The whole paradigm of the genetic engineering technology is based on a misunderstanding

http://www.vancouversun.com/health/Genetically+modified+food+rapped/8308415/story.html

 Vancouver Sun April 29, 2013

Dr. Thierry Vrain Courtenay

 [ re:  Genetically modified food is welcome innovation by Lorne Hepworth President, CropLife Canada

I retired 10 years ago after a long career as a research scientist for Agriculture Canada. When I was on the payroll, I was the designated scientist of my institute to address public groups and reassure them that genetically engineered crops and foods were safe.

I don’t know if I was passionate about it but I was knowledgeable.  I defended the side of technological advance, of science and progress.

I have in the last 10 years changed my position.  I started paying attention to the flow of published studies coming from Europe, some from prestigious labs and published in prestigious scientific journals, that questioned the impact and safety of engineered food.

I refute the claims of the biotechnology companies that their engineered crops yield more, that they require less pesticide applications, that they have no impact on the environment and of course that they are safe to eat.

There are a number of scientific studies that have been done for Monsanto by universities in the U.S., Canada, and abroad.  Most of these studies are concerned with the field performance of the engineered crops, and of course they find GMOs safe for the environment and therefore safe to eat.

There is, however, a growing body of scientific research – done mostly in Europe, Russia, and other countries – showing that diets containing engineered corn or soya cause serious health problems in laboratory mice and rats.

We should all take these studies seriously and demand that government agencies replicate them rather than rely on studies paid for by the biotech companies.

The Bt corn and soya plants that are now everywhere in our environment are registered as insecticides. But are these insecticidal plants regulated and have their proteins been tested for safety?  Not by the federal departments in charge of food safety, not in Canada and not in the U.S.A.

There are no long-term feeding studies performed in these countries to demonstrate the claims that engineered corn and soya are safe.  All we have are scientific studies out of Europe and Russia, showing that rats fed engineered food die prematurely.

These studies show that proteins produced by engineered plants are different than what they should be. Inserting a gene in a genome using this technology can and does result in damaged proteins.  The scientific literature is full of studies showing that engineered corn and soya contain toxic or allergenic proteins.

Genetic engineering is 40 years old. It is based on the naive understanding of the genome based on the One Gene – one protein hypothesis of 70 years ago, that each gene codes for a single protein.  The Human Genome project completed in 2002 showed that this hypothesis is wrong.

The whole paradigm of the genetic engineering technology is based on a misunderstanding.  Every scientist now learns that any gene can give more than one protein and that inserting a gene anywhere in a plant eventually creates rogue proteins.  Some of these proteins are obviously allergenic or toxic.

Dr. Thierry Vrain Courtenay

© Copyright (c) The Vancouver Sun

GM Crops Won’t Solve India’s Food Crisis

http://blogs.wsj.com/indiarealtime/2013/09/22/gm-crops-wont-solve-indias-food-crisis/

By Shanoor Seervai

Adil Bharucha
Dilnavaz Variava.

Earlier this month, India’s Parliamentpassed a bill aimed at delivering subsidized food to around 800 million people. While well-intentioned, the law is expensive and has raised questions about whether India produces enough food to meet demand.

Proponents of genetically modified food say GM technology will boost production to meet India’s food requirements, but critics argue that it is unsustainable, and that the main challenge is not one of production but distribution.

Dilnavaz Variava doesn’t believe that GM food will address India’s food crisis. She is honorary convener for consumer issues for the Alliance for Sustainable and Holistic Agriculture, an alliance of farmers, scientists, economists, non-governmental organizations and citizens who advocate for ecologically and economically sustainable agriculture.

Ms. Variava has worked for a range of organizations, including the World Wildlife Fund India, where she was chief executive, and the Bombay Natural History Society. She has also served on several federal government committees as well as one in Maharashtra for the development of agriculture.

Ms. Variava spoke with The Wall Street Journal’s India Real Time about GM food in India. Edited excerpts:

The Wall Street Journal: Parliament’s passage of the Food Security Bill reflects the urgency of addressing the food security challenge. Would genetically modified food do this?

Dilnavaz Variava: India has enough food grain — almost two-and-a-half times the required buffer stock — and yet 200 million Indians go hungry. The problem of sufficiency is not one of production, but of economic and physical access, which the Food Security Bill attempts to address. Poverty, mounds of rotting food grain, wastage and leakages in the Public Distribution System are the real causes of food insecurity. GM food cannot address this.

