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ISIS Report 13/07/06
GM Egg Plant Contains Bt Toxin Linked to Hundreds of Allergy Cases and Thousands of Sheep Deaths
It would be unthinkable and irresponsible to approve the genetically modified eggplant.
Dr. Mae-Wan Ho and Prof. Joe Cummins find no published studies nor experimental details on safety tests in the application for field releases of the Bt brinjal and raise serious questions
brinjal a test case for other GM food crops
Indian subsidiary of US seeds corporation Monsanto,
Maharashtra Hybrid Seed, has developed genetically modified (GM) brinjal resistant to fruit
and shoot borer and is applying for large-scale test releases . Brinjal, an eggplant, is widely consumed in India and recognized for its health
promoting properties such as reducing serum levels of cholesterol. Field trials
of other GM crops, including mustard and potatoes, will follow the brinjal
The GM brinjal contains the same Cry1Ac toxin from the soil bacterium Bacillus
thuringiensis as the widely cultivated GM cotton that has been implicated
recently in major health controversies in India. Hundreds of farm workers and
cotton handlers developed allergic reactions  (More illnesses linked to Bt crops,
SiS30) and thousands of sheep died from toxic reactions after grazing
on the post-harvest GM cotton fields  (Mass deaths in sheep grazing on Bt
These controversies on the health hazards of Bt crops corroborate findings
dating back to the 1980s, which linked Bt bacteria and spores producing a mixture
of Cry proteins to allergic reactions . Cry1Ac itself has been identified
as a potent systemic and mucosal immunogen  and adjuvant comparable to cholera
toxin . Thus, not only can the Bt toxin provoke immune reactions to itself,
it can also sensitize a person to develop allergies to other components in the
diet. At least 12 dairy cows died in Germany after feeding on GM maize containing
a gene coding for a protein similar to Cry1Ac  (Cows
ate GM maize and died SiS21).
Cry1Ac is not the only Bt transgenic protein linked to serious health problems.
Dozens of villagers fell ill in the south of the Philippines when a Bt maize
with Cry1Ab came into flower in 2003, and five have died since  (GM ban long overdue, dozens
ill & five deaths in the Philippines, SiS 29). Illnesses and
death associated with numerous other GM crops with different transgenes have
been reported in many species. The most dramatic recent example is the severe
stunting and premature deaths in the litter of female rats fed GM soya throughout
their pregnancy , and the debilitating inflammation of the lungs in mice
tested with a transgenic pea containing a normally harmless bean protein 
(Transgenic pea that made mice ill,
A comprehensive public enquiry into the health
hazards of GM crops is long overdue, as is a global ban while the enquiry
is in place. It is unthinkable and irresponsible to release yet another GM
crop with a transgenic protein that has already been implicated in so many
illnesses and fatalities.
The Report accompanying the application for field release  provides such
a superficial description of the GM brinjal and unpublished experiments on environmental
and health impacts that it would never have passed muster in Europe; which is
not to say that Europe’s regulatory system is adequate. We concentrate on health
impact studies that, according to the company, show Bt brinjal is as safe as
non Bt brinjal.
studies raise worrying questions
studies were all unpublished experiments conducted (except for one) at Intox
Pvt Ltd., and amounted to bland assurances that none of the tests caused any
However, some statements in the Report should be examined
carefully. On p. 7, it states (emphasis added): “Acute oral administration
of transgenic Bt brinjal expressing CrylAc protein to Sprague Dawley rats
at the limiting dose of 5000mg/kg did not cause
any toxicity.” What exactly is the limiting dose? Does
it mean that beyond 5 000 mg/kg the Bt brinjal was in fact acutely toxic?
After all, that is equivalent to a person weighing 50 kg eating a medium-size
brinjal, which is not unusual.
The next paragraph reports the results of subchronic
oral toxicity study, where it states that “the no-observed-adverse-effect (NOAEL)
of transgenic Bt brinjal expressing Cry1Ac protein in Sprague Dawley rat, following
oral administration for 90 days was found to be more than 1000 mg/kg body weight.
This study demonstrates that Bt brinjal expressing Cry1Ac protein is non-toxic
to the study animal by oral route.”
