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Implications of rising costs of registering agrochemicals
CROP PROTECTION (1983) 2 (2), 131-141
Implications of rising costs of registering agrochemicals A. C. I.
SAMUEL,B.
W. Cox AND H - H . CRAMER
Groupement International des Associations Nationales de Fabricants de Produits Agrochimiques (GIFAP), Avenue Hamoir 12, B 1180 Brussels, Belgium ABSTRACT. The increased number and complexity of the requirements for registration of agrochemicals are causing a steep rise in the costs of research and development and therefore in the price of agrochemicals. It now takes about 8-9 years for an agrochemical to be developed and marketed, at a probable cost of 10-20 million US dollars, and each of the individual tests required may cost up to US$ 500 000. A continuation of these trends would have serious consequences for industry, farmers, consumers and the developing countries. So far, the agrochemical industry has been able to continue to produce the new and improved materials necessary to combat changing pest attack: whether it can continue to do so may depend upon whether or not registration requirements are increased. Unnecessary requirements must be identified and eliminated, and any new demands must be fully justified in terms of the cost involved and of the ensuing benefits. However, if the search for greater safety were to be pushed to even greater lengths, so that costs exceed what the market will bear, the extra costs would have to be borne by the authorities and, ultimately, by the taxpayer.
Introduction Agrochemicals have played a highly successful part in the great increase in the supply o f food that has been achieved in the last thirty or forty years, and modern insecticides have saved millions o f lives. M a n y of the great scourges, such as potato blight, that brought famine and death to m a n y lands, have been brought under control. However, the materials that have brought these benefits are, and must be, to some extent toxic: obviously, toxic substances should not be applied to edible crops or released into the environment except under controlled conditions. T h e necessary controls are normally applied by national regulatory authorities and take the form of legislation which lays down that the materials may not be sold or used unless they have been 'registered': before registration is granted, the authorities require a long series of tests to be made on the material itself and on any residues or metabolites that it may leave on treated produce. Only when the tests have proved that the material is safe and effective when used in accordance with the instructions, is registration granted. 0261-2194/83/02]0131-11503.00 © 1983 Butterworth & Co (Publishers) Ltd
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Both the number and the complexity of the tests required are continually increasing. In the Netherlands, for instance, the number of points on which the authorities required information in the 1960s was 15; now it is over 100. T h e more data, the more tests the authorities require, the higher will be the cost of registration. For the purpose of this study, the cost of registration is taken to mean the cost in resources, financial and other, of satisfying the authorities that a product is fit to be put on the market, not simply the fee that some authorities charge for the stamp of approval. T h e study will also deal with the cost of maintaining a product on the register when, as often happens, the original approval is reviewed or challenged. It would be difficult, if not impossible, usefully to investigate the consequences of the ever-rising costs of registration--that is, to see whether the rise matters and, if it does, to whom and in what ways--without first explaining how these costs arise: that will involve explaining why new materials are needed, how they are sought and developed, and what kinds of tests are required. Although they vary greatly, some idea of what the costs are, must also be given. Although possibilities of reducing costs will sometimes be apparent, it is not the main purpose of this study to suggest remedies for the present situation because--if for no other reason--it is not for industry to take the final decision on what degree of safety, specificity, persistence etc., society requires of its agrochemicals: that must depend on many factors, not least on the social and economic problems that have to be overcome. T h e industry can do many remarkable things, but there is always a price to be paid, in money or otherwise. Society can have what it will pay for: this study may help society to make its decisions. Why new materials? Are new agrochemicals really necessary? Do we not already have an armoury that is adequate to deal with pest attack? Perhaps the way to deal with rising costs is simply not to incur them, to maintain existing materials but not try to find, and therefore not need to register, any new ones. T h e answer to this is that, although many pest problems have been overcome, many are still with us or have been only partly solved and that problems change because nature is not static. There is controversy about whether there is such a thing as the 'balance of nature': if there is, it is constantly changing--it is not a piece of standing sculpture but a mobile and if man is to survive he must ensure that it is normally tipping his way. Unfortunately, whatever steps man takes to ensure that the balance of nature tips his way, nature will try to find a way round them. T h e resistance of human disease-causing organisms to antibiotics is a well-known example of this, together with the resistance of malaria-carrying mosquitoes to insecticides. It would be absurd to assume that such problems will never occur again, or to ignore the fact that success often brings new difficulties: a child immunized against diphtheria and cured of tuberculosis may live to require the attention of specialists in geriatric medicine whose services were not obviously necessary when the average expectation of life was 45 years. So it is with agriculture: new crop varieties will give higher yields but may be more susceptible to pest attack; more intensive cultivation is likely to need more protection against disease. Improvements in farming and food-processing techniques can sometimes be applied only if the crop is shorter-stemmed or has fewer leaves or is free from this weed or that--problems which would hardly have been foreseen by our grandfathers, but which the research
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laboratories of the industry have been able to solve, it would be very short-sighted indeed not to retain the capacity to deal with developments which cannot now be accurately known, but which will surely occur. Finding new materials
I f new materials are necessary, how are they discovered or synthesized and developed? There are three main ways of doing this: 1.
2.
3.
New molecules. Research scientists construct new molecules or re-examine known ones with a view to finding a material with biological activity; when they succeed, further work is done to determine whether the activity can be put to any practical use. Unfortunately, there is very little chance nowadays of finding a new active material, but if one is found, the probability of its being useful and marketable is high. Analogues. Research workers take molecules or groups of compounds of which they already know the biological activity and, by changing the molecular structure slightly, they try to improve the activity or make it more useful. The chances of achieving this are good, but the improvements very seldom result in a product which, would be so much better than one that is already on the market that it would be worth developing. This method can, however, bring about step-by-step improvements in existing products, for example by making them cheaper or less toxic. Structure/activity relationship. This can perhaps best be explained by analogy. I f you are trying to unlock a door, you can either make 10 000 keys of different patterns in the hope that one will fit, or you can take the lock to pieces, see exactly how it works, and design a key to fit it. In agrochemical terms, this means that instead of constructing 10 000 molecules and hoping that one will have the desired properties, you take the target insect or fungus or weed to pieces and design a molecule which will inhibit it. The probability of finding a new material by this method is quite high, but just as it is not easy to take a lock to pieces when it is in a shut door, the biochemical research required by this technique is enormously difficult.
Points (1) and (2) above indicate how difficult it is becoming to find a new compound which will either do something which has not been done before, or which will be a very significant improvement on an existing product. It was early in the history of modern agrochemicals that certain potentially disastrous infectious diseases of cereals were brought under control by the use of mercury seed-dressings: the next steps, which are the control of less-damaging diseases and the elimination of unwanted side effects, are more difficult and more cosily--to do better than nothing is often not difficult, but to progress from 80°/0 to 90~o is quite another matter. It can often be done and the agrochemical industry has a good record in this, but the price may be high. Moreover, it should not be overlooked that each successful discovery has to bear all the costs of those which were not successful, some of which would have had a great deal of time and money spent on them before they were abandoned. As the number of compounds under scrutiny gradually diminishes because one after another has to be dropped when some insuperable disadvantage is revealed, so the costs that these failures have incurred are concentrated on the remaining candidates.