WSJ: Is there evidence from other countries that GM food improves food security?

Ms. Variava: Macroeconomic data for the largest adopters of GM food indicate the opposite. In the U.S., food insecurity has risen from 12% in pre-GM 1995 to 15% in 2011. In Paraguay, where nearly 65% of land is under GM crops, hunger increased from 12.6% in 2004-06 to 25.5% in 2010-12. In Brazil and Argentina, GM food has not reduced hunger. In any event, GM does not increase yields, as the Union of Concerned Scientists established through a review of 12 years of GM in the U.S.

WSJ: How does GM food differ in quality from non-GM food?

Ms. Variava: About 99% of all GM crops have either one or both of two traits that make food unsafe: a pesticide-producing toxin (Bt) present in every cell of the plant and a herbicide tolerant trait that enables the plant to withstand herbicides used to kill weeds. While food safety regulators have cleared GM foods as safe, many independent scientists disagree. Their studies point to health risks: allergies, cancer, reproductive, renal, pancreatic and hepatic disorders. They say regulators give safety assurances based on studies which the GM industry conducts for a maximum period of 90 days on lab rats. This corresponds to a human life span of less than 15 years, which is too short for long-term health effects such as organ damage or cancer to manifest.

WSJ: In India, why did the Supreme Court-appointed Technical Expert Committee call for a moratorium on field trials of GM crops in July?

Ms. Variava: The TEC majority report by five scientists from the fields of molecular biology, toxicology, nutrition science and biodiversity called for an indefinite moratorium on field trials, stating that ‘the regulatory system has major gaps.’ They concluded that the quality of information in several GM applications was far below that necessary for rigorous evaluation. They recommended a moratorium on field trials for Bt in food crops until there was more definitive information on its long-term safety, and for crops for which India is a center of origin/diversity. They also recommended a ban on the release of ‘herbicide tolerant’ crops, which are inadvisable on socioeconomic grounds in a country where farms are small and weeding provides income to millions of people.

WSJ: Does the report take food security into account?

Ms. Variava: Yes, the report notes that although India has a food surplus in production terms, one-third of the world’s malnourished children live here. It does not see GM as the answer to this.

WSJ: Does it make sense to ban even field trials of GM food?

Ms. Variava: Field trials involve open-air releases of GM. Given that rice and wheat survived their supposed destruction after field trials in U.S. and caused import bans leading to losses of millions of dollars to U.S. farmers, field trials are not harmless scientific experiments. Banning field trials makes sense until a strong biosafety and liability regime is in place.

WSJ: Isn’t India taking regulatory steps to promote the safe use of modern biotechnology, for example with the proposed Biotechnology Regulatory Authority of India Bill?

Ms. Variava: The BRAI Bill appears to be promoting rather than regulating GM. It proposes a single window clearance, with power to clear GM crops dangerously concentrated in the hands of just five people. All its other committees are merely advisory. It will overrule the constitutional powers of state governments over agriculture and circumscribe the Right to Information and legal redressal. It does not mandate long-term studies, assure labeling and post-release health monitoring, or have adequate punitive provisions. There is no mandatory consideration of safer alternatives or preliminary need assessment based on socioeconomic factors. GM crops are input intensive, requiring adequate fertilizers and timely irrigation. With over 70% of India’s farmers being small and impoverished, and 65% dependent on the vagaries of the monsoon, GM is a high cost, high debt and high risk technology for India. The BRAI Bill does not ensure caution for this unpredictable and irreversible technology.

WSJ: What would economically and environmentally sustainable agriculture for India look like?

Ms. Variava: A World Bank commissioned study found that agro-ecological approaches and not GM provide the best solution to the world’s food crisis.In March 2011, the U.N. Special Rapporteur on the Right to Food also reported that small scale farmers could double food production within 5 to 10 years by agro-ecological farming.

An Associated Chambers of Commerce and Industry of India study for West Bengal found that organic farming could increase net per capita income of a farmer in the state by 250%, lead to wealth accumulation of 120 billion rupees ($1.9 billion), generate exports worth 5.5 billion rupees ($87 million) and create nearly two million employment opportunities over five years.

In Andhra Pradesh, Community Managed Sustainable Agriculture was started in 2005-06. It promoted ecologically and economically sound agriculture with state government and World Bank support. About 10,000 villages with one million farmers practice non-pesticidal management on over 3.5 million acres. Pesticide use in the state has decreased by more than 45%. Net income increases were 3,000 to 15,000 rupees per acre, in addition to meeting a household’s food needs.

