Genetically Modified Foods-Are We Worried Yet?


Current Issues Brief 12 1998-99

Rosemary Polya
Science, Technology, Environment and Resources Group
1 June 1999

Contents

Glossary

Abbreviations

Major Issues

Introduction

Why Are Genetically Modified Foods Important?

Are We Worried?

Artificial Selection of Plants and Genetically Engineered Plants

International Agreements

SPS Agreement
Biosafety Protocol or Cartagena Protocol on Biosafety

Biosafety Concerns About Genetically Modified Foods

Antibiotic Resistance
Allergies
Biodiversity risks

Regulatory Concerns About GM Foods

Labelling
Australian GE Food Approvals

How Adequate is the Testing Process?

Who Should Devise a Communications Strategy?

Conclusion

Endnotes

Glossary

Artificially selected:

Conventional plant breeding techniques such as cross fertilisation, progeny selection and backcrossing

Biotechnology:

Using biological systems for industrial purposes

Genetic engineering:

Manipulation of genetic material to achieve changed functions in living organisms; e.g. increased production of a chemical

Genetically modified:

as above

Genetically modified food

Food produced using gene technology is a food which has been derived from an organism which has been modified by gene technology, but does not include any substance regulated as a food additive or a processing aid. (Standard A18, Food Standards Code)

Linters:

Short fibres from cottonseeds

Phytosanitary:

Plant health

Precautionary principle:

Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation (Principle 15, 1992 Rio Declaration)

Substantially equivalent:

When a genetically modified food is deemed to have the same safety status as its conventional food counterpart

Transgenic:

Where living organisms have been altered through the insertion of foreign genetic material

Abbreviations

ABARE

Australian Bureau of Agriculture and Resource Economics

ACA

Australian Consumers Association

AGEN

Australian Gene Ethics Network

ANZFA

Australia New Zealand Food Authority

ANZFSC

Australia New Zealand Food Standards Council

AQIS

Australian Quarantine Inspection Service

ARMCANZ

Agriculture and Resource Management Council of Australia and New Zealand

BA

Biotechnology Australia (Dept. of Industry, Science and Resources)

BSE

Bovine Spongiform Encephaly

Bt

Bacillus thuringiensis

CSIRO

Commonwealth Science Industry and Research Organisation

EC

European Commission

EU

European Union

FAO

United Nations, Food and Agriculture Organisation

GE

genetically engineered, genetic engineering

GM

genetically modified

GMAC

Genetic Manipulation Advisory Committee

GMO

Genetically Modified Organism

GTIU

Gene Technology Information Unit (GMAC)

LMOs

Living Modified Organisms

OECD

Organisation for Economic Cooperation and Development

OGTR

Office of the Gene Technology Regulator (Dept. of Health and Aged Care)

SPS

Sanitary Phytosanitary

UK

United Kingdom

US

United States

USDA

United States Department of Agriculture

USEPA

United States Environment Protection Agency

USFDA

United States Food and Drug Administration

WHO

World Health Organisation

WTO

World Trade Organisation

Major Issues

In Australia, the specific issue of genetically modified foods (GM) is embedded in a tangle of food related issues that is likely to be addressed in some form this year. Of immediate importance is completion and acceptance of the revision of the Food Standards Code and passage of the Australia New Zealand Food Authority Amendment Bill 1999. Fears are being expressed that the Food Standards Code will be watered down to meet competition policy principles, manufacturer, and trade imperatives rather than consumer specifications including public health and the right to know and choose. The Bill proposes to permit the Australia and New Zealand Food Authority (ANZFA) to administer what they consider to be minor issues without consulting the Australia New Zealand Food Standards Council (ANZFSC), although ANZFSC retains the right to veto such decisions.

As an addendum to these concerns, there is uncertainty about future Commonwealth government administrative arrangements. Non-industry stakeholders see the need for a food agency that has a public health and consumer focus rather than an industry one. The Office of the Gene Technology Regulator (OGTR) and Biotechnology Australia (BA) have been allocated funding in the May 1999 Budget but a national strategy for biotechnology is yet to be developed.

December 1998 decisions by Australian and New Zealand health ministers (ANZFSC), to amend Standard A18 of the Australian Food Standards Code(1) led to the insistence that 'substantially equivalent' GM foods should be labelled, as well as non-equivalent foods already stipulated in the Standard. Having asked ANZFA to provide a definition for GM food as well as a labelling amendment, ANZFSC will meet in July 1999 to consider ANZFA's drafts.

Standard A18 came into force on 13 May but the numerous GM foods already in the market place will not have been assessed in compliance with the Standard. In late March, ANZFSC gave permission for such foods to remain on sale pending assessment, providing applications were submitted by 30 April.

On the international front, World Trade Organisation (WTO) talks in November will include discussions about free trade of genetically modified products. The Biosafety Protocol (trade in living genetically modified organisms (GMOs)), has stalled. The United Nation's Codex Alimentarius meeting in May 1999 saw a rejection by Australia and others of the US led resistance to compulsory labelling of GM food in the first stage vote on the proposed international draft labelling standard for GM foods.(2)

Events in 1999 are proceeding in a climate of increased doubt about GM foods on health, environmental and regulatory grounds and concerns about trade implications. Although the selection of more successful plant varieties dates from the beginning of agriculture, genetic engineering presents a quantum shift in terms of speed of change, the prospect of organisms that will only exist because of considerable human intervention, as well as the fear of unknown and unwanted ecological disturbances.

The biotechnology industry is ahead of the development of appropriate regulatory frameworks for biotechnology products. While industry has had ample time and funds to pursue their goals, similar or appropriate matching government resources have not been applied to provide scientific support for the development of regulatory regimes.

GM food implications range from the philosophical, e.g. ethical and democratic considerations to the concrete, possible health, environmental, trade and business outcomes.

Introduction

In 1998 the genetically modified (GM) foods controversy forced revision of European Union (EU) directives on labelling of GM foods; further new regulations are expected shortly.(3) While in Australia Sanitarium has taken pains to indicate that their soy products are not GM, in the United Kingdom (UK), where the popular press has referred to GM foods as 'Frankenstein foods', supermarkets have taken even more stringent measures. GM foods sold under generic or own brand labels are being banned by some chains so as to satisfy customers wishing to be confident that they are NOT purchasing foods containing genetically engineered (GE) ingredients. This process has extended to other supermarkets in the EU. Complete traceability of genetically modified organisms (GMOs) has been called for.(4) The UK's review of their biotechnology regulatory frame work recommended the formation of two strategic commissions to take a broader, long term view, the Human Genetics Commission and the Agricultural and Environment Biotechnology Commission. The Chief Medical Officer and Chief Scientific Adviser's(5) report on human health implications of GM food has recommended greater transparency and the establishment of a GM health monitoring unit. New safeguards for cultivating GM crops have recently been issued.(6) In the US, the third largest corn processor has refused to accept GM corn that has not been approved for import by the EU (7 out of the 11 varieties).(7) Australian opposition to GM foods, by contrast, has been much weaker. Organisations such as the Australian Gene Ethics Network (AGEN) and the Australian Consumers Association (ACA) have led the protest.

This paper will provide a summary of major issues and implications on GM foods. Information sources are included to enable readers keep up to date with an issue that is still unfolding.