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In practice, of course, screening is a continuous process, but the whole of a given research budget has to be paid for from the sales of those few compounds which eventually reach the market.
Developing and testing new m a t e r i a l s for registration Although finding a new material with promising characteristics is hard enough and costly enough, it is only the beginning. It then has to be developed and tested before it can be registered and sold. This process may conveniently be divided into four phases--biological activity (efficacy), toxicology, residues and metabolites, and environmental studies.
Biological e~cacy In the search for materials with useful biological activity, many thousands of new molecules now have to be examined for every one that proves successful. This represents about one year's work for a major research laboratory. Whether a compound succeeds or not in present conditions depends to a large extent on its spectrum of activity. Broad-spectrum materials are those which control several types of pest attack on one or more crops--in other words, materials which will be used in such vast quantities that they will repay the cost Of developing them. Narrowspectrum materials are specific to only one or two types of pest. Although these pests may be of major importance locally, the crop may not be grown on a large enough scale to justify the high cost of developing agrochemicals specially for it. A further complication is that the specificity of an agrochemical varies according to its function: a specific herbicide is required to eliminate all plants (weeds) except the crop, whereas a specific insecticide must control only the harmful insect and not the beneficial ones, the aphids but not the ladybirds.
Toxicology Toxicological development and testing is concerned with the degree of hazard which the compound or its metabolites present to the spray operator who applies it to the crop, to the consumer who eats the treated produce, and to animals, domestic and other. Toxicity studies related to manufacture and formulation are not really a registration cost, as it is normally understood. For the operator, studies have to be made of the acute toxicity of the active ingredient and formulations of it, of skin and mucous membrane irritation, and of sensitivity to repeated exposure. For consumers (who include operators) both shortand long-term studies have to be made of teratogenicity (the effect on the fetus and malformation), mutagenicity (the effect on chromosomes and the mutation of genes), neurotoxicity (the effect on nerves) and carcinogenicity (the tendency to produce spontaneous or abnormal tumours). Reproduction studies are also made (concerned with fertility, premature birth, abortion) with tests on up to three generations of experimental animals, usually rats. The requirements of the registration authorities for toxicological work have grown steadily and the necessary studies now extend over several years. The work involved in some individual tests lasts for up to 3 years. They must now also cover
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ever-widening fields, as will be shown below in the sections dealing with residues and metabolites and with environmental studies. Residues and metabolites In dealing with any chemical residue that may be left on a crop after harvest, the toxicologist must determine what quantity of pesticide residue, if any, will be harmful, whereas the residue analyst will determine what quantity is actually present; both these figures are arrived at by experimental investigation. The toxicologist aims at determining the no-effect level (NEL), by which he means that the substance will have no effect if the determined quantity is taken every day for a lifetime of test species. From this N E L the legislators or regulatory authorities derive by scientifically based judgement the acceptable daily intake (ADI), which is the intake of a chemical substance which, during an entire lifetime, appears to be without appreciable risk to the consumer of produce containing that substance. The ADI is usually one hundredth part of the NEL, which means that the authorities will have built in an appreciable safety factor. Therefore, even if the quantity of residue detected by the residue analyst in a sample of harvested produce should occasionally be over the maximum residue limit (MRL), which has been set taking account of the toxicological acceptability of the residue arising from the practical use of the pesticide, the produce is nevertheless safe for consumption, because the ADI concept entails large safety factors and assumes the consumption of the residue at its maximum level every day for a lifetime. Ten years ago, an applicant for registration had to demonstrate only that the residue in a crop was below the approved level of so many parts per million: today, he has to trace the degradation of the main metabolites. Ten years ago, residue analysis was made only on the edible crop: today, wider residue research has to be done, including studies of the soil, and leaching experiments have to be made to find out whether residues can be carried into ground water. Applicants must show what happens to the residues in the soil, whether they are adsorbed on to the soil particles or decomposed by soil micro-organisms, and this has to be done in various types of soil, for example those containing high, medium or low quantities of organic matter. It is not suggested here that the additional tests that have come to be required in the last 10 years are not necessary or desirable. One reason why the requirements were less stringent in the past was that the equipment and methodology (such as the use of radio-isotopes, or soil-quality assessment) were not available or not sufficiently developed. Now society requires that they be used, and they are used: nevertheless, the cost is high, and there are other consequences. Environmental studies It has been said above that man requires that the balance of nature be tipped in his favour. Whether or not this is unreasonable of him is arguable: what is not arguable is that it is now impossible to go back, to return to some idyllic, bygone state. In Western Germany in 1816 there were 50 people per square kilometre; by 1929, the number was 250. The West Germans could not return to the conditions of 1816, even if they were idyllic, because the 1816 environment could not support the present population. The situation is not significantly different in other countries. It would not be possible to revert even to 1910 because the population per square
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kilometre in West Germany was then only 100. Besides supporting far more people, each square kilometre also supports wildlife. Clearly there is a danger that, unless he is careful, man will tip the balance so far in his favour that he will squeeze out, even destroy, the wildlife. Hence the need--in all his activities, not only in agriculture-for man to protect the animals and plants with which he shares his square kilometres and to know how his activities will affect them: hence the need for environmental studies in the development of agrochemicals. These, too, are costly and are increasing. Applicants for registration are now, and increasingly will be, required to produce data on environmental effects of agrochemicals, the studies becoming increasingly complex in breadth and depth. Such environmental studies, for example, comprise elucidation of the pesticide's toxicity to fish and other aquatic organisms, birds and earthworms and effects on beneficial insects, soil micro-organisms and other wildlife. More detailed studies such as evaluating the bioaccumulation in fish or birds may also be required, depending on the nature of the chemical. To insist, as some people would like to do, that no beneficial insect that might come into contact with a spray will come to harm, either would deprive the farmer of his defences against pest attack because, for instance, the chances of producing a compound which would control the Colorado beetle without harming the ladybird, to which it is closely related, are remote; or, if such a compound could be found, it would be prohibitively expensive. T h e c o s t s i n t i m e and m o n e y
It will have become obvious that, in present conditions, with increasing requirements for data and decreasing chances of finding a new marketable material, the time taken to bring such a material to the user is already long and getting longer. Any figure can be criticized, but a good working hypothesis is that the operation will take between 8 and 9 years (Ernst and Whinney, 1980). Of course, it may sometimes be done more quickly but it will often take longer. In money terms it is equally difficult to give a figure which will cover all products, but a company must be prepared to spend at least 10-20 million US dollars to put a new material on the market, although this figure would not include the cost of building or adapting a plant to produce the material on a commercial scale. As for the individual tests--those tests which it is so easy to ask for--they, too, vary from those which a properly equipped laboratory can do for comparatively small sums (not including, of course, the cost of equipping and maintaining that laboratory) to the US $500 000 which a major manufacturer gives as the cost of an average chronic feeding study. It is also possible to give figures for the kind of rise in research and development costs that the industry is now experiencing: in a paper prepared for an FAO ad hoc Consultation in 1977, Whetstone and Fitzsimmons noted that the real cost (i.e. allowing for inflation) of research and development in agrochemicals doubled between 1967 and 1975, and that Over half the increase was the direct result of regulatory requirements. One source of costs which it would be difficult to quantify but which are particularly irksome (if only because they are unnecessary) is the fact that the authorities in the various countries do not always require exactly the same tests, even when trying to establish the same facts, and they will often not accept tests done elsewhere even though (as in the case of most toxicological tests) they are laboratory