Shanoor Seervai is a freelance writer based in Bombay. Like India Real Time on Facebook here and follow us on Twitter @WSJIndia.

Nip this in the bud

http://www.thehindu.com/opinion/lead/nip-this-in-the-bud/article5012989.ece

Genetically modified crops, whose ecological effects are irreversible, could become a mainstay of Indian agriculture thanks to collusion between the government and the biotech industry

The final report of the Supreme Court-appointed Technical Expert Committee (TEC) on field trials of genetically modified crops is packed with revelations on what is wrong with institutional governance and regulation in India when it comes to GMOs (genetically-modified organisms). The report’s release late last month came days before biotech giant Monsanto decided not to submit any further applications for GMOs to the European Union; a decision forced by non-acceptance on scientific grounds and rejection by civil society.

Remarkable consensus

The TEC Final Report (FR) is the fourth official report which exposes the lack of integrity, independence and scientific expertise in assessing GMO risk. It is the third official report barring GM crops or their field trials singularly or collectively. This consensus is remarkable, given the regulatory oversight and fraud that otherwise dog our agri-institutions. The pervasive conflict of interest embedded in those bodies makes sound and rigorous regulation of GMOs all but impossible.

The four reports are: The ‘Jairam Ramesh Report’ of February 2010, imposing an indefinite moratorium on Bt Brinjal, overturning the apex Regulator’s approval to commercialise it; the Sopory Committee Report (August 2012); the Parliamentary Standing Committee (PSC) Report on GM crops (August 2012) and now the TEC Final Report (June-July 2013). The TEC recommends that in general, there should be an indefinite stoppage of all open field trials (environmental release) of GM crops, conditional on systemic corrections, including comprehensive and rigorous risk assessment protocols. The report includes a specific focus on Bt food crops.

It also calls for a ban on the environmental release of any GMO where India is the centre of origin or diversity. It also says herbicide tolerant (HT) crops, targeted for introduction by the regulator, should not be open field-tested. The TEC “finds them completely unsuitable in the Indian context as HT crops are likely to exert a highly adverse impact over time on sustainable agriculture, rural livelihoods, and environment.”

The PSC report which preceded that of the TEC was no less scathing: it was “ […] convinced that these developments are not merely slippages due to oversight or human error but indicative of collusion of a worst kind […] field trials under any garb should be discontinued forthwith”.

Sound science and factual data form the basis of the TEC decisions. There is practical and ethical sense too. The TEC insists that the government bring in independence, scientific expertise, transparency, rigour and participative democracy into GMO regulation and policy. The accent is on bio-safety.

Assessment and performance

GMOs produce “unintended effects” that are not immediately apparent and may take years to detect. This is a laboratory-based, potent technology, described by WHO as “unnatural.” The risk assessment (RA) protocols for GMOs are an evolving process to be performed by qualified and experienced experts who must be responsive to the latest scientific knowledge. The fact is that GMOs involve us in a big experiment in the idea that human agencies can perform adequate risk assessment, which, it is expected, will deliver safety at every level/dimension of their impact on us — the environment, farming systems, preservation of biodiversity, human and animal safety.

After 20 years since the first GM crop was commercialised in the U.S., there is increasing evidence, not less, of the health and environment risks from these crops. Furthermore, we now have 20 years of crop statistics from the U.S., of two kinds of crops that currently make up over 95 per cent of all GM crops cultivated globally, (like Bt cotton) Bt and HT crops. The statistics demonstrate declining yields. GM yields are significantly lower than yields from non-GM crops. Pesticide use, the great “industry” claim on these GM crops, instead of coming down, has gone up exponentially. In India, notwithstanding the hype of the industry, the regulators and the Ministry of Agriculture (MoA), Bt cotton yield is levelling off to levels barely higher than they were before the introduction of Bt.

It takes roughly $150 million to produce a GMO against $1 million through conventional breeding techniques. So where is the advantage and why are we experimenting given all the attendant risks? We have hard evidence from every U.N. study and particularly the World Bank-funded International Assessment of Agricultural Knowledge and Science for Development Report, which India signed in 2008. The IAASTD was the work of over 400 scientists and took four years to complete. It was twice peer reviewed. The report states we must look to small-holder, traditional farming to deliver food security in third world countries through agri-ecological systems which are sustainable. Governments must invest in these systems. This is the clear evidence.

