MADGE calls for Investigation: GM and Allergies - Body of Evidence

Conclusion:

There is an urgent need to investigate whether GM foods are involved in the
phenomenal rise in allergies and anaphylaxis in Australia.

Summary of findings:

  1. A GM pea caused mice to become allergic to egg
  2. The allergy tests done on this GM pea were far more thorough than any allergy test done on the GM food we are eating.
  3. Our food regulator, FSANZ, does no independent safety tests. They base their safety assessments on evidence provided by the companies wanting to release GM crops and food.
  4. The assessment documents are not clear about exactly what proteins the GM plants produce. There are contradictions within and between national assessment documents.
  5. There is no certain way of testing for allergens.
  6. Understanding of how genes and DNA work has increased rapidly and changed fundamentally. FSANZ has not reviewed the safety of previously approved GM food in light of these discoveries.
  7. One study predicts that Monsanto’s Roundup Ready canola (GM) could prove allergenic to people with sensitivities to red shellfish (prawns, shrimp, lobster). The European Food Safety Authority has advised that people with these allergies should be aware of the possibility of hypersensitivity.
  8. FSANZ does no monitoring of the health effects of GM foods once they are on supermarket shelves. Instead FSANZ expects the companies that developed the GM foods to monitor for adverse effects and inform government regulatory authorities of any issues.
  9. In Australia, rates for anaphylaxis in the 0-4 age group have increased 5-fold since 1995. GM foods first reached our plates in 1996.
  10. Public protest meant UK supermarkets removed most GM food from sale in 1999. The rapid increase in anaphylaxis (severe allergy) in children aged 0-4 stabilised.
  11. Norway has very restrictive policies on GM. The Australian rate of severe reactions to food in 0-4 year olds may be nine times that of Norway.

*Errata: In the section “England” on page 8 previous editions of this report wrongly described the age group as 0-
4, rather than 0-14. Point 4 on the summary page has also been altered slightly to better reflect the main document.

MADGE’s Concern

Allergic reactions to foods are usually caused by the proteins in the food. Genetic modifications make crops produce new proteins to change the way plants behave.
There has been a dramatic increase in all grades of food allergy in Australia1, across all age groups2, over the last decade. MADGE is concerned that GM foods may be contributing to this increase.
The new proteins that GM plants produce could be allergens themselves, or they could cross-react with other proteins to become allergens.

This is illustrated by the following study…

The CSIRO GM pea example3:

Australia’s CSIRO (The Commonwealth Science and Industrial Research Organisation) were developing a GM pea. They wanted the GM pea to produce a bean protein. They managed to get the pea DNA to incorporate some DNA code from the bean.

CSIRO asked the John Curtain School of Medical Research in Canberra to test the pea for allergenicity. They did very thorough tests. One of the tests found that mice became allergic to an egg allergen when it was fed to them with the GM protein from the pea. They did not become allergic to the egg when it was fed with the natural protein from the bean. They were not allergic to the egg when it was fed on its own. The GM proteins made the mice susceptible to developing allergies to foods eaten with the GM food. This is called cross-priming.

Other pea proteins also became more allergenic in the GM pea, in comparison to the natural
pea. No-one knows how this happened. It has been suggested that the bean protein made in the
GM pea was processed slightly differently, turning it into a cross-reactive allergen.

The risk of creating new protein allergens through the GM process is well recognised. This is why the world’s “Food Standards” organization (Codex Alimentarius) advises that regulators assess the allergenic potential of each new crop.


Anaphylaxis Graph:
Paediatric food allergy trends in a communitybased
specialist allergy practice, 1995-2006,
Raymond J Mullins, MJA Vol. 186 No. 12 pp 618-
621 * Rate per million population.
Food Approvals Graph:
Food Standards Australia New Zealand (FSANZ):
Genetically Modified Foods & Their Approval
Status,
http://www.foodstandards.gov.au/foodmatters/gmfo
ods/gmcurrentapplication1030.cfm

Anaphylaxis Admissions vs GM Crop Approvals

Guidelines for Allergenic Assessment

Codex Alimentarius has issued Guidelines4 for how an allergy assessment of a GM crop might proceed.
These Guidelines and many of the assumptions on which the safety assessment of GM crops are based have been widely criticized by independent scientists567. The John Curtain tests on the GM pea are far more rigorous than those done on the GM food we are eating. GM food may be causing allergies like the CSIRO GM pea did, however since similar allergy tests haven’t been done we wouldn’t know.

Are GM proteins cross-priming young children to be allergic to more common allergens such as peanuts, egg and milk? No one has any idea and this is why MADGE is concerned.

