Report prepared by Darryl Macer for the Subcommittee on Food, plant biotechnology and ethics, of the UNESCO International Bioethics Committee.
Comments are welcome to: Darryl Macer, Ph.D. Institute of Biological
Sciences, University of Tsukuba, Tsukuba Science City, Ibaraki 305, Japan Fax:
Int+81-298-53-6614; Email: D.macer@unescobkk.org.
Contents
1. Introduction
1.1. Food production
1.2. What is biotechnology?
2. Roles of plant biotechnology in food production
2.1. Techniques involved in plant biotechnology
2.2. Food, food additives, and medicinal products
2.3. Current status of food products made from plant genetic engineering
2.4. Foreseen benefits and uses of products of plant genetic engineering
3. Ethical concerns about plant biotechnology
3.1. Public attitudes to plant biotechnology
3.2. Intrinsic ethical concerns
3.2.1. What is natural?
3.2.2. Cross species DNA transfer
3.2.3. Does it work?
3.3. Extrinsic ethical concerns
3.3.1. Health effects
3.3.2. Environmental impact
3.3.3. Economic issues
4. Regulation of food safety and biotechnology
4.1. National regulations
4.2. International regulations on food safety
4.3. Regulations on environmental safety
5. Conclusions and the role of UNESCO
6. References
1. Introduction
1.1. Food production
Every living organism relies on consumption of energy and metabolites in order
to live. Food is defined as material that contains essential body nutrients,
such as carbohydrates, fats, proteins, vitamins, or minerals, and is ingested
and assimilated by an organism to produce energy, stimulate growth, and
maintain life. The main sources of food for animals are animals, fungi and
plants. The subject of this report is focused on food for human beings, with
passing reference to animal feeds.
Food is such an important topic that a United Nations Agency, the Food and
Agricultural Organization (FAO) was established. The role of UNESCO in the
debate on food stems firstly from the increasing reliance on scientific
technology such as biotechnology to improve the quantity and quality of food,
goals that are becoming more urgent in the population crisis. Culture is
intertwined with food, a connection recognized by anthropologists
(Levi-Strauss, 1964), additionally, education about healthy food consumption
has recently been promoted as part of preventive medicine, and thus all aspects
of UNESCO are related to food.
We are told that "we are what we eat", an old saying that is a
half-truth linking food safety to human bioethics. Chemically our body is made
from the food and water we consume, and these chemicals flow through the body
throughout our life. The consumption of food is therefore of great importance
for human health. Technical aspects are reviewed in section 2.
In many countries of the world, food production is delicately balanced with
losses due to plant disease and every year increments in production are
necessary to avoid food shortages. Delivery of food and economic policies are
also issues affected by biotechnology. There are many countries where food
supply is not guarantied, and biotechnology is necessary to stimulate
production and reduce losses due to disease (Petrov, 1996). We could vision the
losses caused to production by disease, pests and climatic extremes to mean
that about one quarter of the land in cultivation is non-productive, or wasted.
Once the food supply is guaranteed, the consumer tends to concentrate more on
the particular individual tastes and preferences, and food quality and food
choice are goals that developed economies seek, and are also important for food
exporting nations.
1.2. What is biotechnology?
The word "biotechnology" simply means using living organisms, or
parts of them, to provide goods or services. The word can apply to agriculture
in the past thousands of years, but is often used to apply to new techniques
(Macer, 1994a). We should not forget that 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. The subcommittee member country reports including countries
from Argentina, Colombia, Russia and Spain, and reports from Japan (Harada,
1996), provide background on the situations in each country.
Foodstuffs made from plants bred using genetic engineering are already being
sold in parts of the world. They will generally be no different to the foods we
already eat, but there are various advantages which are outlined in section
2.4. The range of concerns are assessed in section 3, and the roles of
regulation described in section 4.
For the purpose of this report a genetically modified organism (GMO) is defined
as an organism that has had its DNA modified, by genetic engineering. A legal definition
is not intended, and the word transgenic is also commonly used. Some consider
that an organism with DNA deleted is not a GMO for the purpose of regulations,
however, we maintain a broad definition for discussion of the bioethical
implications.
An important part of bioethics is risk assessment, the analysis and prediction
of risks. Risk assessment is the use of scientific data to estimate the effects
of exposure to hazardous materials or conditions. Risk management is a
different activity. It is the process of weighing alternatives to select the
most appropriate regulatory strategy or action. It integrates the results of
risk assessment of different alternatives. When examining proposals for release
of GMOs on an experimental level, risk assessment is needed. The first part of
risk assessment is risk identification, after which comes risk estimation (OTA
1988). Only after the results are known can the wider release of the GMO be
considered against other alternatives, the process of risk management. Benefits
are part of risk management, whereas they are not part of risk assessment.
Bioethics combines risk assessment, the concept of avoiding harm, with an
assessment of benefits, the concept of doing good or beneficence. It is
important to ask whether there are any new risks compared to traditional plant
breeding. There are various risks of genetic engineering, for example the risk
of unintentionally changing the genes of an organism, the risk of harming that
organism, the risk of changing the ecosystem in which it was involved, and the
risk of harming the ecosystem, and the risk of change, or harm, to any other
organism of that species or others, including human beings (who may even be the
target of change). The concept of risk in biotechnology involves both the
potential to change something and the potential to harm. The extent to which a
change is judged to be a subjective harm depends on human values, whether
nature should be "intransient" or modified. This relates to the fears
that technology is unnatural. These issues will be addressed by this report.
2. Roles of plant biotechnology in food production
2.1. Techniques involved in plant biotechnology
This report focuses on plant biotechnology, but the general principles are also
applicable to animal biotechnology. There are additional ethical concerns of
using animals because of their varying capacity to feel pain, sentience, and
self awareness, which are discussed in Macer (1994). There may also be some
additional food safety concerns to humans of using animal genes and hormones,
since we are also an animal. These are discussed by Horsch (1992), Basu et al.
(1993), Berkowitz (1993), Mepham (1994).
A number of plants have been modified by genetic engineering and some of these
have been commercialized (Demarly 1992; Horsch 1993: Smith 1994). There are a
number of concerns about patenting of plant varieties and techniques to produce
them (OTA, 1989), which are discussed later.
For millennium plants and animals have been selectively bred to develop
varieties that are more productive, or suitable for human use. Our modern
varieties originated from gene transfers within crop species, by selective
breeding. There are, however, some major exceptions. For example, about 5,000
years ago wheat was created, when the three genomes of Triticum monococcum,
Triticum tauschii, and a species of Aegilops came to be combined. The
definition of a species rests on the concept of genetic isolation but sexual
exchange of genes between species can and does occur in nature without human
intervention.
Often, the crop species does not contain sufficient genetic diversity to allow
the desired improvements, hence the search for diversity has led plant breeders
to use new genetic technology. The aim is to arrive at a breeding population
consistently expressing the desired trait(s). One of the main weaknesses of
conventional plant breeding is its dependency upon sexual crosses and thus to
genes that exist only in one species. Recombinant DNA technology allows the
transcendence of inter-species barriers and makes very novel genetic
combinations possible. The first transgenic plants were created in 1983.
One of the most popular methods of gene transfer is the use of the soil
bacterium Agrobacterium tumefaciens, which can transfer genes to many plants at
wound sites. However, it works mainly on the dicotyledonous plants which
excludes many crop plants, such as cereals. Direct DNA transfer can be used to
transfer genes to protoplasts (cells which lack a cell wall) from which plants
can be regenerated. About 150 species of plants have already been regenerated
from protoplasts, so the potential application of the technique is already very
large.
Among the techniques for gene transfer another common one is
"biolistics", the use of particle guns to shoot DNA into cells. Some
techniques use tungsten particles, or gold beads. There may also be advantages
of up to a 40% reduction in time for crop production via some biolistic based
approaches over using Agrobacterium. Microinjection also has potential.