Conflict of interest

The response to the TEC Final Report came immediately, with the Ministry of Agriculture strongly opposing the report. The MoA is a vendor of GM crops and has no mandate for regulating GMOs. The same Ministry had lobbied and fought to include an additional member on the TEC after its interim report had been submitted. That ‘new’ member came in with several conflicts of interest, his links to the GM crops lobby being widely known. His entry was in fact a breach of the Supreme Court’s mandate for an independent TEC and provoked me to file an affidavit in the court, drawing attention to this. Oddly enough, he did not sign the final report, or even put up a note of dissent. This allowed the final report, then, to be unanimous; as indeed was the TEC’s Interim Report submitted by the original five members.

The Indian Council of Agriculture Research (ICAR) promotes PPPs (Public-Private-Partnerships) with the biotechnology industry. It does this with the active backing of the Ministry of Science and Technology. The MoA has handed Monsanto and the industry access to our agri-research public institutions placing them in a position to seriously influence agri-policy in India. You cannot have a conflict of interest larger or more alarming than this one. Today, Monsanto decides which Bt cotton hybrids are planted — and where. Monsanto owns over 90 per cent of planted cotton seed, all of it Bt cotton.

All the other staggering scams rocking the nation do have the possibility of recovery and reversal. The GM scam will be of a scale hitherto unknown. It will also not be reversible because environmental contamination over time will be indelible. We have had the National Academies of Science give a clean chit of biosafety to GM crops — doing that by using paragraphs lifted wholesale from the industry’s own literature! Likewise, Ministers in the PMO who know nothing about the risks of GMOs have similarly sung the virtues of Bt Brinjal and its safety to an erstwhile Minister of Health. They have used, literally, “cut & paste” evidence from the biotech lobby’s “puff” material. Are these officials then, “un-caged corporate parrots?”

Along with the GM-vendor Ministries of Agriculture and Science & Technology, these are the expert inputs that the Prime Minister relies on when he pleads for “structured debate, analysis and enlightenment.” The worrying truth is that these values are absent in what emanates from either the PMO or the President.

Ministries, least of all “promoting” Ministries, should not have the authority to allow the novel technology of GMOs into Indian agriculture bypassing authentic democratic processes. Those processes require the widest possible — and transparent — consultation across India. With GMOs we must proceed carefully, always anchored in the principle of bio-safety. Science and technology may be mere informants into this process. After all, it is every woman, man and child, and our animals, an entire nation that will quite literally have to eat the outcome of a GM policy that delivers up our agriculture to it: if a GMO is unsafe, it will remain irreversibly unsafe. And it will remain in the environment and that is another dimension of impact.

(The author is the lead petitioner in the Supreme Court for a moratorium on GMOs and in which case the TEC was formed. She can be reached at: arunarod@gmail.com)

Hematotoxicity of Bacillus thuringiensis as Spore-crystal Strains Cry1Aa, Cry1Ab, Cry1Ac or Cry2Aa in Swiss Albino Mice

The biosafety data submitted by Mahyco on bt cotton also carried similar results…the animal morbidity in AP, Maharashtra after feeding on bt cotton leaves also had similar symptoms….unfortunately indian scientific system never researched upon this.
http://gmoevidence.com/wp-content/uploads/2013/05/JHTD-1-104.pdf

In conclusion, results showed that the Bt spore-crystals   genetically modified to express individually Cry1Aa, Cry1Ab, Cry1Ac or Cry2A can cause some hematological risks to vertebrates, increasing their toxic effects with long-term exposure. Taking into account the increased risk of human and animal  exposures to significant levels of these toxins, especially through diet,our results suggest that further studies are required to clarify the mechanism involved in the hematotoxicity found in mice, and to establish the toxicological risks to non-target organisms,especially mammals, before concluding that these microbiological control agents are safe for mammals

The fight for your plate

http://www.hindustantimes.com/India-news/Mumbai/The-fight-for-your-plate/Article1-1099950.aspx

Smruti Koppikar, Hindustan Times  Mumbai, July 29, 2013

Imagine you have a choice of bananas – one that you have always preferred from the 200 varieties India has to offer and another engineered to give you extra iron but whose impact on your physiology is uncertain. Imagine a similar choice with your staple rice; regular rice or fortified with beta-carotene whose long-term impacts are not fully studied. Or mustard.