Tests for Allergenicity

The 2003 Codex Alimentarius Guidelines say “At present, there is no definitive test that can be relied upon to predict allergic response in humans to a newly expressed protein…”

The tests that are done are very superficial – often just on paper – i.e. “In theory, would this protein be allergenic if the plant produced it exactly as we think it might?”8

In most cases, the actual new proteins produced in the seeds have not been subject to a full allergy assessment9.
In some cases the regulators have been uncertain about which new proteins will actually be in the seeds. There are
differences in the stated proteins both between and within food assessment documents.10

Even if the correct proteins are “assessed” this will not guarantee that the protein will not be allergenic or will not cross-prime for other risky proteins to become allergenic 11

The GM process generally creates other disturbances in the plant DNA, and many new proteins may be created that have not even been identified12. Contrary to the scientific knowledge at the time these crops were developed, we now know that one gene (section of DNA) can code for multiple proteins13.

Finally, our Food Standard’s body (FSANZ) has done no testing of its own. In respect of the GM crop under assessment, the commercial company of interest is responsible for demonstrating the safety of the crop.14

In their Roundup Ready Canola assessment FSANZ cited 27 reports, all provided by Monsanto without independent verification. Therefore this process has been likened to relying on the smoking industry to provide evidence that smoking is safe.

Many public submissions in the GM crop approval process have repeatedly stated the inadequacy of allergenicity assessment methods, and they’ve been dismissed without rational basis or ignored by FSANZ.

Post-Market monitoring of GM food

Our regulators FSANZ and OGTR do no monitoring on the long-term impacts of GM foods.


Therefore there is no mechanism for identifying if allergy issues emerge. Instead the responsibility for post-market monitoring is expected to be done by the developers of GM food.

With Roundup Ready canola, Monsanto will be “expected to monitor for existing and emerging risks that may be associated with its product and notify regulatory authorities whenever new information is uncovered15”.
It would be interesting to discover if there is any post-market surveillance on GM food happening anywhere in the world. To date MADGE has heard of none.

The issue is further compounded by the lack of full labeling of GM food. How can we tell if GM food is affecting us
adversely if it is not labelled?

 

