The need for a more stringent biosafety regime

The need for a more stringent biosafety regime

There are scientific and safety reasons to be very careful about genetic engineering even as the biotech industry is pushing hard to commercialise many genetically modified organisms and products. This article highlights some of the limitations and gaps of current safety assessment of the new biotechnologies and products.

Chee Yoke Ling

GENETIC engineering is currently the largest human and ecological experiment in history.

As a new technology that has probably met with the most public debate, genetic engineering enables scientists to manipulate the genes of plants, animals and micro-organisms in ways that do not occur naturally.

What does this mean for human and animal health and safety? How does it affect biodiversity, environmental integrity, food security and food sovereignty? What are the ethical and moral limits in the pursuit of knowledge and how do we prevent knowledge-seeking from being overshadowed by the greed of commercialism?

These are some of the fundamental questions that challenge society, and those who govern and thus bear a major responsibility in making technology choices that impact on life itself.

It started with Flavr Savr tomato

Some of these questions were aired when the world’s first genetically engineered (GE) whole food came up for commercial approval in the United States. This was the Flavr Savr tomato engineered to delay softening and thus extend shelf life. The biotechnology company was Calgene.

Controversy dogged the approval process, with scientists warning of potential health hazards that had not been properly explored. There was also dissent from scientists within the US Food and Drug Administration (FDA), a fact that came to light later.
Despite the limitations of the risk assessment, the FDA in approving the tomato also decided that subsequent genetically engineered products would not require similar reviews. Worse, a voluntary consultation process replaced formal approval by the FDA. The reasoning was that since the GE tomato was as safe as the conventionally produced tomato, a general conclusion can be made for other GE foods if certain criteria were satisfied. The industry’s push to deregulate was successful.
In an illuminating first-hand account, Belinda Martineau, who was part of the scientific team that produced the Flavr Savr tomato, documents what she calls the ‘transition from a science-driven to a business-driven enterprise’. She wrote that the test case of this tomato did not support that general conclusion. ‘Calgene’s tomato should not serve as a safety standard for this new industry. No single genetically engineered product should. Safety assessment . needs to be carried out on a case-by-case basis.’

Martineau points out that the genetically engineered traits in nearly all of the approximately 40 genetically engineered crops that have entered commercial production since the Flavr Savr tomato have been produced very differently.

In the tomato, scientists shut down an endogenous plant gene using what is called an antisense technique. But for the others, ‘genes from bacteria, viruses, or other plants – and yes, even a fish . – the expression of which results in the production of proteins foreign to the host plant, have been added to essentially all these foods’.

What is not widely known is that less than two years after it entered the market in the full glare of the media, the Flavr Savr tomato forever disappeared from the supermarket shelves. It was a commercial failure, causing Calgene annual losses of tens of millions. The company was later taken over into the Monsanto stable.

The biggest impact, however, remains today – that the US does not have a comprehensive or adequate biosafety law and system, is the world’s largest commercial producer and trader of seeds and products that are not proven safe, and increasingly uses its political muscle to push genetic engineering biotechnology in developing countries.
Getting the science right

Thus, with such an ignominious start, the rest of the world has to truly get the science right when dealing with pioneering research and new technologies.
In a world where human knowledge is ever increasing yet elusive, because of the complexities of nature, of the interactions between humanity and nature and of the dynamics of those relationships over time, an exciting and promising age awaits us if we get the science right.

However, getting it wrong can mean large-scale harm, even irreversible devastation.
In the midst of current growing biosafety concerns, it is often forgotten that the first warning calls over genetic engineering came from scientists themselves. Twenty years before Calgene took its tomato to the market, a conference of scientists (with a lead role played by Paul Berg, the 1980 Nobel laureate for chemistry) called for a moratorium on the commercialisation of genetically modified organisms. The Asilomar Conference of 1975 also brought together media and government policy makers and resulted in a number of restrictions on research in this area.

