GENELICALLY MODIFIED ORGANISMS
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RF_ST_6_SUDHA
UNPREDICTABLE; IRRE VERS ABLE;
UNNATURAL
The story of Genetically Engineered Foods
Greenpeace India
#3360,13th B Main, HAL 2nd Stage
Indira Nagar, Bangalore 560038. India.
www.greenpeaceindia.org
June 2006
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
Genetic engineering (GE) refers to a set of technologies that are being used to change
the genetic makeup of cells of plants and animals to bring about a desired commercial
function e.g. insect resistant plants, herbicide tolerant plants, increased protein content
in vegetables etc. For the first time humans have decided to alter the natural
evolutionary process and create new plants and animals through techniques that involve
highly complicated manipulations of genetic material and other biologically important
chemicals.
UNPREDICTABLE
Genetic engineering can have unpredictable effects because the process is imprecise
and random. Inserted genes may disrupt natural genes, be unstable in their new
environment, or function differently than expected. There are two ways in which genetic
engineering may affect food safety: Gene disruption or instability may lead to new toxins
being produced; and the new protein produced by the foreign gene may cause allergies
or toxicity.
IRREVERSABLE
Releasing GE organisms into the environment poses special threats to the environment
and the food chain. GE crops are living and have the ability to reproduce and multiply.
Through crosspollination, the foreign genes they contain can be transferred to other
crops and wild species. Genetic contamination can, therefore, magnify over time. GE
seeds can also be spilt, mixed with non-GE seed and grown illegally, compounding the
problems.
UNNATURAL
Cow genes in Wheat1 and Spider genes in potato2 are just some examples of genetically
engineered organisms that are being created by scientists in laboratories. Transferring
genes across the species barrier doesn’t occur in nature. Through genetic engineering
scientists have embarked on a journey to alter the evolutionary process. The impacts of
this are unknown.
This document takes you through some of the incidents that have been described as
accidents and the impact to our food and health in the dangerous world where food is
genetically engineered.
Critical health impacts caused by GMOs
There have been several cases of GM crop disasters in the past. This section takes us
through the few cases that have battled corporate efforts to suppress facts and survived
the day to reach the concerned citizen. In some of these cases, scientists owned up to
the monumental disaster and eventually were ostracized by the proponents of the
Genetic Engineering technology. In other cases, data was deliberately suppressed and
the risks of the technology had to be forced open by environmental groups
1 Scientists at the University of Nebraska (Lincoln, USA) have used cow genes in wheat to give wheat fungal (fusarium
resistance).
2 Ref: Scheller J, Henggeler D, Viviani A, Conrad U. 2004. Purification of spider silk-elastin from transgenic plants and
application for human chondrocyte proliferation, Transgenic Research 13: 51-57.
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
Rats that suffered after feeding on GE potato
In 1995 Dr. Arpad Puzstai started a publicly funded major scientific investigation (by the
then Scottish Office Agriculture, Environment and Fisheries Department, SOAEFD) into
the possible environmental and health hazards of GM potatoes. British GE scientists
were using a gene taken from snowdrop bulbs had transformed the potatoes. The gene
of this sugar-recognizing protein (GNA) has been known to give natural protection
against insect pests. It had also shown in extensive and appropriate nutritional studies
carried out by our research group at the Rowett Research Institute in Aberdeen before
ne GNA gene that animals ingesting this
protein as part of their diet even at an
800-fold excess of that present in GM
potatoes, suffered no significant harmful
consequences.
Therefore
it
was
expected for it to be safe for animal and,
later after appropriate testing, possibly
for human consumers.3
Unfortunately, the studies revealed that
the two lines of field-grown GM
potatoes, which originated from the
same transformation and were -both
resistant to aphid pests were not substantially equivalent in composition to parent line
potatoes, nor to each other. Even more importantly, we showed from the results of four
rat feeding studies of different designs and durations (10 to 110 days) that diets
containing GM potatoes in comparison with iso-proteinic and iso-energetic non-GM
parent potato diets had in some instances interfered with the growth of young rapidly
growing rats, the normal development of some of their vital organs, induced changes gut
structure and function and reduced their immune responsiveness to injurious antigens.
In contrast, the animals fed on diets containing the parent, non-GM-potatoes or these
potatoes supplemented with the gene product had no such effects.3
4
The controversy began in August 1998 when Dr Arpad Pusztai, 68, made a public
statement about his fears, about the £1.6m study he conducted at the Rowett Research
Institute (RRI).
Though the establishment ganged up against him, Dr. Pusztai's findings have never
been disproved. This work has in fact clearly demonstrated that, in addition to possible
toxicological studies, the safety of GM - food must be established in both short-term and
long-term feeding, metabolic and immune-response studies with young animals as these
should be the most appropriate to respond to and show up any nutritional and metabolic
stresses affecting the normal development of young animals into healthy adults.
3 Source: Dr Arpad Pusztai; Submission of Health Impacts of GM Crops: Evidence to the Clerk to the Health and
Community Care Committee of The Scottish Parliament)
4 A Pusztai et al. (1999) Expression of the insecticidal bean alpha-amylase inhibitor transgene has minimal detrimental
effect on the nutritional value of peas fed to rats at 30% of the diet The Journal of Nutrition, 129, 1597-1603.
SWB Ewen an A Pusztai (1999) Effects of diets containing genetically modified potatoes
expressing Galanthus nivalis lectin on rat small intestine. The Lancet; 354, 1353-1354.
A Pusztai (2002) Can science give us the tools for recognizing possible health risks of GM food? Nutrition and Health
(2002) 16, 73-84
7. A Pusztai (2002) GM food safety: Scientific and institutional issues. Science as Culture, 11, 70-92.
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
3
Within 48 hours after his public statement he was suspended in disgrace and later
forced to retire. The RRI said he had misinterpreted his results.
When Dr. Pusztai initially voiced his concerns about the health implications of genetically
modified foods on ITV's World In Action on August 12th 1998, the biotech company,
Monsanto, was quick to react in the press on 13th August 1998, asserting in The Times
that "...these revelations are absolute dynamite", adding that "We have...food scares and
doom-laden utterances without anyone looking at the facts."5 The lobby group,
Foodfuture, added that the scandal was due to "sloppy science and over-blown
reporting...6"
Some opinions of other independent scientists on Dr. Puzstai's study:
A group of scientists, drawn from 13 different countries, had re-examined his work and
signed a joint memorandum7 saying his conclusions were justified (1999). The group
included toxicologists, genetic engineers and medical experts. 'We found that his data is
sound", said their spokesman, Dr Vyvyan Howard, a toxipathologist at Liverpool
University,
Dr. Putzai's revelations have been backed by an independent analysis by consultant
pathologist Dr Stanley Ewen, of Aberdeen University, who examined the preserved rats’
organs. But a leading expert said: ‘These were measurable changes in the rats fed
modified potato - and we feel there's been a cover-up. There should be more openness
in the whole business about public money and how it being used in this field.’8
Mice that suffered from inflammation of the lungs after feeding
on GE peas9
After a decade of research, a field trial of genetically engineered (GE) peas was stopped
in Australia because a study10 found serious health impacts in mice that were given the
GE peas to eat. The GE peas contained a gene from a bean to make the peas resistant
to damage by the pea weevil.
The gene inserted into the GE peas was designed to produce an alpha-amylase
inhibitor, a protein that prevents the digestion enzymes of insects from working. This
causes the plant to be toxic to them when eaten.
Small changes in protein structure can cause big changes in allergenicity.
Although the chemistry of the protein produced in the GE pea was almost exactly the
same as that produced naturally in the bean, the structure of the protein was
5 The Scotsman, 13th August 1998.
‘ The Guardian, 13* August 1998.
’ Fears erupt over Genetic food, 12"' February 1999, BBC.
• The UK Mail, dated 31 Jan 1999.
9 CSIRO Plant Industry; 2005; Effective risk assessment of GM field peas
10 Vanessa E. Prescott, Peter M. Campbell, Andrew Moore, Joerg Mattes, Marc E. Rothenberg, Paul S. Foster, T. J V
Higgins, and Simon P. Hogan JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY Volume 53, Issue 23 (November 16,'
2005) pages 9023 - 9030
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
W*N?#icr
unexpectedly changed in the GE plant. Small changes in the 3D protein structure can
affect their potential to cause allergies. In this case, the researchers found that the GE
peas caused allergenic reactions in mice.
B
When they inhaled the GE pea
protein it caused inflammation of
the lungs and when they ate the
GE peas they became more
sensitive to other food allergies.
These effects were not observed with beans
that naturally produce this protein.
The OSIRQ-developed GM Held peas (right)
_r xt_e_
i..
xi_
In the case of this study, the toxic effects
were seen within the four weeks of the experiment. Had the toxic effects developed over
a long-term period, they may not have been detected by the study. This demonstrates
why it is so important that GE crops are property tested and are not released into the
environment.
Rats that suffered after being fed GE corn
On 23 April 2004, Le Monde reported that the French expert body in charge of GMO
evaluation (CGB, Commission du Genie Biomoleculaire) had expressed doubts about
the safety of GM maize MON863. Results of a rat feeding study that Monsanto delivered
to EU authorities showed significant variations between rats fed conventional maize and
those fed with MON863. The variations included an increased number of white blood
cells in the males, reduced immature red blood cells in females, a significant increase in
blood sugar in the females and a higher frequency of physical irregularities in the
kidneys of the males, such as reduced weight and inflammation.
Monsanto requested that
documents
concerning
the risk assessment, like
rat feeding trial results,
should be classified as
“confidential
business
information".
According to European
law, the public has a right
to.
full
access
to
information
concerning
the risk assessment of
GMOs.
In
particular
Article 25 of Directive
2001/18/EC indicates that
"in no case" should the
information
related
to
"environmental risk assessment" (defined as "the evaluation of risks to human health
and the environment, whether direct or indirect”) be kept confidential.
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
5
The Directive also indicates that the risk assessment should "be carried out in a
scientifically sound and transparent manner based on available scientific and technical
data".
Greenpeace had been pursuing this since April 2004, and it took us more than a year to
see the interests of society at large would prevail to have access to “confidential
business information” over Monsanto's economic interests and its policy of opacity and
secrecy.
5
The chronology of the campaign is as follows:
• On 5 May 2004, Greenpeace wrote to the German agriculture ministry, which was in
charge of the initial risk assessment report, to request access to the full documents
concerning Mon 863.
• On 4 August 2004, the German agriculture ministry replied that the applicant,
Monsanto, had refused to agree to publish the initial rat study MSL-18175, which had
been classified as "confidential business information”. ■ On 21 March 2005, the German
authority decided to give access to the full document, because Monsanto could not show
that its request for confidentiality was backed by EU or national law.
• On 27 April 2005, Monsanto filed an appeal against the decision of German
government and, in addition, took out an injunction to stop the authorities publishing the
data.
■ On 9 June 2005, the German court decided to reject Monsanto's request; the data
could not be seen as confidential, the right of society to transparency had to be given
more weight than Monsanto's economic interests. The company appealed the decision.
■ On 20 June 2005, the court rejected the appeal, and ruled that the documents be made
public.
GE Corn (Starlink) - a potential allergen to humans enters the
food chain
Even if the allergenic potential of a GE crop is recognised by the regulatory authorities, it
can still end up in human food. Aventis’ StarLink was a type of insect resistant GE corn
grown in the USA from 1998, which produced the St protein, Cry9C. It was only
approved for animal feed and industrial purposes, as there were concerns that the
Cry9C protein could cause allergies because it shares characteristics of other allergens.
However, in September 2000, StarLink was found in corn taco shells and other foods,
and over 300 com products had to be withdrawn from the market. Traces of StarLink
com were also found in com-based foods in Japan and Korea. It is not known how
StarLink came to be in the human food chain - it may have been inadvertently mixed
with other com at a mill, a conventional crop may have cross-pollinated with a StarLink
crop, or a farmer may have sold StarLink corn for human food to get a higher price.
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
WPNPfiAcr
While StarLink is not being grown anywhere in the world at the moment, it may have
contaminated other corn seed and remain in the food chain. The episode raises
questions about the ability of regulatory authorities to control GE crops.
Industry observers estimate that the entire cost of the scandal has exceeded US $1
billion. Neil E. Hart, a professor of economics at Iowa State University, estimates that the
company has already paid out more than $500 million to farmers, food processors and
grain handlers11. At least 300 food products in the US had to be recalled, at an
undisclosed cost to the food manufacturers. There were also recalls in Canada and
Japan. US com farmers lost huge markets all around the world. US government officials
estimated that it might take four years to get StarLink out of the US food and seed
supply. Now, three years after the scandal, approximately 1% of samples sent to USDA
testing labs are still found to contain StarLink12.
Some of the costs of the contamination scandal can be detailed:
•
•
•
•
•
Aventis paid at least $100 million to buy back the 2000 crop.13
The United States Department of Agriculture spent $20 million to buy seeds from
small companies whose seed stock was contaminated.14
Kraft lost an estimated $10 million in lost sales from its taco shells alone.15 Taco
Bell franchises were awarded $60 million by all the taco shell manufacturers:
Kraft, Azteca Foods and Mission Foods.16
Aventis, Garst and four food companies (Kraft, Kellogg, Azteca Foods and
Mission Foods) settled a class action consumer lawsuit for $9 million to
customers who said they suffered allergic reactions17.
Aventis and Garst settled a class action lawsuit by farmers seeking
compensation for lost markets. The lawsuit sought damages as well as a
requirement for Aventis to decontaminate all soil, farming equipment, etc. to
prevent further contamination. The firms will pay $110 million; farmers are likely
to receive only US$1 per acre.18
Unintended effects of Genetically Modified Organisms (GMOs):
There are numerous cases of documented unexplainable effects of GMOs. Here are a
few examples:
• Researchers at Monsanto who were trying to increase the content of carotenoids (a
chemical which is used to form vitamin A) in oilseed rape (canola) found that vitamin
E and chlorophyll levels in the seeds were dramatically and inexplicably reduced19.
11 Jacobs, P. 2003. Traces of contaminated grain still showing up in corn supply. 30 November. San Jose Mercury News.
12 Ibid
13 Reuters. 2000. Aventis sale of bio-crop unit could hurt farmers. 27 November
14 Schuff, S. 2001. Major seed companies say they have StarLink isolated. 12 March. Feedstuffs.
15 Madigan, K. 2003. Risky business. Los Angeles, CA: State Public Interest Research Groups, As You Sow Foundation
16 Cohen, D. 2001. Taco Bell franchisees to get $60 million. 8 June. Reuters.
17 Carroll, J. 2002. Judge will approve a settlement on use of StarUnk corn products. 7 March. Wall Street Journal (New
York)
18 No author. 2003. Aventis settles StarUnk lawsuit. 12 February. Chemical Week.
19 Shewmaker, C.K., Sheehy, J.A., Daley, M., Colburn, S. & Yang Ke, D. (1999) Seed-specific over expression of phytoene
synthase: increase in cartenoids and other metabolic effects. The Plant Journal, 20, 401-412.
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
•
The colour of the infamous "Golden" rice is an unexpected effect of GE. The GE
construct originally contained three genes. The first two genes produce lycopene
(red pigment in tomatoes) while the final gene transforms the lycopene to beta
carotene (yellow pro-vitamin A).
Rice kernels from plants with only the first two genes were expected to turn out red
because of the lycopene, but they were yellow. The reason behind the colour of rice
turning out yellow and not red with just the first two genes is not understood.
Scientists involved in the study have been unable to explain how the rice turns yellow
with only two genes.20
•
Monsanto’s GE Roundup Ready soybeans have suffered unexpected crop losses in
hot, dry weather due to stem splitting caused, most probably, by increased lignin21.
The soybeans’ phytoestrogen levels are also 12-14 % less than in conventional
soybeans, which may mean that soy-based products derived from Roundup Ready
soybeans would be less useful as sources of phytoestrogens.
10 Beyer P. et al. 2002, Golden rice: introducing the B-carotene biosynthesis pathway into rice endosperm by genetic
engineering to defeat vitamin A deficiency. American Society for Nutrib'onal Sciences, 132: 506S-S10S.
21 Coghlan, A. (1999) Splitting headache - Monsanto's modified soybeans are cracking up In the heat New Scientist, 20th
November, p.2S.
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
SRewraocr
Unexpected effects: GE
Soybean
Greater
proportion of
lignin (woody
stems)
Unexpected effects: GE Poplar trees
Gene for resistance
to insects
Resistance,
yellow leaves,
growth change
No
resistance
Resistance, growth altered and improved, but
now prone to other insects
Disconcerting effects have been observed with poplar trees: a field test which was
started in 1996 produced female blossoms on a plant after only three years, whereas
normally poplars start blossoming only at the age of eight years. This early
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
SReenwrablossoming could increase the rate of unintended spread of the GE trait into the
population.2223
•
In China, poplar trees were engineered for insect resistance. The trees did express
the desired effects towards the pest insects in field trials. However, just two years
later, new and unexpected sensitivities towards other insects occurred.
How ‘risk assessment’ fails to measure human health impacts
Risk assessment is often portrayed as a relatively straightforward process - simply
identify all possible hazards, calculate the probability that they may arise, work out what
the risk is, decide if it is acceptable and how to manage it. It sounds very scientific and
impartial, but it is not. This protocol was initially conceived to deal with failures in
machinery, when it is applied to GMOs it struggles with the complexity of the natural
environment. Because it is this system that underlies the regulation of GMOs worldwide,
protection of the environment and human health is being compromised.
The ‘Precautionary Principle’ builds on a series of straightforward and well-established
ideas that24
• Prevention is better than cure;
• The polluter should pay.
• We should look for 'no regrets’ options.
• We should recognise the intrinsic value of non-human - as well as human - life. •
• The complexity and variability of the real world limits the ability of scientific
knowledge to predict.
• We must recognise the vulnerability of the natural environment.
• The rights of those who stand to be affected by an activity must be prioritized rather
than those who stand to benefit from it.
• There must be scrutiny of all available alternatives and an examination of
justifications and benefits as well as risks and costs.
• Long-term, holistic and inclusive perspectives are needed in environmental
protection.
• Policy analysts have concluded that the Precautionary Principle is more scientific
than conventional risk assessment.25
Therefore, a precautionary approach introduces a more scientifically rigorous analysis,
with a broader scope and wider range of experts. Precaution is involved at all steps in
decision making, in areas where action may lead to seriously harmful effects, from the
practice of science and the research agenda, to regulation and governance. Because
the threats of GE are so broad, and it’s harmful impacts could be severe and irreversible,
the precautionary principle must be strictly applied.
22 Fladung, M.; Nowitzki, O., Ebbinghaus, D., Schellhorn, A.; Bentien, G., Abuja, M.R. & MuhS, HJ. 1999, Reid release of
ROLC-transgenic Aspen-Populus. Online: http://users.ox.ac.uk/~dops0022/conference/forest biotech99 home.html.
Poster 46, 3.12.1999.
23 Ewald, D. & Han, Y. 1999, Freisetzungsversuche mit transgenen Pappeln in China. UBA-Fachgesprach „Freisetzung
transgener Geholze - Stand, Probleme, Perspektiven" 20. & 21. Sept., Humboldt-Universitat zu Berlin.
24 Stirling, A (1999) Science and precaution in the management of technological risk. Report for the European Commission
- JRC Institute of Prospective Technological Studies, Seville. http://www.jrc.es/pub/EURdoc/eurl9056Ien.pdf
25 European Commission (2000), Communication on the Precautionary Principle, COM (2000)1, Brussels: European
Commission
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
Genetically Engineered Brinjal
Safe for the country? Safe for you?
Genetically Engineered (GE) food for Indians: Are we being experimented upon?
Most genetic engineering (GE) crops are processed into food for humans and animals - but are
they safe to eat? GE can have unexpected and unintended effects because the process is
imprecise and random. Inserted genes may disrupt natural genes, be unstable in their new
environment, or function differently than expected. This echoes a scientist's comments in the
scientific journal, Nature, about the long-term effects of GE food that: “Under current monitoring
conditions, any unanticipated health impact of such foods would need to be a 'monumental
disaster" to be detectable".'
This concern for food safety of GE food has been debated and discussed in the west for over a
decade. Today public pressure from European consumers has ensured that most major food
companies and retailers do not stock GE foods on their shelves.
£
Wal-Mart Germany:
The world’s leading retailer, Wal-Mart, does not have a clearly defined GM policy: “As a matter
of principle, Wal-Mart Germany is anxious to exclusively offer food which is free of genetically
modified food ingredients and which does not contain any additives or flavourings derived from
genetically modified organisms (...). We continue to work to exclude genetically modified
ingredients in the future within the means available to us.”
(From a letter to Greenpeace Germany, September 2003)
Kellogg
Kellogg has given a non-GM commitment for its products sold in Europe: “This commitment
towards consumers is applied to the use of cereals was well as to other ingredients in Europe.
Kellogg is aware of the European consumers’ opinion and therefore does not use genetically
modified maize or soya ingredients respectively the derivatives thereof in breakfast cereals sold
in Europe. Concerning the maize used by Kellogg in Europe for breakfast cereals, a variety
grown in Argentina is used. We will continue to assure that it is of non-GM origin. All products
sold by Kellogg in Europe do not contain any ingredients of genetically modified raw materials.”
(From a letter to Greenpeace Feb 2004)
Coop Switzerland
(Coop guidelines: Genetic Engineering in Food and Feed - May 2003)
Coop declared on the issue of genetically modified rice:
“If Thailand would plant genetically modified rice on a large scale in the future, we would have to
rethink the procurement of rice from this region. Because consumers in Switzerland, and in
Europe in general, are so skeptical, the commercialization of genetically engineered rice is not
realistic in the near future.”
(From a letter to Greenpeace Switzerland in August 2004)
Marks and Spencer, UK
“In 1999, responding to consumer concerns, Marks & Spencer announced that it would cease
selling products containing GM ingredients and derivatives. As a 100% 'own brand' company
this policy covers all food and drink purchased at Marks & Spencer. This policy remains in place
and confirms that Marks & Spencer will not be selling any GM labelled foodstuffs in 2004.”
(Letter to Greenpeace UK, February 2004)
1
Butler, D. & Reichhardt, A. (1999) Long-term effect of GM crops serves up food for thought. Nature, 398, 651-653
Europe’s rejection of GE food has cost the GE seed industry dearly, which is why they are
strategically forcing open the Asian market. India has responded to this in a confused manner.
On one hand our scientists and policy makers cannot resist a foreign investment especially
when it is packaged as a “cutting edge technology” but on the other hand they are more than
sure that the real solutions for the agriculture crisis lie elsewhere. 'We can't close our eyes to
biotechnology for agriculture. At the same time we cannot deviate from the goal of sustainable
development in terms of environment and the basic interest of the farmer and consumer safety.
So our approach is a case by case basis", Kapil Sibal, Minister for Science and Technology (GM
crops, drugs critical for India's development: April 10, 2006; Agence France Presse)
Engineering for Convenience: GM Brinjal
Underlying the biotech industry's claim that GE foods are needed to feed the world lies a
fundamentally flawed analysis. The United Nations' World Food Programme ensures us that
more than enough food is already being produced to provide the world with a nutritious and
adequate diet - one-and-a-half times the amount required. Much genetic engineering research
in food has been directed at meeting the commercial needs of seed and pesticide producers,
food processors and others who benefit from the sale of this technology.
Genetically Engineered Brinjal (eggplant/aubergine) could well become India’s first Genetically
Engineered [Genetically Modified] food crop. Brinjal is the second most-cultivated vegetable
crop in India. It is cultivated over 5 lakh hectares with an annual yield of around 8 lakh tones.1
Brinjal is indeed a strategic choice for a seed company to break in and take control of the seed
market in the country.
What are they doing to brinjal?
A genetically modified brinjal has a foreign gene from the bacteria Bacillus thuringenesis which
is injected into the plant so that the plant can produce pesticides and protect itself from the
Brinjal Fruit and Shoot Borer. The process used for this is complicated, and it is both time
consuming and resource intensive. The company responsible for this technology claims that
farmers will benefit from it, as they will not have to spend on pesticides as each cell and each
plant has been converted into a pesticide factory to destroy insects.
However the precise impact on consumers has never been estimated. If approved, this will be
the first time a brinjal will be genetically engineered and Indians will be the first in the world to be
exposed to it. Since all changes in a GE brinjal are internal one can never really spot the
difference between a GE and a non- GE brinjal.
Why we should be worried about eating GM Brinjal
1.
Antibiotic resistance
Two Antibiotic resistant markers are part of the gene package that is inserted in the GM brinjalone for neomycin resistance and one for streptomycin resistance. This raises serious issues of
infectious microbes becoming resistant to antibiotics that are used in the treatment of human
ailments.
Indian Horticultural Database, 2004, National Horticulture Board
2
2.
Toxicity of proteins released by the bacterial genes
Crystal [Cry] proteins used in this GM Brinjal have time and again been proved to be dangerous
to human health. Crystal proteins are found to elicit immune responses when injected or
ingested.2
3.
Current safety testing does not include testing for allergic reactions
The company evades a discussion of the potential toxicity of the Bt brinjal by saying that the
proteins, alkaloids, carbohydrates etc in GM brinjal are no different from non-GM brinjal. This
testing principle called substantial equivalence is fundamentally flawed. Substantial equivalence
means that molecules are chemically similar. It does not examine the structural variances in
proteins, which causes serious rejections and allergies.
4.
No long term safety testing conducted
All clinical tests to assess the health impacts of Bt brinjal have been short term ones, just like
drug trials. But brinjal is a food crop, and therefore is regularly eaten, unlike drugs. Therefore
the fact that the long-term implications of GM brinjal have not been assessed is a cause for
grave concern.
5.
Babies are at a higher risk
Infants are always considered as a high-risk group and the effects of such novel food items like
Bt brinjal needs to be checked for their effects on infants. No such study was done in the case
of Bt brinjal. The Royal Society of London has in the past expressed concern in this regard3.
6.
Ecological Imbalance
Bt brinjal, like any other GE crop, may impact ecological systems by the creation of invasive
species, the loss of diversity, or through toxic effects on non-target species. Toxins from Bacillus
thuringenesis (Bt) have shown to kill butterflies, moths, and beetles and suffer negative effects,
as in the case of the Monarch butterfly in the United States.4
7.
Loss of consumer choice
The advent of GM Brinjal will also be the end of consumer choice in the country as the
consumers will never be able to recognize GM Brinjal from a Non- GM Brinjal in the market.
8.
Farmer’s seed sovereignty under threat
India is the center of diversity for brinjal and farmers from last 4000 years have developed
hundreds of varieties that they used, saved, and exchanged according to their choice and the
need of the hour. Bt brinjal like any other GM crop comes with a list of Dos and Don’ts specified
by the patent regime. On one side with their aggressive marketing techniques, multi national
seed giants and their subsidiaries will lure the farmers into their seed trap, and on the other the
farmer will be denied the system of saving and exchanging as this goes against the profit
motives of the company. All this will finally lead the Indian farmer to depend on multinational
seed companies for the most important input in agriculture - the seed.
2 Intragastricand intraperitoneal administration ofCrylAc protoxin from Bacillus thuringiensis induces systemic and mucosal
antibody responses in mice. Life Sciences 64(21): 1897-1912
3 Royal Society (2002) Genetically modified plants for food use and human health - an update. Policy document 4/02. February
2002, http://www.rovalsoc.ac.uk.
4 Lesley, J.E., et al. 1999. Transgenic pollen harms monarch larvae. Nature 399: 214
(^RggmeF
9.
Irreversible genetic contamination
Brinja! is a highly cross-pollinated crop. This is something that even the company agrees to5
This will lead to contamination of all the non GM Brinjal crops cultivated near by and will thus
eliminate the numerous verities that the farmers of the country have developed through ages.
10.
Organic farmers at risk:
Organic farmers groups are at highest risk, as any adventitious presence of GM material in
organic food materials will disqualify them from calling their products organic, even after
painstakingly following all the stringent rules set by certifying agencies for years to achieve
organic certification.
11.
Increase in the cost of brinjal
The entry of GM food will increase food prices as GM foods have to be tested, packed and
labeled as per the upcoming Food Safety and Security Bill. The Indian market (where packed
food items form a minority) will have to change drastically and the cost of this change will fall on
the consumer. Prices of organic produce also might increase, as more tests may be needed to
assure consumers that any GM material has not contaminated their food.
12.
Regulatory problems
As has been proven time and again Indian GMO regulatory system is not yet ready with a
foolproof mechanism to implement the rules that they have laid down. The Bt cotton and the
Bollgard II episodes where the regulatory bodies failed miserably even to monitor limited field
trials stand as proof of this inadequacy6.
The Country at a Crossroads
India is at a crossroad. Never before in the history of independent India has the country been
put in a situation where it is faced with such significant ecological and socioeconomic threats
from a single technology. Never before has the entire population been turned into a laboratory
for the testing of a novel food item. The precautionary principle which modern science
advocates, promotes the rights of those who stand affected by the activity which must be
prioritized rather than those who stand to benefit from it7. We cannot leave it up to our elected
representatives to make this crucial decision for us; the brinjal is our wakeup call. Let our voices
be heard.
For further information: www.greenpeaceindia.org
Divya Raghunandan, Genetic Engineering Campaigner, Greenpeace India
Tel: +91-9845535406, E-mail: draqhuna@dialb.greenpeace.org
Vivek Sharma, Greenpeace Communications
Tel: +91-9343788424, E-mail: vivek.sharma@in.greenpeace.org
5 M/s. Mahyco.,2006 Development of Fruit & Shoot Borer Tolerant Brinjal,
http://www.envfor.nic.in/divisions/csurv/geac/status.html
6 http://www.greenpeace.ore/india/press/releases/unapproved-bollgard-ll
7 Stirling, A.,1999.,Science and precaution in the management of the technological risk. Report of the European Commission,
JRC Institute-of Prospective Technological Studies, Seville. http://www.irc.es/pub/EURdoc/eurl9056len.pdf
4
To:
June 14, 2006
Dr Anbumani Ramadoss
Hon'ble Minister for Health & Family Welfare
Government of India.