Data We’ve Collected

Mullins Pediatric study
In his study in the Medical Journal of Australia, clinical
immunologist and allergy physician Dr RJ Mullens noted
that there is limited published evidence for hypotheses
explaining the changing prevalence in food associated
allergic allergy16. Paediatric food allergy trends in a
community-based specialist allergy
practice, 1995-2006, Raymond J Mullins,
MJA Vol. 186 No. 12 pp 618-621
* Rate per million population.
Age-adjusted Australian hospital
admission rates for anaphylaxis in
the financial years
1993-94 to 2004-05
Box 2: Monsanto’s Roundup Ready Canola
This is the GM canola planted in Victoria and NSW this
year:
At one end of the 'new code', 40 rungs of the parent plant
DNA 'ladder' (base pairs) are missing.1
At the other end of it there are 22 new rungs of the
DNA 'ladder'. It is not known where they came from.1
The GM canola was predicted to be allergenic2 and the
European Food Safety Authority advised:
“Since crossreactivity between GOX and tropomyosin is
not ruled out completely, persons allergic to shrimp
meal should be aware of the possibility of
hypersensitivity reaction when working with [Roundup
Ready canola].”1
1 The EFSA Journal (2004) 29, 1-19
2 Screening of transgenic proteins expressed in transgenic food
crops for the presence of short amino acid sequences identical to
potential, IgE – binding linear epitopes of allergens; Kleter and
Peijnenburg; BMC Structural Biology 2002, 2:8
Last Updated 25 September 2008 10:35am, Page 5 of 13
In a thorough study examining his own clinical experience and other clinics servicing a major
city (Canberra) he found that there had been a 12-fold increase in the number of 0-5 year olds
seen for food allergy between 1995 and 2006, and a 5-fold increase in tip-of-the-iceberg
serious allergic reaction of food-associated anaphylaxis.
To confirm that this wasn’t a specific issue related to his region or clinic he evaluated
Australian population and hospital morbidity data, finding similar trends for the 0-5 year olds,
and noted increases across the whole population.
Hospitals Database material
When people leave hospital (i.e. “Separate”) their diagnosis is coded into the Hospital
Morbidity Database. This database is accessible through the Australian Institute of Health
and Welfare website17.
Two diagnosis codes18 are of particular interest…
T78.0 Anaphylactic shock due to adverse food reaction
T78.1 Other adverse food reactions not elsewhere classified
There has been a three fold increase in hospital separation rates for these combined codes in
the Under 50’s, and a doubling in the Over 50’s. Every age group has been affected.
Hospital Separation Rates
T78.0 Anaphylactic shock due to adverse food reaction, and
T78.1 Other adverse food reactions, not elsewhere classified
Rates per million
Source: AIHW National Hospital Morbidity Database
0.0
50.0
100.0
150.0
200.0
250.0
300.0
350.0
400.0
450.0
0-4
5-9
10-14
15-19
20-24
25-29
30-34
35-39
40-44
45-49
50-54
55-59
60-64
65-69
70-74
75-79
80-84
85+
Age Groups
Hospital Separation Rates
Rate per Million
1998/9
1999/0
2000/1
2001/2
2002/3
2003/4
2004/5
2005/6
2006/7
Exposure to novel GM proteins
Part of an analysis of experience needs to look at our ‘exposure’ to novel GM proteins. How
much has the population been eating? MADGE is trying to come up with a representative
picture.
It is impossible to assess exposure with accuracy, because food containing GM ingredients
has been almost completely unlabelled. Few people keep records of what they eat. To get an
Last Updated 25 September 2008 10:35am, Page 6 of 13
idea of general exposure we need to know the range and amount of new proteins our
population has been exposed to.
Labelling of GM foods has been avoided as it is claimed that refined foods don’t contain
proteins. Therefore it is assumed that as there are no GM proteins, labeling is unnecessary.
There is a very large body of evidence to the contrary19. Even evidence provided by at least
one GM company shows they know there is protein in refined canola oil20. We also know
from a Foods Standards pilot study that our food has been contaminated by GM, even food
that has been labelled as free of GM ingredients21.
Food approvals began formally around 1998/9. Seven crops are listed as being approved in
the year 2000 – six of these were created by Monsanto22. We know that we were eating
unapproved GM foods before this time. Monsanto said its Roundup Ready soybeans had
been imported into Australia since December 199623 and that its Roundup Ready canola may
have been imported into Australia and New Zealand for ‘several years’24.
According to the International Service for the Acquisition of Agri-biotech Applications
(ISAAA) briefs (a biotech body) commercial crops were first officially planted in 199625. We
also know that at least 12 food crops producing different novel proteins were being grown
world wide in 199626. We may have been consuming a wide variety of novel proteins, albeit
in very small amounts.
Prior to 1996 there had been an escalation in the
