Major concerns on plant biotechnology applications in plants:
safety issues and bioethics
pp. 87-99 in Plant Biotechnology and Plant Genetic Resources for Sustainability and Productivity, ed. K. Watanabe, E. Pehu (R.G. Landes, Austin 1997).
Author: Darryl R. J. Macer
Bioethics is a trendy word, meaning the assessment and study of ethical issues raised in biology and medicine. The word "biotechnology" means using living organisms, or parts of them, to provide goods or services. The word can apply to agriculture over the past thousands of years, but is often applied to new techniques. Biotechnology started when people first started to plant crops, plant biotechnology, and though livestock farming, animal biotechnology. Both share similarly ancient roots. All civilizations were formed needing food, clothes, and medicines, and in that sense biotechnology is not new. What is new is that we can now make new varieties much more quickly, and with greater variation - and some foodstuffs made from plants bred using genetic engineering are already being sold in parts of the world.
Bioethics especially includes medical and environmental ethics. The word was mainly applied for issues of medical ethics in the 1970s and 1980s, but the 1960s and 1990s saw much more attention on environmental ethics. We must include both, medical ethics includes any factor affecting health, and ecological and environmental ethics must include human-human interactions, as these interactions are one of the dominant ecological interactions in the world. Agricultural systems include economic, environmental and human interactions. To resolve the issues, and develop ideals or principles to help us do so, we must involve anthropology, sociology, biology, religion, psychology, philosophy, and economics; we must combine the scientific rigor of biological data, with the values of religion and philosophy to develop a world-view. Bioethics is therefore challenged to be a multi-sided and thoughtful approach to decision-making so that it may be relevant to all aspects of human life.
There are two basic approaches in bioethics, one being descriptive and the other being prescriptive. One describes how people makes decisions, and the other suggests the process that can be used to make decisions. When we think of these terms for plant biotechnology, the descriptive side would look at what happens in the world, describing consumer choices, company marketing programs, researcher's plans and intentions. The prescriptive side would look at the regulations, covering food safety and formation of public policy. Both aspects will be considered here.
Bioethics is a new word, for concepts that have come down to us through the human heritage for millennia. It is the concept of love, balancing benefits and risks of choices and decisions. This heritage can be seen in all cultures, religions, and in ancient writings from around the world. Human civilization has been tied to agriculture for many millennia, and the concept of bioethics first emerged in the relationships that people had with nature, a nature which could be cultivated to provide for human needs. The ethical issues raised are not fundamentally different to those of the past, and I would reject the use of the word "Genethics".
2. Beneficence and biotechnology
Some people think of the negative side of bioethics, the concept of "do no harm", when they hear the word. However, one of the basic concepts of bioethics is beneficence, an imperative to "do good". This is the reason for publicly supported research into technology, and arguably behind the advancement of plant biotechnology in general. Biotechnology has become a popular word and many people hope it will be a solution to the world's ills. Undoubtedly, commercial incentives also play a role in the development of biotechnology, as discussed later in section 7.
While all agree that beneficence is good, we do need to consider who benefits most, an issue with many implications for those in developing countries. Biotechnology has already had an effect on developing countries, which have been said to lose US$10 billion annually from their exports due to biotechnology-based product substitutions. International competition implies that there may be some winners and losers in the competition, and it is not yet predictable whether these will be developing or industrialized countries, the producers or users of techniques, the poor or rich within countries, or even how it will change international relations.
Whether countries can use new biotechnological techniques to improve life depends on several major factors. There must be a social acceptance and willingness to use new technology. We can see there is support from opinion survey data presented here. However, there must be sufficient resources to allow its use, and it must be user friendly. There needs to be trained personnel to introduce the technology so that ordinary people can use it effectively, and training of farmers to use new cultivation systems. The barriers that slow the adoption of better techniques and/or varieties should be removed, and conservatively-minded policy makers, dictatorial scientists, and village elders should accommodate biotechnology to boost sustainable local production. These are questions of national benefit, but international aid is required to allow research, and to introduce new technology, in smaller countries. There are international questions, such as whether technology is transferred from countries with a high level of research capability to countries that do not, and how, if at all, intellectual property rights should be protected, as discussed in other chapters of this book.
The desired benefit may be similar in different countries, to raise the quality of life of citizens, and to maintain living standards at a reasonable level. The maintenance of reasonable lifestyles and quality of the environment, consistent with a sustainable way of life in the international community, are primary goals of many countries. International competition should be adjusted to encourage more sustainable economic policies.
We can hope that trade barriers and protectionism are reduced, but inside most countries the protection of small rural farmers is considered socially important; and one must balance the questions of international trade versus national socio-economic structure. Biotechnology could aid the survival of farmers, if more disease-resistant and climate tolerant varieties are introduced. The production of biomass as renewable energy, and industrial and pharmaceutical products in crops and livestock, will provide additional need for agricultural production. However, multinational petrochemical and pharmaceutical companies may control the seed needed for such crops, and they could produce hybrid seed rather than open-pollinated varieties so as to maintain their control and steady profits. If fees need to be paid for seed, larger farms may succeed more than smaller farms. It is questionable whether biotechnology will support the survival of traditional village structures, and small land holders. A free market approach would not do this, unless there were strong incentives and disincentives established.