Respected Sir
Sub: Bt BRINJAL - HUMAN HEALTH HAZARDS AND BEYOND
We are a group of concerned civil society organizations, representing lakhs of Indians,
approaching you to intervene into the matter of Bt Brinjal, which is on the verge of obtaining
permission for large scale trials and seed production in this country. This would be the first time
that a GM food crop could be allowed to be released into the open environment for this stage of
research. This is the first time in the world that a GM crop would be grown as a vegetable with
the Bt toxin incorporated into it and consumed with very little processing. It is not out of place to
remind here that it was during large scale trials that Bt Cotton's illegal proliferation began in this
country and the regulators only watched with helplessness. Things have not improved an iota
since 2001 when such contamination began with Bt Cotton in this country.
There are grave concerns with regard to these various developments and since the Health
Ministy's mandate is to protect the health of all Indians and since the Ministry constitutes one of
the important regulators of GM in agriculture in India [by virtue of the presence of the Ministry's
representatives in the GEAC, expected to play a very important role in decision-making related to
GMOs] we approach you to seek your positive intervention in the issue.
We would like to begin by stating that while we welcome the fact that GEAC has offered, for the
first time more than a decade after GM crop research began in India, to put up data related to
findings from biosafety tests on Bt Brinjal, the entire process run was completely unacceptable.
The data that was put up, as presentations by M/S Mahyco to the GEAC, is completely
inadequate for any intelligent and scientific feedback to be provided. This also showed the world
how GEAC, in which the Health Ministry representatives are expected to play a pro-active role to
protect the health interests of Indians, takes its decisions. It is clear that a body that should ask
basic, scientific questions related to health and environmental implications in addition to socio
economic implications for our farmers, has decided to function as a mere 'bureaucratic approval'
body and runs its processes only on such company-produced meaningless presentations.
We provide our feedback on Bt Brinjal hereunder. Below, we bring up biosafety issues as well as
more fundamental issues beyond biosafety. Much of this feedback should also serve as a
feedback on the serious shortcomings of our biosafety regime in general and why there is a need
to invoke the precautionary principle on GM crops.
Numerous studies worldwide have raised serious questions about potential health impacts of
delta-endotoxins. Key assumptions used as the basis for safety claims have been overturned and
several adverse findings suggest that GM foods are unsafe. GM-fed animals had problems with
their growth, organ development and immune responsiveness, blood and liver cell formation as
well as damaged organs [bleeding stomachs, excessive cell growth, inflammation in lung tissue],
sterility problems and increased death rates including among the offspring. Risks are increased
by the fact that the genes inserted into GM food not only survive digestion, but transfer Into body
organs and circulation. Transgenes or their fragments have, been found in the blood, liver, spleen
and kidneys.
1.
The Bt gene is a known toxin that impacts human health and livestock health
adversely: Introduction or creation of a new or known allergen or toxin Is a potential
consequence of genetic manipulation, as experience worldwide shows.
❖
When Bt Cotton was introduced in India, the same set of tests that are now being
applied for Bt Brinjal have apparently been run by the company involved and everything
was proclaimed to be safe. However, the human health effects of Bt Cotton in India are
being reported from all cotton-growing states now. Most farmers and farm workers are
experiencing allergies of different kinds. Further, a recent scientific investigation made a
clear correlation between the exposure to Bt Cotton and these adverse health effects
[copy of the report attached - Annexure 11.
❖
Similarly there were also reports on mortality of sheep after grazing on Bt Cotton recently
[copy of the Fact Finding Team's preliminary investigation report attached - Annexure 2].
While there have been no systematic investigations done in other places, there are
informal reports however that livestock is being adversely impacted upon grazing on Bt
Cotton fields from other places too.
❖
While this is the case with cotton, the consequences with a food crop, that too a
vegetable crop which will be consumed quite directly, are unimaginable. Never before in
the world has the Bt toxin been introduced into a vegetable crop, where the toxin would
be consumed in large quantities and without much processing. We are annexing several
scientific papers which point out that CrylAc gene - Annexure 3, the Bt gene being used
in Bt Brinjal, has many established adverse health impacts. These published, peer
reviewed papers by scientists demonstrate that recombinant CrylAc protoxin is a
powerful immunogen (able to produce an immune response), and when fed to mice,
induced antibody responses similar-to those obtained with the cholera toxin. Research
shows that CrylAc actively binds to the inner surface of the mouse small intestine. This
contests the often-heard argument that Cry proteins don't affect mammals since they
supposedly do not have receptors that bind the truncated toxin in the gut!
The entire infamous episode of Starlink contamination [where Cry9C toxin was used]
raises the question of whether other Bt toxins that were supposedly screened might
nevertheless be allergens. Scientists accept that without a better understanding of food
allergenicity, this question cannot be adequately answered. There are serious limitations
to current allergy testing procedures for GMO proteins. For example, recent results in
Australia revealed that a protein previously consumed safely in beans had become
immunogenic (similar to allergic reaction) when engineered into GMO peas. The
immunogenicity of the GMO peas would not have been detected by currently used tests.
Therefore, new allergy tests, and careful, long-term tests, are needed to assure the
safety of Bt brinjal. Other possible risk issues, such as possible unintended harmful
changes in the Bt brinjal plants, can also only be addressed by careful long-term and
other testing. We cannot afford to make the mistake committed by Australian regulators
who discovered the GM peas case only after almost irreversible field trials. We are
annexing to this letter four such infamous accidents which proved to be disastrous for
human health and environment - Annexure 4,
❖ There are some nutritional and toxicological studies carried out on Ingested plant GM
DNA which provide information on the potential nature of the hazards of GM foods/feeds.
These include: wasteful growth of gut tissues and bacterial proliferation, development of
intestinal tumours, depression of the body's immune system, interference with the
normal development of vital organs of the body (liver, kidneys, sexual organs, etc.) and
2
reproduction. The seriousness of these effects cannot be overemphasized because the
harm will be the most pronounced in the young, the old and in people with intestinal
disorders.
❖ The human clinical study carried out and published till date provides strong evidence of
Horizontal Gene Transfer from food to humans. These studies showed that fragments of
GM DNA were incorporated into the bacteria resident in the gut of human volunteers.
Significant amounts of transgenic DNA is found to survive most commercial processing or
in the gut of mammals, as per studies in various places.
2.
The other genes introduced are toxic too:
Antibiotic resistance: In creating Bt Brinjal, Nptll gene has been used as a selectable
marker. Nptll codes for kanamycin resistance and globally, there are serious concerns with
antibiotic resistance marker genes for obvious reasons - when there is horizontal gene
transfer to gut or soil bacteria, this could spread antibiotic resistance widely. Gene flow,
especially to pathogenic organisms, related to antibiotic resistance has been established in
past studies. This will imply that disease treatment would be more and more difficult.
The Bt Brinjal also has an aad marker gene. Streptomycin resistant marker according to EFSA
this is a potentially dangerous marker to animals and human beings and should not be used
in the case of GM plants used as food.
Transcriptional activity in human cells with CaMV 35 S: Similarly, use of the CaMV 35
S
[cauliflower mosaic virus] promoter, used in creating Bt Brinjal is a matter of concern.
Published research shows that the 35S promoter can initiate transcriptional activity in human
cells, despite the promoter being a plant-specific one. A scientific paper attached throws
further light on this - Annexure 5.
The cauliflower mosaic virus (CaMV), the viral promoter used in Bt Brinjal has similarities with
the human hepatitis B virus. As all genomes of living species contain dormant viruses, there
is a potential for the CaMV promoter to reactivate them raising concerns related to cancers.
One of the major omissions in present day GM risk analysis is that no attempt has so far
been made to investigate the obvious link between GM food and intestinal tumour
development. As Dr Arpad Puzstai points out, "full reproductive experiments are required in
which the reproductive performance of both male and female rats fed on GM- versus hon-GM
diets should be monitored for several generations because any problems with reproduction
could have disastrous consequences for the environment".
The problems encountered in the study of 'growth factor-like' effects on young rats, was
attributed most likely, to the CaMv (cauliflower mosaic virus) viral promoter, a promoter put
into Bt Brinjal too. Evidence suggests that the CaMv 35S promoter might be especially
unstable and prone to horizontal gene transfer and recombination with all the attendant
hazards: gene mutation, cancer, re-activation of dormant viruses and generation of new
viruses.
Hazards from GM crops released into the environment may spread more readily through
Horizontal Gene Transfer because GM constructs are specifically designed to cross the
interspecies barrier.
3.
Past history with corporate research shows suppression of important information:
Monsanto, which is supplying the technology to Mahyco and others in the case of Bt Brinjal,
3
is known from past experience to suppress facts that are unfavourable to the company and
its potential markets. A secret study on Bt Maize showed significant harm caused to rats fed
on the variety called MON 863. The study shows kidney abnormalities and unusually high
levels of white blood cells. What is shocking was that the company then went ahead to
conclude that these findings were irrelevant and should not be attributed to Bt Maize even
though the rats fed on non-Bt Maize showed no such signs! Given such dubious history, how
are the regulators relying on data produced only by the company?
The agronomic data unreliable and manipulated: Going through the Annual Report of
the All India Coordinated Research Project - Vegetable Cultivation on ICAR-supervised Bt
Brinjal multi-locational trials in 2005-06, it is clear that the data presented is manipulated and
unreliable. It is not clear why at least 3 out of the 11 Centres for trials did not report back.
The data was not statistically analysed and wrong conclusions were drawn based on skewed
averages. It is not clear how some centres could obtain such unbelievably high yields while
most of the centres were below average. Is this going to be the situation in real life too for
farmers? There is no data at all on pesticide use obtained through the trials though Bt Brinjal
is developed ostensibly to reduce the use of pesticides. It is also clear that there were no
trials taken up to compare with safer, cheaper, farmer-controlled alternatives like organic
brinjal cultivation or NPM or IPM approaches. There was not even a comparison against IPM
experience from all over the ICAR establishment from more than 10 years' of work.
There is a serious and objectionable conflict of interest in the fact that majority of
the tests were undertaken by the company promoting Bt Brinjal [pollen flow studies,
CrylAc protein expression, baseline susceptibility, protein estimation in cooked fruits, soil
analysis, substantial equivalence studies etc. etc.]. Out of the various tests conducted, only
four were conducted by public sector institutions, that too funded by the company. Where
are independent studies to verify the claims of the company? Where are studies
especially from the Health Ministry to confirm the safety of the product?
4.
The science of GM is imprecise: It is well known that GE is based on imprecise science
and is an unpredictable technology as there is little control on where the new genetic
construct will lodge within one or more of the target cell chromosomes. It is also well known
that tests are not conducted to assess the results from the variety of genes that are inserted
along with the desired gene [the markers, promoters, terminators, metabolites etc. etc.].
Scientists do not understand the mechanisms of GE-induced changes in gene expression in
sufficient detail. They do not know what to look for and these things are termed 'unintended
effects'. It is for this reason that on a whole range of issues, a great deal of research is
required before any outcomes can be predicted in a reasonably assured manner.
Unlike in other countries, in a country like India where a majority of our livelihoods depend
on agriculture, any irrevocable or irreversible change to our agriculture needs to be
reasonably sure that the benefits being projected are drawn from sound, long term scientific
testing and that risk assessment parameters are broad-based. Elsewhere, risk assessment of
GMOs also asks a very pertinent question - "is it [introduction of a GMO] socially and
ethically justifiable?''. We are annexing a paper on such risk assessment - Annexure 6 so that
the regulators might at least now pick up the appropriate framework for risk assessment
given that millions of farmers in this country would be affected by your decisions. This kind
of assessment is very important since there is very little awareness related to GM technology
in farmers and consumers. This requires that informed public debate takes place before any
decisions taken.
5.
The tests done here are not adequate - Are we even asking the right questions? A
Public Interest Litigation [PIL] on the lack of rigorous biosafety testing for GMOs in India
4
points out that the current biosafety regime is woefully inadequate in India. A copy of the PIL
petition is attached in the form of a booklet - Annexure 7 for ready reference. Often, we do
not even have the right questions to ask when testing for safety of GMOs. As pointed out
earlier, elsewhere, biosafety regime is inclusive of such pertinent questions as "is this socially
and ethically justifiable?". This requires the testing to be done against other known safer
alternatives including ecological/sustainable agriculture practices. However, this was not
done in the case of Bt Brinjal. Another paper - Annexure 8 by Dr Pushpa Bhargava way back
in 2002 outlines what the biosafety regime should constitute. Going by the set of studies that
the company has been asked to do by the regulators, it is obvious that feedback has not
been picked up and lessons not learnt. An annexure provides specific feedback on the
biosafety claims on Bt Brinjal - Annexure 9.
6.
There is no justifiable reason whatsoever for experimenting on and introducing Bt
Brinjal [and GM crops in general]: The GEAC or the DBT [Department of Biotechnology]
has no good reason and justification to promote a GM Brinjal in this country. Pest
management on Brinjal is being successfully practiced by numerous IPM, NPM and organic
farmers with non-chemical, non-GE approaches with very satisfactory results all over the
country. Within the ICAR establishment, numerous research projects, including on farmers'
fields, show that there are very good, inexpensive and absolutely safe results following non
chemical IPM methods in particular and IPM methods in general. Given such vast experience,
why is there no political will to put the control over the technology in farmers' hands? We are
attaching to this letter a collection of such experiences - Annexure 10 which should provide a
way forward for our thinking. We are once again reiterating that for the pest management
paradigm to shift in this country, what is needed is political will and not GE-like solutions. We
all know that pesticide use in fact has very little to do with pest/disease incidence any more
and it has suited the pesticide industry and the regulators/agriculture scientists very well to
encourage such a situation so far. To get out of this, we don't need a technology-fix but an
alternative paradigm of pest management which empowers the farmers to understand their
farm ecology and depend on local resources and sustainable practices for pest management.
More importantly, there is no crisis with Brinjal production. In fact, due to
overproduction, farmers do not get adequate market price.
7.
Potential environmental hazards with Bt Brinjal:
Existing evidence on environmental hazards with GM crops is enough for a precautionary
principle to be invoked regarding their regulation. For instance, it was found in studies that GM
crops grown in the UK were not only harmful to beneficial insects like ladybirds but could also
indirectly harm other and higher life forms, including mammals, domesticated or wild
animals/birds and ultimately man, both in the short- and long-term.
India is a Center of Origin and diversity for Brinjal: Our pool of genetic reserves would
inevitably be contaminated and this is extremely dangerous given that we are a Centre of Origin
and diversity for Brinjal. We have grown Brinjal for the past 4000 years in this country and It is
an extremely popular and widely consumed vegetable. Needless to say, horizontal gene transfer
from Bt Brinjal into wild, related species of brinjal has serious implications for the very future of
Brinjal research and cultivation in the country. The genetic diversity is important because some of
the strains will be naturally resistant to lethal pathogens and pests that may destroy the crops in
the future. Once lost, this lack of diversity can lead to the complete loss of the crop. Several
published experiments with Bt in rapeseed and sunflower have provided preliminary data that Bt
genes can indeed give some wild plants a competitive advantage. If the gene spreads in wild
relatives of brinjal, its escape into the environment will be permanent. The toxin produced by the
gene may then kill insects that feed on the wild plants. India is a haven of butterflies and the
Cry 1 Ac gene targets lepidopterans including these butterflies and moths. These insects, in turn
provide food for other organisms such as birds and mammals, which may then suffer harm. For
these reasons, it is important to determine the possible harmful effects of the CrylAc gene In
sexually compatible wild relatives and their ecosystems.
The Cartagena Protocol on Biosafety, the only international law to specifically regulate genetic
engineering and GMOs (largely focused on transboundary movement, but whose scope also
applies to the use of all GMOs), recognises the importance of centres of origin and diversity, and
requires this to be taken into account during the risk assessment. How has this principle been
applied in the case of Bt Brinjal in India?
In the case of pollen flow, it is well known that there is ample opportunity for cross pollination in
the case of Brinjal. It has been reported that the extent of natural outcrossing is from 2 to 48%
in the case of India. Further, it is not clear whether there is enough data on the wild and weedy
plants that are either close relatives or have some degree of cross-compatibility with these brinjal
varieties. No tests have been done to check for cross-pollination with such relatives.
Further, farmers from various parts of the country are reporting a decline in their soil productivity
after growing Bt Cotton. While the regulatory tests related to Bt toxin presence and persistence
in the case of Bt Cotton showed that the half-life of CrylAc protein in plant tissue was calculated
at 41 days [which could then persist in the soil as other studies from elsewhere show], it is not
clear how in the case of Bt Brinjal it is non-detectable in soil samples tested. Worldwide, it is
generally accepted that Bt toxin does alter the soil micro-biology and that more studies are
needed to understand the impact of Bt toxin on soil ecology.
It is not clear if the regulators studied the impact of Bt Brinjal on ecologically sensitive areas like
the Eastern and Western Ghats and considered how they would prevent the entry of Bt Brinjal
into such ecologically sensitive areas.
We should also consider a scenario where our predominant pest management strategy relies
more and more on one gene - the Bt toxin gene, across crops for a range of pests. Such a
monoculture of the gene across crops and varieties is bound to spell doom sooner or later.
Resistance is already predicted in the target pest and resistance management strategy suggested
is a 5% refuge. However, Bt Cotton experience shows that farmers do not follow these resistance
management strategies. How will this be done in the case of Bt Brinjal? If there are several GM
crops grown together, the resistance build up will be faster.
8.
Consumer choices and rights: Transgenic contamination (contamination of the natural
environment by GMOs) by more than one method, including wind blown and by cross
pollination is an established fact, beyond dispute and there can be no co-existence between
GM and non-GM crops. Segregation even at the physical level is Impossible in India. What
happens to consumer choices and rights in such a case? Where would be the consumer's
right to choose in the case of vegetables, even If we assume that segregation upto an extent
is possible and labelling could be made mandatory? Indian vegetable purchases from
supermarket shelves are minuscule and obviously, labelling is not going to be an answer
here. How do we then provide non-GM brinjal to Indian consumers?
In conclusion, drawing from the experience with another hazardous technology like pesticides, it
is obvious that biosafety and impact assessments are not carried out before irreversible release
of the technology into the environment. Very often, experimentation is done at the expense of
poor Indians including Indian children as scapegoats. Can India afford to make similar mistakes
again?
6
Given all the above, we demand that:
1
Since the effects of this technology/modified organism are unknown and since these are
potentially hazardous, the use of this technology and release of those organisms must
wait until the hazards are properly understood and the effects known. This requires
the precautionary approach to be followed.
2
Biosafety testing should include testing for medium and long term effects on
the environment and human/animal health, in addition to asking questions on the
justification of releasing the GMO into the open environment on social and ethical
grounds. For this, the regulators as a beginning, should put together all the available
data on safer alternatives, as any environment assessment should, like IPM, NPM,
organic etc., and compare Bt Brinjal with such alternatives.
3
Proper biosafety tests should be taken up by independent and scientifically
competent bodies in a transparent manner. Such tests should be allowed to take
appropriate time needed to understand the medium and long term effects instead of
being hastened in the pursuit of 'fast-track approvals'.
4
The results of such tests should be made public and data published In a manner that
it can be closely examined by the scientific community. It shall also be presented to all
primary stakeholders [farmers and consumers] in a manner that meaningful
debates are possible, through for instance, mandatory public notice and public hearings
etc.
5
Such reviews and debates should also look at issues beyond biosafety and delve into
socio-cultural and political aspects related to GM agriculture, given that millions of our
lives and livelihoods depend on agriculture here in India.
6
The GEAC, especially representatives from the Health Ministry, Environment Ministry and
the Agriculture Ministry on the Committee, should take on board current scientific data'
[health and environmental] from elsewhere to understand the potential Impact of GMOs
and to ask the relevant questions in the Indian context. Based on such available data,
they should lucidly justify why a precautionary principle cannot be invoked straightaway,
instead of falling into the trap of the Department of Biotechnology which apparently has
only one mandate of promoting GMOs.
In summary, we demand that the Health Ministry as one of the most important stakeholder
regulators of GMOs In this country play its rightful and expected role in protecting the health
interests of Indians, to take a precautionary approach and reject the proposal to permit Bt Brinjal
large scale trials in the country.
Sincerely,
Sd/- Members of Coalition for GM-Free India
7
Annexure 9:
Specific feedback to the company's claims on its findings through Bt Brinjal tests and
trials:
It is utterly meaningless to comment on the company's claims that Bt Brinjal Is safe and
profitable apparently based on their studies and trials with Bt Brinjal. This Is because no protocols
are described for the tests nor any numbers or tables presented. However, from whatever's put
up on the MoEF's website,:
1
2
3
4
5
6
7
8
The tests related to allergenecity and toxicity prescribed as part of biosafety testing are
obviously inadequate as the experience with Bt Cotton in India shows. Despite being cleared
as safe, Bt Cotton is reported to be causing widespread allergies in cotton growing belts of
the country. Therefore, the protocols for such tests need to be re-looked at to capture the
real adverse potential and such revised and better protocols applied for Bt Brinjal testing,
especially given that it is a food crop with the toxin consumed in large quantities with no or
very little processing.
Feeding tests done on goats do not capture the potential hazards as goats are known to be
hardy animals, compared to sheep for instance. The protocol used in the case of Bt Cotton
was to feed goats with cotton seed and the results apparently showed that there is no
difference between feeding the goats with Bt Cotton seed and non-Bt Cotton seed. There
were no multi-generational feeding tests done. What was not clear however was what the
exact research protocol was - how old was the cotton seed, for instance? It is now clear that
the tests did not capture the reality of farmers grazing their animals on Bt Cotton plants and
not seeds. They also do not in any way predict what could happen with sheep. In the case of
Bt Brinjal, there was no change in the testing regime from the Bt Cotton testing regime,
despite such valuable lessons emerging from the field and despite this being a vegetable!
It is not enough to understand the effect of the Bt gene alone while understanding the
impacts on human health and environment. It is important to capture the effects of the other,
genes transferred too. For this, a set of tests have to be evolved and undertaken.
It is surprising that the company says that the Bt toxin rapidly degrades in the soil. Published
literature shows that this is not the case. There are many studies that show that Bt toxin can
persist in the soil and retain its insecticidal activity. It is in any case known that the half life
period of CrylAc toxin in plant tissue In the case of Bt Cotton is around 41 days. In such a
case, why are the studies done by the company showing that the protein presence was nondetectable? At what stage of the crop was the test done?
What is the implication of growing Bt Brinjal in terms of the next crop, given the potential
Impacts on soil?
It is also surprising that pollen flow studies were done for just one year in two locations.
Other information from India on pollen flow in Brinjal has results that should make any
regulator sit up and take a cautious approach. The protocols used for devising Minimum
Standards for Seed Production and Certification should be used here, since they have the
worst case scenario built into the framework.
Such pollen flow studies should begin by listing out the wild species and related [compatible]
species available in India in various regions of brinjal cultivation and check the effect of Bt
Brinjal growth on such species, in a controlled environment [and not in farmers' fields].
Where is the data on associated biodiversity [like insects, birds, animals, microbes etc.]
which depend on brinjal and its related crops [both wild, related and cultivated] and where
are the impact studies on such associated biodiversity?
No detailed molecular characterization has been provided by the company. This is important,
since we now know that developers cannot control where the transgene insert lands and that
DNA rearrangements occur, with the potential to affect the spatial and temporal expression
patterns of nearby genes.
8
Bt protoxins differ immunologically from the truncated proteins used for testing purposes.
There is evidence that the toxic portion of CrylA proteins can have a different 3-D
conformation depending on whether it is part of the protoxin or in its free state. DNA
structurally associated with the protoxin is released during the proteolysis process that
generates the toxic fragment from the protoxin. If safety testing was performed on truncated
versions of bacterial surrogate proteins rather than the full-length plant-produced Bt proteins
that people are actually exposed to, such testing is absolutely inadequate. It has been found
often that biosafety testing does not take into account such a difference and it is not clear
how the tests were conducted here.
10
It is obvious that investigations have not been carried out to check whether the bacteria in
the GM agro-ecosystems have 'picked up' DNA sequence fractions of kanamycin resistance
reporter genes or streptomycin-resistance reporter genes.
11
What do the "isolated instances of necropsy" findings in all treatments indicate and what is
the company's explanation, in the case of Sub-Chronic Oral Toxicity studies in rats? How
many such instances in Bt-treated rats and how many in non-Bt treated?
12
Where is the data on how the Bt Brinjal affects children?
13
Where is the data on the cultural diversity that exists with regard to the cooking of brinjal in
this country? Brinjal is also used for medicinal purposes in India. What impact would Bt
Brinjal have on such use? Where is data related to socio-cultural importance of Brinjal in
different communities in India and the possible impact of Bt Brinjal on the same?
14
Where is data on quantified protein expression related to pest incidence in the complete
growing season of the crop? Given that the expression of the toxin is highest in the fruit, the
consumed part, what implications does this have for human health for particular hybrids?
15
Deeper investigations into what the farmers have observed during field trials of Bt Brinjal - of
color change in the fruits as the day passes - have to be taken up.
16
There is no data that shows that pesticide use does come down with Bt Brinjal - by how
much? How does it compare with NPM and organic practices?
9
FINALLY, WHERE ARE INDEPENDENT RESEARCH PROJECTS BY THE REGULATORS THEMSELVES
TO OBJECTIVELY TEST FOR RESULTS ON EACH OF THE ABOVE ISSUES?
9
To
Shri, Sharad Pawar,
Minister of Agriculture,
Krishi Bhawan
New Delhi
June 13, 2006
Greenpeace has been researching and documenting the potential hazards
associated with Genetic Engineering (GE) of our crops for over a decade now.
Internationally there is a raging controversy as to whether GE crops are viable,
sustainable and more importantly safe for the environment, the health of animals
and humans.
Our current concern stems from the fact that GE alters the natural evolutionary
process and creates new plants and animals through techniques that involve
highly complicated manipulations of genetic material and other biologically
important chemicals. Genetic engineering gives rise to unexpected and
unpredictable effects rendering any risk assessment unsound and irrelevant. GE
is a crude and un-precise method that can create unexpected effects regardless
on the source of gene introduced or type of gene that is introduced.
GE cotton has been in our fields for the last 4 years; it was approved after the
company and the government claimed that all safety tests had been done. Two
months ago a report by the Centre for Sustainable Agriculture (CSA)
documented a grave incident where around 1600 sheep had died after grazing
on GE cotton fields in Warangal district of Andhra Pradesh. The NGO makes a
strong case for GE cotton being the cause of death.
We draw your attention to the FAO/WHO codex guidelines on the assessment of
the GE food safety, which advises a need to consider unpredicted changes as
result of genetic engineering (FAO/WHO, 2003)1. It is for the government to
investigate the matter and arrest all further genetic crop experiments both in the
lab and in open fields.
While cause for sheep dying remain unresolved, we believe that GM crops must
be viewed with caution and the health of the nation must be put before corporate
profit. In the 67th meeting of the Genetic Engineering Approval Committee
(GEAC) held on 22nd May 2006, which has representation from your Ministry, the
committee had heard a presentation by M/s Mahyco on the results of the
biosafety studies conducted in respect of Bt Brinjal Cry 1 Ac.
From the minutes of the GEAC's meetings, we come to know that brinjal with the
same Bt gene whose safety is presently under question, is now being considered
for large scale field trials by the GEAC, paving the way for India’s first food crop
that could be eaten by millions across the country.
' FAO/WHO 2003. Codex Alimentarius Guideline for the conduct of food safety assessment of foods derived from
recombinant-DNA plants CAC/GL 45-2003 ftp://ftp.fao.org/cs/esn/food/euide plants en.pdfFAO/WHO 2002.
It is a known fact that large-scale field trials practically lead to uncontrolled
release of GMOs in the environment. We must also keep in mind the consistent
regulatory failure in the past and India’s dubious record in handling Bt cotton
where it was impossible to control the flow of unauthorized seeds. You will agree
that given the ground realities in our country any approval of a large-scale field
trial is a potentially dangerous act because it acts as a tacit approval equivalent
to a commercial approval and therefore must not be allowed.
We have also learnt that the GEAC, in response to the complaints by the CSA on
the 1st of June 2006, rather than commissioning a study with experts on bio
safety studies, preferred to rely on the study done by the state agricultural
department, which lacks the expertise to study a biosafety disaster of this scale.
We are very concerned by the casual attitude of the approval committee and the
various ministries to this GE time bomb at a time when a decision to approve
large scale field trials of Bt brinjal is scheduled. The decisions taken now will
impact the health and lives of every citizen of the country, our cattle and the
environment that nurtures us and therefore we urge you to proceed with caution.
It is in this context that we demand the agricultural ministry:
Commission an investigation on the sheep mortality in Warangal, Andhra
Pradesh and make public the terms of reference of the investigation.
(2)
Assess the health impacts of GE crops by conducting an exhaustive long
term health impact study on the various crops for both food and feed.
(3)
In the interim stop all field trial permissions for all new genetically modified
organisms (GMOs) - starting with Bt brinjal.
(4)
Withdraw permissions for commercial releases of all existing GE crops.
(1)
We sincerely hope that you would ensure justice to the cattle and people of India.
Yours sincerely,
Rajesh Krishnan
Campaigner - GE free India
Greenpeace India
No. 3360, 13th B Main, HAL 2nd Stage,
Indranagar, Bangalore - 560038.
Tel: 080-41154861
Fax:080-41154862
www.qreenpeaceindia.org
UNPREDICTABLE; IRREVERSABLE;
UNNATURAL
The story of Genetically Engineered Foods
Greenpeace India
#3360,13"' B Main, HAL 2nd Stage
Indira Nagar, Bangalore 560038. India.
www.ereenpeaceindia.org
June 2006
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
Genetic engineering (GE) refers to a set of technologies that are being used to change
the genetic makeup of cells of plants and animals to bring about a desired commercial
function e.g. insect resistant plants, herbicide tolerant plants, increased protein content
in vegetables etc. For the first time humans have decided to alter the natural
evolutionary process and create new plants and animals through techniques that involve
highly complicated manipulations of genetic material and other biologically important
chemicals.