planting of trial GM crops, including 37 GM
food crop trials in Australia27. From 1996
Australia had 40,000 hectares of GM cotton
growing28 Did GM cottonseed oil first enter the
market in 1996? Did cottonseed oil from the
extensive test crops enter the market before that?
Under a new Standard A18 adopted in July
1998, GM foods were prohibited unless
‘approved’. The approval requirements came
into force on 13 May 1999, but GM foods
currently on the market were exempted provided
an application for approval was received on or
before 30 April 1999.
Some food additives and processing agents are
produced by genetically engineered bacteria or
are derived from GM crops. This complicates
the issue further.
We have disregarded GM additives in this
rough graph of formal crop approvals by Food
Standards Australia New Zealand (FSANZ –
formally ANZFA)29.
How much of these novel food products were
we eating? It’s difficult to know. The crops
haven’t been widely adopted, particularly in
developed countries other than the USA, but it
World GM Crop Hectares
0
20
40
60
80
100
120
140
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
GM Crop Hectares (millions)
GM Crop Food Approvals
0
5
10
15
20
25
30
35
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
Number of GM Crops Approved
Through the Food System
Last Updated 25 September 2008 10:35am, Page 7 of 13
is estimated that they occupy 8.4% of arable land30, although this has been challenged.
While the acreage of GM crops is small, the food products from two of these crops, soy and
corn, are ubiquitous in processed food. Sixty-four percent of the world soy crop is GM – 93%
of the soy crop in the USA is GM. We import soy and soy products from the USA. It is likely
that these products are contaminated by GM proteins. Inadequately monitored and unlabelled
GM proteins would be expected in a lot of processed food.
Prediction of allergens
Allergies have increased in line with the increase in exposure to novel GM proteins in the
Australian population. An independent study has specifically predicted that some of these
proteins may be allergens31, and the European Food Safety Authority has taken note32.
The study predicted that the gox-related novel protein in Monsanto’s Roundup Ready canola
planted in Australia may be allergenic. The gox-related protein was found to have an identical
amino acid sequence to a known allergenic sequence of Tropomyosin. Tropomyosin is the
allergen commonly found in red shellfish (shrimp, prawn, lobster etc). Roughly 500,000
Australians are estimated to be allergic to red shellfish. This is a large group of people who
can recognise and avoid a prawn, but can’t recognise an untested allergen in unlabelled GM
canola.
The European Food Safety Authority put out a warning for people working with this product
when it was reviewed for animal feed suitability in 2004.
"Since cross-reactivity between GOX and tropomyosin is not ruled out completely,
persons allergic to shrimp meal should be aware of the possibility of hypersensitivity
reaction when working with GT73 [Roundup Ready Canola]."
MADGE are currently researching a different but ubiquitous GM protein with predictions of
allergenicity.
Alternative hypotheses for the rise in allergies
It is argued that we are becoming cleaner and that a lack of early childhood exposure to bugs
of all kinds increases susceptibility to allergic diseases. This is the Hygiene Hypothesis.
However the increase in food related allergy is happening simultaneously across all age
groups.
Factors in this hypothesis such as immunization, breastfeeding, cesarean section, and
“parental cotton woolling” cannot explain the increase in allergy in the older age groups.
With so many mothers returning to the paid workforce over this period33 it is unlikely that our
houses are any cleaner than previously. This return to the workforce does make it more likely
that children have been fed the sort of rapidly prepared processed foods which are more likely
to contain GM ingredients.
It is happening at different rates across similarly hygienic and immunized developed
countries. There appears to be a link with food policy in those countries.
Last Updated 25 September 2008 10:35am, Page 8 of 13
It is difficult to compare international hospital statistics – with over 8,000 codes for ‘principal
diagnosis’ there will be international and inter-hospital differences in diagnoses.
There are also population differences in factors thought to influence base level allergy rates.
For example, breastfeeding is thought to be generally protective, particularly in the first days,
and there are major differences in breastfeeding rates between developed nations. At 3
months 80% of Norwegian babies are fully breastfeeding, about 55% in Australia and 25% in
England (25% of English babies are not put to the breast at all)34.
Despite these differences there are some features in the statistics that are worth noting.
England
In England GM food was sold, including whole foods
such as tomatoes, but there was a massive outcry and