The method of gene transfer alters the risks, for example homologous
recombination inserts DNA at the corresponding site of the replaced DNA
sequence in the genome, whereas nonhomologous recombination does not. In the
latter case there is less certainty about where the gene is inserted and
whether it may have disrupted a regulatory or gene sequence in the genome (Day,
1996). Whereas the former case would generally be considered more stable and
improbable to have unknown consequences. It is increasingly becoming possible
to use homologous recombination, which is the prefered option.
Gene transfer technology has advanced at a far faster pace than our
understanding of plant biotechnology and the factors which are important within
the plant in determining other useful agronomic traits. Because of this,
attention has been focused largely on characters which might be determined by
single genes. In order to provide more basic knowledge, some plants are
included as model genome project. The Arabidopsis genome project is expected to
be the first to be completed. Complete yeast artificial chromosome (YAC)
libraries have been made, and a physical map. The complete sequence is expected
at a similar time to that of the human genome. Arabidopsis is a small sized
rapidly reproducing plant which is suited to laboratory studies. It is closely
related to Brassica family of vegetables, so for example, Arabidopsis genes can
be used directly in rapeseed without a need for recloning the Arabidopsis gene
(Murphy 1996).
2.2. Food, food additives, and medicinal products
There are a range of nonbiotechnological techniques which are being used to
alter food products, including engineered foods, aseptic processing, extrusion,
hydroponics, intermediate moisture foods, microencapsulation, supercritical
fluids extraction and ingredient technology (Smith, 1993). Ingredient
technology includes fat substitutes, which could include fat products that are
made from genetically engineered plants. However, the novel foods which have
drawn the most debate are those made using biotechnology.
Sweeteners are one group of food additives. The thaumatins are a class of
intensely sweet proteins isolated from the fruit of the tropical plant
Thaumatococcus danielli. Thaumatin is approved for use in many countries and
has application as both a flavor enhancer and a high-intensity sweetener. The
gene encoding thaumatin has been introduced into plants (potatoes) and
microorganisms under transcriptional control of heterologous gene promoters
(Zemanek & Wasserman 1995). Yields to date have been low, but commercially
viable levels are expected. The thaumatin gene can also be engineered directly
into selected fruit and vegetable crops to improve their flavor and sweetness.
Another group of products that are made from genetically modified organisms
(GMOs) are food additives, such as amino acid supplements. In 1990 a case of
impure batches of an amino acid L-tryptophan were associated with many cases of
a disease, eosiniophilia-myalgia syndrome, which led to 38 deaths and 1511
total reports of the disease in the USA. The L-tryptophan preparation was
produced by Showa Denko , and the cause was insufficient filtering of the
preparation, so that one substance was left in the preparation that later was
converted to a toxic substance. The FDA said the disease was caused by a toxic
compound EBT formed when acetaldehyde reacted with L-tryptophan, and it could
have been removed by a simple charcoal filter. There were also other possible
contaminants (Belongia, 1990). The reason for its inclusion in those batches
may be because of the reduced purification procedures used in those batches,
but it may also be connected to the different bacterial strain (which was
genetically modified) used in production. Following that, the FDA regulated the
sales of L-tryptophan as a drug, requiring more testing. Not all food additives
may need to pass the extra safety tests, but this case must be considered when
regulating food additive safety.
Vitamins and food supplements and traditional medicinal foods are often
unregulated. Health foods include high fibre, reduced fat, reduced energy,
reduced caffeine, sodium and alcohol, low cholesterol, and calcium fortified
foods. These components can also be sold as food supplements. Just in the USA
the health food market is worth US$100 billion annually.
The boundaries between foods and medicines may be made more cloudy with the
introduction of edible vaccines. Vaccines can be genetically expressed in
plants, such as banana or potato, and these may allow low cost distribution of
these "medicinal foods" (Prakash, 1996).
2.3. Current status of food products made from genetic engineering
Calgene released its Flavr Savr tomato into US supermarkets in 1994, labeled as
a MacGregor tomato. By 1996 the sales were reported to be mildly successful as
far as public acceptance, however the tomato was not so disease resistant as
hoped and there were picking, packaging and transport problems (Rothenburg
& Macer, 1995). Further improvement is being sought before it may be a financial
success. Other companies, like Zeneca in the UK, also market tomatoes, and many
are used in tomato-based foods for processing and tomato paste.
Biotechnology can provide alternative ways to solve the same problem. For
example, the insect resistance of tomatoes can be altered by insertion of
insecticidal genes in tomato, the spraying of insecticidal bacteria or viruses
on the plants, or altering the type of leaf hairs on the tomato. All are being
investigated (Wood, 1994). Tomato leaves have many miniature hairs (trichomes)
which have glands that emit aromatic chemicals that repel or poison insects.
The UK Cooperative and Wholesale Society produces a vegetarian cheese based on
a recombinant chymosin, which has been labeled. Fermentation is a major use of
genes and enzymes, and includes alcoholic beverages and dairy products in daily
consumption, for example.
Genetic engineering can be used to increase, decrease, or add specific
compounds to the edible parts of transgenic crop plants. Companies like Calgene
have engineered the chemical composition of canola vegetable oils (Knauf &
Facciotti, 1995). The transgenic canola produce seed with oils a) that are
modified in average fatty acid carbon chain length, b) that are modified in
content of saturated fatty acids (both lower and higher), or c) that contain
structured lipids. This can also be applied to peanuts or soybeans for example.
A healthier oil content could have more medium chain triglycerides or fatty
acids from fish. There is research by different groups on changing the amino
acid composition of proteins in basic grains.
2.4. Foreseen benefits and uses of products of plant genetic engineering
The greatest need for food production in the world is that the food is made in
sufficient quantity, quality, and sustainably given that the permanent need for
food for a world population that may be double the current one in size, and of
considerably higher average living standards. The issue of food production has
been discussed in a number of conferences (Wahlqvist et al. 1994). The targets
of genetic engineering not only involve insects or deletion of single genes,
but manipulation of metabolism (Herbers & Sonnewald, 1996).
The benefits that are hoped from genetic engineering include:
2.4.1. Increase productivity of crops, growth rates and ratio of utilisable
plant product
The first goal of any farmer is to increase productivity of crops, which can be
accomplished by improvement of the growth rate. An alternative way is to alter
the ratio of the product of the plant which can be used, something seen in the
green revolution with the increased proportion of the seed that was made in
rice plants (Sasson, 1988). Many of the following examples also indirectly
increase productivity.
Increasing the productivity of plants makes better use of the land that they
are grown in. Currently at least one quarter of arable land used each year is
made effectively non-productive because of losses caused by disease, pests and
environmental extremes. We could see enhanced resistance to these factors as a
way to decrease the lost farm land in the world, which is another way to
increase productivity.
2.4.2. Increase quality of crops, including nutritional quality and storage
properties
Future work on altering the nutritional content could include altering specific
vitamin contents such as Vitamin A or E, and the type and content of fiber may
eventually be manipulated (Knauf & Facciotti, 1995). Sulfur-containing
amino acids have been added to maize to increase the protein quality. Caffeine
or phytic acid might be eliminated in the source plant, eliminating current
processing steps that add cost and that lessen flavor and nutrition. Fat
components are being modified for healthier diets.
There are also efforts to remove current food contaminants and toxins.
Aflatoxins are mycotoxins produced by species of Aspergillus flavus group. They
show a high toxicity against humans and animals. Different methods to control
the aflatoxin contamination include inhibiting the biosynthetic and secretory
process responsible for aflatoxin contamination; using biocompetitive agents
that replace aflatoxigenic strains with non aflatoxigenic strains in the field;
and using genetic engineering techniques to incorporate antifungal genes into
specific plant species (Sanchis 1993).
The composition of many cereals and crops is not actually optimum for some of
the purposes they are used. Research on improving the composition for specific
uses, and types of cooking has been underway. Genetic engineering allows levels
of each component to be adjusted, which should improve the diversity of
varieties available for food processing, for example wheat optimised for either
bread or pasta making.
