Science, Technology, Environment and Resources Group
1 June 1999
Why Are Genetically Modified Foods
Are We Worried?
Artificial Selection of Plants and Genetically
Biosafety Protocol or Cartagena Protocol on Biosafety
Biosafety Concerns About Genetically Modified
Regulatory Concerns About GM Foods
Australian GE Food Approvals
How Adequate is the Testing Process?
Who Should Devise a Communications Strategy?
Conventional plant breeding techniques such as
cross fertilisation, progeny selection and backcrossing
Using biological systems for industrial
Manipulation of genetic material to achieve
changed functions in living organisms; e.g. increased production of
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
Short fibres from cottonseeds
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)
When a genetically modified food is deemed to
have the same safety status as its conventional food
Where living organisms have been altered through
the insertion of foreign genetic material
Australian Bureau of Agriculture and Resource
Australian Consumers Association
Australian Gene Ethics Network
Australia New Zealand Food Authority
Australia New Zealand Food Standards Council
Australian Quarantine Inspection Service
Agriculture and Resource Management Council of
Australia and New Zealand
Biotechnology Australia (Dept. of Industry,
Science and Resources)
Bovine Spongiform Encephaly
Commonwealth Science Industry and Research
United Nations, Food and Agriculture
genetically engineered, genetic engineering
Genetic Manipulation Advisory Committee
Genetically Modified Organism
Gene Technology Information Unit (GMAC)
Living Modified Organisms
Organisation for Economic Cooperation and
Office of the Gene Technology Regulator (Dept.
of Health and Aged Care)
United States Department of Agriculture
United States Environment Protection Agency
United States Food and Drug Administration
World Health Organisation
World Trade Organisation
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
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
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
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
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
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
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
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
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
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'
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
- 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
- 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,
- 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
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,
- 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
- Some findings from an Australian nationwide survey(22) by Janet
- GE of plants was more acceptable than GE of animals and
- 76 per cent considered accidental release of GMOs would cause
- 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
- 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
- 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)
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
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
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.
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.
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.
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
- 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
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
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 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
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 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
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
- 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
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
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
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.
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.
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
- 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
- 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
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.
- Food Standards Code, ANZFA, Canberra, 1998.
- 'USA: US loses genetic food bid', Reuters Business
Briefing, 3 May 1999.
- 'Commission planning new rules to meet demand for GMO-free
foods', International Environment Reporter, vol.
22, no. 7, 31 March 1999, p. 271.
- 'EU and US consumer leaders demand mandatory labelling of all
genetically modified food', Transatlantic Consumer Dialogue,
Press Release, 26 April 1999, web site at:
- Debora Mackenzie, 'Unpalatable truths', New Scientist,
17 April 1999, p. 18.
- 'New measures on biotechnology announced', UK Cabinet Office,
CAB 109/99 21 May 1999.
- Meredith Wadman, 'US processor rejects maize that EU won't
take', Nature, vol. 398, 29 April, 1999, p. 736.
- 'About genetically modified food (29-3-99)', ANZFA Fact
Sheet, p. 1, web site at:
- 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.
- 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).
- Regulation of gene technology, ARMCANZ, Canberra,
1997, Appendix 5, p. 1, web site at:
- Biotechnology Australia, web site at:
- Budget 1999-2000, Fact Sheet 5, Biotechnology: mapping out
our future, Department of Health and Aged Care, Canberra,
1999, web site at:
- Steve Lewis and Louise Dodson, 'Biotech gets $60m boost in
Budget policy ploy', The Australian Financial
Review, Thursday, April 29, 1999, p. 1.
- Primary industries: primed for growth, Liberal Party
of Australia, 22 September, 1998, p. 23.
- Steve Lewis and Louise Dodson, op. cit., p. 1.
- Bill Blair, Food a growth industry. The Report of
the Food Regulation Review, The Commonwealth, Canberra, 1998.
- Biotechnology Task Force, web site at:
- Ann M. Thayer, 'Transforming agriculture', C&EN,
April 19, 1999, p. 21.
- 'Toting up the early harvest of transgenic plants',
Science, vol. 282, 18 December 1998, p. 2177.
- 'FED: CSIRO study finds Aussies hungry for gene information',
AAP wire service, 31 March 1999.
- 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,
- Barbara Adam, 'Tables turned on food alteration', Courier
Mail, Friday 4 December, 1998, p. 9.
- Jody Scott, 'Food for thought', Reuters Business
Briefing, 5 May 1999.
- First Australian Consensus Conference on Gene Technology in
the Food Chain 10-11 March, 1999, op. cit.
- General surveys on foods produced through
biotechnology, Consumers International, c1999, p. 1, web site
- David Concar and Andy Coglan, 'A question of breeding', New
Scientist, 27 February 1999, p. 5.
- Regulation of plants that have been genetically manipulated
or artificially selected, AQIS, Plant Quarantine Policy
Branch, Canberra, 1998, pp. 4-8.
- ibid., pp. 4-8.