removal of GM foods from some supermarkets that
culminated mid 199935. By 2001 the rapidly increasing
incidence of anaphylaxis in the 0-14* age group had
stabilized (see graph “Hospital Separation Rates:
England vs. Australia).
By the 2005/6 year there had been a 435% increase in
the number of Australian children (0-14* years) leaving
hospital with a diagnosis of food anaphylaxis or other
adverse food reaction (codes T78.0 and T78.1) over the
1998/9 figures, compared to the 173% increase for the
same age group in England.
*Errata: Previous editions of this report wrongly described the age
group as 0-4, rather than 0-14.
Norway
In Norway there were two rounds of public ‘Consensus Conferences’ in 1996 and 2000 on the
GM issue36. Norway has very restrictive trade policies on GM food, animal feed and
contamination37. US soybeans were disallowed in Norway from 1996, and all food and feed
produced from genetic engineering – including products that no longer contain detectable
traces of agricultural products derived from biotechnology –
must be labelled38. So far no GMO products have been
approved as food or as ingredients in food39.
Unlike Australia, the Norwegian National Reporting System
and Register of Severe Allergic Reactions to Food reported
that the incidence of serious allergic reaction for the 0-4 year
old age group is no higher than that for the young adult age
group40.
“The typical Norwegian patient with a severe allergic
reaction to food appears to be a young adult, female rather
than male. The offending meal is consumed at a restaurant
or fast-food stand or in a private party away from home, and
peanuts, nuts and shellfish are among the most common
offending foods.”
The Norwegian National Reporting System
and Register of Severe Allergic Reactions
to Food; Norsk Epidemiologi 2004; 14
(2): 155-160 155; Martinus Løvik1et al
Figure 2: The age distribution of severe
allergic reactions to food in Norway shows
two peaks: 0-4 year olds and 20-35 year
olds.
Hospital Separation Rates
England vs Australia
0-14* year olds
T78.0 Anaphylactic shock (food)
T78.1 Other adverse food reactions
Rates per million
Source: AIHW National Hospital M orbidity Database
0.0
50.0
100.0
150.0
200.0
250.0
1998/9
1999/0
2000/1
2001/2
2002/3
2003/4
2004/5
2005/6
2006/7
Hospital Separation Rates
per million
Australia England
Last Updated 25 September 2008 10:35am, Page 9 of 13
While this group left open the possibility that they had not received notification of every
severe event (MADGE is awaiting statistics from the Norwegian hospital database), it is
nonetheless possible to see the dramatically different experience within the Australian
population.
Australian rates of young children (0-4 years) requiring hospitalization are three times higher
than young Australian adults (20-29 years). In Norway the 0-4 age group has fewer reported
allergic reactions to food than the 20-29 age group.
With the numbers we have at present and assuming the severe allergy definitions are
equivalent, the Australian levels of severe allergic reaction to food are:
• 9 times greater in the 0-4 age group than in Norway.
• 4 times greater in the 5-14 age group than in Norway.
• 2 times greater in the 15-59 age group than in Norway
Conclusion.
MADGE hopes this document illustrates the urgent need to investigate whether GM foods are
involved in the phenomenal rise in allergies and anaphylaxis in Australia. Allergies are an
immediate and measurable sign of problems with food. Could GM foods be causing less
visible damage to our health that will take years to uncover?
Should GM food approved on the basis of evidence produced by the companies that
developed the product be on our shelves? What monitoring have these companies done into
the post-market effects of GM foods on our health? Have our Governments and regulatory
agencies acted in the public interest in approving GM food for sale?
Please contact MADGE, your Federal and State politicians and your food companies and
retailers if you are concerned about this issue.
References
1 Paediatric food allergy trends in a community-based specialist allergy practice, 1995-2006, Raymond J
Mullins, MJA Vol. 186 No. 12 pp 618-621
2 Separation, patient day and average length of stay statistics by principal diagnosis in ICD-10-AM, Australia,
1998-99 to 2006-07; T78.0 Anaphylactic Shock due to adverse food reaction + T78.1 Other adverse food
reactions, not elsewhere classified; http://www.aihw.gov.au/cognos/cgibin/
ppdscgi.exe?DC=Q&E=/ahs/pdx0607
3 Transgenic Expression of Bean r-Amylase Inhibitor in Peas Results in Altered Structure and Immunogenicity;
J. Agric. Food Chem. 2005, 53, 9023-9030 9023; PRESCOTT VE et al
4 Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants;
CAC/GL 45-2003; www.codexalimentarius.net/download/standards/10021/CXG_045e.pdf
5 The use of the “Substantial Equivalence” criteria and associated untested hypotheses/claims has been broadly
criticized – begin with Genetic Roulette; Jeffrey Smith; ISBN 978-0-646-48131-9
6 Suggestions for the Assessment of the Allergenic Potential of Genetically Modified Organisms; Spök A et al;