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tests which should be valid anywhere.. Applicants for registration then find themselves obliged to duplicate work which has already been done satisfactorily. Besides the obvious and considerable waste of money, this also involves a great waste of the time of trained scientists, of whom there are never enough. The consequences So far the rising costs of registering agrochemicals and of maintaining them on the register have been met without serious disruption. Moreover, as far as technical problems are concerned, the research teams in the industry are confident that, provided that the scientific base is maintained in the innovating companies, most of them can be solved; however, the price will have to be paid, either in money or resource terms, or in a less relentless pursuit of the unattainable goal of absolute safety. Industry is now finding the going very hard indeed: 5 years ago, in their paper for the Food and Agriculture Organization of the United Nations, Whetstone and Fitzsimmons, after saying that they had 'seen no critical impact on the industry during the past period from the increased regulatory costs', added, however, that they had 'a real concern for the consequences of the continuation of these trends' (Whetstone and Fitzsimmons, 1977). We should now examine what those consequences are, looking at them from the standpoints of the industry, of farmers, of consumers, of the environment, and of the developing countries--although this does not mean that the various interests are even separate, let alone opposed.
The consequencesfor industry Because of the vast resources needed and the high risk of failure, only large multi-national companies can now afford to undertake innovatory research: if the costs of registration continue to rise, some of them will be tempted to divert investment into channels which are less risky and more rewarding. The authorities would do well to note the words ofWerner Gebauer (then President of GIFAP, the industry's international trade association) at a conference in Z/irich in 1981: 'The high and steadily rising level of development costs has reduced the number of companies engaged in research to between 25 and 30 world-wide.' It is becoming more and more difficult, even in the developed countries, to find enough scientists with the right qualifications to cope with the continuous advances in such fields as toxicity assessment and analytical method. Moreover, the development of such new techniques itself leads to new requirements by the authorities, and to demands for the investigation by the new techniques of products already registered. If, for instance, a new technique is developed for examining micro-organisms in the soil, the authorities are likely to make its use a requirement for registration: the companies will then have to recruit microbiologists and their assistants; this will be difficult and expensive, and the people concerned will have been taken away from other work. It follows that more tests on new materials and more re-examinations of existing materials mean less money and fewer scientists available for innovation. As Whetstone and Fitzsimmons observed, 'Creative discovery has been undernourished, while regulatory effort has grown fat.' It has been noted that the higher registration costs become, the more likely it is that companies will concentrate their investment on the development of products that will find a very large market. In other words, as research costs rise, the 'minor
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use'* threshold will rise with them; nevertheless, what will be considered a minor use by a manufacturer may be the major source of wealth for a particular region. This could have serious consequences for some farmers and consumers. However, it follows that industry in future will be inclined to concentrate on broad-spectrum materials, as being more likely to repay investment, although this trend could be arrested if consumers were prepared to pay the price. Industry could doubtless produce compounds which would be very specific indeed--it has been done in the past--but the effort will need to be great and the cost high. The problem of differing requirements by the various regulatory authorities, unless solved along the lines being worked out in the Food and Agriculture Organization of the United Nations (FAO), will further reduce the effort that companies can put into innovation and improvement. The very long time needed to register a new product reduces the time during which a product can be sold under patent. It will have to be patented within two years of synthesis to guard against imitation, and by the time it is fully established in the market at least half the patent life will have expired. The producer of a new agrochemical cannot, as is sometimes thought, charge an exorbitant price for his product during the life of the patent, because normally there are competitive, although not identical, materials available which the farmer will stick to rather than pay what he might regard as too high a price for too little improvement. Patents exist to encourage innovators by increasing the chances that they will recover their investment, and society benefits: in this field the benefits are being eroded.
The consequences for farmers In highly developed cereal growing, the cost of the necessary agrochemical protection is not usually a large part of the farmer's total input: increases in its cost are therefore unlikely to make a substantial difference. This would not, of course, apply to agriculture in the developing countries (except, perhaps, in the case of State farms) and certainly not to subsistence farmers, for whom a rise in the cost of agrochemicals could put off still further the time when they could be used at all. Some crops, such as fruit, seed-potatoes, vines and certain vegetables, tend both to need greater protection by agrochemicals than others, and to command higher prices in the market. Hitherto, small rises in their already high prices seem not to have deterred b~ayers, but presumably this will not continue indefinitely. If and when buyers are no longer willing to pay the prices that have to be asked, farmers will cease to grow the crops. In a sense, this is part of the problem of'minor uses' or 'minor crops'. Registration is granted for named uses and named crops, and the authorities require to be satisfied about a product's safety and efficacy on each crop and each vegetable on which it is to be used. I f a company declines to register a product for use on a minor crop because sales for use on that crop would not repay the cost of registration, the farmer will either have to accept lower yields and lower quality in the crop (because it will not be protected effectively against pest attack), in which case he will have to charge higher prices, or he will have to stop growing the crop: he would not regard going out of business as an acceptable alternative. It is important that registration authorities should understand that the word 'minor' is a relative term, and that among the crops * 'Minor uses' are useson crops grownon too smalla scalethemselvesto offeran adequatemarketfor an agrochemical,or on crops inflictedwith pests that are of local importanceonly.
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to which it could be applied before very long are certain vegetables and soft fruit. This would be a disaster for whole areas. Provided that he is not a grower of minor crops, the farmer will not be worried by the trend towards broad-spectrum materials; it suits him best to have a few compounds which will control all his pes t enemies with as few passes over his fields as possible. If each compound controlled only one pest on one crop, the farmer would be faced with enormous problems, for example with timing, application and storage, and might feel that he was running not a farm but a pharmacy which needed its own resident entomologist to tell him which species of caterpillar was eating his cabbages and which compound to spray on it. Things will not, of course, get to that stage, but it should be noted that there is another drawback to greater specificity besides the high cost of achieving it. If the innovatory capabilities of the industry decline, farmers will be left defenceless against the changing forms of attack, already discussed. Society should be careful not to make demands which could weaken the industry's scientific base or the financial incentives to continue to work in this field.