Increased media coverage in Australia was triggered by the December 1998 decision of the Australian and New Zealand health ministers, the Australia New Zealand Food Standards Council (ANZFSC), to amend Standard A18 of the Australian Food Standards Code. ANZFSC insisted that 'substantially equivalent' genetically modified (GM) foods should be labelled, as well as the non-equivalent foods already stipulated in the Standard. The concept 'substantial equivalence' is designed to enable the same food safety regulations that apply to conventional foods and ingredients to be applied to GM foods assessed as 'substantially equivalent'. Having asked ANZFA (Australia New Zealand Food Authority) to provide a definition for GM food, as well as labelling amendments, ANZFSC will meet in July 1999 to consider ANZFA's drafts.

Only two foods deemed to be substantially equivalent have been assessed in Australia; Monsanto's Roundup Ready soybeans and Ingard cottonseed oil. Unamended parts of Standard A18 came into force on 13 May. Most GM foods already in the market place have not been assessed in compliance with Standard A18. Although it is thought that there are hundreds of food products involved, only the GE ingredients require assessment; about 20 applications having been submitted to ANZFA so far. Foods include products containing GE ingredients such as soybeans, canola, corn and potato in foods such as sauces, bread, pasta and confectionary. Concerns arise because of the lack of regulation of such foods in the past as well as uncertainty about how many GE ingredients are in foods on sale in Australia and what those foods might be. By March ANZFA had advised companies responsible for the 56 genetically modified food commodities approved overseas about Australian requirements.(8) In late March, ANZFSC gave permission for such foods to remain on sale pending assessment; giving rise to alarm by those already uneasy about GM foods.

The GM food issue in Australia has demonstrated the nation's tardiness in creating a regulatory framework to deal with foods that have been on sale for several years, let alone futures that the applications of genetic engineering may deliver. This is despite a number of government reports on the subject.(9) Some unease goes beyond the science of genetic engineering but predominantly, concerns are about potential environmental and health implications of the genetic engineering of foodstuffs derived from plants and animals.

Underlying the immediacy of Australia's problem, that GM foods are not yet appropriately regulated, are the agendas of the biotechnology industry, the food trade generally and international trade politics. Australia's ability to regulate for its own taste is intertwined with international trade politics, in its infancy with respect to gene technology. There is also the need to examine how Australia can prosper in the age of biotechnology.

At the end of the 20th century we have the opportunity to look back, reflect and learn from the impact of scientific discoveries on human history and the natural history of the earth. There is a tendency to blame 'science' for negativities perceived to arise from new discoveries. The problem is not 'science' or 'knowledge' as such, but our inability to manage 'science' and 'knowledge' intelligently and efficiently. The challenge of the new millennium is to manage biotechnology with forethought and care.

The GM foods conundrum provides a concrete example of the intrusion of genetic engineering into our lives and alerts us to contemplate the futures that this new technology might bring. The First Australian Consensus Conference on Gene Technology in the Food Chain(10) was devoted to GM foods and demonstrated that a disparate group understood that there were deficiencies in our management of genetic engineering, while not necessarily knowing the extent of Commonwealth Government activity in this area. In part, it is not important that the science of genetic engineering is not widely understood. The main point is that Australia, is 'somewhat behind other OECD countries in establishing a legislative framework'(11) and is inadequately prepared to manage the age of biotechnology.

Only piecemeal GE management arrangements are in place. Responsibilities are not clearly delineated among the numerous Commonwealth bodies with some administrative involvement in genetic engineering. It is hoped that the creation of Biotechnology Australia(12) and Office of the Gene Technology Regulator,(13),(14) will coordinate the activities of the Department of Health and Aged Care (which includes Therapeutic Goods Administration and ANZFA), the Department of Agriculture, Forestry and Fisheries Australia (which includes the Australian Quarantine Inspection Service, the National Office of Food Safety and the National Registration Authority), Environment Australia, and the Department of Industry, Technology and Resources (which includes the secretariat of the Genetic Manipulation Advisory Committee).

Despite Australia being active in both researching and growing GE crops, the Agricultural Biotechnology Strategy,(15) a 1998 Coalition election promise, has just been allocated funds.(16) The US first regulated for biotechnology in 1986 and the EU has had regulation for almost a decade. Shortly, another Inquiry will be undertaken by the House of Representatives Standing Committee on Primary Industries and Regional Services, namely, Primary Producer Access to Gene Technology. Its focus is limited to agricultural industry needs, but the terms of reference include the need for consumer education for the benefits of gene technology along with an examination of the appropriateness of variety protection rights, administrative arrangements and legislation in relation to GMOs. The Food Regulation Review, commonly known as the Blair Report,(17) was also an industry focussed investigation; its purpose being to review the alignment of food regulation with compliance with competition principles. The Biotechnology Task Force(18) also has an industry focus. It appears that an inquiry into consumer and public health aspects of food, including GM food, is overdue. At the very least it is hoped that the proposed Primary Producer Inquiry will adequately examine the implications of GM foods. The Australia New Zealand Food Act Amendment Bill 1999 contains provisions to give ANZFA greater powers and this will also fuel unease. Proposed biotechnology legislation may ameliorate the situation.

To devote a paper such as this purely to the science of GM foods at this time would not reveal the implications that the science of GM foods carries real, feared or imagined consequences for both the history of our species and the earth's natural history. The issue of GM foods may be viewed as analogous to the global warming debate. We are being forced to rethink about how and why biotechnology is being used to produce food. What will the consequences of our actions be? Will there be irreparable harm to the earth and its inhabitants? Will there be a brave new world? Participants must move beyond their respective comfort zones and behaviours, no longer uncritically accepting what we eat, where it comes from and how it is regulated for. The goals of scientists, the biotechnology industry and food manufacturing should be a matter for national and global debate. Governments' management of administration or regulation practices originating in a low technology era when a less technologically literate citizenry questioned less have been clearly found wanting both nationally and internationally. The GM food issue is a global issue. It is necessary to identify common ground, the convergence of agriculture, food trade, science, government and voters' demands.

Why Are Genetically Modified Foods Important?

A key argument used in population debates is that the world will find it increasingly difficult to feed itself. While new high yield rice and wheat varieties of the "green revolution" produced spectacular gains for some countries, e.g. India, producing sometimes four times traditional yields, it has proved to be of limited benefit for farmers who have poor soils and are unable to afford commercial fertilisers. New methods of increasing crop yields are tantalising because developments anticipated include varieties that can cope with poor soils and low rainfall. GE plants have proved to be successful in terms of increased yields and hold the promise of further yield and food quality gains, as well as a new way of delivering vaccines and drugs. A major biotechnology industry driver has been the prospect of reduced usage of pesticides by as much as 60 per cent currently, and prospectively, 90 per cent. Examples of GE crops include:

  • 'Liberty Link' crops engineered to tolerate Liberty glufosinate herbicide
  • DuPont's cotton tolerant to a sulfonylurea herbicide
  • Rhone-Poulenc's bromoxynil herbicides for use on transgenic cotton and canola, and
  • Monsanto's 'Roundup Ready' soybeans.(19)

Some examples of current and anticipated successes are:

  • Bt corn (corn with a gene for one of the toxins produced by Bacillus thuringiensis, a bacterium traditionally used by organic farmers to kill insect pests), increased corn yield per acre by 7 per cent in 1997 in the US
  • sweet potatoes, a staple in the tropics, engineered with a higher percentage of essential amino acids thus holding the promise of providing better quality protein in countries where poor nutrition is a problem
  • the prospect of producing potatoes that protect against Escherichia coli a bacterium that is a major culprit in the foodborne disease stakes, is likely to be trialed soon, and
  • edible forms of insulin and antibodies in tobacco plants to deter tooth decay.(20)

At the end of the 20th century, in a world still beset by major nutrition and health problems, biotechnology, if used ethically, vigilantly and appropriately has enormous potential to improve the quality of life in the poorest of countries.