Int Arch Allergy Immunol 2005;137:167-180
Last Updated 25 September 2008 10:35am, Page 10 of 13
7 Reviewers of the CSIRO study questioned whether a typical GM crop safety assessment would have picked
up the problem with the GM peas. Immunogencity of GM peas – Review of immune effects in mice fed on
genetically modified peas and wider impacts for GM risk assessment; Rudolf Valenta and Armin Spök; 2008;
Bundesamt für Naturschutz (BfN) Federal Agency for Nature Conservation; http://www.bfn.de
8 The 2003 Codex Guidelines set out the following strategies
3.1 Source of the Protein – a paper test – is the source of the protein allergenic?
3.2 Amino Acid Sequence Homology – a paper/computer test – proteins are made up of smaller pieces
called amino acids, and there is a test to see how similar the new protein is to sequences of known
allergens
3.3 Pepsin Resistance – a test-tube test – protein (to be discussed in the next point) is tested in supposed
Simulated Gastric Fluid to see if it quickly degrades, ignoring the fact that many people, including
breastfeeding toddlers and adults with ulcers have a range of gastric experience and susceptibility. A
test may also be done for pancreatin resistance in Simulated Intestinal Fluid.
4.0 Specific Serum Screening - If 3.1 and 3.2 indicate, serum testing may be done in a test-tube
5.0 Other Considerations – in-theory considerations of how the protein may eventually be consumed in
food, and an opening to use other scientific methodology as it evolves.
9 The proteins (if known – to be discussed in the next point) may not have come from the actual plant. They
may have been artificially produced by genetically engineered bacteria in a laboratory, according to the
theoretical sequence of the protein produced in the plant, without regard for the fact that there may be
significant post-translational changes in the plant cell. If the proteins have come from the plant, they may not
have come from the edible part of the plant – from the leaves rather than the seeds, nor from the current
version of the plant.
10 The opportunity to read retrospectively through approval documents from around the world on particular
crops has shown a great deal of discrepancy between the understanding of the various national regulators on
the nature of the plant and protein - of particular note is Monsanto’s Roundup Ready canola GT73.
Regulators depend on the information they are given by the company, but striking confusion is apparent, not
just between the assessment documents, but within them. Supporters of the MADGE network are pursuing
this.
11 As earlier mentioned it is acknowledged both in the Codex Alimentarius Guidelines and in the Food
Standards Australia New Zealand (FSANZ) document “GM Foods – Safety Assessment of Genetically
Modified Foods” that allergens cannot be predicted with certainty. While MADGE would prefer a
Precautionary approach (unsafe until proven safe), if foods from these crops are to be released on the market,
there should be post-introduction surveillance, to see if people do show allergic reaction to the product,
immediately, and after an appropriate period of sensitization.
12 There are lots of ways that unintended proteins could be created. Anything that affects the DNA in the host
cell could have unintended effects on the way the DNA code is used. With the help of scientists from many
fields Jeffrey Smith compiled the following list in his book Genetic Roulette pp 233-236; ISBN 978-0-646-
48131-9
• Inserted foreign genes might create multiple proteins, with unpredictable consequences.
• Foreign proteins may be folded improperly or become attached to other molecules, which could change
their properties. Likewise, gene expression may be affected by the genetic disposition of a host organism,
or even the environment.
• The process of inserting foreign genes can damage the structure and function of the host’s DNA, switch
genes on or off, create never-before-seen genetic sequences and render the genome unstable.
• The promoter may turn on native genes. This can create a flood of proteins with unpredictable
consequences. Some scientists theorize that the promoter might even switch on dormant viruses that are
deposited along the DNA.
• Studies indicate that the promoter may create a “hotspot” in the DNA, whereby the whole DNA section, or
chromosome, can become unstable. This can cause breaks in the strand or exchanges of genes with other
chromosomes.
Last Updated 25 September 2008 10:35am, Page 11 of 13
• Insertion of foreign genes and their new proteins may create complex, unpredictable interactions, not well
understood. Similarly, inserting two or more foreign genes into the same plant may also cause interactions
that have not been studied.
• Inhalation of pollen may cause unpredicted health problems. Transfer of genes from inhaled pollen may
also be possible.
• After GM soy was introduced into the UK, soy allergies sky-rocketed 50%. Current GM corn would not
pass tests recommended by FAO/WHO for potential allergenicity. The EPA’s Scientific Advisory Panel