Even as big business pushes ahead, there is already a shift from genetic determinism (‘we are our genes; our genes are us’) to modern genetics and the ‘fluid genome’ paradigm (‘we are much much more than genes, of which we still know little’). New knowledge exposes the assumptions that have been used, and continue to be used, to rationalise and promote genetic engineering, gene biotechnology and many emerging forms of nanotechnology.

The new genetics acknowledges that genes have a very complex ecology from which they receive layers of biological feedback over every scale of space and time. The new physics does not separate space and time. While the new genetics has yet to move strongly in that same direction and be mainstreamed, the discipline of ‘gene ecology’ is beginning to gain ground.

The new genetics is holistic genetics. This says that changes in ecological conditions can affect an organism, including its genes and genome. Conversely, a foreign gene introduced into an organism through genetic engineering may have influences that propagate outwards to affect the ecosystem. At the same time, a stable, balanced and healthy ecosystem is also essential for the health of genes and genomes.

There are also safety concerns over the genetic engineering process itself, which greatly enhances the scope and probability of horizontal gene transfer and recombination. This is the main way to the creation of viruses and bacteria that cause diseases. Destabilising genes and genomes through genetic engineering can thus be hazardous.
Horizontal gene transfer is a non-sexual transmission of genetic information within or between species. The phenomenon does occur in nature, but our knowledge concerning ecological processes promoting such events and maintaining barriers prohibiting them is scanty. Thus there are scientists who are very concerned that genetic engineering is increasing the incidence of horizontal gene transfer and facilitating such transfers in ways that would not occur naturally. Within the past 15 years, geneticists have discovered that the genetic material – DNA or RNA – not only persists long after the organism is killed, but is capable of being taken up and incorporated into unrelated organisms. This possibility of horizontal gene transfer opens up the potential for recombination that creates new viruses and perhaps new diseases.

Therefore when we are told that genetic engineering biotechnology is ‘precise’ and that specific traits are being created such as herbicide resistance, in reality there is much more going on in the manipulated organism and in the bodies of consuming animals and people than understood or even thoroughly studied by the developers.

Biosafety science is finally trying to catch up but so far the funds for research in this field are minuscule compared to the resources thrown at genetic engineering. At the same time, industry is aggressive in its promotion and many developing-country governments are pulled by the promises and hype of a new source of wealth.


From genetically engineered crops and pharmaceutical drugs to gene therapy, the hazards are often not known, though scientists have identified potential harm, especially in relation to human health. However, where something may cause irreversible harm, it is right and proper for society, and scientists in particular, to seek evidence that it is safe beyond reasonable doubt. Hence biosafety scientists call for the application of the precautionary principle or approach. This generally implies that in the absence of scientific certainty or scientific consensus, we should refrain from taking actions that may lead to irreversible harm.

The Cartagena Protocol on Biosafety, the first international law regulating global movements of genetically engineered organisms, incorporates this approach in its decision-making provisions. Thus, Article 10 (6) says:
‘Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism [the term used in the Protocol] on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate… in order to avoid or minimise such potential adverse effects’.

This is crucial as the burden to prove lack of safety is not on those concerned with safety; rather, those who claim that a genetically modified organism is safe have the duty to establish that assertion.
It is then up to national law to further spell out the use of the precaution.

Unfortunately the quest to ensure safety is often faced with obstacles of denial, and even repression, of knowledge of potential and actual hazards. If we do not seek to ask the necessary questions, if science is not allowed to play its role with integrity and responsibility, then genetic engineering will lead to considerable ecological harm and human suffering. At the same time, precious resources needed to support all our societies, especially those in the developing and vulnerable parts of the world, will be wasted.

To ensure biosafety, we need to develop science policies that appreciate the centrality of nature, and connect science with society. Identifying gaps in knowledge, supporting research in holistic sciences and putting the precautionary principle into practice are among the key challenges before us.

Many unanswered questions

The manipulation of genes in a wide range of organisms, from microorganisms to plants, trees and animals, raises many questions. These include the viability of the genetically engineered organism itself, ecological and health issues, and social and economic issues.