Are We Worried?

Genetic engineering has the potential to unleash negative human emotions about scientific developments; fear of the known and unknown, distrust, and bewilderment. The human element was not heeded until recently by those developing, regulating and applying new biotechnology techniques. Ever accelerating change creates uncertainty and frustration. Humans are remarkably adaptable, but, perceived or real threats to something as basic as conventional foodstuffs are likely to engender far more protest than the scientific developments underpinning the motor car. Consumers are refusing to eat GE foods, but on the other hand accept the physical and environmental dangers that motor cars, for example, bring because of their sheer convenience. Long-term effects of genetically engineered foods are unknown and accordingly the precautionary principle is called for under such circumstances. There are doubts that current regulatory approaches provide appropriate checks and balances. The combination of a fear of what science may produce, coupled with industry's dollar motivation, can be easily exploited in the popular press.

Lack of ready information and concealment of it, as demonstrated by the British BSE (mad cow disease) scare, have fuelled, in part, the determination of citizens in the EU to demand more stringent food regulations. The mantra of economic rationalism of recent decades carries with it the market place controller. If consumers choose to vote with their feet, as has happened in the UK, the market, the supermarkets, have to respond. Essentially we are witnessing an interesting global village phenomenon whereby the EU consumer has slowed down, albeit temporarily, the importation of a range of US GE products. On the other hand, as discussed fully later in this paper, GE nations, which include US, Canada, Australia and Argentina, have refused to accept a popular Biosafety Protocol, adequate control of international trade in genetically modified organisms. Multilateral trade talks in November will further accentuate the dichotomy between GE and non-GE nations.

Recent Australian surveys on GM foods have not produced identical findings.

  • Dr Katrine Baghurst, from a major Australian player in the development of genetically engineered crops, CSIRO, has recently undertaken an, as yet, unpublished survey of public opinion. Dr Baghurst maintains that the survey, based on 623 postal responses, revealed:
    • 47 per cent would be willing to try GM foods, 17 per cent unwilling to eat GM foods
    • 58 per cent said they knew little about gene technology and its use in the food chain
    • 81 per cent saw the need for better communication to the public about gene technology
    • 45 per cent believed scientific and technological benefits would outweigh risks, 37 per cent being unsure and 17 per cent disagreeing.(21)

  • Some findings from an Australian nationwide survey(22) by Janet Norton are:
    • GE of plants was more acceptable than GE of animals and humans
    • 76 per cent considered accidental release of GMOs would cause environmental damage
    • 56 per cent considered that eating GE foods would have long term health effects
    • 52 per cent felt that the risks of GE would outweigh benefits
    • 93 per cent supported government control of GE foods
    • a strong demand for GM food to be labelled, and
    • the more people learn about GM foods, the less they support them.(23)

  • An Australian food survey by Dangar Research Group revealed 45 per cent of those surveyed were concerned about GE food.(24)
  • In March, the Australian Museum chose Gene Technology in the Food Chain as an appropriate topic to demonstrate a method of encouraging participatory democracy at the First Australian Consensus Conference.(25) While there was an acceptance of gene technology as such, recommendations from the Conference included labelling of all GM foods, the creation of a Gene Technology Office and improved dissemination of information on food technology.
  • 89 per cent supported labelling of a GE tomato in a 1995 Department of Industry, Science and Technology survey.(26)

Artificial Selection of Plants and Genetically Engineered Plants

Confusion about the use of the terms 'artificially selected' and 'genetically engineered' has been recently resolved for the Australian Quarantine Inspection Service's (AQIS) regulatory purposes, AQIS having previously used the term 'genetically manipulated' to cover both situations.

The selection of more successful plant varieties dates from the beginning of agriculture itself. The deliberate inter-breeding of plants carrying desirable characteristics followed. Computerisation and sophisticated plant breeding techniques have progressed artificial selection and breeding of plants at an accelerated pace. All that has happened is an increase in the rate of change rather than a radical new technology. For example, the Pioneer Hi-Bred Smart Canola (oilseed rape plant), a plant that has caused some controversy in the EU, is not genetically engineered at all. It has the property of resistance to two families of herbicides through normal breeding techniques. It could pose the same type of environmental threat as GE crops.(27)

AQIS defines 'artificially selected' in their proposed interim arrangements for the importation of such plants in their recent discussion paper as follows:

Developed primarily by conventional plant breeders and involving cross fertilisation, progeny selection and backcrossing to produce varieties, cultivars and hybrids with desired agronomic traits. However, artificial selection also includes unintentional selection. An important example of unintentional artificial selection are those plants that have become progressively more resistant to herbicides due to improper use (note that these plants are often weeds).(28)

Genetically engineered plants differ from plants obtained through artificial selection because inserted genes, foreign to the particular crop, confer desired characteristics such as pesticide resistance (e.g. glyphosate tolerance of Bt cotton). Existing genes may also be cancelled or amplified. AQIS defines 'genetically manipulated plants' for administrative purposes as:

Plants developed by modern biotechnology techniques. These techniques are laboratory based molecular procedures that introduce new genes, including those from across different kingdoms (e.g. Animals, viruses), into a plant where these genes would not naturally occur. The definition of genetic manipulation using modern technology techniques includes: the insertion of genetic material produced outside a cell into a vector so as to allow the genetic material to be incorporated into the genome of a host organism to produce new combinations of heritable genetic material (e.g. Agrobacterium mediated transformation); the direct introduction, into an organism, of genetic material prepared outside it (e.g. biolistics); the fusing of two or more cells to form a cell/s with new combinations of genetic material, including protoplast, cell and embryo fusion; and mutagenesis.(29)

AQIS regulates for imported plants that are either genetically manipulated or artificially selected. Such plants already in Australia can only be acted upon if they carry pests or diseases of quarantine concern. Their role in the administration of GE crops in Australia is quite restricted. Administration of potential pest and disease problems arising because of ecological disturbances must be addressed via other agencies. The Quarantine Proclamation 1998 provides for prohibition of plants pending assessment or 'Interim Arrangements'.(30) AQIS is currently refining its procedures for both artificially selected and genetically manipulated plants, proposing to regulate for all variants of plant species that have been genetically manipulated, as well as some categories of artificially selected plants.

International Agreements

SPS Agreement

Australia has the option to reject importation of plants that pose a sanitary or phytosanitary risk under one of the World Trade Organisation's agreements, the SPS Agreement (Agreement on the Application of Sanitary and Phytosanitary Measures). This can be applied to artificially selected or genetically manipulated plants if pertinent.

Biosafety Protocol or Cartagena Protocol on Biosafety

The Biosafety Protocol, entailing agreement about the regulation of international trade and transport of live GMOs, also referred to as LMOs (living modified organisms), is a draft treaty arising from the Convention on Biological Diversity, and was intended to allow countries to give advanced informed consent before allowing living GMOs into their territories. Negotiations collapsed in early 1999 because producers of GM products, the Miami group (including Australia) opposed a package proposal from three other groups, including the EU.(31) Developing countries, including African nations, want rules that cover products made from GMOs.