The so-called tasty tomato, Flavr Savr (Flavour Savour) was approved for sale in
the USA in 1994. The FDA doesn't need to examine food products, but Calgene
sought their advise for public acceptance. Calgene says the tomato will stay
fresh about a week longer, and used the name MacGregor. Other countries will no
doubt want to use the tomato, especially those with difficulties in transport
of fresh vegetables, and has public approval as seen in many countries (Macer,
1994).
2.4.3. Adaptation of plants to specific environmental conditions
This includes the better adaptation of crop plants to the changing
environmental conditions, including climate change, increased UV radiation,
changed rainfall patterns. Plants may be able to be more resistant to drought,
flooding, salinity or sensitivity to heavy metals, so that they can be grown in
areas of the earth currently beyond the tolerance range of species, or even
those areas unable to be used for agriculture at all. About 30% of the world's
land area has major plant stress conditions, including insufficient soil
nutrients or water, or toxic excesses of minerals and salts.
To exploit other environments, tolerance to low temperature is also important.
The antifreeze gene from an arctic fish has been transferred to soybean, with
the goal of creating plants tolerant to low temperature. There is research by a
number of groups on the development of aluminum resistance in plants. Aluminum
toxicity is a problem in low pH soils, where it may reduce plant growth. By
making plants tolerant, they will grow better in such soils.
Pine trees are being made more drought resistant and suited to warmer weather,
because of the expected climatic changes due to global warming expected in
North America in 30 or 40 years when the trees mature. Due to the long
reproductive cycle, and the need to wait 20-30 years before mature traits can
be evaluated, we are now using only the second and third generations of
genetically improved trees. The long juvenile periods, large size and high
natural heterozygosity limit the application of conventional breeding
techniques, so genetic engineering is more applicable to tree improvement than
to herbaceous agronomic crops. The traits that will be targeted include
climatic adaptation, fusiform rust resistance and herbicide resistance to allow
better plantation establishment. There are other long term targets such as
nitrogen fixation, lignin biosynthesis, cellulose biosynthesis, photosynthetic
efficiency, cytoplasmic male sterility, and apical dominance.
2.4.4. Broaden plants tolerance to stress
Not only may the ability to survive in specific environmental conditions be
improved, but also the range of stress conditions that can be tolerated could
be improved. This includes for example, tolerance to heavy metals, pollution,
fluctuations between wet and dry, and cold and hot climate, especially for
longer lived plants.
2.4.5. Increase disease and pest resistance
The main focus of most biotechnology programs is to produce new cultivars with
improved pest and disease resistance to promote more environmentally acceptable
alternatives for food production. Natural disease resistance is complicated.
Plant breeders have long sought to increase the disease resistance of crops
through selection of resistant varieties and by hybridizing crops with wild
relatives. About one third of total crop losses are directly attributable to
plant disease. Molecular techniques, such as insertion of antiviral or
antibacterial genes from other species into plants, and cellular methods to
allow rapid screening for the desired phenotype, have led to more rapid progress.
Viruses cause serious diseases in many crops. The genetic basis of viral
resistance in plants is narrow, so resistance breaking strains of virus
frequently appear. Isolating the plant's own resistance genes to combat disease
is not practical until they have been isolated. The function of such genes
depends on complex factors, such as the right genomic background. However, they
could be used as good starting materials for protein engineering. Good viral
disease control has been obtained using three different approaches:
* cross protection occurs when plants are deliberately inoculated with a mild
strain of virus. Coat protein genes of several viruses have been inserted into
transgenic plants to provide protection.
* insertion of Satellite viruses (which are unable to replicate themselves)
into the plants' genome to provide protection.
* antisense RNA; the translation of a specific mRNA can be inhibited if the
plant contains a complementary antisense RNA, which will form a double-stranded
RNA molecule with part of the messenger mRNA, preventing translation of the
protein, and thus protecting the plant.
Plants expressing the insecticidal protein of a bacterium, Bacillus
thuringiensis (Bt) are pest resistant. Insect pests will die if they eat the
plants. The Bt insecticidal protein, or delta-endotoxin, gene has been
expressed in many plants as an effective insecticide. On the safety of it
(Goldberg & Tjaden, 1990). Larvae of moths and butterflies can be
selectively killed by different insecticidal proteins. The control of
caterpillar pests with plants expressing this insecticidal gene offers several
advantages. Control is independent of the weather, and in conditions which
would be unsuitable for spraying chemicals or bacteria, the crop is still
protected. All parts of the plant are protected, such as the roots, or new
growth previously susceptible between sprayings. The pests are affected as soon
as they begin to feed. Broad spectrum insecticides kill all insects, which
includes spiders and beetles which are useful predators. The B. thuringiensis
endotoxin kills only killing leaf-eating species. Different insecticidal
proteins have been expressed to kill larvae of Lepidoptera (moths) and
Coleoptera (beetles). There are different proteins produced by different
strains with varying specificity. Being proteins, they are biodegradable, and
can be much cheaper to develop, and to obtain environmental release approval
for use.
An alternative way to control herbivorous insect pests is by introducing the
gene for digestive protease inhibitors into the plants, so the animals cannot
digest food. The expression of these plant genes, which are thought to be a
defensive response to insect attack, can be enhanced. Wounded plants produce a
factor which induces the synthesis of protease inhibitors specific against
insect and microbial proteases. They have an effect on a wide range of insects
and are known not to be harmful to humans.
There has also been work on the development of insecticidal microorganisms to
be sprayed onto plants. The current application costs of spraying
microorganisms containing a toxin gene are similar to the costs of applying
chemicals, but with the significant environmental advantages. These need
continual application, but may not require additional regulatory approval for
human consumption, as they will need to be if they contain novel genes. Losses
to crops also occur during storage after harvest. It is possible that increased
levels of antifeedant could be added to plants to reduce such losses.
2.4.6. Lessen need for agrochemicals
Herbicide tolerant plants remain controversial although they can reduce the
consumption of agrochemicals, and allow use of environmentally friendly
herbicides. This is also because the same companies that are marketting seed are
also producing the specific herbicide, and it raises economic monopoly
concerns. There have been successful varieties of maize, soybean, sunflower and
rapeseed made. Soybeans and modified oilseed rape resistant to the herbicide
glyphosate were approved by the UK Food Advisory Committee in 1994 and 1995.
They were made by inserting a bacterial gene with reduced sensitivity to the
herbicide.
Current intensive agriculture has multiple applications of chemical fertilizers
and pesticides. Although they may need to be used in many countries to produce
food, efforts should be made to switch to crop and animal systems less
dependent upon intervention. However, companies in industrialized countries are
continuing much research on applications of biotechnology that require such
inputs because they are more profitable. Multiple application means farmers
must continually buy products from a company, and the company receives constant
income. A field of a herbicide-tolerant crop can be sprayed with the herbicide
and only the weeds die. In the development of herbicide-tolerant plants by
genetic engineering, both seed and herbicide are controlled by the same
companies (Macer, 1992). The use of these new herbicides and herbicide tolerant
crops should have environmental advantages when substituted for systems using
non-biodegradable herbicides, but there should also be attempts to use
biological pest control. There should be genetic engineering in plant breeding
to insert genes directly into openly pollinated and fertile crops, which can be
used by farmers without dependence upon seed and chemical companies (which are
often controlled by the same multinationals).
2.4.7. Production of substances in food crops
Plants can be made to express antibodies or for use as oral vaccines. Crop
plants can also be used to produce non-edible products, such as medicinal
products and proteins, fuel alcohol, transport oils, bioplastics or
biopolymers, industrial raw materials; and products for later processing as
foodstuffs, such as cooking oils, food packaging materials, sweeteners.
The genes for polymer production may be put into foodcrops, such as potato
tubers. This would also avoid using nonrenewable and energy intensive
production techniques. This research area is attracting much commercial
research, and it is already feasible to produce industrially one type of
polymer, based on polyhydroxybutyrate, as a specialty plastic. It will take
further work before bioplastics can compete financially for the commodity
plastic market.
