Genetic engineering is hailed by some as a means to solve the global problems of disease and hunger, to increase plant and animal productivity to supply food for an overpopulated world. Others worry that it is another attempt at a technological fix for much harder social and economic problems — only this time the technology could open a Pandora's box of dangers far greater than the problems it is trying to "fix". PAT BREWER explores some of the issues.
Recently in Adelaide a very effective genetically engineered cholera vaccine was produced at a cost of 4 to 10 cents per shot. The research took over 20 years and was funded by Australian government grants. No drug companies are interested in developing and distributing this vaccine: the commercial returns aren't high enough.
This example illustrates many of the dilemmas involved in all science and technology. The research fits the model of benign science working to improve society and benefit the human race. Yet in reality, commercial interests dictate what is developed and, increasingly, even what is studied.
Who controls what is researched? Who owns the outcome of the research, and how will it be used? Who benefits from that outcome?
Genetic engineering adds a new dimension to these questions because its subject is the very matter of life. Today scientists can combine the genetic material from unrelated species into a "transgenic product". For example, genetic material from a flounder has been introduced into tomatoes to reduce freezing damage and improve their ability to be stored.
All living organisms are made up of individual living cells. Genes control the chemical messages
within cells that determine the form and functioning of the cell, the organism's various parts and thus the whole organism. Genes consist of four chemical building blocks arranged in pairs like the treads of a spiral staircase. Millions of different combinations of the basic chemicals determine the different genetic make-up of each kind of organism.
Scientists can isolate the genes of any living thing, examine the coding information contained and alter this by manipulating the chemical switches or adding new material from other species. If these changes take place in the germ or reproductive cells of the organism, then they may be passed on to its offspring.
Transgenic technology is quite new. It was less than 10 years ago that the first transgenic plants were created. Since then researchers have applied genetic engineering to more than 50 plant species. Plants can now be made to withstand insects, viruses and herbicides. Cotton has been developed with an internal insecticide which controls caterpillar pests. Vegetables, fruits and flowers can be made to resist spoilage. Carnations have been developed in which ageing of the bloom is slowed. There are now blue roses. Potatoes are now resistant to viruses which formerly distorted their shape, making them unsightly and hard to sell. Grains can be made more nutritious by introducing new proteins. Plants can be adapted to new environments: cotton with greater resistance to water can be grown in wetlands.
Similarly in animal genetics: faster growth can be induced genetically. Resistance to disease can be enhanced; for example, research is in progress to introduce an enzyme into sheep sweat which will kill blowfly larvae. Wool quality could be altered to reduce irritability to human skin. The protein in cows' milk can be changed to reduce human allergic reaction.
The third major area of genetic engineering concerns therapy for humans. Less than two years ago in the United Sates, doctors were allowed to treat a patient with genetically modified cells. White blood cells were removed from the patient, inserted with a functional gene to produce an essential enzyme and reinserted into the patient's body. The transformed cells produced enough of the enzyme to relieve the patient's severe immune deficiency.
Since then major drug companies have been experimenting with ways of inserting new genetic material into target cells. Modified retroviruses are used as the transmission vehicles; in case unintended results occur, "suicide" genetic information is included which ensures that the altered cells can be killed by a particular drug. Airborne viruses are being used to deliver missing protein via an aerosol to sufferers of cystic fibrosis. Trials are now under way or are awaiting approval on a variety of cancers, AIDS, liver malfunctions. Sydney scientist Elizabeth Rapley recently perfected a test which can identify women who carry a gene mutation which causes two terminal muscular wasting diseases.
At present gene therapy consists of periodic infusion of modified cells, but scientists want to move to a once-and-for-all cure. Already in the USA researchers have been given permission to modify the stem cells in bone marrow. This could result in a one-shot cure, as opposed to continuing therapy.
In the past, scientific discoveries of non-living substances have been secured for ownership through patents. The same system now applies to the products of genetic engineering. In Australia this ensures exclusive private property rights for a period of 16 years. It means that royalties must be paid for each and every use of any process or product in any manner.