Australia currently grows about 1 per cent of the world's transgenic crops compared to the US at 74 per cent).(32) More than half of the world's soybean harvest and one third of the corn harvest comes from plants engineered with genes for herbicide or disease resistance.(33) The EU has proposed strict measures for the Protocol. Although a European Commission science panel concluded in February 1998 that genetically modified maize seeds pose no health or environmental risks, this decision is being challenged within the EU. In April 1998 the EU approved shipment of GM maize from the US but Austria, Luxembourg, France, Italy and the United Kingdom have various forms of bans on GMO products. There is considerable consumer pressure in the EU to keep GE and non-GE grain separate in order to keep GE and non-GE foods separate. The Swiss have proposed to keep grains separate, allowing for 2 per cent contamination by GE grain. US grain growing interests would like grains and oilseeds destined for consumption exempted from the Protocol and failing that, the weak labelling option to be employed, 'may contain' GMOs.(34)

By aligning with GE producer countries, including the US and Canada, there is an argument expressed by ACA's Mara Bun that Australia may not be strategically positioning itself for future lucrative international trade prospects in non GE grain in markets such Europe. At the recent Consensus Conference in Canberra, she cited the recent sale by Australia to Europe of $26 million worth of canola on the basis that is was not genetically modified.(35) As yet it is unclear whether the United States can use WTO rules to force trade of their GE products if the Protocol does contain stringent provisions about grains and products. The WTO meeting in November is likely to include discussions on the GE issue. Using the lack of a trade resolution by the WTO over the EU's refusal to import hormone-treated meat from the US over the last decade as a precedent, it is quite likely that resolution of international GE trade issues will not be speedy.

Biosafety Concerns About Genetically Modified Foods

Non-industry(36) biosafety objections about foods produced from GE crops include:

  • testing: foods derived from genetic engineering do not have the advantage of conventional foods that have been used extensively (and hence tested for adverse effects) for lengthy periods
  • allergenicity and toxicity: new gene combinations hold the possibility of producing novel proteins that may be harmful to humans as well as other life forms. Genes already known to convey allergic properties may be used and cause human health problems
  • use of viral or bacterial vectors to insert genetic material: in particular, antibiotic resistance genes used as markers may have the potential for delivering antibiotic resistance, and
  • biodiversity risks: cross breeding with conventional crops and weeds, pesticide resistance and toxicity to flora and fauna, contamination by metal sequestering plants.

Antibiotic Resistance

The possibility that antibiotic resistance could be transferred to gut microbes has been expressed by AGEN in relation to the use of cottonseed oil in stock feed/margarine or other foods.(37) However, although there are heat resistant and organic solvent resistant proteins, it is unlikely that highly processed products such as oils and sugars would contain GE fragments or protein derivatives except perhaps in minimal quantities. There is accordingly a very low risk. It is likely that the EU will adopt the precautionary measure of at least labelling GE animal feeds, because there are concerns about possible risks.

It has been reported that foreign DNA can survive transiently in the gastrointestinal tract of mice and enter the blood stream.(38) The recent United States Food and Drug Administration (USFDA) Draft Guidance states that it is unlikely that antibiotic resistance genes, used as markers, could be transferred from plant genomes to gut microorganisms because there are no known mechanisms for the direct transfer of plant genomic DNA to microorganisms.(39) The Draft Guidance also maintains that foreign DNA could not survive degradation by acid in the stomach and intestines.(40) However, the Draft Guidance stresses that because antibiotics are so important clinically, care should be taken to select antibiotic resistance marker genes that are not likely to be used clinically. A recent UK House of Lords inquiry(41) into the EC's GE regulatory regime called for an end to the use of antibiotic marker genes.(42) This issue may possibly be resolved in the future with the use of different marker genes.

Allergies

Allergies to unusual proteins in transgenic plants have been identified. Lehrer and Reese report on Nordlee et al's finding that 2S albumin (an allergen) from Brazil nuts has been transferred to soybeans.(43) It is reasonably feasible, as in this case, to determine whether the allergen content of the transgenic line is altered relative to nontransgenic varieties. That is, regulatory bodies have the means to distinguish between safe and allergenic products when the allergenicity of a transferred protein is known. The food safety issue is-what happens when proteins of unknown allergenicity are transferred, because there is no definitive procedure available to determine a protein's allergenicity.(44) Lehrer and Reese state:

There is no evidence that recombinant proteins in newly developed foods are more allergenic than traditional proteins. The evidence suggests that the vast majority of these proteins will be completely safe for the consumer. The concern is that if a few transgenic foods cause serious allergic reactions, this could undermine the public's confidence in such products. It essential that proper guidelines are established and tests are developed to assure that this does not happen.(45)

It should be noted that following the USFDA Draft Guidance, the development of the GE soybean variety that caused an allergic reaction was abandoned. The USFDA's 1992 policy statement specifies that foods to which potential allergens have been added must be labelled. For example, tomatoes containing peanut protein would have to be labelled to disclose the presence of peanut protein, unless it was conclusively proved that the transgenic tomato was not allergenic to those allergic to peanuts.(46)

The long term effects of ingesting not just one, but a combination of GE proteins, is of course not known. We are not only the experiment, but also an experiment that cannot be readily evaluated. For example, unlike our ancestors who could either avoid specific plants after observing too many adverse effects, or vary cooking methods to eliminate or detoxify hazardous substances (e.g. the use of Macrozamia), most consumers of the biotechnology age have no avoidance mechanisms available to them. They have no way of detecting what unusual proteins, or combinations there of, have been ingested, let alone from which food or ingredient the food safety threat comes from. Adverse effects may emerge decades after regular or sporadic consumption. Where foods or single ingredients are imported from countries with no or lenient GE labelling regulations, it will be increasingly difficult to distinguish between foods that contain some GM components and those that don't. There could well be scenarios where international food companies may grow GE ingredients in less regulated countries, and under free trade regulations Australia may be obliged not to exclude them.

GM Soy

GM soybean varieties are major candidates for concern about human sensitivities because soy can be integrated into so many foods (in the form of vegetable oil or protein meal) or integrated with non-GE soy. Care must be taken in differentiating between health concerns about the increased use of soy due to increased phytoestrogen intake, especially with respect to infant foods,(47) and, the as yet unverified claims that GM soy may have higher levels of phytoestrogens than traditional soy.(48) A joint submission from the Pacific Institute of Resource Management (NZ) and Revolt Against Genetic Engineering (NZ) to the review of Monsanto's application for ANZFA's approval of glyphosate-tolerant soybeans questioned the analyses of phytoestrogen levels by the applicant. ANZFA's evaluation was that glyphosate-tolerant soybeans would be less susceptible to site related fluctuations of phytoestrogens because they are able to withstand applications of the herbicide.(49) Subsequently, concerns have been expressed because it is not known what long term health effects may arise from raised phytoestrogen levels after spraying by Roundup. Phytoestrogens have the capacity to mimic human sex hormones. Alarm has been expressed because it appears neither US or British authorities required Monsanto to carry out tests after spraying.(50) It appears that Australia has followed what is now seen to be less than adequate international monitoring practice.