The consequencesfor consumers The trend towards more stringent registration requirements, although no doubt subject to the law of diminishing returns, gives greater protection to the consumer. This is, of course, highly desirable and so far few would complain that the price had been too high. However, it is easy to forget that there is a price, not only as part of the cost of food, but also in the diversion of scientific talent away from innovation and from other fields of endeavour Outside agriculture. As the registration requirements increase in number and stringency, the administration of the control system, including the technical support that goes with it, becomes more complex and more expensive. From the time that all registration data are submitted, it can take government authorities two, or even three, years to grant registration. This enormous effort is paid for directly by consumers in the form of taxes, but there is a high indirect cost as well. In January 1981, the U S Council for Agricultural Science and Technology (CAST) published a Report (No. 87) on the
Impact of Government Regulations on the Development of Chemical Pesticides for Agriculture and Forestry. In it, the Council noted that 'at least 500 scientist years may have been diverted to regulatory activities at State experimental stations in the U S during 1972-78'; it comments that 'the diversion of scientific effort to regulatory activities will be very costly to the US public'.
The consequencesfor the environment These revolve around the questions of specificity, residues and persistence. Specific chemicals can be, and have been, developed, but the cost is becoming very high in relation to the likely return. Moreover, as we have seen, such products can be a mixed blessing to the farmer. The environmentalist warmly welcomes materials which leave beneficial insects unharmed and which break down quickly, leaving no residues: the industry and the regulatory authorities, between them, have made much progress in the direction that he would like. But here, too, the blessings may not be--indeed are not--entirely unmixed. A specific insecticide may be harmless to all beneficial insects and wipe out a complete pest species, but that pest species may
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be replaced by something worse. On the other hand, if 80~o of a beneficial species is eliminated by a broad-spectrum material, that species will recover, thanks to nature's ability to cope with disasters. As regards residues and persistence, it is roughly the case that the longer a compound persists, the fewer sprays are needed, or the better the control: to put it the other way round, the quicker the compound breaks down, the sooner the maximum residue limit is reached, but the fewer the days it will have to act on the pest and so more sprays will be needed or less control will be achieved. It may well be that the idea that specific, non-persistent materials are kinder to the environment is true only in the short run. In any case society must decide, and implement its decisions through its registration authorities, how much weight to give to the environmentalists' arguments, bearing in mind the words of Mrs Indira Ghandi at the U N Conference on the Human Environment at Stockholm in 1972, 'The environment cannot be improved in conditions of poverty. Nor can poverty be eradicated without the use of science and technology.' This brings us to the effect on the developing countries of the rise in registration costs.
The consequences for the developing countries The more complex the registration requirements become, the more complex will be the process of evaluation and it may well be beyond the scientific and financial resources of developing countries. Furthermore, it is particularly important in such countries that scientists, who are likely to be scarce, should not be used on unproductive work. For many developing countries, cash crops are the main exports and the main sources of wealth. They have to be sold on world markets, and if the cost of the agrochemicals needed to protect them (and in tropical countries the need is great) continues to rise, the exporting countries risk having to accept a lower return. In the case of subsistence and staple food crops, it would be possible--and it is certainly highly desirable, if not downright essential--to increase yields very considerably by a balanced use ofagrochemicals; however, if their price continues to rise, this possibility will become ever more remote. If developing countries cannot afford modern agrochemicals, they must use older, cheaper ones. Unhappily, many such products are being driven offthe market by the stringent registration requirements of the developed countries, and even by export bans imposed by those countries. It should be for national governments to decide, in the light of local economic, social, financial and climatic conditions, what agrochemicals they should use. It is not for developed countries, in which quite different conditions obtain, to dictate to the rest of the world. At the Stockholm Conference, Mrs Ghandi asked, 'How can we speak to those who live in villages and slums about keeping the oceans, the rivers and the air clean when their own lives are contaminated at the source?'. If developed countries wish their less fortunate neighbours to use more expensive materialS, they could, of course, offer to pay for them. Even this matter of efficacy is not clear-cut; it may vary in different circumstances. As an example, it is arguable that the present epidemic of coffee rust in South America is as likely to be contained by the use of old, cheap copper fungicides as it would be by spending the same amount of money on more modern materials. They are more expensive, so the money would buy a smaller quantity, and a smaller area
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would be covered: all things being equal (which they seldom are), it might be better to spray 10 000 hectares with an old material than 5000 with a new one. Conclusions First, although other factors are involved, the increasing'number and complexity of the requirements for registering agrochemicals are causing the costs of research and development to rise steeply. Most of the requirements hitherto are right and proper, but a serious effort needs to be made by all concerned to identify and eliminate any that are not, to cut out duplication and other unnecessary work, to apply the rules flexibly, and to ensure that any new demands are fully justified by the benefit that they will bring, measured against their cost. Second, the consequences of the rise in costs are serious and affect the whole of society. They are not yet disastrous, largely because the innovating companies in the industry, on which its future depends, have stayed in business and maintained the technical, scientific and financial ability to produce new and improved materials capable of dealing with the changing nature o f pest attack and making progress towards filling the gaps in our defences. Third, industry is capable of continuing to fulfil this function: it can indeed produce materials capable of satisfying a high proportion of man's requirements-the difficulty being that some men require one thing and other men require another, and that the requirements conflict. In the end, it is for society to decide what it requires of the industry, and society will normally make its wishes known through the registration schemes operated by its regulatory authorities. If they are to fulfil so important a function with success, registration schemes will need to be drawn up and operated with careful regard to the consequences of each requirement and the cumulative effect of them all--the effect, moreover, on everyone everywhere. Since agrochemicals have now reached a high degree of efficacy and safety, society may feel that the time has come to rationalize and, if not to reduce, at least not to increase registration requirements, so that market forces can continue to enable the industry to generate sufficient funds to carry on at its present level and eventually expand: alternatively, the search for greater safety everywhere can be pushed to even greater lengths, which will cause costs to rise above what the market will bear. If that is done, industry could still do its job, but the extra costs would have to be borne by the authorities themselves in the first instance, and in the end by the taxpayer. There is no doubt which of these alternatives the industry would prefer, but it is not for the industry to decide. References CAST (1981). The Impact of Government Regulations on the Development of Chemical Pesticides for Agriculture and Forestry. Report No. 87 of the US Council for Agricultural Science and Technology (CAST). ERNSTANDWHINNEY(1980). Industry Profile Survey, National Agricultural Chemicals Association (NACA), Washington, DC. GANDHI,INDIRA(1972). In Proceedings, UN Conference on Human Environment, Stockholm, 1972. WHETSTONE,R.B. AND FITZSIMMONS,K.B. (1977). The Impact of Pesticide Regulations and Decisions on Industrial Pesticide Research. FAO doc. PRR/77/BP39. Rome: FAO. Accepted 12 January 1983
Implications of rising costs of registering agrochemicals A. C. I.