Patenting makes possible worldwide corporate control of biological resources. It is open to abuse if the addition or deletion of one gene from the thousands in a plant or animal makes it into private property.
The potential profits of genetic engineering became quite clear at the Earth Summit in Brazil in June. An attempt to preserve the genetic material in the estimated 10 million species of plant and animals, the Biodiversity Convention, was torpedoed by George Bush's refusal to sign any agreement which could infringe potential US patents on genetic material.
It had been hoped that this convention would include a provision making genetic materials the resource of the originating country, rather than of commercial interests who find a way to exploit naturally occurring species. In this way, Third World countries rich in biodiversity could perhaps begin to redress their overwhelming debt problems.
The US also opposed any code of conduct for biotechnology, and particularly a system of regulation for genetic research.
The first and only animal patent was granted in the United States in 1988 on the oncomouse — a laboratory animal designed to die of human cancers within 90 days. This approval followed a decision by the US Patent and Trademark Office, designating all genetically engineered animals as non-naturally occurring products. Genetically engineered organisms are now seen in the same framework as any commodity.
Patents have also been granted on some plants and micro-organisms.
Similar criteria will be applied by the Australian Patents Office; current applications include transgenic mammals to produce chemical substances such as human growth hormone in their milk.
At present patents on humans are not possible, but the issue is not clear when dealing with parts of humans. Already an application has been lodged by Granada Biosciences of Houston, Texas, at the European, US and Australian patent offices to patent an entire human being. The Pharm Woman is described as a "composition of matter", a "transgenic mammal", engineered to "synthesise biologically active agents" in the mammary glands, secrete them into milk and to transmit the new trait through the germ line to later generations. The patent specifies both human and non-human transgenic mammals with the same features.
Biological matter can also be commercially monopolised through intellectual property rights legislation such as the Australian Plant Variety Act 1987. This act is part of an international convention recently updated to strengthen breeders' rights over plant varieties at the expense of seed merchants and users. It extends breeders' rights to harvested material and products made from this harvested material. It places restrictions on farmers saving seed from their harvest for their own future use.
In February the Australian parliament's Standing Committee on Industry, Science and Technology tabled its report into the development, use and release of genetically engineered organisms. The report, Genetic Manipulation: The Threat or the Glory? was to evaluate the existing and potential benefits of genetic engineering as well as growing public concern that new organisms created in the laboratory could spread and interact with natural species, introducing new diseases or causing ecological havoc.
The report's recommendations were the subject of a forum on genetic engineering organised by the Nature Conservation Council, the BioDiversity Protection Committee and the Australian Genethics
Network in Sydney, August 1-2. The forum presented a range of speakers — genetic scientists, government department spokespersons, legal and civil liberties representatives, animal welfare bodies, consumer organisations, environmentalists and concerned lay persons.
While the report was welcomed as a regulatory step forward, criticisms clustered around three main issues.
1. Regulation
The report supports industry's plan for a two-
tiered approach to regulation, making biotech companies answerable to an authority which supports the general thrust of genetic engineering. The existing Genetic Manipulation Advisory Committee (GMAC) would oversee laboratory work and provide specialist advice. A new body, the Genetically Modified Organisms Release Authority, would regulate field trials and commercialisation.
The minister for science and technology would preside over both of these as well as selecting the members of the release authority. The Department of Industry, Technology and Commerce is already committed to genetic engineering and significantly funds genetic research and development programs. To overcome this conflict between regulation and encouragement, the forum felt that the release authority should be located in the Commonwealth Environmental Protection Agency.
Under the report's proposals, the present voluntary guidelines on research and deliberate release would have the force of law, but operational details would be set out in regulations, made and changed at the minister's discretion without public notice or discussion.
As well, the minister, the authority and the GMAC would have a number of other discretions, including whether to hold hearings on
proposed live releases and whether to include "suicide genes" in genetically engineered organisms. Given the commitment to commercial applications of genetic engineering, these non-
accountable discretionary powers favour industry over the public interest.