Conventional wisdom would have you pick the first item in every category. That’s if you knew which banana, rice and mustard in the market was the natural organism and which genetically modified. The idea of choice works when there’s information to make it.

https://i1.wp.com/www.hindustantimes.com/Images/Popup/2013/7/29_07-pg_11a.jpg?w=720

The pitched debate around genetically modified (GM) crops, including food crops, revolves around two important themes: ambiguity about long-term health and safety impacts and inadequate labelling that hinders choice. The genetically modified organism (GMO) industry – international and Indian companies – believes GM food could deliver food security to India, a line parroted by Agriculture Minister Sharad Pawar. The broad-based anti-GM coalition believes existing data is inadequate to embrace GM food and evidence of its adverse impacts is rising.

The battle is likely to get sharper, perhaps ugly, in the months ahead. There’s a clear division in Dr Manmohan Singh’s cabinet itself. “We have two senior cabinet ministers ranged on either side,” said a Congress party source, referring to environment minister Jayanthi Natarajan and Pawar, “It’s not right to link GM foods to food security.”

“Let’s be honest. Farmers don’t fund elections; rich and big companies do. Besides, we know the PM’s stand on the issue,” says Devinder Sharma, food policy analyst and anti-GM campaigner. Sharma and others like him say “a false crisis about food security is being created; the real agenda is to create a market” in India for GM foods.

https://i0.wp.com/www.hindustantimes.com/Images/Popup/2013/7/29_07-pg_11b.jpg?w=720

https://i1.wp.com/www.hindustantimes.com/Images/Popup/2013/7/29_07-pg_11c.jpg?w=720

The Technical Expert Committee (TEC) of the Supreme Court, recommended last Monday an indefinite moratorium on all field trials till a proper regulatory authority was put in place. Natarajan had announced in April that 20 food crops has been approved for field trials and trials had been initiated in cotton, corn and mustard.

While the Coalition for GM-free India urged the government to accept “the recommendations based on sound science, justice and principle of sustainability”, Monsanto spokesperson stated, “The TEC report sought to go beyond the Terms of Reference and recommendations made are discouraging of science and agriculture.”

https://i1.wp.com/www.hindustantimes.com/Images/Popup/2013/7/29_07-pg_11d.jpg?w=720

In the high-stakes battle, the role of an independent regulatory authority – to   safeguard people’s health and protect the country’s bio-diversity – becomes crucial. The dispute over GM crops these days often segues into a debate over the proposed Biotechnology Regulatory Authority of India (BRAI). “There’s the Genetic Engineering Appraisal Committee. The new regulatory authority will be under the science and technology ministry which is responsible for promoting GM technology. What’s this if not conflict of interest,” asked Sharma. However, the industry believes India’s regulatory framework is good. “India has a robust science-based regulation and regulatory process in place which is comparable to global standards,” stated the Monsanto spokesperson.

https://i2.wp.com/www.hindustantimes.com/Images/Popup/2013/7/29_07-pg_11new.jpg?w=720

This divergence of perspectives is forcing people to take sides. Politicians seem to have chosen theirs. For people to weigh in, “more honestly scientific information” about GM food impacts has to be in the public domain, said Sharma. This includes letting people know what they are consuming by adequate labelling. Cotton seed oil derived from Bt Cotton could already be in your kitchen. “Cotton seed oil contributes to domestic edible oil needs, it’s the number 1 choice in Gujarat,” admitted Monsanto spokesperson. What exactly it does to your gut is still in the realm of research. What a GM-rich diet does to health is left to your imagination.

https://i1.wp.com/www.hindustantimes.com/Images/Popup/2013/7/29_07-pg_11f.jpg?w=720

Accept expert panel report on GM crops: forum

Gargi Parsai

http://www.thehindu.com/todays-paper/tp-national/accept-expert-panel-report-on-gm-crops-forum/article4950675.ece

The report is a strong indictment of regulatory affairs: Coalition

Welcoming the recommendations of the Technical Expert Committee (TEC) on Genetically Modified crops, the Coalition for a GM-free India has urged the government to accept the report and “not come in the way of delivery of justice.”

The panel, set up by the Supreme Court in a Public Interest Litigation, has recommended in its final report that it would not be advisable to conduct any field trials in Bt transgenic crops till gaps in regulatory system are addressed.

“The report is a strong indictment of the state of regulatory affairs with regard to modern biotechnology in the country. We urge that the Central government to take the report seriously and act on it in the interests of food safety, security, and sovereignty as well as protection of environment and farm livelihoods,” the Coalition said in a letter to Prime Minister Manmohan Singh.