determined that GM protein in StarLink corn has a “medium likelihood” of being an allergen.
• Different organisms process genetic information and synthesize proteins differently.
• There are proteins with identical (active site) sequences that differ in other amino acids, and as a result,
function differently.
• One amino acid can alter both the structure and the function of a protein, especially if the change occurs at
the active site of an enzyme.
• The actual transgene sequences of several GM crops differ from that which was registered by the company.
• In some cases cooking does not destroy allergenicity but rather makes proteins more allergenic.
• The loss of pesticidal properties does not insure the loss of allergenic properties.
• RNA can impact gene expression, even in subsequent generations.
• In Roundup Ready soybeans, the NOS terminator was ineffective in ending transcription, and may have
helped process the RNA in four variants.
13 Identification and analysis of functional elements in 1% of the human genome by the ENCODE pilot project;
ENCODE project consortium; Nature. 2007 Jun 14;447(7146):799-816
The ENCODE project aimed to look at the function of 1% of Human DNA – around 300 scientists from 35
groups and 80 organisations took 4 years to look see what DNA does. They found that every bit is used,
‘genes’ overlap, prompting other investigators to come up with an alternative definition for a gene…
“A gene is a union of genomic sequences encoding a coherent set of potentially overlapping functional
products.” What is a gene, post-ENCODE? History and updated definition. Gerstein MB et al; Genome Res.
2007 Jun;17(6):669-81
14 SENATE - STANDING COMMITTEE ON COMMUNITY AFFAIRS – ESTIMATES (Budget Estimates)
- WEDNESDAY, 4 JUNE 2008 pp134-136 http://www.aph.gov.au/hansard/senate/commttee/S10859.pdf
15
http://www.foodstandards.gov.au/newsroom/factsheets/factsheets2002/faqsongmfoods6august163
2.cfm
16 Paediatric food allergy trends in a community-based specialist allergy practice, 1995-2006; Mullins RJ; MJA,
Volume 186, Number 12, 18 June 2007
17 http://www.aihw.gov.au/cognos/cgi-bin/ppdscgi.exe?DC=Q&E=/ahs/pdx0607
18 Principal Diagnosis Separations statistics by ICD10 codes 1998/9 – 2006/7
19 Proteins in Refined Oil
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soy lecithin and soy oil in soybean allergy. Clin. Exp. Allergy, 28: 1559-1564.
2. Crevel, R. W. R., Kerkhoff, M. A. T., Koning, M. M. G. (2000). Allergenicity of refined vegetable oils.
Food Chem Toxicol, 38:385-393.
3. Errahali, Y., Morisset, M., Moneret-Vautrin, D. A., Kanny, G., Metche, M., Nicolas, J. P., Fremont, S.
(2002). Allergen in soy oils. Allergy, 57(7):648-649.
4. Hoffman, D. R. and Collins-Williams, C. (1994). Cold-pressed peanut oils may contain peanut allergen.
J Allergy Clin Immunol, 93(4):801-802.
5. Klurfeld, D. M. and Kritchevsky, D. (1987). Isolation and quanititation of lectins from vegetable oils.
LIPIDS, 22(9):667-668.
Last Updated 25 September 2008 10:35am, Page 12 of 13
6. Nordlee, J. A., Neimann, L. M., Hefle, S. L., Taylor, S. L. (2002). Determination of proteins in soybean
oil from distinct processing steps. Abstracts of the IFT Annual Meeting.
7. Olszewski, A., Pons, L., Moutete, F., Aimone-Gastin, I., Kanny, G., Moneret-Vautrin, D. A., Gueant, J.
L. (1998). Isolation and characterization of proteic allergens in refined peanut oil. Clin. Exp. Allergy,
28:850-859.
8. Paschke, A., Zunker, K., Wigotzki, M., Steinhart, H. (2001). Determination of the IgE-binding activity
of soy lecithin and refined and non-refined soybean oils. J Chromatogr B Biomed Sci Appl, 756(1-
2):249-254.
9. Peeters, K. A. B. M., Knulst, A. C., Rynja, F. J., Bruijnzeel-Koomen, C. A. F. M., Koppelman, S. J.,
(2004). Peanut allergy: sensitization by peanut oil-containing local therapeutics seems unlikely. J Allergy
Clin Immunol, 113:1000-1001.
10. Reeves, R. M. (1999). Letter from Institute of Shortening and Edible Oils to Joint FAO/WHO Expert
Committee on Food Additives, Food and Nutrition Division. Unpublished data analytical results for
protein in oil.
11. Skinner and Haynes. (1998). Seed crushers and oil processors association report as reported in: WHO
Food Additive Series 44 and in EFSA Notification.
12. Tattrie, N. and Yaguchi, M. (1973). Protein content of various processed edible oils. Journal of the
Institute for Cancer, Science Technology and Alimentation, 6:289-290.
13. Teuber, S. S., Brown, R. L., Haapanen, L. A. D., (1997). Allergenicity of gourmet nut oils processed by
different methods. J Allergy Clin Immunol, 99:502-507.
20 The FSANZ (then ANZFA) Final Risk Assessment Report attached to the Final Risk Analysis Report
document reported that the Monsanto Roundup Ready Canola crop line contained 0.290 ppm of protein in the
refined oil
21 Australian Pilot Survey of GM Food Labelling of Corn and Soy Food Products; The TAG Working Group on
GM Food Labelling; June 2003
22 Genetically modified foods and their approval status; Food Standards Australia New Zealand (FSANZ);