As with every technology, different companies benefit from the sale of their own products. In intensive agriculture, with chemical fertilizers and pesticides, and multi-application procedures, companies can benefit more if they sell more product to the farmers. Considering the long-term benefit to the future generations and farmers, and environment, efforts should be made to switch to crop and animal systems less dependent upon intervention. Companies in industrialized countries are continuing much research on applications of biotechnology that require such inputs. An example is the development of herbicide-tolerant plants, where both seed and herbicide are controlled by the same companies, though they should have environmental advantages when substituted for systems using non-biodegradable herbicides. There should also be attempts to use biological pest control, and genetic engineering to insert genes directly into openly pollinated crops, which can be used by farmers in developing countries without dependence upon seed and chemical companies (which are often controlled by the same multinationals). The question is who decides what varieties should be grown in developing countries, and whether it is for local or "international" needs, and for whose benefit?
Within developing countries, applications should attempt to preserve
rural structure, so that villages could create small-scale biotechnology
"factory" supplies to earn income. In developing countries,
the agricultural sector employs over 80% of the active population,
but in industrialized countries only 5-10%. Some crops are labour
intensive, and others are not, for example, oil palm plantations
require about one third of the labour required in banana plantations.
Production of new products, such as single cell protein may reduce
labour. Weeding is one of the most labour intensive operations,
but it will be reduced as herbicide tolerant crops are introduced,
this will lead to loss of work for many people, especially women.
However, year round crop production may increase labour. The effects
depend on the country, for example the use of bovine somatotropin
(BST) to increase milk production in dairy cows is being opposed
by many groups in Western countries because it may favour larger
farms, but in some developing countries, such as Mexico or Pakistan,
its use would be welcomed because it may reduce imports of milk
Table 1: Perceptions of benefits and risks of science and
technology in different countries
Responses to the following question: "Overall do you think science and technology do more harm than good, more good than harm, or about the same of each?"
Abbreviations: NZ = New Zealand, A = Australia, J = Japan, In
= India, Thai = Thailand, R = Russia, Is = Israel. Data from 1993
International Bioethics Survey (Macer 1994), except 1989 Australia
and 1989 UK and Chinese data.
The arguments about benefits are thus complex ethical and social
ones. We need to balance benefits with the concerns about risks,
when we make decisions about policy for plant biotechnology. Most
people believe that science brings more benefit than harm, and
the results of public opinion surveys shown in Table 1 support
this. In all countries there is a positive view of science and
technology, it was perceived as increasing the quality of life
by the majority in all countries. Less than 10% in all countries
saw it as doing more harm than good. One of the intractable policy
questions is how much of the policy in a democracy should be decided
by public opinion?
3. Public concerns about plant biotechnology
The word "concern" can be used as a verb or a noun. Some linguistic analysis is revealing (from the American Heritage Dictionary). The verb includes four meanings: 1. To have to do with or relate to; 2. To be of interest or importance to; 3. To engage the attention of; 4. To cause anxiety or uneasiness in. The noun also distinguishes several meanings including: 1. A matter that relates to or affects one; 2. Regard for or interest in someone or something; 3. A troubled or anxious state of mind arising from solicitude or interest. It is the fourth meaning of the verb, and the third meaning of the noun, that I use in this chapter, however, we do need to ask whether plant biotechnology relates to everyone (meaning 1 for both verb and noun), and if people have an interest in it (meaning 2 and 3 for the verb and meaning 2 for the noun)? Plant biotechnology relates to everyone because we all eat plant derived substances, directly or indirectly. Not all the food in the world could be said to be the result of biotechnology, e.g. simple fishing or hunting of wild animals, but most is.
Do people have an interest in plant biotechnology and a concern about the way food is made? This means an interest in how the food reached them, or what occurred before the supermarket shelves? From consumer patterns we would see that not everyone does have a concern about the production, rather concern about price can sometimes be most important. Hoban and Kendall found that more people in the USA would buy a product because it was 10% cheaper than because it was 10% better quality. This may be different across socio-economic groups which can also be reflected by cultures, and local availability of food, however, some people do not care what they drink, eat, or smoke. Some people judge by taste and others for perceived health benefits. Ultimately all must rely on the public health authorities for their food safety. Even though in surveys many may express suspicion in practice most people do not read food labels beyond the expiry date carefully.
Nevertheless, most of what we know of people's concerns comes from opinion surveys. For details of these I refer people to the references. In summary, the major reasons we can see that have been cited in surveys I have conducted on the unacceptability of plant biotechnology or genetic manipulation can be grouped into five categories:
1. It is unnatural, playing God, unethical, feels wrong
2. Will cause a disaster; fear of unknown; bad ecological and environmental effects
3. Fear of human misuse, eugenics, cloning; insufficient controls exist; human society will be changed
4. Health effects, mutations, deformities
5. Reason not stated.
Group 1 concerns may persist with development of the technology, but group 2 and 4 concerns may be lessened by development of technology and by risk assessment for environmental and food safety (discussed in sections 4 and 6). Group 3 concerns can be lessened by regulations. People who do not cite a reason may feel less strongly about the issue, but there is no real indication of what concerns they had. We should also note that many people expressed reasoning across several of these types of concern. Data from opinion surveys and observation suggests that the diversity of thinking within any one group is much greater than that between any two groups, therefore we can attempt to look at basic universal principles that can be used in deciding these issues
Group 1 concerns, are related to religious concerns, that may not be specific to a particular religion. In agriculture, the major cultural and religious divisions are over use of animals, and the exclusion of certain animals by religious dietary laws tend to follow cultural boundaries more than use of particular plants, which are diverse within all cultures. The Judeo-Christian-Islamic view of the relation of humans and nature is that they are both continually dependent on God. People have been told to subdue, cultivate and take care of the earth, to multiply and to have dominion over the created order (Genesis 1:28, 2:15). Biotechnologists could consider they are to continue the "good" work of creativity. However, we find interpretations of these scriptures differs within followers of each religion, and rather than stressing one particular view the bioethical tradition is that of tolerance for the views of others. Some people interpret biotechnology as playing God and others as serving God, so it is difficult to draw religious boundaries.
