PO Box
155,
Kensington
Park, SA, 5068
Australia
April, 2004
1 Introduction
The Institute of Health and
Environmental Research Inc. (IHER) is a not-for-profit research institute with
an interest in genetically modified (GM) organisms, particularly those destined
for food. Its directors hold the
following degrees: ordinary degrees in Medicine, Science and Agriculture,
Honours Degrees in Agricultural Science and Organic Chemistry, a Master of
Public Health, and PhDs in Plant Genetics and Medicine. The Directors have
training and expertise in plant science, agriculture, medicine, chemistry,
biochemistry, nutrition, epidemiology and biostatistics.
2 Submission
Question 1.
What are the
potential costs or benefits of this application to you as a stakeholder? Do the benefits outweigh the costs?
There is no known or expected benefit
to human health from the introduction of genetically modified wheat, or any
other GM foodstuff. Consequently, if
there are any costs to human health whatsoever, the costs will outweigh the
benefits.
Potential costs include the
development of any of the potential adverse effects of genetically modified
foods and crops. These potential risks will be addressed further in the next
round of submissions on scientific risk assessment. However, it is important to
state here that there is an increasing body of credible scientific evidence to
support the contention that genetically modified foods pose risks to human
health, animals and the environment.
Question 2.
What are the
costs or benefits for consumers in relation to public health and safety, consumer
information and labelling, etc?
There is no genetically modified
food or crop currently on the market which has any benefit for consumers. GM wheat is not known to be an exception.
The "potential benefit of
lower prices" due to "savings from production efficiencies",
while used to justify GM foods in the FSANZ document, has never eventuated. As
GM wheat has never been commercially grown anywhere in the world, due to farmer
and consumer opposition, there is no evidence whatsoever to back up this claim. The FSANZ document also claims that costs
associated with higher retail products for segregated food would eventuate if
the GM wheat is prohibited from food. This assumes that GM wheat would be
widely grown here and overseas. Given
the current strong opposition from farmers to growing it, this is an unfounded
assumption.
The public health and safety
costs for consumers would include the development of any adverse health or
environmental consequences from the consumption, exposure or growth of genetically
modified foods. As previously indicated, we intend to explore these risks in
the next round of submissions. However, a brief summary of these issues is
warranted here.
Human health risks from
consumption of genetically modified foods include increased risks of food
allergies, unexpected toxicity, viral recombination, horizontal gene transfer (including
transfer of antibiotic resistance to bacteria), and the potential hazards of
DNA promoter sequences, such as changes to immune function, bowel pathology and
possibly cancer. Wheat that is resistant to glyphosate is likely to contain increased
levels of glyphosate and this needs to be assessed. Glyphosate is known to
cause skin rashes, decrease human sperm motility (a sensitive marker for
toxicity), and has been linked to non-Hodgkin's' lymphoma.
Furthermore, exposure to GM
pollens and food dusts may also pose hazards, such as a potentially increased
incidence of asthma and allergic disorders.
This also needs assessment.
Environmental risks associated
with GM crops include soil degradation, overuse of herbicides and loss of
biodiversity. Ultimately, the public bears the costs of environmental
degradation.
It is clearly apparent that
consumers derive no benefit from GM crops and foods in general, and GM wheat in
particular. In contrast, consumers are exposed to a large number of diverse
potential risks. Consequently, the
potential risks outweigh the potential benefits.
Moreover, consumer issues
provide no justification for the introduction of GM wheat, but strongly support
its rejection.
Question 3.
What are the
costs or benefits for business – compliance, reporting, costs, savings,
increased market opportunities both domestically and overseas?
GM wheat is not grown
commercially anywhere in the world, nor is it likely to be grown in Australia
for some years, due to the current moratoria on GM crops in various States and
the lack of review by the OGTR. Consequently, it is purely speculative for
FSANZ to make comments on the potential benefits of herbicide tolerant wheat to
business. Australia grows large quantities of wheat for local and international
consumption. Consequently, there is no need for imported wheat or its products
in Australia. Surveys undertaken
locally and internationally repeatedly show a clear majority of consumers
prefer to avoid GM foods. As wheat tends to be present in foodstuffs in
significant quantities, most foods containing GM wheat will require labelling
here and overseas. This will make it much
easier for consumers to avoid food containing GM wheat and its products
compared to foods containing most other GM crops. There is therefore a clear marketing advantage to Australian food
industries and farmers from growing and using only non-GM wheat.
Question 4.
What are the
costs or benefits for government, public health and safety, etc?
Adoption of genetically modified
foods and crops exposes the government to a range of risks. One of them is the financial cost if any of
the potential risks to public health, farming or the environment
eventuate. For example, there may be increased
health costs or costs of environmental cleanups.
Furthermore, adverse events are
likely to result in litigation. Such
liability issues may involve governments, government departments and regulatory
authorities. As courts require government resources, the government will face
costs as cases enter courts, particularly if claimants utilize legal aid. The hearing of these cases will delay the
hearing of other, unrelated cases, which will also result in a cost to the
government and the community.
Another significant risk to the
government is its credibility in the eyes of the public.
It is a matter of public record
that original approval of GM foods by the United States Food and Drug Administration
(FDA) occurred as a result of a political directive, which overrode the
warnings of potential adverse effects by the FDA’s own experts (see www.biointegrity.org). It is
also clear that this FDA’s decision has put pressure on other countries to
approve GM foods as safe. Despite
official reassurances, the public has become more sceptical of the safety of GM
foods, and better educated about the potential risks and the amount of
corporate lobbying which is done in their favour. The public expects the government
to be responsive to public opinion, and in particular to act in the public
good.