SAMUEL,B.
W. Cox AND H - H . CRAMER
Groupement International des Associations Nationales de Fabricants de Produits Agrochimiques (GIFAP), Avenue Hamoir 12, B 1180 Brussels, Belgium ABSTRACT. The increased number and complexity of the requirements for registration of agrochemicals are causing a steep rise in the costs of research and development and therefore in the price of agrochemicals. It now takes about 8-9 years for an agrochemical to be developed and marketed, at a probable cost of 10-20 million US dollars, and each of the individual tests required may cost up to US$ 500 000. A continuation of these trends would have serious consequences for industry, farmers, consumers and the developing countries. So far, the agrochemical industry has been able to continue to produce the new and improved materials necessary to combat changing pest attack: whether it can continue to do so may depend upon whether or not registration requirements are increased. Unnecessary requirements must be identified and eliminated, and any new demands must be fully justified in terms of the cost involved and of the ensuing benefits. However, if the search for greater safety were to be pushed to even greater lengths, so that costs exceed what the market will bear, the extra costs would have to be borne by the authorities and, ultimately, by the taxpayer.
Introduction Agrochemicals have played a highly successful part in the great increase in the supply o f food that has been achieved in the last thirty or forty years, and modern insecticides have saved millions o f lives. M a n y of the great scourges, such as potato blight, that brought famine and death to m a n y lands, have been brought under control. However, the materials that have brought these benefits are, and must be, to some extent toxic: obviously, toxic substances should not be applied to edible crops or released into the environment except under controlled conditions. T h e necessary controls are normally applied by national regulatory authorities and take the form of legislation which lays down that the materials may not be sold or used unless they have been 'registered': before registration is granted, the authorities require a long series of tests to be made on the material itself and on any residues or metabolites that it may leave on treated produce. Only when the tests have proved that the material is safe and effective when used in accordance with the instructions, is registration granted. 0261-2194/83/02]0131-11503.00 © 1983 Butterworth & Co (Publishers) Ltd
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Both the number and the complexity of the tests required are continually increasing. In the Netherlands, for instance, the number of points on which the authorities required information in the 1960s was 15; now it is over 100. T h e more data, the more tests the authorities require, the higher will be the cost of registration. For the purpose of this study, the cost of registration is taken to mean the cost in resources, financial and other, of satisfying the authorities that a product is fit to be put on the market, not simply the fee that some authorities charge for the stamp of approval. T h e study will also deal with the cost of maintaining a product on the register when, as often happens, the original approval is reviewed or challenged. It would be difficult, if not impossible, usefully to investigate the consequences of the ever-rising costs of registration--that is, to see whether the rise matters and, if it does, to whom and in what ways--without first explaining how these costs arise: that will involve explaining why new materials are needed, how they are sought and developed, and what kinds of tests are required. Although they vary greatly, some idea of what the costs are, must also be given. Although possibilities of reducing costs will sometimes be apparent, it is not the main purpose of this study to suggest remedies for the present situation because--if for no other reason--it is not for industry to take the final decision on what degree of safety, specificity, persistence etc., society requires of its agrochemicals: that must depend on many factors, not least on the social and economic problems that have to be overcome. T h e industry can do many remarkable things, but there is always a price to be paid, in money or otherwise. Society can have what it will pay for: this study may help society to make its decisions. Why new materials? Are new agrochemicals really necessary? Do we not already have an armoury that is adequate to deal with pest attack? Perhaps the way to deal with rising costs is simply not to incur them, to maintain existing materials but not try to find, and therefore not need to register, any new ones. T h e answer to this is that, although many pest problems have been overcome, many are still with us or have been only partly solved and that problems change because nature is not static. There is controversy about whether there is such a thing as the 'balance of nature': if there is, it is constantly changing--it is not a piece of standing sculpture but a mobile and if man is to survive he must ensure that it is normally tipping his way. Unfortunately, whatever steps man takes to ensure that the balance of nature tips his way, nature will try to find a way round them. T h e resistance of human disease-causing organisms to antibiotics is a well-known example of this, together with the resistance of malaria-carrying mosquitoes to insecticides. It would be absurd to assume that such problems will never occur again, or to ignore the fact that success often brings new difficulties: a child immunized against diphtheria and cured of tuberculosis may live to require the attention of specialists in geriatric medicine whose services were not obviously necessary when the average expectation of life was 45 years. So it is with agriculture: new crop varieties will give higher yields but may be more susceptible to pest attack; more intensive cultivation is likely to need more protection against disease. Improvements in farming and food-processing techniques can sometimes be applied only if the crop is shorter-stemmed or has fewer leaves or is free from this weed or that--problems which would hardly have been foreseen by our grandfathers, but which the research
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laboratories of the industry have been able to solve, it would be very short-sighted indeed not to retain the capacity to deal with developments which cannot now be accurately known, but which will surely occur. Finding new materials
I f new materials are necessary, how are they discovered or synthesized and developed? There are three main ways of doing this: 1.
2.
3.
New molecules. Research scientists construct new molecules or re-examine known ones with a view to finding a material with biological activity; when they succeed, further work is done to determine whether the activity can be put to any practical use. Unfortunately, there is very little chance nowadays of finding a new active material, but if one is found, the probability of its being useful and marketable is high. Analogues. Research workers take molecules or groups of compounds of which they already know the biological activity and, by changing the molecular structure slightly, they try to improve the activity or make it more useful. The chances of achieving this are good, but the improvements very seldom result in a product which, would be so much better than one that is already on the market that it would be worth developing. This method can, however, bring about step-by-step improvements in existing products, for example by making them cheaper or less toxic. Structure/activity relationship. This can perhaps best be explained by analogy. I f you are trying to unlock a door, you can either make 10 000 keys of different patterns in the hope that one will fit, or you can take the lock to pieces, see exactly how it works, and design a key to fit it. In agrochemical terms, this means that instead of constructing 10 000 molecules and hoping that one will have the desired properties, you take the target insect or fungus or weed to pieces and design a molecule which will inhibit it. The probability of finding a new material by this method is quite high, but just as it is not easy to take a lock to pieces when it is in a shut door, the biochemical research required by this technique is enormously difficult.
Points (1) and (2) above indicate how difficult it is becoming to find a new compound which will either do something which has not been done before, or which will be a very significant improvement on an existing product. It was early in the history of modern agrochemicals that certain potentially disastrous infectious diseases of cereals were brought under control by the use of mercury seed-dressings: the next steps, which are the control of less-damaging diseases and the elimination of unwanted side effects, are more difficult and more cosily--to do better than nothing is often not difficult, but to progress from 80°/0 to 90~o is quite another matter. It can often be done and the agrochemical industry has a good record in this, but the price may be high. Moreover, it should not be overlooked that each successful discovery has to bear all the costs of those which were not successful, some of which would have had a great deal of time and money spent on them before they were abandoned. As the number of compounds under scrutiny gradually diminishes because one after another has to be dropped when some insuperable disadvantage is revealed, so the costs that these failures have incurred are concentrated on the remaining candidates.