People make decisions about plant biotechnology applications based on balancing of the perceived benefits and risks of research goals. The results of an International Bioethics Survey which I conducted in 1993 in several countries,1 with collaborators, show that there are variations in the way benefits and risks are balanced (Figure 1). There are variations in the number of people who said they "don't know", in response to the question "Do you personally believe biotechnology is a worthwhile area for scientific research?", with many in New Zealand and Australia saying so. However, there is general correlation between "Yes" to a benefit and having less worry.
It is an interesting question to ask which is more important, believe in a benefit or concern about risk. The general question does not differentiate between animals, plants, microbes or humans. In 1991 surveys this question was examined, with a series of different questions. Plant biotechnology fares well compared to applications on animals, microbes or human cells as shown in Table 2. Similar results have been found in surveys in New Zealand, and the USA. We see that the general public perceived most benefit from plants and saw them as having the least risk, as did scientists. Interestingly, scientists in New Zealand saw both animals and plants as presenting a similar degree of risk but disproportionally more thought there would be benefits from plant biotechnology applications. In these questions a wide variety of benefits were cited in open response questions to both questions, and a variety of types of concern can be seen.
Therefore we could conclude that from the descriptive viewpoint
the answer from surveys about whether risk or benefit is more
important, appears to be ambivalent. However, from the prescriptive
side, regulatory authorities appear to put more emphasis on risk
assessment and prevention, than they do on the potential benefits
of research. The relative benefits of different applications may
be promoted by budgetary decisions, though budgetary decisions
can also stop public funding of risky areas. This will be discussed
more in section 5 and 7. This emphasis is also reflected in the
nature of the subtitles in this chapter, most deal with safety
and concerns, however, we do need to consider the benefits and
risks of applications.
Figure 1: Scattergram of perceived benefits and risks of biotechnology
by the public in 1993.
Data from International Bioethics Survey (Macer 1994). NZ = New Zealand, A = Australia, J = Japan, In = India, T = Thailand, R = Russia, Is = Israel. Questions were:
"Do you personally believe biotechnology is a worthwhile area for scientific research? Why?..."
Yes No Don't Know
" Do you have any worries about the impact of research or
applications of biotechnology? How much? Why?..."
No worries A few Some A lot
Table 2: Perceptions of benefits and risks from genetic manipulation in Japan in 1991
Nation random mail response surveys conducted in Japan in 1991, except students which were from the University of Tsukuba (Macer 1992)5
Responses to the question: "Which of these biological methods, could provide benefits for Japan?"
Manipulating genetic material in human cells; microbes; plants; animals.
1 No benefit 2 Benefit (If a benefit, what benefits do you believe each one could produce?)
Which, if any, of those biological methods could present serious risks or hazards in Japan?
1 Risk 2 No risk (If a risk, what serious risks or hazards do you believe each one could present in Japan?)
There may be particular uses of plant biotechnology that not everyone agrees with, but the distinction that is seen between luxury (e.g. making sports fish bigger) and utility (e.g. meat with less fat) among animals may be seen less with plants. In plant biotechnology there are major industries based on ornamental plants, not only food and oil production. If less people perceive risks from plant applications, there will be less objections. We can see a case-by-case approach in these responses to questions on the acceptability of different specific applications of genetic engineering, with the highest level of support seen for disease-resistant crops or bacteria to clean oil spills, but with tomatoes with a better taste also being supported by about two thirds of people (Table 3). The approval of the Calgene Flavr Savr modified tomato which has delayed ripening for general cultivation in the USA was given by the USDA in 1993, and it was approved for general commercial food consumption by the FDA in 1994, and sold in the summer 1994 in some parts of the USA. The results show that it would be generally supported around the world.
The case for cows which make more milk received less support than that for less fatty in the International Bioethics Survey than the goal of less fatty meat, which is consistent with the existing milk surplus in some countries. In a recent telephone survey in the USA conducted by Hoban, it was found that consumers gained confident about consuming milk produced from cows treated with BST after receiving scientific facts attributed to respected agencies (e.g. AMA, FDA, NIH). Further discussion of food safety will be made in section 6. Larger sports fish are rejected by more than half of the people in most countries.
A further concern that some people may have is cross-species gene transfer. Four specific questions were used to explore the acceptance of food products made from cross species gene transfer. In all the countries in this survey plant-plant gene transfers (Q9) were most acceptable, with animal-animal (Q11) next, and animal-plant (Q10) or human-animal gene transfers (Q12) were least acceptable (Table 4). In the USA14 the proportion accepting these were 66% (Q9), 39% (Q11), 25% (Q10), and 10% (Q12), and the trend was also seen in Canada. In the International Bioethics Survey, the question "Why?" was added to each option, and a variety of reasons were given. The ideas expressed in the comments were placed into up to two categories and the results of this analysis are shown in Table 5. The range of concerns are as discussed above, and they illustrate there are still ethical concerns with plant biotechnology, which increase with genetic transfer from animals.
Table 3: Approval of environmental release of GMOs
Tomatoes with better taste
Healthier meat (e.g. less fat)
Larger sport fish
Bacteria to clean up oil spills
Disease resistant crops
Cows which produce more milk
Responses to the question: "Q31. If there was no direct risk to humans and only very remote risks to the environment, would you approve or disapprove of the environmental use of genetically engineered organisms designed to produce...?" Yes- Approve No- Disapprove DK Don't know
Abbreviations: NZ = New Zealand, A = Australia, J = Japan, In = India, T = Thailand, R = Russia, Is = Israel, P = Philippines; S = Singapore, HK = Hong Kong Data from 1993 International Bioethics Survey (Macer 1994).