Scientific
aspects of this application, in particular, information relevant to the safety
assessment of food derived from wheat line MON 71800
The Institute of Health and
Environmental Research Inc., recommends that FSANZ consider a range of issues
when making their safety assessment on herbicide tolerant wheat. Issues to
consider include, but are not limited to:
1. The actual gene transformation event(s). What is the exact sequence as expressed in
the plant after transformation? Has only one full sequence been inserted or are
there partial copies, reverse copies or unidentified fragments, as have occurred
in previously approved crops? Where exactly is the new sequence incorporated
into the host genome? Has it been thoroughly assessed as to whether the gene
cassette has been inserted into a functioning part of the plant genome? Is the position of the insertion likely to
increase the chance of other genes being affected by the transformation? Is
there a thorough determination of the potential for new proteins to be produced
or has FSANZ just assumed that this is unlikely? What evidence is there of stability in the crop line, as any
indication of genetic instability means that wheat from this line will be
significantly different over time and under different growing conditions,
making any safety assessment much more difficult.
2. What evidence is there for the actual effects of the
transformation on the wheat's metabolism and composition? Has a thorough
assessment been made for pleiotropic effects, or is the safety data submitted
by the applicant based on the simplistic assumption that there are not any?
3. Has the composition of the GM wheat been adequately
determined? FSANZ has previously been
criticised for its statistical reportage of the compositional analyses of GM
crops in its reports. Will FSANZ
provide the sample size, mean, standard deviation, 95% confidence interval of
the mean, the nature of the statistical tests used and the p-value of each compositional
component? FSANZ has also been
criticised for accepting compositional comparisons using very small sample
sizes. This allows the applicant
company to too-easily find no statistical difference between the composition of
the GM food and its control. This is
profoundly inadequate to assess what may occur in the real world. Will FSANZ be
requiring adequate sample sizes from the applicant company to determine the
composition of the GM wheat? Will FSANZ
also be requiring Monsanto to submit its compositional studies from properly
controlled sites so that the composition of the GM wheat can be properly
assessed compared to its control? Will
FSANZ quantify what it means by substantial equivalence, so that it is clear
what may pass or fail that test?
4. Are any antibiotic-resistant genes incorporated into the
gene cassette? If they are, has the
potential for these to transfer into bacteria in the gut been determined using in
vivo studies, or is this potential just assumed to be negligible?
5. Do considerations of potential allergenicity comply to
standards recommended by independent authorities, such as the National
Academies of Sciences and the WHO? Or are they limited to assessment of
simulated new proteins derived from non-plant sources and crude measures of
digestibility and pH stability? If pH and protease stability are assessed, how
are they assessed? In particular, is pH
2 used as recommended, and do protease levels mirror physiological levels, or
is there any suggestion that abnormally harsh conditions were chosen to hasten
digestion? Did the applicant company
use in vivo measures of digestion or only the far less accurate in
vitro methods?
6. Has a thorough search been made for unexpected toxins in
this GM wheat?
7. What animal studies have been done? Will FSANZ report all
of the results from these animal studies?
FSANZ has been previously criticised for its reportage of the animal
studies. Will FSANZ continue to permit the use of proteins from GM bacteria to
be used in oral gavage studies when the proteins should have been obtained from
the GM plant? Will FSANZ be requiring a
full autopsy of the animals fed the GM wheat (or proteins derived from it) or
will it permit only a very limited “gross pathology” on autopsy? Will FSANZ be requiring long-term feeding
studies to determine the risk from long-term exposure such as cancer risks or
will it continue to rely on exposure feeding studies of 28 days or less? Were there any "unexplained"
illnesses, weight loss or deaths in test animals? Were biochemical and
histopathological assessments made and full data provided? Were sample sizes
adequate for meaningful statistical analysis? What is the evidence of safety
for pregnant and infant animals and foetuses? Were animal studies of a quality
that would allow publication in a peer reviewed journal?
8. What are the potential hazards of the gene promoter
sequences? There is recent evidence of the uptake of cauliflower mosaic virus
promoter into the cells of rats. Clearly, this has serious implications for the
safety of all GM foods. Has FSANZ undertaken a literature search to locate
articles on the safety or hazards of promoter sequences and GM foods generally?
9. What levels of glyphosate residue is expected in RR wheat,
and how much would be ingested by people of various ages who eat a wheat-based
diet? Has FSANZ performed a literature search for evidence of safety and
hazards of glyphosate in food?
10. Has FSANZ undertaken thorough literature reviews of the
claims made by the applicant company in order to verify those claims?
Arguments in
support or opposition to permitting food derived from the wheat line MON 71800
There is widespread consumer and
farmer opposition around the world to the growth of genetically modified wheat
and its incorporation into food. This opposition has been so great, that
Monsanto has been unable to introduce it for a number of years. This opposition
has not softened. The fact is, consumers do not want to eat GM wheat and as a
result, farmers are highly reluctant to grow it.
3 Conclusion
There are no potential benefits,
but many potential costs, associated with GM wheat. As a result, the Institute of Health and Environmental Research
Inc. opposes the approval of food derived from wheat line MON 71800 at this
time.