UNPREDICTABLE
Genetic engineering can have unpredictable effects because the process is imprecise
and random. Inserted genes may disrupt natural genes, be unstable in their new
environment, or function differently than expected. There are two ways in which genetic
engineering may affect food safety: Gene disruption or instability may lead to new toxins
being produced; and the new protein produced by the foreign gene may cause allergies
or toxicity.
IRREVERSABLE
Releasing GE organisms into the environment poses special threats to the environment
and the food chain. GE crops are living and have the ability to reproduce and multiply.
Through crosspollination, the foreign genes they contain can be transferred to other
crops and wild species. Genetic contamination can, therefore, magnify over time. GE
seeds can also be spilt, mixed with non-GE seed and grown illegally, compounding the
problems.
UNNATURAL
Cow genes in Wheat1 and Spider genes in potato2 are just some examples of genetically
engineered organisms that are being created by scientists in laboratories. Transferring
genes across the species barrier doesn't occur in nature. Through genetic engineering
scientists have embarked on a journey to alter the evolutionary process. The impacts of
this are unknown.
This document takes you through some of the incidents that have been described as
accidents and the impact to our food and health in the dangerous world where food is
genetically engineered.
Critical health impacts caused by GMOs
There have been several cases of GM crop disasters in the past. This section takes us
through the few cases that have battled corporate efforts to suppress facts and survived
the day to reach the concerned citizen. In some of these cases, scientists owned up to
the monumental disaster and eventually were ostracized by the proponents of the
Genetic Engineering technology. In other cases, data was deliberately suppressed and
the risks of the technology had to be forced open by environmental groups
1 Scientists at the University of Nebraska (Lincoln, USA) have used cow genes in wheat to give wheat fungal (fusarium
resistance).
2 Ref: Scheller J, Henggeler D, Viviani A, Conrad U. 2004. Purification of spider silk-elastin from transgenic plants and
application for human chondrocyte proliferation, Transgenic Research 13: 51-57.
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
Rats that suffered after feeding on GE potato
In 1995 Dr. Arpad Puzstai started a publicly funded major scientific investigation (by the
then Scottish Office Agriculture, Environment and Fisheries Department, SOAEFD) into
the possible environmental and health hazards of GM potatoes. British GE scientists
were using a gene taken from snowdrop bulbs had transformed the potatoes. The gene
of this sugar-recognizing protein (GNA) has been known to give natural protection
against insect pests. It had also shown in extensive and appropriate nutritional studies
carried out by our research group at the Rowett Research Institute in Aberdeen before
the genetic modification of our potatoes with the GNA gene that animals ingesting this
protein as part of their diet even at an
800-fold excess of that present in GM
potatoes, suffered no significant harmful
consequences.
Therefore
it
was
expected for it to be safe for animal and,
later after appropriate testing, possibly
for human consumers.3
Unfortunately, the studies revealed that
the two lines of field-grown GM
potatoes, which originated from the
same transformation and were both
resistant to aphid pests were not substantially equivalent in composition to parent line
potatoes, nor to each other. Even more importantly, we showed from the results of four
rat feeding studies of different designs and durations (10 to 110 days) that diets
containing GM potatoes in comparison with iso-proteinic and iso-energetic non-GM
parent potato diets had in some instances interfered with the growth of young rapidly
growing rats, the normal development of some of their vital organs, induced changes gut
structure and function and reduced their immune responsiveness to injurious antigens.
In contrast, the animals fed on diets containing the parent, non-GM-potatoes or these
potatoes supplemented with the gene product had no such effects.4
The controversy began in August 1998 when Dr Arpad Pusztai, 68, made a public
statement about his fears, about the £1.6m study he conducted at the Rowett Research
Institute (RRI).
Though the establishment ganged up against him, Dr. Pusztai’s findings have never
been disproved. This work has in fact clearly demonstrated that, in addition to possible
toxicological studies, the safety of GM - food must be established in both short-term and
long-term feeding, metabolic and immune-response studies with young animals as these
should be the most appropriate to respond to and show up any nutritional and metabolic
stresses affecting the normal development of young animals into healthy adults.
3 Source: Dr Arpad Pusztai; Submission of Health Impacts of GM Crops: Evidence to the Clerk to the Health and
Community Care Committee of The Scottish Parliament)
4 A Pusztai et al. (1999) Expression of the insecticidal bean alpha-amylase inhibitor transgene has minimal detrimental
effect on the nutritional value of peas fed to rats at 30% of the diet The Journal of Nutrition, 129, 1597-1603.
SWB Ewen an A Pusztai (1999) Effects of diets containing genetically modified potatoes
expressing Galanthus nivalis lectin on rat small intestine. The Lancet, 354, 1353-1354.
A Pusztai (2002) Can science give us the tools for recognizing possible health risks of GM food? Nutrition and Health
(2002) 16, 73-84
7. A Pusztai (2002) GM food safety: Scientific and institutional issues. Science as Culture, 11, 70-92.
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
^eeN?eAc^
Within 48 hours after his public statement he was suspended in disgrace and later
forced to retire. The RRI said he had misinterpreted his results.
When Dr. Pusztai initially voiced his concerns about the health implications of genetically
modified foods on ITV's World In Action on August 12th 1998, the biotech company,
Monsanto, was quick to react in the press on 13th August 1998, asserting in The Times
that "...these revelations are absolute dynamite", adding that "We have...food scares and
doom-laden utterances without anyone looking at the facts."5 The lobby group,
Foodfuture, added that the scandal was due to "sloppy science and over-blown
reporting...6"
Some opinions of other independent scientists on Dr. Puzstai’s study:
A group of scientists, drawn from 13 different countries, had re-examined his work and
signed a joint memorandum7 saying his conclusions were justified (1999). The group
included toxicologists, genetic engineers and medical experts. "We found that his data is
sound”, said their spokesman, Dr Vyvyan Howard, a toxipathologist at Liverpool
University,
Dr. Putzai's revelations have been backed by an independent analysis by consultant
pathologist Dr Stanley Ewen, of Aberdeen University, who examined the preserved rats'
organs. But a leading expert said: 'These were measurable changes in the rats fed
modified potato - and we feel there’s been a cover-up. There should be more openness
in the whole business about public money and how it being used in this field.’8
Mice that suffered from inflammation of the lungs after feeding
on GE peas910
After a decade of research, a field trial of genetically engineered (GE) peas was stopped
in Australia because a study1" found serious health impacts in mice that were given the
GE peas to eat. The GE peas contained a gene from a bean to make the peas resistant
to damage by the pea weevil.
The gene inserted into the GE peas was designed to produce an alpha-amylase
inhibitor, a protein that prevents the digestion enzymes of insects from working. This
causes the plant to be toxic to them when eaten.
Small changes in protein structure can cause big changes in allergenicity.
Although the chemistry of the protein produced in the GE pea was almost exactly the
same as that produced naturally in the bean, the structure of the protein was
5 The Scotsman, 13th August 1998.
6 The Guardian, 1301 August 1998.
7 Fears erupt over Genetic food, 12,h February 1999, BBC.
8 The UK Mail, dated 31 Jan 1999.
9 CSIRO Plant Industry; 2005; Effective risk assessment' of GM field peas
10 Vanessa E. Prescott, Peter M. Campbell, Andrew Moore, Joerg Mattes, Marc E. Rothenberg, Paul S. Foster, T. J. V.
Higgins, and Simon P. Hogan JOURNAL 01 AGRICULTURAL AND FOOD CHEMISTRY Volume 53, Issue 23 (November 16,
2005) pages 9023 - 9030
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
unexpectedly changed in the GE plant. Small changes in the 3D protein structure can
affect their potential to cause allergies. In this case, the researchers found that the GE
peas caused allergenic reactions in mice.
When they inhaled the GE pea
protein it caused inflammation of
the lungs and when they ate the
GE peas they became more
sensitive to other food allergies.
These effects were not observed with beans
that naturally produce this protein.
FAe CSIRO-d&v&lop&d GM fizid p&as (right)
In the case of this study, the toxic effects
were seen within the four weeks of the experiment. Had the toxic effects developed over
a long-term period, they may not have been detected by the study. This demonstrates
why it is so important that GE crops are properly tested and are not released into the
environment.
Rats that suffered after being fed GE corn
On 23 April 2004, Le Monde reported that the French expert body in charge of GMO
evaluation (CGB, Commission du Genie Biomoleculaire) had expressed doubts about
the safety of GM maize MON863. Results of a rat feeding study that Monsanto delivered
to EU authorities showed significant variations between rats fed conventional maize and
those fed with MON863. The variations included an increased number of white blood
cells in the males, reduced immature red blood cells in females, a significant increase in
blood sugar in the females and a higher frequency of physical irregularities in the
kidneys of the males, such as reduced weight and inflammation.
Monsanto requested that
documents
concerning
the risk assessment, like
rat feeding trial results,
should be classified as
“confidential
business
information”.
According to European
law, the public has a right
to
full
access
to
information
concerning
the risk assessment of
GMOs.
In
particular
Article 25 of Directive
2001/18/EC indicates that
“in no case” should the
information
related to
"environmental risk assessment” (defined as "the evaluation of risks to human health
and the environment, whether direct or indirect") be kept confidential.
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
The Directive also indicates that the risk assessment should "be carried out in a
scientifically sound and transparent manner based on available scientific and technical
data".
Greenpeace had been pursuing this since April 2004, and it took us more than a year to
see the interests of society al large would prevail to have access to "confidential
business information" over Monsanto's economic interests and its policy of opacity and
secrecy.
The chronology of the campaign is as follows:
• On 5 May 2004, Greenpeace wrote to the German agriculture ministry, which was in
charge of the initial risk assessment report, to request access to the full documents
concerning Mon 863.
■ On 4 August 2004, the German agriculture ministry replied that the applicant,
Monsanto, had refused to agree to publish the initial rat study MSL-18175, which had
been classified as "confidential business information". • On 21 March 2005, the German
authority decided to give access to the full document, because Monsanto could not show
that its request for confidentiality was backed by EU or national law.
• On 27 April 2005, Monsanto filed an appeal against the decision of German
government and, in addition, took out an injunction to stop the authorities publishing the
data.
• On 9 June 2005, the German court decided to reject Monsanto's request; the data
could not be seen as confidential, the right of society to transparency had to be given
more weight than Monsanto’s economic interests. The company appealed the decision.
■ On 20 June 2005, the court rejected the appeal, and ruled that the documents be made
public.
GE Corn (Starlink) - a potential allergen to humans enters the
food chain
Even if the allergenic potential of a GE crop is recognised by the regulatory authorities, it
can still end up in human food. Aventis’ StarLink was a type of insect resistant GE corn
grown in the USA from 1998, which produced the St protein, Cry9C. It was only
approved for animal feed and industrial purposes, as there were concerns that the
Cry9C protein could cause allergies because it shares characteristics of other allergens.
However, in September 2000, StarLink was found in corn taco shells and other foods,
and over 300 com products had to be withdrawn from the market. Traces of StarLink
corn were also found in com-based foods in Japan and Korea. It is not known how
StarLink came to be in the human food chain - it may have been inadvertently mixed
with other corn at a mill, a conventional crop may have cross-pollinated with a StarLink
crop, or a farmer may have sold StarLink corn for human food to get a higher price.
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
$ReeN?#)ar
While StarLink is not being grown anywhere in the world at the moment, it may have
contaminated other corn seed and remain in the food chain. The episode raises
questions about the ability of regulatory authorities to control GE crops.
Industry observers estimate that the entire cost of the scandal has exceeded US $1
billion. Neil E. Hart, a professor of economics at Iowa State University, estimates that the
company has already paid out more than $500 million to farmers, food processors and
grain handlers". At least 300 food products in the US had to be recalled, at an
undisclosed cost to the food manufacturers. There were also recalls in Canada and
Japan. US corn farmers lost huge markets all around the world. US government officials
estimated that it might take four years to get StarLink out of the US food and seed
supply. Now, three years after the scandal, approximately 1% of samples sent to USDA
testing labs are still found to contain StarLink’2.
Some of the costs of the contamination scandal can be detailed:
•
•
•
•
•
Aventis paid at least $100 million to buy back the 2000 crop.13
The United States Department of Agriculture spent $20 million to buy seeds from
small companies whose seed stock was contaminated.14
Kraft lost an estimated $10 million in lost sales from its taco shells alone.15 Taco
Bell franchises were awarded $60 million by all the taco shell manufacturers:
Kraft, Azteca Foods and Mission Foods.16
Aventis, Garst and four food companies (Kraft, Kellogg, Azteca Foods and
Mission Foods) settled a class action consumer lawsuit for $9 million to
customers who said they suffered allergic reactions17.
Aventis and Garst settled a class action lawsuit by farmers seeking
compensation for lost markets. The lawsuit sought damages as well as a
requirement for Aventis to decontaminate all soil, farming equipment, etc. to
prevent further contamination. The firms will pay $110 million; farmers are likely
to receive only US$1 per acre.18
Unintended effects of Genetically Modified Organisms (GMOs):
There are numerous cases of documented unexplainable effects of GMOs. Here are a
few examples:
• Researchers at Monsanto who were trying to increase the content of carotenoids (a
chemical which is used to form vitamin A) in oilseed rape (canola) found that vitamin
E and chlorophyll levels in the seeds were dramatically and inexplicably reduced19.
11 Jacobs, P. 2003. Traces of contaminated grain still showing up in corn supply. 30 November. San Jose Mercury News.
“ Ibid
13 Reuters. 2000. Aventis sale of bio-crop unit could hurt farmers. 27 November
14 Schuff, S. 2001. Major seed companies say they have StarLink isolated. 12 March. Feedstuffs.
15 Madigan, K. 2003. Risky business. Los Angeles, CA: State Public Interest Research Groups, As You Sow Foundation
16 Cohen, D. 2001. Taco Bell franchisees to get $60 million. 8 June. Reuters.
” Carroll, J. 2002. Judge will approve a settlement on use of StarLink corn products. 7 March. Wall Street Journal (New
York)
18 No author. 2003. Aventis settles StarLink lawsuit. 12 February. Chemical Week.
19 Shewmaker, C.K., Sheehy, J.A., Daley. M., Colburn, S. & Yang Ke, D. (1999) Seed-specific over expression of phytoene
synthase: increase in cartenoids and other metabolic effects. The Plant Journal, 20, 401-412.
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
The colour of the infamous ‘'Golden" rice is an unexpected effect of GE. The GE
construct originally contained three genes. The first two genes produce lycopene
(red pigment in tomatoes) while the final gene transforms the lycopene to beta
carotene (yellow pro-vitamin A).
Rice kernels from plants with only the first two genes were expected to turn out red
because of the lycopene, but they were yellow. The reason behind the colour of rice
turning out yellow and not red with just the first two genes is not understood.
Scientists involved in the study have been unable to explain how the rice turns yellow
with only two genes.20
Monsanto's GE Roundup Ready soybeans have suffered unexpected crop losses in
hot, dry weather due to stem splitting caused, most probably, by increased lignin21.
The soybeans’ phytoestrogen levels are also 12-14 % less than in conventional
soybeans, which may mean that soy-based products derived from Roundup Ready
soybeans would be less useful as sources of phytoestrogens.
Beyer P. et al. 2002, Golden rice: introducing the B-carotene biosynthesis pathway into rice endosperm by genetic
engineering to defeat vitamin A deficiency. American Society for Nutritional Sciences, 132: 506S-510S.
21 Coghlan, A. (1999) Splitting headache - Monsanto's modified soybeans are cracking up in the heat. New Scientist, 20th
November, p.25.
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
^RfeNWKtT
Unexpected effects: GE
Soybean
Unexpected effects: GE Poplar trees
Disconcerting effects have been observed with poplar trees: a field test which was
started in 1996 produced female blossoms on a plant after only three years, whereas
normally poplars start blossoming only at the age of eight years. This early
Unpredictable; Irreversible; Unnatural; The story of Genetically Engineered Foods; Greenpeace India 2006
blossoming could increase the rate of unintended spread of the GE trait into the
population.22
•
In China, poplar trees were engineered for insect resistance. The trees did express
the desired effects towards the pest insects in field trials. However, just two years
later, new and unexpected sensitivities towards other insects occurred.23
How ‘risk assessment’ fails to measure human health impacts
Risk assessment is often portrayed as a relatively straightforward process - simply
identify all possible hazards, calculate the probability that, they may arise, work out what
the risk is, decide if it is acceptable and how to manage it It sounds very scientific and
impartial, but it is not. This protocol was initially conceived to deal’ wjth failures in
machinery, when it is applied to GMOs it struggles with the complexity of the natural
environment. Because it is this system that underlies the regulation of GMOs worldwide,
protection of the environment and human health is being compromised.
The ‘Precautionary Principle' builds on a series of straightforward and well-established
ideas that24
•
»
•
»
•
•
«
•
•
•
Prevention is better than cure;
The polluter should pay.
We should look for ‘no regrets' options.
We should recognise the Intrinsic value of npn-human - as well as human - life.
The complexity and variability of the real world , limits the ability of scientific
knowledge to predict.
We must recognise the vulnerability of the natural environment.
The rights of those who stand to be affected by an activity must be prioritized rather
than those who stand to benefit from it.
There must be scrutiny of all available alternatives and an examination of
justifications and benefits as well as risks and costs.
Long-term, holistic and inclusive perspectives are needed in environmental
protection.
Policy analysts have concluded that the Precautionary Principle is more scientific
than conventional risk assessment.25
Therefore, a precautionary approach introduces a more scientifically rigorous analysis,
with a broader scope and wider range of experts. Precaution is involved at all steps in
decision making, In areas where action may lead to seriously harmful effects, from the
practice of science and the research agenda, to regulation and governance. Because
the threats of GE are so broad, and it's harmful impacts could be severe and irreversible,
the precautionary principle must be strictly applied.11
*
11 Fladung, M.; Nowitzki, O., Ebbinghaus, D., Schellhorn, A.; Bentien, G., Ahuja, M.R. & MuhS, HJ. 1999, Field release of
ROLC-transgenic Aspen-Populus. Online: http://users.ox.ac.uk/~dops0022/conference/forest biotech99 home.html.
Poster 96, 3.12.1999.
” Ewald, D. & Han, Y. 1999, Freisetzungsversuche mit transgenen Pappeln in China. UBA-Fachgesprach ..Freisetzung
transgener Geholze - Stand, Probleme, Perspektiven" 20. & 21. Sept., Humboldt-Universitat zu Berlin.
M Stirling, A (1999) Science and precaution in the management of technological risk. Report for the European Commission
- JRC Institute of Prospective Technological Studies, Seville. http://www.irc.es/pub/EURdoc/eurl9056Ien.pdf
“ European Commission (2000), Communication on the Precautionary Principle, COM (2000)1, Brussels: European
Unpredictable; Irreversible; Unnatural; Jhe story of Genetically Engineered Foods; Greenpeace India 2006
Briefing
Genetic Engineering Briefing Pack
September 2002
The Precautionary Principle and
GMOs: taking a scientific approach
to risk
Q
enetically modified organisms (GMOs) are
produced by transferring genes from one
organism (usually an unrelated species) into
another. The GMO may, for example, be a
crop for food use, an animal to provide meat
or a microorganism to degrade toxic waste. In
these cases, the GE organism may be
released into the environment where it can
grow and multiply. Its foreign genes may
transfer into related wild species or the GMO
may behave unpredictably, become out of
control and damage ecosystems. Any effects
are likely to be irreversible. Our knowledge of
how and when harm may arise is limited and
surprises are likely.
When faced with such situations, how should
decisions be made about whether and, if so,
how to produce and use a GMO? One
obvious approach is to apply the
Precautionary Principle. This principle has
been developed as a result of experiences
with chemical and other forms of pollution
with the intention of avoiding such harm
arising in the future. The Precautionary
Principle is intended to be a general rule in
situations where there is the potential for
serious or irreversible threats to health and
the environment and requires action to be
taken to avoid such threats even where
definite proof of harm does not yet exist. It
stops the lack of scientific certainty being
used to delay preventive action1,2,3. From
asbestos, PCBs and ozone depletion to mad
cow disease, conventional risk assessments
have failed and the lessons of waiting too long
for proof of harm before taking action have
shown that a rigorous precautionary approach
is long overdue4.
However, the Precautionary Principle is
sometimes criticised as being unscientific,
and stifling progress. This briefing reviews
why precaution is so vital in relation to GMOs,
how it demands a more rigorous approach to
science and brings more democracy into
decisions about whether or not to take risks
and why it does not present a barrier to
progress. Rather than a presumption that
benefits for industry should take precedent,
under a precautionary approach a voice is
given to the environment, individuals and
communities who stand to be affected if
things go wrong.
GMOs: their potential to cause significant,
irreversible harm
When organisms are genetically engineered,
a package of genes is introduced which
includes genes to switch on another ‘gene of
interest’ (that makes a crop produce an
insecticide or be tolerant to chemical
weedkillers, for example) together with a gene
to switch it off. A marker gene is also included
because the GE process is very inefficient
and only a small proportion of cells
incorporate the foreign DNA. So a gene that
gives an identifiable change, such as
antibiotic resistance or florescence, is also
included. All these genes may come from any
species and bacterial and viral genes are
commonly used.
The supporters of genetic engineering claim
that the process is more precise than
conventional breeding because it is known
exactly what genes are added and, therefore,
that their effects can be predicted. However,
the GE process is not controllable and new
The Precautionary Principle and GMOs: taking a scientific approach to risk
scientific research shows that gene function
is much more complex than previously
thought:
• the position at which genes are
inserted is random - other genes may
be disrupted and their function altered;
• many copies may be integrated,
additional fragments inserted, gene
sequences rearranged and deleted5,6 7
•
•
•
ecosystems. For example, if wild plants
gain a gene to produce a protein toxic to a
range of insects or other organisms, they
may survive better than other plants;
new toxins or allergens being produced as
a result of interference with natural gene
function or unexpected interactions
between gene products;
- which may result in lack of operation of
the genes, instability or interference with
other gene function;
one gene does not code for only one
function - findings from studies such as
the human genome project have shown
that there are far fewer genes in higher
organisms than was predicted - 3040,000 in man rather than the 120-140,000
originally thought8. This means that genes
There is evidence that things regularly DO go
wrong with GMOs:
• Experiments to make potatoes resistant to
insects using a lectin gene led to lowered
levels of the plant's natural insect
deterrent chemicals, glycoalkaloids. This
was shown to be an unintended effect of
the GE process itself, as the introduction
of a different insect resistance gene had
the same effect11.
or parts of genes may be involved in
different functions, depending on how they
are read and which other genes are
involved. This undermines the assumption
that adding a gene with one known
function means that this is the only way it
will behave in practice9. Indeed, the
detailed functioning of DNA is not well
understood. Scientific theories and
understanding of the ways in which genes
work is constantly developing, giving new
insights on the complexity of gene
function10;
•
Yeast which had been genetically
engineered to improve alcohol
fermentation unexpectedly had up to 30
times the concentration of methylglyoxal
(a highly toxic compound) compared to
the control non-GE strain12.
•
Researchers at Monsanto who were trying
to increase the content of carotenoids
(chemicals which are used to form
vitamin A) in oilseed rape (canola) found
that vitamin E and chlorophyll levels in the
seeds were dramatically and inexplicably
reduced13.
•
Other researchers trying to genetically
engineer a carotenoid pathway in
tomatoes found over-expression of a gene
caused unexpected dwarfism in the
plant14.
•
Monsanto’s GE Roundup Ready
soybeans have suffered unexpected crop
losses in hot, dry weather due to stem
splitting caused, most probably, by
increased lignin15. The soybeans’
phytoestrogen levels are also 12-14 %
less than in conventional soybeans, which
may mean that soy-based products
derived from Roundup Ready soybeans
would be less useful as sources of
phytoestrogens which are thought to be
beneficial in adult diets16.
a package of genes is introduced for
which there is no evolutionary
precedent-the introduced genes come
from a mix of species which have never
packaged together before. In a complex
genome, how they will behave and interact
over time is unknown.
The consequence of such complexity is that
unpredictable effects are likely. Once
released in the environment, it will not be
possible to recall a living organism so any
impacts are likely to be irreversible because
organisms are self replicating. If the GMOs
cross with related wild species, the genetic
change may be incorporated in the natural
gene pool and alter the path of evolution.
The kinds of impacts that may occur include:
• GE crops becoming more invasive, weedy
and difficult to manage;
• wild plants acquiring the genes and so
changing their characteristics and altering
No independent monitoring takes place of the
GE crops grown across the world so there
-2-
The Precautionary Principle and GMOs: taking a scientific approach to risk
will be no early warnings of unexpected
effects.
prevailing weather. This is sometimes called
‘exposure’ in chemical risk assessment.
It is also becoming clear how unmanageable
the risks of GE crops are. In Canada,
volunteer oilseed rape weeds that are tolerant
to three herbicides (Liberty, Roundup and
Clearfield) were first identified in 1998, only 3
years after GE herbicide tolerant oilseed rape
was first grown17,18. The problem has arisen
Risk assessment is often portrayed as a
relatively straight forward process - simply
identify all possible hazards, calculate the
probability that they may arise, work out what
the risk is, decide if it is acceptable and how
to manage it. It sounds very scientific and
impartial, but it's not. Initially conceived to
deal with failures in machinery, it struggles
with the complexity of the natural
environment. Because it is this system that
underlies the regulation of GMOs worldwide,
protection of the environment and human
health is being compromised.
because some seed is shed at harvest time,
remains in the ground and germinates in
future years. When the plants emerge in
subsequent crops of a different species they
are then unwanted weeds (‘volunteers’) which
have to be removed by the farmer. This
resistance to more than one herbicide is
known as 'gene stacking’ and arises through
pollination of one herbicide tolerant variety by
another. The emergence of super-weeds in
Canada is driving up the use of other, more
toxic chemicals. Both 2,4-D and paraquat
(grammoxone) are being recommended by
government agencies to control herbicide
tolerant oilseed rape volunteers in Canada19.
There is now a well established critique of
conventional risk assessment which has
shown that the process is subject to
scientific, social, political and economic
judgements which tend not to be explicit20.
These judgements are seen in:
• which hazards are considered someone has to choose what to include
and exclude. In the case of GMOs, the
risk assessment focuses on the genetic
change and generally excludes indirect
effects and secondary impacts on
organisms in the food web or
implications for non-GE and organic
farmers. It is this framing of the risk
assessment that drives the outcome and
reflects the interests of those designing
the assessment;
• calculating their probability - there is
always scientific uncertainty, and a
choice has to be made. With GMOs it is
unlikely that probability of an event
happening can ever be calculated with
any confidence as it covers a host of
different environmental and ecological
factors, it also depends on whether
people follow the rules, which is often not
the case;
• what is an acceptable risk - whether a
potential impact is significant or not is a
matter of social or even personal
judgement - it depends on social,
economic and cultural factors. Risk
assessment conceals this and presents
risk as something to be quantitatively
measured by scientists and managed by
experts to “acceptable" levels. The issue
of genetic contamination of indigenous
The unpredictable changes GE can cause,
the difficulties there will be dealing with any
problems and the potential for GMOs to
multiply and grow mean that GMOs fall firmly
within the scope of the precautionary
principle. Conventional risk assessments,
biased towards the interests of the
biotechnology industry (see Box 1), are very
unlikely to provide the degree of protection
required.
How risk assessment fails the
environment and human health
In a risk assessment of releasing a GMO to
the environment, risk may be described by a
seemingly simple equation:
Hazard x probability = risk
The hazard is the type of harm that might
arise, a cancer or death of an animal, for
example. The probability is how likely this is to
happen, ranging from very low - such as one
in a million, to high - such as one in ten.
Probability, like hazard, is a complex issue
covering a range of factors. For example, with
gene flow from one plant species to another
this includes how closely related the two
species are, whether they flower at the same
time, how far apart they grow, whether they
are pollinated by insects or the wind and the
-3-
The Precautionary Principle and GMOs: taking a scientific approach to risk
•
maize varieties in Mexico will be viewed
very differently by Mexicans, who bear the
risk, and Americans whose corporations
profit from GE maize;
dealing with ignorance and surprises when evidence is patchy or missing,
deciding whether there may be a problem
or not depends on informed prediction,
using available information and drawing on
lessons of the past in order to come to a
reasoned but cautious decision. Risk
assessment underestimates this problem,
assuming that knowledge and
understanding are sufficient to calculate
risk, or will become sufficient in time if
further research is commissioned.
•
•
•
•
•
•
•
•
The process is also constrained because only
hazards that can be measured are commonly
included in risk assessments. Long-term
subtle changes in behaviour or fertility are not
easily included. What might ultimately prove
to be the most important changes may simply
not be part of the assessment.
•
‘prevention is better than cure';
‘the polluter should pay' ;
we should look for ‘no regrets' options;
we should recognise the intrinsic value of
non-human - as well as human - life.
the complexity and variability of the real
world limits the ability of scientific
knowledge to predict;
we must recognise the vulnerability of the
natural environment;
the rights of those who stand to be
affected by an activity, must be prioritised
rather than those who stand to benefit
from it;
there must be scrutiny of all available
alternatives and an examination of
justifications and benefits as well as risks
and costs.
long-term, holistic and inclusive
perspectives are needed in environmental
protection.
New techniques are being developed which
allow these ideas to work in practice.
Deliberative techniques, multi-criteria
evaluation and other approaches provide new
ways of conducting technology evaluation and
must be brought into GMO assessments.
Importantly, because a precautionary
approach takes a much broader scope, it
explicitly considers uncertainty and ignorance
and evaluates alternatives. Policy analysts
have concluded that the Precautionary
Principle is more scientific than conventional
risk assessment25,23.
Underlying the risk assessment of GE crops
is an assumption that they form a positive
development for agriculture21. Although rarely
acknowledged in risk assessment, this bias
shapes the way in which GMOs are
evaluated. The odds are stacked in favour of
the industry and against the environment and
human health.