Rapeseed has been one crop which has already a variety of modified varieties
made by genetic engineering that produce different oils (Murphy, 1996). In 1995
a lauric oil rapeseed was cultivated that makes 40% lauric acid (normally
2.4.8. Utilization of new raw materials
Traditional foods often involve consumption of only one or several parts of a
plant, for example fruits, leaves, roots, or stems. Plants grown in one culture
for roots, may be eaten for their leaves in another, such as beetroot. Some
plants may be eaten by humans in one culture, such as the plant rape in Japan,
whereas it is used for rapeseed oil production in Europe. There is existing
diversity in human diet, and biotechnology may allow consumption of further
food products.
Microbes have a long history of use in foods, and genetically engineered
enzymes are among the first products of biotechnology to be consumed. There has
been research in the production of single cell protein throughout the 20th
century, firstly through addition of brewer's yeast extracts. In the UK,
Imperial Chemical Industries manufactures an animal food Pruteen by growing
bacteria on methanol made from North Sea gas. Mycoprotein from fungi can also
be made, and efforts to use wastes from the pulp and paper industry are also
underway. Given the same amount of surface area, the energy yield from the
algae Spirulina in lakes can be tenfold over the yield of wheat, and in
countries with a food shortage these sources may become important dietary
sources of protein.
3. Ethical concerns about plant biotechnology
3.1. Public attitudes to plant biotechnology
In the USA there is a group of one to two thousand restaurants who maintain the
position that they will not serve food from genetically modified organisms
[Nature 359 (1992), 8]. In the UK the Co-op supermarket chain has released a
statement "Your right to know" which claims, they do not stock any
food containing human genetic material; no vegetables or fruits which have been
modified from a food product containing genetic material from animal sources;
and that they will label any foods with genetic material from non-related
species. There will no doubt continue to be further statements, and this is
people's right to choose.
There are various strategies being used to study public opinion scientifically.
The first type is the use of fixed response questions, to chose from set
answers. These include surveys in the USA (Office of Technology Assessment,
1987; Hoban & Kendall, 1992), Canada (Canadian Institute of Biotechnology,
1994), and the Eurobarometer in all 12 countries of the European Community
(Eurobarometer 35.1 (1991), 39.1 (1993)). Recent survey strategies look at
reasoning more than just statistics which may shed more light on the factors
which will affect policy development, and have been conducted in Europe
(Hamstra, 1991, 1992, 1993; Martin & Tait, 1992; Chadwick et al. 1996), and
New Zealand (Couchman & Fink-Jensen, 1990). In Japan there have been
several studies, including one among different groups in society, public, academics,
and high school teachers (Macer, 1992; 1994a).
There is some diversity between countries, but there is large diversity within
each country. The surveys using open questions found that some arguments that
are often used in biotechnology debates, such as eugenic fears or environmental
risk, are not the major concerns voiced by people in open questions. The more
common concerns are interference with nature or general fear of a less concrete
nature. Also the survey found that many people perceive both benefit and risk
simultaneously, they are attempting to balance these. Although some speculate
that education will ease concern, educated people show as much concern, and in
Japan biology teachers considered there was more risk from genetic engineering
than the ordinary public (Macer, 1992; 1994a, b). There is however a great need
for education about biotechnology.
Martin and Tait (1992), conducted surveys of selected groups of the UK public.
They conclude that groups with an interest in biotechnology have probably
already formed attitudes to it, which are unlikely to significantly change.
They looked at industry and environmental groups, and local communities, which
are major players in the development of policy at both national and local
levels. They also suggest that people with the least polarized attitudes are
most open to multiple information sources. Consumer research in the Netherlands
(Hamstra, 1992) conducted by SWOKA - an Institute for Consumer Research, has
involved two major studies of what people in the Netherlands think about eating
foods made through biotechnology. They found that plant food products were more
acceptable than meat products made from biotechnology.
In Australia, Hong Kong, India, Israel, Japan, New Zealand, The Philippines,
Russia, Singapore, and Thailand (Macer, 1994a) there is a positive view of
science and technology. Less than 10% in all countries saw it as doing more
harm than good. When asked about specific developments of technology, including
in vitro fertilization, computers, pesticides, nuclear power, biotechnology and
genetic engineering, both benefits and risks were cited by many respondents.
People do show the ability to balance benefits and risks of science and
technology (Macer, 1992, 1994a, b). People do not have a simplistic view of
science and technology, and can often perceive both benefits and risks. This
balancing of good and harm is necessary for bioethics, and is an indicator of
the bioethical maturity of a society.
In all surveys using the comparison (Hoban & Kendall, 1992; CIB, 1994;
Macer, 1994), plant-plant gene transfers were most acceptable, with
animal-animal less, and animal-plant or human-animal gene transfers were least
acceptable. A variety of reasons were cited, as was the case in questions about
the concerns of consuming products made from genetic engineering. The results
of a question comparing dairy products, meat, vegetables and medicines
(Couchman & Fink-Jensen, 1990; Macer, 1992a) found people have most concern
about meat. One of the main concerns was that the products would be unnatural,
but there were also a variety of other comments, such as that the health
effects were unknown, could be long term and who could guarantie the safety.
The generally higher fears about animal genetic engineering, and meat, is also
seen in Europe (Eurobarometer 39.1; Hamstra, 1991, 1992, 1993).
3.2. Intrinsic ethical concerns
A common and useful separation of ethical concerns is into intrinsic concerns
about the plant or gene itself, and extrinsic concerns because of consequences.
The later type of concern includes health and environmental concerns that can
be more readily answered by scientific research and monitoring, as well as
socio-economic concerns which are more political in nature. Public acceptance
of food depends upon intrinsic concerns and culture.
3.2.1. What is natural?
The argument of being natural is considered illogical by many, however it is
part of human culture. There is a clear mandate for some degree of interference
with nature even in human existence, as we must eat, let alone use the many
medical techniques developed. However, we all have limits.
The term "Playing God" is a term applied to situations where humans
make life or death decisions without reference to God and perhaps even the
opinions of other people, this being seen as pride or arrogance. It is not the
use of power and creativity that is wrong, but rather attributing power to our
own resources (Macer, 1990). What is wrong is not the act itself, but the
attitudes that could be involved. However, useful applications of technology
are advocated in all religious traditions as part of good stewardship of the
earth's resources.
There have been many accusations that scientists are "creating new life
forms", however, our present technology is capable only of transferring
one or two genes into a genetic background containing the order of a hundred
thousand genes. Also, nature has been changing itself constantly, and continues
to do so, especially stimulated by environmental changes and pressures. In the
case of chimeras or cell hybridization, rather than a new life form being
created, two species may be combined that were closely related. It is possible
that future techniques will allow combinations across wider differences.
The expression usefully suggests that we should be cautious in the use of
technology whose potential risks and side-effects we do not fully understand,
which are consequences discussed in the extrinsic ethical concerns below.
For some there is a feeling that we should not explore all the secrets of life,
that the mystery of life will be gone if we discover too much. However, as many
scientists will say, the more we know, the more appreciative of the workings of
life we become. Discovery itself may not be wrong, but how we use it or abuse
it raises ethical questions. The fact that we have practical requirements, such
as to feed, house and heal people of the world, are major justifications for
the pursuit of practical knowledge in any system of religion or philosophy that
places a high value on human life.
3.2.2. Cross species DNA transfer
Modern biologists generally think of species as reproductive communities or
populations. The species are limited by an arbitrary limit to variation. There
is no universal or absolute rule that all species are discretely bounded in any
generally consistent manner (OTA 1989). One species may exchange little or no
genetic material with related or adjacent species, while another may seem to be
almost promiscuous, inbreeding frequently with a neighbouring, related species.
To challenge the integrity of a species requires more than a single gene
change. Mammals like mice contain 50,000 or more genes and changing a small
number of genes will not violate species integrity. Species exist in nature as
reproductive communities, not as separate creatures.
Both cell fusion and recombinant DNA techniques allow species barriers to be
readily overcome. Cell fusion can be used when the characteristics of interest
are controlled in a complex manner by a large number of genes, so that large
portions of the genome can be combined. This technique is used on a large scale
in the commercial production of monoclonal antibodies.