- ibid., pp. 4-8.
- 'Treaty to control gene trade stuck in limbo', New
Scientist, 6 March 1999, p. 13.
- 'Australia must not be left behind', Environmental
Standards Update, March 19 1999, p. 1. (quote by Wendy Craik,
- 'Toting up the early harvest of transgenic plants',
Science, vol. 282, 18 December 1998, p. 2176.
- 'Key issue in Biosafety Protocol talks. Is coverage of products
or just organisms', International Environment Reporter, 20
January 1999, p. 61.
- 'FED: Consumer group warns genetic changes could risk exports',
AAP wire service, 10 March 1999.
- 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:
- 'Ban Bt cotton says gene group', Hazardous substances
alert, August 16 1996, p. 3.
- 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
- 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
- ibid., p. 2.
- 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].
- 'UK gets the green light on modified crops', Nature,
vol. 397, 28 January 1999, p. 286.
- 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.
- Samuel B. Lehrer and Gerald Reese, 'Recombinant proteins in
newly developed foods: identification of allergenic activity',
Int Arch Allergy Immunol, vol. 113, 1997, pp.
- 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.
- 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].
- Soy-based infant formula, New Zealand. Ministry of
Health,Wellington, 1998, web site at: [http://www.moh.govt.nz].
- 'New Zealand: genetically-engineered baby formulas have
"sneaked on to shelves"', New Zealand Press Association,
22/11/1998, Reuters Business Briefing, 22 November 1998.
- Full Assessment Report and Regulatory Impact Assessment.
Subject:A338-Food Derived From Glyphosate-Tolerant
Soybeans, ANZFA, Canberra, c1999, p. 22.
- Doubts raised over safety of GM soya beans, Canberra
Times, 25 May 1999, p. 6.
- Nick Nuttal, 'Bees spread genes from GM crops', The
Times, 15 April 1999, np.
- Alan J. Gray and Alan F. Raybould, 'Reducing transgene escape
routes', Nature, vol. 392, 16 April 1998, p. 653.
- 'Meet the company that would privatise nature itself',
Australasian Science, January/February, 1999, pp. 42-43.
- 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)
- David Concar, 'Dispatches from the killing fields', New
Scientist, 27 February 1999, p. 5.
- 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:
- David Kinney, 'US: study: Genetically engineered corn harms
butterflies, AAP Newswire, 20 May 1999.
- 'Impact on wildlife of genetically modified crops', Press
notice, 18 February, 1999, web site at: [
- 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.
- 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
- 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,
- Labelling of genetically modified foods- the international
status, ANZFA, Canberra, 1998. (ANZFA Fact Sheet).
- EPA, critics soften stance on pesticidal plants,
Science, vol. 284, 9 April 1999, p. 249.
- 'USA: biotech labeling issues divide United States, EU at Codex
meeting', Promt Food Chemical News 10/5/99.
(Reuters Business Briefing 10 May 1999).
- 'How to price what we put on our plate', New
Scientist, 27 February 1999, p. 6.
- The labelling of foods produced using gene technology,
op. cit., p.5.
- 'Enforcement is likely to be costly and slow', The
Times, Friday March 19 1999, np.
- 'GM food labelling rules undermined by lack of reliable tests',
ENDS Report, March, 1999, p. 49.
- Full Assessment Report and Regulatory Impact Assessment.
Subject:A338-Food Derived From Glyphosate-Tolerant
Soybeans, ANZFA, Canberra, c1999, p. 2.
- 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.
- Full Assessment Report and Regulatory Impact Assessment.
A341-Oil and linters derived from insect resistant
cotton, ANZFA, Canberra, c1999, pp. 10, 35.
- Debora MacKenzie, op. cit., p.18.
- ibid., p. 15.
- BioTrack Online, OECD, web site at:
- Paul Waugh, 'Biotech experts lose GM role', Independent,
(London), 12 April 1999, web site at:
- GMAC guidelines, GMAC, Canberra, web site at:
- Regulation of Gene Technology, op. cit., Appendix 4:
The history of developing a legislative approach to GMOs, p.1.
- 'Protecting the public', GTIU, Canberra, nd, web site at:
- Commonwealth Government Directory: The Official Guide, May
1998, Commonwealth of Australia, Canberra, 1998. p.190.
- Latest GMO Update, ANZFA, Canberra, 1999, web site at:
- Cathy Bolt, 'Australia: news-alliance to push benefits of
biotechnology', Australian Financial Review, 17
May 1999, p.10, (Reuters Business Briefing, 17 May 1999).
- 'FED: Govt called on to start GM working group for consumers',
AAP wire service, 30 March 1999.
- 'Industry critic warns that damages claims could 'run into
millions' in 'Briefing GM Crops', Nature, vol. 398, 22
April 1999, p. 658.
- 'Modified food: legal challenge on the cards', The Canberra
Times, Saturday May 8 1999, p. 2.
- Regulation of Gene Technology, op. cit., Executive