The designation of “NOAEL” (no-observed-adverse-effect-level)
is worrying as it has no scientific precedent. Does that mean doses higher than
1 000mg/kg body weight could be toxic? So, a person weighing 50 kg eating a
quarter of a brinjal a day might be putting herself in danger?
The “allergenicity” studies, unpublished and conducted by
another company, Rallis India Limited, contained even less details to support
the statement of “no differences between the allergenicity or inflammatory
characteristics of the 5 brinjal extracts tested including transgenic Bt brinjal
and non transgenic brinjal.”
The same goes for the “primary skin irritation test”, and
the “mucous membrane irritation test”, both conducted by Intox Pvt. Ltd.
studies highly questionable
series of “nutritional studies”, involved “compositional analysis”, which,
the company claims, shows that Bt brinjal is “substantially equivalent” to
“control brinjal” and thus “the food and feed derived from Bt brinjal will
also be substantially equivalent to the food and feed derived from non-Bt
counterpart.” Again, there are no experimental details given whatsoever.
Compositional studies have long been rejected by the European
public as a demonstration of “substantial equivalence”, and “substantial equivalence”
itself is widely seen as unscientific and unacceptable as a principle of risk
assessment  (The Case for a GM-free Sustainable
Another series of unpublished feeding studies with Bt brinjal on
fish, chickens cows, goats and rabbits are reportedly, carried out in a variety
of companies and institutions, all demonstrating “no significant differences”
between Bt and non-Bt brinjal.
In the only case (chickens) where the amount of Bt brinjal
eaten is stated, it constituted 5 or 10 percent of the diets. That is equivalent
to little more than a mouthful of Bt brinjal at each meal for a human being.
are no molecular data in the Report to indicate where and in what form the
transgenes have inserted into the brinjal genome, and whether the insert has
remain stable, which would have been required under the European directive
for deliberate release. It is now generally accepted that genetic modification
is “event-specific”, the transformation causing a lot of collateral mutational
damage to the genome including [10-12] as well as the tendency of the integrated
insert to be unstable [10-11, 13-15] (The Case for A GM-Free Sustainable
World; Living with the Fluid Genome; Transgenic lines proven unstable; Unstable transgenic lines illegal).
The only molecular information provided is that the Cry1Ac
gene is driven by an “enhanced CaMV 35S promoter” (no further details), and
two antibiotic resistance marker genes are present: the nptII gene coding for neomycin phosphotransferase II (NPTII)
(kanamycin resistance) derived from the prokaryotic transposon Tn5; and the
aad gene coding for aminoglycoside adenyl
transferase (AAD) (spectinomycin and streptomycin resistance) isolated from
bacterial transposon Tn7. The aad
gene is under the control of a bacterial promoter and hence not expressed
in Bt brinjal, though it would be fully active in bacteria.
transfer not considered
is strong likelihood that the two antibiotic resistance marker genes will
spread to pathogenic bacteria in all environments by horizontal gene transfer
[16-18] (FAQs on genetic engineering; Recent evidence confirms risks
of horizontal gene transfer) and hence exacerbate resistance to antibiotics
that are currently used in human and veterinary medicine. Horizontal gene
transfer is not considered at all in the Report.
There is evidence that such resistance markers may spread to bacteria in the
gut of animals including human beings  (DNA in GM food and feed, SiS
23), as well as to bacteria in the soil and water  simply because DNA does
not break down fast enough in all environments.
it would be courting disaster to release
yet another GM crop with a transgenic protein that has already been implicated
in so many illnesses and fatalities. The company’s dossier is highly unsatisfactory
and incomplete, and raises some serious safety questions. It can give no comfort
to farmers and cotton handlers who have suffered allergic reactions to Bt
cotton, nor to farmers who have lost their sheep to Bt cotton.
Instead of approving more GM crops, regulatory authorities in India should
start a comprehensive enquiry into the health impacts of Bt cotton and impose
a ban on further releases of all GM crops.