What does the Precautionary Principle
mean in practice?
The Precautionary Principle was first used
formally in German law in the mid-1970s.
Since then it has been adopted as an
approach to protection of environmental and
human health in many other national, regional
and international laws. The Cartagena
Protocol on transboundary movements of
GMOs is based on the Precautionary
Principle and the principle has been endorsed
by the European Commission. But what does
it mean in practice? Too often, precaution
translates into a conventional risk
assessment as it has under the European
Deliberate Release Directives22 which leaves
the pro-biotech bias in place (see Box 1).
Precaution and GMOs: bringing science
to the fore
Genetic engineering can change organisms in
far reaching and unpredictable ways.
Assessing their impacts and whether they are
acceptable must take into account the
complexity of ecosystems, scientific
ignorance (the “unknown unknowns’’) and
uncertainty. Conventional risk assessment
denies the potential for surprises and narrows
the scope of harm to be evaluated to a limited
range of factors. It is often undertaken by a
restricted group of specialists whose narrow
expertise acts against a comprehensive
approach. Whilst science is used in the
assessment, the exclusion of wider criteria
such as indirect impacts on agriculture and
biodiversity and lack of attention to uncertainty
is not scientifically justifiable.
The 'Precautionary Principle’ builds on a
series of straightforward and well-established
ideas that23,24:
-4-
The Precautionary Principle and GMOs: taking a scientific approach to risk
A precautionary approach (see Box 2) does
not stifle progress but can encourage
innovation more widely by stimulating the
search for alternatives and valuing diversity. In
contrast, the demand for proof of harm before
action is taken can lead to 'paralysis by
analysis’*1
4,5as old practices are defended to
the bitter end.
insert. European Food Research Technology,
213, 107-112.
International Human Genome Sequencing
9
Consortium (2001) Initial sequencing an analysis
of the human genome. Nature 409: 860-921.
Commoner, B. (2002) Unravelling the DNA myth.
The spurious foundation of genetic engineering.
Harper's Magazine, February. Available on
www.mindfully.org/GE/GE4/DNA-MythCommonerFeb02.htm.
10
e.g. Dennis, C. (2002) The brave new world of
Therefore, a precautionary approach
introduces a more scientifically rigorous
analysis, with a broader scope and wider
range of experts. Precaution is involved at all
steps in decision making in areas where
action may lead to seriously harmful effects,
from the practice of science and the research
agenda, to regulation and governance.
Because the threats of GE are so broad, and
harmful impacts could be severe and
irreversible, the precautionary principle must
be strictly applied.
RNA. Nature, 418, pg. 1222-124 and related
articles in Nature Insight -RNA, 1101 July 2002.
’’Birch, A.N.E., GMOghegan, I.E., Griffiths, D.W.
&
McNicol, J.W. (2002) The effect of genetic
transformations for pest resistance on foliar
solanidine-based glycoalkaloids of potato
(Solanum tuberosum) Ann. Appl. Biol 140:143149.
12
Inose, T. & Murata, K. (1995) Enhanced
accumulation of toxic compound in yeast cells
having high glycolytic activity: a case study on
the safety of genetically engineered yeast.
International Journal of Food Science and
Technology, 30, 141-146.
13
Shewmaker, C.K., Sheehy, J.A., Daley, M.,
Colburn, S. & Yang Ke, D. (1999) Seed-specific
overexpression of phytoene synthase: increase
in cartenoids and other metabolic effects. The
Plant Journal, 20, 401-412.
14
Fray, R.G., Wallace, A., Fraser, P.D., Valero.
' Raffensberger, C. and J. Tickner (1999),
Protecting Public Health and the Environment:
implementing the Precautionary Principle.
Washington: Island Press.
' Fisher,E. and R. Harding (1999) Perspectives on
D., Hedden, P., Bramley, P.M. & Grierson, D.
(1995) Constitutive expression of a fruit phytoene
synthase gene in transgenic tomatoes causes
dwarfism by redirecting metabolites from the
gibberellin pathway. The Plant Journal, 8, 693701.
15
Coghlan, A. (1999) Splitting headache -
the Precautionary Principle, Sydney Federation
Press.
1 O’Riordan,T and J. Cameron (1994) Inlcipreting
4
8
the Precautionary Principle, London: Earthscan.
Harremoes, P., Gee, D., MacGarvin, M.. Stirling,
A., Keys, J., Wynne, B., and Guedes Vaz, S.
(editors) 2002. The Precautionary Principle in
the 2C/h Century: late lessons from early
warnings. London: Earthscan.
5 Labra, M., Savini, C., Bracale, M., Pelucchi, N.,
16
Monsanto's modified soybeans are cracking up
in the heat. New Scientist, 20th November, p.25.
Lappe, M.A., Bailey, E.B., Childress, C.C. &
Setchell, K.D.R. (1998/1999) Alterations in
Clinically Important Phytoestrogens in
Genetically Modified, Herbicide-Tolerant
Soybeans. Journal of Medicinal Food, 1, 241245.
17
Downey, R.K. (1999) Gene flow and rape - the
Colombo, L., Bardini, M. & Sala, F. (2001)
Genomic changes in transgenic rice (Oryza
sativa L.) plants produced by infecting calli with
Agrobacterium tumefaciens. Plant Cell Reports,
20, 325-330.
0 Shunhong Dai, Ping Zheng, Philippe Marmey,
Canadian experience. 1999 BCPC Symposium
Proceedings No. 72: Gene flow and agriculture:
relevance for transgenic crops. British Crop
Protection Council: Farnham.
18
Hall, L., Topinka, K., Huffman, J., Davis, L. &
Shiping Zhang, Wenzhong Tian, Shouyi Chen,
Roger N. Beachy & Claude Fauquet (2001).
Comparative analysis of transgenic rice plants
obtained by Agrobacterium-mediated
transformation and particle bombardment.
Molecular Breeding 7: 25-33.
' Windels, P., Taverniers, I., Depicker, A., Van
Good, A. (2000) Pollen flow between herbicide
resistant Brassica napus is the cause of
multiple-resistant B. napus volunteers. Weed
Science 48: 688-694.
Bockstaele, E. & De Loose, M. (2001)
Characterisation of the Roundup Ready soybean
-5-
The Precautionary Principle and GMOs: taking a scientific approach to risk
Alberta Agriculture, Food and Rural Development
(2002) Outcrossing Between Canola Varieties A Volunteer Canola Control Issue.
http://www.aqric.qov.ab.ca/crops/canola/outcros
sinq.html
20
Stirling, A (1998) Risk at a turning point? Journal
of Risk Research 1: 97-110, 1998.
Levidow, L. (1994) Biotechnology regulation as
symbolic normalisation. Technology Analysis
and Strategic Management 6(3): pp 273-288.
22
Mayer, S. & Stirling, A. (2002) Finding a
21
precautionary approach to technological
developments - lessons for the evaluation of GM
crops Journal of Agricultural and Environmental
Ethics 15:57-71.
Stirling, A (1999) Science and precaution in the
management of technological risk. Report for the
European Commission - JRC Institute of
Prospective Technological Studies, Seville.
http.//www.jrc.es/pub/EURdoc/eur19056len.pdf
24
Stirling, A. (1999) Science and precaution in the
23
management of technological risk. Volume II
Case Studies. Report for the European
Commission - JRC Institute of Prospective
Technological Studies, Seville.
http://www.jrc.es/pub/EURdoc/eur19056llen.pdf
25
European Commission (2000), Communication
on the Precautionary Principle, COM(2000)1,
Brussels'. European Commission.
-6-
Main Identity
From:
To:
Sent:
Attach:
Subject:
"Jai Krishna" <jaikrishna.r@dialb.greenpeace.org>
<ravi@phmovement.org>
Thursday, June 29, 2006 6:53 I’M
precautionay principle...GP stand.pdf; GM Accidents Report.pdf
FW: Genetically Modified foods
Dear Mr. Narayan,
This is Jai krishna from Greenpeace. I am writing this mail for divya,
my colleague.'
I?)
I hope you remember me-1 was involved in the Kodaikanal- mercury
pollution issue of the HLL.
1 would be glad if you could give us some time tomorrow.
Sin tune with nature
greenjai
"You
must
be
the
change you wish
- M.K.Gandhi
to
see."
----- Original Message-----Irom: Divya Raghunandan [mailto:draghuna@dialb.greenpeace.orgl
Sent: 29 July 2006 12:55
I o: secretariat@phmovement.org; cehatpun@vsnl.com; ctddsf@vsnl.com;
samasaro@vsnl.com
< 'c: Jai; Rajesh Krishnan
Subject: Genetically Modified foods
Dear Dr Ravi Narayan,Dr. Abhay Shukla.Dr. Amit Sen Gupta,Ms Sarojini,
< iiecnpeacc has been campaigning against the use of Genetic Engineering
agriculture and foods for over a decade. Our specific concerns with the
technology and it's potential impact on the environment and the health
all that consume GM foods or feed will hopefully be summarised in the 2
documents that you may find attached.
A// — pifi-coe
52>l
Our immediate concern stems from the fact that the Genetic Engineering
Approval Cominittee( GEAC)housed within the Ministry of Environment and
I 'orcsts is a week from deciding where GM brinjal with an insect
resistant
gene from a soil bacteria(Bt)will be given permission for large scale
field
cb»ya..
6/30/2006
Page 2 <>1’2
trialsfunder 20 acre plots across the country). As shown in the case of
Bl
Cotton GMOs in large scale field trials are impossible to contain.
brinjal
is the first of a long list of
approvals.(http://www.greenpeace.org/india/press/repprts/genetically-eng
inee
red-lbod-ho)
\ number of recent lab reports with GM crops show unexpeced side effects
on
lab animals (please see accidents report), furthermore all over the
world
risk assessment for GMOs is a huge challenge. At Greenpeace we believe
that
(he precautionay approach must be applied when the quantum or the nature
of
the risk cannot be identified.
On the 12th of July the GEAC will decide whether India is to have the
first
GM food crop- Brinjal. By pressurising the GEAC to make public the
biosafety
data and toxicological studies conducted by the company we have this
data on
(lie (il'AC website. The GEAc invites commentsfor all of us until the 7th
July after which they will go on to decide the fate of GM brinjal.
http://www.envfor.nic.in/diyisions/csurv/geac/brinjaljpart-I.pdf
As eminent scientists, and medical professionals I do urge you
collectively
and as individuals to review the data and raise any concerns that you
I would also request an appointment to meet with you either in Delhi or
in
bangalore to see whether JSA would be able to put out a collective
statement
by way of a press release or a submission to the health ministry on you
concerns of Genetically modified Food as (he answer to the nations food
and
health crisis.
Do look forward to hearing from your
Regards
Divya Raghunandan
Greenpeace
191 9845535406
6/30/2006
ecosystems around the world. It’s estimated for every human being on Earth there are at least 2
hundred million insects. Maybe only one out of every thousand species of insects is a pest to human
beings. It doesn’t make sense to spray a chemical that kills all insects to get at the one or two that are
a pest to human beings. The excitement and promise of science obliterated caution and duty and
biologists, geneticists and ecologists did not say anything about their concerns over pesticides. Paul
Muller won the Nobel Prize for medicine in 1948. But by the 1950s, bird watchers began to notice
something funny was happening with birds. They were disappearing. Biologists went into a research
huddle and discovered a phenomenon called ‘biomagnification’, the ability of microorganisms to
absorb DDT; they don’t die, they concentrate it, and at each nutrition level of the food chains, it is
concentrated. So when it gets to the fatty tissues of birds, or the breasts of women, the concentration
of DDT is hundreds of thousands of times higher than the initial application of the chemical. So how
could DDT have been managed when scientists didn’t even know about ‘biomagnification’ until after
the event? It also took 60 years to understand that DDT has oestrogenic effects. In terms of
understanding the biology of
So how can anyone say that GMOs are safe
species, Edward O. Wilson at
Harvard (the leading authority
for the natural world, for the biodiversity?
on 9500 species of ants) says: we
With GM history is being ominously
probably know less than 0.1% of
repeated with all the mistakes of the last 75
the species that exist. We know
perhaps a million and a half
years. However this time round, the stakes
species out of may be 10 million
are enormous. We must get it right pretty
(excluding the microbial world).
‘Knowing’ merely means that
well the first time, because genetic
someone has given a species a
manipulations are essentially irreversible and
name. That is all, no more than
because the contamination of the natural
that.
environment is a biological certainty. And,
whatever we do to the earth we do to
With CFCs, the lesson was
repeated. CFCs seemed to be a
miracle of organic chemistry,
ourselves because what we eat, we make into
because they were chemically
our bodies.
inert. And so they began to be
used in massive amounts. Only
years later did scientists discover
the disastrous effects of these ozone-depleting substances on climate change, because of the very
reason that CFCs are chemically inert; and they don’t break down. They hang around and
accumulate; in the upper atmosphere, ultraviolet light breaks chlorine-free radicals off CFCs, and
chlorine is a potent scavenger of ozone. Then scientists discovered that there is something called
the ozone layer and announced, that CFCs were degrading the ozone layer. How could CFCs have
been managed, when no one could have anticipated what the effect would be ultimately?
So how can anyone say that GMOs are safe for the natural world, for the biodiversity? With GM
history is being ominously repeated with all the mistakes of the last 75 years. However this time
round, the stakes are enormous. We must get it right pretty well the first time, because genetic
manipulations are essentially irreversible and because the contamination of the natural environment is
a biological certainty. And, whatever we do to the earth we do to ourselves because what we eat, we
make into our bodies.
3
The Hazards of Genetic Engineering are Inherent in the
Technology
Genetically modified organisms are unnatural, not just because they have been produced in the
laboratory, but because they can only be made in the laboratory, creating organisms and in ways that
have never existed in the course of 3.8 billion years of evolution. This technology is so powerful,
crude but powerful, but the scientific ignorance of it is huge. Scientists concede that they do not
understand the mechanisms of GE-induced changes in gene expression in sufficient detail. They do
not know what to look for and these things are termed ‘unintended effects’. Unintended effects are
common in all cases where GE techniques are used. So on a whole range of issues, a great deal of
research is required before they can predict an outcome. Independent scientists from all over the
world have gone on record to say that GE crops and foods raise outstanding safety concerns and there
should be a global moratorium on the release of these GMOs into the environment.
One of the most insidious ‘unintended' effects of GE is Horizontal Gene Transfer (HGT). It
happens when genetic material moves between organisms, which is asynchronous with the process of
reproduction of the organisms; so genes can also be
transferred between distant species that would never
Yet it is being used to
interbreed in nature. For example, human genes are
irrevocably change the
transferred into rice and those from pig, sheep, fish and
fundamental molecular
bacteria are transferred into plants. Thereafter,
unintended HGT can take place from GE crops released
structure of the world’s
into the environment. Can we even begin to imagine
food supply and impact the
where this might lead? There is strong evidence for
biodiversity through un-
HGT even though there have been literally, just a
handful of clinical trials. One of the major omissions in
recallable, self-replicating
present day GM risk analysis is that no attempt has so
organisms.
far been made to investigate an obvious link between
GM food and intestinal tumour development. The grave
implications and risks of HGT, for the whole stream of
i
life, don’t require a Ph.D in science to be understood. They include: new strains of antibiotic resistant
bacteria, new viruses and bacteria arising from those introduced into the transgenic plants, random
secondary insertion into other unrelated organisms, causing harmful effects including cancer,
reactivation of dormant viruses, etc. For these reasons, concerns with HGT make the technology of
GE highly unpredictable and also extremely dangerous and put in doubt the safety of the GE process
itself. Yet it is being used to irrevocably change the fundamental molecular structure of the world’s
food supply and impact the biodiversity through un-recallable, self-replicating organisms.
There Has Been No Safety Testing Anywhere
The US has initiated and promoted the commercialisation and spread of GM crops since the 1990s,
because of a White House directive to “foster the biotechnology industry". It is also a fact that in
order to facilitate the release of GM foods onto the market in the US, they are provided GRAS status,
(Generally Recognised As Safe), a process, which contrary to popular belief, means that the FDA
does not formally approve a single GE crop as safe for human consumption, a neat ‘sleight of
hand’ method to get GM foods on to the market! It is a reasonable assertion that if the US had not
4
cleared GM foods and crops for market release, then no other country would have done so. There
have been 10 years of commercialisation of GM crops in the US and Canada. They are sold in both
these countries in the face of increasing consumer resistance to them and a demand for labelling as
the public is only now discovering that they have been hoodwinked into believing that GM food and
animal feed are safe. It is surprising that GM food has become part of the diet of millions of
Americans and Canadians without their being able to exercise a democratic right of informed consent
about their food choices, nutrition and health.
We in India can learn from these 10 years of commercialisation
We may no longer
in America. There is a huge body of evidence that has emerged
ignore the growing
from these countries, of serious safety concerns with GM crops,
evidence of dodgy
science and shaky
ethics surrounding
the GM debate.
despite severe hindrances to such data coming into the public
domain. Independent scientists have been discredited, gagged or
fired; there is substandard and even fraudulent testing and industry
‘confidentiality’ is given priority by governments over safety and
public health and in this India is equally culpable. We may no
longer ignore the growing evidence of dodgy science and shaky
ethics surrounding the GM debate. In India, the only clarity about
the GEAC approvals for the commercial planting of Bt cotton (GM cotton) is their very opaqueness.
Farmers have suffered huge losses with no recourse to compensation. There have been substantiated
reports of fanner suicides directly linked to Bt cotton because they have been economically ruined.
Yet, on the basis of the GEAC approvals for commercial planting of Bt cotton, our farming
community must rightfully expect that the government is trustworthy and has thoroughly examined
the technology from every viewpoint; that theirs are not the ‘killing fields’ of experimentation.
Unfortunately that trust has been betrayed. There are more illegal varieties of Bt cotton than legal
with little sustained effort to stop them. This suggests that an official Nelson’s eye is being turned to
the issue of GM contamination. This is particularly worrying as no comprehensive health and
environmental risk assessment has been carried out with Bt cotton, which is a potentially toxic crop.
Even more worrying is the fact GM DNA has been shown to reach the milk of animals fed GM crops.
Since the GEAC has made no attempt to segregate GM cottonseed from non-Gm cottonseed, the food
chain is likely already contaminated. The biotechnology companies led by the 90% market leader,
Monsanto, are known to frequently sabotage the regulatory structures in many countries. In India,
Monsanto doctored an official report in South India on Bt cotton to circumvent claims for
compensation, because of crop failures.
Environmental and Economic Impacts on the Farm
Weed scientists have warned for about a decade that heavy reliance on herbicide tolerant (HT) GM
crops would trigger changes in weed communities and resistance, forcing farmers to apply additional
toxic herbicides and/or increase herbicide rates of application. There is now incontrovertible evidence
of this in the US, Canada and Argentina and it is accelerating, with the emergence of super pests and
super weeds. Indian farmers who have grown Bt cotton for three years are being warned of resistance
developing on their farms. This is of course, quite contrary to the claims made by the biotech
industry, which has projected GM crops as the technocratic fix for pest and weed management.
We have in particular, looked at the experience of Argentina, which made a major switch to
growing GM soy in the late 90s. Argentina’s experience is a grim warning to India. By 2003, the
warnings to the GM farming community were being fulfilled; GM soy growers registered a 10-fold
5
increase in the use of herbicides (compared to conventional farmers), in 5 years. There are changes to
soil microbiology. Slugs, snails and fungi are moving into the newly available ecological niche.
Charles Benbrook former Executive Director of the Board on Agriculture of the U.S. National
Academy of Science says:
“Argentina faces big agronomic problems that it neither has the resources nor the expertise to
solve. The country has adopted GM technology — based on the current use of RR (Roundup Ready, a
herbicide made by Monsanto). I don't
think its agriculture is sustainable for
more than a couple of years”.
Based on the evidence worldwide
including India, farmers are being
trapped on to a treadmill of
Based on the evidence worldwide
including India, farmers are being
trapped on to a treadmill of
‘unsustainability’, of increasing pesticide
‘unsustainability’, of increasing
and herbicide use and spiralling costs.
pesticide and herbicide use and
GM crops are delivering a rising load of
toxic chemicals into our food supply and
spiralling costs. GM crops are delivering
into the environment. GE then is a
a rising load of toxic chemicals into our
noxious technology on the farm and
food supply and into the environment.
impedes the transition to integrated pest
management systems.
There are other serious concerns with
huge implications for India’s food
GE then is a noxious technology on the
farm and impedes the transition to
integrated pest management systems.
security. For 10,000 years farmers have
preserved and created a diverse genepool through the traditional practice of saving and replanting seeds. But GE turns agriculture into an
industry based on patents, which are paid for by the farming community, forcing farmers to buy seed
each year. Drawing lessons from the American and Argentinian experience we focus on the following
developments that have taken place:
•
Genetic engineering cannot create seeds from scratch. It is vital to understand that biotech
companies need enormous quantities of seeds to engineer their patented manipulations and
then supply GM seed to farmers, worldwide. For the first time in history, one company,
Monsanto, has unprecedented control of the sale and use of crops’ seed and therefore germplasm,
through their ownership of seed companies. This has been accomplished in three main ways:
(a)
control of germplasm through ownership of seed companies; (b) domination of genetic
technology and seeds through patent acquisitions; and (c) breaking age-old farming tradition by
forcing farmers to buy new seed each year. Monsanto has become a monopoly seed vendor
controlling 90% of the GM seed sown globally.
•
In America, the seed system is contaminated; Monsanto has put the diverse gene pools at risk by
contaminating certified and traditional seed stocks, and by not permitting farmers to save seeds.
•
American fanners are hard pushed to find high quality, conventional varieties of com, soy and
cottonseed. This represents a feudal system, which has turned agriculture into an industry where
the corporations consolidate their hold over costly seeds and chemicals that increase fanners’
spending on inputs. Meanwhile monopolies are created in corporate manipulated markets that
include fewer buyers who demand the lowest possible prices for the outputs produced by farmers,
6
forcing them into a debt spiral. In 2003 Monsanto made $3.1 billion in pesticide sales and $1.6
billion in seed sales.
•
Organic and conventional farmers alike have lost their premium markets because their
farms have been contaminated forcing them to join GM market streams. The EU farming
study confirms what independent scientists have warned. At 0.1 % of contamination, there can
be no co-existence between GM and NonGM agriculture.
The experience of both Argentina and America holds a grim warning that a new, untested
technology like GM, vended monopolistically by multinational corporations poses a grave threat to
world agriculture and food security. For India, as with the rest of the developing world, particularly
with our small landholdings, it risks driving millions of small and medium farmers off the land. This
is a doomsday scenario.
Food Safety And Food Security
Our health and nutrition are inextricably tied in with seed quality, variety and abundance. If
farmers lose control over the seed
supply, the diversity of the seed stock
will be imperilled. With GE foods and
crops, the fundamental right to make
food and health choices is removed
The experience of both Argentina and
America holds a grim warning that a new,
entirely from the ambit of choice. This
untested technology like GM, vended
is so because transgenic
monopolistically by multinational
contamination is irreversible. Seed
contamination offers genes and gene
products surreptitious paths to new
corporations poses a grave threat to
world agriculture and food security. For
environments. In most cases neither seed
India, as with the rest of the developing
sellers, nor farmers would be aware of
the contaminant. You can imagine what
world, particularly with our small
would happen in India -we would quite
landholdings, it risks driving millions of
simply be swamped It would take too
small and medium farmers off the land.
long to speak about farmer rights,
damages for contamination of farmlands
This is a doomsday scenario.
and labelling, all of which are hugely
important issues of fundamental
democratic rights. On labelling, I just wish to add that there are very important reasons why
consumers need to know what they are eating, (a) They need to know, so they know what to avoid.
(b)
Food allergies are a serious concern, (c) There are also religious and ethical concerns of particular
relevance to India, since genes from animal sources are being incorporated into food products,
including human genes into rice.
World Consumers Want Non-GM Food & Animal Feed
But there are two other issues, which have priority today for Indian agriculture and farmer
economics, which I need to emphasise because they point to the exact nature of what we are up
against in the murky world of large business, and the corporate control over governments and
international politics.
•
The US has lost at a conservative estimate, around $4 billion in agri-exports to the EU because of
GM trade restrictions and has taken legal action in the WTO. Re-tooling the US grain and
commodity infrastructure even if possible, would be prohibitively expensive. This is why
ignominiously, UN food aid is GM; why the pressure on India to open its agriculture to GM is so
great that the biotech industry and government and private research institutions are experimenting
with every conceivable vegetable and crop. We are perilously close to a full-scale GM onslaught.
•
It is well to recognise that for the USA, the protection of its robust agricultural exports is
dependent on a world that embraces GM crops; I call it the ‘policy of equivalent contamination’,
to be achieved by any means possible. Then, contamination and consumer choice become
irrelevant. Let’s make no mistake about it. This is the agenda. This too is a pressure that must be
successfully resisted.
For those who are unfamiliar with the format of a Suit, the ‘Prayers’ asked for. are at the end of the
Petition on page 34. They are eminently logical and sane. By exposing an unaware population to
serious risks that cannot be undone, the government stands accused of unconscionable offences
against the Indian people. This joint petition before the Supreme Court indicts the Government of
India for the declared intentions of its policy which: “mortgages the public interest, public safety and
the environment, to the commercial interests of Biotech Corporations”.
Aruna Rodrigues
Mhow Cantt.
With
Devinder Sharma
Rajeev Baruah
PV Satheesh
Delhi
Mhow
Hyderabad
Petitioners to the Public Interest Writ Petition in India’s Supreme Court on GMOs
8
IN THE SUPREME COURT OF INDIA
(ORIGINAL CIVIL WRIT JURISDICTION)
Civil Writ Petition NO._____ OF 2005
IN THE MATTER OF:
..Petitioners
Aruna Rodrigues and Others
VERSUS
...Respondents
Union of India and Others
PAPER BOOK
FOR INDEX PLEASE SEE INSIDE
VOLUME - I
WITH I.A. No
of 2005
(Application for ex-parte Interim Orders)
COUNSEL FOR PETITIONERS: PRASHANT BHUSHAN
9
IN THE SUPREME COURT OF INDIA
(ORIGINAL CIVIL WRIT JURISDICTION)
Civil Writ Petition NO._____ OF 2005
INDEX
SJSQ PARTICULARS
1.
2.
3.
4
5
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
PAGE NO.
SYNOPSIS AND LIST OF DATES AND EVENTS
A-F
WRIT PETITION WITH AFFIDAVIT.
1-60
ANNEXURE P 1- ARPAD PUSZTAI TITLED “GM FOODS: POTENTIAL HUMAN
61-105
HEALTH EFFECTS"
ANNEXURE P 2- STATEMENT OF MR. DRUKER AND CONCERNED SCIENTISTS.
106- 111
ANNEXURE P 3- STATEMENT OF THE WORLD SCIENTISTS TO THE UN CONVENTION
112-136
ON BIOLOGICAL DIVERSITY CONFERENCE IN NAIROBI ON MAY 16-24, 2000
ANNEXURE P 4- REPORT OF THE INDEPENDENT SCIENCE PANEL TITLED “THE CASE 137-224
FOR GM FREE SUSTAINABLE WORLD”
ANNEXURE P 5- ARTICLE “EATING GENETICALLY ENGINEERED FOOD IS GAMBLING 225-229
WITH YOUR HEALTH” BY JEFFREY SMITH, IN WEB MAGAZINE
NEWSWITHVIEWS.COM DATED 24.01.2004
ANNEXURE P 6- “SAFETY TESTING AND REGULATION OF GE FOODS”, BY
230-256
DR. WILLIAM FREEZE AND DR. DAVID SCHUBERT IN “BIOTECHNOLOGY &
GENETIC ENGINEERING REVIEWS"
ANNEXURE P 7- REPORT OF THE UNION OF CONCERNED SCIENTISTS TITLED
257-333
“GONE TO SEED”
ANNEXURE P 8- COLLECTION OF DOCUMENTS BY GREEN PEACE INDIA
334-339
ANNEXURE P 9 - ARTICLE BY GEOFFREY LEAN IN THE INDEPENDENT DATED
340-341
17 APRIL 2005
ANNEXURE P10- STATEMENT OF DR.JACK HEINEMANN, DIRECTOR OF THE NEW
342-346
ZEALAND INSTITUTE OF GENE ECOLOGY,, TITLED “PROBLEMS IN MONITORING
HGT IN FIELD TRIALS IN TRANSGENIC PLANTS & OPINION ON HGT’ DATED 29.03.2005.
ANNEXURE PH- ARTICLE TITLED “PROBLEMS IN MONITORING HORIZONTAL
347-351
GENE TRANSFER IN FIELD TRIALS OF TRANSGENIC PLANTS" IN NATURE
BIOTECHNOLOGY BY DR.JACK HEINEMANN AND DR. TERJE TRAAVIK DATED
SEPTEMBER 2004
ANNEXURE P 12- COPY OF THE PRESS NOTE DOWNLOADED FROM THE INTERNET
352-353
ANNEXURE P 13- ARTICLE TITLED “GMOS: GM FOOD AND ANIMAL FEED”,
354-358
BY DR. HARSH NARANG
ANNEXURE P 14- ARTICLE TITLED “TRANSGENIC DNA IN ANIMAL FEED”
359-362
BY DR. ANGELA RYAN AND DR. MAE-WAN HO
ANNEXURE P 15- TECHNICAL REPORT TITLED “HGT OF VIRAL INSERTS PLANTS
363-371
FROM GM PLANT TO VIRUSES” BY DR. JONATHAN LATHAM AND DR. RICARDA
STEINBRECHER.