Biodiversity risks

Major biodiversity risks include:

  • gene flow to wild relatives has now been recorded in quinona, squash, carrot, maize, sorghum, sunflower, strawberries and sugar beet. An UK study has established that bees can carry pollen four kilometres from test sites, there thus being no doubt that pollen from GM crops will get out.(51) While Professors Gray and Raybould report on a method of preventing transgene escape, there is a food safety issue now attached to the environmental one, i.e., what is the potential for contamination of traditional food crops before reaching the farm gate?(52)
  • the potential of the Terminator seed. If owners of the Terminator patent succeed in inserting Terminator genes into patented seeds, plants will only produce sterile seeds. In India, varieties of seeds containing the terminator gene will be refused registration. Ethical questions about food security, especially for developing countries, arise. They will be dependent on purchasing new varieties from overseas and will no longer be able to carry out the traditional practice of collecting and storing seed. The Consultative Group on International Agricultural Research will boycott the use of Terminator technology.(53) They fear that there is a risk that adjacent crops might acquire seed sterilisation via Terminator seed pollen and there may be inherent genetic diversity risks. As of March 1999 the United States Department of Agriculture (USDA) and Monsanto were joint owners of the Terminator patent.(54)
  • there is still uncertainty about the effect of GE crops engineered to produce insecticidal toxins on non target insects. It is agreed that such plants will reduce food available to beneficial insects that feed on targeted pests. Reports vary as to whether they are directly poisoned by GE crops. In view of the laboratory example of lacewings(55) having higher mortality after consuming a diet of Bt maize fed caterpillars, ACRE (the UK Advisory Committee on Releases in the Environment) could not justify a ban but advised continued vigilance.(56) The pollen from Novartis' Bt corn has been found to have an adverse effect on Monarch caterpillars feeding on milkweed in the US.(57) The consequences of spraying regimes on traditional crops and the local flora and fauna are a major unknown. UK farm scale evaluations of three GMO crops will compare the effects of GE and non-GE crops on wildlife.(58) Insect resistance is likely, e.g. an unconfirmed, recently reported case of pesticide resistant aphids in Australia in an area where Bt cotton is grown, and
  • what regulatory controls will need to be imposed on farmers of traditional crops to enable successful management of GE crops? In the future this issue will control both the farmers' ability to choose which crop they wish to grow, and down the market chain, the availability of GE and non-GE foods to the consumer. It has been recognised in Australia with Bt cotton crops that buffer zones of 10 per cent conventional crops are required to prevent the acceleration of the development of pesticide resistant organisms. The recent identification of pesticide resistant aphids demonstrates that a 10 per cent buffer zone may not be sufficient and hence the requirement for greater regulation of what is planted and where, along with specified spraying regimes of both GE and conventional crops.

Regulatory Concerns About GM Foods

Labelling

Australian and New Zealand health ministers have agreed that all GM food should be labelled. Standard A18: Food Produced Using Gene Technology was adopted in July 1998, gazetted on 13 August 1998, and came into force on 13 May 1999. Safety assessment conditions were initially required for foods deemed as 'not substantially equivalent' with respect to nutrition, composition, allergens or end use. After the 17 December 1998 decision of the ministers (ANZFSC) reached in a 6 to 4 vote, the labelling section of Standard A18 is to be revised to include the labelling of substantially equivalent foods also. The revision is to be submitted for approval to the ANZFSC meeting in July 1999 and GM food must be defined. The draft will specify labelling of all GM foods. The deadline for public submissions to ANZFA on GE food labelling is 11 June 1999. Their invitation paper lists possible labelling options.(59) Future labelling is likely to be 'may contain' (a form already rejected by the EU) for foods that may contain GE material, and 'does contain' for foods that definitely do contain GE material. It is of interest to note that the EU has settled for :'does contain' or 'does not contain', in force as of 1 September 1998. Exemptions are similar to the EU.

'Substantial equivalence' had its origins in a 1990 FAO/WHO joint report that developed the concept where a comparison of the final product with one having an acceptable standard of safety was seen to provide an important element of safety assessment. This was further developed by the OECD in a 1993 paper on the evaluation of GE foods. A 1996 FAO/WHO report elaborated further: 'substantial equivalence' is not a safety assessment in itself. Without specific safety assessment, unintended effects such as alterations in concentrations of key nutrients or increases in the level of natural toxicants cannot be readily detected.(60) This report goes on to indicate that while the substantial equivalence approach may have limitations, it provides increased assurance of the safety of food products.

In the EU, genetically modified ingredients must be approved and the Novel Foods Regulation (CE 258/97) stipulates labelling when a food is not judged to be 'substantially equivalent', with rules for labelling foods containing genetically modified soy and maize or if there are health or ethical concerns re GE ingredients. Further directives are 97/281/CE, 97/98 and CE 1139/98. The latter, CE 1139/98 establishes a requirement to label all foods and food ingredients made either wholly or partly from seeds derived from genetically modified soya or maize whenever DNA or protein derived from genetic modification is detectable in food. There is as yet no EU protocol to detect transgenic DNA.(61) The regulation does not apply to food additives, flavourings or extraction solvents produced using gene technology. Also exempted will be highly processed foods where GE products, gene fragments or novel protein residues should not be present e.g. refined oils and glucose and fructose syrups.(62) The EU has proposed labelling of animal feed containing GE ingredients. The UK supports the labelling of all foods containing genetically modified ingredients.

In addition to the requirement to label GM foods in the US if there is an allergen problem, the only other circumstance requiring mandatory labelling of GE foods is if significant or composition or nutritional changes have been made. Of interest is the USEPA's proposal for seeds carrying foreign genes to be labelled as containing antipest substances.(63)

The United Nation's Codex Alimentarius Commission discussed its draft labelling standard for GM foods at a recent meeting fraught with controversy. The US and Canada would prefer a weak labelling option, a voluntary approach, while the EU and New Zealand want mandatory labelling.(64) Australia withdrew its support for the US position at the first stage vote for the proposed international standard. The final recommendation is not expected until after June 2001.

A major objection to labelling by the US government is the cost to food suppliers. A British agricultural economist who points to different varieties of wheat (non GE) that have been traditionally labelled separately for the consumers' benefit has queried this. (For example, pasta connoisseurs would take a dim view if they were not able to purchase pasta made from the durum wheat grain). A number of quantitative examples were provided; Canadian farmers distinguishing GM from non GM canola did so with an additional 8 per cent cost. Monsanto claims segregation would cost up to 150 per cent extra.(65) In their May 1999 paper ANZFA warns that there is a real possibility that consumers will carry the cost.(66)

According to the UK experience, compliance testing could prove difficult because of a lack of appropriate testing stations. At present a test costs from 100 to 200 per sample and takes about ten days.(67) Moreover, if the polymerase chain reaction (PCR) test is the designated test, it cannot guarantee detection below the 1 or 2 per cent threshold.(68) However, necessity is the mother of invention and it is likely that more accurate tests may be devised.

Australian GE Food Approvals

Early in 1999, ANZFA declared that two Monsanto approval applications, Roundup Ready Soybeans (glyphosate-tolerant soybean line 40-3-2) and Ingard Cottonseed (derived from insect resistant cotton lines 531, 757, 1076 and 1849), have no public health and safety concerns. Ingard cotton yields cottonseed oil, which may be used in cooking oil, mayonnaise and salad dressing. Data packages were submitted by Monsanto along with Quality Assurance certification that the studies were done in accordance with Good Laboratory Practice.(69) Public submissions were called for and assessment was carried out consistent with FAO/WHO and OECD protocols for safety assessment of foods using gene technology. ANZFA issued updated Guidelines in March 1999.(70) These were the first two applications for ANZFSC approval as required by Standard A18 of the Food Standards Code. Currently at least twenty more applications are in the ANZFA assessment pipeline. It is not known if there are anymore GE ingredients currently in foods on sale in Australia over and above the 56 known to ANZFA.