Table 4: Public and student acceptance of genetic engineering and cross species gene transfer
Q9. Genes from most types of organisms are interchangeable. Would potatoes made more nutritious through biotechnology be acceptable or unacceptable to you if genes were added from another type of plant, such as corn? Why?
Q10. Would such potatoes be acceptable or unacceptable to you if the new genes came from an animal? Why?
Q11. Would chicken made less fatty through biotechnology be acceptable or unacceptable if genes were added to the chicken from another type of animal? Why?
Q12. Would such chicken be acceptable or unacceptable if the genes came from a human? Why?
+ = Acceptable - = Unacceptable ? = Don't know
Responses to the questions indicated. Abbreviations: NZ = New Zealand, A = Australia, J = Japan, In = India, T = Thailand, R = Russia, Is = Israel, P = Philippines; S = Singapore, HK = Hong Kong Data from 1993 International Bioethics Survey (Macer 1994).
Table 5: Reasoning about genetic engineering and cross species gene transfer (%'s)
|Unnatural, Playing God, Cross species is bad|
|Product bad, Human's are special, Cannibalism|
|Fear of unknown, Feels risky, dangerous|
|Social effects, eugenics|
|Harm to health, deformities|
|Environmental and Ecological effects|
|Insufficient controls. misuse|
|Conditional benefit, Don't Know|
|Agriculture, Food, Increase varieties|
|Humanity benefits, Better|
|Genes are the same; No Problem|
Responses to the questions indicated in Table 4. Abbreviations: NZ = New Zealand, A = Australia, J = Japan, In = India, Th = Thailand, R = Russia, Is = Israel, P = Philippines; S = Singapore, HK = Hong Kong. Data from 1993 International Bioethics Survey (Macer 1994).
The first concern that scientists had with modern plant biotechnology was that of environmental safety, and these concerns are reflected in the regulations for field testing of genetically modified organisms (GMOs), found in many countries, discussed below. We can also see a number of persons in the opinion surveys had environmental concerns (Table 5).
There are different components of the risks to the environment.
The probability of each component occurring must be multiplied
together to give the likelihood of harm. The components include:
* incorporation of gene for hazardous trait into an organism
* chance of release into natural environment
* survival of the organism there
* multiplication of the organism in the environment
* gene exchange or dissemination
* chance that this will be harmful
There have been different schemes proposed for assessment of the risks, and some of the criteria that are used are discussed in section 8.
There have now been over a thousand field trials of GMOs, and a dozen varieties are deregulated in the USA, meaning they can be grown unrestricted. Other countries lack any regulation, and some have been encouraging large scale field trials for a few years, for example, China. From the results of controlled field trials we can obtain estimates of the actual risks of gene transfer, which are finite risks. A Scottish Crop Research Institute (Dundee) using oilseed rape in a 4 hectare area, found the density of airborne pollen from the GMOs was 69% 100m away, and they found significant pollen at 2.5 km. As GMOs are grown over larger areas there will be gene transfer, which makes the final step in the list above "chance that this will be harmful" the most important question to evaluate. Careful choice of genes should be made.
There is an additional concern with the use of biopesticides, plants containing genes or proteins that will selectively kill certain insect pests. Like all pesticides insects will develop resistance. Strategies to lower chances of resistance to Bacillus thuringiensis insecticidal protein include the patchwork farming of treated and untreated fields, and methods to reduce the amount of untreated fields (that may suffer more insect attack!) by computer simulation. There is no assurance that all farmers will use new products in a wise way, thus the fear of unknown human use complicates risk assessment.
There is a fundamental ethical question, why would we be concerned about gene transfer, or "genetic pollution"? Human health does depend on the environment, and the easiest way to argue for the protection of the environment is to appeal to the human dependence upon it. There are also human benefits that come from products we find in nature, from a variety of species we obtain food, clothing, housing, fuel and medicine. The variety of uses also supports the preservation of the diversity of living organisms, biodiversity. As we have learnt, the ecosystem is delicately balanced, and the danger of introducing new organisms into the environment if that may upset this balance is another key issue raised by genetic engineering. However, we have been using agricultural selection for 10,000 years, so the introduction and selection of improved and useful microorganisms, plants and animals is nothing new, and we should learn from mistakes of the past.
The above arguments should convince people of the value of the environment, and that is a first stage. However, it appeals to our sense of values based on human utility. There is a further way to argue for the protection of nature and the environment, and it is a more worthy paradigm. It is that nature has value for itself because, it is there. We should not damage other species, unless it is absolutely necessary for the survival of human beings (not the luxury of human life). Nature has life, thus it has some value. Another paradigm for looking at the world is a religious view, that God made the world so the world has value, and we are stewards of the planet, not owners. This paradigm can make people live in a better way than if they look at the world only with the paradigm of human benefit. We need to know what these perceived limits of changing nature are, before we grossly change the characters of individual organisms, or make irreversible changes to the ecosystem and human society.
Biodiversity may have some value in itself, though it is yet to be defined in non-religious terms. If we want to preserve biodiversity, it is essential that we separate parts of nature on land and ocean as nature reserves or parks, away from the parts of nature which are agricultural areas. However, while we separate these areas physically we should not separate them psychologically as areas which we can abuse and areas which we protect. This applies both in terms of sustainable environmental protection and animal rights. In fact, agricultural biodiversity is of direct human utility, and we should attempt to stop its continued loss.