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In practice, of course, screening is a continuous process, but the whole of a given research budget has to be paid for from the sales of those few compounds which eventually reach the market.
Developing and testing new m a t e r i a l s for registration Although finding a new material with promising characteristics is hard enough and costly enough, it is only the beginning. It then has to be developed and tested before it can be registered and sold. This process may conveniently be divided into four phases--biological activity (efficacy), toxicology, residues and metabolites, and environmental studies.
Biological e~cacy In the search for materials with useful biological activity, many thousands of new molecules now have to be examined for every one that proves successful. This represents about one year's work for a major research laboratory. Whether a compound succeeds or not in present conditions depends to a large extent on its spectrum of activity. Broad-spectrum materials are those which control several types of pest attack on one or more crops--in other words, materials which will be used in such vast quantities that they will repay the cost Of developing them. Narrowspectrum materials are specific to only one or two types of pest. Although these pests may be of major importance locally, the crop may not be grown on a large enough scale to justify the high cost of developing agrochemicals specially for it. A further complication is that the specificity of an agrochemical varies according to its function: a specific herbicide is required to eliminate all plants (weeds) except the crop, whereas a specific insecticide must control only the harmful insect and not the beneficial ones, the aphids but not the ladybirds.
Toxicology Toxicological development and testing is concerned with the degree of hazard which the compound or its metabolites present to the spray operator who applies it to the crop, to the consumer who eats the treated produce, and to animals, domestic and other. Toxicity studies related to manufacture and formulation are not really a registration cost, as it is normally understood. For the operator, studies have to be made of the acute toxicity of the active ingredient and formulations of it, of skin and mucous membrane irritation, and of sensitivity to repeated exposure. For consumers (who include operators) both shortand long-term studies have to be made of teratogenicity (the effect on the fetus and malformation), mutagenicity (the effect on chromosomes and the mutation of genes), neurotoxicity (the effect on nerves) and carcinogenicity (the tendency to produce spontaneous or abnormal tumours). Reproduction studies are also made (concerned with fertility, premature birth, abortion) with tests on up to three generations of experimental animals, usually rats. The requirements of the registration authorities for toxicological work have grown steadily and the necessary studies now extend over several years. The work involved in some individual tests lasts for up to 3 years. They must now also cover
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ever-widening fields, as will be shown below in the sections dealing with residues and metabolites and with environmental studies. Residues and metabolites In dealing with any chemical residue that may be left on a crop after harvest, the toxicologist must determine what quantity of pesticide residue, if any, will be harmful, whereas the residue analyst will determine what quantity is actually present; both these figures are arrived at by experimental investigation. The toxicologist aims at determining the no-effect level (NEL), by which he means that the substance will have no effect if the determined quantity is taken every day for a lifetime of test species. From this N E L the legislators or regulatory authorities derive by scientifically based judgement the acceptable daily intake (ADI), which is the intake of a chemical substance which, during an entire lifetime, appears to be without appreciable risk to the consumer of produce containing that substance. The ADI is usually one hundredth part of the NEL, which means that the authorities will have built in an appreciable safety factor. Therefore, even if the quantity of residue detected by the residue analyst in a sample of harvested produce should occasionally be over the maximum residue limit (MRL), which has been set taking account of the toxicological acceptability of the residue arising from the practical use of the pesticide, the produce is nevertheless safe for consumption, because the ADI concept entails large safety factors and assumes the consumption of the residue at its maximum level every day for a lifetime. Ten years ago, an applicant for registration had to demonstrate only that the residue in a crop was below the approved level of so many parts per million: today, he has to trace the degradation of the main metabolites. Ten years ago, residue analysis was made only on the edible crop: today, wider residue research has to be done, including studies of the soil, and leaching experiments have to be made to find out whether residues can be carried into ground water. Applicants must show what happens to the residues in the soil, whether they are adsorbed on to the soil particles or decomposed by soil micro-organisms, and this has to be done in various types of soil, for example those containing high, medium or low quantities of organic matter. It is not suggested here that the additional tests that have come to be required in the last 10 years are not necessary or desirable. One reason why the requirements were less stringent in the past was that the equipment and methodology (such as the use of radio-isotopes, or soil-quality assessment) were not available or not sufficiently developed. Now society requires that they be used, and they are used: nevertheless, the cost is high, and there are other consequences. Environmental studies It has been said above that man requires that the balance of nature be tipped in his favour. Whether or not this is unreasonable of him is arguable: what is not arguable is that it is now impossible to go back, to return to some idyllic, bygone state. In Western Germany in 1816 there were 50 people per square kilometre; by 1929, the number was 250. The West Germans could not return to the conditions of 1816, even if they were idyllic, because the 1816 environment could not support the present population. The situation is not significantly different in other countries. It would not be possible to revert even to 1910 because the population per square
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kilometre in West Germany was then only 100. Besides supporting far more people, each square kilometre also supports wildlife. Clearly there is a danger that, unless he is careful, man will tip the balance so far in his favour that he will squeeze out, even destroy, the wildlife. Hence the need--in all his activities, not only in agriculture-for man to protect the animals and plants with which he shares his square kilometres and to know how his activities will affect them: hence the need for environmental studies in the development of agrochemicals. These, too, are costly and are increasing. Applicants for registration are now, and increasingly will be, required to produce data on environmental effects of agrochemicals, the studies becoming increasingly complex in breadth and depth. Such environmental studies, for example, comprise elucidation of the pesticide's toxicity to fish and other aquatic organisms, birds and earthworms and effects on beneficial insects, soil micro-organisms and other wildlife. More detailed studies such as evaluating the bioaccumulation in fish or birds may also be required, depending on the nature of the chemical. To insist, as some people would like to do, that no beneficial insect that might come into contact with a spray will come to harm, either would deprive the farmer of his defences against pest attack because, for instance, the chances of producing a compound which would control the Colorado beetle without harming the ladybird, to which it is closely related, are remote; or, if such a compound could be found, it would be prohibitively expensive. T h e c o s t s i n t i m e and m o n e y
It will have become obvious that, in present conditions, with increasing requirements for data and decreasing chances of finding a new marketable material, the time taken to bring such a material to the user is already long and getting longer. Any figure can be criticized, but a good working hypothesis is that the operation will take between 8 and 9 years (Ernst and Whinney, 1980). Of course, it may sometimes be done more quickly but it will often take longer. In money terms it is equally difficult to give a figure which will cover all products, but a company must be prepared to spend at least 10-20 million US dollars to put a new material on the market, although this figure would not include the cost of building or adapting a plant to produce the material on a commercial scale. As for the individual tests--those tests which it is so easy to ask for--they, too, vary from those which a properly equipped laboratory can do for comparatively small sums (not including, of course, the cost of equipping and maintaining that laboratory) to the US $500 000 which a major manufacturer gives as the cost of an average chronic feeding study. It is also possible to give figures for the kind of rise in research and development costs that the industry is now experiencing: in a paper prepared for an FAO ad hoc Consultation in 1977, Whetstone and Fitzsimmons noted that the real cost (i.e. allowing for inflation) of research and development in agrochemicals doubled between 1967 and 1975, and that Over half the increase was the direct result of regulatory requirements. One source of costs which it would be difficult to quantify but which are particularly irksome (if only because they are unnecessary) is the fact that the authorities in the various countries do not always require exactly the same tests, even when trying to establish the same facts, and they will often not accept tests done elsewhere even though (as in the case of most toxicological tests) they are laboratory
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tests which should be valid anywhere.. Applicants for registration then find themselves obliged to duplicate work which has already been done satisfactorily. Besides the obvious and considerable waste of money, this also involves a great waste of the time of trained scientists, of whom there are never enough. The consequences So far the rising costs of registering agrochemicals and of maintaining them on the register have been met without serious disruption. Moreover, as far as technical problems are concerned, the research teams in the industry are confident that, provided that the scientific base is maintained in the innovating companies, most of them can be solved; however, the price will have to be paid, either in money or resource terms, or in a less relentless pursuit of the unattainable goal of absolute safety. Industry is now finding the going very hard indeed: 5 years ago, in their paper for the Food and Agriculture Organization of the United Nations, Whetstone and Fitzsimmons, after saying that they had 'seen no critical impact on the industry during the past period from the increased regulatory costs', added, however, that they had 'a real concern for the consequences of the continuation of these trends' (Whetstone and Fitzsimmons, 1977). We should now examine what those consequences are, looking at them from the standpoints of the industry, of farmers, of consumers, of the environment, and of the developing countries--although this does not mean that the various interests are even separate, let alone opposed.