The first two proposals are deemed to be 'substantially equivalent' to their conventional counterparts. Having gone through the assessment process, public comment will be sought and if approved by ANZFSC will be listed in the pertinent Standard A18 table.

How Adequate is the Testing Process?

Acceptance of GE foods is naturally at least partially dependent on public confidence in the assessment process, transparency and an adequate communication process being fundamental. The extent of scientific information drawn upon in the two released assessment reports was not revealed, making it difficult to judge the adequacy of the assessment. Feeding ten male and female rats with INGARD cotton seed, in an experiment not designed as a toxicity test and not of relevance to humans, appears to be a very weak test for the 'ability to support typical growth and well-being'.(71) There are no laboratories at ANZFA and they would have limited resources for the assessment tasks that lie ahead. Assessment involves matching application data and public submissions and presumably overseas laboratory data and reports with local Australian requirements. (Internationally, it is recognised that current safety assessment practices are insufficient, a whole new approach being called for at a recent OECD meeting).(72) The rudimentary nature of Australia's controls are mentioned in the soybean assessment report, ANZFA stating:

The Authority has neither the expertise nor the mandate to assess matters relating to the environmental risks resulting from the release of food produced using gene technology into the environment. ... GMAC undertook an assessment of this importation ... found it does not represent a significant biosafety risk ... AQIS controls all movement of imported soybean and trash remaining after processing ... GMAC further advised AQIS that particular attention ... to ensure that any escape of seed is minimised ... There are no formal mechanisms in place for the coordination of assessments and approvals of gene technology products by the various regulatory agencies in Australia.(73)

There are some worries about the assessment process. Who should do the testing and assessing? Who should be overseeing, second guessing this process? US trade interests suggest that an international testing body should be created, however, would Australian interests be met? Certainly the OECD's Programme on the Harmonization of Regulatory Oversight in Biotechnology is of value.(74) Should local and international scientists, independent of international and national agencies and independent of funding from biotechnology industries be paid to provide a range of independent advice? It is of interest that in the UK, scientists with current or recent links to the biotechnology industry are to be barred from a key government committee on genetically modified crops.(75) It could also be argued that there is a fundamental flaw in a system that is substantially reliant on public submissions for critical comment. Australian science is operating in a climate of reduced resources and staffing, thus preventing ANZFA from enriching the public submission process by obtaining a range of informed scientific responses. The current climate precludes many informed professionals from contributing to the public submission process in a constructive way.

What kind of testing does the Genetic Manipulation Advisory Committee (GMAC) oversee? Industry must abide by field trial regulations, as set down by GMAC. But, it is industry that does the trials, submits the data and has it assessed as a paper exercise by a panel of experts. Compliance with GMAC guidelines(76) is voluntary.(77) Biosafety matters in Australia are overseen by GMAC, reporting directly to the Minister for Industry, Science and Resources, GMAC's Institutional Biosafety Committees conduct some of the work.(78) Industry provides most of the data for full assessment reports. At ABARE's recent Outlook 99 conference a questioner from the audience bluntly asked: 'When are we going to get a GMAC with teeth?' (i.e. the proposed Office of Gene Technology Regulation). The proposed integrated biotechnology strategy will include an enforceable regulation system.

Who should pay? Who should bear the cost of testing foods that consumers did not particularly yearn for? Should the consumer pay through tax funded agencies such as ANZFA or should the developer of the product be responsible for costs? Should the biotechnology industry contribute to the cost through a levy on GE crops or foods? Who is liable for future environmental and health damage, both compensation and rehabilitation costs?

Some of ANZFA's major objectives are to promote trade and commerce in the food industry and promote consistency between domestic and international food standards where these are at variance.(79) Is there a conflict of interest? Can consumer and trade imperatives be met by the same agency? Is there a call for a public health focussed agency with research and testing capabilities to be responsible for food approvals?

The biotechnology industry is ahead of the development of appropriate regulatory regimes for biotechnology products. While industry has had ample time and funds to pursue their briefs, similar or appropriate matching government resources have not appeared to provide scientific support for the development of regulatory regimes.

Who Should Devise a Communications Strategy?

Inadequate dissemination of information has been identified as a major factor in resistance and uncertainty about GM foods. Coupled with the low visibility of science generally, and an identified lack of knowledge in Australian 'civics' (the workings of government), the need for better public communication is apparent. ANZFA maintains that industry should be primarily responsible for a communications strategy, but will cooperate with industry.(80) The creation of Agrifood Alliance Australia, a joint public education venture between the National Farmers' Federation, Avcare, the Grain Research and Development Corporation, the Seed Industry Association, the Australian Biotechnology Association, the Co-operative Research Centres Association and the fertiliser company Pivot Ltd,(81) provides a warning about public interest implication arising from the meshing of government, industry and jointly funded scientists' interests. This, and the proposal for Biotechnology Australia, the industry portfolio, to manage public awareness rather than the health portfolio, may provide further grounds for claims about a pro-industry bias. A number of Australian organisations with various vested interests have already set up web sites. Consumer education is one of the roles of the newly established food agency in the United Kingdom, a public health education approach that would be of value in Australia. Ideally communication strategies by a variety of sources would be the best option.

The NSW Farmers' Association has called for the Commonwealth Government to create a working group consisting of the ACA, the Australian Food and Grocery Council and ANZFA, in order to look at consumer education and labelling issues.(82) With the exception of ABC transmissions, scientific matters generally have a low profile on Australian television, the medium that reaches the widest audience. Perhaps incentives or content imperatives could increase the Australian public's exposure to communications in science matters of national significance.

Conclusion

Disquiet about GM foods promises huge financial consequences as demonstrated by the delaying tactics of the EU with respect to US GE products. The biotechnology industry has risked considerable funds. In Australia, the biotechnology industry is hampered by the relative scarcity of business capital, the hazard of having to trade away intellectual property, and being unable to progress with R&D of new products when locked out of access to intellectual property owned by multinational companies. While consumer worries have been in recent headlines, the industry itself requires regulatory support. Liability for health and environmental consequences needs to be clarified for industry, government and the consumer, future damages claims could be high.(83) AGEN has hinted at legal action against ANZFA.(84)

The GM food issue demonstrates that the uptake of new technologies by industry should be anticipated and monitored by government. Seamless uniform assessment is required.(85) Good laboratory practice, good agriculture practice and risk assessments should be critically revisited from time to time. Scientific underpinning of policy and regulatory decision making processes need to be supported by adequate funding for monitoring, testing and assessment processes as well as for basic research and an adequate knowledge base, ensuring timely inclusion of effective regulations covering new technologies.

Immediate requirements, as frequently stated by stakeholders recently, appear to be:

  • food labelling that can be trusted
  • adequate education programs so an informed public can make intelligent choices
  • an agriculture biotechnology strategy supported by a coordinating agency, and
  • dedicated, separate agencies, that with no conflict of interest can pursue and represent competing interests including:
    • health and consumer food and drug requirements
    • environmental risks that can damage our valuable agriculture industry
    • risks to our biodiversity through accidental escapes
    • inadequate management of the intellectual property aspects of Australian biodiversity, and
    • coordinated international representation to overseas bodies that protects our trade prospects and maintains our health and environmental standards.