5. Freedom of research and concerns of scientists
Scientific freedom and freedom of expression are admirable goals, but not always absolute if they infringe on other human rights and safety. Scientists are called upon to take responsibility for the social consequences of their research. Recently we can see the growth of ELSI (ethical, legal and social impact) grants from genetics and biotechnology research programs. We can also see the emergence of movements such as the Universal Movement for Scientific Responsibility (MURS). Such moves represent important steps in the growing maturity of scientists. These may illustrate a paradigm shift among scientists to concentrate more attention on the social impacts of their research, especially in areas such as biotechnology and genetics.
Scientists will win more public support for research by involving the public in decision-making, and being open. The public has a high level of suspicion of safety statements made by scientists, especially those involving commercial decisions. In surveys conducted in Japan,15 New Zealand,16 and the USA,17 high school biology teachers and government scientists were even more suspicious of statements than the public. Even company scientists did not trust themselves. Committee meetings involved in the regulation of biotechnology and genetic engineering should be open to the public. Such open decision-making would gain more public support then closed meetings, and openness would improve public confidence in regulators. It may also result in better safety than regulations which put industry on the defensive and result in closed-door discussions. Moreover, an open approach may be better at winning public support than the current approach of spending money on advertisement campaigns that could be seen as pro-biotechnology "propaganda" campaigns. Most people are already aware of the benefits of biotechnology, but they will remain concerned about decision-making that is hidden.
There was higher support for specific applications of genetic engineering than there was for general research, suggesting that the public will better support worthy applications of technology if they are told the details of them. When people were asked whether they would use gene therapy to cure serious genetic diseases, the majority in all countries surveyed do accept the use of human genetic manipulation for curing serious genetic diseases. A similar effect was seen regarding the approval for environmental release of GMOs (Table 3).
There has been an information campaigns supporting biotechnology
by Bioindustry Associations, and specific companies, such as Monsanto.
Recently, following a survey of scientists in the USA engaged
in recombinant DNA research, which found that more saw public
attention on genetic engineering research as beneficial than harmful
to their research, public education programs to stress the benefits
of biotechnology have been called for. The results of the surveys
discussed above question the effectiveness of such programs, and
also whether their goal is desirable. Rather than attempting to
dismiss feelings of concern, society should value and debate these
concerns to improve the bioethical maturity of society. However,
media responsibility is crucial.
6. Food and product safety
There are already products being consumed from GMOs in many countries. In the UK those on the market include chymosin from Aspergillus awamori, and from Kluyveromyces lactis (Gist Brocades), from E.coli (Pfizer), a tomato paste, oil from oilseed rape, and processed products from soybean. The 1990 approval of a baker's yeast was the first foodstuff from a GMO approved but it has yet to be marketed. Sainsbury and SafeWay supermarket stores in the UK label tomato paste made from genetically modified tomatoes. However, the widest controversy has been seen in the USA where there is a campaign against foods made from GMOs.
We can see some of the public concerns with foods from their attitudes to products such as "tomatoes with better taste" (Table 3), and we find that many say they approve. In separate questions on the acceptability of foodstuffs made from GMOs in the International Bioethics Survey, plant products were the ones with the least concern,1 however people did not differentiate as much as with the plant animal distinctions seen in other questions (e.g. Table 5). There have been a range of national studies of perception of risks using surveys, including Europe, the UK, Holland, New Zealand,16 and the USA,17, but the real test is whether they buy the products when they are sold. There have been reasonable sales of the Calgene Flavr Savr tomato, trade name, MacGregor, in the USA since 1994 when it was released. Similar tomatoes are also being sold in the UK.
The more time spent in testing the safety of a new product, or the environmental safety of a new organism, the higher the financial investment. Ethically, we may say do no harm has priority, and require long periods for testing of new products. However, this means that the average costs for development of new drugs are so large that only large companies can take a product through to the market, after safety approval.
Nevertheless, society does impose safety standards to protect human and environmental health. Another method of attempting to ensure safety is to allow liability suits in courts, which is an additional protection. However, there also needs to be limits on liability claims, otherwise research into such areas as contraceptives, or vaccines, may be inhibited, due to company fears of future litigation for unrealistic monetary sums in such sensitive areas.
In early 1991 the US government attempted to restrict regulations on biotechnology products such as foodstuffs, as an incentive to encourage further industrial investment. We will not know whether this compromised human or environmental health until the future if mishaps occur. Large industry may be cautious about liability suits, and better ensure safety of products, but it has been suggested that allowing industry the option of not asking for independent review of product safety, risks exposing the public to untested products marketed by small companies trying to make a quick profit.
Labeling is the most contentious issue. The opposition from Denmark,
Sweden, Germany and Austria over the UK and US positions not to
label foods from genetically engineered soybeans is delaying the
introduction of herbicide-tolerant soybeans into the whole of
the EU in 1996. A report on the European group of Advisors on
Ethical Implications of Biotechnology has announced its guidelines
on the labeling of food from genetically engineered foods recommended
that when the product is significantly changed in composition,
nutritional value or intended use, it should be labeled. Generally
they focus on the product rather than the process.
7. Commercialization and sharing benefits
Although we hope that biotechnology can improve life for every person in the world, and allow more sustainable living, the crucial decisions may be dictated by commercial decisions, and by the socio-economic goals that society considers to be the most important. Human plant and animal breeding is associated with commerce. International trade for many countries has long been based on biological products. International competition has become intense, to export products to gain foreign exchange. It is into this framework that the further use of biotechnology must be viewed, and there could be both positive and negative effects for different countries. Biotechnology will affect every area of countries' economies.