ANNEXURE P 16- ARTICLE IN THE LANCET BY ARPAD PUSTZA1 TITLED “EFFECTS
372-374
OF DIETS CONTAINING GM POTATOES EXPRESSING GALANTHUS NIVALIS LECTIN
OR RAT SMALL INTESTINE” DATED OCTOBER 1999
ANNEXURE P 17- STATEMENT OF DR. ARPAD PUSZTAI TITLED “GAPS IN THE
375-381
CURRENT SAFETY ASSESSMENT OF GM CROPS/FOODS - THE WAY FORWARD”
DATED 27.04.2005
ANNEXURE P18- ARTICLE TITLED “TWIN BIO-SAFETY BRIEFINGS: DNA IN GM
382-392
FOOD AND FEED” BY DR. MAE- WAN HO DOWNLOADED FROM THE INTERNET
ANNEXURE P 19- NEWS STORY IN THE INDEPENDENT TITLED “THE END OF
393-395
GM CROPS” DATED 22.03.2005.
ANNEXURE P20 - PRESS NOTE OF THE UNIVERSITY OF PITTSBURG TITLED
“HERBICIDE RUNOFF IS LETHAL TO AMPHIBIANS” DATED 04.04.2005.
ANNEXURE P 21 - PRESS NOTE TITLED “BENBROOKE REPORT ON PESTICIDE
USE ON GM CROP IN THE FIRST NINE YEARS” DATED 25.04.2004 DOWNLOADED
FROM THE INTERNET.
ANNEXURE P 22 - REPORT TITLED “ARGENTINA’S BITTER HARVEST’ IN
NEW SCIENTIST DATED 17.04.2004
10
396-398
399
400-405
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.
46.
47.
48.
49.
50.
51.
52.
53.
ANNEXURE P 23 - REPORT TITLED “GM COTTON-NO REDUCTION IN PESTICIDE
USE” DATED 28.11.2000 DOWNLOADED FROM THE INTERNET.
ANNEXURE P 24 - “EVALUATING THE ACCEPTABILITY OF GM CROPS: THE
SCOPE FOR AUTONOMY IN DEVELOPING COUNTRIES” BY ERIK MILLSTONE IN JAN
2005 SCIDEV
ANNEXURE P 25- COLLECTION OF ARTICLES DOWNLOADED FROM THE INTERNET.
ANNEXURE P 26 - PRESS REPORT TITLED
“MONSANTO’S GM DRUG STILL THREATENS PUBLIC HEALTH” DATED 05.02.2005
ANNEXURE P 27 - EXCERPTS OF THE FOURTH REPORT OF SESSION 2004-05 OF THE
HOUSE OF COMMONS, HEALTH COMMITTEE OF THE U.K.
ANNEXURE P 28 (COLL.Y) - COMPLAINT FILED BY THE UNITED STATES SECURITIES
AND EXCHANGE COMMISSION IN JANUARY 2005 AND COPIES OF NEWSPAPER
REPORTS
ANNEXURE P 29 (COLLY)- DOCUMENTS INDICATING MONSANTO’S ROLE IN
TAMPERING ANDHRA PRADESH GOVERNMENT DOCUMENTS.
ANNEXURE P 30- ORDER OF THE GEAC DATED 18.10.2001
ANNEXURE P 31 - REPORT IN THE HINDU DATED 05.01.2001
ANNEXURE P 32 - PRESS NOTE DOWNLOADED FROM THE INTERNET TITLED “GM
FOOD AID PRESSURE ON ANGOLA AGAIN” DATED 26.01.2005
ANNEXURE P 33- LETTER OF THE INDEPENDENT SCIENCE PANEL TO THE FDA
ANNEXURE P 34 - DIRECTIVE 2001/18/EC DATED 17.04.2001 OF THE EUROPEAN
COMMISSION.
ANNEXURE P 35 - REGULATION (EC) 1830/2003 DATED 22 SEP 2003 CONCERNING
‘TRACEABILITY’ AND LABELLING OF GMOS AND THE TRACEABILITY OF FOOD
AND FEED PRODUCTS PRODUCED FROM GMOS.
ANNEXURE P 36 - REGULATION (EC) 1829/2003 DATED 22 SEP 2003 ON GM FOOD
AND FEED.
ANNEXURE P 37 - NOTE TITLED “INFORMATION ON THE AMENDMENT TO
GERMANY'S GENETIC MODIFICATION ACT” DOWNLOADED FROM THE OFFICIAL
WEBSITE OF THE GOVERNMENT OF GERMANY,
ANNEXURE P 38 - COPY OF THE CARTAGENA PROTOCOL ON BIOSAFETY TO
THE U.N. CONVENTION ON BIODIVERSITY, 1992.
ANNEXURE P 39 - COPY OF THE U.N. CONVENTION ON BIODIVERSITY, 1992.
ANNEXURE P 40 - REPORT OF THE EUROPEAN UNION TITLED "COEXISTENCE
IN EUROPEAN AGRICULTURE”
ANNEXURE P 41 - NEWS REPORT TITLED “BT. 60 COTTON REMAINS HIGHLY
CONTROVERSIAL IN INDIA” DATED 01.05.2003
ANNEXURE P 42 - PRESS NOTE OF THE ISIS TITLED “MONSANTO VS FARMERS
DATED 28.04.2005
ANNEXURE P 43 - INTERVIEW WITH THE GERMAN CONSUMER PROTECTION
MINISTER MR. RENATE KUENASTOF DOWNLOADED FROM THE INTERNET DATED
18.04.2005
ANNEXURE P 44 - STATEMENT OF MR. SHARAD PAWAR, THE UNION AGRICULTURAL
MINISTER TITLED “INDIA MAY IMPORT GM OIL SEEDS” DATED 18.01.2005
ANNEXURE P 45 - NEWS REPORT IN THE ECONOMIC TIMES TITLED “SOYA OIL
IMPORTS EAT INTO DEMAND FOR PALM OIL” DATED 05.04.2005
ANNEXURE P 46 - AN INCLUSIVE LIST OF GE FOODS AND CROPS UNDER
RESEARCH ETC. IN INDIA
ANNEXURE P 47 - RULES FOR THE MANUFACTURE, USE, IMPORT, EXPORT AND
STORAGE OF THE HAZARDOUS MICRO-ORGANISMS, GENETICALLY ENGINEERED
ORGANISMS OR CELLS, 1989
ANNEXURE P 48 - ARTICLE DATED 13 APRIL 2002 IN THE ECONOMIC AND
POLITICAL WEEKLY TITLED “GMOS: NEED FOR APPROPRIATE RISK ASSESSMENT
SYSTEM” BY DR. P.M. BHARGAVA.
ANNEXURE P 49 - DRAFT NATIONAL BIOTECHNOLOGY DEVELOPMENT STRATEGY
ANNEXURE P 50 - RESPONSE OF CONCERNED CITIZENS TO THE DRAFT
NATIONAL BIO- TECHNOLOGY DEVELOPMENT STRATEGY.
APPLICATION FOR EX-PARTE INTERIM ORDERS
406-07
408-415
416-434
435-437
438-439
440-453
454-469
470-471
472
473-475
476-478
479-516
517-521
522-544
545-545B
546-571
572-589
590-600
601
602-606 ”
607-608
609
610
611-623
624-637
638-642
643-676
677-690
691-693
LIST OF DATES & SYNOPSIS
1989
1995
onwards
The Rules for Manufacture, Use, Import. Export and storage of Hazardous Micro-organisms and Genetically
Engineered Organisms Or Cells, 1989 were brought into force under the Environment Protection Act, 1986.
These rules were in response to a new technology of genetic engineering by which parts of the genes of
viruses and bacteria or other organisms could be transmitted and inserted into the genes of unrelated organisms
by carriers or vectors, which were usually viruses. These rules provided that no genetically modified organisms
could be released to the environment by way of manufacture, import, etc., by any person without the specific
permission of a Committee under the Ministry of Environment called the Genetic Engineering Approval
Committee (GEAC).
The Government started receiving applications from bio-technology companies engaged in the manufacture
of genetically modified foods and crops to allow import and trial of various crops such as cotton, maze, com,
mustard, etc.
27.07.1998
and
05.08.1998
The RCGM (Review Committee on Genetic Modification), which is and a Committee in the Department of
Biotechnology cleared the field trials of Bt Cotton by the company manufacturing this particular crop which
it was seeking to commercialise. This clearance was given by a Committee under the Department which
aggressively promotes this technology and is in violation of the rules of 1989 which provided that environmental
release of genetically modified organisms could only be done by the GEAC under the Ministry of Environment.
1999
The Supreme Court delivered a judgment in A.P. Pollution Control Board Vs. M.V. Nayudu in which it was
held that when a new technology or process can cause serious and irreversible harm to human health and
environment, it is necessary that every possible precaution should be taken to ensure that there are no adverse
effects to health or environment and that if tire effects of certain things which are potentially hazardous to
these are not known, it is necessary to wait till the effects are understood before releasing the potentially
hazardous materials/technology into the environment.
October 1999 A leading Nutritionist and eminent Toxicologist Dr. Arpad Pustzai published his findings regarding the
possibility and likelihood of horizontal gene transfer from genetically modified organisms, transfer of artificial
genetic constructs from the target organism to the other organisms pose completely unknown hazards, since
the effects of the transfer of genes to the new organisms would be completely unknown. Various studies also
indicated that the marker genes used in the technology of genetic modification would increase antibiotic
resistance to humans and other organisms which feed on these genetically modified organisms.
May 2000
More than 69 eminent scientists of the world from 79 countries released an open statement about the hazards
that the release of genetically modified organisms pose to biodiversity, food safety, and therefore to human
and animal health, and they demanded a moratorium on the environmental release of such genetically modified
organisms in accordance with the precautionary principles. This statement was issued on the eve of U.N.
Convention on Biological Diversity Conference in Nairobi in May 2000.
05.04.2002 The GEAC approved commercial release of Bt Cotton on the basis of some safety tests supposed to have been
done by the commercial company producing this particular variety of genetically modified cotton. It is important
to mention that these tests were essentially allowed to be done by the company itself and there was no
transparency or public opinion released about these tests and no independent experts were allowed to critique
the adequacy or otherwise of these tests.
April 2002
Mr. P.N. Bhargava, one of the most eminent Indian scientists in the field published a detailed article on the
biosafety tests that must precede any genetically modified organisms. Most of the aspects were not considered
for the examination of safety risks before any release of genetically modified organisms in the country.
June 2003
An Independent Science Panel consisting of expert independent scientists from 11 countries comprising the
disciplines of agro-ecology, agronomy, biomathematics, botany, chemical medicine, ecology, epidemiology,
histopathology, microbial ecology, molecular genetics, nutritional biochemistry, physiology, toxicology,
virology, etc., published a report on the actual evidence of hazards posed by the genetically modified organisms
which had been released and experimented across the world till that time. They concluded that genetically
modified crops posed serious hazards of various kinds including the possibility of horizontal gene transfers,
resistance to antibiotics, allergies, etc. The report also raised serious doubts about the adequacy of safety
testing which was done prior to release of genetically modified organisms.
11.9.2003
Cartagena Protocol, other wise called the Bio-Safety Protocol for the U.N. Convention on Biodiversity came
onwards
into force. The protocol, which was signed by large number of countries including India, provided that all
participating countries must ensure the transfer, handling and use of genetically modified organisms in a
manner so as to minimize risks to human health and environment and biodiversity. It also emphasizes the
precautionary principle and provides that risk assessment must be made in a scientifically sound and transparent
manner.
12
January 2005 The U.S. Securities and Exchange Commission filed a complaint in the US Courts that Monsanto, a biotech
company controlling a substantial share of genetically modified products worldwide, had bribed 140 officials
of the Ministry of Environment between 1997-2000 in obtaining environmental clearance for their GM Cotton.
Monsanto admitted this charge and paid penalty of US S 1.5 million.
March 2005 The Royal Society for the Protection of Birds and the Centre for Ecology and Hydrology. Lancaster in the
United Kingdom conducted a series of experiments, which showed that genetically modified organisms had
adversely affected wild life and biodiversity.
5.4.2005
The Economic Times reported that the Government is planning import of large amount of soya from Argentina.
These are likely to be genetically modified soya since large part of soya grown in Argentina is genetically
modified soya. Argentina also have no labeling laws and, therefore, any import of soya from Argentina is
likely to be either genetically modified or contaminated with genetically modified soya. Since GEAC has not
allowed release or import of these soya, this import would clearly violate the rules of 1989.
SYNOPSIS
The above facts and circumstances clearly indicate the following:
• That genetically modified organisms posed serious hazards to human and animal health and to the environment.
• These hazards include risks of new kinds of allergies, greatly increased resistance to antibiotics, severe toxicity to humans,
animals and micro organisms, resulting in serious import on human health, loss of wild life, biodiversity, etc.
• Apart from the above, the demonstrated possibility of a unintended transfer of these artificial genetic constructs from the
target organism to the other organisms pose completely unknown hazards, since the effects of the transfer of genes to the
new organisms would be completely unknown.
In these circumstances, the use of the technology of genetic engineering and the release of genetically modified organisms
into the environment would clearly require the application of precautionary principle which mandates that every possible
precaution must be taken to ensure that no harmful effects are caused to human and animal health and environment due to
the use of new and unknown technologies and organisms. In particular, it requires that if the effects of certain technologies/
organisms are unknown and which are potentially hazardous, then the use of this technology and release of those organisms
must wait until the hazards are properly understood and the effects known.
The experts worldwide agreed in the last decade that use of genetically modified crops and organisms has shown that these
organisms and the technology is indeed very seriously hazardous and all kinds of problems have been documented in
various scientific reports which have appeared in very prestigious and respected scientific journals and in the statements of
very eminent and respectable scientists. On the other hand, it has also become evident that biotechnology companies, which
have a commercial stake in the exploitation of this technology are aggressively pushing this technology and the release of
these organisms. They have gone to the extent of bribing officials in third world countries for clearance and release. They
also subverted the Food and Regulatory System of the USA to pronounce that these genetically modified organisms are
substantially equivalent to natural biological organisms and. therefore, they do not need any clearance by the FDA for
release. As a result, therefore, large number of genetically modified crops has been used in the U.S. without any prior safety
testing. This has created an impression in many parts of lite world that since such organisms are used in the U.S.A, they must
be safe.
Despite the fact that in the Rules for Manufacture, Use, Import. Export and storage of Hazardous Micro-organisms and
Genetically Engineered Organisms Or Cells, 1989 under the Environment Protection Act, 1986 provided that no genetically
modified organisms would be released into the environment, without specific approval of a committee under the Ministry of
Environment called GEAC, unfortunately, till today no proper system has been put in place to ensure that GMOs slated for
release undergo proper biosafety tests by independent and scientifically competent bodies in a transparent manner. For this
to happen, it was essential that GEAC laid down a protocol which prepares a list of biosafety tests which are required,
particularly GMOs slated for release and that such tests thereafter done by independent scientific bodies and the results
available for public scrutiny and critique by independent experts. However, no such system/protocol has been put in place
with the result that these organisms are being currently tested essentially by the biotech companies themselves and whose
results are not made available for public scrutiny. This has led to the situation whereby the future health of the people of this
country and the environment has been placed at severe risk by a potentially explosive release of genetically modified
organisms and crops without adequate and proper tests.
It is in these circumstances that the Petitioners arc approaching this Hon’ble Court to ensure that a proper system is put in
place which will ensure that this potentially hazardous genetically modified organisms are put through an adequate and
proper safety tests by independent scientific agencies and whose results put to critique by independent experts so that the
precautionary principle is adhered to before such organisms are released into environment.
13
IN THE SUPREME COURT OF INDIA
(ORIGINAL CIVIL WRIT JURISDICTION)
Civil Writ Petition No._____ OF 2005
IN THE MATTER OF:
1. Aruna Rodrigues,
Bungalow No. 69
Mhow Cantt,
M.P. - 453441
2. Devinder Sharma.
G-3/F, DDA Flats.
Munirka,
New delhi-110067
3. PV Satheesh
Deccan Development Society,
101, Krishnan Residency
Road No. 5, Begumpet
Hyderabad- 500016
4. Rajeev Baruah
14, Signals Vihar,
Mhow,
Madhya Pradesh.
...PETITIONERS
VERSUS
1.
Union of India
Through its Secretary
Government of India
Ministry of Environment and Forests,
Paryavaran Bhavan
CGO Complex, Lodhi Road
New Delhi- 110003
2.
Union of India
Through its Secretary
Government of India
Ministry of Science and Technology,
Block II, CGO Complex, Lodhi Road
New Delhi- 110003
3.
Union of India
Through its Secretary
Government of India
Ministry of Agriculture,
Krishi Bhavan
New Delhi
... RESPONDENTS
14
To,
The Hon’ble Chief Justice of India and His Companion Justices of this Hon’ble Court
MOST RESPECTFULLY SHEWETH:
This Writ petition is filed in public interest, regarding the Biosafety of Genetically Modified Organisms (GMOs), which are
allowed to be released into the environment. The petitioners are concerned about the absence of proper scientific examination
of Biosafety concerns. This petition seeks to put in place a protocol that shall mandate the scientific examination of all
relevant aspects of Biosafety before such release. There is an increasing body of scientific knowledge and evidence, which
points to the existence of serious hazards, and therefore safety concerns for human health and the environment. The reckless
release of GMOs into the environment also threatens the agrarian structure of the country, will lead to the contamination of
the food chain and detrimentally affect biodiversity, in an irreversible and lasting manner. It is submitted that this is a fit case
to employ the Precautionary Principle, as enunciated by this Hon’ble Court in a catena of cases including M.V. Nayudu[ 1999
(2) SCC 718]. In view of the grave and irreversible harmful impacts resulting from the release of GMOs into the environment,
the petitioners pray for a moratorium on the release of any GMOs into the environment until a comprehensive protocol for
all required Biosafety tests of the GMO proposed to be released is put in place, under the regulatory and monitoring
framework of the Rules for Manufacture, Use, Import, Export and Storage of Hazardous Micro Organisms, Genetically
Engineered Organisms or Cells, 1989. Preceding such release, the protocol must insist on requisite Biosafety tests by
independent expert bodies, whose results are made public, and the data to be published is provided in a manner that can be
examined by the scientific community; it shall be accompanied by mandatory public notice and public hearing. The petitioners
also pray for a labelling mechanism to ensure that the moratorium on the release of any GMO into the environment is
safeguarded and effective. Such a mechanism is also necessary to protect the rights of agriculturists and consumers to grow
and consume GM-free crops.
1.
The Petitioners are public spirited individuals who on account of their vocation have the expertise, and access to
information that reveal a grave and hazardous situation with regard to Biosafety concerns, developing in India due to
release of GMOs into the environment. Petitioner No. 1 Ms. Aruna Rodrigues, is an economist and marketing management
consultant with many years of international experience in project development and appraisal, and development economics;
also solar PV applications (photovoltaics) and the energy-economics that are relevant to development She also has
many years of Marketing Management experience in India in nutrition, foods and health foods. Petitioner No.2 Mr.
Devinder Sharma is a trained agricultural scientist and writer. He is a Visiting Fellow at the School of Development
Studies at the University of East Anglia, Norwich (UK) and at the University of Cambridge (UK), and was formerly a
Visiting Fellow to the International Rice Research Institute, in the Philippines. Mr. Sharma also chairs an independent
collective in New Delhi, called the Forum for Biotechnology & Food Security, that examines and analyses various
policy decisions in the field Biotechnology and Food safety. Petioner No. 3, Mr. P.V. Satheesh is an internationally
renowned developmental communication specialist and is a co-founder and General Secretary of the Deccan
Developmental Society, an organisation which works with rural communities. He is the Chair of the Board of Directors,
Genetic Resources Action International, [GRAIN], and , India Coordinator for the S ANFEC, South Asian Network for
Food, Ecology and Culture, a five country South Asian Network with over 200 ecological groups. He is also the founder
Convenor of Andhra Pradesh Coalition in Defence of Diversity, a coalition of over 120 NGOs in AP. Petitioner No. 4,
Mr. Rajeev Baruah is a management specialist and is involved in providing support to local farmers in Madhya Pradesh
and Maharashtra to grow organic cotton following biodynamic farming principles. He is the Managing Director of
Maikaal bioRe, a private service company involved with organic farming of cotton and other crops and provides basic
support to farming communities in improving their standard of living. .Organic cotton for the export of cotton garments
by definition means non-gm and farmers lose their organic status if soil samples show chemical or GM contamination.
2.
Genetic Engineering (GE) or Recombinant DNA Technology, is a new technology that for the first time in history, is
able to artificially manipulate and transfer genetic material between unrelated organisms. Transgenes are unusually
complex combinations of genetic elements, which are unlikely to occur by chance in nature. The technology involves
recombining i.e. joining together in new combinations, DNA that is often from different organisms, e.g. plant to animal,
animal to plant and inserting them into the genomes of target organisms to make GMOs. The intended gene is incorporated
into the genome of a crop using a vector containing several other genetic elements, including as a minimum, promoters
which may come from plant or plant viruses, transcription terminators, reporter genes and antibiotic resistant or herbicide
resistant marker genes. Cells modified by these techniques pass the new genes and their traits on to their offspring. GE
however, is an imprecise technology as there is little control on where the new genetic construct will lodge within one
or more of the target cell chromosomes. Furthermore, although for GM food safety, the intended gene is very important,
the potential effects of the whole construct, i.e. the other genes may contribute substantially to the overall effect. In
addition the protein produced from the gene of interest may interact in unpredictable ways. It is now known for example.
that DNA does not always break down in the Alimentary tract. Such reference may found in the article by Arpad Pusztai
titled “GM Foods: Potential Human Health Effects” attached to this Writ petition as Annexure P1. GMOs are unnatural,
not just because they have been produced in the laboratory, but because they can only be made in the laboratory,
creating organisms and in ways that have never existed in the course of 3.8 billion years of evolution. These mainly
untested and potentially hazardous GM crops are now spreading all over the world, creating irreversible risks for the
environment and the hazards of GE raise outstanding safety concerns for human and animal health. Many of the
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3.
potential hazards arc inherent in the GE process itself, which is not the case with traditional breeding. When the experts
at the FDA undertook an extensive examination of genetically engineered food, they readily recognized the unique set
of risks and clearly reported them to their superiors. This came to light when the FDA was compelled to give its files
during the course of the lawsuit filed by Steve Druker. The statement of Mr. Druker and concerned scientists in the suit,
is attached to this Writ Petition as Annexure P 2. FDA microbiologist Dr. Louis Pribyl. one of the scientists stated:
“There is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering
....” He added that several aspects of gene splicing “.. . may be more hazardous ...” Scientists concede that with GE we
are moving from science to applied technology and the science of GE has not kept pace with the technology. This
technology is so powerful, crude but powerful, but the scientific ignorance of it is huge. Scientists do not understand the
mechanisms of GE-induced changes in gene expression in sufficient detail. They do not know what to look for and
these things are termed ‘unintended effects'. Unintended effects are common in all cases where GE techniques are used.
So on a whole range of issues, a great deal of research is required before they can predict an outcome. Yet, it is being
used to irrevocably change the fundamental molecular structure of the world’s food supply and impact the biodiversity
through un-recallable. self-replicating organisms.
Sufficient scientific evidence has accumulated that GMOs are not safe. In May 2000 761 scientists from 79 countries
expressed their concerns, in an Open Letter, about the hazards that the release of GMOs pose to biodiversity, food
safety, and therefore human and animal health. The World Scientists, including among others, renowned geneticists Dr.
David Suzuki. Canada and Dr. Prof. Ruth Hubbard, Harvard University, molecular biologists Prof. Jonathan King,
MIT. Cambridge, USA and Prof. Gilles-Eric Seralini. Laboratoire de Biochimie & Moleculaire, Univ. Caen, France,
onco-virologists Vladimir Zajac, of the Czech Republic and agronomist. Prof. Oscar B. Zamora from the University of
Philippines, have demanded a moratorium on environmental releases in accordance with the precautionary principle.
That this letter of the World Scientists, as early as May 2000. provides an impressive array of evidence of various
hazards associated with the release of GMOs, raising serious safety concerns for the whole stream of life, including
human and animal health. That this scientific evidence has emerged despite enormous pressure being put on independent
scientists and other deliberate and difficult to override, blocks to transparency, which have hindered objective and
independent examination of the issues and unfettered and truthful bio-safety testing. A copy of the statement of the
world scientists to the UN Convention on Biological Diversity Conference in Nairobi on May 16-24. 2000 is attached
to this Writ Petition as Annexure P 3.
FINDINGS OF THE INDEPENDENT SCIENCE PANEL
4.
5.
The Independent Science Panel (ISP) consists of expert independent scientists from eleven countries spanning the
disciplines of agro-ecology, agronomy, biomathematics, botany, chemical medicine, ecology, epidemiology,
histopathology, microbial ecology, molecular genetics, nutritional biochemistry, physiology, toxicology and virology.
The panel includes world renowned scientists like Mr. Michel Pimbert, Agricultural ecologist and principal associate
International Institute for Environment and Development. Prof. Bob Orskov OBE. Director of the International Feed
Resources Union, Fellow of the Royal Society of Edinburg, Fellow of the Polish Academy of Science and Dr. Mae-Wan
Ho Director of the Institute of Science in Society and a member of the roster of experts for the Cartagena Protocol on
Biosafety. The ISP reviewed the evidence on the hazards and problems of GM crops as well as the proven successes of
sustainable agriculture, and published its report in June 2003. The key findings of the ISP report are as follows:
• Regulations over the releases of GM crops and products have been highly inadequate.
• Few feeding studies have been carried out, but they raised serious doubts over the safety of the transgenic process
itself, which are yet to be followed up by dedicated research.
• GM varieties are unstable; and this may enhance the horizontal spread of transgenes, with the potential to create new
viruses and bacteria that cause diseases, and to disrupt gene function in animal and human cells.
• Many GM crops contain gene products known to be harmful. For example, the Bt proteins that kill insect pests
include potent immunogens and allergens, and food crops are increasingly engineered to produce pharmaceuticals,
drugs, and vaccines in the open environment, exposing people to the danger of inappropriate medication and their
toxic side effects.
• Herbicide tolerant GM crops - accounting for 75% of all GM crops worldwide - are tied to the broad-spectrum
herbicides glyphosate and glufosinate ammonium, and will likely increase their use. Both herbicides are systemic
metabolic poisons linked to spontaneous abortions, birth defects and other toxicides for human beings and laboratory
animals, and also harmful to wild life and beneficial organisms in the soil.
• GM crops have resulted in no benefits to the environment. Overall, there has been no reduction in the use of pesticides,
while herbicide tolerant weeds and volunteers have emerged, and highly toxic herbicides have had to be brought
back in use.
A copy of the Report of the ISP is attached to this Writ Petition as Annexure P 4.
Since its publication, all the major findings of the ISP report have been further corroborated. Furthermore, 10 years of
commercialisation of this technology in the US and Canada, and more recently. Argentina, has produced an increasing
flow of evidence of the serious hazards connected with GMOs. These hazards include:
• Genetically engineered insulin (so-called human insulin) was claimed by its manufacturers to be one hundred percent
safe; but thousands of diabetics have suffered serious adverse side effects from this product, including 50 suspected
16
deaths and this despite the fact that far stricter rules apply to GE drugs than to GE agricultural and food products
Transgenic contamination (contamination of the natural environment by GMOs) by more than one method, including
wind blown and by cross- pollination, is an established fact, beyond dispute and there can be no co-existence between
GM and non-GM crops. Extensive transgenic contamination has occurred in maize landraces (crops grown by
traditional farmers from wild species) in remote regions of Mexico, despite an official moratorium that has been in
place since 1998. The fact of transgenic contamination is so important precisely because of the serious nature of the
hazards connected with GMOs; Furthermore, given that there is de-facto, zero tolerance of pharmaceuticals in food,
this means that once pharma-crops are grown, they will get out.
Both of the two human clinical studies carried out and published till date, provide strong evidence of HGT from food
to humans. Thus, it was shown that fragments of GM DNA were incorporated into the bacteria resident in the gut of
human volunteers who were previously given a single meal containing GM soybean, something entirely unexpected.
On this analogy, had this meal contained a GM plant that had been engineered using an antibiotic-resistance marker
gene in the construct, the gut bacteria could have been made resistant to that particular antibiotic by horizontal gene
transfer, opening the way for the spread of antibiotic-resistance to medically important bacterial species, making
infections very difficult to treat.
The very few nutritional and toxicological studies carried out on ingested plant GM DNA, provide information on
the potential nature of the hazards of GM foods/feeds. These include: wasteful growth of gut tissues and bacterial
proliferation, development of intestinal tumours, depression of the body’s immune system, interference with the
normal development of vital organs of the body (liver, kidneys, sexual organs, etc.) and reproduction. The seriousness
of these effects cannot be overemphasized because the harm will be the most pronounced in the young, the old and
in people with intestinal disorders.
Plant GM DNA has been shown to reach the milk of cows fed GM crops; the danger to infants and children will be
disproportionately high. Thus, the GOI approvals of Bt cotton in States like Gujarat, MP and Punjab, which are the
milk-producing heartlands of India, raise concerns of serious health issues, because cottonseed products like oil and
cottonseed cake are used extensively in human and animal nutrition. This raises the possibility of the contamination
of milk, and milk-derived products, including processed foods.
Bt cotton is a potentially toxic crop whose toxins/anti-nutrients such as gossypol. cyclopropenoid fatty acids, or the
potent carcinogenic aflatoxins produced by contaminating fungi, are well known to accumulate in the subcutaneous
fatty tissues of consumers. “In the absence of conclusive evidence for the lack of toxicity, responsible GM regulatory
authorities must prevent the cultivation, commercialisation and food use of GM cotton and its products
Feeding rats with diets containing genetically modified (GM) potatoes affected their growth, organ development and
immunity (unintended effects).
Another unintended effect is that Bt com hybrids descended from Monsanto’s MON 810 and Sygenta’s Bt 11, both
have markedly increased levels of lignin in stem tissue which may make the com less digestible. There is some
suggestion that given a choice between equivalent feeds, domesticated animals will eat the non-GM feed.
Finding the same unintended effect in the above two different transformation events suggests that the GE process
itself, is responsible for the increase in Lignin levels and perhaps other undetected effects. The increased lignin
content of Bt com was brought to light only 5 years after market introduction. The failure to carry out the required
testing highlights the serious gaps in the human health assessment of Bt com.