The consequencesfor industry Because of the vast resources needed and the high risk of failure, only large multi-national companies can now afford to undertake innovatory research: if the costs of registration continue to rise, some of them will be tempted to divert investment into channels which are less risky and more rewarding. The authorities would do well to note the words ofWerner Gebauer (then President of GIFAP, the industry's international trade association) at a conference in Z/irich in 1981: 'The high and steadily rising level of development costs has reduced the number of companies engaged in research to between 25 and 30 world-wide.' It is becoming more and more difficult, even in the developed countries, to find enough scientists with the right qualifications to cope with the continuous advances in such fields as toxicity assessment and analytical method. Moreover, the development of such new techniques itself leads to new requirements by the authorities, and to demands for the investigation by the new techniques of products already registered. If, for instance, a new technique is developed for examining micro-organisms in the soil, the authorities are likely to make its use a requirement for registration: the companies will then have to recruit microbiologists and their assistants; this will be difficult and expensive, and the people concerned will have been taken away from other work. It follows that more tests on new materials and more re-examinations of existing materials mean less money and fewer scientists available for innovation. As Whetstone and Fitzsimmons observed, 'Creative discovery has been undernourished, while regulatory effort has grown fat.' It has been noted that the higher registration costs become, the more likely it is that companies will concentrate their investment on the development of products that will find a very large market. In other words, as research costs rise, the 'minor
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use'* threshold will rise with them; nevertheless, what will be considered a minor use by a manufacturer may be the major source of wealth for a particular region. This could have serious consequences for some farmers and consumers. However, it follows that industry in future will be inclined to concentrate on broad-spectrum materials, as being more likely to repay investment, although this trend could be arrested if consumers were prepared to pay the price. Industry could doubtless produce compounds which would be very specific indeed--it has been done in the past--but the effort will need to be great and the cost high. The problem of differing requirements by the various regulatory authorities, unless solved along the lines being worked out in the Food and Agriculture Organization of the United Nations (FAO), will further reduce the effort that companies can put into innovation and improvement. The very long time needed to register a new product reduces the time during which a product can be sold under patent. It will have to be patented within two years of synthesis to guard against imitation, and by the time it is fully established in the market at least half the patent life will have expired. The producer of a new agrochemical cannot, as is sometimes thought, charge an exorbitant price for his product during the life of the patent, because normally there are competitive, although not identical, materials available which the farmer will stick to rather than pay what he might regard as too high a price for too little improvement. Patents exist to encourage innovators by increasing the chances that they will recover their investment, and society benefits: in this field the benefits are being eroded.
The consequences for farmers In highly developed cereal growing, the cost of the necessary agrochemical protection is not usually a large part of the farmer's total input: increases in its cost are therefore unlikely to make a substantial difference. This would not, of course, apply to agriculture in the developing countries (except, perhaps, in the case of State farms) and certainly not to subsistence farmers, for whom a rise in the cost of agrochemicals could put off still further the time when they could be used at all. Some crops, such as fruit, seed-potatoes, vines and certain vegetables, tend both to need greater protection by agrochemicals than others, and to command higher prices in the market. Hitherto, small rises in their already high prices seem not to have deterred b~ayers, but presumably this will not continue indefinitely. If and when buyers are no longer willing to pay the prices that have to be asked, farmers will cease to grow the crops. In a sense, this is part of the problem of'minor uses' or 'minor crops'. Registration is granted for named uses and named crops, and the authorities require to be satisfied about a product's safety and efficacy on each crop and each vegetable on which it is to be used. I f a company declines to register a product for use on a minor crop because sales for use on that crop would not repay the cost of registration, the farmer will either have to accept lower yields and lower quality in the crop (because it will not be protected effectively against pest attack), in which case he will have to charge higher prices, or he will have to stop growing the crop: he would not regard going out of business as an acceptable alternative. It is important that registration authorities should understand that the word 'minor' is a relative term, and that among the crops * 'Minor uses' are useson crops grownon too smalla scalethemselvesto offeran adequatemarketfor an agrochemical,or on crops inflictedwith pests that are of local importanceonly.
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to which it could be applied before very long are certain vegetables and soft fruit. This would be a disaster for whole areas. Provided that he is not a grower of minor crops, the farmer will not be worried by the trend towards broad-spectrum materials; it suits him best to have a few compounds which will control all his pes t enemies with as few passes over his fields as possible. If each compound controlled only one pest on one crop, the farmer would be faced with enormous problems, for example with timing, application and storage, and might feel that he was running not a farm but a pharmacy which needed its own resident entomologist to tell him which species of caterpillar was eating his cabbages and which compound to spray on it. Things will not, of course, get to that stage, but it should be noted that there is another drawback to greater specificity besides the high cost of achieving it. If the innovatory capabilities of the industry decline, farmers will be left defenceless against the changing forms of attack, already discussed. Society should be careful not to make demands which could weaken the industry's scientific base or the financial incentives to continue to work in this field.