The greatest public concern is over the mixing of human and animal genes.
People object to the insertion of human growth hormone genes in pigs. Since
much transgenic animal research is aimed at increased understanding of human
diseases, the insertion of human genes will be very common. Other research also
involves the insertion of human genes into animals. The reason for this is
convenience, as a large number of human genes have been cloned. The most
convenient, readily available form of a gene will be used for manipulation. It
is unlikely that animal genes will be introduced into humans as therapy at this
stage, and it is unlikely that any will be needed as the appropriate human
genes should be available. However, reflecting this public concern, the UK
government labels products that contain genes from humans, from an animal that
is the subject of religious dietary restriction, or an animal gene when in a
plant or microbe. The label says "contains copies of X gene". The
labeling of plants containing animal DNA may be important for some vegetarians.
3.2.3. Does it work?
The adoption of new technology should rely on the improvement to the provision
of products and services to a community. At the time of writing there were
doubts as to the effectiveness of insect resistant cotton which included the Bt
resistance gene. After large scale field trials of the cotton made by Monsanto,
cotton bollworms were still found to have infected some of the cotton
(MacIlwain, 1996). Different management strategies could alter field success of
transgenic crops. Ecological and scientific studies to produce better crops and
farming practices should lie at the heart of biotechnology.
3.3. Extrinsic ethical concerns
3.3.1. Health effects
There are two basic types of health effect on humans. Those which are confined
to the individual and those which could be infectious to either families or the
wider community. The first type focuses on toxic substances, pleiotropic or
allergic effects in an individual, while the later could involve the spread of
a gene transfer vector between consumers, which is improbable for plant
viruses. Some food like fruits and vegetables include intact DNA when consumed,
especially when fresh. Other food is consumed after cooking, and other only
reaches the consumers after food processing which breaks down the DNA.
Human beings consume food infected with plant viruses almost every day and it
is extremely unlikely that any plant genetic vector would transmit between
persons, if it did manage to enter the bloodstream of the consumer. With
virus-resistant plants which are made to express part of the virus protein
(analogous to human vaccination); the plant will be the same except that it
will contain this extra protein. Already we probably consume more of this virus
protein in our food, because the vegetables we eat contain plant viruses from
the natural infection of crops. There is no harm at all for humans from most
plant viruses, so virus-resistant vegetables made in this way should in general
require little testing.
On the other hand, when we attempt to improve the nutritional qualities of
vegetables, which has been achieved for potato, we will need to examine the new
variety more carefully. But, if the improvement was made by the addition of a
protein gene from soybean to potato, for example, because we already consume
soybean we would have little fear of consuming the new potato variety. We may
still want to check that the levels of substances produced in the potato were
safe however, because there are some naturally occurring toxins in vegetables
that have been selected by plant breeders to remain at a low level of
expression, and we should not consume a variety that contains a lot more of
this toxin than is in the varieties we already consume. This test could be
performed very simply by food scientists and biochemists, without the need for
extensive safety testing, unless there was something strange about the observed
composition. We should also note the future potential of genetic engineering,
to produce more nutritious and safer food than we consume now, by the breeding
of new varieties of crops excluding the naturally occurring toxins and
carcinogens that we consume everyday from our food.
The transfer of genetic material and DNA does occur in the digestive tract of
human beings, and the rate of transfer can be quantified. The most common type
of DNA transfer is among microorganisms which inhabit the digestive system. A
study of Gruzza et al (1993) studied conjugal transfer, both in vitro and in
vivo (in mice digestive tract) of DNA from Lactococcus lactis donor strains to
an Enterococcus faecalis bacterial strain isolated from human faeces. They
followed the transfer of a self-transmissible plasmid pIL205; two
non-self-transmissible but mobilizable plasmids, pIL252 and pIL253; and one
plasmid, pMS1.5B, integrated into the chromosome of L. lactis. In vivo, only
transfer of pIL205 and pIL253 occurred, but the transfer of pMS1.5B was not
detected in vitro or in vivo. Therefore it would appear that genetic elements
incorporated onto the chromosome are more stable than those remaining as
plasmids.
The pleiotropic effects include the possibility that there are toxic or
carcinogenic substances. Carcinogens have evoked much concern, typified by the
Delaney Clause of the US Federal Food, Drug, and Cosmetic Act 1958 prohibited
the addition to the human food supply of any chemical that had caused cancer in
humans or animals. Because of progress in the understanding of the mechanism of
carcinogenesis and cancer causation, and in analytical technology allowing
accurate determination of trace amounts of chemicals, the Clause is being
modified under a law in the US Congress in 1996 (Weisburger 1994). Carcinogens
will be allowed in foods if they create a "negligible risk" of
causing cancer. Risks will be assessed separately for children, who may be at
greater risk because of lower body weight.
Many documented human carcinogens are DNA reactive or genotoxic, and attention
should be on prohibition of the addition to human foods of proven genotoxins.
Such genotoxic carcinogens are those reliably positive in a battery of three
tests, the Ames test in Salmonella typhimurium, the Williams test with evidence
of DNA repair in hepatocytes, and direct documentation of DNA adduct formation
in the 32P-postlabeling technique of Randerath (Weisburger 1994).
There have been extensive safety tests conducted on some transgenic foodstuffs,
for example the Calgene Flavr Savr tomato which was given to rats and no
serious health effects were found even in large quantities; for
glyphosate-tolerant soybeans over 450 different components were studies for 20
lines of six different crops; and other studies on virus resistant squash
(OECD, 1996). These products are therefore unregulated as GMOs in the USA.
Some transgenic crops still contain antibiotic resistance genes when they are
grown. This concern lead to rejection of a maize with an inserted Bt gene that
is resistant to European corn borer, that was being marketed by Ciba-Geigy
(Coghlan, 1996). The maize includes three extra genes, including a resistance
gene to ampicillin, and only France seemed to support the introduction among
the EU countries. Technically unanimous disapproval is needed to block a
product, but it raises further questions of international versus national
regulation. Studies in mice and rats of the protein product of the marker gene for
neomycin resistance found it is safe for consumption (Fuches et al., 1993). A
general review of the issues is ACNFP (1994).
In the European Union a program FLAIR (Food Linked Agro-Industrial Research)
was conducted 1990-1993 to stimulate research in food. This included hazard
analysis and food safety. The toxicity of Bt gene protein in concentrations up
to 4000 times the maximum likely to be ingested (1kg of tomatoes per day) was
found to have no harmful effect on the growth of mice after exposure for 28 days.
This product also has a history of previous use, being licensed in various
formulations since 1962 (OTA 1988). It is available in a number of formulations
in over 400 products in the USA. There have been very few instances of harm
being noted, even though hundreds of thousands of tons of the protein have been
administered. One harmful effect observed was an association with corneal
ulcers in humans (Samples & Buettner 1983). It will be important to clarify
all possible effects before approving the consumption of transgenic plants that
contain this toxin.
People express a variety of allergies to food components, and studies show that
allergic components can be transferred by genetic engineering. Nordlee et al.
(1996) showed that 2S albumin which is the principle allergen of Brazil nuts
can be transferred to soybeans. Skin-prick tests can be used to detect
allergies, but it is not feasible on a population scale. Therefore if allergens
are associated with the traits being transferred, people should be warned of
the potential allergic reaction to the novel food. In that study, the
particular variety of soybeans that was made by Pioneer Hi-Bred would have had
to been labeled under US FDA policy, however it decided to abandon development
of this variety (Nestle, 1996).
In fact genetic engineering can alleviate allergic reactions. Shiseido is
marketing rice without globulin as a health product, a new class of food,
physiologically functional food, which is an alternative for about 70% of the
people who have allergies, (Nature 364: 180).
These concerns also apply to animal food, both because of animal welfare and
disease concerns, and because of downstream effects upon humans of consumption
of animals. Food is not the only product, for example increasing the sulfur
containing amino acids in clover for sheep food is designed to increase wool
production.
A practical problem in farming will be the segregation of similar looking seeds
that produce different varieties of the same plant designed for different uses.