Developing countries are currently economic losers in international competition, so many would say that the situation can only get better. However, if commercial forces are left to operate unconstrained by morality, and trade barriers to the import of foodstuffs continue to exist, in terms of international competition, the situation will clearly get worse for developing countries. This is principally because of product substitution, and by the increasing ability of industrialized countries to produce enough foodstuffs to become self-sufficient. Products such as sugar, shikonin, coffee, cocoa, vanilla, and cotton, are just some potential cases. Agricultural producers already have very difficult times, especially with protectionism. If trade barriers were removed, the future would be brighter for developing countries if they could produce cheaper foodstuffs, industrial raw materials and products in transgenic plants and animals, and especially so if the storage life of foods was increased so that it did not spoil during transport.
The situation in terms of food production and life quality in developing countries, may improve nevertheless, because developing countries will become more self-sufficient and have better quality foodstuffs, and increased energy production from biomass. For example, if a pest resistance gene saved 1% of total rice crop in India from disease, it would save US$300 million a year. However, self-sustainability for most developing countries is several decades away, and we need to think of different solutions to this trend which harms the developing countries.
Research has for many decades also been viewed in terms of the business opportunities, both internationally and within nations. As national budgets become more stretched with other needs, many are encouraging more research by industry, either by industry cooperation with government researchers, or independent facilities. If research was performed in publicly-funded laboratories, and was published freely, there may be less problem with international technology transfer. National governments may transfer technology to other countries as part of development aid. Nonprofit private organizations are also very important in biomedical research in some countries, and they usually allow export of technology. For example, one of the world's largest gene-mapping laboratories in France, the Genethon, funded by charity, has used automatic DNA sequencing to map the human genome. However, the largest genomic research centre is The Institute of Genomic Research (TIGR) of Human Genome Sciences Incorporated (HGS), and there has been much controversy over the conditions for data access. HGS has begun sequencing plant genomes and the same issues will be seen with plant biotechnology for the coming decade.
Another issue is that of prospecting agreements. In 1991, the
company Merck & Co., made an agreement with Costa Rica, to
exclusive rights to new potential "products" it finds
in an area of its tropical forests until the year 2,000. It is
like a hunting license for useful compounds. If successful, a
share of the profits will be paid to Costa Rica. This also should
encourage other countries to preserve large areas of their forests.
It is important to encourage in situ conservation, and
if no other group will put up the finance than it will be left
to large companies who will benefit from the new substances found.
This is not such a new phenomenon, industrialized countries have
been gathering seeds and genetic resources from other countries
for centuries, for the development of new crops and products.
In June 1992, at the World Environment and Development Conference
in Rio de Janeiro, Brazil, a Biodiversity Treaty was signed, which
has important implications for the protection of biodiversity
by all countries, and may preserve the intellectual property rights
of products derived from the diverse species. Intellectual property
rights are discussed elsewhere in this book.
8. Regulation of plant biotechnology
There have a variety of laws and regulations made in different countries around the world. Some countries have chosen to have specific laws, for example, The European Union, Russia, and others have achieved control through government regulations, for example the USA and Japan. The European Parliament set minimum legal standards for European Community countries, though regulations vary between strict, as in Germany, to non-existent in other countries - which rely on the default European regulations. In Japan, each of the major ministries have their own regulations.15
The country with the widest experience of GMO release is the USA, with most field releases regulated by the Department of Agriculture, except those for microorganisms and pesticide genes which are regulated by the Environmental Protection Agency. The USDA amended the regulations on genetically engineered plants introduced under USDA's notification and petition regulatory processes in 1996, to allow most genetically modified plants that are considered regulated articles to be introduced into the environment under the notification process, as long as they meet certain eligibility criteria and performance standards. In addition, under the notification process, the amendment would allow a reduction in the field test reporting requirements when no unexpected or adverse effects are observed. Under the petition process, the proposed amendments would enable USDA scientists to extend an existing determination for non-regulated status to certain additional regulated articles that closely resemble an organism for which a determination has already been made.
There are many countries which do not have sufficient resources to enact their own regulations, so a Global Biosafety protocol was discussed in the Jakarta meeting of signatories to the Biodiversity Convention which ended 17 Nov, 1995. The decision was postponed to be made by 1998, and the developing countries wanted to include internal guidelines as well as international movement of GMOs, whereas the EU wanted to only regulate the latter. There are 168 signatories to the Convention now, and there is debate over how strict and when a biosafety protocol under article 19 of the convention would be. In September, Argentina adopted the UNEP guidelines which are developed by the UK and Netherlands, as an alternative. In the absence of specific laws, researchers may follow guidance suggested by various academics, or international bodies.
Islands may develop particularly different regulations and enforce them, but regions, such as Europe, need common minimum regulations, as neighboring countries are at risk. Conversely, any country which imposes extra regulations must suffer the lower industrial development of their neighbours, without a significant reduction in risk. We must also gather information from past releases of new organisms and their ecological consequences. We can hope that the information is shared globally, to avoid others making the same mistakes, and to ensure all countries have a similar minimum standard of protection. It is clear that the authorities and committees that have the most experience with releases should have developed the most skill in assessing the ecological risk. Review should of course be independent, to avoid conflict of interest.
Independent clinical review of drug safety is already standard in most countries, and to be ethical, we must ensure that all people of the world share its protection. Such protection should be standardized, but it is a more difficult question when a country wants to impose stricter standards. A government has a duty to allow beneficial products and technologies to be used by its citizens. There are various laws concerning the food and product safety in different countries. There are guidelines released for foodstuffs in Europe as mentioned in section 6, and in the USA by the FDA, and in Japan. Generally foods made using GMOs do not need very exhaustive safety examination, only if novel components are included, as discussed in section 6. There are however, differences in the labeling requirements, with some requiring labeling and others not. Some companies voluntarily label products, and others do not, and supermarket chains have different policies as discussed above. In a rapidly moving and new area, an independent committee approach to regulation is the only way to efficiently and safely examine food safety.
