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

1. Bioethics and biotechnology

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 powder.

Table 1: Perceptions of benefits and risks of science and technology in different countries

More harm 54 105 77 35 109 2
More good 5766 5642 5353 5440 6644 82
Same 3427 2645 3136 4249 2237 12
Don't know 53 28 104 16 210 5

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



HighSchool Biology Teachers
Number485192 221518

Human cells
No Benefit6348 4639
Benefit3852 5461
No risk1710 1429
Risk8390 8671

Plant cells
No Benefit2115 1312
Benefit7985 8788
No risk6140 4557
Risk4060 5543

No Benefit3125 1913
Benefit6975 8187
No risk4626 3048
Risk5474 7052

No Benefit4739 2926
Benefit5361 7174
No risk3927 3146
Risk6173 6954

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

Medical or biology students

Tomatoes with better taste
Yes49 5469 7383 3540 5453 7177 8868 7458
No35 3520 2010 4544 2136 1517 527 1732
DK16 1111 77 2016 1511 146 75 910

Healthier meat (e.g. less fat)
Yes54 6057 6684 3544 7471 6568 8875 7262
No30 3126 229 4342 2023 1818 421 1727
DK16 917 127 2114 66 1714 84 1111

Larger sport fish
Yes22 1922 4858 1320 2823 2450 6454 4442
No61 6554 2725 6158 6365 5231 2040 3937
DK17 1624 2517 2622 912 2419 166 1721

Bacteria to clean up oil spills
Yes75 8271 7487 6370 9289 7674 8578 8670
No11 1113 145 2012 14 1013 619 623
DK14 816 128 1718 77 1413 93 87

Disease resistant crops
Yes70 7866 7891 5450 8181 6781 9182 8372
No16 1317 134 2528 713 1311 515 814
DK14 917 95 2122 126 208 43 914

Cows which produce more milk
Yes36 3944 7584 2338 5544 4972 8670 5754
No45 4232 197 3840 3135 2919 526 2534
DK19 1924 69 3920 1421 229 94 1812

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?
+56 5639 5682 4550 8675 5158 7865 7976
-27 2325 214 2424 99 1818 717 811
?17 2136 2314 3126 516 3124 1518 1313

Q10. Would such potatoes be acceptable or unacceptable to you if the new genes came from an animal? Why?
+19 2311 2948 1622 4942 1627 4817 2525
-60 5440 4219 4252 3224 3739 1958 4848
?21 2349 2933 4226 1934 4733 3325 2727

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?
+29 4020 4068 3226 5042 3042 6842 4142
-46 4041 2710 3546 2527 3524 1336 2731
?25 2039 3322 3328 2531 3534 1922 3227

Q12. Would such chicken be acceptable or unacceptable if the genes came from a human? Why?
+10 166 1629 1014 2020 1118 307 1419
-78 6653 5244 6664 6553 5241 4481 6570
?12 1841 3227 2422 1527 3741 2612 2111

+ = 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)

Not stated
9 24 2435 41 2152 66 2517 32 4015 40 4031
10 23 2140 49 2362 66 2520 37 4414 43 5242
11 24 2139 49 2961 66 2222 34 4918 44 5437
12 22 2441 50 3060 60 1926 40 5322 41 4139
9 0.6 00.6 0 00 0 00 1 0.60 0.6 00
10 12 123 6 12 4 1426 2 92 8 63
11 13 116 8 0.62 2 2325 6 102 7 119
12 6 79 6 56 4 1417 6 55 7 812
Unnatural, Playing God, Cross species is bad
9 16 1113 11 15 6 44 8 84 2 47
10 32 2821 18 59 14 1912 16 146 20 1420
11 2416 18 112 6 1417 12 125 2 74 11
12 23 2218 9 66 8 1211 16 63 8 1211
Product bad, Human's are special, Cannibalism
9 3 33 4 12 0 21 2 40 2 21
10 3 32 2 20 0 22 1 31 3 44
11 2 23 2 13 0 10 1 31 0 21
12 25 127 17 127 16 3118 9 1214 27 1919
Fear of unknown, Feels risky, dangerous
9 3 68 2 25 6 21 6 22 4 15
10 10 913 3 65 6 20 15 47 10 611
11 7 610 2 43 4 22 8 24 7 38
12 13 1020 4 108 6 43 16 710 11 710
Social effects, eugenics
9 00.5 0 0.20 0.2 00 0 00 0 00 0
10 2 00 0 00 0 00 0 0.30.4 0 00
11 0 01 0 00 0 00 0 00.4 0 00
12 0.3 01 0.4 00 0 02 1 00 0 10
Harm to health, deformities
9 23 3 21 0.2 43 6 52 3 43 2
10 32 4 23 1 02 6 44 6 74 1
11 3 24 2 31 0 15 4 0.65 6 51
12 3 32 3 30 0 13 2 24 3 41
Environmental and Ecological effects
9 1 34 0.4 0.40.4 0 26 3 10 0 10
10 0.6 32 0.2 0.30 0 23 1 0.30 0 01
11 1 12 0.4 0.32 0 03 2 0.30 3 00
12 0 01 0 00 0 01 2 0.30 0 00
Insufficient controls. misuse
9 2 05 0.6 01 0 30 4 00 0 00
10 3 25 0 0.31 0 20 4 00.4 0.6 00
11 42 6 0.20.3 2 03 1 90 0 00 0
12 5 27 0 01 0 73 5 00.4 0.6 01
Don't need
9 109 7 11 2 06 6 81 2 20 2
10 99 6 12 4 45 6 51 3 30 0
11 13 1511 2 13 2 118 11 31 7 25
12 7 105 1 32 4 86 4 0.64 1 22
Conditional benefit, Don't Know
9 10 1010 7 512 6 1112 14 64 11 75
10 9 1113 8 1112 6 1322 17 1213 10 118
11 1312 8 76 9 1015 26 118 7 710 6
12 612 8 57 6 26 17 129 10 37 3
Medical Benefit
9 8 83 9 41 2 1926 5 114 10 113
10 3 32 3 40 0 115 0.5 34 0.6 10
11 7 118 3 71.6 4 116 4 189 16 1017
12 7 11.8 2 20 2 30 2 31 0.6 11
Agriculture, Food, Increase varieties
9 13 1317 13 95 2 126 11 1810 12 1219
10 27 2 33 2 05 3 24 6 33 5
11 2 54 2 22 2 33 4 23 4 23
12 0 20.6 0 0.70.4 0 02 0 01 1 0.82
Humanity benefits, Better
9 17 1412 11 196 4 1920 11 1428 16 1028
10 4 42 5 91 2 137 4 415 3 35
11 5 85 3 113 0 105 7 520 3 23
12 2 21 0.6 30.4 0 22 1 16 3 25
Genes are the same; No Problem
9 1411 4 1031 5 1224 16 57 20 824 11
10 69 1 821 3 412 15 27 18 37 5
11 713 1 624 3 213 11 25 25 55 9
12 4 22 7 149 0 77 2 616 7 15
9 328199 335 528686 452 5095 109 421316 230 154250 104
10 325 199338 532 687451 50 95109 421 315229 153 250103
11 325 199337 530 685451 50 95109 422 315230 153 250100
12 322 199341 532 684451 50 95110 428 314229 155 250103

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).

4. Environmental safety

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 knowledge.

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. 23
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.

11. References

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 (").

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