How can regulators build in citizen and national choice in the face of international biotechnology business directions? The extent to which Australia is able to control its environment in terms of both human health and natural imperatives will strongly influence the way we participate and hopefully prosper with biotechnology in the future.

Endnotes

  1. Food Standards Code, ANZFA, Canberra, 1998.

  2. 'USA: US loses genetic food bid', Reuters Business Briefing, 3 May 1999.

  3. 'Commission planning new rules to meet demand for GMO-free foods', International Environment Reporter, vol. 22, no. 7, 31 March 1999, p. 271.

  4. 'EU and US consumer leaders demand mandatory labelling of all genetically modified food', Transatlantic Consumer Dialogue, Press Release, 26 April 1999, web site at: [http://www.tacd.org/press_releases/meeting260499.html].

  5. Debora Mackenzie, 'Unpalatable truths', New Scientist, 17 April 1999, p. 18.

  6. 'New measures on biotechnology announced', UK Cabinet Office, CAB 109/99 21 May 1999.

  7. Meredith Wadman, 'US processor rejects maize that EU won't take', Nature, vol. 398, 29 April, 1999, p. 736.

  8. 'About genetically modified food (29-3-99)', ANZFA Fact Sheet, p. 1, web site at: [http://www.anzfa.gov.au/_private/About_Genetically_Modified_Food_.htm].

  9. For example: Genetic manipulation: the threat or the glory? Report of the House of Representatives Standing Committee on Industry Science and Technology, The Parliament, Canberra, 1992. And Prime Minister's Science and Engineering Council, Gene technology, Office of the Chief Scientist, Canberra, 1993.

  10. First Australian Consensus Conference on Gene Technology in the Food Chain 10-11 March 1999, web site at: [http://www.austmus.gov.au/consensus/02.htm] (March 1999).

  11. Regulation of gene technology, ARMCANZ, Canberra, 1997, Appendix 5, p. 1, web site at: [http://www.dpie.gov.au/armcanz/gene/appendix5.html].

  12. Biotechnology Australia, web site at: [http://www.isr.gov.au/ba/body_index.html].

  13. Budget 1999-2000, Fact Sheet 5, Biotechnology: mapping out our future, Department of Health and Aged Care, Canberra, 1999, web site at: [http://www.health.gov.au/pubs/budget99/fact/hfact5.htm].

  14. Steve Lewis and Louise Dodson, 'Biotech gets $60m boost in Budget policy ploy', The Australian Financial Review, Thursday, April 29, 1999, p. 1.

  15. Primary industries: primed for growth, Liberal Party of Australia, 22 September, 1998, p. 23.

  16. Steve Lewis and Louise Dodson, op. cit., p. 1.

  17. Bill Blair, Food a growth industry. The Report of the Food Regulation Review, The Commonwealth, Canberra, 1998.

  18. Biotechnology Task Force, web site at: [http://www.isr.gov.au/biotaskforce/index.html].

  19. Ann M. Thayer, 'Transforming agriculture', C&EN, April 19, 1999, p. 21.

  20. 'Toting up the early harvest of transgenic plants', Science, vol. 282, 18 December 1998, p. 2177.

  21. 'FED: CSIRO study finds Aussies hungry for gene information', AAP wire service, 31 March 1999.

  22. Jane Norton, Graham Wood and Geoffrey Lawrence, 'Public acceptance of genetically-engineered foods', Paper presented at the Forum on Critical Issues in Transnational Agri-food Systems: The Millenium and Beyond, The Australian Sociological Association Annual Conference, Queensland University of Technology, Brisbane, December, 1998.

  23. Barbara Adam, 'Tables turned on food alteration', Courier Mail, Friday 4 December, 1998, p. 9.

  24. Jody Scott, 'Food for thought', Reuters Business Briefing, 5 May 1999.

  25. First Australian Consensus Conference on Gene Technology in the Food Chain 10-11 March, 1999, op. cit.

  26. General surveys on foods produced through biotechnology, Consumers International, c1999, p. 1, web site at: [http://193.128.6.150/consumers/campaigns/food/codex/survey0499.html].

  27. David Concar and Andy Coglan, 'A question of breeding', New Scientist, 27 February 1999, p. 5.

  28. Regulation of plants that have been genetically manipulated or artificially selected, AQIS, Plant Quarantine Policy Branch, Canberra, 1998, pp. 4-8.

  29. ibid., pp. 4-8.

  30. ibid., pp. 4-8.

  31. 'Treaty to control gene trade stuck in limbo', New Scientist, 6 March 1999, p. 13.

  32. 'Australia must not be left behind', Environmental Standards Update, March 19 1999, p. 1. (quote by Wendy Craik, NFF).

  33. 'Toting up the early harvest of transgenic plants', Science, vol. 282, 18 December 1998, p. 2176.

  34. 'Key issue in Biosafety Protocol talks. Is coverage of products or just organisms', International Environment Reporter, 20 January 1999, p. 61.

  35. 'FED: Consumer group warns genetic changes could risk exports', AAP wire service, 10 March 1999.

  36. Risks of genetic engineering, Union of Concerned Scientists, Cambridge, nd, web site at: [http://www.ucsusa.org/agriculture/gen.risks.html], Australian Gene Ethics Network, web site at: [http://zero.com.au/agen/body_index.html], Australian Consumers Association, web site at: [http://www.choice.com.au] and Consumers International, web site at: [http://193.128.6.150/consumers/index.html].

  37. 'Ban Bt cotton says gene group', Hazardous substances alert, August 16 1996, p. 3.

  38. R. Schubbert, U. Hohlweg, D. Renz and W. Doerfler, 'On the fate of orally ingested foreign DNA in mice: chromosomal association and placental transmission to the fetus, Mol. Gen. Genet. Vol. 259, no. 6, pp. 569-76, October 1998. (Medline Abstract) and R. Schubbert and W. Doerfler, 'Uptake of foreign DNA from the environment: the gastrointestinal tract and the placenta as portals of entry', Weiner klinische Wochenschrift, vol. 110, no. 2, pp. 40-4, January 30 1998. (Medline abstract) and R. Schubbert, D. Renz, B. Schmitz and W. Doerfler, 'Foreign (M13) DNA ingested by mice reaches peripheral leukocytes, spleen and liver via the intestinal wall mucosa and can be covalently linked to mouse DNA', Proceedings of the National Academy of Science, USA, vol. 4, no. 3, pp. 961-6, February 4 1997. (Medline Abstract)

  39. Guidance for industry: use of antibiotic resistance marker genes in transgenic plants. Draft guidance, [Draft released for comment on: September 4, 1998.], Center for Food Safety and Applied Nutrition. Center for Veterinary Medicine, US Food and Drug Administration, p. 9.

    The USFDA finding was that the product of the kan' gene used in Flavr Savr TM tomatoes, APH(3')II, would not compromise the therapeutic efficiency of orally administered neomycin and kanomycin (Kanamycin gene). Neither would therapy with antibiotics be compromised through transfer of the kan' gene from plants to microorganisms in the gut or in the environment or to the cells lining the gastrointestinal tract. There is, however, an unsubstantiated argument supported by a study on a genetically engineered form of B. subtilis, marked by the Kanamycin resistance gene; cross resistance against other clinically important antibiotics amikacin and tobramycin, new generation antibiotics. Accordingly there has been a claim that the kan' gene should not be used for transgenic purposes.

    ibid., p. 7.