http://www.foodstandards.gov.au/foodmatters/gmfoods/gmcurrentapplication1030.cfm
23 FULL ASSESSMENT REPORT AND REGULATORY IMPACT ASSESSMENT SUBJECT: A338 - FOOD
DERIVED FROM GLYPHOSATE-TOLERANT SOYBEANS
http://www.foodstandards.gov.au/_srcfiles/A338FAR.pdf
24 FINAL RISK ANALYSIS REPORT - APPLICATION A363 - Food produced from glyphosate-tolerant
canola line GT73; http://www.foodstandards.gov.au/_srcfiles/A363%20draft%20IR.pdf
25 ISAAA Briefs; http://www.isaaa.org/RESOURCES/PUBLICATIONS/BRIEFS/default.html
26 Global Status of Transgenic Crops in 1997; Clive James; Chair ISAAA board of Directors;
http://www.isaaa.org/RESOURCES/PUBLICATIONS/BRIEFS/05/download/isaaa-brief-05-1997.pdf . The
crops were Herbicide Tolerant Soybeans, Insect Resistant Corn, Herbicide Tolerant Canola, Herbicide
Tolerant Cotton, Insect Resistant Cotton, Herbicide Tolerant Corn, Virus Resistant Tomatos, Herbicide
Tolerant Hybrid Technology Canola, Insect Resistant Hybrid Technology Cotton, Lauric Canola, Insect
Resistant Potato, Delayed Ripening Tomato
27 Global Review of the Field Testing and Commercialization of Transgenic Plants: 1986 to 1995; The First
Decade of Crop Biotechnology; Clive James and Anatole F. Krattiger, ISAAA;
http://www.isaaa.org/RESOURCES/PUBLICATIONS/BRIEFS/01/download/isaaa-brief-01-1996.pdf
28 Table 9. Global GM plantings by country 1996-2005 (‘000 hectares); GM Crops: The First Ten Years -
Global Socio-Economic and Environmental Impacts; Graham Brookes and Peter Barfoot; PG Economics
Ltd., UK
http://www.isaaa.org/RESOURCES/PUBLICATIONS/BRIEFS/36/download/isaaa-brief-36-2006.pdf
29 Genetically modified foods and their approval status; Food Standards Australia New Zealand (FSANZ);
http://www.foodstandards.gov.au/foodmatters/gmfoods/gmcurrentapplication1030.cfm
30 GM Crops Around the World – an accurate picture June 2008; GM Freeze; citing www.nationmaster.com and
ISAAA; http://www.gmfreeze.org/uploads/GM_crops_land_area_final.pdf
Last Updated 25 September 2008 10:35am, Page 13 of 13
31 Screening of transgenic proteins expressed in transgenic food crops for the presence of short amino acid
sequences identical to potential, IgE – binding linear epitopes of allergens; Kleter and Peijnenburg; BMC
Structural Biology 2002, 2:8
32 Opinion of the Scientific Panel on genetically modified organisms [GMO] on a request from the Commission
related to the Notification (Reference C/NL/98/11) for the placing on the market of herbicide-tolerant oilseed
rape GT73, for import and processing, under Part C of Directive 2001/18/EC from Monsanto; The European
Food Safety Authority (ESFA) Journal (2004) 29, 1-19, Section 4.3 Conclusions
33 cat. no. 4102.0 - Australian Social Trends, Data Cube; Released at 11.30am (Canberra time) 23 July 2008;
Table 1 Family and community, National Summary, 1997-2007;
34 Australia
Australian Bureau of Statistics,“Breastfeeding in Australia, Electronic delivery”,
www.abs.gov.au/Ausstats/abs@.nsf/ Maternal and Child Health Services Annual Reports, Office For
Children, Department of Human Services, State Government of Victoria. 2000/1-2004/5 at
http://www.office-for-children.vic.gov.au/children/ccdnav.nsf/childdocs/-
F6E555C5D757CA2BCA256E18006497D4-ED1E2431B9EB4892CA256E2000088BF8-
AE9FB320272ADFE6CA256E20000882FF?open
England
Infant Feeding Survey 2005; Bolling, Grant, Hamlyn, Thornton; “A survey conducted on behalf of The
Information Centre for health and social care and the UK Health Departments by BMRB Social Research” ;
The Information Centre; (ISBN: 1-84636-124-9, www.ic.nhs.uk, email: enquiries@ic.nhs.uk)
Norway
Directory for Health and Social Affairs. “Dietary survey among infants, 1998",
www.ssb.no/english/subjects/03/01/kostspe_en/art-2003-03-28-01-en.html
35 GM Foods in the UK between 1996 and 1999: comments on “Genetically Modified Crops: Risks and
Promise” by Gordon Conway; John R Krebs; Ecology and Society, Vol. 4, No. 1, Art. 11
http://www.ecologyandsociety.org/vol4/iss1/art11/
36 CONSENSUS CONFERENCES ON GENETICALLY MODIFIED FOOD IN NORWAY; Alf J. Mørkrid;
OECD 2001 http://www.oecd.org/dataoecd/53/56/2537449.pdf
37 USDA Foreign Agricultural Service - GAIN Report - Global Agriculture Information Network
http://www.fas.usda.gov/GainFiles/200303/145884831.pdf
38 2008 report on Norway from the Office of the United States Trade Representative;
http://www.ustr.gov/assets/Document_Library/Reports_Publications/2008/2008_NTE_Report/asset_upload_f
ile589_14676.pdf
39 The Norwegian Food Standards body: Mattilsynet www.mattilsynet.no
“I'll try to answer you as well as I can (in English): In Norway there are very strict laws when it comes to
approval and labelling of genetically modifies foods (GMO). So far no GMO products have been approved as
food or as ingredients in food. But Norway imports food from countries which have approved the use of
GMO products. Therefore it is very likely that GMO foods can end up in Norwegian stores.”
40 The Norwegian National Reporting System and Register of Severe Allergic Reactions to Food; Lovik M et al;
Norsk Epidemiologi 2004; 14(2): 155-160