- Maharashtra Hybrid Seed, Company DEVELOPMENT OF FRUIT AND SHOOT BORER TOLERANT
BRINJAL 2006 http://www.envfor.nic.in/divisions/csurv/geac/macho.pdf
- Ho MW. More illnesses linked to Bt crops. Science in Society 2006,
30, 8-10, http://www.i-sis.org.uk/isisnews.php
- Ho MW. Mass death in sheep grazing on Bt cotton. Science in Society
2006, 30, 12-13, http://www.i-sis.org.uk/isisnews.php
- Bernstein IL, Bernstein JA, Miller M, Tierzieva S, Bernstein DI, Lummus
Z, Selgrad MJK, Doerfler DL, Seligy VL. Immune responses in farm workers after
exposure to Bacillus thuringiensis pesticides. Environmental Health Perspectives
1999, 107 (7), http://www.ehponline.org/members/1999/107p575-582bernstein/bernstein-full.html
- Vázquez-Padrón R, Moreno-Fierros L, Neri-Bazan L, de la Riva G and López-Revilla
R. Intragastric and intraperitoneal administration of Cry1Ac protoxin from
Bacillus thuringiensis induces systemic and mucosal antibody responses
in mice. Life Sci. 1999, 64, 1897-912.
- Vazquez RI, Moreno-Fierros L, Neri-Bazan L, De La Riva GA and López-Revilla
R. Bacillus thuringiensis Cry1Ac protoxin is a potent systemic and mucosal
adjuvant. Scand J Immunol 1999, 578-84.
- Ho MW and Burcher S. Cows ate GM maize and died. Science in Society
2004, 21, 4-6, http://www.i-sis.org.uk/isisnews.php
- Ho MW. GM ban long overdue, dozens ill and five deaths in the Philippines.
Science in Society 2006, 29, 28-29, http://www.i-sis.org.uk/isisnews.php
- Ho MW. Transgenic pea that made mice ill. Science in Society 2006,
29, 26-27, http://www.i-sis.org.uk/isisnews.php
- Ho MW, Lim LC et al. The Case for A GM-Free Sustainable World, Independent
Science Panel Report, TWN and ISIS, Penang and London, 2003, republished
as GM-Free, Vital Health Publishing, Ridgefield, CT, 2004, translated into
Spanish, French, German, Portuguese, Chinese and Indonesian, http://www.i-sis.org.uk/onlinestore/books.php#232
- Ho MW. Living with the Fluid Genome, TWN, ISIS, Penang, London, 2003, http://www.i-sis.org.uk/onlinestore/books.php#232
- Latham JR, Wilson AK, Steinbrecher RA. The mutational consequences of plant
transformtion. J Biomed Biotech 2006, Article ID 25476, pp. 1-7.
- Collonier C, Berthier G, Boyer F, Duplan M-N, Fernandez S, Kebdani N, Kobilinsky
A, Romanuk M, Bertheau Y. Characterization of commercial GMO inserts: a source
of useful material to study genome fluidity. Poster presented at ICPMB: International
Congress for Plant Molecular Biology (n°VII), Barcelona, 23-28th June 2003.
Poster courtesy of Pr. Gilles-Eric Seralini, Président du Conseil Scientifique
du CRII-GEN, www.crii-gen.org
- Ho MW. Transgenic lines proven unstable. Science in Society 2003,
20, 35, http://www.i-sis.org.uk/isisnews.php
- Ho MW. Unstable transgenic lines illegal. Science in Society 2004,
21, 23, http://www.i-sis.org.uk/isisnews.php
- Ho MW. Recent evidence confirms risks of horizontal gene transfer. ISIS
contribution to ACNFP/Food Standards Agency Open Meeting 13 November 2002,
- de Vries J, Herzfeld T and Wackernagel W. Transfer of plastid DNA from tobacco
to the soil bacterium Acinetobacter sp. by natural transformation. Molecular
Microbiology 2004, 53, 323-34.
- Nielsen K, van Elsas J and Smalla K. Transformation of Acinetobacter
sp. strain BD413(pFG4DeltanptII) with transgenic plant DNA in soil microcosms
and effects of kanamycin on selection of transformants. Appl Environ Microbiol.
- Ho MW. DNA in GM food and feed. Science in Society 2004, 23, 34-36,