There is already modification of a number of the world’s major food crops. Soya, maize and canola have been modified for herbicide and pest resistance, and constitute the bulk of commercially grown and traded genetically engineered organisms and products.

Thus far, there has been no commercial approval of genetically engineered wheat in any country because of growing awareness of biosafety, increasing consumer preference for non-GE food, as well as fears of field and trade chain contamination that may adversely affect the wheat market.

Research and field trials on GE rice are taking place in some countries but again there is great caution and even resistance against commercialisation such as in the US, on the basis of insufficient scientific certainty on the environmental and health impacts as well as consumer rejection.

The impact on rice biodiversity is also a major concern for many Asian countries since the region is the centre of origin and diversity of rice. Associated with rice is the region’s rich cultural diversity. Thus the recent revelations by Greenpeace that China’s rice fields in Hubei have been contaminated by GE rice and that samples from retailers have tested positive for the unapproved variety, have created shockwaves.

Bt cotton, the other commercialised GE crop, has become controversial with reports of inconsistent yields, even crop failures, and a host of socio-economic problems in China, India, Indonesia and South Africa.

While there has been public attention on some of the major crops (including crops engineered for pharmaceutical production), there is far less awareness on other GE plants (including ornamental plants and flowers), trees, animals, fish and micro-organisms.

There is considerable research on and field testing of many genetically modified organisms (GMOs) that is taking place without public knowledge, and often, without the knowledge of all relevant parts of a national government. Thus very few countries, especially developing countries, have had the opportunity to consider and weigh all aspects of gene technology and GMOs. This is urgently needed if the appropriate policies on science and technology, agriculture, forest management, biodiversity conservation and health are to be in place under the rubric of sustainable development.

Agriculture under siege

Food safety, food security and food sovereignty are the goals of sustainable agriculture in most societies. For agriculture to be sustainable there must be conservation of agricultural and wild biodiversity, soil and water management that minimises external inputs, and technologies and practices that respect the laws of nature in all its complexities.

The measurement of productivity is then also holistic, taking into account specific food crop yields, multiple crops as opposed to monocultures, nutrition from wild biodiversity (including fisheries) and the ecological capital of soil, water and seeds. Maintaining a healthy ecosystem and environment is also essential to ensure long-term sustainable productivity.

Beyond having enough food for its people, there is a need for a society to have control over its food production and supply. In many countries today, the transnational corporate web is increasing its control over agriculture at the cost of food sovereignty.
Gene technology in agriculture is used to introduce various traits into a range of food crops, especially the world’s staple food crops. Crops engineered for herbicide tolerance and pest resistance are the most known, commercialised GE organisms. Criticisms have been made that the needs of developing countries are not served by current GE crop plants. Moreover, there are flaws in adopting such a reductionist approach which focuses on specific traits in agriculture, when evidence points to holistic approaches to agriculture and sound ecosystem management as the way forward for sustainable agriculture.

Biosafety concerns over agricultural biotechnology include genetic instability, horizontal gene transfer, the emergence of volunteers and weeds (including ‘superweeds’), impact on non-target species, pest resistance and contamination of traditional or conventional varieties by GE plants.
These hazards can impact negatively on biodiversity and the environment. Human and animal health impacts of concern include toxic and allergenic effects, as well as probable new diseases.
Thus it is important and necessary to have a moratorium on commercial and other environmental releases (see box) pending a fuller understanding of the consequences of the genetic engineering techniques and processes that are used in manipulating traits in agriculture.

Medical uses – less awareness

While there is growing knowledge among policy makers, regulators and the public on genetic engineering in agriculture, awareness is still lacking in the fields of pharmaceuticals and medical treatments such as gene therapy and xenotransplantation.

The use of GMOs in the production of pharmaceutical products such as insulin and hepatitis vaccines raises issues related to production process, containment to prevent contact with the environment, animals and human population, and possible human health effects.

The development and imminent commercialisation of live GE vaccines is taking place with very little public knowledge and even less regulatory scrutiny. These require specific biosafety assessment and cannot be treated in the same manner as conventional vaccines. They are GMOs and each vaccination is actually a ‘release’ with all its environmental and health implications. A human and animal health risk that has been identified by some scientists is the creation of new viruses which are potentially infectious.