For example, some rapeseed with altered oil composition are suited for food
oils and others are not. Crushing mills will have to distinguish the different
types also.
3.3.2. Environmental impact
The major concerns are ecological and have been the subject of a number of
studies and reports (OTA, 1988; Tiedje et al. 1989; HMG, 1991). The issue has,
and continues to need to be, addressed by scientific studies.
In Europe a BRIDGE program study in 5 countries including industry and academic
researchers developed materials to allow better monitoring of environmental
safety (Rudelsheim et al. 1994). They found greenhouse tests were useful
predictors of environmental behaviour, but could not predict everything. They
found the relative weediness or fitness was not significantly different from
the corresponding non-modified plants. Of specific plants, they found potato
did not transfer genes to weedy relative species, but sugarbeet could transfer
genes to wild beet species. Oilseed rape did transfer genes to Brassica rapa,
but special circumstances were required for transfer to three other weedy
species they tested. Gene transfer was later reported by this group in Alfalfa
to non-cultivated relatives. The rates of transfer decrease rapidly with
distance, however the problem is that weeds often invade the crop fields so the
distances may not be major.
Pollen transfer is the easiest method that one could imagine for transfer. The
distances for different crops are already known from experience with plant
breeding. Research in the USA on genetically modified cotton shows that pollen
movement decreases rapidly after 12 meters (Umbeck et al., 1991). Around a
central transgenic test plot of 98,800 plants with rows running north-south,
they planted 23 one-meter border rows of nontransgenic cotton to the east and
to the west, and 25 meters of non transgenic cotton border rows to the north
and to the south, each divided into two 12.5 meter long plots. The border rows
to the north and south were continuous with the transgenic rows. They took
32,187 seed samples from all border rows at bottom, middle, and top plant
position (representing seasonal variation) and used a kanamycin resistance
marker gene to test for seeds resulting from pollen movement out of the central
transgenic plot. To the east and west, gene movement at the first row was 0.057
and 0.050, and dropped rapidly to row 8, and was not detected in subsequent
rows to the east, and detected occasionally at
For soybean there is very little chance that pollen will escape from plots.
Soybeans are almost completely self pollinated, and honey bees are responsible
for the occasional cross-pollination. US Certified Seed Regulations (7 CFR
{201.67 - 201.78) recognize this cross- pollination unlikelihood in the
safeguards set up for Foundation, Registered, and Certified seed. For
Foundation seed, the most stringent category in the Certified Seed Regulations
Table 5, soybeans are permitted to be grown zero distance from the nearest
contaminating source (i.e.other soybean cultivars), as long as the distance is
adequate to prevent mechanical mixing. Soybean seed has a short time potential
for high germination and vigor, and in commercial operation, fresh soybean seed
is produced annually for each new season. However, some remaining seed from one
crop is capable of germinating the following season, and is therefore able to
cause a temporal, if not geographic, dispersal of the soybean plant. The
Certified Seed Regulations require for Foundation, Registered, and Certified
seed that at lease one year must elapse between the destruction of a stand of
soybean and a subsequent establishment of a new soybean stand. Vegetative
reproduction of soybean plants does not occur under field conditions (USDA
on-line information, 1996). This type of analysis is ethically necessary for
all GMO species before use in farms, in additional to field trials in limited
space.
By the use of traits such as male sterility, it is possible to avoid the risk
of transfer of pollen or seeds. The approach taken will depend upon the species
in question, and needs of the local community. For example, socio-economic
concerns may mean that some farmers prefer to produce seeds for their future
use rather than buying hybrid seed each year. Such decisions may not be best
left to producers if there is perceived to be serious risks.
The extensive use of monoculture in agriculture has resulted in loss of
biodiversity for crop species, not only the previously existing species growing
in the space taken over (in land, water or air). The effects may be complex,
for example insect species which rely on certain pollen or nectar may be lost
if they cannot utilise the newly appearing species. The International
Convention on Biological Diversity recognised a value in continued existance of
biodiversity. There is not evidence that genetically modified plants will make
the situation any worse than current agricultural varieties, but we would urge
that methods to presevre biodiversity in agriculture be encouraged, and
monitorring studies are done.
3.3.3. Economic issues
Agriculture has always been a major economic force of trade between countries
and biotechnology promises to continue to alter the balances of trade (Juma,
1991; OTA, 1991). Much of the new wave in biotechnology research is being
performed by private companies. These companies are being encouraged to perform
research in their countries' national interests, including the hope of more
export earnings from the sale of products and/or technology. This association
of biotechnology with business, means that the primary goal is economic profit,
rather than human or environmental benefit. This is not a new phenomenon, and
internationally the public is becoming aware of this clash of priorities. In
biotechnology we can expect benefits to humanity, but this is not the reason
for industrial investment; the human and environmental benefits will come about
as a secondary consequence.
It is important to think of the trans-frontier nature of biotechnology. There
has been a move by the G77 group of countries to make internationally binding
regulations on the use of GMOs, and regulations on import and export have been
agreed upon. However some countries also want to include handling and use of
GMOs, and a clause on compensation for human health or environmental damage,
and a clause to assess and possibly compensate for the impact of biotechnology
on traditional agriculture (Masood, 1996).
Intellectual property issues are some of the most controversial in modern
biotechnology (OTA, 1989; Lesser, 1991). Bioprospecting has been partially
controlled by the Convention on Biological Diversity, which regulates
collecting of species after 1993 in the wild. It does not regulate the use of
samples from botanical gardens that were collected before this, and also it
does not regulate the resources found in the oceans of international waters
(Tangley, 1996). It covers the country of ownership, but inside countries there
are also disputed claims to which community has rights. This new approach
contrasts with the pratice which still continues among many researchers for
free exchange of materials, and there are unresolved ethical questions about
whether one country or group can claim ownership on a species. Another approach
would be to see them as the common heritage of all species and all humanity.
There are also unresolved legal and practical implications of the ethical
issues when someone improves upon a variety that another has developed. Many
medicinal plants have been collected and selected by indigenous groups, local
farmers, and traditional medicinal healers. Modern approaches can identify the
active ingredients, and several patents have been issued to these companies.
These are being challenged, but the issue needs further ethical resolution. The
practical issues of royalty sharing also needs to be resolved.
Companies have been responsible for about 80% of the releases of GMOs in the
world (Krattiger & Rosemarin, 1994). The risks that companies take include
investment into unprofitable products, risks of environmental and/or medical
legal claims, and risks of unwelcome legal restraints. As commercial seeds and
animals are passed on to farmers the farmers will assume increasing
responsibility for sensible farming practice, which is usually in their long
term interests also, e.g. monitoring of pest resistance to insecticidal
proteins. The risks to the farmers include, crop failure, unprofitable
products, damage to their land or their health, and even possible legal claims
against them.
Each of the groups involved in the release of GMOs also has their own set of
benefits. Ideally, all may share the goal of human progress, but they also
share the benefits for their own progress. All three have economic interests,
perhaps scientists less than the other two groups if the scientists have the
luxury of financial support unlinked to research application. The general
public also shares these benefits, but may have a longer term economic and
environmental framework, and has the benefit of being consumers. Variety or
alternatives can give choice, if such a variety is available, and many people
may also welcome a variety which is lower cost. In fact, when we consider this
factor the public may also have short term economic sights, when it enters the
supermarket.
4. Regulation of
food safety and biotechnology
4.1. National regulations and guidelines
The WHO estimated in 1988 (WHO, 1988) that less then 10% of foodborne disease
is reported in countries of the European region, let alone for poorer countries
who lack those resources. In that report the food safety guidelines of 32
European countries were reviewed, and there were a number of differences. The
impact of food contamination on adverse health is not able to be fully
recognized, and one of the basic needs is methods to better detect food
contamination, and ways to allow practical regulation of food safety standards.
Even if there is a monitoring service, within each country different ministries
and levels of government may also have overlapping responsibilities.
