.
    Under Canada’s leadership the OECD is working on registration strategies. The draft document contains many unworkable requirements. The covering text considerably exaggerates the risks. Furthermore, environmental assessments cannot be made at a national, and even less at an international level: they relate to microclimatic and ecological situations. The ‘recommended’ quarantine measures for initial testing of any novel beneficial raise fundamental questions about who would undertake the work and who would cover the cost of non-patentable agents. It does not consider how quarantine would work, given that international transfer of plants and material is widespread, and organisms are moved inadvertently with shipments. 

Recommendations
IBMA advocates a global moratorium on initiatives to register biological control agents, including insect pheromones, natural products, microorganisms and macroorganisms. New regulations should be elaborated within the framework of a declared policy for sustainable agricultural development. Four basic aspects have to be taken into consideration: the nature of the problem; the nature and level of risks; the sustainable cropping system; property rights, costs and benefits and the sharing of costs between public and private sectors
    In order to establish original new and appropriate regulations, rather than extrapolate from chemical pesticide systems, biologists and biocontrol experts must become involved, specific ecological situations must be taken into consideration, and the balance of risks and benefits must be compared. These deliberations should be based on common sense and scientific knowledge, with flexibility to react rapidly to new situations that arise.

Bernard Blum, is vice president of the IBMA, POB 252, CH-4009 Basel, Switzerland, Agrometrix.blum@balcab.ch, www.ibma.ch

[This article first appeared in Pesticides News No. 57, September 2002, page 18]