Guidelines also differ on what is included as a GMO. Some exclude
organisms that have gene deletions from these guidelines, only
including organisms which contain "recombinant DNA"
sequences or parts of vectors. In some democracies the public
has a clear role in the process of regulation, and clear opportunities
to voice concerns. This opportunity to voice concerns is important
to gain public trust, especially considering the lack of trust
(see Section 5). In some countries hearings are conducted in public,
as in the RAC committee hearings on human gene therapy in the
USA. The above-mentioned survey responses suggest that the public
can make well reasoned arguments concerning biotechnology risk
and benefit. The public should be involved more in committees
making science policy and regulating applications of science.
This requires more public willingness to be involved, and the
scientists and bureaucrats should allow third party and public
entry to committees. As a minimum standard for ensuring ethical
biotechnology, decisions should be made in forums open to public
9. The need to address hopes and concerns
Perceptions of the impacts of technology are more complex than simple perception of benefit or risk, as they should be. The capacity to balance benefit and risk of alternative technologies, while respecting human autonomy and justice and the environment, while simultaneously being under the continual influence of commercial advertisements and media stories of varying quality and persuasion, may prove to be an important indicator of the social and bioethical maturity of a society.29 In addition, to develop the bioethical maturity of society, global human rights need to be increasingly respected so that we get social progress as well as scientific progress. All people should equally share both the benefits of new technology and the risks of its development.
There will be future conflicts in determining what is ethical biotechnology. Our concepts will change, and there is no guarantee that unethical applications will be made, and even supported, by future public majorities. We need to remember history, and also may need to introduce some international laws which make it more difficult for future unethical uses to occur. However, we need to be flexible, as we gather experience we may need less stringent regulations.
We can think of some summary criteria which may be useful in determining
whether any given application of biotechnology is ethical.
1. What is the benefit? To whom? Is it life-saving? Human benefit is greater than monetary benefit.
2. Do no harm to humans. What is an acceptable level of risk?
3. Do not cause pain.
4. Do no harm to the environment. Use the technology that is most environmentally sustainable over the long-term. Minimize consumption.
5. Protect biodiversity. Protect endangered species. Allow farmers affordable or free access to breeding stock, and encourage planting of diverse crops.
6. Justice to all people, and future generations. Share benefits and risks.
7. Independent open decision-making on safety questions, consider ethical and social impact.
8. Inform and educate the public and scientists about all dimensions of the projects, scientific, social, economic and ethical, using third party media.
In conclusion we need to think of key concepts of education, progress, responsibility and sustainability. People have hopes in the future of plant biotechnology, and the food problem is the most widely cited hope that people express for "biotechnology" in the surveys that have been conducted.1 They also have hopes for medical advances. However, among the fears that people have, environmental concerns and human misuse make us aware of the need for responsible science, to look before we leap. This is essential for the future well being of the world.
On-line bioethics resources, books, and the Eubios Journal of Asian and International Bioethics, and up-to-date news are available from Eubios Ethics Institute world wide web site (http://eubios.info/index.htm").
1. Macer DRJ. Bioethics for the People by the People. Christchurch: Eubios Ethics Institute, 1994.
2. Macer DRJ. Bioethics: Descriptive or Prescriptive?. Eubios Journal of Asian and International Bioethics 1995; 5:144-6.
3. Macer DRJ. Shaping Genes: Ethics, Law and Science of Using Genetic Technology in Medicine and Agriculture. Christchurch: Eubios Ethics Institute, 1994.
4. Macer DRJ. Biotechnology, International Competition, and its economic, ethical and social implications in developing countries. In: Ravichandran, V, ed.Concepts in Biotechnology. Orient LongMan Inc., India: Universities Press Pvt. Ltd, 1995: chapter 14.
5. Kumar N. Biotechnology Revolution and the Third World: An Overview. In Biotechnology Revolution and the Third World. New Delhi: Research & Information System for the Non-Aligned and other Developing Countries, 1988.
6. Sasson A, Vivien Costarini V. eds. Biotechnologies in Perspective. Socio-economic Implications for Developing Countries. Paris: UNESCO, 1991.
7. Macer DRJ. Bioethics and life style to protect the environment in the age of biotechnology. In Ishizuka K, Hisajima S, Macer DRJ, Traditional Technology for Environmental Conservation and Sustainable Development in the Asian-Pacific Region, Tsukuba: Master's Program in Environmetnal Sciences, 1996: 37-43.
8. Krupp H ed. Energy Politics and Schumpeter Dynamics. Japan's Policy Between Short-Term Wealth and Long-Term Global Welfare. Tokyo: Springer-Verlag, 1992.
9. Hassebrook C, Hegyes G. Choices for the Heartland: Alternative Directions in Biotechnology and Implications for Family Planning, Rural Communities and the Environment. Walthil, NE.: Center for Rural Affairs, 1989.
10. Ahmed I. Biotechnology and rural labour absorption. In Sasson A, Vivien Costarini V. eds. Biotechnologies in Perspective. Socio-economic Implications for Developing Countries. Paris: UNESCO, 1991: 57-72.
11. U.S. Congress Office of Technology Assessment. U.S. Dairy Industry at a Crossroad: Biotechnology and Policy Choices. Washington: U.S.G.P.O., 1991.