For some substances there is broad international consensus, for example, since
the discovery of the aflatoxins in the 1960s, regulations have been established
in many countries to protect the consumer from harmful effects of mycotoxins
that may contaminate foodstuffs. At least 77 countries now have regulations for
mycotoxins, though tolerated limits vary (van Egmond & Dekker, 1995). It is
quite important to have international approaches and support because food
products are sold and transported across borders, and a ban in one country
could be circumvented if a neighbouring country approved its production.
Conversely, many food additives are accepted in foodstuffs following
demonstration that they are safe (Hallagan et al. 1995). The demonstrations of
safety rely on scientific tests, and the safety issues associated with novel
products or organisms can be addressed by essentially the same methods
independent of whether genetic engineering has been used (OECD, 1986).
Because many of the GMOs destined for food production were first grown
extensively in the USA, the decisions of the US FDA have been influential in
international policy. The US Food and Drug Administration opposed systematic
labeling of foods made from plant biotechnology in 1992. A description of FDA
procedures for approval of foods from genetic engineered organisms is Henkel
(1995). The FDA exempts food from case by case review unless there are signs
that there will be a problem, for example an allergic reaction. This has been
criticised by some, especially the decision to leave it up to industry to
decide, and also that labels may not be necessary for some products. Chicago
passed a local law requiring all foodstuffs made from genetically engineered
organisms to be labeled as such (Nature 365: 96). There is also regulation by
the United States Department of Agriculture (USDA). The USDA Food Safety and
Inspection Service (FSIS) is also responsible for ensuring that transgenic
animals intended for human consumption are wholesome, unadulterated, and
properly labeled (Basu et al. 1993).
The UK guidelines on novel foods (Jonas 1995; ACNFP 1989-1995) are implemented
through the Ministry of Agriculture, Fisheries and Food, and the Department of
Health. Voluntary guidelines have been followed since 1989. Each year a public
report is issued including the details of each submission, the arguments
discussed, data that was presented, and recommendations made. The Advisory
Committee on Novel Foods and Processes (ACNFP) actually also considers food
treated in novel ways, not only biotechnology. This is quite consistent with
the ethical concerns, because there is no reason to single out one method of
food preparation.
Product-based assessment is a theme seen in both the UK and the USA, and in
most international reports on the subject. In both countries labeling and
review is not statutory, but the choice to do so is often voluntarily made. The
UK committee does not recommend labeling if there is no viable genetic material
in the final food to be consumed, for example in oils (ACNFP, 1995).
4.2. International regulations on food safety
The Group of Advisors on Ethical Aspects of Biotechnology to the European
Commission (1995), recommended food be labeled to indicate when its composition
and characteristics have been substantially modified by genetic engineering
techniques, but said that labeling was inappropriate when changes are
insubstantial. An earlier draft directive on novel foods opposed systematic
labeling to avoid any stigma, also noting that such labels may not provide any
useful information to the public (Butler, 1995). However, pressure from
consumer groups and the recognition of consumer's right to choose, led this
group to recommend (article 2.3):
"the consumers must be provided with information which, for transparency,
should be:
* useful, adequate, and informative;
* clear, understandable, non-technical;
* honest, not misleading or confusing, and which aims to prevent fraud;
* enforceable, i.e., possible to verify."
Basically these labels apply when the product is significantly changed in
composition, nutritional value or intended use. Generally they focus on the
product rather than the process. European Union Novel Food and Novel Food
Ingredient Legislation was passed in 1996 (awaiting decision) and is expected
to provide a statutory basis for all EU countries, and food will only be sold
in one EU country if no other country objects. There are disputes over labeling
requirements, seen in 1996 with the proposals to import soybeans. Because these
beans are mixed after farming, it is difficult to know which beans are from
GMOs and which are not. There are several European Commission Directives on the
production of food additives or GMOs (93/114/EEC), on medicinal products
(93/41/EEC), and on plant protection products (91/414/EEC - and update?).
The Confederation of Food and Drink Industries (Brussels) supports labeling
only when there is a change in the food's nutritional value or the way it is
metabolized in the body. However, some companies like Zeneca and Calgene which
market tomatoes with delayed softening support the idea of labeling because
this removes suspicion from the public mind and gives choice (Butler, 1995).
Some professional associations have made statements, American Dietetic
Association (1995); or published discussion papers, American Veterinary Medical
Association (Kopchick, 1992).
The OECD (1996) has had several workshops on the subject of safety of novel
foods, and in 1994 held a workshop in Oxford, UK, which used the principle of
substantial equivalence, and concluded that the same approach could be applied
to microbes, plants and animals. Substantial equivalence suggests that existing
organisms used as food, or as a source of food, can be used as a basis for
comparison when assessing food safety (OECD, 1993). They considered three
situations:
1) There is substantial equivalence between the new food and a traditional
counterpart (e.g. virus resistant plants produced by insertion of the viral
coat protein, or herbicide tolerant plants produced by introducing a protein comparable
to one already present in a plant but tolerant to a selective herbicide);
2) There is substantial equivalence between the new food and a traditional
counterpart, except for the inserted trait (e.g. insect protected plants
produced by the insertion of the Bt gene or disease resistant plants produced
by the introduction of a new protein); and
3) There is not substantial equivalence between the new food and a traditional
counterpart (e.g. introduction of a gene or genes that encode a trait that
significantly alters the plant for use in food or feed, such as production of a
new oil or carbohydrate).
If substantial equivalence is established they considered that the novel food
be treated the same as the familiar one. If there was a new trait, then the evaluation
should be case-by-case for the product of the gene. The RNA/DNA toxicity is not
an issue, though the potential for transfer is. Some of the factors considered
important in evaluation are the source, identity, construction, effect, degree
of digestibility, allergenicity, stability of the trait, protein and any
products of its action (secondary metabolites), site of expression (tissue
specificity) and colonization potential for microorganisms (OECD 1996). In the
case that a novel food does not have substantial equivalence to a current food,
then safety testing was called for.
We may not need to apply any additional regulations to those that cover food
safety, unless novel components are introduced to the food. This was also the
recommendation of a FAO consultation group (WHO 1991). In 1988, the
International Food Biotechnology Council (IFBC 1990) was formed with the aim of
identifying the issues and assembling a set of scientific criteria to evaluate
the safety of food derived from plants and microorganisms resulting from the
applications of biotechnology. They did not consider animal foodstuffs. The
membership of the Council was comprised of approximately 30 companies, who set
up committees to look at scientific, legal/regulatory and policy/public relations
aspects. They discussed the variability of composition inherent in foods and
food ingredients, such as the nutrients and toxicants. There are several
vitamins (A & D), certain trace minerals (Fluorine, Iodine, Copper,
Selenium) and other essential nutrients that are consumed safely only within a
narrow range. Intake below that range results in deficiency or disease, and
above that range in toxicity. There are many food toxicants that are already
accepted at low levels in foods. For intentional introductions a safety factor
of 100 is commonly used. They surveyed the range of toxicants and nutrients in
traditional foods as a basis for comparison with new foods, and as the standard
for defining food that is considered safe. They also recommended that the
regulation of food from GMOs be directly patterned on the existing law.
The IFBC (1990) recommend that the following types of genetic elements be
considered acceptable for use in food:
* Uncharacterized genetic material presently consumed in food, that was
introduced from non-food species used as sources of genetic variation in
developing and improving foods using traditional methods of genetic
modification and for which documentation of safe food product is available.
* Fully characterized genetic material derived from nontoxic, nonpathogenic
microorganisms that are not intentionally consumed as food but are commonly
found in or on food and accordingly have an established record of safe use.
* Fully characterized noncoding DNA from sources that are not traditional
foods. Since noncoding DNA can not encode any protein then only the intrinsic
properties need be considered. The only concern is a quantitative one: large
quantities of nucleic acids can cause gout.
* Coding DNA from nonfood species that have already been used as sources of
genetic variation in developing and improving foods using traditional methods
of genetic modification and for which documentation of safe food product use is
available.