The consequencesfor consumers The trend towards more stringent registration requirements, although no doubt subject to the law of diminishing returns, gives greater protection to the consumer. This is, of course, highly desirable and so far few would complain that the price had been too high. However, it is easy to forget that there is a price, not only as part of the cost of food, but also in the diversion of scientific talent away from innovation and from other fields of endeavour Outside agriculture. As the registration requirements increase in number and stringency, the administration of the control system, including the technical support that goes with it, becomes more complex and more expensive. From the time that all registration data are submitted, it can take government authorities two, or even three, years to grant registration. This enormous effort is paid for directly by consumers in the form of taxes, but there is a high indirect cost as well. In January 1981, the U S Council for Agricultural Science and Technology (CAST) published a Report (No. 87) on the
Impact of Government Regulations on the Development of Chemical Pesticides for Agriculture and Forestry. In it, the Council noted that 'at least 500 scientist years may have been diverted to regulatory activities at State experimental stations in the U S during 1972-78'; it comments that 'the diversion of scientific effort to regulatory activities will be very costly to the US public'.
The consequencesfor the environment These revolve around the questions of specificity, residues and persistence. Specific chemicals can be, and have been, developed, but the cost is becoming very high in relation to the likely return. Moreover, as we have seen, such products can be a mixed blessing to the farmer. The environmentalist warmly welcomes materials which leave beneficial insects unharmed and which break down quickly, leaving no residues: the industry and the regulatory authorities, between them, have made much progress in the direction that he would like. But here, too, the blessings may not be--indeed are not--entirely unmixed. A specific insecticide may be harmless to all beneficial insects and wipe out a complete pest species, but that pest species may
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be replaced by something worse. On the other hand, if 80~o of a beneficial species is eliminated by a broad-spectrum material, that species will recover, thanks to nature's ability to cope with disasters. As regards residues and persistence, it is roughly the case that the longer a compound persists, the fewer sprays are needed, or the better the control: to put it the other way round, the quicker the compound breaks down, the sooner the maximum residue limit is reached, but the fewer the days it will have to act on the pest and so more sprays will be needed or less control will be achieved. It may well be that the idea that specific, non-persistent materials are kinder to the environment is true only in the short run. In any case society must decide, and implement its decisions through its registration authorities, how much weight to give to the environmentalists' arguments, bearing in mind the words of Mrs Indira Ghandi at the U N Conference on the Human Environment at Stockholm in 1972, 'The environment cannot be improved in conditions of poverty. Nor can poverty be eradicated without the use of science and technology.' This brings us to the effect on the developing countries of the rise in registration costs.
The consequences for the developing countries The more complex the registration requirements become, the more complex will be the process of evaluation and it may well be beyond the scientific and financial resources of developing countries. Furthermore, it is particularly important in such countries that scientists, who are likely to be scarce, should not be used on unproductive work. For many developing countries, cash crops are the main exports and the main sources of wealth. They have to be sold on world markets, and if the cost of the agrochemicals needed to protect them (and in tropical countries the need is great) continues to rise, the exporting countries risk having to accept a lower return. In the case of subsistence and staple food crops, it would be possible--and it is certainly highly desirable, if not downright essential--to increase yields very considerably by a balanced use ofagrochemicals; however, if their price continues to rise, this possibility will become ever more remote. If developing countries cannot afford modern agrochemicals, they must use older, cheaper ones. Unhappily, many such products are being driven offthe market by the stringent registration requirements of the developed countries, and even by export bans imposed by those countries. It should be for national governments to decide, in the light of local economic, social, financial and climatic conditions, what agrochemicals they should use. It is not for developed countries, in which quite different conditions obtain, to dictate to the rest of the world. At the Stockholm Conference, Mrs Ghandi asked, 'How can we speak to those who live in villages and slums about keeping the oceans, the rivers and the air clean when their own lives are contaminated at the source?'. If developed countries wish their less fortunate neighbours to use more expensive materialS, they could, of course, offer to pay for them. Even this matter of efficacy is not clear-cut; it may vary in different circumstances. As an example, it is arguable that the present epidemic of coffee rust in South America is as likely to be contained by the use of old, cheap copper fungicides as it would be by spending the same amount of money on more modern materials. They are more expensive, so the money would buy a smaller quantity, and a smaller area
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would be covered: all things being equal (which they seldom are), it might be better to spray 10 000 hectares with an old material than 5000 with a new one. Conclusions First, although other factors are involved, the increasing'number and complexity of the requirements for registering agrochemicals are causing the costs of research and development to rise steeply. Most of the requirements hitherto are right and proper, but a serious effort needs to be made by all concerned to identify and eliminate any that are not, to cut out duplication and other unnecessary work, to apply the rules flexibly, and to ensure that any new demands are fully justified by the benefit that they will bring, measured against their cost. Second, the consequences of the rise in costs are serious and affect the whole of society. They are not yet disastrous, largely because the innovating companies in the industry, on which its future depends, have stayed in business and maintained the technical, scientific and financial ability to produce new and improved materials capable of dealing with the changing nature o f pest attack and making progress towards filling the gaps in our defences. Third, industry is capable of continuing to fulfil this function: it can indeed produce materials capable of satisfying a high proportion of man's requirements-the difficulty being that some men require one thing and other men require another, and that the requirements conflict. In the end, it is for society to decide what it requires of the industry, and society will normally make its wishes known through the registration schemes operated by its regulatory authorities. If they are to fulfil so important a function with success, registration schemes will need to be drawn up and operated with careful regard to the consequences of each requirement and the cumulative effect of them all--the effect, moreover, on everyone everywhere. Since agrochemicals have now reached a high degree of efficacy and safety, society may feel that the time has come to rationalize and, if not to reduce, at least not to increase registration requirements, so that market forces can continue to enable the industry to generate sufficient funds to carry on at its present level and eventually expand: alternatively, the search for greater safety everywhere can be pushed to even greater lengths, which will cause costs to rise above what the market will bear. If that is done, industry could still do its job, but the extra costs would have to be borne by the authorities themselves in the first instance, and in the end by the taxpayer. There is no doubt which of these alternatives the industry would prefer, but it is not for the industry to decide. References CAST (1981). The Impact of Government Regulations on the Development of Chemical Pesticides for Agriculture and Forestry. Report No. 87 of the US Council for Agricultural Science and Technology (CAST). ERNSTANDWHINNEY(1980). Industry Profile Survey, National Agricultural Chemicals Association (NACA), Washington, DC. GANDHI,INDIRA(1972). In Proceedings, UN Conference on Human Environment, Stockholm, 1972. WHETSTONE,R.B. AND FITZSIMMONS,K.B. (1977). The Impact of Pesticide Regulations and Decisions on Industrial Pesticide Research. FAO doc. PRR/77/BP39. Rome: FAO. Accepted 12 January 1983