Plant-generated GE pesticides have potential health impacts as well as environmental impacts. For example, several
Cry proteins in Bt products could be a source of allergens and antibodies.
Random, unintended effects including unexpected toxins and allergens in food plants and cancer in mammalian cells
have arisen from the inherently random, uncontrollable nature of the process of GE
The cauliflower mosaic vims (CaMV), the viral promoter that is in practically all transgenic plants, has similarities
with the human hepatitis B virus. As all genomes of living species contain dormant viruses, there is a potential for the
CaMV promoter to reactivate them, raising cancer concerns
Thus, hazards from GM crops released into the environment may spread more readily through HGT because GM
constructs arc specifically designed to cross the interspecies barrier. Apart from the above list, these hazards include
the reactivation of dormant viruses, the creation of new viruses and super viruses and the spread of drug and antibiotic
resistance marker genes to pathogens, making infections untreatable or at least very difficult to treat.
Significant amounts of transgenic DNA is found to survive most commercial processing or in the gut of mammals.
Thus, GM plant materials used in silage and manure from animals fed with GM feed has a greater likelihood of
containing fragments of DNA bearing antibiotic resistance genes.
GM crops grown in the UK were not only harmful to beneficial insects like ladybirds but could also indirectly harm
other and higher life forms, including mammals, domesticated or wild animals, birds and ultimately man, both in the
short- and long-term.
The three-year UK farm-scale trials were the largest study ever to evaluate, the ecological effects of GM crops.
Released on March 21 2005, the study indicated that GM crops damage wild life and farmland bird populations
would fall even further if the crops were widely planted. Birds are a primary indicator of environmental health.
Glyphosate and Glufosinate the herbicides used with Herbicide Resistant/Tolerant (HR/HT) GM crops account for
75% of all GM crops worldwide. Both are systemic metabolic poisons with a wide range of harmful effects.
17
• GM lines are notoriously unstable, do not breed true and do not perform consistently in the field. Evidence is
emerging of yield drag, susceptibility to disease and other problems.
• 9 years of US Dept of Agriculture data, shows conclusively, that GE crops have led to an increase, not decrease in
herbicides and pesticide use, involving millions of pounds, demolishing the basic claim by biotech companies that
GM crops were such a boon to farmers because their use would lead to less herbicide and insecticide use and the
management of pests and weeds would be so much easier.
• Resistance is growing, leading to super pests and super weeds; even triple herbicide-tolerant oilseed rape weeds
(volunteers) that have combined transgenic and non-transgenic traits are now widespread in Canada. A similar
problem has emerged in the US, which may take over from Australia as the Nol 'resistant' country to Monsanto’s
RR. Indian farmers who have grown Bt cotton for three years have been warned of resistance developing on their
farms. Thus GM crops trap farmers onto a treadmill of highly toxic and increasing pesticide and herbicide use; it is
therefore by definition, a noxious technology on the farm, with significant safety concerns for health and for the
environmental. It also impedes the use of and transition to, safer integrated pest and weed management systems by
farmers.
THE IRRESPONSIBLE CLEARANCE OF GMOS BY THE US FDA AND IT’S IMPACT ON REGULATION LN
OTHER PARTS OF THE WORLD.
6.
7.
8.
An impression been fostered in the minds of people that GM crops are safe and in fact offer a technological solution to
food shortages. This impression has been created because of the extensive use of GM foods in the US, that therefore,
they must have gone through an approval process by the regulatory authorities in the US, including the US FDA.
However, nothing could be further from the truth. This is demonstrated in the evidence provided below:
The FDA openly acknowledges it has been operating under a policy "to foster" the biotechnology industry. A memo by
former FDA Commissioner David Kessler, who described the agency’s policy as "consistent with the general bio
technology policy established by the Office of the President", said, "It also responds to White House interest in assuring
the safe, speedy development of the U.S. biotechnology industry." Reference in this regard made in the article “Eating
Genetically Engineered Food is Gambling with Your Health” by Jeffery Smith, Director of the Institute for Respon
sible Technology and author of “Seeds Of Deception”, published in the website www.NewWithViews.com dated
24.01.2004 is attached to this Writ Petition as Annexure P 5.
That, GM foods would not have come onto the market if the facts about their unique risks had been acknowledged and
if national laws had been honoured. Their introduction depended on a systematic cover-up and deliberate deception by
both the biotech industry and the Government of the United State, to push a commercial agenda for spawning a multi
billion dollar industry for the United States. This continues today and is the reason why GM foods continue to be
aggressively marketed in more and more countries. The US clearance of GE foods and crops for commercial release has
given them a flawed stamp of legitimacy and hoodwinked the public into believing that they are safe. If the US had not
done so, then no other Country would have allowed their introduction. That India has clearly been influenced by the US
clearance of GE crops, as is evident from the manner in which it has given approvals for the commercial cultivation of
Bt crops and other permissions, because there is a complete absence of any genuine biosafety testing protocol in India.
The US Review Process Means That Contrary to Popular Belief the FDA Has Not Approved a Single GE crop As Safe
for Human Consumption
9.
Theoretically, transgenic proteins in foods fall under the food additive provisions of the FFDCA (Federal Food, Drug
and Cosmetic Act). Food additives must undergo extensive pre-market safety testing including long-term animal studies,
unless they are deemed to be, ‘generally recognised as safe’ (GRAS). The FDA's own records indicate that because the
process of genetic engineering can induce unpredictable side effects, its resultant products are not even recognized as
safe among the agency’s own scientists let alone by a consensus in the scientific community. It is important to emphasize
that the extent of the disagreement clearly precludes GRAS status. As both the FDA’s regulations and the federal courts
make clear, general recognition of safety can only be imputed if there is an overwhelming consensus in the community
of qualified experts. While unanimity is not required, a significant disagreement prevents a determination that consensus
exists. Even so, the FDA has left it to the biotech industry to decide whether or not a transgenic protein is GRAS and so
exempt from testing. (FDA Policy, 1992). Thus, the FDA’s policy presumes every genetically engineered food is as safe
as its conventional counterpart unless demonstrated otherwise, inviting a strong presumption of ‘substantial equivalence’
(SE). Biotech industry and government officials have testified to the great influence exerted by the industry on the
formulation of this policy, which was designed to give speedy clearance without having to go through formal approvals
before market release of GE crops and foods, while at the same time reassuring consumers that GE foods have passed
government review. According to Henry Miller, in charge of biotechnology at the FDA from 1979-1994: “In this area,
the US government agencies have done exactly what big agribusiness has asked them to do and told them to do”. This
is quoted by David Schubert, Head of the Salk Institute’s Cellular and Neurobiology Lab, in his peer reviewed document
‘Safety Testing and regulation of GE Foods’, in the Journal “Biotechnology & Genetic Engineering Reviews. The
article is attached to this Writ Petition as Annexure P 6. The main study that attempted to demonstrate the safety of a
bio-engineered food through standard toxicological testing, failed conspicuously to do so; that product was “Flavr Savr
Tomato”. So, although GRAS exemption was intended to permit marketing of substances whose safety has already
18
been demonstrated through sound testing, the FDA is now using it to circumvent testing and uses it instead to expedite
product approvals, at the expense of public health. This amounts to a ‘scientific sleight-of-hand- in the use of GRAS
exemption for GE clearances. It is emphasised that the FDA does not require the testing of any GM food before it is
released on the market and that it has consistently ignored the warnings and advice of its own scientific experts in
clearing GE crops and foods for market release. The irresponsibility of the FDA is adequately documented in the
Statement of Steven M. Druker, who represented nine scientists who were plaintiffs in the Law Suit challenging FDA
policy on genetically engineered foods. The Statement of Steven M. Druker and the list of Scientist-Plaintiffs are
already attached to this Writ Petition as Annexure P 2. The FDA’s irresponsible clearance of GE Foods Is also documented
by David Schubert in his peer-reviewed paper, ‘Safety Testing and Regulation of GE Foods’ already annexed to this
Writ Petition as Annexure P6.
SIGNIFICANT HAZARDS FURTHER EXPLAINED: EXPERIENCE WITH “ FLAVR SAVR” TOMATO,
STARLINK AND Bt 10
10.
Flavr Savr tomato was the first GE food reviewed by the FDA. It went through standard toxicological testing to
demonstrate the safety of a GE food, which it failed. The report prior to 1999 submitted to the US FDA revealed
harmful effects on rats fed on GM tomatoes. Several of the rats developed erosions (early ulcers) of the lining of the
stomach similar to those seen in the stomach of older humans on aspirin or similar medication. (Some rats died and
were replaced). Substantial life threatening haemorrhage may occur in humans from these early ulcers. Reference of
this can be found at page 38 of the report of the Independent Science Panel already attached to this Writ petition as
Annexure P4. Yet the FDA approved the product anyway on the ground that it is GRAS (Generally Recognised As
Safe), but it was subsequently taken off the market. The FDA ignored the advice of senior scientists of the FDA itself on
the need for further safety testing. Instead, FDA officials claim that Flavr Savr passed muster so well that the rigor of its
testing will not have to be repeated for other bio-engineered foods. This evidence can be found in the statement of
Mr.Steven Druker, already annexed to this petition as Annexure P2.
Experience with StarLink
11.
In 1997/98, the EPA had approved StarLink (com engineered to contain a Bt. toxin pesticide which produces the now
banned Cry9C insecticidal protein) for animal feed, but not human food. In 2000, it was found in taco shells that set in
motion widespread product recalls and an expensive chain of events of testing and diverting contaminated lots of grain.
The cost of the impacts ran into hundreds of millions of dollars. The USDA (US Department of Agriculture) ended up
by bailing out seed companies involved in the effort to contain the contaminants. The Starlink episode “involved crops
planted on less than 0.5% of US com acreage, yet the product ended up contaminating grain throughout the food
system. Also affected were the seed stocks of at least 63 small and medium-sized companies. Banned StarLink genes
still contaminate the seed supply. In fact, a most recent study of February 2005, backed by the international group
Friends of the Earth found that samples of UN World Food Program shipments collected in Guatemala included StarLink.
the banned com long since pulled from the market in the United States because of concerns it could provoke allergic
reactions. Reference can be found in the report of the Union of Concerned Scientists titled “Gone to Seed” annexed to
this Writ Petition as Annexure P 7. The StarLink episode should serve as a timely warning to India of how easily GM
contamination of food crops can happen and how virtually impossible it is to clean up contamination from the system.
In view of this, the DBT approval of Cry 9C for experiments on cabbages and cauliflower (which is the same as
Starlink) in experiments by Bayer (owners of Aventis Crop Science which engineered StarLink) is surprising. A collection
of documents prepared by an organisation called Green Peace India documenting this evidence is attached to Writ
Petition as Annexure P8 (colly.). Seed contamination would exacerbate this problem by making it even more difficult
for growers and food companies to know the exact composition of the products they buy and sell. Commingling is
being reported with regard to Indian cotton, BT cottonseed commingling with non-GM cottonseed, as the GOI has no
mechanism in place to prevent this. Products like StarLink that are not intended for use in food raise the highest level of
concern. They are unlikely to be reviewed for food safety at all and many such farm and industrial crops are likely to
produce bioactive and toxic compounds. StarLink was denied approval for food use because its Bt toxin failed screens
for digestibility and heat stability. Starlink raises the question of whether other Bt toxins that were screened might
nevertheless be allergens. Scientists accept that without a better understanding of food allergenicity, this question
cannot be adequately answered. The failure to remedy and rectify such a critical research need is a major flaw in the US
regulatory process for GE food. Reference to this can be found in foot note 54 of Annexure P 7. already attached to this
Writ Petition.
Sygenta BtlO
12.
In a variation of the above incident, in April 2005, imports of US com were banned at UK ports following the discovery
that the US has been illegally exporting a banned GM maize, BtlO to Europe for four years. BtlO also has an antibiotic
resistance marker conferring resistance to antibiotics The Bush administration failed for three months to inform European
customers about the banned maize. The scandal was only admitted on 22 March, after its exposure by the scientific
magazine Nature Biotechnology. Reference to these facts is made in the article published in the Independent dated 17
April 2005 attached to this Writ Petition as Annexure P 9.
19
UNINTENDED EFFECTS INCLUDING HORIZONTAL GENE TRANSFER(HGT)
13.
The GE process itself is achieved through Horizontal Gene Transfer (HGT) because it moves genetic material between
organisms, which are asynchronous with the reproduction of the organism, so genes can also be transferred between
distant species that would never interbreed in nature. For example, human genes are transferred into rice and those from
pig. sheep, fish and bacteria are transferred into plants. Thereafter, secondary, unintended HGT can take place from GE
crops released into the environment and several serious examples of this insidious hazard connected with the GE
process are provided below as evidence of the grave risks they pose for human and animal health and for the environment,
including: new strains of antibiotic resistant bacteria, new viruses and bacteria arising from those introduced into the
transgenic plants, random secondary insertion into other unrelated organisms, causing harmful effects including cancer,
reactivation of dormant viruses etc. For these reasons, concerns with HGT make the technology of GE highly unpredictable
and also extremely dangerous and puts in doubt the safety of the GE process itself.
Insufficient scientific knowledge and research on HGT
14.
Horizontal transfer of transgenes and antibiotic resistant marker genes from genetically engineered crops into soil
bacteria and fungi has been documented in the laboratory. Dr. Jack Heinemann. Director of the New Zealand Institute
of Gene Ecology, University of Canterbury, speaking about one form of HGT says: "the question of HGT from transgenic
plants to soil micro-organisms is not ‘will it happen' but ‘when and where will it happen’”; and “it is very possible that
the relevance of HGT to assessing the risk of genetically modified organisms will be more important than can be
extrapolated from present data”. This reference is in this regard can be found in a statement by Mr. Jack Heinemann to
Petitioner No. I. Aruna Rodrigues daetd 29.03.2005 is attached to this Writ Petition as Annexure P 10. At present, there
are significant limitations on research on HGT, that have lead to underestimating the frequency of HGT. Jack Heinemann,
an authority on HGT, an Associate Professor at the University of Canterbury, and the Director of the University’s New
Zealand Institute of Gene Ecology, in his statement has stated that HGT has not been studied to a sophistication, that is,
to within a reasonable fraction of the scale with which gene technologies have developed. “An increasing body of
scientific evidence supports the suggestion that the capacity to detect and monitor GMOs is below what is sometimes
claimed. It also falls short of what would be necessary for the purposes of containing GMOs in some environments or
eliminating them from others. The assessments about frequency and importance of HGT are premature at present. Mr.
Heinemann has stated that more research is needed to even develop the appropriate tools to monitor at the necessary
levels of sensitivity. Further, in a study with co-author and expert Dr. Terje Traavik. published in the reputed journal
“Nature: Biotechnology", August 2004, they also stated that analysing the sensitivity of the current techniques for
monitoring HGT from GM plants to soil micro-organisms, they felt that it could have an environmental impact even at
a frequency that was approximately trillion times lower than what the current risk assessment literature assumes it to be.
They concluded that current methods of environmental sampling to capture genes or traits in a recombinant are too
insensitive for monitoring evolution by HGT. Since there is critical risk to health and environmental safety and the
scientific uncertainty surrounding the environmental application, the authors recommend a slow down of genetic
modification till new approaches of monitoring emerge. A copy of the article titled “Problems in monitoring horizontal
gene transfer in field trials of transgenic plants” published in Nature Biotechnology, September 2004 , is attached to this
Writ Petition as Annexure P 11.
Resistance to antibiotics through marker genes
That during the process of genetic modification, to identify the modified cells, and for this reason only, an extra gene
called a ‘marker gene’ is added. This is a passenger gene and it is carried along with the one for improvement, growth,
pesticide resistance or whatever desired characteristic one is trying to introduce into the genetically modified cell. This
is how GM cells are sorted from non-GM cells. Many marker genes used in commercial crops currently on the market,
are antibiotic resistance genes and they work by producing a chemical that reacts with antibiotics to protect the GM
cells from the harmful effects of the antibiotic Therefore many GM products contain a gene that produces the desired
trait and something that overcomes the antibiotic (an ‘anti-antibiotic’).. This leads to resistance of the specific organism
to antibiotics, which gives rise to grave concerns to human and animal health.
16.
There have been several cases of GM crops that contain antibiotic resistant genes. The case of GM com/ maize in the
European Union, developed by the company Syngenta, is an effective illustration of this. The European Union has
called for an end to cultivation of several genetically modified varieties including Syngenta Bt. 176 com. for the reason
that it could generate resistance to antibiotics. A copy of the press note downloaded from the internet detailing the event
is attached to this Writ Petition as Annexure P 12.
17.
Various studies have found that DNA from GM material can persist in the environment and is not completely broken
down by processing, decomposition or digestion.. Antibiotic resistance genes may escape from both silage and manure
to bacteria in the gut and in the environment. GM animal feed serves to greatly increase the potential for new strains of
antibiotic resistant bacteria, a hazard, which adds to the growing global threat of multi-drug resistant bacteria. Furthermore,
antibiotic resistance genes have the potential to spread in our environment via horizontal gene transfer, to other bacteria,
making it very dangerous. A copy of the article titled “GMOs: Genetically Modified Food and Animal Feed What Have
We Learned”, authored by Dr. Harsh Narang, a leading expert with more than thirty years of field research behind him
and who held a crucial position as a government scientist at the United Kingdom Public Health Service Laboratories, is
15.
20
attached to this Writ Petition as Annexurc P 13.
The UK Ministries of Agriculture Fisheries and Food (MAFF) too, has recommended that: “In view of the potential
health impacts due to the secondary horizontal transfer of transgenic DNA on livestock and human beings, all current
anima] feed should be withdrawn immediately. Steps should be taken to ensure that no GM material is fed to animals
directly or incorporated into commercial animal feed”. A copy of the article that reports the study is attached to this Writ
Petition as Annexure P 14.
19.
Recent studies have proved that the GM plants containing viral inserts (as transgenes or promoters) may lead to HGT.
which makes it an inherently hazardous technology. The study by Jonathan Latham, PhD and Ricarda Steinbrecher,
PhD on HGT published as a Technical Report titled “HGT of viral inserts plants from GM plant to viruses" is attached
herewith as Annexure P 15.
18.
Other Safety Concerns with GM Foods
GM Food Raises Serious Safety Concerns. In the only systematic investigation on GM food ever carried out in the
world, ‘growth factor-like’ effects were found in the stomach and small intestine of young rats that were not fully
accounted for by the transgene product and were hence attributable to the transgenic process/construct. This was the
finding of the multi-centre collaborative research conducted by the public-funded Rowett Institute of the UK, under the
co-ordinatorship of Dr. Arpad Pusztai, a leading nutritionist and an eminent toxicologist. At the start of this project in
1995, there wasn’t a single paper published in peer-reviewed scientific journals on the biological evaluation of GM
foods. These effects could not be replicated by supplementing the parent line potato diets with GNA, the natural gene
product, given at the same level as expressed in the GM potato. The conclusion therefore seems inescapable.that it was
not the GNA but the genetic technology itself that caused the harm. According to Dr. Pusztai, "one of the major omissions
in present day GM risk analysis is that no attempt has so far been made to investigate this obvious link between GM
food and intestinal tumour development. Further, “ full reproductive experiments (are required) in which the reproductive
performance of both male and female rats fed on GM- versus non-GM diets should be monitored for several generations
because any problems with reproduction could have disastrous consequences for the environment. Despite official
denials by the USDA that this had nothing to do with GM but that it was caused by a mould contamination of the com.
curiously, the same problem did not seem to occur with non-GM com". A copy of the peer-reviewed article published
in the Lancet titled “Effects of diets containing GM potatoes expressing Galanthus nivalis lectin or rat small inetstine”
is dated October 1999 attached to this Writ Petition as Annexure P 16.
21.
Various studies also demonstrated that GM crops grown in the land were not only harmful to beneficial insects like
ladybirds but could also harm other and higher life forms, including mammals, domesticated or wild animals, birds and
ultimately man, both in the short- and long-term. When GM crops are grown widely it will be unavoidable that both
domestic and wild animals will have to ingest them. As most of first generation GM crops have been developed using
the same unpredictable gene transfer technology as that used for GM potatoes, it can be expected that the health damage
found with these could also generally occur with other GM crops. Consequently, animal health will be massively
compromised leading to a major disruption of the ecological steady state balance. This is so because the problems
encountered in the study of ‘growth factor-like’ effects on young rats, was attributed most likely, to the CaMv (cawliflower
mosaic virus) viral promoter, a promoter spliced into nearly all GE foods and crops and may hence be general to all GM
food. Evidence suggests that the CaMv 35S promoter might be especially unstable and prone to horizontal gene transfer
and recombination with all the attendant hazards: gene mutation, cancer, re-activation of dormant viruses and generation
of new viruses. This promoter as mentioned, is present in most GM crops being grown commercially today.
22.
That it is relevant that Pusztai was fired from his job after an extremely distinguished career of 35 years in this Institute,
due to pressure from the GM industry. No further follow-up studies have been done to ascertain whether GM foods in
the market create the same damaging effects as those observed by Pusztai.
23.
In a significant study on the potential human health effects due to GE foods. Dr. Pusztai and two other scientific experts
in the field Susan Bardocz and Stanley W.B. Ewen stated that, "from the results the conclusion seems inescapable that
the present crude method of genetic modification has not delivered GM crops that are predictably safe and wholesome"...
“we need to consider that these GM feed, ration-fed animals will eventually be consumed by humans and there is
absolutely nothing known about the potential hazards (if any) on human health of this indirect exposure to GM food.
There is an urgent need to come up with novel scientific methodologies to probe into the compositional, nutritional/
toxicological and metabolic differences between GM and conventional crops if we want to put this technology on a
proper scientific foundation and also to allay the fears of the general public. We need more science and not less. For
proper safety assessment our first concern ought to be to establish on a case-by-case basis the impact of components of
GM foods on the digestive system, its structure and metabolism, because the way our body will respond to GM foods
will be pre-determined at this level. According to The Royal Society (1999) we need ‘to refine the experimental design
of the research done to date’.” A copy of the report is already attached to this Writ Petition as Annexure Pl.
24.
The statement of Dr. Arpad Pusztai recommends that a minimum of the enumerated investigations must be carried out
in the areas of allergenicity, toxicity and nutrition viz.,
a.
the comparison of the GM and isogenic lines should include investigation with novel and up-to-date analytical
techniques, such as proteomic analysis (2D electrophoresis and mass spectrometric analysis of relevant components),
b.
a full biochemical, nutritional and toxicological comparison of the in planta produced Bt toxin with that of the
20.
21
original used for the transformation must be done
microarray analysis of all novel RNA species in the genetically modified plant must be performed
full molecular biological examination should be carried out with particular attention to the possibility of secondary
DNA insertions into the plant genome
e.
a full metabolomic NMR. etc analysis of the transformed plant is obligatory
f.
variation in the amounts of gossypol. cyclopropenoid fatty acids and other toxins related to these should be investigated
in Bt cotton grown under different agronomic conditions
g.
the stability to degradation by acid or pepsin or other proteases/hydrolases of GM products, foreign DNA, including
the gene construct, promoter, antibiotic resistance marker gene, etc, must be established in the gut of animals in vivo,
and not in vitro as done presently.
h,
with GM lectins, including the Bt-toxins (Bacillus thuringiensis toxin) the presence/absence of epithelial binding in
the gut should also be demonstrated by immunohistology.
i.
the nutritional, immunological, hormonal properties and allergenicity of GM-products must be established with the
gene product isolated from the GM crop and not with the recombinant material from E. coli as these two may be
substantially different.
25.
Dr. Pustzai stated that GM food is unlikely to be highly poisonous and instantaneously deadly. “Toxicity” is therefore
an unhelpful and loose concept and in contrast, nutritional studies in which GM crop-based diets are fed to young
growing animals should reveal their possible harmful effects on metabolism, organ development, immune and endocrine
systems and gut flora which together determine the safety of the GM crop are the most appropriate. Therefore for the
next stage in the regulatory risk assessment process an animal testing protocol based on methods already used in animal
feedstuff evaluation is necessary. A copy of the statement of Dr. Pusztai for this honourable court titled ‘Gaps in the
current safety assessment of GM crops/foods - the way forward’ is attached to this Writ Petition as Annexure P17.
c.
d.
Contamination of milk due to GMOs
25. Recently, Greenpeace, Germany, highlighted the results of a study from the Research Centre for Milk and Foodstuffs in
Weihenstephan, Bavaria, which was reportedly “kept under lock and key for three years”. It contains the results of a
farmer’s milk samples that tested positive for GM DNA from Roundup Ready soy and Bt 176 maize. A copy of the
article that refers to this incident titled Twin Biosafety Briefings: DNA in GM food and feed” by Dr. Mae- Wan Ho is
attached to this Writ Petition as Annexure P 18.
26.
That the implications for India are particularly relevant. Given the strong evidence for GM DNA in animal feed,
including GM cottonseed in animal feed and secondary horizontal gene transfer, the serious risk of GMO contamination
of the food chain and its consequences for public health as a result of the GOI approvals of Bt cotton for commercial
planting is very grave. Thus, commingling of BT cottonseed cake in animal feed, particularly for milch cattle and the
potential for contaminating milk and the next link, processed milk foods, including infant foods, milk powder, butter,
cheese etc. is a most immediate danger and a widespread route to the potential contamination of our food chain at this
time, with impacts across the whole of India.
27.
The significant example of the genetically altered hormone called recombinant bovine growth hormone or rBGH and
its serious health effects on cows highlights the problems connected with animal health. Besides, their milk may contain
a substance that has been implicated in human breast and stomach cancers. rBGH and its effects are dealt with in a later
part of the petition; but it has already taught us a lesson about how a GM hormone can have a devastating effect on both
animal and human health and it is one of the most disturbing cases of biotechnology gone haywire.
GM CROPS AND THE ENVIRONMENT
Evidence for TYansgenic Contamination:
28.
The proven contamination of Mexican com landraces (traditional maize crops in Mexico from wild species) has raised
deep concern among scientists about the consequences of transgenic contamination, precisely because there are such
outstanding safety concerns linked with the technology of GE, as has been enumerated in the foregoing sections of this
Suit. In November 2001, Berkley plant geneticists Ignacio Chapela and David Quist presented evidence of transgenic
contamination of the landraces. The report was published in Nature, but subsequently withdrawn under pressure. Dr.
Chapela was discredited and his university tenure terminated. Subsequent research by scientists confirmed that the
contamination was much more extensive that previously suspected. 95% of the sites sampled were contaminated,
varying from 1 %-35%, averaging 10%-15%. The issue of the Mexican landraces is particularly important for a number
of reasons: (a) Mexico has in place a moratorium on GM crops (since 1998). Therefore the contamination of the
landraces could only have occurred from GM com crops originating from the US; (b) The rapid dispersal of transgenes
to Mexico only a few years after their first commercial use in the US must serve as a dire warning to India of how easily
transgenic contamination can take place and with what impacts, because Mexico is the centre of com diversity and
Teosinte, the crops wild progenitor grows alongside in Mexican cornfields. Whatever novel genes are found in Mexican
‘landraces’ are also likely to be transferred into the Teosinte plants via pollen. Reference in this regard can be found in
footnote 83 & 86 of the report of the Union of Concerned Scientists titled Gone to Seed, already attached to this Writ
petition as Annexure P 7. This is particularly relevant to India as it is the centre for rice diversity; (c) The GM companies
involved have refused to provide molecular information or probes for research, which would sort out which are the
22
parties liable for the damages caused, (d) Even more serious than the issue of contamination is the possibility that
because the transgenic constructs were unstable, (the unstable CaMV), they could be fragmenting and scattering
throughout the genomes; this is known to cause DNA rearrangements, deletions, translocations and other disturbances,
which could destabilise the genomes of the landraces, driving the landraces towards extinction (All the transgenic
maize constructs that might have been responsible for the contamination contained the CaMV 35S promoter, which was
why the promoter could be used to test for transgenic contamination).
29.
Transgenic contamination is not limited to cross-pollination. New research shows that transgenic pollen, wind-blown
and deposited elsewhere, or that has fallen directly to the ground, is a major source of transgenic contamination. Such
transgenic DNA was even found in fields where GM crops have never been grown, and soil samples contaminated with
pollen were demonstrated to transfer transgenic DNA to soil bacteria. The source of the aforementioned information the
report of the Independent Science Panel already attached to this petition as Annexure P4. The ISP had stated unequivo
cally “that transgenic contamination is unavoidable and there can be no co existence between GM and Non-GM agri
culture. Most important of all, GM crops have not proven safe”— “and if ignored could result in irreversible damage to
health and the environment”
GM crops harmful to Wildlife
Significantly, a four-part series of experiments conducted over 3years by the Royal Society for the Protection of Birds
and the Centre for Ecology and Hydrology, Lancaster in the United Kingdom, concluded that GiM crops could be more
harmful to many groups of wild life than their conventional equivalent. A copy of the news story titled “The end of GM
crops” in the Independent dated 22.03.2005 reporting the studies are attached to this Writ Petition as Annexure P 19.
The experiment confirms the fact that Bt. proteins, incorporated into 25% of all transgenic crops worldwide, have been
found harmful to a range of non-target insects, worms and amphibians. Some of them are also potent immunogens and
allergens.
31.
In a significant field experiment reported recently, scientists from the University of Pittsburg, found that glyphosate and
the Roundup herbicide that contain it. and is used on most herbicide resistant crops is lethal to amphibians. “The most
shocking insight coming out of this was that Roundup, something designed to kill plants, was extremely lethal to
amphibians.” said Relyea, who conducted the research at Pitt’s Pymatuning Laboratory of Ecology. “We added Roundup.
and the next day we looked in the tanks and there were dead tadpoles all over the bottom.” A copy of the press note of
the University titled “Herbicide runoff is lethal to Amphibians” dated 04.04.2005 is attached to the Writ Petition as
Annexure P 20.
30.