2. Environment and public health
The report recommends that bio-industry be made liable for any foreseeable damage it causes, that the social impact of any release be considered, that indirect ecological effects be studied, and that sanctions for non-compliance include heavy fines and imprisonment. But these provisions are weak and subject to legal interpretation. Full liability really applies only to damage from an unapproved release.
The notion of "foreseeability" is limited. Evidently, those responsible did not foresee the consequences of introducing "exotic" species in Australia — rabbits, foxes, prickly pear.
The report recommends regulation at the end of the process, when the organism is due for release and all of the costs of research and development have already been incurred. There is no mechanism to consider the merits and dangers of the project at the planning stage. Hence there will be strong commercial pressure to allow release built in to the regulatory procedures.
Data on the Australian environment is incomplete. The performance of transgenic organisms in the laboratory and field trials cannot guarantee how they will impact in open environments.
Unplanned genetic exchanges with another species could occur. Worst-case scenarios need to be publicly evaluated, with possible solutions. For example, large resources are going into developing herbicide-tolerant crops so that chemicals can bed
use on weeds more effectively; cross-fertilisation with weeds would massively increase chemical use, not decrease it. Many genetically engineered organisms are designed to thrive. Cross-
fertilisation could spread this potential so that domestic and wild relatives would be out-competed and biodiversity reduced.
Environmental acceptability should rest on long-term ecological sustainability and biodiversity. We should learn from past mistakes with other technologies. The nuclear industry promised cheap, safe energy yet was introduced without the problem of hazardous waste management being solved. Similar premature release of chemicals has contributed to the ecological crisis we face today.
3. Public scrutiny
Organisations making decisions on the public's behalf should have the basis for their decisions completely open for scrutiny. Public education is basic to this. Both the release authority and GMAC are to be funded to provide public information and liaison, but the only other external body to be funded for educative purposes is the CSIRO — hardly a neutral, disinterested body.
The report endorses biological patents, which theoretically provide some measure of public disclosure. But the increasing complexity of patents and breeders' rights makes access to this information difficult.
In addition, the public right to know is weakened by reinforcing commercial confidentiality. The report recommends the onus of proof being put on the parties seeking access to information. The reverse should apply: commercial interests should be required to demonstrate significant disadvantage if the information is disclosed before public access is denied.
Accessible and open processes are needed for the notification, assessment and monitoring of the deliberate release of genetically modified organisms. The public must have the right to know and have a genuine, effective, role in deciding about proposals.
The report opposes selective labelling of engineered products and processes. It accepts that genetically engineered products are not different from other products and do not require distinctive labelling. But this contradicts its support for biological patents on the grounds that they introduce new or novel features into organisms.
Genetically modified foods are already on supermarket shelves in Australia. Cheese is processed here using genetically engineered rennin. The meat of 67 transgenic research pigs was sold in Adelaide without consumer knowledge.
Given the recent decision of the US government not to label genetically engineered products, transgenic foods from the US may be imported and not be identified unless new rules are imposed by the Australian Food Authority.
The right of the public to know what is involved in any product for sale isn't an abstract question: health issues, such as allergies, are involved.
The commercial impact of transgenic products is going to accelerate. Already genetically engineered plant species include alfalfa, apple, asparagus, broccoli, cabbage, carrot, cauliflower, celery, corn, cotton, cranberry, cucumber, eggplant, flax, grape, horseradish, kiwi fruit, lettuce, muskmelon, oilseed rape, papaya, pea, pepper, plum, poplar, potato, raspberry, rice, rye, soybean, spruce, strawberry, sugar beet, sugarcane, sunflower, sweet potato, tobacco, tomato, walnut and wheat.
The government is committed to this technology and
the industry it will generate, and is already acting on the recommendations of the report. The recent budget allocated $5.9 million to establish a genetic manipulation authority to regulate the release of genetically engineered organisms over four years. The rights and interests of the public need to be spelled out and guaranteed now.