12. Anderson I. A first look at Australian attitudes toward science, New Scientist 16 Sept.1989; 42-3.
13. Zhang Z. People and science: public attitudes in China toward science and technology. Science and Public Policy 1991; 18:311-7.
14. Hoban TJ, Kendall, PA. Consumer Attitudes About the Use of Biotechnology in Agriculture and Food Production. Raleigh, N.C.: North Carolina State University, 1992.
15. Macer DRJ. Attitudes to Genetic Engineering: Japanese and International Comparisons. Christchurch: Eubios Ethics Institute, 1992.
16. Couchman PK, Fink-Jensen K. Public Attitudes to Genetic Engineering in New Zealand, DSIR Crop Research Report 138. Christchurch: Department of Scientific and Industrial Research, 1990.
17. U.S. Congress Office of Technology Assessment. New Developments in Biotechnology, 2: Public Perceptions of Biotechnology - Background Paper. Washington D.C.: U.S.G.P.O, 1987.
18. Macer, DRJ. Bioethics and biotechnology: What is ethical biotechnology?. In Brauer D. ed. Modern Biotechnology: Legal, Economic and Social Dimensions, Biotechnology, Volume 12. Weinheim, Germany: VCH, 1995: 115-154.
19. Hoban, TJ. Reported in USDA Biotechnology Notes March 1994, 2-3.
20. Canadian Institute of Biotechnology, 1993.
21. Mantegazzini MG. The Environmental Risks from Biotechnology. London: London University Press, 1986.
22. Tiedje, JM et al. The planned introduction of genetically engineered organisms: ecological considerations and recommendations. Ecology 1989; 70:298-315.
23. Dale PJ. R&D regulation and field trialling of transgenic crops. TIBTECH 1995; 13:398-403.
24. New Scientist 11 Nov 1995; 10.
25. Alstad DN, Andow DA. Managing the evolution of insect resistance to transgenic plants. Science 1995; 268:1894
26. Fowler C, Mooney P. The Threatened Gene. Food, Politics, and the Loss of Genetic Diversity. Cambridge: Lutterworth Press, 1990.
27. Macer DRJ, Akiyama S, Alora AT, et al. International perceptions and approval of gene therapy. Human Gene Therapy 1995; 6:791-803.
28. Rabino I. The impact of activist pressures on recombinant DNA research. Science, Technology & Human Values 1991; 16:70-87.
29. Macer DRJ. Perception of risk and benefits of in vitro fertilisation, genetic engineering and biotechnology. Social Science and Medicine 1994; 38:23-33.
30. Frewer LJ, Sheperd R. Ethical concerns and risk perceptions associated with different applications of genetic engineering: Interrelationships with the perceived need for regulation of the technology. Agriculture & Human Values Winter 1995; 48-57.
31. Sparks P, Sheperd R. Public perceptions of the potential hazards associated with food production and food consumption: An empirical study. Risk Analysis 1994; 14:799-806.
32. Rothenburg L, Macer D. Public acceptance of food biotechnology in the USA. Biotechnology and Development Monitor 1995; 24:10-13.
33. President's Council on Competitiveness. Report on National Biotechnology Policy. Washington D.C, 1991.
34. New Scientist 2 Dec 1995, 12.
35. Nature 1995; 375: 443.
36. Walgate R. Miracle or Menace? Biotechnology and the Third World. London: Panos Institute, 1990.
37. Robertson, I. Will biotechnologies be a threat or an opportunity for the south?. In Sasson A, Vivien Costarini V. eds. Biotechnologies in Perspective. Socio-economic Implications for Developing Countries. Paris: UNESCO, 1991: 173-9.
38. U.S. Congress Office of Technology Assessment, Biotechnology in a Global Economy. Washington: U.S.G.P.O., 1991.
39. Nature 1992; 357:526-7;Science 1994; 265:2049-70.
40. Dickson, D. HGS seeks exclusive option on all patents using its cDNA sequences. Nature 1994. 371:463.
41. Joyce C. Prospects for tropical medicines. New Scientist 19 Oct 1991; 36-40.
42. Juma C. The Gene Hunters. Biotechnology and the Scramble for Seeds. Princeton University Press, 1989.
43. European Parliament. Council directive of 23 April 1990 on the contained use of genetically modified micro-organisms, 90/219/EEC. Council directive of 23 April 1990 on the deliberate release into the environment of genetically modified organisms. 90/220/EEC.Official Journal of the European Communities 5 May 1990.
44. Science 1995; 268:1558.
45. Webber DJ. The emerging federalism of US biotechnology policy Politics & Life Sciences 1995; 14: 65-72.
46. Federal Register 22 August, 1995, 43567-43573 (wais.access.gpo.gov).
47. Background reports in Nature 1995; 377:94; 378:5; 1996; 379:13; Science 1995; 270: 723.
48. Miller HI. et al. An algorithm for the oversight of field trials in economically developing countries. Biotechnology 1995; 13:955-9.
49. Biotechnology and Development Monitor 1995; 25:11-4.
50. Henkel J. Genetic engineering. Fast forwarding to future foods. FDA Consumer April 1995, 6-11.
51. Guidelines for Safety Assessment of Foods and Food Additives Produced by the Recombinant DNA Techniques (Draft revision). Eubios Journal of Asian and International Bioethics 1996; 6:21.
52. World Health Organisation. Report of a joint FAO/WHO Consultation, Strategies for assessing the safety of foods produced by biotechnology. Geneva: WHO, 1991.
53. Crisp R. Making the world a better place: Genes and ethics. Science & Engineering Ethics 1995; 1:101-10.
Please send comments to Email < Macer@sakura.cc.tsukuba.ac.jp >.