GM crops and increasing herbicide use
That the reality has been contrary to the claims of the GM industry that GM crops lead to a major reduction in pesticide
use. Scientific data shows that overall, GM crops have led to an increase in pesticide use, financially hurting farmers
and harming the environment. The report of the Independent Science Panel, mentioned earlier and annexed to this
petition effectively documents this. Further, the technical report of Dr. Charles Benbrook, former Executive Director of
the Board on Agriculture of the U.S. National Academy of Science for seven-years, further corroborates and confirms
this evidence. Dr Charles Benbrook in his latest technical report, drawing on 9 years of US Dept of Agriculture data, has
concluded that the use of GM crops in the USA hasled to an overall increase in pesticide use involving an amount of 122
million pound since 1996. A copy of the press note downloaded from the internet tilled "Benbrooke report on pesticide
use on GM crop in the first nine years” dated 25.04.2004 is attached to this Writ Petition as Annexure P 21.
33.
Argentina’s experience in this regard is a warning to India. Argentina used to be one of the world’s major suppliers of
wheat and beef, but the wholesale shift to mainly GM soy of half of the arable land. i.e. 11.6 million acres changed all
that. Roundup Ready (RR) soy growers were using more that twice as much herbicide as conventional farmers and in
2003 used an estimated 150 million litres or a lOfold increase in 5years. The warnings to GM soy growers has fallen on
deaf ears but are now being fulfilled, including changes to soil microbiology. Slugs, snails and fungi are moving into the
newly available ecological niche. Charles Benbrook says: “Argentina faces big agronomic problems that it neither has
the resources nor the expertise to solve. The country has adopted GM technology - "based on the current use of RR I
don’t think its agriculture is sustainable for more than a couple of years". Argentina demonstrates a grim lesson that the
new and untested technology of GM provided by multinational companies increases a country’s vulnerability and
agriculture and food security are seriously threatened and undermined. A copy of the news report titled "Argentina's
Bitter Harvest” in the New Scientist dated 17.04.2004 is attached to this Writ Petition as Annexure P 22.
34.
The increase in herbicide use on HT crop acres should come as no surprise. Scientists have always known that resistance
would occur. Weed scientists have warned for about a decade that heavy reliance on HT crops would trigger changes in
weed communities and resistance, in turn forcing farmers to apply additional herbicides and/or increase herbicide rates
of application. The ecological adaptations predicated by scientists have been occurring in the case of Roundup Ready
crops for three or four years and appear to be accelerating.
35.
In March 2000, the WWF published one of the most extensive reviews relating to GE crops titled "Transgenic Cotton:
Are There Benefits for Conservation?”. The review concluded, that the technology has been "misrepresented in ways
that suggest, that genetic improvement can take the place of management and skill in solving pest problems. This may
explain in part why farmers have so readily adopted the technology to the degree that they have". Reference in this
32.
23
regard can be found in review on the report on the WWF review titled "GM Cotton - No Reduction In Pesticide
Use" dated 28.11.2000 attached to this Writ Petition as Annexure P 23.
The Need for safety Testing
36.
That it is clear that genetic engineering is fundamentally different from traditional breeding. Expert scientist Dave
Schubert (head of the Salk Institute's Cellular and Neurobiology Lab) has strongly advocated mandatory safety testing
for genetically engineered food in the USA because of the fundamental difference between genetic modification and
traditional breeding and citing various adverse effects. Such tests are equally necessary for India, for the release of any
GMO into the Indian environment. It is matter of grave concern that there are very few established protocols for
assessing the potential health impacts of GE crops. David Schubert says: "instead one finds loose guidelines that in
most cases only list certain tests or procedures without specifying how they are to be conducted”. "As a result biotech
companies have been free to devise procedures of their own choosing that often vary markedly from tests conducted by
independent researchers”. David Schubert and William Freese outline a peer-reviewed safety-testing protocol, which
addresses the unique risks posed by the GE process and better protect public health. In the absence of such studies, it is
not possible to identify errors or intentional deception and get at the facts about the safety of GM foods. A copy of the
peer-reviewed article by William Freeze and David Schubert published in Biotechnology and Genetic Engineering
Reviews is already attached to this Writ Petition as Annexure P 8.
PRECAUTIONARY PRINCIPLE
37.
Such compelling evidence suggests that the technology of GE is a fit case for the application of the Precautionary
Principle. The precautionary principle necessitates that if there are reasonable scientific grounds for believing that a
new process or product may not be safe, it should not be introduced until we have convincing evidence of reasonable
certainly of no harm. The principle can also be applied to existing technologies when new evidence appears, suggesting
that they are more dangerous than what society had previously expected: as in the case of cigarettes, CFCs, greenhouse
gasses and now GMOs. Then, it requires that we undertake research to better assess the risk and that in the meantime we
should not expand our use of the technology and should institute measures to reduce our dependence on it. If the
dangers are considered serious enough, then the principle may require us to withdraw the products or impose a ban or
a moratorium on further use.
38.
This Hon'ble Court in A.P. Pollution Control Board versus M.V. Nayudu [1999 (2) SCC 718| held that that precautionary
principle is applicable to India. The principle mandates that when a new technology or process can cause serious and
irreversible harm to human health and the environment, precautionary measures should be taken even if some cause and
effect relationships are not fully established scientifically. In this context, the proponent of the novel and uncertain
activity rather than the public should bear the burden of proof. As. if one is embarking on something new, one should go
ahead only and until one is reasonably convinced that it is safe. Pushing forward with untested, inadequately researched
technologies, and insisting that it is for the society to prove conclusively that they are harmful before they can be
stopped, is self defeating and extremely dangerous.
39.
That this is a fit case to employ the Precautionary' Principle. There is adequate scientific evidence in terms of research
carried out in various parts of the world, to at least doubt the safety of the process of Genetic Engineering. That this
evidence has emerged despite active efforts by the GM industry to stifle independent scientific research and systematically
dismantle regulatory mechanisms in various important countries in the world including India. Hence, it is submitted
that it is in the public interest that the precautionary principle be employed and a moratorium be ordered on any further
release, till there is reasonable certainly of the safety of such releases, through independent scientific studies. That it is
submitted that such studies would in the normal course take a number of years, akin to the scientific studies mandatory
before the approvals given for pharmaceuticals. It is submitted that such a moratorium should also be accompanied
with isolation, destruction and recall of the GMOs that have already been released, to the extent that is possible. It is
instructive that the proponents of the technology also refuse to accept liability. The implication therefore is, that, if the
technologies turn out to be hazardous, as in many cases they have, the rest of society is left to pay the penalty.
FLAWED CORPORATE TESTING & FLAWED CLEARANCES UNDER THE US REGULATORY SYSTEM
40.
In its official statements, the FDA carefully avoids vouching for the safety of GE foods, which is consistent with its
voluntary review process. Clearly, however, this is not the case with communications with food additives or drug
companies. In these cases, the agency conducts an exhaustive review or a full set of required studies on the product,
then, either approves or rejects it on its own authority. The following represent significant examples of flawed testing
procedures by biotech companies which are ignored by the FDA: (a) GE companies rarely test the transgenic protein
actually produced in their GE crops but instead they make use of a bacterially-generated surrogate protein. Says David
Schubert, “testing for a bacterial protein should not substitute for testing the plant-expressed proteins” for various
important reasons and that “immunologic differences between the plant-produced and bacterial surrogate proteins
could haves serious medical consequences”. The Starlink case used a surrogate protein, and so does MON810, which
was approved and about which more will be said; (b) Inherent to the process of GE is the creation of ‘unintended
effects’ including “over-expression” of the gene and excess lignin production etc., as explained earlier in this Suit.
These issues were recognised by FDA scientists in the early 1990s but their recommendations to require appropriate
24
testing were overruled; (c) Neither the EPA nor the FDA demanded characterisation of the novel Bt fusion protein
apparently produced by Mon810; the records point to deliberate deception, cover-up of the true facts of the case. This
is a particularly troubling example because the US FDA responsible for food safety has "fundamentally flawed molecular
characterisation data on such a widely planted GE crop”; (c) the EPA plays a critical role in the introduction of HT
plants by raising or establishing tolerance levels for herbicide residues on crops. In 1992. Monsanto successfully petitioned
the EPA to raise the tolerance levels for glyphosate residues on soybeans from 6 to 20 ppm (EPA rule, 1992). This
anticipated the introduction several years later of glyphosate-tolerant soybeans, which use higher levels of glyphosate
than conventional soybeans. Reference to these facts may be made in peer reviewed article of William Freeze and
David Schubert already attached to this Writ Petition as Anncxure P 6.
41.
Biotech companies frequently deny access, or allow strictly conditioned access, to data on crop materials on the basis
of confidentiality, making it impossible for regulatory authorities and independent researchers to verify or review test
claims on the safety of GE crops and foods. The following incident is a good example of how dangerous and flawed the
regulatory process is, even in Europe with Governments seeming to side with the industry in opposition to their own
scientists’ advice on safety assessment. In 2003, the French commission for bioengineering, the CGB refused approval
to Monsanto’s MONS 863 com because of a study showing rats developed several abnormalities. (The EFSA European
Food Safety Authority overturned this decision). Gerard Pascal, Director of Research at the National Institute of
Agronomic Research, is reported by Le Monde as saying, "...what struck me in this file is the number of abnormalities.
I never saw that in another file.” In April last year, Greenpeace asked the German regulatory authority for the report
(which it only became aware of from the Le Monde story). The supporting Monsanto dossier held by EFSA. and the
report on a 90-day rat feeding study, arc treated as secret, as is a review document by Dr Arpad Pusztai, commissioned
by the German competent authority. His review has not been released and he is effectively “gagged” and prevented
from either revealing his findings verbally or issuing copies of his report. Monsanto has refused to release the government
body from the confidentiality agreement it had signed. This facts can be referred in article titled “Evaluating the
acceptability of GM crops: the scope for autonomy in developing countries” by Erik Millstone in the Journal SciDev in
January 2005 is attached to the Writ Petition as Annexure P24. These facts point to the importance for India to ensure
that there is full disclosure by law of product material and data for examination by the scientific community of each
GMO that is required to be tested according to the laid down biosafety testing protocol.
Flawed Clearances of Two Products with Dangerous Health Risks: The Cases of Recombinant Bovine Growth
Hormone and Aspartame
Two examples nail the US FDA for its failure to safeguard the health of the US public and point conclusively to just
how compromised is this much- vaunted US institution and watchdog of public health: they are recombinant bovine
growth hormone or r BGH and Aspartame, the ‘sweelner’ used in nearly all foods and soft drinks, promoted as a healthy
alternative to sugar. Both are Monsanto products. Aspartame is not necessarily genetically engineered, and it is not
known when it is and when it isn’t; but its inclusion demonstrates very starkly just how irresponsible and untrustworthy
the FDA has become and how keen it is to toe the industry line, to the exclusion of its prime role as a health regulator.
43.
Recombinant Bovine Growth Hormone (rBGH or rBST) is a genetically engineered drug produced by the Monsanto
Corporation. It is injected into dairy cows and induces them to increase milk production by 5-15. The FDA approved
Monsanto’s genetically engineered cattle drug, Bovine Growth Hormone (rBGH). despite being in possession of a
substantial amount of scientific information on the grave dangers it presents to human and animal health. The confidential
files of Monsanto submitted to the FDA in 1987, revealed evidence of widespread pathological lesions, infertility, and
chronic mastitis of cattle given the drug. Also, cows hyper-stimulated by repeated rBGH injections, were found to be
seriously stressed.
44.
The above data was leaked to the public as a result of which, in 1990, the House Committee of the U.S. Government
carried out an investigation and charged “that Monsanto and the FDA have chosen to suppress and manipulate animal
health test data — in efforts to approve commercial use" of rBGH. This charge is also consistent with the Committee's
1986 report, “Human Food Safety and the Regulation of Animal Drugs.” The report concluded: "The FDA has consistently
disregarded its responsibility—has repeatedly put what it perceives are interests of veterinarians and the livestock
industry ahead of its legal obligation to protect consumers—jeopardizing the health and safety of consumers of meat,
mil);------ ", Even so, despite the damning evidence against the use of the drug, the FDA did not refuse clearance of
rBGH and, in 1994 approved the commercial use of Posilac, Monsanto’s trade name for rBGH. Overwhelming evidence
had already compelled Monsanto to insert a label, which states that the use of Posilac "is associated with increased
frequency of use of medication in cows for mastitis” and some 20 other adverse health effects. Reference may be made
of these facts from articles attached to this Writ petition as Annexure P 25 (colly).
45.
Acting on this cumulative evidence, the European Commission entrusted a team of internationally recognized experts
to examine the issues. The report of the experts concluded that "avoidance of rBGH dairy products in favour of natural
products would appear to be the most practical and immediate "dietary intervention to... (achieve) the goal of preventing
cancer”. A copy of the press report on the facts titled "Monsanto’s GM drug stil threatens Public Health” dated 05.02.2005
downloaded from the internet is attached to this Writ Petition as Annexure P 26. Based on this evidence, all 25 nations
of the European Union have banned rBGH, as have Canada, Australia, New Zealand and Japan. In fact, most industrialized
nations of the world have disallowed its use. The U.N. food safety organization. Codex Alimentarius, had declined to
42.
25
declare the drug safe three times.
Aspartame is the generic name for the brands ‘Nutrasweet’ and ‘Equal'. Given clearance by the FDA in 1993, a $350million class-action lawsuit has now been filed in order to prove how deadly aspartame consumption truly is to the
human body. Also included in the lawsuit, is the central role, played by Donald Rumsfeld, current United States Secretary
of Defence, in helping to get aspartame approved through the Food and Drug Administration. A close examination of
the process for approving aspartame by the FDA provides an example of how powerful corporations are influencing
once trusted institutions. The documentary “Sweet Misery. A poisoned World" is annexed to this Writ Petition. Loaded
with compelling interviews, this powerful examination includes:
i)
Archival footage from GD. Searle, the producer of aspartame, and federal officials to describe the amount of
propaganda and “dirty tricks” big business used to push aspartame on the market.
ii)
Key dialogue with Arthur Evangelista, a former Food and Drug Administration investigator, who exposes how far
major conglomerates went to legalize the use of aspartame in the United States, and the resulting domino effect on
its use in other countries.
iii)
Consumer attorney jim turner’s candid report of his exchange with Donald Rumsfeld. Rumsfeld was the ceo of
SEARLE, and, at the same time, part of Reagan's transition team when the FDA’s board of inquiry was overruled
to allow the marketing of aspartame as a food additive, until this time aspartame was unanimously rejected by the
FDA.
47.
Not long ago, aspartame was on a Pentagon list of bio-warfare chemicals submitted to Congress — yet this lethal
product remains on grocery shelves. Aspartame complaints represent 80-85% of food complaints registered with the
FDA. So-called “diet” products containing the chemical sweetener aspartame can have multiple neurotoxic, metabolic,
allergenic, foetal and carcinogenic affects. The FDA’s own report has recently come to light, prized from their reluctant
grip. It is a self-confessed list of 92 documented symptoms triggered by aspartame from 4 types of seizures to coma and
death. In Operation Desert Storm, US troops were ‘treated’ to liberal quantities of aspartame-sweetened beverages,
which ‘cooked’ in the Saudi Arabian desert to temperatures over 86 degrees F. Many of them returned home sick with
symptoms characteristic of formaldehyde poisoning. In a 1993 act that can only be described as “unconscionable”, the
FDA approved aspartame as an ingredient in numerous food items that would always be heated to above 86°degrees F
(30°Degrees C). Much worse, on 27 June 1996, without public notice, the FDA removed all restrictions from aspartame
allowing it to be used in everything, including all heated and baked goods.
48.
The Aspartame clearance by the FDA is a prototype of the GM clearance in three respects: (a) it reveals one of the most
pervasive, insidious forms of corporate ‘negligence’ since tobacco (b) Like the tobacco story, it horrifically attempts to
put the burden of proof with regard to toxicity on consumers (c) safeguarding Public Health is the FDA’s raison detre,
but curiously, this is no longer the priority or focus of their actions and objectives. Credible evidence validates corporate
fraud, greed, manipulation to further Industry and commercial interests and in the case of GE, an “admitted agenda”, as
part of a White House directive “to foster the biotech industry” including aggressively pushing the corporate biotech
agenda on to other countries through patent monopolies and the resulting dominance of world markets.
49.
Further corroboration of the fact that the FDA is a seriously compromised institution, was provided by no less than Dr
David Graham. Associate Director for Science and Medicine in the FDA’s Office of Drug Safety. His straight forward
remarks about the relationship between the regulators and industry was part of his evidence before a hearing of the US
Senate Committee on Finance. His remarks have been recorded in and were recently quoted by the Fourth Report of
Session 2004-05 of The House of Commons, Health Committee of the UK: ““There was little doubt that, even in the
best-resourced regulatory bodies, the pressure on individual employees may become intense when problems arise.. .The
FDA has become an agent of industry. I have been to many, many internal meetings and, as soon as a company says it
is not going to do something, the FDA backs down. The way it talks about industry is ‘our colleagues in industry’... it
is rather because the body is entirely geared towards concentrating on approving drugs, doing little once they are on the
market”. A copy of the relevant excerpts of the Report of the Committee is attached to this Writ Petition as Annexure
P27.
46.
SABOTAGE OF REGULATORY STRUCTURES BY GM COMPANIES
That Monsanto, the 90% market leader in GE products, has a track record of sabotaging regulatory regimes of many
third world countries, including bribing Government officials to get clearances for the release of GMOs. This was
established in the U.S. Courts in the case of Monsanto’s business dealings in Indonesia. To achieve this task a consulting
company, on behalf of Monsanto, paid huge bribes to Indonesian environmental officials. Monsanto wanted to increase
acceptance of GMO crops in Indonesia. Monsanto has admitted to paying over $ 750,000 in bribes to more than 140
Indonesian Government Officials and members of their families between 1997 and 2002, financed through improper
accounting of its pesticides sales in Indonesia. Monsanto has also accepted that $50,000 was paid to senior environmental
ministry in 2002 in a bid to by-pass environmental controls on GM cotton. Monsanto was subsequently fined $1.5
million by justice department, payable to U.S. Government. The copy of the complaint filed by the United States
Securities and Exchange Commission in January 2005 and copies of the newspaper reports has been annexed herewith
as Annexure P 28 (colly).
51.
Monsanto has also been found tampering with data in Andhra Pradesh where Bt. cotton has failed drastically. According
to Greenpeace, Andhra Pradesh, one of the most proactive states in safeguarding the rights of cotton farmers, responded
50.
26
to the increase in farmer suicides by introducing a Memorandum of Understanding, with the primary aim to arbitrate
cases involving seed companies and farmers and to provide quick relief to the latter. Repeated failure of Bt. cotton in the
state in 2002-03 and 2003-04 caused the government to make Monsanto-Mahyco accountable to the farmers for losses
in Bt. cotton. While the data in the original report reveals the comprehensive failure of Bt Cotton in Andhra Pradesh, a
second, visibly tampered-with version exaggerates the yields, thereby reducing Monsanto’s compensation burden by
nearly Rs. 2 Crore. The fact that data has been so clearly manipulated in this case raises serious doubts about the
authenticity of any data that GEAC would use to review Bt Cotton. The copy of these documents which clearly indicate
how Monsanto has been manipulating data collected by the Government of Andhra Pradesh, as were procured by
Greenpeace have been annexed herewith as Annexure P 29 (colly).
52.
That the decision of the GEAC (Genetic Engineering Approval Committee), the regulator that is responsible for approvals
for the commercial release of GMOs, in the matter of the clearance of Bt cotton in India, conflicts with its own stance
and is inexplicable; thereby revealing not only a genuine lack of clarity in the mind of the regulators but also the abject
opaqueness of the process of regulation. The GEAC by its order dated 18.10.2001 directed the destruction of the entire
standing crop of transgenic Navbharat- 151. In this case Navbharat-151 seeds were found to be transgenic cottonseed
and was being sold without bio-safety clearances. GEAC vide its above mentioned order directed the uprooting and
burning of the entire crop, and also directed that the cotton and the seeds harvested by the farmers from Navbharat-151
be recovered along with the plants and burnt; seed production plots were to be destroyed along with the breeding lines,
hybrids, and any seed material available with Navbharat Seeds Company. Most importantly, such severe directions,
including the uprooting and burning of the entire standing crop were passed solely on the ground that the seeds are
transgenic and represent an untested technology, and hence is extremely unsafe. Having admitted the hazards of the
technology of transgenic seeds, it is inexplicable that, the required Biosafety tests are not carried out independently by
the regulator. That within five months of passing severe restrictions and asking for uprooting and burning of the entire
standing crop, the GEAC gave permission for commercial release of Bt. cotton to MAHYCO, the Indian subsidiary of
Monsanto. A copy of the order of the GEAC dated 18.10.2001 is attached to this Writ Petition as Annexure P 30.
53.
Even the circumstances surrounding the initial approvals of Bt. Cotton in India are highly dubious. The Review Committee
on Genetic Monitoring (RCGM), under the Department of Biotechnology, is a body that did not have the jurisdiction to
grant permission for release of GMOs into the environment, and is under a department, which is primarily responsible
for promotion of such untested Biotechnology. It was originally the RCGM who illegally permitted the release of the
GMOs into the country for the first time. It was only when there was a public outcry over the serious illegality of these
clearances, attempts were made to then get the release of such GMOs cleared, retrospectively.
54.
In this regard, the recent report by a major US financial risk assessor, Innovest is instructive on the manner in which the
Biotech companies and government regulators have sabotaged bio-safety regulatory structures. It states that “It is
understandable that the US Government has essentially taken the industry position on GE safety and labelling.... US
Government support for GE crops appears to stem from the fact that the crops are mostly US-developed and that GE
companies have made substantial financial contributions to US politicians and political parties. This is not said as a
criticism of politicians, but rather of the campaign finance-system, which allows politicians to accept money from the
firms they are supposed to regulate. Money flowing from GE companies to politicians as well as the frequency with
which GE company employees take jobs with US regulatory agencies (and vice versa) creates large bias potential and
reduces the ability of investors to rely on safety claims made by the US Government. It also helps to clarify why the US
Government has not taken a precautionary approach to GE and continues to suppress GE labelling in the face of
overwhelming public support for it.”
55.
That it is the recognition of these issues that forms the basis of the refusal of Insurance companies to underwrite the
risks entailed by this technology. Agricultural insurance policies of most insurance companies in the world, including
NFU Mutual, the UK’s largest agricultural insurer, specifically exclude cover for “any liability arising from the production,
supply, or presence on the premises of any genetically modified crop, where liability may be attributed directly or
indirectly to the genetic characteristics of such crop".
56.
That the influence that the GM industry has managed to exert over regulatory structures is insidious for the subtle ways
which are employed, which include regulator ‘education’, awareness etc. For example in India and many other developing
countries, organisations which are substantially funded by the biotech industry have sought to influence regulatory and
other decision making processes by conducting “awareness” and “educational” programmes. The Press report of activities
in India in January 2001, of an organisation that calls itself the Einstein Institute for Science, Health and the Courts,
based in the United States of America, well illustrated this point. The Report in The Hindu dated 05.01.2001 is attached
to this Writ Petition as Annexure P 31.
That the Government of the United States of America has been a handmaiden to the GE Industry is clear from the
57.
manner in which various developing and developed countries have been arm-twisted to take a pro-GM stand. In April
2004 Angola expressed apprehensions for the safety of its citizens health and environment due to GM food aid. The
World Food Programme, of the UN and clearly influenced by the US effectively denied food aid to Angola, with the
objective of coercing the Government of Angola to retract its decision of banning import of GM products. The press
note that points to these facts titled “GM Food Aid pressure on Angola again” dated 26.01.2005 is attached to this Writ
Petition as Annexure P 32.
58.
That it is submitted that the current basis typified by the US system of a “voluntary consultation” process is non-
27
rigorous and undefined, with regulations that arc haphazard. It works to entrench the FDA as the handmaiden of the
biotech industry. In the US. the provision of and process under GRAS status through which GE products are cleared, is
unacceptable and dangerous. What is crucially required instead, is a safety-testing regimen that will detect potentially
harmful changes in GE foods and crops and their environmental impacts, through a mandatory, science-based, testing
protocol by independent agencies. The Independent Science Panel, consisting of scientists from eleven countries,
encompassing disciplines of agro-ecology, agronomy, biomathematics, botany, chemical medicine, ecology, epidemiology,
histopathology, microbial ecology, molecular genetics, nutritional biochemistry, physiology, toxicology and virology.
wrote an open letter to the Commissioner of the FDA in late 2004. The letter is cogent with reasons on why a “voluntary
consultation" is inappropriate and unsatisfactory for checking contamination: and exhorts the FDA to undertake a
mandatory science-based review process designed to guarantee that GM crops are safe for food and feed. A copy of the
letter of the Independent Science Panel is attached to this Writ Petition as Annexure P 33.
59.
That it is relevant and significant, that the regulatory structure in India has similarly opted against the path of a mandatory
science-based review process designed to guarantee the biosafety of GM crops. That such irresponsible action in the
name of regulation has created the erroneous impression that GMOs are safe.
DEVELOPMENTS IN THE EUROPEAN UNION
That the European Union has legislated Directive 2001/18/EC. which provides for protection of human health and
environment in Europe from adverse effects that may be caused by the deliberate release into the environment of the
GMOs. This Deliberate Release Directive (Directive 2001/18/EC) came in to force 17th April 2001. The Directive has
set out a system of clearance for such releases, where approval on biosafety grounds, is a prerequisite. The Directive
requires uniformity in safety strandards for all domestic countries under the jurisdiction of the European Union. A copy
of the EC Directive 2001/18 is attached to this Writ Petition as Annexure P 34.
61.
Following the Directive, the European Commission has also legislated two regulations to implement the provisions of
the Directive viz., Regulation (EC) 1830/2003 dated 22 Sep 2003 concerning ‘traceability' and labelling of GMOs and
the traceability of food and feed products produced from GMOs, as well as Regulation (EC) 1829/2003 dated 22 Sep
2003 on genetically modified food and feed. Copies of the two Regulations are attached to this Writ Petition as Annexure
P 35 and Annexure P 36 respectively. Further the Federal Republic of Germany has amended its GE Act bringing its
legal structure in line with the Directive. A copy of the “Information on the Amendment to Germany's Genetic
Modification Act" downloaded from the official website of the Government of Germany, the only available material
accessible in English, dated nil, is attached to this Writ Petition as Annexure P 37.
60.
INDIA’S OBLIGATIONS UNDER INTERNATIONAL AGREEMENTS
The Cartagena Protocol on Biosafety for the Convention on Biodiversity, was adopted in 2002 and came into force on
11 Sep 2003. It is a binding International agreement on Biosafety. India is a signatory and is bound to implement its
provisions. Art. 1 of the Protocol lays down the objective to contribute to ensure adequate levels of protection in the
field of safe transfer, handling and use of Living Modified Organisms (LMOs or GMOs) that may have adverse effects
on the conservation and sustainable use of biodiversity, taking into account the risks to human health. A.2(2) stipulates,
that parties to ensure, that the development, handling, transport, use, transfer, and release of LMOs is undertaken in a
manner that prevents or reduces risk to biodiversity.
63.
Further. A. 10 (6) (Precautionary Principle) necessitates that the lack of scientific certainty due to sufficient relevant
scientific information and knowledge regarding the extent of potential adverse effects shall not prevent the contracting
party from taking a decision, as appropriate, in order to avoid/ minimise potential adverse effects. According to Para
9(h) of the Annex III of the Protocol, the parties are bound to to consider information on the location, geographical,
climatic and ecological characteristics, including relevant information on biodiversity and centres of origin of the likely
potential receiving environments. Annex III of the protocol includes, inter alia, the general principles of risk assessment:
(i) Risk assessment should be carried out in a scientifically sound and transparent manner, and can take into account
expert advice as well as guidelines developed by relevant international organisations. According to Art. 26 of the
Protocol parties may account for socio-economic considerations arising from the impact of LMOs on biodiversity
conservation and sustainable use, specially, with regard to value of biodiversity to indigenous and local communities.
According to A, 23(iii) of the Protocol parties shall consult the public in the decision making process regarding LMOs;
while Article (iv) mandates that parties shall make decisions available to the public, but respecting confidential
information. Further. A 21 (6) prescribes that the information about a summary of the risk assessment cannot be made
confidential. A copy of the Cartagena Protocol is attached to this Writ Petition as Annexure P 38.
64.
The U.N. Convention on Biological Diversity (CBD). 1992 inter alia requires that the contracting parties shall
domestically regulate or manage the risks associated with the use and release of LMOs resulting from Biotechnology
and which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of
biodiversity, and the risks to human health [A. 8(g)]; introduce appropriate procedure to require impact assessment of
proposed projects likely to have significant adverse effects on biodiversity and to allow public participation in the
procedure where appropriate [A. 14], Further, Article 19 (3) of the CBD had urged parties to consider the need for and
modalities of a protocol setting out appropriate procedures in the field of the safe transfer, handling and use of any
LMOs that may have adverse effect on the conservation and sustainable use of bio-diversity. A copy of the U.N.
62.
28
65.
Convention on Biological Diversity is attached to this Writ Petition as Annexure P 39.
Despite the eroding effects of the insidious relationships between research, regulation and industry, strong public pressure
has nevertheless, forced numerous regions of Europe and other parts of world to declare themselves, GM free. Over 58
countries have enacted Biosafety laws to restrict import and commercialisation of GM products and/or require labelling
of food containing GM ingredients. More than 100 regions and 3500 sub-regions in Europe, the most important market
for such products, have declared themselves GMO-free, and have demanded new European laws to protect them from
GM contamination.
TRANSGENIC CONTAMINATION OF THE SEED STOCK IS IRREVERSIBLE AND DANGEROUS AND WILL
PRECLUDE CHOICE
With the inevitable contamination of the seed stock, which is certain to take place with GE crops, recovering the
original genetic stock will be impossible. Thus, Seeds are foundational. If GE should fail, then seeds will be the only
recourse; but it will be too late because under the US regulatory system, agencies do not analyse GE crops for food
safety, until there is alarming evidence of a safety hazard emerging from the field as happened in the case of Starlink.