In conclusion a balance must be found between the right of consumers to
information and the imposition of unnecessary information which may confuse
people over what are the major facts relevant to their diet, e.g. containing
allergens, phenylalanine for sufferers of phenylketonuria, fat content, sugars,
etc. An article in the conclusion is made regarding this. Whether the
information should be in the form of a label or an information sheet, and what
should be in that information (e.g.g this product has undergone safety
assessment or this product contains X gene), are matters of debate.
4.3. Regulations on environmental safety
A review of International biosafety guidelines was prepared by the United
Nations Economic Commission of Europe (ECE, 1995). The ECE began involvement in
the collection of biosafety guidelines following the concluding document of a
1986 meeting of the Representatives of the Participating States of the
Conference on Security and Cooperation (CSCE) in Europe, held in Vienna. This
work allows exchange of information on biosafety and is already well underway.
They include submissions from 30 governments, the UN Industrial Development
Organization (UNIDO), the Commission of the European Community, and the OECD.
In July 1991 a Voluntary Code of Conduct for the release of organisms into the
environment was prepared for the informal UNIDO/UNEP/WHO/FAO working group on
safety. The OECD issued safety guidelines on genetic engineering earlier, in
1986 which have been used as a basis for regulations in many countries, not
only those of the OECD.
Countries which have passed specific laws on the regulation of genetic
engineering include Austria (1994), Denmark (1986), Finland (1995), France
(1993), Germany (1990), New Zealand (1996), Norway (1993), Russia (1996), Spain
(1994) and the UK (1989). Most other industrialized countries have Ministry
guidelines on genetic engineering. There are critics of legislation which was
aimed at the process of manufacture, not the product (Tzotzos, 1995).
A major impetus for European countries to enact laws on genetic engineering was
the European Commission Directives: 90/219/EEC of 23 April 1990 which covers
the contained use of genetically-modified microorganisms, both for research and
commercial purposes; 90/220/EEC of 23 April 1990 on experimental and
marketing-related aspects of GMOs, which covers any research and development
release of these organisms into the environment and contains a specific
environmental risk assessment for the placing of any product containing or
consisting of such organisms onto the market; 90/679/EEC of 31 December 1990
and 93/88/EEC of 29 October 1993, which provide a minimum requirement designed
to guarantee a better standard of safety and health as regards the protection
of workers from the risks of exposure to biological agents. Competent authorities
for the first two directives are appointed in all member states.
The USA regulates through government departments or agencies. The USDA has the
greatest number of applications, and has deregulated various GMOs since 1992.
Crops approved for open release (Petitions under 7 CFR Part 340 of the USDA GMO
release guidelines) include (note for some several companies have approval):
Phosphinothricin tolerant soybean; PRV resistant papaya; CMV resistant/ WMV2
resistant/ ZYMV resistant squash; Colorado potato beetle resistant potato;
Fruit ripening altered tomatoes; Sulfonylurea tolerant cotton; Male sterile/
Phosphinothricin tolerant cotton; European Corn Borer resistant corn;
Phosphinothricin tolerant corn; Lepidopteran resistant corn; Lepidopteran
resistant cotton; Coleopteran resistant potatoes; Oil profile altered rape;
Glyphosate tolerant soybean; Bromoxynil tolerant cotton; WMV2 resistant/ZYMV
resistant squash.
5. Conclusions and
the role of the UNESCO
If we were asked whether the overall affect of biotechnology on environmental
and food safety will be positive or negative, the answer given the current
technologies would be unequivocally positive. This is because biotechnological
methods already allow better monitoring of both environmental and food safety,
and we can also hope for overall benefit in production.
The goal of regulations is the promotion and protection of human health, so
that burdens on particular approaches should not be used, rather benefit/risk
evaluation of all alternatives.
There is a right for consumers to be informed about the content of the foods
made from organisms modified by genetic engineering. The information should be
available at the site of sale for consumers. Such information should include
any relevant health information, especially the possibility for allergies, and
any information that may be important for religious or specific diets, e.g.
animal gene products.
Local socio-economic conditions vary, and there may be both positive and
negative effects of plant biotechnology on different communities and countries.
There is not a consensus on whether biotechnology will favour international
trade or not, nor whether it will have net positive or negative effects on
national economies, though it should have advantages in environmental
sustainability and in food production.
Some of the specific roles of UNESCO (and/or other UN organizations) could be:
1. Promotion of research into the socio-economic implications of plant
biotechnology upon different cultures and countries, by encouraging broader
study of bioethics.
2. There is a need for an independence and credibility of information, where
people may trust the information on safety that is provided. Organizations that
promote industrial activity may be more suspect than those which are
independent of it. There could be a role specifically for UNESCO in provision
and storage of safety information.
3. There is a need for education of the public, experts, and government
officials, of the benefits and risks of biotechnology. This should include
workshops on risk assessment and biosafety, and public meetings to inform
people of biotechnology. In general we should think how to best stimulate
research and teaching in bioethics in member countries, supporting local
workshops and visits by experts.
4. Training of food scientists in use of current biotechnological methods,
including assays and toxicity tests.
5. Promotion of research into areas of plant technology thought to be
applicable to developing countries to supplement the well-funded industrial
research.
6. Specific areas of research could be promoted such as identification of
traits that influence weediness (the competitive behaviour that leads to
undesired effects on the position and impact of a plant in the environment);
identification of any problems of sizing up to commercial scale harvests from
field trials; identification of genes or genotypes that convey competitive
advantage on plants possessing them that would in turn result in the spreading
of leaked genes.
7. Supporting global data-sharing on food safety, environmental safety, and
technical methods for improving crops, some of which is already underway by the
United Nations Economic Commission of Europe (ECE, 1995), and UNIDO. However,
the compilations are not complete or up-to-date, and they do rely upon the
submissions by member states. The USDA maintains an on-line information server
which is accessible by all persons, and relays the latest information on each
application for a field permit, or safety studies. An international version of
this service would be valuable, and could be spread through the United Nations
Internet sites.
8. There is a need for research on intellectual property protection for both
traditional and new genetics. How do we distinguish inventions from discoveries.
The impact on vulnerable developing countries and groups should also be
studied.
Additionally, for the work of UNESCO IBC some issues of plant biotechnology
should be included within the scope of intention of the articles of Universal
Declaration on the Protection of the Human Genome and Human Rights (version of
6 March 1996), namely:
1. Preamble conclusions sections a,b,c,d should be made to be more general,
(whether these remain in preamble or not):
a. could change human genome to genome
b. and d are already in general language.
c. the human genome could be changed to genetics. There are already several
microbial genome sequences completely finished, some pathogenic organisms could
be genetically manipulated just as easily as the human genome - although they
are already outlawed, they could easily be included in the IBC Declaration by
this wording change.
2. The last sentence of the preamble and article 1 could be reworked as
suggested, I do not have any good suggestions to add to those discussed.
3. Page 4; section B - heading could be changed to Research on Genetics?
Then articles 4,5,6 could all be read to clearly apply to genetics in general.
Leave article 4 mention of human species as opposed to other species for which
cross species gene transfer would not be inferred.
4. Article 16, could change the human genome to genetics
5. Article 17, mention should be given to environmental implications of biology
and genetics. Question is where to put the word environmental - maybe after
human would be OK, as there are also environmental foundations of biology.
6. The section F. International Co-operation could be made a little more
specific by saying International Co-operation in Genetics?
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7. Acknowledgements
This report was prepared for the UNESCO International Bioethics Committee
Fourth Session, 1996, with aid from members of the subcommittee on food, plant
biotechnology and bioethics. In particular I thank Mark Cantley, Norio Fujiki,
Genoveva Keyeux, Se Yong Lee, Ruben Y. Lisker, Jose Maria Mato, Rem V. Petrov,
Lidia Vidal Rioja for their comments on draft versions of this report. An
electronic copy of this document can be viewed at http://eubios.info/food.html.
Further comments are welcome to: Darryl Macer, Ph.D. Institute of Biological
Sciences, University of Tsukuba, Tsukuba Science City, Ibaraki 305, Japan Fax:
Int+81-298-53-6614;
Please send comments to Email
< D.macer@unescobkk.org >.