However, the Association of Biotech Led Enterprise – Agriculture Group (ABLE AG) that represents the industry has termed the document — though an improvement over the interim report that called for a 10-year moratorium on field trials of Bt transgenic in all food crops (those used directly for human consumption) — as “regressive and a troubled treatise” that promises to push Indian agriculture into an archaic age.

“The industry believes the TEC report, besides being incomplete, is also anti-science and anti-research and will severely dent the future of country’s farmers besides destroying the domestic private and public sector research. While improving the testing programmes is a continuous process, we do not believe that testing should be stopped in the interim,’’ said Ram Kaundinya, Chairman, ABLE AG in a press statement.

The report submitted to the Supreme Court has not been signed by R.S. Paroda, the representative of Agriculture Ministry who was inducted after the submission of the interim report last year.

“This is not surprising given the fact that Dr. Paroda’s very inclusion in the Committee was controversial and objectionable — his organisation receives funding from biotech majors like Monsanto and Mahyco — and this constitutes a clear conflict of interest. It is ironical that even this court-appointed committee has had to face such a conflict of interest situation, given that this has been the case with almost all GM-related issues in India so far,” the Coalition’s letter said.

The TEC’s comments with regard to bio-safety dossiers that were approved by the current biotechnology regulator is a scathing indictment of the failings of the existing regulatory regime, the Coalition noted.

The TEC could not find any compelling reason for India to be the first country, where Bt transgenics are widely consumed in large amounts for any major food crop that is directly used for human consumption.

The TEC has therefore reiterated its recommendation made in the Interim Report that there should be a moratorium on field trials for Bt in food crops, until there is more definitive information from sufficient number of studies as to the long-term safety of Bt in food crops.


  • Industry calls report as regressive, biased and a troubled treatise
  • Report not signed by R.S. Paroda, Agriculture Ministry representative

SC Technical Expert Committee recommends ‘GM Field Trials to wait till the regulatory system is improved’

The Technical Expert Committee appointed by the Supreme Court made the following recommendations.

  1. On field trials

    1. Overall recommendation for open field trials: Based on and in particular, “the examination/study of the safety dossiers, it is apparent that there are major gaps in the regulatory system. These need to be addressed before issues related to tests can be meaningfully considered. Till  such time it would not be advisable to conduct more field trials”
    2. Bt food crops: The TEC “reiterates its recommendation made in the Interim Report that there should be a moratorium on field trials for Bt in food   crops   (those   that   are   directly   used   for   food)   intended   for commercialization (not research) until there is more definitive information from sufficient number of studies as to the long term safety of Bt in food crops”.
    3. Herbicide Tolerant crops: The TEC finds them completely unsuitable in the Indian context and recommends that field trials and release of HT crops ‘   not be allowed in India.”
    4. Crops in their Centre of Origin or Diversity: The TEC therefore recommends that release of GM crops for which India is a centre of origin or diversity should not be allowed”
    1. 1.      Other recommendations and TOR a &b: Nature and sequencing of risk assessment and point of release for Open Field Trials  (pg 79-83):
    • to introduce a consultation step to start with, ideally prior to the GM product intended for field trials having been developed” , encompassing  the scope of issues that need to be addressed, relating to health and environmental safety — on a  “case-wise basis keeping in mind the overall phases of risk assessment: hazard identification; hazard characterization; exposure assessment; risk characterization; and mitigation options.   Need, socioeconomic factors, and sustainability should also be considered and thoroughly discussed at this stage with involvement of all the stakeholders”.
    • “There is a need to include chronic and trans-generational toxicity testing in feeding studies of rodents based on the fact that food is consumed over the entire lifetime and that nutritional stress can also lead to adverse or unintended effects over long-term exposure. The sensitive stages of reproduction also need to be included.
    • The regulatory process should be open to new scientific information that may have a bearing on the risk assessment, if necessary even after deregulation of an event.
    • The applicant is responsible for providing to the regulator, all information that has a bearing on the risk assessment, regardless of whether it was obtained for the purpose of the risk assessment.
    • Stakeholder participation, need, socioeconomic considerations, societal impact, and sustainability should be some of the dimensions to be incorporated in the risk assessment and this should be done at an early stage in the risk assessment process”.
    • The TEC noted that Post Release Monitoring (PRM) is also an important aspect of environmental safety as well as health safety (if the plant is consumed as food) and this has not received adequate attention in the regulatory system (1R: p3, 9) or in practice.