Meanwhile, live GE vaccines are already being tested in livestock. These vaccines raise the same issues and concerns.


Rapid developments in biotechnology, genetics and genomics already pose a variety of environmental, ethical, political and social questions. There are now increased biological warfare risks posed by the use of new and emerging technologies to create new types of biological and bio-chemical weapons. These include micro-organisms that degrade material.
There is a need for more public knowledge and understanding of the scientific research being done, the actual development of these biological weapons as well as the type of government actions required to address risks in national biosafety laws and international rules.

Meanwhile, the expanded programme on ‘biodefence’ in the US which involves a great deal of research in producing disease-causing micro-organisms is alarming. There are moves by some scientists and their supporting governments to open up research on, including genetic engineering of, the smallpox virus and its parts. This issue will be taken up by governments at the World Health Assembly in May – the World Health Organisation (WHO) has succeeded in eradicating smallpox but is facing refusal by the US and Russia to destroy the remaining smallpox virus stocks in their custody.

What lies ahead?

Evidence of health and environmental risks and hazards is emerging. The socio-economic dimension of genetic engineering biotechnology is slated for international discussion. A global liability system is to be fought out among governments to deal with harm from these new biotechnologies.

These and more will be on the table for the second Meeting of the Parties to the Cartagena Protocol on Biosafety that will take place from 30 May to 3 June in Montreal, Canada. One hundred and nineteen countries are Parties with legal obligations to ensure biosafety under this United Nations treaty. The big players – the US, Canada, Australia, Argentina – are not Parties but will be there to influence the negotiations, as the UN democratically allows all Member States to have a say.

The hope is that the developing countries, and Europe (where the public, many scientists and some national and regional governments have opted for precaution and even zones and countries free of genetically engineered crops) will do the right and proper thing.

Chee Yoke Ling coordinates the Third World Network’s environment programme.


Contained use versus release to the environment

FOR biosafety purposes, it is customary to distinguish between contained uses of genetically engineered organisms and their releases to the environment. Contained uses occur inside a physical facility designed to prevent escape into the open environment. It can be controlled in principle, and made as safe as possible, though the current laws on contained use are far from adequate, and in most developing countries there are no laws at all.

Releases of genetically engineered organisms to the environment consist of all uses that occur outside a physical facility. Apart from commercial releases and open field trials, they should also include caged transgenic organisms placed in open water, gene therapy and vaccinations and transgenic wastes disposed into the environment. All of these are capable of spreading transgenic DNA by horizontal gene transfer. Released genetically engineered organisms and transgenic DNA cannot be controlled nor recalled, which is why great care must be taken in advance of release.

Most industrial processes involve both contained use and environmental releases. Some examples of contained uses include:
_ Genetically modified micro-organisms to produce pharmaceuticals and enzymes
_ Genetically modified livestock to produce pharmaceuticals or industrial chemicals
_ Genetically modified livestock destined for environmental release
_ Production of new vectors for manipulating and transferring genes
_ Transformation of plant tissues to create transgenic plants destined for environmental release
_ Production of new vaccines destined for environmental release
_ Research in cancer genes (oncogenes)
_ Genetically modified cell lines
_ Gene cloning, including amplifications with PCR
_ Gene therapy research
_ Transgenic laboratory animals for research such as mice, fruitflies, fish and flatworms
_ Production of transgenic micro-organisms, including pathogens, in research
_ Production of transgenic viruses, including pathogens, in research
_ Biological warfare research

Examples of environmental releases include:
_ All commercial plantings
_ All marketing of genetically engineered organisms and products made from these organisms
_ All field trials
_ All caged aquatic genetically engineered organisms (fish, shellfish, etc.) placed in open water
_ Vaccinations
_ Gene therapies
_ Escapes from contained uses
_ Waste products from contained uses (air, water and solids)

Mae-wan Ho
Director, Institute of Science in Society

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