    Antibiotic resistance genes and bacterial resistance to antibiotics', web site at:
    [http://home1.swipnet.se/~-18472/antibiot.htm]. (source: V. V. Smirnov et al., Antibiot. Kkimioter ' Susceptibility to antimicrobial drugs of strains of bacilli used as a basis for various probiotics', vol. 39, no. 4, pp. 23-8, April 1994. (Medline abstract)

  40. ibid., p. 2.

  41. Novel foods and processes Government Response to the House of Lords Select Committee on the European Communities Report on EC Regulation of Genetic Modification in Agriculture, MAFF, London, c1999, p. 6. web site at : [http://www.maff.gov.uk/food/novel/holrepot.htm].

  42. 'UK gets the green light on modified crops', Nature, vol. 397, 28 January 1999, p. 286.

  43. Julie Nordlee et al., 'Identification of a brazil-nut allergen in transgenic soybeans', The New England Journal of Medicine, March 14 1996, pp. 688-692.

  44. Samuel B. Lehrer and Gerald Reese, 'Recombinant proteins in newly developed foods: identification of allergenic activity', Int Arch Allergy Immunol, vol. 113, 1997, pp. 122-124.

  45. Samuel Lehrer et al., 'Why are some proteins allergenic? Implications for biotechnology', Clinical review in food science and nutrition, vol. 36, no. 6, 1996, p. 553.

  46. FDA's Statement of Policy; foods derived from new plant varieties Q & A Sheet: June 1992, U.S. Food and Drug Administration. Center for Food Safety and Applied Nutrition, web site at: [http://vm.cfsan.fda.gov/~lrd/bioqa.html].

  47. Soy-based infant formula, New Zealand. Ministry of Health,Wellington, 1998, web site at: [http://www.moh.govt.nz].

  48. 'New Zealand: genetically-engineered baby formulas have "sneaked on to shelves"', New Zealand Press Association, 22/11/1998, Reuters Business Briefing, 22 November 1998.

  49. Full Assessment Report and Regulatory Impact Assessment. Subject:A338-Food Derived From Glyphosate-Tolerant Soybeans, ANZFA, Canberra, c1999, p. 22.

  50. Doubts raised over safety of GM soya beans, Canberra Times, 25 May 1999, p. 6.

  51. Nick Nuttal, 'Bees spread genes from GM crops', The Times, 15 April 1999, np.

  52. Alan J. Gray and Alan F. Raybould, 'Reducing transgene escape routes', Nature, vol. 392, 16 April 1998, p. 653.

  53. 'Meet the company that would privatise nature itself', Australasian Science, January/February, 1999, pp. 42-43.

  54. Shand Hope, 'USA: terminator seeds - Monsanto moves to tighten its grip on global agriculture', Multinational Monitor, vol. 20 no.11. (Reuters Business Briefing 5 March 1999)

  55. David Concar, 'Dispatches from the killing fields', New Scientist, 27 February 1999, p. 5.
  56. Michael Meacher calls for more research on lacewings and GM maize, Advice for the Secretary of State, 3 August, 1998, p. 3, web site at: [http://www.environment.detr.gov.uk/acre/advice02.htm].

  57. David Kinney, 'US: study: Genetically engineered corn harms butterflies, AAP Newswire, 20 May 1999.

  58. 'Impact on wildlife of genetically modified crops', Press notice, 18 February, 1999, web site at: [ http://www.environment.detr.gov.uk/acre/advice04.htm].

  59. The labelling of foods produced using gene technology. An invitation to comment or make a submission on proposals to extend the labelling requirements of Standard A18, ANZFA, Canberra, 1999, p. 2.

  60. Biotechnology and food safety. Report of a Joint FAO/WHO Consultation. Rome, Italy, 30 September-4 October 1996, FAO/WHO, Rome, 1996, pp. 4-5. ( FAO Food and nutrition paper 61).

  61. Daniel Ramon, M.D. Calvo and J. Peris, 'New regulation for labelling genetically modified foods: A solution or a problem?' [Letter], Nature biotechnology, vol. 16, October 1998, p. 889.

  62. Labelling of genetically modified foods- the international status, ANZFA, Canberra, 1998. (ANZFA Fact Sheet).

  63. EPA, critics soften stance on pesticidal plants, Science, vol. 284, 9 April 1999, p. 249.

  64. 'USA: biotech labeling issues divide United States, EU at Codex meeting', Promt Food Chemical News 10/5/99. (Reuters Business Briefing 10 May 1999).

  65. 'How to price what we put on our plate', New Scientist, 27 February 1999, p. 6.

  66. The labelling of foods produced using gene technology, op. cit., p.5.

  67. 'Enforcement is likely to be costly and slow', The Times, Friday March 19 1999, np.

  68. 'GM food labelling rules undermined by lack of reliable tests', ENDS Report, March, 1999, p. 49.

  69. Full Assessment Report and Regulatory Impact Assessment. Subject:A338-Food Derived From Glyphosate-Tolerant Soybeans, ANZFA, Canberra, c1999, p. 2.

  70. Guidelines for the safety assessment of foods to be included in Standard A18-Food produced using gene technology. For guidance in making an application to amend the Food Standards code, ANZFA, Canberra, 1999.

  71. Full Assessment Report and Regulatory Impact Assessment. A341-Oil and linters derived from insect resistant cotton, ANZFA, Canberra, c1999, pp. 10, 35.

  72. Debora MacKenzie, op. cit., p.18.

  73. ibid., p. 15.

  74. BioTrack Online, OECD, web site at: [http://www.oecd.org/ehs/service.htm]

  75. Paul Waugh, 'Biotech experts lose GM role', Independent, (London), 12 April 1999, web site at: [http://www.oecd.org/ehs/service.htm]
  76. GMAC guidelines, GMAC, Canberra, web site at: [http://www.science.gov.au/gmac/gmacguid.htm]

  77. Regulation of Gene Technology, op. cit., Appendix 4: The history of developing a legislative approach to GMOs, p.1.
  78. 'Protecting the public', GTIU, Canberra, nd, web site at: [http://www.geneinfo.gov.au/regulate.htm].

  79. Commonwealth Government Directory: The Official Guide, May 1998, Commonwealth of Australia, Canberra, 1998. p.190.
  80. Latest GMO Update, ANZFA, Canberra, 1999, web site at: [http://www.anzfa.gov.au/FoodStandards/Latest_GMO_Update.htm] (15 April 1999).

  81. Cathy Bolt, 'Australia: news-alliance to push benefits of biotechnology', Australian Financial Review, 17 May 1999, p.10, (Reuters Business Briefing, 17 May 1999).

  82. 'FED: Govt called on to start GM working group for consumers', AAP wire service, 30 March 1999.

  83. 'Industry critic warns that damages claims could 'run into millions' in 'Briefing GM Crops', Nature, vol. 398, 22 April 1999, p. 658.

  84. 'Modified food: legal challenge on the cards', The Canberra Times, Saturday May 8 1999, p. 2.

  85. Regulation of Gene Technology, op. cit., Executive Summary, p.1.

 

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