This is also the process that India has followed with approvals given for Bt. Crops. This means that transgenic crops are
potentially available to contaminate the seed supply long before any tests have been made or a decision taken about
their safety. In Canada and the US, as a result of 10 years of the commercialisation of GE crops, the whole seed system
is contaminated. Dr. Lyle Friesen of the University of Manitoba tested 33 samples of pedigreed, oilseed rape seed stock
and found 32 contaminated. The Union of Concerned Scientists (UCS), a non-profit partnership of scientists has in its
Report, ‘Gone to Seed’, sounded the alarm bells ringing on seed contamination, because “the value to the food supply
of the seeds entrusted to our generation cannot be overstated” -and that “nothing is more fundamental to agriculture and
our food supply than seeds”. A study based on tests conducted by two respected commercial laboratories using duplicate
samples of seeds of six traditional varieties each of com, soybeans and canola, found that in one lab fifty percent of the
com and soybean, and hundred percent of the traditional canola varieties tested transgenic; while in the other laboratory,
transgenic DNA was detected in 83 percent of the traditional varieties of each of the three crops. The Starlink episode
given in evidence in the early part of this Suit, demonstrates just how easily contamination can happen and how difficult
and expensive any damage control exercise is, without any surety thereafter that the system has been cleaned up. This
petition has provided evidence that Starlink is still in the US system. A copy of the UCS report “Gone to Seed” is
already attached to Writ Petition as Annexure P 7.
67.
Genetic engineering cannot create seeds from scratch. It is vital to understand that biotech companies need enormous
quantities of seeds to engineer their patented manipulations and then supply GM seed to farmers, worldwide. For this
purpose they have bought out virtually every major seed supplier in the US so that sourcing seeds from non-gm sources
is getting increasingly difficult for US farmers. Seed contamination offers genes and gene products surreptitious paths
to new environments. In most cases neither seed sellers, nor farmers would be aware of the contaminant. In India where
there has been no mechanism instituted by the GOT to segregate Bt cotton from non-GM cotton, the risk of seed
contamination seems inevitable.
66.
US Transgenic Contamination of Farmlands and Seeds: The Implications For India
In the US, much of the non-engineered grain and oilseed is contaminated with varying levels of genetic sequences
derived from GE varieties, as mentioned in paragraph 81. This would not matter if export customers were willing to eat
GE foods. But this is not the case. In the first official test of public opinion in the National GM Debate in the UK, 80%
of Britons are opposed to GM crops and only 2% will eat GM food. (London Times, 25lh Sept. 2003). Worldwide, 90%
of the world’s consumers are demanding mandatory labelling of GE foods: the logical conclusion being that people
want to know so that they can avoid buying them. Even in the US, there is increasing consumer rejection of GM foods.
Several polls in the USA have shown that a significant percentage of people - up to 58% - would not eat GM foods if
they were labelled as such. In the past year, 79 towns in Vermont passed resolutions against GMOs while the State
government passed a seed-labelling bill, the first of its kind in the USA. In California, Mendocino County passed the
first law in the USA to ban GMO releases into the environment; and other counties have followed suit.
69.
That in the light of this, the US is aggressively marketing GE foods in other countries and promotes GM food by
actively blocking labelling laws that prohibit or require foods to be labelled for GM content. For example, the EU is
facing enormous pressure by the US to relax its rules with regard to establishing minimum thresholds for unintended or
technically unavoidable traces of GM content in US imports. The fact is that at 0.1% of GMO contamination, co
existence of GM and Non-GM cultivation would not be possible. A study commissioned by the European Union was
conducted to ascertain the question of consumer choice in the presence of GE crops, because consumers are demanding
a “reasonable degree of choice between GMO and non GMO derived products, keeping in mind that different modes of
agriculture are not naturally compartmentalised.” The study was done for three crops, for which GM crops are available
in the European Union, oil seeds for seed production, maize for feed production and potatoes for consumption. The
conclusion reached was that “it is virtually impossible to have coexistence with thresholds in the region of 0.1 % in any
of the scenarios concerned”. A copy of the summary of the findings of the report of the European Union titled “Coexistence
in European Agriculture” is attached to this Writ petition as Annexure P 40.
68.
29
The Right To Choose: Farmer and Consumer Choices
That it is clear from the evidence provided, of the many ways that contamination does take place, that for India, the only
way to safeguard and implement a moratorium on the release of any GMO into the environment, until adequate biosafety
tests demonstrate safety beyond reasonable doubt, is with concurrent mandatory labelling for “no GM content” for
imports sourced from countries which produce GM crops and foods. The route for example to the contamination of
India’s seed stock, will be through the import of seeds for planting and via bulk commodity imports which are made up
of viable seed.
71.
We eat for nourishment and vitality and the food we eat is made into our bodies. Our health and nutrition are inextricably
tied in with seed quality, variety and abundance. This is what farmers have traditionally provided and in India, continue
to provide. With GE foods and crops, the fundamental right to make food and health choices is removed entirely from
the ambit of choice. This is so because transgenic contamination is irreversible. Therefore, both the moratorium and
labelling must be concurrent mandatory requirements. There are other very important reasons why consumers need to
know what they are eating. (a)They need to know, so they know what to avoid. (b)Food allergies are a serious concern.
There
(c)
are also religious and ethical concerns of particular relevance to India, since genes from animal sources are
being incorporated into food products, including human genes into rice.
72.
That, farmers have the right to save seed for sowing in the next season, which a patent-based regime of GM seeds,
controlled by multi-national biotech corporations, will effectively deny. That, farmers also have the right to respond to
consumer choice and produce food according to what the market demands. It is pertinent in this connection that the
India Economic Survey 2004-5 asked the question whether India can afford to grow GM crops. Referring to the exports
of oil cake for feed, the survey said that its growth was sustained and increased on account of its non-gm content. The
animal feed market is enormous and demand is growing for non-gm soy and cottonseed cake. Most of the world’s 70
million acres of GM crops is for this purpose and this market is already being seriously threatened by the option of nongm feed. India is one of the few countries that can meet this demand. It is for this reason that the Parliamentary Standing
Committee on Agriculture, on 25 April 2003 asked the Union Government to re-evaluate the economic viability of Bt.
Cotton. A copy of the news report titled “Bt. Cotton remains highly controversial in india” dated 01.05.2003 is attached
to this Writ Petition as Annexure P 41.
73.
That Indian farmers therefore, have as never before, an economic opportunity and comparative advantage created by
the GM fiasco, to respond to a domestic market, as well as a robust and expanding global market demand for organic
products including medicines, which are critical for Indian systems of medicine, as well as non-gm conventional crops
of food and feed, because the world does not want to eat GM food. This choice must be retained as a fundamental right
and for better farming prospects and livelihoods. The key organic standards by definition mean non-GM. Pressure is
growing as demonstrated above, for animal feed to likewise, be non-GM. Without a moratorium and mandatory labelling
as defined, farmer rights to save seed and choose what they want to grow will be effectively denied, along with the
unravelling of India’s agriculture, which is essentially based on small holdings: and India’s food security will be threatened.
American farmers are in a serious crises and the process by which GM has de-stabilised farming in the USA is adequately
described in the press note of the ISIS titled “Monsanto vs Farmers” dated 28.04.05 attached to this Writ petition as
Annexure P42. The recent response of Renate Kuenastof, the German Consumer Protection Minister, during an interview
she gave to Spiegel International in the context of the banned US GM com variety into Germany, is key evidence of and
an accurate pointer to the trends in consumer choice round the world in so far as GM food and feed is concerned and
how she sees Germany’s role in responding to this choice:
“Organic farming has already created 150,000 jobs in Germany alone. A study by Ernst & Young showed that there are
only 2,000 jobs in the sector of agricultural genetic engineering. And our clear-cut requirements — security, labelling,
and traceability — have already created an economic advantage, especially in the export sector. Throughout the world,
consumers are weary of genetically modified products. Producers know this. For many, abstaining from these products
is already paying off’. Reference to this may be made from the interview with the German Minister posted as press note
dated 18.04.2005 attached to this Writ petition as Annexure P43.
74
That the Indian Government has made various moves to import GM products into India. That various processed foods
with GM ingredients like US com, Canadian mustard etc are already available in India. A news report of the statement
of Mr. Sharad Pawar, the Union Agricultural Minister on the move to import GM oil seed titled “India may import GM
oil seeds” dated 18.01.2005 is attached as Annexure P 44 to this Writ Petition. The Government is also reported to be
planning to import 5.2 million tonnes of vegetable oil in the year ending in 2005. Dealers estimate that soy oil imports
this year will total 30-35% of the total edible shipments, including 350,000 to 400,000 tonnes from Argentina and
Brazil, in April and May alone. A copy of the news report in the Economic Times titled “Soya oil imports eat into
demand for palm oil” dated 05.04.2005 is attached to this Writ Petition as Annexure P45. It is very clear that the
Government has not only ignored concerns of Biosafety, but also has no plans to require, that only GM free products
will be allowed into the country. The Soy from Argentina based on the evidence provided in this Suit will by definition
be either GM Soy or contaminated soy. This is because. In a short space of a few years, Argentina has converted 50% of
its arable land (11.6 million acres) to growing GM soy, is without regulatory safety testing or labelling mechanisms
(The US and Argentina together account for 84% of the GM crops worldwide). India has no scientific facilities to test
for GM contamination levels, especially for those that do not survive the development process, as they cannot be tested
with PCR-based tests (polymerase chain reaction).
70.
30
That GE projects have been undertaken on more than twenty crops in the country including Brinjal, Cabbage, Caulifower,
Blackgram, Chickpea, Groundnut, Muskmelon, Rice, Okra, Cotton, Potato, Sorghum, Sugarcane, Tobacco, Sunflower,
Tomato, Com/Maize, Wheat, Chilli and Banana. An inclusive list of such GE foods and crops are attached to this Writ
petition as Annexure P 46.
76
That all these aforementioned projects in India have been carried without any meaningful examination of the Biosafety
implications of their release.. The statutory framework for the regulation of such release is provided by “Rules for the
Manufacture, Use, Import, Export and Storage of the Hazardous Micro-organisms, Genetically Engineered Organisms
or Cells, 1989” under the Environment Protection Act, 1986. That no guidelines or practice have been stipulated by the
GEAC, the body responsible for clearances, to conduct independent scientific examination of the Biosafety implications
of the release of GMOs. A copy of the “Rules for the Manufacture, Use, Import, Export and Storage of the Hazardous
Micro-organisms, Genetically Engineered Organisms or Cells, 1989” is attached to this Writ Petition as Annexure P
47.
77
According to Dr. P. M. Bhargava, the world eminent bio-scientist, who also founded the Centre for Cellular and Molecular
Biology based in Hyderabad, the following tests are absolutely necessary for any meaningful Biosafety risk assessment
before the release of any GMO into the environment:
• Molecular characteristics of the GMO with complete information on the site and sequence of every genetic change
that has occurred in the GMO.
• Details of the technology, with all steps clearly stated, that was used to effect the above-mentioned genetic changes
(intentional and unintentional).
• Automated karyotyping and gross chromosomal analysis.
• Details of plasmids, transposons or insertion elements introduced.
• Properties of the products of gene(s) considered to be introduced (allerginicity: toxicity; will it lead to resistance to
a micro-organism or pest?).
• Growth characteristics of the GMO (comparison with the starting host organism).
• Nutrient, soil, climatic and other requirements of the GMO (comparison with the host or wild type).
• Nutritional and toxicity studies with the organism or its product that may be intended to be used as food.
• Dispersal patterns of the GMO where applicable, and comparison with those of the starting organisms.
• Gene flow from the GMO under normal ecological conditions.
• If the GMO is a plant, the viability of hybrids (comparison as above).
• If the GMO is a plant, its biomass productivity.
• Gross chemical composition of the GMO.
• Details of any structural or surface changes in the GMO.
• Impact on ecology in controlled field trials.
• Reproductive inferences if any.
• The manner and mode of the use of the GMO (When and where will it be grown, harvested and processed? If it is to
be grown in the containment facility, what are the chances of its escape?)
A copy of Dr. Bhargava’s article, “GMOs: Need for Appropriate Risk Assessment System” dated April 13 2002, is
attached to this Writ Petition as Annexure P 48. That most of these aspects were not considered for the examination of
safety risks before any release of the aforementioned GMOs in India.
78.
Thus what is required in a proper regulatory regime for approval of GMOs, is the following:
a.
The regulatory authorities must prepare a list of the biosafety tests that are required, for each GMO that is to be
examined.
b.
The above list of tests should be prepared in a transparent manner with an opportunity for independent experts and
citizens to have their say, before the safety protocol is finalised.
c.
That independent expert bodies and scientists must carry out these tests and adequate GM materials must be provided
by the biotech companies, to the scientists, to enable them to carry out the necessary tests.
d.
The test results must be open to public scrutiny and independent experts must get an opportunity to respond. The data
given out must be in a manner that can be used by the scientific community.
79.
Instead of this, however, the current practice is the following: The commercial company itself is asked to do some
testing, the adequacy of which has not been put up for public scrutiny. The test results are also not available for public
scrutiny and to top it all most of the testing is done by the same biotech company that has a commercial interest in the
approval of the GMO. This is entirely without logic and is a clear conflict of interest.
80.
That even for technologies which have been tried and tested, and found to be far safer than Genetic Engineering, for
instance Hydro-electric projects, the statute mandates a public notice and public hearing before an Environmental
Impact Assessment is completed. Hence, it is arbitrary and unreasonable not to have a mandatory public notice and
Public Hearing before approvals for the release of GMOs are granted. That the rules do not provide public access to
such critical information, or allow public participation in decision making processes, and are in direct contravention of
the ruling of this Hon’ble Court in Research Foundation for Science, Technology and Ecology v Union of India [2003
(9) SCALE 303]:
’’Clearly the Right to Information and Community Participation necessary for protection of Environment and Human
Health is an inalienable part of Article 21 and is governed by the accepted environment principles. The Government and
75
31
the authorities have to motivate the public participation by formulating the necessary programmes".
However, instead of strengthening the regulatory system, for such an inherently hazardous technology, the Department
of Biotechnology, of the GOI. has issued a draft National Biotechnology Development Strategy that proposes to weaken
it in order to promote the industry. A copy of the draft strategy of DBT is attached to this Writ Petition as Annexure P
49 . Responding to this, a large and prominent group of people representing independent scientists, farmer groups,
NGOs, organisations, and concerned citizens have signed on a detailed statement, which severely criticises the DBT for
a strategy paper that completely mortgages public interest, public safety and the environment, to the commercial interests
of Biotech Corporations. A copy of this letter is attached to this Writ Petition as Annexure P 50.
82.
This Writ petition is filed on the following among other
81.
GROUNDS
Release of GMOs into the environment without a Protocol and a transparent, independent, credible and publicly accessible
system of testing of the GMOs for Biosafety and environmental hazards is a violation of the Precautionary Principle.
This Hon’ble Court had declared in A.P.Pollution Control Board versus M.V. Nayudu [1999 (3) SCC 718]:
“There is nothing to prevent decision makers from assessing the record and concluding there is inadequate information
on which to reach determination. If it is not possible to make a decision with ‘some’ confidence, then it makes sense to
err on the side of caution and prevent activities that may cause serious or irreparable harm. An informed decision can be
made at a later stage when additional data is available or resources permit further research."
As a result of more than ten years of commercialisation of this technology, ample evidence has emerged from many
countries to raise serious doubts about its safety for human and animal health and the environment. That this evidence
has been placed on record by independent scientists as well as regulators despite active efforts by the GM industry not
only to stifle such research, but also to systematically dismantle regulatory mechanisms in various important countries
in the world including India. Such evidence has firmly established the potential impacts of the hazards on the biodiversity.
Since genetic manipulations are essentially irreversible, there is a critical need for India to get it right the first time that
a GMO is released into the environment.
B)
That any release of GMOs into the environment without the requisite scientific testing for bio-safety concerns would be
unconstitutional. Since enumerated evidence clearly demonstrate that release of GMOs have, at the very least, the
potential to cause grave and irreversible harm to health of human beings and ecology, such indiscriminate releases
would violate the fundamental right to health and environment under Art. 21 of the Constitution. This Hon’ble Court
has held in a number of cases that the Right to life under Art. 21 includes the right to a healthy and safe environment.
This Hon’ble Court in Virender Gaur v. State of Haryana [1995 (2) SCC 577] had held that:
“Article 21 protects the right to life as a fundamental right Enjoyment of life... including the right to live with
human dignity encompasses within its ambit the protection and preservation of environment, ecological balance free
from pollution of air and water, sanitation, without which life cannot be enjoyed. Any contra acts or actions would
cause environmental pollution. Environmental, ecological, air, water pollution etc. should regarded as amounting to
violation of Article 21.’’ That it is amply clear that the Rules notified in the year 1989 and the Guidelines framed
thereunder are not sufficient to provide requisite safeguards to the Environment as well as Human and Animal
health, and have therefore, rendered themselves unconstitutional. These rules and guidelines must be modified so
they are consonant with the present scientific knowledge and experience, as well as the requirements under the U.N.
Convention on Biological Diversity (CBD), 1992 and the Cartagena Protocol, the binding international instrument
in the realm of Biosafety. A failure to take into account such overwhelming scientific evidence that cast doubts on the
safety of the technology would be arbitrary and unreasonable.
C)
It has been held by this Hon’ble Court in the case of Gramophone Company of India v. B.B. Pandey [ 1983 (2) SCC 534]
and Visakha v. State of Rajasthan [1997 (6) SCC 241] that international treaties signed by India can be read into the
domestic law of the country provided that they are not in conflict with any statutory provisions in the country. The U.N.
Convention on Biological Diversity (CBD), 1992 require that the contracting parties shall domestically regulate or
manage the risks associated with the use and release of LMOs resulting from Biotechnology and likely to have adverse
environmental impacts that could affect, the conservation and sustainable use of biodiversity, and the risks to human
health [A. 8(g)]; introduce appropriate procedure to require impact assessment of proposed projects likely to have
significant adverse effects on biodiversity and to allow public participation in the procedure where appropriate [A. 14].
Further, Article 19 (3) of the CBD had urged parties to consider the need for, and modalities of, a protocol setting out
appropriate procedures in the field of the safe transfer, handling and use of any LMOs that may have adverse effect on
the conservation and sustainable use of bio-diversity. Such releases of GMOs may result in irreversible damage to
Biodiversity with grave implications for food security and devastation of the livelihood of farmers; especially since
India being the centre of origin/ diversity of major food crops including rice. Since India is a signatory to the CBD and
its provisions are not in conflict, but in fact in aid of the domestic laws, India is bound by its provisions.
D)
That India is a signatory and is bound by the provisions of Cartagena Protocol, the binding International agreement on
the matter of Biosafety. The Protocol aims to ensure adequate levels of protection in the field of safe transfer, handling
and use of LMOs, (Living Modified Organisms) that may have adverse effects on the conservation and sustainable use
of biodiversity, taking into account the risks to human health. The protocol, under A.2(2), stipulate parties to ensure that
the development, handling, transport, use, transfer, and release of LMOs is undertaken in a manner that prevents or
A)
32
reduces risk to biodiversity. Further, A. 10 (6) (Precautionary Principle) stipulates that a lack of scientific certainty due
to insufficient relevant scientific information and knowledge regarding the extent of potential adverse effects shall not
prevent the contracting party from taking an appropriate decision, to avoid/ minimise potential adverse effects. According
to Para 9(h) of the Annex III of the Protocol, the parties have to consider information on the location, geographical,
climatic and ecological characteristics, including relevant information on biodiversity and centres of origin of the likely
potential receiving environments. Annex III of the protocol includes, inter alia, the general principles of risk assessment:
(i) Risk assessment should be carried out in a scientifically sound and transparent manner, and can take into account
expert advice, as well as guidelines developed by relevant international organisations. According to Art. 26 of the
Protocol parties may account for socio-economic considerations arising from the impact of LMOs on biodiversity
conservation and sustainable use, specially with regard to value of biodiversity to indigenous and local communities.
E)
That the Cartagena Protocol also stipulates that parties shall consult the public in decision-making processes regarding
LMOs [Art. 23 (3)]; and shall make all relevant decisions available to the public, albeit respecting confidential information.
Further, the Cartagena Protocol through Art 21 (6) stipulates that information about a summary of the risk assessment
cannot be made confidential. It is clear from the aforementioned provisions of the Cartagena Protocol that India is
required to not only put such a safety protocol in place, but also that such a protocol would mandate openness, transparency
and public participation. The decision to release GMOs in India without any access to the public, information regarding
the kind of safety tests conducted, the results of the test and an opportunity to the public to critique the tests is a
violation of this provision of the Cartagena Protocol.
F)
That Article 21 of the Constitution also mandates that a public notice and public hearing be held in tandem with
Scientific Risk Assessment before any release of such GMOs. Even for technologies that have been tried and tested, and
found to be far safer than Genetic Engineering, for instance hydro-electric projects, the statute mandates a public notice
and public hearing before an Environmental Impact Assessment is completed. Hence, it is arbitrary and unreasonable
not to have a mandatory public notice and Public Hearing before clearances for such releases are granted. Further, such
public notice and mandatory public hearing would facilitate proper and transparent functioning of regulatory bodies
responsible for risk assessment and clearance. The existing rules do not provide public access to such critical information,
or allow public participation in decision-making process. Hence, they are in violation ve of Article 21 as held by this
Hon’ble Court in Research Foundation for Science, Technology and Ecology v Union of India [2003 (9) SCALE 303]:
“Clearly the Right to Information and Community Participation necessary for protection of Environment and Human
Health is an inalienable part of Article 21 and is governed by the accepted environment principles.”
G)
To ensure the effective functioning of the Protocol, and a meaningful employment of the precautionary principle it is
important that a labelling mechanism of GM food and GM products are put in place. It also requires that the import of
any biological organism, food or animal feed is prohibited unless they have been tested and certified and labelled to be
GM free. The Rules for Manufacture, Use, Import, Export and Storage of Hazardous Micro Organisms, Genetically
Engineered Organisms or Cells, 1989 mandate specific permission of the GEAC before import of any substances or
products which contain GMOs etc. GM products and food are wantonly imported without any regulation whatsoever by
the GEAC. There are no facilities to ascertain the transgenic nature of the imported food and food products, before such
goods are allowed inside the country; this is especially important in cases where such imports are from countries like
Argentina and the U.S.A. There are no legal requirement in these countries to have GM labelling. Secondly, the reckless
and wanton release of GMOs in various commercial crops, have genetically contaminated even non GM products.
Hence, it would be only reasonable to conclude that products from such countries, where there is a history of wanton
release, and where exist no labelling mechanism, are GM products or at least contaminated by GMOs. For instance in
the case of Argentina, by the year of 2002, 11.6 million acres, which is half of Argentina’s arable land was planted with
Soya, almost all of it GM. There would be very little chance that the Soya imported from Argentina would be GM free.
Enforcement agencies in this country are under an obligation to strictly enforce environmental laws. Hence, for such a
strict implementation of the said rules would require (i) a strict implementation of a ban on import of products that are
not labelled as GM free and (ii) an immediate blanket ban on products from such countries that wantonly release GMOs
and have no effective internal labelling mechanisms.
H)
Allowing GM food and crops to be sold in India without a requirement of labelling violates the fundamental right to
choose. Such action violates the right of a producer to choose non- GM, and violates the right of consumer to chose to
consume non-GM. Such a right is inherent in Article 21 of the Constitution.
83.
The petitioners have not filed any similar petition in this Court earlier.
33
PRAYER
The petitioners therefore, pray that in the facts and circumstances of the case, this Hon’ble Court may be pleased to issue
appropriate writs or directions to:
A)
Direct the Union of India not to allow any release of GMOs into the environment by way of import, manufacture, use
or any other manner unless the following precautions are taken.
(a) a protocol for all the required bio-safety tests of the GMOs proposed to be released is prepared by the GEAC after
processes of public notice and public hearing.
(b) The GMO has been subjected to all the required bio-safety tests, prepared on the basis of the required Biosafety
tests on the basis of the above protocol, by agencies of independent expert bodies, and results of which have been
made public.
B)
Direct the Union of India to ban the import of any biological organism, food or animal feed unless they have been
certified and labelled to be GM free, by the exporting country.
C)
Direct the Union of India to put in place rules to ensure that it shall be compulsory for any dealer or grower selling
GMOs to label them as such.
D)
Pass such other and further orders as this Hon’ble Court may deem fit and proper in the facts and circumstances of the
case.
PETITIONERS
Through
Prashant Bhushan
(counsel for the petitioners)
34
IN THE SUPREME COURT OF INDIA
(ORIGINAL CIVIL WRIT JURISDICTION)
I. A. No. /2005
in
Civil Writ Petition NO._____ OF 2005
IN THE MATTER OF:
...Petitioners
Aruna Rodrigues and Others
VERSUS
..Respondents
UNION OF India and Others
APPLICATION FOR EX-PARTE INTERIM STAY ON BEHALF OF THE PETITIONERS
To,
The Honourable Chief Justice and his companion judges of the Supreme Court of India: -—
Most respectfully sheweth:
1)
The petitioners have filed the accompanying writ petition seeking to put in place a protocol that shall mandate the
scientific examination of all relevant aspects of Biosafety before such release. The petitioners are concerned about the
absence of proper scientific examination of Biosafety concerns in the country. There is an increasing body of scientific
knowledge and evidence, which points to the existence of serious hazards, and therefore safety concerns for human
health and the environment. The reckless release of GMOs into the environment also threatens the agrarian structure of
the country, will lead to the contamination of the food chain and detrimentally affect biodiversity, in an irreversible and
lasting manner. It is submitted in the Writ Petition that this is a fit case to employ the Precautionary Principle, as
enunciated by this Hon’ble Court in a catena of cases including M.V. Nayudu[1999 (2) SCC 718]. In view of the grave
and irreversible harmful impacts resulting from the release of GMOs into the environment, the Writ petition pray for a
moratorium on the release of any GMOs into the environment until a comprehensive protocol for all required Biosafety
tests of the GMO proposed to be released is put in place, under the regulatory and monitoring framework of the Rules
for Manufacture, Use, Import, Export and Storage of Hazardous Micro Organisms, Genetically Engineered Organisms
or Cells, 1989. The Writ petition also prays for a labelling mechanism to ensure that the moratorium on the release of
any GMO into the environment is safeguarded and effective. Such a mechanism is also necessary to protect the rights
of agriculturists and consumers to grow and consume GM-ffee crops. The petitioners crave leave to refer to and rely
upon the content of the accompanying writ petition for the purpose of this application.
2)
From the facts and circumstances mentioned in the petition it is clear that the petitioners have a very strong prima facie
case and every hope of succeeding in this Hon’ble Court. That various moves to import GM products into the country
have been mentioned in the writ petition. The statement of Mr. Sharad Pawar, the Union Agricultural Minister on the
move to import GM oil seed dated 18.01.2005 is attached to the Writ Petition. The Government is also reported to be
planning to import 5.2 million tonnes of vegetable oil in the year ending in 2005. Dealers estimate that soy oil imports
this year will total 30-35% of the total edible shipments, including 350,000 to 400,000 tonnes from Argentina and
Brazil, in April and May alone. The Soy from Argentina based on the evidence provided in the writ petition will by
definition be either GM Soy or contaminated soy. This is because, in a short span of a few years, Argentina has converted
50% of its arable land (11.6 million acres) to growing GM soy and is without regulatory safety testing or labelling
mechanisms (The US and Argentina together account for 84% of the GM crops worldwide). India has no scientific
facilities to test for GM contamination levels, especially for those that do not survive the development process, as they
cannot be tested with PCR-based tests (polymerase chain reaction). It is very clear that the respondents have not only
ignored concerns of Biosafety, but also have no plans to require, that only GM free products will be allowed into the
country.
3)
Such imports are ex- facie violative of the Rules for Manufacture, Use, Import, Export and Storage of Hazardous Micro
Organisms, Genetically Engineered Organisms or Cells, 1989. The Rules mandate specific permission of the GEAC
before import of any substance or product which contain GMOs etc. There are no facilities to ascertain the transgenic
nature of the imported food and food products, before such goods are allowed inside India; this is especially important
in cases where such imports are from countries like Argentina and the U.S.A. There are no legal requirement in these
countries to have GM labelling. Secondly, the reckless and wanton release of GMOs in various commercial crops, have
genetically contaminated even non GM products. Hence, it would be only reasonable to conclude that specific produce
from such countries, where there is a history of wanton release of GMOs, and where exist no labelling mechanism, are
GM produce or at least contaminated by GMOs. For instance in the case of Argentina, by the year of 2002, 11.6 million
acres, which is half of Argentina’s arable land was planted with Soya, almost all of it GM. There would be very little
chance that the Soya imported from Argentina would be GM free. Enforcement agencies in our country are under an
obligation to strictly enforce environmental laws. Hence, for such a strict implementation of the said rules would
35
require (i) a strict implementation of a ban on import of products that are not labelled as GM free and (ii) an immediate
blanket ban on products from such countries that wantonly release GMOs and have no effective internal labelling
mechanisms.
4)
That apart from the aforementioned mandatory requirement under the Rules such imports seriously affect the health
and safety of citizens of this country. There is a grave danger of seed contamination arising out of such imports.
PRAYER
It is therefore prayed that during the pendency of the accompanying writ petition, this court may be pleased to:
A)
Direct the respondents not to allow agricultural imports until they are certified and labelled to be GM free,
B)
Order, ex-parte, a moratorium of any further release of any GMO into environment till such time a protocol in consonance
with Prayer A (a) of the Writ petition is put in place, and
C)
Pass any other orders as this court may deem fit and proper.
PETITIONERS
Through
Prashant Bhushan
(counsel for the petitioners)
36
Correspondence may be addressed to
arunarod@gmail.com
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